Kornimate/medical-research-clean huggingface dataset:
effects of face mask continuous positive airway pressure vs. noninvasive ventilation vs. high-flow nasal oxygen on intubation-free survival in acute hypoxemic respiratory failure: the tripod randomized clinical trial

Conditions: Acute Hypoxemic Respiratory Failure; High-Flow Nasal Oxygen Therapy; Noninvasive Ventilation; Continuous Positive Airway Pressure (CPAP)

Summary: acute hypoxemic respiratory failure (ahrf) is a common indication for admission to an intensive care unit (icu), with mortality exceeding 50% in cases where invasive mechanical ventilation is needed. therefore, assessment of the most adequate oxygen strategy to avoid intubation in patients with ahrf deserves consideration.previous studies have indicated that non-invasive oxygenation strategies, including high-flow nasal oxygen (hfno), helmet or face mask noninvasive ventilation (niv), and continuous positive airway pressure (cpap), are effective in preventing endotracheal intubation in adult patients with ahrf when compared to the standard oxygen therapy. however, the optimal non-invasive oxygenation strategies remain uncertain. this study aim to determine whether cpap, compared with hfnc or niv, increase the intubation-free survival during study period in patients with ahrf.


Eligibility criteria:
inclusion criteria: 1. age≥18 yrs; 2. a ratio of the partial pressure of arterial oxygen (pao2) to the fio2 of 300 mm hg or less, or a ratio of pulse oximetry oxygen saturation (spo2) to the fio2 of 315 or less (spo2≤97%) and the need for (1) noninvasive positive pressure ventilation with at least 5 cm h2o peep, or (2) high-flow nasal cannula at 30l/min or higher, or (3) standard oxygen with oxygen flow rate of at least 10 l/min; 3. sign informed consent. exclusion criteria: 1. patients that have already received continuous positive airway pressure, noninvasive ventilation continuously for more than 24 hours before the screening visit. 2. previous bout of mechanical ventilation during index hospitalization. 3. exacerbation of chronic lung disease, including asthma or chronic obstructive pulmonary disease. 4. moderate to severe cardiac insufficiency (new york heart association class \>ii or left ventricular ejection fraction\<50%) or cardiogenic pulmonary edema. 5. hemodynamic dysfunction, defined as vasopressor dose \> 0.3 µg/kg/min of norepinephrine-equivalent to maintain systolic blood pressure \> 90 mm hg. 6. impaired consciousness with a glasgow coma score ≤ 12. 7. patients with urgent need for intubation, including respiratory or cardiac arrest, respiratory pauses with loss of consciousness or gasping for air, severe hypoxemia defined as spo2 lower than 90% despite maximal oxygen support. 8. patients with contraindication to niv according to the french consensus conference, patient refusal, cardiorespiratory arrest, coma, non-drained pneumothorax, unresolved vomiting, upper airway obstruction, hematemesis or severe facial trauma, thoracic or abdominal surgery in the previous 7 days. 9. a do-not-intubate order at time of inclusion. 10. pregnancy.
a study evaluating abi-h0731+ entecavir vs entecavir alone for the treatment of viremic hbeag-positive participants with chronic hepatitis b virus infection (chbv)

Conditions: Chronic Hepatitis B

Summary: the purpose of this study is to determine if abi-h0731 given in combination with a standard of care (soc) entecavir (etv) is safe and effective in participants with chronic hepatitis b infection (chbv)

this is a phase 2a, multi-center, double-blind, placebo-controlled study evaluating abi-h0731+ etv vs etv alone for the treatment of viremic hepatitis b "e" antigen (hbeag)-positive participants with chbv.

