Kornimate/medical-research-clean huggingface dataset:
low creatinine level and respiratory failure

Conditions: Intensive Care Unit; Respiratory Insufficiency; Muscle Weakness

Summary: low creatinine levels may be a sign of muscle atrophy or weakness, and therefore predictive for respiratory insufficiency in the intensive care unit (icu) patients. the investigators compared the outcomes of participants with low creatinine levels with subsequent icu participants admitted into icu in the tertiary hospital.

the investigators have found a total of 46 participants with low creatinine levels and compared their outcome data with a group of participants with normal or high creatinine levels (control group, n=61). low creatinine was defined as values of ≤40 μmol/l. demographic data, type of admission (medical vs. surgical), hemoglobin values, crp, and ventilator days were compared. a statistical analysis was performed using chi square and t-test.

Eligibility criteria:
inclusion criteria: * inclusion criteria for study group was value of ≤40 µmol/l serume creatinine level during hospitalization in icu from july 2015 to november 2016. exclusion criteria: * patients who were younger than 18 years

Keywords: low serume creatinine levels, respiratory insufficiency, icu
a trial assessing the effectiveness and safety of [s,s]-reboxetine in patients with fibromyalgia

Conditions: Pain

Summary: the purpose of this study is to assess the safety and effectiveness of \[s,s\]-reboxetine in patients with fibromyalgia.


Eligibility criteria:
inclusion criteria: * at screening patients must meet the acr criteria for fibromyalgia (i.e. widespread pain for at least 3 months, and pain in at least 11 of 18 specific tender point sites). * at screening and randomization, patients must have a score of \>/=40mm on the visual analog scale (vas) of the short-form-mcgill pain questionnaire (sf-mpq). exclusion criteria: * patients with other severe pain (e.g. dpn and phn) that may confound assessment or self-evaluation of the pain associated with fibromyalgia. * patients with severe hepatic impairment.
study of icotinib hydrochloride in treating patients with recurrent or metastatic esophageal cancer after failure of conventional chemotherapy

Conditions: Esophageal Squamous Cell Carcinoma

Summary: phase ii study of icotinib hydrochloride in treating patients with recurrent or metastatic esophageal squamous carcinoma after failure of conventional chemotherapy.

currently,there is no standard second-line therapy for esophageal squamous cell carcinoma.more effective therapy for patients with this disease who developed disease progression after first line therapy is needed.although erlotinib is recommended in nccn guideline version 2.2013,there is still insufficient evidence on egfr-tki as second-line therapy for esophageal squamous carcinoma.therefore,further research is necessary.in this phase ii study,we evaluate the efficacy and safety of icotinib hydrochloride as treatment for patients with recurrent or metastasis esophageal squamous carcinoma after failure of conventional chemotherapy,and analyse the value of biomarkers of these patient to identify who benefit.

Eligibility criteria:
inclusion criteria: * patients have provided a signed informed consent form * age: 18-75 years old * histologically confirmed diagnosis of esophageal squamous cell carcinoma * patients have received and progressed on 1 line of prior fluoropyrimidine, platinum or taxane based palliative chemotherapy * measurable disease in at least 1 diameter by ct scan or mri as per recist 1.1 criteria * life expectancy ≥ 3 months * karnofsky score ≥70 * patient has adequate bone marrow and organ function * absolute neutrophil count (anc) ≥ 1.5 x 109/l * platelets ≥ 75 x 109/l * hemoglobin ≥ 9.0 g/dl * patient has adequate liver function * ast and alt not more than 2.5 times uln (not more than 5.0 times uln if there is liver metastasis) * serum bilirubin ≤ 2 x uln * creatinine ≤ 1.5 times uln * no malabsorption or other gastrointestinal disorders affecting drug absorption. * no serious complications such as active gastrointestinal hemorrhage, perforation, jaundice, gastrointestinal obstruction, non cancerous fever \> 38 ℃. * expect good compliance exclusion criteria: * patient has received previous treatment with egfr inhibitors * patient is currently receiving phenytoin, rifampin, barbiturates, c masi bing * known severe hypersensitivity to icotinib or any of the excipients of this product * cns metastases without radiotherapy and/or surgery * patients with treated cns metastases may participate in this trial,except for those who must receive hormone therapy and those whose prior hormone therapy for cns metastases is less than 4 weeks * evidence of clinically active interstitial lung diseases * severe systemic disease out of control such as unstable or uncompensated respiratory,cardiac,liver,renal diseases * patient has a concurrent malignancy or has a malignancy within 5 years of study enrollment, (with the exception of nonmelanoma skin cancer or cervical carcinoma in situ * psychiatric illness that would prevent the patient from giving informed consent * patient is concurrently using other approved or investigational antineoplastic agent * pregnant or lactating women
special investigation of lipacreon on long-term use in patients with pancreatic exocrine insufficiency

