Kornimate/medical-research-clean huggingface dataset:
correlation of right-left shunt detection in cardioembolism etiology in stroke patient.

Conditions: Foramen Ovale Patent

Summary: the aim of the study is to compare correlation for right to left shunts (mainly patent foramen ovale) detection for three methods-transesophageal echo as a gold standard, transcranial doppler with contrast agent (microbubbles) and new method- flow detection system ( cardiox tm) in young stoke patients ( age under 55 years).

the aim of the study is to compare correlation for right to left shunts (mainly patent foramen ovale) detection for three methods-transesophageal echo as a gold standard, transcranial doppler with contrast agent (microbubbles) and new method- flow detection system ( cardiox tm) in young stoke patients ( age under 55 years). flow detection systém is a new method for right to left shunt detection comfortable for patients, not dependent on experienced examinator and only one method with exact valsalve maneuver measurement. right to left shunt could be important etiology of cardioembolization in young stroke patient population, therefore screening for this condition is recommended in all young patient after ischemic stroke especially with unclear etiology. flow detection systes seams to be ideal screening method for this patients.

Eligibility criteria:
inclusion criteria:ischemic stroke / tia, signed informed consent - exclusion criteria:imposibillity to undergo transesophageal echo, transcranial doppler with contrast or cardiox flow detection system -
the effect of pulse field ablation on atrial mechanics in catheter ablation of paroxysmal atrial fibrillation

Conditions: Atrial Fibrillation Paroxysmal

Summary: the goal of this clinical trial is to compare the effect of pulmonary vein isolation on atrial function between pulse-field and cryoablation in patients over the age of 18 with paroxysmal atrial fibrillation. the main question it aims to answer is: • is catheter ablation energy (pulse field ablation) revealing a better preservation of the atrial function architecture than with conventional catheter ablation technologies ? participants will performed 2 irms with injection and completed quality of life questionnaires. they participate in the study for 4 months. researchers will compare 2 arms: * pulse-field ablation * cryoablation


Eligibility criteria:
inclusion criteria: * patient age ≥ 18 * established diagnosis of paroxysmal fibrillation, with a i/iia/iib indication for catheter ablation (esc 2020 guidelines) * episode of af documented by ecg within the last 12 months * patient able to give written informed consent * if female of childbearing potential, have a negative serum pregnancy test and using effective contraception * be affiliated with a french social security system or entitled exclusion criteria: * non-paroxysmal atrial fibrillation * contraindication to oral anticoagulation * intracardiac thrombus * previous ablation in the left atrium * previous heart surgery * significant valvular heart disease defined as any moderate (grade 3) or severe (grade 4) mitral regurgitation, mitral stenosis, aortic regurgitation, aortic stenosis, tricuspid regurgitation, or tricuspid stenosis * contraindication to perform mri or using the dotarem™ contrast product (pacemaker, defibrillator, foreign body or prosthesis, old generation heart valves, old generation ferromagnetic vascular surgical clips, percutaneous devices for endocranial aneurysms, neurosimulator, cochlear implants, automated injection device such as insulin pump, and more generally any non-removable electronic device, severe kidney disease with gfr \< 30 ml/min, documented hypersensitivity to gadoteric acid or to excipients, severe claustrophobia) * patient on ame (state medical aid) * pregnant or breast-feeding female * patient protected by law (guardianship, tutelage measure, deprived of liberty) * participation in another interventional study or being in the exclusion period at the end of a previous study.
addition of paclitaxel to high-dose combination chemotherapy in treating patients with high-risk breast cancer

Conditions: Breast Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells, allowing higher doses of chemotherapy to be used. purpose: phase i/ii trial to study the effectiveness of paclitaxel when added to high-dose combination chemotherapy followed by peripheral stem cell transplantation in treating women with breast cancer at high risk of relapse.

