Kornimate/medical-research-clean huggingface dataset:
clinical and ecological impact of a primary care antimicrobial stewardship program based on telematic educational interviews (telémaco trial)

Conditions: Community Acquired Infections

Summary: brief summary: open-label, cluster randomized, multicenter clinical trial to evaluate the clinical and ecological impact of a primary care asp based on telematic educational interviews.

the objective of this project is to measure the effect of an antimicrobial stewardship program (asp) in primary care, based on an educational intervention. this will consist of periodic structured telematic educational interviews between infectious diseases experts and family medicine and paediatrics specialists. in these interviews, the principles for the optimal use of antimicrobials will be addressed on real cases, analyzing together prescriptions randomly chosen from the primary care physician himself. the repetition over time of key pedagogical messages for the optimisation of prescriptions is expected to improve the quality of antibiotic use, reduce the overall consumption, improve the use of microbiological tests, reduce the incidence of community infections caused by resistant microorganisms, and preserve patients' safety measured by the rate of admission for serious infections. the results derived from these educational interventions, in the framework of a multimodal asp, have been evaluated in hospital and primary care settings in quasi-experimental studies with a favourable outcome, but not in a clinical trial that specifically assesses the efficacy of educational interviews and avoids the bias of uncontrolled studies. to demonstrate this hypothesis, a cluster randomized trial has been designed, in wich all healthcare centers will be assigned either to a control group (the standard measures defined by the regional asp pirasoa will be maintained), and an experimental group (whose physicians will receive the educational intervention described).

Eligibility criteria:
inclusion criteria: a) primary care centres within the reference area of the university hospital virgen del rocío. exclusion criteria: 1. emergency departments. 2. odontology offices. 3. ddd per health centre less than 5.78

Keywords: antimicrobial stewardship program (asp) primary care telemedicine pirasoa
remodulin as add-on therapy for the treatment of persistent pulmonary hypertension of the newborn

Conditions: Persistent Pulmonary Hypertension of the Newborn

Summary: this study assessed the safety and treatment effect of intravenous (iv) remodulin as an add-on therapy in neonates with persistent pulmonary hypertension of the newborn (pphn).

this study was designed to investigate if the addition of remodulin reduced the rate of clinical worsening (defined as the need for additional treatment targeting pphn, need for extracorporeal mechanical oxygenation \[ecmo\], or death) in neonatal subjects with pphn who did not show an adequate response to inhaled nitric oxide (ino). this study was part of a pediatric investigation plan agreed upon by the ema (emea 000207-pip01-08-m08).

Eligibility criteria:
inclusion criteria: * parent(s) or legal guardian provided consent for the subject to participate * weight at least 2 kg at screening * gestational age of ≥34 weeks and ≤14 days old at screening * diagnosis of pphn, which was either idiopathic in nature or associated with the following: meconium aspiration syndrome, pneumonia, respiratory distress syndrome, sepsis, birth hypoxia, perinatal encephalopathy, or unilateral congenital diaphragmatic hernia * currently requiring ventilator support * two consecutive oxygenation index (oi) of 15 or greater separated by at least 30 minutes, after receiving ino for at least 3 hours * echocardiographic (echo) evidence of pulmonary hypertension with elevated right ventricle pressure * dedicated venous access for the administration of study drug (central line or peripherally inserted central venous catheter) exclusion criteria: * previous or concurrent use of a phosphodiesterase-5 inhibitor, endothelin receptor antagonist, or prostanoid * significant congenital heart disease as detected by echo, minor valvular abnormalities, or expected transitional findings such as a patent foramen ovale, or patent ductus arteriosus. * clinically significant, untreated active pneumothorax at screening * evidence of clinically significant bleeding at screening * necrotizing enterocolitis (≥bells stage ii at screening) * uncontrolled hypotension (mean systemic pressures ≤35 mmhg at screening) * uncontrolled coagulopathy and / or untreated thrombocytopenia (\<50,000 platelets/µl at screening) * history of severe (grade 3 or 4) intracranial hemorrhage at screening * currently receiving extracorporeal mechanical oxygenation (ecmo) or had immediate plans to initiate ecmo * expected duration on mechanical ventilation of \<48 hours * life expectancy was less than 2 months or had a lethal chromosomal anomaly * contraindication to ecmo * bilateral congenital diaphragmatic hernia * active seizures at screening * currently participating in another clinical drug study

