Kornimate/medical-research-clean huggingface dataset:
opioids versus non-opioids postoperative after knee arthroscopic surgery

Conditions: Knee Injuries; Pain, Postoperative; Opioid Use

Summary: the purpose of this study is to look at pain management with opioids versus non-opioids after knee arthroscopy. this study will determine 1) whether the most commonly used non-narcotic medications provide pain relief comparable with the most commonly prescribed narcotic medications in patients undergoing arthroscopic knee surgery, and 2) whether patients' characteristics (gender, pre-operative knee symptoms, workers compensation status and employment status) affect pain level following surgery or medication usage.


Eligibility criteria:
inclusion criteria: 1. subjects ≥ 18 years of age through ≤ 80 years of age 2. subjects undergoing elective arthroscopic knee surgery, to include partial meniscectomy, chondroplasty, or loose body removal. exclusion criteria: 1. previously enrolled in this study (enrolled for contralateral knee in this study) 2. knee arthroscopy patients scheduled for knee ligament reconstructions 3. bilateral knee arthroscopy 4. history of chronic opioid use or long-term analgesic therapy 5. documented or suspected substance abuse 6. documented or suspected chronic pain syndrome 7. any known allergy or adverse reaction or contraindication to the components of hydrocodone, acetaminophen, or ibuprofen 8. history or symptoms of any significant medical problem in the last year (i.e., arrhythmia, impaired cardiovascular function, gastrointestinal bleeding, liver disease, renal disease) 9. with active peptic ulcer disease (history of severe heartburn) 10. symptoms of infection with initial enrollment 11. pregnant or nursing 12. diagnosis of cognitive impairment 13. unable or unwilling to provide informed consent for surgery or enrollment in this clinical study 14. inability to understand the requirements of the study or be unwilling to provide written informed consent (as evidenced by signature on an informed consent document approved by institutional review board) and agree to abide by the study restrictions. 15. patient refusal 16. currently taking coumadin, plavix, anticoagulation medications, or medications that increase bleeding, with the exception of asa 81mg. 17. patients with other medical or psychological health conditions that preclude them from either receiving the intervention or returning for follow-up visits. 18. alcoholism
long-term data collection for subjects in mdx-010 studies

Conditions: Metastatic Melanoma

Summary: the objective of this study is to collect disease status and overall survival information for all subjects in mdx-010 studies.

this is a multicenter, follow-up study in up to 191 subjects with metastatic melanoma who were previously enrolled and treated in ipilimumab studies mdx010-02, mdx010-08, and mdx010-15. the purpose of this study is to 1) collect the date and cause of death, if known, for all deceased subjects who participated in any of the specified studies; 2) collect the date of progression for subjects who completed the studies with stable disease or better; and 3) prospectively follow all surviving subjects to determine progression-free and overall survival.

Eligibility criteria:
inclusion criteria: 1. subjects who were previously enrolled in mdx-010 studies mdx010-02, mdx010-08, or mdx010-15. 2. subjects (or if applicable, next of kin), who are alive at the time of contact must have read, understood, and provided written informed consent and health insurance portability and accountability act (hipaa) authorization after the nature of the study has been fully explained. 3. for subjects who have died or have been lost to follow-up(the subject status at end of original ipilimumab study), approval from the appropriate site irb, specifying or limiting appropriate means for obtaining information, must be granted prior to collection of any information.
vibration and cold for pain relief during peripheral intravenous cannulation in children with intellectual disability

Conditions: Pain Relief

Summary: needle procedures are the most common and important source of pain and distress in children in the health care setting. children with intellectual disability from any cause experience pain more frequently than healthy children. they often require venipuncture or iv cannulation for diagnostic or therapeutic procedures. pain in this population is often unrecognised because these patients are frequently unable to self-report their pain. now it's possible to measure pain in children with intellectual disability with specific pain scales, like nccpc-pv (non-communicating children's pain checklist, post-operative version). the efficacy of a device combining vibration and cold for pain relief during venipuncture or iv cannulation has been recently reported in children. the device's actions are based on the gate control theory, whereby cold and vibrations stimulate large fiber and inhibitory neurons to interrupt nociception. this non-pharmacologic technique for pain relief could be useful in this kind of patients in emergency department. to date, there is no study that validated buzzy device for pain relief in children with intellectual disability. the aim of this study is to test the effectiveness of buzzy® (a device that provides cold and vibration), in reducing the pain during venipuncture or iv cannulation, in children with intellectual disability.


