Kornimate/medical-research-clean huggingface dataset:
a study of baricitinib (ly3009104) in participants with systemic lupus erythematosus (sle)

Conditions: Systemic Lupus Erythematosus

Summary: the main purpose of this study is to evaluate the efficacy and safety of the study drug known as baricitinib in participants with systemic lupus erythematosus.


Eligibility criteria:
inclusion criteria: * have received a diagnosis of sle at least 24 weeks prior to screening, meeting the american college of rheumatology (acr) 1982 revised criteria or the 2012 systemic lupus erythematosus international collaborating clinics (slicc) criteria. * have a positive antinuclear antibody (ana) (titer ≥1:80) and/or a positive anti-double-stranded deoxyribonucleic acid (dsdna) as assessed by a central laboratory at screening. * have a sledai-2k score ≥4 based on clinical symptoms (not including lab values) at randomization. * have active arthritis and/or active rash as defined by the sledai-2k at randomization. exclusion criteria: * have active severe lupus nephritis. * have active severe central nervous system (cns) lupus. * have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute an unacceptable risk when taking investigational product or interfere with the interpretation of data. * have a current or recent clinically serious viral, bacterial, fungal, or parasitic infection. * are currently receiving oral corticosteroids at doses \>20-milligrams per day of prednisone (or equivalent) or have adjusted the dose of corticosteroids within 2 weeks of planned randomization. * have started treatment with or adjusted the dose of nonsteroidal anti-inflammatory drugs (nsaids) (for which the nsaid use is intended for treatment of signs and symptoms of sle) within 4 weeks of planned randomization. * have started treatment with or adjusted the dose of an antimalarial within 12 weeks of planned randomization. * have started treatment with or adjusted the dose of an immunosuppressant within 12 weeks of planned randomization. * have received cyclophosphamide (or any other cytotoxic agent) within 12 weeks prior to screening.
dose proportionality study of pf-00345439 formulation under fed conditions

Conditions: Healthy

Summary: to evaluate the dose proportionality of 5 mg, 20 mg and 40 mg of pf 00345439 formulation under fed conditions in healthy volunteers.


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects between 18 and 55 years of age exclusion criteria: * evidence or history of clinically significant disease. * positive urine drug test

Keywords: dose proportionality oxycodone
evaluation of an individualised written education package for stroke patients

Conditions: Stroke

Summary: the primary aim of the randomised controlled trial was to evaluate the effectiveness of a tailored written education package ("what you need to know about stroke") on the outcomes of: * knowledge about stroke, self-efficacy, anxiety, depression, perceived health status, satisfaction with the content and presentation of the information received, and desire for additional information for patients following stroke and * knowledge about stroke, self-efficacy, anxiety, depression, satisfaction with the content and presentation of the information received, and desire for additional information for their carers. a secondary aim was to evaluate the effect of written information on the outcomes of knowledge about stroke, self-efficacy, anxiety, depression, and perceived health status of patients following stroke and on knowledge about stroke, self-efficacy, anxiety, and depression of their carers.


Eligibility criteria:
inclusion criteria: * had a stroke or transient ischemic attack (tia) or was the informal carer of a person who had a stroke or tia; * had a reported english-proficiency level, corrected hearing and vision, and communication status adequate to participate in an interview and complete assessment tasks; * did not have reported or observable dementia; * lived within 50km of the hospital, for ease of follow-up; and * was medically stable.
evaluation of the high dose of icotinib in advanced lung cancer patients after failure of target therapy

Conditions: NSCLC

Summary: the purpose of this study is to evaluate the efficacy and safety of dose escalation of icotinib in advanced non small cell lung cancer (nsclc) patients after the therapy of icotinib, iressa and tarceva.

