Kornimate/medical-research-clean huggingface dataset:
study of reminding to improve medication adherence in heart failure

Conditions: Heart Failure

Summary: this study is being done to look at how people manage their heart failure. the investigators are testing two medication reminder systems and the investigators want to know which one people like better. the investigators also want to see if they have any effect on ease of managing medication in individuals with heart failure.

a pilot and feasibility randomized trial of two medication reminder systems for patients with heart failure (hf). the investigators believe that medication reminder systems will improve adherence and will reduce the effects of cognitive impairment on medication adherence. the investigators believe that patients will accept and use a medication reminder system, but the investigators cannot specify which system will be preferred. each has different features which may be perceived as more or less desirable. the investigators will enroll 60 patients with hf and randomize them to four conditions in a 2 (device 1 versus device 2) by 2 (active versus passive) design. after enrollment in the trial, patients will be consented and will complete pretesting at summa health system in the center for clinical trials. they will primarily undergo brief computerized cognitive testing, complete self-report measures (e.g., quality of life, depression, self-management related social support), and will give consent for medical information to be collected from their electronic medical record. they will then be randomized to condition. in-home training will be provided regarding how to use the equipment. medication adherence will be monitored for 28 days, followed by an in-home post-test (all pre-test measures) during which the equipment is returned.

Eligibility criteria:
inclusion criteria: * 45-90 years of age * documented systolic or diastolic heart failure exclusion criteria: * history of neurological disorder * moderate or severe head injury with greater than 10 min loss of consciousness * past or current history of severe psychiatric illness. specifically, psychotic disorders (e.g. schizophrenia) and bipolar disorder. potential study participants will not be excluded on the basis of managed depressive or anxiety disorder. these conditions are common in hf patients and their exclusion may limit generalizability of findings. * 5 year past or current history of alcohol or drug abuse (defined by dsm-iv criteria) * history of learning disorder or developmental disability (defined by dsm-iv criteria) * renal failure requiring dialysis * current home telemonitoring program to assist with hf self-management * they do not have a land-line telephone * cardiac surgery \< 3 months

Keywords: heart failure
prospective international study of coronary subtraction using 320 detector row ct (corsub)

Conditions: Coronary Artery Disease

Summary: background: - this study is designed for people who need a standard, non-research invasive coronary angiogram to find out if they have heart disease. researchers want to take a computed tomography (ct) scan of people s hearts before their procedure to see if this less invasive test can also diagnose coronary artery disease. objectives: - to learn if a new way to view ct pictures is able to accurately diagnose coronary artery disease. eligibility: - people age 55 and older who need a coronary angiogram. design: * participants will be screened with their medical records. * participants may give a blood sample. * participants may have a ct scan of the heart with and without contrast. the ct scan will not interfere with their medical care. * participants blood pressure and heart rhythm will be monitored before, during, and after the ct scan. they may have an electrocardiogram. * before the scan, participants will have an intravenous catheter put into their arm. it will be used to inject contrast. * participants may take a beta blocker to slow their heart rate. * participants may take nitroglycerin under their tongue. it will enlarge their heart blood vessels and improve picture quality. it may cause a flushing sensation or headache. * participants will lie on their back on a padded table. the table slides into a large, donut-shaped machine. an x-ray tube will move around their body, taking pictures. they will be asked to hold their breath for 5 seconds at a time. * participants will be called 30 days after their angiogram. they will answer questions about their health, hospital visits, or medical treatments.

coronary calcium can impair the accurate evaluation of the coronary arteries with coronary computed tomography angiography (ccta). a novel approach to potentially overcome this limitation is coronary calcium subtraction, where areas of calcification identified on a non-contrast scan are removed from the contrast enhanced images. .

Eligibility criteria:
* inclusion criteria: 1. age over 55 years 2. subjects referred for coronary angiography 3. able to understand and willing to sign the informed consent form exclusion criteria: 1. known allergy to iodinated contrast media 2. estimated gfr less than 50 ml/min 3. atrial fibrillation or other continuous cardiac arrhythmias 4. known or suspected intolerance or contraindication to beta-blocker medication (i.e. significant reactive airway disease, decompensated heart failure, mobitz type 2 second degree or 3rd degree atrio-ventricular heart block) 5. inability to adequately hold breath for 5 seconds 6. pregnancy. women of child bearing potential must demonstrate a negative pregnancy test within 24 hours of the study mdct.

Keywords: cardiac computed tomography coronary artery disease
observational prospective study to evaluate aes, risk factors and drug utilization of buscapina compositum n in adults from metropolitan lima

Conditions: Acute Pain; Dysmenorrhea

Summary: what ae occur in routine clinical practice, what is the incidence of ae and adverse drug reaction, how many patients present with ae symptoms related to a potential liver injury. what are the drug utilization patterns in patients, what are the predisposing factors for the occurrence of adverse events and adverse drug reactions.


