Kornimate/medical-research-clean huggingface dataset:
use of baked milk in oral immunotherapy for severe ige-mediated cow's milk protein allergic patients

Conditions: Cow's Milk Allergy

Summary: oral immunotherapy (oit) programs for milk, egg and peanut, desensitize patients to their respective allergens and thereby decrease their risk of morbidity and mortality. oit programs, however, are not without adverse events, particularly in highly sensitive patients. recently, it has been demonstrated that the administration of baked milk (bm) products to ige-cma patients that are non-reactive to bm, can promote tolerance to unheated milk (um). the goal of our research is to determine whether bm can promote desensitization even in the highly sensitive patient, who reacts to baked milk as well. in a second step, we hypothesize bm-oit will promote desensitization to unheated milk, as well. importance: the change in the risk/benefit ratio of such a program will alter the therapeutic approach to an ige-cmp allergic patient. probable implications to medicine: bm-oit will allow highly sensitive patients to tolerate milk products, decreasing their risk of life-threatening reactions. furthermore, analysis of the immune modulation parameters that change during the treatment program, should pave the way for defining mechanisms underlying tolerance in cmp allergy.

in our first aim, we will test over a four day induction (escalating) program, whether highly sensitive um-reactive patients) can tolerate bm . those successful will be randomized to a treated bm-oit group (group a) and an observational control group (group b). in the second aim, the fraction of patients in group a who successfully progress in bm-oit (tolerate ≥ 360 mg bm) over a 6 month period will be determined and compared to the fraction of patients in group b who can tolerate 360mg. the results will also be compared to the progression of highly sensitive ige-cma patients on um-oit (group c, reactive to ≤21 mg of um ). in aim-3, the fraction of bm-oit patients able to tolerate minimally ≥ 12.5 mg of um or higher than their initially eliciting dose. will be assessed. methods: severe patients (\>4 years) with a positive clinical history, spt and a positive dbpcfc to cmp will be first tested for their ability to tolerate bm. the treatment group will undergo three rounds of oral induction, each consisting of 4 days and performed every 4 weeks. on day #1, the patient will be rapidly desensitized up to their threshold. on days 2-3, the maximum tolerable dose and interval is determined. day #4 mimics the home treatment. home treatment will then continue until the next induction. after 6 months of treatment patients will be evaluated for reactivity to um.

Eligibility criteria:
inclusion criteria: patients with ige-cow's milk allergy reacting to \<12.5 mg (any reaction) on oral food challenge to unheated milk exclusion criteria: patients with unstable asthma\*\* or those with suspected compliance issues will be excluded. patients with stable asthma are included. * defined as active wheezing and/or use of oral steroids within one month prior to initiation of program and/or fev1\<75% or a greater than 18% increase in fev1 after bronchodilator treatment.
melpro-0322 (cristina trial) [microbiome predicts apd1 effectivnes in melanoma patietns]

Conditions: Melanoma, Skin; Melanoma Stage Iii

Summary: the goal of this observational study is to learn about if new biomarkers such as gut microbiota and molecular genetics melanoma features could predict clinical radiological and pathological response to neoadjuvant monotherapy with anti-pd1 agents in patients with resectable stage iiib-d melanoma. the main questions it aims to answer are: * radiological and pathological response rate to three doses of antipd1 agents; * do radiological and pathological responses correlate with gut microbiota and melanoma molecular genetics features participants will receive three doses of apd1 monotherapy as per center routine practice and will undergo regional lymphadenectomy. before treatment initiation patients will be asked to bring faeces probes and fill out dietary questionnaire as well as just before the surgery. after sugery adjuvant therapy will be prescribed for 12 month and patients will be followed up according to institutional routine practice for 5 years.

the clinical efficacy of pd1 inhibitors on the 2-year recurrence-free survival of patients with resectable stage iii b-d melanoma will be assessed. this indicator will be compared with a historical control group using adjuvant pd1 immunotherapy and targeted therapy. various factors will be analyzed for their potential impact on immunotherapy effectiveness, including demographics, disease stage and sub-stage, molecular-genetic status of the tumor, composition of the tumor\&#39;s lymphoid infiltrate, ldh levels, gut microbiome composition, radiological and pathological response to treatment, and the development of immune-mediated adverse events. these findings may help optimize treatment by implementing neoadjuvant therapy for stage iii b-d cutaneous melanoma.

