Kornimate/medical-research-clean huggingface dataset:
host response to infection by direct analysis of leukocyte single cell-type gene expression/transcript abundance, direct ls-ta

Conditions: Gene Expression; Gene Expression Profiling; Infection; Viral Diseases; Bacterial Infections; Active Tuberculosis

Summary: febrile illness is a common condition, particularly among young patients and it is crucial to have an early triage of patients according to various aetiologies to enable appropriate treatment. most diagnostic tests are targeted towards the detection of pathogens while other assays are mostly related to serum proteins. blood cells transcriptome has been explored to differentiate bacterial and viral infections. here, we propose to develop a rapid test using the host responses in terms of gene expressions of single-cell populations of peripheral leukocytes (monocytes and granulocytes) to differentiate three major categories of infections that are bacterial, viral, and tuberculosis. the assay is called direct leukocyte single cell-type transcript abundance (ta) assay (direct ls-ta) as it can directly determine the gene expression of a specified single cell-type (e.g. monocytes and granulocytes) among various leukocyte cell populations directly in a peripheral blood sample. such results signify the nature of host response and can be used to indicate the type of infection (viral, bacterial or active tuberculosis).

direct ls-ta is a ratio-based biomarker (rbb) for blood gene expression analysis which can be performed in commonly available equipments (e.g. qpcr or digital pcr machines). using the ratio of ta of prior defined numerator gene and denominator gene, this rbb can quantify gene expression of the specified constitutional single cell-type (e.g. monocytes and granulocytes) inside a cell-mixture sample of whole blood. direct ls-ta was a method pioneered by the pi \[tang 2017, https://patents.google.com/patent/us9589099b2/\]. and it has been developed for quantification of early b cell response after vaccination \[doi: 10.3390/genes12070971\]. recently, the method is used to develop host response biomarkers after infection to differentiate the type of pathogens (such as viral, bacterial or active tuberculosis). numerator and denominator genes have been identified by using public gene expression datasets for monocytes and granulocytes. diagnostic performance was good using these public data. therefore, these rbbs will be applied in these retrospective samples to evaluate and compare their diagnostic (triage) performance of febrile patients into different pathogen etiologies.

Eligibility criteria:
inclusion criteria: * bacterial infection sample: positive isolation of organism in blood culture (bacterial infection sample group) * clinical diagnosed active tb (tuberculosis infection group) exclusion criteria: * end stage renal failure * pregnancy * infections for which long term antibiotic treatment is strongly recommended (including infective endocarditis, osteoarticular infections, cerebral or hepatic or lung abscesses, tuberculosis or nontuberculous mycobacterial infections)

Keywords: host response transcriptome single cell-type gene expression triage fever febrile patients
bond study: the benefit of night splinting in dupuytrens'

Conditions: Dupuytren Contracture

Summary: the bond study is a prospective, randomised single blinded controlled trial to assess the effect of night splinting in patients who have had collagenase injection and manipulation therapy for dupuytren's contracture.

this trial will assess the effectiveness of night splinting in dupuytrens' contracture on functional and quality of life outcomes.

Eligibility criteria:
inclusion criteria: 1. single digit contractures greater than 30 degrees 2. no prior surgery for their contractures. 3. successful collagenase and manipulation therapy (contracture reduced to within 10 degrees of full extension). exclusion criteria: 1. multiple digit contractures 2. prior surgery for their contractures. 3. failure of collagenase and manipulation therapy (contracture not reduced to within 10 degrees of full extension). 4. inability to consent to treatment.

Keywords: collagenase, night-splinting, dupuytrens, contracture
study to evaluate the safety and efficacy of sorafenib, in subject with refractory solid tumors

Conditions: Refractory Solid Tumors

Summary: this study is a single arm, pilot study of sorafenib in patient with braf mutation refractory solid tumor and specific sensitivity to sorafenib 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 sorafenib 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 * braf mutation, refractory solid tumor and/or specific sensitivity to sorafenib 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, platelets\>=100x 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 sorafenib
proof of concept study to determine the safety and antiviral effect of bzf961 with or without ritonavir boosting in hepatitis c virus infected patients

Conditions: Hepatitis C

Summary: to evaluate the antiviral activity of 3 days of bzf961. to determine safety and tolerability of bzf961 in hcv patients. to evaluate pharmacokinetics of bzf961 in hcv patients.