Eligibility criteria:
inclusion criteria: 1. patients 18 years of age and older who have received at least one dose of buscapina compositum n according to label indications and who attend to one of the pharmacies, clinics, or private doctors office selected for the study. 2. patients who agree to adhere to the protocol procedures of this study. 3. women who are not pregnant or breast feeding 4. persons who sign the informed consent exclusion criteria: 1. patients with allergy to buscapina compositum n or any of the compounds in the formula. 2. patients with mechanical stenosis of the gastrointestinal tract. 3. patients with myasthenia gravis. 4. patients with megacolon. 5. patients breastfeeding at the time of enrollment or who have become pregnant during treatment with buscapina compositum n. 6. patients with clinical evidence of immunosuppression. 7. patients with urinary retention subvesical obstruction (such as prostatic adenoma). 8. patients with right-angle glaucoma. 9. patients with tachycardia and tachyarrhythmia. 10. patients with severe hepatic impairment. 11. patients with psychiatric disorders. 12. patients with alcohol dependence or drugs. 13. patients who discontinue the protocol are not eligible for re-enrollment. 14. researchers, company personnel or their relatives.
vr as a facilitator for participation in society among persons with mhd/sud

Conditions: Substance Use Disorders; Mental Disorder

Summary: this study is the first part of a larger project called "virtual reality (vr) as a facilitator for participation in society among persons with mental health/substance use disorders" in which aims to explore,develop and evaluate a vr-based paradigm that facilitates social participation and promotes social recovery of individuals with mental health and/or substance use disorders (mhd/sud). the overall project comprises three work packages: an exploration study, a development study, and an evaluation study. this study will make up work package 1. the primary aim of this study (wp1) is to explore facilitators and barriers for participation in society among person with mhd/sud, and to provide an understanding of mechanisms of social participation and social cohesion among persons with mhd/ sud that may be affected by vr-based interventions. the investigators will derive a socio-emotional learning domain to facilitate key interpersonal and social processes among persons with mhd/sud in vr-based interventions. to achieve the purpose of this study, the invistigators conduct 10 indepth interviews with service-user with mhd/sud, 2 focus group interviews with 14 service-providers and an interview-survey with 100 service users. this gives the investigators the possibility to explore facilitators and barriers for social participation as experienced as by individuals with mhd/sud and identify key interpersonal and social processes suitable to be addressed by tailored vr based interventions.


Eligibility criteria:
inclusion criteria: * above 18 years of age * receiving services in the municipality due to mental health and or addiction problems. exclusion criteria: -visual and hearing impairment, neurological disorders, and mental retardation \[score ≤70 on the test of intelligence\].
glucose metabolism in patients with non-small cell lung cancer treated with targeted therapy and chemotherapy

Conditions: Lung Cancer

Summary: rationale: measuring changes in glucose metabolism in patients with cancer may help doctors predict how patients respond to treatment. purpose: this clinical trial is studying glucose metabolism in patients with non-small cell lung cancer treated with targeted therapy and chemotherapy.

objectives: * determine the prognostic significance of changes in glucose metabolism measured by fludeoxyglucose f 18 positron emission tomography (fdg-pet)/ct scan in patients with non-small cell lung cancer treated with targeted drugs comprising gefitinib, erlotinib hydrochloride, or other erbb inhibitors, cyclooxygenase-2 inhibitors, or estrogen receptor blockers in combination with conventional chemotherapy. outline: this is a prospective study. patients undergo fludeoxyglucose f 18 positron emission tomography (fdg-pet) scan and ct scan at baseline and at 2 weeks and 12 weeks after receiving targeted anticancer treatment. metabolic changes detected by fdg-pet and size changes identified by ct scan are related to patient outcome and tumor response to treatment. projected accrual: a total of 120 patients will be accrued for this study.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed non-small cell lung cancer * any disease stage allowed * undergoing targeted treatment exclusion criteria: none

Keywords: recurrent non-small cell lung cancer stage i non-small cell lung cancer stage ii non-small cell lung cancer stage iiia non-small cell lung cancer stage iiib non-small cell lung cancer stage iv non-small cell lung cancer
study of the economics of pulmonary artery catheter use in patients with acute respiratory distress syndrome (ards)

Conditions: Acute Respiratory Distress Syndrome; Acute Lung Injury; Lung Diseases

Summary: study of the long term outcomes and economic impact of the pulmonary artery catheter in acute respiratory distress syndrome (ards/ali) patients.

