Kornimate/medical-research-clean huggingface dataset:
pathogenesis of adverse drug reactions

Conditions: Seizures

Summary: the purpose of the study is to examine the individual metabolic profiles of pediatric patients receiving carbamazepine or valproate therapy, in an attempt to determine identities of the reactive metabolites or, alternatively, the identities of those metabolites that serve as potential precursors to reactive species.

adverse drug reactions can be broadly defined as any undesirable response associated with therapeutic drug use. a simple and clinically useful classification is to divide adverse events into those that are dose-dependent and largely predictable from the known pharmacologic properties of the compound in question, and those that are dependent on characteristics unique to susceptible individuals, or idiosyncratic in nature. the long term objective of this research is to characterize the mechanisms responsible for the pathogenesis of idiosyncratic hypersensitivity reactions in children, particularly those involving carbamazepine and other aromatic anticonvulsants. the study is divided into two phases. phase 1 of the study involves collecting urine from 50 patients taking cbz therapeutically. participants will be asked to provide a spot urine sample during routine health visits. the urine will be analyzed for the presence of cbz and its metabolites. in phase 2 of the study, urine will be collected from patients taking either cbz or vpa therapeutically. if blood samples are drawn from these patients for medical purposes not related to this study the residual blood sample will be recovered before it is discarded for use in genotyping analysis. participants will be asked to provide a urine sample covering one complete dosing interval of cbz or vpa (preferably overnight). patients will also be followed longitudinally, with urine collections at each clinic visit over at least a two year period.

Eligibility criteria:
inclusion criteria: * pediatric patients of both genders between 1 and 16 years of age receiving cbz or vpa mono-therapy will be recruited for this study. additionally, for those patients who are receiving drugs other than cbz or vpa to control their seizures, if cbz or vpa are subsequently added to their treatment regimen, then these patients will also be recruited for this study. exclusion criteria: * none

Keywords: seizures epilepsy
a pilot clinical trial to determine the feasibility of administering an electronic tool to assess postoperative pain, nausea, and vomiting in english or spanish-speaking pediatric patients with neoplastic conditions.

Conditions: Neoplastic Conditions

Summary: the feasibility of using an electronic tool to measure pain, nausea, and vomiting after surgery in english or spanish-speaking pediatric cancer patients.

primary objective: to determine the feasibility of administering an ar-based electronic tool to assess postoperative pain, nausea, and vomiting in english or spanish-speaking pediatric patients with neoplastic conditions. secondary objectives: 1. to evaluate the willingness to use the ar app, 2. to evaluate the time spent using the ar app (recorded in the study device), 3. to calculate the difference (delta) between pain and nausea intensity recorded from the app and those gathered by nursing personnel, 4. to evaluate app recorded responses to pain intensity, 5. to evaluate app recorded responses to nausea intensity, 6. to assess the frequency of vomiting, 7. to measure the length of stay in pacu (calculated from the emr), 8. to determine the rate (number) of assessments completed, 9. to calculate pacu opioid use, 10. to calculate opioid use during hospitalization, 11. to assess the quality of life using the pedsql cancer module survey responses (administered by the study team), 12. to evaluate patient/caregiver satisfaction following the pacu stay 13. to assess nursing experience with ar tool following patient discharge from pacu. exploratory objectives: 1. to assess the primary/secondary outcomes for the english and spanish-speaking patients separately. 2. to correlate pain-reported intensity to the analgesia nociception index (ani).

