Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety and efficacy of satralizumab in participants with neuromyelitis optica spectrum disorder (nmosd)

Conditions: Neuromyelitis Optica Spectrum Disorder

Summary: this multicenter, single-arm, open-label study will evaluate the long-term safety and efficacy of satralizumab in participants with neuromyelitis optica spectrum disorder (nmosd) who completed open-label extension (ole) period of studies bn40898 and bn40900. participants will receive satralizumab as monotherapy or in combination with one of the following background immunosuppressive treatments: azathioprine (aza), mycophenolate mofetil (mmf), or oral corticosteroids.


Eligibility criteria:
inclusion criteria: * participants aged less than 18 years at the time of informed consent for study bn40898 can continue treatment with a combination of oral corticosteroids and either aza or mmf * participated in study bn40898 or study bn40900 with satralizumab in nmosd, are on ongoing satralizumab treatment and were anti-aquaporin-4 igg antibody (aqp4-igg) seropositive at screening in these studies. participants with nmosd who were aqp4-igg seronegative at screening in study bn40898 or study bn40900 can be enrolled if the investigator considers the continued treatment with satralizumab to be beneficial for the participant * for women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for 3 months after the final dose of satralizumab. exclusion criteria: * pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of study drug. women of childbearing potential must have a negative urine pregnancy test result on the baseline visit prior to initiation of study drug * evidence of any serious uncontrolled concomitant diseases that may preclude participation including nervous system disease, cardiovascular disease, hematologic/hematopoiesis disease, respiratory disease, muscular disease, endocrine disease, renal/urologic disease, digestive system disease, congenital or acquired severe immunodeficiency * known active infection that requires delaying the next satralizumab dose at the time of enrollment * nmosd relapse at the time of enrollment * laboratory abnormalities at the last assessment in study bn40898 or study bn40900 that preclude re-treatment with satralizumab
turkish thoracic society usual interstitial pneumonia registry study

Conditions: Idiopathic Pulmonary Fibrosis; Usual Interstitial Pneumonia

Summary: the turkish thoracic society usual interstitial pneumonia registry (turk-uip) is a collaborative project to coordinate a team of investigators from various regions of turkey. the purpose of the registry is to collect epidemiological data on patients with idiopathic pulmonary fibrosis and other causes of uip, and to obtain information about the natural course of the disease and the treatment response.

the turk-uip registry is a web based application that will store information about patients. a hrct pattern consistent with uip will be confirmed by 3 radiologists. at the 3-month visits, the pulmonary function tests and the 6-minute walk test will be recorded. patients will be prospectively followed for a 5-year period.

Eligibility criteria:
inclusion criteria: 1. understand and sign the informed consent document. 2. the presence of a definite or possible uip pattern on high resolution computed tomography (hrct) or a histologic uip pattern (definite, probable and possible) on surgical lung biopsy (as defined by ats/ers/jrs/alat criteria). exclusion criteria: 1. hrct findings inconsistent with uip pattern (peribronchovascular predominance, extensive ground glass abnormality,profuse micronodules, discrete cysts , consolidation in bronchopulmonary segment(s)/lobe(s), diffuse mosaic attenuation/air-trapping), 2. histopathological findings inconsistent with uip pattern (as defined by ats/ers/jrs/alat criteria).

Keywords: idiopathic pulmonary fibrosis, usual interstitial pneumonia
efficacy and safety of da-2802 in chronic hepatitis b patients

Conditions: Hepatitis B， Chronic

Summary: a study demonstrates the non-inferiority of da-2802 when compared with ㅍviread® in chronic hepatitis b patients

1. da-2802 319mg group: administration with da-2802 319mg tablet qd and placebo tablet matching to viread® 300mg for 0-48 weeks. 2. viread® 300mg group: administration with viread® 300mg tablet qd and placebo tablet matching to da-2802 319mg for 0-48 weeks.

