Kornimate/medical-research-clean huggingface dataset:
study to evaluate safety and efficacy of lifeliver in acute or acute-on-chronic liver failure patients

Conditions: Acute Liver Failure; Acute-On-Chronic Liver Failure

Summary: this is a prospective, comparative, open label, phase 2b study designed to investigate the safety and efficacy of lifeliver (an extracorporeal bio artificial liver). the study will recruit approximately 40 acute or acute-on-chronic liver failure patients.

patient should have acute or acute-on-chronic liver failure and be registered in konos (korean network for organ sharing) system as a candidate of liver transplantation. patients who meet the eligibility criteria will be assigned to control group or experimental group. experimental group patients will receive lifeliver treatment in addition to the best supportive care for the disease. primary objective: 1. to evaluate the efficacy of lifeliver in terms of a comparison of 30 day-survival rate between control group and experimental group. (after patient's konos (korean network for organ sharing) registration date) secondary objective: 1. to compare a median value of 2 week-survival rate and duration of survival between both study groups 2. survival analysis respect to each group of patients divided according to the konos status 3. to investigate safety and change of overall efficacy indicators in terms of glasgow coma scale, west heaven criteria for hepatic encephalopathy, meld (model for end-stage liver disease) score, blood ammonia, inflammatory cytokine

Eligibility criteria:
inclusion criteria: * 18 to 60 years of age * acute or acute-on-chronic liver failure patients who is waiting for liver transplantation (konos liver transplant emergency grade 2 or 3) * hepatic encephalopathy grade ii or above * the following laboratory values must be documented within the screening period: * inr (international normalized ratio) 2.0 or above * serum ammonia 56 micromole/l or above * total bilirubin 5mg/dl or above * body weight 45kg or above * patient who can not expect effective treatment or prolonged survival * patient or patient's legal representative willing to provide informed consent and commit to study procedures exclusion criteria: * patient who has contraindication to plasmapheresis * severe hypotension (systolic blood pressure 80mmhg or less) * platelet \< 15,000/mm3 * contraindications to liver transplantation (sepsis, severe heart disease, uncontrollable hemorrhage, irreversible brain damage) * cerebral hemorrhage * positive hiv infection * serious or life-threatening hemorrhage just before initiation of the study * patients with high gastrointestinal bleeding tendency (a history or suspicion of gastrointestinal bleeding within last 3 months) * hepatocellular carcinoma patient with 7 (or more) tumors or a 6cm (or larger) diameter single tumor * pregnant or lactating women * antibiotics (beta-lactam family) hypersensitive and streptomycin, amphotericin b sensitive patients * patients with inappropriate condition to participate the study under investigator's judgement

Keywords: acute liver failure acute-on-chronic liver failure artificial liver liver transplantation
traditional chinese medicine constitution study and the diagnosis and treatment of chronic disease in taiwan population

Conditions: Autoimmune Rheumatologic Disease; Kidney Disease; Endocrine, Metabolic or Nutritional Diseases or Conditions

Summary: several questionnaires have been developed for clinical research in traditional chinese medicine. the objective of this study is to evaluate the consistency and relevance of two questionnaires, the constitution in chinese medicine questionnaire (ccmq) and the body constitutions questionnaire (bcq).

aim: several questionnaires have been developed for clinical research in traditional chinese medicine. the objective of this study is to evaluate the consistency and relevance of two questionnaires, the constitution in chinese medicine questionnaire (ccmq) and the body constitutions questionnaire (bcq). method: between december 2015 and december 2016, a sample of 150 participants aged above 20 years from the chinese medical university "elder college" curriculum and outpatients at the hospital in taichung, taiwan, will be interviewed to complete both questionnaires based on subjective symptoms in a 3-d interval. there are three common patterns of body constitutions in ccmq and bcq: gentleness/plain, ying-deficiency, and yang-deficiency. as for other body constitutions, qi-deficiency, phlegm-dampness, dampness-heat, blood-stasis, qi-depression, and special diathesis are described only in ccmq, while stasis is a feature only defined in bcq. average and standard deviation will be used to describe the measurement scores of the questionnaires and the percentages of constitution distribution. statistical analysis of the kappa value, pearson chi-square, odds ratio, and pearson's correlation coefficient would be employed to examine the consistency and association between the two questionnaires. expected result: the investigators hope to 1) describe the constitution profile of the study population; 2) assess the consistency between two questionnaires; and 3) examine the associations between ccmq and demographic life style factors.

Eligibility criteria:
inclusion criteria: * people above 20 years old exclusion criteria: * people who cannot understand the description of questionnaire

Keywords: traditional chinese medicine
efficacy and safety of hrs-7535 tablets in obese subjects .

Conditions: Overweight and Obesity

Summary: the aim of this trial is to evaluate the efficacy and safety of hrs-7535 in chinese obese subjects.