Keywords: pphn
screening for risk factors of prediabetes among adult patients at sohag university hospital

Conditions: PreDiabetes

Summary: * prediabetes is an intermediate state of hyperglycemia with glycemic parameters above normal but below the diabetes threshold.. * during the average 3 years of follow-up prediabetes is diagnosed based on laboratory tests: fasting plasma glucose level (100-125 mg/dl) ;hba1c, (5.7-6.4%) or plasma glucose level after an oral glucose tolerance test ( 140-199 mg/dl). * reports estimate that more than 470 million people will have prediabetes by 2030. * according to an expert panel of the american diabetes association, up to 70% of individuals with prediabetes will eventually develop diabetes. * observational evidence suggests as association between prediabetes and complications of diabetes such early nephropathy(10%) , small fiber neuropathy(18-25 %), early retinopathy (8-12%) and risk of macrovascular disease (52%) . * screening for prediabetes is designed to save lives or enhance an individual's quality of life by early detection so that screening will minimize the risk of developing diabetes or its complications .

* in this case control study we aim to screen for risk factors of prediabetes among adult patients to minimize the risk of developing diabetes or its complications . * prediabetes screening is also required to minimize medical costs such as hospitalization, outpatient care, surgery, medications, and laboratory test costs . * several studies had shown efficacy of lifestyle interventions in diabetes prevention by targeting obesity with increase in physical activity and dietary changes with a relative risk reduction of 40%-70% in adults with prediabetes ,also there is increasing evidence to prove the efficacy of pharmacotherapy in prevention of diabetes in adults with prediabetes

Eligibility criteria:
inclusion criteria: * adult patient above 18 years old . exclusion criteria: * all patients known to be diabetics . * pregnancy . * chronic depleting diseases, * those who were taking drugs known to influence blood glucose levels e.g. metformin, thiazolidinedione and steroids.
effect of epidural analgesia on the parameter ani during childbirth

Conditions: Labor Pain

Summary: there are many methods used for the assessment of pain in the area of anesthesia including heart rate variability which reflects the influence of the autonomic nervous system on the heart. an original index, the ani (analgesia nociception index), quantifies pain during anesthesia. obstetric epidural analgesia is particularly suited to evaluate ani in conscious patients with a comparison of ani with the measurement of pain by a visual analog scale (vas). evaluation of ani is performed just before epidural catheter insertion and during the 10 first minutes after saline, sufentanil or lidocaine epidural administration.


Eligibility criteria:
inclusion criteria: * over 18 years, * asa i or ii, * no history of cardiovascular or respiratory disease * no cardiovascular medication * no treatment with a tocolytic agent(salbutamol, nicardipine) * desiring epidural analgesia at the early phase of labor pain exclusion criteria: * too fast labour * a pain score at or above 70 on the pain scale * a disturbed ekg signal or extrasystoles * pace-maker * diabetes mellitus
short-term effects of kinesio taping in patients with mechanical low back pain

Conditions: Low Back Pain

Summary: the aim of this study is to estimate the effect of kinesio tape (kt) combined with supervised exercise programs compared to exercise alone on pain, lumbar range of motion, and self-reported disability of adults with mechanical low back pain (lbp). methods: this was a randomized, controlled clinical trial carried out on 60 individuals with mechanical lbp. participants were randomly assigned to the control group (n=30) that received mckenzie exercises for 7 days or experimental group (n=30) that received kt application in addition to mckenzie exercises for 7 days. pain measured by visual analogue scale, lumbar range of motion, and the disability measured by oswestry disability index (odi) were used as outcome measures. pre and post measurements were taken at baseline and after 7 days.


