Kornimate/medical-research-clean huggingface dataset:
a trial comparing the safety and efficacy of semaglutide once weekly in monotherapy or in combination with one oad in japanese subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in asia. the aim of the trial is to investigate safety and efficacy of semaglutide once weekly in monotherapy or in combination with one oad (oral anti-diabetic drug) in japanese subjects with type 2 diabetes who are insufficiently controlled on diet/exercise therapy or oad monotherapy. all subjects will continue their pre-trial treatment (diet and exercise therapy or oad monotherapy in addition to diet and exercise therapy) during the trial.


Eligibility criteria:
inclusion criteria: * male or female, age at least 20 years at the time of signing informed consent * hba1c (glycosylated haemoglobin a1c) between 7.0% and 10.5% (53-91 mmol/mol) (both inclusive) * japanese subjects with type 2 diabetes mellitus (diagnosed clinically) and on stable treatment (defined as unchanged medication and unchanged dose) who are: a) on diet and exercise therapy for at least 30 days before visit 1 (week -2). or b) on oad monotherapy (either of su (sulfonylurea), glinide, a-gi (a-glucosidase inhibitor) or tzd (thiazolidinediones)) within approved japanese labelling in addition to diet and exercise therapy for at least 60 days before visit 1 (week -2) exclusion criteria: * female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (e.g., abstinence \[not having sex\], diaphragm, condom \[by the partner\], intrauterine device, sponge, spermicide or oral contraceptives) throughout the trial including the 5 week follow-up period * treatment with glucose lowering agent(s) other than stated in the inclusion criteria within 60 days before visit 1 (week -2) and treatment with once weekly glucagon-like peptide-1 (glp-1) receptor agonists within 90 days before visit 1 (week -2). an exception is short-term treatment (below or equal to 7 days in total) with insulin in connection with inter-current illness * any disorder which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol * history of chronic or idiopathic acute pancreatitis * screening calcitonin value above or equal to 50 ng/l (pg/ml) * personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2 (men2) * impaired renal function defined as estimated glomerular filtration rate (egfr) below 30 ml/min/1.73 m\^2 per modification of diet in renal disease (mdrd) formula (4 variable version) * acute coronary or cerebrovascular event within 90 days before randomisation (visit 2 \[week 0\]) * heart failure, new york heart association (nyha) class iv
upper airway ultrasound in the assessment of difficult visualization of the larynx

Conditions: Airway Assessment

Summary: failed and difficult tracheal intubation after direct laryngoscopy is a dreaded complication of general anesthesia as it is associated with serious morbidity and mortality. there are several conventional clinical airway assessment parameters such as the modified mallampati classification,thyromental and hyomental distance, interincisor distance, neck movementsand neck circumference, which are usually used to predict a difficult airwayand are components of multivariate risk indices. despite the use of these parameters, the diagnostic accuracy of a preanesthetic airway assessment in predicting difficult intubation is very low. ultrasound has been evolving as a useful device for airway assessment,and sublingual ultrasound has been used for this purpose.

by an anesthesiologist who is experienced in airway ultrasound, patients will preoperative sonographic assessment . the patient will lie in the ramped up position , with head in the neutral position.the linear probe of the ultrasound machine will be used. under the patient's chin, the probe of ultrasond will be placed , at different levels, to get the of the submandibular area in transverse view and the upper part of the neck. the transverse view will be used for measuring the the skin to hyoid, tongue volume,and the skin to epiglottis distance. the mid-sagittal view will be used for measuring the distance between epiglottis ,pre-epiglottic space , vocal cords, and the neck fat volume .