Eligibility criteria:
key inclusion criteria: * male or female between ages 18 and 70 years * hbeag-positive at screening * in good general health except for chbv * hbv viral load ≥2×105 iu/ml * hepatitis b surface antigen (hbsag) \>1000 iu/ml at screening key exclusion criteria: * any prior treatment with lamivudine or telbivudine, previous treatment with an investigational agent for hbv other than abi-h0731; or any other soc treatment for \>4 weeks * co-infection with hiv, hepatitis c virus (hcv), hepatitis e virus (hev) or hepatitis d virus (hdv) * history or evidence of hepatic decompensation (including gastrointestinal bleeding or esophageal varices) at any time prior to or at time of screening * clinically significant cardiac or pulmonary disease, chronic or recurrent renal or urinary tract disease, liver disease other than hbv, endocrine disorder, autoimmune disorder, diabetes mellitus requiring treatment with insulin or hypoglycemic agents, neuromuscular, musculoskeletal, or mucocutaneous conditions requiring frequent treatment, seizure disorders requiring treatment, or other medical conditions requiring frequent medical management or pharmacologic or surgical treatment that in the opinion of the investigator or the sponsor makes the participant unsuitable for the study * previous treatment with an investigational agent for hbv other than abi-h0731 in the last 6 months before screening * history of hepatocellular carcinoma (hcc) * females who are lactating or pregnant or wish to become pregnant are excluded from the study * exclusionary laboratory parameters at screening: * platelet count \<100,000/mm3 * albumin \<lower limit of normal (lln) * direct bilirubin \>1.2×upper limit of normal (uln) * alanine aminotransferase (alt) \>10×uln at screening * serum alpha fetoprotein (afp) ≥100 ng/ml. if afp at screening is \>uln but \<100 ng/ml, participant is eligible if a hepatic imaging study prior to the initiation of study drug reveals no lesions suspicious of possible hcc * international normalized ratio (inr) \>1.5×uln * glomerular filtration rate (gfr) \<60 ml/min/1.73 m2 by chronic kidney disease epidemiology collaboration (ckd-epi) equation

Keywords: chbv hbv hbeag-positive hepatitis b vebicorvir vbr
transcranial direct-current stimulation in childhood dystonia

Conditions: Childhood Onset Dystonias

Summary: the investigators hypothesize that transcranial direct current stimulation over the motor cortex will reduce muscle overflow and improve hand function in children with primary or secondary dystonia.


Eligibility criteria:
inclusion criteria: * dystonia affecting one or both hands * age 4 to 21 years exclusion criteria: * metal implants in the head * inability to cooperate with instructions

Keywords: childhood dystonia
alcohol after bariatric surgery 2

Conditions: Sleeve Gastrectomy

Summary: the goal of this observational study is to learn how the body processes ingested alcohol and how alcohol affects mood and blood sugar in both men and women after undergoing sleeve gastrectomy. the main question\[s\]it aims to answer are: * are there differences in the way that ingested alcohol is handled in men versus women after sleeve gastrectomy? * what is the consequence of drinking alcohol on an empty stomach versus after a meal on blood sugar control after undergoing sleeve gastrectomy? participants will participate in two types of alcohol tests (alcohol given orally or administered intravenously) after not eating anything overnight or after having a meal. researchers will compare men and women who underwent sleeve gastrectomy with men and women who had no surgery, are of similar age and body composition, and have similar alcohol intake patterns.

the primary goal of the proposed study is to determine sex-related differences in the impact of sleeve gastrectomy (sg) on the pharmacokinetics (aim 1), subjective effects (aim 2), and glycemic effects (aim 3) in the fasted versus prandial state when alcohol is ingested or given intravenously clamped (the gold standard to measure alcohol elimination rate and acute alcohol tolerance). we will use a cross-sectional study to compare participants who underwent sg surgery 1-5 years ago with matched non-operated controls (both sexes). this project will answer the questions of whether there are sex-related differences in the impact of sg on alcohol's pharmacokinetics and pharmacologic effects, whether drinking alcohol with a meal is effective post-sg, and clarify the site of alcohol first-pass metabolism in men. findings from this study will contribute to evidence-based recommendations on the impact of sg on alcohol-related toxic effects and could help expand the knowledge base of sex-related differences in human alcohol pharmacokinetics.

