Kornimate/medical-research-clean huggingface dataset:
association between trimethylamine-n-oxide and gestational diabetes mellitus

Conditions: Gestational Diabetes

Summary: background: the microbiota-dependent metabolite trimethylamine-n-oxide (tmao) has been reported as a novel and independent risk factor for the development of cardiovascular and metabolic diseases, but the association with gestational diabetes mellitus (gdm) remains unclear. objective: to investigate the association between plasma tmao concentration and gdm in a two-phase study. design: the initial discovery phase included 866 pregnant women (433 gdm cases and 433 matched controls) in wuhan china. study participants were recruited from pregnant women who attended the outpatient clinics of the department of endocrinology, tongji hospital, to screen for gdm between august 2012 and april 2015, or pregnant women who visited the hubei maternal and child health hospital or the central hospital of wuhan for a routine antenatal checkup from may 2014 to november 2016. the inclusion criteria of participants were: age ≥ 20 years, gestational age between 24 and 32 weeks, no history of a diagnosis of diabetes or gestational diabetes, and no history of receiving pharmacological treatment known to affect glucose metabolism. an independent replication phase study was nested within an ongoing prospective cohort study, namely the tongji maternal and child health cohort (tmchc). beginning in january 2013, women receiving prenatal care prior to 16 weeks of gestation were invited to join the tmchc. exclusion criteria included pre-pregnancy diabetes, clinically significant neurological, endocrinological or other systemic diseases and multiple pregnancies. all enrolled pregnant women received a regular prenatal checkup in hospital and underwent an oral glucose tolerance test (ogtt) during 24-32 weeks of gestation to screen for gdm. 276 members who developed gdm before may 2016 and had fasting blood collected before 20 weeks'gestation were included as cases in this analysis. two controls were individually matched to each case from among women without gdm. these two studies were approved by the ethics committee of tongji medical college. all the participants gave informed written consent before they were included in the study. plasma tmao concentrations were determined by stable isotope dilution liquid chromatography with online electrospray ionization tandem mass spectrometry.


Eligibility criteria:
inclusion criteria: * age ≥ 20 years; * screened for gdm during 24-32 weeks of gestation; * with fasting blood samples collected before 20 weeks of gestation (only for nested case-control subjects). exclusion criteria: * history of a diagnosis of diabetes or gestational diabetes; * history of receiving pharmacological treatment known to affect glucose metabolism; * clinically significant neurological, endocrinological or other systemic diseases and multiple pregnancies.

Keywords: trimethylamine-n-oxide; gestational diabetes mellitus
evaluation of differences in video laryngeal mask airway and fastrack laryngeal mask

Conditions: The Device Placement Times; Intubation Times; Postoperative Complications

Summary: in our study, patients who are intubated using vlm and fastrack lma for intubation purposes will be included. the placement times, intubation times, and the number of failed attempts for both devices will be recorded. additionally, postoperative complications (sore throat, hoarseness, nausea-vomiting, additional antiemetic medication requirements, etc.) will be monitored and recorded.

the 2015 difficult airway society guidelines specify that in cases where an unexpectedly difficult airway is encountered, and the initial intubation attempt is unsuccessful, the insertion of a supraglottic airway device (sad) is recommended to maintain ventilation and oxygenation, followed by tracheal intubation through the sad. sad has been designated as a rescue airway device in difficult airway algorithms and resuscitation guidelines to "buy time." additionally, sad is used to maintain airway and anesthesia in surgeries that do not require intubation. the video laryngeal mask (vlm) is a newly developed type of sad. with vlm, direct visualization of the glottis is achieved immediately after sad placement. vlm has a channel that allows for endotracheal tube passage for intubation purposes and provides direct visualization. the fastrack lma, on the other hand, possesses all the ventilation features of classic sads but is designed for blind or fiberoptic-guided tracheal intubations. these devices are used as rescue devices in cases of limited neck extension and difficult airway situations. both devices are routinely used for ventilation and intubation purposes in patients. the use of these two devices is preferred in patients where neck extension is undesirable or neck movements are restricted for intubation purposes. in our study, patients who are intubated using vlm and fastrack lma for intubation purposes will be included. the placement times, intubation times, and the number of failed attempts for both devices will be recorded. additionally, postoperative complications (sore throat, hoarseness, nausea-vomiting, additional antiemetic medication requirements, etc.) will be monitored and recorded.

Eligibility criteria:
inclusion criteria: 1. individuals between the ages of 18 and 80. 2. patients with asa (american society of anesthesiologists) scores i, ii, or iii. 3. patients undergoing surgery under general anesthesia in the operating room. exclusion criteria: 1. patients under 18 years old or over 80 years old. 2. patients who refuse to participate in the study.

