Kornimate/medical-research-clean huggingface dataset:
high-flow nasal cannula vs. helmet psv vs. helmet cpap during respiratory failure

Conditions: Respiratory Failure; Hypoxemia

Summary: the investigators designed a cross-over, randomized trial to assess the physiological effects of helmet pressure support ventilation (psv) and continuous positive airway pressure (cpap) as compared to high-flow nasal cannula during the early phase of acute hypoxemic respiratory failure

setting: 21-bed general icu, emergency room of the emergency department (ed), fondazione policlinico universitario "agostino gemelli" irccs, rome, italy.. patients: adult hypoxemic non-hypercapnic patients admitted to the emergency department or the icu with de novo acute respiratory failure will be assessed for the enrolment. each eligible patient, in the absence of exclusion criteria, will receive 15 minutes of heated and humidified 60% oxygen at a rate of 50 l/min via a non-rebreathing face mask. an abg will be then collected and pao2/fio2 ratio computed: given the high flows used, actual fio2 will be approximated to the set one. nonhypercapnic patients with a pao2/fio2≤200 mmhg will be enrolled. in the absence of exclusion criteria and if all other inclusion in criteria are met, patients showing pao2/fio2≤300 and \>200 mmhg will be treated according to the clinical practice eventually reassessed for the presence of oxygenation criterion subsequently. enrolled patients will receive all the interventions (helmet cpap, psv and high-flow nasal cannula) in a randomized, cross-over fashion, for 40 minutes each. at the end of the study, the patient will receive the treatment that will be shown as more appropriate for the patient, according to the attending physician, who will be informed about the results of the study on the individual patient.

Eligibility criteria:
inclusion criteria: patients: adult hypoxemic non-hypercapnic patients admitted to the emergency department or the icu with de novo acute respiratory failure will be assessed for the enrolment. patients will be considered eligible whether all the following inclusion criteria are met: 1. respiratory rate\>25 bpm. 2. pao2/fio2 ≤200 in the supine position, measured after 15 minutes of high flow treatment with face mask (60 l/min, temperature of the humidification chamber set at 37°c, fio2 set to achieve a spo2 \>92% and \<98%). given the use of the high flows, nominal fio2 will be considered a reliable estimate of the actual one. 3. paco2 \<45mmhg 4. absence of history of chronic respiratory failure or moderate to severe cardiac insufficiency. 5. written informed consent exclusion criteria: * exacerbation of asthma or chronic obstructive pulmonary disease; * cardiogenic pulmonary oedema; * haemodynamic instability (systolic blood pressure \ 5 mmol/l) and/or clinically diagnosed shock * metabolic acidosis (ph \<7.30 with normal- or hypo-carbia); * glasgow coma scale \<13; * recent head surgery or anatomy that prevent the application of helmet or nasal cannula to patient's face.
reduction of postherpetic neuralgia in herpes zoster

Conditions: Herpes Zoster; Post-herpetic Neuralgia

Summary: the addition of gabapentin therapy to standard antiviral treatment with valacyclovir in acute herpes zoster patients will decrease the incidence of post-herpetic neuralgia.


Eligibility criteria:
inclusion criteria: * male or female patients of 50 years of age and older. * patients with a clinical diagnosis of uncomplicated herpes zoster presenting within the first 72 hours of vesicles. * patients who are willing and able to comply with the requirements of the study. * patients who are willing and able to give written informed consent. * average pain score pre-therapy greater or equal than 4 on 10-point likert scale. exclusion criteria: * sexually-active women of childbearing potential, including postmenopausal women less than 1 year since last menses, not employing adequate contraception (approved oral contraceptive, intrauterine device, barrier methods or total abstinence). * pregnant females and nursing mothers. * patients with immune dysfunction including congenital immune deficiency, active malignancy of any type, collagen vascular diseases, organ or bone marrow transplantations, known infection with hiv or severe atopic dermatitis. * patients who have received cytotoxic drugs or immunosuppressive therapy (e.g., chronic systemic corticosteroids) within the previous 3 months. * patients with evidence of cutaneous or visceral dissemination of herpes zoster infection (cutaneous dissemination is defined as \> 20 discrete lesions outside adjacent dermatomes). * patients who have received systemic anti-vzv medications or immunomodulatory medications (including interferon) within the previous 4 weeks. * patients currently receiving probenecid. * patients with impaired renal function: calculated creatinine clearance of \<30 ml/min using cockcroft and gault formula. * patients with abnormal liver function (alanine transaminase (alt) or aspartate;transaminase (ast) levels greater than five times the upper limit of the normal range). * patients with a history of intolerance or hypersensitivity to acyclovir, penciclovir, valacyclovir, famciclovir or gabapentin. * patients currently receiving therapy with gabapentin or tricyclic antidepressants. * patients with clinical evidence of ocular involvement of herpes zoster. patients with herpes zoster of the ophthalmic branch of the trigeminal nerve without evidence of ocular involvement will be included.