Eligibility criteria:
inclusion criteria: * surgery groups: * male and female, 21-64 yrs. of age * drink at least 1 standard drink per month but no more than 7 per week (women or \> 14 for men) * underwent sg surgery 1-5 years ago non-surgery control group * male and female who did not undergo bariatric surgery * age , bmi, race , and alcohol pattern of consumption equivalent to participants in the sg surgery groups exclusion criteria: * for all groups (surgery and non-surgery groups) * smoking or having quit smoking less than 2 months ago * pregnant or breastfeeding * taking any medications that might affect alcohol metabolism * anemia * gastritis, colitis, crohn's disease, malabsorptive diseases, inflammatory diseases, liver disease, kidney disease, cancer less than five years ago, stroke, or severe organ dysfunction * body weight \>450 pounds (because of a limit on body composition machine) * alcohol use disorder * regular use of drugs with addiction potential or regular misuse of substances * abnormality on ekg as determined by a study physician to present a safety risk

Keywords: alcohol metabolism bariatric surgery hypoglycemia metabolic surgery
effect of a medium chain triglyceride supplemented diet on cognitive function and brain activation in type 1 diabetes.

Conditions: Hypo-unawareness; Type 1 Diabetes Mellitus

Summary: insulin treatment often causes the blood glucose levels to fall too low (hypoglycemia). hypoglycemia can be associated with confusion and disorientation as well as other symptoms such as palpitations, sweating and tremors. medium chain triglycerides (mct) can be used as a fuel in the brain during low blood sugar levels and therefore may prevent or reduce some of the confusion and disorientation seen during hypoglycemia. we would like to determine if a diet supplemented with medium chain triglycerides can improve cognitive function during hypoglycemia, diabetes control and also look at brain activity.

30 subjects with well controlled type 1 diabetes will be recruited for the study. if you agree to participate you will be scheduled for, dietitian visits, and a study visit which will include insulin and glucose infusions, an mri scan and brain function tests. all visits will be on the hospital research unit (hru) on the 10th floor of yale new haven hospital. you will be randomized to either the mct-supplemented diet or the standardized western diabetic diet. if you are on the mct diet, the mct oil will be given to you and you will be shown how to incorporate it into your diet. the mct supplemented diet is for two weeks (with a two gradual transition onto the diet) and the standardized western diet is for two weeks (with a 1 week transition onto the diet). at the end of the study you will be admitted to the hospital research unit for the insulin 'clamp' and mri scan. a 'clamp' is a procedure which involves insulin and glucose infusions. during a 'clamp' study, the insulin infusion is held constant, while the glucose infusion is adjusted every 5 minutes as needed to maintain the desired blood glucose levels. compensation for the study is $750.

Eligibility criteria:
inclusion criteria: * type 1 diabetes * hba1c \<8% * bmi 18-30 * hypo unawareness exclusion criteria: * pregnancy * significant diabetes complications * liver disease, cirrhosis * cardiac disease * neurological disorder * kidney disease

Keywords: medium chain triglycerides hypoglycemia cognitive function functional mri
difference between monofilament versus multifilament suture material in isthmocele formation

Conditions: Uterine Scar

Summary: this thesis conducts the effect of using different suture materials on the development of uterine scar niche after cesarean section. the difference between monofilament and multifilament sutures and the special properties of each one . the primary outcome of the study is to know which material conducts more scar niche formation . secondary outcomes are the extent of blood loss , the need of extra hemostatic sutures


Eligibility criteria:
inclusion criteria: * age: 20-45 years old * singleton pregnancy. * gestational age between 37 completed weeks to 42 weeks. * patients undergoing elective primary caesarean section exclusion criteria: * history of uterine surgery (e.g. hysterotomy, myomectomy, perforation, caesarean section). (to be able to differentiate between the recent cs scar and the old scar) * abnormal placental invasion (placenta previa and accrete ) ( more liable to undergo cesarean hysterectomy) * uterine anomalies (e.g., septum, mullerian anomalies or fibroids). (may be localized at the suture line and therefore affect the scar) * drugs intake that affects bleeding or tissue healing e.g., anti-coagulants, immunosuppressive drugs and chronic use of steroids (more than 14 days pre-operative) * any medical co-morbidity (diabetes mellitus, hypertension and thyroid abnormalities) (more liable to affect the healing)
a study of apatinib in patients with advanced hepatocellular carcinoma

Conditions: Advanced Hepatocellular Carcinoma

Summary: this phase ii trial will be studying how well apatinib working in patients with hepatocellular carcinoma.


