Kornimate/medical-research-clean huggingface dataset:
evaluating tele-emergency care in costs and outcomes for rural sepsis patients

Conditions: Sepsis

Summary: sepsis is a life-threatening emergency for which provider-to-provider telemedicine has been used to improve quality of care. the objective of this study is to measure the impact of rural tele-emergency consultation on long-term health care costs and outcomes through decreasing organ failure, hospital length-of-stay, and readmissions.

sepsis is responsible for over 1.7 million hospitalizations at a cost of $26 billion annually, making it the most expensive acute care condition in us hospitals. high-quality early sepsis care has been associated with decreased organ failure, shorter icu and hospital length-of-stay, and improved survival. rural sepsis patients are more likely to be transferred to tertiary centers, and they also have higher mortality and health care costs. ed-based telemedicine (tele-ed) consultation between a rural provider and a board-certified emergency physician may deliver the expertise to reduce care delays and improve outcomes while avoiding unnecessary costs. in 2017, the study team partnered with avera ecare, the largest tele-ed provider in north america, to implement a standard telemedicine-based sepsis care pathway. subsequently, the investigators showed (using patient-level primary data collection across several networks) that tele-ed use was associated with improved adherence with international sepsis guidelines. in addition to its association with short-term clinical outcomes, however, the study team hypothesize that telemedicine may also decrease costs. the investigators have shown that high-quality sepsis care is associated with decreased readmissions and post-discharge mortality. high quality care may also prevent organ failure, avoid icu admissions, reduce mechanical ventilation and vasopressor use, decrease icu and hospital length-of-stay, and decrease post-discharge care-primarily through reducing avoidable organ failure. all of these factors are likely to have a significant effect in terms of reducing healthcare cost. the objective of the proposed project is to measure the effect of tele-ed consultation at reducing healthcare costs and long-term outcomes in sepsis patients in rural eds. the following primary hypotheses will be tested: * total healthcare expenses and 90-day mortality will be lower in patients treated in a tele-ed hospital, with the effect primarily through reduced hospital length-of-stay and fewer readmissions. * total expenses and mortality will be lower in cases where tele-ed is used vs. matched controls in non-tele-ed hospitals.

Eligibility criteria:
inclusion criteria: * sepsis, according to icd-10 codes exclusion criteria: * no infection diagnosed in the ed

Keywords: telemedicine
integration of cryobiopsies for ild diagnoses- experience based on 250 biopsy procedures.

Conditions: Interstitial Lung Disease

Summary: a retrospective study on safety and diagnostic yield in using cryobiopsies as a diagnostic tool in diagnosing patients under investigation for interstitial lung diseases. this includes a registration of procedural techniques, complications ( pneumthorax, hemorrhage, exacerbation and mortalt), days admitted at the hospital, diagnoses and diagnostic yield.


Eligibility criteria:
inclusion criteria: * \>18years of age * suspected of interstitial lung disease * cryobiopsies performed. exclusion criteria: * fvc below 50% of predicted * dlco below 35% * body mass index (bmi) above 35 * pulmonary hypertension with a tricuspidal gradient above 40 mmhg * other cardiac or other comorbidities that would increase the risk of complications

Keywords: cryobiopsy
evaluation interest of the circulating tumor dna dosage in patient with hepatic metastatic uveal melanoma candidate to complete resection (ct dna r0)

Conditions: Uveal Melanoma

Summary: prospective, open labelled, monocentric trial to evaluation of the circulating tumor dna rate in the blood, before and after curative resection of hepatic metastasis of uveal melanoma (hmum) and during post-surgery follow-up

the ct dna r0 study is a prospective, open labelled, monocentric trial. the aim is to evaluate the circulating tumor dna rate in the blood, before and after curative resection of hepatic metastasis of uveal melanoma (hmum) and during post-surgery follow-up. the patient will have a blood sample before and after the surgery and during the post-surgery follow-up. the patient will have a maximum of 10 blood samples during the 2 years of his follow-up of the study.

