Kornimate/medical-research-clean huggingface dataset:
lorazepam sedation for critically ill children

Conditions: Critical Illness

Summary: this clinical trial is being performed under the best pharmaceuticals for children act, signed into law in 2002 in order to improve pediatric labeling for off-patent drugs. the purpose of this study is to make sure that lorazepam, when given to children who are very sick in the intensive care unit and who are on a breathing machine, is safe and works as well as a drug called midazolam. midazolam is already approved by the fda for this use, but lorazepam is not, even though both drugs are commonly used for sedation.

lorazepam is used clinically for sedation of mechanically ventilated children, but has not been approved by the fda for this indication in children. the purpose of this study, in response to the written request by fda, is to determine the safety, efficacy, and dosage required for lorazepam compared with midazolam, which is approved by fda for children for this indication. study participants must be children who are critically ill and receiving mechanical ventilation who require sedation. participants will be randomized to lorazepam (intermittent bolus or continuous infusion) or midazolam (continuous infusion). sedation will be monitored using the comfort score. blood will be drawn to measure lorazepam/midazolam plasma concentrations, and to measure the plasma concentrations of excipients (benzyl alcohol and glycols) in patients receiving lorazepam.

Eligibility criteria:
inclusion criteria: * males or females from full term birth (at least 38 weeks post conceptual age) through 18 years * patients must be intubated and mechanically ventilated in the picu less than or equal to 24 hr * patients in whom the use of neuromuscular blocking agents would normally not be expected to be used. * patient's parent or guardian has signed a consent form prior to initiation of study procedures * patients with cardiac, renal, or hepatic dysfunction will be actively sought exclusion criteria: * life expectancy \< 48 hr * expected duration of sedation \< 48 hr * patient with history of hypersensitivity to any component of lorazepam, midazolam, fentanyl, thiopental * females pregnant or breast feeding * patient requires sedatives or analgesics other than study drug

Keywords: lorazepam midazolam best pharmaceuticals for children act critically ill pediatrics mechanical ventilation sedation
evaluation of coronary microvascular dysfunction (evacory)

Conditions: Coronary Artery Disease

Summary: the proposed study is to validate a new non-invasive imaging technique for evaluation of cardiac microciculation in coronary artery disease with a comparison with validated technique invasive, which is measure of index of myocardial resistance.

coronary microvascular dysfunction is closely associated with coronary artery disease, it is an independent risk factor and predicts future coronary events or clinically manifest disease up to 10 years later. index of microcirculatory resistance (imr) is a validated method to assessment of the coronary microcirculation but this is an invasive technique. in this study, we use a new mathematic technique from homogeneity analysis to provide precise, objective, automated quantification of perfusion heterogeneity at stress with new camera czt spect. we compare the results with those of the measurement of imr.

Eligibility criteria:
inclusion criteria: * stable angina * cadmium-zinc-telluride gamma camera spect * coronarography exclusion criteria: * pregnant woman * patient with terminal illness, * terminal renal failure * allergy to iodine * contraindications for adenosine: asthmatic patients, second- or third-degree av block without a pacemaker or sick sinus syndrome, systolic blood pressure less than 90mm hg, recent use of dipyridamole or dipyridamole-containing medications, methyl xanthenes such as aminophylline caffeine or theobromine block the effect of adenosine and should be held for at least 12 hours prior to the test, known hypersensitivity to adenosine, unstable acute myocardial infarction or acute coronary syndrome

Keywords: coronary microvascular dysfunction coronary artery disease index of myocardial resistance
establishment of retrospective and prospective multicenter cohort for chronic hepatitis b

Conditions: Chronic Hepatitis B

Summary: according to the world health organization about 1,400,000 deaths reported annually, are related to chronic liver disease. chronic liver disease is very prevalent in south korea, placing a large economic burden nationwide. subsequently, an effective and systematized approach to managing chronic hepatitis is imperative in korea. the natural history of chronic liver disease differs greatly according to race and ethnicity. however, there is scarcity of epidemic data on chronic hepatitis based on korean patients. therefore, the investigators plan to establish a retrospective and prospective multicenter cohort for chronic hepatitis b based on korean patients that may be utilized for various future clinical studies on chronic hepatitis b in korea, and thereby serve as a basis for the establishment and distribution of clinical guidelines for korean patients with chronic hepatitis b, as part of a nationwide project supported by the centers for disease control (cdc), korea. the investigators plan to collect 500 cases as have been advised by the cdc during the study period (september, 2014-march, 2015) from 4 tertiary hospitals located in korea. in the past 5 years, there have been about 800 subjects with chronic hepatitis b who have undergone liver fibroscan and liver biopsy from these 4 institutions. the investigators plan to register available cases retrospectively from those who are available to agree to give written informed consent to participate in this study, and to register the remaining numbers of cases prospectively, according to the inclusion and exclusion criteria.


