Kornimate/medical-research-clean huggingface dataset:
clinical outcomes from enhanced screening strategies for nash in type 2 diabetes (screen nash t2d)

Conditions: Nonalcoholic Steatohepatitis; Type 2 Diabetes

Summary: the study is stratified cluster randomized trial. the study population will include adults with t2d and presumed nash.

the study is a multi-centered, stratified cluster randomized controlled, open-labeled two-phase study. clusters will be independent lmc clinic sites with patients as participants. the use of the stratified cluster randomization design will help prevent the potential for cross-contamination of screening methods. study participants who meet eligibility criteria undergo nash screening. everything, other than routineness of screening, is maintained the same in both the groups. the screening intervention received is determined by the site of the participant's provider. all participants enrolled will undergo biochemical screening. regardless of randomization, any participants meeting biochemical cut-offs (fib-4 index ≥1.3 or nfs \>-1.455) will undergo fibroscans. clinical data and a health-related quality of life assessment will also be collected.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of t2d * age 18 - 80 years * bmi \>25 kg/m2 or waist circumference ≥102 cm in men and ≥88 cm in women * informed consent exclusion criteria: * known history of biopsy-proven nafld or nash, hepatitis b, hepatitis c, hiv, liver cirrhosis, hemochromatosis, drug-induced hepatitis, alcohol-related or autoimmune hepatic disease, history of hepatic decompensation, solid organ transplant, or primary liver cancer, based on electronic medical record * history of alcohol abuse (≥30 g/day or ≥3 drinks/day for males and ≥20 g/day or ≥2 drinks/day for females) * unstable patients with t2d (e.g. end stage renal disease on dialysis, late stage cancer, acute cardiovascular event or any hospitalization in the past 3 months). note - emergency room visit without hospitalization is not exclusionary * pregnancy/lactation * presence of implanted electronic medical device (i.e., pacemaker, as fibroscan cannot be performed) * language barriers (i.e. inability to read the consent form translated in any of the multiple languages)
effects of delayed cord clamping in very low birth weight infants

Conditions: Bronchopulmonary Dysplasia; Necrotizing Enterocolitis; Intraventricular Hemorrhage; Late Onset Neonatal Sepsis; Motor Skills Disorders

Summary: the purpose of this study was to see if a brief delay in cord clamping for 30 to 45 seconds would result in higher hematocrit levels, fewer transfusions, healthier lungs, and better motor function at 40 wks and 7 months of age.

when cord clamping is delayed at birth or the cord is milked, infants receive a placental transfusion of 10-15 ml/kg during the first few minutes of life. this additional blood improves hemodynamic stability and may reduce the risk of intraventricular hemorrhage (ivh) and the vulnerability of infants to inflammatory processes. this blood also contains stem cells that are important in repairing tissue and building immunocompetence. the current randomized controlled trial prospectively tested the effects of dcc for 30-45 seconds followed by 1 cord milking with the aim of confirming our prior work and providing long-term follow-up. our a priori hypotheses were that dcc would reduce the incidence of ivh, los, and result in better motor function at 18-22 months.

Eligibility criteria:
inclusion criteria: * women pregnant with gestation 24 to 31.6 weeks of singleton pregnancy by obstetrical evaluation * obstetrician's approval of enrollment into study * parental consent * any mode of birth will be included exclusion criteria: * obstetrician's refusal to enroll infants * parental refusal for consent * prenatally-diagnosed major congenital anomalies \[or multiple gestations\] * intent to withhold or withdraw care * severe or multiple maternal illnesses, frank vaginal bleeding, placenta abruption or previa * mothers who are institutionalized or psychotic

Keywords: delayed cord clamping very low birthweight infant bronchopulmonary dysplasia intraventricular hemorrhage motor function
ql1706 plus chemotherapy±bevacizumab for the first-line treatment of persistent, recurrent or metastatic cervical cancer

