Kornimate/medical-research-clean huggingface dataset:
extracorporeal lung assist to avoid intubation in patients failing noninvasive ventilation for hypercapnic arf

Conditions: Hypercapnia; Respiratory Insufficiency

Summary: the study´s intention is to evaluate the feasibility, safety and effectiveness of a pump driven extracorporeal device for removal of carbon dioxide from the blood in oder to avoid intubation and invasive mechanical ventilation in patients with acute respiratory failure retaining carbon dioxide due to the failure of their ventilatory muscle pump and not responding to prior non-invasive mask ventilation.

the study´s intention is to evaluate the feasibility, safety and effectiveness of a pump driven extracorporeal device for removal of carbon dioxide from the blood in oder to avoid intubation and invasive mechanical ventilation in patients with acute respiratory failure retaining carbon dioxide due to the failure of their ventilatory muscle pump and not responding to prior non-invasive mask ventilation. since intubation with subsequent (prolonged) invasive mechanical ventilation is associated with considerable side effects this new strategy has the potential to improve overall clinical outcome in this selected patient group.

Eligibility criteria:
inclusion criteria: * acute or acute-on-chronic hypercapnic respiratory insufficiency (ph ≤ 7,35, paco2 \> 45 mmhg) * failure of noninvasive ventilation * fulfilling criteria for endotracheal intubation exclusion criteria: * under 18 years of age * prior inclusion in other interventional study * pregnancy * heparin allergy or heparin-induced thrombocytopenia type 2 * on home non-invasive ventilator * "do not resuscitate" order or moribund condition * life expectancy less than 6 months * no informed consent available

Keywords: hypercapnia noninvasive ventilation acute respiratory failure endotracheal intubation invasive mechanical ventilation
evaluation of 3 versus 10 days of antibiotics in skin abscesses after surgical drainage

Conditions: Skin Disease, Bacterial; Abscess

Summary: the objective of this study is to determine if there is a difference in treatment failures and recurrent skin infections when patients are given 3 or 10 days of antibiotics for uncomplicated skin abscesses after they have been surgically drained.

patients age 3 months to 17 years presenting to a pediatric emergency department (ed) with an uncomplicated skin abscess that required surgical drainage were randomized to receive 3 or 10 days of oral trimethoprim-sulfamethoxazole. patients were evaluated 10 to 14 days later to assess for cure. patients were contacted 1 month later to determine if they had developed another skin infection. outcomes were also stratified by methicillin-resistent staphylococcus aureus (mrsa) and methicillin-sensitive staphylococcus aureus (mssa).

Eligibility criteria:
inclusion criteria: * patients presenting with a skin abscess that requires surgical drainage (induration ≥ 1 cm in diameter) * minimally invasive surgical technique with the insertion of a subcutaneous drain can be utilized on the patient exclusion criteria: * patients requiring immediate hospitalization * patients who have received 2 or more doses of antibiotics in the previous 36 hours * patients with diabetes, sickle-cell disease, an immuno-compromising disease, an underlying medical condition predisposing the patient to frequent hospitalizations or medical visits, or indwelling catheters or percutaneous medical devices * patients with a concurrent, non-abscess infection * patients with an allergy to trimethoprim-sulfamethoxazole

Keywords: methicillin resistent staphylococcus aureus staphylococcus aureus
a study to observe treatment patterns in patients in colombia who have heart failure

Conditions: Heart Failure

Summary: researchers want to learn more about the treatments doctors choose to treat heart failure. heart failure means the heart isn't pumping as well as it should be. heart failure can lead to other serious medical conditions, and it can lead to hospitalization or death. there are different types of treatments available for people who have heart failure, and these work in different ways. in this study, the researchers will collect information about colombian patients who have heart failure. the main purpose of this study is to identify patterns in the treatments that doctors first prescribe to heart failure patients in columbia. to do this, the researchers will review information from the patients' medical records and from a drug-dispensing database. the study will include adult patients who have been diagnosed with heart failure in columbia from june 1st, 2019 to may 31st, 2020. there will be no required visits, treatments, or procedures in this study. the researchers will collect information about the treatments the patients have been prescribed by their own doctors.


