Kornimate/medical-research-clean huggingface dataset:
dexmedetomidine combined with lidocaine infusion affect ponv

Conditions: Lidocaine; Dexmedetomidine; Nausea and Vomiting, Postoperative

Summary: background: few researches have manifested that intravenous (iv) lidocaine or dexmedetomidine decreased the incidence of postoperative nausea and vomiting (ponv). the investigators investigated whether iv lidocaine plus dexmedetomidine infusion could better reduce the incidence of ponv after laparoscopic hysterectomy. methods: two hundred and forty women with elective laparoscopic hysterectomy were randomly divided into four groups: the control group (group c, n=60) received an equal volume of saline, the lidocaine group (group l, n=60) received iv lidocaine (bolus infusion of 1.5 mg/kg over 10 min, 1.5 mg/kg/h continuous infusion), the dexmedetomidine group (group d, n=60) received dexmedetomidine administration (bolus infusion of 0.5 µg/kg over 10 min, 0.4 µg/kg/h continuous infusion), the lidocaine plus dexmedetomidine group (group ld, n=60) received combination of lidocaine (bolus infusion of 1.5 mg/kg over 10 min, 1.5 mg/kg/h continuous infusion) and dexmedetomidine administration (bolus infusion of 0.5 µg/kg over 10 min, 0.4 µg/kg/h continuous infusion). primary outcome was the incidence of the first 48 h nausea, vomiting and ponv after surgery. the secondary outcomes included perioperative propofol and remifentanil consumption, postoperative fentanyl requirement, ramsay sedation score, and bradycardia during post-anaesthesia care unit (pacu) stay.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical statusⅰand ⅱ * aged 40-60 years * scheduled for elective laparoscopic hysterectomy exclusion criteria: * history of allergy to local anesthetics * bmi\>30 * severe respiratory disease * renal or hepatic insufficiency * history of preoperative opioids medication and psychiatric * preoperative bradycardia * preoperative atrioventricular block * subjects who experienced severe hypotension (mean arterial pressure \[map\] \<60 mmhg) or bradycardia (heart rate \[hr\] \<40 bpm), urticaria, or arrhythmia during lidocaine and dexmedetomidine infusion period

Keywords: lidocaine dexmedetomidine postoperative nausea and vomiting laparoscopic hysterectomy
annual study to investigate inactivated subunit influenza vaccine for the 2006/2007 influenza season in europe.

Conditions: Healthy Volunteers

Summary: influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year. in europe, manufacturers/marketing holders of these vaccines are required to be involved in ongoing clinical trials and to present the results to the competent authorities each year. the current study is a phase iiia clinical trial with a commercially available vaccine (influvac®) supplied in pre filled syringes. it is part of the ongoing clinical trial program for influvac® and will be done to assess the immunogenicity and safety and tolerability of next season's trivalent influenza subunit vaccine in two groups of healthy subjects: subjects aged \>= 18 and \ = 61 years of age (elderly).


Eligibility criteria:
inclusion criteria: * signed and dated informed consent. * healthy and aged \>= 18 and \ = 61 years of age. * mental health good enough to understand the study and the informed consent form and to fill in the questionnaire. exclusion criteria: * known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine. * having fever and/or presenting with an acute infectious episode of the upper and/or lower respiratory airways. * having experienced a documented serious systemic reaction after previous influenza vaccination. * having an auto-immune disorder (e.g. ra, sle, auto-immune thyroid disorders) or other disorders affecting the immune system, taking immunosuppressive medication (such as systemic corticosteroids) including the four weeks preceding the start of the study (date of informed consent), or having a disease in a terminal stage. * having received vaccination against influenza within the previous six months before visit 1. exclusion criteria only for female subjects aged \>=18 and \<=60 years and of childbearing potential: * pregnancy (positive urine pregnancy test on day 1) or breastfeeding. * absence of use of a medically accepted method of birth control (i.e. oral contraceptive, intra uterine device, double barrier method).