Eligibility criteria:
inclusion criteria: 1. adult patients above 18 years of age. 2. both genders 3. patients scheduled for elective surgery under general anesthesia 4. obese patients with bmi \> 30 kg/m2 exclusion criteria: 1. patients with psychological disorders or those lacking co-operation. 2. patients with maxillofacial anomalies, restricted neck movements and limited mouth opening. 3. american society of anesthesiologists (asa) physical status class iv 4. emergency operations
contribution of multimodal imaging in early coarctation

Conditions: Aortic Coarctation; Congenital Heart Disease

Summary: the ct-coarct-ped study is a multicentred observational study aiming to describe the population of early coarctation during the last 10 years in south of france. the secondary objective is to assess the importance of cross-sectional imaging in the surgical management of aortic coarctation in the first year of life

coarctation of the aorta is one of the most common congenital heart diseases (5 to 8%). this heart disease can clinically result in two major clinical presentation: a neonatal form, early and potentially severe, which will require urgent care. and a later form, the discovery of which may be fortuitous. even in it neonatal presentation, aortic coarctation will not occur during the pregnancy. but the performance of prenatal screening makes it possible to predict a "risk of coarctation" based on criteria that have been clarified with practice and time. (hypoplasia of the left cavities, isthmus / canal ratio etc.) surgically, there are multiple techniques that will take into account the anatomy of the aortic arch and whether or not it is hypoplastic, the associated heart defects and the patient's characteristics. the choice of this surgical technique is one of the predominant elements of the future prognosis of this heart disease (recoarctation, arterial hypertension, etc.) it is in this context that the contribution of multimodal imaging (echocardiography, angiography ct scan and cardiac mri), can be a determining element in the choice made by the surgeon of the aortic plastic surgery technique, by detailing the anatomical but also hemodynamic specificities despite the lack of technical difficulty in performing a cardiac ultrasound in a newborn or an infant, the use of a cross sectional imaging (as ct angiography) is common in order to obtain a more comprehensive assessment of the aortic arch using 2d or 3d reconstruction techniques. however, current practices in terms of radiation protection encourage us to limit the irradiation of our patients especially if the are to be expose potentially repeatedly to radiation during their medical care. thus, this multicenter study aims to clarify the role of cross-sectional imaging in the surgical management of aortic coarctation in the first year of life

Eligibility criteria:
inclusion criteria: * patients \<1 years old * aortic coarctation in the first year of life * surgical management in one of the four participating centers * no associated heart defect exclusion criteria - age \> 1 years

Keywords: multimodal imaging neonatal coarctation radiation protection
early surfactant to reduce use of mechanical breathing in low birth weight infants

Conditions: Infant, Newborn; Respiratory Distress Syndrome; Respiratory Insufficiency

Summary: mechanical ventilation (mv) of preterm infants with respiratory distress syndrome (rds) is associated with lung injury and nosocomial infection. moderately premature infants with mild respiratory distress do not routinely receive artificial surfactant early in their course of treatment. this multi-center, randomized trial tested whether early surfactant therapy and nasal continuous positive airway pressure (cpap) in infants 1,250-2,000g with rds reduced mechanical ventilation usage without added complications. infants with mild to moderate respiratory distress syndrome were enrolled in the trial and given either early administration of surfactant followed by extubation within 30 minutes and the use of cpap, or standard practice (surfactant according to current center practice, only after initiation of mechanical ventilation), to see whether the experimental method would reduce the need for subsequent mechanical ventilation.

mechanical ventilation (mv) of preterm infants with respiratory distress syndrome (rds) is associated with lung injury and nosocomial infection. moderately premature infants with mild respiratory distress do not routinely receive artificial surfactant early in their course of treatment. the role of surfactant therapy in the management of larger infants with respiratory distress syndrome (rds) was unclear. in many neonatal intensive care units, these infants were routinely managed with continuous positive airway pressure (cpap) alone. this trial tested whether early use of surfactant combined with cpap would ameliorate the course of rds without an increased risk of death. primary study outcomes were measures of use of mechanical ventilation, and thereby likely reduction in risk of ventilator-associated morbidity. eligible infants were randomized before the infant is 12 hours of age to receive either: early surfactant followed by extubation within 30 minutes and application of cpap (intervention group); or surfactant according to current center practice, only after initiation of mechanical ventilation (control group). the trial was stopped after 7 months for lack of recruitment.

