Kornimate/medical-research-clean huggingface dataset:
clinical analysis of juvenile dermatomyositis patients

Conditions: Juvenile Dermatomyositis

Summary: this study aimed to investigate the clinical effectivity of intravenous methylprednisolone repeated intermittent pulse combined with mycophenolate mofetil in the treatment of newly diagnosed juvenile dermatomyositis.

reviewed the clinical data of 12 juvenile dermatomyositis patients, from january 2014 to january 2017, hospitalized and treated with intravenous methylprednisolone repeated intermittent pulse combined with mycophenolate mofetil

Eligibility criteria:
inclusion criteria: 1. patients with age of jdm onset \<16 years 2. newly treated cases 3. no contraindications to corticosteroids 4. provide signed informed consent form 5. regular follow-up for more than 30 months. exclusion criteria: 1. patients with serious complications of heart, liver and kidney 2. patients with a history of contraindications and/or allergies to gc 3. patients who underwent treatment before admission 4. patients who failed to regularly follow-up 5. patients with positive anti-melanoma differentiation-associated gene 5 (mda5) antibodies

Keywords: intravenous methylprednisolone repeated intermittent pulse mycophenolate mofetil
alk rearrangements in lung adenocarcinoma: epidemiology in latin america (clicap)

Conditions: Lung Cancer

Summary: evaluation of the frequency and clinical characteristics of alk rearrangements in latin-american countries. latin american countries are heterogeneous in terms of lung cancer incidence, ethnicity, and exposure to potential carcinogens. the discovery of the echinoderm microtubule-associated protein like 4-anaplastic lymphoma kinase (eml4-alk) translocation as an oncogenic driver has led to the development of novel therapies with activity in vitro and in the clinic.

the precise frequency of alk in latin american population has not been determined. studies isolated in some latin american countries like brazil report a frequency of 3.2%, argentina of 4.2% and mexico of 9.0% of alk fusion in a small number with lung cancer. reliable information about alk frequencies and disparities among ethnic groups is critical. our study pretends to know the frequency and clinical characteristics of alk rearrangement of latin american patients with nsclc. discusses the difficulty of having a single diagnostic test for this chromosome abnormality. the development of efficient and reliable laboratory test is critical in the selection of patients likely to respond to these targeted agents. currently, the current gold standard for testing for eml4-alk translocation is fluorescent in situ hybridization (fish) for selecting patients for alk-tyrosine kinase inhibitors (tki) therapy according to the united states food and drug administration (fda). but, an important aspect is the amount of available tumor present in a determined sample, given the labor-intensive nature and cost of the test, there has been interest in validating other screening and diagnostic tools. recent evidence suggests that alk immunohistochemistry (ihc) instruments globally protocols, can be very effective in the detection of alk rearrangement in nsclc (alk+) tumors expressing the fusion alk protein.

Eligibility criteria:
inclusion criteria: * histologically confirmed lung cancer and tissue availability for alk analysis. exclusion criteria: * not lung cancer

Keywords: alk latin american
phase i/ii study of monoclonal factor ix concentrate for factor ix deficiency

Conditions: Hemophilia B; Factor IX Deficiency

Summary: objectives: assess the safety and long-term efficacy of monoclonal factor ix concentrate in patients with factor ix deficiency.

protocol outline: patients receive monoclonal factor ix replacement therapy as inpatients. patients with a satisfactory response receive further therapy as needed for bleeding for up to 36 months at home.

Eligibility criteria:
protocol entry criteria: patients with factor ix deficiency.

Keywords: hematologic disorders rare disease
effect of physical exercise program on outcomes and level of depression

Conditions: Pregnancy

Summary: due to physical and physiological changes that occur in pregnant women, depression is very common during this period. recent research findings indicate that antenatal maternal mood state impacts on babies health. nowadays, many researchers are focussed on examining the effects of physical exercise on foetal and maternal outcomes. the main aim of this study was to assess the effectiveness of a supervised exercise program consisted of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvis floor muscles training, on the prevention and treatment of depression in pregnant women. additionally, the other purpose of the study was to analyze the effects of depression and physical exercise on outcomes. hypothesis: pregnant women who do regular exercise during their pregnancies would have a better mood state than pregnant women who are sedentary, without having any negative effect on outcomes.

backround: recent studies have estimated the prevalence of depression during pregnancy at between 10% and 30%. this state can produce negative effects on the fetus as: * affect cerebral development * increase the risk of preterm birth and low birth weight * increase the risk of childhood overweight problems * adverse impact on the cognitive, emotional, social, and behavioural development of infants due to the possible side effect of antidepressants on mother and fetus, its necessary to examine alternative solutions to this state.