Keywords: influenza, vaccine, chmp criteria
impact of virtual reality on peri-interventional pain, anxiety and distress in a pediatric oncology outpatient clinic

Conditions: Pediatric Cancer; Procedural Anxiety; Procedural Pain

Summary: pain and anxiety-inducing interventions have a major impact on pediatric patients. pain reduction by virtual reality (vr) during port and vein punctures is well studied. this study investigates peri-interventional reduction of pain, anxiety and distress using vr compared to the standard of care (soc) in a pediatric oncology outpatient clinic. in a randomized, controlled cross-over design, patients aged 6-18 years experience potentially painful interventions accompanied by vr. all patients included in the study underwent port puncture or peripheral venous puncture in two observations : soc (a) and vr (b) in a randomized order. observational instruments include numeral rating scale (nrs), faces pain scale revised (fps-r), behavioral approach avoidance distress scale (baads), modified yale preoperative anxiety scale (mypas-sf). in addition, parents and staff are interviewed. specific conditions for vr in an outpatient clinic setting are being discussed.


Eligibility criteria:
inclusion criteria: * aged 6-18 years * any sex * port puncture or placement of a peripheral venous catheter in pediatric outpatient clinic * hematological or oncological diagnosis * informed consent exclusion criteria: * epilepsy * coronary artery disease * history of severe vertigo * obstacles to putting on and wearing vr glasses * lack of informed consent for study participation.

Keywords: virtual reality pediatric oncoloy outpatient clinic peri-interventional pain
ultrasound-based liver fat quantification (lfq) pilot study

Conditions: Non-Alcoholic Fatty Liver Disease; Non-Alcoholic Steatohepatitis

Summary: this clinical study will involve performing a series of medical imaging procedures of the abdomen using both ultrasound and mri modalities in subjects at risk for or already diagnosed with nonalcoholic fatty liver disease (nafld). the primary objective of this clinical study is to evaluate the clinical feasibility of an investigational ultrasound technique for quantifying liver fat by comparing specific ultrasound-derived biomarkers with the liver fat percentage obtained from mri proton density fat fraction (mri-pdff) measurements. all subjects enrolled in this study will undergo two investigational abdominal ultrasound examinations using the philips epiq ultrasound system and one mri pdff examination according to the clinical standard of care.


Eligibility criteria:
inclusion criteria: * must be at least 18 years old and able to provide written informed consent * must attest to absent or minimal alcohol consumption (i.e. \< 2 alcoholic beverages per day for women and \< 3 alcoholic beverages per day for men, where an alcoholic beverage is defined as 12 oz. of regular beer, 5 oz. of wine, or 1.5 oz. of distilled spirits). * must be eligible for a standard abdominal ultrasound examination and standard non-contrast mri examination. * at least one of the following criteria must also be met: overweight or obese (bmi ≥ 25); diagnosed with type 2 diabetes; diagnosed with hypercholesterolemia; diagnosed with or clinically suspected of having nafld/nash exclusion criteria: * evidence of moderate/heavy/binge alcohol consumption exceeding the thresholds above * evidence of hepatotoxicity * history of chronic liver disease (e.g., viral, cholestatic, or autoimmune). * use of drugs associated with hepatic steatosis * subjects anticipated or planned to undergo any diagnostic or therapeutic intervention during enrollment period that, at discretion of the investigator, may affect liver fat content * hepatic lesions that cannot be excluded from the imaging field during ultrasound lfq data acquisition * history of previous liver surgery or hepatic implants that, at the discretion of the investigator, may adversely impact ultrasound or mri image quality or the subject's eligibility to undergo ultrasound or mri

Keywords: liver fat quantification ultrasound liver disease digestive system disease
prediction of preeclampsia by comprehensive markers.