objectives: i. estimate the maximum tolerated dose of paclitaxel when given with high-dose carboplatin/cyclophosphamide with autologous peripheral blood stem cell support in women with high-risk stage ii/iii breast cancer. ii. assess the nonhematologic toxicities associated with this combination. iii. assess the progression-free and overall survival of these patients following this treatment. outline: this is a dose-finding study. all patients undergo collection of peripheral blood stem cells (pbsc) with granulocyte colony-stimulating factor (g-csf) mobilization prior to high-dose chemotherapy. cohorts of 3-5 patients are treated at successively higher dose levels of paclitaxel until a maximum tolerated dose (mtd) is found. paclitaxel is given as a single 6-hour infusion, followed by fixed doses of high-dose cyclophosphamide for 2 days, then carboplatin for 3 days. four days later, patients receive pbsc and g-csf for hematopoietic reconstitution. additional patients are entered at the mtd. patients are followed every 3 months for 1 year, every 4 months for 1 year, then every 4-6 months thereafter. projected accrual: it is expected that 24-30 patients will be accrued; a study duration of 1-1.5 years is anticipated.

Eligibility criteria:
disease characteristics: histologically diagnosed adenocarcinoma of the breast of the following stages: stage ii/iiia disease with 4 or more involved axillary lymph nodes stage iiib inflammatory no bone marrow involvement documented on bone marrow aspiration and biopsy prior breast cancer allowed hormone receptor status: not specified patient characteristics: age: 18 to 65 sex: women only menopausal status: not specified performance status: karnofsky 70%-100% hematopoietic: not specified hepatic: bilirubin no greater than 2.0 mg/dl renal: creatinine clearance at least 60 ml/min cardiovascular: left ventricular ejection fraction at least 50% by muga no abnormal cardiac conduction documented as second- or third-degree heart block or bundle branch block pulmonary: dlco at least 60% of predicted other: not hiv positive no history of second malignancy within 5 years except: nonmelanomatous skin cancer in situ carcinoma of the cervix no pregnant women prior concurrent therapy: at least 3 courses of induction therapy required, with regimen at the discretion of the investigator no disease progression during induction

Keywords: stage ii breast cancer stage iiia breast cancer stage iiib breast cancer inflammatory breast cancer
serum serotonin and pruritus after intrathecal morphine in cesarean section

Conditions: Pruritus

Summary: pruritus is the commonest side effect of intrathecal morphine especially in parturient, but the exact mechanism of pruritus is not clear. many mechanisms have been suggested. among these mechanisms is the activation of the 5-ht3 receptors by the intrathecally injected morphine.

forty parturients underwent elective cesarean section under spinal anesthesia were divided into two groups of 20 each in this prospective randomized study. group i received 100 µg of intrathecal morphine (itm) mixed with 12 mg of 0.5% heavy bupivacaine (m100) while group ii received 200 µg of itm mixed with 12 mg of 0.5% heavy bupivacaine (m200). two blood samples were taken from each patient for serotonin estimation, preoperatively and 4 hrs later. postoperatively all patients were assessed for pruritus (incidence \& severity), visual analog scale (vas), first request of analgesia, and total analgesic dose required within 24 hrs.

Eligibility criteria:
inclusion criteria: * asa i - ii term pregnant patients scheduled for elective cesarean section exclusion criteria: * patients with a known allergy to the study drugs * significant cardiac, respiratory, renal, neurological, or hepatic disease; -coagulation disorders * bmi \> 30 kg/m2 * any itchy skin diseases.

Keywords: morphine, pruritus, serotonin
stemi versus nstemi: clinical and angiographic differences

Conditions: Acute Coronary Syndrome

Summary: the purpose of this study is to assess differences in the risk profile and in the coronary angiographic presentation between stemi and nstemi. moreover possible relationship between myocardial infarction presentation and renal function will be investigated.

assessment of risk profile. diabetes mellitus diagnosed when fasting blood glucose (fbg) was \>= 126mg/dl or if patients were taking oral hypoglycaemic drugs or were on insulin treatment. hypertension defined as blood pressure \>= 140/90 mmhg or history of antihypertensive treatment. hypercholesterolemia,adjudicated when cholesterol levels were \>= 200 mg/dl or with patients on lipid lowering treatment. hypertriglyceridemia adjudicated on fasting triglyceride levels\>= 200 mg/dl or triglyceride-lowering therapy . obesity, defined as bmi \>= 30 kg/m2. patients with stemi, who had not been previously treated with thrombolysis, and those who had been undergone to an unsuccessful thrombolysis, as well as patients with nstemi with a timi score\> 3 who were immediately referred to the cat lab and whenever possible treated with ptca and stenting of the culprit lesion. the other patients who were referred to cat lab within 48 hours from the beginning of chest pain, unless their general conditions did not strongly suggest to delay the procedure after 2 more days.

