Kornimate/medical-research-clean huggingface dataset:
skeletal muscle and adipose tissue study

Conditions: Idiopathic Scoliosis

Summary: the purpose of this research study is to compare the current standard of care for prophylactic cefazolin administered every 3 hours intravenously with continuous infusion of cefazolin during pediatric spinal surgery.

determine the skeletal muscle and adipose tissue disposition of prophylactic cefazolin using microdialysis sampling in a cohort of patients diagnosed with idiopathic scoliosis undergoing posterior spinal fusion (psf) for administration of cefazolin by either continuous infusion or intermittent bolus.

Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic scoliosis * planned posterior spinal fusion surgery (psfs) * age: 12-20 years old * american society of anesthesiology status i or ii undergoing posterior spinal fusion for at least 6 levels * no known allergy to cefazolin exclusion criteria: * known allergy to cefazolin * anatomical or other abnormalities that precluded insertion of a microdialysis catheter into the selected paraspinal muscle * known renal or hepatic insufficiency or failure

Keywords: tissue microdialysis spinal fusion surgical site infection
the decisiveness of mfi-11 in predicting complications in patients > 65 years who underwent ebus-tbna under sedation

Conditions: Sedation Complication; EBUS Guided Transbronchial Needle Aspiration; Monitored Anesthesia Care; Elderly Patients

Summary: the aim is to evaluate the feasibility of mfi-11, one of the comprehensive frailty tests, before ebus-tbna. the secondary aim is to evaluate the usefulness of mfi-11 in predicting complications in risk assessment before ebus-tbna.

patients who will receive anesthesia are directed to the anesthesia clinic for preoperative evaluation. the primary purpose of preoperative assessment is to reduce perioperative morbidity and increase quality, reduce the cost of perioperative care, and ensure that the patient recovers as quickly as possible. in this context, the american society of anesthesiology (asa) score is a classification that includes medical comorbidities. the classification system alone does not predict perioperative risks, but when combined with other factors (e.g. type of surgery, frailty) it may help predict perioperative risks. age is not among the criteria in the asa. in elderly patients, the indicator of decreased reserves and resulting weakness is called "frailty". frailty is considered vulnerability and functional impairment caused by a significant decline in multiple systems. objective, repeatable, and accepted scales must be used when evaluating frailty. mfi-11 is a strong predictor of mortality and postoperative complications.

Eligibility criteria:
inclusion criteria: * patients who underwent ebus-tbna under sedation * patients aged \>65 years * asa 1-3 patients exclusion criteria: * patients who did not volunteer for the study * \< 65 years old patients * asa \> 3 patients * patients with psychiatric illness * intubated patients * patients with tracheostomy * patients with body mass index \> 30 kg/m2 * patients with nasal and nasopharyngeal disease * patients with drug allergies (drugs used in anesthesia)

Keywords: sedation ebus guided transbronchial needle aspiration monitored anesthesia care elderly patients
cystic fibrosis related diabetes screening.

Conditions: Cystic Fibrosis-related Diabetes

Summary: cystic fibrosis-related diabetes is a late cystic fibrosis (cf) associated comorbidity whose prevalence is increasing sharply lifelong. guidelines for glucose metabolism (gm) monitoring relies on oral glucose tolerance test . however, this test is neither sensitive nor specific. the aim of this study is to compare sensitivity and specificity of different methods for gm monitoring in children and adolescents with cf. continuous gm system (cgms) will be used as the reference method. results will be compared to those of oral glucose tolerance test (ogtt), intravenous glucose tolerance test (igtt), homeostasis model assessment index of insulin resistance (homa-%ir) , homeostasis model assessment index of beta-cell function (homa-%b) and hba1c dosage (glycated haemoglobin a1c). patients will be classified into three groups according to cgms: normal glucose tolerance, impaired glucose tolerance and diabetes mellitus.


Eligibility criteria:
inclusion criteria: * subjects with confirmed diagnosis of cystic fibrosis with a sweat chloride \> 60 mmol/l. * subjects will be aged between 10 and 18 years with at least one class 1 or 2 cystic fibrosis transmembrane conductance regulator (cftr) mutation. * subjects will be pancreatic insufficient. * subjects must have a forced expiratory volume 1 (fev1)\> 40 % of predicted normal for age, sex and height at the screening visit. * stable cf disease as judged by the investigator exclusion criteria: * subjects with glucose intolerance abnormalities * subjects with pulmonary exacerbation within 4 weeks before screening * history of lung or hepatic transplantation or awaiting transplantation
a safety study of combination treatment with avonex and zocor in relapsing remitting multiple sclerosis

Conditions: Relapsing Remitting Multiple Sclerosis

Summary: the purpose of this study is to determine if using avonex in combination with zocor is a safe and effective therapy for subjects with relapsing remitting multiple sclerosis.

