Kornimate/medical-research-clean huggingface dataset:
a research on hidden blood loss in laparoendoscopic single-site radical hysterectomy with pelvic lymphadenectomy

Conditions: Hidden Blood Loss; Single-site Laparoscopy; Radical Hysterectomy

Summary: the aim of this cross-sectional study is to evaluate the hidden blood loss in patients who undergo laparoendoscopic single-site radical hysterectomy with pelvic lymphadenectomy and identity its risk factors.

the electronic medical data of 105 patients who undergo laparoendoscopic single-site radical hysterectomy in the following year to treat cervical cancer will be analyzed retrospectively in this study. the amount of hidden blood loss will be calculated according to gross's formula. and multiple linear regression analysis will be employed to identify its risk factors.

Eligibility criteria:
inclusion criteria: 1. volunteer to participate in the study with informed consent; 2. females aged 20-80 who are confirmed with cervical cancer and are treated with laparoendoscopic single-site radical hysterectomy with pelvic lymphadenectomy. exclusion criteria: 1. pregnancy, lactation, postmenopause, or planned pregnancy within two years; 2. suspected or identified as other tumors of genital tract; 3. history of hyperparathyroidism, infectious diseases (tuberculosis, aids), autoimmune diseases, or digestive system diseases (malabsorption, crohn disease and dysentery); 4. other diseases or heavy injuries that will interfere with the results; 5. simultaneous participation in another clinical study with investigational medicinal product(s) or researcher thinks the subjects are not suitable for this trial.
multicentre medical-economic study evaluating the efficacy of adding zolédronique acid to steréotaxique radiotherapy in the treatment of vertebral metastases

Conditions: Vertebral Metastasis

Summary: hypo-fractured radiotherapy in stereotactic conditions (rshf) of bone metastases allows high doses to be delivered to the affected bone segment while sparing adjacent healthy tissues as well as possible. in addition, it not only reduces pain and prevents spinal cord compression, but also improves long-term control of metastatic disease. zoledronic acid reduces bone complications. the economic literature shows that stereotactic radiotherapy, like zoledronic acid, are cost-effective strategies in these indications. the objective of this research project is to evaluate the efficiency of adding zoledronic acid to stereotactic radiotherapy in the treatment of vertebral metastases.


Eligibility criteria:
inclusion criteria: * cancer with inoperable thoracic and/or lumbar vertebral metastasis; * age ≥ 18 years old ; * life expectancy greater than 1 year; * oms or ps ≤ 2 ; * effective contraception for women of childbearing age; * patient information and free, informed and written consent, signed by the patient and investigator; * patient affiliated or beneficiary of the social security system. exclusion criteria: * cancer with inoperable thoracic and/or lumbar vertebral metastasis; * painful patient unable to maintain a lying position for 30 minutes despite analgesic treatment; * patient who has received external irradiation from the proposed irradiation area \> 20 gy ; * signs of neurological compression; * spinal cord compression or epidural damage requiring surgery before radiotherapy; * clinically significant hypersensitivity to zoledronic acid, other bisphosphonates or any excipient; * history of osteonecrosis of the maxilla or bone exposure or delayed healing after dental surgery; * previous (less than 2 years) or ongoing treatment with a bisphosphonate; * creatinine clearance \< 30 ml/min; * pregnant or breastfeeding woman; * patient protected or under guardianship or incapable of giving consent; * impossibility to submit to the medical follow-up of the trial for geographical, social or psychological reasons.

Keywords: hypo-fractured radiotherapy in stereotactic conditions (rshf) zoledronic acid medico-economic vertebral compressive fracture
randomized trial of 2% chlorhexidine-70% isopropanol vs 5% povidone iodine-69% ethanol for skin antisepsis in reducing surgical-site infection after cardiac surgery

