Kornimate/medical-research-clean huggingface dataset:
evaluating perioperative dexamethasone and the risk of bleeding in tonsillectomy

Conditions: Post-operative Hemorrhage

Summary: tonsillectomy (removal of the tonsils) is a very common surgery in children. bleeding after tonsillectomy is one of the risks of this surgery and can be more dangerous in children since they have less blood volume than adults. in order to improve recovery after tonsillectomy, steroids (medication that is a strong anti-inflammatory) are often given during the surgery. recently, a study showed steroids given at the time of tonsillectomy increase the risk of bleeding significantly over children who did not receive steroids. this finding has raised concerns in the ear, nose, and throat (ent) community since most ent's use steroids during tonsillectomy in children. the investigators look to explore this question further. to answer the question of whether perioperative steroid administration significantly affects the rate of post-tonsillectomy bleeding, the investigators propose to test the following hypotheses in a prospective, randomized, blinded placebo-controlled trial: dexamethasone does not cause an increase in post-operative bleeding rate in tonsillectomy.

detailed description is entered above

Eligibility criteria:
inclusion criteria: * patients ages 3 to 18 undergoing tonsillectomy or adenotonsillectomy by electrocautery alone for the indication of sleep disordered breathing or infectious tonsillitis. * patients with complex medical conditions or craniofacial abnormalities will be included. * informed consent and child assent are required for enrollment. * eligibility will be determined by the principal investigator, associate investigator or research nurse. exclusion criteria: * subjects with a known personal or family history of any bleeding disorder will be excluded. * subjects currently on oral corticosteroids for other medical conditions or have recently taken any oral corticosteroid within two weeks of surgery. * patients with tonsillectomy performed using a cold knife technique, microdebrider, coblation or plasma knife due to surgeon or parent preference. * where appropriate subjects who do not have informed consent or child assent signed will be excluded * children less than three years old will be excluded due to the fact the majority of these children at the collaborating centers have an adenotonsillectomy using the microdebrider for pain control purposes.
safety study of oxycodone hydrochloride and naltrexone hydrochloride extended-release capsules in subjects with moderate to severe chronic noncancer pain

Conditions: Chronic Noncancer Pain

Summary: the study will provide information to assess the benefits versus risks of extended exposure to oxycodone hcl and naltrexone hcl extended-release capsules in a chronic noncancer pain population.


Eligibility criteria:
inclusion criteria: * subject has moderate to severe chronic noncancer pain (duration of at least 3 months) requiring a continuous around-the-clock opioid analgesic for an extended period of time. conditions may include, but are not limited to, osteoarthritis, chronic low back pain, or other opioid -responsive pain conditions. * subject agrees to refrain from taking opioid medications other than study drug during the study. (the exception is during the pre-treatment period when the subject may continue current opioid therapy to guide first 4 weeks of the treatment period when the subject may administer immediate-release oxycodone to support conversion to study drug.) exclusion criteria: * subject has moderate or severe chronic pain due to cancer, migraine, recent trauma, infection, or other pain expected to be short-term (duration less than 3 months). * subject has a documented history of alcohol or drug abuse within 1 year prior to study entry that in the investigator's judgment would impact subject participation. * subject has ongoing or active alcohol or drug abuse that in the investigator's judgment would impact subject participation. * subject has a positive urine drug test for illicit drug use or medications at screening without legitimate medical explanation. * subject has a clinically significant medical condition (e.g., cardiovascular, neurological, renal, hepatic, pulmonary, gastrointestinal, endocrine, hematological, immunological, rheumatological, metabolic, or psychiatric) or physical examination, vital signs (vs), 12-lead electrocardiogram (ecg), clinical laboratory abnormalities that in the opinion of the investigator would impact the safety of the subject during study participation. * if female, the subject is pregnant or breast-feeding. * subject has a known history or known hypersensitivity to oxycodone, oxycodone salts, naltrexone or acetaminophen,or pharmacological similar compounds. * subject is historically non-responsive to oxycodone treatment or requires greater than 160 mg oxycodone in a 24-hour time interval.

Keywords: chronic noncancer pain oxycodone naltrexone
a clinical comparison of three soft daily disposable contact lenses

Conditions: Myopia

Summary: this study aims to compare the clinical performance of the somfilcon a, nelfilcon a ii 2 and omafilcon a ii 2 daily disposable contact lenses.

this will be a randomised, subject-masked, crossover, bilateral study, controlled by cross comparison. fifty subjects will use each lens type for a week in random sequence. follow-up visits for each lens will be performed after one week of wear. lenses will be worn on a daily wear, daily disposable wear schedule.