Conditions: Pre-Eclampsia

Summary: preeclampsia is one of the most serious complications in pregnancy that causes maternal death and preterm delivery. series studies has show that the competing risk model developed by the fetal maternal foundation in early pregnancy has the potential to predict preeclampsia effectively but has show crowd difference. we aim to evaluate the performance of various screening model based on fmf model in chinese population.

the prospective multi-center observational study aimed to recruit at least 10,000 pregnant woman during the first trimester conducted among 12 medical centers in china. the medical history of each candidate was recorded , blood pressure was measured , blood sample was taken between 11 gestational weeks and 13+6 gestational weeks, to get the plgf and pappa tested. routine ultrasound was taken with measurement of the uterine artery pulsatility index. the results of the recruited patients were not released to the patients or the doctor. pregnancy outcome was recorded as to whether the women develop preeclampsia , the sga babies, or low birth apgar score and other preeclampsia related adverse maternal and neonatal outcomes. the basic medical information, the mean artery pressure, the plgf and pappa mom, the uta pi were used in combination to do the risk stratification, and to develop prediction model for chinese people.

Eligibility criteria:
inclusion criteria: 1. gestational weeks between 11\~13+6 2. agreed to participate the study 3. live fetus at recruitment. exclusion criteria: 1. first obstetric visit beyond 14 gestational weeks 2. artificial abortion or spontaneous abortion before 20 weeks or lost to follow-up. 3. refused to participate the study. 4. fetus with major chromosome or structural abnormality

Keywords: preeclampsia prediction competing risk model 11~13+6 gestational weeks
ischemic post-conditioning in acute ischemic stroke thrombectomy (protect-2)

Conditions: Acute Ischemic Stroke

Summary: ischemic post-conditioning is a neuroprotective strategy that has been proven to attenuate reperfusion injury in animal models of stroke. the investigators have conducted a 3 + 3 dose-escalation trial to demonstrate the safety and tolerability of ischemic post-conditioning incrementally for a longer duration of up to 5 min × 4 cycles in stroke patients undergoing mechanical thrombectomy. the purpose of this study is to further determine the efficacy and safety of ischemic post-conditioning in patients with acute ischemic stroke who are treated with mechanical thrombectomy.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years; 2. acute ischemic stroke within 24 hours from stroke onset (or from time last known well) to groin puncture; 3. previous mrs ≤ 2; 4. baseline nihss ≥ 6; 5. baseline aspects ≥ 6; 6. unilateral middle cerebral artery occlusion with or without ipsilateral internal carotid artery occlusion; 7. successful recanalization after mechanical thrombectomy (etici 2b-3); 8. written informed consent provided by the patients or their legal relatives. exclusion criteria: 1. confirmed or clinically suspected cerebral vasculitis/fibromuscular dysplasia; 2. difficulty in reaching the designated position of the balloon used for ischemic post-conditioning; 3. complications related to thrombectomy, such as contrast agent extravasation, vascular perforation/rupture, dissection, and escape of thrombus; 4. stenting in the middle cerebral artery m1 segment/distal intracranial carotid artery during thrombectomy; 5. \> 2 times of balloon dilations as rescue therapy due to angioplasty during thrombectomy; 6. patients with contraindications to mri; 7. other conditions that the investigator considered inappropriate for inclusion.
dietary quality and subsequent cardiovascular disease

Conditions: Cardiovascular Diseases; Heart Diseases

Summary: to examine dietary quality and subsequent cardiovascular disease (cvd).

