Kornimate/medical-research-clean huggingface dataset:
post-surgical aortic hemodynamics after aortic valve replacement

Conditions: Valve Heart Disease

Summary: the purpose of this pilot study is to obtain both near valve and downstream flow characteristics, using 3d transthoracic echocardiography and 4d flow mri respectively, in an existing patient population at northwestern memorial hospital, to determine the hinge washout characteristics and downstream flow patterns of the on-x valve and compared to competing designs.

prospective, concurrent 4d flow magnetic resonance imaging (mri) and echocardiography of on-x and st jude medical (sjm) masters hp or carbomedics carbo-seal or carbo-seal valsalva aortic valve replacement (avr) patients will be performed. echocardiography analysis will include: valve function (opening angle), pressure gradients, and degree of valve washout. mri analysis will focus on downstream flow patterns (helicity and vorticity), energy loss, pressure recovery, and measurement of wall shear stress in the anastomosis regions.

Eligibility criteria:
inclusion criteria: * male and female subjects 18-89 years of age * patients with aortic valve disease who within the last five years underwent avr using the on-x aortic valve, sjm masters hp, or carbomedics aortic valves. exclusion criteria: * patients contraindicated against mri * patients with pacemakers, cochlear (in the ear) implants, or aneurysm clips or patients who have worked with metal * patients unwilling or unable to give written informed consent * pregnant women * prisoners * patients with an effective orifice area index (eoai) \<0.85 cm2/m2

Keywords: mechanical heart valve on-x
thermal biofeedback for the treatment of diabetic neuropathy

Conditions: Diabetic Neuropathy, Painful

Summary: the purpose of this study is to examine potential treatment options for a condition in diabetics that causes tingling, pain, and numbness in the hands and /or feet, also known as diabetic peripheral neuropathy.

participants attend 6 sessions lasting from 35 minutes to 2 hours (depending on the session). sessions can be scheduled once or twice per week. sessions involve a walking task, filling out questionnaires, and having temperature of hands and feet monitored. this study involves no drugs, blood draws, or any other invasive procedures. participants are urged to continue the treatment of diabetes and diabetic neuropathy as directed by their physician for the duration of their involvement with the study. after 3 months, a packet of questionnaires will be mailed with a stamped addressed envelope to be returned.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of diabetic neuropathy in hands and/or feet * must have some sensation left in hands and feet exclusion criteria: * any partial or total amputation of an limb or digit * any previous experience with biofeedback * prior treatment for alcohol abuse * severe psychopathology

Keywords: diabetes neuropathy peripheral painful thermal temperature biofeedback relaxation diabetic
efficacy and safety study of oral bg00012 with active reference in relapsing-remitting multiple sclerosis

Conditions: Relapsing-Remitting Multiple Sclerosis

Summary: to determine if treatment with bg00012 can decrease the number of ms relapses during a certain time period. other goals of the study are to determine if, over time, bg00012 treatment can decrease the number of certain types of brain lesions commonly seen in ms patients and slow down the time it takes for ms to get worse. other objectives of the study are to determine the safety and tolerability of bg00012, as well as the effect it may have on tests and evaluations used to assess ms. additionally, glatiramer acetate is being used to compare its benefits and risks with placebo and bg00012.

multiple sclerosis (ms) is a chronic disease of the central nervous system that affects approximately 400,000 persons in north america and 365,000 persons in europe. it is predominantly a disease of young adults, primarily women, with disease onset typically occurring between the ages of 20 and 40.

Eligibility criteria:
unless otherwise specified, to be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of the randomization: key inclusion criteria: * must have confirmed diagnosis of rrms according to mcdonald criteria #1-4 * must have a baseline edss between 0.0 and 5.0, inclusive. * must have relapsing-remitting disease course. key exclusion criteria: * other chronic disease of immune system, malignancies, urologic, pulmonary, gastrointestinal disease * pregnant or nursing women note: other protocol-defined inclusion/exclusion criteria may apply.

