Kornimate/medical-research-clean huggingface dataset:
lotta alla sepsi ospedaliera - fighting hospital sepsis

Conditions: Severe Sepsis

Summary: sepsis is widespread (1.8 million cases annually worldwide) and accounts for a very high mortality: 20-25% of all severe sepsis, 40-70% of all septic shock. the surviving sepsis campaign (ssc) recommends a first 6 hours "resuscitative bundle" to improve patient's outcome. despite this, the bundle is poorly performed, because of a superficial knowledge of the guidelines and several difficulties in their clinical implementation. in recognition of this, a "sepsis six" bundle is designed to facilitate early intervention with just three diagnostic and three therapeutic steps to be delivered by staff within 1 h. the aim of our study is to evaluate if an educational and organizational intervention (eoi) could improve septic patient's outcome in no critical care units. the second endpoint is to evaluate if the compliance to the "sepsis six" bundle could improve after this sort of intervention.

methods 39 medical wards and 12 emergency departments, belonging to 12 hospitals, were voluntarily enrolled. through the collaboration of 12 multidisciplinary teams (mt), we took a pre-eoi picture of the human resources (i.e. doctors to patients ratio) and of the organisational structures (i.e. laboratory's opening hours) of each hospital. for six months, each unit enrolled was asked to fill in a clinical checklist for every patient suspected for severe sepsis or septic shock; so that the pre-eoi "sepsis six" bundle compliance could be evaluated. then, we planned several pre-agreed educational meetings for all of the doctors and nurses belonging to the enrolled wards. in the meanwhile the mt worked to overcome any impediment to a better septic patient management. finally, the educated medical staff was asked to fill in again the same clinical checklist used in the pre-eoi phase; so that the post-eoi "sepsis six" bundle compliance could be evaluated and a comparison with the pre-eoi phase could be done. hypothesis this is the first study aimed to analyze the impact of an educational and organizational intervention in the outcome of septic patients managed in no critical care units. we guess that the differences showed in human resources and organizational structures among the hospitals could have a role in the "sepsis six" bundle compliance and in the patient's outcome, but only a comparison with data collected from the clinical checklist and patient's outcome will confirm our guess. likewise, we believe that an educational intervention could improve the septic patient's management, but we need the post-eoi phase conclusion to demonstrate or not our hypothesis.

Eligibility criteria:
inclusion criteria: * any patient having a sirs due to sepsis and at least on of the following criteria: systolic blood pressure \ 4 mg/dl and/or organ failure exclusion criteria: * age \< 18 years

Keywords: severe sepsis septic shock sepsis six bundle
infusion of panobinostat (mtx110) into the fourth ventricle in children and adults with recurrent medulloblastoma

Conditions: Medulloblastoma

Summary: the purpose of this study is to establish the safety of infusions of panobinostat (mtx110) into the fourth ventricle of the brain or tumor resection cavity in patients with recurrent medulloblastoma and to assess the antitumor activity of simultaneous infusions of panobinostat (mtx110) into the fourth ventricle of the brain or resection cavity in patients with recurrent medulloblastoma based upon mri scans and lumbar cerebrospinal fluid (csf) cytology.


Eligibility criteria:
inclusion criteria: * diagnosis: patients with histologically verified medulloblastoma with recurrence or progression involving anywhere in the brain and/or spine. * patient must have either measurable or evaluable tumor as assessed by mri of the brain and total spine * an implanted catheter in the fourth ventricle or posterior fossa tumor cavity attached to a ventricular access device or agreement to have one placed. * a minimum of 7 days between last dose of systemic chemotherapy and/or radiation therapy and first infusion of chemotherapy into fourth ventricle * life expectancy of at least 12 weeks in the opinion of the principal investigator * lansky score of 50 or greater if ≤16 years of age or karnofsky score of 50 or greater if \> 16 years of age * existing neurological deficits must have been stable for a minimum of 1 week prior to study enrollment * patients must have recovered from the acute toxic effects of all prior anticancer chemotherapy * adequate bone marrow function defined by peripheral absolute neutrophil count (anc) ≥ 500/µl, platelet count ≥ 50,000/µl (transfusion independent), and hemoglobin ≥ 9.0 gm/dl (may receive red blood cells(rbc) transfusions) * patient or patient's legal representative, parent(s), or guardian able to provide written informed consent. * patient with prolonged qt interval on screening ekg will need cardiology consultation prior to enrollment * patients with abnormal liver function tests (alt, aspartate aminotransferase(ast),or total bilirubin) will need gastroenterology consultation prior to enrollment exclusion criteria: * enrolled in another treatment protocol * has received another investigational or chemotherapy agent or radiation therapy within 7 days prior to intraventricular chemotherapy infusions * evidence of untreated infection * pregnant or lactating women

