Kornimate/medical-research-clean huggingface dataset:
preclinical detection of sepsis early in hospitalized patients following surgery, injury or severe illness

Conditions: Sepsis

Summary: this clinical study is to evaluate a novel biomarker - cna rapid sepsis dx - to predict the development of sepsis in patients admitted to the hospital with non-sepsis conditions. using circulating cell-free dna (cfdna) in the blood stream, it has been demonstrated to detect infection response days before clinical evidence of sepsis manifests. the hypothesis is that blood biomarkers drawn daily in the hospital will identify patients who develop sepsis within seven days of hospital presentation.

this is a prospective observational trial evaluating cna rapid sepsis dx -novel biomarkers (cna diagnostics inc.; calgary, canada) based on circulating cell-free dna (cfdna) in the blood stream to identify patients originally admitted with non-sepsis conditions who ultimately develop sepsis according to sepsis-3 criteria within seven days of hospital presentation. this novel technology has been demonstrated to detect host-related response to infection days before clinical evidence of sepsis manifests. the primary objective of this study is to assess the performance of the novel diagnostic assay, cna rapid sepsis dx, based on the biomarkers, drawn daily from the day of hospital presentation, to identify patients who ultimately develop sepsis according to sepsis-3-definition within seven days of hospital presentation. the secondary objective is to correlate the cna rapid sepsis dx with clinically relevant outcomes such as infections that otherwise do not meet sepsis-3 criteria, intensive care unit (icu) length of stay, hospital length of stay, fluid culture results, and hospital mortality.

Eligibility criteria:
inclusion criteria: 1. patient 18 years of age or older at the time of enrollment 2. presence of any of the following high-risk features: * victims of trauma with either an injury severity score of ≥ 15 or a glasgow coma score of ≤ 8\[2\] or * any patient undergoing high-risk surgical procedures including any emergency surgery and high risk elective surgery procedures involving the thorax, esophagus, stomach, small bowel, large bowel \[3, 4\] or * any patient being admitted to any icu setting for any reason with no current evidence or suspicion of active infection (by primary team).\[5, 6\] 3. able to collect sample within 24 hours of presentation to the hospital. exclusion criteria: 1. prisoners or in police custody 2. pregnancy 3. pre-existing infection for which patient is being treated with antibiotics as an outpatient. 4. plan for ongoing antibiotic therapy by treating team (up to three doses antibiotics for peri-procedure prophylaxis is allowable). 5. moribund, unlikely to survive the duration of active enrollment 6. comfort care measures in place or ordered at time of screening or indication from treating team that active medical care will not be pursued due to patient's condition or patient's/family's wishes. 7. palliative care or hospice consult at time of screening.

Keywords: biomarker sepsis
appetite and adiposity across a continuum of activity

Conditions: Physical Activity and Sedentary Behavior

Summary: the purpose of this study is to understand what happens when someone either becomes more active or more inactive. this study will measure your energy intake, energy expenditure, and body composition under normal conditions, when you become active, and when you become inactive.


Eligibility criteria:
inclusion criteria: * men and women * age 25-35 yrs * bmi ≥25.0 to \<35.0 kg/m2 * subjective physical activity (pre run-in): sedentary for the previous 3 months (\< 20min, 3 times/week of structured exercise) * objective physical activity (run-in): daily steps/day \>4500 yet \<7,000 during 7 day run-in period * weight-stable (± 5%) within the previous 3 months * non-smoking for last year * able to provide own transportation to study visits and intervention * not currently involved in any other research study * willing and able to participate in all aspects of the trial including research testing * willing to give informed consent to participate * able to participate in a moderate physical exercise program exclusion criteria: * self-reported significant cardiovascular disease including but not limited to serious arrhythmias, cardiomyopathy, congestive heart failure, myocardial infarction, stroke * other self-reported medical conditions including but not limited to metabolic disorders such as diabetes, chronic or recurrent respiratory conditions, active cancer, musculoskeletal disease interfering with exercise, or any serious medical condition that may affect adherence to the protocol or exercising safely, or be aggravated by exercise * medications known to affect exercise performance or metabolism (e.g. thyroid medication, beta-blockers, or stimulants) * excess caffeine use (\> 500mg/day) * restrained eater (\>13) on the restraint section of the three-factor eating questionnaire * current or past diagnosis of an eating disorder * any self-reported contraindications to exercise according to the american college of sports medicine criteria * pregnant or actively trying to become pregnant * gave birth in the past 12 months or \<6 months post-lactation * other medical, psychiatric or behavioral factors that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention protocol. * known allergy to the metal nickel * known allergies to pasta or tomato sauce
prediction of drug response in gastric cancer based on 3d bioprinting