Eligibility criteria:
inclusion criteria: * written informed consent must be obtained before any assessment is performed male \& female treatment naive subjects, age 18-60 years of age with hepatitis c genotype-1. subjects must weight at least 50kg to participate in the study, and must have a body mass index (bmi) within the range of 18-36 kg/m2 able to communicate well with the investigator, to understand and comply with the study requirements. exclusion criteria: * use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer: or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations. subjects that were previously treated for hcv infection.
pharmd transitions of care program (pharmd-toc): a community pharmacy transitions of care program

Conditions: Disease, Chronic

Summary: many hospitals and medical groups have developed transitions of care (toc) programs or procedures in an attempt to reduce hospital readmission and reutilization rates of patients discharged from the hospital. as healthcare's most accessible practitioners, community pharmacists have a unique opportunity to assist with reducing unnecessary hospital re-utilization (re-admissions and emergency department visits) after hospital discharge. the purpose of this study is to conduct and evaluate the implementation of a community pharmacy-based transitions of care (toc) program for high-risk post-discharge patients of pih health hospital-whittier (pih). the primary objective will be to compare the proportion of patients with hospital re-utilization (readmission, observation status, ed visits) during 30-days post hospital discharge between patients randomly assigned to the pharmd-toc group vs. the historic rate at pih. secondary analyses will examine differences between groups and describe implementation details of the pharmd-toc model of patient care.


Eligibility criteria:
inclusion criteria: * - admission lace score: in moderate range (5 to 9) and * taking high risk medication(s): anticoagulants, insulin, oral antiplatelet agents, oral hypoglycemic agents, opioid analgesics, digoxin or taking at least 5 medications and have one of following: chf, copd, asthma, pneumonia, diabetes, esrd, schizophrenia, bi-polar, dizziness, history of falls and * medical or surgical unit patients * age \> 18 years * being discharged to home (with or without home health services) * english and/or spanish speaking * will have access to a telephone post-discharge * ability to give consent * patient admitted to hospital through the emergency department, as a direct admission or as a transfer, or as an elective surgery patient exclusion criteria: * - patients with observation status * caremore health plan patients (caremore has a separate post-discharge program) * patients discharged and followed up by the pih coumadin clinic * patients discharged to residential md house calls program * patients discharged to skilled nursing facility * anyone with planned readmissions * obstetrics patients * hospice patients * oncology patients * anyone who does not meet provisions of protocol * anyone unwilling or unable to give consent for study procedures and data access
exercise with dual task in knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: the purpose of this study is to evaluate the neuromuscular and perceptual responses, pain intensity and performance in patients with severe knee osteoarthritis in a preoperative setting with low-load resistance training with a self-regulated mathematical dual-task.


Eligibility criteria:
inclusion criteria: * men and women above 55 years old. * diagnosed with severe knee osteoarthritis. * scheduled for unilateral tka surgery in a local hospital during 2021- 2022. exclusion criteria: * pain in the contralateral limb (maximum pain, ≥80 of 100 mm on a vas during daily activities). * another hip or knee joint replacement in the previous year. * any medical condition in which exercise was contraindicated. * participated in exercise programs (\>2 days/week, training at intensities of 10-15rm) in the 6 months prior to the study. * history of stroke, brain surgery, major depression, or any self-perceived cognitive alterations that could affect the performance of dual tasks.

Keywords: knee osteoarthritis electromyography muscle activity resistance training
role of sglt2i in patients with myocardial infarction

Conditions: Myocardial Infarction; Diabetes Mellitus

Summary: role of sglt2i in diabetic patients with myocardial infarction


Eligibility criteria:
inclusion criteria: 1. acute myocardial infarction patients 2. type 2 diabetics. exclusion criteria: 1. patients undergoing coronary artery bypass grafting (cabg). 2. severe valvular heart disease. 3. contraindications of secondary medical preventive therapy for myocardial infarction, such as β-blockers, angiotensin-converting enzyme inhibitors (acei)/ angiotensin-converting enzyme inhibitors (arbs), antiplatelets, and statins. 4. previously used sglt2i. 5. severe hepatic and renal insufficiency.
proclaim: effect of ac2592 administered by continuous subcutaneous infusion in subjects with advanced chronic congestive heart failure

Conditions: Congestive Heart Failure

Summary: this phase 2, randomized, placebo-controlled, multicenter outpatient study is designed to test the safety and tolerability of ac2592 as well as examine the effect of ac2592 on oxygen consumption during maximal tolerated exercise in adult subjects with chronic congestive heart failure.


Eligibility criteria:
main inclusion criteria: * has heart failure classified as new york heart association (nyha) class iii or class iv at screening despite treatment with standard therapy. * is able to perform a treadmill test. * has an hba1c of \<= 11%. * is physically and mentally capable of operating the continuous subcutaneous infusion (csci) pump (i.e., adequate vision, manual dexterity, and mental capacity), or has a dedicated caretaker or adult family member who meets this requirement. main exclusion criteria: * has received metformin or nesiritide within 2 weeks prior to screening visit. * is currently participating in any other clinical study, or has received an investigational drug within 1 month of the screening period. * has participated previously in a study using glp-1, exenatide, or exenatide lar. * is using a left ventricular assist device or other mechanical circulatory support.