Keywords: fastrack laryngeal mask video laryngeal mask
noninvasive ventilation in acute myocardial infarction

Conditions: Acute Myocardial Infarction

Summary: cardiovascular diseases, especially acute myocardial infarction (ami), represent the major cause of mortality and morbidity in the world. the myocardial ischemia is often the precipitating cause of pulmonary edema and noninvasive ventilation (niv) with positive pressure has been used as a therapeutic modality. objective: to evaluate the effects of niv on heart rate variability (hrv) and on ventilatory and hemodynamic variables in patients with myocardial infarction. materials and methods: ten patients with acute myocardial infarction, with killip i classification, will use continuous positive airway pressure (cpap) and bilevel ventilation during 30 minutes, according randomization. then ventilatory and hemodynamic variables will be registered and electrocardiogram signals will be recorded for posterior analyses of hrv. data will be collected before, during and after positive pressure ventilation. statistical analysis: data will be compared using one way anova repeated measures, followed by tukey test.

the patients will be recruited in bonsucesso federal hospital with diagnosis of myocardial infarction, confirmed by electrocardiogram and cardiac enzymes, between 24 and 72 hours after the event. participation in the study protocol will be done according to eligibility criteria: the study will be a randomized and crossover clinical trial for evaluation and comparison of heart rate variability and ventilatory and hemodynamics variables during ventilation with cpap and bilevel. cpap will be applied via a facial mask, with expiratory positive airway pressure of 10 cmh2o. bilevel will be applied via facial mask, with inspiratory positive pressure (ipap) of 20 cmh2o and expiratory positive airway pressure (epap) of 10 cmh2o.

Eligibility criteria:
inclusion criteria: * acute myocardial infarction with killip i classification, hemodynamic stability, between 24 and 72 hours post event; * agreement to participate in the study, according written informed consent; * 45 to 80 years old age. exclusion criteria: * unstable angina; * systolic blood pressure \< 80 mmhg; * patients who presented st elevation \> 2 mm or with second-degree atrioventricular block; * presence of pacemaker.

Keywords: noninvasive ventilation autonomic nervous system
lymphedema severity on shoulder joint function and muscle activation patterns in breast cancer survivors

Conditions: Breast Cancer; Breast Cancer Female

Summary: breast cancer-related lymphedema (bcrl) is a common complication affecting the upper extremity following breast cancer treatment. this study aims to investigate the relationship between lymphedema severity and shoulder joint function and muscle activation patterns in breast cancer survivors.


Eligibility criteria:
inclusion criteria: * female * adults (18 years or older) * diagnosis of breast cancer-related lymphedema for a minimum of 3 months * no current evidence of active cancer * able to provide informed consent exclusion criteria: * pre-existing musculoskeletal conditions affecting the upper extremities (e.g. adhesive capsulitis, rotator cuff tear) * previous upper extremity surgery * physical inability to perform the required physical movements and assessments
bioavailability study of colcrys® in apple juice

Conditions: Healthy

Summary: the purpose of this study is to evaluate and compare the relative bioavailability of a single 0.6 mg tablet of colcrys® (colchicine, usp) when crushed and dissolved in apple juice relative to the same dose given as an intact tablet to healthy subjects following an overnight fast.

the purpose of this study is to evaluate and compare the relative bioavailability of a single 0.6 mg tablet of colcrys® (colchicine, usp) when crushed and dissolved in apple juice relative to the same dose given as an intact tablet to healthy subjects following an overnight fast. sixteen healthy, non-smoking, non-obese, male and female volunteers between 18-55 years of age will be randomly assigned in a crossover fashion to receive each of two dosing regimens in sequence with a 14 day washout period between dosing periods. in each of the dosing periods, after an overnight fast, subjects will receive one intact colcrys® 0.6 mg tablet (followed by 240 ml of water) or one colcrys® 0.6 mg tablet crushed and dissolved in 20 ml of apple juice (followed by 220 ml of water) according to the randomization schedule. blood samples will be drawn from all participants before dosing and for 48 hours post-dose at times sufficient to adequately define the pharmacokinetics of colchicine. vital signs (blood pressure, heart rate, respiratory rate, and temperature) will be measured prior to dosing and at 1 hour ± 30 minutes post dose. subjects will be monitored throughout their participation in the study for adverse reactions.

