Kornimate/medical-research-clean huggingface dataset:
does iv acetaminophen reduce opioid requirement in pediatric patients with acute sickle cell crises?

Conditions: Sickle Cell Anemia Crisis

Summary: the purpose of this study is to determine whether iv acetaminophen can decrease the need for subsequent opioid administration in the acute management of sickle cell crisis pain in the pediatric emergency room.

this is a single-center, prospective, randomized, double-blinded, controlled study in an academic urban pediatric emergency department of children with sickle cell disease presenting with acute sickle cell crisis pain between ages of 4 to 16 years, with a pain score of 6/10 or higher on the wong-baker modified faces pain scale. in order to detect a difference of 0.2 mg/kg in cumulative dosage of morphine (at our institution, 0.3 mg/kg morphine deems an inpatient admission for parenteral pain management) with 80% power and alpha of 0.05, we calculated a sample size of 33 patients in each group. all patients will receive iv ketorolac and iv morphine. patients will be randomized to receive iv acetaminophen or iv saline (volume-equivalent). pain scores will be obtained at baseline, and again at 30 minutes, 60 minutes, 90 minutes, and 120 minutes after medication administration. cumulative morphine dosing, rates of admission, and rates of adverse effects of morphine will also be analyzed. our primary objective is to decrease the need for subsequent opioid administration. our secondary objectives are to determine if iv acetaminophen decreases pain score at 30 minutes, 60 minutes, 90 minutes, and 120 minutes, decreases the rate of admissions, and decreases the rate of adverse effects from opioids.

Eligibility criteria:
inclusion criteria: * any patient age 4-16 years with sickle cell disease who presents the pediatric er with acute sickle cell pain crisis with a pain of 6/10 or higher exclusion criteria: * patient with fever (38c or 100.4f) * patient less than age 4 years * patient greater than age 16 years * patient with hypersensitivity/allergy to either morphine, nsaids, or acetaminophen * patient received acetaminophen within the past 4 hours * patient with known liver disease or renal disease * patient not requiring iv morphine (pain score 5/10 or less) * patient enrolled in the study within the past 72 hours

Keywords: sickle cell acetaminophen in pain crises opioid-sparing
evaluation of a neurostimulation device for insomnia: a randomized trial

Conditions: Insomnia; Insomnia Chronic; Sleep

Summary: examine the safety and effectiveness of the fisher wallace cranial electrotherapy stimulator device (ces) for the treatment of insomnia characterized by difficulties with sleep maintenance using a 20-minute treatment right before bedtime.


Eligibility criteria:
age greater than or equal to 21 us resident can receive packages to their home via ups/fedex/usps read/write english insomnia severity index score greater than 14 diagnosis of insomnia by a medical physician subjects with a generalized anxiety diagnosis will be excluded have not contemplated suicide in the past year not been institutionalized for mental health issues. not currently being treated for or suspect a mental health issue not currently experiencing problems with alcohol or drug abuse can commit to not drinking alcohol 4 hours before bedtime for the duration of the study not taking medications affecting the nervous system (e.g. psychiatric medications) not taking hypnotics or any sleep aid or marijuana (in any form) can commit to one (1) 20 minute session per day for 8 weeks has not used a brain stimulation treatment in one year no suspected or known history of heart disease no pacemaker, or any form of medical electronics, including but not limited to a deep brain stimulator, electronic stent, etc. not under medical supervision for other serious medical condition not taking opioids no pain or headaches that interrupt sleep not participating in any other sleep study not experiencing restless leg syndrome no nickel allergy no sleep apena as measured by stop-bang assessment
vr and script training of pwa

Conditions: Aphasia, Acquired; Chronic Stroke

Summary: the goal of this intervention study is to investigate the effects of immersive virtual reality in rehabilitation of language and communication of individuals with post-stroke aphasia. the main research questions are: 1. is vr-based script training a feasible treatment to cantonese-speaking pwa? 2. will vr-based script training, when compared to conventional script training, better enhance treatment outcomes in functional communication of pwa? participants will be assessed before, in the middle of, immediately after treatment and 8-week post treatment in terms of their performance on: 1. accuracy and time for producing trained scripts. 2. accuracy and time for producing un-trained scripts 3. standardized aphasia test on severity of language impairment 4. standardized aphasia test on functional communication the participants will be randomly allocated to receive one of the treatment: 1. virtual reality-based computerized script training; or 2. computerized script training without virtual reality researchers will compare the treatment outcomes of the two treatment conditions and see if treatment with virtual reality would better promote outcomes when compared to training without virtual reality.


