Kornimate/medical-research-clean huggingface dataset:
a prospective validation cohort study of a prediction system on nsln metastasis in early breast cancer

Conditions: Lymph Node Metastases; Breast Cancer; Predictive Cancer Model

Summary: in the previous study, the investigator established a predictive model for non-sentinel lymph node involvement in early breast cancer (ct1-2cn0, 1-2 slns involvement). to validation the clinical value of the model, the investigator design a prospectively research using the model guiding for further axillary lymph node dissection in sln-positve early breast cancer.

in the previous study, a predictive model for non-sentinel lymph node involvement in early breast cancer (ct1-2cn0, 1-2 slns involvement) was established. this model was designed for predicting the status of non-sentinel lymph node in ct1-2cn0 with 1-2 slns involvement breast cancer based on peripheral blood ck19 and contrast-enhanced ultrasound. the investigator previously tested this model comparing with mskcc model in a same population and confirmed a result of satisfactory low false-negative rate and high auc. this model had a potential practise value in clinic applying. for further validation, the research group design the ck19b trial to prospectively using this model in decision strategy of whether receiving alnd in 1-2slns+ patients. if the model predictive result is negative, the risk of nslns involvement is estimated very low and the patients should be avoid alnd, even radiotherapy no matter the surgery is mastectomy or conserving. if the model result is positive, then further alnd or radiotherapy should be accepted by patients to decrease the risk of local and regional recurrent. a prospectively and conditional grouping method is planned for this cohort study. the primary endpoint is disease-free survival (dfs) in two groups, the second primary endpoint is local recurrent rate (lrr) and overall survival (os).

Eligibility criteria:
inclusion criteria: the test group should be in accordance with the pathological diagnosis of breast cancer, the clinical stage of breast cancer (stage ctis, ci, cii and ct3n1m0), the initial treatment to receive surgical treatment. complete preoperative clinical diagnosis data, including the ipsilateral axillary lymph node ceus data and peripheral blood sample; the negative-control group should comply with the pathological diagnosis, breast adenosis, fibrocystic lesions, breast cysts and other benign lesions, with complete preoperative clinical data, also including ipsilateral axillary lymph node ceus data and peripheral blood sample exclusion criteria: 1. metastatic breast cancer, inflammatory breast disease, surgery without lymph node staging 2. pregnancy or lactation 3. patients with hematopoietic system disease or cancer, autoimmune diseases 4. preservation of substandard peripheral blood samples.

Keywords: non-sentinel lymph node breast cancer prediction ck19 contrast-enhanced ultrasound
multiperfusion neonatal system

Conditions: Preterm Birth

Summary: infusion and parenteral nutrition play an important role in the management of neonatal intensive care patients. administration of drugs and parenteral nutrition solutions to the patient is performed via different systems including a catheter and a perfusion system. in critically ill, high risk neonates, use of these systems is associated with complications such as infections, interactions between drugs simultaneously infused on the same route (precipitates, catheter obstruction), less effective treatment due to modified amount of drug administered compared to expected or to compatibility issues between drugs. sepsis and reduction of treatment efficacy can have an impact on survival or subsequent neurodevelopment. late onset sepsis is one of the most frequent complications in very premature infants born before 33 weeks gestational age and most of those infections occur in infants requiring a perfusion system and an intravenous catheter. in this context, a new multiperfusion device was developed (multiline néo®, doran, france) to remove access to the infusion system from the incubator where high temperature and humidity favour bacterial growth. but also to allow the administration of several drug solutions simultaneously avoiding contact between drugs. our hypothesis is that the new perfusion system helps to reduce the risk of infections, without increase in costs.


Eligibility criteria:
inclusion criteria: * born between november 30, 2018 and december 31, 2022, * gestational age below 33 weeks exclusion criteria: * severe malformation and / or disease requiring heavy surgical management in the neonatal period * admitted at croix rousse hospital after the third day of life
inhalation of 20,000 endotoxin units(eu) of clinical center reference endotoxin in healthy volunteers

Conditions: Healthy Adults

Summary: the purpose of this study is to determine the inflammatory response to 20,000 endotoxin units (eu) of ccre (clinical center reference endotoxin) inhalation in a cohort of healthy volunteers. preferably these subjects will have participated in ozone exposure studies, allowing a direct comparison of their responses to both endotoxin and ozone. additionally, cardiovascular endpoints will be investigated with the ccre exposure.