Keywords: gabapentin valacyclovir phn shingles
outcome after 24 months of participants in the toby xenon study

Conditions: Perinatal Asphyxia; Encephalopathy

Summary: the objective of this study is to document the outcome at 2-3 years of age of participants of the toby xe trial, to provide preliminary information about the later clinical effects of treatment with xenon gas combined with moderate hypothermia following perinatal asphyxia. the toby xe trial was a randomised controlled trial of inhaled xenon gas combined with hypothermia for the treatment of perinatal asphyxia. the trial primary outcome was changes on magnetic resonance parameters examined prior to discharge from hospital. continuing clinical follow-up of trial participants is important following any therapeutic trial and is essential in early phase trials where information on the clinical effects of the intervention are lacking. therefore, we have set up this study to determine the major clinical and neurological outcomes of participants of the toby xe trial and to determine whether the magnetic resonance parameters in that trial are qualified to predict outcome following neural rescue therapy. this information is necessary for planning further studies of this intervention.


Eligibility criteria:
inclusion criteria: surviving participants in the toby xenon study exclusion criteria: lack of consent to participate
a study of implantation of retinal pigment epithelium in subjects with acute wet age related macular degeneration

Conditions: Age Related Macular Degeneration

Summary: phase 1 trial of retinal pigment epithelium replacement in subjects with wet age-related macular degeneration in whom there is rapidly progressing vision loss

phase 1, open-label, safety and feasibility study of implantation of pf-05206388 (human embryonic stem cell derived retinal pigment epithelium) in subjects with wet age related macular degeneration and rapid vision loss

Eligibility criteria:
inclusion criteria: * male and /or post-menopausal female subjects aged 60 years or above. * diagnosis of wet age-related macular degeneration (amd) plus rapid recent vision decline * an informed consent document signed and dated by the subject or a legal representative. exclusion criteria: * pregnant females; breastfeeding females; and females of childbearing potential. * treatment with an investigational drug within 30 days (or as determined by the local requirement, whichever is longer) or 5 half-lives preceding the first dose of study medication. * current or previous significant other ocular disease in the study eye, as determined by the investigator.
reliability, sensitivity and validity of the 6 minute step test in chronic obstructive pulmonary disease (copd) patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: chronic obstructive pulmonary disease (copd) leads to a reduction in exercise capacity that affects the quality of life and increases mortality of these patients. so, exercise tests are considered as an essential component of the clinical evaluation of the patients with copd. the objective of this study is to evaluate the reproducibility sensitivity and validity of the six minute step test (6mst) in patients with copd and in health volunteers, and verify its relation with the "body-mass index, airways obstruction, dyspnea and exercise capacity" index (bode). this observational, transversal, prospective study will be conducted in the "special unit of respiratory physiotherapy", of the "federal university of são carlos". to participate in this study, 120 subjects, both gender, will be invited and will be allocated in five groups: group i (30 healthy young subjects of 17 to 27 years old), group ii (30 healthy elderly individuals of 60 to 75 years old), and patients copd, 60 to 80 years old, with mild, moderate, severe and very severe obstruction determined by the forced expiratory volume in one second (fev1) by forced vital capacity (fvc) relation "fev1/fvc" \<70% and fev1 in predict percentage \< 80% composing the group iii (20 copd patients in gold stage i), group iv (20 copd patients in gold stage ii) and group v (20 patients copd stages iii and iv). all subjects will be submitted to body composition and anthropometric assessment, pulmonary function test, three 6-minutes walk test (6mwt) and three 6mst. furthermore, the patients of the groups iii, iv and v will answer the modified medical research council (mmrc) scale, and bode index will be calculated to each of them.


