Kornimate/medical-research-clean huggingface dataset:
time to protein target using a high whey protein enteral nutrition in critically ill patients

Conditions: Critically Ill

Summary: this study evaluates the feasibility of a high whey-protein enteral nutrition formula in 20 ventilated icu patients. the primary endpoint of study is the feasibility to attain the individualized protein target (≥1.2 g/kg ideal body weight/day) 96-hours after icu admission. secondary endpoints include tolerance and efficacy in terms of the amino acid response in blood.

in the present pilot study, the investigators will use a high whey-protein nutrition formula during the first four days of icu admission. the reason for using a high protein nutrition is that the investigators previously found that an early high protein intake in non-septic non-overfed patients was associated with lower hospital mortality (weijs pjm et. al., critical care 2014,18). furthermore, during the first days of critical illness tolerance to full enteral nutrition is often diminished. the use of a high protein nutrition will facilitate an early high protein intake. the whey protein is hydrolysed. hydrolyzation of protein prevents coagulation and subsequent solidification in the digestive tract and therefore promotes efficient absorption of the protein. of all nutrition proteins, whey protein has the largest leucin content. leucin is crucial for muscle protein synthesis. (meyer rf, et.al.: bmc gastroenterol 2015, 15), (marik pe: ann intensive care 2015,5:51) our previous observational data also showed that early overfeeding was associated with higher mortality, while an intake of 80-100% of measured energy expenditure at day 4 of icu admission was associated with lower mortality. (weijs pjm et. al., critical care 2014, 18) therefore, the energy target during the first four days will be 90% of the measured energy expenditure (ee). to optimize energy intake, the investigators will measure ee by metabolic monitoring (deltatrac®, datex, helsinki, finland), if metabolic monitoring is not available, the investigators will assess ee from the ventilator derived vco2 (8.19\*vco2). (stapel s, et.al., critical care 2015,19:370)

Eligibility criteria:
inclusion criteria: * admission to the intensive care unit * age \>18 years * mechanical ventilation * expected intensive care stay of four days or longer exclusion criteria: * contraindication for enteral nutrition (gut ischemia, obstruction or perforation) * expected intolerance for enteral nutrition (paralytic ileus) * inability to start enteral nutrition within 24-hours due to logistic reasons (i.e. surgery or other interventions) * short bowel syndrome * child c liver cirrhosis or acute liver failure * dialysis dependency * requiring other specific enteral nutrition for medical reason * extensive treatment limitations * written deferred patient or proxy consent is not obtained * participation in another intervention study * inability to measure energy expenditure (pulmonary air leakage)

Keywords: enteral nutrition intensive care unit whey protein muscle mass leucin energy expenditure
effects of non-surgical periodontal therapy on cardiovascular risk

Conditions: Cardiovascular Diseases; Periodontitis

Summary: this study is to evaluate whether non-surgical periodontal therapy can help to control the cardiovascular risk among patients with moderate/severe periodontitis and at risk of cardiovascular disease.

previous studies showed that the treatment of periodontitis can partially improve the control of risk factors of cardiovascular disease (e.g. blood pressure, interleukin 6), whereas the evidence is still limited. moreover, there is currently no study reporting the impact of periodontal treatment on the overall risk of cardiovascular disease. the prevalence of periodontitis in china was 62.4%. in clinical practice, a large number of patients with moderate/severe periodontitis and at risk of cardiovascular disease seek medical advice. however, the existing guidelines lack relevant recommendations. therefore, this study intends to evaluate whether non-surgical periodontal therapy can help to control cardiovascular risk. 376 patients with moderate/severe periodontitis and at risk of cardiovascular disease will be randomized. those randomized to the intervention arm will receive non-surgical periodontal therapy which includes full-mouth subgingival scaling and root planing. those randomized to the control arm will receive supragingival ultrasonic scaling. all patients were given instructions on basic oral hygiene.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years; * at risk of cardiovascular disease (defined as "framingham score" predicted 10-year risk of cardiovascular disease ≥ 20%); * moderate//severe periodontitis; exclusion criteria: * cardiovascular diseases at baseline (coronary heart disease, stroke and peripheral artery disease); * received periodontal treatment within the past 6 months; * pregnant or lactating females; * non residents of guangzhou and its surrounding cities or expected to leave guangzhou or its surrounding cities within 1 year; * malignant tumors or other end-stage diseases with life expectancy less than 1 year; * end-stage renal disease; * patients with high bleeding risk, high blood pressures or other situations that make them unable to receive interventions; * refuse to provide informed consent;

