Kornimate/medical-research-clean huggingface dataset:
sirolimus eluting orsiro stent versus biolimus-eluting nobori stent

Conditions: Coronary Artery Disease; Ischemic Heart Disease

Summary: the aim of the danish organization for randomized trials with clinical outcome (sort out) is to compare the safety and efficacy of the sirolimus eluting orsiro stent and the biolimus-eluting nobori stent in a population-based setting, using registry detection of clinically driven events

sort out vii is a randomized, multicenter, all-comer, two-arm, non-inferiority trial comparing the sirolimus eluting orsiro stent to the biolimus-eluting nobori stent in treating atherosclerotic coronary artery lesions. primary endpoint: target lesion failure within 12 months of stent implantation (combination of cardiac death, myocardial infarction (not index procedure related) not related to other than index lesion or target lesion revascularization). secondary endpoints: individual components of the primary end point comprised the secondary end points and stent thrombosis rate according to the academic research consortium definition (see protocol for further specification of secondary endpoints). clinically driven event detection will be used to avoid study-induced reinterventions. data on mortality, hospital admission, coronary angiography, repeat percutaneous coronary intervention, and coronary bypass surgery will be obtained for all randomly allocated patients from the following national danish administrative and healthcare registries: the civil registration system; the western denmark heart registry; the danish national registry of patients, which maintains records on all hospitalizations in denmark; and the danish registry of causes of death inclusion criteria: at least 18 years old chronic stable coronary artery disease or acute coronary syndromes at least one coronary artery lesion with more than 50% diameter stenosis requiring treatment with a drug-eluting stent exclusion criteria: life expectancy of less than one year allergy to aspirin, clopidogrel, sirolimus, or biolimus participation in another randomized trial nability to provide written informed consent

Eligibility criteria:
inclusion criteria: * patients aged 18 years or over with chronic stable coronary artery disease or acute coronary syndromes, and at least one coronary artery lesion with more than 50% diameter stenosis, requiring treatment with a drug-eluting stent. there are no restrictions on number of treated lesions, number of treated vessels, or lesion length. exclusion criteria: * exclusion criteria are life expectancy of less than one year; an allergy to aspirin, clopidogrel, ticagrelor, prasugral, sirolimus, or biolimus; participation in another randomized trial; or inability to provide written informed consent

Keywords: drug-eluting stent safety efficacy
mediastinitis and staphylococcus aureus

Conditions: Surgery, Cardiac; Infection

Summary: cardiac surgery with extracorporeal circulation (ecc) yields a deep immune system dysfunction that exposes patients to postoperative infectious complications. among these, post-operative mediastinitis with staphylococcus aureus (sa) generates significant morbidity and mortality. two radically different approaches have been proposed in recent years to reduce the incidence of this complication. a first approach has attempted, without real success, to decrease postoperative immunosuppression. the second, more efficient, consisted of screening and preoperatively treating patients colonized with sa. however, although its incidence has decreased, postoperative mediastinitis remains a terrible nosocomial infection. the authors believe that a thorough analysis of the immunological changes induced by cardiac surgery will initiate active therapeutics to reduce the post-operative immunosuppression phase, thereby decreasing the risk of nosocomial infections. in addition, a study of the interactions between the operated (host) and staphylococcus aureus (pathogenic) immune systems will provide a better understanding of the mechanisms that expose patients to this bacterium.

in particular, changes induced by the ecc will be evaluated on: * indoleamine 2,3-dioxygenase activity (ido) * apoptosis of lymphocytes and dendritic cells * polymorphonuclear neutrophils (pmns) * myeloid derived suppressor cells (mdsc ) after general anesthesia and arterial catheterization and prior to the start of ecc, blood samples will be taken for flow cytometry studies, for the purification of pmns and monocytes. the purified pmns and monocytes will then be used for the measurement of cytokine, phagocytosis and bactericidal production capacities. the morning following surgery, blood samples will be taken and follow the same process.