Eligibility criteria:
inclusion criteria: * age 4 to 17 years * presence of intellectual disability * need of peripheral iv line or venipuncture * informed consent signed by parents or legal guardians exclusion criteria: * presence of abrasion, infection or break in skin in the area of buzzy® placement * cold hypersensibility

Keywords: procedural pain phlebotomy intellectual disability child buzzy
n-butyl-2-cyanoacrylate injection versus band ligation for gastric variceal hemorrhage

Conditions: Gastric Variceal Hemorrhage

Summary: the purpose of this study was to test the hypothesis by comparing the efficacy of cyanoacrylate injection (gvo) and band ligation (gvl) in the treatment of acute gvh in liver cirrhotic patients with or without concomitant hepatocellular carcinoma (hcc).

gastric variceal hemorrhage (gvh) has a poorer prognosis than esophageal variceal hemorrhage. however, data on its optimal treatment are limited. we designed a prospective study to compare the efficacy of endoscopic band ligation (gvl) and endoscopic n-butyl-2-cyanoacrylate injection (gvo). liver cirrhotic patients with or without concomitant hepatocelluar carcinoma (hcc) and patients presenting with acute gvh were randomized into two treatment groups. forty-eight patients received gvl, and another 49 patients received gvo. both treatments were equally successful in controlling active bleeding (14/15 vs. 14/15, p = 1.000). more of the patients who underwent gvl had gv rebleeding (gvl vs. gvo, 21/48 vs. 11/49; p = .044). the 2-year and 3-year cumulative rate of gv rebleeding were 63.1% (95% confidence interval \[ci\], 44.5%-81.7%), 72.3% (95% ci, 51.3%-93.3%) for gvl and 26.8% (95% ci, 12.5%-41.1%), 26.8% (95% ci, 12.5%-41.1%) for gvo; p = .0143, log-rank test. the rebleeding risk of gvl sustained throughout the entire follow-up period. multivariate cox regression indicated that concomitance with hcc (relative hazard: 2.453, 95% ci: 1.036-5.806, p = .041) and the treatment method (gvl vs. gvo, relative hazard: 2.660, 95% ci: 1.167-6.061, p = .020) were independent factors predictive of gv rebleeding. there was no difference in survival between the two groups. severe complications due to these two treatments were rare. in conclusion, the efficacy of gvl to control active gvh appears to have no difference with gvo, but gvo is associated with a lower gv rebleeding rate.

Eligibility criteria:
inclusion criteria: \* patients who were aged between 18 and 80 years and had endoscopy-proven acute gastric variceal hemorrhage (gvh) exclusion criteria: * cases with concomitant large gv and large ev, but without stigmata of recent bleeding * cases had previous endoscopic, surgical treatment or transjugular intrahepatic portosystemic shunt for gvh * cases had a terminal illness of any major organ system, like heart failure, uremia, chronic obstructive pulmonary disease, or nonhepatic malignancy

Keywords: gastric varices liver cirrhosis hepatocelluar carcinoma rebleeding long-term
preoperative ondansetron lozenge for prevention of postoperative nausea and vomiting in caesarean section

Conditions: Ondansetron Lozenge; Postoperative Nausea and Vomiting; Caesarean Section

Summary: the aim of this study is to estimate the effect of preoperative ondansetron lozenge on prevention of postoperative nausea and vomiting in caesarean section.

caesarean section has become increasingly popular, and it is the most performed surgical procedure. despite consciousness allowing the patient to have an early intimate bond with the newborn, the procedure may be associated with complications. around 30% of individuals undergoing elective procedures under general anesthetic are affected by postoperative nausea and vomiting (ponv). ponv may decrease the quality of recovery and cause aspiration, intracranial hypertension, dehydration, acid-base disturbance, electrolyte imbalance, and neurological deterioration which leads to a prolonged hospital stay and increased medical cost. the latest guidelines for the management of ponv recommend the administration of prophylactic antiemetic drugs (aed) as part of a multimodal therapy in high-risk adults. ondansetron is generally considered to be the first-line antiemetic for patients because of its favorable side effect profile. ondansetron reduces the activity of the vagus nerve, which deactivates the vomiting center in the medulla oblongata, and also blocks serotonin receptors in the chemoreceptor trigger zone, ondansetron is an effective drug in the prevention and treatment of ponv by having low side effects

