Kornimate/medical-research-clean huggingface dataset:
the effect of white noise and pacifier applications on pain and crying time

Conditions: Newborn

Summary: the objective of the study was to determine the effect of white noise and pacifier applications on pain and crying time in newborns during painful interventions. the research was planned experimentally. pacifier application was applied to the newborns, who had undergone surgery, and they formed the control group. white noise and pacifier applications were applied to the newborns, who had undergone surgery, and they formed the experimental group.

data from children's hospitals around the world reveal that pain in pediatric patients from infancy to adolescence is common, under-recognized and undertreated. compared to adult patients, pediatric patients with the same diagnosis receive fewer doses of analgesics, and the younger children are, the less likely they are to receive adequate analgesia in the medical setting. a particularly vulnerable group of patients are infants and newborns. during the day, newborns most frequently experience painful interventions such as heel prick blood collection and peripheral venous catheter placement in the neonatal intensive care unit. within the scope of the research, no research comparing the effectiveness of white noise and pacifier applications was found in the literature review. by examining this information, the effects of two effective methods on pain management and crying time in newborns in the postoperative period were examined in this study.

Eligibility criteria:
inclusion criteria: * birth weight over 1500 grams * having passed the newborn hearing screening test * having a history of previous surgery (excluding brain surgeries) * not using sedative substances (dormicum, fentanyl) * not using opioids * having a full stomach 30 minutes before painful interventions * having permission from their mothers * newborns undergoing blood transfusion only exclusion criteria: being intubated * having hiberbilirubinemia * birth weight below 1500 grams * having cerebral palsy * having hydrocephalus * having spina bifida * having had brain surgery

Keywords: white noise pain crying time newborn
a new mode of action of anti-tnf, reverse signaling, in rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: blood test in rheumatoid arthritis (ra) patients with good response to anti-tumor necrosis factor (anti-tnf) and in patients with moderate or non-response will be done in the month following the evaluation of clinical response to therapy. isolation of mononuclear cells and purification of monocyte by negative selection. cell culture of monocyte in presence or not of anti-tnf for 24 hours and analyze of cd36 (cluster of differentiation antigen 36) expression (principal outcome). for secondary outcomes analyze monocyte phenotype, nrf2 nuclear translocation, and clinical data of patients.


Eligibility criteria:
inclusion criteria: * ra defined according to the american college of rheumatology (acr) 2010 criteria, * treated by anti-tnf + methotrexate, good responders in in one arm, and moderate or non-responders in the other arm according to eular (european ligue against rheumatism) response criteria after three months of treatment exclusion criteria: * contra-indication to anti-tnf * corticosteroid more than 10mg by a day equivalent prednisone, * modification of dmard (disease-modifying antirheumatic drugs) in the last three months * comprehension trouble * factors modifying cd36 -cluster of differentiation antigen 36- expression as diabetes mellitus, kidney disease, hiv

Keywords: reverse signaling anti-tnf
mitigating the pro-inflammatory phenotype of obesity

Conditions: Blood Pressure; Diabetes; Obesity; Insulin Resistance; Diuretics Drug Reactions; Sympathetic Nerve Activity

Summary: the purpose of this study is to examine the hypothesize that 4 weeks of sympathetic nerve activity (sna) inhibition (oral clonidine) will cause a significant reduction in circulating blood concentrations and endothelial cell expression of inflammatory markers (e.g., tnf-α, il-6). our study is a prospective study using a randomized, double-blinded design to test 4 weeks of sna blockade (oral clonidine) compared with a bp-lowering control condition (diuretic, hydrochlorothiazide) or a placebo.

1. using a randomized, double-blinded, parallel-design approach, we hypothesize that 4 weeks of sna blockade (oral clonidine) will cause a significant reduction in expression of inflammatory markers in blood, endothelial cells, and central adipose compared with a bp-lowering control condition using hydrochlorothiazide (hctz) and a separate placebo treatment. 2. determine the extent to which inflammation in the body is caused by elevated sympathetic nerve activity

Eligibility criteria:
inclusion criteria: * male or female, age 18-79 * obese: bmi \> 30 m/kg2 * hypertensive: blood pressure \>130/80 * elevated insulin resistance (homa-ir \> 2.5) * waist circ: \>102 cm (men) and \>88 cm (women) * fasting glucose \< 126 mg/dl * fasting triglycerides \< 250 mg/dl * hba1c \< 6.5% * willing to visit research lab (fairway ctsu) * willing to undergo a blood draw * able to provide written informed consent exclusion criteria: * current use of clonidine or beta-blockers * current smoker or history of smoking in the past 3 months. * hyperlipidemia: fasting triglycerides \> 250 mg/dl * currently taking hypertension medication * history of heart disease (e.g., myocardial infarction, stent, byass, heart attack, stroke, heart failure, valvular heart disease, cardiomyopathy) * history of neurological disorders * history of transplant * actively participating in other studies, except for a registry study.
performance evaluation of different daily disposable multifocal contact lenses