Eligibility criteria:
inclusion criteria * patients over 18 years of age * patients who require cardiac surgery (valvular and / or coronary) with extracorporeal circulation. non inclusion criteria * chronic respiratory diseases, * preoperative left ventricular dysfunction (lvef \<50%), * immunosuppression (hiv infection, systemic corticosteroid therapy, history of cancer in the year before surgery), * persons subject to legal protection (safeguard of justice, curatorship, guardianship), * persons deprived of liberty.

Keywords: staphylococcus aureus nosocomial infection
efficacy, safety, and tolerability of once daily indacaterol in chronic obstructive pulmonary disease (copd) using formoterol twice daily as active control

Conditions: Chronic Obstructive Pulmonary Disease

Summary: this study was designed to assess the efficacy and long-term safety of 300 and 600 µg doses of indacaterol when delivered via a single-dose dry-powder inhaler (sddpi) in patients with chronic obstructive pulmonary disease (copd). patients were randomized to receive either indacaterol 300 µg once daily, indacaterol 600 µg once daily, formoterol 12 µg twice daily, or placebo.


Eligibility criteria:
inclusion criteria: * male and female adults ≥ 40 years, with a diagnosis of chronic obstructive pulmonary disease (copd) according to global initiative for chronic obstructive lung disease (gold) guidelines 2005 and: 1. smoking history of at least 20 pack years 2. post-bronchodilator forced expiratory volume in 1 second (fev1) \< 80% and ≥ 30% of the predicted normal value 3. post-bronchodilator fev1/fvc (forced volume capacity) \< 70% (post refers to within 30 minutes after inhalation of 400 μg of salbutamol) exclusion criteria: * patients who were hospitalized for a copd exacerbation in the 6 weeks prior to screening. * patients who had a respiratory tract infection within 6 weeks prior to screening. * patients with concomitant pulmonary disease. * patients with a history of asthma. * patients with diabetes type i or uncontrolled diabetes type ii. * any patient with lung cancer or a history of lung cancer. * patients with a history of certain cardiovascular co-morbid conditions. other protocol-defined inclusion/exclusion criteria applied to the study.

Keywords: chronic obstructive pulmonary disease copd indacaterol long-acting β2 agonist
neptune match study

Conditions: Nephrotic Syndrome in Children; Focal Segmental Glomerulosclerosis; Minimal Change Disease; Minimal Change Nephrotic Syndrome; Membranous Nephropathy; FSGS; MCD; MCD - Minimal Change Disease

Summary: neptune match is an additional opportunity offered to neptune study participants to prospectively recruit and communicate patient-specific clinical trial matching with kidney patients and their physician investigators.

this is a prospective, open-label study testing the ability to effectively communicate patient-specific clinical trial matching with kidney patients and clinician investigators. the study consists of four components: 1. recruitment of participants from the neptune observational cohort study 2. generation of participant profile-trial match assessment using data from the neptune observational study and profiling units by the neptune molecular nephrology board 3. establishing and testing a framework to communicate disease-trial drug mechanism matching with investigators and patients 4. retrospective comparison of kidney health outcomes in subjects enrolled in trials that aligned with their match vs. trial subjects with mis-aligned or unknown match alignment.

Eligibility criteria:
inclusion criteria: 1. consented and eligible participants in the biopsied or non-biopsied cohorts of the neptune observational study 2. must be potentially eligible for the neptune match partnering trials (e.g. if no trial is enrolling a participant under age 6, those under 6 are not eligible). note: neptune match partnering trials and associated eligibility criteria are expected to be dynamic and change as trial protocols are developed, activated, and amended. 3. regular nephrology healthcare provided at a neptune study site. 4. willing and able to consent, and as appropriate assent, to participate in neptune match exclusion criteria: currently non-neptune observational study participants are not eligible to be matched to a clinical trial using these biomarker assessments. exclusion criteria: 1. non-english or non-spanish speaking

Keywords: nephrotic syndrome neptune match clinical trial match
circulating tumor cells in high-risk prostate cancer treated with high-dose radiotherapy and hormone therapy