Eligibility criteria:
inclusion criteria: 1. ages 7-17 years old, 2. able to provide assent, and a legal guardian able to provide informed consent 3. current diagnosis of pediatric cancer or benign neoplasm, 4. surgery with an estimated duration longer than 2 hours, 5. an expected prescription of opioids during the inpatient perioperative period 6. demonstrate capacity to comprehend and interact with the game in english or spanish. exclusion criteria: 1. any concerns from the principal investigator or primary team about the use of the app, 2. inability or refusal from the parents to provide written informed consent.
comparative bioavailability study of codeine sulfate

Conditions: Pain

Summary: the objective of this study was to assess the comparative bioavailability of codeine from roxane laboratories' codeine sulfate 30mg tablets to tylenol® #3 (acetaminophen 300mg with codeine phosphate 30mg) under fasted conditions


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to codeine sulfate or any comparable or similar product.
expression of microrna-133a and microrna-208b in acute myocardial infarction

Conditions: Myocardial Infarction, Acute

Summary: cardiac-enriched micro-rnas (mirnas), micro rna 208b and 133a(mir-208b, mir-133a)) corresponds to the health and disorders of the cardiovascular system. an intron of the cardiac myosin heavy chain gene myh7 encodes mir-208b. it is found on chromosome 14 in humans. identify new diagnostic biomarkers based on mirnas, researchers examine the expression of mir-133a and 208b at various time points (04 hours, 08 hours, 12 hours, 24 hours, 48 hours) following the development of the infarct and compared it to the traditional myocardial infarction biomarkers cardiac troponine (ctnl) and creatine kinase-mb (ck-mb).

the 98% of human genes are non-coding rna, which is further divided into long non-coding rna (lncrna, \> 200 bp) and short non-coding rna (200 bp, including microrna (mirna) and circular rna). more than 2000 human mirnas have been discovered, and it seems that they regulate around 60% of human genes.through a number of pathways, mirnas control the development, re-modelling, and regeneration of the heart as well as endothelial function, vasculo-genesis, and neoangiogenesis. 30% of the genes in the human genome are regulated by about 1000 mirnas. endogenous mirnas are 19-22 nucleotide single-stranded rna molecules that frequently target the 3' untranslated regions (3'-utr) of mrnas to regulate gene expression at the post-transcriptional level in physiological processes, disease development, and conditions like cancer, autoimmune and inflammatory diseases, neuro-degenerative diseases, and cardiovascular diseases. cardiac-enriched mirnas, mir-208 in health and disorders of the cardiovascular system are investigated. identify new diagnostic biomarkers based on mirnas, researchers examine the expression of mir-133a and 208b at various time points (04 hours, 08 hours, 12 hours, 24 hours, 48 hours) following the development of the infarct and compared it to the traditional myocardial infarction biomarkers ctnl and ck-mb.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed with st-elevated myocardial infarction will be identified at the coronary care unit at ain-shams university hospital 2. acute episode of myocardial infarction 3. with no history of previous myocardial infarction treatment exclusion criteria: 1. patients not diagnosed with st-elevated myocardial infarction and healthy at the coronary care unit at ain-shams 2. university hospital 2. previously known patients of myocardial infacrtion 3. previous medication
does inclusion of viral prescription pad resources increase responsiveness to feedback about antibiotic prescribing in primary care

Conditions: Infection

Summary: antibiotic overuse is common and antibiotic prescribing contributes to rising rates of antimicrobial resistance. primary care physicians prescribe the majority of all antibiotics and there is large inter-physician variability in prescribing that cannot be explained by differences in patient populations. in ontario, audit and feedback (a\&f) is routinely offered to primary care providers from a variety of sources. ontario health - an agency created by the government of ontario - provides a\&f via email to physicians who voluntarily sign up for their "mypractice" reports. these are multi-topic reports with aggregated (physician-level) data. as of november 2021, the mypractice reports for family physicians will include data on antibiotic prescribing. to date, less than half of ontario family physicians have signed up for the mypractice reports from ontario health. for this study, the investigators will conduct a trial to investigate the effect of adding viral prescription pad resources to family physician a\&f received through a mypractice: primary care report. this evaluation provides an opportunity to determine if the addition of this resource to an a\&f intervention increases changes to antibiotic prescribing.

