Kornimate/medical-research-clean huggingface dataset:
positive end-expiratory pressure (peep) in predicting fluid responsiveness in patients undergoing one-lung ventilation

Conditions: Lung Cancer; Lung Diseases

Summary: the present study is to evaluate the effect of positive end-expiratory pressure (peep) in predicting fluid responsiveness in patients undergoing one-lung ventilation.

appropriate fluid challenge is crucial during lung surgery under one-lung ventilation. applying peep in mechanically ventilating patients changes dynamic hemodynamic parameters (stroke volume variation, pulse pressure variation), which is more pronounced in hypovolemic patients. the aim of the present study is to evaluate the mechanically ventilating patients under one-lung ventilation requiring fluid resuscitation by applying peep to predict fluid responsiveness. the investigators hypothesized that applying peep in one-lung ventilating patients can also change dynamic parameters and the magnitude of the change of stroke volume variation, pulse pressure variation can predict fluid responsiveness. the investigator applied peep 10 mmhg in one-lung ventilating patients and observed the dynamic parameters including stroke volume variation, pulse pressure variation and then infused 6ml/kg of crystalloid for fluid challenge and diagnosed fluid responsiveness as 10% increase of stroke volume after fluid challenge.

Eligibility criteria:
inclusion criteria: * patients undergoing lung surgery under one-lung ventilation exclusion criteria: * arrhythmia * moderate to severe valvular heart disease moderate to severe pericardial effusion left ventricular ejection fraction \< 40% * moderate to severe chronic obstructive lung disease * unable to insert oesophageal doppler monitor (odm) probe ( esophageal stent, esophageal cancer, previous esophageal surgery, esophageal stricture, esophageal varices, pharyngeal pouch and severe coagulopathy ) * patient refusal * cannot understand the protocol * less than 50kg or over 100kg in weight
anti-cancer dc cell vaccination to treat solid tumors

Conditions: Solid Tumor, Adult; DC

Summary: placental or tumor-derived heat shock protein gp96 is collected, purified, and stored. the dc cells are isolated from the patient's blood and then cocultured with the gp96 to obtain the activated dc cell product. the manufactured dc cells are subcutaneously or intra-tumor injected into the patient. clinical studies will be performed to test anti-cancer function of the dc vaccination for immunotherapy of cancer patients. in this phase i study, the safety, tolerance, and preliminary efficacy of the dc vaccine immunotherapy on advanced cancers will firstly be evaluated.

1. choose appropriate patients with advanced solid cancers, with written consent for this study; 2. perform biopsy to get fresh sample for generation gp96 protein; collect dc cells from the cancer patient; 3. produce appropriate dc cell vaccine and deliver the vaccine into selected patients via local injections, and follow up closely to collect related results as required; 4. to enhance the killing capability, cotreatment the patients with vaccine aduvants or pd1/pdl1/ctla4 antibodies may be applied; 5. evaluate the clinical results as needed.

Eligibility criteria:
inclusion criteria: 1. patients with advanced cancer; 2. life expectancy \>12 weeks; 3. adequate heart, lung, liver, kidney, and blood function; 4. available high quality vaccine for human use; 5. informed consent explained to, understood by and signed by patient/guardian. patient/guardian given copy of informed consent. - exclusion criteria: 1. had accepted gene therapy before; 2. severe virus infection such as hbv, hcv, hiv, et al; 3. known hiv positivity; 4. active infectious disease related to bacteria, virus,fungi,et al; 5. other severe diseases that the investigators consider not appropriate; 6. pregnant or lactating women; 7. systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day); 8. other conditions that the investigators consider not appropriate.

Keywords: solid tumor dc vaccine gp96
a study of trabectedin in patients with advanced ovarian cancer

Conditions: Ovarian Neoplasms; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female

Summary: the purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with advanced ovarian cancer.

patients will be enrolled in the study after all study-specific entry criteria are met and informed consent is obtained. patients will be required to attend regular clinic visits to receive study medication and have their status monitored. patients will also be required to have radiologic tumor assessments performed at multiple times throughout the study. a detailed explanation can be provided by the study physician (investigator) conducting this study. trabectedin at a starting dose of 0.58 mg/m2 will be given to patients intravenously (i.v). as a 3-hour infusion every week for 3 weeks (on days 1, 8, and 15) of a 4 week cycle via a central venous catheter (also referred to as a "central line" which is a tube ie, "catheter" placed into a large vein). all patients will receive dexamethasone 10 mg i.v. 30 minutes prior to each trabectedin infusion. patients may receive multiple cycles of trabectedin in the absence of disease progression.