Conditions: Patients With High-risk Prostate Cancer

Summary: the detection and quantification of circulating tumor cells ctcs in peripheral blood of patients with prostate adenocarcinoma may be useful at least for: getting a correct stratification of patients with high-risk prostate cancer (pca). set the prognosis at baseline. evaluate the response to different treatments (predictive value and monitoring). establish individualized therapies.

prospective analysis of biologic samples from peripheral blood of 65 patients with localized high-risk pca (nccn 2011) treated with rtc-3d-imrt combined with ad. following the sign of the informed consent of the patient, the blood samples will be analyzed for ctcs using an immunomagnetic method based on the cellsearch system (veridex), in 4 periods of time: 1. prior to any treatment; 2. following ad and prior to rt; and 3. following the end of rt (1-3 months afterwards). 4. six to twelve months following the end of rt in those patients with 0 ctcs in the first determination and positive ctcs in the second or third determination comparison between the expression of ctcs in peripheral blood before and following ad and rt will be performed. the quantification of the ctcs obtained in these phases of treatment will be correlated with the treatment results in terms of biochemical failure according to phoenix definition, distant metastasis rate and overall survival to identify a significant prognostic relationship and to determine the potential effect of the treatment in the number of ctcs our working group will include 65 patients because the amount is based on routine clinical activity can be safely enrolled in the project development time by the participating centers.

Eligibility criteria:
inclusion criteria: * patients aged \> 18 with capacity to give informed consent. * patients with histologically confirmed prostate cancer. * patients with a high risk factor: psa\> 20 ng / ml, gleason 8-10 and / or stage t3a-b, n0m0 (nccn 2011, stage iib-iii ajcc classification 2010). staging by: histology-gleason score-, psa, tr, eco tr, ct, mri. * patients who accept radical treatment with radiotherapy. * patients who give written informed consent to participate in the study exclusion criteria: * any patient diagnosed with prostate cancer, which does not meet the prerequisites. * any patients with another malignancy diagnosed in the past 5 years (except basal cell or squamous cell carcinoma of skin). * any patient who has prostate biopsy performed 7 days prior to study entry. * patients who have received prior treatment with hormonal therapy, chemotherapy or radiotherapy. * patients with psa\> 100 ng / ml. * any situation or condition of the patient which in the opinion of the investigator, advised against participation in the study.
effect of bupivacaine concentration on ultrasound guided pericapsular group nerve block efficacy in hip surgery patients

Conditions: Perioperative Pain

Summary: fractures in and around the hip are quite common irrespective of both the young and elderly population groups and are associated with extreme pain.the anterior hip capsule is innervated by articular branches of femoral nerve, obturator nerve and accessory obturator nerve (aon) as reported by previous anatomic studies, suggesting that these nerves should be the main targets for hip analgesia, which can be blocked by peri-capsular nerve group (peng).

fractures in and around the hip are quite common irrespective of both the young and elderly population groups and are associated with extreme pain. a hip fracture is a serious injury, with complications that can be life-threatening and is a common orthopedic emergency in the elderly. early surgery within 48 h of fracture has shown to decrease the complication and mortality rates. spinal anaesthesia is the most common mode of anaesthesia used to fix these fractures. extreme pain due to fracture does not allow ideal positioning for these procedures. and hence a problem to access the subarachnoid space. inadequate postoperative analgesia can restrict the limb mobility thereby delaying recovery along with increased consumption of opioids. effective perioperative analgesia that reduces the requirement of opioids and its adverse effects is essential in this population. the anterior hip capsule is innervated by articular branches of femoral nerve, obturator nerve and accessory obturator nerve (aon) as reported by previous anatomic studies, suggesting that these nerves should be the main targets for hip analgesia, which can be blocked by peri-capsular nerve group (peng) . pnb with lower volume and higher concentration of local anesthetic was more efficacious than higher volumes and lower concentrations of local anesthetic of equivalent dose. using this information, the investigators will conduct this study to evaluate the efficacy of bupivacaine at three different concentration and doses in equivalent volume used in ultrasound guided peng block for positioning \& post-operative analgesia.