this study will examine ways to optimize the effects of a\&f for antibiotic prescribing in primary care. this study will aim to determine if emphasis (or not) on the use of a viral prescription pad developed by choosing wisely canada (cwc) can help physicians act upon the feedback from their mypractice report to reduce their antibiotic prescribing. antibiotic prescribing feedback within the multi-topic mypractice: primary care report will be sent to family physicians who signed up for this program from ontario health. this report includes a link to the choosing wisely viral prescription pad. physicians will be randomized to the control group or intervention group. physicians in the intervention group will receive additional emphasis on the use of the viral prescription pad and will also have a paper copy of the prescription pad mailed to their practice. one month after the initial intervention, participants will be invited to complete a process evaluation survey to determine why or why not the intervention worked and how individual factors can affect physician motivation, willingness, and ability to engage in new practices. intervention participants will also be invited to take part in a process evaluation interview.

Eligibility criteria:
inclusion criteria: * family physicians who sign up for the mypractice reports by september 2021 exclusion criteria: * family physicians who did not sign up for the mypractice reports by september 2021

Keywords: audit and feedback antibiotics
comparison of pressure support and pressure control ventilation in chronic respiratory failure

Conditions: COPD; Chest Wall Disease; Neuromuscular Disease; Obesity Hypoventilation

Summary: this study is looking at whether there is a difference in outcomes using two different types of breathing support in those patients who have chronic respiratory failure (patients who under-breathe). there is little data to demonstrate which mode of ventilation is better in terms of physiological outcomes and outcome data relating to patient symptoms. we hypothesize that one type of breathing support: pressure support ventilation would be more comfortable for patients as it more closely matches a patient's own respiratory pattern and and so leads to improved adherence and consequent improvement in quality of life. patients with respiratory failure will be randomly assigned to receive either pressure support ventilation or pressure control ventilation for the first 6 weeks and then cross-over to receive the mode not previously used for a further 6 weeks. they will have baseline data recorded and then be followed up after each 6 week block.


Eligibility criteria:
inclusion criteria: * patients with chest wall deformity, neuromuscular disease or obesity hypoventilation syndrome with an fev1/fvc ratio of \>70% and vc \<50% predicted or patients with copd with a fev1/fvc ratio of \<70% an fev1 \<50% predicted * stable * ph \>7.35 * ess \<18 * symptomatically stable with clinical resolution of intercurrent infection: normal c reactive protein, white cell count and afebrile * daytime symptoms compatible with nocturnal hypoventilation i.e. poor sleep, morning headache, daytime somnolence, shortness of breath * arterial carbon dioxide partial pressure (paco2) \> 6.0kpa during day with evidence of nocturnal hypoventilation (tcco2 \>7.5kpa or a rise in tcco2 of \>1 kpa) * no prior domiciliary ventilation use * patients with copd must be established on optimal medical treatment prior to enrolment exclusion criteria: * psychological, social or geographical situation that would impair compliance with the schedule * patients who have underlying malignancy or severe cardiac dysfunction (ejection fraction \<40%) * complex osa
the potential for metformin to improve tumor oxygenation in locally advanced cervix cancer: a phase ii randomized trial

Conditions: Uterine Cervical Neoplasms; Squamous Cell Carcinoma; Adenocarcinoma; Carcinoma, Adenosquamous

Summary: cervical cancer remains an important health problem worldwide. poor tumor oxygenation (hypoxia) is associated with inferior survival in cervical cancer and resistance to radiation treatment. hypoxia-modifying therapies improve survival, but existing therapies are impractical and/or toxic. metformin, a non-toxic drug for diabetes, has been shown to decrease tumor hypoxia in animal studies and its use is associated with better survival in diabetic cancer patients. it is hypothesized that metformin may decrease cervical tumor hypoxia and thereby improve tumor response to radiation and survival in patients with locally advanced cervix cancer. this is a randomized, multicenter phase ii study of standard chemoradiation in combination with metformin versus standard chemoradiation alone in women with locally advanced cervix cancer. women randomized to the metformin group will take metformin starting 1 week prior to standard chemoradiation and throughout the duration of external radiation treatment. tumor hypoxia will be measured by a special x-ray test called positron emission test (pet) performed with a hypoxia dye called faza. the main purpose of this study is to see if metformin decreases tumor hypoxia measured on faza-pet; information about response and side effects will also be collected.


