Kornimate/medical-research-clean huggingface dataset:
the effect of dexmedetomidine on airway complications after deep or awake extubation

Conditions: Adenotonsillar Hypertrophy; Obstructive Sleep Apnea; Tonsillitis; Adenoiditis

Summary: the investigators aim to investigate the effect of dexmedetomidine on the perioperative respiratory complications in this patient population undergoing both awake and deep tracheal extubation.

we propose a prospective double-blinded randomized controlled trial. 336 pediatric patients presenting to massachusetts eye and ear infirmary (meei) for adenotonsillectomy who are eligible for the study based on inclusion and exclusion criteria will be recruited. a clinical pharmacy specialist, will be in charge of preparing the dexmedetomidine and placebo doses and will randomize the patients to four equally numbered groups. the anesthesiologist will receive the assignment for the extubation method in a sealed envelope from the clinical pharmacy specialist. multiple parameters will be recorded in perioperative period to quantify perioperative adverse respiratory events.

Eligibility criteria:
inclusion criteria: * patients between 3 to 16 years of age undergoing adenotonsillectomy, with or without myringotomy or myringoplasty * asa 1 \& 2 exclusion criteria: * known allergy or hypersensitivity reaction to dexmedetomidine * organ dysfunction (renal/hepatic failure or leukemia) * cardiac disease (congenital or acquired) * airway or thoracic malformation * cerebral palsy * hypotonia * need for premedication * current/recent upper respiratory infection (within four weeks prior to the surgery) * asthma * allergy or intolerance to clonidine * non-english speaking parents/patients.
hemophilia and bone metabolism: study of monocytic populations and inflammatory proteins

Conditions: Hemophilia; Osteopenia; Arthropathy

Summary: the investigators propose, as part of the study, to carry out for each patient: * an analysis of monocytic populations by flow cytometry (cd14, cd16, cd45, cd68, cd115, ccr2, cx3cr1, cd163 and cd206). * a population assessment of myeloid-derived suppressor cells (mdsc). * assays of cytokines and chemokines involved in inflammation by multiplex analyzes: il-1 (α and β), il-4, il-6, il-10, il-13, tnf- α, tgf- β, crp , leptin, ifn- β. * specialized dosages of proteins involved in bone metabolism. rankl, osteoprotegerin, m-csf, trapcp5.


Eligibility criteria:
inclusion criteria: * major patients followed at the hemophilia treatment reference center, * presenting the diagnosis of severe, moderate or minor hemophilia a / b, * having a social security system, * obtaining the oral non-objection collection from the patient after information. exclusion criteria: * minor patients, under guardianship or curatorship. * causes of secondary osteoporosis: * systemic corticosteroid therapy in progress (≥ 3 consecutive months, at a dosage ≥ 7.5 mg / d of prednisone equivalent). * other treatment or condition responsible for osteoporosis: prolonged or medicated hypogonadism, untreated active hyperthyroidism, hypercorticism, primary hyperparathyroidism. * treatment with biphosphonates, biotherapies or hormone therapy in the treatment of prostate cancer.
serum magnesium level in type 2 diabetes mellitus

Conditions: Diabetes Mellitus

Summary: diabetes mellitus (dm) is a chronic metabolic disorder characterized by persistent hyperglycemia. it may be due to impaired insulin secretion, resistance to peripheral actions of insulin, or both . chronic hyperglycemia in synergy with the other metabolic aberrations in patients with diabetes mellitus can cause damage to various organ systems, leading to the development of disabling and life-threatening health complications, most prominent of which are microvascular (retinopathy, nephropathy, and neuropathy) and macrovascular complications leading to a 2-fold to 4-fold increased risk of cardiovascular diseases mg2+ deficiency is usually identified by the measurement of serum mg2+ concentration. hypomagnesemia is defined by a serum mg2+ concentration \< 0.75 mmol/l, but a deficiency due to low dietary intake in otherwise healthy people is uncommon. although overt signs of clinical mg2+ deficiency are not routinely recognized in the healthy population, relatively low mg2+ intake and/or mg2+ status have been shown to be associated with chronic diseases, including cardiovascular disease, t2dm, osteoporosis, pulmonary disease, depression, migraine headaches, inflammation, and cancer