Conditions: METASTATIC CERVICAL CANCER

Summary: this study is a randomized, double-blind, placebo-controlled, multicenter phase iii clinical study in 498 patients with persistent, recurrent or metastatic cervical cancer.experimental: ql1706 + chemotherapy (paclitaxel-cisplatin/carboplatin) ± bevacizumab; control group: placebo + chemotherapy (paclitaxel-cisplatin/carboplatin) ± bevacizumab

subjects must provide sufficient archival or newly obtained tumor tissue samples to determine pd-l1 expression level to be eligible for screening.during the screening phase, eligible subjects will be stratified by use of bevacizumab (yes vs no), prior concurrent chemoradiation therapy (yes vs no), and pd- l1 level (cps \< 1 vs 1 ≤ cps \< 10 vs cps ≥ 10) and randomized 1:1 into the experimental or control arm.experimental: ql1706 + chemotherapy (paclitaxel-cisplatin/carboplatin) ± bevacizumab;control group: placebo + chemotherapy (paclitaxel-cisplatin/carboplatin) ± bevacizumab

Eligibility criteria:
inclusion criteria: * the subject fully understood and voluntarily signed the informed consent form. * histologically confirmed cervical cancer. * at least one measurable tumor lesion by ct or mri according to recist 1.1 criteria. * all subjects must provide archived or freshly obtained tumor tissue samples, approximately 7 (minimum of 5) unstained ffpe pathology slides (preferably newly obtained tumor tissue samples) within 5 years prior to randomization. * eastern cooperative oncology group (ecog) performance status of 0 or 1. * expected survival ≥ 12 weeks. * adequate level of vital organ function exclusion criteria: * previously received immunotherapy, including immune checkpoint inhibitory antibodies (such as: anti-pd-1, pd-l1, ctla-4 antibodies, etc.), immune checkpoint agonistic antibodies (such as: anti-icos, cd40, cd137, gitr, ox40 antibodies, etc.), and immune cell therapy; previously received vegf/vegfr inhibitors, such as bevacizumab, ramucirumab, abercept and tyrosine kinase inhibitors. * systemic infection or other serious infection requiring intravenous antibiotics for 7 days before randomization, or unexplained fever \> 38.5℃ during screening or before enrollment (except fever caused by tumor, as judged by the investigator) * within two weeks before randomization, there is a need for systemic use of corticosteroids (\> 10 mg daily prednisone or equivalent) or other immunosuppressive drugs (such as cyclophosphamide, azathioprine, methotrexate, thalidomide, tnf-α inhibitors, etc.) treatment of the disease; topical corticosteroids, nasal sprays, and inhaled steroids are allowed. systemic corticosteroids are permitted for the prevention of contrast allergy。 * systemic treatment with immunomodulatory drugs (such as thymosin, lentinan, interferon, interleukin, etc.) within two weeks before randomization
indirect calorimetry in patients at risk of malnutrition

Conditions: Burns; Critical Illness; Indirect Calorimetry; Resting Energy Expenditure; Nutrition Disorders

Summary: burn patients treated in an outpatient clinic and icu survivors are at risk of malnutrition. there are no clear guidelines determining the energy target in those two populations. the aim of this observation study is to measure the resting energy expenditure of those patients, using indirect calorimetry.


Eligibility criteria:
inclusion criteria: * minor burn treated in an outpatient setting * icu survivor, who was discharged from icu after a stay of at least 7 days exclusion criteria: * oxygen supply * chest drainage * not french speaking * confusion, coma * cognitive disorder * patient refusal
the use of the glidescope ranger in pediatric critical care transport

Conditions: Respiratory Failure

Summary: this study seeks to assess the role of the glidescope ranger video laryngoscope in facilitating successful neonatal/pediatric intubation by pediatric critical care transport teams. the central hypothesis of this study is that the glidescope ranger video laryngoscope reduces the rates of failed intubation attempts by pediatric critical care transport teams. the aims of this project are designed to specifically: (1) establish competencies for glidescope ranger video laryngoscopy-assisted intubation for pediatric and neonatal patients; and (2) compare the intubation success rates for intubation using glidescope ranger video laryngoscopy and using conventional, direct laryngoscopy by pediatric and neonatal critical care transport teams.


