Kornimate/medical-research-clean huggingface dataset:
aligning pulse oximetry with guidelines

Conditions: Bronchiolitis

Summary: the primary objective is to measure the feasibility, acceptability, and appropriateness of audit and feedback with educational outreach as a strategy to align continuous pulse oximetry use in stable bronchiolitis patients with evidence and guideline recommendations.

continuous pulse oximetry (spo2) monitoring has revolutionized detection of oxygen desaturation in operating rooms and other high-risk areas, improving outcomes in those settings. however, research suggests that overuse of continuous spo2 monitoring in stable children with bronchiolitis who are unlikely to benefit from it is low-value care that places some children at risk of adverse outcomes. despite national guidelines discouraging continuous pulse oximetry use in stable bronchiolitis patients, 46% of those infants and children are continuously monitored. this pragmatic, prospective, non-randomized, single-arm feasibility pilot will be performed on non-intensive care unit (icu) hospital units that care for bronchiolitis patients. the primary subjects are hospital staff who order or manage continuous pulse oximetry monitoring for bronchiolitis patients; secondary subjects are patients age 2 through 23 months with a primary diagnosis of bronchiolitis.

Eligibility criteria:
inclusion criteria: * primary subjects - hospital staff 1. nurses, physicians, physician assistants, nursing assistants, or respiratory therapists 2. providing care to patients on units included in the study. * secondary subjects - patients 1. males or females 8 weeks through 23 months old hospitalized on non-intensive care unit (icu) wards 2. cared for by generalist inpatient services (e.g. general pediatrics, hospital medicine) 3. primary diagnosis of acute bronchiolitis according to hospital chart 4. not currently requiring supplemental oxygen therapy or nasal cannula flow at an fraction of inspired oxygen in the air (fio2) of 21% (room air flow) exclusion criteria: * primary subjects - hospital staff 1) none. staff may self-exclude by choosing not to interact with the electronic communications and may choose to not attend meetings where the intervention is discussed. * secondary subjects - patients 1. premature birth: \<28 weeks completed gestation 2. cyanotic congenital heart disease 3. pulmonary hypertension 4. home oxygen or positive pressure ventilation requirement 5. tracheostomy 6. neuromuscular disease 7. immunodeficiency 8. cancer 9. historical, current, or suspected diagnosis of heart failure, myocarditis, or arrhythmia 10. historical, current, or suspected diagnosis of coronavirus disease 2019 (covid-19)
observational study to evaluate the use of targeted therapies in metastatic colorectal cancer

Conditions: Metastatic Colon Cancer

Summary: the purpose of this study is to evaluate, in terms of overall survival, the benefit of monoclonal antibodies in the start time of the diagnosis of advanced disease or administer a deferred basis after progression to treatment with chemotherapy alone. initially expected target population was 1950 patients (pts), in 2015 protocol was ammended to 1028 patients, because the size was sufficient to evaluate the superiority of the use of monoclonal antibodies the start time of the diagnosis against deferred use, with hr of 0.8, power of 90% and an alpha of 0.05. finally in july 2018, recruitment was completed with a total of 1104 patients enrolled.


Eligibility criteria:
inclusion criteria: * patients diagnosed with metastatic colorectal cancer with biopsy positive for adenocarcinoma. * ecog ps0-2. * who have not received prior chemotherapy treatment for metastatic disease. * measurable or evaluable disease. * no previous surgery for metastatic disease. surgery for metastasis allowed after inclusion in the study aftercare at the discretion of investigadors. * chemotherapy treatment with doublets (capox, folfox, folfiri) exclusion criteria: * patients older than 70 years with frailty criteria.

Keywords: metastatic colon cancer monoclonal antibodies chemotherapy first line
a study to investigate the safety, tolerability and pharmacokinetics of suvn-g3031 in healthy subjects

Conditions: Cognitive Disorders

Summary: the purpose of this study is to investigate the safety, tolerability and pharmacokinetics of suvn-g3031 in healthy male subjects following single or multiple ascending doses.

this is a single and multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of suvn-g3031 administered orally once a day to healthy male subjects. the study will be conducted under double-blind conditions. the primary objective is to evaluate the safety and tolerability of suvn-g3031 following oral administration of single or multiple ascending doses and estimate the maximum tolerated dose of suvn-g3031, if possible. the secondary objectives are to evaluate the single and repeat dose plasma pharmacokinetics following oral administration of single and multiple ascending doses of suvn-g3031 in healthy male subjects.

Eligibility criteria:
inclusion criteria: • healthy male aged 18 to 45 years with a bmi between 18 and 30 kg/m2, (inclusive). exclusion criteria: * standard exclusion criterion for phase 1 clinical trial in healthy subjects. * history of any clinically significant disease or disorder which, in the opinion of the investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate * history or presence of gi, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs as judged by investigator.