Keywords: relapsing multiple sclerosis oral remitting
navigated αtms in treatment-resistant schizophrenia

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: since 1990s, stimulation of prefrontal cortex (pfc) has shown therapeutic effects on auditory hallucinations as well as negative symptoms of schizophrenia. however, previous studies have reported mixed or negative results. majority of the repetitive transcranial magnetic stimulation (rtms) studies to date has set the target of cortical stimulation based on scalp site. recently introduced method, navigated transcranial magnetic stimulation (ntms) integrates the individual mri data, and thus allows more precise targeting on brain cortical regions enhancing the efficacy of rtms. previous eeg studies have suggested reduced alpha band activity in patients with schizophrenia. some recent studies using alpha (α) eeg guided tms for treating positive and negative symptoms of schizophrenia have demonstrated promising results. the aim of the study is to investigate the efficacy of navigated individualized αtms in treatment-resistant patients with schizophrenia. approximately fifty patients with dsm-iv schizophrenia will be enrolled in this randomized, double-blind, sham-controlled study. the patients will receive 13 - 15 session of αtms to the left dorsolateral prefrontal cortex (dlpfc), as adjunctive therapy, for 3 weeks. we assess patients via the positive and negative syndrome scale (panss), clinical global impression (cgi) and neurocognitive test battery at baseline, 5 days after and 3 months after treatment. serum and plasma levels of brain derived neurotrophic factor (bdnf) are assayed at pre and post treatment weeks.


Eligibility criteria:
inclusion criteria: * male righthanded inpatients, 18 to 64 years of age * the diagnosis of schizophrenia or schizoaffective disorder according to dsm-iv * capacity and willingness to give informed consent * patient is treatment-resistant, cgi-s 4 or more * patient is not requiring a change in antipsychotic medication 2 weeks prior to or during treatment * no foreseeable changes in patient's smoking habits during treatment exclusion criteria: * serious somatic illness * progressive neurological illness, recent brain damage (less than 3 months ago) or sequela of serious brain damage * unstable epilepsy * electro convulsive therapy (ect) less than 3 months prior to treatment

Keywords: transcranial magnetic stimulation repetitive transcranial magnetic stimulation schizophrenia schizoaffective disorder treatment negative symptoms positive symptoms tms rtms
suitability of unobtrusive bed monitoring and wrist-worn heart rate monitor for patient monitoring

Conditions: Arrhythmia; Hemorrhage; Septic Shock; Consciousness, Loss of; Sleep

Summary: novel technology enables it to monitor noninvasively the vital signs of a patient. such a monitoring is immediately required to improve patient safety and to reduce hospital readmissions. in this study, novel bed- and wearable sensors are studied for this purpose.

unobtrusive bed monitoring devices have gained popularity in the area of voluntary sleep quality monitoring for wellness purposes. most of these devices rely on the measurement of ballistocardiographic forces caused by the acceleration of blood when the heart pumps it to aorta, forces caused by respiration movements and other movements of the person being monitored. a thin film-type force sensor placed under the bed mattress, between the matrices or under the bed sheet is often used for measuring these forces. while proven to provide adequate reliability and accuracy for wellness monitoring of healthy people, unobtrusive bed monitoring solutions have not yet been widely deployed in hospital patient monitoring even though there would be much use for such technology e.g. in regular hospital wards where currently the amount of patient monitoring is very limited. if proven operational in this application, bed monitoring technology would provide tremendous benefits in both clinical and home monitoring scenarios. wrist worn pulse plethysmography (ppg) devices have increased their popularity as heart rate monitors, referred as optical heart rate monitors (ohr) for sports and wellness in recent years and their ability to measure average heart rate during movement and beat-to-beat heart rate while at rest accurately with healthy people has been shown. the objective of the study is to collect ecg and movement data measured with a wearable ecg monitor and simultaneously record data with unobtrusive bed sensor and wrist worn ppg device. data recorded with the bed and wrist sensors and vital parameters calculated from that or provided by the monitoring devices directly will be compared with the reference. the purpose of the study is to gain knowledge about the feasibility of unobtrusive bed and wrist monitoring devices for patient monitoring. the collected data will directly provide information on the accuracy of the current algorithms of the monitors. besides this evaluation, the collected data will be used in developing new algorithms for detection of cardiac problems. the study includes collection of data from vascular patients referred to surgical operation in tampere university hospital. data collection takes place at vascular surgical ward where one dedicated research bed is equipped with bed monitoring devices. another group of subjects is formed by healthy volunteers.