Conditions: STOMACH NEOPLASM

Summary: the therapeutic regimens for adjuvant and neoadjuvant chemotherapy in gastric cancer (gc) predominantly hinge on clinical experience. consequently, there is an imperative need for preclinical models to facilitate the guidance of individualized medicine. the investigators plan to establish three-dimensional (3d) bioprinted gc models derived from surgically resected tumor tissues of gc patients. these in vitro 3d models will be subjected to treatment with the identical chemotherapy drugs administered to the corresponding patients from whom the models are sourced. the sensitivity of the chemotherapy drugs will be assayed within the in vitro models, and the actual response to chemotherapy in patients will be meticulously evaluated. this observational study aims to substantiate the potential utility of 3d bioprinted tumor models in prognosticating the response to chemotherapy in gc.


Eligibility criteria:
inclusion criteria: * more than 18 years old * patients previously diagnosed with gastric cancer or confirmed by pathology as having gastric cancer postoperatively. * patients who have undergone preoperative imaging examinations, including plain and contrast-enhanced ct scans of the chest, abdomen, and pelvis, as well as gastric mri for tumor staging, and who are planned for preoperative (neo)adjuvant therapy after multidisciplinary team (mdt) discussion; patients with advanced gastric cancer who are confirmed by postoperative pathology to require (neo)adjuvant therapy. * the patient or their family members are able to comprehend the research protocol and are willing to participate in this study, providing written informed consent. exclusion criteria: * history of other malignancies or serious medical conditions * inability to provide independent informed consent
immune response in children revaccinated with pneumococcal conjugate vaccine

Conditions: Invasive Pneumococcal Disease

Summary: the primary purpose of this study is to evaluate the immune response to 13-valent pneumococcal conjugate vaccine (13vpncv) in children who as infants received either a complete series of pncv versus a combination of pncv and pneumococcal polysaccharide vaccine (psv). this study is also intended to evaluate the safety of the 13vpnc.

follow-up measure for the emea supporting a type ii variation for prevenar (pcv7) label

Eligibility criteria:
inclusion criteria: * fully vaccinated children who participated in a previous wyeth study (study d139-p506) and received a booster dose of either 23-valent pneumococcal polysaccharide vaccine (ppv23) or pneumococcal conjugate vaccine (pncv) per the original protocol for that study. * subjects must be in good health as determined by medical history, physical examination and clinical judgment. exclusion criteria: * known allergy to any component of the 7-valent pneumococcal conjugate vaccine (7vpnc) or 13-valent pneumococcal conjugate vaccine (13vpnc). * history of documented invasive pneumococcal disease (defined as a positive culture of s. pneumoniae from a normally sterile body site). * any known or suspected disease or dysfunction of the immune system, including: hiv infection, malignancy, receipt of immunosuppressive therapy, sickle cell hemoglobinopathy. * receipt of immune-globulin within the past 3 months. * receipt of either psv or 7vpncv since the completion of study d139-p506.