Keywords: congestive heart failure ac2592 glp-1 amylin metabolic abnormality
efficacy and safety of maz-101 in the treatment of persistent allergic rhinitis (per)

Conditions: Allergic Rhinitis

Summary: the purpose of this study is to evaluate the efficacy and safety of maz-101 in the treatment of moderate-severe persistent allergic rhinitis.


Eligibility criteria:
inclusion criteria: * participants of both sexes, with age greater than or equal to 12 years; * clinical diagnosis of moderate-severe persistent for at least 1 year; * screening visit: a 12-hour reflective tnss ≥ 8 out of a possible 12 and a congestion score of 2 or 3; * randomization visit: a 12-hour reflective tnss (am or pm) ≥ 8 on 3 separate symptoms assessments during the lead-in period; an am or pm 12-hour reflective nasal congestion score of 2 or 3 must have been recorded on 3 separate symptom assessments; * present skin sensitization test to at least one aeroallergen. exclusion criteria: * any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants; * other clinical forms of rhinitis; * subjects receiving immunotherapy; * presence of nasal polyposis; * patients with severe arterial hypertension, severe coronary diseases, cardiac arrhythmias, glaucoma, ocular herpes simplex, cataracts, hyperthyroidism; * asthma sufferers; respiratory tract infections and lung disease, including chronic obstructive pulmonary disease (copd); * presence of grade ii or iii septal deviation and/or presence of nasal polyps or other conditions that determine nasal obstruction; * concomitant chronic or intermittent use of decongestants and/or antihistamines and/or inhaled, oral, intramuscular, intravenous or potent topical corticosteroids; * participants using monoamine oxidase inhibitors (maois); * participants with known allergy or hypersensitivity to the components of the drugs used during the clinical trial; * history of alcohol abuse or illicit drug use; * pregnancy or risk of pregnancy and lactating patients;
study on burst fractures (sunburst)

Conditions: Thoracolumbar Burst Fracture

Summary: thoracolumbar (tl) burst fractures are seen in all ages and usually associated with high-energy trauma. treatment include both surgical and non-surgical options. in cases without neurological deficit or definite rupture of the posterior ligament complex (plc) both surgical treatment and non-surgical treatment are considered standard of care. this study aims to compare outcome between surgical and non-surgical in patients with a single level tl burst fracture (ao a3/4) in a randomized controlled trial (rct).

the study is an international, multicenter, randomized controlled trial. 202 patients with a single level tl burst fracture will be enrolled in the study. they will be randomized 1:1 to either surgery with posterior fixation or non-surgical treatment. the study is pragmatical in its approach, i.e., the treating physician can decide on details of the surgical treatment as well as details of the non-surgical treatment. in non-surgically treated patients brace treatment is not required, but a hyperextension brace may be offered. the subjects will be followed with patient reported outcomes, clinical assessments, and radiological assessments. data will be collected from questionnaires, patient files or national registers to compare sick leave, medical complications, pharmaceutical prescriptions and overall costs for each treatment.

Eligibility criteria:
inclusion criteria: * a single level thoracolumbar (th10-l3) burst fracture, a3 or a4, according to the ao spine classification * aged 18-66 years * informed consent * acute injury with diagnosis and treatment within 2 weeks * may have minor fractures in adjacent vertebras if these fractures in themselves would not have resulted in any treatment * may have a single nerve root injury exclusion criteria: * unable to consent, no consent given or not informed * neurological injury involving more than a single level root, i.e., spinal cord and/or cauda equina injury * definite rupture of the posterior tension band (through bony and/or ligamentous structures) verified on mri * patients with ankylosing spinal disorders spanning the fracture area * prior spinal surgeries within the fractured area * open vertebral fracture * additional injury which would impair early ambulation, e.g., long bone fractures, severe head injury, long-lasting intensive care * patients not deemed suitable due to severe co-morbidities. (e.g., established osteoporosis that would impair the possibility to maintain integrity of spinal implants, pathological fractures, severe cardiac or pulmonary compromise, or other systemic disease that would result in such high anesthesiologic risk that surgery would not be attempted.) * patients already included in the study cannot be randomized again if they get an additional spine fracture

Keywords: thoracolumbar spine burst fractures thoracic or lumbar vertebrae register-based randomized controlled trial conservative treatment surgical treatment non-surgical treatment
tcm daoyin therapy in individuals at-risk for copd

