Kornimate/medical-research-clean huggingface dataset:
the effects of stress on the clinical performance of residents in simulated trauma scenarios

Conditions: Trauma; Stress

Summary: medical practice \& training are inherently stressful situations. however, the effects of stress on educational \& clinical performance are not well defined. the purpose of the current study is to examine the effects of stress on performance of residents in simulated trauma scenarios. the hypothesis is: 1) acutely stressful scenarios will be appraised as threat by residents and result in elevations of heart rate and salivary cortisol; 2) increased subjective \& physiological stress will result in impairments in performance; and 3) greater stress responses will result in greater clinical impairments.


Eligibility criteria:
inclusion criteria: * university of toronto general surgery \& emergency medicine residents exclusion criteria: * no atls training * residents from other programs

Keywords: trauma stress simulation
therapeutic effect of the low fodmap diet in children with functional abdominal pain.

Conditions: Functional Abdominal Pain Syndrome

Summary: diet components are important factors in pathogenesis of functional gastrointestinal disorders, especially in the irritable bowel syndrome. fermentable oligosaccharides, disaccharides, monosaccharides and polyols (fodmap) are a group of short chain, poorly absorbed and osmotically active carbohydrates, which can induce gastrointestinal symptoms because of rapid fermentation in different segments of the gut. low fodmap diet is a novel treatment option with proven efficacy in reducing symptoms of functional gastrointestinal disorders in adults. conversely, although functional abdominal pain is a common health problem in children, the efficacy of a low fodmap diet remains understudied in this population. the aim of this study was to compare the effects of two diets: a low fodmap diet and a diet based on standard dietary advice of the national institute for health and care excellence (nice), on abdominal symptoms in children with functional abdominal pain.


Eligibility criteria:
inclusion criteria: * functional abdominal pain according to rome iii criteria * consent to participate in the study * positive decision of gastroenterologist concerning enrolment of the patient to the trial exclusion criteria: * organic causes for gastrointestinal tract disorders, * occurrence of an abdominal migraine, ibs, food allergies or intolerances, other significant disorders, acute infection * antibiotic treatment within the last 8 weeks

Keywords: low fodmap diet functional abdominal pain children
oxytocin vs. prostaglandin for induction of labor in primiparas with prelabor rupture of membrane and low bishop

Conditions: Premature Rupture of Fetal Membranes

Summary: the purpose of the study is to compare between oxytocin to prostaglandin (pge2), regarding time from induction of labor (iol) to delivery among primiparas at term with prelabor rupture of membrane (prom) and an unfavorable cervix.

the purpose of the study is to compare between oxytocin to prostaglandin (pge2), regarding time from induction of labor (iol) to delivery among primiparas at term with prelabor rupture of membrane (prom) and an unfavorable cervix. our secondary outcome is to compare between the groups regarding obstetric complications including: cesarean delivery, operative vaginal delivery, maternal intrapartum fever, postpartum hemorrhage, apgar score at 5 minutes ≤ 7, ph, admission to nicu and the time from initiation of induction to active labor. the study population will include primiparous at term with prom and unfavorable bishop score (≤3). subsequent to confirming inclusion criteria and after receiving informed consent parturients will be randomly allocated to receive oxytocin or pge2. induction with oxytocin (group 1) will be initiated by infusion of intravenous oxytocin: 2.5 miu per minute with increments of 2.5 miu every 20 minutes until achieving 4-5 contractions during 10 minutes. then after continuous infusion without increasing oxytocin dose will be continued. in case of lack of painful contraction/active labor after 24 hours with oxytocin a trial with pge2 will be initiated (as described for group 2) induction with pge2 (group 2) will be initiated by inserting to the posterior fornix pge2 2 mg, this will be repeated every 6 hours until achieving painful contractions or up to 4 doses (24 hours). in case of lack of painful contraction/active labor after the fourth dose of pge2 a trial with oxytocin will be initiated (as described for group1). failed induction will be defined for parturients who failed to develop active labor after 48 hours from initiation of induction. decisions regarding management of labor including all aspects of labor (augmentation, delivery, postpartum) will be made by the physician in charge and will be based on standards of our labor room.

