Kornimate/medical-research-clean huggingface dataset:
pds*plus and wound infections after laparotomy

Conditions: Wound Infection; Incisional Hernia

Summary: the aim of this study is to ascertain if the use of pds plus® reduces the number of wound infections and incisional hernia after midline and transverse laparotomy comparing to polyglactin suture.

all patients are treated using clinical pathways (cp) to standardise surgical procedures in our high volume centre. part of the clinical process management was the standardisation of wound incision and abdominal wall closure. wound closure is achieved using continuous absorbable loop suture. the suture length to incision length ratio is at least 4:1. the running sutures are 1 cm apart and at least 1.5 cm from the wound edge. in the first time period , the cp step for fascia closure foresees a triclosan-coated pds 910 loop suture (pds plus®, ethicon gmbh, norderstedt, germany). in the second time period the cp step will be altered to the use of pds loop suture (pds ii®, ethicon gmbh, norderstedt, germany). the cp- step is changed every 100 patients to cluster-randomize the patients. the primary outcome is the number of wound infections. together with this the number of incisional hernia will be recorded. patients demographic and disease as well as procedure related data are collected in a clinical information system (ishmed on sap platform, gsd, berlin, germany) prospectively. risk factors for poor wound healing, such as operation time, patients age, sex, body mass index, blood loss, peritonitis, antibiotics, and performance level classified according to the american society of anesthesiologists (asa), are collected prospectively to compare the two groups.

Eligibility criteria:
inclusion criteria: * surgical pathologies accessed via midline or transverse abdominal incision * primary fascial closure exclusion criteria: * pregnancy * age under 18 years * open abdominal treatment * known hypersensitivity against pds/triclosan

Keywords: open abdominal surgery fascial closure
cangrelor in patients with acute myocardial infarction undergoing pci after cpr, ventilated or cardiogenic shock

Conditions: Acute Myocardial Infarction

Summary: this registry will provide information about the efficacy and safety of cangrelor in a very high-risk group of patients with acute myocardial infarction undergoing pci. it will not only include patients with cardiogenic shock, but a variety of patients not able to swallow tablets, such as those after cpr and/or with invasive or non-invasive ventilation. therefore it will provide information about the use of cangrelor beyond the current knowledge.

this registry is a non-interventional, multicentre, retrospective cohort study in patients with acute myocardial infarction undergoing pci after crp, ventilated and/or with cardiogenic shock. the study is purely observational; data will be documented retrospectively based on available medical records. no additional data will be collected, no study-related treatment will be initiated. about 10 - 20 high-volume pci clinics in germany treating patients with myocardial infarction are eligible for participation. participating sites will be given a maximum of 6 months for retrospectively documenting eligible patients. eligible are all patients with acute myocardial infarction (stemi, nstemi) who underwent pci after crp, ventilated and/or with cardiogenic shock and were treated with cangrelor during index procedure. it is planned to enrol about 400 patients in total. patient characteristics, procedural details and clinical events occurring during the period between index mi and discharge or death (whichever came first) will be documented based on the relevant existing medical charts of the patients.

Eligibility criteria:
inclusion criteria: * age ≥18 years * acute myocardial infarction (nstemi or stemi) * pci with stent implantation * treatment with cangrelor during index procedure * at least one of the following criteria: * cpr prior to pci * cardiogenic shock * heart failure with the need for mechanical or non-invasive ventila-tion exclusion criteria: no explicit medical exclusion criteria are stated to avoid selection bias.
clinical verification of peptide biomarkers for human aging

Conditions: Aging

Summary: aging in human physically refers to a multidimensional process that all the changes were accumulated in a person over time. these aging changes are responsible for the progressive increases in the chance of disease and death associated with them. so far, there are several theories have been developed to understand the aging process, such as cross-linking, which is led by maillard reactions. maillard reaction is a complex series of reactions between reducing sugar/aldehydes and amino groups on proteins. under physiological conditions, aldehydes are products of various exogenous and endogenous amines catalyzed by semicarbazide-sensitive amine oxidase (ssao), a family of heterogeneous enzyme. it was reported that ssao shows a significant higher catalytic activity, producing more aldehydes in age-related diseases. however, ssao is not a perfect candidate to be monitored for evaluating aging, because it is widely distributed in tissues, which are not readily accessible sample-sources for clinical applications. in this work, the investigators have found 6 biomarker candidates by developing a standard-free, label-free ms-based proteomics method based on standard protein (human serum albumin, the highest abundance protein in human plasma) model in vitro. then, the investigators wanted to verify these biomarker candidates by clinical plasma samples to see if there is significant quantitative difference among people with different ages.

the procedure of clinical study was: 1. to get plasma samples from hospital; 2. digestion of plasma protein-mixture by trypsin in lab; 3. run mass spectrometry and monitor the amount of target hsa-peptides.