Eligibility criteria:
inclusion criteria: * patients admitted in the coronary care unit (ccu) of the department of clinical and experimental medicine at the federico 2nd university hospital; * patient with indication to angiographic study even if not immediately; * patients referred to ccu with the diagnosis of acute myocardial infraction (ami), type stemi, or nstemi, based on pre-admission assessment of troponin i (tpi) and myocardial band creatin kinase (ck-mb; * diagnosis of nstemi/stemi performed according to standard criteria exclusion criteria: * patients who could not undergo angiographic study

Keywords: myocardial infarction coronary angiography stemi nstemi
retina projection system trials for low vision people

Conditions: Vision, Low

Summary: 1. purpose a. examination on efficacy of retina projection system 2. patients a. low vision patients 3. methods 1. vision aids * retina projection system * face-mounted video display as control 2. comparison of reading speeds with both vision aids

1. purpose a. examination on efficacy of a new vision aid of retina projection system 2. patients 1. low vision patients 2. vision between 0.06 and 0.3 3. no exclusion on kinds of ocular diseases 3. methods 1. vision aids * retina projection system * face-mounted video display as control 2. computer-aided measurement of reading speeds of individual characters 3. comparison of reading speeds with the two vision aids

Eligibility criteria:
inclusion criteria: * low vision patients * vision between 0.06 and 0.3 exclusion criteria: * light perception * hand motion * vision less than 0.06

Keywords: low vision
a non-interventional study to describe the dupilumab long-term treatment, safety and patient reported outcomes in chronic nodular prurigo (prurigo nodularis) in clinical routine

Conditions: Prurigo Nodularis

Summary: prurigo nodularis (pn) is a skin disease characterized by the presence of single to multiple symmetrically distributed, intensively itching nodules. the main symptom is uncontrollable itching leading to prolonged, repetitive, and uncontrollable rubbing, scratching which in turn causes injuries to the skin. in recent years, number of studies evaluating pn, the affected population and the disease burden has increased but pn remains still understudied. this non-interventional study is intended to describe the long-term effectiveness of dupilumab (dupixent®) in participants aged 18 years or older and suffering from moderate-to-severe pn who receive dupilumab for pn treatment in a real-world setting in germany according to the prescribing information (summary of product characteristics \[smpc\]). the decision to initiate dupilumab treatment is made by the treating physician and participant according to the participant's medical need and to the standard of best medical practice. this decision is made independently and before data inclusion in this non-interventional study.

the individual observational period is planned to be up to 2 years, with assessments at baseline, one month after baseline and afterwards, every 3 months in the 1st and every 6 months in the 2nd year after dupilumab initiation, respectively.

Eligibility criteria:
inclusion criteria: * participants at least 18 years of age at baseline visit * signed written informed consent * new initiation with dupilumab or in whom treatment with dupilumab was started within the last 7 days for moderate to severe prurigo nodularis according to the prescribing information/summary of product characteristics (smpc) * patients who received the initial diagnosis of pn exclusion criteria: * patients who have a contraindication to dupilumab according to the current prescribing information label/smpc * patients who have been treated for more than 7 days with dupilumab * any acute or chronic condition that, in the treating physician´s opinion, would limit the patient´s ability to complete questionnaires or to participate in this study or impact the interpretation of the results * participation in an ongoing interventional or observational study that might, in the treating physician´s opinion, influence the assessments for the current study the above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
propofol and dexmedetomidine on inflammation

Conditions: Inflammation; Postoperative Delirium; Anesthesia

Summary: dexmedetomidine, was reported to prevent postoperative delirium in elderly patients following its use in intensive care units. possible mechanisms included improved quality of sleep and an inhibitory effect on inflammation. a greater number of studies indicated that propofol has negative effect on postoperative cognitive function. in this study, we planned to investigate the influence of these two different sedative drugs on peripheral inflammation induced by surgery and postoperative cognitive function of patients who will receive hip and knee arthroplasty.

