Kornimate/medical-research-clean huggingface dataset:
ai activity study in patients with elevated blood pressure

Conditions: Hypertension

Summary: in this pilot rct, a total of 40 adults with hypertension will be randomized to either an artificial intelligence (ai) physical activity intervention group or an active control group with a 1 to 1 ratio after completing a 2-week run-in period and 4-week training. the ai intervention group will receive an automated and personalized daily step goal intervention involving a sophisticated activity analytics algorithm using advanced statistics and machine learning, while the active control group will receive a standardized and fixed 10,000 daily steps goal. both groups will receive an identical smartphone app (app content differs between the two groups) and actigraph gt9x link to assess objectively measured physical activity (primary outcome) during the study period.


Eligibility criteria:
inclusion criteria: * age ≥18 years * systolic blood pressure between 130 mmhg to 180 mmhg or/and diastolic blood \*pressure between 80 to 100 mmhg in a research office * speaking and reading english * being physically inactive at work or during leisure time and willing to be physically active * having an iphone 8 or newer or an android lollipop or newer exclusion criteria: * self-reported diagnosis of coronary heart disease, medical condition or other physical problem necessitating special attention in an exercise program (e.g., cancer, eating disorder, uncontrolled diabetes) * current participation in a lifestyle modification program or research study * self-report of being currently pregnant.
evaluation of efficacy and safety of pln-74809 in patients with idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis

Summary: a phase 2a, multicenter, 4-part, randomized, double-blind, dose-ranging, placebo-controlled study to evaluate the safety, tolerability, and pk of once-daily treatment with pln-74809 in participants with idiopathic pulmonary fibrosis.

four part study: part a - 4 week treatment period evaluating pln-74809 or matching placebo part b - 12 week treatment period evaluating pln-74809 or matching placebo part c - 12 week treatment period evaluating up to two intermediatery pln-74809 doses or matching placebo part d - ≥ 24 week treatment period evaluating higher pln-74809 dose or matching placebo

Eligibility criteria:
inclusion criteria: * diagnosis of ipf based upon the fleischner society guidelines within 3 years from screening (part a) or based on ats/ers/jrs/alat 2018 guidelines within 5 years from screening (part b, c \& d) * fvc % of predicted ≥45% * dlco (hemoglobin-adjusted) ≥30% * participants receiving treatment for ipf with nintedanib or pirfenidone are allowed, if on a stable dose for at least 3 months exclusion criteria: * currently receiving or planning to initiate treatment for ipf (fibrosis) with agents not approved for that indication by the fda * forced expiratory volume during the first seconds of the forced breath (fev1)/fvc ratio \<0.7 at screening * clinical evidence of active infection, including but not limited to bronchitis, pneumonia, sinusitis that can affect fvc measurement or ipf progression * known acute ipf exacerbation or suspicion by the investigator of such, within 6 months of screening * smoking of any kind within 3 months of screening
characterization and epigenetics of post-partum preeclampsia

Conditions: Post Partum Pre-eclampsia

Summary: this study will recruit women with post partum pre-eclampsia and match them to controls without postpartum pre-eclampsia to identify an epigenetic signature that is specific to women with post partum pre-eclampsia to help characterize the underlying pathophysiology of post partum pre-eclampsia.

preeclampsia (pec) is a heterogeneous disease that complicates 5-8% of pregnancies. approximately 10% of pec patients will present with post-partum pec without having developed the syndrome during the pregnancy (pp-pec). management of post-partum preeclampsia (pp-pec) is challenging because many women do not seek care until neurologic symptoms result from severe-range elevated blood pressure. the pathogenesis and clinical characteristics of pp-pec are understudied and poorly understood. identifying clinical risk factors and biomarkers of pp-pec would help to identify women at risk.