Keywords: periodontitis non-surgical periodontal therapy cardiovascular risk
bortezomib with steroid pulse therapy for acute cellular rejection in kidney transplantation

Conditions: Kidney Transplantation

Summary: the purpose of this study is to determine whether bortezomib is effective in the treatment of acute cellular rejection after kidney transplantation.

when acute cellular rejection occurred in kidney allograft, investigators administer high dose steroid. however, there is insufficient effect in about 20-30%. bortezomib acts not only on plasma cells, but also t cells, b cells and dendritic cells. in addition, bortezomib is relatively safe drug compared to thymoglobulin which investigators use in the cases of steroid failure. therefore, investigators administer bortezomib with steroid in one group, and compared the group with the other group in which conventional steroid treatment is done.

Eligibility criteria:
inclusion criteria: * living donor kidney transplantation recipients * patients who were performed kidney biopsies because of laboratory and clinically suspected rejection * biopsy proven acute cellular rejection (banff i - iia) with c4d negative * single luminex panel reactive antibody (pra) i \& ii mean fluorescent intensity (mfi) \< 3000 exclusion criteria: * patients who received other major organ transplantation * combined with urinary tract infection or obstruction * combined with acute antibody mediated rejection * poor compliance
evaluation of proteasome as a marker of hepatocellular carcinoma in cirrhotic patients following curative treatment

Conditions: Hepatocellular Carcinoma; Cirrhosis

Summary: this study will evaluate the usefulness of plasma proteasome levels as a tumor marker of hepatocellular carcinoma (hcc) by studying their variation following curative treatment of hcc. the hypothesis of the study is that plasma proteasome levels will decrease following curative treatment, and that proteasome levels could be used as a marker to detect early recurrence.

hcc occurs in the vast majority of cases in the context of cirrhosis. cirrhosis is considered a pre-cancerous state, which justifies systematic screening for hcc. screening currently relies on measurement of alpha-foetoprotein (afp) levels and ultrasound scans every 4 to 6 months. however, afp has poor sensitivity as a marker for hcc. we have recently shown that plasma proteasome levels have a higher sensitivity than hcc for detecting hcc in cirrhotic patients, particularly when the tumors are small and can still benefit from curative treatment. the hypothesis of the study is that plasma proteasome levels will decrease following curative treatment, and that proteasome levels could be used as a marker to detect early recurrence. the goal of this study is to determine whether plasma proteasome levels in cirrhotic patients with hcc decrease following curative treatment (radiofrequency, surgical resection, liver transplantation). plasma proteasome levels will be measured before treatment and 3 months after treatment, then subsequently at 3 month intervals over one year following treatment. the variation of proteasome levels will be compared to afp levels. the sensitivity of proteasome as a marker to detect tumor recurrence will be evaluated, and compared to afp.

Eligibility criteria:
inclusion criteria: * cirrhotic patients with hepatocellular carcinoma proven by histological examination of a biopsy specimen, eligible for curative treatment (radiofrequency, surgical resection, liver transplantation) * patient able to give informed consent * patient with social security coverage exclusion criteria: * secondary liver tumors * non hepatocellular carcinoma primary liver tumor * hepatocellular carcinoma without cirrhosis * patients with hepatocellular carcinoma and cirrhosis not eligible for curative treatment * prisoners * adults under guardianship or curatorship * pregnancy

Keywords: hepatocellular carcinoma cirrhosis proteasome alpha-fetoprotein
effectiveness of duloxetine in the treatment of stress urinary incontinence(uncontrolled leakage of urine)

Conditions: Urinary Incontinence, Stress

Summary: the study evaluates the effectiveness of duloxetine in reducing urinary incontinence occurrences in women due to physical stress(e.g. stomach pressure on bladder). incontinence is the inability to control bladder function with leakage of urine.