Keywords: suvn-g3031 histamine 3 (h3) receptor inverse agonist first in human safety pharmacokinetics tolerability single dose repeat dose
low-dose ketamine and postpartum depression in parturients with prenatal depression

Conditions: Perinatal Depression; Ketamine; Cesarean Delivery; Postpartum Depression

Summary: postpartum depression is common in mothers early after childbirth and produces harmful effects not only on mothers, but also on infants and young children. parturients with prenatal depression are at increased of postpartum depression. low-dose ketamine can be used for antidepressant therapy. we hypothesize that low-dose ketamine has a therapeutic effect on parturients with prenatal depression. this study is designed to investigate whether low-dose ketamine administered during cesarean delivery can decrease the incidence of postpartum depression in parturients with prenatal depression.

postpartum depression refers to maternal depression developed early after childbirth, with reported incidences varied from 15% to 20%. the development of postpartum depression produces harmful effects not only on mothers, but also on infants and young children. prenatal depression or high depression score is an independent risk factor for the development of postpartum depression. ketamine is commonly used as an general anesthetic. in addition, low-dose ketamine is recommended for antidepressant therapy. we hypothesize that low-dose ketamine has a therapeutic effect on parturients with prenatal depression. however, evidences in this aspect are insufficient. the purpose of this study is to investigate whether low-dose ketamine administered during cesarean delivery can decrease the incidence of postpartum depression in parturients with prenatal depression.

Eligibility criteria:
inclusion criteria: * parturients with age from 18 to 45 years and scheduled for elective cesarean delivery; * prenatal depression score (epds) of 10 or higher; * provide written informed consents. exclusion criteria: * refused to participate in the study; * history of schizophrenia or other disease that prevent normal communication before delivery; * presence of contraindications to neuraxial anesthesia, including central nervous system diseases (such as poliomyelitis), spinal diseases (such as spinal canal tumor, lumbar disc prolapse, history of spinal trauma), systemic infection (such as sepsis, bacteremia), local infection in the site of puncture, or coagulopathy; * severe complications during pregnancy (such as severe preeclampsia, placenta accreta, hellp syndrome); * severe comorbidity before pregnancy (such as severe cardiac dysfunction); * scheduled to undergo cesarean delivery under general anesthesia; * other reasons that are considered unsuitable for study participation.

Keywords: prenatal depression ketamine cesarean delivery postpartum depression
patient reported satisfaction with contoura lasik utilizing the phorcides analytic software

Conditions: Myopia

Summary: the objective is to determine the percentage of subjects satisfied (completely satisfied or very satisfied) with vision after phorcides planned contoura lasik.

this study is a single site, single-arm, prospective, observational study of subject satisfaction, after successful bilateral lasik surgery. subjects will be assessed pre-operatively, operatively and at 1 week, 1 month, and 3 months post-operatively. clinical evaluations will include measurement of visual acuity, manifest refraction, and topography, aberrometry, and administration of the osdi and prowl questionnaires.

Eligibility criteria:
subjects are eligible for the study if they meet the following criteria: note: ocular criteria must be met in both eyes. * appropriate candidate for uncomplicated bilateral lasik surgery * gender: males and females. * age: 21 to 39 years of age. * refractive error range - se refractive errors up to 0.00 to -9.00 d with maximum cylinder up to 3.00 d and sphere ≤ -8.00 d. * if currently wearing contact lenses: * soft ctl wearers discontinue for minimum 3 days * rgp ctl wearers discontinue for 1 month per decade of wear * stable refraction (2 consecutive manifest refractions within 0.25 se) * stable k readings (2 consecutive k readings in 2 consecutive visits) * residual bed thickness 250um or greater * willing and able to comply with scheduled visits and other study procedures. * pre-surgery bcdva of 20/20 (0.00 logmar) or better in each eye. if any of the following exclusion criteria are applicable to the subject or either eye, the subject should not be enrolled in the study. * subjects with history of previous ocular surgery. * subjects with topographic evidence of keratoconus, or ectasia. * subjects with autoimmune diseases. * subjects who are pregnant or nursing. * systemic disease likely to affect wound healing, such as diabetes and severe atopy. * any ocular disease (including un-controlled dry eye) which in the investigator's opinion would affect the outcome of refractive surgery. the principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial. pregnancy has a known effect on the stability of refractions and visual acuity. as such, subjects who become pregnant during the study will not be discontinued but their data may be excluded from analyses of effectiveness.
effects of high voltage pulsed current on post-traumatic injuries

Conditions: Ankle Sprain

Summary: the investigators hypothesis is that hvpc with negative polarity diminishes local post-traumatic edema in ankle sprains. therefore, the objective of this study was to analyze the effect of hvpc on edema secondary to ankle sprains in humans.

most studies have investigated the effects of hvpc on edema in animals and only one in humans was identified. the studies had showed that hvpc had some advantages for controlling edema in animals but there are not yet conclusive results on the effect of this intervention in humans.for this reason, we proposed a randomized controlled double-blinded clinical trial with three groups of intervention. in our study compared the effects of standard physical therapy treatment with the hvpc with negative and positive polarity.