Eligibility criteria:
inclusion criteria: * age from 18 to 35 years old. * american society of anesthesiologists (asa) physical status ii. * undergoing caesarean section under general anesthesia. exclusion criteria: * medical history of alcohol or drug abuse. * history of allergic reactions or intolerance to any study medications. * bmi \> 40 kg/m2. * history of nausea and/or vomiting within 24 h prior procedures. * history of treatment with antiemetic medication for nausea or vomiting within 24 h of their procedure. * history of chemotherapy treatment within 4 weeks prior to surgery.
optimization of treatment of advanced nonsmall cell lung cancer using radiotherapy and chemotherapy

Conditions: Non Small Cell Lung Cancer

Summary: primary objectives of the study are: to assess the differences in survival of the two treatment options in both stage iii (a and b) nonsmall cell lung cancer (nsclc) (study a) and stage iiib (wet) and stage iv nsclc (study b), respectively secondary objectives are: to assess the differences in toxicity of two treatment options in both stage iii (a and b) nsclc (study a) and stage iiib (wet) and stage iv nsclc (study b), and to assess the differences in health related quality of life (hrqol) of two treatment options in both study a and study b

to compare survival rates (median and 1-year), and toxicity of two treatment regimens in patients with locally advanced incurable nsclc (study a), to compare survival rates (median and 1-year) of two treatment regimens in patients with locally advanced and metastatic nsclc (study b) to compare hrqol and cost effectiveness of two treatment regimens in patients with locally advanced incurable nsclc (study a), and in patients with locally advanced and metastatic nsclc (study b) and to evaluate the effect of hrqol assessment on qol dimensions

Eligibility criteria:
study a inclusion criteria: * histologically or cytologically confirmed nsclc * stage iiia/iiib staged with * ct chest and upper abdomen * liver, renal, hematological reserve appropriate (according to "standard" institutional values) * brain ct and/or bone scan only if clinical symptoms request such investigation * performance status kps 60-90 * no second cancer except skin non-melanoma * no previous treatment * patient must be contactable for follow-up * patient to be able to start treatment within 2 weeks from randomization (institutional confirmation needed) * life expectancy \> 3 months * patient must be able and willing to give informed consent, and fill in questionnaires study a exclusion criteria: * stage iii b "wet" (existing pleural effusion , but not necessarily cytologically verified) * rt field \> 200 cm2 * pregnancy study b inclusion criteria: * kps 60-90 * stage iv and stage iii b (existing pleural effusions , but not necessarily cytologically verified) * histologically or cytologically confirmed * ct staged disease (thorax and possible upper abdomen) * no second cancer except skin non-melanoma * liver, renal, haematological reserve appropriate (according to "standard" institutional values) * no previous treatment * patient must be contactable for follow-up * patient must be able and willing to give informed consent and fill in questionnaires * patient to be able to start treatment within 2 weeks from randomization (institutional confirmation needed) * life expectancy \> 3 months study b exclusion criteria: * brain metastasis (brain ct and/or mri not needed, unless symptoms exist - clinically indicated) * rt field \> 200 cm2 * pregnancy * a-p separation too large to be adequately treated with 60-co (?)

Keywords: lung cancer nonsmall cell lung cancer radiation therapy chemotherapy locally advanced and metastatic nonsmall cell lung cancer
oxygenation by 100% oxygen via high flow nasal cannula in surgical patients

Conditions: Anaesthesia, General; Anesthesia, Intravenous; Ventilation

Summary: oxygenation with high-flow nasal cannula with 100% oxygen has only been evaluated in a limited number of studies. although data are convincing it is of importance to evaluate this new concept in our department before implementing it into clinical practice. the general purpose of this project is to evaluate a new ventilation strategy during ent-surgery based on oxygenation with high-flow nasal cannula with 100% oxygen with focus on gas exchange.