multiple sclerosis (ms) is an inflammatory demyelinating disease of the central nervous system (cns). there are many forms of ms; althoughthe majority are relapsing remitting (rrms) representing approximately 80% of the cases. the disease appears to be more inflammatory in rrms as manisfested by an increase ingadolinium enhancement on mri and an increase in inflammatory bioassay markers. zocor is in a class of drugs (statins) that are used to lower cholesterol. statins also have an anti-inflammatory effect on the cns. zocor has been shown in a small clinical trial to reduce the number of new mri-detected brain lesions over a six month treatment period in patients with rrms. this study is to evaluate the safety of combining avonex with zocor for a a period of fourteen months in patients with rrms and to evaluate the effect of treatment on new or enlarging lesions as measured by mri.

Eligibility criteria:
inclusion criteria: 1. male or non-pregnant females age 18-55 who have clinically and laboratory definite relapsing-remitting ms using the macdonald criteria. 2. subjects must be taking some form of interferon therapy (rebif, avonex or betaseron) for a duration of 12 months with documented breakthrough disease as defined: * or = 1 documented clinical relapse in past 12 months while on interferon therapy. for eligibility, a pre-study relapse is defined as neurologic symptoms and signs documented by review of the history with the subject or in the medical record, of sufficient severity and duration to be determined by the investigator as consistent with an acute ms relapse. the relapse does not need to have been treated to qualify. the timing of the relapse is defined based on the onset of symptoms. or \> or = 1 documented gd-enhancing lesion on cranial or spinal mri. the presence of a gd-enhancing lesion must be documented either by a report in the medical record or review of the films by the investigator. 3. the kurtzke edss score must be between 0- 5.0. 4. all subjects must give written consent prior to evaluation and testing. exclusion criteria: 1. subjects with primary or secondary progressive ms. 2. female patients may not be pregnant, attempting pregnancy or breastfeeding. 3. female subjects must use an acceptable form of contraception during the study as defined by the investigators. the rhythm method is not to be used as the sole method of contraception. 4. subjects unwilling or unable to give informed consent. 5. subjects that are nab+ (titers \> or = 20). 6. abnormal baseline blood test exceeding any of the limits defined below: 1. alt or ast \> 2x upper limit of normal (uln) 2. cpk \> 2x upper limit of normal (uln) 3. total wbc \< 3,000/mm3 7. no chronic infections (including hiv and hepatitis b/c) may be present.
research on aging project in iceland: second stage

Conditions: Atherosclerosis; Osteoporosis; Obesity; Glucose Abnormalities; Alzheimer's Disease; Vascular Dimentia

Summary: background: - researchers are interested in studying the environmental and genetic factors that play a role in health and living conditions as people age. since 2002, the u.s. national institute on aging and the icelandic heart association research institute have been conducting a long-term study known as the research in aging project to collect personal data and samples from icelandic men and women in order to study risk factors related to disease and disability in old age. researchers plan to initiate a second stage of the study. objectives: - to collect additional personal information, medical records, and blood samples from individuals who have previously provided materials for the research in aging project in iceland. eligibility: - individuals who have previously participated in the research in aging project in association with the u.s. national institute on aging and the icelandic heart association research institute. design: * participants will have a physical examination with imaging analysis procedures and hearing and eye tests, provide information on health and diet, and provide a 100-ml blood sample for testing. * participants will also provide consent for researchers to consult data and samples collected during the first stage of the research on aging project.

in anticipation of the sequencing of the human genome and description of the human proteome, the age, gene/environment susceptibility-reykjavik study (ages) was initiated in 2002. ages was designed to examine risk factors, including genetic susceptibility and gene/environment interaction, in relation to disease and disability in old age. the study is multidisciplinary, providing detailed phenotypes related to the cardiovascular, neurocognitive (including sensory), and musculoskeletal systems, and to body composition and metabolic regulation. relevant quantitative traits, subclinical indicators of disease, and medical diagnoses are identified by using biomarkers, imaging, and other physiologic indicators. the ages sample is drawn from an established population-based cohort, the reykjavik study. this cohort of men and women born between 1907 and 1935 has been followed in iceland since 1967 by the icelandic heart association. the ages cohort, with cardiovascular risk factor assessments earlier in life and detailed late- life phenotypes of quantitative traits, will create a comprehensive study of aging nested in a relatively genetically homogeneous older population. this approach should facilitate identification of genetic factors that contribute to healthy aging as well as the chronic conditions common in old age.

Eligibility criteria:
* inclusion criteria: individuals who have previously participated in the research in aging project in association with the u.s. national institute on aging and the icelandic heart association research institute.