Conditions: Presbyopia

Summary: the objective of the study was to compare the lens performance of two daily disposable multifocal contact lenses.

this was a prospective, randomized, participant-masked, crossover, bilateral dispensing study. each lens type was worn for approximately 3-4 weeks: the lens prescription of each lens type was optimized after a 3-8 days wearing experience, then participants began a 2 week (14-21 day) wear period.

Eligibility criteria:
inclusion criteria: 1. were at least 42 years of age and had full legal capacity to volunteer; 2. had read and signed an information consent letter; 3. self-reported having had a full eye examination in the previous two years; 4. anticipated being able to wear the study lenses for at least 8 hours a day, 5 days a week 5. were willing and able to follow instructions and maintain the appointment schedule; 6. habitually wore multifocal soft contact lenses, for the past 3 months minimum * maximum of 7 participants per site were habitual wearers of daily disposable lenses * maximum of 3 habitual wearers per site of 1-day acuvue moist multifocal * maximum of 1 habitual wearer per site of acuvue oasys max 1-day multifocal * maximum of 3 habitual wearers per site of myday multifocal * maximum of 7 participants per site were habitual wearers of frequent replacement lenses * maximum of 1 habitual wearer per site of acuvue oasys for presbyopia 7. had refractive astigmatism no higher than -0.75dc in each eye; 8. were presbyopic and required a reading addition of at least +0.75d and no more than +2.50d; 9. could be fit and achieved binocular distance vision of at least 20/30 snellen (or +0.20 logmar) which participants also deemed to be 'acceptable', with the available study lens parameters (powers +4.00 to -6.00ds, near addition as per study design) exclusion criteria: a person was excluded from the study if they: 1. were participating in any concurrent clinical or research study; 2. had any known active ocular disease and/or infection that contraindicated contact lens wear; 3. had a systemic condition that in the opinion of the investigator may have affected a study outcome variable; 4. were using any systemic or topical medications that in the opinion of the investigator may have affected contact lens wear or a study outcome variable; 5. had known sensitivity to the diagnostic sodium fluorescein to be used in the study; 6. self-reported as pregnant, lactating or planning a pregnancy at the time of enrolment; 7. had undergone refractive error surgery or interocular surgery.
efficacy study of a sensory feedback knee orthosis in patients suffering from unoperated severe knee sprain

Conditions: Sprain

Summary: ortheses are commonly used for the repair of damage to the musculoskeletal system. however, immobility, by itself, causes serious side effects that require long and costly rehabilitation. the sensory feedback ortheses allow to artificially maintain the proprioceptive and tactile flow in order to maintain the activity of their host brain areas and thus reduce significantly the usual therapy duration. the clinical study orthosens will evaluate the efficacy and safety of the sensory feedback ortheses.


Eligibility criteria:
inclusion criteria: * patients agreeing to participate in the study and who signed informed consent. * indication of bracing immobilization for 6 weeks following a unoperated severe sprain of the knee with partial or total rupture of the anterior cruciate ligament and a peripheral injury, medial or lateral collateral ligament, with or without meniscal lesion. * mri scan confirming the nature of the lesion to be provided during the inclusion visit. * patients whose knee is immobilized for 7 to 15 days in zimmer-like splint. * patients aged from 18 to 65. * patients agreeing to choose their physiotherapist from a list provided by the investigators. * patient (s) with insurance coverage. exclusion criteria: * patients with a bucket handle meniscus tear. * patients with a pentad injury. * patients with osteochondral fragments. * patients with a knee fracture apart from "segond fracture" and "bone bruise". * patients who underwent ligament surgery for the concerned knee. * patients with a bone lesion which may interfere with the knee joint(distal femur, proximal tibia, patella). * patients with any history of rupture of the central pivot (anterior cruciate ligament and posterior cruciate ligament), of lateral ligament planes rupture (medial collateral ligament and lateral collateral) or lateral planes ligament injury without rupture, dating from less than 1 year. * patients whose sprain results from an accident at work. * patients with an inability / unwillingness to follow protocol requirements. * patients for whom there would be no suitable brace size in the thuasne range. * patients participating in another clinical study or who have tested an experimental drug within 30 days prior to study entry. - patients with another disease which, according to the investigator, may interfere with the results or the conduct of the trial and thus justify their non-inclusion in the study.

