Kornimate/medical-research-clean huggingface dataset:
comparison of the non-invasive icp headsense monitor vs lumbar csf pressure measurement

Conditions: Intracranial Hypertension

Summary: in current practice patients with a suspected increase of intracranial pressure (icp) will undergo a lumbar puncture with measurement of cerebral spinal fluid (csf) pressure (as a marker for icp). a lumbar puncture is an invasive and sometimes painful procedure. using a new type of icp monitor (headsense) it is possible to measure icp non-invasively through an acoustic signal

in this study we will prospectively collect relevant clinical data on 60 neurological patients, who are being referred for an elective lumbar puncture (eg. suspected multiple sclerosis, raised intracranial hypertension, etc). each enrolled patient will be monitored in parallel to the lumbar puncture with the headsense icp monitor. subjects who meet the study inclusion and exclusion criteria will be enrolled in the study. step 1: 10 minute measurement of headsense monitor. once the patient is inclined with his upper body 30 degrees to the bed the pressure values, the clinical procedure can begin. the device must be preset in a continuous monitoring mode. the continuous monitoring allows a loop of measurements for an unlimited time in a rate of four measurements per minute. step 2: 10 minute measurement of headsense monitor in supine position. step 3: patient will be placed in a left lateral position. the lumbar puncture will be done and csf pressure will be measured following standard procedures. step 4: 10 minute measurement of headsense monitor in supine position. lumbar puncture and headsense measurement will be done by two different doctors and they will not share measurement values during the procedure. after the study the patient's ears will be examined for internal ear infection or irritation that might be caused by the ear buds. patient adverse events will be documented on the case report forms in case they occurred and the family or advocate of the patient will be informed. in case of clinical relevant adverse events appropriate clinical action will be taken. as the procedure does not affect the patient management, there is no need to provide any specific medical care related to the trial. patients will receive the relevant clinical care related to their clinical management, without any consideration to their participation in the trial.

Eligibility criteria:
inclusion criteria: * male or female in the age range of 18 years and older * all patients who are referred for elective or subacute lumbar puncture including csf pressure measurement exclusion criteria: * local infection in the ear * pregnant or lactating women * cervical spine stenose * arnold-chiari malformations * aqueductal stenosis or other changes causing an uneven csf pressure between different compartments * mass lesions * current or previous craniotomy or craniectomies * suspicion of meningitis or encephalitis

Keywords: intracranial pressure noninvasive monitoring lumbar puncture
the chinese stemi ppci registry (cspr)

Conditions: ST-segment Elevation Myocardial Infarction (STEMI)

Summary: the purpose of this study is to develop a risk score to predict the risks of in-hospital major adverse cardiac events in st-segment elevation myocardial infarction patients treated by primary percutaneous coronary intervention.

the cspr trial is an observational clinical trial to derive and validate a readily useable risk score to identify patients at high risk of in-hospital major adverse cardiac events in 5594 patients presenting with a st-segment elevation myocardial infarction and treated by primary percutaneous coronary intervention.

Eligibility criteria:
inclusion criteria: 1. age≥18 2. st-segment elevation myocardial infarction was defined according to the universal definition of myocardial infarction 3. stemi treated by ppci exclusion criteria: 1. patient with heart failure in admission 2. stemi with symptom-onset-to-balloon time\>24h 3. ppci was not successful or only underwent coronary angiography 4. killip class ≥ii in admission
olanzapine versus active comparator in the treatment of depression in patients with schizophrenia

Conditions: Depression; Schizophrenia; Schizoaffective Disorder

Summary: this is a research study comparing the safety and efficacy of two active study medications


Eligibility criteria:
inclusion criteria: * male or female subjects 18-60 years of age * female subjects of childbearing potential must be using a medically accepted means of contraception * each subject must have a level of understanding sufficient to perform all tests and examinations required by the protocol * subjects must be considered reliable exclusion criteria: * treatment with a drug within the last 30 days that has not received regulatory approval at the time of study entry * female subjects who are either pregnant or nursing * uncorrected hypothyroidism or hyperthyroidism * narrow-angle glaucoma