Conditions: Exocrine Pancreatic Insufficiency; Pancreatic Diseases; Digestive System Diseases

Summary: this study aims at collecting the information related to the safety and effectiveness in the pancreatic exocrine insufficiency patients receiving the treatment with lipacreon for a long term in order to evaluate the effective and safe use of lipacreon.

criteria for evaluation: 1. adverse events 2. nutritional endpoints * bmi (height \[only prior to the start of lipacreon treatment\] and weight) * serum total protein * albumin * total cholesterol * triglycerides * haemoglobin 3. symptoms related to exocrine pancreatic insufficiency * steatorrhoea * frequency of bowel movements * diarrhoea * foul stool odour * decreased appetite * abdominal distension 4. patient's quality of life (qol) 5. degree of general improvement

Eligibility criteria:
inclusion criteria * patients who receive lipacreon for the replacement of pancreatic digestive enzymes in pancreatic exocrine insufficiency exclusion criteria * patients with a history of hypersensitivity to the ingredient of lipacreon. * patients with a history of hypersensitivity to porcine protein.

Keywords: digestive system diseases therapeutic uses pancreatectomy gastrointestinal agents pancreatic diseases pancrelipase exocrine pancreatic insufficiency
executive function in early childhood

Conditions: Reading Disability

Summary: despite the fact that a substantial number of school age children struggle with both reading and math acquisition, the brain mechanisms of the overlapping aspects of reading and math skills, thought in part to be linked via executive functions (ef), have not been unpacked. this project will use a longitudinal design, following children from kindergarten through 1st grade, to understand how the brain networks associated with reading, math, and ef interact to predict academic outcomes and, in those who struggle academically, intervention response.

this longitudinal study will be conducted with 260 kindergartners, staggered across multiple cohorts, who are followed through 1st grade. there will be three time points of testing for each cohort: fall of kindergarten, spring of kindergarten, and in the fall of 1st grade. after the third testing time point, in the fall of 1st grade, the bottom 1/3 of readers in the sample will be selected to participate in the intervention arm of the study. these students will be randomly placed in one of two arms: business-as-usual, in which children receive no additional instruction; or the reading intervention condition, in which they receive 20 hours of 1:1 reading intervention over 6 weeks. children in both sub-sample arms are assessed again after tutoring is complete, in the spring of 1st grade. neuroimaging through magnetic resonance imaging (mri) and functional magnetic resonance imaging (fmri) will occur as part of study participation in conjunction with testing at fall of kindergarten, fall of 1st grade, and spring of 1st grade time points.

Eligibility criteria:
inclusion criteria: 1. children in kindergarten (approximate ages 4-9 years) 2. native english speakers exclusion criteria: 1. children not in kindergarten at time of enrollment; 2. previous diagnosis of intellectual disability; 3. known uncorrectable visual impairment; 4. documented hearing impairment greater than or equal to a 25 decibel (db) loss; 5. medical contraindication to mri procedures (e.g., metal devices) - excludes from mri procedures only; 6. known intelligence quotient (iq) below 70; 7. a pervasive developmental disorder; and 8. any known neurologic pathology, including epilepsy, spina bifida, cerebral palsy, traumatic brain injury, and brain tumors. 9. comorbid severe psychiatric disorders will also be excluded, as will those who are taking psychotropic medications, with the exception of stimulant medication for attention deficit hyperactivity disorder (adhd). children who meet criteria for adhd will be eligible as long as they are not taking psychotropic medications, with the exception of stimulant medication for adhd.
gastric emptying time in traumatic injuries