Keywords: immune response pneumococcal conjugate vaccine polysaccharide
dabigatran as an alternative anticoagulant in patients with left ventricular assist device (lvad)

Conditions: Thrombosis; Bleeding

Summary: patients with severe heart failure supported by left ventricular assist device (lvad) require adequate long-term anticoagulant therapy. new oral anticoagulants such as the direct thrombin inhibitor dabigatran may represent an alternative to coumarin for long-term anticoagulation. in this pilot single-center study, thirty lvad patients with stable renal function were scheduled to receive phenprocoumon or dabigatran for long-term anticoagulation after implantation of a heartware hvad system following an open-label balanced parallel group design.


Eligibility criteria:
inclusion criteria: * lvad (hvad, heartware inc., framingham, ma, usa) implantation more than one month ago * stable renal function (clinical judgement) * age 18 years or older * ability to give informed consent exclusion criteria: * severe chronic renal impairment (cl\<30) * history of significant thromboembolic events * significant bleeding disorder * hiv or hepatitis c infection * heparin induced thrombocytopenia * known hypersensitivity to dabigatran or phenprocoumon
oral treatment for gynaecological post-operative pain with dexketoprofen trometamol and tramadol hydrochloride

Conditions: Acute Pain

Summary: this study aims to evaluate the analgesic efficacy of single and repeated doses of fixed combination of dexketoprofen trometamol (dkp) and tramadol hydrochloride (tram) in comparison to the single agents (and placebo for the single dose phase only). approximately 600 female patients presenting moderate to severe pain after a total/subtotal abdominal hysterectomy are eligible to be randomised provided that they experience moderate to severe pain on the day after surgery.

in this clinical trial patients were randomized to the described 6 treatment arms, where each arm define the treatment to be received in the first single dose phase (lasting 8 hours after the 1st treatment intake) and in the subsequent multiple-dose phase (lasting from the second treatment intake up to the 8 hours after the last intake). namely: * dkp/tram followed by dkp/tram; * dkp followed by dkp; * tram followed by tram; * placebo followed by dkp; * placebo followed by tram; * placebo followed by dkp/tram; the analyses of endpoints pertinent to the single dose phase were performed combining all the 3 treatment arms including placebo into one group, which resulted in the following 4 analysis groups: dkp/tram, dexketoprofen, tramadol, and placebo. the analysis of endpoints pertinent to the multiple dose phase were performed combining the treatment arms including the same active treatment, which resulted in the following 3 analysis groups: dkp/tram, dexketoprofen, and tramadol.

Eligibility criteria:
inclusion criteria: * female patients aged 18 to 75 years. * scheduled to undergo a total or subtotal abdominal hysterectomy (with or without salpingo-oophorectomy) for benign conditions. * patients experiencing pain at rest of at least moderate intensity the day after surgery. exclusion criteria: * patients not suitable for study treatments and rescue medication (rm) or those for whom non-steroidal anti-inflammatory drugs (nsaids), opioids, acetyl salicylic acid, pyrazolones or pyrazolidines are contraindicated. * patients with clinically significant abnormalities in vital signs, safety laboratory tests and 12-lead ecg at screening. * patients with history of any illness or condition that might pose a risk to the patient or confound the efficacy and safety study results. * patients using and not suitable to withdraw analgesics other than those specified in the protocol. * patients using and not suitable for withdrawing any of the prohibited medication specified in the protocol. * breastfeeding women.

Keywords: moderate to severe acute pain postoperative pain abdominal hysterectomy analgesics dexketoprofen tramadol
study of clevidipine assessing its preoperative antihypertensive effect in cardiac surgery (escape-1)

Conditions: Hypertension

Summary: the purpose of this study is to determine the efficacy of clevidipine injection versus placebo in treating preoperative hypertension.

initiation of study drug infusion will commence with the occurrence of protocol-defined preoperative hypertension (sbp \> 160 mmhg) as measured via an indwelling arterial line. the study drug (clevidipine or placebo) may be administered to treat hypertension until one hour has elapsed, or until induction of anesthesia, whichever occurs first. the primary endpoint of bailout described (as defined per protocol) as bailout for lack of efficacy, bailout for safety reason or bailout due to treatment failure will be determined during the 30-minute period from study drug initiation.