Eligibility criteria:
inclusion criteria: 1. male or female subjects, 18-65 years of age at the time of signing informed consent; 2. at screening and random visit, 28.0 ≤bmi≤ 40.0 kg/m2; 3. diet and exercise control for at least 3 months before screening and random visit, and less than 5 % self-reported change within the last 3 months. 4. able and willing to provide a written informed consent exclusion criteria: 1. presence of clinically significant lab or ecg results that may affect the evaluation of the efficacy or safety of the study drug at screening visit; 2. uncontrollable hypertension; 3. phq-9 score ≥15; 4. history of diabetes; 5. history of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening; 6. any organ-system malignancies developed within 5 years except for cured local basal cell cancer of the skin and in-situ cancer of the cervix; 7. confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness; 8. use of any medication or treatment that may have caused significant weight change within 2 months; 9. history of bariatric surgery; 10. history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening; 11. surgery is planned during the trial; 12. female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method; 13. researchers and relevant staff of the research centre or other people directly involved in the implementation of the programme, and their immediate family members.
a randomized study to evaluate efficacy and safety of a fixed combination therapy of amlodipine and atorvastatin

Conditions: Hypertension; Hypercholesterolemia

Summary: to assess the changes in the trough systolic blood pressure (sbp) and the percent changes in low density lipoprotein-cholesterol (ldl-c) from baseline at week 8 in the treatment period


Eligibility criteria:
inclusion criteria: * the out-patient with concurrent hypertension and hyper-ldl-cholesterolemia is a male or female \>=20 to \<80 years of age at visit 1. * the sbp at visit 4 (week -1) and visit 5 (week 0) is continuously sbp \>=140 mmhg and \<180 mmhg, * ldl-c \>=140 mg/dl and \<250 mg/dl at visit 3 (week -2) and 4 (week -1). exclusion criteria: * subjects who had experienced the following coronary artery disease within the past 3 months. * myocardial infarction * receiving pci（percutaneous coronary intervention）or cabg (coronary artery bypass grafting) * any clinically meaningful valvular disease * subjects with a history of cerebrovascular diseases such as stroke or transient ischemic attack within the past 3 months.
a study of oral tebipenem pivoxil hydrobromide (tbp-pi-hbr) compared to intravenous imipenem-cilastatin in participants with complicated urinary tract infection (cuti) or acute pyelonephritis (ap)

Conditions: Urinary Tract Infection; Acute Pyelonephritis

Summary: the primary purpose of this study is to assess the efficacy of oral tbp-pi-hbr as compared with intravenous (iv) imipenem-cilastatin with respect to the overall response (combined clinical cure plus microbiological eradication) at the test-of-cure (toc) visit in hospitalized adult participants (≥18 years of age) with cuti or ap.


Eligibility criteria:
inclusion criteria: 1. have a diagnosis of cuti or ap. 2. have an adequate urine specimen for evaluation and culture obtained within 24 hours prior to randomization with evidence of pyuria that includes at least one of the following: 1. at least 10 white blood cells (wbcs) per high power field (hpf) in urine sediment 2. at least 10 wbcs per millimeters cubed (mm\^3) in unspun urine 3. positive leukocyte esterase (le) on urinalysis note: participants may be randomized and administered study drug prior to knowledge of urine culture results, but pyuria must be documented. 3. expectation, in the judgment of the investigator, that the participant will survive with effective antimicrobial therapy and appropriate supportive care for the anticipated duration of the study. exclusion criteria: 1. presence of any known or suspected disease or condition that may confound the assessment of efficacy. 2. gross hematuria requiring intervention other than administration of study drug or removal/placement of urinary tract instrumentation. 3. urinary tract surgery within 7 days prior to randomization or urinary tract surgery planned during the study period. 4. creatinine clearance (crcl) of ≤30 milliliters per minute (ml/min), as estimated by the cockcroft-gault formula. 5. anticipated concomitant use of non-study antimicrobial drug therapy between randomization and the lfu visit that would potentially effect outcome evaluations of cuti/ap. 6. receipt of a potentially effective antimicrobial within 72 hours prior to study randomization. 7. severe hepatic impairment at screening, as evidenced by alanine aminotransferase (alt) or aspartate aminotransferase (ast) \>5×upper limit of normal (uln) or total bilirubin \>3×uln, or clinical signs of cirrhosis or end-stage hepatic disease (e.g., ascites, hepatic encephalopathy). 8. pregnant or lactating women. 9. history of epilepsy or known seizure disorder (excluding a history of childhood febrile seizures). 10. history of proven or suspected clostridioides difficile associated diarrhea. 11. history of human immunodeficiency virus (hiv) infection. 12. qt interval corrected using fridericia's formula (qtcf) \>480 milliseconds (msec) based on screening ecg. 13. history of known genetic metabolism anomaly associated with carnitine deficiency. 14. requirement for concomitant use of valproic acid, divalproex sodium, or probenecid between randomization and eot. note: other inclusion and exclusion criteria as per protocol may apply.
registry trial to determine pcle image interpretation criteria and preliminary accuracy in the lung

