Kornimate/medical-research-clean huggingface dataset:
an open, randomized, two way crossover study comparing the effect of 20mg esomeprazole administered orally and intravenously as a 15 minute infusion on basal and pentagastrin-stimulated acid output in subjects with symptoms of gastroesophageal reflux disease (gerd)

Conditions: GERD

Summary: this study looks at the effect on basal and pentagastrin-stimulated acid output of 40 mg esomeprazole (nexium) administered orally and intravenously as a 15-minute infusion to people with symptoms of gastroesophageal reflux disease (gerd)


Eligibility criteria:
inclusion criteria: 1. heartburn on at least 2 days of the past 7 days prior to screening, with or without a history of ee or a documented diagnosis of gerd within 6 months prior to screening, with or without a history of ee. 2. body mass index (bmi) of ≥18.5 and ≤35 kg/m2. \[bmi will be calculated using the following formula: weight (kg)/height (m)2.\] 3. able to communicate with the investigator and to understand and comply with the requirements of the study. exclusion criteria: 1. history of esophageal, gastric, or duodenal surgery, except for simple closure of an ulcer. 2. history of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis. 3. any significant "alarm symptoms", within the past 6 months, such as, unintentional weight loss, gastrointestinal bleeding, jaundice or any other sign indicating serious or malignant disease. 4. abnormal lab test results, as indicated in the protocol. 5. other diseases, as indicated in the protocol.

Keywords: gastroesophageal reflux disease (gerd), esomeprazole, nexium
a study of baricitinib (ly3009104) in participants with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this post-marketing study is designed to compare the safety of baricitinib versus tumor necrosis factor (tnf) inhibitors with respect to venous thromboembolic events (vtes) when given to participants with rheumatoid arthritis.


Eligibility criteria:
inclusion criteria: * participants must have at least one of the following characteristics: * documented evidence of a vte prior to this study * at least 60 years of age * a body mass index (bmi) greater than or equal to 30 kilograms per meter squared (kg/m²), or * age 50 to less than 60 years and bmi 25 to less than 30 kg/m². * participants must have an inadequate response or intolerance to at least 1 disease-modifying antirheumatic drugs (dmard) (synthetic or biologic). exclusion criteria: * participant should have no reason to not take a tnf inhibitor. * participants must not be pregnant or breastfeeding. * participants must not have had more than one vte. * participants must not have cancer. * participants must not have active herpes zoster, serious infection, active tuberculosis, or any other serious illness. * participants must not have had a live vaccine within four weeks of study start. * participants must not have participated in any other clinical trial within four weeks of study start. * participants must not have a history of iv drug use, other illicit drug abuse, or chronic alcohol abuse in the past year.
a twice-daily individual targeted exercise program in frail hospitalised older medical in-patients (rct)

Conditions: Frail Older Adults

Summary: this study will help to determine whether frail older medical inpatients will benefit from targeted exercise sessions performed twice daily while in hospital. half of the patients will complete targeted strengthening, balance and endurance exercises and the other half, stretching and relaxation exercises. the exercise sessions will be assisted and supported by a senior physiotherapist.

it is well known that older medical patients can experience functional decline following an acute hospital admission and this can persist for up to three months. the targeted exercises are designed to prevent this functional decline by maintaining the patients' strength, balance and endurance. to counterbalance the considerable time spent with the physiotherapy services in the intervention arm, the control group will receive stretches and relaxation exercises. patients' length of stay is the primary outcome measure. their physical performance and quality of life at discharge and at 3 months post discharge and their readmission rates are the secondary outcome measures.