Keywords: medulloblastoma malignant neoplasms, brain mtx110 panobinostat antineoplastic
retrospective evaluation of asipp guidelines implementation

Conditions: Guideline Implementation

Summary: to demonstrate clinically significant improvements in the patients treated following asipp guidelines compared to the patients who were treated prior to the establishment of asipp guidelines.

we have performed one study in the past showing that the implementation of guidelines improved outcomes by reducing the number of procedures and also the cost. however,, no large scale study has been performed thus far.

Eligibility criteria:
inclusion criteria: evaluate all patients undergoing the following interventional techniques during 1999 and 2000 compared to patients undergoing interventional techniques during 2004 and 2005 * cervical facet joint nerve blocks * thoracic facet joint nerve blocks * lumbar facet joint nerve blocks * lumbar interlaminar epidural steroid injections * cervical interlaminar epidural steroid injections exclusion criteria: non-availability of appropriate data

Keywords: asipp guidelines
a study of darbepoetin alfa in anemic subjects with low risk myelodysplastic syndrome

Conditions: Myelodysplastic Syndromes

Summary: the purpose of this study is to assess the effect of 13 weeks of darbepoetin alfa treatment on erythroid response in anemic subjects with low risk myelodysplastic syndrome (mds).


Eligibility criteria:
eligibility criteria: general: - low risk mds (low or intermediate-1 risk as defined by ipss) and fab classification of ra, rars, or raeb with blasts less than or equal to 10% determined via a bone marrow biopsy and cbc - adequate iron stores determined by bone marrow film or section staining for iron via a bone marrow biopsy - ecog performance status score of 0, 1, or 2 laboratory: - local laboratory screening hgb less than or equal to 11.0g/dl - adequate renal function (serum creatinine concentration less than or equal to 2.0 mg/dl) - adequate liver function (total bilirubin less than or equal to 2 times, alt less than or equal to 3 times, and ast less than or equal to 3 times the upper limit of the respective normal range) ethical: - must be 18 years of age or older - provide written institutional review board (irb)-approved informed consent before any screening procedures are performed

Keywords: myelodysplastic syndrome
effects of ahcl insulin pump on glycemic control and psychosocial outcomes in pediatric patients with type 1 diabetes

Conditions: Type 1 Diabetes

Summary: prospective, non-randomized, single-arm clinical trial to investigate the effects of advanced hybrid close-loop (ahcl) system insulin pump in pediatric patients with type 1 diabetes

this trial consists of baseline phase of 3 weeks sustaining the treatment previously maintained by the patient, followed by study phase of 12 weeks of ahcl system application.

Eligibility criteria:
inclusion criteria: 1. the subject is age 7-19 2. the subject with one or more of the below * serum c-peptide ≤ 0.6 ng/ml at diagnosis * positive glutamic acid decarboxylase (gad) antibody * positive islet cell antibody * positive anti-insulin antibody * positive anti-islet antigen-2 (ia-2) antibody 3. the subject was diagnosed with type 1 diabetes ≥ 1 year 4. the subject has been continuously treated at least for 8 weeks at the start of the study, by one of the existing insulin treatment methods \[insulin multi-injection (mdii), general insulin pump (csii), sensor-linked insulin pump (sap), or 770g insulin pump (hcl system)\] 5. the subject has been applied with real-time continuous glucose monitoring at least for 8 weeks at the start of the study exclusion criteria: 1. any systemic treatment with drugs known to interfere with glucose metabolism within 8 weeks prior to trial 2. subjects with underlying hematologic disorders that can affect the hba1c levels 3. subjects with underlying medical disorders that can affect glucose metabolism 4. subjects with a neuropsychiatric disorder such as depression or eating disorder 5. subjects with underlying thyroid disorders and abnormal thyroid function
use of incretins in diabetic patients