Eligibility criteria:
inclusion criteria: * age\>50 * indication for operation: peripheral arterial bypass and/or endarterectomy, aortic surgery, carotid surgery * volunteering exclusion criteria: * pacemaker * denial

Keywords: sensor wearable
comparative study about the influence of diabetes diatress and depression on treatment adherence in chinese type 2 diabetes patients

Conditions: Compare Diabetes Distress and Depression

Summary: an effective treatment adherence was a key to make the treatment success, some reports had shown that psychologicl factors impact patients adherence seriously,however, in china, the researches were only limited to depression and diabetes,diabetes distress was neglected. some western studies had demonstrated the impact of diabetes distress on diabetes. thus, we hypothesized that: 1.perhaps our present depression-oriented health education was inadequate to promote patients' adherence, diabetes distress might played a more important part than depression in patients' treatment adherence. 2. there might be a high prevalence of diabetes distress in chinese type 2 diabetes; so, the comparative study between diabetes distress and depresion was conducted. objectives: to explore the relationship of diabetes-related distress and depression，and to compare the influence of diabetes distress and depression on treatment adherence in chinese type 2 diabetes . research design and method:we surveyed 200 type 2 diabetic patients from 2 third-class hospitals using the diabetes distress scale, zung self-rating depression scale, and revised treatment adherence in diabetes questionnaire (radq)simultaneously.


Eligibility criteria:
inclusion criteria: * 1)aged between 18-80 years, 2)diagnosed with diabetes for at least 6 month, 3) having the ability to communicate fluently and clearly, exclusion criteria: * patients who had the diagnosis of dementia or psychosis and severe diabetes complications (e.g., on dialysis)
a smart design for attendance-based prize cm

Conditions: Substance Abuse

Summary: the purpose of this study is to compare different forms of treatment for substance abuse. this study will involve a type of treatment called contingency management, in which patients receive incentives (prizes) for attending outpatient treatment. this study will compare contingency management to standard treatment that does not involve incentives. this study will also compare contingency management treatment that lasts 6 weeks to contingency management that lasts 12 weeks. finally, this study will compare contingency management treatment delivered at the beginning of outpatient treatment to contingency management treatment delivered later during outpatient treatment. the investigators hypothesize that (1) a 12-week attendance-based contingency management intervention will improve retention and enhance drug abstinence versus standard treatment, (2) initial short-term exposure to attendance-based contingency management (in weeks 1-6 only) will improve substance abuse treatment outcomes compared to standard treatment alone, and (3) contingency management in weeks 7-12 will be particularly useful for those with sporadic attendance or continued drug use during initial stages of treatment.


Eligibility criteria:
inclusion criteria: * age \> 18 years * current dsm-iv diagnosis of cocaine abuse or dependence or recent cocaine use (self-reported use in past 30 days or positive urine toxicology screen) * willing to sign informed consent and able to pass an informed consent quiz exclusion criteria: * serious, uncontrolled psychiatric illness (e.g., acute schizophrenia, bipolar disorder, severe or psychotic major depression, or suicide risk) on the basis of history or medical examination * in recovery from pathological gambling (meet dsm-iv criteria for lifetime pathological gambling and are actively trying to refrain from gambling) * do not speak english (all treatment is provided in english at these clinics)

Keywords: substance abuse contingency management
the effects of diode laser as an adjunct to non-surgical periodontal treatment on periodontal status in patients with stage iii-iv periodontitis

Conditions: Periodontal Diseases

Summary: periodontal disease is serious and global chronic disease. the prevalence of periodontal diseases in united arab emirates is not clear but data from dubai health authority showed that one in five patients has received periodontal treatment in recent years. several studies reported the additional benefits provided by the use of diode laser in combination with ultrasonic debridement in the treatment of gum disease. the use of diode laser may debridement of deep pocketing areas while improving healing of gum tissues. the aim of the study is to compare the effect of removing bacterial deposit (biofilm) from deep tooth pocket using combined diode laser and conventional pocket debridement versus conventional pocket debridement alone on tooth supporting tissue parameters in patients with advanced gum disease (periodontitis). methodology: a total of 22 patients with advanced gum disease will be randomly allocated to two groups: a control group, which will receive conventional pocket debridement and a test group which will receive ultrasonic debridement with diode laser. gum measurements will be recorded by a masked calibrated examiner at six points for each tooth and patients' postoperative experience and satisfaction will be assessed using special forms.