Eligibility criteria:
inclusion criteria: * post partum pre-eclampsia matching based on: * maternal age (years +/-3) * bmi (+/-5 points) * ethnicity * mode of delivery * gestational age at delivery (+/7 days) * smoking status exclusion criteria: * intrapartum pre-eclampsia

Keywords: post partum pre-eclampsia
study of effectiveness of different lifestyle interventions for health and wellbeing

Conditions: Metabolic Syndrome Risk Factors; Overweight; Psychological Stress

Summary: the purpose of this study is to examine the effectiveness and applicability of different interventions designed for enhancing overall wellbeing. lifestyle changes, as well as psychological and physiological health variables are assessed. the interventions are based on the principles of cognitive behavioural therapy, and delivered either face-to-face, via mobile phone application, or internet.

the study focuses on targeting overweight, stress, and impaired overall wellbeing with new cost-effective intervention methods. the intervention methods are based on the principles of cognitive behavioural therapy (cbt) and further acceptance-commitment therapy (act). the interventions are delivered either face-to-face, via mobile application, or via internet. the purpose of each intervention is to improve the subjects lifestyles and activate them towards beneficial changes in their everyday life. the psychological and physiological effects of interventions are measured with various invasive and non-invasive methods. the study gives new insight into effectiveness and acceptability of up-to-date psychological intervention methods, and new knowledge of different ways to deliver interventions for improving wellbeing of an individual.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) 27-34.9 * psychological stress (3/4 or 4/4 points in general health questionnaire) * possibility to use computer and internet connection exclusion criteria: * diagnosed severe chronic illness * symptomatic cardiovascular disease * type 1 or 2 diabetes * severe psychiatric conditions * remarkable clinical operation within past 6 months * heart attack or stroke within past 6 months * kidney disease requiring dialysis * regular use of cortisone pills * eating disorder: bulimia * disability pension for psychological reasons * pregnancy or breastfeeding within the pas 6 months * shift work (in three shifts) or night work * participation in other intervention studies during the present study

Keywords: cognitive behavior therapy acceptance commitment therapy psychological stress metabolic syndrome overweight life style
surveillance for early liver injuries caused by xianlin gubao pill.

Conditions: Drug-Induced Liver Injury

Summary: this is a prospective registry study to surveil early liver injuries caused by xianlin gubao pill (xlgb pill) through a non-intervention observational way. and attempt to establish a predictive model to screen susceptibilities to xlgb pill.

the primary objectives of this study include: (i) the detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of xlgb pill; (ii) the record of overall individuals with demographics, underlying diseases, physical status, medication information, clinical laboratory index, and so on; (iii) the specimen collection of surveiled individuals. (iv) the attempt to establish a predictive model to screen susceptibilities to xlgb pill.

Eligibility criteria:
inclusion criteria: 1. individuals in accordance with indications for xlgb pill, including symptoms of osteoporosis; 2. the age range of 18 to 70 years； 3. individuals taking xlgb pill over 2 weeks; 4. abnormalities of serum liver biochemistry achieving one of the criteria as follows: (i) alanine aminotransaminase (alt) or aspartate transaminase (ast) ≥2 folds of upper limit of normal (uln); (ii) total bilirubin (tbil) ≥ 2 uln; (iii) alkaline phosphatase (alp) ≥ 2 uln; 5. individuals can provide informed consent form. exclusion criteria: 1. individuals without indications for xlgb pill; 2. unconformity to the xlgb pill drug label; 3. individual taking xlgb pill less than 2 weeks; 4. individuals taking other hepatotoxic drugs combined with xlgb pill, simultaneously; 5. unconformity to the diagnostic standard for herb-induced liver injury (the guideline for diagnosis and treatment of herb-induced liver injury, rpgip-2016cn003）.

Keywords: drug-induced liver injury
a study to evaluate the safety and effect of cfz533 on patients with graves' disease

Conditions: Graves' Disease

Summary: an open label study to evaluate the safety and efficacy of cfz533 following 12 weeks treatment in patients with graves' disease


