Kornimate/medical-research-clean huggingface dataset:
effect of intensive blood pressure control on progression of coronary atherosclerosis: randomized evaluation by intravascular ultrasound

Conditions: Coronary Artery Disease; Hypertension

Summary: the purpose of this study is to evaluate the effect of intensive blood pressure control compared to standard blood pressure control on progression of coronary atherosclerosis by intravascular ultrasound in hypertensive patients with coronary artery disease.

antihypertensive therapy is reported to reduce cardiovascular events in patients with coronary artery disease. the goal of blood pressure in patients with coronary artery disease is recommended to control below 140/90mmhg. however, the effect of intensive blood pressure control compared to standard blood pressure control is still unknown. the purpose of this study is to evaluate the effect of intensive blood pressure control compared to standard blood pressure control on progression of coronary atherosclerosis by intravascular ultrasound in hypertensive patients with coronary atherosclerosis after 18 months. the goal of systolic blood pressure is under 120mmhg in intensive blood pressure control group and under 140mmhg in standard blood pressure control group. the design of this study is randomized control study.

Eligibility criteria:
inclusion criteria: * coronary artery diseases which require coronary angiography or percutaneous coronary intervention * primary hypertension (systolic blood pressure 140-180mmhg within one month) exclusion criteria: * severe hypertension * secondary hypertension * treated with more than three antihypertensive drugs * left main trunk trunk coronary artery disease * moderate heart failure * severe valvular disease * liver dysfunction renal dysfunction (cr\>=2.0mg/dl) pregnant or nursing women severe arrhythmia

Keywords: coronary artery disease hypertension
study of m2es with paclitaxel/carboplatin (tc regimen) in advanced non small cell lung cancer (nsclc)

Conditions: Non Small Cell Lung Cancer

Summary: the purpose of this study is to evaluate safety and tolerance of m2es with tc regimen in advanced nsclc.


Eligibility criteria:
inclusion criteria: 1. aged 18-70 years old; 2. patients with ⅲ/ⅳ nsclc confirmed by histopathology or cytology who ware naive or previous chemotherapy without tc regimen; 3. no contraindication for chemotherapy; 4. ecog performance scale 0-2; 5. no history of anti-angiogenesis therapy; 6. patients are voluntary to participate and sigh the informed contents. exclusion criteria: 1. concurrent use of other anti-cancer agents; 2. allergic history to m2es and biological agents; 3. pregnant or breast-feeding women; 4. with other malignancy; 5. with severe cardiopulmonary disease; 6. uncontrolled brain metastasis patients; 7. other conditions that are regarded for exclusion by the trialists.

Keywords: m2es nsclc phase i trial advanced nsclc recurrent nsclc
comparison of nirs and serum lactate to predict poor post-operative outcomes

Conditions: Congenital Disorders

Summary: mortality after neonatal cardiac repair remains significant, and neonates who have undergone operative repair of congenital heart disease may experience sudden and unexpected demise. most of these deaths occur within the first 72 hours and have been attributed to poor systemic cardiac output. the literature currently does not define an early and reliable predictor of poor post-operative outcome in children with congenital heart disease who have recently undergone surgery. the investigator wishes to perform a retrospective chart review to independently define the predictive values of both nirs score and serial serum lactate levels in the setting of early post-operative morbidity.

the retrospective data will be collected on the nirs score and serum levels within the first 72 hours, in the pediatric cardiac population that is less than one month of age requiring intra-operative cardiopulmonary bypass. this information will be reviewed from medical charts between january 1, 2002 and december 31, 2005 at children's healthcare of atlanta, egleston hospital. we predict approximately 1000 charts will be reviewed. the investigator wishes to evaluate the relationship of those levels with cardiac diagnosis, operation performed, post-operative course and outcome; poor outcome defined as initiation of ecmo or death. the investigator then wishes to compare the predictive values of nirs score and serial serum lactate levels in the above setting to assess their respective efficacies in post-operative cardiac intensive care. the investigator will collect the following information from the medical record: laboratory: nirs indices, serum ph, lactic acid, co-ox, cbc, chemistry) diagnosis surgical procedure incidence of re-operation length of icu stay length of hospital stay complications length of ventilation (how many days on the ventilator) medications cross clamp time bypass time echocardiogram data cardiac catheterization data vital signs monitored hemodynamic measures final outcome (discharged versus ecmo or death) demographic data will be summarized for all subjects. for each patient summary statistics will include the mean, standard deviation, frequency distribution, minimum, maximum and range. the investigator wishes to perform a retrospective chart review to independently define the predictive values of both nirs score and serial serum lactate levels in the setting of early post-operative morbidity.