Eligibility criteria:
inclusion criteria: 1. a stroke onset more than six months, with an aphasia quotient (aq) below 96.4, as evaluated by the cantonese version of western aphasia battery (cab; yiu, 1992), 2. premorbid fluent cantonese speakers, 3. aged between 30 and 80 years, 4. no reported progressive neurogenic disorders such as dementia or parkinson's disease, 5. no motor speech disorders of moderate to severe level, and 6. normal or corrected-to-normal vision and hearing functions exclusion criteria: 1. concurrent participation in other aphasia treatment trials, and 2. incompatibility with immersive vr exposure such as complains of nausea, headache, or other severe discomforts during trial use of a head-mounted device during screening.

Keywords: functional communication randomized study script training immersive virtual reality aphasia intervention
monocyte activation in preclinical atherosclerosis

Conditions: Atherosclerosis

Summary: the study of proinflammatory and anti-inflammatory cytokines and chemokines expression profiles in human monocytes to identify new effective biomarkers that have the best diagnostic potential in asymptomatic atherosclerosis.

this project is the first step in creating a method for assessing an individual activity of macrophages. the problems addressed in the project are socially significant because of the high incidence of life-threatening diseases and their effects in the population. the method of evaluation of monocyte-macrophages activity in human blood will be based on the analysis of expression of cytokines and chemokines - markers of inflammatory and anti-inflammatory activity of macrophages. the most informative panel of cytokines and chemokines obtained during the project can be further used to create effective diagnostic tests.

Eligibility criteria:
inclusion criteria: * men and women aged 40 to 74 years * arterial normotension or mild arterial hypertension (systolic blood pressure \<160 mm hg, diastolic blood pressure \<90 mm hg) * absence of chronic diseases demanding permanent drug administration (more than 2 month per year) exclusion criteria: * personal history of transient ischemic attacks * personal history of chronic diseases demanding permanent drug administration (more than 2 month per year) * personal history of life-threatening diseases * indications for surgical treatment of atherosclerotic lesions localized in the extracranial brachiocephalic system

Keywords: proinflammatory cytokines anti-inflammatory cytokines human monocytes activation biomarkers asymptomatic atherosclerosis
premedication trial for tracheal intubation of the neonate

Conditions: Premedication; Endotracheal Intubation

Summary: multicenter double blind randomized controlled trial comparing "atropine+propofol" vs "atropine+atracurium+sufentanil" as a premedication prior to endotracheal intubation of the neonate. primary outcome: pulse oxymetry value \< 80% for more than 60 seconds. secondary outcomes: number of attempts, duration of the procedure, changes in physiologic parameters, short- and long-term neurodevelopmental outcome. hypothesis: "atropine + propofol" compared to "atropine+atracurium+sufentanil" will significantly reduce the frequency of severe hypoxemia.


Eligibility criteria:
inclusion criteria: * corrected age \< 45 weeks of gestational age * currently hospitalized in a neonatal intensive care unit * requiring semi-urgent or elective intubation * equipped with a reliable and permeable iv line * parental consent exclusion criteria: * lack of parental consent * parental refusal * sedative or anesthetic treatment in the previous 24 hours * hemodynamic compromise defined as mean blood pressure\ 3 seconds * upper airway malformation * life-threatening situation requiring immediate intubation * inclusion in another trial not permitting any other participation * impossibility to establish venous access * any contra-indication to any experimental drug

Keywords: pain newborn anaesthesia opioids propofol neuromuscular blocker atropine
efficacy of trazodone to treat insomnia in older adults (tradition study)

Conditions: Insomnia Chronic; Older People; Drug Therapy

Summary: this study aims to evaluate how effective trazodone is in treating insomnia in adults aged 65 years and older. the main question it aims to answer is : - is trazodone more effective than a placebo in reducing the severity of insomnia symptoms in older adults? participants will : * take 25 to 50 mg of trazodone or a matching placebo before bed for 28 days. after a 2-week break, they will then take the other medication for another 28 days. * visit the clinic three times for checkup and test * complete a sleep diary and wear an actimeter during the night.


