Kornimate/medical-research-clean huggingface dataset:
sildenafil for secondary pulmonary hypertension due to valvular disease

Conditions: Pulmonary Hypertension; Valvular Heart Disease

Summary: the purpose of this study is to evaluate the clinical efficacy of the mid-term treatment with sildenafil in patients with persistent moderate or severe pulmonary hypertension (ph) after a heart valve intervention.

phase iv, prospective, multicenter, randomized, double-blind, placebo-controlled, academically funded clinical trial, with 6 months follow-up. a total of 354 patients will be recruited. inclusion criteria are: 1) successful surgical or percutaneous repair of a cardiac valve at least one year before screening and 2) persistent moderate or severe ph, and 3) absence of any residual significant valvular lesion. patients will be randomized 1:1 to received sildenafil 40 mg t.i.d. or placebo. the primary endpoint is a clinical composite score combining: all-cause mortality, hospital admission for heart failure, world health organization (who) functional class, and the patient global assessment score. additional clinical and mechanistic secondary end-points are defined.

Eligibility criteria:
inclusion criteria: * age at the date of selection ≥ 18 years * mean pulmonary pressure ≥ 30 mmhg, measured by a swan-ganz catheter placed in the pulmonary artery * heart valve intervention: surgical or percutaneous replacement, repair or dilatation performed at least one year before inclusion * stable clinical condition for at least one month, without hospital admissions for heart failure, and on appropriate and stable doses of conventional cardiovascular medications exclusion criteria: * requiring or likely to require the following medications: organic nitrates, alpha-blocker therapy, potent cytochrome p450 3a4 inhibitors (erythromycin, ketoconazole, cimetidine, hiv protease inhibitors such ritonavir and saquinavir) patients who have suffered a myocardial infarction, stroke, or life-threatening arrhythmia within the last 6 months. * patients with resting hypotension, with systolic blood pressure \< 90 mmhg * patients with retinitis pigmentosa * anatomical deformation of the penis (such as angulation, cavernosal fibrosis or peyronie's disease) or patients who have conditions which may predispose them to priapism (such as sickle cell anemia, multiple myeloma, or leukemia) * severe renal impairment with creatinine clearance \< 30 ml/min * significant hepatic dysfunction * prosthesis or valvular dysfunction with hemodynamic repercussion. * pregnant or breast-feeding women * patients unlikely to cooperate in the study or with inability or unwillingness to give informed consent * life expectancy less than 2 years due to non-cardiac disease

Keywords: secondary pulmonary hypertension valvular heart disease phosphodiesterase-inhibitors sildenafil outcomes research
risk factors for achieving to after ldpphr-t

Conditions: Pancreatic Neoplasm of Uncertain Behavior Head

Summary: this is a single, retrospective, observational study to investigate the risk factors for achieving textbook outcome after laparoscopic duodenum-preserving total pancreatic head resection.

increasing numbers of benign or low-grade malignant neoplasms at the head of pancreas are being diagnosed due to computed tomography (ct), magnetic resonance imaging (mri) and endoscopic ultrasonography (eus). laparoscopic duodenum-preserving total pancreatic head resection (ldpphr-t) has been accepted as a valid alternative treatment for benign and low-grade malignant neoplasms at the head of the pancreas. the evaluation of quality of ldpphr-t is important for surgeons to improve surgical quality. currently, the evaluation of surgical quality mainly depends on some single outcome indicators, such as morbidity, mortality, readmission rate, or hospital stay. these single outcome indicators are difficult to accurately reflect the overall surgical quality and the composite outcome measures may be better than single outcome indicators. textbook outcome (to) is such a composite concept and is realized when all the requirements after operation are achieved according to the "all or none" principle. to reflects the ideal surgical outcome and is a multidimensional measure for surgical quality assurance. however, the risk factors for achieving to after ldpphr-t is unknown and no relevant articles have been reported so far. the objective of study was to identify the risk factors for achieving to after ldpphr-t.