Eligibility criteria:
inclusion criteria: * patients aged 18 years and older. * performance status according to the eastern cooperative oncology group (ecog) of 0-1. * patients who have not previously received immunotherapy with anti-pd1, anti-pdl1, or anti-ctla4 agents. * clinical stage iii (b-d), i.e., with clinically or radiologically determined metastatic changes in lymph nodes. * histologically confirmed involvement of regional lymph nodes. * lesions assessable by response evaluation criteria in solid tumors (recist) version 1.1. exclusion criteria: * patients with melanoma of non-skin localizations. * patients with active autoimmune diseases. * patients with active infectious diseases. * patients with severe concomitant diseases with an ecog status \&gt;1. * pregnant or lactating patients. * patients requiring the intake of glucocorticoids at a dose greater than 10 mg of prednisone (or equivalent) per day. * patients requiring the use of, or having received, systemic antibiotics within 4 weeks prior to the start of the study.

Keywords: neoadjuvant therapy stage iiib-d resectable melanoma gut microbiota
tumor response prediction in neoadjuvant chemoradiation of locally advanced rectal cancer using metabonomics analysis

Conditions: Locally Advanced Rectal Cancer

Summary: this study suggested an effective application of pattern recognition, which figured the possible biological function of potential bio-markers of rectal cancer found in our study based on their chemical structures. hence, this study identified the precursor protein and metabolic mechanism of these bio-markers and may contribute to the neoadjuvant chemoradiation of locally advanced rectal cancer


Eligibility criteria:
inclusion criteria: 1. history of primary rectal cancer with distance from anal verge being less than 12 cm; 2. histologically confirmed adenocarcinoma; 3. initial pathological stage of t3 or t4 and/or n+; 4. no history of initial distant metastases; 5. karnofsky performance status score of ≥75 6. ≥18 years;≤75 years 7. sign the inform consent exclusion criteria: 1. pregnancy or breast-feeding women 2. serious medical illness 3. baseline blood and biochemical indicators do not meet the following criteria: neutrophils≥1.5×10\^9/l, hb≥90g/l, plt≥100×10\^9/l, alt/ast ≤2.5 uln, cr≤ 1 uln

Keywords: neoadjuvant chemoradiation treatment effect prediction metabonomics
the pk characteristics of the co-administration of metformin sr and rosuvastatin and jlp-1310 in healthy male volunteers.

Conditions: Diabetes; Hyperlipidemias

Summary: a randomized, open-label, single dose, crossover study to compare the pharmacokinetic characteristics of the co-administration of metformin sr and rosuvastatin and jlp-1310 in healthy male volunteers.


Eligibility criteria:
inclusion criteria: * healthy male volunteer, age is over 19 years body weight is over 50 kg, the result of body mass index(bmi) is not less than 18.0 kg/m2 , no more than 29.0 kg/m2. * subject who has the ability to comprehend the study objectives, contents and the property of the study drug before participating in the trial. * subject who has the ability and willingness to participate the whole period of trial. exclusion criteria: * presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system. * subjects who are allergic to investigational drug. * subjects who have a medical history which can affect the clinical trial. * 100 mmhg ≥ systolic bp ≥ 150mmhg or 55 mmhg ≥ diastolic bp ≥ 95 mmhg * ast or alt \> x 2 unl * total bilirubin \> 2.0 mg/dl * ck \> x 2 unl * egfr \< 60 ml/min/1.73m2 * history of drug abuse or positive drug screening. * participation in other drug studies within 3 months prior to the drug administration. * whole blood donation within 60 days, blood component donation within 30 days or who got transfusion within 30days.
efficacy and safety of fospropofol disodium versus propofol for sedation in mechanically ventilated icu 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 sedation in mechanically ventilated icu patients.

this is a randomized, open-label, small sample study using fospropofol disodium and propofol for 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 are to be evaluated.

Eligibility criteria:
inclusion criteria: * patients aged \>= 18 and \ = 24 hours; demand for light/moderate sedation (a rass score of -3 to 0). exclusion criteria: * informed consent is unsigned； participated in any other interventional research within 3 months; tracheostomy; bmi \ = 35 kilograms per square meter pregnant; lactant; known or suspected allergy to various components of the study drug or to opioids and their salvage drugs, or other diseases (such as pancreatitis associated with hyperlipidemia) for which lipid emulsion should not be used; patients who cannot be evaluated for rass for various reasons (such as mental illness, acquired or congenital mental retardation, deafness, severe neuromuscular disease, parkinson's disease, huntington's disease, alzheimer's disease, cerebrovascular disease, coma, or severe cognitive impairment due to structural diseases such as stroke, intracranial hemorrhage, head injury, malignancy, hypoxic brain injury, or cerebral edema); patients with an expected survival period of less than 48 hours; severe hepatic insufficiency (ctp score is 10-15 points); chronic kidney disease (ckd grade 3 above); unstable angina pectoris or acute myocardial infarction; left ventricular ejection fraction \<= 30%; heart rate \< 50bpm(intravenous pumping of isoproterenol \<4ug/min, heart rate ≥50bpm may not be excluded); type 2 second-degree or third-degree atrioventricular block (except those implanted a pacemaker); two vasoconstrictors are used to maintain sbp above 90mmhg after sufficient fluid resuscitation; myasthenia gravis; patients with a history of drug abuse, drug abuse, alcohol abuse and long-term use of psychotropic drugs within 2 years before the screening period. binge drinking is defined as regular drinking more than 14 times per week (1 time = 150ml of wine or 360ml of beer or 45ml of spirits);