Eligibility criteria:
inclusion criteria: * medical patients * anticipated length of stay greater than 2 days * planned for discharge home * mobility aid and /or assistance required on admission exclusion criteria: * contraindications to exercise * unable to follow commands in the english language * unable to exercise with the assistance of one person only * when active palliative care is required * when full isolation for containment of a contagious infection is required

Keywords: frailty older adult hospital exercise randomised control trial functional decline
protocol to support breastfeeding for postpartum women and mothers of babies with congenital heart disease

Conditions: Breastfeeding; Congenital Heart Disease

Summary: to evaluate the effect of applying a hybrid protocol (face-to-face and via call center) of breastfeeding assistance and guidance on the duration of breast milk supply to babies with congenital heart disease for 6 months.

the objective of this randomized, multicenter clinical trial is to evaluate the effect of applying a hybrid protocol (face-to-face and telemarketing) of assistance and guidance on breastfeeding and duration of breast milk supply for infants with congenital heart disease in the first 6 months of life. recruitment of infants diagnosed with congenital heart disease occurs within the first 72 hours of life, being followed up for 6 months. initially, the mothers in the control group, as well as the mothers in the intervention group, receive a booklet with guidelines on breastfeeding, a standardized measuring cup for milk collections and a breastfeeding booklet. in addition, mothers in the intervention group receive monthly videos with guidance on breastfeeding, monthly consultations with a breastfeeding consultant and a support group via whatsapp with the researcher and scientific initiation student until the baby is 6 months old.

Eligibility criteria:
inclusion criteria: * infants diagnosed with congenital heart disease, * the parents must have a cell phone enabled to receive video calls. exclusion criteria: * mothers carriers of the human immunodeficiency virus (hiv), * mothers users of medications without medical indication to initiate or maintain breastfeeding.

Keywords: breast milk congenital heart desease nutritional status 6 months call center
study to evaluate met642 in patients with nash

Conditions: NASH - Nonalcoholic Steatohepatitis

Summary: a randomized, double-blind, placebo-controlled study to evaluate met642 in nash patients.


Eligibility criteria:
inclusion criteria: * diagnosis of nash via biopsy, magnetic resonance elastography (mre), or transient elastography (te, fibroscan) * liver fat content ≥ 10% as measured by magnetic resonance imaging-proton density fat fraction (mri-pdff). exclusion criteria: * history of significant liver disease (eg, alcoholic liver disease, viral hepatitis, etc.) or liver transplant. * presence of cirrhosis on any prior liver biopsy (stage 4 fibrosis). * excessive consumption of alcohol.

Keywords: nash fatty liver
a phase 2 study of mavacamten in adults with symptomatic non-obstructive hypertrophic cardiomyopathy (nhcm)

Conditions: Non-obstructive Hypertrophic Cardiomyopathy

Summary: this is a multicenter, exploratory, randomized, double-blind study of the administration of mavacamten in 60 participants with symptomatic nhcm randomized to receive a 16-week course of mavacamten doses titrated to achieve 1 of 2 target drug concentrations.


Eligibility criteria:
key inclusion criteria: * diagnosed with nhcm (hypertrophied and non-dilated left ventricle in absence of systemic or other known cause), with lv wall thickness ≥ 15mm at screening or ≥ 13mm with a positive family history of hcm. * age 18 and greater, body weight \> 45kg * documented lvef ≥ 55% at the screening as determined by echo central lab * lvot gradient \< 30 mmhg at rest and during valsalva and post-exercise * nyha functional class ii or iii * elevated nt-probnp at rest key exclusion criteria: * history of syncope, sustained ventricular tachyarrhythmia with exercise, obstructive coronary artery disease or myocardial infarction within the past 6 months * history of resuscitated sudden cardiac arrest at any time or known appropriate implantable cardioverter defibrillator (icd) discharge within 6 months prior to screening * current treatment with disopyramide or ranolazine (within 14 days prior to screening) * current or planned treatment during the study with a combination of beta-blockers and calcium channel blockers * has been treated with invasive septal reduction (surgical myectomy or percutaneous alcohol septal ablation \[asa\]) within 6 months prior to screening * history of resting or post-exercise lvot \>30 mmhg unless subsequently treated by septal reduction * has qtc fridericia (qtcf) \>480 ms or any other ecg abnormality considered by the investigator to pose a risk to participant safety (eg, second-degree atrioventricular block type ii) * has persistent or permanent atrial fibrillation not on anticoagulation for at least 4 weeks prior to screening and/or not adequately rate-controlled within 1 year of screening * history of clinically significant malignant disease within 10 years such as non-metastatic cutaneous squamous cell or basal cell carcinoma * history or evidence of any other clinically significant disorder, condition, or disease that, in the opinion of the investigator or myokardia physician, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
hospital mortality in patients submitted to pharmacoinvasive strategy with tenecteplase (tnk)