Eligibility criteria:
inclusion criteria: * adult patients (older than 18 years) with a diagnosis of hf according to icd-10 with a dispensing of some medicine and it is registered in the database of audifarma s.a. during the observation period will be included exclusion criteria: * patients with acute hf without prior diagnosis of hf
optimized admission to the intensive care unit by using crisis resource management (crm)

Conditions: Critical Illness

Summary: admission to the intensive care unit (icu) is vital for surviving critical illness. an admission to icu without having a consistent structure, structured review of the patient and a solid team organization lead to unclear communication and responsibility. factors that correlate with patient acceptance and safety, morbidity and mortality. the hypothesize was that a structured admission can improve patients safety, reduce delays in treatment, reduce icu length of stay, and improve mortality rate. the overall objective was to optimize patient safety, and effectively use available resources to reduce admission time, delays in treatment and procedures and mortality by using both quantitative and qualitative methods.

the quantitative before-data is a one-year observational period prior to the intervention measured by different perspectives; patients and staff outcomes. after the intervention, was qualititive data collected from participants, who received simulation training. the quantitative after-data is a one-year observational period post-intervention with same outcomes as before starting the intervention. data is already collected registry data from hospital quality assurance board. data will be compared before and after with assessor blinded analysis. missing data will not be replaced but reported as missing. the investigators will try to compare the results with data from an approximately comparative icu in denmark due to the implementation of a new patient management system called the health portal. the statistical analysis plan is based on descriptive and comparative analyses of the group before and after the trial. the quantitative results are explained in in-depths description from participants.

Eligibility criteria:
inclusion criteria: * icu admissions exclusion criteria: * none * drop-out are deaths

Keywords: intensive care crisis resource management simulation training before and after study
ck19 combined with contrast-enhanced ultrasound: a prediction system on axillary lymph node metastasis in breast cancer

Conditions: Lymph Node; Breastcancer

Summary: to establish a predicting system on axillary lymph node metastasis based on peripheral blood ck19mrna and contrast-enhanced ultrasound.

the feasibility and predictive accuracy of peripheral blood ck19mrna and contrast-enhanced ultrasound of axillary lymph nodes metastasis in breast cancer were verified by the data of specimen bank; to establish the evaluation system of predicting the lymph node status based on ck19 and ceus, validate the sensitivity, specificity, negative predictive value, positive predictive value and roc curve of the system model and use youden index, negative likelihood ratio, positive likelihood ratio to evaluate the diagnostic efficiency.

Eligibility criteria:
inclusion criteria: 1. female, age 18\~70 years old 2. 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: lymph node metastasis breast cancer ck19 contrast-enhanced ultrasonography
ncap pain relief patch vs. placebo

Conditions: Osteoarthritis, Knee

Summary: the purpose of this study is to determine whether use of the ncap medical nano-capacitive pain relief patch reduces subject pain as measured by subject pain scores, womac scores (pain, stiffness and physical function), global assessment scores, and pain medication change as compared to participants randomly assigned to the sham patch group.


Eligibility criteria:
inclusion criteria: * meet altman's clinical criteria for knee osteoarthritis * male and female adults age 40-79 * vas pain score of \> 4 at the beginning of the study exclusion criteria: * subject unable to walk unassisted. participants must be able to stand/walk for 30 minutes * inability to read and understand english. must be able to complete womac scale and questionnaires * severe systemic disease limiting ability to ambulate for 30 minutes * use of a tens unit for one week before study or during study * history of total knee replacement on the affected knee * knee surgery on the affected knee in the last 12 months * injection into the knee in the last 6 months * knee pain \< 411 * inability to cognitively understand consent form or research study, or inability to give consent * diagnosis of fibromyalgia, rheumatoid arthritis, gout, dysplasia, septic arthritis, knee pain from other diseases. * malignancy * injury to knee within 6 months * concomitant use of opioids, nsaids or other analgesics for 1 week before trial (or 5 half-lives, whichever is greater)9, or during trial with exception of acetaminophen. * pregnant or lactating * poor general health (asa classification of iv+)

Keywords: pain, arthritis
do generic volar locking plates provide similar outcomes at a reduced cost?

Conditions: Distal Radius Fractures

Summary: across orthopedics, the investigators will be using the generic volar locking plates for patients undergoing open reduction and internal fixation (orif) of the distal radius using a block schedule, meaning one month we the generic implants and one month we use conventional implants from the surgeon's brand of choice. at the end of each month the health system will switch which type of implants (generic vs. conventional) they will use at their facilities. from a quality perspective each patient will be monitored both short and long term for complication and reoperation. this will be done through chart review.