Eligibility criteria:
inclusion criteria: * ankle post traumatic edema secondary to a sprain * sprain with evolution between 2 and 96 hours * sprain positive to anterior drawer test or lateral inclination mobilizations. exclusion criteria: * subjects with grade iii sprains that required surgical management * edema secondary to systemic illness * muscular dystrophy or atrophy * injuries, open or infected zones * people taking anti-inflammatory medication or using empirical treatment as tractions, strong massages or manual.

Keywords: sprain electric stimulation physical trauma inflammation
quantitative 13n-ammonia cardiac rest/stress digital pet/ct

Conditions: Coronary Artery Disease

Summary: accurate measurements from a non-invasive test like myocardial perfusion positron emission tomography/ computed tomography (pet/ct) may decrease the need for invasive procedures such as cardiac catheterization.the investigators wish to see if the measurements from cardiac catheterization can be predicted using a non-invasive 13n-nh3 digital pet/ct scan.

cardiac imaging using standard-of-care nuclear medicine techniques assess the relative radiopharmaceutical distribution from coronary arteries to cardiac tissue. this standard interpretation however, lacks the clinical utility of modern quantitative techniques that are now routinely obtained during cardiac catheterization, such as fractional flow reserve (ffr). cardiologists routinely base critical management decisions, including the choice for revascularization, stenting, or angioplasty, on these measurements. non-invasive measurements of mbf (myocardial blood flow), cfr (coronary flow reserve) and rfr (relative flow reserve) using pet/ct have been investigated, but have yet to reach clinicl use. given the inherent gains in sensitivity and resolution, digital pet/ct, may allow for a more robust and accurate platform to obtain quantitative measurements of mbf, cfr and rfr which may greatly enhance the clinical utility of cardiac pet/ct for management of coronary artery disease.

Eligibility criteria:
inclusion criteria: * patient is ≥ 18 years old at the time of the scan * patient has known or suspected coronary artery disease * patient has had a recent or will be scheduled for a diagnostic coronary angiogram * patient provides written informed consent * patient is referred for myocardial perfusion scan * patient is capable of complying with study procedures * patient is able to remain still for duration of imaging procedure (approximately 60 minutes total for both pet/ct) exclusion criteria: * patients who are pregnant or breast feeding * patients with contraindications to regadenoson
safety and efficacy of neuroflo technology in ischemic stroke (sentis)

Conditions: Cerebrovascular Accident

Summary: the purpose of this study is to assess the safety and efficacy of the neuroflo™ catheter for use in patients with ischemic stroke. the neuroflo device is intended to increase blood flow to the brain and potentially reduce the damage caused by stroke.

the study is a prospective, controlled, randomized, single-blind, multi-center study of neuroflo treatment plus standard medical management versus standard medical management alone. randomization will be 1:1 and stratified to ensure equivalent patient distribution between treatment and control for the following key parameters: 1. national institute of health stroke scale (nihss) at baseline (stratify \<10, 11-18) 2. time from symptom onset (tfso) to time of baseline nihss evaluation (stratify \<5 hrs, or ≥5 hrs).

Eligibility criteria:
inclusion criteria: * ischemic stroke * nihss between 5-18 * time from symptom onset less than 14 hours exclusion criteria: * hemorrhagic stroke * certain types of heart disease * kidney disease * other conditions the doctor will assess

Keywords: acute ischemic stroke randomized device treatment
referral recommendations for axial spondyloarthritis

Conditions: Spondyloarthropathy; Ankylosing Spondylitis; Spondyloarthritis

Summary: the purpose of this study is to determine which of the proposed screening parameters or which combination of screening parameters perform best in daily clinical practice for making the diagnosis of axial spondyloarthritis (spa)in patients with chronic low back pain.

ankylosing spondylitis (as) and its early form accounts for up to 5% of all patients with chronic back pain. shortening the delay of 5-10 years between first symptoms and making a diagnosis of as has become a challenge especially because effective treatments have become available. easy to apply referral parameters for physicians in primary care may contribute to make the diagnosis earlier. methods: orthopedists and primary care physicians were offered to refer patients with i) chronic low back pain (duration \>3 months) and ii) onset of back pain at an age \< 45 years to a specialized rheumatology outpatient clinic for further diagnostic work-up if at least one of the following screening parameters was present: 1) inflammatory back pain (ibp), 2) positive hla-b27, 3) sacroiliitis as detected by imaging. the final diagnosis was made according to expert opinion. it was analyzed, which parameters or combination of parameters performed best in making a diagnosis of axial spa.