Eligibility criteria:
inclusion criteria: * infants born at 1,250-2g000 grams birth weight * \<12 hours of age * clinical and radiographic diagnosis of respiratory distress syndrome (rds) * receiving supplemental oxygen with head-hood fi02 of 0.35 to 0.50 or cpap fi02 of 0.25 to 0.50 to maintain oxygen saturation less than 90 percent and more than 96 percent exclusion criteria: * receiving mechanical ventilation * air leak * pulmonary hemorrhage * major congenital anomaly * congenital non-bacterial infection * parental refusal of consent * refusal of attending neonatologist

Keywords: nichd neonatal research network pulmonary ventilation respiratory distress syndrome respiratory insufficiency surfactant, pulmonary mechanical ventilation survanta
harnessing macrophage lysosomal lipid metabolism in obesity (atm)

Conditions: Obesity; Non-Alcoholic Fatty Liver Disease; Diabetes Mellitus, Type 2; Healthy

Summary: the goal of this study is to evaluate the role of transcription factor eb (tfeb) in adipose (fat) tissue macrophages (atm) in regulating adipose tissue and systemic metabolic function in obesity. the investigators will assess the differences in atm lipid metabolism in people with metabolically abnormal obesity and lean individuals. both groups will have: * screening visit * imaging (body composition testing - dual-energy x-ray absorptiometry (dexa) scans, magnetic resonance imaging \[mri\] and magnetic resonance spectroscopy \[mrs\] scans) * overnight visit with intravenous infusion (iv), muscle, and fat tissue biopsies


Eligibility criteria:
inclusion criteria : * age: ≥18 but ≤70 years * not pregnant or breastfeeding * weight stable and sedentary before enrollment * no use tobacco products, excessive amounts of alcohol, or dietary supplements, or medications known to or suspected to affect glucose and lipid metabolism (aside from certain medications used to treat diabetes in the metabolically abnormal obesity \[mao\]-type 2 diabetes group) * no evidence of significant organ system dysfunction or disease (e.g. chronic severe kidney disease, cancer) * participants must fulfil all of the following group-specific inclusion criteria below: lean group: * body mass index (bmi) ≥18.5 but \<25.0 kg/m2 * intrahepatic triglyceride (ihtg) content \<5% * fasting blood glucose concentration: \<100 mg/dl * blood glucose concentration 2 h after a 75 g oral glucose challenge: \<140 mg/dl * hemoglobin a1c (hba1c) \<5.7 % metabolically normal obesity (mno) group: * bmi ≥30.0 but \<45.0 kg/m2 * ihtg content \<5% * fasting blood glucose concentration: \<100 mg/dl * blood glucose concentration 2 h after a 75 g oral glucose challenge: \<140 mg/dl * hba1c \<5.7 % metabolically abnormal obesity (mao)-insulin resistance and non-alcoholic fatty liver disease (nafld) group: * bmi ≥30.0 but \<45.0 kg/m2 * ihtg content \>7.5% * fasting blood glucose concentration: ≥100 but \<126 mg/dl * blood glucose concentration 2 h after a 75 g oral glucose challenge: ≥140 but \<200 mg/dl * hba1c: ≥5.7 but \<6.4 % mao-type 2 diabetes group: * bmi ≥30.0 but \<45.0 kg/m2 * clinical diagnosis of type 2 diabetes or fasting blood glucose concentration \>126 mg/dl or blood glucose concentration 2 h after a 75 g oral glucose challenge\>200 mg/dl or hba1c \>6.4 % without medication if not diagnosed and medically treated for diabetes exclusion criteria: - individuals that do not meet all inclusion criterion
a study of the impact of hemophilia and its treatment on brain development, thinking and behaviour in children with hemophilia

Conditions: Haemophilia A; Haemophilia B

Summary: the hemophilia growth and development study (hgds) nearly 25 years ago showed haemophilia and hiv impacted brain development, thinking, and behaviour in children and adolescents. the ethink study is designed to understand whether advances in hemophilia treatment have removed any impact of hemophilia. if there still is an impact of hemophilia, the ethink study will help to identify which children or adolescents are still at risk, and how to screen other children. participants and their child will participate in a comprehensive assessment of child's brain development, thinking and behavior through completing tests and questionnaires. there is only one study visit of 1 to 1.5 hours with no follow-up required