Eligibility criteria:
inclusion criteria: * histologically or cytologic confirmed advanced hepatocellular carcinoma * patients who are unable to or unwilling to undergo surgery or interventional procedures via hepatic artery, or patients who have relapsed/progressed after surgery or interventional procedure via hepatic artery for ≥ 4 weeks and are unable to use sorafenib. * life expectancy of more than 12 weeks. * ecog performance scale 0 - 2. * child -pugh score a，bclc stage b or c. * at least one therapy naïve measurable lesion (larger than 10 mm in diameter by spiral ct scan, conforming to recist 1.1). * have not received systemic chemotherapy or molecular targeted therapy. at least 4 weeks must have elapsed for patients who have previously underwent radiotherapy or surgery, and all the adverse drug reactions (adrs) or wounds have completely healed. at least 6 months must have elapsed for patients who have received adjuvant chemotherapy. * adequate organ functions (hemoglobin≥ 90g/l ,platelets ≥80 × 109/l, neutrophil≥ 1.5 × 109/l, albumin ≥ 29 g/l, plasma creatinine ≤ 1.5 × uln , alt and ast\< 5 × uln; tbil ≤ 1.5 × uln. * signed and dated informed consent.willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedure. exclusion criteria: * pregnant or lactating women. * patients with known intrahepatic cholangiocarcinoma, mixed hepatocellular carcinoma, and fibrolamellar hepatocellular carcinoma; other malignancies previously or currently, except for cured skin basal cell carcinoma and cervical carcinoma in situ. * dysphagia, chronic diarrhea, and intestinal obstruction, which significantly affect drug intake and absorption. * evidence of cns metastasis. * subjects with hypertension which cannot be well controlled by antihypertensives; grade ii or greater myocardial ischemia or myocardial infarction, poorly controlled arrhythmia, and cardiac insufficiency grades iii to iv according to nyha criteria; cardiac color doppler ultrasound examination: lvef (left ventricular ejection fraction) of \< 50%. * subjects with abnormal coagulation functions, and the tendency of bleeding or those who are currently treated by a thrombolytic or anticoagulant therapy. * definite concern of gastrointestinal hemorrhage, and history of gastrointestinal hemorrhage within 6 months. * patients with symptomatic ascites requiring therapeutic paracentesis or drainage, or with a child-pugh score of ≥ 2.

Keywords: hcc, apatinib, phase ii, cancer
to explore the protective effect of sars-cov-2 vaccination on cancer patients infected with sars-cov-2

Conditions: COVID-19 Infection; COVID-19 Vaccine

Summary: for tumor patients, the virus antibody titer produced by the sars-cov-2 vaccine is often lower than that of normal people in a short period of time, but in the long run, it can significantly reduce the infection rate and fatality rate of the new coronavirus, and the adverse reactions are mild and there is no significant difference with normal people. however, there is still no real-world research data in china to prove the protective effect of the sars-cov-2 vaccine on patients with tumors infected with the sars-cov-2 virus.

to explore the protective effect of sars-cov-2 vaccination on cancer patients infected with sars-cov-2. serum samples were collected from cancer patients who had been infected with sars-cov-2 and were previously vaccinated or unvaccinated. the sars-cov-2 antibodies (igg and igm concentrations) were detected by micro-magnetic particle chemiluminescence method, and the differences were compared. the results of this real-world prospective cohort study can be used to guide the vaccination of cancer patients in clinical practice.