Eligibility criteria:
inclusion criteria: * being healthy and able to exercise following american college of obstetricians and gynecologists (acog) guidelines * being able to communicate in spanish * giving birth at hospital universitario de fuenlabrada exclusion criteria: * multiparity * obstetrician complications * being interested in the study after 18 weeks * not being regular in physical exercise program * younger than 18 years old

Keywords: pregnancy, outcomes, depression, mood, physical exercise
lap-band surgery on adolescents for safety and efficacy

Conditions: Obesity; DM

Summary: this study is to demonstrate the safety and efficacy of the use of the lap-band surgery in the morbidly obese adolescent population.

study objectives: is to demonstrate the safety and efficacy of the use of the lap-band® system in the morbidly obese adolescent population in the united states, and therefore provide these individuals with a significantly less morbid and reversible surgical option for weight loss. study variables:the primary efficacy variable is weight loss evaluated in terms of % excess weight loss (ewl). design:prospective, open-label, and single center

Eligibility criteria:
inclusion criteria: * be at least 14 and less than 18 years of age at the time of enrollment into the study. * have a bmi of at least 40 * have a history of obesity for at least 5 years, including failed attempts at diet and medical management of obesity. * confirmation by a psychologist or psychiatrist experienced with adolescents that the subject is sufficiently mature emotionally to comply with the study protocol. express willingness to follow protocol requirements. •assure investigators that subject, if female of childbearing potential, is using an appropriate form of contraception. exclusion criteria: * intention or need to have another surgical procedure for weight reduction within 12 months of lap band placement. * history of congenital or acquired anomalies of the g.i. tract, such as; congenital or acquired intestinal telangiectasia, crohn's disease or ulcerative colitis; severe cardiopulmonary disease or severe coagulopathy; hepatic insufficiency or cirrhosis. * presence of dysphagia or documented esophageal dysmotility. * patients with autoimmune connective tissue disorders * patients with acute abdominal infections * pregnancy or intention of becoming pregnant in the next 12 months. * presence of psychiatric problems or immaturity which would compromise cooperation with the study protocol. * history of previous bariatric surgery, intestinal obstruction or adhesive peritonitis. * presence of localized or systemic infection at the time of surgery. * chronic use of aspirin and/or non-steroidal anti-inflammatory medications and unwillingness to discontinue the use of these concomitant medications. * history of gastric or esophageal surgery. * use of weigh loss medications simultaneously

Keywords: child obesity
lateral pharyngoplasty outcomes in children undergoing tonsillectomy

Conditions: Sleep-Disordered Breathing; Sleep Apnea Syndromes in Children; Sleep Apnea, Obstructive; Tonsillitis; Tonsillar Hypertrophy; Tonsil Stone; Tonsil Disease

Summary: the goal of this treatment study is to determine if doing lateral pharyngoplasty with tonsillectomy is better for children than doing tonsillectomy alone. the main questions it aims to answer are: * do children experience less pain after surgery when lateral pharyngoplasty is performed with tonsillectomy compared to tonsillectomy alone? * do children eat/drink better when lateral pharyngoplasty is performed with tonsillectomy compared to tonsillectomy alone? * is there a lower risk of bleeding after tonsillectomy when lateral pharyngoplasty is performed? researchers will compare children undergoing tonsillectomy and lateral pharyngoplasty with children undergoing tonsillectomy alone to see if the participants experience less pain, better oral intake, and less bleeding complications after surgery. parents of participants will be asked to record pain scores and pain medications given, approximate amounts of daily oral intake, and any complications after surgery.