Conditions: Chronic Obstructive Pulmonary Disease; Lung Diseases, Obstructive

Summary: chronic obstructive pulmonary disease (copd) is a common, preventable and treatable disease. the aim of prospective randomized study is to evaluate the effects of tcm daoyin training on individuals at-risk for copd.

chronic obstructive pulmonary disease (copd) is the third leading cause of death worldwide. early prevention and treatment of copd is crucial, but there is a lack of specific interventions for individuals at-risk for copd in clinical guidelines. the study focuses on individuals at-risk for copd (copd-sq≥16, current lung function failed to meet diagnostic criteria for copd but with manifestations of early airflow limitation). this is a two-group prospective, randomized, assessor-blinded trial, planning to enroll 60 participants (30 for tcm daoyin intervention group receiving health education plus a tcm daoyin training program, and 30 for health education control group only receiving health education). tcm daoyin is a form of mind-body exercise with a profound philosophical foundation rooted in chinese culture. previous researches have provided some evidence of beneficial effects on tcm daoyin for copd patients with an established diagnosis, such as liuzijue and baduanjin. however, the evidences of tcm daoyin on patients with early copd is limited. the aim of prospective randomized study is to evaluate the effects of tcm daoyin training on individuals at-risk of copd.

Eligibility criteria:
inclusion criteria: * subject at-risk for copd (chronic obstructive pulmonary disease screening questionnaire (copd-sq) score≥16; and pre-bronchodilator fev1/fvc ≥ 0.70, or pre-bronchodilator fev1/fvc\<0.70 but post-bronchodilator fev1/fvc ≥ 0.70). * aged 40 to 75, male or female. * subject has a clear mind and the ability to lead an independent life. * subject agrees to perform a blood-test. * subject agrees to participate in this study and sign to the informed consent. exclusion criteria: * subject with acute exacerbation of copd. * subject with respiratory infectious disease (e.g., tuberculosis, influenza, etc.) within 1 month. * subject with serious current unstable physical illness and mental illness. * subject with definite clinical diagnosis of alzheimer's disease, or severe cognitive impairment. * subject is pregnant or lactating women.

Keywords: tcm daoyin at-risk for copd early copd chronic obstructive pulmonary disease
a study of nst-6179 in subjects with intestinal failure-associated liver disease (ifald).

Conditions: Intestinal Failure Associated Liver Disease

Summary: this is a phase 2a, multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (pk), and pharmacodynamics (pd) of nst-6179 in subjects with intestinal failure-associated liver disease (ifald) receiving parenteral nutrition (pn). the study will be conducted in 2 sequential parts. up to 36 subjects diagnosed with ifald will be enrolled in the study, of which up to 18 subjects will be enrolled in each of the 2 parts and randomized (2:1) to receive nst-6179 (n=12/part) or matched placebo (n=6/part). subjects in part a will receive once daily (qd) oral administration of 800 mg (32 ml solution) nst-6179 or placebo for 4 weeks. the nst-6179 dose for part b is planned to be 1200 mg qd for 12 weeks. actual dose, however, will be determined during the safety review meeting.


Eligibility criteria:
key inclusion criteria: * adult persons aged 16 years or older at the time of informed consent. * minimum of 6 months on parenteral supplementation. * established clinical diagnosis of ifald based on a persistent elevation of 1. liver enzymes (alp, ast, alt, or ggt ≥1.5 × upper limit of normal \[uln\]) for ≥6 months and/or 2. total bilirubin \> uln for ≥6 months. * laboratory parameters consistent with stable liver disease without cirrhosis as defined by: 1. alt and ast \<5 × uln; 2. total bilirubin ≤2.5 mg/dl in the absence of gilbert's syndrome. 3. serum albumin ≥2.5 g/dl; 4. international normalized ratio (inr) ≤1.3 in the absence of anticoagulant therapy; 5. platelet count ≥120,000/mm3. key exclusion criteria: * clinical, laboratory, imaging, or histopathologic evidence of other causes of acute or chronic liver disease, including autoimmune, viral, metabolic, or alcoholic liver disease. * clinical evidence of compensated or decompensated hepatic cirrhosis as assessed by historical liver histology, ultrasound-based and/or signs and symptoms of hepatic decompensation (including, but not limited to, jaundice, ascites, variceal hemorrhage, and/or hepatic encephalopathy). * presence of hepatic impairment, end-stage liver disease, and/or a model for end-stage liver disease (meld) score \>12. * transient elastography read \>20.0 kpa within 3 months prior to or during the screening period. * estimated glomerular filtration rate \<45 ml/min based on the 2021 ckd-epi creatinine equation. * poor nutritional status defined as body mass index (bmi) \<17 kg/m2.