Kornimate/medical-research-clean huggingface dataset:
coronary computed tomography versus invasive angiography for non-st elevation acute coronary syndrome

Conditions: Ischemic Heart Disease; Non STEMI; Angina Pectoris, Unstable; Coronary Disease; Heart Attack; Acute Myocardial Infarction (AMI); Randomized Controlled Trial; Diagnostic Imaging; Coronary Stenoses; Coronary Artery Disease; Multidetector Computed Tomography; Percutaneous Coronary Intervention

Summary: coronary computed tomography angiography (ccta) is a widely accepted initial diagnostic test for individuals suspected of having chronic coronary syndromes. however, there is limited evidence supporting its use in the acute setting. so far, no large-scale randomized trial has examined the performance of ccta as an alternative to invasive coronary angiography (ica) in individuals with non-st-segment elevation myocardial infarction (nsteacs). if ccta were to replace ica as a routine procedure for individuals with nsteacs, it could reduce the risk of complications related to ica, improve patient comfort, expedite decision-making, and reduce healthcare expenses and interhospital transfers.


Eligibility criteria:
inclusion criteria: * admitted with non-st-segment elevation myocardial infarction or unstable angina pectoris and an indication for subacute ica * elevated troponin or ischemic electrocardiographic changes * written informed consent exclusion criteria: * instability requiring acute or emergent ica * history of percutaneous coronary intervention or coronary artery bypass grafting * estimated glomerular filtration rate \&lt; 30 ml/min/1.73m2 * probable type 2 acute myocardial infarction * severe valvular heart disease as primary diagnosis or potential need for valve intervention * history of spontaneous coronary artery dissection * expected poor quality of the ccta * prior ccta or ica during index admission or within 1 week * known allergy to beta-blockers or contrast agent * pregnant or nursing * previously randomized in this trial

Keywords: angiography computed tomography coronary non-steacs ccta ica randomized interventional triage traction diagnostic imaging interventional cardiology verdict ct coronary angiography complications coronary ct-team ischemic heart disease acute myocardial infarction non-st-elevation myocardial infarction (nstemi) unstable angina pectoris percutaneous coronary intervention coronary artery bypass grafting pci cabg diagnostic procedure interhospital transfers myocardial ischemia
longitudinal acute air pollution systemic effects

Conditions: Healthy

Summary: air pollution continues to be a key global issue with many governments focusing great attention on air quality legislation because of its harmful environmental and health impacts. whilst there is much that remains unknown about the mechanisms underlying the negative health effects of air pollution, it is generally acknowledged that air pollution exposure leads to an increase in cardiovascular, cerebrovascular and respiratory mortality and morbidity. the current study will investigate systemic effects during a 72 hour period after a controlled diesel exhaust exposure.

exposure to air pollution (both indoor and outdoor sources) contributes to the premature deaths of 7 million people each year, primarily linked to cardiovascular and respiratory conditions. within the complex mixture which air pollution comprises, combustion derived particulate matter (pm) has been suggested as one of the most harmful components to the cardiopulmonary system. in urban areas pm derived from combustion originates largely from diesel vehicles. numerous experimental chamber studies have demonstrated respiratory as well as cardiovascular dysfunctions after the inhalation of diesel exhaust. many of these dysfunctions are driven by inflammation and oxidative stress. there is much less knowledge concerning the systemic effects of diesel exhaust exposure, and especially over longer time courses than 24 hours. the investigators aim to investigate the time course of systemic effects (such as markers of inflammation, cardiovascular dysfunction, and oxidative stress) in blood and urine samples taken after a diesel exhaust exposure. the effects of exercise or rest in an experimental chamber exposure will also be investigated.

Eligibility criteria:
inclusion criteria: * normal clinical examination * normal ekg * normal routine blood tests * normal lung function * normal skinprick test exclusion criteria: * cardiovascular disease * diabetes mellitus * asthma and/or allergy * smoking

Keywords: diesel exhaust oxidative stress systemic inflammation air pollution
s100b kinetic during the occurrence and treatment of delayed cerebral ischaemia after a subarachnoid haemorrhage.