background: although considerable evidence exists for associations between diet and subsequent cardiovascular disease (cvd) among younger and middle-aged adults, no comprehensive studies of these relationships have been conducted using a national sample of older americans. national guidelines have recommended reductions of dietary fat, saturated fat, cholesterol and sodium as dietary practice to reduce cvd. however, it is possible that the focus on eliminating dietary components may obscure the advantages of consuming diets that are nutritionally adequate. findings from this study could have important implications for setting research priorities to further study the effects of specific dietary variables on cvd, and for implementing national nutrition policies to assist americans in selecting healthy diets. design narrative: data from nhanes i and the three cycles of nhanes i epidemiologic followup study (nhefs) were used to 1) to examine the associations between several measures of dietary quality at baseline and subsequent 14-year morbidity and mortality from cvd for a national sample of 6109 united states adults aged 45 to 74 years at baseline; 2) to assess the relative importance of the associations of dietary quality and cvd for older adults compared to middle-aged adults. dietary variables were based on responses to the 24-hour dietary recall and the food frequency questionnaire administered at baseline and included a composite measure of dietary quality, intakes of specific nutrients, and usual consumption of foods from 19 food groups. baseline measures used as covariates included body mass index, blood pressure, serum cholesterol, sociodemographic variables (e.g., age, race, income, occupation), behavioral variables (e.g., smoking, alcohol consumption, activity level), and chronic health conditions. cvd outcomes were determined from medical history questionnaires, hospital records and death certificates. change in blood pressure between baseline and 10-year followup were examined as an outcome variable as well as a covariate in the association between diet and cvd. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
long-term safety and efficacy of rfixfc in the prevention and treatment of bleeding episodes in previously treated participants with hemophilia b

Conditions: Severe Hemophilia B

Summary: the primary objective of the study is to evaluate the long-term safety of rfixfc in participants with hemophilia b. the secondary objective of this study is to evaluate the efficacy of rfixfc in the prevention and treatment of bleeding episodes.

participants will follow either a prophylaxis or on-demand regimen. the starting dose in this study will be determined by the clinical profile of the patient in the preceding studies, b-long 998hb102 (nct01027364) and kids b-long study 9hb02ped (nct01440946)

Eligibility criteria:
key inclusion criteria: * subjects who have completed studies 998hb102 (nct01027364) or 9hb02ped (nct01440946) or other studies with rfixfc * ability to understand the purposes \& risks of the study and provide signed and dated informed consent. key exclusion criteria: * high-titer inhibitor (\>/=5.00 bu/ml) note: other protocol defined inclusion/ exclusion criteria may apply.

Keywords: b-long b-yond b-long extension rfixfc severe hemophilia b
personalised hyperlipidaemia therapies guided by pharmacogenomics

Conditions: Cardiovascular Diseases

Summary: this trial aims to evaluate the impact of clinical pharmacists' pharmacogenomics-guided choice and statin titration for managing hyperlipidaemia. the central hypotheses of this trial are (1) clinical pharmacists' pharmacogenomics-guided choice and titration of statins will lead to a more significant reduction in ldl-c; (2) lower incidence of myopathies with the use of statins for hyperlipidaemia management over 12 months compared to usual care by doctors alone. active follow-up and titration should occur over the first six months. however, the participants will be followed up to 12 months to confirm the sustained ldl level attainment.

the primary aims are: * the changes in low-density lipoprotein cholesterol (ldl-c), total cholesterol, triglycerides (tg), and high-density lipoprotein cholesterol (hdl-c) levels, and * the incidence of myopathies over 12 months. the secondary aims include: * characterisation of the pharmacogenomic relationship between serum levels of statins (and their metabolites) with the changes in ldl-c levels and incidence of myopathies over six months * economic outcomes include but are not limited to the cost-effectiveness of pharmacogenomic testing in attaining ldl-c targets * change in health-related quality of life over 12 months is measured using the euroqol 5-dimension 5-level questionnaire