Eligibility criteria:
inclusion criteria: * young and elderly healthy subjects presented pulmonary function within the normal range, confirmed by spirometry * patients with clinical and spirometric diagnosis of copd exclusion criteria: * lung disease exacerbated * decompensated heart disease * rheumatic, neurological or orthopedic disease, preventing them from doing the tests by limiting the exercise * peripheral oxygen saturation \< 80% without physical effort * subjects who does not complete the first day of evaluation

Keywords: exercise test reproducibility of results mortality
routine validation and reproducibility testing of laboratory measures and research techniques used for metabolism research (val)

Conditions: Obesity

Summary: the purpose of this research study is to validate (check the accuracy of) laboratory assays, intravenous catheter insertion, and equipment or devices and their reproducibility, which is necessary to perform high quality research on chronic diseases (obesity, pre-diabetes and type-2 diabetes, dyslipidemia, non-alcoholic fatty liver disease, cardiovascular disease, etc.), nutrition, and metabolism (the process by which a substance is handled in your body) at the university of missouri. as technology changes and we start to use new testing methods, it is necessary to compare results from old tests, equipment and devices and new tests, equipment, or devices and the reproducibility of these measurements to make sure we are getting accurate results. reproducibility means performing the same test more than once to see if the same results can be achieved each time.


Eligibility criteria:
inclusion criteria: * ≥18 and ≤75 years of age * body mass index ≥18.5 and ≤45 kg/m2 * weight stable (i.e., ≤3% change) * ≤150 min of structured exercise/week for at least 2 months before entering the study * blood glucose: \< 126 mg/dl fasted, \< 200 mg/dl with 2 hour oral glucose tolerance testing * hemoglobin a1c (hba1c) ≤6.5% * dyslipidemia triglycerides ≥125 mg/dl * no chronic kidney disease * not vegan or vegetarian or on high protein diet (e.g. atkins) or supplements that are not allowed * no intolerance or allergies to study diet ingredients * no excessive alcohol or tobacco consumption exclusion criteria: * \ 75 years of age * body mass index \ 45 kg/m2 * history of or current significant organ system dysfunction (e.g., heart disease, stroke, diabetes, cancer in remission for \<5 years, dementia, chronic kidney disease) * allergies or intolerances to meal ingredients, vegans or vegetarians * use of medications that could confound the study outcomes (e.g., anti-inflammatories, immune modulators, etc) * take dietary supplements (e.g., certain pre- and pro-biotics, fiber, fish oil supplements) * engaged in regular structured exercise \>150 min per week * alcohol use disorder as defined by the national institute of alcohol abuse and alcoholism or use of controlled substances * pregnant women * persons who use tobacco * prisoners * the inability to grant voluntary informed consent.
cmr assessment of cardiac microvascular dysfunction in patients with hfpef

Conditions: Microvascular Coronary Artery Disease; Heart Failure With Reduced Ejection Fraction

Summary: heart failure with preserved ejection fraction (hfpef) causes hospitalizations, premature mortality and high health care costs. this is also due to poor understanding of hfpef pathogenesis and, thus, lack of specific therapies. prompted by the recent demonstration that hfpef clusters different clinical phenotypes, the investigators propose that these phenogroups are driven by distinct myocardial abnormalities. cardiac magnetic resonance (cmr) can help filling this gap in knowledge: on top of providing gold standard measurements for myocardial volume and cellular mass, recent technical advantages mean that this test can assess and quantify left ventricular extracellular volume, fibrosis and microvascular function accurately and non-invasively. in hfpef patients, the investigators aim at assessing 1) the coronary microvascular function impairment; 2) the myocardial fibrotic burden; - seeking to understand the disease in order to improve care and cardiovascular outcomes for these patients.