Conditions: Subarachnoid Hemorrhage

Summary: nearly half of the survivors of subarachnoid haemorrhage (sah) retain irreversible neurological damage resulting from the early lesions associated with the initial bleeding, and the occurrence of possible delayed cerebral ischaemia (dci). the early diagnosis of the occurrence of an dci is therefore a major challenge in order to optimise management before irreversible lesions are formed. however, the means of diagnosis are often not available, and up to a third of dci are discovered on follow-up images when the lesions are already present. among the markers of brain injury, s100 calcium-binding protein b (s100b) is an astrocyte protein released into the bloodstream at the time of the appearance of a brain lesion. its short half-life makes it a prime candidate for patient follow-up to diagnose a new ischemic lesion and assess the effectiveness of its management. among the elements at the origin of dci, the occurrence of proximal vasospasm is the main element on which we can have a therapeutic action. the strategy implemented in the department consists of performing a mechanical angioplasty when proximal vasospasm is detected with a decrease in downstream cerebral perfusion. nevertheless the benefit of this therapeutic action is discussed and there is currently no early marker of the effectiveness of this procedure.


Eligibility criteria:
inclusion criteria: * adults * patient hospitalised in the neurological intensive care unit for a subarachnoid haemorrhage. * delayed cerebral ischaemia suspected during routine care. * presence of a catheter (arterial or venous) for repeated sampling. * patient having been informed and having formulated his non-opposition or close to the patient having been informed and having formulated his non-opposition. in this case, the patient's non-opposition will be collected as soon as his condition allows it. exclusion criteria: * pregnant or breastfeeding women in class. * patients under legal protection, guardianship, curatorship, under judicial safeguard. * patients participating in a study that may interfere with this study. * persons under psychiatric care under duress

Keywords: subarachnoid haemorrhage s100b delayed cerebral ischemia
the effectiveness of metoprolol in the prevention of syncope recurrence in children and adolescents

Conditions: Syncope, Vasovagal

Summary: the purpose of this study to evaluate the effectiveness of metoprolol versus conventional treatment in the prevention of syncope recurrence in children and adolescents.

syncope is often a frustrating clinical problem seen in pediatric patients. most pediatric syncope is benign, and vasovagal syncope (vvs) is the most common type of syncope seen in children . the diagnosis of vvs is established by history, often confirmed by tilt tests. a wide range of drugs has been proposed for vvs , with β-adrenergic blocking agents being first-line therapy. however, clinical studies have shown conflicting results in terms of therapy effectiveness. β-blockers have been claimed to be effective for 60% to 100% of young patients in many uncontrolled studies but not in most short- and long-term controlled studies . sheldon et al., in a recent multicenter, double-blinded, placebo-controlled, randomized study of adult patients, reported that metoprolol was not effective in preventing vvs. to our knowledge, no pediatric randomized controlled trials with long-term follow-up have demonstrated the efficacy of β-blockers for the prevention of syncope.

Eligibility criteria:
inclusion criteria: * children with a history of syncope were included if they had had at least three syncopal episodes per year and had a positive head-up tilt test result. exclusion criteria: * patients were excluded if they had: * other causes of syncope; * cardiovascular and/or systemic disease; * systolic blood pressure \>130 mm hg or diastolic blood pressure \>90 mm hg； or * history of asthma, impaired liver function, ⅱ to ⅲ degrees of atrioventricular block, sinus bradycardia \< 40 beats/min, or other contraindications for β-blockers.

