Kornimate/medical-research-clean huggingface dataset:
hpv infection and genital microecology of childbearing-age female in china: a cohort and multicenter study

Conditions: Papillomavirus Infections; Uterine Cervical Neoplasms; Sexual Transmitted Disease

Summary: the purpose of this study to access the relations between genital microecology, hpv infection and cervical intraepithelial neoplasia of childbearing-age female in china

the volunteers will be recruited from the women who come to the hospital to do the thinprep cytologic test. after being informed about the potential risks, each volunteer giving written informed consent will be asked to complete a questionnaire. then, cervical and vaginal swabs and cervical exfoliated cells will be taken from each volunteer to perform 16s rrna gene sequencing microecology assessment on cervical secretions and detection and genotyping of hpv and pathogens of sexually transmitted diseases. if there is something abnormal with the diagnostic outcomes in the previous examinations, according to the doctor's judgement, those volunteer will be asked to undergo a vaginoscope and a cervical biopsy to evaluate the grade of cervical intraepithelial neoplasia. after six months since the entry, each volunteer will be asked to go back to each research center to do the same sampling and examination as previously did in entry.

Eligibility criteria:
inclusion criteria: * female of childbearing age conducting thinprep cytologic test * having an experience of sexual intercourse * not during the menstrual period * no sexual intercourse or vaginal medication or vaginal flushing in 3 days before sampling exclusion criteria: * within 8 weeks of pregnancy or postpartum * having had tumors in reproductive tract * having had hpv bivalent, tetravalent or nine-valent vaccination * having received treatment for anti- hpv or other stds pathogens infection * having had hysterectomy, cervical surgery and pelvic radiotherapy * having used broad-spectrum antibiotics, probiotics or vaginal suppositories in reproductive tract within 1 month
visual acuity after using a new monofocal intraocular lens compared to standard monofocal lens

Conditions: Lenses, Intraocular

Summary: this is a prospective comparative interventional clinical study, that took place from january 2021 to november 2021. twenty patients (20) were enrolled in this study 10 patients in each group. it was designed for comparison of uncorrected and best corrected distance and intermediate vision in patients whom implanted with monofocal tecnis eyhance or tecnis 1-piece iols.

purpose to determine the uncorrected and best-corrected distance, and intermediate visual acuity in a new innovative monofocal intraocular lens compared with standard monofocal lens. methods this is a prospective comparative interventional clinical study, that took place from january 2021 to november 2021. 40 eyes of twenty patients (20) were enrolled in this study, patients who are candidates for cataract extraction by phacoemulsification were included in this study and underwent thorough preoperative examination and post-operative evaluation at 3 months after the 2nd eye operation, of distance, intermediate, near add, contrast sensitivity and incidence of photic phenomena using a printed questionnaire for evaluating this incidence and binocular defocus curves were analyzed.

Eligibility criteria:
inclusion criteria: * patients aged 50-75 years old undergoing cataract surgery. * preoperative corneal astigmatism equal to or less than - 1.00 d. * availability, willingness and sufficient cognitive awareness to comply with examination procedures exclusion criteria: * visual potential of less than 0.63 due to ocular pathologies. * corneal astigmatism over -1.00 d cylinder. * pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils, or pupils that do not dilate at least 3.5 mm under mesopic/scotopic conditions). * capsule or zonular abnormalities that would affect postoperative centration or tilt of the lens and pseudoexfoliation syndrome. * macular degeneration, cystoid macular edema,diabetic retinopathy, history of uveitis, optic nerve diseases, glaucoma and amblyopia.

Keywords: intraocular lens intermediate vision contrast sensitivity monofocal
a trial to evaluate the safety, tolerability, and immunogenicity of a booster dose of a group b streptococcus 6 valent polysaccharide conjugate vaccine (gbs6) in healthy adults

Conditions: Group B Streptococcal Infections

Summary: this study is an extension to the completed first-in-human c1091001 study (nct03170609) and is to evaluate the safety and immunogenicity of a single booster vaccine dose of gbs6, administered approximately 2 years or more after a primary gbs6 dose, to healthy adult males and nonpregnant women. the study will determine whether individuals who received a primary dose of gbs6 have additional benefit following a booster dose.