Eligibility criteria:
inclusion criteria: * individuals aged 65 or older in an outpatient setting * insomnia according to the criteria of the icsd-3r exclusion criteria: * contraindication to trazodone (hypersensitivity) * presence of a ventricular cardiac arrhythmia (e.g., torsades de pointes) * recent myocardial infarction (\< 6 months) * substances that may alter sleep (hypnotics or any other medication intended to induce sleep, such as mirtazapine or quetiapine, corticosteroids, melatonin, psychostimulant drugs) * active, unstable psychiatric disorder * initiation or titration of an antidepressant within the past 6 months * cognitive-behavioral therapy ongoing or planned during the study period * major neurocognitive disorder (ncd) moderate or severe, or other cognitive disorders that may prevent the participant from being able to participate in the study, according to the judgment of the evaluating physician * parkinson's disease * priapism * known angle-closure glaucoma * symptomatic restless leg syndrome \> 3 times per week * qtc interval \> 500 ms * parasomnias, dyssomnias other than insomnia * severe sleep apnea with ahi \> 30 without cpap treatment * use of a monoamine oxidase inhibitor * use of a strong cyp 3a4 inducer or inhibitor * hospitalized individuals * seizure within the past 6 months * history of orthostatic hypotension * history of delirium within the last 6 months * consumption of \> 14 alcoholic drinks per day or use of alcohol to induce sleep.

Keywords: insomia trazodone older adults randomized controlled trial
a study of tanespimycin (kos-953) in patients with multiple myeloma in first relapse

Conditions: Multiple Myeloma

Summary: this is a phase 3, open label trial for patients with multiple myeloma in first relapse. trial will compare tanespimycin (kos-953), in combination with a fixed dose of bortezomib versus bortezomib alone.

phase 3 combination study comparing tanespimycin (kos-953) plus bortezomib to bortezomib alone in patients with multiple myeloma in first relapse after failure of previous anti-cancer therapy and/or bone marrow transplantation. primary objective is to compare the progression-free survival (pfs) associated with the use of tanespimycin (kos-953) in combination with bortezomib versus that associated with administration of bortezomib alone.

Eligibility criteria:
inclusion criteria: * good performance status * documented evidence of multiple myeloma * documented progression of disease after initial response to one line of therapy * measurable disease (serum m-protein \>.5g/dl or \> 200 mg urinary m protein excretion) exclusion criteria: * prior treatment with a heat shock 90 inhibitor or an investigational proteasome inhibitor * known active infections of hav, hbv, hcv, or hiv * administration of chemotherapy, radiation therapy, or immune therapy within 21 days prior to randomization. * acute diffuse infiltrate pulmonary disease or pericardial dise

Keywords: multiple myeloma heat shock protein 90 hsp90 kos-953 17-aag bortezomib first relapse tanespimycin time-1
effect of the repeated loading dose of clopidogrel and high dose of clopidogrel continuous therapy on the platelet aggregation inhibition in patients with myocardial infarction undergoing interventional treatment.