Eligibility criteria:
inclusion criteria: * patients with chronic hepatitis b aged 18 years or older * subjects who have evidence to demonstrate a history of chronic hepatitis b for at least six months from the time of screening visit * subjects who have hbsag positive test at screening visit * subjects who did not receive the hepatitis b treatment, including interferon or pegylated interferon, within 24 weeks of starting the screening test * subjects with an alt of 80 units or more and 10 times lower than the normal upper limit at the time of screening exclusion criteria: * subjects infected with hepatitis c, hepatitis d or human immunodeficiency virus * subjects with creatinine clearance of less than 50 ml/min at the screening visit * at the time of screening visit, alpha-fetoprotein level was higher than 50 ng/ml and related imaging test showed hepatocellular carcinoma * subjects with decompensated liver disease who meet the following criteria: 1. total bilirubin levels greater than 2.5 mg/dl 2. prothrombin time is at least 3 seconds longer than normal upper limit 3. serum albumin value less than 30 g/l 4. subjects with a history of ascites, jaundice, bleeding from varicose veins, hepatic encephalopathy, or other signs of liver failure.
concept: a 1-year comparison of a stable dose of seretide® inhaler with an adjustable maintenance dose of symbicort® inhaler. seretide® inhaler is a trademark of gsk group of companies. symbicort® inhaler is a trademark of astra zeneca.

Conditions: Asthma

Summary: to compare a stable dose of salmeterol/fluticasone propionate with a variable dose of formoterol/budesonide where the dose is adjusted according to a physician-guided self-management plan

a randomised, double-blind, double-dummy, 52-week, parallel group study of a standard dosing regimen with salmeterol/fluticasone propionate combination 50/250mcg bid (via the diskus/accuhaler inhaler) versus a symptom-driven variable dosing regimen with formoterol/budesonide combination 6/200mcg (via a breath-actuated dry powder reservoir inhaler)in adults asthmatics

Eligibility criteria:
inclusion criteria: * documented clinical history of asthma * forced expiratory volume in 1 second between 60% and 90% of predicted * using an inhaled corticosteroid (ics)at a dose equivalent to 200 to 500 mcg daily of beclomethasone (bdp)or equivalent combined with a long-acting beta-2-agonist or an ics alone at a dose equivalent to \>500 to 1000mcg daily of bdp daily exclusion criteria: * lower respiratory tract infection within 1 month of study entry * use of systemic corticosteroids within 1 month of study entry * smoking history of 10 pack years or more changes in regular asthma therapy within 12 weeks of study entry * any significant disorder that in the investigator's opinion might put the patient at risk or influence the study outcomes

Keywords: formoterol/budesonide exacerbations salmeterol/fluticasone propionate adjustable maintenance dosing asthma control
effects of exercise training on endothelial function, inflammation, arterial stiffness and autonomic function in cad

Conditions: Coronary Artery Disease

Summary: the main purposes of this study is to analyze, in a randomized controlled trial, the effects of an exercise-based cardiac rehabilitation program (i) on biomarkers of endothelial function, (ii) on biomarkers of inflammation, (iii) on autonomic function, and (iv) on arterial stiffness in coronary artery disease patients (cad). additionally, the investigators aim to analyze the (v) contribution of age and the changes in traditional risk factors to the modification of the endothelial dysfunction and inflammation, and (vi) the contribution of the changes in inflammatory and endothelial function biomarkers to the modification of autonomic function and arterial stiffness. the investigators hypothesize that exercise training will improve the autonomic function, arterial stiffness and mitigate the endothelial dysfunction and inflammation in cad patients even in the absence of significant changes in traditional risk factors. thus, the investigators expect with the present study to promote, develop and expand the knowledge in this field by assessing the impact of exercise on a pool of markers that provide a wide picture of the pathophysiological processes underlying cad.