Keywords: depression comorbid depression schizophrenia schizoaffective disorder
efficacy of electroacupuncture combined with pregabalin in the treatment of trigeminal herpetic neuralgia: a multicenter randomized controlled trial study protocol

Conditions: Trigeminal Herpetic Neuralgia

Summary: trigeminal herpetic neuralgia is a common type of zoster-associated pain (zap), which troubles individuals in all ages and burdens society all over the world. eleactroaupuncture (ea) is increasingly used in the treatment of zap due to its advantages such as low price, high safety, no adverse reactions, and high patient acceptance. therefore, it is necessary to conduct randomized controlled trials to evaluate the effectiveness and safety of ea on zap and whether ea can be used as a substitute for pregabalin.

trigeminal herpetic neuralgia is a common type of zoster-associated pain (zap), which troubles individuals in all ages and burdens society all over the world. eleactroaupuncture (ea) is increasingly used in the treatment of zap due to its advantages such as low price, high safety, no adverse reactions, and high patient acceptance. therefore, it is necessary to conduct randomized controlled trials to evaluate the effectiveness and safety of ea on zap and whether ea can be used as a substitute for pregabalin.

Eligibility criteria:
inclusion criteria: 1. meet the aforementioned diagnostic criteria for trigeminal zap, with a disease duration of 1 to 3 months; 2. have a visual analog scale (vas) score of 4 points ≤ vas ≤ 7 points; 3. be between 18 and 85 years old, regardless of gender; 4. have clear consciousness, the ability to distinguish pain, and complete basic communication; 5. voluntarily participate in the study, sign a written informed consent form, and fully understand the plan. exclusion criteria: 1. do not meet the above-mentioned inclusion criteria; 2. have concomitant herpes zoster on the trunk or extremities, or other special types of herpes zoster like meningeal herpes zoster or visceral herpes zoster; 3. are pregnant or lactating patients; 4. are allergic to pregabalin or acupuncture stimulation; 5. have severe organ damage, cognitive dysfunction, mental disorder, aphasia, or other serious diseases that hinder cooperation with treatment; 6. have severe skin diseases; 7. have a pacemaker; 8. have been or are currently participating in other clinical studies within the past 3 months.

Keywords: electroacupuncture pain randomized controlled trial protocol
vaginal birth after caesarean section and levator ani avulsion

Conditions: Birth Injuries

Summary: there is no data regarding the risk of levator ani avulsion in women after a vaginal birth after caesarean although a possible increased risk has been suggested. the aim of the study is to describe the incidence of levator ani avulsion and compare it to primiparous women. in addition, health related quality of life will be evaluated and compared

levator ani muscle avulsion is a frequent postpartum trauma imposing a considerable risk of pelvic organ prolapse on women in later life. furthermore, the trauma reduces the effectiveness of pelvic reconstructive surgery and has a detrimental effect of the sexuality of the affected women. the trauma occurs most frequently in the first vaginal delivery with an incidence of 10-30%. however, the risk of levator avulsion in women after vaginal birth after caesarean section (vbac) is unknown although possible increased risk has been suggested. the aim of the study is to assess the prevalence of levator ani avulsion among women who delivered vaginally after a caesarean section and make a comparison with a primiparous cohort. the secondary aim is to evaluate and compare the health related quality of life regarding pelvic floor disorders and sexuality.

Eligibility criteria:
inclusion criteria: * one term vaginal delivery in obstetric history * agreement with the enrollment exclusion criteria: * women with a history of repeat vbac or a vaginal delivery prior to the index caesarean section * women with preterm labor * epidural analgesia * multiple pregnancy * dead or malformed fetus

Keywords: vbac, levator ani avulsion, quality of life
study to determine the effects of different doses of methotrexate (mtx) when taken with adalimumab in subjects with early rheumatoid arthritis (ra)

Conditions: Early Rheumatoid Arthritis

Summary: the purpose of this study is to determine the effects of different doses of methotrexate (mtx) when taken with adalimumab in subjects with early rheumatoid arthritis (ra).


