Kornimate/medical-research-clean huggingface dataset:
study of daclatasvir (bms-790052) and simeprevir (tmc435) in patients with genotype 1 chronic hepatitis c virus

Conditions: Hepatitis C Virus

Summary: the purpose of this study is to assess the safety and efficacy of daclatasvir and simeprevir with and without ribavirin for genotype 1 chronic hepatitis c virus infection in patients who are treatment-naive or null responders to previous pegylated interferon/ribavirin therapy.


Eligibility criteria:
key inclusion criteria: * hepatitis c virus (hcv) genotype 1a or 1b * males and females, ≥18 years of age * hcv rna ≥10,000 iu/ml * participants with compensated cirrhosis are permitted * advanced fibrosis (f3/f4) is capped at approximately 35% of the total treated population with a minimum of 20% f4 patients * if no cirrhosis, a liver biopsy within 3 years prior to enrollment * if cirrhosis is present, any prior liver biopsy key exclusion criteria: * liver or any other transplant (other than cornea and hair) * evidence of a medical condition contributing to chronic liver disease other than hcv infection * current or known history of cancer, (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment * evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy * patients infected with hiv or hepatitis b virus * gastrointestinal disease impacting absorption of study drug * uncontrolled diabetes or hypertension * prior exposure to an hcv direct-acting agent * any criteria that would exclude the patient from receiving ribavirin * absolute neutrophil count \<1.5\*1,000,000,000 cells/l (\<1.2\*1,000,000,000 cells/l for black/african americans) * platelets \<90\*1,000,000,000 cells/l * hemoglobin \<12 g/dl for females, \<13 g/dl for males * alanine aminotransferase ≥5\*upper limit of normal * in patients without cirrhosis, total bilirubin ≥2 mg/dl unless patient has a documented history of gilbert's disease * in patients with cirrhosis, total bilirubin o ≥1.5 mg/dl * international normalized ratio ≥1.7 * qtcf or qtcb \>500 msec * creatinine clearance ≤50 ml/min * alpha fetoprotein (afp) \>100 ng/ml or * afp ≥50 ng/ml and ≤100 ng/ml requiring liver ultrasound * albumin \<3.5 g/dl
incidence of complications associated with anesthesia in obesity parturient undergoing cesarean delivery

Conditions: Cesarean Section Complications; Anesthesia Complication; Obesity, Morbid

Summary: the incidence of obesity parturient has been increasing worldwide. there was a report revealing one third of pregnant women in united state considered obesity. obesity is associated with increased in maternal and neonatal complications. also, there was an increasing in the rate of cesarean delivery. anesthetic management of the obese parturient is differ from non-obese parturients. there were higher risk of difficult intubation, failed intubation, pulmonary aspiration and difficult regional anesthesia such as spinal anesthesia or epidural catheter placement comparing with non-obese parturient. the aim of the study is to report complication associated with anesthesia in obese patients undergoing cesarean delivery in single university hospital, bangkok, thailand.

the incidence of obesity parturient has been increasing worldwide. there was a report revealing one third of pregnant women in united state considered obesity. obesity is associated with increased in maternal and neonatal complications. also, there was an increasing in the rate of cesarean delivery. anesthetic management of the obese parturient is differ from non-obese parturients. there were higher risk of difficult intubation and difficult regional anesthesia such as spinal anesthesia or epidural catheter placement comparing with non-obese parturient. who categorised obesity into 3 classification; grade 1: bmi 30-34.9 kg/m2, grade 2: bmi 35-39.9 kg/m2, grade 3: bmi \> 40 kg/m2. this study emphasised in grade 3 obese pregnant women (bmi\>40 kg/m2) undergoing cesarean delivery that were at risk of increasing in anesthetic complications such as airway complications as well as complications derived from regional anesthesia eg. high spinal block, failed spinal block etc. therefore, the primary objective of the study is to report complication associated with anesthesia in obese patients undergoing cesarean delivery in single university hospital, bangkok, thailand. the secondary objectives rate of postpartum haemorrhage, rate of hysterectomy and neonatal outcomes.