Eligibility criteria:
inclusion criteria: * egleston hospital, children's healthcare of atlanta patients' charts * jan. 1, 2002 through dec. 31,2005 * data collected on nirs score and serum levels within the first 72 hours, in the pediatric cardiac population that is less than one month of age requiring intra-operative cardiopulmonary bypass. * exclusion criteria: * those who do not meet inclusion criteria

Keywords: near infrared spectroscopy serum lactate levels post operative outcomes
construction and validation of an in-hospital mortality risk prediction model for acute ischemic stroke patients

Conditions: Acute Ischemic Stroke

Summary: firstly, the application effect of the existing predictive models, soar and gwtg-stroke, was verified in guangdong acute ischemic stroke population, and the clinical application effect of the existing predictive models was verified. secondly, the predictive value of clinical indicators was analyzed, soar and gwtg-stroke scores were optimized, and an improved prediction model (new model) was constructed. the third is to apply the new model to clinical practice, collect clinical data and evaluate the prediction effect of the model, and evaluate the prediction efficiency of the improved prediction model.

this research is mainly divided into two parts. the first part is to verify and optimize the existing prediction model. through continuous collection of clinical data of acute ischemic stroke patients hospitalized in shenzhen second people's hospital from january 2017 to december 2021, including baseline indicators and end point events, based on the existing prediction model (soar, gwtg-stroke), the predictive probability was calculated and compared with the actual mortality during hospitalization. the roc curve, calibration curve and decision curve were used to evaluate the model's differentiation, calibration and clinical application value. using retrospective data, multivariate logistic regression was used to analyze the predictive value of baseline clinical indicators, screen risk factors, and optimize the prediction model of soar and gwtg-stroke. extreme gradient boosting (xgboost) was used to select variables, and logistic regression model was used based on akaike information criterion. aic) was used to construct an improved mortality risk prediction model (new model). decision curves were used to compare the models. combined with the clinical significance of the indicators, the construction of the prediction model was improved. the model was validated internally by resampling with computer simulation. the second part is to evaluate the clinical application effect of the improved prediction model. the clinical data of acute ischemic stroke patients hospitalized in shenzhen second people's hospital and shenzhen longhua district people's hospital from january 2022 to december 2023 are collected continuously. the new model is applied in the clinic, and the new model is validated in the external time and space. evaluate prediction effectiveness and extrapolation.

Eligibility criteria:
inclusion criteria: 1. ≥18 years old; 2. it meets the diagnostic criteria of china guidelines for the diagnosis and treatment of acute ischemic stroke 2018, and bleeding is confirmed by head mri or excluded by ct after admission; 3. admission within 72 hours of onset. - exclusion criteria: 1. non-vascular causes and transient ischemic attack; 2. with severe hepatic and renal dysfunction; 3. central nervous system infection, recent history of severe trauma, and malignant tumors affecting survival time; 4. incomplete main clinical data. -

Keywords: in-hospital mortality
bpo vs hibiclens soap for surgical preparation

Conditions: Propionibacterium Acnes

Summary: this is a randomized trial of benzoyl peroxide soap versus hibiclens soap for surgical preparation. the objective is to determine whether benzoyl peroxide soap, commonly available in drug stores for over-the-counter acne treatment, is as or more effective than the standard surgical preoperative soap, hibiclens soap (chlorhexidine gluconate), in reducing loads of propionibacteria (propi) on or under the skin of patients prior to shoulder arthroplasty (joint replacement).