Eligibility criteria:
inclusion criteria: * acute myocardial infarction exclusion criteria: * ventricular tachyarrhythmia * uncontrolled hypertension (systolic blood pressure \>180 mmhg or diastolic blood pressure \>100 mmhg) * significant valvular disease * unstable angina pectoris * reduced left ventricular function (ejection fraction \< 45%) * abnormal hemodynamic response * myocardial ischemia and/or severe ventricular arrhythmias during baseline exercise testing * uncontrolled metabolic disease (e.g. uncontrolled diabetes or thyroid disease) * presence of pulmonary and renal co-morbidities * peripheral artery disease and/or orthopedic limitations

Keywords: myocardial infarction autonomic function arterial stiffness endothelial function inflammation rehabilitation program exercise
neuromuscular training vs strength training

Conditions: Ankle Injuries

Summary: chronic ankle instability is a complex condition. limited mobility, perceived instability, and recurrent ankle sprains are common characteristics that reduce the quality of life in subjects who suffer chronic ankle instability. neuromuscular training and strength training has been recommended in chronic ankle instability management interventions. however, there are contradictory findings on results when comparing neuromuscular training, strength training, and control group.

participants were randomly assigned to the neuromuscular training group, strength training group, and control group with no intervention if participants met the inclusion criteria. neuromuscular training group. it consisted of a multi-station training with 6 exercises, increasing the difficulty progressively as the participants controlled the execution. the exercises were all performed barefoot and with the injured foot. these were a combination of standing and jumping exercises involving the injured ankle. a strength training group was performed with resistance bands. the band was fastened to the unaffected ankle, while the participant was told to perform front and back pulls, as well as adduction and abduction movements with the affected ankle. participants were told to control the ankle movement and to make it slow. control group received no intervention.

Eligibility criteria:
inclusion criteria were consistent with recommendations made from international ankle consortium16 and were checked before the intervention: * to have suffered the first sprain at least 6 months before the beginning of the study. * cumberland ankle instability score ≤24. * to be physically active. exclusion criteria. * participants could not have suffered an acute sprain in the 6 previous weeks to the beginning of the study. * history of recent ankle surgery. * epilepsy or previous seizures.
chronic fatigue in sarcoidosis

Conditions: Sarcoidosis

Summary: background: chronic fatigue (cf) is a prominent symptom in many sarcoidosis patients, affecting quality of life (qol) and interfering with treatment. this study investigates neuropsychobiological mechanisms and markers of cf in sarcoidosis.

patients with a histological diagnosis of sarcoidosis are included. the multidimensional fatigue inventory (mfi) is used to define patients with and without cf. all patients are then characterized using several fatigue, depression, qol and executive functioning questionnaires. cognitive functioning and underlying neural correlates are assessed using an n-back task measuring working memory and (sustained) attention during functional magnetic resonance imaging (fmri). sarcoidosis disease activity is determined using lung function, laboratory parameters, and exercise capacity.

Eligibility criteria:
inclusion criteria: * histologically diagnosed sarcoidosis * age ≥18 years * provision of written informed consent * sufficient german language skills to fully understand all questionnaires exclusion criteria: * patients unable to understand study-related information * insufficient language skills in german language * mri-related contraindications: * any kind of implants or extraneous material inside the body * past thoracic or ophthalmologic surgery * medical history of epilepsy, tinnitus or seizure * extensive tattoos * current pregnancy * claustrophobia

Keywords: fatigue fmri
study to compare welchol and tricor to tricor alone in patients with high cholesterol

Conditions: Hypercholesterolemia; Hyperlipidemia, Familial Combined

Summary: the primary objective of this study is to compare the effect of welchol in combination with tricor compared to tricor alone on low-density lipoprotein cholesterol (ldl-c) in patients with high cholesterol.


Eligibility criteria:
inclusion criteria: * 30-70 years of age * history of mixed hyperlipidemia * prescribed a step 1 diet at least 30 days prior to screening * women were not pregnant, breast-feeding, or plan to become pregnant during the study * women had a hysterectomy or tubal ligation, were post-menopausal, or practiced reliable birth control procedures * serum ldl-c \>/= 115 mg/dl; serum tg \>/= 150 \& \< 750 mg/dl exclusion criteria: * bmi \>40 * hba1c \> 10% * type 1 diabetes * intolerance to fibrates * history of intolerance to colesevelam hcl * history of swallowing disorders or intestinal motility disorders * any other disorder that might interfere with the conduct of the study * history of drug or alcohol abuse * recent (within 28 days) history of cardiac disease (mi, chf, cabg, etc.)