Eligibility criteria:
pre-randomization inclusion criteria: * provide written informed consent before initiation of any study-related procedures. * be at least 18 years of age * be scheduled for cardiac surgery (including coronary artery bypass grafting \[cabg\], off pump coronary artery bypass \[opcab\], minimally invasive direct coronary artery bypass \[midcab\] surgery, and/or valve replacement/repair procedures) * have a recent history (within 6 months of randomization) of hypertension requiring treatment with antihypertensive medication(s) or be actively hypertensive upon admission pre-randomization exclusion criteria: * women of child-bearing potential (unless they have a negative pregnancy test) * recent cerebrovascular accident (within 3 months before randomization) * known intolerance to calcium channel blockers * allergy to soybean oil or egg lecithin (components of the lipid vehicle) * pre-existing left bundle branch block or permanent ventricular pacing * any other disease or condition, which, in the judgment of the investigator would place a patient at undue risk by being enrolled in the trial. * participation in another therapeutic drug or therapeutic device trial within 30 days of starting study post-randomization inclusion criteria: * after the insertion of an arterial line, the patient is determined to meet the per protocol preoperative definition of hypertension, i.e. systolic blood pressure (sbp) \> 160 mmhg * it is the investigator's intent to lower the patient's sbp by a minimum of 15% from its baseline value

Keywords: pre-operative hypertension
pharmacokinetic and injection site toleration of biod-238 and biod-250 compared to humalog® in subjects with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: a double-blind study of the pharmacokinetic properties of biod-238 and biod-250 compared to humalog® in subjects with type 1 diabetes

the purpose of this study is to assess the speed of absorption of biod-238 and biod-250 compared to humalog®. secondary objectives are to assess other pharmacokinetic characteristics of biod-238 and biod-250 compared to humalog®, and to evaluate the safety and tolerability of biod-238 and biod-250 compared to humalog®.

Eligibility criteria:
inclusion criteria: * age: ≥18 to ≤70 years * body mass index: ≥18 and ≤35 kg/m2 * diagnosed with type 1 diabetes mellitus for at least 1 year exclusion criteria: * type 2 diabetes mellitus * serum c-peptide \>1.0 ng/ml * hba1c \>10.0% * history of hypersensitivity to any of the components in the study medication * treatment with any other investigational drug in the last 30 days before dosing. * current drug or alcohol abuse, or a history of drug or alcohol abuse which in the opinion of the investigator will impair subject safety, protocol compliance, or interpretation of study results. caffeine, nicotine or alcohol addiction which might be expected to result in withdrawal symptoms during the course of a study dosing day would fall into this category.

Keywords: diabetes
systemic chemotherapy, apatinib plus sintilimab for metastasis icc

Conditions: ICC

Summary: this study were designed to verify the better method of survival for metastatic icc. since the traditional method for metastatic icc was gemox(first-line treatment from nccn guideline), our previous study found similar results from folfox (second-line treatment from nccn guideline) compared with gemox. our current study were conducted for further investigation to verify the better method for metastatic icc.

icc(intrahepatic cholangiocarcinoma) patients with metastasis has a short survival time and poor prognosis after diagnosis. treatment methods was few and far from satisfaction. the treatment recommended from nccn guideline was gemox(systemic chemotheray) and clinical trials. our previous study has demonstrate folfox (systemic chemotheray based on oxaliplatin#5- fluorouracil) has a similar survival and tumor response compared with gemox. further study was needed to intensive confirmation of the result. we designed this study to demonstrate the hypothesis. metastasis iccs were recruited and screened by our criteria. all patients were treated with folfox (systemic chemotheray based on oxaliplatin#5-fluorouracil ), apatinib (one of tyrosine kinase inhibitors) plus sintilimab (one of pd-1 antibody). our study were designed to verify the better method of survival for metastatic icc.