Eligibility criteria:
inclusion criteria: 1. aged 18 years old or more 2. patient with hepatic injury of metastatic uveal melanoma eligible for curative surgery (r0). 3. no other distant metastasis (ct thoracic -abdomino -pelvic, bone scan).measurable metastatic disease (echography, ct and/or mri, fdg-pet, (fluoro- d-glucose integrated with computed tomography)). 4. patient able to stand a blood collection. 5. patient explanation given and consent information signed or by legal representative. exclusion criteria: 6. patient without social protection / insurance.. 7. patient with hepatic metastasis unresectable by surgery 8. patient with extra-hepatic metastasis. 9. person deprived of liberty or under guardianship 10. inability to submit to medical monitoring of the trial for reasons of geography, social or psychological.

Keywords: circulating tumor dna
an electronic data capture study to assess the long-term performance of the depuy proxima™ hip in primary total hip replacement

Conditions: Rheumatoid Arthritis; Osteoarthritis; Post-traumatic Arthritis; Avascular Necrosis; Traumatic Femoral Fractures; Congenital Hip Dysplasia

Summary: the purpose of this study is to monitor the performance of the depuy proxima™ hip in the treatment of patients with hip joint disease requiring a total hip replacement. patients who enter the study will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.


Eligibility criteria:
inclusion criteria: * male or female subjects between 18 and 70 years of age. * subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained. * subjects who, in the opinion of the investigator, are able to understand this investigation, co-operate with the investigational procedures and agree to return to the hospital for all the required post-operative follow-ups. * subjects who are scheduled to undergo a primary thr whom the surgeon considers to be suitable for the depuy proximatm hip femoral prosthesis. exclusion criteria: * subjects with active local or systemic infection * subjects with loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb rendering the procedure unjustified. * subjects with poor bone quality, such as osteoporosis, where, in the surgeon's opinion, there could be considerable migration of the prosthesis or a significant chance of fracture of the femoral shaft and/or the lack of adequate bone to support the implant(s). * subjects with charcot's or paget's disease. * subjects with hip dysplasia with severe neck anteversion or severe dysplasia of the proximal femur. * subjects with severe osteoporosis. * subjects with previous proximal femoral fractures. * subjects who, in the opinion of the investigator, have an existing condition/co-morbidity or infection that would compromise their long-term participation and follow-up in this study. * women who are pregnant. * subjects who are known drug or alcohol abusers or with psychological disorders that could affect follow-up care or treatment outcomes. * subjects who have participated in a clinical study with an investigational product in the last 6 month(s). * subjects who are currently involved in any injury litigation claims. * subjects for whom the surgical procedure is a revision of a previous thr, hemi-arthroplasty or hip resurfacing * subjects who have previously undergone osteotomy or arthrodesis of the hip. * subjects undergoing a simultaneous bilateral hip operation. * subjects undergoing the second stage of a staged bilateral for whom the contralateral hip is part of this clinical investigation. * subjects undergoing the second stage of a staged bilateral for whom the contralateral hip was implanted less than six months previously or is not performing satisfactorily

Keywords: arthroplasty replacement hip conservative anatomic cementless
a clinical study of 6mw3211 in patients with renal cancer

Conditions: Advanced Clear Cell Renal Cell Carcinoma

Summary: single arm, non-randomized, multicenter, open label, phase 2 clinical trial in patients with advanced clear cell renal cacer

this study is a single arm, non-randomized, multicenter, open label, phase 2 clinical trial to evaluate preliminary efficacy and safety in patients with advanced clear cell renal cacer