Eligibility criteria:
inclusion criteria: * subjects will only be eligible for the study if: 1. they are of legal age (18) and capacity to volunteer. 2. they understand their rights as a research subject and are willing and able to sign a statement of informed consent. 3. they are willing and able to follow the protocol. 4. they agree not to participate in other clinical research for the duration of this study. 5. they have a contact lens spherical prescription between -1.00 to - 6.00d (diopters) (inclusive) 6. they have a spectacle cylindrical correction of -0.75d or less in each eye. 7. at dispensing, they can attain at least 0.10 logmar distance high contrast visual acuity in each eye with the study lenses within the available power range. 8. they currently use soft contact lenses or have done so in the previous six months. 9. they are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day). exclusion criteria: * subjects will not be eligible to take part in the study if: 1. they have an ocular disorder which would normally contra-indicate contact lens wear. 2. they have a systemic disorder which would normally contra-indicate contact lens wear. 3. they are using any topical medication such as eye drops or ointment. 4. they have had cataract surgery. 5. they have had corneal refractive surgery. 6. they have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. 7. they are pregnant or breast-feeding. 8. they have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear. 9. they have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. hiv), or a history of anaphylaxis or severe allergic reaction. 10. they have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
clinical study to evaluate efficacy and safety of da-1229 in patients with cavd

Conditions: Calcific Aortic Valve Disease

Summary: this study will evaluate the efficacy and safety of da-1229 in patients with calcific aortic valve disease.


Eligibility criteria:
inclusion criteria: * adult male and female subjects of ages in the range over 19 * the subjects whose echocardiography or heart ct result meets the criterion in the screening period or 4 weeks before screening visit * criterion : 2.0m/s ≤ peak aortic-jet velocity \< 4.0m/s or aortic valve calcium score ≥300au * the subjects completely understood the clinical trial through detailed explanation presented, determined to participate in the clinical trial spontaneously, and agreed to observe precautions suggested thereby through written consent exclusion criteria: * the cause of cavd is niether degenerative nor bicuspid aortic valve * the subjects who have other aortic valve disease as other clinically significant aortic insufficiency or mitral disease * the subjects who had an aortic valve operation or are expected to need aortic valve operation
safety and tolerability of iph4502 in patients with advanced solid tumors

Conditions: Advanced or Metastatic Solid Tumors

Summary: this is a first-in-human, open-label, multicenter, phase 1 study to evaluate the safety, tolerability and preliminary efficacy of iph4502 and to determine the recommended phase 2 dose (rp2d) in advanced solid tumors that are known to express nectin-4

this is a first-in-human, open-label, multicenter, single-arm phase 1 study, with a part 1 dose escalation guided by a bayesian optimal interval design with backfilling (boin-bf), followed by a part 2 dose optimization in up to 2 selected indications. this study is to measure the safety, tolerability, pharmacokinetics, and preliminary efficacy of escalating doses of iph4502 in patients with advanced solid tumors that are known to express nectin-4.

Eligibility criteria:
main inclusion criteria: * histologically confirmed, unresectable, locally advanced or metastatic solid tumors that are known to express nectin-4 * prior systemic treatment for locally advanced or metastatic disease, yet no therapy with demonstrated clinical benefit for the tumor type is available. * measurable disease according to recist 1.1. * archival tumor tissue obtained within 4 months of screening and since the last anticancer therapy prior to the study or agree to undergo a tumor biopsy at baseline. * adequate organ function and hematological function. main exclusion criteria: * known or suspected brain metastases. * participants with an active infection, any other infection requiring systemic treatment or latent infection. * participants with clinically significant comorbidity(s). * history of treatment for, or suspicion or confirmed interstitial lung disease (ild) at baseline. * condition being treated with systemic corticosteroids or immunosuppressive therapy during iph4502 treatment. * thromboembolic event requiring anticoagulation therapy ≤14 days prior to the first dose of iph4502. * clinically significant cardiovascular disease and/or cardiac repolarization abnormality. * participants with symptomatic heart failure, acute coronary syndromes * participant is receiving or has received anticancer therapy prior to enrolment that may have impact on the assessment of iph4502. * major surgery ≤28 days and minor surgery ≤7 days prior to first dose of iph4502 or 6 months for coronary artery bypass surgery. * concomitant medications or vaccines : live-attenuated vaccines ≤ 6 weeks prior to first dose of iph4502; systemic corticosteroids or other immunosuppressive agents within 14 days prior to the first dose of iph4502; systemic use of moderate or strong cyp 3a4 inhibitors; systemic use of moderate or strong cyp 3a4 inducers.