Eligibility criteria:
inclusion criteria: 1. patients underwent laparoscopic duodenum-preserving total pancreatic head resection. 2. aged 18 to 75 years old. exclusion criteria: 1. peritoneal seeding or metastasis to distant sites. 2. incomplete clinical data.

Keywords: textbook outcome risk factors endoscopic nasobiliary drainage total pancreatic head resection duodenum-preserving laparoscopic
skin disease in methamphetamine abuse

Conditions: Methamphetamine Abuse

Summary: 1. to detect the skin diseases in patients using methamphetamine

methamphetamine is a stimulant drug that associated with a broad spectrum of health conditions, include addiction, mental health disorders, and overdose. the drug enforcement agency (dea) classifies it as a schedule ii drug. this means that the drug has a high potential for misuse. the drug is also called crystal meth, ice, and blue. methamphetamine use has increased in egypt especially in upper egypt. literature on cutaneous manifestations among methamphetamine users is limited, although cellulitis, delusion of parasitosis (dop), hyperhidrosis, formication and prurigo nodularis (pn) have been attributed to methamphetamine users. while the relationship between skin lesions and substance use in not fully defined, there is some evidence that points to the development of these itchy, red lesion also known as meth sore after meth use. meth sores often look like small round red patches on your skin, they can often be confused with acne when they appear on the face or a rash when they appear on other parts of the body. meth sores form as a result of heavy meth misuse. other signs of meth abuse at the stage where sores likely to develop include: * weight loss * paranoia * hallucinations * aggressive behavior * being easily distracted * tooth and gum decay * changes in brain structure

Eligibility criteria:
inclusion criteria: * patients using methamphetamine exclusion criteria: * 1. pregnant and lactating patients. 2. patients with chronic diseases
medtronic reveal xt study

Conditions: Atrial Fibrillation

Summary: while surgical treatment for atrial fibrillation (af) has been performed for over 20 years, virtually all of the historical series reported only the recurrence of symptomatic af and have used only intermittent electrocardiogram (ecg) follow-up. this study compares the use of traditional arrhythmia assessment (ecg and 24-hour holter monitoring) with the use of the medtronic reveal xt device to continuously record heart rhythm to quantify postoperative arrhythmia burden following surgical treatment for af in patients undergoing either lone or concomitant heart surgery.


Eligibility criteria:
inclusion criteria: 1. patients undergoing planned, elective af surgery, either as a stand-alone procedure or as a concomitant cardiac operation. 2. patients will have either a cox-maze procedure (full-biatrial lesion set) or surgical pulmonary vein isolation (pvi). 3. patients 18 years or older. 4. all eligible patients will be considered, regardless of gender or race. 5. patients able and willing to provide informed consent and willing to comply with the required interval follow-up. exclusion criteria: 1. patients with a preoperative permanent pacemaker. 2. patients with a projected lifespan of less than six months. 3. patients requiring emergent cardiac surgery. 4. patients unwilling or unable to give written informed consent. 5. patients undergoing a right atrial or left atrial lesion set procedure.

Keywords: patients
chinese hcc efficacy evaluation, response and safety study of taresphere

Conditions: Unresectable Hepatocellular Carcinoma

Summary: the goal of this clinical trial is to evaluate the efficacy and safety of nrt6003 injection compared to ctace in patients with unresectable hcc.

the main questions it aims to answer are: 1. does nrt6003 injection improve tumor response rates compared to ctace in patients with unresectable hcc? 2. what adverse events do participants experience when receiving nrt6003 injection compared to ctace? investigators will compare nrt6003 injection to ctace to determine: 1. whether nrt6003 injection demonstrates superior efficacy in tumor control and long-term survival (e.g., objective response rate, time to progression, etc.). 2. whether nrt6003 injection has a comparable or improved safety profile vs. ctace (e.g., incidence of adverse events, etc.). participants will: 1. receive either nrt6003 injection or ctace as per randomized assignment. 2. undergo scheduled follow-up visits for imaging assessments (e.g., mri or ct scans, etc.) and safety evaluations. 3. provide blood samples for biomarker analysis. 4. report any symptoms or medical events through a patient diary and during clinic visits.