dexmedetomidine, was reported to prevent postoperative delirium in elderly patients following its use in intensive care units. possible mechanisms included improved quality of sleep and an inhibitory effect on inflammation. a greater number of studies indicated that propofol has negative effect on postoperative cognitive function. in this study, patients who will receive hip and knee arthroplasty will be divided to two groups: propofol group and dexmedetomidine group. spinal anesthesia will be used to meet the requirement of intraoperative analgesia. patients in two groups will be sedated by propofol and dexmedetomidine, respectively. tnf-α and il-6 in blood will be detected. and postoperative cognitive function of patients will be investigated. the objective of this study is to clarify the influence of these two different sedative drugs on peripheral inflammation induced by surgery, and the relationship with the change of postoperative cognitive function.

Eligibility criteria:
inclusion criteria: * the patients included in this study were 65 years or older, were undergoing total hip arthroplasty, and were classified as american society of anesthesiologists (asa) physical health class i-iv. exclusion criteria: * contraindications to spinal anesthesia (i.e., coagulopathy, concurrent use of anticoagulants, infection at puncture site, and refusal of spinal anesthesia), patients with infectious diseases, patients with mental or language barriers, patients who had been anesthetized within the past 30 days, severe congestive heart failure (new york heart association, class iv) and/or severe chronic obstructive pulmonary disease (global initiative for chronic obstructive lung disease guidelines, stages iii-iv), sick sinus syndrome, severe sinus bradycardia (\< 50 beats per min), and second or greater atrioventricular block without pacemaker. in addition, patients exhibiting cognitive impairment (i.e., a mini-mental state examination (mmse) score \< 24) and/or preoperative delirium (i.e., positive confusion assessment method (cam) result) were excluded.
enzymatic versus (vs) autolytic debridement of diabetic foot ulcers

Conditions: Diabetic Foot Ulcers

Summary: this study compares two standard methods for cleaning the surface of wounds on the feet of patients with diabetes mellitus. the question being asked is whether inflammation of the wound affects the ability of one or both of the methods to work.


Eligibility criteria:
inclusion criteria: * the informed consent document must be read, signed, and dated by the subject or the subject's legally authorized representative before conducting any study procedures or exams. in addition, the informed consent document must be signed and dated by the individual who consents the subject before conducting the screening visit. a photocopy of the signed informed consent document must be provided to the subject, and the original signed document placed in the subject's chart. * of either sex, aged 18 years or older. * a diagnosis of diabetes mellitus, type i or ii, requiring medication to control blood glucose levels. * a qualifying ulcer, defined as follows: * ulcer grade 1 or 2 on the wagner classification scale (refer to section 9.4.1) * infection / inflammation grade 1 or 2 for wound bed inflammation (refer to section 9.4.2) * has not been treated or has not responded to treatment during the past 30 days * has an apparent area ≥ 3.0 cm² * requires debridement of the wound bed * is sufficiently moist to allow collection of wound fluid using a filter paper disc * adequate arterial blood flow evidenced by ankle brachial index (abi) of ≥ 0.7 and ≤ 1.1; if the abi is greater than 1.1, then toe pressure of \>50 mmhg. * subject must be willing to use the darco shoe off-loading device and insole, or a comparable device, as indicated. * subject able to follow instructions, particularly regarding the application of test articles and dressings at home. able to apply the test articles, or has a caregiver available to apply the test articles according to the protocol. exclusion criteria: * contraindications or known hypersensitivity to the test articles or their components. * cellulitis extending \>2 cm around the target ulcer, lymphangitic streaking, spread beneath the superficial fascia, deep-tissue abscess, gangrene, or infection of muscle, tendon, joint or bone. * target ulcer tunneling per probing and visual assessment. * use of systemic antibiotics or any drug listed in section 9.1.6 of this protocol within 10 days of scr visit. * concomitant illness or condition which, in the opinion of the principal - investigator, places the subject at risk for this study. * the medical monitor may declare any subject ineligible for a valid procedural or medical reason.
effects of aerobic training on exercise capacity in patients with advanced cirrhosis 2

Conditions: Cirrhosis

Summary: cirrhosis is associated with a reduction in muscle mass and exercise capacity. this has an impact on morbidity and mortality. regular aerobic exercise training is a proven effective therapy to improve exercise capacity in healthy and clinical populations. the effect of this training has not yet been evaluated in the decompensated cirrhosis patient population. the safety of this intervention also requires further study. using a randomized controlled design, the investigators aim to determine the safety and efficacy of eight weeks of aerobic exercise training on aerobic capacity, functional performance, and muscle mass in decompensated cirrhosis patients.