Conditions: Acute Coronary Syndrome

Summary: this study has the following objective: to identify related factors to hospital mortality in patients with st-segment elevation acute myocardial infarction submitted to pharmacoinvasive strategy within a structured healthcare network.

primary percutaneous coronary intervention is the main therapy for patients with st-segment elevation acute myocardial infarction. however, a significant portion of these patients won't receive optimal treatment due to the small number of tertiary centers with interventional laboratories available for 24 hours a day, 7 days a week. specially in large urban centers and rural areas, where tertiary care hospitals are restricted to a specific region, alternative approaches must be developed. the pharmacoinvasive strategy has emerged as an alternative for patients admitted to primary care centers. it is based in up-front intravenous thrombolytic therapy and transfer to a tertiary center where early, systematic, coronary intervention will be performed between 3 to 24 hours after the administration of thrombolytic drugs, even in cases in which successful reperfusion was obtained.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of st-segment elevation acute myocardial infarction submitted to pharmacoinvasive strategy with tenecteplase. exclusion criteria: * absence of obstructive coronary disease * surgical reference * did not undergo catheterization
a clinical trial to assess the effect of hc-svt-1001 and hc-svt-1002 in the surgical treatment of atrophic pseudarthrosis of long bones (bonecure)

Conditions: Pseudoarthrosis

Summary: the purpose os this study is to evaluate the safety and effectiveness of hc-svt-1001 and hc-svt-1002 in the surgical treatment of atrophic nonunion in long bones.


Eligibility criteria:
inclusion criteria: * patients of either sex between 18 and 65 years of age (both inclusive). * diagnosis of atrophic pseudoarthrosis of long bones confirmed radiographically. exclusion criteria: * present infection (infection signs should not be evidenced). * other lesions which interfere with the body weight load. * open pseudoarthrosis (at the time of inclusion). * congenital bone diseases (hypophosphatemia), metabolic bone disease associated with primary or secondary hypoparathyroidism. * other conditions or circumstances that compromise the study participation according to medical criteria.
cpap vs asv for insomnia

Conditions: Insomnia; Sleep-Disordered Breathing

Summary: the study will determine which of two different types of positive airway pressure (pap therapy) modes are more effective in reducing sleep breathing events in chronic insomnia patients and in decreasing insomnia severity.

patients presenting to the sleep clinic with a primary complaint of insomnia will be potential participants for this study. following diagnostic polysomnography (psg) testing, insomnia patients diagnosed with sdb and meeting inclusion criteria will be randomized to a pap treatment arm, cpap or asv. participants will complete titration studies with their assigned pap mode and attend clinical follow-up appointments over a 14-16 week timeframe. titration psg studies will assess pap pressure needs to ensure that patients are receiving optimal therapy at all times during this study. pap adaptation barriers will be addressed as they arise during the study, because it is important that participants are able to use pap therapy nightly during participation in this protocol. baseline scores on insomnia severity, sleep quality, subjective insomnia parameters, sleep related impairment, and quality of life will be compared to outcome measures at the 4 month mark. pre-treatment and post-treatment objective improvements on sleep studies will also be compared including sleep breathing indices, sleep consolidation indices, and objective data download information.

