Kornimate/medical-research-clean huggingface dataset:
correlations between oxidative stress biomarkers, h-fabp and left ventricular dysfunction in patients with acute myocardial infarction undergoing primary pci

Conditions: STEMI; Oxidative Stress; Oxidative Stress Induction; Primary PCI; hFABP; Left Ventricular Dysfunction; BCM

Summary: the investigators intend to evaluate oxidative stress biomarkers through a. catalase activity assay; b. lipid peroxidation assay; c. sod assay; d. total antioxidant capacity assay; e. glutathione peroxidase at patients with acute myocardial infarction stemi referred for primary pci; the investigators also aim to evaluate cardiac necrosis by measuring heart fatty acid binding protein (h-fabp), tni, ck, ck-mb, ldh and ast in these patients with acute myocardial infarction referred for primary pci; also, the investigators intend to evaluate body composition through bioimpedance spectroscopy (bcm - fresenius care) at the moment of admission. the investigators aim to fully characterise these patients through oxidative millieu, hfabp and make correlations with lvef dysfunction.

gathered data: * descriptive general demographic data; * previous pathologies (ischemic heart disease, peripheral arterial disease, stroke, heart failure, previous percutaneous coronary interventions, coronary artery bypass grafting - cabg, known renal disease); * cardiovascular risk factors (age, weight, height, abdominal perimeter, body mass index, smoking, sedentariness, diabetes, hypertension, dyslipidaemia); * oxidative stress biomarkers: catalase activity assay; lipid peroxidation assay; sod assay; total antioxidant capacity assay; glutathione ; * cardiac necrosis markers: heart fatty acid binding protein (h-fabp), tni, ck, ck-mb, ldh and ogt; * routine biological data; * metabolic data (obtained from two body composition monitoring evaluations - before and 12 hours after coronary intervention) - body water, body fat tissue; * information regarding primary pci (less than 12 hours of ischemic symptoms); * coronarographic details, type of used stent, periprocedural specific complications, final timi - thrombolysis in myocardial infarction - flow); * echocardiography at admission (lvef); * measurement of arterial stiffness through sphigmocore pulsed-wave-velocity (24 hrs post-procedural, 2 velocities: carotid - femoral and carotid - radial); * calculating of cardiovascular risk scores: syntax score, framingham score, assign score, qrisk2 score, procam score, crusade score, grace score, chads vasc score, mesa score, ascvd score, hamilton depression rating scale (ham-d), hamilton rating scale for anxiety; * in-hospital and one month follow-up mace.

Eligibility criteria:
inclusion criteria: * adults with st elevation myocardial infarction (\<12h) diagnostic confirmed; * included in the romanian national programme of primary percutaneous revascularisation (for who the guidelines recommend primary pci); exclusion criteria: * patients who do not sign informed consent for primary pci
bictegravir/emtricitabine/tenofovir alafenide plus doravirine

Conditions: HIV-1-infection

Summary: the current study proposal is an open label observational trial for maintenance of virologic suppression, and is designed as a non- inferiority switch trial. the study will involve approximately 30 patients, which includes a pk arm of approximately 10 patients. the study will also include secondary outcomes of quality of life (qol) and weight changes hypothesis: patients with prior nuc or nnrti resistance (but not to rilpivirine or doravirine) will maintain their virologic suppression after a drug regimen switch from rilpivirine/emtricitabine/tenofovir alafenamide in combination with dolutegravir, to bictegravir/emtricitabine/tenofovir alafenamide in combination with doravirine. the switch therapy will avoid food interactions, and will be well tolerated by subjects.


Eligibility criteria:
inclusion criteria: * hiv positive males, age 45 or older * any genotypic or phenotypic resistance except k65r, 69 insertion, integrase resistance, or resistance to rilpivarine or doravirine. * receiving combination antiretroviral regimen of rilpivirine/emtricitabine/tenofovir alafenamide in combination with dolutegravir \> 12 months and with viral load \<50 copies/ ml on at least one occasion within the six months prior to switch. * suppressed viral load as defined by one plasma hiv rna level \< 50 copies/ml within previous 6 months. * capable of providing informed consent exclusion criteria: * any current or prior integrase inhibitor resistance * nucleoside reverse transcriptase (nrti) mutation 69 insertion or k65r mutation * documented second generation non-nucleoside reverse transcriptase inhibitor (nnrti) resistance (rilpivirine or doravirine)