Eligibility criteria:
inclusion criteria: * age \< 18 years * presence of respiratory failure requiring tracheal intubation by the critical care transport team either at the referring institution or during the transport to the receiving institution * ability of parent or legal guardian to provide written informed consent exclusion criteria: * patients 18+ years of age * patient has a functioning tracheostomy * patient does not require orotracheal intubation

Keywords: respiratory failure, intubation, glidescope, pediatric
derm nmsc validation study

Conditions: Non-melanoma Skin Cancer

Summary: this study aims to establish the effectiveness of an artificial intelligence (ai) algorithm (derm) to determine the presence of basal cell carcinoma (bcc) and squamous cell carcinoma (scc) and frequently observed benign conditions, when used to analyse images of skin lesions taken by commonly available smart phone cameras.

derm, an artificial intelligence (ai)-based diagnosis support tool, has been shown to be able to accurately identify non-melanoma skin cancers (nmsc) and other conditions from historical images of suspicious skin lesions (moles). this study aims to establish how well derm determines the presence of these conditions in images of skin lesions collected in a clinical setting. suspicious skin lesions that are due to be assessed by a dermatologist and a patch of healthy skin will be photographed using three commonly available smart phone cameras with a specific lens attachment. the images will be analysed by derm, and the results compared to the clinician's diagnosis (all lesions) and histologically-conformed diagnosis (any lesion that is biopsied).

Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the study, * male or female, aged 18 years or above, * have at least suspicious skin lesion which is suitable for photographing (\<15mm, not located on an anatomical site inappropriate to photograph (genitalia, hair-bearing areas, under nails), not previously biopsied, not located in an area of visible scarring or tattooing), * in the investigator's opinion, able and willing to comply with all study requirements. exclusion criteria: * any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study
vericiguat in pediatric participants with heart failure due to left ventricular systolic dysfunction (mk-1242-043)

Conditions: Systolic Dysfunction

Summary: the primary objective of this study is to monitor the safety and tolerability of vericiguat.


Eligibility criteria:
inclusion criteria: * was randomized, received at least 1 dose of study intervention (vericiguat or placebo), and completed the week 52 visit and safety follow-up period for the valor base study. * a participant assigned female sex at birth is not pregnant or breastfeeding, and is not a participant/participants of childbearing potential (pocbp) or is a pocbp who uses a contraceptive method that is highly effective, has a negative highly sensitive pregnancy test, abstains from breastfeeding during the study intervention period and for at least 30 days after study intervention., and whose medical history, menstrual history, and recent sexual activity has been reviewed by the investigator to decrease the risk for inclusion of a pocbp with an early undetected pregnancy. * is able to receive medication via the oral or gastric route . exclusion criteria: * is hypotensive for age at visit 1 * has a known allergy or sensitivity to vericiguat, any of its constituents, or any other soluble guanylate cyclase (sgc )stimulator. * has undergone heart transplantation or has an implanted ventricular assist device. * has severe chronic kidney disease * has hepatic disorder * has concurrent or anticipated concomitant use of phosphodiesterase type 5 inhibitors during the study. * has concurrent or anticipated use of an sgc stimulator. * is both ≥18 years of age and vericiguat is commercially available to the participant
herpes simplex virus type 1 infection/reactivation of patients with severe pneumonia（the hsv-sp study）

Conditions: Severe Pneumonia

Summary: severe pneumonia(sp) is a one of the main causes of death for critically ill patients.samples of bronchoalveolar lavage fluid (balf) from sp patients often report positive for herpes simplex virus type 1 (hsv-1) dna. however, to date, it is unclear the impact and significance of this positive result on sp patients. this study will evaluate the prognostic impact of lower respiratory tract hsv-1 infection/reactivation on icu severe pneumonia patients.at the same time, by analyzing the risk factors that affect prognosis, we will identify populations with the potential for intervention benefits and provide a basis for further intervention treatment.


Eligibility criteria:
inclusion criteria: * 1: age\>18 years old. 2: clinical diagnosis for severe pneumonia. 3: icu stay time \>72 hours. 4: a written informed consent form was obtained from the members of the patients' family. exclusion criteria: * 1: severe ventilation dysfunction, and effective respiratory support has not been used; 2: aortic aneurysm and esophageal varices at risk of rupture; 3: recent acute coronary syndrome, uncontrolled severe hypertension, and malignant arrhythmia; 4: irreversible bleeding tendencies, such as severe coagulation dysfunction, massive hemoptysis, or gastrointestinal bleeding; 5: multiple pulmonary bullae at risk of rupture. 6: estimated survival time\<24 hours. 7: included in another interventional clinical study.