Eligibility criteria:
inclusion criteria: 1. healthy adults (male and female) at enrollment who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study. 2. participants who were enrolled in the c1091001 study, received gbs6, and completed the 1-month blood draw. exclusion criteria: 1. pregnant female participants; breastfeeding female participants; positive urine pregnancy test for women of childbearing potential (wocbp) at visit 1 (prior to vaccination); and wocbp who are, in the opinion of the investigator, sexually active and at risk for pregnancy and fertile men and wocbp who are unwilling or unable to use effective methods of contraception as outlined in this protocol from the signing of the informed consent until at least 3 months after the last dose of investigational product. 2. acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study. chronic medical conditions include human immunodeficiency virus, chronic hepatitis b virus (hbv) infection (hbv surface antigen positive), and/or hepatitis c virus infection. 3. history of severe adverse reaction and/or severe allergic reaction (eg, anaphylaxis) to any vaccine. 4. history of microbiologically proven invasive disease caused by group b streptococcus (streptococcus agalactiae). 5. previous vaccination with any licensed or investigational group b streptococcus vaccine (other than gbs6), or planned receipt during the participant's participation in the study (through 6-month telephone call).
comparison of catheters orifice configuration for continuous infraclavicular analgesia

Conditions: Pain, Postoperative; Catheter Blockage; Anesthesia

Summary: infraclavicular nerve catheter for postoperative analgesia will be included in the 70 adult patients undergoing upper extremity surgery included in the study. these patients will be randomized to the catheter tip configuration as cemp (closed-ended multiport catheter) group and oesp (open-ended single port catheter) group. patient controlled analgesia device will be attached to the peripheral nerve catheter of these patients. demographic data of the number of pushing the button, the amount of bolus dose given, the total dose given in the patient controlled anesthesia device, the need for additional analgesia and the amount, pain scores, complications will be recorded for three days postoperatively. records will be compared statistically.

ethics committee approval was received on 10 december 2019, numbered 19/398. the study was planned to include 70 adult patients undergoing upper extremity surgery at gulhane training and research hospital between 10 december 2019 and february 2020. continue infraclavicular nerve catheter for postoperative analgesia will be included in the patients included in the study. these patients will be randomized to the catheter tip configuration as cemp(closed-ended multiport catheter) group and oesp(open-ended single port catheter) group. patient controlled analgesia device will be attached to the peripheral nerve catheter of these patients. demographic data of the patients who have placed an infraclavicular catheter and used the catheter successfully for three days postoperatively, the number of pushing the button, the amount of bolus dose given and the total dose given in the patient controlled anesthesia device,the amounts of need for additional analgesia and pain scores(numeric rating scale), complications will be recorded. records will be compared statistically.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) score i-iii * upper extremity surgery exclusion criteria: * emergency surgery, * secondary surgery, * chronic pain treatment * pregnancy, * any contraindication to peripheral nerve blockade, * pre-existing peripheral nerve neuropathy, * allergy to local anesthetics (study medications), * asa score ≥ 4, * neurologic or neuromuscular disease, * psychiatric disease, * renal failure, * hepatic failure, * nsaid contraindication, * inability to use a patient controlled analgesia (pca) device, * infection at the injection site * withdrawal of consent.

Keywords: infraclavicular catheter upper extremity surgery postoperative analgesia continuous nerve block catheter tips configurations
estimate the effect of telaprevir and boceprevir on maraviroc pharmacokinetics in healthy subjects

Conditions: Healthy

Summary: the purpose of this study is to determine the effect that telaprevir and boceprevir has on the pharmacokinetics of maraviroc.


