Kornimate/medical-research-clean huggingface dataset:
a study of hs-10383 in chinese adult subjects with refractory or unexplained chronic cough (rucc)

Conditions: Cough

Summary: this is a multicenter, randomized, double-blind, placebo-controlled, parallel-designed phase 2 clinical trial to evaluate the efficacy, safety and pharmacokinetic (pk) characteristics of hs-10383 in chinese adult subjects with refractory or unexplained chronic cough (rucc).

the primary objectives of this study are to evaluate the efficacy of hs-10383 in reducing cough frequency as measured over a 24-hour period, and to determine the safety and tolerability of hs-10383. the primary hypothesis is that at least one dose of hs-10383 is superior to placebo in reducing coughs per hour (over 24 hours) at week 4.

Eligibility criteria:
inclusion criteria: 1. subjects should have a full understanding of the study contents, process, and possible adverse reactions, and voluntarily sign the informed consent form; 2. subjects aged 18-70 years (including the critical value) with rucc ≥1 year (diagnosis of rucc according to the expert consensus on diagnosis and treatment of refractory chronic cough in china \[released in 2021\]); 3. subjects whose serum pregnancy test is negative in both screening and baseline visits; exclusion criteria: 1. subjects who are diagnosed with chronic obstructive pulmonary disease, bronchiectasis, idiopathic pulmonary fibrosis and other serious lung diseases; 2. any physiological or mental disease or condition that may increase study risks or interfere with the conduct of the study or affect the ability to complete this study in the opinion of the investigator, such as medical history of depression; 3. subjects who cannot meet the requirements for piror treatment or who cannot adhere to the concomitant treatment as specified in section 6.7-prior/concomitant medications and non-drug treatment. 4. subjects with positive hepatitis a igm antibody, hepatitis c antibody (hcvab), syphilis antibody or human immunodeficiency virus (hiv) antibody at screening visit; subjects with positive hepatitis b surface antigen (hbsag) at screening (except for quantitative detection result of hbv-dna is below the lower limit of the detection reference range). 5. any former smoker with more than 20 packs/year; or have quited smoking for less than 6 months; or subjects who are still smoking (including e-cigarettes); 6. subjects who have a history of serious drug, food or environmental allergies, or who are known to be allergic to the ingredients of investigational product; 7. history of drug dependence,drug or alcohol abuse in the past year; 8. female subjects who are pregnant or breastfeeding; 9. subjects who have previously received anything that may affect drug absorption, including but not limited to: gastrectomy, gastroplasty, any type of weight-loss surgery, vagotomy or enterotomy; 10. subjects who have been vaccinated within 30 days before screening visit, or have a vaccination plan during the whole study period.
regulatory mechanism of orphanin fq in patients with chronic ischemic heart failure

Conditions: Heart Failure

Summary: β 1 adrenergic autoantibody on cardiomyocytes β 1 adrenergic receptor increased the occurrence of malignant arrhythmia in patients with chronic heart failure, accelerated myocardial cell damage, and participated in sudden cardiac death. our team found for the first time that endogenous orphanin enkephalin promotes arrhythmia after acute myocardial ischemia in rats, and its mechanism includes pkc pathway, regulation of action potential duration and cell membrane surface β 1 adrenoceptor internalization disorder. at the same time, n / ofq can regulate the level of immune factors, and immune factors participate in the formation of β1-aa. this study will be verified by clinical observation and animal experiments: first, n / ofq, il-6 and chronic ischemic heart failure, and β 1-aa; second, relationship between il-6 gene 572g / c polymorphism and chronic ischemic heart failure correlation of β 1-aa production; last, objective to verify whether n / ofq is involved in the regulation of il-6 on chronic ischemic heart failure by knocking out n/ ofq gene in the animal model of chronic ischemic heart failure. so as to clarify the mechanism of myocardial cell and extracellular injury, and find a new target for the treatment of chronic heart failure.