Eligibility criteria:
inclusion criteria: * prior participation in ozone study * healthy adults * nonsmokers * no chronic illness * no active allergies exclusion criteria: * reduced lung function * asthma
leveraging the emergency department (lead) study

Conditions: Lung Cancer

Summary: this is a pilot type 1 hybrid effectiveness-implementation trial. the study will first examine reach in a non-traditional setting (the emergency department - ed) that uses an electronic health record (ehr)-embedded social determinants of health (sdoh) screening tool to identify lung screening-eligible patients for a tailored intervention to increase lung screening uptake. reach is defined as the absolute number, proportion, and representativeness of individuals targeted for lung screening knowledge, awareness, and uptake. then, a pilot trial will be conducted to examine the preliminary effectiveness of a tailored lung screening intervention compared to enhanced usual care to influence individual-level potential drivers of lung screening (health literacy, mistrust, stigma, fatalism, knowledge, lung screening health beliefs) and the ability to increase lung screening uptake among screening-eligible patients. quantitative (randomized controlled trial and ehr data) methods will be used for data collection and analysis to address the study aims.


Eligibility criteria:
inclusion criteria: * aged 50 years to 80 years * currently smoke cigarettes or quit smoking cigarettes within the past 15 years * 20 pack-year smoking history * has never had lung cancer screening * able to provide informed consent * able to speak and understand english exclusion criteria: * diagnosed with lung cancer * has a history of having a lung cancer screening scan * unable to speak and understand english

Keywords: screening lung cancer disparities social determinants of health emergency department
morphine versus morphine-promethazine combination for acute low back pain relief in the adult emergency department

Conditions: Low Back Pain

Summary: acute low back pain is a common cause for emergency department visits. controversy remains regarding the optimal medication for acute low back pain relief. the investigators hypothesized that administration of pharmacological anxiolysis in addition to analgesia will improve pain relief and patient management in the emergency department.

acute low back pain is a common problem in the emergency department and pain relief is usually the first step in patients' management. numerous medication options are available for acute lbp relief,each class of medication has its associated benefits and harms.controversy remains regarding the optimal analgesic treatment.anxiety has been found to be a predictive factor of pain intensity in patients with acute low back pain and anxiolysis by non-pharmacological measures has been shown to have a positive effect on pain management in the ed setting. promethazine is a first-generation h1 receptor antagonist of the phenothiazine chemical class used commonly as an antihistamine antiemetic. it has a strong anxiolytic-sedative effect and its safety and efficacy in managing anxiety related to medical procedures is well documented.it may be reasonable to assume that pharmacological anxiolysis with promethazine may assist in alleviation of acute pain in the strenuous environment of the ed.

Eligibility criteria:
inclusion criteria: 1. an indication for opioid analgesia based in the ed (i.e. severe pain \> 70mm on a 100mm vas) 2. age between 18-65 years 3. american society of anesthesiologists (asa) score of 1 or 2, and no preexisting glaucoma, cardiac arrhythmia or pulmonary disease 4. systolic blood pressure higher than 90 mmhg on admission 5. willingness and ability to provide an informed consent 6. no known hypersensitivity to the medication used. exclusion criteria: 1. pregnant women 2. patients who can not be under adult supervision following discharge from the emergency department.

Keywords: low back pain, emergency medicine, promethazine, morphine, pain relief
study to evaluate cardiac hemodynamics and safety of slv320 in subjects with congestive heart failure

Conditions: Congestive Heart Failure

Summary: the study is a randomized, placebo controlled, multi-center, single dose study to evaluate cardiac hemodynamics and safety of iv slv320 in 110 subjects with congestive heart failure requiring diuretic treatment. each subject will receive one dose of slv320 or placebo or furosemide. the study consists of three visits (or study days when in-subjects are included). ambulatory subjects will be in hospital for two nights and one day.


Eligibility criteria:
inclusion criteria: * history of chronic, symptomatic, mild to severe (nyha class ii-iv) chf for at least three months requiring treatment with diuretics and with documented systolic dysfunction * on stable doses of their individually optimized medication regimen for at least one week prior to enrollment exclusion criteria: * required hospitalization (for cardiovascular disease) or adjustment of background medications for chf * orthostatic hypotension or symptomatic orthostasis * sitting systolic or diastolic blood pressure \< 90 mmhg * 2nd or 3rd degree atrio-ventricular block or sick sinus syndrome * heart rate of \ 110 bpm on the ecg * transplanted heart * heart failure due to primary valvular disease (unless surgically corrected), obstructive cardiomyopathy, pericardial disease, cor pulmonale or congenital heart disease * hemodynamically significant left ventricular outflow tract obstruction

Keywords: congestive heart failure, adenosine receptor blocker, cardiac hemodynamic
a study of lung cancer screening in people with unexplained weight loss

Conditions: Lung Cancer Screening

Summary: the researchers are doing this study to see if people with unexplained weight loss who have lung cancer screening are more likely to have or develop lung cancer than people without unexplained weight loss. the lung cancer screening will involve use of low-dose computed tomography (ldct), a ct scan that gives off very low doses of radiation and can make detailed pictures of the lungs to help find tumors. the study researchers will also analyze participants' blood samples to determine if blood testing can be used to help to diagnose lung cancer.