Eligibility criteria:
inclusion criteria: * • type 2 diabetes mellitus according to who criteria. exclusion criteria: * • renal failure patients. * type i dm patients. * acute pancreatitis. * hyperthyroidism. * hyperparathyroidism. * malignancies. * patients on loop/thiazide diuretics. * patients on mg supplement. * patients on mg containing antacids. * any other conditions causing low mg levels were excluded from the study.
xena study - a study of xeloda (capecitabine) in patients with invasive breast cancer

Conditions: Breast Cancer

Summary: this single arm study stratified patients into two treatment cohorts based on her2-neu overexpression/amplification. each cohort will be independently powered for the primary endpoint. the study will evaluate the efficacy, safety and impact on quality of life of treatment with oral xeloda plus intravenous (iv) taxotere (docetaxel). patients with her2-neu negative breast cancer will receive chemotherapy alone with oral xeloda plus intravenous (iv) taxotere (docetaxel). patients with her2-neu positive breast cancer, will receive the same chemotherapy in combination with intravenous (iv) herceptin (trastuzumab). patients will receive 3-weekly cycles of treatment with xeloda (825mg/m2 oral administration \[po\] twice daily (bid) on days 1-14) + taxotere (75mg/m2 iv on day 1). her2-neu positive patients will also receive herceptin (loading dose of 4mg/kg iv followed by 2mg/kg iv weekly). the anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * women \>=18 years of age; * newly diagnosed; * infiltrating (invasive) her2-neu-negative or her2-neu-positive breast cancer. exclusion criteria: * evidence of metastatic disease, except ipsilateral (same side) axillary lymph nodes; * previous systemic or local primary treatment.
clinic-based hiv identification and prevention project using electronic resources

Conditions: HIV Prevention; Primary Care; PrEP

Summary: hybrid type ii effectiveness-implementation trial to investigate whether electronic medical and sexual history data collection with hiv risk categorization/scoring will increase pre-exposure prophylaxis (prep) uptake among cis-gender women attending routine well-woman gynecologic preventative visits.

forty-two obgyn providers will be randomized into 1 of three arms. patients of enrolled providers who attend an obgyn clinic for any preventative visit will complete an electronic history form (ehxform) before clinic through a message sent through the patient portal (mychart), email, or secure text messaging. the sexual history questions will be scored and categorized into 3 categories. patients with a low score (0-3) will receive an electronic message offering a laboratory hiv test per uspstf guidelines. if she accepts, then an automated epic order will be placed for the provider to sign during the office visit. patients with a medium/high score (4-10) will be assigned a study arm based on their provider's group (arm 1: control, arm 2: patient will view score and a prep video, arm 3: procedures in arm 2 plus providers will receive an electronic health record alert that the patient may have hiv risk factors. this will occur automatically via programming integrated into the electronic health record. the primary outcome is prep uptake. the implementation strategy will be evaluated using the reach, effectiveness, adoption, implementation, and maintenance (re-aim) framework.

Eligibility criteria:
inclusion criteria: * patients of enrolled providers aged 15-65 years * presenting for preventive care (i.e., well-woman exam, sexually transmitted infection testing, pre-conception counseling, or birth control). exclusion criteria: * pregnant and has established prenatal care, i.e., visit is for prenatal care * non-english or non-spanish speaking * living with hiv * unable to complete the ehxform

Keywords: hiv prevention prep cis-gender women
prevalence and predictors of proton pump inhibitor partial response in gastroesophageal reflux disease in systemic sclerosis

Conditions: Systemic Sclerosis; Gastroesophageal Reflux; Proton Pubm Inhibitor

Summary: proton pump inhibitor (ppi) twice daily dosing regimen-a standard dose therapy for gastroesophageal reflux disease (gerd)-is an effective therapy for uncomplicated gerd in systemic sclerosis (ssc) but there is no data of response rate of standard dose of ppi and predictors of ppi-partial response (ppi-pr) gerd in ssc.objectives of the study were to determine the prevalence of omeprazole partial response gerd in ssc and to define the predictors of ppi-pr gerd in ssc. adult ssc patients having gerd were treated with omeprazole 20 mg twice daily 30 minutes before meal for 4 weeks. severity of symptom-grading by visual analogue scale (vas) and frequency of symptoms by frequency scale for symptoms of gerd (fssg) were assessed at baseline and 4 weeks after treatment. ppi-pr gerd was defined by less than 50% improvement in vas of severity of symptom and acid reflux score by fssg after treatment compare to baseline.