Eligibility criteria:
inclusion criteria: * healthy adults age 18-55, non-smoking, non- pregnant (post-menopausal, surgically sterile or using effective contraceptive measures) with a body mass index of 18-30 kg/m² exclusion criteria: * recent participation (within 30 days) in other research studies * recent significant blood donation or plasma donation * pregnant or lactating * test positive at screening for human immunodeficiency virus (hiv), hepatitis b surface antigen (hbsag), or hepatitis c virus (hcv) * history of treatment for drug or alcohol addiction within the previous 12 months or use of tobacco products within 90 days of the start of the study * significant history or current evidence of chronic infectious disease, system disorders, organ dysfunction, especially cardiovascular disorders (angina, heart failure, irregular heartbeats, heart attack, hypertension, hypotension) stroke, renal or hepatic disorders, diabetes or bleeding disorders, gastrointestinal disease or history of malabsorption within the last year * history of or psychiatric disorders occurring within the last two years that required hospitalization or medication * presence of a medical condition requiring regular treatment with prescription drugs * use of any drugs or substances known to inhibit or induce drug-metabolizing enzymes within 30 days prior to dosing with the study drug * drug allergies or sensitivity to colchicine * positive test results for drugs of abuse at screening

Keywords: bioavailability
studying biomarkers in samples from younger patients with kidney cancer

Conditions: Childhood Kidney Neoplasm; Clear Cell Renal Cell Carcinoma; Congenital Mesoblastic Nephroma; Rhabdoid Tumor of the Kidney

Summary: this laboratory study is looking into biomarkers in samples from younger patients with kidney cancer. studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. it may also help doctors find better ways to treat cancer.

primary objectives: i. to determine whether focal adhesion kinase (fak) is expressed and if fak is phosphorylated in pediatric renal tumors. outline: archived tumor tissue samples are analyzed for fak expression by immunohistochemistry (ihc). ihc staining is compared in normal renal tissue, wilms tumor (routine and anaplastic), malignant rhabdoid tumor of the kidney, clear cell sarcoma of the kidney, and mesoblastic nephroma.

Eligibility criteria:
inclusion criteria: * formalin-fixed, paraffin-embedded tissue samples from patients diagnosed with the following renal tumors: * anaplastic wilms tumor * malignant rhabdoid tumor of the kidney * clear cell sarcoma of the kidney * mesoblastic nephroma
individualized metabolic assessment and nutritional optimization in children with chronic respiratory insufficiency

Conditions: Nutrition

Summary: the investigators aim to examine the feasibility of individualized diet intervention in children dependent on long-term mechanical ventilator support at home. the investigators will use a multidisciplinary model that will allow for diet modification based on comprehensive nutrition, metabolic and respiratory assessments performed in the subjects' home. the impact of this intervention (for 12 weeks) on body composition and respiratory variables will be assessed.

a strategy of individualized diet intervention and its impact on respiratory and nutritional outcomes in children on long-term mechanical ventilation has not been previously evaluated. the investigators' objective is to assess the feasibility of individualized diet intervention in children dependent on long-term mechanical ventilator support using a multidisciplinary model. the investigators will optimize energy intake (based on indirect calorimetric measurement) and protein intake (based on recommended intake values) in this group. the subjects will be administered the modified diet for 12 weeks, and a comprehensive nutrition, metabolic and respiratory assessment will be performed before and after intervention, in the subjects' home. the investigators will examine the effect of individualized diet optimization on nutritional status, body composition, co2 production (vco2) and minute ventilation (mv). the investigators hypothesize that optimizing energy and protein intake would be associated with improved nutritional status, particularly increment in lbm, and decrease in vco2 and mv. if nutritional optimization is associated with positive outcomes in our study cohort, this concept could be generalized to a wider patient population with respiratory insufficiency.

Eligibility criteria:
inclusion criteria: - children aged 1 month to 17 years will be included if they were dependent on at least 12 hours of mechanical ventilation per day via a cuffed tracheostomy tube, with a fractional oxygen requirement (fio2) less than 0.6, and a leak less than 10% around the cuff at the time of data collection exclusion criteria: -intercurrent illness such as fever, seizures and/or infectious disease in the 24 hours preceding the study, and/or respiratory decompensation requiring an increase in ventilator settings of \>20% from baseline in the 72 hours preceding the study

Keywords: indirect calorimetry protein mechanical ventilation respiratory failure
a study of long-term safety and efficacy of lanadelumab for prevention of acute attacks of non-histaminergic angioedema with normal c1-inhibitor

Conditions: Angioedema

Summary: the purpose of this study is to evaluate the long-term safety and efficacy of repeated subcutaneous (sc) administration of lanadelumab in adolescents and adults with non-histaminergic angioedema with normal c1-inhibitor who completed study shp643-303 (nct04206605).

this study consists of 26-week treatment period (day 0 to day 182) and a 2-week follow-up period. participants who completed the double-blind treatment period at day 182 of study shp643-303 (nct04206605) will enroll into this extension study.