Eligibility criteria:
key inclusion criteria: * male and female patients 18 to 65 years of age included. * women of child-bearing potential must be willing to use highly effective methods of contraception during the study treatment epoch and for 12 weeks after the last study treatment. * graves' hyperthyroidism, with the following labs measured at screening: * tsh\ uln or ft4\> uln and * trab ≥ 2.5 iu/l * patients must weigh at least 40 kg to participate in the study key exclusion criteria: * history of treatment of graves' disease with radio-iodine ablation or thyroidectomy and/or current treatment with anti-thyroid drugs (methimazole or propylthiouracil) within one week of starting the study treatment * history of hyperthyroidism not caused by graves' disease (e.g. toxic multinodular goiter, autonomous thyroid nodule, or acute inflammatory thyroiditis) and/or history or presence of thyroid storm (fever, profuse sweating, vomiting, diarrhea, delirium, severe weakness, seizures, markedly irregular heartbeat, yellow skin and eyes (jaundice), severe low blood pressure, and coma). * previous treatment with a b cell-depleting biologic agent or any other immune-modulatory biologic agent within 5 half-lives (experimental or approved). * history of recurrent clinically significant infection or of recurrent bacterial infections with encapsulated organisms. * history of primary or secondary immunodeficiency, including a positive hiv (elisa and western blot) test result. * history or evidence of tuberculosis by either of the following tests: * positive ppd skin test (size of induration measured after 48-72 hours, and a positive result is defined as an induration of ≥ 5mm or according to local practice/guidelines) or * positive quantiferon tb-gold test * plans for immunization with a live vaccine within a 2-month period before enrollment or during the study period. * treatment with immunomodulatory drugs, such as cyclosporine a, methotrexate, and/or cyclophosphamide within 3 months from baseline. glucocorticosteroid therapy with prednisolone up to 10 mg daily is permitted if patients are on stable dose for more than 3 months before enrollment in the study. * pregnant, breastfeeding females, and women of child bearing potential unless they are using highly effective contraception

Keywords: graves' disease hyperthyroidism cfz533 tsh
hepastem long-term safety registry

Conditions: Urea Cycle Disorder; Crigler-Najjar Syndrome; Acute on Chronic Liver Failure

Summary: all patients having received at least one infusion of the investigational medicinal product (imp) hepastem hhalpc during a previous interventional clinical study conducted by promethera biosciences


Eligibility criteria:
inclusion criteria: * all patients having received at least one infusion of hepastem during a previous interventional clinical study conducted by promethera. exclusion criteria: * patients who received an olt and completed 6-month fu documentation prior to the start of the prolongstem study. * patients who have received mature liver cells or stem cells other than hepastem prior to the start of the prolongstem study.
thyroid function in term infants with respiratory distress

Conditions: Transient Hypothyroxinemia; Infant, Newborn

Summary: this study was designed to evaluate the level of certain hormones (thyroid hormones and cortisol) in full term or close to full term infants who have respiratory distress severe enough to require respiratory support. the purpose of this study is to determine if there is a relationship between these hormone levels and how sick these infants are who require help with breathing following birth. hypothesis: infants who are born full term or near full term and who have low hormone levels will have higher severity of illness.

transient hypothyroxinemia, as demonstrated by low t4 and free t4 levels with normal levels of tsh, in preterm infants has been associated with increased severity of illness and adverse outcomes. effects of thyroid function in term infants is less well studied. previous research in the special care nursery at christiana hospital has indicated that transient hypothyroxinemia in intubated term infants was associated with increased severity of illness and the need for more intensive rescue therapies. however, free t4, the biologically active substance was not measured in our previous study. infants who meet criteria for the study will begin participation after parental informed consent is obtained. infants who are enrolled will have serial measurements of thyroid stimulating hormone (tsh), t4, free t4, free t3, and cortisol. these measurements will be obtained at four specific time intervals throughout the first week of the infant's life. the medical team will be blinded to the results of the hormone testing. the results will be reviewed by an unblinded study investigator and an endocrinologist will be consulted if abnormal results are reported. these hormone levels will be compared with severity of illness and level of respiratory support needed in order to establish an association between thyroid function and illness severity. illness severity will be quantified by using the score for neonatal acute physiology (snap). snap scores require collecting data from vital signs and results of labs that are considered standard of care.