the pulmonary artery catheter (pac) is a commonly used device that provides hemodynamic data to guide care of the critically ill, such as patients with acute lung injury or the acute respiratory distress syndrome (ards/ali). clinicians believe pac use improves decision-making and patient outcomes but evidence is lacking and recent data suggest the pac may increase mortality as well as considerably increasing costs. in response, the nhlbi funded a large multicenter trial (fluid and catheter treatment trial (factt) (n01-hr-46054-46064)) where ards/ali patients were randomized to receive a pac or the less invasive central venous catheter (cvc) and received a liberal or conservative fluid management protocol in response to data provided by the pac or cvc. the primary end-point is in-patient mortality. we are complementing factt with a concurrent economic analysis of the pac. our aims are to: 1.) compare differences between study arms in long-term survival, quality of life, and quality-adjusted survival; 2.) compare differences between study arms in acute care and long-term costs; 3.) calculate the cost-efficacy of pac use (i.e., the balance of costs and effects under the controlled environment of the factt trial), and; 4.) estimate cost-effectiveness under more "real-world" conditions and produce life-time cost-effectiveness ratios, thereby facilitating comparison of our results to other cost-effectiveness analyses. we are achieving aims 1-3 by augmenting factt data collection with detailed information on hospital costs, extended survival follow-up for a minimum of one year, and post-discharge patient interviews to determine quality of life and resource use in the first year. we will achieve aim 4 by constructing a microsimulation model first calibrated by results from factt and published data on life-expectancy and costs and then adjusted to reflect the broader patient case-mix and clinical effects of pac use in routine clinical practice. we are using patient-level data from the king county lung injury project epidemiology study (nhlbi hl-96-014) to adjust case-mix and patient-level data from a large pragmatic trial of pac use in the united kingdom to adjust the clinical effects of pac use. the results of our adjunct to factt will substantially amplify the value of the data being collected and provide, for the first time, robust estimates from randomized data of the economic effects of the widespread application of this important technology.

Eligibility criteria:
inclusion criteria: * enrolled in the fluid and catheter treatment trial (factt) exclusion criteria: * did not consent to economic substudy and long-term follow-up

Keywords: acute respiratory distress syndrome ards acute lung injury ali cost-effectiveness pharmacoeconomics long-term follow-up
amisulpride treatment for bpsd in ad patients

Conditions: BPSD; Amisulpride; Olanzapine; Dementia of the Alzheimer Type

Summary: currently, olanzapine is the most widely used and studied drug for the treatment of behavioral and psychological symptoms in patients with alzheimer's disease, but there are significant side effects. amisulpride is a new antipsychotic that not only controls mental symptoms but also improves cognitive function. therefore, the aim of this study was to evaluate the effectiveness and tolerability of both amisulpride and olanzapine for treating the behavioral and psychological symptoms of dementia in patients with dementia of the alzheimer type.

this study was a randomized, open-label, prospective clinical study in which patients were randomized to receive amisulpride and olanzapine for 8 weeks. drug efficacy and safety assessments were assessed at baseline, 2 weekends, 4 weekends, and 8 weekends.

Eligibility criteria:
inclusion criteria: 1. it conforms to the diagnostic standard of alzheimer's disease in international classification of diseases 10th revision (icd-10) 2. a total score of mmse\<24 3. the patients had active behavioral symptoms with a minimum score of 20 on the 12-point neuropsychiatric inventory (npi) 4. participant or guardian has to sign informed consent. the patients' guardians will sign the informed consent on behalf of the participants when the capacity of participants to consent is compromised exclusion criteria: 1. people with vascular dementia, frontotemporal dementia, dementia with lewy bodies or other neurocognitive disorders; 2. patients with severe brain organic diseases or brain trauma; 3. physical illnesses associated with severe respiratory, circulatory, immune, and endocrine systems; 4. history of other mental disorders; 5. those who are allergic to amisulpride or olanzapine; 6. patients who are contraindicated with amisulpride and olanzapine: pheochromocytoma, prolactin-dependent tumors and narrow-angle glaucoma;
evaluate efficacy of certolizumab in crohn's patients with draining fistulas

Conditions: Crohn Disease

Summary: to investigate the clinical efficacy of certolizumab pegol for fistula closure in crohn's disease subjects with active draining fistulas.