Eligibility criteria:
inclusion criteria: * diagnosis of advanced epithelial ovarian cancer * progression or recurrence during or after platinum-containing regimen * at least one measureable tumor lesion * adequate bone marrow, hepatic and renal function * eastern cooperative oncology group (ecog) performance status of 0 or 1 exclusion criteria: * known hypersensitivity to any components of the i.v. formulation of trabectedin or dexamethasone * pregnant or lactating women * known metastases (spread) of cancer to the central nervous system * history of another neoplastic disease unless in remission for five years or more.

Keywords: ovarian cancer ovary cancer trabectedin yondelis et743 ecteinascidin 743 antineoplastic agents, alkylating alkylating agents
efficacy and safety of fospropofol disodium versus propofol for deep sedation in critically ill patients

Conditions: Critical Illness

Summary: the purpose of this study is to evaluate the efficacy and safety of fospropofol disodium for injection compared to propofol for deep sedation in mechanically ventilated icu patients.

this is a randomized, open-label, small sample study using fospropofol disodium and propofol for deep sedation in mechanically ventilated icu patients. subjects are randomized to different treatment groups (including 1 for fospropofol disodium and 1 for propofol). remifentanil is co-administered with fospropofol or propofol. efficacy and safety profiles of fospropofol disodium and propofol are to be monitoted.

Eligibility criteria:
inclusion criteria: * age ≥ 18 and ≤ 80 years; expected to require deep sedation ≥8 hours; requirement for deep sedation (a narcotrend index between 13 and 64). exclusion criteria: * body mass index (bmi) \ 30 kg/m2; contraindicate or allergic to study drugs; moribund state; expected to have a general anesthesia within 8 hours; myasthenia gravis; acute hepatitis or serious hepatic dysfunction (child-pugh class c); chronic kidney disease with glomerular filtration rate (gfr) \< 29 ml/min/1.73m2; systolic blood pressure less than 90 mm hg after appropriate intravenous volume replacement and continuous infusions of 2 vasopressors; acute severe neurological disorder and any other condition interfering with rass assessment; pregnancy or lactation; unstable angina; acute myocardial infarction; left ventricular ejection fraction less than 30%; heart rate less than 50 beats/min; second- or third-degree heart block in the absence of a pacemaker; alcohol abuse or drug abuse.

Keywords: deep sedation fospropofol propofol intensive care unit
the only blood culture for diagnosis of bacteremia - comparative study of practice

Conditions: Bloodstream Infection

Summary: current recommendations for the diagnosis of bacteremia based on the embodiment february-march blood cultures separated by a minimum interval of 30 minutes. each blood culture comprises seeding a pair of aerobic and anaerobic vials inoculated each with 5 to 10 ml of blood. the sensitivity and specificity of this technique depends essentially on the amount of blood removed since there is a direct relationship between the volume of blood inoculated into each flask and the efficiency of the technique. a preliminary study conducted at the university hospital of caen found that 14-30% of patients depending on the services had received only one blood culture. in addition, at least four blood cultures in 24 hours were taken for 10 to 20% of patients. the practice of a single blood culture reduces the sensitivity of the analysis due to insufficient total amount of blood collected. the practice of too many blood cultures increases the risk of false positive (presence of contaminating bacteria), generates extra work for healthcare personnel (and laboratory) and represents a significant cost for an unproven benefit. the investigators propose to evaluate a single blood culture sampling technique with seeding 4 vials (2 aerobic and anaerobic 2).

blood cultures will be collected from patients admitted with on of the following signs: fever (≥38.5°c), hypothermia (≤36°c), chills or shock. for the first blood culture, 40 ml of blood will be obtained aseptically by a single phlebotomy and equally distributed into two bact/alert fa aerobic bottles and two bact/alert fn anaerobic bottles (biomérieux, la-balme-les-grottes, france). the four bottles will be labelled from one to four in the following order: aerobic-anaerobic-aerobic-anaerobic. within the next 24 h, one to three other 20-ml blood cultures consisting of a single pair of aerobic and anaerobic bottles will have to be performed, spaced by a minimum of 30 minutes. bottles will be incubated for 5 days or until positivity reported by the bact/alert 3d instrument.

Eligibility criteria:
inclusion criteria: * patient who is at least 18 years * patients admitted to an emergency department of a three chu caen, lille, rouen * patient with clinical justifying the realization of blood cultures (as good practice recommendations) * patients who received information about the study or if his legal representatives or his close entourage * patient not objecting to the venipuncture exclusion criteria: * patient who direct venipuncture is impossible * patient refusing venipuncture * patient aged under 18 * patient with impaired vigilance and not accompanied by a family member or a trusted person may receive clear information protocol * vulnerable patient and not accompanied by a family member or a trusted person may receive clear information protocol

Keywords: blood culture bacteremia single sampling
clinical study on the correlation between imr（index of microcirculation resistance） and ffr（fractional flow reserve）

Conditions: Myocardial Ischemia

Summary: to study the effect of myocardial microcirculation disturbance on coronary flow reserve fraction, compare the evaluation value of imr, ffr and qca on myocardial ischemia, and discuss the correlation among them.

in this study, 60 patients with critical lesions indicated by coronary angiography will be admitted. the investigators collected the basic clinical data (gender, age, body mass index, smoking history, hypertension, diabetes, hyperlipidemia), laboratory data (creatinine, cholesterol, triglycerides) and measured their ffr and imr.