Keywords: fospropofol propofol sedation intensive care unit
functional modeling of the pediatric airway

Conditions: Subglottic Stenosis (SGS); Pierre Robin Sequence (PRS); Micrognathia; Normal Controls From CT Scans of the Upper Airway

Summary: the investigators hypothesize that a functional computational model that simulates the mechanical and aerodynamic behavior of the upper airway in children with pierre robin sequence (prs) and laryngeal lesions (e.g. subglottic stenosis or sgs) can be used as an effective diagnostic and treatment planning tool.


Eligibility criteria:
inclusion criteria: 1. micrognathia, suspected or diagnosis of prs, defined (gorlin) as: micrognathia (mandibular hypoplasia), cleft palate and airway obstruction, and/or diagnosis of sgs defined (bluestone) as: * subglottic airway diameter of 4 mm or less in a term neonate; * subglottic airway diameter of 3.5 mm or less in a premature neonate; * inability to pass an endotracheal tube of expected size for age 2. informed consent by parent or legal guardian 3. age \< 18 years at enrollment 4. scheduled for clinically indicated endoscopic upper airway evaluation 5. ability to comply with study visits and study procedures as judged by the site investigator inclusion criterion also included for specific aim 2 (longitudinal): subjects must be scheduled for an operative procedure to correct or bypass upper airway obstruction (i.e. mandibular distraction, endoscopic airway surgery, laryngotracheoplasty, cricotracheal resection, or tracheostomy) or recently (within past 4 weeks) diagnosed as having an anomaly not currently requiring surgical management. exclusion criteria: 1. acute, intercurrent respiratory infection, defined as an increase from baseline in cough, wheezing, or respiratory rate with onset in the preceding week. 2. physical findings at screening that would compromise the safety of the participant or the quality of the study (i.e. fever, increased respiratory rate above baseline, significant acute emesis, or alteration in baseline neurologic status). 3. for research ct scans any sedation risk, such as bronchopulmonary dysplasia (bpd) with upper airway obstruction, residual oxygen requirement, and an unsecured airway. control data will be collected from clinically indicated neck or maxillofacial ct imaging data that include the entire airway with no noted airway obstructions or airway abnormalities.

Keywords: airway modeling pierre robin sequence or prs micrognathia subglottic stenosis or sgs
single-centre, registry trial, the patients presented with stable coronary artery disease

Conditions: Coronary Artery Disease

Summary: this is a prospective study to analyze the outcome of provisional main vessel stenting on side branch by utilizing two-dimensional (2d) and three-dimensional (3d) frequency domain optical coherence tomography (fd-oct). to analyze the fate of side-branch after provisional main vessel stenting based on morphology defined prior to pci by oct. offline analysis of side branch impingement of the ostium of sb leading to acute loss in sb diameter area, carina shift and plaque shift will be also be performed.

patients with stable coronary artery disease with angiographic main vessel lesion not involving side branch (sb) in whom provisional stenting strategy is planned will be recruited. all the participants of the registry will receive same stent. oct will be performed to analyze plaque morphology, sb size, sb angle and side branch ostial involvement.

Eligibility criteria:
inclusion criteria: * over 18 years of age presenting with stable coronary artery disease. * angiographic lesion not involving side branch (sb) in whom provisional main vessel stenting strategy is planned after reviewing angiogram will be recruited exclusion criteria: * patient with lesion involving side branch ( \>70 %) by angiogram and need pre-dilation. * patients with ostial left main artery lesions or ostial right coronary artery lesions * female patients with child bearing potential not taking adequate contraceptives or currently breastfeeding * known allergy to acetylsalicylic acid or clopidogrel. * planned surgery within 12 months. * history of bleeding diathesis * major surgery within 15 days * life expectancy \< 12 months. * patients with kidney dysfunction (crcl\<30)

Keywords: cad
development of an artificial intelligence model for the identification and prevention of smoking-related diseases.

Conditions: Lung Cancer Screening Program; Artificial Intelligence (AI)

Summary: the study is an interventional pilot study. the study is designed to be monocentric and it presents additional procedues.

interventional pilot study, single-center with additional procedures, such as completion of eortc-qlq-lc29, eortc-qlq-c30 questionnaires, motivational test, fagestrom test, anamnestic questionnaire, spirometry, measurement of carbon monoxide, low-dose spiral computed tomography without contrast medium, peripheral venous blood sampling for a volume of 20 ml. the study has the main objective of traininig and validate a reliable and unbiased artificial intelligence (ai) algorithm that detects the presence of nodules and differentiates between malignant or benign tumor types. the study considers patients with suspected diagnosis or with a dignosis of lung cancer, smokers and former smokers over 50 years of age at high risk of lung cancer and subjects enrolled in previous screening cohorts at this institute.

