Kornimate/medical-research-clean huggingface dataset:
a clinical study of shr-3276 for injection in patients with advanced malignant tumors

Conditions: Advanced Solid Tumors

Summary: this study is an open-label, multicenter phase i/ii clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of shr-3276 for injection in patients with advanced solid tumors.


Eligibility criteria:
inclusion criteria: 1. able and willing to sign a written informed consent； 2. age 18-70 years old (including both ends), both male and female； 3. pathologically confirmed advanced malignant tumors that have failed sufficient standard treatment or have no effective standard treatment plan； 4. existence of measurable lesions； 5. ecog score: 0-1； 6. expected survival time ≥ 12 weeks； 7. the functional level of the major organs must meet the requirements； 8. fertile female patients must have a serum pregnancy test within 7 days before the first medication and the result is negative; and must be non-lactating. exclusion criteria: 1. central nervous system metastasis or meningeal metastasis with clinical symptoms; 2. spinal cord compression that has not been treated radically by surgery and/or radiotherapy； 3. patients with uncontrolled tumor-related pain as judged by the investigator 4. a third space effusion with uncontrolled pleural effusion, pericardial effusion, or peritoneal effusion, as determined by the investigator； 5. systemic antitumor therapy was administered within 28 days prior to treatment in the first study； 6. surgical procedures requiring tracheal intubation and general anesthesia were performed within 28 days prior to the initial study, or elective surgery was expected during the trial period； 7. serious drug-related adverse reactions during previous immune checkpoint inhibitor therapy； 8. has unresolved toxicities from previous anticancer therapy, defined as toxicities not yet resolved to nci-ctcae version 5.0 grade ≤ 1； 9. live attenuated vaccines were used within 28 days prior to administration in the first study or were expected to be required during the study treatment； 10. systemic immunosuppressive therapy was administered within 14 days prior to the first study 11. arterial/venous thrombosis events occurred within 3 months prior to initial administration 12. patients with clinical significant lung disease; 13. patients with history of autoimmune diseases; 14. the first study studied any other malignancy within 5 years prior to medication 15. a known history of severe allergic reactions to the investigational drug and its principal formulation ingredients； 16. have a history of immune deficiency or organ transplantation； 17. other serious accompanying illnesses, which, in the investigator's assessment, could seriously adversely affect the safety of the treatment.
calprotectin levels in necrotizing enterocolitis

Conditions: Necrotising Enterocolitis Neonatal

Summary: necrotizing enterocolitis (nec) is a serious condition that can affect premature babies, leading to complications like intestinal damage and infection. in our study, we measured specific markers (called calprotectin) in blood and stool to understand how severe nec is and predict outcomes. we found that these markers were higher in babies with more severe nec (stage 3), especially in those who needed surgery or sadly did not survive. this information can help doctors detect nec earlier, understand its severity, and make better decisions for treating affected babies.


Eligibility criteria:
inclusion criteria: before 32 weeks of gestation with a birth weight of ≤1500 grams exclusion criteria: infants whose families did not provide consent and those with congenital anomalies were excluded.

Keywords: calprotectin necrotising enterocolitis
osteopathic consultation in the emergency department for fresh lateral ligament sprain

Conditions: Ankle Sprains

Summary: the study consists in recruiting patients with ankle sprains who visit the emergency department (ed). each patient will be tested by an osteopath who we will measure pain, swelling and/or edema, and mobility of the ankle. patients will be asked to reproduce exercises such as to hold on one foot, to stand on tiptoes... then, patients will be divided into two groups. the first group will undergo medical treatment during the ed visit, while the second group will undergo osteopathic treatment. three time points will be planned. the first one will be the patient's consultation in the ed where treatment will be carried out according to its assignment, as well as the clinical measures previously described. the second time point will be seven days later (plus or minus three days), where only clinical measurements will be performed. the third time point will be three weeks later (plus or minus three days), when the ankle sprain has consolidated, in order to carry out the clinical measurements again. these clinical measurements will allow to evaluate the effectiveness of a single osteopathic consultation in the ed. the investigators expect a reduction in immediate pain, and thereafter, a reduction in swelling, and an improved mobility and stability of the ankle.