Conditions: Acute Myocardial Infarction

Summary: rel-0609 trial's hypothesis is that repeated loading doses of clopidogrel (600 mg) administration in addition to high dose of clopidogrel continuous therapy (150 mg/day) results in higher inhibition of the platelets' aggregation in patients with myocardial infarction undergoing interventional treatment comparing to the standard therapy. such treatment strategy will not cause increased risk of bleeding complications. in many trials treatment with to repeated loading doses of clopidogrel together with high dose of clopidogrel continuous therapy resulted in: mace reduction, improvement of the long term therapy results, lower risk of ischemic complications. currently, data regarding to the results of the above treatment are still limited.

the objectives of the study is: * to evaluate the effect of the repeated loading dose of clopidogrel (600 mg) in addition to high dose of clopidogrel continuous therapy (150 mg/day) on the platelet aggregation inhibition in patients with myocardial infarction undergoing interventional treatment * to evaluate the safety of the repeated loading dose of clopidogrel (600 mg) in addition to high dose of clopidogrel continuous therapy (150 mg/day) in patients with myocardial infarction undergoing interventional treatment

Eligibility criteria:
inclusion criteria: •≥18 years of age, * myocardial infarction with or without st segment elevation, * clopidogrel treatment (confirmed administration of loading dose of 600 mg or chronic therapy of 75 mg/day), * signed written informed consent. exclusion criteria: * prior administration of fibrinolytic therapy and/or gp iib/iiia inhibitors within the last 14 days, * prior administration of prasugrel within the last 14 days, * subject with known hypersensitivity to the active ingredient or other components of the product * increased risk of bleeding complications:bleeding diathesis, thrombocytopenia (platelet count \ 1.6), uncontrolled hypertension (systolic blood pressure \>200 mmhg), major bleeding, trauma or surgery within the last 30 days, * acute renal failure, * acute liver failure, * pregnancy.

Keywords: stemi nstemi clopidogrel areplex rel-0609
utilization of genomic signature as decision-making for adjuvant treatment of breast cancer

Conditions: Breast Cancer

Summary: method: this multicentric prospective cohort is composed of patients with no metastatic breast cancer selected by tumor's genomic analysis and treated by chemotherapy with anthracycline without taxanes (6 cycles of fec 100). the patient can be included before or after the surgery and a written consent must be signed for the proteomic and genomic analysis of the tumor. patients who have a "good signature" for the genomic analysis will receive the standard chemotherapy. primary objective: * to compare metastasis free survival at 5 years in a cohort of patients with no metastatic breast cancer, who are selected by their genomic profile of the tumor and received a standard chemotherapy containing anthracycline, with result of retrospectives studies. secondary objectives: * overall survival. * creation of a circuit (transport-extraction-genomic analysis-result) which allows the beginning of the chemotherapy within 6 weeks following the primary surgery. * histological and seric proteomic exploratory studies.


Eligibility criteria:
inclusion criteria: * women aged between 18 and 70 * patient with life condition \< 2 (who scale) * one-sided breast adenocarcinoma with a histological evidence (all type) * clinical presentation which allowed a complete surgery with healthy limits * absence of metastasis detectable at clinical examination or radiology * histological evidence for homolateral axillary ganglionic invasion, whatever is the number of node invaded (n \> 1) * the beginning of the chemotherapy within 6 weeks following the primary surgery exclusion criteria: * all metastatic affect * tumor classed \>= t4a: cutaneous invasion, deep adherence, inflammatory breast * all chemotherapy, hormonotherapy or radiotherapy before surgery * tumoral residue not removed * any suspect clinic or radiologic lesion, in the contralateral breast, which is not controlled * history of invasive neoplasm, mammary or other (except in situ carcinoma of cervix uteri and epithelioma)

Keywords: genomic signature lymph nodes no metastases
automated sperm sample preparation protocol

Conditions: Infertility

Summary: this clinical trial would be directed at determining the effectiveness of an innovative sperm sample preparation protocol for intrauterine insemination (iui). the goal of the protocol would be to enable clinics not performing iui to be able to perform iui without requiring specialized training in sperm sample preparation.

nanonc proposes an automated system for sperm sample preparation that will take in raw ejaculate and output a purified sperm population in an iui syringe in less than 15 minutes. the iui syringe will be detachable from the rest of the system. during the 15 minutes, the clinician will not need to perform any actions; as the system will run all of the sample processing steps in an automated fashion. furthermore, the system will have a footprint of a small desktop printer that is portable to be conveniently placed on a bench in clinical setting. a portable system that performs automated isolation of sperm from ejaculate will revolutionize sperm processing and increase access to sperm sample preparation. additionally, the system will decrease cost, time and skill required to process sperm, and potentially improve outcomes for patients with low sperm counts. by increasing the yield and precision of sperm isolation and concentration techniques, the investigator's approach has the potential to offer this exact benefit by specifically providing the opportunity for some patients to try less invasive and less expensive procedures.