Eligibility criteria:
inclusion criteria: * the diagnosis of icc * with distant metastasis * patients must have at least one tumor lesion that can be accurately measured according to mrecist criteria. * with no previous treatment * no cirrhosis or cirrhotic status of child-pugh class a only * not amendable to surgical resection ,local ablative therapy and any other cured treatment * the following laboratory parameters: platelet count ≥ 60,000/μl hemoglobin ≥ 8.5 g/dl total bilirubin ≤ 30mmol/ l serum albumin ≥ 32 g/l asl and ast ≤ 6 x upper limit of normal serum creatinine ≤ 1.5 x upper limit of normal inr ≤ 1.5 or pt/aptt within normal limits absolute neutrophil count (anc) \>1,500/mm3 exclusion criteria: * evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy * known history of hiv * history of organ allograft * known or suspected allergy to the investigational agents or any agent given in association with this trial. * cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * evidence of bleeding diathesis. * patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.

Keywords: icc systemic chemotheray apatinib sintilimab
ultrasound guidance for intravenous cannulation in emergency department patients.

Conditions: Difficult IV Access

Summary: a randomized trial of the use of ultrasound by emergency physicians in the placement of intravenous catheters in emergency patients who are found to have difficult intravenous access (defined as two failed attempts by nursing staff).


Eligibility criteria:
inclusion criteria: * patients requiring an iv in the emergency department and who have two failed attempts by nursing staff exclusion criteria: * emergent need for iv access

Keywords: ultrasound iv access patients with difficult iv access in emergency departments.
role of a2a receptor in hypercholesterolemic patients

Conditions: Hypercholesterolemia

Summary: hypercholesterolemia promotes chronic inflammation, endothelial dysfunction, atherosclerosis and is a major risk factor for cardiovascular disease (cvd). treatment with lipid-lowering drugs (statins, ezetimibe, pcsk9 inhibitors or ldl-apheresis) reduces the risk of major cardiovascular events in proportion to the absolute reduction of ldl-cholesterol (ldl-c). nevertheless, a better understanding of the effects of hypercholesterolemia on the cardiovascular and immune systems could help identify all the mechanisms responsible for the excess risk of cvd in hypercholesterolemic patients and develop better prevention and treatment strategies. adenosine via a2a receptors (a2ar) plays a crucial role in the regulation of the cardiovascular and immune systems. in this project, the investigators wish : * to study whether the expression and function of a2ar in pbmcs are altered in human hypercholesterolemia, using as a study model a larger cohort of patients with hypercholesterolemia of increasing level and severity: polygenic form, heterozygous genetic form and homozygous genetic form in comparison with healthy subjects with normal cholesterol levels. * to study whether a2ar expression and function in pbmcs are associated with blood levels of ldl-c and homocysteine and with the inflammatory status of patients. * to assess whether the cholesterol-lowering therapies currently used to reduce ldl-c levels and thus the risk of cvd in hypercholesterolemic patients have an impact on possible alterations of a2ar expression and function in pbmcs.


Eligibility criteria:
inclusion criteria: * male or female subjects aged 18-80 years * for the group of hypercholesterolemic patients : * ldl-cholesterol level \>1.9 g/l with or without treatment to make the diagnosis of hypercholesterolemia (laboratory test less than 12 months old at inclusion) * for the healthy group : ● no cholesterol-modifying therapy. * subject not having hypercholesterolemia (biological assessment less than 12 months old at inclusion with ldl-cholesterol level \< 1.9 g/l) and not taking cholesterol-lowering treatment. * subjects who are affiliated or beneficiaries of a social security plan * subject agreeing to participate in the study and having signed an informed consent exclusion criteria: * protected person, as defined by articles l1121-5, l1121-6 and l1121-8 of the public health code: pregnant or breastfeeding woman, person deprived of liberty by judicial decision, adult person unable to give consent. * person who does not understand the french language

Keywords: hypercholesterolemia adenosine receptor pbmc