Kornimate/medical-research-clean huggingface dataset:
understanding what matters most to patients: establishing the validity of a best-worst scaling survey

Conditions: Hematologic Neoplasms

Summary: this study will evaluate the validity of using a survey to quantify patient preferences at the point-of-care and the potential effectiveness of the survey to improve goal-concordant care. the primary hypothesis is that by identifying the strength of patient preferences for outcomes with this survey clinicians will be able to improve goal-concordant care by aligning clinical recommendations with patients' preferences. this study will have 50 patients with newly diagnosed hematologic malignancy complete the survey throughout their disease course (up to 2 years) and conduct qualitative interviews with a subset (n = 20) of participants. the information obtained from these participants will be used to refine the survey. interviews with oncologists and palliative care specialists (up to 10) will inform implementation.


Eligibility criteria:
inclusion criteria: * confirmed new diagnosis of one of the following hematologic malignancies: aggressive lymphoma, multiple myeloma, cll, cml, aml, all, mds eb1 or eb2 * age≥60 * ability to read, understand, and communicate fluently in english * ability to understand and comply with study procedures * willingness and ability to provide written informed consent exclusion criteria: * dementia, altered mental status, or psychiatric condition that would prohibit the understanding or rendering of informed consent or participation in the discrete choice experiment. * significant medical conditions, as assessed by the investigators, that would substantially increase the burden on the patient to complete study assessments (such as multiorgan failure, respiratory failure, or other critical illness).

Keywords: leukemia lymphoma myeloma myelodysplastic syndrome best-worst scaling survey
creon use in coeliac patients with low faecal pancreatic elastase

Conditions: Patients With Coeliac Disease and Chronic Diarrhoea (>3 Loose/ Liquid Motions a Day for More Than 4 Weeks); Patients With Pancreatic Exocrine Insufficiency

Summary: faecal elastase is an enzyme test used to identify the presence of pancreatic exocrine insufficiency. this condition manifests with symptoms of diarrhea, weight loss, causing potential impairment on an individual's quality of life. creon, a pancreatic enzyme supplement, marketed by abbott laboratories, inc. is currently the standard treatment for this condition. however, there has been limited work evaluating the merits of this medication in this condition. this study aims to evaluate the benefits that creon may have in coeliac patients with low faecal pancreatic elastase by randomising patients with low faecal pancreatic elastase (\<200 ug/g) to either treatment with creon or placebo. outcome measures that we aim to assess to determine the benefits of creon include evaluation of stool frequency, abdominal pain, body mass index (bmi) and quality of life.


Eligibility criteria:
inclusion criteria: * patients with coeliac disease and having chronic diarrhoea (\>3 loose/ liquid motions a day for more than 4 weeks) * patients with a low faecal elastase (\<200 ug/g), * patients aged 16 years or over * patient able to give written consent to participate * patient not currently on creon exclusion criteria: * patients with normal faecal elastase (\> 201ug/g), * patients under the age of 16 * patients allergic to pork or any pig product (advice from the drug manufacturer) * patients that are pregnant or are breast-feeding * patients taking alternative medication that could affect bowel frequency * where an alternative diagnosis for the chronic diarrhoea is established, these patients will be excluded from the trial * patients who are unable to speak or understand english

Keywords: pancreatic exocrine insufficiency faecal elastase diarrhoea coeliac creon gastrointestinal
study to evaluate safety and effectiveness of dynamic stabilization versus lumbar fusion in treatment of multilevel lumbar disc degeneration disease

Conditions: Lumbar Spine Disc Degeneration

Summary: the purpose of this study is to compare outcomes of (i) surgical treatment with posterior dynamic stabilization and (ii) surgical treatment with internal fixation and fusion in patients with multilevel lumbar degenerative disk disease.

study aims are: 1. to evaluate superiority of surgical treatment with posterior dynamic stabilization compared to surgical treatment with internal fixation and fusion in lumbar range of motion; 2. to compare surgical treatment with posterior dynamic stabilization compared to surgical treatment with internal fixation and fusion in functional outcomes as measured by change in oswestry disability index; 3. to compare radiological, clinical, patient-reported and, safety outcomes between the two surgical approaches.

Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. age between 30 and 75 years inclusive 3. radiographic evidence of multi-level lumbar disc degeneration disease 4. scheduled for 2- or 3-level lumbar discectomy at levels from l1 to s1 with or without dynamic stabilization or fusion 5. preoperative odi ≥ 30% 6. clinical symptoms consistent with diagnosis of lumbar ddd: * radicular back or lower extremity pain and/or * decreased muscular strength and/or * abnormal sensation 7. failed to gain adequate symptom relief from at least one month of adequate non-operative treatment exclusion criteria: 1. cauda equina syndrome 2. patients with other lumbar conditions that will, in the opinion of the investigator, interfere with clinical outcomes (e.g. spinal structural deformities, spinal fractures, ankylosing spondylitis, spinal tuberculosis, spinal infection, spinal tumors, symptomatic cervical spinal disease) 3. osteoporosis defined as t-score ≤ -3.5. bmd will be measured by dexa performed on lumbar spine 4. systemic infection such as aids and active hepatitis 5. recent history (less than 3 years) of chemical substance dependency or significant psychosocial disturbance, which may impact the outcome or study participation 6. participation in a clinical trial of investigational drug or device within the past 30 days

Keywords: disc degeneration disease ddd multilevel lumbar disc degeneration disease
a trial of connecting to promote foster teen well-being

Conditions: Relationship, Family (Foster); Substance Use Prevention

Summary: this study evaluates the efficacy of a self-directed parenting program called connecting in reducing risk of substance use and other risky behaviors in young foster teens (ages 11-15). half of the participants will receive services as usual from the foster system, while half will participate in the connecting program. connecting is a 10-week, self-directed parenting workbook with two digital video discs (dvds). families receive weekly telephone support as they complete the program.


Eligibility criteria:
inclusion criteria: * foster youth ages 11-15 years * in current placement 60+ days * in relative/suitable adult care, in licensed relative/suitable adult care, in licensed foster care, in dependency guardianship * caregiver and teen speak english well enough to use the program manual and respond to survey questions exclusion criteria: * the teen has regularly used drugs or alcohol in the last 30 days * the teen has been involved in the criminal justice system * the placement is not viewed as stable * the caregiver is not committed to a long-term placement * the teen will not likely be in the placement for at least 6 months * group home placements and behavioral rehabilitative services placements

Keywords: foster families
dpp4 inhibitor and coronary atherosclerosis in patients receiving insulin therapy

Conditions: Diabetes Mellitus

Summary: the study aim is to evaluate whether dpp4-inhibitor could reduce coronary atherosclerosis assessed by ct scan in patients receiving insulin for diabetes mellitus. in this retrospective study, changes in obstructive coronary artery disease prevalence and coronary calcium burden between two coronary ct scans will be compared in patients with and without receiving dpp4-inhibitor.

this is a retrospective study using medical records in two hospitals affiliated to the catholic university of korea. patients with diabetes mellitus who received insulin are retrospectively enrolled. among those, only patients who underwent coronary ct scan for more than two times will be included. included patients will be classified into dpp4-inhibitor group and no dpp4-inhibitor group according to the prescribed medication. the changes in obstructive coronary artery disease prevalence and coronary calcium score per one year will be compared between the two groups.

Eligibility criteria:
inclusion criteria: * diabetes mellitus * receiving chronic insulin therapy (prescription of insulin pen) * who underwent more than 2 times of coronary ct scan exclusion criteria: * age \<18
multi-omics noninvasive inspection of tumor risk for gastric cancer

Conditions: Gastric Cancer

Summary: this is a prospective, case-control study intended to develop and validate a blood-based multi-omics assay and computational model for early detection of gastric cancer. approximately 450 subjects who receive esophageogastroscopy (egd) will be enrolled and assigned to three arms including gastric cancer, precancerous lesion, and healthy control based on the diagnosis of egd and histological results. cell free dna will be extracted from peripheral blood of all participants and assayed by next-generation sequencing for biomarkers including somatic mutation, methylation, and chromosome instability signals. in the first stage a multi-omics models will be developed for classification between malignancy group and control groups, and between precancerous group and healthy control. sensitivity and specificity of the model will be evaluated in an independent validation group in the second stage.