Keywords: mixed hyperlipidemia
phenotypic measurements and their relation to disease exacerbation in copd patients

Conditions: COPD Exacerbation; Copd

Summary: this is an observational pilot study focused on collecting data on clinical variables that can improve the understanding of potential predictors of disease exacerbation and readmissions in copd patients. the study aim is to understand how the variability of clinical parameters (respiratory rate, forced expiratory volume in one second, and oxygen saturation), physical activity and quality of life is associated with the risk of exacerbation in copd patients.

the investigational product to be used in this trial is the resmed biomotion sensor (resmed sensor technologies, dublin, ireland). this device uses very low power radio waves (\~1/100th of the strength of a mobile phone signal) to detect respiratory movements of a person while asleep- without physical contact with the individual. the device is designed to measure up to 5 feet, so that only the person on the side of the bed nearest the device is monitored. algorithms have been developed to analyze the respiratory movement signals and extract information about respiration rate, bodily movements, sleep/wake patterns and sleep disordered respiration.

Eligibility criteria:
inclusion criteria: 1. medically stable and ambulatory copd (primary diagnosis) patients who have had an emergency room visit or hospitalization for an acute exacerbation of copd within the past 30 days. 2. sufficient understanding of the english language to be able to read and understand study procedures. exclusion criteria: 1. currently on admission in the hospital, on non-invasive positive airway pressure ventilation 2. visual, hearing or cognitive impairments at the discretion of their physician. 3. currently participating in a copd telemonitoring program. 4. no at\&t cellular coverage at their primary residence 5. any other medical or psychological condition that, in the opinion of the investigator may present an unreasonable risk to the study participant as a result of his/her participation in this study, may make participant's participation unreliable, or may interfere with study assessments.
melatonin and glucose tolerance among individuals with a variant of the mtnr1b gene

Conditions: Diabetes; Glucose Tolerance

Summary: the effect of 3 months of melatonin 4mg treatment on glucose tolerance in different variants of the melatonin receptor 1b gene will be evaluated. the following will be done at 0 and 3 months: * ogtt * questionnaires about sleep and activity * actigraph * anthropometry * blood pressure

http://www.sciencedirect.com/science/article/pii/s1550413116301607

Eligibility criteria:
inclusion criteria: * signed informed concent * known genotype for mtnr1b from the botnia-ppp study * age 18-75 years exclusion criteria: * diabetes * positive gad-ab * sever dysregulated hypertension * glaucoma * severe coronary heart disease or arrythmias * previous or ongoing severe ventricle or duodenal ulcer * psychosis or anxiety disorder * regular use of sleep pills, antidepressants or neuroleptics * creatinine \> 130 µmol/l * elevated liver enzymes (asat, alat, alp, gt, bilirubin) \> 3 times reference value * inability to sign informed concent * other factor with according to the physician may affect treatment or results. * participation in other clinical study * allergy to melatonin or other substance in the capsule * hereditary galactose intolerance or glucose/galactose malabsorption * intention to become pregnant

Keywords: diabetes melatonin glucose tolerance sleep
retrieval-extinction paradigm on internet gaming disorder

Conditions: Internet Gaming Disorder

Summary: the overall aim of this experimental study is to apply the new paradigm of substance addiction intervention to the study of internet gaming disorder(igd) subjects' intervention.

this study is based on the retrieval-extinction paradigm.as with the efficacy, the experiment aims to test the effect of the retrieval-extinction paradigm on game craving and behave of igd subjects, so as to provide an empirical basis for the development of effective intervention means of internet gaming disorder.