Keywords: metoprolol and syncope
study of glpg1837 in subjects with cystic fibrosis (g551d mutation)

Conditions: Cystic Fibrosis

Summary: 32 cystic fibrosis patients with the g551d mutation will be treated for 4 weeks, consisting of three consecutive treatment periods: two 1-week periods followed by one 2-week period, evaluating one dose of glpg1837 each. after the treatment period, there is a 7-10 days follow-up period. during the course of the study, subjects will be examined for any side effects that may occur (safety and tolerability). changes in sweat chloride will be assessed as biomarker from baseline onwards, and changes in pulmonary function (efficacy) will be explored throughout the study. the amount of glpg1837 present in the blood (pharmacokinetics) will also be determined.


Eligibility criteria:
inclusion criteria: * male or female subjects ≥ 18 years of age, with a confirmed diagnosis of cystic fibrosis * subjects with gating g551d cftr mutation on at least one allele in the cftr gene * subjects currently receiving treatment with ivacaftor on a stable regimen or not on a treatment regimen with ivacaftor, for at least 2 weeks prior to screening * weight ≥ 40.0 kg * subjects on stable concomitant treatment regimen for at least 4 weeks prior to baseline (excluding ivacaftor) * pre- or post-bronchodilator fev1 ≥ 40% of predicted normal * subject will have to use highly effective contraceptive methods exclusion criteria: * on an ivacaftor-containing treatment regimen and unable or unwilling to discontinue ivacaftor for the washout and treatment periods of the study * concomitant use of antifungal drugs within 4 weeks of baseline * a history of a clinically meaningful unstable or uncontrolled chronic disease * liver cirrhosis and portal hypertension * any significant change in the medical regimen for pulmonary health within 4 weeks of baseline * unstable pulmonary status or respiratory tract infection or changes in therapy for pulmonary disease within 4 weeks of baseline * abnormal liver function * clinically significant abnormalities on ecg * history of malignancy, solid organ/haematological transplantation * abnormal renal function * participation in another experimental therapy study within 30 days or 5 times halflife

Keywords: cystic fibrosis g551d mutation glpg1837
methods to enhance azr-md-001 for meibomian gland dysfunction (mgd)

Conditions: Meibomian Gland Dysfunction

Summary: single-center, single-masked (the individual(s) performing efficacy and safety measures will be masked to treatment assignment for the patient(s) they are assessing), vehicle-controlled, randomized study.

randomized study with 6 visits. for all dose groups a screening visit will be followed by a baseline visit 14 days later (qualification period). at the end of the qualification period patients who still exhibit signs of meibomian gland dysfunction (mgd) at the baseline visit will be enrolled into a 3-month treatment period. at the baseline (day 0) visit, patients will be randomly assigned to receive either azr-md-001 ointment/semi-solid drug or azr-md-001 vehicle twice-weekly.

Eligibility criteria:
inclusion criteria: * evidence of meibomian gland obstruction (based on a meibomian gland secretion (mgs) score of ≤12 for 15 glands of the lower lid) in both eyes at the baseline visit * reported dry eye signs and symptoms within the past 3 months: ocular surface disease index (osdi) score ≥ 13; tbut \< 10 seconds in both eyes exclusion criteria: * uncontrolled ocular disease (except for mgd) or uncontrolled systemic disease * patient has glaucoma or ocular hypertension as demonstrated by an intraocular pressure (iop) in either eye at screening of ≥24 mm hg determined by goldman applanation tonometry or has planned insertion/removal of glaucoma filtration shunts/devices during the study * corneal abnormality or disorder that impacts normal spreading of the tear film (keratoconus, pterygia, scarring) or corneal integrity * recent (within the past 3 months of the baseline visit) ocular surgery, trauma, herpes, or recurrent inflammation * contact lens use anticipated during the study
study to assess the impact of vaccination on hospitalizations and outpatient visits due to rotavirus gastroenteritis

Conditions: Infections, Rotavirus; Rotavirus Vaccines

Summary: this study aims at assessing the impact of rv vaccination in hospitals in nagoya city (administrative district), japan, where rv vaccines have been introduced since november 2011 and financial support for vaccination costs by nagoya city, japan have been implemented from october 2012.

the electronic admission database or any other applicable database of the hospital will be reviewed to identify hospitalized children/children with outpatient visits/emergency room visits, less than five years of age who had been diagnosed with acute gastroenteritis (age) or rv ge either by the international classification of diseases and related health problems 10th revision (icd 10) diagnostic code (aa00-aa09 for intestinal infectious diseases and a08.0 for rv specific ge) or by rv positive rapid diagnosis kit results. note: the outcomes for the outpatient and emergency room visits will be assessed only in case the data for outpatient and emergency room visits can be obtained from at least one of the study centers.