Eligibility criteria:
inclusion criteria:(1) age: 18-75 years old, unlimited for men and women; (2) quantitative coronary angiography (qca) showed that there was a critical lesion in the proximal or middle segment of the coronary artery (diameter stenosis rate was 50% - 70%), and the diameter of the artery was more than 2.5mm; (3) agree to participate in the study and sign informed consent - exclusion criteria:(1) patients with acute myocardial infarction within one month; (2) patients with congenital heart disease, severe valve disease, dilated cardiomyopathy, pulmonary heart disease and hypertrophic cardiomyopathy; (3) with severe heart failure (nyha cardiac function grade ≥ grade iii or left ventricular ejection fraction \< 35%); (4) patients with less than 1 year of stent implantation or with coronary artery bypass grafting; (5) patients with left main lesion, severe distorted calcification, open lesion, bifurcated lesion or complete occlusion; (6) patients with severe hepatorenal insufficiency; (7) contraindications to adenosine, aspirin and clopidogrel; (8) patients with advanced tumor or life expectancy less than 1 year; (9) patients with severe asthma or uncontrolled asthma; (10) women in pregnancy. -

Keywords: microcirculation resistance index (imr) fractional flow reserve(ffr)
n-acetyl cystein and contrast nephropathy

Conditions: Chronic Kidney Disease Stage 2; Radiographic Contrast Agent Nephropathy

Summary: there are many controversies about the role of n-acetyl cystein in preventing of contrast nephropathy. these contradictory results may be due to different criteria for patients' selection, different end points, different type and dose of n-acetyl cystein administration and finally different prophylactic measures other than n-acetyl cystein. the investigators try to enroll a double blind double dummy study with a good power to compare the effect of this drug both in the form of oral and intravenous against the placebo in preventing the contrast nephropathy in the patients whom undergo coronary angiography/angioplasty.

contrast nephropathy is the third cause of acute kidney injury in hospitalized patients. the morbidity and mortality of this disorder is considerable. there is no treatment for this condition and all measures should be taken into account to prevent this complication. among the all prophylactic measures hydration and the dose ant type of contrast are the only factors that have been proved to be effective in preventing contrast nephropathy. n-acetyl cystein is an antioxidant agents that may be effective in different aspects of medicine, but it,s use in this condition is controversial. while some studies showed it is effective in prevention of contrast nephropathy, others showed no benefit. different studies used different dose and route of administration. so more clinical trials with good power are needed to compare different oral vs iv administration of the drug in a randomized double blinded clinical trial. in this study we allocate the eligible patients with chronic kidney diseases stages 2 to 4 to three groups. oral n-acetyl cystein group, iv n-acetyl cystein group, placebo group. all group will be matched according to stages of chronic kidney diseases, diabetes, anemia, heart failure, age and sex.

Eligibility criteria:
inclusion criteria: * age more than 18 * chronic kidney disease stage 2-4 * use of nephrotoxins in last week leading to angiography exclusion criteria: * acute kidney injury * concomitant use of other nephrotoxins * need of repeated imaging with contrast in five days after the first surgery * need for surgery in next five day after the contrast exposure * need of using nephrotoxins in next five days after contrast exposure

Keywords: contrast nephropathy n-acetyl cystein prophylaxy
the big breakfast study

Conditions: Obesity; Weight Loss

Summary: this weight loss study will investigate the impact of diet composition and meal size (large breakfast meals and smaller evening meals) on body weight, energy balance and eating behaviour, by altering calorie (meal) distribution.

the aim of this study is to further strengthen our understanding of the role of dietary components (in particular fibre and protein) in a healthy diet. the information gained from this research will lead to better policy advice, particularly in relation to healthy weight management, metabolic control, mental health and intestinal health. it will also lay the foundations to produce healthier primary products and aid the food industry in developing new and healthier products (e.g. products that aid hunger control and satiety). this will be addressed through four interlinked objectives: o1: healthy weight management and improved metabolic and mental health o2: identification of gut bacteria and compounds of relevance to vascular and gut health o3: linking fibre consumption to intestinal microbial communities and health o4: mathematical modelling of interactions between diet and gut microbial communities