patients will be consented to surgery per a standard surgical consent form. six surgeons who regularly perform distal radius fracture (drf) orif are included (five hand and one orthopaedic trauma fellowship-trained). per the practice protocol, patients will either be treated with a generic plate or a brand name plate as described above. ultimately, the decision to use a generic volar locking plate (vlp) is left up to surgeon discretion. all surgical and follow-up data will be collected. implants used, age at time of surgery, weight, height, gender, race, ethnicity, comorbidities (diabetes, heart disease, etc.), complications including, but not limited to: readmission, reoperation, non-union, wound dehiscence, and lab tests will be collected. this will be evaluated all within 90 days following surgery. implants will be cross referenced with the institution's data base to determine cost. all data will be collected on a secure server and be kept password protected. the primary outcome was 90-day postoperative complications (readmissions, reoperations, and mortality rates) by implant vendor type (generic vs. conventional). secondary outcomes consisted of implant costs, estimated blood loss, and tourniquet time. an a priori power analysis was conducted to estimate the minimum sample size needed to adequately detect a difference in reoperation rates with a large effect size (cohen's d=0.8). at a type i error rate of 0.05, a power of 80%, and a 1:1 group allocation, the estimated sample size was 36 patients (18 generic vlps vs. 18 conventional vlps). statistical significance was set to p≤0.05.

Eligibility criteria:
inclusion criteria: * isolated distal radius fracture * treated surgically with a volar locking plate exclusion criteria: * volar locking plate not used * additional fixation was used * polytrauma (non-isolated injury) * open fracture * \<18 years old

Keywords: volar locking plate generic implants
animal source food supplement and pregnancy in vietnam

Conditions: Low Birth Weight; Preterm Birth

Summary: the purpose of this study is to determine if a nutrient-rich supplement of animal-source foods ingested 5d/wk from pre-conception to term improves maternal nutrient status, decreases infections, and improves birth weight and rates of prematurity compared with supplemental ingestion during pregnancy ( from mid-gestation to term) or routine prenatal care.

it has been known for over 80 years that maternal starvation reduces fetal growth and increases neonatal infections. many different nutrition programs have been targeted to pregnant women to improve pregnancy outcomes. the impact of these programs has been disappointing, and the prevalence of low birth weight (lbw) and infant mortality remains high, especially in developing countries. more recently, as a result of improved access to cereals following the 'green revolution,' nutritional concerns shifted from protein and energy to micronutrient deficiencies, especially those micronutrients in animal-source foods (asfs)-iron, zinc, vitamins a and b12. diets of pregnant women are usually limited to rice and a few vegetables, and they lack key nutrients known to reduce preterm delivery, to support fetal growth, and to prevent infections that leads to early neonatal deaths. vietnam has a well-established farm system that supports the local production of fish, pork, poultry, and eggs. this provides an opportunity to evaluate the impact of a food-based, micronutrient-rich supplement on pregnancy outcome in high-risk, rural vietnamese women. since maternal nutritional status at conception is strongly linked to pregnancy outcomes, we will compare the effect of consuming a micronutrient-rich, animal-source food (asf) supplement from pre-conception to term with a supplement from mid-gestation to term or routine prenatal care on infant birth weight, prematurity rate, and infant growth during the first 6 months of life. this study will be the first to compare a food-based, micronutrient-rich supplement consumed prior to conception to term with one given only during pregnancy. although it is recognized by many that pregnancy may be too narrow a window to improve maternal nutritional health, it is typical for micronutrient supplements to only be given from the time of enrolling for prenatal care to term. the results of our study, therefore, will have world-wide implications regarding when maternal supplementation should be given to have the greatest impact on pregnancy outcome.

Eligibility criteria:
inclusion criteria: * non-pregnant women registering to marry in the cam khe district of phu tho province * nulliparous * planning to reside in the study site for the next 3 years. exclusion criteria: * married * have had a previous pregnancy * have a history of severe infections (hiv, tb) or metabolic disease (diabetes) * bmi \<17 kg/m2 * do not reside in study communes * unable to provide informed consent

Keywords: birth weight prematurity gestational age low birth weight pregnancy nutrition vietnam
dit after rygb - a prospective study

Conditions: Obesity; Morbid Obesity; Bariatric Surgery

Summary: bariatric surgery is the only satisfactory treatment for loss and weight maintenance in obese patients. this loss is a result of several factors that go beyond the simple anatomical abnormality of the gastrointestinal tract and may be the product of post-op energy expenditure changes. the respiratory quotient (rq) and diet-induced thermogenesis (dit) are important components of energy expenditure and possible changes in them can perform an important role in weight loss after roux-en-y gastric bypass (rygb). previously, we conducted a cross-sectional study where we measured the rq and dit in pre and post-op rygb patients, which was published in the surgery of obesity and related diseases (soard) journal. the objective of this study is to perform a prospective analysis of these same variables (rq and dit), evaluating them in the same patients, when pre and postoperatively.