Keywords: multi-drug resistant
evaluating the efficacy and safety of different human thrombopoietin (rhtpo) regimens in the treatment of patients with primary immune thrombocytopenia (itp)

Conditions: ITP

Summary: this is a review of the efficacy and safety of different recombinant human thrombopoietin (rhtpo) regimens in the treatment of patients with primary immune thrombocytopenia (itp).

evaluating the efficacy and safety of different human thrombopoietin (rhtpo) regimens in the treatment of patients with primary immune thrombocytopenia (itp) this trial was designed as a multicenter, randomized, open, parallel controlled study

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old, male or female * for patients who have been diagnosed with itp, the diagnostic criteria are consistent with the chinese expert consensus on diagnosis and treatment of primary immune thrombocytopenia (2016 edition) * recurrence after previous treatment with glucocorticoids is ineffective or effective * no contraindications to rhtpo (terbyus) application, and willing to accept rhtpo treatment * platelet count before enrollment ≤ 30 × 109 / l, or \> 30 × 109 / l but with active bleeding * volunteer to participate in the study and sign the informed consent form exclusion criteria: * pregnant or lactating * those with a history of thrombosis * severe cardiopulmonary liver and kidney dysfunction: creatinine level ≥ 176.8μmol / l (2mg / dl), transaminase, bilirubin levels higher than the upper limit of the normal value of 3 times * those who have used rhtpo in the past 2 weeks, or who have undergone splenectomy within 2 months, or who have been treated with danazol for less than 1 month, or have recently applied the following itp treatments but have not yet reached the efficacy judgment time. : c-ball (7 days), vincristine or vinblastine amide or rhil-11 (2 weeks), eltrombopag (1 month), or rituximab (2 months) * in the case of previous treatment of rhtpo: rhtpo 300u/kg/d, 14 days of treatment is invalid; * severe or uncontrollable infections * have a history of mental illness * the investigator believes that the patient is not eligible to participate in any other circumstances of the trial.
celecoxib in treating patients with stage iiib or stage iv non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: celecoxib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. it may also stimulate the immune system in different ways and stop tumor cells from growing. purpose: this phase i trial is studying the side effects and best dose of celecoxib in treating patients with stage iiib or stage iv non-small cell lung cancer.

objectives: primary * determine the optimal biologic dose (obd) of celecoxib that is necessary to decrease peripheral blood lymphocyte cd4+ and cd25+ t-lymphocyte regulatory cells in patients with stage iiib or iv non-small cell lung cancer. secondary * determine the obd of this drug that is necessary to decrease peripheral blood lymphocyte foxp3 levels in these patients. outline: this is a nonrandomized, dose-escalation study. patients receive oral celecoxib twice daily on days 1-7 in the absence of unacceptable toxicity. cohorts of 3 patients receive escalating doses of celecoxib until the optimal biologic dose (obd) is determined. the obd is defined as the lowest dose that results in the maximum decrease in peripheral blood lymphocyte cd4+ and cd25+ t-lymphocyte regulatory cells and foxp3 levels where no dose-limiting toxicity occurs. an additional 15 patients are treated at the obd. projected accrual: a total of 24 patients will be accrued for this study.

Eligibility criteria:
inclusion criteria: * histologically confirmed non-small cell lung cancer * stage iiib or iv disease * radiographically measurable disease * 18 and over * performance status: ecog 0-2 * renal: creatinine ≤ 2 mg/dl * negative pregnancy test * fertile patients must use effective contraception * more than 4 weeks since prior chemotherapy * endocrine therapy: more than 4 weeks since prior corticosteroids; no concurrent corticosteroids, including chronic corticosteroids, except for medically-indicated topical steroids * radiotherapy: more than 4 weeks since prior radiotherapy * more than 4 weeks since other prior anticancer therapy * more than 4 weeks since prior non-cytotoxic investigational agents * at least 72 hours since prior nonsteroidal anti-inflammatory drugs (nsaids) exclusion criteria: * pregnant or nursing * comorbid disease, psychiatric condition, chronic medical condition, or laboratory abnormality that would preclude study treatment or compliance with study requirements * hypersensitivity to celecoxib, sulfonamides, aspirin, other nsaids, or any study reagent * history of gastrointestinal ulceration, bleeding, or perforation * other concurrent cyclooxygenase-2 or -3 inhibitors * other concurrent nsaids