Keywords: severe pneumonia herpes simplex virus type 1 infection/reactivation prognostic effect
caring for those who share: improving the health of wisconsin blood donors

Conditions: Anemia; Colorectal Cancer

Summary: blood donors are a precious community resource. each month at blood center of wisconsin (bcw), 200 men and 600 women over age 50 are turned away ("deferred") because of anemia. in those over 50, anemia may signal serious underlying disease such as colorectal cancer (crc). crc is the #3 cause of cancer death in wisconsin with more than 1,000 deaths in 2006. yet with proper testing crc outcomes can be improved by early diagnosis. this project will focus on a population of deferred older blood donors to develop and test educational materials that will motivate donors to seek medical attention for their anemia, so that the underlying cause is diagnosed and treated. this project has the potential to lead to better crc outcomes in wisconsin blood donors.


Eligibility criteria:
inclusion criteria: * adult blood donors who have been "deferred" (not allowed to donate) due to low blood count, specifically all male donors found to have hematocrit \< 38% and to all female donors over 50 years old found to have hematocrit \< 36% exclusion criteria: * deferred donors who have previously donated more than 3 times in the past year, as their anemia is more likely due to frequent donation * women less than 50 years old
the impact of perioperational malnutrition on the cost on gastroenterological cancer patients

Conditions: Malnutrition; Gastroenterological Cancer; Surgical Procedures, Operative

Summary: undernutrition is a state marked by energy and/or protein intake deficiency or mal-absorption, and is often described as protein energy malnutrition (pem). malnutrition is common in hospitalized patients worldwide. the prevalence of malnutrition in hospitalized patients range from 20% - 50%, depends on the varieties of diseases, health system, population and assessment tools. it is well documented in western countries that malnutrition affects clinical outcomes negatively. compared with well-nourished patients, patients with malnutrition stay longer in hospitals and related cost is significantly higher. there is increasing evidence which indicates that appropriate nutrition support (e.g., standardized nutrition screening procedures, delivering nutrients with appropriate path, etc) may improve clinical outcome on malnutrition, along with cost saving. to date, there is no study to document specifically the impact of malnutrition and related nutrition support on the health economics in china. considering china now is on its way to establish public health security system and a diagnosis-related grouping system, the understanding of the cost effectiveness of nutrition support under the current clinical conditions is crucial. this study aims to investigate the prevalence of perioperational malnutrition in gastroenterological cancer patient, the nutrition support status and related health economic effects.


Eligibility criteria:
inclusion criteria: * age 18 or older * with gastroenterological cancer * will receive resectional operation * consent informed exclusion criteria: * with severly cardiac, pulmonary, liver or renal disease * with endocrine or metabolic disease * with dyslipidemia * without consent

Keywords: nutritional support
2 weeks of citrulline supplementation on arterial function in postmenopausal women with elevated blood pressure or hypertension

Conditions: Menopause; Hypertension

Summary: the objective of this project is to elucidate the effect of l-citrulline (l-cit) supplementation on vascular function at rest and during rhythmic handgrip exercise and functional sympatholysis via lower-body negative pressure in postmenopausal women with elevated blood pressure and hypertension.

using a double-blind, randomized, placebo-controlled, and crossover design, overweight or obese postmenopausal women with elevated blood pressure (bp) or hypertension will receive cit (6 grams/day) or placebo for 2 weeks, separated by a two-week washout period. there will be a total of 5 laboratory visits. the 1st visit will take approximately 1 hour. the 2nd - 5th visits will take about 2 hours and 15 minutes. visit 1 will be a screening visit, visits 2 and 4 will be considered baseline visits, and visits 3 and 5 will be following the participants' two weeks of supplementation. arterial stiffness (carotid-femoral and femoral-dorsalis pedis pulse wave velocity) and endothelial function will be assessed at rest. additionally, brachial artery blood flow, forearm muscle oxygenation, cardiovascular hemodynamics (stroke volume, cardiac output, systemic vascular resistance), and bp will be assessed at rest, during 6 minutes of rhythmic handgrip exercise at 30% of a predetermined maximal voluntary contraction, and 2 minutes of superimposed lower body negative pressure to increase sympathetic activity.