Eligibility criteria:
inclusion criteria: * participants between 21 and 75 years old * participants who are planning to start on statin\* medication or whose ldl-c goals have not been met, per appendix b. * participants who are able to communicate in english, chinese or malay. participants who are planning to start or will be started on the following doses are eligible: atorvastatin 10-80 mg/day, rosuvastatin 10-40 mg/day, or simvastatin 10-40 mg/day within the last two to four weeks before enrolment exclusion criteria: * participants who are statin-intolerant or in whom statins are contraindicated * participants on a statin dosing schedule of every other day (eod) * participants administered on potent cytochrome p450 3a4 (cyp3a4) or cytochrome p450 2c9 (cyp2c9) or oatp inhibitors or inducers. * participants on evolocumab and alirocumab prior to enrolment * participants with documented diagnosis of psychiatric conditions * participants requiring palliative care, end-of-life care, or those with a life expectancy of less than one year * pregnant and lactating women * participants with complaints of myalgia or muscle weakness at baseline, before the commencement of statin * participants who are unable to swallow a whole statin tablet
the open lung approach during one lung ventilation in thoracic surgery

Conditions: Hypoxemia

Summary: * question: ventilatory strategy to counterbalance the effect of one lung ventilation during thoracic surgery. * findings: the open lung approach improved oxygenation and lung compliance, reducing respiratory system driving pressure and transpulmonary driving pressure. * meaning: patients undergoing thoracic surgery during one lung ventilation may benefit of an open lung approach strategy to avoid ventilator lung injury.

background: during thoracic surgery in lateral decubitus, one lung ventilation (olv) may impair respiratory mechanics and gas exchange. the investigators tested a strategy based on an open lung approach (ola) consisting in lung recruitment immediately followed by a decremental positive-end expiratory pressure (peep) titration to the best respiratory system compliance (crs) and separately quantified the elastic properties of the lung and the chest wall. the investigators hypothesis was that this approach would improve gas exchange and increase lung compliance (cl). methods: in thirteen patients undergoing upper left lobectomy the investigators studied lung and chest wall mechanics, transpulmonary pressure (pl), respiratory system and transpulmonary driving pressure (δprs and δpl), gas exchange and hemodynamics at two time-points (a) during olv at zero end-expiratory pressure (olvpre-ola) and (b) after the application of the open-lung strategy (olvpost-ola).

Eligibility criteria:
inclusion criteria: * age \> 18 years, * surgery and olv lasting ≥ 60 min exclusion criteria: * lung reduction surgery, pneumonectomy, patients with severe copd with preoperative forced expiratory volume in 1 s (fev1) to forced vital capacity (fvc) ratio, expressed as a percentage (fev1/fvc%) \<60%, presence of large bullae, pleural diseases and/or acute or chronic uncompensated cardiac disease
effect of tranexamic acid on blood loss after high tibial osteotomy

Conditions: Osteoarthritis, Knee

Summary: this study aims to examine whether tranexamic acid has an meaningful clinical effect on blood loss after high tibial osteotomy. this study design is a double-blind randomized controlled trial. the patients were randomly assigned to intervention or usual care groups. intervention patients receive tranexamic acid 2g for 10 minutes just before surgery. primary outcome is hemoglobin level preoperatively, postoperative 1 day, 2 days, 3 days, 2 weeks. secondary outcome included hematocrit level, hemovac drainage, total blood loss, need for transfusion, deep vein thrombosis, visual analog pain scale, and wound complication.

high tibial osteotomy is proved treatment option for medial compartment osteoarthritis of knee joint. especially, open wedge high tibial osteotomy might cause moderate amount of bleeding and hematoma formation. bleeding and hematoma could be a reason of soft tissue infection and wound complications. tranexamic acid (txa) is a medication used to treat or prevent excessive blood loss from major trauma, postpartum bleeding, surgery, tooth removal, nosebleeds, and heavy menstruation. the objective of the study is to test whether preoperative tranexamic acid could reduce the postoperative complications due to bleeding.

Eligibility criteria:
inclusion criteria: * patients for high tibial osteotomy * having medicare insurance * accepted patients exclusion criteria: * history of lower extremity infection or neurologic problems * inflammatory arthritis * using thrombins * history of treatment for anemia * history of thromboembolic event * chronic kidney disease