Keywords: stage iiib non-small cell lung cancer stage iv non-small cell lung cancer recurrent non-small cell lung cancer
a post marketing study in participants with early alzheimer's disease treated with lecanemab

Conditions: Alzheimer's Disease

Summary: the primary purpose of this study is to investigate the characteristics of amyloid related imaging abnormalities (aria) and investigate the treatment continuation status (e.g., continuation, interruption) after the onset of aria in routine clinical practice in participants treated with lecanemab.


Eligibility criteria:
inclusion criteria: * all participants who are treated with lecanemab in routine clinical practice exclusion criteria: * none

Keywords: early alzheimer's disease lecanemab aria
eeg characteristics and postoperative delirium

Conditions: Postoperative Delirium; Cognitive Function Abnormal; PSI; Frailty

Summary: the goal of this \[type of study: observational study \] is to \[compare energy differences in various bands of intraoperative electroencephalogram in elderly patients with postoperative delirium and non delirium.\] in \[describe participant population selected 69 patients who underwent laparoscopic radical surgery for colorectal cancer on a selective basis\]. the main question\[s\] it aims to answer are: • \[is there any difference in the spectral range of eeg between pod patients and non pod patients\] participants will \[cognitive.•postoperative delirium.•preoperative weakness.\]

the goal of this \[type of study: observational study \] is to \[compare correlation between eeg data and postoperative delirium in elderly patients undergoing colorectal cancer radical surgery under preoperative frailty monitoring.\] in \[describe participant population selected 69 patients who underwent laparoscopic radical surgery for colorectal cancer on a selective basis\]. the main question\[s\] it aims to answer are: • \[is there any difference in the spectral range of eeg between pod patients and non pod patients\] participants will \[sedline eeg monitoring electrodes were placed 1cm above the eyebrows on both sides of the patient and at the temples on both sides, and were continuously monitored from the start of anesthesia in the operating room until the end of the surgery.pay close attention to the vital signs and wait for the patient to fully recover and the vital signs to basically return to the preoperative level before returning to the ward.•assessment of cognitive function using the mini mental state scale (mmse) 1 day before surgery and 7 days after surgery.•preoperative assessment of frailty using the frailty screening scale.•assess delirium using the icu patient ambiguity assessment form (cam-icu) 1 day, 2 days, 3 days, and 7 days after surgery.\].

Eligibility criteria:
inclusion criteria: * asa i-iii * the preoperative frailty scale (frail) assessed frailty * the patient or his/her family is informed about the study and signs an informed consent form exclusion criteria: * serious insufficiency of heart, liver, kidney and other functions * those with a history of psychiatric or neurological illness, long-term use of psychotropic drug * history of cerebrovascular disease, brain trauma, or surgery * the patient was allergic to coupler or unable to place electrodes on the head * the patient was unable to complete the scale assessment as required.patients with severe attention to hearing impairment were unable to complete the interview * the patient was diagnosed with delirium before surgery
a study of emicizumab administered subcutaneously (sc) in pediatric participants with hemophilia a and factor viii (fviii) inhibitors

Conditions: Hemophilia A

Summary: this non-randomized, multicenter, open-label, phase iii clinical study will evaluate the efficacy, safety, and pharmacokinetics of emicizumab administered subcutaneously initially once weekly (qw) in pediatric participants with hemophilia a with fviii inhibitors. this study will open two additional non-randomized cohorts to investigate once every 2 weeks (q2w) and once every 4 weeks (q4w) regimens in pediatric participants.