Conditions: Cardiac Surgery in Adult Patient

Summary: despite completion of more than 9 million procedures each year in france, the best antiseptic solution to be used for preparing the skin to reduce risk of surgical site infection (ssi) remains unknown. 2% chlorhexidine gluconate (chg)-alcohol is superior to povidone iodine (pvi)-alcohol for short term vascular catheter care (mimoz o, lancet 2015; pages j, intensive care med 2016), but studies comparing both antiseptic solutions for clean-contaminated surgical procedures led to conflicting results. the present study will be the first large scale multicenter randomized controlled trial adequately powered to compare efficacy and safety of chg-alcohol over pvi-alcohol in reducing ssi after clean surgery. a clean surgery was chosen because pathogens involved in ssi mostly originate from skin. therefore, optimisation of skin disinfection before surgery has the potential to reduce the incidence of ssi. cardiac surgery was chosen because ssi may be severe, diagnosis of ssi is easy to monitor and to define and infections arise earlier than other frequent clean surgeries using implants such as orthopaedic or vascular surgery. the incidence of reoperation for any purpose will be used as the main objective because there are easy to track and define and are less susceptible to interpretation in an open trial than superficial ssi. according to cdc criteria, patients will be monitored up to day 90 because mediastinitis after cardiac surgery may occur after the usual 30-day ssi surveillance period.


Eligibility criteria:
inclusion criteria: * adult patients (age ≥ 18 years) * undergoing any (scheduled) surgery of the heart (valve, coronary or combined surgery) or of the aorta via a median sternotomy * having given their informed consent exclusion criteria: * patients with known allergies to chg, pvi, isopropanol or ethanol * surgery for heart transplantation * any signs of inflammation or sternal instability at the site of sternotomy or operation for infection (swi or endocarditis) * patients with history of cardiac surgery within 3 months preceding enrolment * participation to another clinical trial aimed at reducing ssi * patients already enrolled in this study * pregnant or breastfeeding women * women at age to procreate and not using effective contraception * patients not benefiting from a social security scheme or not benefiting from it through a third party * persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, adults under legal protection.

Keywords: skin antisepsis chlorhexidine povidone iodine surgical site infection
specified drug use survey on ajovy subcutaneous injection for long-term use

Conditions: Migraine Disorders

Summary: to evaluate the long-term safety of ajovy in patients under actual use conditions and to specifically evaluate cardiovascular events. in addition, information on efficacy will be collected.


Eligibility criteria:
inclusion criteria: - exclusion criteria: * patients with a known hypersensitivity to components of ajovy
lichtenstein patch or prolene hernia system (phs) for inguinal hernia repair

Conditions: Chronic Pain

Summary: this randomised prospective study was designed to compare the convalescence and the long-term sequelae in inguinal hernia repair with either a bilayer mesh as devised by gilbert (prolene hernia system®) or an onlay mesh applied according to lichtenstein.


Eligibility criteria:
inclusion criteria: * uni- or bilateral * primary or recurrent exclusion criteria: * body-mass index over 40kg/m2, severe co-morbidities

Keywords: inguinal hernia open mesh repair long term outcome recurrence discomfort
efficacy of retinal nerve fiber layer (rnfl) / retinal thickness ratio by cirrus oct utilizing spectral -domain technology as a diagnostic predictor of glaucoma

Conditions: Glaucoma; Myopia

Summary: glaucoma is presumed to be an axonal disease which starts at the lamina cribrosa. this assumption has led to the monitoring of the retinal nerve fiber layer thickness for the diagnosis and monitoring of progression of glaucoma. however, varying disc size, myopia and tilted discs affect the thickness of the retinal nerve fiber layer. this study aims to ascertain the ration of the retinal nerve fiber layer against full retina as a predictor of glaucoma diagnosis and progression.


Eligibility criteria:
inclusion criteria: * primary open angle glaucoma * myopia * myopia with evidence of glaucoma * normal controls exclusion criteria: * evidence of retinal disease * bcva \< 0.4 * secondary glaucoma due to intraocular inflammation * lens induced glaucoma * tumor induced glaucoma * neovascular glaucoma

Keywords: glaucoma myopia myopia with glaucoma normal control
evaluation of long-term immunogenicity in subjects boosted with a tbe vaccine for adults

Conditions: Encephalitis, Tick-Borne

Summary: the purpose of this study it is to evalutate the persistence of antibodies after a booster immunisation with a tbe vaccine for adults


Eligibility criteria:
inclusion criteria: * healthy volunteers of both sexes aged \>18 who participated in another study on tbe vaccination exclusion criteria: * subjects with any condition, in the opinion of the investigator, might interfere with the evaluation of the study objectives.