Eligibility criteria:
inclusion criteria: * chronic heart failure patients with reduced ejection fraction due to ischemic heart disease. exclusion criteria: * restrictive or hypertrophic cardiomyopathy, hypertensive cardiomyopathy, acute myocarditis, acute coronary syndrome or acute myocardial infarction in the last 2 months, valvular disease (except mitral regurgitation secondary to left ventricular dilation).
training resiliency in youth (try) study

Conditions: Attention Concentration Difficulty; Depression; Anxiety

Summary: the aim of the study is to determine whether a neuroscience-inspired cognitive remediation video game (evo) that targets the cognitive control network (ccn) will improve executive functioning (ef) and resilience to psychiatric symptoms in typically developing 6th grade students, unselected for specific psychiatric symptoms. the primary goals are to 1) determine if evo will result in improved ef and lower internalizing (e.g., mood, anxiety) and externalizing (e.g., attention deficit/hyperactivity disorder, ad/hd) psychiatric symptoms, 2) evaluate whether the benefit experienced by youth changes depending on their level of life stress (e.g., academic or social difficulties), 3) determine if evo will promote resilience to stress. the investigators will measure ef, symptoms, and stress using self- and parent-report questionnaires. other secondary outcomes include information on behavior in the classroom and academic performance (i.e., grades) that we will collect via school records. the investigators hypothesize that engagement with evo 20-minutes per day, 5-days a week across 4-weeks will improve ef, lower psychiatric symptoms, improve academic/behavioral functioning at school, and decrease maladaptive responses to stress.


Eligibility criteria:
inclusion criteria: * currently enrolled in 6th grade during the 2017-2018 school year at lucille umbarger elementary school in the burlington-edison school district * physical ability to use a touchscreen ipad * cognitive ability to assent, complete questionnaires, and play evo game * english speaking child, english or spanish speaking parent * child has legal parent/guardian (i.e., not a ward of the state) exclusion criteria: * the child is identified by parent or school as diagnosed with an intellectual disability * the child is identified by parent or school as diagnosed with a physical disability (i.e., unable to use hands or fingers) that would preclude use of a touchscreen ipad and appropriate engagement with evo * the child is identified by parent or school as unlikely to engage for 20 minutes with evo * child unable to read or understand english * parent unable to read or understand english/spanish * child is in public (i.e., child welfare) custody

Keywords: digital health intervention executive function depression anxiety
beginning early and assertive treatment for methamphetamine use disorder

Conditions: Methamphetamine Use Disorder

Summary: the overall goal of the study is to evaluate the effectiveness of a secondary prevention strategy implemented at a systems-level to prevent stimulant related overdoses.

to date, a public health systems approach to enhance linkage and engagement in care for stimulant use disorders is lacking. this shortcoming arises in part from the lack of effective treatments for stimulant use disorders (stud), the specific pathology of methamphetamine use, and gaps in epidemiologic knowledge related to methamphetamine use disorder. unlike opioid use disorders, for which medications relieve dysphoric symptoms of acute withdrawal and prevent relapse, patients with stud present to care with methamphetamine-induced psychosis and may be combative, agitated, and poorly insightful to their need for treatment. in response to community demands, our team at denver health recently established a pilot program, beginning early and assertive treatment for methamphetamine use disorder (beat meth), to protocolize the assessment and treatment of patients with methamphetamine-induced psychosis.the current research project aims to develop and conduct process and outcomes evaluations of a linkage intervention aimed at increasing continuation and engagement in treatment for stimulant use disorder.

Eligibility criteria:
inclusion criteria: * 18 years of age and older * identified in the denver health healthcare system who have had a methamphetamine-related encounter at denver health exclusion criteria: * unable to complete the interview in english * intoxicated or impaired and unable to consent to participate in the project and/or respond to the interview * currently under residential involuntary psychiatric or substance treatment order (i.e., mental health hold, emergency commitment, or short-term certification) * received any type of substance use treatment at dhha in the last 90 days * planning to enter substance treatment * unable to complete the research visits in the next 90 days
comprehensibility of colorectal cancer screening educational materials: effects on patient knowledge and motivation

Conditions: Colorectal Neoplasms

Summary: the purpose of this study is to determine whether a newly developed patient education document concerning colorectal cancer screening will be better understood and have greater effects on patient knowledge of and motivation for screening than a standard educational document.