Eligibility criteria:
inclusion criteria: * voluntarily participate in the study and sign the informed consent. * advanced clear cell renal cancer. * at least one measurable tumor target lesion. * life expectancy≥3 months. * suitable organ functions. * patients who had failed at least one line therapy. * ecog 0-1. * the samples of tumor tissue should be provided exclusion criteria: * patients who had received anti-tumor therapy/radiotherapy/immunotherapy within 4 weeks. * history of other malignant tumors within 5 years. * patients with cns metastasis. * history of active autoimmune diseases. * patients with poor-controlled systemic diseases after treatment. * patients with severe infection or requiring antibiotic treatment within 4 weeks before dosing. * adverse reactions related to previous treatments failed to recover to ctcae 5.0 ≤1 * patients who had experienced immune-related adverse events (irae) with grade 3 or above. * patients who were allergic to any composition of experimental drug. * subjects with poor treatment compliance. * pregnant or lactating woman. * live vaccination within 28 days before first dosing. * history of drug abuse or addiction * patients with active hbv or hcv, or hiv antibody positive,or tp-ab positive.
relationship between multi-exposure to noise and air pollution and the onset of hypertension disorders during pregnancy

Conditions: Women Who Gave Birth at Dijon and Besançon CHUs Between 2005 and 2009

Summary: this retrospective study aimed to analyse the relationship between multi-exposure to noise and air pollution the onset of hypertension disorders during pregnancy it will be conducted in 2650 mothers who gave birth at dijon or besançon chu between 2005 and 2009 split into two groups: * 530 cases (women who experienced hypertension disorders during pregnancy * 2120 controls (women who did not experience a hypertension disorder during pregnancy)


Eligibility criteria:
inclusion criteria: * women living in besançon or one of the 15 communes of the dijon conurbation * who gave birth at dijon or besançon chu * between 1st january 2005 and 31st december 2009 criterion for the inclusion of cases: * onset of a hypertension disorder during pregnancy defined according to expert recommendations criterion for the inclusion of controls: * no hypertension disorder during pregnancy exclusion criteria: * medical termination of pregnancy * opposition to the use of their data
a 17-week trial to assess pregabalin for the treatment of nerve pain due to spinal cord injury

Conditions: Neuralgia; Spinal Cord Injuries

Summary: the purpose of this study is to evaluate if pregabalin relieves nerve pain associated with spinal cord injury compared to placebo (pill that contains no active medicine). this study will also evaluate the safety of pregabalin in this patient population.


Eligibility criteria:
inclusion criteria: * subjects with nerve pain after spinal cord injury (traumatic, diving, ischemic and after removal of benign tumors (except meningioma and fibromas) * pain has to be chronic(continuous for at least 3 months or intermittent for at least 6 months * pain score at least 4 in 4 of 7 days prior to receive treatment. exclusion criteria: * pregabalin use in the last 60 days, prior intolerance to pregabalin * creatinine clearance \<60 ml/min. * white blood cell count \<2500/mm3; neutrophil count \<1500/mm3; platelet count \<100 x 103/ mm3. * abuse of drugs or alcohol * unstable medial conditions * clinically significant abnormal electrocardiogram (ecg). * presence of severe pain associated with conditions other than spinal cord injury that could confound the assessment or self-evaluation of pain due to spinal cord injury.

Keywords: pain central neuropathic pain
pharmacokinetics of ciprofloxacin in critically ill patients

Conditions: Bacterial Infections

Summary: optimal understanding of ciprofloxacin pharmacokinetics in critically ill patients is lacking resulting in large variation of achieved exposure and possible inadequate therapy. the investigators hypothesize that drug dosing based on ckd-epicr-cys provides a useful method to individualize and optimize therapy for ciprofloxacin and eventually improve outcome. in a multi-centre, observational, open-label study the investigators aim to define : the model for estimation of renal function that most accurately predicts ciprofloxacin clearance in critically ill patients.