* 1:to evaluate the efficacy correlation between the tyrosine kinase inhibitor (tki) drugs and high-dose icotonib group in advanced nsclc patients with high -dose icotinib going on after the routine tki therapy * 2 to evaluate the efficacy correlation between different high-dose group in advanced nsclc patients with high -dose icotinib going on after the routine tki therapy

Eligibility criteria:
inclusion criteria: 1. nsclc patients were confirmed by histology or cytology 2. the time interval must be over 4 weeks from previous chemotherapy to registration to participate in this experiment if he or she received chemotherapy,and also have any toxicity to recover. 3. at least one measureable lesion accord to recist 1.1 criteria and the lesion accepted no radiotherapy. * 1 at least one measureable lesion .if only one measureable lesion, the biological nature must be confirmed by cytology or histology. * 2 a single diameter of lesion could be measured by at least one of the following methods: chest or abdominal computed tomography(ct)or magnetic resonance imaging(mri),conventional methods of diameter at least 20mm diameter spiral ct or at least 10mm. 4. ecog 0-2 score 5. at least 12 weeks of expected survival time 6. women of childbearing age must have a pregnancy test 7 days before treatment and the result were negative ,men of childbearing age: surgical sterilization or treatment during and after the end of three months to take contraceptive measures 7. understand and sign a written informed consent voluntarily. exclusion criteria: if the subject meet any of the following exclusion criteria ,he is no eligible to participate in this study, 1. before enrollment in this trial have used erbitux, herceptin and carried out anti-cancer therapy. 2. use of phenytoin, carbamazepine, rifampicin, phenobarbital or st. john's wort when take this trial 3. severe allergies to icotinib

Keywords: adverse reaction to drug self efficacy
bosentan for treatment of hepatopulmonary syndrome in patients with liver cirrhosis

Conditions: Hepatopulmonary Syndrome; Liver Cirrhosis

Summary: the most common observed cause of gas exchange abnormalities and hypoxemia in cirrhosis is the hepatopulmonary syndrome (hps) with a reported prevalence of 20-47% in patients with hepatic impairment and cirrhosis. hps is by far the most frequent respiratory complication of cirrhosis. it is a progressive disease leading to significantly increased mortality. up to date, the only therapeutic option is liver transplantation. the study hypothesis is that administration of bosentan in patients with liver cirrhosis suffering from hepatopulmonary syndrome improves gas exchange. 18 patients with liver cirrhosis fulfilling criteria of hps according to the ers task force criteria will be included in this block randomized, double-blind, placebo controlled study (12 patients will be treated with bosentan, 6 with placebo). patients will receive bosentan 62,5mg b.i.d. for 4 weeks and 125 mg b.i.d. for 8 weeks or placebo. the duration of the treatment phase of the study is 12 weeks. the primary endpoint is the alteration of gas exchange after 3 months of therapy. the expected duration of the study is 2 years.


Eligibility criteria:
inclusion criteria: * presence of hps * age ≥ 18 years exclusion criteria: * intracardiac shunting * pregnancy * known hypersensitivity to bosentan * use of glyburide * use of cyclosporin a * elevation of aminotransferase level of \> 3 times the upper limit of normal * use of rifampicin * females of childbearing potential without use of adequate contraception * systolic blood pressure \< 85 mmhg * clinical relevant anemia * hiv-infection

Keywords: patients
bone fragility evaluation in obese patients

Conditions: Obesity; Bariatric Surgery Candidate

Summary: this research will study the bone fragility in obese patients, on dxa and ct-scan, in a transversal study. the investigators want also to study the specific risk factors of bone fragility in these obese patients (relationship between body composition on whole body on dxa, fat mass and its location, lean mass, weight loss after surgery and sbac-l1), to improve the bone screening.


Eligibility criteria:
inclusion criteria: * patients followed at nancy university hospital for a bariatric surgery * ct-scan and dxa performed before surgery, with maximum 1 year before the 2 exams exclusion criteria: * \< 18 years * protected adults
safety and efficacy of autologous platelet-rich plasma for erectile dysfunction.