Eligibility criteria:
inclusion criteria: * (asa )classes i and ii * patients of either sex * above the age of 18 who will undergo hip surgeries( (dynamic hip screw fixation or hemiarthroplasty)(not older than 2 weeks) with persistent pain and scheduled for surgery under sa with an expected duration of 2.5 hours). exclusion criteria: * patient's refusal to participate * any contraindications to sa or peripheral nerve blocks * history of ischemic heart disease * patients on opioids for chronic pain * patients with significant cognitive impairment. * patients who have surgery on the hip or spine within 3 months or have no pain while sitting by themselves (resting pain less than 4 on nrs) for sa without any support

Keywords: pain positioning peng block
predictive factors for resection and survival in type a borderline resectable pancreatic ductal adenocarcinoma patients after neoadjuvant therapy

Conditions: Carcinoma, Pancreatic Ductal

Summary: radical surgical resection is the only curative treatment option for pancreatic cancer, but borderline resectable tumors have a high probability of incomplete exeresis. although neoadjuvant therapy can improve the chances of complete exeresis, not all patients respond as expected.

pancreatic cancer is an important cause of cancer-related death worldwide. radical surgical resection still is the only curative treatment option today, but not all tumors are considered resectable. among resectable tumors, some are deemed borderline and have a high probability of incomplete exeresis. neoadjuvant therapy (nat) can be a game-changer for borderline cases, and there is a lack of evidence on the predictive factors associated with resectability after neoadjuvant treatment. this study aims to assess the prognostic factors for resectability and survival after nat in type a borderline resectable pancreatic ductal adenocarcinoma patients.

Eligibility criteria:
inclusion criteria: * patients ≥18 years old. * both sexes. * diagnosed with a type a br-pdac between january 2010 and december 2019. * minimum follow-up period of 12 months. exclusion criteria: * patients diagnosed with a type b or type c br-pdac. * patients diagnosed with a type a br-pdac who had disease progression prior to receiving nat.

Keywords: br-pdac pancreatic ductal adenocarcinoma borderline resectable ca 19-9 anatomical
smoking cessation treatment with transdermal nicotine replacement therapy - 1

Conditions: Tobacco Use Disorder

Summary: the purpose of this study is to look at how feasible it is to incorporate a state-of-the-art smoking cessation treatment program into community substance abuse treatment programs and its impact on substance abuse and cigarette smoking.


Eligibility criteria:
inclusion criteria: * patient is alcohol or drug dependent, in outpatient drug-free or opiate substitute program and is interested in quitting smoking exclusion criteria: * patient is psychotic * use of smokeless tobacco * use of other smoking cessasation product * pregnancy * patient has hyper-tension, heart problems, or skin condition

Keywords: nicotine dependence
pilot study to evaluate syl1001 safety and effect in patients with ocular pain

Conditions: Ocular Pain; Dry Eye Syndrome

Summary: the aim of this pilot study is to compare the analgesic effect of syl1001 versus placebo in patients with ocular pain associated with dry eye syndrome. general and local tolerability are also evaluated.