Eligibility criteria:
inclusion criteria: 1. subject aged 20 years or older 2. subject who has been diagnosed with chronic hepatitis b (hbs ag (+) for minimum of 6 months_ 3. subject who is currently under clinical follow up at the registered institution 4. subject who has undergone or who can undergo liver fibroscan at the time of registration 5. subject who has given informed consent to the enrollment exclusion criteria: 1. subject with decompensated liver cirrhosis or hepatocellular carcinoma at the time of initial liver fibroscan 2. subject who had previously undergone antiviral therapy for chronic hepatitis b 3. subject who are concomittantly infected with hcv, hdv or hiv 4. subject with chronic alcoholism defined as equal to or greater than 40g of alcohol for duration of 5 years or longer 5. subject who has been diagnosed with right sided heart failure 6. subjects whose liver fibroscan result is not valid 7. subject who is considered ineligible to the enrollment to clinical study by the researcher 8. subjects who is pregnant at the time of registration 9. pregnancy

Keywords: chb, cohort, fibroscan
pleurectomy/decortication followed by intrathoracic/intraperitoneal heated cisplatin for malignant pleural mesothelioma

Conditions: Pleural Mesothelioma; Malignant Pleural Mesothelioma

Summary: the purpose of this study it to determine the safety and maximally tolerated dose (mtd) of cisplatin administered in the operating room and put into the chest and abdomen for one hour. we are also looking at the effects of heating the chemotherapy to a temperature of 42 degrees celsius.

* patients will undergo surgery with pleurectomy/decortication which entails the removal of the inner and outer skin of the lung, including the pleura overlying the pericardium and diaphragm. resection of the pericardium and diaphragm are occasionally necessary to debulk the tumor. this surgery is part of standard care for pleural mesothelioma. * after surgery, a one hour lavage with heated cisplatin will be administered to the hemithorax (and abdominal regions if the diaphragm is no longer present). the lung itself is not removed, only the diseased portion of the lung and surrounding areas with tumor. * immediately following the one-hour lavage, a six hour infusion of sodium thiosulfate will begin to help reduce the side effects of the cisplatin. * patients will remain hospitalized until they have recovered from surgery (usually 7-14 days). * patients will return to the hospital three months after their surgery to have fluid drawn from their chest via an ultrasound guided thoracentesis. this is called a saline wash. * patients will be in the study actively for three months. this includes a 2-week and 4-week post-operative follow-up in which blood work is performed. as well as a 3-month follow-up for the saline wash. long-term follow-up includes computed tomography of the chest and abdomen every 6 months to assess recurrence.

Eligibility criteria:
inclusion criteria: * histopathologic confirmation of malignant pleural mesothelioma * patients who are able to tolerate surgical cytoreduction but unable to undergo extrapleural pneumonectomy due to poor cardiopulmonary reserve or tumor invasion * 18 years of age or older * malignancy is confined to the affected hemithorax. * grossly normal cardiac function with an ekg showing no cardiomyopathy or acute changes * evidence of adequate renal and hepatic function * karnofsky performance status of 70% or greater exclusion criteria: * extended disease outside the ipsilateral hemithorax as determined radiologically and intraoperatively * distant metastases * non-malignant systemic disease * active concomitant malignancy * psychiatric or addictive disorders which would preclude obtaining informed consent * prior treatment within the last 2 months, other than surgical resection for their current malignancy

Keywords: cisplatin pleurectomy decortication heated cisplatin
role of leukotrienes and adenosine in hyperpnea-induced bronchospasm

Conditions: Asthma, Exercise Induced

Summary: this research is being conducted to help us better understand what causes exercise induced asthma. the investigators hypothesize that two types of chemicals, cysteinyl leukotrienes and adenosine, play an important role. the investigators will be measuring these chemicals in the exhaled breath of volunteers with exercise induced asthma as they undergo a test to mimic exercise induced asthma. the investigators will determine how the levels of these chemicals change in association with how lung function changes before, during and after an episode of exercise induced asthma.


Eligibility criteria:
inclusion criteria: * physician diagnosed asthma * age 12-75 yrs * fev1 \> 70% predicted * hib response \> 10 % * no smoking last 6 mo and \< 10 pack yrs * no uri last 4 weeks * no asthma exacerbation last 4 weks * able to withhold saba \> 8 hrs and laba \> 24 hrs exclusion criteria: * other lung disease * cardiac disease or other condition that would preclude safe participation, on theophylline or leukotriene modifiers

Keywords: asthma exercise induced bronchospasm hyperpnea induced bronchospasm leukotrienes adenosine exhaled breath condensate
a study of aripiprazole in children and adolescents with aspergers and pervasive developmental disorder.