Eligibility criteria:
inclusion criteria: - male child or young adult (ages 1:0-3:6 and 4:0-21:11 years with diagnosis of congenital hemophilia a or b, any severity, with or without inhibitors - parent able and willing to provide consent, and young adult with hemophilia (age 18-21) able to provide consent; children (ages 7-14) and adolescents/young adults (ages 14-17) able and willing to provide assent based upon local institutional policies - parent able and willing to complete neurodevelopment and cognitive parent reported scales during comprehensive or other hemophilia treatment center visit for about 45-60 minutes in english or spanish depending on age group) - children, adolescents and young adults with hemophilia (ages 1-21) able to participate in assessments of development and intelligence for about 40-45 minutes and adolescents and young adults (age 11-21) with hemophilia able and willing to complete additional self-assessment scales for about 30-45 minutes during comprehensive or other elective visit for in english or spanish (depending on age group) - provision of informed consent before the start of any study-related activities exclusion criteria: - patient aged 3:7-3:11 years (43-47 months) - prior participation in the study - prior neurocognitive screening with the same or related instruments in the prior 6 months - patients with hemophilia or their caregivers for whom test measures may be culturally inappropriate - patients with hemophilia with known history of alcohol or substance abuse - patients with hemophilia who have used opiates in the past 24 hours or other illicit drugs within the past 48 hours - patients with hemophilia currently experiencing an acute bleed that has not resolved - patients with hemophilia with recent head injury or concussion within the past 4 weeks - concurrent diagnosis of another bleeding or thrombotic disorder - mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
a study of alimta/cisplatin/gefitinib for asian non-smoking participants with non small cell lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: the purpose of this study is to compare two different approaches to treating non-small cell lung cancer (nsclc) in east asian never-smoker participants. half of the participants will receive chemotherapy (pemetrexed/cisplatin) followed by an oral anti-cancer agent (gefitinib) and the other half of the participants will receive only the oral anti-cancer agent (gefitinib).


Eligibility criteria:
inclusion criteria: * histological diagnosis of nsclc with locally advanced or metastatic disease that is of non-squamous histology. * participants must be "light ex-smokers" or "never-smokers". * "light ex-smokers" defined as having ceased smoking for greater than or equal to 5 years and not to have exceeded 10 pack-years. * "never-smokers" are defined as having smoked \<100 cigarettes or equivalent during his/her lifetime. * participants must be of east asian ethnicity. * no prior systemic therapy for lung cancer. * eastern cooperative oncology group (ecog) performance status of 0 or 1. exclusion criteria: * presence of clinically significant (by physical exam) third-space fluid collections, for example, ascites or pleural effusions that cannot be controlled by drainage or other procedures prior to study entry. * any evidence of clinically active interstitial lung disease. asymptomatic participants with chronic, stable, radiographic changes are eligible. * participants whose epidermal growth factor receptor (egfr) mutation status is known prior to study entry will be excluded. participants in which egfr mutation testing has not been performed, or whose egfr mutation status is unknown or inconclusive at study entry are eligible.
multimodal deep learning signature for evaluation of response to bevacizumab in patient with colorectal cancer liver metastasis

Conditions: Colorectal Cancer; Liver Metastases

Summary: establishment and validation of the deep learning signature of bevacizumab efficacy in initially unresectable crlm patients

initially unresectable crlm patients were included in this study. the tumor response was assessed by local mdt group. the signature will classified patients into responder or non-responder group. we will administer mfolfox6+bevacizumab regimen to responders, and folfoxiri regimen to non-responders.