Eligibility criteria:
inclusion criteria: * patients of both genders * age ≥ 18 years old * give written informed consent to participate in the study after having been informed of the study design, objectives and possible derived risks * common mild to moderate dry eye symptoms. persistent daily symptoms for more than three months: * osdi scale: 13-30 * vas scale: 2-7 * ocular tests in both eyes: * corneal staining with fluorescein. oxford scale \> 0 * tear breakup time test: (but) \< 10 seconds * schirmer test with anaesthesia \< 10 mm/5min exclusion criteria: * pregnant or breastfeeding females or those with a positive pregnancy test. * females of childbearing potential who will not use a medically acceptable contraceptive method from selection and during the whole study. * current relevant disease, including respiratory disease, cardiovascular, endocrine, neurological, haematological, renal, neoplasic, hepatopathy, gastrointestinal distress, hypertension, or infectious acute processes. * past history of a chronic o recurring condition that could interfere with study according to the investigator's judgement. * concomitant use of other drugs with analgesic activity by any route of administration at the enrolment period. * changes in any ocular and/or systemic concomitant medication one month prior to the study commencement and during the study development. * changes on the preestablished artificial tears dosage 15 days prior to the study commencement and during the study development. * cyclosporine treatment initiation or changes in cyclosporine dosage or dosing regimen during the 6 months prior to enrolment. * previous history of drug hypersensitivity. * use of contact lenses * case history of drug or alcohol abuse or dependence. * relevant abnormal laboratory results as judged by the investigator * previous refractive surgery * participation in a clinical trial within 2 months before the enrolment visit * relevant ocular pathology judged by the investigator.

Keywords: ocular pain dry eye syndrome sirna rnai trpv1
italian non-interventional study of flt3 mutated aml patients

Conditions: AML; FLT3-ITD Mutation; FLT3-TKD Mutation

Summary: this is an observational study involving a retrospective and prospective collection of clinical and molecular data regarding patients with aml with flt3+ mutations

this is an observational study involving a retrospective and prospective collection of clinical and molecular data. patients will follow their regular diagnostic and clinical practice. thus, no additional procedure/blood withdrawal will be performed. the study will be conducted as follows: 1. retrospective phase: clinical and molecular data of aml patients with flt3+ mutations detected at diagnosis or at any refractory/relapse state will be collected. 2. prospective phase: clinical and molecular data of each new flt3+ aml patient identified in participating centers at diagnosis or at any refractory/relapse state will be collected prospectively. every effort will be done to include all consecutive patients, in order to avoid selection bias. for patients with a mutation found at the time of disease relapse, any effort will be done to collect all the clinical and molecular information since the time of diagnosis. the primary objective of this study is to analyze how flt3 mutational status evolve during the management of the disease looking at the percentage of patients with no flt3 mutations at diagnosis who relapse with a new flt3 mutation detected, and the percentage of flt3 positive aml patients that after having obtained a complete remission relapse with flt3 negative. the secondary objective of the study is to investigate the association between different flt3 mutations and the clinical, molecular and biological information.

Eligibility criteria:
inclusion criteria: 1. aml patients 2. male or female 3. aged ≥ 18 years 4. flt3 mutations (itd or tkd) positive tests performed at diagnosis or at relapse. 5. participant is willing and able to give informed consent for participation in the study. exclusion criteria: 1. to be currently involved in experimental clinical protocol, or have been treated with experimental drugs are not exclusion criteria.

Keywords: aml italian observational study flt3-itd mutation flt3-tkd mutation
iv vs im oxytocin in the third stage of labor for prevention of postpartum hemorrhage

Conditions: Postpartum Hemorrhage

Summary: the study will evaluate whether prophylactic oxytocin administered in the third stage of labor via iv infusion results in a lower mean blood loss compared to im injection.

the study will compare the effect of iv infusion and im oxytocin administration on the proportion of women who experience blood loss greater than or equal t 350 ml, the proportion of women who experience blood loss greater than or equal to 500 ml, side effects, adverse events and change in hemoglobin pre- to post-delivery. it will also assess whether a bleeding history questionnaire can identify women at risk for excessive bleeding and help to define the distribution of bleeding scores among women with and without excessive bleeding.

Eligibility criteria:
inclusion criteria: * all women who present in active labor for a live birth at the study hospital will be considered for participation in the study exclusion criteria: women who are: * planned or transferred for delivery via cesarean section * not delivering a live birth * unable to provide informed consent due to mental impairment, distress during labor or other reason * unwilling and/or unable to respond to questionnaires about background characteristics and/or bleeding history.

Keywords: postpartum hemorrhage oxytocin third stage of labor hemoglobin prevention intravenous intramuscular