Eligibility criteria:
inclusion criteria: * postmenopausal women (defined as the absence of menstruation for at least 1 year). * resting systolic blood pressure 120-150 mmhg. * between the ages of 50 - 70 years. * sedentary (\< 120 minutes of exercise/week). * body mass index of 25 - 39.9 kg/m2. * fasting glucose \< 126 mg/dl and hba1c \< 6.5%. exclusion criteria: * body mass index ≥ 40 or \< 25 kg/m2. * systolic blood pressure \> 150 mmhg. * taking more than two antihypertensive medications. * cardiovascular diseases, type i/ii diabetes, musculoskeletal disorders, or cancer. * changes in hypertensive medication in the past three months. * began or changed hormone replacement therapy in the past 6 months. * current smoker. * heavy drinking (\> 7 alcoholic drinks/week). * participants on beta-blockers or other vasodilatory supplements (nitrates). * incorporated in a weight loss program and/or aerobic or resistance training program.

Keywords: endothelial function blood flow blood pressure functional sympatholysis
an observational real world study on the efficacy and safety of toripalimab injection combined with tace in the treatment of extrahepatic cholangiocarcinoma

Conditions: Extrahepatic Cholangiocarcinoma

Summary: this is an open-label, single-arm, multicenter phase ii clinical study to preliminarily observe and evaluate the efficacy and safety of toripalimab combined with tace in the treatment of extrahepatic cholangiocarcinoma.


Eligibility criteria:
inclusion criteria: * age \> 18 years and \< 75 years * both men and women * ecog performance status score 0-2 points * child-pugh score ≤ 7 points * expected survival ≥ 12 weeks * patients with histologically or cytologically confirmed extrahepatic cholangiocarcinoma, patients with obstructive jaundice need to return to normal after drainage * at least one measurable lesion \[spiral ct scan ≥ 10 mm (ct scan slice thickness no greater than 5 mm)\] (recist version 1.1) * vital organ function meets the following requirements: a. absolute neutrophil count (anc) ≥ 1.5 × 109/l; b. platelets ≥ 75 × 109/l; c. hemoglobin ≥ 8 g/dl; d. serum albumin ≥ 2.8 g/dl; e. bilirubin ≤ 3 uln, alt/ast ≤ 2.5 uiln; if there is liver metastasis, alt/ast ≤ 5 times uln; f. creatinine clearance ≥ 50 ml/min (cockcroft-gault, see appendix iii); g. normal thyroid function. h. adequate cardiac function, 2-dimensional cardiac ultrasound examination of the score (lvef) \> 50% * no history of serious drug allergy * women of childbearing age must have taken reliable contraceptive measures or have a pregnancy test before enrollment * the subject voluntarily participates in this study. sign the informed consent form, with good compliance and cooperation in follow-up exclusion criteria: * known to be allergic to recombinant humanized pd-1 monoclonal antibody drugs and their components * presence of any active autoimmune disease or history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism; patients with vitiligo; complete remission of asthma in childhood, no intervention after adulthood can be included; patients with asthma requiring bronchodilators for medical intervention can not be included) * patients are using immunosuppressive agents, or systemic hormone therapy to achieve the purpose of immunosuppression (dose \> 10 mg/day prednisone or other effective hormones), and continue to use 2 times before enrollment * pregnant or lactating women * other malignant tumors have been diagnosed within 5 years before the first use of the study drug, except for effectively treated cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma and/or effectively resected in situ cervical cancer and/or breast cancer * patients prone to infection and poor blood glucose control * incomplete important imaging examination and incomplete record of adverse reactions * previous surgery, chemotherapy, targeted, radiotherapy and immune-related therapy * other conditions that the investigator judges may affect the conduct of the clinical study and the judgment of the study results