Eligibility criteria:
inclusion criteria: * children less than (\<) 12 years of age, with allowance for participants 12 to 17 years of age who weigh \<40 kilograms (kg) (cohort a only); and participants \<2 years of age will be allowed to participate only after the protocol-defined interim data review criteria are met (cohort a only) * diagnosis of congenital hemophilia a of any severity and documented history of high-titer inhibitor (that is \[i.e.\], greater than or equal to \[\>/=\] 5 bethesda units \[bu\]) * requires treatment with bypassing agents * adequate hematologic, hepatic, and renal function exclusion criteria: * inherited or acquired bleeding disorder other than hemophilia a * ongoing (or planning to receive during the study) immune tolerance induction (iti) therapy or prophylaxis treatment with fviii * previous (in the past 12 months) or current treatment for thromboembolic disease or signs of thromboembolic disease * other disease that may increase risk of bleeding or thrombosis * history of clinically significant hypersensitivity associated with monoclonal antibody therapy or components of the emicizumab injection * known infection with human immunodeficiency virus (hiv) or hepatitis b or c virus * use of systemic immunomodulators at enrollment or planned use during the study period * planned surgery (excluding minor procedures such as tooth extraction or incision and drainage) during the study * inability (or unwillingness by caregiver) to receive (allow receipt of) blood or blood products (or any standard-of-care treatment for a life-threatening condition) * participants who are at high risk for thrombotic microangiopathy (tma) (e.g., have a previous medical or family history of tma), in the investigator's judgement
pharmacokinetic drug interaction study following co-administration of valsartan, hydrochlorothiazide and amlodipine in patients with hypertension

Conditions: Hypertension

Summary: the purpose of this study is to determine potential pharmacokinetic drug-drug interaction when three drugs (valsartan, amlodipine, and hydrochlorothiazide) are co-administered.


Eligibility criteria:
inclusion criteria: - patients diagnosed as hypertensive * untreated confirmed hypertensive patients (consistent sbp \>140 mm hg or dbp \>90 mm hg) * uncontrolled hypertensive patients (consistent sbp \>140 mm hg or dbp \>90 mm hg) on one drug therapy. * uncontrolled hypertensive patients (consistent sbp \>140 mm hg or dbp \>90 mm hg) on two drug therapy. exclusion criteria: * inability to switch from all prior antihypertensive medications safely as required by the protocol. * need for drugs other than study drugs at the time of baseline. * patients with sbp ≥ 180 mmhg and/or dbp ≥ 110 mmhg at screening. * patients on four or more antihypertensive drugs at screening. * pregnant or nursing (lactating) women. * patients with diabetes mellitus * patients with heart diseases and any other disease other protocol-defined inclusion/exclusion criteria may apply

Keywords: high blood pressure, hypertension, drug interaction, steady state, valsartan, hydrochlorothiazide, amlodipine
assessment of efficacies of cardiac resynchronization therapies (crt-p/d) for heart failure patients in china

Conditions: Heart Failure

Summary: the adopt study is a prospective, nested case-controlled and open label clinical trial. about 40 centers across china participate in this study with a planned 800 chinese cases enrollment. all patients will receive optimal medical treatment. patients who have successful crt-p/d implant will be assigned to crt group. according to the baseline evaluation, matched cases will be selected from the enrolled opt(optimal medical treatment) alone group (group for selection). after successful match, the cases in group for selection enters into follow-up and become control group. the unmatched cases in the group for selection will be removed. if patients agree, after re-evaluation of the baseline situation, she or he may enter into group for selection again. since patients know she/he already have a device implant and the examiners are aware of the grouping of the patients after seeing the incision scar and post-implant electrocardiogram, this study is open-label designed, however the executive committee will be kept blind when making event-adjudication. prospectively defined primary end points for the study include combined all-cause mortality and hospitalizations. a variety of secondary end points will further define the efficacy and mechanism(s) of action of cardiac resynchronization in heart failure. the last date of the study shall be the day after 24 months of follow-up of the last enrolled patient. all cases collection complete in 2010 and study result will be reported in 2012.


Eligibility criteria:
inclusion criteria: heart failure patients who must meet all criteria:1.ischemic or nonischemic cardiomyopathy;2.nyha classes iii-iv despite opt;3.normal sinus rhythm;4.lvef≤35%;5.lv end-diastolic diameter≥55mm;and 6.wide qrs complex≥120ms. exclusion criteria: 1.potentially reversible forms of cardiomyopathy;2.cardiac surgery, percutaneous coronary intervention, cardiomyoplasty, myocardial infarction, unstable or severe angina or stroke within 6 weeks before randomization;3.in-patients requiring continuous intravenous therapy for heart failure;4.life expectancy\<1 year for disease unrelated to heart failure;5.mechanical tricuspid valve;6.anticipated problem with compliance;7.participation in another trial;8.age\<18 years old;9.women who are pregnant or not using medically acceptable birth control.