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects. * body mass index (bmi) of 17.5 to 30.5 kg/m2. * total body weight \>50 kg (110 lbs). exclusion criteria: * use of prescription or nonprescription drugs and dietary supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. * use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day. * positive result for hiv-1, hiv-2, hepatitis b serology (hbsag, hbcab) or anti hepatitis c virus serology (as determined by a multi antigen eia).

Keywords: maraviroc boceprevir telaprevir drug interaction pharmacokinetics hiv
advanced heart care at home

Conditions: Palliative Care; Heart Failure; Health Care Utilization; Quality Improvement

Summary: end-of-life (eol) care for heart failure (hf) patients includes high healthcare utilization and costs, in part due to the lack of integration of optimal hf management and home-based palliative care. in a pilot quality improvement project of clinician "nudges" to enroll seriously ill hf patients in a home-based, integrated hf and palliative care platform, the investigators demonstrated decreased healthcare utilization and costs and increased hospice utilization among seriously ill hf patients. the investigators propose a pragmatic randomized trial for clinicians of seriously ill hf patients admitted to three university of pennsylvania health system hospitals, randomly assigning an opt-in approach (usual care) versus a "nudge" or opt-out approach of a visit from an advanced heart care at home (ahcah) liaison to clinicians of eligible patients to discuss and enroll in the ahcah program, to rigorously and scientifically evaluate clinical, utilization, and cost outcomes among high-risk hf patients at the eol, and to promote physician uptake of best practices.


Eligibility criteria:
inclusion criteria: 1. at least 18 years of age 2. reside within caring way's geographic catchment 3. heart failure icd code from any previous healthcare encounter (inpatient or outpatient) in the 12 months prior to index hospitalization 4. admitted to a cardiology or hospitalist service 5. palliative connect score greater than 0.3 6. index hospitalization during study period exclusion criteria: 1. less than 18 years of age 2. pregnant women 3. incarcerated patients 4. homeless patients 5. reside outside of caring way's geographic catchment 6. patients without an identifiable primary physician for ahcah staff to communicate with as determined by the ahcah liaison via epic 7. prior hospitalization during study period
balance and leg function after hip replacement

Conditions: Hip Injuries; Coxarthrosis; Hip Replacement

Summary: task-oriented leg exercise are commonly used after joint surgeries in various hip pathologies. based on this theory, it was hypothesized that task-oriented exercise without conventional physiotherapy can have better result in recovery of balance and leg function than with a conventional post-hip physiotherapy program after hip replacement surgery. the aim of the study was to determine the effect of task-oriented exercise on balance and leg function after total hip replacement.

study included 40 subjects. all subjects were randomly divided into control and intervention groups. vas scale was used to assess the pain, hip range of motion were measured using a goniometer, strength of the muscles was assessed on the oxford 5 point scale, leg function was evaluated with modified harris hip scale, abili balance analyzer was used to assess static balance and berg balance scale was used to measure dynamic balance. intervention duration was 18 days.

Eligibility criteria:
inclusion criteria: * bmi \< 40; * hip coxarthrosis; * hip total replacement; * posterior incision; * surgery performed no more than 1 week ago; * ability to comprehend and execute the tasks. exclusion criteria: * revision surgery; * surgery intervention for other reasons (fracture, arthritis); * severe cardiovascular disease; * vestibular disorders; * vision disorders; * proprioception disorders; * neurological disorders.