Eligibility criteria:
inclusion criteria: * primary complaint of insomnia when presenting at clinic * diagnosis of moderate to severe insomnia through the insomnia severity index (isi) with a score ≥ 15 * meet diagnostic criteria of insomnia disorder (per american academy of sleep medicine) * diagnosis of sdb, either osa as determined by an ahi ≥ 5 events/hour or uars with a rdi ≥ 15 events/hour and ahi \< 5 events/hour * naïve to treatment for sleep-disordered breathing (sdb), including cpap, apap, asv; mandibular repositioning devices (mrds), and any other nasal or oral therapy with a primary indication of treating sdb * able to fully understand study information in english and sign informed consent exclusion criteria: * primary complaint of sleep-disordered breathing or issues with apneas during sleep * severe respiratory disorder or severe sleep disorder such as restless leg syndrome (rls), idiopathic hypersomnia, or narcolepsy * bmi \> 30 kg/m2 * epworth sleepiness scale (ess) score ≥ 10 * frequent napping behavior, such as a few times a week or more * anticipated changes to start or stop sedative or psychotropic medications during the course of the trial * medical history of congestive heart failure (chf) or other potentially unstable cardiac disease as well as chronic lung diseases or other debilitating medical conditions that manifest as more prominent in the patient's health compared to their sleep complaints * daily use of opiate medications * known contraindications to pap therapy as listed in the indication for use * requires a cpap (fixed) pressure \> 20 cm h2o * inability to comply with study procedures
efficacy of different doses of pregabalin as a multimodal analgesic agent in postoperative pain control after total knee arthroplasty

Conditions: Knee Osteoarthritis

Summary: the purpose of this study is to compare the efficacy of 75 mg of pregabalin and 150 mg of pregabalin in postoperative pain control after tka.

after being informed about the study and potential risks, all patients giving written informed consent will be chosen for eligibility for the study entry. at the day before surgery date, patients who meet the eligibility criteria will be randomized in a double-blind manner (participant and investigator) in a 1:1 ratio to 75 mg of pregabalin and 150 mg of pregabalin groups.

Eligibility criteria:
inclusion criteria: 1. symptomatic primary knee osteoarthritis undergoing unilateral tka 2. aged between 55 and 80 years old 3. comply with protocol exclusion criteria: 1. allergy to any of the medications in this protocol (pregabalin, morphine, paracetamol, celecoxib, tramadol, aspirin) 2. secondary osteoarthritis of the knee including autoimmune diseases and post-traumatic 3. previous surgery on the knee 4. contraindicated to spinal anesthesia (sb) or adductor canal block (acb) 5. gfr \< 30ml/min, severe liver function (child-pugh c) 6. history of seizure or cerebrovascular diseases

Keywords: total knee arthroplasty pregabalin
effectiveness of an automated falls-risk screening and referral tool in the emergency department (ed)

Conditions: Falls-Risk

Summary: the purpose of this retrospective cohort study is to evaluate the effectiveness of an ehr-based clinical decision support system (cds) for automatically screening older adult ed patients for risk of future falls and providing ed clinicians opportunity to place referrals orders to the uw health mobility and falls clinic for those at highest risk prior to discharge. this cds tool has already been implemented at the uw hospital ed, and as a qi initiative will be implemented in a staged process at two other uw health-affiliated emergency departments (the american center and swedish american hospital).

the specific aim of this retrospective cohort study is to test the effectiveness of the automated screening and referral intervention on completed referrals to the uw health fall prevention clinic and rates of injurious falls, using a limited dataset created from ehr and medicare claims data. the investigators hypothesize that ed patients referred using the falls risk cds tool will have decreased healthcare use due to fall-related injuries, and that the intervention will have similar levels of effectiveness across different types of patient characteristics. the investigators will also systematically examine barriers to patients completing their clinic referrals, as well as clinic scheduling and pre-visit planning protocols that may have excluded patients from receiving falls clinic services. effectiveness will be assessed based on examination of a limited dataset consisting of ehr and medicare claims data measuring rates of (1) patient referrals at each ed, (2) completed referrals to the mobility and falls clinic (i.e., a completed clinic appointment), and (3) healthcare visits for fall-related causes occurring within the six months following the initial ed visit. the primary analysis to evaluate effectiveness of the fall-risk cds tool will include data from older adult patients (age ≥65) who visit study eds during the intervention period at each site, have a uw health system-affiliated primary care provider, and are discharged from the ed or ed observation unit (not admitted). members of the uwh applied data science team (not part of the study team) will extract data from patient ehr to create a limited dataset including: past falls and fall-related injuries (in the 12 months pre-visit, including the index ed visit), post-visit falls and fall-related injuries (in the 6 months following the index ed visit), patient demographics (age, gender, race/ethnicity, insurance), comorbidities, active medications, and utilization (e.g., primary and specialty care visits). education and income levels will be approximated using census track data. area deprivation index will also be employed based on patient address. these variables will be extracted retrospectively and stored on secure servers.