correct estimation of glomerular filtration rate (gfr) is necessary in critically ill patients in order to asses renal function. gfr is subsequently used to derive and appropriate drug dosing of renally excreted drugs and warrant adequate dose adaptations. it is known that estimation of gfr based on creatinine clearance is not precise, especially in populations with altered muscle mass or instable renal function, such as the intensive care unit (icu) population. the use of combined filtration markers together, cystatin c and creatinine, can improve precision in estimating gfr (egfr). studies confirmed that egfr based on both creatinine and cystatin c is more precise than egfr creatinine or egfr cystatin c. the equation based on both creatinine and cystatin c, the chronic kidney disease epidemiology collaboration creatinine-cystatin c (ckd-epicr-cys), may therefore improve egfr and thus drug dosing in icu patients, a population that does not reach pk/pd targets frequently. so far little is known about drug dosing based on ckd-epicr-cys. currently optimal understanding of ciprofloxacin pharmacokinetics in critically ill patients is lacking, resulting in large variation of achieved exposure and possible inadequate therapy. the investigators hypothesize that drug dosing based on ckd-epicr-cys provides a useful method to individualize and optimize therapy for ciprofloxacin and eventually improve outcome. in a multi-centre, observational, open-label study the investigators aim to define the model for estimation of renal function that most accurately predicts ciprofloxacin clearance in critically ill patients.

Eligibility criteria:
inclusion criteria: 1. patient is admitted to an icu 2. subject is at least 18 years on the day of the first dosing 3. is managed with an arterial line or central venous catheter 4. is managed with an urinary catheter 5. is already treated with ciprofloxacin as part of routine clinical care exclusion criteria: 1. has previously participated in this study 2. is on renal replacement therapy (rrt)

Keywords: ciprofloxacin pharmacokinetics intensive care unit cystatin c ckd-epi renal function
interindividual variation in response to green coffee

Conditions: Overweight and Obesity

Summary: the study is a multifaceted approach to investigate the effects of regular consumption of green coffee rich in polyphenols (hydroxycinnamic acids) on weight, body composition, cardiometabolic and inflammatory biomarkers in a sample population of overweight and obese people aimed at identifying a population of responders to green coffee experimenting the highest benefit from this product, and to contribute to the understanding of the influence of some of the main factors on the response to green coffee and their association with the differences between individuals (high-responders vs. low-responders).

a randomized, cross-over, blind clinical trial will be carried out to evaluate the health effects of a polyphenol-rich green (slightly roasted) coffee in comparison with traditional roasted coffee to identify high- and low-responders. participants will consume the green and roasted coffee in a randomized order during 12 weeks, separated by a 4-week wash-out (and a previous 2-week run-in). fasting blood samples will be collected in each of the 6 visits to the research centre. blood pressure and body composition and anthropometric variables will be measured. in addition, urine and fecal samples will be obtained at the beginning and end of each intervention stage to analyze the bioavailability and metabolism of phenolic compounds, and the intestinal microbiota, respectively. physical activity and energy expenditure will be measured in each of the interventions. besides a thorough cardiometabolic and inflammatory characterization of the volunteers, the frequency of specific genotypes (related with obesity, energy metabolism, inflammation and coffee intake) will be analyzed, as well as lifestyle and dietary habits of the participants, including aspects such as chrono-nutrition, sleep quality and wellbeing perception with the aim to contribute to clarify the determinants of inter-individual variability in the health effects of coffee bioactive phenolic compounds.

Eligibility criteria:
inclusion criteria: * body mass index 25-35 kg/m2 exclusion criteria: * smoking * vegetarian/vegan * pregnant/lactating women * on prescription drugs other than for thyroid/hypertension/dyslipemia, or changes in dosage in the last 3 months. * consumption of vitamins or dietary supplements * on weight-reduction dietary regime or physical training to reduce body weight * having taken antibiotics 3 months before starting the intervention * intestinal, hepatic or renal diseases, coffee intolerance

Keywords: inter-individual variability (poly)phenols green coffee obesity genotype microbiota bioavailability and metabolism lifestyle cardiometabolic and inflammatory biomarkers
use of guidance videos to increase engagement and decrease anxiety in patients undergoing pleural tap

Conditions: Pleural Effusion; Pleural Effusion, Malignant; Pleural Pleurisy Effusion

Summary: patients planned to undergo a pleural tap will get verbal explanation or watch a personalized guidance video in addition to verbal explanation. questionnaires will be filled to assess the effect of the video training on understanding, cooperation and anxiety.