Eligibility criteria:
inclusion criteria: * age greater of or equal to 18 years at enrolment * able to provide written informed consent * diagnosis of hfpef as defined by the 2016 esc guidelines (only for hfpef group) exclusion criteria: * pregnancy or breastfeeding * absolute contraindication to adenosine perfusion cardiac mri (including uncontrolled asthma and severe chronic kidney failure, defined as glomerular filtration rate \< 30ml(min/kg) * atrial fibrillation * previous chemotherapy and/or mediastinal radiotherapy * known cad * diabetes mellitus * systemic inflammatory diseases * any other medical condition which, in the investigators' opinion, could affect the study results * only for control group: any known cardiac, pulmonary, haematological or neoplastic known medical condition and/or any chronic therapy.
different techniques for emergency cricothyroidotomy

Conditions: Intubation, Intratracheal

Summary: this educational study will examine two different techniques for training emergency residents and staff on achieving a surgical airway (called a cricothyroidotomy).

introduction: in patients that cannot be intubated or ventilated by conventional means an emergency cricothyroidotomy is a potentially life saving intervention that is the common final pathway of difficult airway algorithms. significant debate surrounds the ideal method of performing an emergency cricothyroidotomy. the literature remains divided between the open (surgical) and closed (wire assisted, or seldinger) techniques. we feel that these two methods are not mutually exclusive and are proposing a novel "incision first" modification to the traditional seldinger closed technique. making a small (1 cm) incision prior needle insertion could facilitate localization of landmarks and may improve speed or success rate of the closed seldinger procedure. introduction: in patients that cannot be intubated or ventilated by conventional means an emergency cricothyroidotomy is a potentially life saving intervention that is the common final pathway of difficult airway algorithms. significant debate surrounds the ideal method of performing an emergency cricothyroidotomy. the literature remains divided between the open (surgical) and closed (wire assisted, or seldinger) techniques. we feel that these two methods are not mutually exclusive and are proposing a novel "incision first" modification to the traditional seldinger closed technique. making a small (1 cm) incision prior needle insertion could facilitate localization of landmarks and may improve speed or success rate of the closed seldinger procedure. methods: using concealed allocation, this randomized controlled cross-over trial will be performed in a laboratory setting. outcome assessment will be blinded. both staff and resident emergency physicians will be included in this trial. we will use a well-validated swine trachea model for this study. results: results will be collected using standardized case report forms (crf) and independently entered into a pre-constructed microsoft access database. the primary outcome will be time to procedure completion. secondary outcomes will be proportion of successful cricothyroidotomy, complications and ease of procedure and ability to increase clinical confidence using this model. paired t-tests and fisher's exact test will be used to compare the outcomes and due to multiple statistical tests, a correction will be used to adjust for multiple tests (p \< 0.025) to indicate significance. conclusions: this study will assess and evaluate both the incision first model and closed seldinger cricothyroidotomy techniques. we will discuss the merits of each technique and the effectiveness of the model.

Eligibility criteria:
inclusion criteria: all staff and residents presenting to a airway lab for informed verbal consent. exclusion criteria: non-physicians

Keywords: cricothyroidotomy intubation airway emergency medicine education
carbohydrates and related biomarkers

Conditions: Healthy; Overweight

Summary: this study is designed to investigate associations of low- and high-glycemic load diets with biomarkers of hyperglycemia, hyperinsulinemia and inflammation, potential biomarkers for cancer risk.

this is a randomized, crossover feeding study conducted in normal weight and overweight individuals. participants will be given all their food to eat and drink (except water) for two 28-day feeding periods (a total of 56 days). the diets will be carefully controlled and energy intake will be regulated to maintain weight stability for each participant. the two feeding periods will be separated by a 28 day "washout" period when participants will eat their own food. dinner will be eaten at the hutchinson center monday through friday. each evening, breakfast, lunch and snacks will be brought home for the next day. on friday evenings all the food will be taken home for the weekend. samples of blood will be collected after an overnight fast at the beginning and the end of each feeding period. all urine will be collected for 24 hours at the end of each feeding period. a number of questionnaires will also be completed during each diet period. a small stool sample will be collected in your own home, before the first feeding period, and once during each feeding period. the stool sample collection is optional. one can decide not to provide a stool sample and still participate in the study.