Eligibility criteria:
inclusion criteria: * cases with different ages exclusion criteria: * cases with diabetes mellitus and hepatitis b

Keywords: formaldehyde; maillard reaction; cross-linkage; human aging
genetic and epigenetic background of inner ear dysfunction in turner syndrome

Conditions: Sensorineural Hearing Loss; Turner Syndrome; Inner Ear Disease

Summary: the goal of this case-control study is to pave the way for new revolutionary treatment measures within hearing loss that could either replace or delay the need for hearing aids. the study focuses on people with turner syndrome (ts). the aim is to find out if there are specific dna methylation patterns and/or rna expression profiles linked to sensorineural hearing loss (snhl) in people with ts. additionally, the structure and function of the inner ear in these individuals will be examined to see if there is a connection to their epigenetic profile. the main question it aims to answer is: does epigenetics constitute a common denominator for some of the unexplained snhl cases? turner syndrome (ts) represents an ideal model for studying epigenetics related to sensorineural hearing loss (snhl). participants will undergo the following tests: * ear examinations * hearing tests * balance tests * blood tests * mri scans * cbct (cone-beam computed tomography) scans


Eligibility criteria:
inclusion criteria: * age between 18 and 60 years old exclusion criteria: * contraindications for the mri or cbct * serious medical disorders * neurological or psychiatric disorders of any kind * use of medication that is known to influence inner ear function * medical history with dizziness or hearing problems (controls only)

Keywords: epigenetics sensorineural hearing loss turner syndrome inner ear dysfunction
observational monocentric study on biliary tract cancer (babel)

Conditions: Biliary Tract Cancer

Summary: babel is an observational, single-center, prospective study about patients affected by biliary tract cancers (btc) treated at the medical oncology unit of the fpuag - irccs.

babel is an observational, single-center, prospective study with an historical cohort. study population is represented by patients affected by biliary tract cancers (btc) treated at the medical oncology unit of the fpuag - irccs. the study involves an historical cohort and a prospective cohort. primary aim of the study is to associate btc patients' overall survival with idh1/2 mutations, in order to confirm the prognostic role of these genes both metastatic and resectable disease setting. the secondary aims are to correlate fgfr mutations and overall survival of btc patients and to find new clinical and molecular characteristics linked with survival and response to treatment.

Eligibility criteria:
inclusion criteria: * patients with biliary tract cancer; * patients with radiological evident disease; * patients \>18 anni; * written informed consent; * patients with at least one oncological visit. exclusion criteria: * patients without available clinical data; * patients without histological diagnosis of btc; * patients without written informed consent.
galactomannan antigen in bronchoalveolar lavage in the diagnosis of invasive aspergillosis in neutropenic patients

Conditions: Invasive Aspergillosis

Summary: invasive aspergillosis (ia) is a very serious fungal infection. hematological patients are the most affected group. ia has a very high morbimortality due to its rapid progression and because it is very difficult to be early diagnosed. diagnosis is used to be done too late or even post-mortem. they are two new methods (techniques) trying to make the diagnosis on an early stage: detection of galactomannan antigen of aspergillus species and real - time polymerase chain reaction (pcr) of its dna in blood. ia in immunocompromised patients is mainly located in lungs, so our hypothesis is that in patients where the investigators suspect ia the investigators should find earlier galactomannan antigen or real -time pcr of aspergillus in respiratory samples such as bronchoalveolar lavage (bal), and its detection could be useful for diagnosis. objectives: to detect galactomannan antigen and real time - pcr for aspergillus dna in bronchoalveolar lavage. to validate the routine utility of these tests in bal as a diagnostic method of ia and investigate if galactomannan antigen and real time - pcr for aspergillus dna in bronchoalveolar lavage can optimize blood test sensibility. methods: prospective study. the investigators will include 200 patients. 100 of them will be hematological patients, neutropenic and at high risk to develop an ia. the other 100 will be patients without risk or no suspicion at all of ia. the investigators will perform a bal in all patients. and blood detection of galactomannan antigen in hematological patients. the investigators will perform a standard microbiological culture of bal and galactomannan antigen in both samples (bronchoalveolar lavage and blood). the investigators also will carry out real time - pcr for aspergillus dna detection in bronchoalveolar lavage. expected results: to detect galactomannan antigen and real time - pcr for aspergillus dna in bal with more specificity and making earlier diagnosis than in blood. the investigators also expect to implant these techniques in bal in the routine for ia diagnosis in neutropenic patients.