Eligibility criteria:
inclusion criteria: * male subjects * subjects scheduled for elective shoulder arthroplasty at the university of washington medical center * subjects between ages 18-89 exclusion criteria: * subjects who self-report very sensitive skin * subjects who are sensitive to benzoyl peroxide * subjects who are allergic to chlorhexidine * subjects who had recent prior use of antibiotics (or expect to use them prior to surgery) * subjects who had recent use of acne treatment * subjects who are not fluent in english.
prevention for the development of liver tumorigenesis by the oral supplementation of branched-chain amino acids

Conditions: Liver Cancer

Summary: the long-term outcomes of branched-chain amino acid (bcaa) administration in patients undergoing hepatic resection remain unclear. the aim of this study is to assess the impact of oral supplementation with bcaa on the prevention for the development of liver tumorigenesis in patients undergoing liver resection.

this study might demonstrate a tendency of the improvement in the cumulative tumor recurrence rate after hepatectomy for liver neoplasm in the livact group compared to that in the control group. the investigators believe that bcaa seems to be a remarkable benefit for liver resection, especially on its reduction in the recurrence of liver cancer. this treatment regimen has potential to offer benefits for clinical use selectively, especially for patients with chronic liver diseases.

Eligibility criteria:
inclusion criteria: * these patients were scheduled for elective liver resection to treat hepatocellular carcinoma or adenocarcinoma of the liver. exclusion criteria: * a body-weight loss greater than 10% during the 6 months prior to surgery, * the presence of distant metastases, or * serious impairment of organ function due to respiratory, renal, or heart disease.
study of the c5a/c5ar1 axis in igg4-associated disease: a potential therapeutic target

Conditions: Immunoglobulin G4-Related Disease

Summary: this is a monocentric, comparative, cross-sectional, case-control study seeking to identify abnormalities of the c5a-c5ar1 axis between a population of patients with active igg4-associated disease (mag4) and two control groups: healthy subjects without mag4 and patients with mag4 in remission.

igg4-associated disease is a rare fibrosing and inflammatory disorder whose pathophysiology remains poorly understood. activation of certain monocyte/macrophage populations (in particular m2-type macrophages) has been shown to be involved during the course of the disease. the mechanisms behind this monocyte/macrophage activation are not known. expression of the c5ar receptor on the surface of these populations, and preliminary findings of elevated c5a in these patients, suggest a potential role for this c5a-c5ar axis. demonstration of the involvement of this pathway would open a path to therapeutic perspetives (c5ar inhibitors) for these patients, who frequently suffer from cortico-dependence and relapses. the aim of this research is to use healthcare technologies to identify cellular and molecular therapeutic targets in the context of the igg4-associated disease

Eligibility criteria:
inclusion criteria for patients suffering from ig4-related disease and patients in remission : * age \> 18 * diagnosis of igg4-associated disease according to acr/eular 2019 classification criteria (4,5) with a score ≥20. * disease activity score (igg4-rd responder index) ≥2 in at least one affected organ exclusion criteria for patients suffering from ig4-related disease and patients in remission : * presence of a differential diagnosis ("igg4-rd mimicker") or exclusion criterion according to acr/eular 2019 classification criteria (4,5). * systemic corticosteroid treatment ≥5 mg/day ongoing or \< 1 month ; study c5-mag4_rcaphm21_0433 protocol version 1.1 of 16/01/2024 page 15 of 41 * immunosuppressive therapy ongoing or \< 3 months ; * current biotherapy treatment or \< 6 months; * absence of signed informed consent; * absence of affiliation to a social security scheme. * patient participating in an ongoing therapeutic trial ; * any condition which, in the opinion of the investigator, could influence the results of the study. inclusion criteria for healthy volunteers : - age \> 18 exclusion criteria for healthy volunteers : * infectious episode (temperature \>38°c, flu-like signs) in the 30 days prior to inclusion; * known inflammatory (including ig4-related disease) or autoimmune pathology; * treatment with corticosteroids in progress or taken in the month prior to sampling, or immunosuppressants in progress or taken in the 3 months prior to sampling, or biotherapy in the 6 months prior to sampling; * absence of signed informed consent; * absence of affiliation to a social security scheme; * persons taking part in an ongoing therapeutic trial; * any condition which, in the opinion of the investigator, could influence the results of the study.
fabry patient's experience of pegunigalsidase alfa monthly infusion