Eligibility criteria:
inclusion criteria: age 18-38 years primiparas term (37-42) efw 2500-4000 prom \< 12 hours confirmed prom no painful contractions vertex presentation willing to be induced bishop score: (3 or less) cervix: elongated, posterior, closed, firm-medium, head sp-1 or higher exclusion criteria: intrauterine growth retardation preterm\<37 weeks painful contraction other reasons for induction aside from prom as: severe pih, uncontrolled gdm medical conditions that the researcher thinks will affect the outcome -

Keywords: premature rupture of membrane primipara term bishop
drug use investigation for volibris® (ambrisentan) (pulmonary arterial hypertension)

Conditions: Hypertension, Pulmonary

Summary: the objective of this post-marketing surveillance study is to evaluate the incidence of adverse events in japanese subjects with pulmonary arterial hypertension treated with ambrisentan basd on prescribing information under the conditions of general clinical practice and also to grasp the following items; 1. unknown adverse drug reactions (adrs) 2. incidence of adrs to medical products in actual clinical practice 3. factors influencing safety of ambrisentan 4. factors influencing efficacy of ambrisentan 5. prognosis of subjects as well as efficacy and safety of ambrisentan in long-term use (volibris® is a trademark of gilead sciences, inc,. that gsk uses under license.)


Eligibility criteria:
inclusion criteria: * must use ambrisentan for the first time exclusion criteria: * subjects with hypersensitivity to ambrisentan * subjects who is pregnant or might be pregnant * subjects with severe hepatic disorder
long-term intraocular lens (iol) decentration and tilt in eyes with pseudoexfoliation syndrome (pes) following cataract surgery

Conditions: Cataract; Pseudoexfoliation Syndrome; Pseudophakia

Summary: to evaluate long-term intraocular lens (iol) decentration and tilt in eyes with pseudoexfoliation syndrome (pes) following cataract surgery using visante anterior segment oct and itrace visual function analyzer.

64 eyes following cataract surgery from 2009 to 2012 were included, 34 eyes had pes, 30 eyes did not show pes. a standard phacoemulsification procedure followed by iol implantation was performed and patients were followed 4-6 years after surgery (mean=69 months). best corrected visual acuity (bcva), intraocular pressure (iop) and capsulorhexis size were measured. iol tilt and iol decentration were evaluated using visante omni anterior segment oct (carl zeiss jena gmbh, germany). the itrace vfa (visual function analyzer, topcon medical systems, inc.) was used to measure internal, corneal and total optical aberrations.

Eligibility criteria:
inclusion criteria: * patients 4-6 years after standard cataract surgery * pseudoexfoliation syndrome (pes) exclusion criteria: * diabetic retinopathy * age related macula degeneration * retinal bloodvessel disease

Keywords: pseudoexfoliation syndrome cataract aberration iol decentration iol tilt
effects of non-invasive ventilation on function diaphragmatic and caval distension

Conditions: Healthy

Summary: introduction: understanding how the applicability of non-invasive ventilation can directly affect the anatomy and diaphragmatic function, as well as the opening diameter of the inferior vena cava in healthy individuals is fundamental to knowing how this therapy can interfere with treatment results. objective: identify the acute effects of peep and ventilatory support pressure on thickening fraction, diaphragmatic mobility and vena cava distension in healthy people. methods: this is a crossover, randomized study, blinded to the evaluator and the researcher responsible for the statistical analysis. volunteers will undergo a niv session, randomized into groups: cpap, bi-level and spontaneous breathing, without niv support (control). the outcomes evaluated will be diaphragmatic ultrasound and inferior vena cava distensibility. the cpap levels will be: 5, 10 and 15 cmh2o after 5 minutes of use and in the bi-level group we will maintain the peep value at 5cmh2o and modify the pressure support values to the values: 5, 7 and 10 cmh2o pressure support, with all outcomes also being assessed after 5 minutes. participants will remain in a supine position, with the right upper limb positioned behind the head, throughout the protocol and all measurements will be collected in the inspiratory and expiratory phases with volumes basal currents. for statistical analysis, intention-to-treat analysis will be employed and groups will be compared using student's t-test, for continuous variables, or chi-square, for categorical variables. anova split-plot, repeated measures for primary occurrences. analyzes of covariance to identify differences between groups using baseline scores as covariates. effect sizes and confidence intervals will be calculated using eta squared (η²). expected results: elucidate the effects of different blood pressure levels on diaphragmatic function and inferior vena cava distension.