Eligibility criteria:
inclusion criteria: * 100 bal in hematological neutropenic patients at high risk of ia, admitted to our hospital, in which we usually perform a bal for microbiological study when they present persistent fever and an opportunist infection suspicion. * 100 bal in patients without hematological illness and without ia suspicion, in which we perform an bal because of another reason. exclusion criteria: * patients without fulfilling inclusion criteria. * patients with some contraindication to perform a bronchoscopy.

Keywords: invasive aspergillosis in neutropenic patients
a study to evaluate the antiviral activity and safety of hh-003 in chronic hepatitis b subjects with low-level viremia

Conditions: Chronic HBV Infection

Summary: this is a multicenter, randomized, controlled phase iia study of hh-003 to evaluate the antiviral activity and safety in nucleos(t)ide analogues-treated chronic hepatitis b subjects with low-level viremia. hh-003 is a human monoclonal antibody targeting the pre-s1 domain of the hbv large envelope protein. it blocks engagement of pres1 with sodium taurocholate co-transporting polypeptide (ntcp), the cellular receptor for hbv.


Eligibility criteria:
inclusion criteria: * signed informed consent form; * male or female aged from 18 to 60 years (inclusively); * 18 kg/m\^2≤bmi≤30 kg/m\^2, body weight≥50 kg for men and ≥45 kg for women; * subjects who have chronic hbv infection greater than or equal to 6 months at screening; * 10 iu/ml≤hbsag≤3000 iu/ml; hbv dna≤2000 iu/ml; alt≤3×uln; * subjects who have been on nucleoside reverse transcriptase inhibitors therapy for more than 1 year prior to screening. exclusion criteria: * females who are pregnant or lactating at screening; * history of alcoholic liver disease, moderate fatty liver, autoimmune liver disease, other hereditary liver disease, drug-induced liver disease or other clinically significant chronic liver disease induced by non-hbv infection; * history of cirrhosis at any time prior to or at time of screening, or having progressive liver fibrosis at screening ; * history or evidence of hepatocellular carcinoma at any time prior to or at time of screening; * exclusionary laboratory results at screening: total bilirubin \>2xuln or direct bilirubin \>1.5xuln，hemoglobin \<120 g/l for males or \<110 g/l ro females，platelets count\<100,000/mm\^3 (100×10\^9/l), and absolute neutrophils count \<1,500/mm\^3 (1.5×10\^9/l).
exploratory study of the edwards apture transcatheter shunt system (alt-flow canada)

Conditions: Heart Failure

Summary: the exploratory study of the edwards apture transcatheter shunt system (apture system) is a multi-center, prospective, exploratory study to evaluate initial clinical safety, device functionality, and effectiveness of the apture system.