Eligibility criteria:
inclusion criteria: * eligible for american cancer society lung cancer screening, as follows: * age 50-80 years old * at least 20-pack year history of smoking * weight loss of 3-10%, defined as uwl, within any timeframe over the past in the 18 months prior to enrollment, that cannot be attributed to an underlying medical condition at the discretion of the enrolling investigator * note that patients who have 3-10% weight may still be enrolled if the enrolling investigator does not conclude that the weight loss can be attributed to the patient's intentional efforts. * documented weight loss can be self-reported or extracted from weights obtained during physician visits. however, if self-reported weight loss is contradicted by weight loss documented in the medical record (e.g. a patients states that (s)he lost 10 lbs in the past 6 months, but a weight documented in the medical record does not support that history), the measured and quantified weight change will be used to ascertain eligibility * life expectancy greater than 1 year, per assessment of the treating clinician. exclusion criteria: * currently pregnant or trying to become pregnant via self-report * prior history of recent ct scan of the chest either through ldct screening or with a scan of the chest (standard, not ldct) performed within the past 12 months * prior history of nsclc ○ note that patients with a history of diagnosis of non-lung cancers are eligible for the study. * currently undergoing or referred for diagnostic evaluation due to clinical suspicion for malignancy (e.g., referred to a medical or surgical oncologist, or scheduled for biopsy on the basis of a suspicious imaging abnormality). * patients with a germline pathogenic genetic variant who have undergone whole body mri within the past 12 months * unable to comply with study procedures

Keywords: ctdna analysis low dose computed tomography (ct)
ighid 12219 - a brief alcohol intervention for prep users

Conditions: Unhealthy Alcohol Use

Summary: the purpose of this study is to evaluate the effectiveness of a brief alcohol intervention (bai) vs. standard of care (soc) to improve pre-exposure prophylaxis (prep) use among prep initiators and re-initiators.

this is a two-arm effectiveness randomized controlled trial (rct) to compare the brief alcohol intervention (bai) to the standard of care (soc) among prep initiators and re-initiators with unhealthy alcohol use who are initiating or reinitiating oral, event-driven, or injectable prep. the bai draws from motivational interviewing (mi)/motivational enhancement therapy (met) and cognitive behavioral therapy (cbt) and includes 2 in-person sessions and 2 telephone sessions. eligible participants (n=564) will be randomized 1:1 to each arm (282 per arm). additional assessments among a subset of participants in the bai arm will assess acceptability of the intervention (n=48). study activities will span 5 years. individual prep initiators and re-initiators will be followed-up for 12 months with assessment visits at 3, 6, 9, and 12 months after enrollment.

Eligibility criteria:
inclusion criteria: * newly initiating prep or re-initiating prep after at least 3 months from a missed prep appointment, based on local prep guidelines * audit-c score ≥ 4 or crafft score ≥ 2 (for those ≤21 years old) * 16 years of age or older * intention to receive prep care in hanoi for 12 months * willingness to provide informed consent exclusion criteria: * psychological disturbance, cognitive impairment, or threatening behavior * unwilling to provide locator information * current participation in alcohol programs or studies * current participation in other research studies (including hiv and prep studies) * ever enrolled in an hiv vaccine study * clinical institute withdrawal assessment of alcohol scale (ciwa) ≥ 10, indicating risk for alcohol withdrawal

Keywords: preexposure prophylaxis (prep) alcohol intervention motivational interviewing cognitive behavioral therapy motivational enhancement therapy cost analysis economic evaluation
ferric carboxymaltose versus iron sucrose for treating anemia in pregnant women

Conditions: Iron Deficiency Anemia (IDA); Pregnancy

Summary: this clinical trial aimed to determine whether intravenous ferric carboxymaltose is more useful than iron sucrose for treating anemia in pregnant women. the main question it aimed to answer was: is intravenous ferric carboxymaltose is more useful than iron sucrose for treating iron deficiency anemia in pregnant women. sixty pregnant women with iron deficiency anemia were enrolled to one of two intravenous treatments. * participants in ferrous carboxymaltose group received a maximum dose of 1000 mg per sitting diluted in 200 ml 0.9% normal saline and administered as an iv infusion over 30 min. * participants in iron sucrose group were administered an infusion of 300 mg in 200 ml ns over 15-20 min twice weekly till dosage was completed, not exceeding 600 mg per week.

the study was conducted after the ethics review committee approval. a total of 60 pregnant women presenting to the department of obstetrics and gynecology and fulfilling the eligibility criteria were enrolled in the study after informed consent. patient's characteristics including age, parity, area of residence, educational status, socioeconomic status and baseline hb were recorded. all women were administered anthelminthic therapy with tablet mebendazole 100 mg twice daily for three days and given 5 mg folic acid once daily. patients were be randomly assigned to group a \& b. patients in group a were treated with intravenous ferrous carboxymaltose and group b were given intravenous iron sucrose complex. parenteral iron therapy was administered under doctor's supervision. the women were then followed up after 3 weeks of completion of therapy. on follow up, hemoglobin and serum ferritin were measured again.