Eligibility criteria:
inclusion criteria: - children aged less than five years visiting hospitals for rv ge or age from 2007 to 2016, who live in the study area. exclusion criteria: - not applicable.

Keywords: impact vaccination hospitalizations rotavirus gastroenteritis japan
hemodynamic response to pain during retinopathy of prematurity screening

Conditions: Preterm

Summary: study of cerebral hemodynamic changes in preterm infant and the effect of topical anesthetic eye drops ( benoxinate hydrochloride 0.4% ) on pipp score and cerebral hemodynamic changes during fundus examination in neonates with gestational age ≤ 34 weeks or birth weight ≤ 2.000 kg regardless their gestational age , after postnatal day 28.


Eligibility criteria:
inclusion criteria: preterm infants with gestational age ≤34 weeks or infant with birth weight ≤ 2.000 kg regardless their gestational age,with postnatal age ≥ 28 days undergoing routine rop screening. exclusion criteria: patients with any of the following will be excluded at the time of assessment: * evidence of intrauterine infection (torch). * chromosomal abnormalities. * major congenital anomalies. * major brain pathology such as grade 3-4 intraventricular hemorrhage and periventricular leukomalacia.
long-term study of safety and efficacy of welchol® as an additional therapy in patients with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: this extension study is designed to evaluate the long-term safety and tolerability of colesevelam hydrochloride (welchol®) in patients with type 2 diabetes.


Eligibility criteria:
inclusion/rollover criteria: * patients who have completed studies wel-301, wel-302, or wel-303 with treatment compliance at least 80% * patients who have completed studies wel-301, wel-302, or wel-303 who have not met withdrawal criteria

Keywords: open label, diabetes mellitus long term safety study, extension study
pain perception comparison of computerized vs conventional injection methods

Conditions: Pain Perception; Local Anesthesia

Summary: this study was conducted to a comparison of pain perception for nerve block and infiltration injection using the conventional method and two computerized control systems.

the study evaluates and compares pain perception of the inferior alveolar nerve block (ianb) and buccal infiltration anaesthetic in children using a conventional syringe, sta single tooth anesthesia® system and star pen anaesthesia device.

Eligibility criteria:
inclusion criteria: 1. apparently healthy children (5-8) years old, and free from systemic diseases. 2. children who require local anesthetic injection for any dental treatment. 3. cooperative children (positive or definitely positive on frankel's scale). 4. children who have no contraindications to the usage of selected local anesthetic agents. exclusion criteria: * all that does not correspond to inclusion criteria.

Keywords: pain perception inferior alveolar nerve infiltration local anesthesia sta single tooth anesthesia® system star pen anesthesia device conventional syringe
the effects of acute ketone monoester supplementation on 20-minute time-trial performance in trained cyclists

Conditions: Exercise; Ketosis

Summary: diet can alter blood ketone levels and this in turn may affect exercise capacity. this study will determine if the acute ingestion of a ketone supplement alters cycling time trial performance. participants will perform two trials in a randomized order. each trial will involve a 20-minute bout of cycling on a stationary ergometer. participants will ingest either a ketone supplement or a taste-matched placebo drink prior to exercise. blood samples will be obtained to assess selected metabolic responses. this study will provide information regarding the effect of ketone supplementation on exercise responses.

this study will determine if the acute ingestion of a ketone supplement alters cycling time trial performance. trained participants with competitive cycling experience will be recruited. exercise will involve a 20-minute bout of cycling on a stationary ergometer with the goal of producing the highest power output possible. participants will ingest either a ketone supplement or a taste-matched placebo drink prior to exercise using a randomized, double-blind crossover design. diet prior to exercise will be standardized between trials for a given participant. blood samples will be obtained to assess selected metabolic responses. this study will provide information regarding the effect of ketone supplementation on exercise responses.