Eligibility criteria:
inclusion criteria: * male and female subjects at least 18 years of age * subject has a diagnosis of rheumatoid arthritis (ra) as defined by either the 1987-revised american college of rheumatology (acr) classification criteria or the new acr/ european league against rheumatism (eular) diagnostic criteria for ra 2010 and has a disease duration of less than 1 year from diagnosis by a licensed health care provider * subject must meet the following criteria: 1. disease activity score of c-reactive protein (das28\[crp\]) ≥ 3.2 (at the baseline visit only) 2. at least 6 swollen joints out of 66 assessed (at the screening and baseline visits) 3. at least 8 tender joints out of 68 assessed (at the screening and baseline visits) 4. c-reactive protein (crp) ≥ 1.5 mg/dl (at the screening visit only), or erythrocyte sedimentation rate (esr) ≥ 28 mm/1h (at the screening and baseline visits) 5. fulfill at least one of the following three criteria: rheumatoid factor (rf) positive, have at least 1 bony erosion, anti-cyclic citrullinated peptide (anti-ccp) antibody positive * subject is judged to be in good health as determined by the principal investigator based upon the results of medical history, laboratory profile, physical examination, chest x-ray (cxr), and a 12-lead electrocardiogram (ecg) performed during screening exclusion criteria: * subject has previous exposure to any systemic biologic therapy including adalimumab * subject has been previously treated with greater than 1 disease modifying antirheumatic drugs (dmards) or with methotrexate (mtx) * subject has undergone joint surgery within the preceding two months (at joints to be assessed within the study) * subject has chronic arthritis diagnosed before age 17 years * history of invasive infection (e.g., listeriosis and histoplasmosis), chronic or active hepatitis c infection, human immunodeficiency virus (hiv) infection, immunodeficiency syndrome, chronic recurring infections or active tuberculosis (tb) * hepatitis b virus: hepatitis b surface antigen (hbs ag) positive (+) or detected sensitivity on the hepatitis b virus dna (hbv dna) polymerase chain reaction (pcr) qualitative test * infection(s) requiring treatment with intravenous (iv) anti-infectives within 30 days prior to the baseline visit or oral anti-infectives within 14 days prior to the baseline visit * female subject who is pregnant or breast-feeding or considering becoming pregnant

Keywords: arthritis erosion humira adalimumab injection rheumatoid methotrexate
lead, endocrine disruption and reproductive outcomes

Conditions: Lead Poisoning; Infertility

Summary: this prospective cohort study of 400 lead exposed and 400 non-lead exposed women and their husbands assesses endocrine dysfunction and adverse reproductive outcomes. residing in two study areas in shenyang, china, the women are married, 20 and 34 years of age, never smokers, have obtained permission to have a child, and have attempted to become pregnant over the course of the study. lead exposure is defined by lead levels in blood samples collected at the baseline survey (both women and their husbands), first and second trimesters, and at delivery (both maternal and cord blood). endocrine dysfunction is monitored by urinary hormone metabolites including follicle-stimulating hormone (fsh), luteinizing hormone (lh), estrone conjugates (e1c), and pregnanediol-3-glucuronide (pdg). reproductive endpoints include menstrual disturbance, time to conception, spontaneous abortion, preterm delivery, and low birth weight.


Eligibility criteria:
married women who: * currently reside in two study areas in shenyang, china * between 20 and 34 years of age * never smokers * have obtained permission to have a child * are attempting to become pregnant over the course of the study.

Keywords: lead endocrine dysfunction
safety, tolerability, and efficacy study of idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis

Summary: to evaluate the safety and tolerability of fg-3019 in subjects with idiopathic pulmonary fibrosis (ipf) and the efficacy of fg-3019 for attenuating fibrosis in these subjects.

major changes: fgcl-3019-049 protocol amendment 3 offers long-term extension of treatment with fg-3019 to eligible cohort 1-ex (approximately 14 subjects) and cohort 2 (approximately 28 subjects) subjects who complete the week 48-ex and week 48 assessments described in protocol amendment 2, respectively. a subject is eligible for long-term extension of treatment if the investigator, after discussion with the fibrogen medical monitor, believes that the subject would benefit from continued treatment with fg-3019.