Eligibility criteria:
inclusion criteria: * age≥40 * received egd; * subjects must have given written informed consent, and the subjects compliance are good. exclusion criteria: * subjects who could not accept egd; * subjects who had previously undergone total or partial gastrectomy; * there are other serious acute or chronic medical or mental diseases or laboratory abnormalities that may interfere with the interpretation of the research results and make the subjects unsuitable for the study in the judgment of the researchers; * subjects with a history of malignant tumor or two or more malignant tumors at the same time; * pregnant subjects; * subjects who had a history of bone marrow or organ transplantation, or had a history of blood transfusion one month before enrollment. * the subjects with incomplete clinical data collection or other reasons judged by the researchers are not suitable for this study.
early-myo-sepsis registry

Conditions: Sepsis

Summary: the diagnosis and pathophysiology of sepsis-induced cardiac dysfunction remain unknown. this registry is to evaluate characteristics of sepsis patients by multi-modalities imaging, including echocardiography, cardiovascular magnetic resonance imaging in 300 patients in 5 sites. subjects will be followed up to 2 years.

approximately 20-30 million patients worldwide suffer from sepsis every year, which is increasing at the rate of 8% to 13% per year. it is possible that sepsis progress to multiple organ dysfunction in the early stage, with a fatality of 30% to 60%. myocardium is one of the most vulnerable tissue under the abnormal 'inflammation storm'.cardiac dysfunction is one of the important predictors for mortality of sepsis.patients with myocardial depression have an apparently higher mortality rate (70%) as compared with septic patients without cardiac impairment (20%). although several trials had explored the diagnosis and treatment of sepsis-induced cardiac dysfunction, the effective characteristic depict and effective therapy remain incompletely understand. this is a prospective, multi-center, non-randomized, observational registry study of sepsis patients that undergo multi-modality imaging.

Eligibility criteria:
inclusion criteria: * patiants meets the criteria of sepsis 3.0 as below: * sepsis is a lifethreatening organ dysfunction caused by a dysregulated host response to infection * 1 patients in icu： * 1.1 have at least one organ dysfunction * 1.2 sofa score ≥2 * 2 patients not in icu * 2.1 have at least one organ dysfunction * 2.2 sofa score or qsofa score ≥2 exclusion criteria: * 1. patient who is unable to comply with the follow-up schedule. * 2. patient who has any medical conditions that in the opinion of the investigators will not be appropriate to participate in the study. * 3. patient has a life expectancy of less than 6 months due to any condition
cardiac synchronization and tricuspid regurgitation with leadless pacemaker

Conditions: Bradycardia

Summary: comparison of cardiac synchronization and tricuspid regurgitation with or without leadless pacemaker pacing in different site

right ventricular pacing might lead to pacing-induced cardiomyopathy by dyssynchrony and tricuspid regurgitation. pacing at various sites had different effects on synchrony and tricuspid regurgitation. this study is to observe the effect of leadless pacemaker implantation in different regions on ventricular synchronization and tricuspid regurgitation. ultrasound and ecg parameter indices are applied.

Eligibility criteria:
inclusion criteria: patients consent to lp implantation surgery exclusion criteria: 1. patients with inferior vena cava thrombus, a cancer thrombus, an abnormal inferior vena cava; 2. patients with femoral vein stenosis and tortuosity failed to accommodate the pacemaker delivery system; 3. patients with myocardial infarction; 4. patients who have been implanted with devices that affect the pacemaker delivery system, such as vena cava filters or tricuspid valve mechanical valves; 5. cannot understand or are unwilling to give informed consent.