Conditions: Fabry Disease

Summary: pegunigalsidase alfa (prx-102) is a long-term enzyme replacement therapy design for the treatment of patients with fabry disease. although in the clinical development program patient-reported outcomes and clinician-reported outcomes have been included, this may not allow for a sufficiently accurate assessment of the quality of life in patients with fabry disease treated with pegunigalsidase alfa. this study will collect the patient experience on the pegunigalsidase alfa treatment administered intravenously every 4 weeks in the bright-f51 clinical study (nct03614234).

this is an additional qualitative concept elicitation interview-based study to further understand the patients' experience with fabry disease and with the pegunigalsidase alfa administered intravenously every 4 weeks. patients will be asked a set of open-ended questions with probes to describe their experiences with fabry disease on treatment with pegunigalsidase alfa. qualitative research methods will be used to obtain a deeper understanding of the patient experience by generating in-depth information about the experiences, perspectives, and feelings of patients and others, in their own words (fda patient-focused drug development guidance 2). the study will be offered to the 29 patients participating in the bright-f51 clinical trial (nct03614234).

Eligibility criteria:
inclusion criteria: * the patient is participating in study pb-102-f51 * the patient is willing and able to participate in a 60-minute recorded interview * the patient is able to read, understand, and speak sufficiently to participate in the interviews * the patient signs informed consent to participate in the study exclusion criteria: * at investigators discretion, patient is considered to be unable to participate in a 60- minute telephone interview. * patient has any clinically relevant medical or psychiatric condition that, in the opinion of the investigator would interfere with the completion of the study activities. this includes but is not limited to language, speech, hearing or cognitive disorders that could impact a patient's ability to participate in an interview-based discussion.
human papilloma virus vaccine safety and immunogenicity trial in young adolescent women with gsk bio hpv-16/18.

Conditions: Infections, Papillomavirus

Summary: human papilloma virus (hpv) are viruses that cause a common infection of the skin and genitals in men and women. several types of hpv infection are transmitted by sexual activity and, in women, can infect the cervix (part of the uterus or womb). this infection often goes away by itself, but if it does not go away (this is called persistent infection), it can lead in women over a long period of time to cancer of the cervix. if a woman is not infected by hpv, it is very unlikely that she will get cervical cancer. this study will evaluate the safety and immunogenicity of gsk biologicals hpv-16/18 vaccine over 12 months, in pre-teen and adolescent women of 10-14 years of age at study start. approximately 2000 study subjects will receive the hpv vaccine or a control vaccine (hepatitis a vaccine) administered intramuscularly according to a 0-1-6 month schedule.


Eligibility criteria:
inclusion criteria: a woman between, and including, 10 and 14 years of age at the time of the first vaccination. written informed consent from the subject prior to enrolment. subject must be free of obvious health problems. subject must have negative urine pregnancy test. exclusion criteria: pregnant or breastfeeding. known acute or chronic, clinically significant pulmonary, cardiovascular, neurologic, hepatic or renal functional abnormality. history of chronic condition(s) requiring treatment such as cancer, chronic hepatitis or kidney disease(s), diabetes, or autoimmune disease. previous vaccination against human papillomavirus (hpv).
brain-derived neurotrophic factor and the antidepressant efficacy of brain stimulation

Conditions: Treatment Resistant Depression

Summary: this study evaluates an association between brain-derived neurotrophic factor(bdnf) polymorphisms and the antidepressant efficacy of transcranial magnetic stimulation device in patients with treatment-resistant depression. in a double-blind design, all patients are randomized to three groups, i.e.repetitive transcranial magnetic stimulation treatment, intermittent theta-burst stimulation treatment or sham treatment.