Eligibility criteria:
inclusion criteria: * 18 years and older * unilateral sprain * stage 1 or 2 sprain * recent sprain \< 72 hours * with or without the presence of edema and/or hematoma * receiving prior consultation from an ed physician * understanding french * agreeing to participate in the study and having signed the consent form * apyretic * patient affiliated to a social security schem exclusion criteria: * fractured foot, tibia, fibula * stage 3 ankle sprain * operated sprain * current use of drugs/alcohol * altered mental state * chronic ankle injury on the contralateral side * person deprived of liberty by a judicial or administrative decision * neoplasia * any contraindication to osteopathy
a study to evaluate readiness to self-inject on adherence and compliance to copaxone® therapy

Conditions: Multiple Sclerosis

Summary: this study has patients responding to two sets of surveys that will tell their doctor or nurse about their readiness to begin self-injection. in addition, patients will have their self-injection observed and evaluated on up to three visits


Eligibility criteria:
inclusion criteria: 1. male or female, 18 years of age or older, with diagnosis of rrms 2. naive to treatment or previously treated with an ifn. exclusion criteria: 1. not eligible for treatment based on clinical criteria and current indication. 2. unable to respond to surveys or provide informed consent.
normal saline versus plasmalyte in initial resuscitation of trauma patients

Conditions: Wounds and Injuries; Multiple Trauma; Disorder of Fluid Balance

Summary: the purpose of this study is to determine whether an intravenous salt solution called "plasmalyte" causes less abnormality of the body's acid levels than a solution called "normal saline."

electrolyte-containing intravenous fluids are routinely administered to patients in the first few hours after acute traumatic injury. although normal saline (0.9% sodium chloride) is commonly used in this setting, it causes a hyperchloremic acidosis that may exacerbate metabolic derangements that occur after acute injury. plasmalyte a is a solution that more closely matches physiologic electrolyte levels. in this study, we will evaluate whether plasmalyte a results in less disturbance of the base deficit 24 hours following traumatic injury than does normal saline.

Eligibility criteria:
inclusion criteria: * triaged upon arrival to the hospital as severely injured * at least 18 years of age * meets at least one of the following criteria: 1. intubated or likely to become intubated within 60 minutes of arrival at the hospital 2. likely to need an operation within 60 minutes of arrival 3. received or likely to receive a blood transfusion within 60 minutes of arrival exclusion criteria: * greater than 60 minutes since arrival at the hospital * death likely within 48 hours * transfer from another hospital * pre-existing renal failure requiring dialysis * pregnancy * prisoner status

Keywords: normal saline plasmalyte intravenous fluid traumatic injury fluid resuscitation
relationship between aortic parietal inflammation on 18f-fdg pet scan and arterial stiffness as a function of age

Conditions: Arterial Stiffness

Summary: show that there is a relationship between arterial stiffness and aortic parietal inflammation and that this relationship is different in the three age groups with aortic parietal inflammation occurring earlier than arterial stiffness.

in the literature, a relationship has been demonstrated between local inflammation in the aortic wall and increased arterial stiffness. arterial stiffness is commonly represented by pulse wave velocity (pwv) measured using an applanation tonometer. it would seem that this parietal inflammation precedes arterial stiffness and consequently, arterial hypertension . arterial stiffness is an important factor of cardiovascular morbidity and mortality and therefore represents a major public health interest in prevention in the face of the continuous aging of our population . this study will consist in studying on a population divided into three age groups, less than 40 years old, 40 to 60 years old and more than 60 years old, the relationship between thoracic aortic parietal inflammation evaluated using the standard uptake value parameters (suv) and hounsfield units (hu) measured on 18f-fdg pet/ct scans performed between 09/04/2018 and 11/06/2020 and arterial stiffness parameters. we will seek to show that there is a relationship between arterial stiffness and aortic parietal inflammation and that this relationship is different in the three age groups with aortic parietal inflammation occurring earlier than arterial stiffness.