Eligibility criteria:
inclusion criteria: * female outpatients \> or = 18 years of age * experience episodes of stress urinary incontinence * must have an educational level and degree of understanding english * are free of urinary tract infections * can use the toilet independently exclusion criteria: * any in or outpatient surgery in the last six months * suffer from severe constipation * extension of any internal organs beyond vaginal opening * currently breastfeeding * any nervous diseases affecting normal urinary function
randomized evaluation and verification of ventricular enhancement

Conditions: Ischemic Cardiomyopathy; Heart Failure

Summary: a prospective, multi-center, dual-arm randomized controlled study comparing treatment of ischemic cardiomyopathy induced heart failure with the revivent tc system plus guideline directed medical therapy (gdmt) compared to gdmt alone.

the purpose of the study is to demonstrate that treatment with the bioventrix revivent tc system is more effective than guideline directed medical therapy for the treatment of ischemic heart failure. this is a prospective, multi-center, dual-arm randomized controlled study comparing treatment of ischemic cardiomyopathy induced heart failure with the revivent tc system plus guideline directed medical therapy (gdmt) compared to gdmt alone. this study will include 180 patients of which 120 patients will be treated with the investigational device and 60 patients will be maintained on gdmt.

Eligibility criteria:
inclusion criteria: * patients suffering from heart failure symptoms with cardiac dysfunction caused by a previous myocardial infarction resulting in increased lv systolic volume and in a discrete, contiguous, acontractile, (akinetic and/or dyskinetic) scar located in the antero-septal, apical (may extend laterally) region of the left ventricle. exclusion criteria: * calcified ventricular wall in the area of intended scar exclusion as verified by one or more appropriate imaging modalities; * inadequate myocardial viability in regions remote from the scar. * thrombus or intra-ventricular mass in the left atrium or ventricle as verified by echocardiography or equivalent that has not been adequately treated with weeks of anticoagulant at therapeutic levels; * cardiac resynchronization therapy (crt) consisting of bi-ventricular pacemaker device (i.e., not icd only) placement ≤ 60 days prior to treatment; * patient intolerance or unwillingness to take anti-coagulation medication; * functioning pacemaker leads in antero-apical rv, which, in the opinion of the investigator, would interfere with anchor placement; * pulmonary arterial pressure \> 60 mm hg shown by right heart catheterization to be precapillary or unresponsive to vasodilator therapy; * myocardial infarction within 90 days prior to the procedure; * previous right neck surgery, previous pericardiotomy, previous left chest surgery that precludes device placement; * chronic renal failure with a serum creatinine \>2 mg/dl; * inoperable coronary disease with significant ischemia or pulmonary disease that would preclude transient single lung ventilation. * baseline 6-minute walk distance of \>450m

Keywords: ischemic cardiomyopathy, heart failure, revivent tc system
reducing recurrence of symptomatic atrial fibrillation after catheter ablation by app-based mental training

Conditions: Paroxysmal Atrial Fibrillation; Persistent Atrial Fibrillation; Meditation

Summary: atrial fibrillation (af) is one of the most common heart rhythm disorders and it is associated with a variety of symptoms leading to a considerable deterioration in quality of life. the mental-af trial is intended to inquire if an app-based mental training can reduce the occurrence of symptomatic af episodes within the blanking period, i.e. the first three months after catheter ablation for af.

to explore the potential of a daily app-based mindfulness mental training in improving af symptoms, assessed by self-reported outcome measures, i.e. the af 6 questionnaire, af effect on quality of life (afeqt) and patient reported outcome measurement information system (promis) global health questionnaires, as well as in reducing af burden in 7-day-holter, within the first 12 weeks following af ablation.