Conditions: Lung Neoplasms; Disorder Related to Lung Transplantation

Summary: patients will be enrolled that are undergoing bronchoscopy for diagnosis of discrete lung lesions or for detection of acute rejection following lung transplants. the hypothesis is that bronchoscopy together with probe-based endomicroscopy (pcle)results in improved and/or incremental diagnostic yield (definitive diagnosis) over conventional bronchoscopy.

the primary aim of this study is to develop the criteria to differentiate healthy versus diseased tissue in patient with discrete lung lesions or to characterize acute lung rejection in patients with transplanted lungs. once these criteria have been defined, the diagnostic parameters and the reproducibility of pcle will be assessed.

Eligibility criteria:
inclusion criteria: * male or female \> 18 years of age * willing and able to comply with study procedures and provide written informed consent to participate in the study * indeterminate discrete nodule(s) suspicious for cancer scheduled for diagnostic bronchoscopy * newly discovered \&/or prior discovered non classified nodules, hard to define based on ct scan * purpose of bronchoscopy is for diagnosis of lesion(s) - can be solitary pulmonary nodule or multiple lesions * all lesion locations are acceptable * any patient undergoing clinically indicated bronchoscopies after lung transplantation * patients post transplant showing clinical signs of acute rejection \>3 weeks; \< 1 year * patient with single or double lung transplant exclusion criteria: * contraindication to short-acting anesthetic agents; * contraindications to transbronchial biopsy * bleeding diathesis; * a pacemaker/defibrillator; * a diagnosis by other means (sputum cytology, microbiology). * unwilling to consent * unable to safely tolerate a bronchoscopic procedure * unwilling to comply with surveillance bronchoscopy follow up * chronic rejection * fungal disease * ax histological assessment or incomplete biopsy procedure should be considered as a screen failure

Keywords: lung cancer lung neoplasms lung transplant
study of the mechanism of action of cp-690,550 in the skin of subjects with moderate to severe chronic plaque psoriasis

Conditions: Plaque Psoriasis

Summary: there are cells in the skin and blood of humans with chronic moderate to severe plaque psoriasis with specific activities that may determine the effectiveness of treatment. these activities may be described by obtaining samples of skin and blood and analyzing them using a variety of tests.

the final subject in cohort 1 completed the study on 19-nov-2013 (lslv date). because the study analyses were novel and exploratory, they required extensive analyses by study team and external experts. as a result of this analysis it was determined on 21-july-2014 that the data from cohort 1 were sufficiently definitive and that enrollment of cohort 2 would not be justified. since this decision resulted in the lslv for cohort 1 becoming the lslv for the study, the full data analysis and reporting is not projected to be complete within 12 months of lslv. the final analysis and final reporting is planned to be completed on 18-feb-2015. results for this data are anticipated to be released in april 2015.

Eligibility criteria:
inclusion criteria: * adults over 18 years of age with a diagnosis of chronic moderate to severe plaque psoriasis for at least 12 months; in generally good health; on stable dose of non-prohibited medications; able to stop current psoriasis therapy (systemic or topical) for several weeks prior to and during study participation. exclusion criteria: * serious underlying disease including viral disorders such as hepatitis or hiv or skin condition that would interfere with skin biopsies or evaluation of psoriasis; conditions that could interfere with drug absorption after oral administration; history of malignancy or auto-immune disease. * use of oral or injected corticosteroids (steroids).

Keywords: plaque psoriasis tofacitinib biopsy janus kinase randomized placebo controlled clinical trial psoriasis vulgaris
interdisciplinary and family intervention to prevent type 2 diabetes

Conditions: Prediabetes

Summary: the purpose of the study is to evaluate the effect of a family and interdisciplinary approach on individual and family insulin resistance and insulin secretion in patients with prediabetes.

this a randomized clinical trial designed to evaluate the efficacy of the following treatments: 1. family and interdisciplinary approach that includes nutritional, physical activity and psychological counseling + metformin 850mg twice at day for 12 months 2. individual approach that includes nutritional and physical activity counseling + metformin 850mg twice at day for 12 months to improve individual and family insulin resistance and insulin secretion in patients with prediabetes. patients will have a follow-up visit every month in the metabolic research laboratory at the university of guanajuato, mexico, and will have a fasting measurement of lipids, glucose and insulin every 3 months, as well as 2h oral glucose tolerance test (ogtt) at basal, 6 and 12 months.