Eligibility criteria:
inclusion criteria: * aged 18 or over. * diagnosed with unstable generalised periodontitis, stage iii-iv and grade b or c. * good compliance and commitment to attend follow-up review appointments. * willing to provide informed consent. exclusion criteria: * received periodontal treatment in the last 12 months. * received systemic antibiotic in the last 6 months. * pregnancy or lactating participants
metformin efficacy and safety in epileptic patients

Conditions: Epilepsy

Summary: the goal of this clinical trial is to evaluating metformin efficacy and safety when co-administered with antiepileptic drugs in patients with seizures. the main question it aims to answer is: * does metformin have beneficial effect on epileptic patients? * how metformin can affect epileptic patient's health? participants will be divided into 2 groups (control group and treatment group) * control group will receive standard treatment (levetiracetam \&/or sodium valproate). * treatment group will receive standard treatment (levetiracetam \&/or sodium valproate) + metformin


Eligibility criteria:
inclusion criteria: * age: 18 - 65 years old * obese and overweight patients with body mass index (bmi) ≥ 25. * diabetic \& non diabetic patients. exclusion criteria: * patients with severe liver damage or kidney disease (egfr below 45ml/min/1.73 m²). * patients having acute or chronic disease which may cause tissue hypoxia and increase the risk of lactic acidosis (e.g. cardiac/respiratory failure, recent myocardial infarction). * patients who are already taking metformin. * cancer patients. * pregnant or lactating women. * patients with known hypersensitivity to the drug.
intestinal remodeling and reprogramming of glucose metabolism following laparoscopic roux-en-y gastric bypass

Conditions: Type 2 Diabetes; Obesity

Summary: the purpose of this study is to investigate small intestinal remodeling and reprogramming of glucose metabolism in patients with type 2 diabetes mellitus (t2dm) who undergo laparoscopic roux-en-y gastric bypass (rygb). our specific goal is to determine if the gene and protein expression levels of glut-1 are up regulated in the roux limb and whether this is a major mechanism for the remission of t2dm following rygb. the two aims of the study are: 1) to demonstrate that the basement membrane glucose transporter 1 (glut-1) is upregulated in the roux limb following rygb, and 2) to demonstrate that the upregulation of glut-1 is a major mechanism for the improvement in glycemic control observed in t2dm patients undergoing rygb.


Eligibility criteria:
inclusion criteria: 1. diagnosis of type 2 diabetes mellitus 2. age between 18 and 65 years of age 3. bmi \> 35kg/m² 4. diagnosis of gastritis, esophagitis, ulcer, or other mucosal abnormality discovered at routine preoperative upper endoscopy, requiring follow-up endoscopy in the post-operative period. exclusion criteria: 1. patients undergoing revision from another bariatric procedure to rygb 2. presence of a seizure disorder (glut-1 deficiency syndrome) 3. use of tricyclic antidepressants 4. use of tobacco products

Keywords: roux-en-y gastric bypass
the risk factors for acute radiation pneumonitis in patients with prior receipt of immune checkpoint inhibitors

Conditions: Cancer Patients

Summary: the purpose of this non-interventional study is to collect data on the risk factors for acute radiation pneumonitis in patients with prior receipt of immune checkpoint inhibitors.

1. incidence of acute radiation pneumonitis (arps) in in patients with prior receipt of immune checkpoint inhibitors. 2. risk factors (especially analysis of the dosimetric risk factor) which may affect the product of arps events. 3. establish a model to predict arps and guide clinical treatment.