Eligibility criteria:
inclusion criteria: * habitually ingesting \>50 g of dietary carbohydrate daily i.e. not following a ketogenic diet. * regularly performing cycling exercise at least 3 days per week and for a total of ≥5 hours per week. * having an estimated peak oxygen uptake of ≥55 ml/kg/min for males and ≥48 ml/kg/min for females based on the online fitness calculator available at: www.worldfitnesslevel.org. * having competitive cycling experience. exclusion criteria: - experiencing a condition that might preclude safe participation in physical activity and exercise, as determined by answering "yes" to any question on page 1 of the canadian society for exercise physiology get active questionnaire.

Keywords: performance
postoperative pain control with lipossomic extended release bupivacaine

Conditions: Pain, Postoperative; Lung Cancer

Summary: randomized trial of intraoperative intercostal block with bupivacaine with epinephrine compared to lipossomal extended release bupivacaine.

patients undergoing minimally invasive thoracic surgery will be randomized to receive 0.05% bupivacaine with 1:200,000 epinephrine (control group) or extended release lipossomal bupivacaine. primary outcomes are postoperative pain measured by visual analog scale, amount of morphine equivalent narcotics used, and postoperative complications. patients are excluded if they undergo open thoracotomy, or minimally invasive decortication.

Eligibility criteria:
inclusion criteria: patients who will be undergoing minimally invasive thoracic surgery * patients who will be undergoing minimally invasive thoracic surgery exclusion criteria: * open surgery * chronic use of narcotics * use of pregabalin or similar * significant liver or kidney dysfunction

Keywords: bupivacaine lipossomal extended release bupivacaine intercostal nerve block thoracic surgery minimally invasive surgery
a study to assess safety, tolerability, and efficacy of htl0018318 in patients with dementia with lewy bodies

Conditions: Dementia With Lewy Bodies

Summary: to establish the safety and efficacy of htl0018318 compared with placebo when administered once daily for 12 weeks to patients with dementia with lewy bodies.

to assess the safety, tolerability and efficacy of htl0018318 at 3 dose levels (once daily) compared with placebo over a 12-week treatment period in patients with dementia with lewy bodies (dlb). approximately 140 dlb patients who have not received donepezil (aricept®) and/or other acetyl cholinesterase inhibitors (achei) and approximately 32 dlb patients who have had prior treatment experience with donepezil but have stopped usage will be enrolled.

Eligibility criteria:
inclusion criteria: * diagnosed with probable dlb according to the fourth revision of consensus diagnostic criteria for dlb. * clinical imaging evidence from either spect or mibg cardiac scintigraphy that is consistent with a clinical diagnosis of dlb. * partner or caregiver able to support the patient for the duration of the clinical trial. exclusion criteria: * patients with a diagnosis of parkinson disease at least 1 year prior to onset of dementia. * patients with the presence of severe extrapyramidal symptoms * patients with the presence of an illness/condition apart from dlb that could contribute to cognitive dysfunction * patients with poorly controlled hypertension despite lifestyle modifications and/or pharmacotherapy, who are currently on more than 2 different antihypertensive treatments * patients with prominent, recurrent episodes of syncope are related to orthostatic hypotension * patients with pulmonary disease or evidence of clinically significant moderate or severe pulmonary symptoms * patients who are taking a range of prohibited and restricted medication * patients who have been prescribed individualised cognitive rehabilitation, stimulation or training that was performed under medical supervision in the 6 months prior to the screening visit * patients who have any known condition(s) that may be contraindicated or interfere with the completion of the nuclear imaging scans.