Keywords: balance hip function hip replacement elderly physical functioning
intervention to improve medication adherence in cardiovascular patients

Conditions: Cardiovascular Diseases

Summary: the purpose of this study is to investigate whether a nurse-based intervention, consisting of structural informative consulting and motivational counseling, on top of usual care with or without personalized web-based visualization of cardiovascular risk levels, improves the medication adherence in high risk cardiovascular patients.

poor adherence to medication is one of the limitations in the treatment of cardiovascular disease. as a consequence the risk of premature death, hospital admissions and related costs is increasing. therefore, detection of apparent poor adherence and interventions to improve adherence, are of great importance to enhance cardiovascular risk management over time. this study is a prospective randomized trial, which compares 1) usual care with 2) the effect of a personalized visualization of cardiovascular risk levels (website) to support self management and 3) the additional effect of a communication intervention by a nurse on adherence on top of 2). adherence is determined and continuously monitored with a dedicated calculation of refill data obtained from patient's pharmacy.

Eligibility criteria:
inclusion criteria: * all subsequent patients, included in the hospital-screening program with manifestations of atherosclerotic disease (acute coronary syndrome, peripheral arterial disease or stroke/tia) or elevated cardiovascular risk due to hypertension, diabetes or hyperlipidemia. exclusion criteria: * age below 18 years, actual pregnancy, problems with dutch language or logistic problems, which may hinder intervention on adherence behavior. severe co-morbidity, including mental handicap, according to their physician.

Keywords: pad cva acs
cost-effectiveness of egdt using flotrac/ev1000

Conditions: Coronary Artery Disease

Summary: coronary artery bypass graft (cabg) with cardiopulmonary bypass (cpb) is a high-risk surgery with significant morbidity that results in a prolonged stay in the intensive care unit (icu) at an increased cost. early goal-directed therapy (egdt) using the flotrac/ev1000 platform improved outcomes in these patients with shorter icu stay but with extra cost for a flotrac transducer. the objective of this study is to assess the cost-effectiveness of implementing the flotrac/ev1000 in these patients.

egdt using flotrac/ev1000 platform has been reported to improve outcomes in patients undergoing cabg with cpb resulting in a reduction in cardiovascular and thoracic icu (cvt icu) and hospital stay. however, the use of the flotrac sensor has an extra cost that impedes its implementation. there is still no study that assesses the cost-effectiveness of implementing flotrac in cardiac surgery. the objective of our study is to evaluate the cost-effectiveness of applying egdt using the flotrac/ev1000 platform in patients undergoing cabg with cpb. there are 2 steps in this study: 1. assessing the efficacy of the flotrac/ev1000 platform 2. assessing the daily cvt icu cost assessing the efficacy of the flotrac/ev1000 platform we compare the efficacy of the flotrac/ev1000 versus standard practice. the sample size of 30 patients per group was calculated based on data from a previous study, an α value of 0.05, a β value of 0.2, and a 30% decrease in icu stay. sixty patients undergoing cabg with cpb at srinagarind hospital or queen sirikit heart center of the northeast between july 2018 and june 2020 will be recruited. they will be divided into 2 groups: ev1000 and control. the intraoperative hemodynamic optimization in the ev1000 was managed using goal-directed therapy via the flotrac/ev1000 platform and the control was managed using a standard protocol as described in the study of tribuddharat et al. the extracted data for comparison were: demographic and clinical data, cvt icu stay, ventilator time in cvt icu, postoperative complications, and hospital stay. the icu stay of both groups will be compared. assessing the daily cvt icu cost we will evaluate the icu cost of the cvt icu of srinagarind hospital by recruiting another group of patients who were admitted to the cvt icu during october 2021 to identify the average daily cost. the cost of a flotrac sensor and the icu cost saved will be compared.

Eligibility criteria:
inclusion criteria: * adult patients who underwent cabg with cpb. exclusion criteria: * patients who required an intra-aortic balloon pump or extracorporeal membrane oxygenator.