Eligibility criteria:
inclusion criteria: * patients who underwent whole-body 18f-fdg pet/ct included in the pactep study * patient with an assessment of arterial stiffness by applanation tonometer exclusion criteria: * patients without an assessment of arterial stiffness by applanation tonometer
motor-cognitive dual-task in healthy older adults and early parkinson's disease patients

Conditions: Parkinson Disease; Motor Disorders; Cognitive Impairment

Summary: neuromuscular dysfunction is common in older adults and even more pronounced in neurodegenerative diseases. in parkinson's disease (pd), a complex set of factors often prevents effective performance of activities of daily living that require intact and simultaneous performance of motor and cognitive tasks. in the current study we aim at employing the mobile brain/body imaging approach (mobi) to gain further insides of neuromuscular biomarkers revealing the decrements of older adults with an early pd. the cross-sectional study will be evaluated through the multifactorial mixed-measure design.


Eligibility criteria:
inclusion criteria: inclusion criteria for the healthy older participants will be: * no diagnosis of cognitive or movement disorder, * score \> 7 for the short physical performance battery (sppb), * living independently in the community, * age range between 55 and 70 years, * no color blindness. inclusion criteria for the early-stage pd patients: * diagnosed according to the last mds criteria (2015), * duration of the disease less than 5 years, * positive datscan, * diagnosed akinetic-rigid or mixed phenotype, * score of 1 or maximally 2 on the hoehn and yahr scale (hoehn \& yahr, 1967), * moca score ≥ 24 points, * score \> 7 for the sppb, * age range between 50 and 75 years, * no color blindness * living independently in the community. exclusion criteria: * advanced stages of pd (hoehn and yahr score \> 2) * any acute or chronic diseases, especially of the peripheral and central nervous system, heart failure, respiratory failure, severe osteoarthritis, and major psychiatric illness such as depression * moca score \< 24 points, * severe disabling tremor, * recurrent falls, * impaired vision that is not corrected with e.g., glasses, * low sppb score
the safety and efficacy of adjunct carvedilol in children with moderate heart failure

Conditions: Heart Diseases

Summary: we would like to see if using carvedilol in adjunct with ace inhibitors will increase ejection fraction of the heart under echo. all interpretation of data will be sent to boston children's hospital to be reviewed, which is the primary research center in this study. there are 5 hospitals participating in this study. the population targeted are children with moderate heart failure and must be on ace inhibitors at the time of enrollment. our outcome after placing them on carvedilol is to change their ejection fraction on echo. the patients will be seen every 1-2 weeks, while we will titrate their medication to a maintenance dose. secondary outcome is to increase quality of life, exercise tolerance and decrease their symptom scores as noted on their questionnaires.


Eligibility criteria:
inclusion criteria: * etiology of heart failure in group 1 or group 2 * moderate heart failure as evidenced by ventricular shortening fraction \<= standard deviations below the mean, or ejection fraction \<= 40% d) documented shortening fraction or ejection fraction that meet criteria for greater than 3 months * standard medical therapy include ace inhibitors plus or minus diuretics plus or minus digoxin; all efforts will made to maximize therapy prior to entry. medication doses must be stable for 3 months prior to entry * willingness to comply with followup testing

Keywords: moderate heart failure
relieving the emergency department by using a 1-lead ecg device for atrial fibrillation patients after pulmonary vein isolation

Conditions: Atrial Fibrillation

Summary: in this study, the researchers explored a new approach to manage atrial fibrillation, a disease that affects millions worldwide. the goal was to see if using a simple handheld ecg device for monitoring heart rhythm could help patients avoid unnecessary visits to the emergency department (ed) after undergoing a common procedure known as pulmonary vein isolation (pvi). this procedure is often used to treat af, but following it patients frequently visit the ed due to concerns about their heart rhythm, which can strain healthcare resources. the researchers proved a group of patients with a 1-lead ecg device , which allowed users to check their heart rhythm at any time. the researchers compared the ed utilization over a year with that of patients who received standard care after pvi. the hope was that by using the 1-lead ecg device, patients could better manage their condition from home and only seek medical help when truly necessary.