Eligibility criteria:
inclusion criteria: 1. ssc patients aged between 18 and 65 years. 2. clinically diagnosed as gerd 3. must not receive any ppi or prokinetic drug within 2 weeks before baseline evaluation exclusion criteria: 1. pregnancy or lactation 2. previous history of gastroesophageal surgery or endoscopic therapy due to severe erosive esophagitis 3. present of barrett's esophagus 4. bedridden and confined to no self-care 5. evidence of active malignant disease 6. present of uncontrolled or severe medical problems such as asthma, angina, hepatic or renal diseases 7. present of active infection that needs systemic antibiotic 8. allergic history of omeprazole 9. receiving prohibit co-medications that may have drug interaction or attenuate gerd symptoms such as tetracycline, ferrous salt, digoxin, isoniacid, oral bisphosphonate
feasibility and reliability of ultrasound in acute burns.

Conditions: Burns

Summary: this trial investigates the feasibility and reliability of different ultrasound protocols to determine quadriceps muscle architecture in acutely admitted burn patients. the results of this trial will provide more clarity as to whether ultrasound can be used as a bedside tool to monitor muscle wasting.

background despite the ubiquity of muscle wasting following burns, practical and accurate tools to measure the degree of muscle wasting are lacking in burn care. ultrasound has been used for this purpose in the critically-ill population and has shown to be valid and reliable. whether this can be extrapolated to the burn population, however, remains unclear. open wounds, fluid status, and uncertainty regarding which protocol to use are amongst factors that complicate the use of ultrasound during the acute phase of burns. aim this study examines the reliability and feasibility of ultrasound measures in the acute burn setting comparing different techniques and locations of application. methods burned adults were assessed at admission in two belgian burn centers by two trained assessors using b-mode ultrasound with a linear transducer. ultrasound-derived variables included quadriceps muscle layer thickness (qmlt) and rectus femoris cross-sectional area (rf-csa) on both thighs. both maximum and minimum compression techniques were used for qmlt, while rf-csa was determined by minimum compression only. qmlt was measured at a proximal and distal location on the thigh, and rf-csa was measured at the most proximal location possible where the entire muscle belly still remained visible.

Eligibility criteria:
burn subjects: inclusion criteria: * ≥10 - ≤80 %tbsa * burn depth: 2nd deep / 3rd degree exclusion criteria: * electrical burn (except flash burns) * associated injury: fracture lower limb * diabetes mellitus type 1 * central / peripheral neurological/neuromuscular disorders (interfering with exercise) * cognitive / psychological disorders (interfering with cooperation) * cardiopulmonary disease (interfering with exercise safety) * pregnancy * palliative care healthy subjects: * none

Keywords: burns ultrasound muscle wasting muscular atrophy reliability feasibility
intraoperative ultrasound guided glioma surgery; a randomised, controlled trial.

Conditions: Glioma

Summary: the main goal of high grade glioma (hgg) surgery is to achieve gross total resection (gtr) without causing new neurological deficits1-8. intraoperative navigated high resolution ultrasound (us) is a promising new tool to acquire real-time intraoperative images to localize and to resect gliomas9-12. the aim of this study was to investigate whether intraoperative guided surgery leads to a higher rate of gtr, when compared with standard non-ultrasound guided surgery.

study design: the us-glioma study is a randomized controlled trial with blinded primary outcome measure. study population: fifty patients with newly diagnosed contrast enhancing presumed high grade glioma on first mri scan. intervention: the study consists of two treatment arms: non-ultrasound guided glioma resection (conventional treatment) versus ultrasound guided glioma resection (intervention) . main study parameters/endpoints: * gross total resection (yes/no) * extent of resection (%) * neurological outcome (karnofsky performance status) * quality of life (eortc qlq-c30 and qlq-bn20 quality of life questionnaire) * surgery associated neurological deficits (national institutes of health stroke scale) * adverse events (classified according to the us national cancer institute common toxicity criteria version 4.0) * survival time (days)

Eligibility criteria:
inclusion criteria: * individuals of 18 years or older * newly diagnosed, untreated, contrast enhancing presumed high-grade glioma * kps ≥ 60 * preoperative intention to perform gross-total resection of the enhancing tumor * written informed consent conform ich-gcp exclusion criteria: * tumours crossing the midline basal ganglia, cerebellum, or brain stem prohibiting gross total resection * multifocal contrast enhancing lesions * pre-existing neurological deficit (e.g. aphasia, hemiparesis) due to neurological diseases (e.g. stroke) * inability to give consent because of dysphasia or language barrier