Eligibility criteria:
high-risk screening subjects inclusion criteria: * age \>= 50 years old * active smokers * former smokers (from no more than 15 years) * pack/year \>20 * risk-prediction model from prostate, lung, colorectal, and ovarian study (plcom2012) \>1.2% * provision and signature of informed consent exclusion criteria: * previous or concurrent neoplastic disease, excluding skin cancers * cognitive or other problems that could hinder the collection of informed consent * severe pulmonary or extra pulmonary disease * previous low-dose computed tomography (ct) scan in the past 12 months previous high-risk positive screening subjects inclusion criteria: * subjects enrolled in previous lung cancer screening with the presence of lung nodules \>4 mm and candidate to additional computed tomography (ct) * signed informed consent exclusion criteria: - none previous high-risk negative screening subjects inclusion criteria: * subjects enrolled in previous lung cancer screening in this institute with negative computed tomography (ct) * signed informed consent exclusion criteria: - none lung cancer patients inclusion criteria: * patients with diagnosis or suspicious diagnosis of lung cancer candidate to surgical treatment or already submitted to it * patients with diagnosis of lung cancer treated with surgical resection * signed informed consent exclusion criteria: * computed tomography (ct) scans not available at san raffaele hospital * previous neoadjuvant treatment

Keywords: ct scan low-dose artificial intelligence high-risk sucjects lung cancer
efficacy of preoperative administration of paracetamol-codeine on pain following impacted mandibular third molar surgery

Conditions: To Control Pain After Third Molar Surgery

Summary: objectives: the aim of this study was to determine the effectiveness of preoperative administration of single-dose of paracetamol-codeine, in the relieving of acute post-operative pain after the surgical removal of an impacted mandibular third molar. materials and methods: the study cohort consisted of 32 caucasian outpatients, giving a total of 64 bilateral symmetrical impacted mandibles. patients were randomized in two experimental groups to receive a preoperative oral dose of paracetamol-codeine (analgesic group) or a placebo (placebo group) at the first and second surgeries. study participants were asked to record pain intensity scores during the operation and the next 2 days, the time of the first request for rescue analgesic, and the total number of postoperative-supplement paracetamol-codeine tablets.


Eligibility criteria:
inclusion criteria: * absence of systemic pathologies (asa class i); * non-smoker; * not pregnant or lactating; * good oral hygiene; * no drug consumption for 10 days before the operation; * bilateral impacted mandibular third molars with comparable position, depth and inclination; * presence of the first and second molars; * absence of painful symptoms and associated inflammatory or osteolytic pathologies in a radiographic examination; * extraction difficulty index of \>7 according to pederson's scale and a degree of iv (complex procedures) on a modified version of parant's scale. exclusion criteria: -

Keywords: postoperative pain paracetamol codeine tooth extractions analgesia premedication
effect of different concentrations of xylitol and erythritol on gut peptide release and gastric emptying in humans

Conditions: Physiological Satiation Mechanisms

Summary: xylitol and erythritol have become increasingly popular as sugar substitutes in the food industry. both substances are freely available. while glucose ingestion stimulates satiation hormone secretion in the gut and slows down gastric emptying, artificial sweeteners such as aspartame, sucralose and acesulfame-k have no such effect. however, acute intake of 50g xylitol or 75g erythritol in 300ml tap water leads to a marked increase in the satiation hormones and induces a significant retardation in gastric emptying. the concentrations used to show this effect were rather high (50g xylitol and 75g erythritol) and led to bloating and diarrhea in 60-70% of all subjects two hours after administration. the aim of the present study is to find an effective concentration of xylitol and erythritol still stimulating satiation hormone release without any gastrointestinal adverse events.


Eligibility criteria:
inclusion criteria: * healthy normal weight subjects with a body-mass index of 19.0-24.9 * normal eating habits (no diets; no dietary changes; no special dietary habits, such as vegetarian/vegan) * age 18-40 years * stable body weight for at least three months * informed consent as documented by signature exclusion criteria: * pre-existing consumption of xylitol or erythritol on a regular basis (usage of xylitol or erythritol as sugar replacement; xylitol or erythritol containing toothpaste is allowed) * regular intake of medications (except for oral contraceptives) * evidence of relevant cardiovascular, pulmonary, renal, hepatic, pancreatic, gastrointestinal, metabolic, endocrinological, neurological, psychiatric or other diseases at screening * clinically relevant abnormalities in haematological laboratory parameters * food allergies, food intolerance * pregnancy * participation in another study with investigational drug within the 30 days preceding and during the present study.