Keywords: exatecan topo-isomerase i inhibitor squamous cell carcinoma of the head and neck esophageal squamous cell carcinoma triple negative breast cancer non-small cell lung cancer gastro-esophageal junction and gastric cancer colorectal carcinoma ovarian carcinoma prostate cancer cervical cancer melanoma urothelial carcinoma antibody-drug conjugates adc
ct dose simulation study for appendicitis

Conditions: Appendicitis

Summary: the study will explore ct radiation dose as low as reasonably achievable in diagnosing acute appendicitis, by using of dose simulation technique and iterative reconstruction.

three sequential non-inferiority tests are planned. first, three readers will review the original 2-msv images. second, the readers will review the 75%-dose images. after the readers review the 75%-dose images and before the readers reviewed the 50%-dose images, the non-inferiority of 75% dose to the original dose will be tested. if the non-inferiority is not accepted, the study will be terminated with the conclusion of 2 msv as the lowest acceptable dose. if the non-inferiority is accepted, the study will be continue to the next step. in the same manner, the readers will review the next lower-dose images (50% and then 25%), and then the noninferiority will be tested against the original dose.

Eligibility criteria:
inclusion criteria: * 18-44 years of age. * emergency department visit with suspected symptoms and signs of acute appendicitis * intravenous contrast-enhanced computed tomography examination requested due to suspicion of appendicitis exclusion criteria: * having contraindications of intravenous contrast agent

Keywords: appendicitis tomography, x-ray computed receiver operating characteristic (roc) curve computer simulation
korean cohort study of aki & hrs in cirrhosis

Conditions: Liver Cirrhosis; Acute Kidney Injury; Hepatorenal Syndrome

Summary: the aim of this study is to investigate i) whether two biomarkers (urine nag, urinary cystatin c) could be predictive factor in patient with liver cirrhosis, , and ii) whether these biomarkers can predict response of terlipressin.

acute kidney injury (aki) in patients with liver cirrhosis is sometimes accompanied by tubular injury which can lead to poor outcome. current aki criteria using serum creatinine (cr) has some limitations to predict reversibility of renal function and discriminate renal parenchymal injury in cirrhotic patients. the aim of this study is to evaluate whether urine biomarkers \[cystatin c, n-acetyl-β-d-glucosaminidase (nag)\] can predict survival and response to terlipressin in cirrhotic patients with aki.

Eligibility criteria:
inclusion criteria: * patients with liver cirrhosis diagnosed as acute kidney injury or hepatorenal syndrome * patients who voluntarily agreed to the study exclusion criteria: * patients with active bleeding (eg, varix bleeding) within 7 days * patients with hepatocellular carcinoma * patients with hypersensitivity to terlipressin * patients with anuria * pregnant and lactating patients * patients who did not agree with the study
study of abt-267 in treatment naive hepatitis c virus (hcv) genotype 1 infected subjects

Conditions: Chronic Hepatitis C; Hepatitis C Virus (HCV) Infection

Summary: the purpose of this study was to assess the safety, pharmacokinetics, and 4-week rapid virologic response (rvr) of 3 different doses of abt-267 (also known as ombitasvir) in combination with pegylated interferon/ribavirin (pegifn/rbv) compared with pegifn/rbv alone (abt-267 placebo) in treatment naïve, hepatitis c virus (hcv), genotype 1-infected participants.

the study was a randomized, double blind, placebo controlled study consisting of 2 substudies. in substudy 1, participants received 1 of 3 doses of abt-267 or placebo + pegifn/rbv for 12 weeks. in substudy 2, participants received pegifn/rbv for 36 weeks. participants were followed for 48 weeks post abt-267 treatment for evaluation of efficacy and safety.

Eligibility criteria:
inclusion criteria: * treatment naïve participants * females must be either postmenopausal for at least 2 years or surgically sterile * males must be surgically sterile or practicing specific forms of birth control * chronic hepatitis c virus (hcv), genotype-1 infected participants * documented fibrotest score in combination with an aspartate aminotransferase to platelet ratio index (apri), or a liver biopsy within the last 12 months to document absence of cirrhosis exclusion criteria: * pregnant or breastfeeding female * use of any medications contraindicated for use with pegylated interferon(pegifn) or ribavirin (rbv) 2 weeks prior to study drug administration or 10 half-lives, whichever is longer * clinically significant cardiac, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic disease, or any uncontrolled medical illness or psychiatric disease or disorder * current or past clinical evidence of cirrhosis or bridging fibrosis * abnormal screening laboratory results
efficacy of optive versus systane concomitant with restasis (cyclosporine a) for the treatment of dry eye symptoms

Conditions: Dry Eye

Summary: the purpose of this study is to evaluate the efficacy of optive versus systane used concomitantly with topical cyclosporine for the treatment of dry eye.