Conditions: Erectile Dysfunction

Summary: the purpose of this study is to evaluate changes in vascular parameters and international index of erectile function (iief) scores with the administration of platelet rich plasma (prp) to participants with erectile dysfunction (ed)


Eligibility criteria:
inclusion criteria: 1. be male 2. be 30 to 75 years of age (inclusive). 3. be able to provide written informed consent. 4. have a diagnosis of ed due to organic origin for at least 6 months prior to consent. 5. sexually active in a stable, heterosexual relationship of more than three months duration. 6. iief-ef score 11-25 at screening (even if taking a single pde5). 7. agree to attempt sexual intercourse at least 4 times per month for the duration of the study without being under the influence of alcohol or recreational drugs. 8. agree to comply with all study related tests/procedures. exclusion criteria: 1. previous penile surgery of any kind (except circumcision and condyloma removal), such as penile lengthening, penile cancer surgery, penile plication, grafting. 2. previous history of priapism or penile fracture 3. abnormal morning serum testosterone level defined as a value lower than 300 ng/dl (±5%) (indicative of untreated hypogonadism), or greater than 1197 ng/dl (±5%). 4. current or previous hormone usage, other than prescribed testosterone, clomiphene or thyroid medication. (subjects with prior or current use of hormonal treatment for prostate cancer are also excluded. 5. psychogenic ed as determined by study investigator. 6. anatomical (peyronie's disease or penile curvature that negatively influences sexual activity) or neurological abnormalities in the treatment area. 7. patients using intra cavernous injection (ici)for management of ed 8. patients with generalized polyneuropathy, or neurological conditions irrespective of cause, such as severe diabetes, multiple sclerosis or parkinson's disease. 9. have a serious comorbid illness/condition/behavior that, in the opinion of the investigator, may compromise the safety or compliance of the subject or preclude successful completion of the study. 10. history of consistent treatment failure with pde5 inhibitors for therapy of ed. 11. any history of significant psychiatric disease, such as bipolar disorder or psychosis, greater than one lifetime episode of major depression, current depression of moderate or greater severity. patients who are currently using selective serotonin reuptake inhibitor or psychotropic medications. 12. hemoglobin a1c \>9%.

Keywords: ed
the effects of cannabidiol on the driving ability of healthy adults

Conditions: Driving Performance; Cognitive Impairment; Sedation Complication; Mood

Summary: a randomized, parallel-group, double-blind, exploratory two-arm trial to assess the effects of cbd on driving ability along with changes in psychological status (i.e. mood, drowsiness, sedation) and cognitive function. forty healthy west virginia university (wvu) students will be allocated and randomized to receive: (1) 300 mg of pure cbd oil or (n=20) (2) placebo matched in appearance and taste (n=20). after consuming the study drug, each individual will participate in a 25-35-minute driving simulation and their driving performance measured. to assess changes in psychological status (i.e. mood, drowsiness, sedation) and drug impairment-related cognitive function, the visual analog mood scale, stanford sleepiness scale , digital symbol substitution test, trail making test part a and b, psychomotor vigilance test, and simple reaction time test will also be administered to participants at baseline (prior to study drug consumption) and following completion of the driving simulation test. the entire protocol will be completed in one day and should take 4-4.5 hours to complete for each participant.


Eligibility criteria:
inclusion criteria: 1) the participant must be currently enrolled as a wvu student, 2) be 18-30 years of age at time of study, 3) have a current drivers' license issued from any state in the united states, 4) has driven at least once in the past 30 days 5) is able to speak and read english, 6) is willing to be randomized and comply with study requirements including a urine drug test on the day they consent to participate in the experiment and complete a test drive to ensure the absence of simulation sickness, 7) not currently taking any daily prescription medications other than birth control, 8) have not been diagnosed with any serious chronic disease by a licensed healthcare provider (including but not limited to alzheimer's and related dementias, parkinson's disease or other neurodegenerative disorder, major depressive or anxiety disorder, schizophrenia or other serious mental illness, arrhythmias, cataracts, glaucoma, chronic obstructive pulmonary disease, diabetes, epilepsy, sleep apnea, and fibromyalgia), and 9) has an individual able to drive them home after testing or is willing to be driven home by study staff after testing completion. exclusion criteria: participants will be excluded if they 1) currently smoke or use tobacco products, 2) have used illegal drugs (including cocaine/crack, heroin, methamphetamine, 3,4-methylenedioxy-methamphetamine, inhalants, phencyclidine, lysergic acid, mushrooms, or marijuana) in the past 30 days, 3) has consumed cbd in the past 7 days, or 4) is currently pregnant or lactating
lactobacillus gg in the prophylaxis of ventilator associated pneumonia