Keywords: heart failure clinical trial biventricular pacing cardiac device
laparoscopic and open ventral hernia repair using the intramesh t1

Conditions: Ventral Hernia

Summary: the purpose of the registry is to evaluate safety and efficacy of the intramesh t1. this registry will collect data from 100 patients treated for a ventral hernia repair.


Eligibility criteria:
inclusion criteria: * patient is older than 18 years * written informed consent is obtained from patient * patient with a primary or incisional ventral hernia exclusion criteria: * patient with a recurrent ventral hernia * patient with asa class 5 and 6 * patient underwent emergency surgery * patient is pregnant * patient with a known allergy to components of the eptfe prosthesis * patient has a life expectancy less than 1 year * patient is unable to be compliant with the follow-up visits due to geographical, social or psychological factors

Keywords: hernia treatment laparoscopic open technique
tarceva with or without apatinib in the advanced lung adenocarcinoma

Conditions: Lung Cancer

Summary: tarceva now was established first-line therapy for advanced lung adenocarcinoma with mutant egfr patients.however,the benefit lasted for about 6-8 months.so we consider to add apatinib,a tyrosine kinase inhibitor of vegf,to the therapy of these patients.

lung adenocarcinoma is the most common nsclc,most patient were diagnosed to advanced stage.the first-line therapy include chemotherapy of targeted therapy .tarceva now was established first-line therapy for advanced lung adenocarcinoma with mutant egfr patients.however,the benefit lasted for about 6-8 months.so we consider to add apatinib,a tyrosine kinase inhibitor of vegf,to the therapy of these patients.we designed the study to find out whether the addition of apatinib to the tarceva would enhance the efficacy of tarceva.

Eligibility criteria:
inclusion criteria: * lung adenocarcinoma proved by histology;with mutant egfr;ecog ps 0-2;clinical stage iiib or iv;without other fatal disease;without hemorrhagic disease;normal liver,renal and bone marrow function,not pregnant. exclusion criteria: * ecog ps 3-5;abnormal liver,renal and bone marrow function,pregnant;with severe diseases;wild type egfr
i̇s there a relationship between severity of preeclampsia and maternal heavy metal levels?

Conditions: Mild Pre-eclampsia; Severe Preeclampsia

Summary: the purpose of this study, to investigate whether severity of preeclampsia is associated with altered levels of heavy metals (cd, hg, arsenic and pb) in maternal blood, fetal blood, and maternal hair.

the unfavorable effects of heavy metals on human health is well known. the main threats to human health from heavy metals are associated with exposure to lead, cadmium, mercury and arsenic. they may be toxic at the levels previously thought to have no adverse effect on human.in utero environmental exposures can have long term consequences to health and development.i̇n spite of what is known about the neurotoxicity from exposure to heavy metals, the health effects from co-exposure to these chemicals and the biologically effective doses are not known exactly. preeclampsia is associated with increased maternal and infant mortality and morbidity. the exact etiology is not clear. several evidences indicate that various environmental factors and elements may play a role in pre-eclampsia. significant increase in pb, cadmium (cd), copper (cu) and magnesium (mg) and decrease in zinc (zn) in amniotic fluid are associated with preeclampsia. pb as this metal has well known adverse effects on renal system and blood pressures effects of pb on reproductive system have been studied intensively, e.g. other pregnancy outcome and pregnancy hypertension. however, the relationship between the severity of pre-eclampsia and heavy metal levels have not been investigated. the purpose of this study, to investigate whether severity of preeclampsia is associated with altered levels of heavy metals (cd, hg, arsenic and pb) in maternal blood, fetal blood, and maternal hair.

Eligibility criteria:
inclusion criteria: clinical diagnosis of preeclampsia (diagnosed per acog criteria) exclusion criteria: known chronic disease multipl pregnancies

Keywords: cadmium lead mercury preeclampsia pregnancy