Eligibility criteria:
inclusion criteria: * receive primary care at one of the participating outpatient offices * age 50-75 * able to read and speak english * adequate vision, hearing, and hand function to read printed documents, communicate with research staff, answer questionnaires, and otherwise participate * not up to date for colorectal cancer screening (defined as fecal occult blood test within 1 year, flexible sigmoidoscopy within 5 years, or colonoscopy within 10 years)

Keywords: health behavior randomized controlled trials self-efficacy patient education comprehension mass screening prevention and control
epidemiological study to describe non small cell lung cancer clinical management patterns in mena. lung-epiclin/ gulf

Conditions: Non Small Cells Lung Cancer

Summary: the overall aim of the study is: to provide accurate and reliable information regarding nsclc clinical management across mena region in order to detect unmet medical needs of this disease in terms of: * patient and hospital characteristics. * diagnostic and treatment approaches: initial and subsequent. * follow-up patterns in clinical management. * outcomes: symptoms, death, functionality, quality of life. * use of resources and burden on patients and health care systems.

epidemiological study to describe nsclc clinical management patterns in mena

Eligibility criteria:
inclusion criteria: * confirmed nsclc diagnosis (e.g. bronchoscope or fnab), all stages, men and women, attending the responsible department of treating this type of patients for the first time between november 1st, 2011 and august 30th, 2012 for pro * sub-sample: * ability to read and write since they will be asked to participate in the pro part of the study. * selection will not be based on the disease stage of each patient, in order to avoid a selection bias. exclusion criteria: * according to the study design there will not be any exclusion criteria in order to provide a high validity and to obtain the most accurate real daily practice information.

Keywords: all patients with nsclc attending participating hospitals
effect of mulberry leaf extract on blood glucose

Conditions: Prediabetic State

Summary: the purpose of this study is to evaluate the effect of mulberry leaf extract on blood glucose in subjects with impaired fasting glucose.

the purpose of this study is to evaluate the effect of mulberry leaf extract on blood glucose in subjects with impaired fasting glucose. after 2 weeks run-in period for wash-out, subjects will randomly assigned to two groups, i.e. control group (placebo) or mulberry leaf extract group. they will intake placebo or mulberry leaf extract for 4 weeks. biomarkers will be analyzed in blood samples in 0 and 4 weeks.

Eligibility criteria:
inclusion criteria: * age: over 20 years * fasting glucose: 100mg/dl ≤ \~ ≤ 125mg/dl * hba1c: \< 6.5% exclusion criteria: * subject who has taken medicines, chinese medicines and health/functional foods which can affect glucose metabolism in 30 days prior to screening visit * subject who has taken part in other clinical trials in 30 days prior to screening visit * subject who is pregnant or breast feeding * subject who lost body weight over 4 kg in 30 days prior to screening visit * alcoholic * heavy smoker (≥ 20 cigarettes/day) * subject who has heart failure, coronary artery disease, uncontrolled hypertension (≥ 140/90mmhg), diabetes (fasting blood glucose ≥ 126mg/dl), renal dysfunction, liver failure, hyperthyroidism, hypothyroidism, cancer or mental disease * subject who has an allergy to the ingredients of study product
closed-loop fio2 controller during high flow oxygen treatment in pediatric patients (coficohfot)

Conditions: Respiratory Failure

Summary: recently, high flow oxygen therapy (hfot) is becoming more popular in the treatment of any kind of respiratory failure. pediatric mechanical ventilation consensus conference (pemvecc) guidelines suggest measuring oxygen saturation by pulse oximetry (spo2) in all ventilated children and furthermore to measure partial arterial oxygen pressure (pao2) in moderate-to-severe disease in order to prevent excessive use of oxygen while preventing hypoxemia and hyperoxemia. this study aims to compare the safety and efficacy of a closed-loop fio2 controller (cloc) with conventional control of fio2 during hfot of pediatric patients in a pediatric intensive care unit (picu). the hypothesis of this study is: close-loop fio2 controller increases the time spent within clinically targeted spo2 ranges and decreases the time spent outside clinical target spo2 ranges as compared to manual oxygen control in picu patients treated with hfot.