Keywords: tbe vaccine adults
a study to evaluate the safety and efficacy of the pcsk9 inhibitor ak102 in patients with hofh

Conditions: Homozygous Familial Hypercholesterolemia

Summary: ak102 is being developed for the treatment of hofh. the study will be conducted in 2 parts, part 1 is open label, single arm study to evaluate the safety, tolerability and efficacy of pcsk9 inhibitor ak102, and part 2 is double blind, randomized, placebo controlled study to evaluate the efficacy and safety of pcsk9 inhibitor ak102. the treatment period will last 12 week.


Eligibility criteria:
inclusion criteria: * males and females, ≥18 years of age with a diagnosis of homozygous familial hypercholesterolemia by genetic confirmation or a clinical diagnosis based on a history of an untreated low-density lipoprotein cholesterol (ldl-c) concentration \>500 mg/deciliter (dl) \[13 millimoles/liter (mmol/l)\] together with either xanthoma before 10 years of age or evidence of heterozygous familial hypercholesterolemia in both parents * stable on pre-existing, lipid-lowering therapies (statins in combination with ezetimibe) for at least 4 weeks with no planned medication or dose change for the duration of study participation * fasting central lab ldl-c concentration \>130 mg/dl (3.4 mmol/l) and triglyceride concentration \<400 mg/dl (4.5 mmol/l). * body weight of 40 kilograms (kg) or greater at screening exclusion criteria: * received ldl plasma replacement therapy within 8 weeks before investigational product administration * received lomitapide or mipomersen within 5 months before investigational product administration * received prior treatment with pcsk9 inhibitors or ak102. * unexplained creatine kinase (ck) ≥ 5 times the upper limit of normal (uln) * subjects with untreated chronic hepatitis b or chronic hepatitis b virus (hbv) dna exceeding 500 iu/ ml or active hepatitis c virus (hcv) should be excluded. subjects with non-active hbsag carriers, treated and stable hepatitis b (hbv dna \<500 iu/ ml) , and cured hepatitis c can be enrolled. subjects with positive hcv antibodies are eligible only if the hcv rna test results are negative. * known allergic reactions to any ingredients of ak102 * any other condition(s) that would compromise the safety of the patient or compromise the quality of the clinical study as judged by the investigator and/or medical monitor.

Keywords: hofh ldl-c
evaluation of enteral nutrition in critically ill children

Conditions: Critical Illness; Enteral Feeding Intolerance

Summary: the aim of this study was to evaluate the effect of calorie and enteral feeding timing on survival in critically ill children receiving inotropic, vasopressor and inodilatory supplements.

the aim of this study was to evaluate the effect of calorie and enteral feeding timing on survival in critically ill children receiving inotropic, vasopressor and inodilatory supplements. early enteral nutrition will be initiated within the first 24 hours of hospitalization in critically ill children who have inotropic vasopressor and inodilator support without any problems and contraindications in gastrointestinal system functions. the energy requirement of the intubated patients will be measured by indirect calorie meter method. schofield method will be used to calculate the daily energy needs of extubated patients. 30% of the targeted energy in the first 48 hours of hospitalization and 80% of the targeted energy in the first week will be achieved by enteral nutrition.nutritional solutions with a concentrated formula of 1 / 1.5 will be given to patients with cardiac pulmonary or renal disease requiring fluid restriction.patients will be followed up for vomiting, diarrhea, abdominal distention, feeding intolerance, gastric residues and gastrointestinal bleeding. if these findings develop, the patient's nutrition will be interrupted according to the clinician's assessment and enteral nutrition will be re-fed as soon as possible.

Eligibility criteria:
inclusion criteria: * children with normal gastrointestinal system function * children receiving inotropic, vasopressor or inodilatory support exclusion criteria: * children with gastrointestinal system dysfunction * children with enteral nutrition contraindicated * children with metabolic disease with special nutrition

Keywords: enteral feeding vasopressor lactate
fibricheck data registry

Conditions: Cardiac Arrhythmia

Summary: the goal of this interventional clinical trial is to establish a comprehensive, structured database that includes photoplethysmography (ppg) measurements with simultaneously recorded electrocardiography (ecg) data to evaluate the fibricheck algorithm in patients with heart rhythm disorders.