Eligibility criteria:
inclusion criteria: * any couple with doctor's order for iui with density gradient centrifugation exclusion criteria: * azoospermia
alterations in cd8αβ and cd8αα t cell levels in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: to evaluate the changes in the frequencies of circulating cd4+ and cd4- t cells expressing cd8αα and cd8αβ in peripheral blood of ra patients in comparison with healthy controls. also, to correlate circulating and synovial fluid levels of these cells with disease activity score (das28) and other indices of disease severity.

rheumatoid arthritis (ra) is a chronic, inflammatory, systemic autoimmune disease of the joints . cd4+ t cells are predominant in the synovial tissue with increased number of cd8 effector and memory t cells in synovial fluid and tissue of ra patients . cd8 functions as a dimer; including homodimer cd8αα and heterodimer cd8αβ . cd8αβ is a superior t-cell co-receptor that enhances functional avidity, cd8αα functions as a tcr corepressor to negatively regulate t cell activation . cd8αα t cells are found in human intestine and peripheral blood . cd8αα t cells increased markedly in the lesions of psoriasis where they played a pro-inflammatory role . the lower percentage of cd8αα+ mucosa associated-invariant t (mait) cells was found to be associated with mait cell dysfunction in gut immunity in necrotizing enterocolitis patients . t cells express the cd8β chain either at a high (cd8βhigh) or low density (cd8βlow ). there was a relative increase in cd8βlow cells in patients with sle which were associated with an increased disease activity . double positive (dp) t lymphocytes, include cd4cd8αβhigh and cd4cd8αα t cell subsets in the human blood . dp8α cells decreased in the blood and colonic mucosa of patients with inflammatory bowel disease compared with healthy individuals . cd4cd8αβhigh t cells are present at higher frequencies in some auto-immune diseases . whether cd8αα or cd8αβ t cells contribute to the pathogenesis of ra, has not been clarified so far. investigators hypothesize that, an alteration in the frequency and distribution of these t cell subsets in ra patients might be associated with disease activity

Eligibility criteria:
inclusion criteria: * patients with ra who fulfilled the 2010 european league against rheumatism/american college of rheumatology (eular/acr) revised criteria for ra (12). patients having knee effusion . exclusion criteria: * patients with autoimmune diseases other than ra. patients or controls with tumors, infections, or other severe organ damage.
triglyceride/high-density lipoprotein cholesterol ratio in chronic kidney disease

Conditions: Chronic Kidney Disease

Summary: the triglycerides (tg) to high density lipoprotein cholesterol (hdl-c) ratio is a feature of insulin resistance and an independent predictor of cardiovascular risk. the investigators aimed to evaluate the relationship between tg/hdl-c ratio and the endothelial functions in patients with ckd.

cardiovascular disease (cvd) risk is substantially increased in subjects with chronic kidney disease (ckd).the reasons for the elevated risk of cvd in patients with ckd are not fully elucidated. there is not a good prognostic tool for the prediction of increased cardiovascular risk in ckd. a simple, widely available, relatively inexpensive, and generally reproducible marker to predict the cvd risk in subjects with ckd is needed. the triglycerides (tg) to high density lipoprotein cholesterol (hdl-c) ratio is a feature of insulin resistance and an independent predictor of cardiovascular risk. no study has been performed so far, to evaluate the role of tg/hdl ratio to predict the cvd risk in patients with ckd. this study is designed to evaluate the relationship between tg/hdl-c ratio and the endothelial functions in patients with ckd.

Eligibility criteria:
inclusion criteria: * patients with chronic kidney disease exclusion criteria: * taking drugs that may influence endothelial function * acute infections

Keywords: chronic kidney disease endothelial dysfunction inflammation insulin resistance tg/hdl ratio