Eligibility criteria:
inclusion criteria: 1. age \> 18 years old, regardless of gender; 2. patients with previous or current tumor, regardless of tumor type; 3. have a history or current infection with sars-cov-2; 4. the vital signs were stable, without severe pulmonary, heart, liver and other important organ dysfunction; 5. those with good compliance, agreed to participate in this clinical study, receive corresponding treatment, and signed the informed consent. exclusion criteria: 1. those who do not meet the inclusion criteria or diagnostic criteria, and cannot cooperate with blood sampling and arrangement; 2. patients with severe bleeding disorders such as coagulopathy or essential thrombocytopenia; 3. local skin ulceration affecting blood drawing, severe rash, or infectious diseases;
mos-fed (mosaicism in focal epilepsy cortical dysplasia tissue)

Conditions: Focal Cortical Dysplasia; Epilepsy

Summary: focal cortical dysplasia (fcd) is a malformation of brain development, the most common cause of drug-resistant epilepsy and often caused by mutations in mammalian target of rapamycin (mtor) pathway genes. patients with fcd develop drug-resistant seizures. this study will look at fcd tissue removed during epilepsy surgery and aims to detect mutations in mtor pathway genes in brain cells. secondly, the investigators will establish if evidence of mutations found in brain cells can also be detected as circulating free dna (cfdna) in blood. by looking at which genes are made into proteins in individual cells found in epilepsy surgical tissue (single cell expression profiling),the investigators will attempt to identify new genetic targets in fcd. the main outcome will be finding new causes of epilepsy with fcd and the development of new diagnostic and screening tools.

primary objectives: 1. to identify if somatic mosaicism for mtor is present in resected tissue from patients with fcdiia/b, and can be detected in dna from patient's serum as circulating free dna (cfdna) or from nasal epithelial cells collected non-invasively by olfactory mucosal brush swab. 2. to establish if single cell expression profiling from resected fresh frozen tissue reveals novel fcd causing pathways and single cell rna sequencing increases the yield of mtor pathway variant detection. 3. to determine if phosphorylated upstream and downstream mtor pathway components can be characterised by immunohistochemistry and western blot as novel biomarkers of mtor activation in human fcdii tissue. secondary objectives: to engage with patients, representatives and charitable organisations to assess feasibility and develop plan to set up a future trial of mtor inhibitor treatment.

Eligibility criteria:
epilepsy in focal cortical dysplasia type iia/b key inclusion criteria: 1. adult and paediatric patients (male and female) 2. a histologically proven diagnosis of fcdiia/b or a suspected diagnosis of fcdiia/b (on mri/eeg and pet grounds) awaiting resective epilepsy surgery. 3. able to attend appointment/hospital and undergo sampling of serum and nasal swab 4. informed consent available key exclusion criteria: 5. any acute or chronic conditions that could limit the ability of the patient to participate in the study. 6. refusal to give informed consent.
efficacy and safety of aclidinium bromide 400 µg bid (twice a day)compared to placebo in patients with stable moderate to severe chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the aim of the present study is to evaluate the effect of aclidinium bromide 400 μg twice a day (bid) administered twice a day versus placebo on exercise endurance and on hyperinflation and dyspnoea at rest and during exercise after 3 weeks of treatment.


Eligibility criteria:
inclusion criteria: * adult male and female patients aged ≥ 40 with stable moderate to severe copd (global initiative for chronic obstructive lung disease (gold) guidelines). * post-salbutamol forced expiratory volume in one second(fev1) \< 80% and ≥ 30% of predicted normal value and post-salbutamol fev1/forced vital capacity (fvc) \< 70%. * current or ex-smokers of ≥ 10 pack-years * functional residual capacity (frc) measured by body plethysmography at screening visit ≥ 120% of predicted value exclusion criteria: * history or current diagnosis of asthma * signs of an exacerbation within 6 weeks ( or 3 months if results in hospitalisation) prior to the screening visit or during the run-in period. * clinically significant respiratory and/or cardiovascular conditions or laboratory abnormalities. * conditions where the use of anticholinergic drugs is contraindicated, such as known symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma. * patients with an oxygen saturation \< 85% during cycle exercise on room air at screening visit, run- in visit and visit 1. * contra-indications of cardiopulmonary exercise testing. * patient who in the investigator's opinion will need to start a pulmonary rehabilitation program during the study and/or patients who have just started/finished pulmonary rehabilitation at least 3 months prior to the screening visit.

Keywords: copd antimuscarinic