Eligibility criteria:
inclusion criteria: * at least 18 years old * access to a smartphone to perform daily measurements * ability to understand dutch * atrial fibrillation diagnosis or one of the following: * cha2ds2-vasc score ≥2 (male) or ≥3 (female) * underwent elective cardiac surgery * known with: * chronic obstructive pulmonary disease * obstructive sleep apnea * heart failure * hypertension * previous stroke or transient ischaemic attack * having palpitations and/or racing heart as symptoms * other arrhythmia such as atrial flutter, premature atrial contractions (pac), premature ventricular contractions (pvc) exclusion criteria: * individuals which are currently in follow-up with their physician, using the fibricheck application * individuals with unnaturally coloured fingers (i.e. tattoos, ink); this may weaken the signal and may interfere with the effectiveness of the device * persons with conditions causing tremors or the inability to hold their hand still for at least 60 seconds (e.g. parkinson or dementia) as, in this case, the device may not be able to accurately process a measurement * persons with reduced blood flow in the fingertips (e.g. perniosis or severe callus formation) as the device may not be able to detect the intensity variations induced by the blood flow * persons that have a disability to perform the measurements according to the instructions for use * persons with cardiac pacemakers, implantable cardioverter-defibrillators, or other implanted electronic devices as these can control the natural heart rhythm

Keywords: photoplethysmography single-lead electrocardiography
thermal stimulation for stroke patients

Conditions: Stroke; Upper Limb Paresis

Summary: sensory and/or motor deficits in upper limb following stroke often have negative impacts on their daily living. thermal stimulation with hot and cold pack alternatively incorporated into conventional rehabilitation has been reported and proved to be effective for upper limb functional recovery after stroke. however, whether hot- and cold-water stimulation alternatively based on thermal stimulation also has the effect still remains unknown. the aim of present study is to investigate the facilitated effect of hot and cold water stimulation alternatively on upper limb after stroke.

stroke patients from department of rehabilitation in tzu chi general hospital will be recruited and randomized into two groups, one for experimental group and the other for control group. in addition to receiving routine standard rehabilitation for both groups, the experimental group will receive additional hot- and cold-water stimulation alternatively for five times one session, consecutive four sessions a set, one set for 30 minutes a day and five sets a week for six weeks. the control group will be given ergometer exercises with the similar duration as experimental group. both groups will be evaluated at baseline before ts and every two weeks till six weeks after ts, then at 3, 6 and 12 months for follow-up. a variety of evaluations used in the present study include semmes-weinstein monofilaments for sensory functions; brunnstrom's stage, fugl-meyer assessment scale and motricity index were used for upper limb motor control and strength; box and block test for hand dexterity. the modified motor assessment scale and barthel index are utilized for evaluating general motor functions and daily activity performance, respectively. the modified ashworth scale is used for change of muscle tone of upper limb.

Eligibility criteria:
inclusion criteria: * a first-time ischemic or hemorrhagic stroke. * no severe diabetes or peripheral vascular disease causing sensory deficits. * no cognition problem and follow directions indicated by therapist during experiment. * motor deficit of the upper limb under (including) brunnstrom stage iv, either in the arm or hand. exclusion criteria: * a cardiac disease or orthopedic problem history, * medically unstable such as experienced unstable angina, uncontrolled hypertension according to the treating physician, psychological history before stroke.

Keywords: stroke follow up upper limb rehabilitation
treatment of covid-19 with a herbal compound, xagrotin

Conditions: Covid19

Summary: this is an interventional, multi-center, randomized study. adults with confirmed covid-19 disease not more than 10 days before enrollment date were recruited (n=361). patients in same condition who had treated with standard of care were randomly assigned to the control group (n=178). the investigators analyzed the effect of a herbal compound, xagrotin, and also investigated impact of different characteristics for instance gender, age, duration of disease, smoking habits and concomitant diseases on the outcome.

this is an interventional, multi-center, randomized study that has been performed in an outpatient setting (n=361). adults with confirmed covid-19 disease not more than 10 days before enrollment date were recruited. patients in same condition who had treated with standard of care were randomly assigned to the control group (n=178). the investigators analyzed the effect of a herbal compound, xagrotin, and also investigated impact of different characteristics for instance gender, age, duration of disease, smoking habits and concomitant diseases on the outcome. adverse events were registered.