atrial fibrillation (af) is a prevalent and clinically significant cardiac arrhythmia, with a growing incidence. the primary objectives in af management are symptom relief, stroke risk reduction, and prevention of tachycardia-induced cardiomyopathy. two key strategies for rhythm control include antiarrhythmic drug therapy and pulmonary vein isolation (pvi), with pvi being recommended for selected patients. even though pvi is effective, post procedural health care utilization is high, contributing to emergency department (ed) overcrowding, which is a global healthcare concern. the use of remote rhythm diagnostics, such as a 1-lead ecg device, may mitigate this issue by reducing ed visits and facilitating more plannable af care. objective: this study aimed to assess whether providing af patients with a 1-lead ecg device for 1 year after pvi would reduce ed utilization compared to standard care. additionally, the study assessed whether this would enhance plannability of af related healthcare utilization. methods: a historically controlled, prospective clinical trial was conducted. the 'intervention' group are patients undergoing pvi for af, all patients in this group receive a km device for 1 year for remote rhythm monitoring. the historical control group were patients undergoing pvi between january 2016 and december 2017; these patients did not receive a km. data on ed visits, planned and unplanned cardioversions, and outpatient contacts in the year after the pvi were collected for both groups.

Eligibility criteria:
inclusion criteria: * af and pvi exclusion criteria: * \<18y

Keywords: 1-lead ecg ed visits
motor and visual development in 2 year olds

Conditions: Development, Child; Motor Skills Disorders; Visual Disorder

Summary: it is a study where investigators are going to measure variables related to motor development and vision through objective tests in children with typical development of two years of age.


Eligibility criteria:
inclusion criteria: * typical development * be enrolled in a nursery school of the university of seville exclusion criteria: * visual deficit * developmental disorder

Keywords: developmet motor visual infant
optimizing ctdna-based mrd assessment in dlbcl, mcl, and fl patients undergoing car therapy

Conditions: Follicular Lymphoma; Diffuse Large B Cell Lymphoma; Mantle Cell Lymphoma

Summary: in this study, invesigators propose to analyze 150 dlbcl patients, 50 mcl patients, and 100 fl patients to determine the clinical utility of ctdna- as well as circulating tumor cell (ctc)-based mrd assessment in car therapy patients. the project detailed in this protocol will utilize the clonoseq platform as specific quantification of residual dlbcl/fl/mcl and correlate its results with radiologic assessment of disease and clinical outcomes. invesitgators predict there will be a strong correlation between ctdna and pet/ct and dynamic changes in ctdna will precede radiologic evidence of disease recurrence in patients following car therapy.


Eligibility criteria:
inclusion criteria: * immunophenotypically confirmed diagnosis of follicular lymphoma (fl), immunophenotypically confirmed diagnosis of large b cell lymphoma (lbcl) (including transformed fl and primary mediastinal b-cell lymphoma) or immunophenotypically confirmed diagnosis of mantle cell lymphoma (mcl) undergoing commercially approved car-t therapy in accordance with fda indication with enrollment in this trial prior to car infusion * car-t product must meet manufacturer specifications * pet measurable disease at the time a decision is made to prescribe car treatment * has sample from diagnosis or relapse available for genomic dna extraction to identify patient's clonotype via clonoseq (see lab manual for details) exclusion criteria: * lack of archival diagnostic or fresh/archival relapse tissue for purposes of determining patient's lymphoma clonotype. given that 5-10% of patients cannot have a clonotype identified by clonoseq, those patients will be removed from the study and excluded from analysis, but their samples will continued to be stored for future analysis as improvements to the analysis platform are made. * no patients are to be excluded on the basis of gender, race, ethnic background, sexual orientation, or other demographic characteristics.
frailty and post-operative complications in older surgical patients: the implication of frailty and preoperative risk assessment