Eligibility criteria:
inclusion criteria: * pregnant women bmi\>,= 40 kg/m2 underwent cesarean delivery exclusion criteria: * patients with gestational age \<,= 24 weeks * patients with death fetus in utero * multiple gestation * patients with intrapelvic cavity pathology eg. myoma uteri * patients with abnormal placentation * patients with polyhydramnios

Keywords: anesthetic complications maternal outcomes neonatal outcomes cesarean section obesity
post radiotherapy mri based ai system to predict radiation proctitis for pelvic cancers

Conditions: Pelvic Cancer

Summary: in this study, investigators utilize a artificial intelligence (ai) supportive system to predict radiation proctitis for patients with pelvic cancers underwent radiotherapy. by the system, whether the participants achieve the radiation proctitis will be identified based on the radiomics features extracted from the post radiotherapy magnetic resonance imaging (mri) . the predictive power to discriminate the radiation proctitis individuals from non-radiation proctitis patients, will be validated in this multicenter, prospective clinical study.

this is a multicenter, prospective, observational clinical study for seeking out a better way to predict the radiation proctitis in patients with pelvic cancers based on the post-radiotherapy magnetic resonance imaging (mri) data. patients who have been pathologically diagnosed as pelvic cancers will be enrolled from the sixth affiliated hospital of sun yat-sen university, sir run run shaw hospital and the third affiliated hospital of kunming medical college. patients with pelvic cancers who received radiotherapy will be enrolled and their post-radiotherapy mri images will be used to predict their radiation proctitis or not. the clinical symptoms, endoscopic findings, imaging and histopathology as a standard. the predictive efficacy will be tested in this multicenter, prospective clinical study.

Eligibility criteria:
inclusion criteria: * pathologically diagnosed as pelvic tumours * intending to receive or undergoing radiotherapy * mri (high-solution t2-weighted imaging, contrast-enhanced t1-weighted imaging, and diffusion-weighted imaging are required) examination is completed after radiotherapy exclusion criteria: * insufficient imaging quality of mri (e.g., lack of sequence, motion artifacts) * incomplete radiotherapy

Keywords: radiation proctitis pelvic cancers artificial intelligence
chloridehexidine versus povidine jodine both soluted in alcohol in forefoot surgery

Conditions: Hallux Valgus; Arthritis of the First Metatarsophalangeal Joint

Summary: the study will prospectively compare the efficacy and safety of chloride hexidine soluted in alcohol with povidine-jodine soluted in alcohol in forefoot surgery.

it will be a comparative study in which we will swab cultures before skin preparation directly after skin preparation and at the and of the operation (hallux valgus correction and arthrodesis of the first metatarsophalangeal joint. there will be a quantitative and quality analysis of the swabs. we will also measure allergic reactions. during the post-operative period of 6 weeks we will measure the wound infections stated by prezies.

Eligibility criteria:
inclusion criteria: * age above 18 years * written informed consent * indication for hallux valgus correction or arthrodesis of the first metatarsophalageal joint exclusion criteria: * allergic for jodine-povidine and/or chloride-hexidine * active infection * skin defect * blood clotting or coagulation disorder

Keywords: infection skin preparation fore-foot surgery chloride-hexidine povidine-jodine alcohol
diaphragmatic rapid shallow breathing index for predicting weaning outcome from mechanical ventilation

Conditions: Weaning Failure

Summary: predicting successful discontinuation from mechanical ventilation has been a focus of interest to all critical care physicians . various weaning indices have been investigated to optimize the weaning process. among them, the rapid shallow breathing index (rsbi) has gained wide use but it have different sensitivities and specificities. by substituting tidal volume (vt) with diaphragmatic displacement (dd) in the calculation of rsbi a new index (the diaphragmatic rapid shallow breathing index drsbi) was proposed and it was independently associated with weaning failure and its accuracy for predicting weaning outcome is expected to be superior to the traditional rsbi.