Eligibility criteria:
inclusion criteria: * individuals diagnosed with mechanical lbp by a physician exclusion criteria: * individuals with any structural or pathological changes (spondylitis, spondylolisthesis, cauda equina syndrome, lumbar canal stenosis) in lumbar spine on x-ray or mri * individuals with or without neurological signs in the lower extremity suggestive upper motor or lower motor neuron involvement, * individuals with a history of trauma or any surgery in the region of back, * individuals with recent aggravation of symptoms, * individuals on a waiting list for spinal surgery or had a spinal surgery in the past 6 months
a study of oxycodone/naloxone controlled-release tablets (oxn) to assess analgesic efficacy and management of opioid-induced constipation (oic) in opioid-experienced subjects with moderate to severe chronic low back pain

Conditions: Low Back Pain

Summary: the primary objective is to assess the efficacy of oxycodone/naloxone controlled-release tablets (oxn) for the management of opioid-induced constipation (oic) compared with oxycodone controlled-release tablets (oxy) in subjects with moderate to severe low back pain and opioid-induced constipation who require around-the-clock opioid therapy.


Eligibility criteria:
inclusion criteria include: * male and female subjects ≥ 18 years of age with moderate to severe, chronic low back pain (lasting at least several hours daily) as their predominant pain condition for at least 3 months prior to screening period; * the low back pain must be related to nonmalignant and nonneuropathic conditions and may be with or without radiation; * subjects must have a self-reported history of opioid induced constipation (oic). exclusion criteria include: * subjects with rheumatoid arthritis or other inflammatory arthritis; * subjects with neuropathic conditions that have been painful or required therapy within the past 3 months; * subjects with evidence of significant structural abnormalities of the gastrointestinal (gi) tract or other significant conditions affecting gi motility; * subjects with chronic constipation not related to opioid use; * subjects who had surgical procedures directed towards the source of chronic low back pain within 6 months of the screening visit or planned during the study; * subjects with a history of malignancy within past 2 years, with exception of basal cell carcinoma that has been successfully treated. other protocol specific inclusion/exclusion criteria may apply.

Keywords: low back pain chronic pain opioid constipation moderate to severe
effect of tci188 probiotic on oral health

Conditions: Periodontal Diseases

Summary: to assess the efficacy of tci188 (pediococcus acidilactici) probiotic on oral health


Eligibility criteria:
inclusion criteria: * male or female over 18 years old * participants suffer from severe periodontal disease throughout the mouth with symptoms at third and fourth stages, do not have immediate indications for the extraction of multiple teeth or complex denture stimulation, and have not undergone periodontal planing within one year. exclusion criteria: * participants have had periodontal or antimicrobial treatment within the past 6 months * participants are smokers, pregnant or with systemic diseases * participants had probiotic supplements or with history of adverse reactions to lactose or fermented dairy products

Keywords: pediococcus acidilactici probiotics
instantaneous wave-free ratio guidance strategy evaluation in the treatment of multivessel acute coronary syndrome.

Conditions: Cardiac Ischemia; Acute Coronary Syndrome

Summary: a single-center, prospective, randomized, open-label, blinded end-point clinical trial of instantaneous wave-free ratio (ifr) guidance strategy impact on clinical outcomes in multivessel acute coronary syndrome (acs) patients.

the "all-comers" study population consists of hemodynamically stable de novo acs patients with a stenosis of 50% and more by visual estimation in at least two separate coronary arteries with thrombolysis in myocardial infarction (timi) flow ≥ 2 and willing to sign a patient informed consent. acs diagnosis established by angina pectoris symptoms and/or ecg changes and/or hs-troponin i levels. the use of drug-eluting stents is mandatory in both treatment groups. in the intervention strategy group, patients are treated by the ifr-guided percutaneous coronary intervention (pci) in one stage. in the control group, patients are treated in accordance with the standard practice of angiography-guided staged approach.

Eligibility criteria:
inclusion criteria: * 18 years of age and older * willing to give informed consent * hemodynamically stable de novo acute coronary syndrome patients with a stenosis of 50% and more by visual estimation in at least two separate coronary arteries * adequate coronary flow, thrombolysis in myocardial infarction (timi) flow ≥ 2 * sinus rhythm exclusion criteria: * inability to give consent; * younger than 18 years of age * atrial fibrillation rhythm at the time of inclusion * with significant valve disease * in cardiogenic shock * with reduced kidney function - egfr \< 30 (ml/min/1.73m2); * with congenital heart defects * with acute pulmonary artery embolism; * with isolated left main ostial stenosis; * on active oncologic treatment or toxic cardiomyopathy; * revascularization by pci is not possible due to other comorbidities or patient denial of treatment.