Eligibility criteria:
inclusion criteria: * pre-op: body mass index (bmi) ≥ 40 kg/m2 or bmi ≥ 35 kg/m2 with associated co-morbidities. age \> 18 years * post-op: patients who underwent surgery ≥ 12 months by the head surgeon of the gastrocirurgia de brasilia clinic; exclusion criteria: * patients aged \> 65 years. severe heart and/or respiratory problems; pregnant women.

Keywords: diet-induced thermogenesis; respiratory quotient; roux-en-y gastric bypass; energy expenditure.
study of high efficient killing cell therapy for advanced nsclc

Conditions: Non Small Cell Lung Cancer

Summary: the purpose of this study to preliminarily evaluate the safety and efficacy of high efficient killing cell therapy for refractory and advanced non-small cell lung cancer

patients with pathological confirmed non-small cell lung cancer with no standard treatment are enrolled. the patients fails in previous at least 2 lines of chemotherapy and 1 line of targeted therapy where applicable. this is a prospective exploratory trial.

Eligibility criteria:
inclusion criteria: * male or female patients' age from 18 years to 70 years. * patients who have a life expectancy of at least 3 months. * pathologically confirmed non-small cell lung cancer. * failed in previous standard chemotherapy and targeted therapy. * karnofsky performance status 0-1. * adequate organ functions. exclusion criteria: * pregnant and lactating women. * patients with t cell lymphoma, syphilis, aids or combination * patients with highly allergic or have a history of severe allergies * patients with severe hepatic or renal dysfunction * patients with severe autoimmune disease or who is being treated with immunosuppressive agents * patients with severe infection not controlled or high fever * patients with organ transplantation or waiting for organ transplantation. * patients with brain metastasis * patients with severe coagulopathy (e.g. hemophilia) * patients without adequate ability to understand, sign informed consents and take part in the clinical research voluntarily.
inaticabtagene autoleucel injection treatment for adult relapsed or refractory acute lymphocytic leukemia

Conditions: B-cell Acute Lymphoblastic Leukemia

Summary: this clinical trial is a non-interventional, observational, multicenter, post-marketing real-world study to evaluate the efficacy and safety of inaticabtagene autoleucel injection in chinese adult patients with relapsed or refractory b-cell acute lymphoblastic leukemia.

the study is a non-interventional, observational, multicenter, post-marketing real-world study, and its objective is to evaluate the efficacy and safety of inaticabtagene autoleucel injection in the treatment of relapsed or refractory acute lymphoblastic leukemia. the study consists of screening period including leukapheresis, treatment period, and follow-up period (2 years at most).

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years; 2. diagnosed with relapsed or refractory b-cell acute lymphoblastic leukemia; 3. patients deemed eligible for receiving commercial inaticabtagene autoleucel injection treatment as determined by the investigator; 4. patients voluntarily participate in this study and sign an informed consent form. for patients lacking full legal capacity, informed consent must be obtained from their legal guardian exclusion criteria: none
study to evaluate the safety and efficacy of pazopanib, in subject with refractory solid tumors

Conditions: Refractory Solid Tumors

Summary: this study is a single arm, pilot study of pazopanib in patient with fgfr2 amplification refractory solid tumor and/or specific sensitivity to pazopanib by avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy. to investigate the efficacy and safety of pazopanib in patient with refractory solid tumor.


Eligibility criteria:
inclusion criteria: * provision of fully informed consent prior to study specific procedures. * patients must be \>= 19 years of age * fgfr2 amplification ,refractory solid tumor and/or specific sensitivity to by avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy. * ecog performance status0-2 * have measurable or evaluated disease based on recist 1.1 as determined by investigator. * adequate organ function laboratory values * absolute neutrophil count \>= 1.5 x 109/l, hemoglobin \>= 9g/dl, pazopanibplatelets\>=100 x 109/l bilirubin \<= 1.5 x upper limit of normal ast/alt \<= 2.5 x upper limit of normal(5.0 x upper limit of normal, for subject with liver metastases) creatinine\<= 1.5 x unl * patients of child-bearing potential should be using adequate contraceptive measures should not be breast feeding and must have a negative pregnancy test prior to start of dosing * adequate heart function exclusion criteria: * patients with second primary cancer, except:adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumor curatively treated with no evidence of disease for \<= 5 years. * has known active central nervous system(cns) metastases * has an active infection requiring systemic therapy * pregnancy or breast feeding * patients with cardiac problem * any previous treatment with pazopanib