Conditions: Diabetes Mellitus, Type 2

Summary: observational, retrospective study, conducted in diabetic patients aimed to evaluate the effects on the glyco-metabolic control and on cardiovascular events of different dpp-4 inhibitors. patients will be stratified in patients taking different dpp-4 in addition to sulfonylureas, biguanides, thiazolidinediones, insulin, compared to those in therapy with other hypoglycemic classes, such as sulphonylureas, biguanides, thiazolidinediones, insulin, alone or in combination, in primary and secondary prevention.


Eligibility criteria:
inclusion criteria: * type 2 diabetic patients * on oral hypoglycemic agents ± basal insulin * in primary and secondary prevention exclusion criteria: - patients with a follow-up of less than 8 years
serum erythropoietin level in perinatal asphyxia

Conditions: Perinatal Hypoxia

Summary: this study is to evaluate brain and kidney injuries in full-term neonates with perinatal asphyxia by detecting specific biomarker in blood (erythropoietin).

perinatal hypoxic-ischemic encephalopathy (hie) is an important cause of brain injury in the newborn and can result in long-term devastating consequences. acute kidney injury (aki) occurs in (50 - 72%) among asphyxiated term infants. the kidney cells that make erythropoietin are sensitive to low oxygen levels in the blood that travels through the kidney. these cells make and release erythropoietin when the oxygen level is too low.

Eligibility criteria:
inclusion criteria: cases group: 1. the presence of a sentinel hypoxic event immediately before or during delivery 2. history of fetal distress (bradycardia, late decelerations, absence of heart rate variability). 3. need for neonatal resuscitation at delivery 4. one-min apgar score \<3 or 5-minapgar score\<7 5. metabolic acidosis (be \> 10 in cord blood) 6. cardiocirculatory instability (cci), clinical indications of hypoxic-ischemic encephalopathy (hie) and multiple organ involvement (moi). control group: newborns who were delivered normally after uncomplicated pregnancy. none of them have clinical nor biochemical signs of asphyxia. exclusion criteria: * newborns who do not fulfill the above criteria. * newborns with congenital heart diseases and perinatal hemolytic anemia or congenital liver affection. * whose parents refuse to participate in the study. * cases above 4 days old. * preterm neonates (less than 37 weeks).
measuring herpes zoster and phn associated burden of illness and health care utilization costs in thailand

Conditions: Herpes Zoster

Summary: total 7 institutions will be recruited i.e. clinical infectious disease research unit department of clinical tropical medicine, faculty of tropical medicine mahidol university,bamrasnaradura infectious disease institute ,pramonkutklao hospital,rajavithi hospital,nationalcancerinstitute,institute of dermatology,raj pracha samasai institute objectives * measure the burden of illness due to herpes zoster (zoster) and post-herpetic neuralgia (phn) (severity and duration); * assess the quality of life (qol) and quality adjusted life years (qaly) lost due to zoster and phn; * describe health care resource utilization associated with zoster and phn; * describe the direct and indirect costs per case of zoster and phn

this will be a prospective cohort study of patients presenting with zoster rash in 7 specialized institutions in thailand. subjects will be entered in the cohort at the time of presentation with zoster rash. after the baseline assessment (day 0) that will be conducted at the investigator's office there will be 4 assessments (prospective part of the study) that will be conducted at day 7, month 1, month 3 and month 6. we expect that there will be approximately 150 patients included in the study cohort. cohort assembly will take place between april 2007 and october 2007. the study will be conducted in 3 groups eligible patients for each group will include * group a: both male and female patients ≥ 50 years of age with zoster rash. * group b: both hiv infected male and female patients ≥ 20 years of age with zoster rash. * group c: both oncology male and female patients ≥ 20 years of age who on chemotherapy with zoster rash. key exclusion criteria includes patient who refuses to sign informed consent.