Eligibility criteria:
inclusion criteria: * chronic back pain with a duration of more than 3 months * onset of back pain before age of 45 years exclusion criteria: * age younger than 18 years

Keywords: pre-radiographic screening early diagnosis
gynaecologic organ segmentation and motion tracking using ultrasound

Conditions: Cervical Cancer

Summary: this study will establish the feasibility and accuracy of localising and outlining the uterus on ultrasound images using both healthy volunteer and cervical patient cohorts. this will enable us to determine whether or not ultrasound will be a good option to ensure the correct patient position prior to radiotherapy for cervical cancer patients.

radiotherapy is an established and effective method for treating cancer, but it can have negative side effects if healthy tissues are also exposed to radiation. in the case of cervical cancer, the bladder, small bowel, and bone marrow are often irradiated, which can result in both short-term and long-term side effects. there are sophisticated radiation delivery techniques (known as imrt and vmat) which are capable of administering the radiation dose in a precise and controlled manner so that the intended target is irradiated and the healthy tissue is spared. however, the only way for these sophisticated radiation delivery methods to work in cervical cancer is to localise the uterus prior to radiotherapy treatment so that the lineup between the radiation beam and the target is ensured. the uterus is a relatively mobile organ, and can have very different positions within the body depending on the patient position, bladder volume, tumour site, etc. currently, we are unable to take advantage of the sophisticated radiation delivery techniques as we have no reliable way of seeing where the uterus is. ultrasound is a promising way to overcome this problem. ultrasound is non-ionising, has good soft-tissue contrast, and can easily be incorporated into the radiation treatment room. we wish to establish the feasibility and accuracy of localising and outlining the uterus on ultrasound images. this will enable us to determine whether or not ultrasound will be a good option to ensure the correct patient position prior to radiotherapy for cervical cancer patients.

Eligibility criteria:
inclusion criteria: * healthy volunteer cohort: healthy female adult volunteers * patient volunteer cohort: patients receiving radiotherapy for cervical cancer who will receive a planning ct scan and daily cbct scanning as part of their treatment. exclusion criteria: * both cohorts: women who have received hysterectomies and women who are pregnant at the time of the study

Keywords: imaging, ultrasound image-guided radiotherapy cancer
same day oral ec and implant initiation

Conditions: Contraception

Summary: this is a study for clients presenting for emergency contraception (ec). ec is used to prevent pregnancy after unprotected intercourse. clients presenting for ec may be offered either the copper or hormonal iud or oral ec. current guidelines allow for same-day implant initiation at the time of an ec encounter, as long as oral lng ec is co-administered. this study will look at pregnancy rates and clients willingness to receive same-day implant + oral ec and same-day iuds.

recommended options for ec include oral ec (levonorgestrel (lng), ulipristal acetate (upa), or combination oral contraceptive pills), or the copper intrauterine device (iud). recent data will also allow women presenting for ec to be offered the lng iud. these recommendations leave out the only other long-acting reversible contraceptive (larc), the eng implant. current guidelines allow for same-day eng implant initiation at the time of an ec encounter, as long as oral lng ec is co-administered. we lack data on pregnancy risk for the ec-eligible population desiring same-day eng implant placement and oral ec. women presenting for ec often need ongoing contraception, but clinical practice is not standardized in same-day counseling and initiation due to system, provider, and client-level barriers. interest in larc use continues to increase as well as same-day contraception initiation at the time of an ec encounter. women presenting for ec may not have considered larc options before. generating estimates and continuation rates for same-day initiation with an ec encounter will improve contraceptive options for women seeking ec.

Eligibility criteria:
inclusion criteria: * healthy women * age 18-35 years * fluent in english and/or spanish * bmi \< 30 kg/m2 * no known contraindication to either the eng contraceptive implant or oral lng ec using the cdc medical eligibility criteria for contraceptive use 2016 * negative urine pregnancy test * willing to abstain from further upi in the 7 days following insertion * know the date of their last menstrual period * regular menstrual cycle (24-35 days) * be willing to comply with the study requirements * desiring to avoid pregnancy for at least 12 months exclusion criteria: * current pregnancy or breastfeeding * previous use of oral ec in the current cycle * report of upi beyond 5 days in current cycle * vaginal bleeding of unknown etiology * allergy to lng or eng, iud or implant in-place * history of permanent contraception through sterilization or hysterectomy * monogamous partner with a vasectomy * depo-provera injection within past 15 weeks

Keywords: emergency contraception contraceptive implant