Eligibility criteria:
inclusion criteria: * pediatric patients older than 1 month and younger than18 years of age; hospitalized at the picu with the intention of treatment with hfot at least for the upcoming 5 hours * requiring fio2 ≥ 25% to keep spo2 in the target ranges defined by the clinician * written informed consent signed and dated by the patient or one relative in case that the patient is unable to consent, after full explanation of the study by the investigator and prior to study participation exclusion criteria: * patient with indication for immediate noninvasive ventilation (nimv), or invasive mechanical ventilation (imv) * hemodynamic instability defined as a need of continuous infusion of epinephrine or norepinephrine \> 1 mg/h * low quality on the spo2 measurement using finger and ear sensor (quality index below 60% on the spo2 sensor, which is displayed by a red or orange colour bar) * severe acidosis (ph ≤ 7.25) * pregnant woman * patients deemed at high risk for the need of mechanical ventilation within the next 5 hours * patients deemed at high risk for the need of transportation from picu to another ward, diagnostic unit or any other hospital * diseases or conditions which may affect transcutaneous spo2 measurement such as chronic or acute dyshemoglobinemia: methemoglobinemia, carbon monoxide (co) poisoning, sickle cell disease * formalized ethical decision to withhold or withdraw life support * patient included in another interventional research study under consent * patient already enrolled in the present study in a previous episode of acute respiratory failure

Keywords: acute respiratory failure (arf) pediatric acute respiratory distress syndrome (pards), oxygen closed-loop
the effects of vr interactive games on balance and quality of life enhancement for elderly in the community

Conditions: Virtual Reality

Summary: the goal of this clinical trial is to learn about the effectiveness of the incorporating vr interactive games into exercise courses of the elderly in the community.the main questions it aims to answer are: can it improve their balance ability and the quality of life. participants will receive a twelve-week intervention of 36 sessions using vr interactive games in their exercise prescription, while the control group will follow the original iinstructor-led exercise intervention as the course content.

both groups will undergo three sessions per week, one hour per session, for a total of 12 weeks and 36 sessions of intervention. before and after competing all sessions, the effectiveness of this intervention will be assessed. some physical assessments will be done by all participants such as 2-minute step, right chair sit and reach, left chair sit and reach to compare if any difference between two groups. and participants will do a questionaire to evaluate the psychological and environmental quality of life.

Eligibility criteria:
inclusion criteria: 1. aged 65 or above 2. capable of communicating in mandarin or taiwanese, and willing to participate in interviews or complete questionnaires 3. free of mobility impairments exclusion criteria: 1. stroke with sequelae of mobility impairments 2. parkinson's disease 3. motor neurone disease 4. severe cardio-vascular disease 5. degenerative joint disease with flare-ups in past three months 6. with a lower limb joint surgery in past 3 months 7. vertigo

Keywords: vr balance quality of life
micronutrient-supplemented milk study in women of childbearing age

Conditions: Increase the Concentration of Folic Acid in Women of Childbearing Age

Summary: the purpose of this study is to determine if consuming anmum materna (a fortified milk product) over a 12-week period increases red blood cell folate concentrations in women of childbearing age in singapore, compared to an equivalent amount of standard (unfortified) milk.

folic acid (\~400 µg/day) taken around the time of conception significantly reduces the risk of a neural tube defect (ntd)-affected pregnancy. strategies to reduce ntd with folic acid, include supplement use and food fortification. an attractive strategy for ntd prevention is the use of fortified foods targeted for use by women planning a pregnancy. fonterra currently markets a fortified-milk (anmum materna) in asia, designed for use prior to and during pregnancy. this milk product, if consumed as directed, provides \~400 µg folic acid per day. it is not known whether anmum materna will reduce ntd rate. however, in a case-control study the risk of ntd was inversely associated with maternal red blood cell (rbc) folate concentrations. accordingly, if anmum materna increases rbc folate, it could be expected to decrease ntd risk. in this study, the anmum materna fortified milk will be tested against a standard control (unfortified) milk over a 12 week period. the subjects will consume 75g of milk powder daily throughout the supplementation period.