Eligibility criteria:
inclusion criteria: 1. adult, \>18 years old 2. ent-surgery where apnea is of benefit for the surgeon (eg. intraoral or laryngeal surgery) and the anesthesia time is \<40 mins. 3. capable of understanding the study information and sign the written consent. exclusion criteria: 1. asa\>2 2. nyha \>2 3. bmi \>30 4. pregnancy 5. manifest cardiac failure or coronary disease 6. neuromuscular disease
preoperative topical gatifloxacin on anterior chamber cultures after cataract surgery

Conditions: Endophthalmitis

Summary: postoperative endophthalmitis, a possible severe complication of cataract surgery, is an infection of the anterior chamber of the eye caused by bacterial contamination and colonization through surgical incisions. bacteria are thought to originate mainly from the patient's skin and studies show that bacteria are commonly found in the anterior chamber following surgery. however, innate immune defences are usually able to control and eliminate bacterial growth before postoperative endophthalmitis occurs. also, due to the low incidence of postoperative endophthalmitis, it is difficult to accurately evaluate preventative methods. this study will examine the efficacy of topical preoperative administration of gatifloxacin (a new fourth generation fluoroquinolone antibiotic) on reduction of bacterial contamination of the anterior chamber following cataract surgery. if the antibiotic is shown to lower bacteria count in cultures from anterior chamber fluid, it has the potential to lower the incidence of postoperative endophthalmitis. patients undergoing cataract surgery will be notified and asked to participate in the study by the physician in advance of the surgery, provided they do not possess any exclusion criteria. the participants will be randomly split into two groups; one group will receive topical application of gatifloxacin prior to surgery, while the other group will receive no eye drops. during surgery, a small sample of anterior chamber fluid will be removed from the eye and cultured in both broth and enrichment media for all subjects. bacterial growth, i.e., colony forming units (cfus), will be used as an indicator of the bacterial contamination of the fluid.


Eligibility criteria:
inclusion criteria: * cataract surgery on first eye (i.e., first cataract surgery. exclusion criteria: * uveitis, * herpetic eye disease, * corneal ulceration, * severe blepharitis, * past trauma to the eye, * complicated cataract surgery (e.g., posterior capsule rupture), * previous intraocular surgeries.

Keywords: post-cataract surgery endophthalmitis
oral tranexamic acid versus diosmin for treatment of menorrhagia in women using copper iud

Conditions: Menorrhagia

Summary: to compare the efficacy of tranexamic acid and diosmin in reducing menstrual blood loss in women having intra uterine contraceptive device (iud) and suffer from menorrhagia.


Eligibility criteria:
inclusion criteria: * women complaining from an menorrhagia secondary to a current copper iud use. * age: 20-40years. * menorrhagia , will be defined as a pbac-score greater than 100. * no systemic causes of abnormal uterine bleeding as hypertension and hemorrhagic blood diseases. * no other local causes of abnormal uterine bleeding as, (fibroid, adenomyosis, polyps). * no drugs decreasing blood coagulation. * well fitted iud not misplaced. exclusion criteria: * age \ 40y. * irregular menstrual cycle. * presence of systemic causes of abnormal uterine bleeding as hypertension and hemorrhagic blood diseases. * presence of other local causes of abnormal uterine bleeding as, (fibroid, adenomyosis, polyps). * taking drugs decrease blood coagulation. * misplaced iud.
delayed cold-stored platelets -plts-1

Conditions: Platelets; Bleeding; Cardiopulmonary Bypass; Cardiac Surgery

Summary: plts-1 is a multicentre, randomized, controlled, pilot trial, using a conventional, parallel group, two-armed design at 2 cardiac surgery centres in canada. the study is designed to assess the feasibility of a future, definitive rct to determine the non-inferiority of cold-stored platelets compared to conventional platelets with respect to hemostatic effectiveness (total number of allogeneic blood products transfused within 24 hours after cpb), as well as safety.