Eligibility criteria:
main inclusion criteria: 1. age 35 to 80 years, inclusive. 2. clinical diagnosis of ipf by high resolution computed tomography (hrct) scan (and in some cases by surgical lung biopsy) and reduced lung function (forced vital capacity). 3. history of ipf of 5 years duration or less. 4. evidence of progression of ipf within the last 3-12 months for cohort 1, or within the last 18 months for cohort 2 before screening. 5. women of childbearing potential, and men, must be willing to use a medically acceptable method of contraception during the trial and 3 months after the last dose of study drug. main exclusion criteria: 1. women who are pregnant or nursing. 2. history of any other types of lung or heart disease and any other medical conditions that, in the opinion of the investigator, would preclude the subject's participation in the study. 3. clinically important abnormal laboratory tests. 4. upper or lower respiratory tract infection of any type within 4 weeks of the first screening visit. 5. acute exacerbation of ipf within 3 months of the first screening visit. 6. use of certain medications within 4 weeks of the first screening visit. 7. receipt of an investigational drug within 6 weeks of the first screening visit. 8. history of cancer of any type in the 5 years preceding the first screening visit, excluding non-melanomatous skin cancer, localized bladder cancer, or in situ cervical cancer. 9. trauma or surgical procedures requiring hospitalization within 4 weeks of the first screening visit. 10. planned elective surgery during the study including 4 weeks following the final dose of study drug. 11. history of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies. 12. inability to cooperate with study personnel or history of non-compliance to a medical regimen. 13. previous treatment with fg-3019.
in utero magnesium sulfate exposure: effects on extremely-low-birth-weight infants

Conditions: Infant, Newborn; Infant, Low Birth Weight; Infant, Small for Gestational Age; Infant, Premature; Intracranial Hemorrhages; Leukomalacia, Periventricular; Cerebral Palsy

Summary: this study examined the effect of magnesium sulfate (mgso4) exposure on adverse outcome in extremely low birth weight (elbw) infants. for infants included in the nichd neonatal research network generic database whose mothers were given prenatal mgso4, data were prospectively collected on maternal/infant conditions and magnesium exposure (including indications, timing and duration of exposure).

retrospective studies suggested that the risk of cerebral palsy and intraventricular hemorrhage (ivh) in extremely premature infants of mothers given magnesium sulfate (mgso4) may be reduced. the purpose of this study was to examine the effects of mgso4 exposure on adverse outcomes in extremely low birth weight (elbw) infants. for infants included in the nichd neonatal research network generic database, data were prospectively collected on maternal/infant conditions and mgso4 exposure (including indications, timing and duration of exposure).

Eligibility criteria:
inclusion criteria: * infants born in nrn centers with a birth weight of 401-1,500g exclusion criteria: * none

Keywords: nichd neonatal research network extremely low birth weight (elbw) prematurity antenatal magnesium sulfate
study to evaluate the efficacy and safety of dronabinol metered dose inhaler (mdi) in acute treatment of migraine headache

Conditions: Migraine With Aura; Migraine Without Aura

Summary: the primary objective of this study is to evaluate the efficacy and safety of dronabinol mdi for the acute treatment of moderate to severe migraine headache.


Eligibility criteria:
inclusion criteria: * male or female subjects 18 to 65 years, inclusive, with clinically diagnosed migraine with or without aura based on international headache society criteria exclusion criteria: * subjects who experience migraine with prolonged aura; familiar hemiplegic migraine; migrainous infarction or basilar migraine; and those with greater than eight migraine attacks per month and/or greater than 14 migraine days per month.