this is a randomized controlled trial to elucidate the benefits of performing lateral pharyngoplasty with tonsillectomy and encourage its use as a standard of care procedure. participants will be randomized to receive either tonsillectomy +/- adenoidectomy or tonsillectomy +/- adenoidectomy with lateral pharyngoplasty (research intervention), with lateral pharyngoplasty referring to the placement two figure-of-8 sutures with 3-0 vicryl to reapproximate the anterior and posterior tonsillar pillars on each side. the investigators' hypothesis is that participants undergoing lateral pharyngoplasty will experience less pain, lower post-tonsillectomy hemorrhage rate, and a faster return to normal oral intake than participants undergoing tonsillectomy alone.

Eligibility criteria:
inclusion criteria: * participants ages 3-17 years of age undergoing tonsillectomy +/- adenoidectomy at loma linda university health exclusion criteria: * subjects with congenital syndromes and/or developmental delay * subjects with cancer * subjects with gastrostomy tube use or dependence * subjects undergoing intracapsular tonsillectomy

Keywords: tonsillectomy post-tonsillectomy hemorrhage post-tonsillectomy complication lateral pharyngoplasty
the efficacy and safety of anticoagulation in chinese patients with non-st segment elevation acute coronary syndrome

Conditions: Acute Coronary Syndrome

Summary: the primary objective of the easy-china registry is to describe the clinical epidemiology of chinese patients with nste-acs, to evaluate their current anticoagulation management in china, and the resources used for it.

non-st-elevated acute coronary syndromes (nste-acs)are the leading cause of emergency medical care in the usa. in china, these syndromes have also become the major causes of morbidity and mortality and account for several thousands of death and hospitalizations annually. anti-platelet drugs, anticoagulants and intervention therapy for high-risk nste-acs patients may increase bleeding events while reducing ischemic coronary events. there are some evidences supporting the association between hemorrhagic complications and short- and long-term mortality. therefore, future advances in antithrombotic therapy for nste-acs need to focus on reducing ischemic event rates without increasing hemorrhagic complication rates. in this general framework, there is the need for an appropriate adoption of the available evidences concerning therapeutic strategies, specifically the use of the different antithrombotic strategies, in real world patients in order to further improve their outcomes.the primary objective of this study is to describe the clinical epidemiology of chinese patients with nste-acs, and to evaluate their current management in china. this study will be an observational survey, thus zero interference is emphasized throughout it. no randomization, blinding or special treatment will be assigned for the subjects. issues concerning the care of subjects are completely left to the discretion of investigators in order to collect the real-world information about the pharmacological treatments for nste-acs patients in china.

Eligibility criteria:
inclusion criteria: * with symptoms of ua or mi without persistent st elevation and at least 1 of the following additional criterias: 1)troponin t or i or ck-mb above the upper limit of normal,2)electrocardiogram (ecg) changes compatible with ischemia (ie, st depression at least 1mm in 2 contiguous leads or t-wave inversion \>3 mm),3)any dynamic st shift or transient st elevation * must be willing to signed informed consent * age from 21-80 years * without pregnancy or under contraception exclusion criteria: * age\ 80 years * any contraindication to anticoagulant * hemorrhagic stroke within 12 months * indication for anticoagulation other than acs * prior enrollment in anticoagulants trials in acs * revascularization procedure performed for the qualifying event in one month * severe renal insufficiency (ie,serum creatinine\>=3 mg/dl or 265umol/l) * pregnancy or breast-feeding women * life expectancy\<6 months * enrollment in other medicine trials in 3 months * with mental illness or uncooperative

Keywords: non-st-elevated acute coronary syndromes (nste-acs) anticoagulation
role of provider-at-triage on ed efficiency and quality of care