Eligibility criteria:
inclusion criteria: * 28-34 weeks of gestation * iron deficiency anemia (ida): ida will be labelled if hemoglobin is \<10 gm% and serum ferritin \< 30 ng/ml. exclusion criteria: * hepatitis (serum transaminases more than 1.5 times the upper limit of normal) and hiv infection * serum creatinine level of more than 2.0 mg/dl * history of allergic reaction to intravenous iron infusion

Keywords: iron deficiency anemia pregnancy ferric carboxymaltose iron sucrose
post-authorization safety study of iptacopan in adult patients with paroxysmal nocturnal hemoglobinuria (pnh) using data from the ipig pnh registry

Conditions: Hemoglobinuria, Paroxysmal

Summary: this is an observational single-arm descriptive cohort study based on the secondary use of data collected on iptacopan-treated patients with paroxysmal nocturnal hemoglobinuria (pnh) through the international pnh interest group (ipig) pnh registry.

this multinational, non-interventional, descriptive single-arm cohort study is based on secondary analysis of data collected within the iptacopan silo of the ipig pnh registry (data on iptacopan-treated patients made available to novartis). this is a non-interventional study utilizing secondary data and is considered a "registry-based study." the ipig pnh registry (ct.gov nct06524726), the parent registry, includes a dedicated drug silo to collect data from patients using iptacopan in routine care.

Eligibility criteria:
inclusion criteria: * signed informed consent to participate in the ipig pnh registry * pnh confirmed by flow cytometry * incident users of iptacopan * aged at least 18 years at the iptacopan initiation exclusion criteria: * participation in an interventional clinical trial

Keywords: paroxysmal nocturnal hemoglobinuria iptacopan
tace combinated with sorafenib in treating patients with unresectable hepatocellular carcinoma

Conditions: PHENYTOIN/SORAFENIB [VA Drug Interaction]; Carcinoma, Hepatocellular

Summary: tace is widely used in patients with unresectable hcc. however, it is a non-curative approach; thus ,strategies to further improve the survival of these patients are needed. sorafenib is regarded as standard treatment for advanced hcc. it is the first systemic therapy to demonstrate a significant survival benefit in hcc patients.the hypothesis is that the combination of tace with sorafenib could improve the survival of patients with unresectable hcc.


Eligibility criteria:
inclusion criteria: * patients newly diagnosed as hcc according to european association for study of the liver criteria. * bclc stage b or c * child-pugh class score≤8 * ecog performance status ≤2 * etiology: hepatitis b virus(hbv) infection * written informed consent (approved by the institutional review board \[irb\]obtained prior to any study specific screening procedures * patient must be able to comply with the protocol * age 18-75 years * haematology:absolute neutrophil count (anc) \> 1.5 x 109/l, platelet count \> 50 x 109/l, haemoglobin \> 9 g/dl (may be transfused to maintain or exceed this level) prothrombin time international normalized ratio \< 1.5 * biochemistry:alanine aminotransferase (alt) and aspartate aminotransferase (ast)\ 0.5x the lower limit of normal，prealbumin\>0.5x the lower limit of normal. * life expectancy of \> 3 months exclusion criteria: * bclc stage d * child-pugh score≥9 * clinically severe gastrointestinal bleeding within 4 weeks of the start of treatment * preexisting or history of hepatic encephalopathy * uncontrolled hypertension * pregnancy (positive serum pregnancy test) or lactation * serious, non-healing wound, ulcer, or bone fracture * currently or recent (within the 30 days prior to starting study treatment) treatment of another investigational drug or participation in another investigational study * clinically significant (i.e. active) cardiovascular disease for example cerebrovascular accidents ( ≤ 6 months prior to study entry), myocardial infarction ( ≤ 6 months prior to study entry), unstable angina, new york heart association (nyha) grade ii or greater congestive heart failure, serious cardiac arrhythmia requiring medication * evidence of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of sorafenib/tace or patient at high risk from treatment complications * other severe concomitant disease that may reduce life expectancy * risk of allergic reactions to the study drugs * drug abuse or other physical, psychological , or social problems that may interfere with the participation in the study or evaluation of study results

Keywords: hepatocellular carcinoma transarterial chemoembolization sorafenib