Keywords: unoperated severe sprain of the knee with partial or total rupture of the anterior cruciate ligament and medial or lateral collateral ligament
effect of blueberry supplementation on alzheimer's biomarkers

Conditions: Mild Cognitive Impairment; Alzheimer Disease

Summary: the purpose of this study is to study the effects of blueberries on neuronal, glial, and pathology blood biomarkers in mild cognitive impairment (mci) and to estimate sample size for future confirmatory studies. the blood biomarkers to be measured are neurofilament light (nfl), glial fibrillary acidic protein (gfap), aß40, aß42, p-tau181, and cytokines, using an ultra-sensitive state-of-the-art immunoassay.

after determining subject eligibility and after subjects have abstained from consuming all berry fruits (including red wine) for 2 weeks, subjects will have blood drawn for biomarkers and will then will undergo 12 weeks of blueberry supplementation in the form of 18 grams lyophilized blueberry powder mixed with water and taken twice daily with meals. all subjects will be asked to abstain from berry fruits (including red wine) for the duration of the 12 week trial. subjects will receive telephone calls at 4 and 8 weeks to check compliance as well as concomitant medications and adverse events and then all subjects will return at 12 weeks for a repeat biomarker blood draw. plasma nfl, gfap, aβ40, aβ42, p-tau181, and cytokine biomarker assays will be done using the quanterix sr-x instrument, a new, state-of-the-art digital immunoassay platform employing simoa technology, which enables the detection and quantification of biomarkers previously difficult or impossible to measure.

Eligibility criteria:
inclusion criteria: 1. 55 to 85 years old inclusive 2. meets criteria for amnestic mild cognitive impairment defined by education adjusted performance on the wechsler memory scale (wms) iii logical memory delayed recall score and clinical evaluation. 3. medically stable exclusion criteria: 1. dementia 2. significant confounding active neurological/psychiatric disease 3. participation in an experimental investigational drug trial in the past 30 days 4. unwilling to restrict consumption of anthocyanin-rich foods 5. inability to complete cognitive testing (e.g. significant visual or hearing impairment) 6. allergy or intolerance to blueberries 7. significant gastrointestinal disorders or surgery that influences digestion and absorption 8. presence of unstable, acutely symptomatic, or life-limiting illness 9. women of childbearing potential

Keywords: mci biomarkers memory loss
phase iia study of nimotuzumab to treat colorectal cancer

Conditions: Colorectal Cancer

Summary: nimotuzumab is an igg1 humanized monoclonal antibody that recognized an epitope located in the extra cellular domain of the human epidermal growth factor receptor (egfr). clinical efficacy has been shown in adult with head and neck cancer. the study assessed the safety, and efficacy of the combination of nimotuzumab administered concomitantly with chemotherapy in patients with advanced colorectal cancer.

nimotuzumab and irinotecan will be administered to the patient until disease progression or development of toxicity preclude further treatment. irinotecan will be administered once every 14 days, the dosage is 180mg/m2; nimotuzumab treatment be divided 3 levels: 200mg/w, 400mg/w, 600mg/w, weekly. the patients'blood test and liver and renal function tests will be monitored weekly, a physical exam and reassessment of the tumor will be performed and every 6 weeks, when the total result is the cr or pr, the result of the 6th and the 12th week should be compared.

Eligibility criteria:
inclusion criteria: * informed consent form signed before performing any of the study's specific procedures. * ecog performance status 0-2. * age \> 18，both genders. * metastatic colorectal cancer confirmed by pathology, or locally advanced unresectable colorectal cancer, or postoperative recurrence and metastasis colorectal cancer * disease progression after receiving oxaliplatin ± fluorouracil in first-line treatment * at least 1 measurable lesions ,( longest diameter≥ 1 cm by spiral computed tomography (ct) scan or mri) * life expectancy more than 3 months. * k-ras is wild type * use of an effective contraceptive method for patients of both sexes when there is a risk of conception and/or pregnancy. * liver metastasis, lesions smaller than 50% of the liver; lung metastasis, lesions smaller than 30% of the lung * haemoglobin≥90g/l , granulocyte≥1.5×109/l ,wbc ≥3×109/l, platelet count≥100×109/l * tbil≤ 1.5 x uln ,alk≤ 2.5 x uln or ≤ 5uln（liver metastasis），ast and alt≤ 2.5 x uln or ≤ 5uln（liver metastasis）,creatinine ≤ 1.5 x uln * no brain metastasis exclusion criteria: * previous radiotherapy at lesions within three months * other first line chemo-agents treatment except oxaliplatin ± fluorouracil * received other anti egfr monoclonal antibody treatment * complete or incomplete intestinal obstruction * participation in other interventional clinical trials within 1 month * psychiatric disease affected cognitive ability, including brain metastasis * peripheral neuropathy lesion is more than i stage. * history of serious allergic or allergy * pregnant or breast-feeding women * patients with the history of serious lung or hear disease * other malignant tumor