Conditions: Patient Satisfaction With Emergency Department Efficiency

Summary: the united states spends over $8,000 per capita annually on health care and its health care system is more expensive than other developed countries. even with high per capita costs and a high proportion of physician specialists, the us lags in health care performance from patients' perspectives. the hospital emergency department (ed) is often the portal of entry for patients seeking health care services and is therefore an ideal setting for initiatives to improve efficiency of care delivery and patient satisfaction. reduction in wait times, enhanced information delivery and ed staff service quality all have a positive influence on patient perception of health care quality and satisfaction. prior studies have attempted to increase patient satisfaction by improving staff communication and courtesy, implementing a patient satisfaction team in triage, and delivering information to patients in a timely manner. another strategy to increase the efficiency of ed operations is adding a physician to triage to perform brief medical screenings and initiate necessary patient testing and treatment. this contrasts to usual practice in which physicians evaluate patients only following registration and nurse assessment of illness or injury severity.

this study will assess the impact of early patient assessment by a physician at emergency department (ed) triage on patient perception of information delivery, overall patient satisfaction and ed efficiency. ed efficiency will be assessed by ed length of patient stay, ed left-without-being-seen and ed left during treatment rates. participants who decide to take part in this study, will be asked questions by research staff, who will document responses on a secure ipad device. the survey will ask participants how they feel about their health condition, the emergency department wait, the care they received in the emergency department and how satisfied the participant was with the care received.

Eligibility criteria:
inclusion criteria: participants are eligible to participate in the study if they are: * english speaking * without hemodynamic or respiratory compromise * do not have a nurse-assigned triage severity score of emergency severity index 1 (most severe illness or injury score). exclusion criteria: participants will be excluded if they are: * unwilling or unable to sign an informed consent * in police custody * too ill to participate in study.

Keywords: patient satisfaction emergency department efficiency
sof/vel±rbv: efficacy and safety in gt 3 and 6 hcv patients

Conditions: Hepatitis C

Summary: 150 gt3 or gt6 chc patients with or without compensated cirrhosis will be recruited from five centers in china including g3a 50, g3b 50, g6 50 respectively. gt3a and gt6 chc with or without compensated patients will be administered one pill of epclusa each day for 12 weeks, and gt3b patients will be administered epclusa each plus ribavirin for 12 weeks.

this is a prospective, observational, multi-center, real-world study to investigate real world effectiveness and safety of sof/vel±rbv in chinese patients infected by hcv gt-3 and 6. 150 gt3 or gt6 chc patients with or without compensated cirrhosis will be recruited from five centers in china including g3a 50, g3b 50, g6 50 respectively. gt3a and gt6 chc with or without compensated cirrhosis will be administered one pill of epclusa each day for 12 weeks, and gt3b patients will be administered one pill of epclusa each plus ribavirin for 12 weeks.demographic, clinical, adverse event and virological data were be collected throughout treatment and post-treatment follow-up.

Eligibility criteria:
inclusion criteria: * hcv rna ≥ 15 iu/ml at screening * hcv genotype 3a ,3b and 6 * hepatitis c without decompensated cirrhosis of the liver exclusion criteria: * patients failed to previous ns5a-containing daas therapy * decompensated cirrhosis * hcc * infection with hepatitis b virus (hbv) or human immunodeficiency virus (hiv).
pilot study testing the effect of ivacaftor on lung function in subjects with cystic fibrosis and residual cftr function

Conditions: Cystic Fibrosis

Summary: this study is a multiple within participant crossover study to evaluate the effect of ivacaftor on lung function in participants aged 12 years and older with cystic fibrosis (cf) who have phenotypic or molecular evidence of residual cf transmembrane conductance regulator (cftr) function.

cftr mutations associated with residual function or defective messenger ribonucleic acid (mrna) splicing include the following: r117h, e56k, p67l, d110e, d110h, r117c, r347h, r352q, a455e, d579g, s945l, l206w, r1070w, f1074l, d1152h, s1235r, d1270n, 2789+5g-\>a, 3849+10kbc-\>t, 3272-26a-\>g, 711+5g-\>a, 3120g-\>a, 1811+1.6kba-\>g, 711+3a-\>g, 1898+3a-\>g, 1898+1g-\>a, 1717-1g-\>a, 1717-8g-\>a, 1342-2a-\>c, 405+3a-\>c, 1716g/a 1811+1g-\>c, 1898+5g-\>t, 3850-3t-\>g, ivs14b+5g-\>a, 1898+1g-\>t, 4005+2t-\>c, 621+3a-\>g, 621+1g-\>t.