Eligibility criteria:
inclusion criteria: * all patients undergoing af ablation with symptomatic paroxysmal or chronic atrial fibrillation (ehra ii-iv) * availability of smart phone with the capability to run android 5 or ios 9 or newer versions * capability to use mobile phone applications * internet access * consent to study participation exclusion criteria: * patients \< 18 years of age * unavailability of smart phone running at least android 5 or ios 9 * pregnancy
a study to evaluate safety and efficacy of convalescent methylene blue treated (mbt) plasma from donors recovered from coronavirus disease 2019 (covid-19)

Conditions: COVID-19

Summary: the purpose of the study is to determine if convalescent anti-severe acute respiratory syndrome coronavirus 2 (sars-cov-2) methylene blue treated (mbt) plasma plus standard medical treatment (smt) can reduce all-cause mortality versus smt alone in hospitalized participants with covid-19 requiring admission to the intensive care unit (icu) through day 29.


Eligibility criteria:
inclusion criteria: * hospitalized male or female subjects of ≥ 18 years of age at time of screening who are being treated in the intensive care unit (icu) for covid-19 for not longer than 48 hours or for whom a decision has been made that covid-19 disease severity warrants icu admission. * subject (or a legal representative or a nearest relative or a relative by marriage, as appropriate) provides informed consent (icf) prior to initiation of any study procedures. * has laboratory-confirmed novel coronavirus (sars-cov-2) infection as determined by qualitative polymerase chain reaction (pcr) (reverse transcriptase \[rt\]-pcr), or other commercial or public health assay in any specimen during the current hospital admission prior to randomization. * illness (symptoms) of any duration, and the following: 1. radiographic infiltrates by imaging (chest x-ray, computerized tomography \[ct\] scan, etc.), and 2. requiring mechanical ventilation and/or supplemental oxygen * subjects with no limitation of therapeutic effort (decision on the status and future of the subject). * female subjects of child-bearing potential must have a negative test for pregnancy blood or urine human chorionic gonadotropin (hcg)-based assay at screening/baseline visit. exclusion criteria: * clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may place the subject at undue medical risk. * the subject has had a known serious anaphylactic reaction to blood, any blood-derived or plasma product or methylene blue. * a medical condition in which the infusion of additional fluid is contraindicated. * shock unresponsive to fluid challenge and/or multiple vasopressors and accompanied by multiorgan failure considered by the principal investigator not able to be reversed.

Keywords: coronavirus disease severe acute respiratory syndrome coronavirus 2 sars-cov-2
comparison of custom and standard total knee replacements

Conditions: Knee Osteoarthritis

Summary: total knee arthroplasty (tka) is the most common surgery in north america and the second most common in europe. one of the most critical issues for stability and durability of the interventional is the prosthesis-bone geometric fit, where a required a perfect match; the recent availability of custom 3d implants can overcome this problem. in order to further improve a tka surgery, it is in fact, it is possible today to completely customize the procedure for each individual patient, with cost and time now accessible. this intervention can be performed with the use of instrumentation specific to the patient (so-called resin 'cutting templates' referred to as psi, "patient specific instrumentation") to make cuts accurate bone cuts in accordance with a specific 3d preoperative plan . also the design and fabrication in of the components prosthetic components themselves, in metal and polyethylene, is done by means of 3d printing. based on the unique anatomy of each patient, the precise sagittal orientation and axial rotation of the components of the prosthesis customized for the surgeon, it is possible to plan and perform the surgery quickly and in accordance with the exact specifications of the individual patient. these procedures should also make it possible to greatly reduce the instrumentation and the sizes that need to be available in the operating room, reducing time and costs associated with transportation and storage . the objective of this study is to compare primary tkas performed with a customized procedure (prostheses customized for each patient based on his or her reconstructed knee morphology by tomographic scans, and implanted via cutting guides customized for the patient) with standard primary tkas, considering: the objective radiological results, the subjective results of the patients and the costs of both procedures.