Keywords: glioma, intraoperative ultrasound, gross total resection, quality of life
y-90 sirt for unresectable hcc larger than 7cm

Conditions: Hepatocellular Carcinoma Non-Resectable

Summary: this is a phase ii clinical study to evaluate the efficacy and safety of sirt in patients with hcc greater than 7 cm. after enrollment, patients received yttrium-90 selective internal radiation therapy. the primary endpoint of the study is objective reponse rate (orr) as assessed by mrecist. secondary endpoints were: objective response rate (orr) as assessed by recist 1.1, disease control rate (dcr), progression-free survival (pfs), time to response (ttr), duration of response (dor), overall survival (os), and safety (incidence and severity of adverse events).


Eligibility criteria:
inclusion criteria: * pathologically confirmed or clinically diagnosed hcc * unresectable hcc as assessed by a team of surgeons * the largest tumor size \> 7 cm * tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment * at least one measurable intrahepatic target lesion * appropriate for sirt treatment after evaluation (including spect/ct evaluation after arterial perfusion with 99tc-maa) * child-pugh score ≤ 7 * ecog ps ≤ 1 * adequate organ and hematologic function with platelet count ≥75×10\^9/l, leukocyte \>3.0×10\^9/l, neutrophil count ≥1.5×10\^9/l, haemoglobin ≥85 g/l, alt and ast≤5×uln, creatinine≤1.5×uln, and prolongation of prothrombin time ≤4 seconds * life expectancy of at least 6 months exclusion criteria: * macrovascular invasion or extrahepatic metastasis * decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy * organ (heart and kidneys) dysfunction * history of other malignancies * uncontrollable infection * history of organ or cells transplantation * history of hiv * pregnant or lactating patients

Keywords: hepatocellular carcinoma yttrium-90 selective internal radiation therapy
preserflo® microshunt extension study

Conditions: Primary Open-angle Glaucoma

Summary: this prospective, concurrent controlled, open-label, multicenter study is designed to collect additional safety data through 5 years of follow-up for subjects randomized to either the treatment arm (preserflo® microshunt with mmc) or the control arm (trabeculectomy with mmc) of the inn-005 clinical study.

the objective of this study is to evaluate the long-term safety of the preserflo® microshunt in subjects with primary open-angle glaucoma who have completed their month 24 follow-up visit in the inn-005 clinical study, by collecting safety data through 5 years post-operative follow-up.

Eligibility criteria:
inclusion criteria: 1. subject has completed their month 24 follow-up visit in the inn-005 clinical study conducted under ide g130028. 2. subject was randomized into the inn-005 study and received the preserflo® microshunt device or trabeculectomy. (subjects who have had the device explanted, or replaced with another device, may be included). 3. subject is willing and able to comply with all study requirements, including signing an informed consent form. exclusion criteria: 1. subject has exceeded the timeframe for the month 60 follow-up visit prior to enrollment for participation in this long-term follow-up study.

Keywords: poag
dzx mediated insulin suppression in obese men

Conditions: Obesity

Summary: the purpose of this study is to determine whether there is an additive effect of metformine on the weight reduction of obese hyperinsulinemic men who are treated with diazoxide.


Eligibility criteria:
inclusion criteria: * male * age 25-50 years * bmi 30-35 kg/m2 * stable body weight during 3 months before the start of the study * glucose \<= 6.0 mmol/l * c-peptide \>= 1.0 nmol/l * hba1c \<= 6.0% exclusion criteria: * comorbidity * medication * serum creatinine \> 120 micromol/l * liver enzymes \> 2 times upper limits of normal * gout * alcohol use \> 2 alcoholic drinks a day * drug abuse * cessation of smoking less than 6 months ago

Keywords: obesity hyperinsulinism diazoxide metformin
cognitive behavioral therapy for paranoia in schizophrenia

Conditions: Paranoid Delusions

Summary: the main objective of this study is to determine the preliminary efficacy of paranoia-focused cognitive behavioral therapy (pfcbt) relative to standard care in the treatment of persecutory delusions in patients diagnosed with schizophrenia or schizoaffective disorder.