Eligibility criteria:
inclusion criteria: 1. the 5th edition of diagnostic and statistical manual of mental disorders (dsm-5 ) recommended diagnosis of internet gaming disorder : the scores of the 9 items of dsm-5 recommended diagnosis for internet gaming disorder ≥ 5. 2. the scores of the young-internet addiction test ≥ 50 3. engagement in popular internet games (e.g. arena of valor, league of legends and player unknown's battle grounds) for over 20 hours per week for a minimum of 12 months. exclusion criteria: 1. current or history of use of illegal substances and other addictions; 2. current or history of psychiatric or neurological illness; 3. current use of psychotropic medications.
manual immediately sequential bilateral cataract surgery (m-isbcs) vs refractive laser-assisted immediately sequential bilateral cataract surgery (rela-isbcs)

Conditions: MCS vs ReLACS; Pain Perception Postoperative; Early Anesthesia vs Standard Anesthesia; Immediately Sequential Bilateral Cataract Surgery

Summary: the focus of this study is to assess the differences in patient perceptions of pain undergoing cataract surgery by using the refractive laser-assisted cataract surgery (relacs) technique compared to the standard manual cataract surgery (mcs) technique using an immediately sequential bilateral approach. this study also aims to further explore difference in patients' perceptions of pain depending on timing of neurolept anesthesia in the relacs technique. the importance of this study is appreciated patient perception of pain during relacs, which is an emerging technique for cataract surgery and has been sparsely reported on to date. this investigation will include the analysis of various surgical, ocular, medical, and psychosocial metrics of patients undergoing both relacs and mcs at uptown eye specialist.


Eligibility criteria:
inclusion criteria: * patients undergoing uncomplicated cataract surgery with either surgical technique (m-isbcs or rela-isbcs) * patients who require surgery in both eyes by the same surgeon * able to understand english and complete a pain assessment (nrs) exclusion criteria: * deafness or communication disorder, known dementia, severe copd/asthma (severe lung disorder), severe osa, psychiatric or anxiety conditions, involuntary movement disorders, allergy to the anesthesia, any conditions requiring intraoperative iris manipulation, any prior ocular surgery * pre-existing chronic eye pain or uveitis, or complicated cataracts (dislocation, zonulopathy) * pre-existing uncontrolled glaucoma/high iop * intraoperative complications or non-routine cataracts (eg. sutures, excessive time of surgery) * any patient who requires deep sedation (propofol), ga or preop ativan * patients under 40, severe obesity (bmi \>35) * chronic pain/narcotics/recreational or medical marijuana
preoperative vitamin d for post-thyroidectomy hypocalcemia

Conditions: Hypocalcemia

Summary: the purpose of this study is to determine if pre-operative vitamin d supplementation lowers the incidence of post-operative transient or permanent hypoparathyroidism in patients undergoing total thyroidectomy.


Eligibility criteria:
inclusion criteria: * patients undergoing total thyroidecomty +/- cnd * adult (age \> or = 18) exclusion criteria: * known chronic kidney disease * known primary hyper or hypoparathyroidism * known hypoalbuminemia * concurrent use medications affecting calcium metabolism * completion hemithyroidectomy

Keywords: permanent temporary hypocalcemia
procalcitonin as a marker for the length of antibiotic treatment in peritonitis and intra-abdominal infections

Conditions: Secondary or Tertiary Peritonitis

Summary: procalcitonin level used for determining length of antibiotic treatment in peritonitis and intra-abdominal infections. hypothesis is that length of antibiotic use can be shortened by this method.

prospective randomized trial

Eligibility criteria:
inclusion criteria: * more than 18 yo * patient requiring surgery for peritonitis or intra-abdominal infection following: perforation, necrosis, previous operation... * mannheim peritonitis score \> 14 * sirs present * probability of survival \> 72h * informed consent by patient/relatives exclusion criteria: * no sirs * long date corticoid treatment * immunosuppression * thyroid medullary carcinoma * anaphylactic shock * acute hepatic deficiency