Eligibility criteria:
retrospective analysis will include data from: * ed patients 65 years or older * discharged from the ed (not admitted)
the prevalence of pulmonary hypertension in patients with covid-19.

Conditions: Hypertension, Pulmonary; Right Ventricular Overload; COVID

Summary: the virus infection covid-19 fills our hospitals and intensive care departments in a very unique way and there is a lack of essential insight into the pathophysiology of the disease. as a result, very specific treatment options are missing. the us medicines agency (fda) has in the last days given a general license for treatment with inhaled nitric oxide (ino). inhaled no in sweden (and europe) is approved for the indication of pulmonary hypertension in adults. however, no one has yet described the occurrence of pulmonary hypertension, with or without right ventricular loading, in the covid-19 patients who become so seriously ill that they need to be treated at an iva ward. knowledge of this is, of course, a prerequisite for determining the need for pulmonary artery catheterization (pa catheter, swan-ganz catheter) and also to better understand whether ino treatment or other forms of lung selective vasodilation therapy may be of benefit to this patient group.

demographics and data from study variables will be documented in paper crfs at the investigational site. * demography o age, sex * covid-19 related variables o covid-19 diagnosis * concomitant diseases o comorbidity, previous and present * cardiovascular risk factors o smoking * laboratory values * on-site measurements o evaluation with echocardiography

Eligibility criteria:
inclusion criteria: * men and women at least 18 years of age * diagnosed with covid-19 and is treated at an intensive care unit. exclusion criteria: * responsible investigator considers that co-morbidity is so pronounced that it does not allow reasonable interpretation of data. * missing verified diagnosis of covid-19
maternal brain imaging in opioid use disorder

Conditions: Opioid Use Disorder; Substance-Related Disorders; Substance Use; Pregnancy Related; Narcotic-Related Disorders; Buprenorphine Dependence

Summary: this research study aims to learn more about opioid use disorder (oud) during pregnancy and how outcomes for pregnant women and their newborns can be improved. during pregnancy, people with oud are prescribed medication-assisted therapy (mat). the investigators are interested to know how the medication is broken down by the body during pregnancy and how effective it is. the investigators also want to learn if this medication and oud have any effect on the different parts of the brain when compared to mothers without oud.


Eligibility criteria:
pregnant women with oud inclusion criteria: * age: \>18 years old * any subject that is currently on buprenorphine at time of screening * singleton pregnancy exclusion criteria: * serious maternal medical illness * hiv or aids * polysubstance use * score \>9 on the phq-9, and score \>0 on item 9 which is about suicidality * score of 8 or more on gad-7 * any contraindications for mri * known or suspected major fetal congenital abnormalities pregnant women with no history of oud inclusion: * age: \>18 years old * singleton pregnancy exclusion: * serious maternal medical illness * hiv or aids * score of \>9 on the phq-9, and a score of \>0 on item 9 which is about suicidality * score of 8 or more on gad-7 * known or suspected major fetal congenital abnormalities * any contraindications for mri * opioid or polysubstance abuse as identified on urine screening

Keywords: pregnant with opioid use disorder opioid use disorder subutex buprenorphine pregnant taking buprenorphine/subutex