Eligibility criteria:
inclusion criteria: * healthy volunteers; * age equal to or over 18 years old and under 50 years old. exclusion criteria: * cardiopathy; * pneumopathy; * participants who develop any disabling condition that prevents completion of the protocol.

Keywords: non-invasive ventilation diaphragmatic ultrasound inferior vena cava
electric stimulation on nausea and vomit chemotherapy induced

Conditions: Breast Cancer Female; Acupuncture

Summary: chemotherapy induces nausea and vomit for some large patients. but, some chemotherapy protocol has a high indices of the incidence as observed in a combination of anthracycline and cyclophosphamide (ac). to prevent this symptoms, some medication can be used as ondansetron. by other hands, the traditional acupuncture on chinese medicine have been used a pc6 point to avoid nausea and vomit. more recently, a transcutaneous electric nerve stimulation (tens) also has been used for this application. our study will test the tens applied on pc6 point with two different frequencies (high and low) to evaluated the nausea and vomit inhibition effects.

we will enroll 84 women that being starts a chemotherapy protocol with a anthracycline and cyclophosphamide (ac) as a part of breast cancer treatment. all volunteers will be submitted a 30 minutes tens prior to chemotherapy administration. three different tens treatment will be test: 1) placebo; 2) high frequency and 3) low frequency. the self-adhesive electrodes will be positioned in the same position for all different tens treatment (opposite arm to the chemotherapy infusion). the eletctrodes will be positioned as follows: the first electrode at the pc6 point which is located proximal to the flexion fold of the wrist in the middle of the anterior face of the forearm, between the tendons of the long palmar and radial flexor muscles of the carpus and the second electrode at any point in the hand. after that, all volunteers will receipt a formulary to self-complete a nausea and vomit symptoms record during the next 24 hours. number of incidence and magnitude of the symptoms will express the accumulated indices the occurrence and severity of the symptoms, as further describe in this protocol.

Eligibility criteria:
inclusion criteria: * having breast cancer diagnosed through anatomopathological investigation; * indication of neoadjuvant or adjuvant chemotherapy treatment with the combination of anthracycline and cyclophosphamide associated with ondasetron used as a routine of the santa rita hospital chemotherapy service; * present karnofsky score (kps) higher than 70 points; * being female; * be between 18 and 65 years of age and be able to participate in outpatient chemotherapy. exclusion criteria: * patients with breast cancer treated with chemotherapeutic regimens other than anthracycline and cyclophosphamide; * inability to report nausea and vomiting due to neurological changes, difficulty understanding and / or lack of caregivers that may contribute to the completion of the report; * be submitted to radiation therapy concomitant with chemotherapy; * presence of gastrointestinal and cerebral metastases; * presence of cardiac pacemaker; * presence of active skin infection in pc6; * nausea and vomiting caused by electrolyte disturbances or intestinal; * presence of intra-cranial hypertension.

Keywords: chemotherapy nausea vomiting transcutaneous electrical acupoint stimulation
l-carnitine in modulating pain and inflammation in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this study aims at evaluating the possible efficacy and safety of l-carnitine in rheumatoid arthritis via targeting jak/stat pathway and tgf-β1


Eligibility criteria:
inclusion criteria: * patients with active rheumatoid arthritis (not in remission) according to american college of rheumatology/european league against rheumatism (acr/eular) 2010 criteria (9) i.e., 28 joints disease activity score (das-28) \>2.6. * patients receive the conventional dmards * both sexes. * age range between 18 and 70 years old. exclusion criteria: * patients with heart disease (congestive heart failure, arrhythmia, hypertension, ischemic heart diseases), diabetes, active infection, other illness except rheumatoid arthritis. * patients with renal and hepatic dysfunction. * patients receiving biological dmards. * patients receiving oral prednisolone greater than 15 mg/day. * patients with hypersensitivity to study medications. * patients using antioxidants. * pregnant and lactating females.
spinal sufentanil for obstetric analgesia