Eligibility criteria:
inclusion criteria: * physician confirmed diagnosis of zoster rash * of onset of zoster rash must be documented in the patient's chart. * patient is capable of understanding the study and the content of the consent form and has agreed to participate in the study by signing the informed consent. * patient will be available for the study follow up period exclusion criteria: * no specific exclusion criteria

Keywords: burden of illness for herpes zoster in thailand.
impact of ai on trainee adr

Conditions: Adenoma; Adenoma Colon; Colorectal Cancer

Summary: adenoma detection rate (adr) is a validated quality metric for colonoscopy with higher adr correlated with improved colorectal cancer outcomes. artificial intelligence (ai) can automatically detect polyps on the video monitor which may allow endoscopists in training to improve their adr. objective and purpose of the study: measure the effect of ai in a prospective, randomized manner to determine its impact on adr of gastroenterology trainees.

our objective is to determine the impact of ai on the adenoma detection rate of gastroenterology trainees. the secondary aim of this quality improvement study is to determine the impact of ai based endoscopy on the rate of recording of quality improvement metrics versus historical performance in our program. fellows will undergo educational session prior to the start of study, describing commonly used metrics for assessing quality of colonoscopy and how to use the artificial intelligence software. gastroenterology fellows will be consented for the study prior to initiation. the fellows will be randomized on a daily basis to perform colonoscopies in a room. outcomes will measure the effects of ai in fellows

Eligibility criteria:
inclusion criteria: * all gastroenterology fellows at usc performing endoscopies will be included in the study. exclusion criteria: * if fellows refuse informed consent they will be excluded. * procedures performed in the intensive care unit or the operating room will not be counted toward the study metrics as the ai system will only be available in the endoscopy unit. * if procedures are performed only by faculty, in which the fellow is not the primary operator, they will not be used for study metrics.
evaluation of reliability and validity of reflectance pulse oximeter in screening children with obstructive sleep apnea

Conditions: Apnea, Obstructive

Summary: polysomnography (psg) has some disadvantages, such as time-consuming, effort-consuming, long appointment time and high cost. during psg examination, multiple sensors need to be placed in the patient's head, face, neck, chest and limbs, and sensors are needed to monitor data throughout the night. it is difficult for young children to cooperate, and it is easy to fail due to inaccurate sensor signal acquisition. psg examination may miss diagnosis or underestimate the disease due to the first night effect. based on the above reasons, the application of psg in clinic, especially in pediatric patients is limited. the reflective optical path detection can be used to measure the peripheral blood oxygen saturation in the flat part of human skin. the investigators intend to use a reflectance pulse oximeterto evaluate its reliability and validity in the diagnosis of osa in children at the same time as psg.

during psg examination, the participants wear reflectance pulse oximeter for continuous monitoring. use psg to record eeg, oculogram, chin electromyography, body movement, chest and abdomen movement, nose and mouth airflow, snoring, electrocardiogram, blood oxygen saturation and finger pulse monitoring. the effective monitoring time should be at least 6 hours. oxygen desaturation index (odi), average blood oxygen saturation, minimum blood oxygen saturation, percentage of blood oxygen saturation less than 90% in the whole recording time (ts90%), fastest heart rate, slowest heart rate and average heart rate are recorded by reflectance pulse oximeter. to compare the effective time (tst), the total number of hypoxemia events, the coincidence rate of comparing each hypoxemia event, identifying osa, and identifying moderate and severe osa by psg and reflectance pulse oximeter.

Eligibility criteria:
inclusion criteria: 1. snoring more than 3 nights per week in the last month 2. pediatric sleep questionnaires score ≥ 0.33 exclusion criteria: 1. acute exacerbation of asthma 2. pulmonary infection 3. heart disease
hypertensive ambulatory trial to compare the efficacy of hctz and lisinopril

Conditions: Hypertension, Grade 1; Hypertension Treatment; N of 1 Study Design; Hypertension

Summary: the purpose of this trial is to evaluate if an objective clinical decision of anti-hypertensive therapy can be made using an n-of-1 (single patient) trial design.