Eligibility criteria:
inclusion criteria: * patients with prediabetes (fasting glucose 100-125mg/dl and/or 2h post ogtt glucose 140-199mg/dl) * family of patients with prediabetes (in case of the patients that are randomized to family approach) * signing of the inform consent exclusion criteria: * type 2 diabetes * pregnancy * liver disease * renal disease
cardiovascular acoustics and an intelligent stethoscope

Conditions: Heart Valve Diseases

Summary: the aim of the project is to develop an artificial intelligence software capable of analysing heart sounds to provide early diagnosis of a variety heart diseases at an early stage. since the invention of the stethoscope by laennec in 1816, the basic design has not changed significantly. our software could be coupled with existing electronic stethoscopes to create an 'intelligent' stethoscope that could be used by healthcare assistants or practice nurses to screen for sound producing heart diseases. it could also be used at home by patients who would otherwise go undiagnosed. the study investigators at cambridge university engineering department (cued) have developed a proof-of-concept ai algorithm to detect heart murmurs. however, in order to accurately detect the specific pathology and severity underlying the murmur, more heart sound recordings (matched with the ground truth from the patient's echocardiogram) are required. patients presenting to one of the partner hospitals requiring an echocardiogram as part of their routine care will be invited to consent to this study. participation will entail recording of a patient's heart sounds using an electronic stethoscope as well as collection of routine clinical data and a routine clinical echocardiogram at a single routine out patient visit.

this project will develop an ai algorithm which can be imported into a stethoscope to make it capable of automatically diagnosing any valve disease present and its severity. this will help gps produce more accurate diagnoses, reduce costs by having fewer unnecessary referrals for echocardiogram, and produce more accurate diagnoses in countries where echocardiograms are not readily available due to their cost. using a small sample of data as well as some which has been labelled by clinician auscultation, the team has created an award-winning ai algorithm capable of accurate detection of heart murmurs. however, in order to improve the accuracy and capability of this system more heart sound recordings from a range of diseases (matched with echocardiogram diagnosis) are required. the key to the success of this study will be to produce an ai algorithm that is more accurate than different grades of doctors at detecting the specific abnormality and severity underlying a heart murmur. this methodology will also provide a comprehensive study on acoustic characteristics of different heart sounds. so far all the acoustic characteristics of heart sounds taught to medical students are based on subjective opinion. this study will be able to objectively analyse these acoustic characteristics.

Eligibility criteria:
inclusion criteria: * participant willing and able to give informed consent for participation in study * participant to undergo an echocardiogram as part of their routine assessment exclusion criteria: * informed consent is not given * new york heart association (nyha) functional class = 4
impact of maternal stress on infant stunting

Conditions: Maternal; Malnutrition; Infant Malnutrition; Physiological Stress; Emotional Stress; Life Stress; Domestic Violence; Infection; Breast Feeding; Mastitis

Summary: this study takes place in rural mam-mayan communities of guatemala characterized by high rates of childhood stunting. it aims to characterize women's exposure to nutrition, infection and psychosocial stressors vs. resilience factors, to evaluate the cumulative impact of maternal-level factors (nutritional, infectious, psychosocial), social factors (autonomy, social support, domestic violence), and household factors (socioeconomic status, food security) on early infant growth, and to evaluate whether maternal cortisol may be a mediator in the vertical transmission of stress.

grounded in participatory action research and a socio-ecological framework, this mixed-methods, observational study enrolled a longitudinal cohort of 155 women, seen during pregnancy (6-9 mo), early (0-6 wks) and later (4-6 mo) postpartum, and two cross-sectional cohorts (60 early, 56 later postpartum). maternal and infant anthropometry was recorded, maternal fecal, urine and saliva samples were collected, and questionnaires were used to explore household factors (socioeconomic status, food security), social factors (autonomy, paternal/social support, domestic violence), and maternal-level factors (nutrition, infection, emotional distress). analyses focused on (1) characterizing women's exposure to nutrition, infection and psychosocial stressors vs. resilience factors, (2) describing the maternal diurnal salivary cortisol rhythm in pregnancy and postpartum and explore its association with psychosocial variables, (3) assessing the cumulative impact of maternal-level factors (nutritional, infectious, psychosocial), social factors (autonomy, social support, domestic violence), and household factors (socioeconomic status, food security) on early infant growth, and (4) evaluating whether maternal cortisol may be a mediator in the vertical transmission of stress. in addition, photovoice activities involved giving a camera to 23 women from study communities, who documented sources of stress vs. resilience for local women, and shared photo-elicited narratives through six group sessions.

Eligibility criteria:
inclusion criteria: * woman from study communities * either pregnant or 0-6 wk postpartum or 4-6 mo postpartum * consenting to participate exclusion criteria: * twin pregnancy * not consenting to participate

Keywords: maternal health guatemala indigenous population stunting food insecurity poverty social support maternal autonomy paternal support cortisol rhythm