Eligibility criteria:
inclusion criteria: * patients with single or multiple fistulas, including perianal and enterocutaneous fistulas for at least 3 months as a complication of crohn's disease exclusion criteria: * symptomatic obstructive intestinal strictures, bowel resection, proctocolectomy or total colectomy, abscesses present at screening, current total parenteral nutrition, short bowel syndrome. * all the concomitant diseases or pathological conditions that could interfere with crohn's disease assessment or to be harmful for the well being of the patient. * previous clinical trials and previous biological therapy that could interfere with the results in the present clinical trial

Keywords: crohn disease certolizumab pegol fistula
effect of hiit vs yoga on level of pain, catastrophizing and qol in dysmenorrhea

Conditions: Primary Dysmenorrhea

Summary: this study is aimed at determining the effect of high intensity interval training vs yoga on pain, catastrophizing and quality of life among young females with dysmenorrhea.

dysmenorrhea is defined as a pain experienced by females before or during menstruation and it is a common and important gynecological condition found in females of reproductive age that adversely affects their quality of life. the cause of pd is believed to be the excess release of prostaglandins during normal ovulation cycle. the health care costs were altogether higher among females with dysmenorrhea compared with females who didn't experience the ill effects of this condition, and excess costs were essentially determined by outpatient care, so poses greater burden of disease than any other gynecological complaint. females having more pain catastrophizing scores leads to increases chances of disability. proper evidence behind hiit training among females with primary dysmenorrhea is sparse and is based on different clinical experiences and a less number of studies with limited methodological design.

Eligibility criteria:
inclusion criteria: * unmarried females with age 18-25 years * normal menstrual cycles 21-35 days * primary dysmenorrhea diagnosis made on the walidd score * walidd score of 1- 7 (mild to moderate dysmenorrhea) exclusion criteria: * history of regular exercise (3 times weekly for 30-45 min) * motor disabilities ( als, multiple sclerosis, muscular dystrophy ) * autoimmune conditions (ra, hashimotos thyroiditis) * chronic illnesses that might contraindicate physical exercise (asthma, epilepsy, migraine, anemia, complete heart block, acute congestive heart failure, unstable angina, and uncontrolled severe hypertension)

Keywords: yoga dysmenorrhea pain catastrophizing exercise
siit based on ust cdst in patients with cd

Conditions: Crohn Disease

Summary: ustekinumab (ust) can effectively induce and maintain clinical remission and mucosal healing of crohn's disease (cd), but some patients still have poor response. dose optimization is an effective way to improve the response rate of ust, and re-intravenous induction is a common way of optimization. for patients with secondary loss of response, about half of the patients can re-respond after dose optimization. we plan to use cdst-ust to stratify the response level of patients before treatment, select patients with poor response, and initially give multiple intravenous therapy as an intensive induction therapy strategy, so as to improve the response rate of these patients and achieve individualized treatment.


Eligibility criteria:
inclusion criteria: * diagnosed with cd; * active period; age 18-75 years old; * ust-cdst scores were used to treat patients with moderate and low responsive activity exclusion criteria: * subjects had undergone extensive colectomy, subtotal colectomy, or total colectomy; the subject currently has ileostomy and colostomy; patients with significant liver, kidney, endocrine, respiratory, neurological or cardiovascular diseases; patients with fibrous stenosis and prestenosis dilatation; contraindications of ust as documented in other specifications.
metacognitive training in schizophrenia

Conditions: Delusions; Schizophrenia

Summary: over a period of 4 weeks, metacognitive training for schizophrenia patients (mct), delivered both in a group and individually, is compared to cognitive remediation (cogpack training). blind to treatment assignment, both groups are assessed before intervention and four weeks later with the positive and negative symptoms scale (panss), the psychosis rating scales (psyrats) and cognitive tests. delusion severity serves as the primary endpoint. it is assumed that mct will improve delusion severity to a greater extent than cr in the course of 4 weeks taking medication into account.

metacognitive training for schizophrenia patients (mct) is a manualized group intervention that can be obtained cost-free online. mct seeks to sharpen the awareness of schizophrenia spectrum patients on cognitive biases (e.g. jumping to conclusions) contributing to delusion formation and maintenance and conveys cognitive strategies to counter these. the present trial combines group mct with an individualized cognitive-behavioral oriented approach entitled mct+. patients with schizophrenia are randomly allocated to either metacognitive treatment (mct) or cognitive remediation (cogpack training). blind to treatment assignment, both groups are assessed prior to intervention and four weeks later with the positive and negative symptoms scale (panss), the psychosis rating scales (psyrats) and cognitive tasks. delusion scores derived from the panss and psyrats serve as main outcome parameters. we also explore if mct improves jumping to conclusions with a probabilistic reasoning task. to make results as generalizable as possible to a typical inpatient population, broad inclusion criteria are chosen. patients are only excluded if age is \ 65 years and diagnoses do not meet criteria of a schizophrenia spectrum disorder.

Eligibility criteria:
inclusion criteria: * schizophrenia spectrum disorder exclusion criteria: * intellectual disability (iq \< 70) * unable to provide informed consent * hostility on panss \> 4 * suspiciousness on panss \> 5

Keywords: schizophrenia delusion paranoia psychosis