paranoia-focused cognitive behavioral therapy (pfcbt) is a manualized intervention that combines group and individual modalities to reduce paranoia-biased information-processing and social avoidance, and to increase insight and reality testing capacity. this is a randomized controlled clinical trial. twenty four adults ages 18-65 with the primary dsm-iv schizophrenia and schizoaffective disorder and drug-refractory persecutory delusions will be recruited from outpatient clinics in new york city metropolitan area. participants will be randomly assigned to either experimental or control group. the experimental group will receive pfcbt in addition to standard care and the control group will receive standard care alone. pfcbt will include participation in one group session and one individual therapy session weekly over the 15 weeks. the preliminary efficacy of the intervention will be evaluated using standardized measures by blind evaluators conducted at baseline, post-treatment, and at 6-months post-termination follow-up.

Eligibility criteria:
inclusion criteria: * age 18 to 65 years * met dsm iv diagnostic criteria for schizophrenia or schizoaffective disorder, confirmed by the clinical structural diagnostic interview (scid, first et al, 1997) -reported persistent and distressing paranoid delusion(s); * a minimum severity score of 4 point persecution subscale on the positive and negative syndrome scale (panss) * had an adequate trial (6 months or more) and were stabilized on antipsychotic medications (no change in psychiatric medication prescribed in the last month exclusion criteria: -substance misuse or medical disorder identified as the primary cause of delusions

Keywords: psychosis paranoia cognitive behavioral therapy delusions group therapy
efficacy of addition of naproxen in the treatment of critically ill patients hospitalized for covid-19 infection

Conditions: COVID-19

Summary: the symptoms of respiratory distress caused by covid-19 may be reduced by drugs combining anti-inflammatory and antiviral effects. this dual effect may simultaneously protect severely-ill patients and reduce the viral load, therefore limiting virus dissemination we want to demonstrate the superiority of naproxen (anti-inflamatory drug) treatment addition to standard of care compared to standard of care in term of 30-day mortality.

coronavirus disease 2019 (covid-19) is due to sars-cov-2 infection. (1,2) the exacerbated inflammatory response in covid-19 infected critically ill patients calls for appropriate anti inflammatory therapeutics combined with antiviral effects. thus, drugs combining anti-inflammatory and antiviral effects may reduce the symptoms of respiratory distress caused by covid-19. this dual effect may simultaneously protect severely ill patients and reduce the viral load, therefore limiting virus dissemination. naproxen, an approved anti-inflammatory drug, is an inhibitor of both cyclo oxygenase (cox-2) and of influenza a virus nucleoprotein (np). the np of coronavirus (cov), positive-sense single-stranded viruses, share with negative-sense single-stranded viruses as influenza the ability to bind to- and protect genomic rna by forming self-associated oligomers in a helical structure with rna. naproxen was shown to bind the influenza a virus np making electrostatic and hydrophobic interactions with conserved residues of the rna binding groove and c terminal domain. (3) consequently, naproxen binding competed with np association with viral rna and impeded the np self-association process which strongly reduced viral transcription/replication. this drug may have the potential to present antiviral properties against sars-cov-2 suggested by modelling work based on the structures of cov np. the high sequence conservation within the coronavirus family, including severe acute respiratory syndrome (sars-cov) and the present sarscov-2 coronavirus allows to perform this comparison. (4) a recent clinical trial shown that the combination of clarithromycin, naproxen and oseltamivir reduced mortality of patients hospitalized for h3n2 influenza infection. (5). inappropriate inflammatory response in codiv-19 patients was demonstrated in a recent study where intensive care unit (icu) patients had higher plasma levels of il2, il7, il10, gscf, ip10, mcp1, mip1a, and tnf? compared with non-icu patients.(2) we suggest that naproxen could combine a broad-spectrum antiviral activity with its well-known anti inflammatory action that could help reducing severe respiratory mortality associated with covid-19.

Eligibility criteria:
inclusion criteria: * covid-19 infected patient * age 18 years or older * presence of pneumonia * pao2/fio2 \ 50% * medical insurance exclusion criteria: * presence of do-not-resuscitate order * pregnancy * prisoners * known naproxen allergy or intolerance * severe renal failure

Keywords: covid-19 sars-cov-2 naproxen nonsteroidal anti-inflamatory drug