Eligibility criteria:
inclusion criteria: * males and females, 12 years of age and older diagnosed with non-histaminergic normal c1-inh angioedema at the time of enrollment into the antecedent study shp643-303 (nct04206605). * participants must have completed the treatment period (through visit 26/day 182) of study shp643-303 (nct04206605) without reporting a clinically significant teae that would preclude subsequent exposure to lanadelumab. * agree to adhere to the protocol-defined schedule of treatments, assessments, and procedures. * males, or non-pregnant, non-lactating females who are of child-bearing potential and who agree to be abstinent or agree to comply with the applicable contraceptive requirements of this protocol for the duration of the study; or females of non-childbearing potential, defined as surgically sterile (status post hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or post-menopausal for at least 12 months. * the participant (or the participant's parent/legal guardian, if applicable) has provided written informed consent approved by the institutional review board/research ethics board/ethics committee (irb/reb/ec) at any time prior to study start. if the participant is a minor (i.e. lesser then (\<) 18 years of age), have a parent/legal guardian who is informed of the nature of the study provide written informed consent (i.e. permission) for the minor to participate in the study before any study-specific procedures are performed. assent will be obtained from minor participants. exclusion criteria: * discontinued from study shp643-303 (nct04206605) after enrollment but before visit 26 for any reason. * presence of important safety concerns identified in study shp643-303 (nct04206605) that would preclude participation in this study. * dosing with an investigational product (ip, not including ip defined in antecedent study shp643-303 \[nct04206605\]) or exposure to an investigational device within 4 weeks prior to day 0. * participants has a known hypersensitivity to the investigational product or its components. * have any condition (surgical or medical) that, in the opinion of the investigator or sponsor, may compromise their safety or compliance, preclude the successful conduct of the study, or interfere with interpretation of the results (e.g. significant pre-existing illness or other major comorbidities that the investigator considers may confound the interpretation of study results).
laser therapy on neuromuscular performance

Conditions: Fatigue

Summary: objective: investigating the immediate effects of low level laser therapy (lllt) on neuromuscular performance in healthy subjects after an induced muscle fatigue protocol. methods: eighty volunteers of both genders aged between 18 and 28 years underwent a preliminary evaluation using surface electromyography and isokinetic dynamometer of the flexor muscles of the elbow. the subjects were randomly allocated into 4 groups: g1 was control group; g2 placebo; g3 laser applied before fatigue protocol; and g4 immediately after. muscular fatigue protocol consisted of 30 maximal concentric isokinetic contractions at 120°/s of the elbow flexor muscles. an 808 nm equipment was used for applying laser therapy, with a power of 100 mw and total energy of 20 j. volunteers were reassessed after interventions.


Eligibility criteria:
inclusion criteria: * being between 18-28 years of age, having no pain in the shoulder area, elbow or hand, and not having suffered any to injury to the assessed upper limb in the last six months. exclusion criteria: * presenting pain that prevented the completion of the evaluation, subjects whose data were improperly recorded or if the volunteer withdrew from the study.
basal ganglia local field potentials in gait and speech

Conditions: Basal Ganglia Diseases

Summary: electrid activity of the basal ganglia will be recorded with an implantable deep brain stimulation device (supplied by medtronic inc). study hypothesis is that these activities differ according to what the patient does, i.e. are different during gait and speech.


Eligibility criteria:
inclusion criteria: * good levodopa response exclusion criteria: * dementia

Keywords: deep brain sitimulation local field potentials
dentine hypersensitivity treated with laser and fluoride.

Conditions: Sensitive Dentin

Summary: the aim of the present report is to evaluate the amino fluoride gel with or without application of diode laser on pain due to dentine hypersensitivity. nrs (numerical rating scale) index will be used to evaluate the pain suffered by each patient after cold air blow stimulus. after treatment application, the follow-up timing planned for each patient will be at 1 week, 1 month, 3 months and 6 months

the aim of the present report is to evaluate the amino fluoride gel with or without application of diode laser on pain due to dentine hypersensitivity. the study is designed with a split mouth design. nrs (numerical rating scale) index will be used to evaluate the pain suffered by each patient. the pain response will be stimulated by thermal urge (cold air blow). teeth will be divided in two groups. the treatment group, treated with 980nm diode laser and amino fluoride gel; the control group, treated only with amino fluoride gel. the follow-up timing planned for each patient will be at 1 week, 1 month, 3 months and 6 months. in these follow-up sessions a revaluation of the pain response is performed using the nrs index.

Eligibility criteria:
inclusion criteria: * teeth in good periodontal health * good oral hygiene * dentine hypersensitivity: nrs (numerical rating scale) ≥ 3 exclusion criteria: * teeth local disease or fractures in treatment area * irreversible teeth necrosis or pulpitis * definitive restorations or veneers * recent use of painkillers or anti-inflammatory drugs, * treatment for dentine hypersensitivity less than 6 months before the study start * therapies contraindication

Keywords: dentine hypersensitivity fluoride laser