personalized medicine involves choosing the optimal treatment for a patient based on data gathered by the physician that is specific to that individual. the n-of-1 or single patient trial is a study design motivated by the new era of personalized medicine. the joint national committee on prevention, detection, evaluation, and treatment of high blood pressure (jnc 7) recommends a personalized medicine approach to hypertensive drug class choice based on compelling indications. however, the hypertensive decision algorithm is limited. with the advent of new technology the amount of data available to a physician has grown substantially improving the robustness of surveying a more complete picture of the patient's health care status. medicine is quickly becoming data intensive with new technology decreasing the cost of data collection and analysis. the typical standard care for patients with stage 1 hypertension first involves a non-pharmacological modification of lifestyle changes. health care providers diagnose hypertension when the blood pressure is persistently elevated after three to six visits over a several month period. jnc 7 recommends thiazide-type diuretics for stage i hypertension for most patients. in the united states, this recommendation results in most patients being given a dose of hydrochlorothiazide (hctz) at 12.5 to 25 mg per day. a patient would then return for follow-up and would be prescribed a few month supply of an antihypertensive medication (e.g. hctz or lisinopril). the choice of treatment by the physician is based on jnc 7 guidelines, patient's risk factors, and a provider's experience. the objective of this trial will be to evaluate if an objective clinical decision of anti-hypertensive therapy can be made using an n-of-1 (single patient) trial design. in this study we propose to do a series of n-of-1 trials in patients with stage 1 hypertension who will be randomized to alternating courses of hctz and lisinopril.

Eligibility criteria:
inclusion criteria: * diagnosis of grade 1 hypertension * treatment naïve * gfr \> 60 within previous 3 months * urinary microalbumin level normal during previous 3 months exclusion criteria: * pregnancy (fetal morbidity and mortality may occur with the use of ace inhibitors.) * uncontrolled hyperthyroidism * sleep apnea * primary aldosteronism * renovascular disease * cushing's syndrome or steroid therapy * no evidence of end organ damage * ekg with evidence of lvh within previous 3 months * collagen vascular disease * current smoker

Keywords: hypertension blood pressure control hypertension treatment antihypertensive n of 1 study
a study to evaluate the pharmacokinetic, pharmacodynamic characteristics and the safety after administration by doses of br1400-1, br1400-2, br1400-3 in healthy adult volunteers

Conditions: Essential Hypertension

Summary: the purpose of this clinical study is to evaluate the pharmacokinetic, pharmacodynamic characteristics and the safety after administration by doses of "br1400-1", "br1400-2", "br1400-3" in healthy volunteers


Eligibility criteria:
inclusion criteria: * those who have body mass index (bmi) of 18.0kg/m2 to 30.0kg/m2 at screening visit. * for men, those who weigh 50 kg or more * for women, those who weigh 45 kg or more * those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using methods of contraception accepted in clinical trial\* from the date of consent to 7 days after the last administration and disagree to provide their sperm or ovum. * methods of contraception accepted in clinical trial: combined use of non hormonal intrauterine device, vasectomy, tubal ligation, and barrier methods (male condom, female condom, cervical cap, contraceptive diaphragm, sponge, etc.) or combined use of two or more barrier methods if spermicide is used. * those who spontaneously decide to participate and sign written consent to observe the subject's compliance during this clinical trial after listening to and understanding sufficient explanation of the purpose and contents of this clinical trial, characteristics of the investigational products, expected adverse events, etc. exclusion criteria: * those who have taken drugs that induce and inhibit metabolizing enzymes such as barbiturate within 30 days prior to the first day of administration or have taken ethical drugs, over the counter drugs, herbal medicines, health functional foods concerned about affecting this clinical trial within 10 days before the first administration date. (however, participation is possible considering pharmacokinetics and pharmacodynamics such as interaction of investigational products, half-life of concomitant drugs, etc.) * those who have participated in bioequivalence tests or other clinical trials and administered their investigational products within 6 months before the first administration date(however, the termination for participation in other clinical trials are based on the last administration date of their investigational products) * those who have a medical history of gastrointestinal diseases (ex. crohn's disease, ulcerative colitis, etc.) or gastrointestinal resection (except for simple appendectomy, hernia surgery) that may affect the absorption of drugs or have gastrointestinal diseases * those who can't discontinue a diet (ex. raw grapefruit, grapefruit juice or food containing grapefruit, etc.) that may affect the absorption, distribution, metabolism, and excretion of the drug within 48 hours before the first administration date * in the case of a female subject, pregnant woman or those suspected pregnancy or lactating woman.