Conditions: Pneumonia; Ventilator Associated Pneumonia

Summary: this study utilizes lactobacillus, or probiotics, delivered twice daily to the mouth and stomach, via feeding tube, in effort to determine whether the oral administration of a naturally occurring lactobacillus species reduces the incidence of ventilator associated pneumonia therefore reducing intensive care unit(icu)complications.

the long-term objective of this research is to determine the utility of altering the oral and gastric bacterial flora in mechanically ventilated patients in order to reduce intensive care unit (icu)complications. specifically, our goal is to determine whether the oral administration of a naturally occurring lactobacillus species reduces the incidence of ventilator associated pneumonia (vap). icu admission is commonly accompanied by overgrowth of the natural gastrointestinal (gi) and oropharyngeal flor by pathogenic organisms. patients requiring endotracheal intubation are predisposed to developing vap, presumably via micro-aspiration of the altered oropharyngeal flora. by reducing vap rates, we hope to improve icu outcomes, minimize icu expenses, and most importantly, decrease morbidity and mortality.

Eligibility criteria:
inclusion criteria: * admission to the medical, surgical, or cardiac icu * age 19 years or greater (the age of majority in the state of nebraska) * anticipated need for \>72 hours of endotracheal intubation * initial intubation during hospitalization * approval of the attending physician responsible for the patient's care * informed surrogate consent within 24 hours of intubation exclusion criteria: * pregnancy * pharmacologic immunosuppression (\>10mg prednisone daily or equivalent for at least 14 days) * native immunosuppression: 1)known hiv disease or aids, 2)history of malignancy, 3)multiple organ system failure * history of prosthetic or bioprosthetic cardiac valve placement * history of prosthetic vascular graft placement * cardiac trauma * history of rheumatic fever, endocarditis, congenital cardia abnormality, or acquired cardia abnormality * gastroesophageal surgery or perforation associated with current admission * intestinal surgery or perforation associated with current admission * significant oropharyngeal mucosal injury * placement of a tracheostomy

Keywords: pneumonia ventilator associated pneumonia probiotics lactobacillus gg
looking for a blood epigenetic signature to predict female infertility

Conditions: Female Infertility

Summary: the present research project aims to study the dnam mechanisms underlying the reduction of fertility due to the progressive depletion of oocyte quality. specifically, our project aims to build an epigenetic clock for mgcs by using outcomes that are certainly related to female fertility. the validation of such findings will be carried out on peripheral blood in order to guarantee its non-invasiveness and allow for any clinical transferability. in order to identify a blood epigenetic signature able to predict female infertility, we planned to explore the problem from different points of view by conducting several studies in different settings.


Eligibility criteria:
inclusion criteria: * 18\< age \<43, infertile woman undergoing art, recurrent pregnancy loss exclusion criteria: * age \ 44, previous ovarian surgery, severe male factor infertility
frontal bone window in icuf (fbw-icu)

Conditions: Acute Brain Injury

Summary: transcranial doppler (tcd) is an established tool for monitoring flows in intracranial cerebral arteries. its use is recommanded in the last guidelines on traumatic brain injury. the temporal bone window (tbw) is limited in evaluating flow in the anterior cerebral arteries (aca) because of an unfavorable insonation angle. thereby tcd could be unfit to detect a segmental lesion on the anterior cerebral arteries (aca). the frontal bone window (fbw) is a promising approach in evaluating flows in the aca. however, the utility of the fbw for patients with acute brain injury (abi) in icu has not been yet determined. the goal of the present study is to determine the rate of detection of the aca by using the fbw in patients with abi in icu.