Eligibility criteria:
key inclusion criteria: 1. diagnosed as hepatocellular carcinoma (cnlc ⅰa-ⅲa) clinically, by imaging and/or pathology based on the guideline of the national health commission of the people's republic of china (2024). 2. evaluated by the investigator as not suitable for surgical resection/ablation/liver transplantation, or there is high risk for surgical resection, or the participant refuses surgical resection/ablation/liver transplantation. 3. child-pugh score ≤ 7. 4. eastern cooperative oncology group performance status ≤ 1. 5. adequate organ function. key exclusion criteria: 1. imaging evidence or suspicion of extrahepatic metastases (including regional lymph node metastases). 2. prior antitumor treatment for primary hepatocellular carcinoma. 3. prior external radiation therapy or intra-arterial brachytherapy. 4. liver vascular evaluation results that do not meet all the requirements of the study.

Keywords: selective internal radiation therapy yttrium-90 transarterial radioembolization conventional transarterial chemoembolization
plavix, prasugrel and drug eluting stents pilot trial

Conditions: Coronary Artery Disease; Platelet Aggregation Inhibitors; PCI- Percutaneous Coronary Intervention

Summary: * the purpose of this study is to determine the level of inhibition of platelet activation of an approved thienopyridine(clopidogrel or prasugrel) and aspirin regimen in the setting of drug eluting coronary stent implantation. * in subjects with high residual levels of platelet reactivity after receiving either a maintenance or loading dose of either clopidogrel or prasugrel, a cross over of thienopyridine treatment to the alternate medication will occur. * the study tests the hypothesis that adequate platelet inhibition will occur in subjects who have high levels of platelet reactivity and are subsequently switched from clopidogrel to prasugrel(loading or maintenance dose) without increased episodes of bleeding or mace events at discharge and 30 days post percutaneous coronary intervention (pci).


Eligibility criteria:
inclusion criteria: * subject presenting for clinically indicated pci with implantation of at least one drug-eluting stent. * no planned use of glycoprotein iib/iiia inhibitors during pci procedure. * subject must be taking aspirin or enteric coated aspirin 81 mg-325 mg daily. * willing to participate and sign an informed consent. exclusion criteria: * subject older than 75 years of age. * subject weight is 60 kg or less. * subject who have received intravenous eptifibatide or tirofiban within 48 hours prior to pci or abciximab within 14 days before or during pci. * subject taking warfarin or with clinical indication to resume warfarin post pci for any indication. * subject currently requiring daily treatment with nsaid or cox2 inhibitors. * subject with a known platelet disorder. * subject with known active pathological bleeding or heightened risk of bleeding including but not limited to: gastrointestinal bleeding within 6 months, recent surgery or trauma. * subject with a history of a stroke or tia * subject with pre-pci hematocrit or platelet count outside the ranges validated for verify now p2y12 test (33-52% and 119.000-502.000/μl, respectively). * subject with a history of hepatic impairment * subject with known nyha class iii or greater for heart failure. * inability of subject to provide informed consent. * subject with known hypersensitivity or contraindication to clopidogrel, prasugrel or asa, which would result in inability of patient to adhere to trial protocol. * presence of valvular heart disease left main coronary artery stenosis or urgent need for cabg.

Keywords: coronary artery disease clopidogrel prasugrel verify now pru measurements drug eluting stents (eds) p2y12 platelet reactivity
safety & efficacy of peginesatide for treatment of anemia in participants on dialysis not receiving an esa

Conditions: Anemia; Chronic Renal Failure; Chronic Kidney Disease

Summary: the purpose of this study is to evaluate the safety and efficacy of peginesatide for the treatment of anemia in participants with chronic kidney disease who are on dialysis and are not taking any treatment to increase their red blood cell production.