Eligibility criteria:
inclusion criteria: * symptomatic hf: * nyha ii w/ history of \> ii; iii; or ambulatory iv and * ≥1 hf hospitalization or treatment with iv or oral diuresis within 12 months or elevated nt-probnp value \> 150 pg/ml in normal sinus rhythm, \>450 pg/ml in atrial fibrillation, or a bnp value \> 50 pg/ml in normal sinus rhythm, \> 150 pg/ml in atrial fibrillation within the past 6 months prior to study entry * on stable gdmt for hf * left ventricular ejection fraction (lvef) ≤ 40% as determined by site cardiologist * hemodynamic criteria o at rest: elevated lap (or pcwp) \> 15 mmhg and lap \> rap + 5 mmhg and/or supine ergometer exercise: elevated lap (or pcwp) \> 25 mmhg and lap \> rap + 10 mmhg * pulmonary vascular resistance (pvr) \< 5.0 wu as determined by site cardiologist exclusion criteria * severe hf: * nyha iv, stage d, non-ambulatory, transplant list * cardiac index ≤ 1.5 l/min/m2 * left ventricular end-diastolic diameter (lvedd) \> 8 cm * lvef \<20% * valve disease * mr \>3+ or \> moderate ms, tr \>3+ (severe on 5-point scale), ar \>2+, * or \> moderate as * mi or therapeutic invasive cardiac procedure \< 3 months * tia, stroke, crt implanted \< 6 months * rv dysfunction \> mild by tte or tapse \<1.2 or rv size ≥ lv size by tte, or right ventricular fractional area change (rvfac) ≤ 25% * dialysis or renal dysfunction (s-cr \> 220 micromol/l or e-gfr \< 25ml/min/1.73 m2) * 6mwt \ 400m * active endocarditis or infection \< 3 months * mean right atrial pressure (mrap) \> 15 mmhg as determined by site cardiologist * body mass index (bmi) ≥ 45 kg/m2
influence of ric on the orthostatic competence of the microcirculation

Conditions: Microcirculation; Orthostatic Intolerance; Remote Ischemic Preconditioning; Hemodynamics

Summary: the goal of this clinical trial (pilot study) is to learn about the microcirculatory regulation of the lower extremity under orthostatic stress with and without ric - remote ischemic preconditioning in healthy participants. the main question it aims to answer are: do the beneficial effects of ric withstand orthostatic stress? / does ric benefit lower extremity microcirculation in ortho-statically stressed subjects? is there a relationship/correlation between the variables of microcirculation and hemodynamics in the context of ric and orthostatic loading?

the use of free flaps is a standard procedure in reconstructive plastic surgery, in which a wide variety of tissue units are microsurgically transplanted, often to cover defects on the body surface. microvascular tissue transplants depend on an adequate blood supply, which is particularly vulnerable in the first postoperative phase. in the case of reconstructions of the lower extremities in particular, the flap perfusion is stressed during the first mobilizations due to the orthostatic load. for this reason, the mobilization of the patients is gradually increased from day to day with precise monitoring of the blood flow (so-called flap training). a procedure for temporarily improving the blood flow in free flaps is ischemic preconditioning (ric - remote ischemic preconditioning). repeated, short cycles of ischemia/reperfusion applied to a circumscribed vascular territory (e.g. supra systolic tourniquet arm) lead to an increase in tissue perfusion, even outside the area of application (arm). ric could have the potential to optimize the tissue perfusion of flaps even under orthostatic stress and to promote an earlier mobilization of patients. our work investigates the influence of ric on orthostatic competence (as part of a standardized orthostatic load with a tilting table) of the microcirculatory system in the lower extremities and the orthostatic hemodynamic regulation itself.

Eligibility criteria:
inclusion criteria: * non-smokers * no diseases relevant to circulation and blood flow (arterial hypertension, peripheral arterial occlusive disease, chronic venous insufficiency) * subjects must be capable of insight. anyone who can understand the nature, significance, and scope of the clinical trial and determine their will accordingly is capable of insight. exclusion criteria: * non-consent * lack of compliance * syncope tendency

Keywords: microcirculation remote ischemic preconditioning
multi-dimensional investigations of negative emotions and drug-resistant auditory verbal hallucinations in psychosis

Conditions: Schizophrenia Spectrum and Other Psychotic Disorders; Hallucinations, Auditory

Summary: auditory verbal hallucinations (avh) are commonly reported as source of distress, disability and mortality in schizophrenia. despite proven efficacy of antipsychotics, many patients still experience drug-refractory avh. it has been postulated that avh is maintained by negative emotions. yet, little is known about the temporal relationship and underlying mechanisms between negative affect and avh. utilizing both an ecologically-validated method and brain imaging technique, this study aims to uncover the role of emotions in the maintenance of psychotic symptoms.