the rapid shallow breathing index (rsbi), calculated from respiratory rate divided by tidal volume (rr/vt), is a well-known weaning index and one of the most clinical indices used to predict weaning outcome. however, it has some limitations in predicting weaning outcomes. several previous studies have defined different sensitivities and specificities for rsbi less than 105 to predict weaning success which may lead to errors in predicting successful weaning. on the other hand, weaning failure is likely to occur if there is an imbalance between the load on the inspiratory muscles and their neuromuscular capacity, the imbalance between the mechanical load imposed on the diaphragm which is the major muscle of inspiration and its ability to cope with it. therefore, evaluating the function of diaphragm before any weaning trial could be useful in predicting weaning outcome. bedside ultrasonography is an easy, fast, noninvasive, and accurate maneuver for evaluating diaphragmatic function. diaphragmatic displacement (dd) reflecting the ability of diaphragm to produce force and subsequently tidal volume during inspiration and defined as displacement of less than 10 mm has been found to be a predictor of weaning failure among patients in medical icus. spadaro et al. proposed substituting vt with dd in the rsbi, and calculating diaphragmatic rsbi (drsbi) would result in a more accurate predictive index than the traditional rsbi.

Eligibility criteria:
inclusion criteria: * patient or relative acceptance * mechanically ventilated for more than 48 hours * ready to wean and at their first spontaneous breathing trial * meeting all weaning criteria exclusion criteria: * history of any neuromuscular disease * diaphragmatic palsy * cervical injury * current chest trauma * thoracotomy for any reason * patients in whom neuromuscular blockers are used in the last 48 hours before the study * patients for whom aminoglycosides are prescribed during their course in icu
inactivity, balance problems and fall risk in institutionalized frail elderly

Conditions: Institutional Frail Elderly

Summary: the overall objective of the research is to identify the prevalence and incidence of bppv and the impact on balance problems, fall risk and inactivity in frail elderly. the investigators will demonstrate the importance of early diagnosis and treatment in this patient group.


Eligibility criteria:
inclusion criteria: * institutionalized in a nursing home for at least 3 months * able to understand and follow simple instructions * able to stand independently for 30 seconds * willing to participate in the study exclusion criteria: * diagnosis of progressive neurological diseases (such as amyotrophic lateral sclerosis) resulting in a fast decline within 3 months * rehabilitating for a neurological or orthopaedic incident such as knee prosthesis, stroke,... ) * contra-indication for hallpike and epley maneuver
comparison of the cardiovascular benefits of resistance, aerobic, and combined exercise

Conditions: Cardiovascular Diseases

Summary: as the leading cause of death, cardiovascular disease (cvd) accounts for about one-third of u.s. mortality. physical inactivity, one of the main cvd risk factors, causes 6% of coronary heart disease worldwide. the american heart association has identified cardiovascular health behaviors including smoking, obesity, diet, and aerobic exercise; however, resistance exercise was not included due to the limited evidence of its efficacy. comparatively, the cardiovascular benefits of aerobic training have been well-documented whereas the independent and additive benefits of resistance training on cardiovascular health have not been established. thus, this project is aimed to answer one of the most common questions about exercise and health:"what type or combination of exercise is most effective for cvd prevention?" this project will significantly contribute to developing more effective cvd prevention approaches, advancing more comprehensive physical activity guidelines, and providing important insights and novel opportunities for the future science of physical activity and health.

participants will be randomly assigned to aerobic exercise, resistance exercise, combined aerobic and resistance exercise, or a no exercise control group for 1 year. participants in all four groups will receive healthy diet and lifestyle education sessions and will track their daily steps, body weights, and food intake throughout the 1-year intervention. they will also complete baseline, 6-month, and 12-month physical examinations, which will include assessments of blood pressure, blood lipids, body composition, and aerobic and muscular fitness.