Eligibility criteria:
inclusion criteria: age 18-75 years; histologically proven colorectal adenocarcinoma; simultaneous liver-limited metastases; initially unresectable liver metastases determined by a local mdt; life expectancy of \> 3 months; ras mutation and braf v600e wild-type; ecog 0-1; available pet/ct imaging before treatment; available colonoscopy biopsy specimens before treatment exclusion criteria: previous systemic treatment for metastatic disease; previous surgery for metastatic disease; extrahepatic metastases; unresectable primary tumor; major cardiovascular events (myocardial infarction, severe/unstable angina, congestive heart failure, cva) within 12 months before randomisation; acute or subacute intestinal obstruction; second primary malignancy within the past 5 years; drug or alcohol abuse; no legal capacity or limited legal capacity; pregnant or lactating women; uncontrolled hypertension, or unsatisfactory blood pressure control with ≥3 antihypertensive drugs; peripheral neuropathy;

Keywords: colorectal cancer liver metastasis bevacizumab radiomics multimodal
the effect of massage on stress in premature babies

Conditions: Stress; Cortisol

Summary: the practices of the neonatal intensive care unit that reduce the stress of premature babies and respond to behavioral cues have a positive effect on the development of newborns. the stress experienced by premature infants affects the baby's behavior and laboratory findings. massage is an effective application in facilitating the adaptation of premature babies to extrauterine life and ensuring that they are least affected by adverse environmental conditions. massage in premature babies has an important place in reducing stress and supporting psychological, mental and physiological development as a healthy tactile stimulus.

this study was planned to examine the effects of massage on stress behaviors and salivary cortisol levels in premature infants. the research was planned on a randomized controlled experimental. in the research, the group to which massage will be procedure is the experimental group, and the group to which the swaddling procedure will be the control group will form.

Eligibility criteria:
inclusion criteria: * families being voluntary to participate in the study * babies being born between 30 and 36 weeks plus 6 days of gestation * postnatal 3-5. premature babies between days * not taking analgesics or sedatives * absence of congenital anomaly * absence of skin disease * the premature babies passing to oral feeding * not having a proven sepsis diagnosis * no need for mechanical ventilator support exclusion criteria: * having a congenital anomaly * presence of skin disease * having intracranial bleeding * having sepsis * receiving phototherapy * taking analgesic / sedative type drugs

Keywords: massage premature stress
metabolic response to food in lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: this goal of this study is to describe how unintentional weight loss influences fasting and post-prandial metabolic flexibility in participants with advanced non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years * diagnosis of non-small-cell lung cancer * reported weight stability or loss after cancer diagnosis * body mass index less than or equal to 35 kilograms per meter squared * ability to provide written informed consent * willing and able to comply with all scheduled visits, treatment plans, lab tests, and other study procedure * allow the collection and storage of biospecimens and data for future use exclusion criteria: * prior diagnosis of diabetes mellitus (type 1 or type 2) * currently pregnant or breastfeeding * contraindication to consuming the liquid mixed meal * any medications affecting gastric motility * any other condition that, in the investigator's opinion, would preclude participation or successful compliance with the protocol
motor control exercise in osteoporotic women

Conditions: Osteoporosis; Postmenopausal

Summary: the objective of this study was to explore the effectiveness of motor control exercise on pain, postural alignment and spinal curvatures in women with osteoporotic vertebral fractures.

osteoporosis is a common metabolic bone disease that usually affects the aging population. it is an important public health problem, due to its association with vertebral and nonvertebral fractures leading to increased morbidity. vertebral fractures are accompanied by kyphosis, reduced pulmonary function, loss of height, and are often associated with elevated pain while they may also lead to subsequent vertebral fractures. osteoporotic individuals exhibit kyphosis in the erect standing position, which, in turn, is compensated by the deformation of other parts of the body. improvement of postural alignment may lead to less stress on the spine, facilitate posture and proper body mechanics and may improve balance. the aim of the present study was to assess the effectiveness of motor control exercise on pain, postural alignment and spinal curvatures in women with osteoporotic vertebral fracture against the results of a control group that received the basic therapies for osteoporosis.

Eligibility criteria:
inclusion criteria: * postmenopausal osteoporosis * osteoporotic vertebral fractures * pain * under medical osteoporotic treatment exclusion criteria: * osteoporosis other than primary postmenopausal * vertebral collapse with neurological deficits * more than 5 fractured vertebrae * major respiratory conditions * receiving pain reducing agents, teriparatide or calcitonin

Keywords: osteoporosis pain kyphosis posture exercise therapy