Eligibility criteria:
inclusion criteria: * age \>18 and ≤ 70 years * cirrhosis * child pugh class b or c * if required, primary or secondary variceal prophylaxis in place exclusion criteria: * post-liver transplantation * hepatocelluar carcinoma beyond transplant criteria * active non-hepatocelluar carcinoma malignancy * significant cardiac disease * hemoglobin (\<80 g/l) * oxygen saturation at rest \<95% * known myopathy * chronic renal failure on dialysis * physical impairment making it impossible to ride an exercise bike or treadmill * orthopedic abnormality preventing exercise training * hiv infection * patient unwilling to consent to study
a study to compare tenofovir disoproxil fumarate versus adefovir dipivoxil for the treatment of hbeag-negative chronic hepatitis b

Conditions: Chronic Hepatitis B

Summary: this primary objectives of this study are to compare the efficacy, safety, and tolerability of tenofovir disoproxil fumarate (tdf) versus adefovir dipivoxil (adv) for the treatment of pre-core mutant chronic hepatitis b. participants will receive tdf or adv for 48 weeks (double-blind). after 48 weeks, eligible participants switched to open-label tdf for up to 480 weeks.


Eligibility criteria:
key inclusion criteria: * chronic hepatitis b virus (hbv) infection, defined as positive serum hepatitis b s-antigen (hbsag) for at least 6 months. * 18 through 69 years of age, inclusive. * active hepatitis b e-antigen (hbeag) negative chronic hbv infection, with all of the following: * hbeag negative and hbeab positive at screening * alanine aminotransferase (alt) levels \> the upper limit of the normal range (uln) and ≤ 10 x uln * serum hbv dna \> 100,000 copies/ml at screening * creatinine clearance ≥ 70 ml/min * hemoglobin ≥ 8 g/dl * neutrophils ≥ 1,000 /ml * knodell necroinflammatory score ≥ 3 and a knodell fibrosis score \< 4; however, up to 120 patients with cirrhosis, ie, a knodell fibrosis score equal to 4, will be eligible for enrollment * negative serum β-human chorionic gonadotropin (hcg) * nucleotide naive, ie, no prior nucleotide (tdf or adv) therapy for greater than 12 weeks * nucleoside naive, ie, no prior nucleoside (any nucleoside) therapy for greater than 12 weeks. however, up to 120 patients with \> 12 weeks prior lamivudine experience will be eligible * willing and able to provide written informed consent * had a liver biopsy performed within 6 months of baseline and has readable biopsy slides or agrees to have a biopsy performed prior to baseline key exclusion criteria: * pregnant women, women who are breast feeding, or women who believe they may wish to become pregnant during the course of the study * males and females of reproductive potential who are unwilling to use an effective method of contraception during the study. * decompensated liver disease defined as conjugated bilirubin \> 1.5 x uln, prothrombin time (pt) \> 1.5 x uln, platelets \< 75,000/ml, serum albumin \< 3.0 g/dl, or prior history of clinical hepatic decompensation (eg, ascites, jaundice, encephalopathy, variceal hemorrhage) * received any nucleoside, nucleotide (tdf or adv) or interferon (pegylated or not) therapy within 6 months prior to the pre treatment biopsy * evidence of hepatocellular carcinoma (hcc) * coinfection with hepatitis c virus (hcv), human immunodeficiency virus (hiv), or hepatitis d virus (hdv) * significant renal, cardiovascular, pulmonary, or neurological disease * received solid organ or bone marrow transplantation * is currently receiving therapy with immunomodulators (eg, corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion * has proximal tubulopathy note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: tenofovir adefovir hepatitis b virus hbeag negative