Eligibility criteria:
inclusion criteria: * non-smoker * systolic/diastolic blood pressure of 120-139/80-89 mmhg (without taking any anti-hypertensive medication) * overweight or obese: body mass index of 25-40 kg/m2; asian 23-40 kg/m2 * inactive: less than 150 min/week of exercise over the past 3 months * capable of performing the required exercise training exclusion criteria: * unstable coronary heart disease or heart failure * uncontrolled arrhythmias or severe aortic stenosis * acute myocarditis, endocarditis, or pericarditis * cancer, requiring treatment in the past 5 years * autoimmune diseases, affecting the immune system * plans to be away/travel for greater than 4 weeks in the next year * pregnancy/anticipated pregnancy during the study * other medical condition that is life-threatening or can interfere with or be aggravated by the exercise training
a study of rituximab and bevacizumab in patients with follicular non-hodgkin's lymphoma

Conditions: Lymphoma, Follicular

Summary: the purpose of this study is to assess the feasibility, efficacy and safety of adding bevacizumab to rituximab compared to rituximab alone in patients with previously treated follicular non-hodgkin's lymphoma (nhl) whose disease has progressed following at least one previous chemotherapy regimen and not more than 2 previous chemotherapy regimens.

upon determination of eligibility, patients will randomly be assigned to one of two treatment arms: * rituximab * rituximab + bevacizumab for every 2 patients randomized, 1 will receive treatment number 1 (rituximab), and 1 patient will receive treatment number 2 (rituximab + bevacizumab). this is not a blinded study, so both the patient and doctor will know which treatment has been assigned.

Eligibility criteria:
inclusion criteria: to be included in the study, you must meet the following criteria: * follicular nhl, grades 1 or 2 confirmed by a biopsy sample * 18 years of age or older * evidence of disease progression at time of study entry * must have had at least one previous chemotherapy regimen and not more than two previous chemotherapy regimens. * patients who have received previous rituximab are eligible as long as progression occurred more than six months following completion of previous rituximab therapy. * measurable or evaluable disease * able to perform activities of daily living without considerable assistance * adequate bone marrow, kidney, and liver function * signed informed consent obtained prior to initiation of any study-specific procedures or treatment. exclusion criteria: you cannot participate in the study if any of the following apply to you: * treatment with more than two previous chemotherapy regimens * prior treatment with bevacizumab or other similar agents * progressive nhl less than 6 months after receiving previous rituximab * more than 1 prior treatment with investigational agents within 4 weeks prior to entering this study * spread of nhl to brain or nervous system * history of any other uncontrolled or significant disease or medical condition that may put them at high risk for treatment complications with these agents please note: there are additional inclusion/exclusion criteria. the study center will determine if you meet all of the criteria. if you do not qualify for the trial, study personnel will explain the reasons. if you do qualify, study personnel will explain the trial in detail and answer any questions you may have. you can then decide if you wish to participate.

Keywords: lymphoma bevacizumab rituximab
assessing dietary requirements in relation to resting metabolic rate in spinal cord injury

Conditions: Spinal Cord Injuries; Dietary Habits

Summary: assess the relationship between body composition, metabolism, and dietary needs in people with spinal cord injury compared to their healthy controls that are age and sex matched.

this study will quantify body composition and resting metabolic rate and then compare these parameters to results from a nutritional analysis. participants will have two study visits that include physical exam, blood draws, resting metabolic rate, dual energy x-ray absorptiometry (dxa) scan, and dietary assessments.

Eligibility criteria:
inclusion criteria: 1. c4-l2 motor complete (ais a \& b) spinal cord injury for duration greater than 12 months. 4. \<5% change in body in body weight over the past 12 months 5. fluent in written and spoken english exclusion criteria: 1. \<22% body fat 2. coronary artery disease 3. type 1 diabetes mellitus, insulin-requiring type 2 or untreated diabetes mellitus (fasting glucose\>126 or hgba1c\>7.0) 4. hypothyroidism, and/or renal disease 5. decisional impairment 6. prisoner

Keywords: resting metabolic rate
screening for atrial fibrillation with self pulse monitoring