Eligibility criteria:
inclusion criteria: * · males or females \> 18 years old * score of at least 2 and no more than 4 on the sesod at the initial screening visit (mild to severe patients) * at least grade 2 conjunctival staining * likely to complete all study visits and able to provide informed consent exclusion criteria: * · prior unsuccessful use of topical cyclosporine (defined as patients taking it at least 3 months and saw no improvements) * current use of topical cyclosporine * known contraindications to any study medication or ingredients * female of child bearing potential not using reliable methods of birth control, or pregnant or lactating females. * planned use of contact lenses (unless discontinued use ³ 30 days prior to randomization) * active ocular diseases or uncontrolled systemic disease (blepharitis patients that are actively being treated or disease that is uncontrollable) * ocular surgery within the past 3 months, * active ocular allergies
a first in human study to evaluate safety, tolerability, and pharmacology of pf-06826647 in healthy subjects and subjects with plaque psoriasis

Conditions: Plaque Psoriasis

Summary: this first in human study will evaluate the safety, tolerability, pharmacokinetics (pk), and pharmacodynamics (pd) of pf-06826647 in healthy subjects and subjects with plaque psoriasis.


Eligibility criteria:
healthy participants: inclusion criteria: * healthy male subjects between ages of 18-55 years * healthy female subjects of non-childbearing potential between the ages of 18-55 years * body mass index (bmi) of 17.5 to 30.5kg/m2; and a total body weight \>50kg (110lbs). * no evidence of active or latent or inadequately treated infection with mycobacterium tuberculosis (tb) * (optional) japanese subjects who have four japanese biologic grandparents born in japan exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) * pregnant female subjects; breastfeeding female subjects; female subjects of childbearing potential * fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product * have a clinically significant infection currently or within 6 months of first dose of study drug psoriasis participants: inclusion criteria: * healthy male subjects between ages of 18-65 years * healthy female subjects of non-childbearing potential between the ages of 18-65 years * have a diagnosis of plaque psoriasis for at least 6 months prior to first study dose * have plaque-type psoriasis covering at least 15% of total body surface area (bsa) at day-1(prior to randomization in the study * no evidence of active or latent or inadequately treated infection with mycobacterium tuberculosis (tb) exclusion criteria: * currently have non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis * have a clinically significant infection currently or within 6 months of first dose of study drug, or a history of chronic or recurrent infectious disease * pregnant female subjects; breastfeeding female subjects; female subjects of childbearing potential * fertile male subjects who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after the last dose of investigational product
a study of the effects of single dose corticosteroids on response to allergens

Conditions: Allergic Rhinitis

Summary: this study will investigate whether changes in inflammatory mediators produced by the nose after exposure to an allergen can be used to evaluate the anti-inflammatory effects of novel drugs for the treatment of allergic asthma.


Eligibility criteria:
inclusion criteria: * patient is allergic to timothy grass pollen * female patients have a negative pregnancy test and agree to use birth control throughout the study * male patients agree to use birth control throughout the study * patient has been a nonsmoker for at least 6 months * patient agrees to avoid the use of aspirin and other non-steroidal anti-inflammatory drugs (nsaids) throughout study exclusion criteria: * patient is breastfeeding * patient has any respiratory disease other than mild stable asthma that does not require treatment * patient consumes more than 3 alcoholic beverages per day * patient consumes more than 6 caffeinated beverages per day * patient has had major surgery or has donated or lost 1 unit of blood within 4 weeks of screening * patient has severe allergies
continuation treatment protocol for patients who participated in the adagio tvp 1012/501 clinical trial

Conditions: Parkinson Disease

Summary: the purpose of the study is to extend the use of rasagelin mesylate 1mg per day by subjects who participated in the adagio tvp 1012/501 according to form 4a for additional three years.


Eligibility criteria:
inclusion criteria: * subjects who are willing to contiue this treatment. * subjects who took part in the tvp 1012/501 clinical trail. exclusion criteria: * subjects who didn't take part in the tvp 1012/501 clinical trail.
invasive group a streptococcal infection

Conditions: Sepsis Due to Streptococcus, Group A; Risk Factors; Severe Infection; Medical Care; Medical Complications; Outcome, Fatal; Therapy; Strain; Virulence Factors

Summary: this study is observational, retrospective and prospective study in pediatric patients hospitalized with invasive streptococcal a infection

the main of this study is to identify and record cases of invasive and severe infections due to streptococcus pyogenes. in order to evaluate the incidence of severe forms of disease and the possible contributing factors, and to optimize their management. admitted patients to intensive care or critical care units in reported via santé publique france may also be included in this study. secondly, epidemiological, clinical, bacteriological data of all severe or not cases, of group a streptococcal infections will be compiled to describe their characteristics, and try to explain this recrudescence as well as possible.

Eligibility criteria:
inclusion criteria: * age\<18 years * documented invasive group a streptococcus infection (identification of gas in a normally sterile site or from another site in case of toxin shock or necrotizing dermo-hypodermatitis) exclusion criteria: * opposition of the patient or his/her legal representative