Keywords: aging gene environment inflammation iceland
an indicator of successful peripheral nerve block

Conditions: Temperature Change, Body

Summary: the aim of the study was to investigate whether a color changing nail polish would be an indicator to assess infraclavicular brachial plexus block success based on skin temperature differences before and after performed the block.

after performed the block, sensory and motor block assessments will be carried out by blinded observer every 5 min after needle removal for 30 min in the regions of the radial, median, ulnar, and musculocutaneous nerves of the forearm. skin temperature measurements will be performed from both the anesthetized side and the contralateral arm before the procedure and every 5 min for 30 min by a blinded observer. before the block, the color changing nail polish will be applied to all hand nails of the patient. an independent observer will photograph the reaction of the nail polish (i.e. color change) in both hands immediately after application of nail polish and at two minute intervals for 30 min after performing the block. two blinded observers were reviewed the digital photographs. they were asked to compare the colors of nail polish in both hands and to score the difference based on a three-point scale (0: absolutely no difference, 1: i am not sure, 2: indisputable difference)

Eligibility criteria:
inclusion criteria: * patients who received infraclavicular brachial plexus block for elective elbow, forearm, wrist, or hand surgery * american society of anesthesiologists class i, ii or iii exclusion criteria: * patients \<18 years old * \>65 years old * body mass index (bmi) \ 35 kg/m2 * inability to provide written informed consent * refusal of regional anesthesia * pregnancy * contraindication for regional anesthesia * peripheral neurological disease, * raynaud disease
fanca gene transfer for fanconi anemia using a high-safety, high-efficiency, self-inactivating lentiviral vector

Conditions: Fanconi Anemia

Summary: this is a phase i/ii clinical trial of gene therapy for treating fanconi anemia using a self-inactivating lentiviral vector to functionally correct the defective gene. the objectives are to evaluate the safety and efficacy of the gene transfer clinical protocol.

fanconi anemia is a rare, inherited disease that is caused by a gene defect and that primarily affects an individual's bone marrow, resulting in decreased production of blood cells. the major problem for most patients is aplastic anemia, the blood counts for red blood cells, white blood cells, and platelets are low. in addition, some patients have physical defects usually involving the skeleton and kidneys. fanconi anemia is typically diagnosed in childhood, and there is a high fatality rate. hematopoietic stem cell transplantation (hsct) is a common treatment for fanconi anemia. however, there are many risks associated with hsct including rejection of the transplanted cells and graft-versus-host disease. the primary objectives are to evaluate the safety of the self-inactivating lentiviral vector, the ex vivo gene transfer clinical protocol and the efficacy of immune reconstitution in patients overcoming immune abnormalities present at the time of treatment, assessment of gene correction efficiency, and finally the long-term correction of fanconi anemia associated disease symptoms.

Eligibility criteria:
inclusion criteria: 1. diagnosis of fanconi anemia fanca type based on dna sequencing and sensitivity test for chromosomal cleavage by mitomycin c or butylene oxide. 2. no cytogenetic abnormalities and the proportion of myelodysplastic abnormalities does not exceed 5% within 3 months prior to stem cell collection. 3. age: ≥ 4 years. 4. karnofsky: ≥ 70%. 5. anc ≥ 5×10\^8/l; plt ≥ 2×10\^10/l. 6. hemoglobin ≥ 8g/dl. 7. proper renal and hepatic functions (uln denotes "upper limit of normal range") with * serum creatinine ≤ 1.5×uln; * serum bilirubin ≤ 3×uln; * ast/alt ≤ 5×uln. 8. pulmonary function is normal; dlco \> 50%. 9. written, informed consent obtained prior to any study-specific procedures. exclusion criteria: 1. diagnosis of active malignant disease or myelodysplastic syndrome. 2. diagnosis of myeloid leukemia. 3. pregnant or lactating females. 4. existence of an available hla-identical related donor. 5. subject infected with hbv (hbsag positive), hiv (hiv antibody positive), htlv (htlv antibody positive), treponema pallidum antibody positive or tb culture positive. 6. patients, in the opinion of investigators, may not be eligible or not able to comply with the study.

Keywords: fanconi anemia lentiviral vector fanca gene
comparative effects of different noninvasive ventilation mode on neural respiratory drive in recovering aecopd patients