Eligibility criteria:
inclusion criteria: * male or female participants with confirmed diagnosis of cf * clinical evidence of residual cftr function based on any 1 of the following: 1) clinically documented residual exocrine pancreatic function, 2) sweat chloride value less than equal to (\ =) 12 years and at least 1 copy of a cftr mutation associated with residual cftr function or defective mrna splicing * fev1 \>= 40 percent (%) * 12 years of age or older * willing to agree to meet the contraception requirements * able to swallow tablets exclusion criteria: * a copy of any of the following cftr mutations: g551d, g178r, s549n, s549r, g551s, g970r, g1244e, s1251n, s1255p, or g1349d * unable to perform spirometry * an acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 4 weeks before day 1 * ongoing participation in another therapeutic clinical study or prior participation in an investigational drug study within the 30 days prior to screening
intrapleural gene transfer for pleural mesothelioma

Conditions: Malignant Pleural Mesothelioma

Summary: this research will study how to activate the immune system by using gene transfer. gene transfer involves inserting a specially designed gene into cancer cells. a gene is a part of the genetic code that instructs the cells of our bodies to produce specific compounds (proteins) important for the makeup or function of the cell. the study hypothesis is that repeated doses of sch 721015 given over a three day interval would result in gene transfer.

ad.hifn-α (sch 721015, adenoviral-mediated interferon alpha) is a replication-defective recombinant adenoviral vector containing the human interferon-alpha (hifn-alpha) gene. this phase i study is designed to evaluate the safety and maximum tolerated dose (mtd) of two doses of ad.hifn-alpha injected into the pleural (intrapleural, ip) and given 4 days apart in subjects with pleural mesothelioma. subjects who meet eligibility will have a pleural catheter placed 2 weeks prior to the first dose. subjects are then admitted to the research center on days 1 and 4 for dosing and overnight observation. subjects are then followed-up as outpatients for a total of 6 months. radiographic evaluations are repeated on day 64 and at 6 months. the pleural catheter is removed once it is not necessary.

Eligibility criteria:
inclusion criteria: * evidence of progressive disease after standard first line treatment of mesothelioma; or patient has refused standard first line treatment of mesothelioma * evaluable disease * no radiotherapy and/or treatment with chemotherapeutic, cytotoxic, or immunologic agents within 14 days prior to infusion of the ifn-α vector * must have a pleural space involved with tumor accessible for pleural catheter insertion * fev1\> 1 liter or 40% of predicted value * must have an anti-adenoviral neutralizing antibody titer equal to or less than 1:1000. this will be measured by the penn vector core exclusion criteria: * presence of hiv or hepatitis b infection * use of concurrent systemic steroids, immunosuppressives, or any other medications that can directly or indirectly suppress the immune system * presence of any other life-threatening illness, such as unstable angina, severe oxygen dependence, significant chronic obstructive pulmonary disease (copd), end stage liver or renal disease * presence of untreated brain metastases * prior bone marrow or stem cell transplants

Keywords: gene transfer immunology cancer
study assessing saxagliptin treatment in type 2 diabetic subjects who are not controlled with metformin alone

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this clinical research study is to learn whether saxagliptin added to metformin therapy is more effective than metformin alone as a treatment for type 2 diabetic subjects who are not sufficiently controlled with metformin alone

all subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. subjects who complete the short-term period will be eligible to enter the long term extension period. also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control will be eligible to enter the long-term treatment extension period where they will receive pioglitizone added onto their blinded study medication

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus requiring treatment with at least 1500 mg but not greater than 2550 mg of a maximum tolerated dose of metformin therapy for at least 8 weeks prior to screening. * hba1c \>= 7.0% and \<= 10.0 % * body mass index \<= 40 kg/m2 * fasting c-peptide \>= 1 ng/dl exclusion criteria: * symptomatic poorly controlled diabetes * recent cardiac or cerebrovascular event * serum creatinine \>= 1.5 mg/dl for males and \>= 1.4 mg/dl for females