Conditions: Anesthesia; Gastric Ultrasound; Sonography; Point of Care Ultrasound (POCUS); Regurgitation; Pulmonary Aspiration During Anesthetic Induction; Trauma Patients

Summary: the investigators plan to do serial sonographic examinations of the gastric antrum (quantity, quality) to estimate the gastric emptying time and dependant factors after traumatic injurys.

the investigators plan to do serial sonographic examinations of the gastric antrum (quantity, quality) in patients suffering from a relevant traumatic injury. patients which are admitted to the emergency department with a corresponding history are considered for inclusion. patient with life-threatening injuries are excluded. after inclusion, the investigators plan to carry out gastric ultrasound (pocus) all 2 hours until the operative treatment (maximal 5 examinations). to identify factors which may be correlated with delayed gastric emptying several demographic and patient related factors are collected.

Eligibility criteria:
inclusion criteria: * relevant traumatic injury exclusion criteria: * life-threatening traumatic injury (immediate treatment is necessary) * underage * known pregnancy

Keywords: point of care ultrasound gastric ultrasound trauma patients aspiration anesthesia
an interventional study of avastin (bevacizumab) in patients with advanced/metastatic epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer

Conditions: Ovarian Neoplasms; Peritoneal Neoplasms; Fallopian Tube Neoplasms

Summary: this multicenter prospective study will evaluate the safety and efficacy of avastin (bevacizumab) in routine clinical practice in patients with advanced/metastatic epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer. data will be collected from eligible patients until death, withdrawal of consent, loss to follow-up, or study closure.


Eligibility criteria:
inclusion criteria: * prescribed to receive bevacizumab or already ongoing on treatment with bevacizumab for advanced/metastatic ovarian cancer, fallopian tube cancer or primary peritoneal cancer (figo stage iiib, iiic and iv) according to routine clinical practice exclusion criteria: * not eligible for treatment with bevacizumab according to the local prescribing information
clinical study of decitabine and paclitaxel combination therapy

Conditions: Advanced Breast Cancer

Summary: phase ib clinical study of decitabine and paclitaxel combination therapy

an open-labelled, parallel, multiple ascending dose, phase ib clinical study of decitabine and paclitaxel combination therapy in treating patients with metastatic and locally advanced breast cancer

Eligibility criteria:
inclusion criteria: 1. age ≥ 19 years as female 2. be unable to operate for therapy with her2 negative breast adenocarcinoma and metastatic breast cancer, one or more chemotherapy 3. according to recist ver.1.1, one or more evaluable lesion 4. eastern cooperative oncology group(ecog) performance score is o or 1 5. lesion for core biopsy 6. within 28days of planned first study treatment day, laboratory safety test is satisfied. anc ≥1500cells/microliter, platelet count ≥ 100,000 cells/microliter, hemoglobin≥8.5g/dl, alt and ast ≤ 2uln, alp≤2.5uln, serum total bilirubin≤1.25 uln, pt-inr and aptt≤1.5uln, creatinine≥50ml/min 7. menopause or informed that effective contraception must be used during the entire treatment period of this study and for 6 months after exiting from the study 8. given signed and dated written informed consent form exclusion criteria: 1. symptomatic metastasis and leptomeningeal metastasis 2. injection of paclitaxel for metastatic breast cancer within 6 months 3. her2, positive breast adenocarcinoma 4. cancertherapy for whole body within 3 weeks 5. radiotherapy for metastatic region within 4 weeks 6. major surgery, open biopsy and trauma within 4 weeks 7. less than 4 weeks post major surgery 8. treatment with consistently systemic corticosteroid or immunosuppressive drug 9. more than 2 grade for peripheral neuropathy 10. congenital ling qt syndrome or qtc interval \> 480 milisecond 11. occur myocardial infartion within 6 months 12. unstable angina pectoris 13. hiv(+) or aids 14. hbsag(+) or hcv(+) 15. treatment bisphosphonate for hypercalcemia 16. except metastatic and locally advanced breast cancer, personal history with malignancy within 5 years 17. hypersensitivity reaction with paclitaxel or cremophor el formulation 18. pregnant or breast feeding 19. be unable or unwilling to abide by the study protocol or to cooperate fully with the investigator or designee
transthoracic ultrasound in the diagnosis and follow-up of ventilator associated pneumonia