Keywords: ifr instantaneous wave free ratio virtual percutaneous coronary intervention acute coronary syndrome multivessel
prevention of postoperative nausea and vomiting (ponv) by acupressure

Conditions: Postoperative Nausea and Vomiting; Acupressure Point P6

Summary: the purpose of this study is to determine whether stimulation to the akupressurpoint p6 with a recently developed bracelet are effective preventing postoperative nausea and vomiting


Eligibility criteria:
inclusion criteria: * female, * non-smoker, * \>18 years, * asa 1 or 2, * signed patient information, * iv-anaestesia. exclusion criteria: * male, * smoker, * asa 3 or 4, * pregnancy, * nausea and vomiting within the last 24 h before operation, * diabetes, * carpaltunnel syndrome, * lymphedema of arms, * eczema of forearm, * patients who earlier has undergone removal of lymph nodes in the armpits, * inhalation anaestesia.
furosemide stress test as a predictor of tubular function in chronic kidney disease

Conditions: Chronic Kidney Disease

Summary: in kidney diseases, tubule-interstitium has become much more relevant, as formerly only the glomerulus was considered to have the main importance. kidney's tubular atrophy and interstitital fibrosis is now recognized as long term prognostic value. we aim to evaluate the function of the kidney's tubule-interstitium through furosemide excretion after intravenous administration of this drug, and correlate the rate of excretion of furosemide with interstitial fibrosis findings in scheduled kidney biopsy for patients with chronic kidney disease.

all patients scheduled for kidney biopsy will be invited to participate in a standard isovolemic furosemide stress test before the biopsy procedure. the latter will consist in 1.5 miligrams per kilogram of weight of intravenous furosemide administration, with urinary output follow up and measurement. the urinary output will be replaced intravenously with normal saline to avoid dehydration and/or hypotension. a standard 5ml sample of blood will be taken before the test and aliquots of urine before and after furosemide administration will be frozen. after completion of the formely mentioned test, patients will proceed to their scheduled kidney biopsy along with interventions considered appropiate by their attending physician. kidney biopsy sample will be examined by histopathology service and the degree of interstitial fibrosis will be described. the degree of fibrosis will be correlated with the degree furosemide excretion and urinary output.

Eligibility criteria:
inclusion criteria: * accept to participate (informed consent) * legal age or older * an estimated glomerular filtration rate greater than 15ml/min/1.73m2, calculated by ckd-epi. exclusion criteria: * known alergic reaction to furosemide * contraindication to kidney biopsy * patient already in renal replacement therapy

Keywords: furosemide interstitial fibrosis
circulating tumor cells for hepatocellular carcinoma

Conditions: Carcinoma, Hepatocellular; Neoplasm Circulating Cells

Summary: to explore the clinical value of circulating tumor cells (ctcs) measurement for hepatocellular carcinoma (hcc) patients.

background:the lack of tumor tissue for drug target and biomarker studies significantly limit the development of novel treatment for advanced hcc. in recent years, circulating tumor cells (ctcs) have been shown to be important prognostic biomarkers of overall survival for patients with breast, prostate, and colorectal cancer after anti-cancer therapy. methods and materials:this project plans to enroll 50 hcc patients who receive curative surgery or radiofrequency ablation therapy, 50 patients who receive trans-arterial chemoembolization, and 50 patients who receive systemic therapy at national taiwan university hospital in 24 months for ctcs analysis. the eligible patients will receive blood tests before and after anti-cancer therapy. the blood samples will be separated to blood cells and plasma. blood cells will be used for isolation and enumeration of ctcs. plasma will be used to extract dna to measure molecular aberration (gene mutations related to hepatocarcinogenesis or response of hcc cells to molecular targeted therapy) 1. to explore the correlation between ctcs numbers and other clinical characteristics in hcc patients with different stages; 2. to compare the patterns of molecular aberrations between ctc and hcc tumor tissue in hcc patients who have archival tumor tissue available; and 3. to measure the changes of ctcs numbers and molecular aberrations in hcc patients before and after molecular targeted therapy.