Eligibility criteria:
inclusion criteria: * bmi ranging from 27-42 kg/m2; * those habitually consuming breakfast (at least 5 times a week). exclusion criteria: * women who are pregnant, planning to be pregnant or breastfeeding * subjects with food allergy * diagnosis of diabetes, hypertension, renal, hepatic, haematological disease or coronary heart disease * having given a pint of blood for transfusion purposes within the last month * unsuitable veins for blood sampling * inability to understand the participant information sheet * inability to speak, read and understand the english language * those on any prescription medications (other than oral contraceptives) * those on any specific diet regimes * those on any weight loss programmes (that may be affecting lifestyle, physical activity and diet).
ai noise reduction in phonak hearing aids

Conditions: Hearing Loss

Summary: the purpose of this study is to determine if artificial intelligence- based noise reduction can offer objective improvement in hearing and speech perception for hearing impaired patients.


Eligibility criteria:
inclusion criteria: * patients with hearing impairment not using hearing aids * individuals with hearing impairment currently using hearing aids * cochlear implant patients with a single-sided implant (using a hearing aid in the opposite ear)

Keywords: hearing aid
insulin sensitivity response to high-intensity training in insulin resistance during pregnancy

Conditions: High Intensity Interval Training; Diet, Healthy

Summary: insulin resistance is one of the common complications that occur during pregnancy. early intervention is essential to prevent the development of the diseasethere is evidence that physical inactivity increases the risk of a lot of adverse health problems, including coronary heart disease, type 2 diabetes, breast and colon cancers. it also shortens life expectancy. pregnancy is a period in the life of women that is often associated with decreased daily physical activity and decreased participation in sports and exercise . in the first few weeks of pregnancy, maternal carbohydrate metabolism is affected by a rise in maternal levels of estrogen and progesterone that stimulates pancreatic β-cell hyperplasia and insulin secretion. as pregnancy progress, pancreatic islet cell hypertrophy continues and there is an increased insulin response to glucose or meal stimulation.

this study was carried out upon twenty multigravida pregnant female between 5-6 months gestation with ir calculated by homa test (fasting blood glucose× fasting insulin) ÷ 22.5. fasting blood glucose was assessed by the method approved by (7, 13) .the test materials for this method were supplied as kits by "diamond diagnostics," while insulin concentrations were stated in formerly frozen and defrosted serum samples by enzyme immunoassay using the human insulin elisa kits.

Eligibility criteria:
inclusion criteria: * forty multigravida females. * their age ranged between 25 to 35 years old. * body mass index (bmi) \<30kg/ m². exclusion criteria: * females with pelvic pathology as endometriosis. * females have irregular menstrual cycles.

Keywords: training insulin resistance pregnancy
improvement of metabolic health after thylakoid supplementation

Conditions: Metabolic Syndrome; Obesity

Summary: objective: the purpose of this study was to investigate the possible effects of green-plant thylakoid supplementation to a restricted diet intervention study in overweight to obese men. methods: overweight-obese men (bmi 25 - 35) were treated to a 30 e% restricted diet for one month, followed by one month of stabilization. then they were divided in two treatment arms of one month each; one thylakoid-enriched diet (n=10) and one control diet (n=10). body measurements and blood samples were taken throughout the study.

twenty healthy, non-vegetarian, non-smoking caucasian men were included in the study. inclusion criteria: men aged 40 to 70 years with a bmi of 25 to 35. exclusion criteria: metabolic disturbances, bariatric surgery, recent diet, food allergies or treatment with antibiotics. the study protocol was approved by the ethical committee of lund university, sweden (#2006/361). the trial consisted of three periods: 1) diet-restriction period (one month) 2) stabilizing period (one month) 3) diet-restriction period with supplementation of thylakoids or placebo (one month). the two weight-losing periods included strict diet recommendation with -30 energy % (e%), and macronutrient composition: 55-65 e% carbohydrates, 10-15 e% protein and 25-35 e% fat. sixty minutes of low intensive exercise per day was also required. during the stabilizing month participants were instructed to eat a healthy diet to be able to keep their achieved weight-loss. day 0, 28, 56 and 84 the participants arrived after 12-hour fasting for blood sampling and anthropometric measurements. the blood samples were analyzed for plasma-glucose, insulin, hba1c, inflammation markers, cholecystokinin, ghrelin, total cholesterol, ldl-cholesterol, hdl-cholesterol, and triacylglycerol.

Eligibility criteria:
inclusion criteria: * healthy, overweight, non-vegetarian, non-smoking exclusion criteria: * medication for metabolic disturbances, previous bariatric surgery, diabetes, had been on diet or treated with antibiotics during last 3 months, food-allergies