Conditions: Frailty; Surgery; Older Patients

Summary: frailty is prevalent in older adults and may be a better predictor of post-operative morbidity and mortality than chronological age. preoperative risk factors and physiological reserves were assessed on patients more than 70 years old who are scheduled for surgery under general or regional anesthesia. the aim of this retrospective analysis was to examine the impact of relevant geriatric assessments on adverse outcomes in older surgical patients.

the goal of this study is to analyze the effect of frailty status on postoperative outcomes. these include postoperative complications (only icd-10 coded diagnoses), length of hospitalization (ward/icu), disposition, and survival. the project will also attempt to find synergism between a positive frailty status and common medical conditions (e.g. diabetes, congestive heart failure, coronary artery disease, dementia, and kidney disease), as well as anesthesiological and surgical processes (e.g. duration and type of anesthesia, surgical risk, and surgical discipline). different assessment tools will be analyzed regarding their predictive power and clinical practicability. this should help improve preoperative risk assessment and allow for the multidimensional (physical, cognitive, social) identification of relevant frailty characteristics in the perioperative setting. all outcome parameters, including admission and discharge periods, will be collected using coded information from our hospital database. there will be no follow-up measurements after hospital discharge.

Eligibility criteria:
inclusion criteria: * male and female patients with age 70 years and above scheduled for surgery in the department of anesthesiology and intensive care medicine (ccm, cvk), charité - universitätsmedizin berlin
frailty and body composition in the elderly cancer patients treated with chemotherapy

Conditions: Cancer

Summary: the investigators could hypothesize that age-related changes in body composition parameters play a role in the variable tolerance to chemotherapy in the elderly.

however none of the studies relating body composition and chemotoxicity included elderly as a specific subpopulation. furthermore in the majority of studies, body composition analyses are based on the estimation of muscle mass by ct scanner (axial l3 section). this method is to date not validated in the elderly cancer patients. nevertheless some studies used dual energy x-ray absorptiometry (dexa), which is considered the gold standard in the assessment of body composition in older adults. the investigators main hypothesis is that the appendicular muscle mass (i.e. muscle mass of the 4 limbs) operationalized as an index by dividing the muscle mass by squared height following baumgartners' approach (baumgartner, 1998) measured by dexa (total of muscle mass of 4 limbs / height ²) represents a predictive factor of chemotoxicity in the elderly. the finding that body composition is associated with poor tolerance of chemotherapy could lead to consider these parameters in the treatment decision of the elderly cancer patients and improve the current decision-making algorithms when treating older adults.

Eligibility criteria:
inclusion criteria: * breast, prostate, bladder, colo-rectal, ovarian cancers, and lymphoma * metastatic or locally advanced neoplasm * initiation of first line chemotherapy * performance status world health organization (who) 0-3 * capacity to give a written informed consent * life expectancy \> 3 mouths exclusion criteria: * concomitant targeted therapy * concomitant targeted radiotherapy * height \> 196 cm, weight \> 136 kg (dexa not feasible) * hemopathy excluding lymphoma * cognitive impairment compromising the well proceeding and security of the study * cognitive impairment compromising the obtaining of a written informed consent

Keywords: cancer chemotherapy toxicity elderly patients dexa muscle mass
molecular taxonomy of surgically-harvested ocular tissues defined by single-cell transcriptomics

Conditions: Diabetic Retinopathy; Proliferative Vitreoretinopathy; Pterygium; Glaucoma

Summary: the surgically-harvested eye tissue (ie. vitreous-retinal proliferative membrane, outflow pathway, retinas, and pterygium) is a complex tissue responsible for maintaining intraocular homeostasis or mediating ocular pathogenesis. dysfunction of one or more resident cell types within the tissues results in different ocular disorder, leading to vision loss, or even blindness. in this study, we aim to use single-cell rna sequencing to generate a comprehensive cell atlas of surgically-harvested eye tissues.


Eligibility criteria:
inclusion criteria: 1. patients with ocular diseases and require surgery intervention. 2. the surgery intervention remove pathological tissue during surgery. 3. patients consent to the treatment and single-cell sequencing. exclusion criteria: 1. surgically removed eye tissue cannot meet with the quality control of single-cell sequencing (mainly the tissue weight and cell counts);