anemia associated with chronic kidney disease is due to several factors, primarily the inability of the diseased kidneys to produce adequate amounts of endogenous erythropoietin. ancillary factors include the shortened lifespan of red blood cells, iron and other nutritional deficiencies, infection, and inflammation. the presence and severity of anemia are related to the duration and extent of kidney failure. anemia is associated with increased mortality, increased likelihood of hospitalization, reduced cognitive function, and increased left ventricular hypertrophy and heart failure. erythropoiesis stimulating agents (esas) have been established as a treatment for anemia in chronic renal failure subjects, and have improved the management of anemia over alternatives such as transfusion. peginesatide is a parenteral formulation developed for the treatment of anemia in patients with chronic kidney disease. peginesatide binds to and activates the human erythropoietin receptor and stimulates erythropoiesis in human red cell precursors in a manner similar to other known erythropoiesis-stimulating agents. eligible participants were randomized in equal proportions to two peginesatide treatment regimens, in which participants received peginesatide once every 4 weeks, and one control, epoetin alfa, treatment regimen, in which participants received epoetin alfa three times per week. total commitment time of this study was a 4 week screening period followed by a minimum of 7 months of treatment.

Eligibility criteria:
inclusion criteria 1. on hemodialysis for chronic renal failure for at least 2 weeks prior to randomization. 2. two consecutive hemoglobin values of ≥ 8.0 g/dl and \< 11.0 g/dl within the 4 weeks prior to randomization. exclusion criteria 1. females who are pregnant or breast-feeding. 2. prior treatment with an erythropoiesis stimulating agent (esa) in the 12 weeks prior to randomization. 3. known intolerance to any esa, parenteral iron supplementation, or pegylated molecule. 4. known bleeding or coagulation disorder. 5. known hematologic disease or cause for anemia other than renal disease 6. poorly controlled hypertension. 7. evidence of active malignancy within one year. 8. a scheduled kidney transplant.

Keywords: anemia chronic kidney disease ckd chronic renal failure crf erythropoietin epo erythropoiesis stimulating agent esa hematide™ hemoglobin hb hgb omontys peginesatide red blood cell red blood cell production
detection of pattern of some unusual signs and symptoms of multiple sclerosis

Conditions: Multiple Sclerosis

Summary: each multiple sclerosis patient will be submitted to cognitive abilities screening instrument (casi), expanded disability status scale, epowrth sleeping scale(ess),fatigue severity scale(fss), hamilton depression rating scale, hamilton anxiety rating scale, headache disability index, specific questionnaire based on international headache society (ihs) recommendations


Eligibility criteria:
inclusion criteria: 1. male or female. 2. age:30-50 years 3. accepting all study requirement exclusion criteria: 1. comorbid patient e.g (diabetic, hypertensive.......etc ) 2. opposition of the patient or their family
safety and efficacy study of a new chemotherapy agent to treat non small cell lung cancer.

Conditions: Non Small Cell Lung Cancer

Summary: the purpose of this study is to determine whether the study drug is effective and safe in the treatment of patients with non small cell lung cancer who have already received one platinum based chemotherapy.

the study has previously been posted by schering ag, germany. schering ag, germany has been renamed to bayer schering pharma ag, germany.bayer schering pharma ag, germany is the sponsor of the trial.

Eligibility criteria:
inclusion criteria: * non small cell lung cancer, stage iiib or stage iv * one and only 1 prior platinum-based chemotherapy * no other uncontrolled concurrent illness * use of highly effective birth control methods in males or females with reproductive potential exclusion criteria: * previous participation in another trial within the last 4 weeks * surgery within 10 days prior to the start of study treatment * brain metastases * confirmed diagnosis of infection with the human immunodeficiency virus (hiv) * current treatment with warfarin sodium (coumadin) or similar anticoagulation medication * breast feeding
children vaccination from 11 to 14 years old