Eligibility criteria:
inclusion criteria: 1. healthy males and female subjects 2. between the ages of 18 to 45 3. bmi between 18.5 kg/m2 to 24. 9 kg/m2 (normal weight) and between 28.0 kg/m2 to 39.9 kg/m2 (overweight) 4. willingness to refrain from alcohol during the study 5. able to come to the fhcrc in seattle every weekday night for dinner exclusion criteria: 1. younger than 18 years of age or older than 45 years of age. 2. do not fit into one of the study weight groups (normal weight and overweight): bmi \ 40.0 kg/m2, and between 25.0 kg/m2and 27.9 kg/m2 3. have diseases that are treated by diet and/or medications including but not limited to diabetes, kidney disease, heart disease 4. taking prescription medications every day (this includes women taking birth-control pills, shots, patch or iud with hormones) 5. diagnosed with or treated for cancer within the previous five years (except those with a diagnosis and/or treatment of non-melanomatous skin cancer are eligible) 6. currently pregnant or breastfeeding or planning a pregnancy in the next 3 months. 7. using any tobacco products on a daily basis (cigarettes, pipes, cigars, chewing tobacco). 8. using recreational drugs 9. drinking the following amount of alcohol almost every day: 2 or more cans/bottles of beer or 2 or more glasses of wine or 3 or more ounces of hard liquor. 10. inability (e.g., food allergy or intolerances) or unwillingness to consume the foods that are part of the feeding study diet.

Keywords: glycemic response glycemic index obesity carbohydrates insulin blood glucose
assessment of enhanced recovery after surgery implementation at pediatric surgery practices in mainland china

Conditions: ERAS

Summary: enhanced recovery after surgery (eras) is a new mode to optimize perioperative management, the core of which is to reduce perioperative physiological and psychological trauma and stress damage, and accelerate postoperative rehabilitation. eras has been gradually introduced in pediatric surgery in recent years, however, there are limited reports on its overall implementation. we aimed to determine the popularity of eras among pediatric populations in mainland china.

the application of eras in children with congenital biliary dilatation (cbd) was investigated. a total of 31 province-level administrative regions in mainland china were involved and each of them had at least one participating center. a questionnaire was designed to assess the baseline adherence of 17 recovery elements and chief pediatric surgeons at each center were invited to complete.

Eligibility criteria:
inclusion criteria: * chief pediatric surgeons at each center exclusion criteria: * incomplete questionnaire
preoperative anemia frequency

Conditions: Preoperative Evaluation

Summary: in our retrospective study, it was aimed to determine the frequency of anemia in non-emergency patients over the age of 18 who applied to the anesthesiology and reanimation department of our hospital.


Eligibility criteria:
inclusion criteria: * -patient over 18 years old, * patients applying to the department of anesthesiology and reanimation ad exclusion criteria: * pregnant, * under 18 years old, * will undergo cardiac and emergency surgery * patients with massive bleeding * patients who underwent multiple surgeries during the study period

Keywords: preoperative evaluation preoperative anemia
precise and objective identification of bertolotti syndrome using novel kinematic biomarkers

Conditions: Bertolotti's Syndrome; Lower Back Pain

Summary: the purpose of this study is to collect lumbar rotations, velocity, and accelerations, along with pain scores using a novel dynamic vas device, from twenty (20) bertolotti syndrome patients and twenty (20) non-bertolotti low back pain patients during range-of-motion tasks. the assessments will be analyzed to determine the differences in kinematics and continuous pain scores between bertolotti patients and non-bertolotti low back pain patients.


Eligibility criteria:
inclusion criteria: lower back pain cohort * positive diagnosis of sacroiliac pain or lumbosacral facet arthritis pain * age ≥ 18 years bertolotti's syndrome cohort * positive diagnosis of bertolotti's syndrome * age ≥ 18 years * positive imaging for bertolotti's syndrome * previous analgesic injection results exclusion criteria: lower back pain cohort * history of spinal deformity, previous spinal surgeries, spinal infections * pregnant women bertolotti's syndrome cohort * history of spinal deformity, previous spinal surgeries, spinal infections * pregnant women