Conditions: Asperger's Disorder; Pervasive Developmental Disorder

Summary: the purpose of this study is to develop a better tolerated and more effective pharmacologic treatment for individuals with asperger's disorder and pervasive developmental disorder. this is an open-label investigation of aripiprazole in the management of the maladaptive behaviors of autistic disorder. we hypothesize that aripiprazole will be effective for reducing aggression and repetitive behavior.

pervasive developmental disorders (pdd) are characterized be severe impairments in social interaction and communication in addition to restricted patterns of interests and activities. research suggests that a dysregulation of the dopamine and serotonin systems contributes to these interfering behaviors in individuals with pdd. after benefits of typical neuroleptics were reported in subjects with pdd's, research shifted to the atypical antipsychotics, which have been shown to be better tolerated and effective in this population. however, the atypical antipsychotics have also been associated with adverse effects. thus there remains a need for a novel pharmacotherapy that would be safe and effective for children and adolescents with pdd's including asperger's disorder and pdd not otherwise specified (pdd nos). we hypothesize that aripiprazole will be effective for reducing aggression and repetitive behavior. we also hypothesize that aripiprazole will be well tolerated, with low risk for extrapyramidal symptoms, hyperprolactinemia, weight gain, or corrected qt interval (qtc) prolongation. in addition, this open-label study will serve to stimulate more definitive, controlled research.

Eligibility criteria:
inclusion criteria: * mental age of 18 months * diagnosis of asperger's disorder or pervasive developmental disorder * good health overall * free of all psychotropic medication for 2 weeks exclusion criteria: * weight less than 15kg * subjects who have received an adequate trial of aripiprazole * an active seizure disorder * a significant medical condition * history of neuroleptic malignant syndrome * females with positive beta human chorionic gonadotropin(hcg) pregnancy test

Keywords: aggression behavioral symptoms
prospective comparative analysis of acdf vs fusion interbody cages with nanolock osseointegrative technology

Conditions: Cervical Radiculopathy; Cervical Myelopathy

Summary: study team will plan a prospective, randomized control trial using our institution's spine clinical outcomes registry. eligible patients undergoing acdf (see inclusion criteria listed below) will be randomized to an intervention or control group, which will differ according to the interbody cage used during the procedure. in the intervention group (100 patients), medtronic titan endoskeleton tcs zero-profile, stand-alone interbody cages with nanolock osseointegrative technology will be implanted at each treated level. in the control group (100 patients), patients will receive an alternative interbody cage system that does not employ nanolock ossteointegrative technology. interbody cages used in the control group (along with the decision to apply anterior plate fixation) will be determined according to surgeon preference. there will be no blinding to the type of implant used. standard demographic and procedural variables will be collected for all patients (including history of diabetes, tobacco, use, prior use of oral corticosteroids, number of levels fused, and presence of bicortical screw placement). clinical and radiographic outcomes in the intervention and control groups will be directly compared.

aim 1: examine the effect of nanolock technology on rates of postoperative dysphagia after acdf. aim 2: evaluate the effect of nanolock technology on radiographic fusion. aim 3: evaluate how nanolock technology influences the development of radiographic adjacent segment disease.

Eligibility criteria:
inclusion criteria: * subjects 18 years of age or older * subjects undergoing acdf surgery for degenerative pathology (one, two or three levels) * subjects with no prior history of cervical spine surgery * subjects with complete/usable data exclusion criteria: * subjects under the age of 18 * subjects not undergoing acdf surgery * subjects with prior cervical spine surgery * subjects with cervical neoplastic or infectious disease pathology * subjects with cervical trauma pathology * acdf performed at c2-3 * subjects with incomplete/unusable data

Keywords: spine cervical discectomy bony fusion dysphagia radiographic fusion radiographic adjacent segment disease
vr integrated into multicomponent interventions for improving sleep in icu

Conditions: Critical Care; Sleep Quality

Summary: background: the patients who are admitted to icus mostly experience sleep disturbance. seeking an effective strategy and integrating it into the daily routine is of clinical importance. therefore, we aim to examine the effects of guided virtual reality integrated into the multicomponent program (sleep care) on sleep quality and quantity in critically ill patients. this will be a randomized controlled trial with assessor-blinded and two-arm parallel-group design. a total of 120 critical ill adults will be randomly allocated to the sleep care group and eyemask groups in a 1:1 ratio (60 participants in each group).