Conditions: Labor Pain

Summary: background: this descriptive study was designed to evaluate effects and adverse effects of spinal sufentanil for relief of labor pain in primi- and multiparous women. methods: the retrospective study design was approved by the regional human research ethics review board, lund, sweden (dnr 2015/687). the investigators included 164 (82 primi- and 82 multiparous) obstetrical patients given 10 µg of intrathecal sufentanil for labor pain. any maternal hypotension, third- or fourth-degree perineal tear, intrapartum cesarean section, abnormal fetal heart rate, low apgar score, use of neonatal intensive care, postdural puncture headache, epidural blood patch, and breastfeeding problem was recorded. major outcome measures were maternal satisfaction with pain relief, and provision of supplementary analgesia.

a total sample size of 150 parturients had been calculated to enable differences of at least 20 % versus 5.0 % in proportions of obstetrical and neonatal problems between (equal numbers of) primi- and multiparous mothers to be statistically confirmed with 80 % power and 95 % probability. descriptive parametric data is reported as mean ± standard deviation (sd), and descriptive non-parametric data as median with interquartile range (iqr). proportions are reported in percent with 95 % confidence interval (ci). parametric data was compared with two-tailed unpaired student's t-test, and non-parametric data with the mann-whitney u-test. proportions were analyzed with two-tailed fisher's exact test. probability (p) values at \< 0.05 were considered statistically significant.

Eligibility criteria:
inclusion criteria: intrathecal sufentanil for labor pain exclusion criteria: demographic, obstetrical or neonatal data is missing

Keywords: labor intrathecal sufentanil obstetrical spinal analgesia
safety evaluation of dexmedetomidine for ebus-tbna

Conditions: Lung Cancer

Summary: lung cancer is the second most commonly diagnosed primary neoplasia in canada accounting for 22 865 new cases in 2007. recent randomized trials have shown a significantly better diagnostic yield and fewer unnecessary thoracotomies with endobronchial ultrasound-guided transbronchial needle aspiration (ebus-tbna) when compared to conventional tbna for various clinical conditions including peripheral pulmonary lesions and sarcoidosis. ebus-tbna are now routinely performed in our institution for staging of pulmonary and mediastinal cancer. ebus-tbna are performed under monitored anesthesia care (mac) in the endoscopy suite at the centre de soins ambulatoires of the hôpital maisonneuve-rosemont. remifentanil, used in combined regime or as single agent proved to be effective and safe for mac. nonetheless, anesthesiologists are still confronted to the respiratory depression profile of remifentanil and other commonly used agents. an analysis of the asa closed claims demonstrated that respiratory depression remains a significant drawback during mac in remote locations. furthermore, patients with coexisting pulmonary diseases scheduled for ebus-tbna are at increased risk of such complications. the investigators hypothesize that compared to the use of remifentanil-based mac protocol, the use of dexmedetomidine-based mac protocol for ebus-tbna will result in a lower incidence of major respiratory and hemodynamic adverse events (bradypnea, apnea, oxygen desaturation, hypotension, hypertension, bradycardia and tachycardia) with equivalent overall procedure conditions.

see above

Eligibility criteria:
inclusion criteria: * subjects with planned ebus-tbna under conscious sedation. * age 18-75 years old. * american society of anesthesiologists class i-iii. * the subject is able to understand the study objectives, the experimental protocol and procedures, and is capable of providing an informed consent. exclusion criteria: * subjects allergic to any of the study drugs. * bmi \> 34 kg/m2. * severe renal or hepatic failure. * pregnancy. * emergent procedure. * heart failure nyha \> iii. * systolic blood pressure \< 90 mmhg. * advanced heart block (unless patient has a pacemaker). * unstable angina and/or myocardial infarction within past 6 weeks. * fev1 ≤ 0.8 l. * oxygen-dependent patient. * use of α2-adrenoreceptor agonist or antagonist within 14 days.