Keywords: leadless pacing synchronization
the evaluation for prognostic factors after catheter ablation of atrial fibrillation: cohort study

Conditions: Atrial Fibrillation

Summary: 1. purpose of the study 1) to explore clinical recurrence associated clinical factors including age, sex, clinical, electrophysiological, anatomical, imaging, and serologic characteristics. 2) to develop simulation model to predict clinical recurrence and the efficacy of catheter ablation 2. scientific evidence of the study 1. in atrial fibrillation patients, the maintenance of normal sinus rhythm showed significant reduction of mortality. 2. drug therapy with anti-arrhythmic drug showed many complications and side effect, thus non-drug therapy such as catheter ablation is developed. 3. catheter ablation has been performed for 10years world-wide, and showed superior treatment outcome compared with drug therapy. 4. clinical outcome after catheter ablation is affected not only by age, sex and underlying disease, but also by electrophysiologic, imaging, serologic and electroanatomical remodeling of the heart. however, there are few studies concerning these multifactorial variables. 3. study population


Eligibility criteria:
inclusion criteria: * patients who undergoing catheter ablation of atrial fibrillation due to symptomatic, drug refractory atrial fibrillation exclusion criteria: * patients who do not agree with study inclusion * permanent af refractory to electrical cardioversion * af with valvular disease ≥ grade 2 * patients with left atrial diameter greater than 60mm * patients with age less than 19

Keywords: atrial fibrillation catheter ablation recurrence
development cellular models of the ear and nose to study the mechanisms of hearing

Conditions: Hearing Loss, GJB2, Cis Regulation, DFNB1

Summary: development of cells culturesissued from nose and ear to study auditory mecanisms. study of the cis-modulation of the gene gjb2 for the patients with early presbycusis to identify the genetic cause of hearing loss.


Eligibility criteria:
inclusion criteria: * hearing loss presbycusis exostosis exclusion criteria: * genetic hearing loss
behavioral treatment of menopausal insomnia; sleep and daytime outcomes

Conditions: Menopause

Summary: insomnia is recognized as the most prevalent and "costly" sleep disorders and is associated with considerable morbidity including significantly reduced quality of life, impaired work performance, and increased risk for major depressive disorder.1-4 insomnia is a key symptom of the menopausal transition. cognitive-behavioral therapy for insomnia (cbt-i) yields equivalent short-term efficacy and superior long-term durability to pharmacological treatment of insomnia. the efficacy of cognitive behavioral therapy for insomnia comorbid with menopause will be tested.

specific aim 1: determine the efficacy of multi-component cbt-i compared to a wait-list control group on self report and laboratory-based polysomnographic (psg) sleep parameters. we hypothesize that multicomponent cbt-i will increase sleep efficiency, reduce the frequency of awakenings, reduce wake after sleep onset, and increase sleep bout duration compared to the control group evaluated using polysomnographic (psg) and self-report measures of sleep. specific aim 2a: test the efficacy of a brief two week single component sleep restriction therapy (srt) to a wait-list control group on psg and self-report sleep measures (sleep efficiency, frequency of awakenings, wake after sleep onset, and sleep bout duration). we hypothesize that brief srt will be efficacious compared to the control condition in women with menopausal-related insomnia. specific aim 2b: test the comparability (non-inferiority analysis) of srt to cbt-i. we hypothesize that srt will produce comparable efficacy in terms of the psg and self-report measures of sleep compared to cbt-i (primary endpoints: sleep efficiency, frequency of awakenings, wake after sleep onset, and sleep bout duration). specific aim 3: determine if cbt-i and srt improves specific aspects of daytime functioning in patients with menopausal-related insomnia. we hypothesize that patients treated with cbt-i or srt will have greater improvements in depressive symptomatology, quality of life, sleepiness and fatigue compared with a wait list control group.