Conditions: Vaccination Refusal; Opinions

Summary: the human papilloma virus infection is the most frequent sexually transmitted infection around the world. in the vast majority of cases, these are inapparent infections that disappear spontaneously. in some cases, the hpv infection persists and can generate anogenital warts or cancer. in france, the papillomavirus is responsible for 6000 new cases of cancer/year with several possible localizations : cervical, anal, penile, oropharyngeal, vulvar or vaginal. among them, 4580 new cases of cancer/year occur in women, and half of them are diagnosis of cervical cancer. a quarter of cancers caused by papillomavirus occur in men. in france, the commercialization of anti-hpv vaccine in 2007 was addressed only to girls, in order to gain a group immunity that would therefore protect the boys. this vaccination did not achieve the cover immunization target that were announced: the objective was fixed at 60% of vaccination coverage and at the end of 2018, only 24% was achieved on the complete vaccination schedule. in december 2019, the french national authority for health recommended the anti-hpv vaccinations in girls and boys.

this qualitative study evaluates parents' opinion regarding the vaccination and the hpv. parent's eligible to participate in this study are those with boys between 11 and 14 years old. the anti-hpv vaccination is perceived favorably in 38% of parents, but 42% of parents are undecided. the investigators would like to evaluate qualitatively the opinions and the obstacles in this vaccination, using interviews in parents of boys aged between 11 and 14 years old.

Eligibility criteria:
inclusion criteria: * parents having boys between 11 and 14 years old, followed-up by a general practitioner that participate in the study * signed inform consent form exclusion criteria: * language barrier that could prevent the understanding or formulation of opinions during the interview

Keywords: human papilloma virus vaccination
non interventional study for patients treated with somavert®

Conditions: Acromegaly

Summary: this open-label, national, prospective, observational, non-interventional, multi-center, post marketing surveillance study was performed in order to examine the efficacy and safety of somavert® in treatment of subjects with acromegaly and its effects on acromegaly related co-morbidities.

non probability samples

Eligibility criteria:
inclusion criteria: * subjects with diagnosed acromegaly who were already being treated with somavert® or were to start treatment with somavert® were included in the study. exclusion criteria: * subjects treated with an investigational drug for treatment of acromegaly. * subjects with symptoms such visual field loss, cranial nerve palsies or intracranial hypertension, indicating need for surgery. * women who were pregnant or lactating.

Keywords: open-label, national, prospective, observational, non-interventional, multi-center, post marketing surveillance study
evolution of two cohorts of children (univentricular and bi-ventricular heart) after strapping of the pulmonary artery

Conditions: Congenital Heart Malformations

Summary: pulmonary artery strapping is a surgical technique aimed at providing a palliative treatment to newborns suffering from congenital heart defects, characterized by an increase in blood flow and pulmonary blood pressure. the intervention consists of placing a band around the pulmonary artery. this band causes an artificial stenosis, therefore inducing a reduction of the pulmonary arterial pressure. it acts as a first step, preparing the ground for a future definitive repair intervention. it is mainly used in the context of septal defects, atrio-ventricular canal defects or uni-ventricular hearts. the complications linked to strapping include, among others, the erosion of the band in the artery lumen, its migration and the obstruction of the pulmonary artery, a pulmonary valvular insufficiency, the obstruction of the coronary artery and an ineffective strapping. the early mortality rate of pulmonary artery strapping after 1980 varies between 1.8% and 13.6%, while strapping readjustment rates oscillate around 20%. it is assumed that the mortality is linked to the nature of the cardial malformation (uni-ventricular or bi-ventricular) rather than the procedure itself. this retrospective study aims to evaluate the intra-hospital and extra-hospital mortality rate of pulmonary artery strapping, as well as the readjustment rate within two groups of patients: those benefiting from an uni-ventricular cardiac reparation and those benefiting from a bi-ventricular cardiac reparation. the aim is to determine the short term mortality rate of the intervention and the incidence of complications within the hospital, within the two groups.


Eligibility criteria:
inclusion criteria: * all patients treated with pulmonary artery strapping between 2005 and 2016 at the queen fabiola children hospital exclusion criteria: * outdated indications

Keywords: pulmonary artery strapping