100 patients with pleural effusion, planned to undergo a diagnostic or therapeutic pleural tap, will be randomized to watch a personalized custom video training, explaining the procedure, in addition to the verbal explanation given by the medical staff, or to get the standard verbal explanation alone. questionnaires regarding their understanding of the procedure, their feelings and the level of anxiety will be filled before and after the video/verbal explanation, and after the procedure. the study aims to check whether the video training provides better understanding of the procedure, increases cooperation and engagement and decreases anxiety.

Eligibility criteria:
inclusion criteria: * patients hospitalized in internal medicine c and d, tel-aviv sourasky medical centers * patients with pleural effusion, planned to undergo diagnostic or therapeutic pleural tap * patients who can read and understand the questions * patients who were interested in participating in the clinical trial and signed an informed consent form exclusion criteria: * minors \< 18 years of age * pregnant women * patients who cannot read and understand, at the discretion of the investigator * patients which their medical condition does not allow them to undergo the study procedure

Keywords: personalized video training thoracocentesis pleural tap
diabetic macular edema and diabetic retinopathy screening (telemed) with automated retinal photography

Conditions: Mild Nonproliferative Diabetic Retinopathy; Moderate Nonproliferative Diabetic Retinopathy; Severe Nonproliferative Diabetic Retinopathy; Proliferative Diabetic Retinopathy; Diabetic Macular Edema

Summary: the purpose of this study is explore if a partnership and screening program put in place between a busy retina practice and their referring diabetes care offices can improve diabetic retinopathy and diabetic macular edema diagnosis, care and overall diabetes control in patients with diabetic eye disease.

retina institute of hawaii will place an infrastructure to screen for diabetic retinopathy/diabetic macular edema in 5 of the states largest primary care clinics, general medical and or endocrine practices which re our primary referrals for diabetes patients. each sub-site will receive a drs automated retinal camera and our staff will train the sub-site's staff on taking images. the submission of these images to our practice will be administered by an automated job scheduler in the drs automated retinal camera removing the requirement of the locations to send images. images will be electronically uploaded and sent to the retina institute of hawaii for detailed interpretation and report sent back to the patients, their diabetes care md's and their nurse practitioners/diabetic educators.

Eligibility criteria:
inclusion criteria: * patients diagnosed with diabetes that have not seen an ophthalmologist in the past 1 year exclusion criteria: * patients with diabetes already under the care of an ophthalmologist. * patient not willing to give consent for participation in the study
study of xl647 in subjects with nsclc who have progressed after responding to treatment with gefitinib or erlotinib

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the purpose of this study is to determine the best confirmed response rate of daily administration of the multiple receptor tyrosine kinase (rtk) inhibitor (including egfr and vegfr2) xl647 in subjects with nsclc who have progressed after responding to treatment with either erlotinib or gefitinib.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of unresectable stage iiib or stage iv relapsed or recurrent nsclc. * subjects must have: 1. documented (radiological or clinical) progressive disease (pd) following a prior response (including stable disease) to monotherapy with erlotinib or gefitinib that was administered for at least 12 weeks prior to progression or 2. a documented t790m egfr mutation * measurable disease defined according to recist * ecog performance status of 0 or 1. * sexually active subjects must use an accepted method of contraception during the course of the study. * female subjects of childbearing potential must have a negative pregnancy test at enrollment. exclusion criteria: * received radiation to ≥25% of his or her bone marrow within 30 days of xl647 treatment. * received erlotinib or gefitinib, or other anticancer therapy within 14 days of the first dose of study drug. * received an investigational drug (excluding erlotinib or gefitinib) within 30 days of the first dose of study drug. * receiving anticoagulation therapy with warfarin. * not recovered to grade ≤1 from adverse events (aes) due to antineoplastic agents, investigational drugs, or other medications that were administered prior to study enrollment. * corrected qt interval (qtc) of \>0.45 seconds. * progressive, symptomatic, or hemorrhagic brain or leptomeningeal metastases. * requires steroid or anticonvulsant therapy for the treatment of brain metastases.

Keywords: non-small-cell lung cancer