Eligibility criteria:
inclusion criteria: * male and female subjects older than 40 years and younger than 70 years (≥ 40 age ≤ 70 years) candidates for primary cemented total knee replacement. * consenting patients and able to complete scheduled study procedures and follow-up evaluations. * patients who have signed the "informed consent" approved by the ethics committee. exclusion criteria: * social conditions (homeless patients, with restrictions on personal freedom) * asa 3 * deep venous insufficiency lower limbs * history of erisipelas lower limbs * neurological or psychocognitive disorders * neurological diseases * post-traumatic arthritis * axial deformities of the knee \>10° * personal or family history of dvt or ep * prosthetic and/or arthrodesis surgeries at another joint of the lower extremities lower limb except that candidate for knee prosthesis * pregnant women * patients with rheumatic diseases
does b vitamin supplementation decrease homocysteine concentrations in newborns

Conditions: Mild Hyperhomocysteinemia

Summary: the purpose of this study is to determine whether supplementation with folinic acid, a b vitamin, lowers the concentrations of total homocysteine in newborns. increased homocysteine concentrations are associated with an increased risk of cerebrovascular accidents in adult, children and newborns. these increased concentrations can easily and safely be lowered by folic acid in adults.

the incidence of cerebrovascular accidents (cva) occurring perinatally is relatively high and aspects of the multifactorial pathophysiology remain unclear. elevated homocysteine concentrations are shown to be associated with an increased risk for cva in newborns. we want to study the possible homocysteine lowering effect of folinic acid in newborns. we will include newborns in our prospective randomized folinic acid intervention study from patients admitted to our neonatal intensive care unit. we will measure total homocysteine (thcy) and folate concentrations at three time points. the intervention group will be treated with folinic acid (70 µg/kg/day) for two weeks.

Eligibility criteria:
inclusion criteria: * admitted at our nicu exclusion criteria: * midline defects * extracorporeal membrane oxygenation (ecmo) treatment * blood transfusion * overt renal failure

Keywords: cva stroke newborns homocysteine folinic acid
n-acetyl-cysteine and carbohydrate metabolism disorder in obese women

Conditions: Insulin Resistance; Obesity; Carbohydrate Metabolism Disorder

Summary: the effect of n-acetylcysteine supplementation on carbohydrate metabolism disorder and homocysteine concentrations in obese women will be analysed.


Eligibility criteria:
inclusion criteria: * women diagnosed with carbohydrate metabolism disorder, * obesity (bmi \>29,9 kg/m2) * patients not participating in other similar research programs at the same time, * written agreement to take part in the research. exclusion criteria: * the use of medicament that may affect on carbohydrate metabolism within 4 weeks, * failure to comply with dietary recommendations established during the nutritional intervention, * pregnancy and breast feeding.

Keywords: n - acetylocysteine obesity insulin resistance nutrition intervention carbohydrate metabolism
immunotherapy with depigmented and polymerized allergen extract of phleum pratense

Conditions: Rhinitis, Allergic, Seasonal; Conjunctivitis, Allergic; Asthma

Summary: the objective of this trial is to evaluate the clinical effectiveness of the administration of a depigmented and polymerized allergen extract of phleum pratense in the rhinoconjunctivitis and/or asthma of slight or moderate intensity, due to allergy to grass pollen.

immunotherapy is a specific treatment for allergic diseases. unlike conventional pharmacological treatment, immunotherapy is the only treatment that could modify the natural course of allergic disease. this is a prospective double-blind placebo controlled study with three arms of treatment: placebo and two active (one of the active arms will receive a dose that is 10x the dose of the other arm).

Eligibility criteria:
inclusion criteria: * positive clinical history of allergy to phleum pratense * patients of both gender aged from 12 up to 50 years. * positive prick test to phleum pratense allergen extracts * specific ige to phleum pratense * positive clinical history of allergic rhinoconjunctivitis and/or asthma * written informed consent. exclusion criteria: * use of immunotherapy during the last four years. * any contraindication for the use of immunotherapy in accordance with european allergy and clinical immunology immunotherapy subcommittee criteria: * treatment with ß-blockers * coexistence of immunopathological diseases (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases) in which autoimmune mechanisms play a role * patients suffering from immune deficiencies * patients with serious psychiatric / psychological disturbances * in addition, the following was considered as exclusion criteria: * pregnant or/ in lactation patients * patients aspirin intolerance

Keywords: allergoid depigmented polymerized allergen-extract rhinoconjunctivitis asthma