Eligibility criteria:
inclusion criteria: adult (≥18 years old) patients undergoing elective cardiac surgery with cpb will be eligible for inclusion if they are planned to undergo at least moderately complex surgery or have a preoperative platelet count ≤150,000 x106/l (this is a group at high risk of requiring platelet transfusions post-cpb). moderately complex index surgery is defined as: 1. repair/replacement of more than one valve; 2. aorta (root/ascending/arch) replacement; 3. any combination of coronary artery bypass grafting, valve repair/replacement, or aorta (root/ascending/arch) replacement; or 4. re-do procedures consisting of a repair or revision of a prior cardiac intervention. exclusion criteria: patients will be excluded if cold-stored platelets are not going to be available at the time of surgery or if the patient: 1. has a congenital or acquired hemostatic disorder (including platelet refractoriness due to anti-platelet and anti-human leukocyte antigen \[hla\] antibodies) and/or requires specially matched platelets (including patients with anaphylaxis to blood due to immunoglobulin a \[iga\] deficiency), 2. has known contraindications to heparin, thereby excluding cases where non-reversible anticoagulants (i.e. argatroban) are used, 3. is on warfarin or direct oral anticoagulants (dabigatran, rivaroxaban, apixaban or edoxaban) within 3 days prior to surgery, 4. is on antiplatelet drugs within 5 days prior to surgery (excluding acetylsalicylic acid \[asa\]), 5. refuses allogeneic blood products, 6. has a known pregnancy, 7. has already enrolled in this study, 8. is enrolled in another interventional clinical trial where routine care and management are altered, 9. has hemodynamic instability defined as critical care admission, vasopressor, or inotrope dependence prior to index surgery, or 10. has pre-operative requirement for, or expected post-operative dependence upon mechanical circulatory support (i.e., intra-aortic balloon pump, ventricular assist device).

Keywords: blood platelets cardiac surgical procedure blood preservation/methods blood preservation/adverse effects
lumacaftor/ivacaftor combination therapy in subjects with cf who have an a455e cftr mutation

Conditions: Cystic Fibrosis

Summary: this is a phase 2, randomized, double-blind, placebo-controlled, multicenter, crossover study that will evaluate the efficacy of lum/iva in subjects with cf 12 years of age and older who have at least one a455e mutation.


Eligibility criteria:
inclusion criteria: * male or female with confirmed diagnosis of cf * all subjects must have an a455e mutation on at least 1 cftr allele; no more than 10 subjects may have an f508del mutation on 1 cftr allele. * forced expiratory volume in one second (fev1) ≥30% of predicted and ≤90% of predicted at the screening visit, based on the global lung function initiative (gli)-2012 multi ethnic all-age reference equations. * stable cf disease as judged by the investigator. * willing to remain on a stable medication regimen for cf from 4 weeks before day 1 through the follow up visit. exclusion criteria: * history of any comorbidity reviewed at the screening visit that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject. * a g551d, g1244e, g1349d, g178r, g551s, s1251n, s1255p, s549n, s549r, or r117h mutation on at least one cftr allele. * pregnant or breastfeeding. * any abnormal laboratory values at the screening visit. * history of cataract/lens opacity, or evidence of cataract/lens opacity determined to be clinically significant by the ophthalmologist or optometrist during the ophthalmologic examination at the screening visit. * use of strong inhibitors or strong inducers of cyp3a, including consumption of certain herbal medications and certain fruit and fruit juices, within 14 days before day 1 * sexually active subjects of reproductive potential who are not willing to follow the contraception requirements
foster® pmdi (chf 1535) versus symbicort® turbohaler in copd patient

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of the study is to demonstrate the non-inferiority of chf1535 pmdi versus symbicort® turbohaler® in terms of lung function parameters and patients reported outcomes and to assess its safety and tolerability.


Eligibility criteria:
inclusion criteria: * adults aged ≥ 40 years, chinese ethnicity * patients with copd diagnosed at least 12 months before the screening visit. * a smoking history of at least 10 pack years * post-bronchodilator fev1 \< 50% of the predicted normal value * post-bronchodilator fev1/fvc ratio \< 0.7 * one exacerbation in the 12 months prior the screening visit exclusion criteria: * patients requiring ocs/antibiotics/pde inhibitors in the 4 weeks prior to screening * copd exacerbation requiring ocs/antibiotics or hospitalization during the run-in period * known respiratory disorders other than copd * diagnosis of asthma

Keywords: lung functions copd
prevelance of dental caries in agroup of egyption children using caries assessment spectrum and treatment

Conditions: Dental Caries

Summary: to explore the prevalence of dental caries in egyptian children aged from 6 to 9 years oldusing cast index and dmft index

to explore the prevalence of dental caries in egyptian children aged from 6 to 9 years oldusing cast index and dmft index. from must university outpatient clinic

Eligibility criteria:
inclusion criteria: * - parental or guardian acceptance for participation in the study. * children who are medically free from any systemic diseases. * children with mixed dentition aging from 6-9 years old. * both genders. exclusion criteria: * uncooperative patient