Conditions: Atrial Fibrillation New Onset

Summary: the goal of this clinical trial is to determine the efficacy of self-pulse monitoring in detecting atrial fibrillation (af) in adult patients at increased risk of stroke. the main questions it aims to answer are: * is self-screening an effective modality for diagnosis of af? * are there clinical differences and outcomes for patients who self-screen? eligible participants will be randomized to either the intervention group or control group. the control group will continue with usual standard of care. participants randomized to the intervention group will be asked to: * view an online educational video to teach them the appropriate way to manually check their pulse for irregularities. * manually check their pulse for 30 seconds twice daily for 14 days. * patients who screen positive for irregularities will be sent a 14-day wearable cardiac monitor to assess for underlying arrhythmias. researchers will compare the intervention group to the control group to see if there are clinical differences and outcomes.

participants will be recruited for this study using mychart recruiting. participants meeting inclusion criteria will be invited to participate and can respond "interested" or "decline." participants who respond interested will complete a brief survey to confirm eligibility prior to consenting. one the participant consents, they will be randomized to the self-pulse check/intervention group or control group.

Eligibility criteria:
inclusion criteria: * age 18 or greater * no known history of atrial fibrillation or atrial flutter * access to mychart * cha2ds2-vasc sore (described below) \>/= 2 (male) or \>/=3 (female) based on the following criteria: * two points: age ≥75, prior stroke * one point: age ≥65-74, congestive heart failure, hypertension, diabetes, vascular disease exclusion criteria: * prior diagnosis of atrial fibrillation or atrial flutter * unable to consent * currently incarcerated * self-pay/uninsured * taking anticoagulation for other medical conditions than atrial fibrillation or atrial flutter

Keywords: atrial fibrillation
promoting prosocial bystander behavior in intoxicated men: evaluation of realconsent2.0

Conditions: Alcohol Intoxication; Sexual Violence; Helping Behavior

Summary: sexual violence (sv) is a significant public health problem particularly among 18-24 year old populations. a major risk factor for sv is alcohol use, which via its negative impact on cognitive abilities and decision-making acts as a barrier to intervening in situations at-risk for a sv. this study has two main goals: (1) to determine the effects of proximal alcohol use on young (age 21 to 25) men's prosocial bystander behavior in situations considered at-risk for sv, and (2) to determine the efficacy of an evidence-based, web-based program called realconsent, which has been augmented to include alcohol-specific content within the context of bystander sv ("realconsent2.0"), on men's prosocial bystander behavior. the primary study endpoint is prosocial bystander behavior and will be assessed via two modes: (1) a virtual reality (vr) environment ("b-save") and (2) a validated self-report measure of bystander behavior that has been modified to include assessment of proximal alcohol use and presence of alcohol within the context.


Eligibility criteria:
inclusion criteria: * identify as a man or transgender man, age (21-25) * consume weight-based amount of alcohol at least three times during the past year exclusion criteria: * weight over 250 pounds * current treatment-seeking for an alcohol use disorder * any medical or psychiatric condition, as well as current use of a medication, that would contraindicate alcohol administration. * in a relationship over 6 months * married/living together * neurological disorder: diagnosis of a neurological disorder * psychiatric disorder: past or current diagnosis of bipolar disorder (i or ii), schizophrenia, schizoaffective disorder, or any other psychotic disorder * treatment for alcohol or drug use: currently being treated for alcohol, or drug problems; currently interested in seeking treatment for drinking or drug use * physical disability: anh physical disability that would prevent an individual from participating in the virtual reality task (self-report and determined) * significant hearing problems: significant hearing problems that would prevent an individual from hearing and responding to the virtual reality task (self-reported and determined) * cardiac pacemaker * asthma: emergency room visit related to asthma in the past year; use of inhaler more frequently when drinking alcohol; use of oral steroid treatments for asthma in the past year; * legal: any legal restrictions against drinking (e.g., as a condition of probation or parole) * alcohol abstinence: individuals who consume alcohol monthly or less; individuals who have consumed the amount of alcohol they would be expected to drink during the lab session (determined by their weight) less than 3 times in the last year * head injury: any past serious head injuries (as indicated by helps brain injury screening tool) * acute psychiatric symptomatology: elevated psychological distress as indicated by a score greater than 65 on the brief symptom inventory