Eligibility criteria:
inclusion criteria: * male or female, 21 to 70 years of age. * diagnosed with the recurrent major depressive disorder (mdd) and currently having a major depressive episode (mde) * participants failed to respond to at least one adequate antidepressant treatment in their current episode * participants have a clinical global impression - severity score of at least 4 and a total score of at least 18 on the hamilton depression rating scale (hdrs-17) at both screening and baseline visits ( day -14 and day 0) * participants must discontinue their antidepressant medications at least for one week ( at least two weeks if fluoxetine) prior to the tms intervention and keep antidepressant-free during the study duration. exclusion criteria: * a lifetime psychiatric history of bipolar disorder, schizophrenia, psychotic disorders, or organic mental disorder including substance abuse and dependence (based on dsm-iv criteria) * participants with a lifetime medical history of major systemic illness and clinically significantly abnormal screening examination that might affect safety, study participation, or confound interpretation of study results. * participants with a lifetime medical history of neurological disorder records (e.g., stroke, seizure, traumatic brain injury, post brain surgery), brain implants (neurostimulators), cardiac pacemakers * women with breastfeeding or pregnancy * participants with a current strong suicidal risk (i.e., a score of 4 on item 3 of the hdrs-17)
prevalence of cutaneous enterococci at femoral insertion site in transcatheter aortic valve implantation (tavi)

Conditions: Aortic Valve Disease

Summary: the general rules of antibiotic prophylaxis in surgery or interventional medicine include the choice of an antibiotic active on the bacteria most frequently encountered in surgical site infections. this antibiotic must cover, the bacteria present on the skin and recognized as responsible for surgical site infections. the aim of this study is to identify bacteria found in skin flora in the inguinal region of patients undergoing transcatheter aortic valve implantation (tavi). flora found will allow to evaluate the impact of skin preparation and antibiotic prophylaxis protocols as they are currently practiced.


Eligibility criteria:
inclusion criteria: * patient scheduled for aortic valve replacement by tavi procedure with trans femoral approach * patient with pre-tavi assessment performed at clinique pasteur * patient affiliated or beneficiary of a social security scheme * patient accepting to participate and having given his no objection exclusion criteria: * tavi procedure by non-trans femoral approach * protected patients: adults under guardianship or other legal protection; pregnant or breastfeeding woman; hospitalized without consent.

Keywords: enterococci infective endocarditis antibiotic prophylaxis tavi
thalidomide in treating patients with refractory or resistant epithelial ovarian cancer

Conditions: Ovarian Cancer

Summary: rationale: drugs such as thalidomide may stop the growth of cancer cells by stopping blood flow to the tumor. purpose: phase ii trial to study the effectiveness of thalidomide in treating women who have epithelial ovarian cancer that has not responded to previous therapy.

objectives: * determine the time to progression of disease in patients with platinum-refractory or resistant ovarian epithelial carcinoma treated with thalidomide. * evaluate the quality of life of patients treated with this regimen. outline: patients receive oral thalidomide once daily. treatment continues in the absence of disease progression or unacceptable toxicity. quality of life is assessed at baseline and then every 4 weeks. projected accrual: a total of 45 patients will be accrued for this study within 9-15 months.

Eligibility criteria:
disease characteristics: * histologically confirmed ovarian epithelial carcinoma * platinum-refractory or resistant disease * at least 1 prior non-platinum chemotherapy agent required * prior bilateral salpingo-oophorectomy and hysterectomy required * bidimensionally measurable disease or ca-125 greater than 100 units/mm3 patient characteristics: age: * over 18 performance status: * karnofsky 70-100% life expectancy: * more than 3 months hematopoietic: * not specified hepatic: * bilirubin normal * ast no greater than 2.5 times upper limit of normal (uln) renal: * creatinine no greater than 1.5 times uln or * creatinine clearance at least 50 ml/min other: * no other prior malignancy except non-melanoma skin cancer unless curatively treated with no evidence of disease within the past 5 years and at low risk for recurrence * no other clinical circumstances that would preclude study prior concurrent therapy: biologic therapy: * at least 4 weeks since prior biologic therapy and recovered * no prior thalidomide chemotherapy: * see disease characteristics * at least 4 weeks since prior cytotoxic therapy and recovered endocrine therapy: * at least 4 weeks since prior hormonal therapy and recovered radiotherapy: * at least 4 weeks since prior radiotherapy surgery: * see disease characteristics * at least 4 weeks since prior major surgery

Keywords: recurrent ovarian epithelial cancer