Conditions: Ventilator Associated Pneumonia; Lung Ultrasound

Summary: to evaluate the sensitivity, specificity and diagnostic accuracy of bedside transthoracic ultrasound examination in the diagnosis and follow up of ventilator associated pneumonia.

vap is the most frequent hospital-acquired infection in intensive care units. depending on the diagnostic criteria used, its incidence ranges from 5% to 67%. the risk of acquiring vap is 3% per day during the first 5 days on mechanical ventilation, and it is decreased to 1% per day for the following days. vap is suspected when subject shows high grade fever, increase in leukocyte count, change in color of sputum and tachypnea. it's a leading cause of mortality in 15- 65% of the cases. serial chest x-ray for diagnosis and follow up, done at time of diagnosis, after 5 days and after 10 days. chest radiography is consistently carried out after lus , lus is done every other day, measuring the largest area of consolidation according to the intercostal space and direction of the probe . chest radiography is read by two physicians.

Eligibility criteria:
inclusion criteria: * mechanical ventilation for at least 48 hours. * new or evolving infiltrate on chest radiograph (cxr). * clinical pulmonary infection score more than or equal 6 exclusion criteria: * patients who are less than 18 years old. * patients who have evidence of pneumonia before or prior to being mechanically ventilated. * patients with pulmonary infarction.
impact of resected gastric volume on postoperative weight loss after laparoscopic sleeve gastrectomy for morbid obesity

Conditions: Morbid Obesity

Summary: impact of resected gastric volume on postoperative weight loss after laparoscopic sleeve gastrectomy for morbid obesity. observational study with a mathematical method to approximate the calculation of the resected gastric volume after a sleeve gastrectomy and see the outcome on weight loss.


Eligibility criteria:
inclusion criteria: * bmi over 60 kg/m2 in high-risk patients, * bmi between 50 and 60 kg/m2 in nondiabetic patients, * bmi between 40 and 50 kg/m2 in patients refusing a complex procedure like roux-en-y gastric bypass, * patients with severe gastric inflammatory disease and h. pylori infection, * patients with previous abdominal surgery involving the intestines, and young patients refusing gastric banding exclusion criteria: * severe and documented gastroesophageal reflux disease * previous gastric surgery.

Keywords: sleeve gastrectomy morbid obesity resected gastric volume
phase 2 evaluation of the elad system in the management of acute liver failure

Conditions: Fulminant Hepatic Failure

Summary: the purpose of this study is to determine if treatment with the elad bioartificial liver assist device is beneficial to patients in acute liver failure either as a bridge to liver transplant or bridge to native liver recovery.

current treatment with modalities in acute liver failure still carry unacceptable morbidity and mortality. it is hoped that by intervening with elad a patient will have an opportunity to be bridged to transplant or to avoid transplantation and to have their native liver recover.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of fulminant hepatic failure with encephalopathy, and coagulopathy * weight not less than 40 kilograms * not listed for organ transplant, but no medical contraindications for transplant exclusion criteria: * listed for organ transplant at stud entry * history of jaundice for greater than 28 days at screening * liver dysfunction due to trauma * concomitant serious disease

Keywords: fulminant hepatic failure
analgesic effectiveness of three different doses of a new formulation of lamaline in a model of painful knee (gonarthrosis)

Conditions: Knee Osteoarthritis

Summary: this study aims to assess the analgesic effectiveness and safety of three different doses of a new formulation of lamaline® versus dafalgan® codeine after 10 days administration in subjects with painful gonarthrosis