Eligibility criteria:
inclusion criteria: * patient must be diagnosed with hcc via one of following methods according to present clinical practice: 1. diagnosed as hcc by biopsy or cytology 2. patients with chronic hepatitis b or other reason induced liver cirrhosis who have diagnosed as hcc based on a typical contrast enhanced ct or mri profile with malignant lesion \[tumor hyper-vascularization\]. * asian male or female subjects \>=20 years of age. * child-pugh class a or b liver function.. * hcc patients who will receive anti-cancer therapy, including surgery, radiofrequency ablation therapy, trans-arterial chemoembolization, or systemic therapy (according to current hcc practice guidelines) at national taiwan university hospital. * signed informed consent. exclusion criteria: * other significant organ disease or condition his/her investigator judged that the subject should not participate in the study.

Keywords: biomarkers
biomarkers in patients with rhabdomyosarcoma

Conditions: Sarcoma

Summary: rationale: studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. purpose: this research study is studying biomarkers in patients with rhabdomyosarcoma.

objectives: * determine genome-wide alterations in dna methylation in arms and erms. * determine genome-wide dna copy number alterations in arms and erms. * determine pathogenic genes and pathways by integrative genomic analysis. outline: genome-wide dna-methylation analysis on arms, erms, and normal human skeletal myoblasts will be conducted using the help (hpaii tiny fragment enrichment by ligation-mediated pcr) assay. the methylation status of 1.3 million cpgs at promoters, gene bodies, and intergenic areas will be analyzed. parallel gene expression analysis will be done and correlated with changes in methylation to uncover genes regulated by epigenetic alterations and altered by genomic losses or gains. genes that are altered by both genetic and epigenetic alterations in different sets of patients will be selected by the might (multi-dimensional integration of genomic data from human tissues) algorithm to uncover new genes that are potentially involved in the pathogenesis of arms and erms. gene ontology, pathway, and dna motif analysis algorithms, and other computational approaches will be used to determine the biological consequences of the changes. prioritized set of epigenetic and genetic alterations will be validated by bisulfite massarray, fish, and qrt-pcr in larger numbers of arms and erms samples.

Eligibility criteria:
disease characteristics: * 10 arms and 10 erms frozen samples will be collected from the cog bank via the cooperative human tissue network (chtn) * human skeletal myoblasts (zenbio, research triangle park, nc) will serve as controls patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: childhood rhabdomyosarcoma
efficacy and safety of amr101 (ethyl icosapentate) in patients with fasting triglyceride (tg) levels ≥ 500 and ≤ 2000 mg/dl

Conditions: Hypertriglyceridemia

Summary: the primary objective is to determine the efficacy of amr101 (ethyl icosapentate) compared to placebo in lowering fasting triglyceride levels in patients with very high fasting triglyceride levels ≥ 500 and ≤ 2000 mg/dl.


Eligibility criteria:
inclusion criteria: * men and women, ages \>18 * fasting triglyceride ≥500 mg/dl and ≤2000 mg/dl * provide written informed consent and authorization for protected health information disclosure exclusion criteria: * women who are pregnant or lactating, or planning to become pregnant * use of non-statin lipid-altering drugs which cannot be stopped including fibrates, niacin, fish oil and other products containing omega-3 fatty acids or other dietary supplements with potential lipid-altering effects * history of pancreatitis * history of bariatric surgery or currently on weight loss drugs * uncontrolled hypertension (bp \> 160/100) * hiv infection or on treatment with hiv-protease inhibitors, cyclophosphamide,or isotretinoin * consumption of more than 2 alcoholic beverages per day * history of cancers (except if been disease free for \>5 years or history was basal or squamous cell skin cancer) * participation in another clinical trial involving an investigational agent in the last 30 days * other parameters will be assessed at the study center to ensure eligibility for this study.

Keywords: hypertriglyceridemia omega-3 fatty acids statin triglycerides lipids epa docosahexaenoic acid fish fatty acids fibrates niacin lipid atorvastatin lovaza simvastatin lovastatin pravastatin fluvastatin rosuvastatin trilipix vytorin simcor ezetimibe zetia ethyl-epa ethyl icosapentate crestor zocor lipitor niaspan ldl hdl cholesterol dyslipidemia vascepa icosapent ethyl