Keywords: cost-effectiveness early goal-directed therapy flotrac/ev1000 icu stay
improvement of sensibility in the foot in diabetic patients induced by emla-application to the lower leg

Conditions: Diabetes Mellitus

Summary: sensory input from the foot as well as all other body parts results in activation of sensory cortex. it is well known that the cortical body map is experienced-dependant and can rapidly change in response to changes in activity and sensory input from the periphery \[10-12\]. increased activity and sensory input from the hand results in expansion of the cortical hand representation \[13-15\], while decreased sensory input, for instance by anaesthesia, amputation or nerve injury, results in shrinkage of the cortical hand representation \[16-21\]. due to the constant ongoing "cortical competition" between body parts the adjacent cortical areas expand and take over the silent area, deprived of sensory input. the investigators have recently described striking examples of such rapid cortical re-organisations induced by selective cutaneous anaesthesia of the forearm: application of emla cream to the volar aspect of the forearm results in improved sensory functions of the hand \[18\] linked to expansion of the hand representational area in sensory cortex . in analogy, emla application to the lower leg in healthy controls results in improved sensory functions in the sole of the foot linked to expansion of the foot representational area in sensory cortex. to test the hypothesis that emla application to the lower leg of diabetic patients will result in improved sensory functions in the sole of the foot as well as expansion of the foot representation in sensory cortex. the investigators hypothesize that repeated applications of emla will result in a long lasting sensibility improvement.


Eligibility criteria:
inclusion criteria: * adult patients (18-75 years) suffering from diabetes with subjective sensory impairment in the sole of the foot. exclusion criteria: * patients with painful neuropathy or established ulcer formation in toes or sole of the foot, known hypersensitivity to local anaesthetics, major vascular reconstructions, communication problems due to severe language problems. * patients with pacemakers or magnetic implants or suffering from claustrophobia will not be subjected to fmri-investigation.

Keywords: diabetes mellitus neuropathy foot sensibility brain plasticity
responsiveness and validation study of mfm-32 in sma patients treated with nusinersen

Conditions: Spinal Muscular Atrophy

Summary: the motor function measure (mfm), a reliable tool assessing motor function and its progression in most neuromuscular diseases, is widely used in france in many teams. it can be used regardless of the severity of the motor impairment or the ambulatory status of the patient, allowing its use throughout the whole follow-up period of the patient, even in case of the loss of walking. two versions of the mfm exist, one composed of 32 items originally validated for patients from 6 years old (mfm-32) and a shorter version composed of 20 items originally validated for patients between 2 and 6 years old (mfm-20). in order to prove the possible use of mfm-32 as early as the age of 2 years to validly and reliably monitor the evolution of the motor function of children treated with nusinersen, we propose in this project to study the sensitivity to treatment-induced change of mfm-32 and the validity of the scale in this population.


Eligibility criteria:
inclusion criteria: * boys and girls with type 1 or 2 spinal muscular atrophy, genetically confirmed * aged 2 to 6 years old * treated by nusinersen for at least two months * with parental assent exclusion criteria: * patients with associated cognitive impairment making impossible evaluation of motor function * patients participating to a clinical study with a potential effect on their motor function.

Keywords: spinal muscular atrophy, motor function measure,nusinersen
stroke prognosis in intensive care

Conditions: Acute Stroke Patients Requiring Invasive Mechanical Ventilation

Summary: the s.p.i.c.e registry is an investigator-initiated prospective multicenter cohort study which will be conducted in 35 icus in the paris area.the aim of the study is to determine the trajectory of acute stroke patients requiring invasive mechanical ventilation, focusing on functional outcomes at 3 months and 1 year following icu admission. this project is funded by the french agence régionale de santé (ars).


Eligibility criteria:
inclusion criteria: * age\>18 years * acute stroke (acute ischaemic stroke, brain hemorrhage, subarachnoid hemorrhage). the stroke diagnosis date is defined by the date of the initial brain imaging (tdm or mri). * admitted to icu within 7 days before or after the diagnosis of stroke. * requiring invasive mechanical ventilation in icu for more than 24 hours. exclusion criteria: * traumatic causes of stroke * refusal of the patient, or his reliable person, to participate in the study. * privation of liberty by administrative or judicial decision

Keywords: mechanical invasive ventilation course of the care prognosis stroke