Eligibility criteria:
inclusion criteria: * history of knee (unilateral or bilateral) osteoarthritis for at least 6 months * pain intensity assessed by visual analogue scale ≥ 40 mm * partial functional disability assessed by lequesne index ≥4 and \< than 12 exclusion criteria: * patient unable to interrupt his/her nsaids to participate in the clinical study

Keywords: osteoarthritis, pain
a cluster-randomized, pragmatic trial of hemodialysis session duration

Conditions: End Stage Renal Disease

Summary: the purpose of the time trial is to determine whether dialysis facility implementation of a minimum hemodialysis session duration of 4.25 hours (versus usual care) for patients with end-stage renal disease initiating treatment with thrice weekly maintenance hemodialysis has benefits on mortality, hospitalizations and health-related quality of life. the trial also aims to demonstrate the capacity to conduct a large, pragmatic clinical trial in partnership with two large dialysis provider organizations.

the time trial is a cluster-randomized, parallel-group pragmatic clinical trial for patients initiating treatment with maintenance hemodialysis. facilities will be randomized in a 1:1 distribution to the intervention arm or the usual care arm. facilities randomized to the intervention arm will adopt the practice of recommending dialysis session durations of at least 4.25 hours for all patients initiating hemodialysis treatment regardless of body size or dialysis solute clearance measurements. facilities randomized to usual care will maintain their existing approaches to prescribing dialysis session duration. participants will be followed for up to 3 years. the primary endpoint is mortality; major secondary endpoints are hospitalization rate and quality of life. pragmatic features of the time trial include 1) high generalizability due to non-restrictive eligibility criteria and broad representation of participating facilities, 2) implementation of the intervention by clinical care providers rather than by research personnel, and 3) reliance on data obtained through routine clinical care rather than through research activities.

Eligibility criteria:
inclusion criteria: end stage renal disease patients treated by hemodialysis on a thrice weekly maintenance schedule: * initiation of maintenance dialysis within the past 120 days. * treatment with maintenance dialysis in a participating facility. * age ≥18 years. exclusion criteria: * unwillingness to participate. * inability to provide consent for dialysis care.

Keywords: dialysis hemodialysis pragmatic trial end stage renal disease randomized clinical trial
whole body vibration therapy in individuals with type 2 diabetes

Conditions: Type 2 Diabetes; Whole Body Vibration; Muscle Oxygenation; Aerobic Exercise

Summary: the aim of this interventional study is to investigate the effect of whole body vibration therapy on muscle oxygenation, vibration sensation, functional capacity and balance in individuals with type 2 diabetes. the main questions aimed to be answered are: * does whole body vibration therapy affect peripheral muscle oxygenation? * does whole body vibration therapy improve vibration sense, functional capacity and balance compared to aerobic exercise? participants' muscle oxygenation, vibration sensation, functional capacity and balance parameters will be assessed. they will participate in a whole body vibration therapy or aerobic training program.


Eligibility criteria:
inclusion criteria: * volunteering to participate in the research * being diagnosed with type 2 diabetes * 18 years of age or older * hba1c level to be 6.5-10% * having a clinical history of diabetes between 2-10 years * receiving oral hypoglycemic agent treatment * at least three hba1c measurements within 12 to 24 months * hemoglobin variability score (hvs) \<50 * being able to walk independently * mini mental test score ≥ 24 * vastus lateralis muscle adipose tissue thickness \<20mm * bmi \<30 kg/m2 exclusion criteria: * previous or concurrent psychiatric, neurological, orthopedic or systemic illness * use of insulin in treatment * diabetic neuropathy * foot ulcer * participation in any exercise program in the last 6 months * history of major hypoglycemia in the last 12 months * working or have worked in a job with high exposure to mechanical whole body vibrations * conditions that may contraindicate whole body vibration (deep vein thrombosis, severe osteoporosis, active cancer, implanted medical devices, etc.) * hearing, vision and perception problems that may affect research results

Keywords: aerobic exercise diapason balance hba1c type 2 diabetes whole body vibration muscle oxygenation