Eligibility criteria:
inclusion criteria: * membership in a health insurance scheme * patients with an acute cerebral pathology * hospitalized patients in a supportive care unit of montpellier university hospital * be able to benefit from transcranial doppler within 3 days of admission exclusion criteria: * clinical suspicion of encephalic death * known allergy to ultrasound gel

Keywords: adults frontal bone window transcranial doppler
complications in inguinal hernia surgery

Conditions: Inguinal Hernia

Summary: inguinal hernia repair is the most common procedure in general surgery. even with acceptable complication rates, thousands of patients worldwide suffer from inguinal hernia surgery complications every year. in finland, the finnish patient insurance centre (fpic) receives reports from surgical complications. in this study, the database of fpic is used to compare the complication profiles of open and laparoscopic inguinal hernia surgery with mesh.


Eligibility criteria:
inclusion criteria: * surgery between 2002 and 2010 * complicated inguinal hernia surgery reported to fpic exclusion criteria: * none
non-invasive pulmonary artery prediction

Conditions: Heart Failure; Pulmonary Arterial Hypertension

Summary: cardiac remote monitoring devices have expanded our ability to track physiological changes used in the diagnosis and management of patients with cardiac disease. implantable remote monitoring technologies have been shown to predict heart failure events, and guide therapy to reduce heart failure hospitalizations. the cardiomems system, the most studied and established remote monitoring system, relies on a pulmonary artery implant for continuous pap measurement. however, there are no commercially available wearable systems that can reproduce continuous pap tracings. this study aims to determine if a machine-learning algorithm with data from a wearable cardiac remote-monitoring system incorporating ekg, heart sounds, and thoracic impedance can reproduce a continuous pap tracing obtained during right heart catheterization.


Eligibility criteria:
inclusion criteria: 1. subjects age 18+ years 2. undergoing a right heart cardiac catheterization or in the cardiac care unit with active monitoring using an arterial line or swan-ganz catheter. exclusion criteria: 1. vulnerable population 2. unable to consent for any reason 3. unstable patient 4. known skin reaction to latex or adhesives
effectiveness and cost-effectiveness of the check your health preventive programme

Conditions: Health Promotion; Cardiovascular Disease; Physical Inactivity; Selfreported Quality of Health; Mental Health

Summary: check your health is a prevention intervention designed to create awareness and action on health condition with focus at physical activity at a population-level to 30-49 years of age. it consists of a behavioural and clinical examination followed by either (i) referral to a health promoting consultation in general practice (ii) targeted behavioural programmes at the local health centre or (iii ) no need for follow-up; stratified after risk-profile. the core trial (check your health) aim to investigate effectiveness on health and social outcomes of the preventive health check and to establish the cost-effectiveness according to life years gained; direct costs and total health costs. a pragmatic cluster randomised controlled trial has been established to meet the aims and in total 10.600 individuals from 35 practices have been randomized in to two groups that will be invited in 2013-14 and 2017-18 respectively. the group offered the preventive health check in 2013-14 will constitute the intervention group and the group examined in 2017 - 18 the control group. a follow up of the intervention group in 2017 - 18 will provide data for the intention to treat analysis revealing the effect. outcome measures are level of physical activity, risk of getting cardiovascular disease, sick leave and labor market attachment.


Eligibility criteria:
inclusion criteria: * all citizens living in randers municipality aged 30-49 on 1 january 2012, identified in the danish civil registers (dcr) and randomised for health check in 2013 or 2017. exclusion criteria: * terminal illness, reported by their gp is exclusion criteria for receiving invitation.

Keywords: health check health promotion prevention diabetes prevention cardiovascular disease mental health