this study is expected to enroll 120 critically ill patients. we will collect basic data on the first day of admission to the intensive care unit, including demographics and disease characteristics, pain, anxiety, and stress, sleep quality and quantity, measure 5-minute hrv, wear an actigraph watch, and connect to the on-lead eeg sensor, and attach the brain wave to monitor the brain wave and sleep cycle. then they will be randomly assigned 1:1, dividing into sleep care group and eyemask group. participants who are in the control will receive eyemask intervention and daily care in the icu. participants who are assigned to the sleep care group will receive the vr and night sleep promotion routine. the researcher will assist participants to wear a virtual reality helmet for a 30-minute program at 10 pm, and then remove the helmet and wear eye masks until 6:30 in the morning. the icu routine care of promoting sleep is still maintained. the next morning (the second day of the icu), the researcher will assist participants to remove eeg sensors and evaluate the rcsq scale to understand the previous night's sleep. the above process will repeat for three days (icu days 1 to 3) until the intervention and measurement during the intensive care unit are completed on the morning of the fourth day. in order to understand the impact of sleep on cognitive function during the stay in the intensive care units and after discharge, the psqi, vas of pain, anxiety, and stress (confounders), and moca will be evaluated in the first and sixth months after discharge.

Eligibility criteria:
inclusion criteria: * aged 20 years and above. * conscious and able to communicate with chinese or mandarin. * to stay in icu at least 72 hrs exclusion criteria: * the medical history of sleep disorder, cognition impairment, psychiatric disorders, seizures, visual difficulty or hearing difficulty * the apache ii score over than 25 * the participates who are delirium

Keywords: intensive care unit sleep deprivation virtual reality multicomponent intervention
a long-term safety, tolerability and efficacy study of darifenacin in adult patients with overactive bladder

Conditions: Overactive Bladder Syndrome

Summary: this study will evaluate the safety, tolerability and efficacy of darifenacin, in the long-term treatment of adult patients with overactive bladder.


Eligibility criteria:
inclusion criteria: * adult patients with overactive bladder who completed a previous darifenacin short-term trial. * patients capable of independent toileting and able of independently completing the patient diary. exclusion criteria: * patients in whom the use of anticholinergic drugs was contraindicated * evidence of severe liver disease * patients with other clinically significant urinary or gynecological conditions other protocol-defined inclusion/exclusion criteria may apply.

Keywords: overactive bladder, incontinence, antimuscarinic, darifenacin, long-term treatment
neoadjuvant treatment of early triple-negative breast cancer with chidamide and chemotherapy

Conditions: Triple-negative Breast Cancer

Summary: objective to evaluate the efficacy and safety of neoadjuvant therapy with chidamide combined with chemotherapy for stage ii - iii triple-negative breast cancer，and to compare the efficacy and safety of chemotherapy with chidamide and chemotherapy alone in the neoadjuvant treatment of stage ii - iii triple-negative breast cancer


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 and ≤ 70, postmenopausal / premenopausal women; 2. patients with unilateral or bilateral primary invasive triple-negative (er expression \< 1%, pr \< 1%, and her2 negative \*) confirmed by histology or cytology; 3. non-metastatic invasive tnbc（stage ii-iii）with at least one axillary lymph node involvement (t1cn1-2m0 or t2-3n1-2m0); 4. previously untreated for breast cancer; 5. there was at least one measurable primary lesion (according to recist v1.1); 6. ecog score 0-1; 7. adequate organ and marrow function as defined below: absolute value of neutrophils ≥ 1.5 × 109 / l, platelets ≥ 100 × 109 / l, hemoglobin≥ 90 g / l; 8. volunteer to participate in this clinical trial and sign written informed consent exclusion criteria: 1. no measurable lesions, such as pleural or pericardial effusion, ascites, etc; 2. major surgical procedures or significant trauma were performed within 4 weeks before enrollment, or patients were expected to receive major surgical treatment (not related to breast cancer); 3. previously treated with chemotherapy or hdac inhibitors (including romidepsin, vorinostat, belinostat, and panobinostat，etc); 4. have allergic history to the components of this regimen; 5. treated with radiotherapy within 4 weeks before admission; 6. have a history of immunodeficiency, including hiv positive, or other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation; 7. uncontrolled cardiovascular diseases, history of clinically significant qt interval prolongation, or qtc interval \> 450 ms at screening; 8. abnormal liver function \[total bilirubin \> 1.5 times of the upper limit of normal value; alt / ast \> 2.5 times of upper limit of normal value for patients without liver metastasis ; alt / ast \> 5 times of upper limit of normal value for patients with liver metastasis \], abnormal renal function (serum creatinine \> 1.5 times of upper limit of normal value); 9. pregnant, lactating or fertile women with a positive baseline pregnancy test; or subjects of childbearing age who are not willing to take effective contraceptive measures during the study period and at least 8 weeks after the last administration; 10. according to the judgment of the investigator, there are some concomitant diseases (such as severe hypertension, diabetes, thyroid disease, active infection, etc.) that seriously endanger the safety of patients or affect patients to complete the study; 11. a clear history of epilepsy or dementia, including neurological disorders; 12. the investigator determined not suitable to participate in this study.

Keywords: neoadjuvant chidamide triple-negative breast cancer