Eligibility criteria:
inclusion criteria: * age 18 or higher * newly diagnosed (no longer than 10 days) * pcr or clinically confirmed covid-19 exclusion criteria: * severe pulmonary disease * severe cardiovascular disease * severe hepatic disease * severe renal disease * diabetes mellitus type one * metabolic acidosis * oxygen saturation \<70% * pregnancy * breast feeding * concomitant treatment with anticoagulation drugs * concomitant treatment with cyp3a4 medicines with narrow therapeutic window
continence across continents to upend stigma and dependency

Conditions: Urinary Incontinence; Falls, Accidental; Quality of Life; Stigma

Summary: to determine whether women exposed to the continence promotion intervention will report improved urinary symptoms and quality of life, and lower incontinence-related stigma and falls than women who receive a control intervention at one-year post-intervention.

this is a cluster-randomized 4-site intervention study testing the effect of a continence-promotion intervention on: 1. improved urinary symptoms and quality of life 2. reduction in falls 3. reduction in stigma a cost-effectiveness component will also be included

Eligibility criteria:
inclusion criteria: * women * 65 years and older * urinary incontinence at least once weekly exclusion criteria: * living in residential or long-term care * received treatment for incontinence within the past year * dementia or other neurological conditions that preclude the ability to provide -informed consent

Keywords: urinary incontinence falls quality of life stigma community-dwelling older women continence promotion
does cannabidiol attenuate the acute effects of ∆9-tetrahydrocannabinol intoxication in individuals diagnosed with schizophrenia? a double-blind, randomised, placebo-controlled experimental study

Conditions: Schizophrenia; Cannabis Use

Summary: this study will recruit schizophrenia patients who use cannabis recreationally. each participant will attend the laboratory on three occasions: an initial visit to check that they are safe to join the study and two days of testing. participants will be administered, in a randomized order, a pre-treatment with either cbd (1000mg) orally or a matching placebo. on both experiments, participants will then inhale cannabis containing thc. the thc administration will follow a standardised inhalation procedure using a medical-grade vaporizer device. participants will complete a series of tasks measuring cognition, psychosis, anxiety and other subjective experiences. the study will be carried out at the nihr-wellcome trust clinical research facility at king's college hospital.


Eligibility criteria:
inclusion criteria: * age 18-65 years. * clinical diagnosis of schizophrenia (i.e. documented as such in the patient's clinical records and satisfying icd-10 criteria for f20) * clinically stable for at least three months (since discharge from hospital, home treatment team, or prior clinical deterioration, and with agreement from the patient's responsible clinician) * regular (at least weekly) cannabis use for the past 3 months or more * evidence from either clinicians or from the patient that cannabis use exacerbates their symptoms or increases their risk of relapse * treatment with regular doses of antipsychotic medication for at least 1 month, confirmed by a blood test at the baseline visit, and with the participant agreeing to be maintained at a stable dose over the course of the experiment * the participant agrees to abstain from cannabis use for at least 24hours prior to study visits * the participant is willing to have an intravenous cannula inserted to collect blood samples on experimental visits * sufficiently fluent english * providing written informed consent exclusion criteria: * extreme cannabis use: participant is estimate to be using over 1gram of cannabis/day * dependence on alcohol or illicit substances other than cannabis as defined by icd-10 * pregnancy (current or planned) or breastfeeding * physical health disorder or another mental health disorder that the study psychiatrist judges may influence the patient's ability to tolerate the procedure, or that may alter the results of the study. * taken part in any drug study within the last 3 months or taking part in another study over the course of the trial * drug sensitivity/allergy to cannabis or lorazepam * unlikely to be able to complete the study sessions for any reason, as judged by the study psychiatrist additional criteria which must be met on experimental visits: * negative alcohol breath test * negative urine drug screen (apart from cannabis and prescribed medication) * negative urine pregnancy test * stable mental state as judged by the study psychiatrist