Eligibility criteria:
inclusion criteria: 1. pathologically or cytologically confirmed malignant tumor 2. cancer patients with previously received icis underwent thoracic intensity-modulated radiotherapy exclusion criteria: 1. cancer patients did not receive immunotherapy before thoracic intensity-modulated radiotherapy 2. non-thoracic radiotherapy patients

Keywords: imrt radiotherapy immune checkpoint inhibitor pneumonitis risk factors
can low molecular weight heparin during pregnancy with intrauterine growth restriction increase birth weight?

Conditions: Fetal Growth Retardation

Summary: the purpose of the study is to investigate if treatment with an anticoagulant drug increases birth weight in pregnancies complicated by fetal growth restriction.

clinical purpose: 1. to examine whether treatment with low molecular weight heparin in pregnant women with intrauterine growth restriction (iugr)increases the birth weight of the child. our hypothesis is that an increased birth weight leads to reduced morbidity and mortality among these children. laboratory purposes: 1. to evaluate three new methods to monitor the effect of lmwh. 2. to investigate if 2 biochemical markers are positive predictors of iugr iugr is defined as a foetus that grows less than expected. iugr is estimated to occur in up to 5% of all pregnancies, and iugr is the second most common cause of perinatal morbidity and mortality. thus, 75% of all stillbirths are caused by iugr. iugr is diagnosed by ultrasonography. in iugr the uteroplacental blood flow is often compromised resulting in foetal growth restriction. design: the study is a prospective randomised study where pregnant women with suspected severe iugr are randomised either to treatment with innohep® or no treatment. half of the women receive innohep® and half of the women do not receive treatment. endpoints the primary endpoint is the difference in birth weight in children born of women receiving innohep® during pregnancy and children born of women who have not received innohep® during pregnancy

Eligibility criteria:
inclusion criteria: 1. singleton pregnancy 2. iugr shown by ultrasonography: 3. can understand and read danish exclusion criteria: 1. age below 18 years 2. pregestational weight \< 90 kilograms 3. not able to give informed consent 4. chronic kidney disease with creatinine \>150 μmol/l 5. chronic hypertension with blood pressure \>140/90 mmhg 6. diabetes mellitus; type 1 or 2 or gestational diabetes 7. inflammatory bowel disease 8. severe heart disease (including mechanical heart valves) 9. drug or alcohol abuse 10. known coagulopathy (von willebrand disease, thrombocytopenia, carrier of haemophilia) 11. treatment with vitamin k antagonists 12. known allergy to low lmwh 13. previous heparin-induced thrombocytopenia (hit (type ii)) 14. clinically significant bleeding within the last month 15. women with indication for prophylactic treatment with lmwh during pregnancy e.g. previous thromboembolic disease or serious types of thrombophilia (deficiency of antithrombin, protein c or protein s) 16. chromosome anomaly in the child 17. severe malformations in the child 18. contraindication to innohep® 19. gestational week \> 32 weeks

Keywords: birth weight thrombosis anticoagulant therapy
effect of indacaterol maleate in chronic obstructive pulmonary disease (copd) on lung volume and related dyspnea

Conditions: COPD; Lung Diseases; Dyspnea; Hypoxemia; Tachycardia

Summary: the purpose of this study is to determine whether indacaterol maleate 300 micrograms (mcg) is effective in the acute treatment of copd and in particular on reducing lung hyperinflation and dynamic volumes.

enrolled patients: copd of any disease severity in stable conditions. 48 hours of inhalatory drugs wash out. evaluation: plethysmographic test, blood gas analysis, blood pressure, cardiac frequency and borg scale evaluation in basal condition and after 60 minutes of indacaterol maleate 300 mcg inhalation.

Eligibility criteria:
inclusion criteria: * signature of consensus * copd diagnosis * age from 50 to 85 years old * history of copd at least of one year * respiratory stable conditions at least of one month * any basal fev1 expressed in % of predicted value * fev1/ forced vital capacity (fvc) less than 70% * former or active smokers with at least a smoking history of 20 pack year exclusion criteria: * pregnancy * fev1/fvc more than 70% * known deficit of alpha 1 antitrypsin * subjects submitted to a lung volume reduction surgery (lvrs) * subjects with known positivity to human immunodeficiency virus (hiv) * misuse of alcool or drugs * absence of compliance in performing respiratory tests

Keywords: copd inspiratory capacity residual volume total lung resistance arterial oxygen