Conditions: Chronic Obstructive Pulmonary Disease

Summary: background: the efﬁciency of neural respiratory drive (nrd)expressed by a ratio of ventilation to the diaphragm electromyogram (emgdi) decreases in patients with copd .improving the neural respiratory drive efficiency of copd will help to relieve the clinical symptom and make the patients feel comfort.noninvasive positive pressure ventilation(nppv)is a good treatment to aecopd patients.it is unknown the effects of different mode of noninvasive positive pressure ventilation(nppv) such as proportional assist ventilation (pav) and pressure-support ventilation (psv) on the efﬁciency of neural drive of aecopd and which mode benefit the patients more. objective: to compare the short-term effects of mask pressure support ventilation (psv) and proportional assist ventilation (pav) on neural respiratory drive in recovering patients of aecopd

methods: after the baseline data of spontaneous breathing was collected, 20 hypercapnic recovering aecopd patients were placed on different mode of noninvasive positive pressure ventilation(nppv, such as the pav or psv mode) randomly. for each mode, three levels (pa-, pa, pa+or ps-, ps, ps+), ) of support were applied.ps and pa are set for the patient's comfort . on the basis of these two levels, 25% increase and reduction assisted level of pressure were set both for ps and pa (pa-, pa+or ps-, ps+). at each level, the patients were ventilated at least 20 minutes until the breathing was stable. the respiratory frequency (rr), tidal volume (vt), transdiaphragmatic pressure (pdi) the pressure-time product (ptp) and root-mean-square(rms) of emgdi were calculated. esophageal and gastric balloon-catheters were used to detect the intra-thoracic and abdominal pressure. airway pressure was also measured simultaneously. emgdi was recorded from a multipair esophageal electrode .during ventilation airflow and ventilation were measured with pneumotachograph.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of the copd (chronic obstructive pulmonary disease) the copd patients were all in stable condition during recovery from acute exacerbation. exclusion criteria: * severe cardiovascular disease * pneumonia * neuromuscular and chest wall deformity * respiratory arrest * cardiovascular instability (hypotension, arrhythmias, myocardial infarction) * change in mental status; uncooperative patient * high aspiration risk * viscous or copious secretions * recent facial or gastroesophageal surgery * craniofacial trauma * fixed nasopharyngeal abnormalities * burns * extreme obesity

Keywords: neural respiratory drive in different level of nppv
prospective evaluation of computerized physician order entry in the emergency department

Conditions: Operational Metrics of the Emergency Department

Summary: this study will evaluate various performance metrics of emergency department operations after the implementation of computerized physician order entry in an academic emergency department.

the study will be a prospective before-after study comparing various operational and performance metrics before and after the implementation of a computerized physician order entry system in the emergency department. the investigators will collect 6 month before, 6 month after of data along with a 2-4 week washout period. the investigators will also administer a computerized physician order entry survey after the study is completed. this confidential survey will be emailed to all ed nurses, residents, and attendings using redcap. consent will be implied if they choose to participate.

Eligibility criteria:
inclusion criteria: * all consecutive adult patients (age \>=18) presenting to the emergency department during the study period will be included in the study. exclusion criteria: * patients who eloped, left without being seen, or signed out against medical advice will be excluded.

Keywords: alert systems, medication computerized physician order entry system cpoe medication alert systems medical order entry systems
a safety and tolerability study of pci-24781 in subjects with cancer

Conditions: Lymphoma; Non-Hodgkin's Lymphoma; Hodgkin Disease; Multiple Myeloma; Leukemia; Lymphocytic

Summary: the purpose of this study is to determine the long-term (\> 6 months) safety of pci 24781 po in subjects with lymphoma.

an open-label, monotherapy, multicenter, extension study open to subjects who have derived benefit from pci 24781 po for at least 6 months and want to continue receiving study drug. subjects enrolled in this study will receive pci-24781 at the schedule and dosage from their prior protocol. treatment may be continued as long as there is no evidence of progressive disease or unacceptable toxicity.

Eligibility criteria:
inclusion criteria: 1. men and women with cancer that did not progress while treated with pci 24781 po for at least 6 months and who want to continue receiving study drug 2. eastern cooperative oncology group (ecog) performance status of ≤ 2 3. agreement to use contraception during the study and for 30 days after the last dose of study drug if sexually active and able to bear children 4. willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty 5. ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local subject privacy regulations) exclusion criteria: 1. a life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of oral pci-24781, or put the study outcomes at undue risk 2. significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any class 3 or 4 cardiac disease as defined by the new york heart association functional classification 3. malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel or ulcerative colitis, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction 4. immunotherapy, chemotherapy, radiotherapy, corticosteroids (at dosages equivalent to prednisone \> 20 mg/day) or experimental therapy (other than pci-24781 po) within 4 weeks before first dose of study drug 5. concomitant use of medicines known to cause qt prolongation or torsades de points (see appendix 2) 6. central nervous system involvement by lymphoma 7. known history of human immunodeficiency virus (hiv) or active infection with hepatitis c virus (hcv) or hepatitis b virus (hbv) or any uncontrolled active systemic infection 8. creatinine \> 1.5 x institutional upper limit of normal (uln); total bilirubin \> 1.5 x uln (unless due to gilbert's disease); and aspartate aminotransferase (ast) or alanine aminotransferase (alt) \> 2.5 x uln 9. lactating or pregnant

Keywords: pci-24781 lymphoma non-hodgkin's hodgkin disease multiple myeloma leukemia lymphocytic chronic