Eligibility criteria:
inclusion criteria: * histologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix, figo stage ib2-iva * planned for radical radiotherapy and concurrent cisplatin chemotherapy. * able to receive weekly cisplatin. * no prior anticancer treatment for cervical cancer * ecog 0 or 1 * life expectancy of greater than 3 months. * normal organ and marrow function * able to take oral medications. * ability to understand and willing to sign the consent form * willing to undergo biopsies of cervical tumor. exclusion criteria: * evidence of distant metastases * receiving any other investigational agents concurrently or within 4 weeks. * known diabetes mellitus. * currently taking metformin, sulfonylureas, thiazolidinediones or insulin. * history of allergic reactions attributed to compounds of similar chemical or biologic composition to metformin or cisplatin. * any condition associated with increased risk of metformin-associated lactic acidosis * uncontrolled inter-current illness * pregnant women * history of another invasive malignancy, except for non-melanoma skin cancer or tumors curatively treated with no evidence of disease for \>=5 years. * known hiv-positive * history of bowel obstruction or malabsorption syndromes * history of active clinically significant bleeding * contraindications to radiotherapy * taking drug disulfiram (antabuse).
health-economic evaluation of early diagnosis of epithalial ovarian cancer recurrence using the roma score: a prospective multicenter randomized trial

Conditions: Epithelial Ovarian Cancer

Summary: in this study, we hypothesize that calculating the roma score (ca125 + he4 blood marker assay) will enable faster, more targeted diagnosis and management of epithelial ovarian cancer recurrence than the ca125 marker assay alone. this early identification of recurrence would then improve patients' quality of life, since it would increase the chances of benefiting from less invasive and less morbid surgery. it would also reduce the cost of patient management following disease progression. if our hypothesis is confirmed, the results of this study will enable us to update the recommendations for post-treatment follow-up of patients in remission from epithelial ovarian cancer, as well as reimbursing the he4 marker assay (and thus the calculation of the roma score).


Eligibility criteria:
inclusion criteria: * women aged 18 or over and less than 85 years old * with proven figo stage i to iv epithelial ovarian cancer (ovary/tumor/peritoneum) * women in remission after first-line chemotherapy, with a normal ca125 less than 4 months old at study entry (end of first-line chemotherapy). * woman having completed chemotherapy at least 6 months previously * written informed consent * french social security exclusion criteria: * any physical or psychiatric condition that may interfere with the patient's cooperation in data collection * patient with normal ca125 at initial diagnosis of epithelial ovarian cancer * patient under guardianship * patient deprived of liberty
a naturalistic study of adolescents and young adults in treatment for opioid dependence

Conditions: Opioid Dependence

Summary: many buprenorphine treatment programs do not have services dedicated to adolescents and young adults. as a precursor to developing and evaluating an adolescent and young adult buprenorphine treatment program at apt foundation inc, we propose to conduct a 1 year prospective study of 16 to 25 year old treatment-seeking individuals enrolled in the apt adolescent and young adult suboxone program

participants will consent to in-person assessments and monthly chart reviews. we anticipate that the results from this study will inform the development of future services targeted towards adolescents and young adults with opioid dependence.

Eligibility criteria:
inclusion criteria: * ages 16 through 25 at time of induction * meet criteria for enrollment in the apt adolescent and young adult suboxone program (opioid dependence per dsm-v criteria; no contraindications to buprenorphine (concomitant benzodiazepine, alcohol use, sedative use), * stable enough to participate in outpatient care/intensive outpatient care for at least 12 weeks; * can commit to at least 12 weeks of treatment through the apt adolescent and young adult suboxone program * are willing to provide locator information for follow-up. * are fluent in english and have a 6th grader or higher reading level exclusion criteria: * have an untreated bipolar or schizophrenic disorder, or active suicidal ideation * are physically dependent on alcohol, benzodiazepines, or other sedatives. * are in custody of the department of children and families
study of preventive treatment with symbicort or budicort turbohaler in childhood asthma return to school epidemic