Eligibility criteria:
inclusion criteria: * aged 18 to 65 years * clinical diagnosis of schizophrenia spectrum disorder * present hallucinations exclusion criteria: * left-handedness * intellectual disability * organic psychosis

Keywords: auditory hallucinations psychosis mood brain imaging experience sampling method
italian observational study of patients with acute myeloid leukemia treated with small molecule inhibiting bcl-2

Conditions: Acute Myeloid Leukemia

Summary: this is a multi-center retrospective observational study. every patient with acute myeloid leukemia (aml) treated with anti-b-cell lymphoma 2 (bcl2) treatment outside clinical trial from 1st january 2015 up to 01 april 2019 may be included in this study. no additional drug/procedures/patient visits in comparison with the usual clinical practice are planned for the study. the decision to treat patient with ant-bcl2 inhibitors is made by the physician based on his clinical judgment, independently from the decision to include the patient in this study.

in phase 1-2 studies, anti bcl-2 treatment has shown evidence of anti-leukemic activity as single agent and in combination and proved to be particularly effective in providing a deep response, with an acceptable safety profile. since 2015 anti-bcl2 treatment has been available in other indications and in off-label use in italy. in this non-interventional retrospective study, toxicity, effectiveness and costs assessment data will be collected from patients with aml, to improve the knowledge about anti-bcl2 treatment in clinical practice. collecting and analyzing data from a large unbiased patient-set receiving anti-bcl2, would enlarge our knowledge on therapies inhibiting bcl2. this is a multi-center retrospective observational study. every patient with aml treated with anti-bcl2 treatment outside clinical trial from 1st january 2015 up to 01 april 2019 may be included in this study. no additional drug/procedures/patient visits in comparison with the usual clinical practice are planned for the study. the decision to treat patient with ant-bcl2 inhibitors is made by the physician based on his clinical judgment, independently from the decision to include the patient in this study. as this study is intended to be purely observational (not interventional), the patient's medical records will be the source of all data to be recorded. no additional procedures/patient visits should be planned in the study with respect to clinical practice. clinical data (treatment, survival, adverse events) will be collected for patients enrolled.

Eligibility criteria:
inclusion criteria: * patient with aml according to world health organization (who) 2016 classification * patient who have received any anti-bcl-2 treatment as single agent or in combination with other drugs from 1 jan 2015 to 1 apr 2019 outside clinical trials exclusion criteria: • patient who have received any anti-bcl-2 treatment within a clinical trials

Keywords: aml bcl-2 anti bcl2 inhibitors clinical practice
evaluating the effects of folic acid supplementation in older adults: the folic acid supplementation trial (the fast study)

Conditions: Heart Diseases

Summary: high levels of homocysteine, which is an amino acid in the blood, have been linked to an increased risk of heart disease. this study will examine the effect that differing levels of folic acid have on reducing homocysteine levels among older adults.

elevated levels of homocysteine may be a risk factor for coronary heart disease, stroke, and peripheral vascular disease. folate is a type of b vitamin that occurs naturally in food. in nutritional supplements, folate is known as folic acid, and it has been shown to lower the concentration of homocysteine in blood. folic acid supplements are a simple way for people to increase their folate intake, lower their homocysteine levels, and reduce their risk of developing heart disease. however, more research is required to determine the most effective dose of folic acid needed to lower homocysteine levels. the purpose of this study is to examine the effect that varying doses of folic acid have on folate levels and homocysteine concentration levels in older adults. this 6-week study will enroll healthy adults over the age of 60 who do not currently take multivitamins or b-vitamins. at a screening visit, participants will complete questionnaires on medical history, demographics, and diet. also, height and weight will be measured, and a blood collection will occur. at a baseline study visit, participants will be randomly assigned to receive either placebo or one of four doses of folic acid-100 mcg, 400 mcg, 1000 mcg, or 2000 mcg-to be taken once a day for 6 weeks. participants will attend a final study visit at week 6, at which time another blood collection will occur.

Eligibility criteria:
inclusion criteria: * healthy * living in the baltimore area exclusion criteria: * taking multivitamins or b-vitamins * unwilling to discontinue supplements for 8 weeks before study entry * use of intramuscular vitamin b12 * seizure disorder * pernicious anemia * long-term use of anti-folate drugs (e.g., methotrexate, sulfa-antibiotics)

Keywords: plasma homocysteine concentration folate homocysteine supplements folic acid