Keywords: efficacy & safety, migraine headache, placebo-controlled migraine headache with or without aura
an investigation on the role of emergency departments in combatting against covid-19 in zhejiang province

Conditions: COVID-19 Pneumonia

Summary: the epidemic caused by the new coronavirus appeared in december 2019 and spread rapidly, and it has had a serious impact on the social development and people's lives in the world. on february 11, 2020, the world health organization (who) named the infectious disease caused by the virus covid-19. my country classifies it as a class b infectious disease, and controls it as a class a infectious disease. in order to effectively respond to the epidemic, on january 23, 2020, zhejiang province first launched a first-level response to major public health emergencies across the country. some patients with new coronary pneumonia, especially critically ill patients, may go to the emergency department first. emergency medical staff must identify and isolate patients with new coronary pneumonia in a timely manner while ensuring the treatment of critically ill patients. people face greater unknowns and challenges in the anti-epidemic work. this research participating in the prevention and control of the new crown pneumonia epidemic through investigations in the emergency department of zhejiang province related conditions, to further improve the hospital's emergency medical service capabilities for reference.

references： 1. huang cl, wang ym, li xw, et al. clinical features of patients infected with 2019 novel coronavirus in wuhan, china\[j\]. lancet, 2020, 395(10223): 497-506. doi:10.1016/s0140-6736(20)30183-5. 2. zhu n, zhang dy, wang wl, et al. a novel coronavirus from patients with pneumonia in china, 2019\[j\]. n engl j med, 2020, 382(8): 727- 733. doi:10.1056/nejmoa2001017. 3. gupta m, abdelmaksoud a, jafferany m, et al. covid-19 and economy\[j\]. dermatol ther, 2020: e13329. doi:10.1111/dth.13329. 4. coronaviridae study group of the international committee on taxonomy of viruses. the species severe acute respiratory syndrome- related coronavirus: classifying 2019-ncov and naming it sars- cov-2 \[j\]. nat microbiol, 2020, 5(4):536-544. doi:10.1038/s41564- 020-0695-z. 5. lai cc, shih tp, ko wc, et al. severe acute respiratory syndrome coronavirus 2 (sars-cov-2) and coronavirus disease-2019 (covid-19): the epidemic and the challenges\[j\]. int j antimicrob agents, 2020, 55(3): 105924. doi:10.1016/j.ijantimicag.2020.105924.

Eligibility criteria:
inclusion criteria: * county-level people's hospitals, tcm hospitals and above comprehensive public hospitals in zhejiang province; * voluntary participation in this study. exclusion criteria: * incomplete data

Keywords: emergency department covid-19 epidemic prevention and control zhejiang province
influence of post-thaw embryo culture interval on assisted reproduction success rates

Conditions: Infertility

Summary: the transfer of frozen / thawed embryos has been routinely performed in the last 30 years as part of assisted reproduction treatment (art). currently, more than 50% of couples submitted to art have surplus embryos eligible for freezing followed by transfer in subsequent cycles. therefore the selection criteria for the thawed embryos to be transferred must be rigorous in order to maximize pregnancy and of live birth rates. usually, the evaluation of the embryos before transfer can be performed based on blastomeres survival after a short culture period between thaw and embryos transfer, i.e., 2 to 5 hours, or based on embryo development over a prolonged period of culture (18h to 24h). post-thaw embryo culture might have an impact on the recovery of mitosis and normal cellular functions. however, until now, there is no consensus in the literature on which post-thaw culture interval has a better impact on pregnancy and live birth rates. also, blastocysts formation after freezing/thawing of embryos at cleavage stage may bring relevant information about post-thaw culture. moreover, this strategy can be used as an alternative treatment. therefore, the authors proposed this prospective randomized, triple-blind study to evaluate the impact of post-thaw embryo culture on the pregnancy and live birth rates.


Eligibility criteria:
inclusion criteria: * patients submitted to art treatment due to infertility that had frozen embryos and need an embryo transfer after endometrial preparation and embryo thawing exclusion criteria: * patients that does not reach criteria for frozen embryo transfer (thin endometrium, bleeding, inappropriate use of hormones) * difficult embryo transfer * embryos that were frozen twice

Keywords: cryopreservation human embryos vitrification embryo culture embryo transfer pregnancy rate