Eligibility criteria:
inclusion criteria: * infants born \> or = to 35 weeks gestation * infants admitted to the neonatal intensive care unit at christiana hospital * respiratory distress requiring use of mechanical ventilation or nasal cpap (continuous positive airway pressure) * parental informed consent exclusion criteria: * infants born \< 35 weeks gestation * infants with documented congenital abnormalities which directly impact the cardiorespiratory system

Keywords: hypothyroxinemia full term infants near term infants respiratory distress thyroid disease
anthocyanin-rich blackcurrant and vascular function

Conditions: Vascular Stiffness; Inflammation

Summary: regular consumption of fruits and vegetables may improve human health and reduce the risk of chronic diseases, such as heart disease, certain cancers and type 2 diabetes, but the active components and the underlying mechanisms are poorly understood. berry fruits are abundant in anthocyanins and this study aims to test the hypothesis that ingestion of an anthocyanin-rich blackcurrant beverage will improve markers of cardiovascular health (health of blood vessels, inflammation and platelet function). further, the study will investigate the anthocyanin bioavailability from the blackcurrant beverage.


Eligibility criteria:
inclusion criteria: * aged 30-55 years * non-smoker * bmi between 20 - 30 kg/m2 * generally healthy as established by a 'health and lifestyle' questionnaire and a screening blood sample * blood pressure \< 140/90mmhg * total cholesterol \< 6.2 mmol/l * fasting glucose \< 7.0 mmol/l exclusion criteria: * diabetes mellitus * heart problems, stroke, vascular disease * inflammatory disease * kidney, liver, pancreas or gastrointestinal diseases * medication for hyperlipidaemia, hypertension, hypercoagulation, inflammatory conditions * asthma * allergies * smokers (social smokers who agree to abstain for 1 month before and during the study not excluded) * taking phytochemical, antioxidant or fish oil supplements (unless willing to stop for the study period) * taking aspirin \> 2 times per month and unwilling to abstain from aspirin ingestion for 14 days prior each study visit * history of alcohol misuse * consumption of alcohol \>21 units (men) or \>15 units (women) * vegans * intense aerobic exercise \>20 min 3 x per week * participation in another clinical trial * antibiotics in previous 3 months before study * low haemoglobin levels * females who are pregnant, lactating, or if of reproductive age and not using a reliable form of contraception (including abstinence)

Keywords: anthocyanins bioavailability
carbidopa/levodopa/entacapone versus immediate release (ir) carbidopa/levodopa on non-motor symptoms in patients with idiopathic parkinson's disease and demonstrating non-motor symptoms of wearing off

Conditions: Parkinson's Disease

Summary: the purpose of this study is to test the effects of carbidopa/levodopa/entacapone compared to the effects of immediate-release carbidopa/levodopa on non-motor symptoms of end-of-dose wearing off in persons who have parkinson's disease.


Eligibility criteria:
inclusion criteria: * be aged 30 to 85 years. * be male or female - female patients must be either not of childbearing potential (defined as post menopausal for at least one year or surgically incapable of bearing children), or must be practicing contraceptive methods as outlined in the protocol. * have a clinical diagnosis of idiopathic parkinson's disease, exhibiting at least 2 of 3 symptoms (rigidity, resting tremor, bradykinesia) * have non-motor symptoms of end of dose wearing off i.e., the presence of at least one non-motor symptom of parkinson's disease which improves with the next immediate release (ir) carbidopa/levodopa dose as determined by the quantitative wearing-off questionnaire 9 and investigator's assessment. at least one non-motor item has to show a severity of at least 2 points (of a maximum of 4) and show an improvement of at least 1 one hour after immediate release (ir) carbidopa/levodopa administration. also there should not have been a deterioration of 1 point or more in another non-motor item.(all criteria must be fulfilled) * be taking a stable dose of immediate release (ir) carbidopa/levodopa for at least 21 days prior to randomization at an equivalent total daily dose of immediate release (ir) carbidopa/levodopa between 300 to 800 mg. dosing should be either 3 to 6 times per day. exclusion criteria: * have a previous history of being non-responsive to entacapone or tolcapone treatment or having experienced a serious or severe adverse event(s) which resulted in the discontinuation of treatment from the previous use of entacapone or tolcapone; current treatment with entacapone or tolcapone or discontinued treatment with either therapy or discontinued less than 60 days before randomization; * have a history, signs, or symptoms suggesting a diagnosis of secondary or atypical parkinsonism; * have unstable parkinson's disease requiring frequent booster doses; * disabling dyskinesias, indicated by a score of greater than 1 on unified parkinson disease rating scale question #32, or a score of greater than 1 on unified parkinson disease rating scale question #33; * have a history or current diagnosis of psychotic features according to the investigator; other protocol-defined inclusion/exclusion criteria applied to the study.