Eligibility criteria:
inclusion criteria: * female 21-35 years old. * able to understand the nature and purpose of the study, including potential risks and side effects. * willing to consent to study participation and to comply with study requirements. * negative pregnancy test at screening exclusion criteria: * consumption of vitamins and/or mineral supplements known to contain folate 6 months prior. * chronic disease. * milk and/or lactose-intolerant. * pregnancy in the last 12 months, or currently planning a pregnancy. * prior history of ntd-affected pregnancy * serum folate deficiency

Keywords: folic acid supplement neural tube defect-affected pregnancy homocysteine concentration plasma folate concentration plasma vitamin b12 concentration
data collection of routine clinical use with the spectra optia® apheresis system for white blood cell depletion

Conditions: Leukocytosis

Summary: this study is a multicenter, retrospective data collection of routine clinical use with the spectra optia® apheresis system for white blood cell depletion.

the goal of this study is to gather a broader knowledge and information from routine clinical use on the performance and safety of white blood cell depletion procedures with the spectra optia® apheresis system. in order to do so, retrospective data on white blood cell depletion procedures with the spectra optia® apheresis system done in routine use in 3 different centers will be collected and analyzed.

Eligibility criteria:
inclusion criteria: * patients having received a minimum of 1 white blood cell depletion procedure via the spectra optia apheresis system exclusion criteria: * none

Keywords: white blood cell depletion apheresis
computerized tight glycemic control in cardiac surgery

Conditions: Hyperglycemia

Summary: the debate about tight glycemic control (tgc) in the operating room and on the intensive care unit is ongoing, especially in cardio-surgical patients treated with blood cardioplegia, due to high blood glucose levels during operations and subsequent high rates of sternal wound infections. we showed in a feasibility study that early computer based insulin therapy starting in the operating room is a safe therapy that allows to better warrant normoglycemia in patients undergoing major cardiac surgery with the use of blood cardioplegia.

patients are enrolled and randomized into 3 groups. start of therapy is determined as the beginning of cardiopulmonary bypass. group a: therapy with computer-based algorithm and measurement of blood glucose every 30 min. group b: measurement of blood glucose every 15 min using the identical computer-based algorithm. group c: conventional therapy using a fixed insulin dosing scheme. end of therapy is defined as discharge from icu.

Eligibility criteria:
inclusion criteria: * patients over 18 scheduled for elective cardiac surgery with the use of cardiopulmonary bypass and blood cardioplegia exclusion criteria: * under 18 years of age, or if patients had a premedical history of steroid therapy

Keywords: computer based glycemic control, insulin, blood glucose
cardiovascular and metabolic risk after arthroplasty

Conditions: Osteoarthritis of the Knee; Osteoarthritis of the Hip; Cardiovascular Diseases; Metabolic Syndrome

Summary: osteoarthritis is a chronic joint disease that lacks curative therapy. epidemiological studies show increase in the burden of disease. total joint arthroplasty is one of the best treatment options for end-stage osteoarthritis. however, the specific effects of total joint arthroplasty on cardiovascular risk and metabolic profile are largely unknown. the aim of this project is to elucidate how hip and knee total joint arthroplasty impacts cardiovascular risk and metabolomic profile in comparison with general population. we hypothesize that arthroplasty decreases pain, systemic inflammation levels and increases functional status that all lead to decreased metabolic and cardiovascular risk.


Eligibility criteria:
inclusion criteria for the arthroplasty group: primary hip and knee oa (according to the american college of rheumatology criteria) eligible for total joint arthroplasty exclusion criteria for the arthroplasty group: posttraumatic oa, infectious and endocrine related arthropathy, any acute or chronic inflammatory disease, malignancy, renal insufficiency (estimated glomerular filtration rate (egfr) \< 60ml/min/1.73m2), cardiac arrhythmia, clinically significant heart failure, valvular disease, diabetes. exclusion criteria for the control group: any concomitant acute or chronic inflammatory disease, a visit to family practitioner due to hip or knee joint complaints, any persistent knee or hip joint pain, diabetes, symptomatic coronary artery disease, cardiac arrhythmia, cerebrovascular or peripheral artery disease, malignancies and renal insufficiency.

Keywords: metabolomics arthroplasty cardiovascular risk arterial stiffness