Eligibility criteria:
inclusion criteria: * post-menopausal insomnia exclusion criteria: * unstable medical conditions

Keywords: treatment
recalled international index of erectile function-5 collected post prostatectomy in assessing preop erectile function

Conditions: Erectile Dysfunction Following Radical Prostatectomy

Summary: the accurate assessment of erectile function before radical prostatectomy, using validated questionnaires like iief-5, is crucial to evaluate postoperative changes in erectile function, as the preoperative erectile function is a prognostic factor for the postoperative recovery of erectile function. in clinical practice, patients usually present at the urologist's office 3 months after the operation without a preoperative iief-5 score and at that time the doctors ask them about their preoperative erectile function. with this study, the investigators would like to evaluate the agreement between a real-time preoperative iief-5 and a recalled one 3 months after radical prostatectomy.

radical prostatectomy (rp) is a widely performed procedure for patients with clinically localized prostate cancer and its most common side effects include urinary incontinence and erectile dysfunction. these two side-effects become progressively more important to health-related quality of life (hrqol) and thus the balance between cancer control and preservation of hrqol is challenging. the postoperative changes in erectile function are directly related with the preoperative erectile function status of the patient. the most accurate evaluation of the pretreatment erectile function is the international index of erectile function-5 questionnaire. the fact that in some cases the preoperative questionnaire results are negatively affected by several factors, indicates the necessity of the assessment of the degree of agreement between real time iief-5 scores and retrospective iief-5 scores after radical prostatectomy. frequently the andrologists do not have a preoperative iief-5 score in their hands and this might happen for various reasons. the main reason is that urologists ask about the preoperative erectile function often with just a simple question. they rarely use a questionnaire mainly due to time constraints. according to the experience at the sexual rehabilitation clinic of the university's general hospital of patras, 3 months is the usual time point when most patients come to the clinic after radical prostatectomy. in the first two months after surgery, patients are interested primarily in the oncological and continence issues and later they seek help for their erectile dysfunction.

Eligibility criteria:
inclusion criteria: * men above 18 years old wih clinically localized prostate cancer, who have undergone open or laparoscopic radical prostatectomy, with or without use of phosphoodiesterase-5 inhibitors exclusion criteria: * penile anatomic defects * uncontrolled major medical illnesses such as uncontrolled diabetes, severe renal, hepatic or cardiovascular disease * major psychiatrics disorders * drug or alcohol abuse

Keywords: erectile dysfunction prostate cancer iief-5 radical prostatectomy
flourish™ pediatric esophageal atresia

Conditions: Esophageal Atresia; Digestive System Abnormalities; Esophageal Disorders Congenital

Summary: this study is continued evaluation of the safety and probable benefit of the flourish pediatric esophageal atresia device through the humanitarian device exemption (hde) pathway.


Eligibility criteria:
inclusion criterion: * patient treated for esophageal atresia with flourish device starting may 12, 2017

Keywords: esophageal atresia congential
custodiol-htk (histidine-tryptophan-ketoglutarate) solution as a cardioplegic agent

Conditions: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Valvular Heart Disease

Summary: the purpose of the study is to demonstrate that custodiol-htk is not inferior to cold cardioplegic solution in patients undergoing cardiovascular surgery requiring cardioplegic arrest.

the objective of this study is to demonstrate that custodiol is not inferior to cold cardioplegic solution for myocardial protection by comparing standard cold blood cardioplegia to custodiol solution with respect to myocardial injury as measured by creatine phosphokinase mb isoenzyme (ck-mb),troponin-i at 7 hours post surgery and changes in ejection fraction by trans-thoracic echocardiogram (tte)or trans-esophageal echocardiogram (tee) at 24 hours post surgery.

Eligibility criteria:
inclusion criteria: * patients undergoing scheduled cardiac surgery requiring cardioplegic arrest with expected cross clamp time\>45 minutes * patients age 18 and older exclusion criteria: * pregnant women\* * urgent or emergent cases * repeat cardiovascular surgical procedures * patients on dialysis * any known allergies to components of either cardioplegia solution \*all women of child bearing potential must have a negative serum or urine pregnancy test.

Keywords: physiological effects of drugs cardiovascular agents therapeutic uses pharmacologic actions mannitol cardiac surgery cardioplegic solutions htk solution myocardial protection coronary artery disease myocardial ischemia coronary disease heart diseases