Conditions: Asthma Exacerbation

Summary: during the second week of september( week 38 of the year)there are recorded data of exacerbation of asthma all over the world, including israel. a short preventive treatment of 6 weeks may reduce asthma exacerbation in children,reduce primary care and er visiting and hospitalization.

during the second week of september( week 38 of the year)there are recorded data of exacerbation of asthma all over the world, including israel. a short preventive treatment of 6 weeks may reduce asthma exacerbation in children,reduce primary care and er visiting and hospitalization. we will study the effectiveness of budicort or symbicort turbuhaler as a preventive treatment in children aged 6-18 years.

Eligibility criteria:
inclusion criteria: age : 6-18 years suffering from asthma asthma exacerbation during 1/9/2009-15/10/2009 - exclusion criteria: any chronic condition that can involve respiratory tract (other than asthma) treated as prevention with ics or montelukast from july 2010 treated with oral steroids during the august 2010 asthma exacerbation one week prior study inclusion

Keywords: asthma, september epidemic, children, preventive
chemoradiotherapy with gemcitabine/s-1 vs gemcitabine/s-1 for locally advanced pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the purpose of this study is to evaluate the clinical effectiveness of gemcitabine/s-1 combination chemoradiotherapy with gemcitabine /s-1 combination chemotherapy for unresectable locally advanced pancreatic cancer.

when cancer develops outside of the pancreas from within the anatomical placement of the pancreas itself, it becomes difficult to excise in most cases. generally, most pancreatic cancers are already unresectable at the time of diagnosis when we have recognized infiltration of over 1/2 the circumference of major arteries such as the celiac artery and super mesenteric artery in particular. in comparison with advanced pancreatic cancer with distant metastases, it is not easy to treat unresectable locally advanced pancreatic cancer, even when performing standard gemcitabine monotherapy. in the case of unresectable locally advanced pancreatic cancers without distant metastases, we are left with the choice of whether or not to perform radiation therapy. this decision remains unsolved worldwide, despite the continuing efforts of researchers to bring an end to the clinical doubt. we will report our results as well as the problems of combining treatments with chemoradiotherapy, using the novel anticancer agent gemcitabine as well as/or s-1, not 5fu, predominantly from our own clinical trials on this occasion.

Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed adenocarcinoma, adenocarcinoma squamous carcinoma of pancreatic cancer. 2. patients who confirmed unresectable locally advanced pancreatic cancer with the criteria below. * involving over 1/2 circumference of major artery (sma/ca). (under 1/2 that was borderline lesion.) * involving over the merging section of portal-smv. * no distal metastasis with diagnostic imaging. * confirmed by ct image performed with in four weeks before registration. 3. performance status:0-1(ecog) 4. patients of age =\>20 and 80\> 5. sufficient organ functions * neutrophils\>=1,500/mm3 * platelets\>=100,000/mm3 * hemoglobin\>=9.0g/dl * ast(got)/alt(gpt) \<=150iu * total bilirubin \<=2.0mg/dl, (or \<=3.0mg/dl if biliary drainage were present) * serum creatinine \<= 1.2mg/dl * creatinine clearance\>=60ml/min 6. life expectancy more than 3 months. 7. written informed consent. exclusion criteria: 1. lung fibrosis or intestinal pneumonia, and anamnesis or imaging findings. 2. watery diarrhea 3. severe infection 4. severe complication (heart failure, renal failure, hepatic insufficiency,hemorrhagic peptic ulcer, intestines paralysis,ileus or uncontrolled diabetes etc) 5. massive pleural or abdominal effusion. 6. metastasis to central nervous system. 7. active synchronous or metachronous malignancy other than carcinoma in situ. 8. regular use of flucytosine, fenitoin or warfarin 9. pregnant or lactation women, or women with known or suspected pregnancy and men who want let to pregnancy 10. severe mental illness 11. patients who are judged inappropriate for the entry into the study by the investigator.