Keywords: ebus-tbna dexmedetomidine precedex remifentanil ultiva monitored anesthesia care sedation bronchoscopy lung cancer mediastinal node cancer staging anesthesia remote location
a placebo-controlled, randomized, safety and efficacy study to evaluate the change in hemoglobin a1c levels in type 2 diabetic subjects while taking nutralin

Conditions: Diabetes

Summary: the purpose of this clinical research study is to evaluate the effects an investigational food product has on the blood sugar and insulin levels in individuals with diabetes.

the investigational product has helped decrease the amount of insulin needed in treating diabetic dogs and has improved the dogs' longevity and quality of life. observational analysis by trained veterinarians has indicated that the natural fluctuations in blood glucose levels do not exist in dogs consuming the product. an initial phase 1 study tested the product in a brownie form. the product has been reformulated to capsule form for the phase 2 study. the hypothesis for this study is that diabetic individuals will decrease their insulin/diabetic medication usage and have a decrease in glucose levels after consuming the product for 16 weeks.

Eligibility criteria:
inclusion criteria: * men and women who are at least 18 years old * diagnosis of type 2 diabetes * has been on stable diabetes medication/insulin for the past three months exclusion criteria: * women who are pregnant, breastfeeding or planning to become pregnant * diagnosis of celiac disease or gluten intolerance * current or active kidney disease * current or active liver disease * any food allergies

Keywords: diabetes blood sugar insulin nutritional supplement nutraceutical
medial collateral ligament reconstruction with anteromedial reinforcement for medial and anteromedial rotatory knee instability

Conditions: Collateral Ligament, Knee; Sprain (Strain), Medial; Anterior Cruciate Ligament Injuries

Summary: the aim of this study is to assess the outcomes of the combined quadriceps tendon-bone (qtb) aclr and mclr with anteromedial reinforcement performed as described in the published technique: k. malinowski, k. hermanowicz, a. góralczyk, r.f. laprade, medial collateral ligament reconstruction with anteromedial reinforcement for medial and anteromedial rotatory instability of the knee, arthrosc. tech. 8 (2019) e807-e814. https://doi.org/10.1016/j.eats.2019.03.019.

medial collateral ligament (mcl) injuries are one of the most common sports knee injuries, commonly occuring together with anterior cruciate ligament (acl) injuries. their effect on the knee joint can be detrimental with patients experiencing medial instability and anteromedial rotatory instability (amri), leading to progressive damage of the intraarticular structures. while healing potential of medial knee stabilizing structures is relatively high, medial collateral ligament reconstruction (mclr) is sometimes indicated. multiple reconstructions techniques were described, including both procedures utilizing native semitendinosus tendon with distal attachment left intact as well as with auto- or allo-grafts. however, in part of these techniques, amri is not addressed. therefore, the aim of this study is to assess the outcomes of the combined quadriceps tendon-bone (qtb) aclr and mclr with anteromedial reinforcement performed as described in the published technique: k. malinowski, k. hermanowicz, a. góralczyk, r.f. laprade, medial collateral ligament reconstruction with anteromedial reinforcement for medial and anteromedial rotatory instability of the knee, arthrosc. tech. 8 (2019) e807-e814. https://doi.org/10.1016/j.eats.2019.03.019. the primary outcome consists of the international knee documentation committee questionnaire (ikdc) and the knee injury and osteoarthritis outcome score (koos).

Eligibility criteria:
inclusion criteria: * symptomatic knee medial and anteromedial rotatory instability associated with anterior and rotatory instability after an mcl + acl injury * primary cases exclusion criteria: * active inflammation of the knee * revision cases * additional plc, pcl or pfj injuries * fractures around the knee * removal of more than ½ of medial or lateral meniscus * contralateral knee injury * cartilage damage icrs grade iii or higher * non-adherence of the patient to the treatment protocol
study of brinzolamide and timolol when added to travoprost in primary open-angle glaucoma or ocular hypertension

Conditions: Primary Open-angle Glaucoma; Ocular Hypertension; Pigment Dispersion Glaucoma

Summary: the purpose of the study is to compare the efficacy and safety of timolol 0.5% solution to brinzolamide 1% each given twice daily when added to travoprost 0.004% given each evening.


Eligibility criteria:
inclusion criteria: * patients who are treated with any prostaglandin analogue monotherapy (excluding unoprostone) and who have an intraocular pressure between 19 and 32 mmhg at 08:00 hours. exclusion criteria: * under 18 years