Keywords: idiopathic parkinson's disease carbidopa/levodopa/entacapone non-motor symptoms motor-symptoms
effect of tadalafil on erectile dysfunction treatment and qol improvement effect (by sf-12) in andropause patients with erectile dysfunction

Conditions: Erectile Dysfunction; Andropause

Summary: observational study to evaluate the effect of tadalafil 5mg once daily on erectile dysfunction and qol in andropause patients with erectile dysfunction. patients will be observed for 8weeks.


Eligibility criteria:
inclusion criteria: 1. above 35 years men 2. approving adam questionnaire and andropause patients with symptoms under contents ; easily fatigue, decreased sexual desire, general weakness, decreasing memory ect. 3. patient with erectile dysfunction above 6 months 4. international index of erectile function(iief-5) score under 21 5. voluntarily one want to treatment with tadalafil 5 mg daily 6. voluntarily one agree this study and write informed consent exclusion criteria: 1. persons who have taken pde-5 inhibitor within last one month for erectile dysfunction 2. persons who taken testosterone treatment within last one month 3. persons who be history of myocardiac infarction 4. the history of taken organic nitrate drug 5. the history of cardiovascular disease * in myocardial infarction within the last 90 days was now * unstable angina or angina pectoris during intercourse that occurred * new york heart association class 2 during the last six months or more sever cardiac failure * uncontrolled arrythmia, hypotension(\ 170/100mmhg) * persons who have a stroke within the last six months 6. persons who have degrative retinal disease including pigmentary retinites 7. formerly persons who have one eye blindness by artery anterior ischemic optic neuropathy with or without taking pde5 inhibitor. 8. persons who use inhibitor or agonist drug f hepatic cytochrome p4503a4 9. persons who use alpha antagonist add antihypertensive drug 10. moderate liver or kidney failure 11. major psychiatric or personality disorder 12. persons have phobia trial drug 13. persons have invasive treatment of prostate gland 14. congenital anomaly of penis 15. galactose, lactose, glucose intolerance patient 16. research coordinators who are deemed unfit
eus-rfa for unresectable pancreatic ductal adenocarcinoma

Conditions: Pancreatic Adenocarcinoma Non-resectable

Summary: the study evaluate the efficacy and safety of eus-rfa using habib eus-rfa catheter with a prospective randomised trial in patients with inoperable pdac.

the five year survival for pancreatic ductal adenocarcinoma (pdac) is less than 5% in spite of the advances in management of cancers in the last few decades. endobiliary application of radiofrequency ablation (rfa) has been developed in our unit and used in patients with unresectable bile duct and pancreatic head adenocarcinomas presenting with biliary obstruction. various techniques of eus-guided tumour ablation have been described, including rf ablation, photodynamic therapy, laser ablation, and ethanol injection. endoscopic ultrasound guided rfa (eus-rfa) of the pancreatic head using habib eus-rfa catheter through a 19-gauge needle was well tolerated in 5 yucatan pigs and with minimum amount of pancreatitis .

Eligibility criteria:
inclusion criteria: * patients in the age group 20 to 80 years * a cytological or histological diagnosis of inoperable pdac based on multidisciplinary review of cross sectional imaging and cytology or histology results. * patients who have been deemed unfit for surgical resection of the pdac subjects who are fit for surgical resection but have declined surgery will also be considered for the study * pdac patients presenting with jaundice to be considered after a successful biliary drainage * patients ought to be fit enough to be considered for the study (ecog performance status 0, 1 or 2) * patients capable of giving informed consent exclusion criteria: * inability to give informed consent * pregnancy or breast feeding * ecog performance status 3 or 4 * life expectancy less than 3 months * patients with distant metastases or malignant ascites

Keywords: pancreatic adenocarcinoma radiofrequency ablation endoscopic ultrasound