Keywords: nimotuzumab colorectal cancer chemotherapy
study to assess the safety of azd1480 in patients with myeloproliferative diseases

Conditions: Primary Myelofibrosis (PMF); Post-Polycythaemia Vera; Essential Thrombocythaemia Myelofibrosis

Summary: this study is being conducted to test study drug azd1480 to see how it may work to treat myeloproliferative diseases. the main purpose of this study is to determine the safety and tolerability of azd1480. this is the first time the drug has been given to humans and is classed as a first time in man study. its main purpose is to establish a safe dosage of the drug and provide additional information on any potential side effects this drug may cause. the study will also assess the blood levels and action of azd1480 in the body over a period of time and will indicate whether the drug has a therapeutic effect on myeloproliferative diseases.


Eligibility criteria:
inclusion criteria: * patients with myelofibrosis requiring therapy * evidence of post-menopausal status or sterile * ecog performance status \</=2 exclusion criteria: * prior therapy with any jak2 medications * significant lung disorder or lung disease * previous radiation therapy to chest wall or chest infection requiring antibiotic treatment within 28 days before study screening * eye disease of the cornea * patients requiring oxygen supplementation * ejection fraction \ 40 mm hg (by echo/doppler) * forced expiratory volume (fev1)/forced vital capacity (fvc) \ 130% predicted * diffusing capacity of the lung for carbon monoxide (dlco) corrected for hemoglobin \<60% predicted, oxygen saturation \<88% at rest or after a 6-minute flat walk, without supplemental oxygen * chest infection requiring antibiotics within 7 days of the first dose of investigational product.

Keywords: primary myelofibrosis (pmf) post-polycythaemia vera/essential thrombocythaemia myelofibrosis (post-pv/et mf) myeloproliferative diseases phase i phase ii bone marrow
comparison of early caries detection in children utilizing an electrical conductance device and the gold standard of visual-tactile technique.

Conditions: Dental Caries in Children

Summary: the purpose of this study is to evaluate a methodology for detecting early forming cavities in children that is more accurate and reliable than the gold standard used by dentists around the world. the new method uses an electrical current device to detect early enamel mineral loss before it can develop into a cavity. the manual gold standard is for a dentist to probe the surfaces of the teeth with a fine pick, searching for areas of defect.


Eligibility criteria:
inclusion criteria: children whose parents authorize participation by signing a consent form. children who attend public school only. children in good health. children between 6 and 9 years of age. children with all first permanent molars erupted. all permanent first molars must not have any signs of cavitation but only one molar can have some mineral loss(e.g. white spots). children must show some caries in the primary molars as a sign of caries susceptibility. - exclusion criteria: children of parents or a guardian who do not agree to participate in the study. children registered in private schools. children not in good health. children undergoing antimicrobial or antibiotic treatment. children outside the range of age selected for the study. children with one or more first permanent molars unerupted. children with any cavitation in the occlusal surface of any first permanent molar. children who do not have a sign of dental caries in the primary molars as a sign of caries susceptibility. children who do not allow themselves to be examined. -
comparison of percutaneous image-guided gastrostomies

Conditions: Cancer of Head and Neck

Summary: percutaneous image-guided gastrostomy (pig) is an increasingly popular technique of creating gastroenteric access through the anterior abdominal wall for nutrition and/ or compression. large-bore mushroom-retained catheters via the pull technique and small-bore cope loop catheters via the push technique are both used at interventional radiology for pig at our institution. to date, there is no guideline for pig and no direct comparison of two pig techniques. the proposed pilot study is to compare the two different types of pig techniques in head and neck cancer patients who require prophylactic enteral feeding by pig. the purpose of the study is to assess the feasibility of a large randomized clinical trial to compare these two pig techniques.


Eligibility criteria:
inclusion criteria: 1. male or female ≥18 years; 2. life expectancy \> 6 months; 3. diagnosed with head and neck cancer; and 4. scheduled to have prophylactic enteral feeding by percutaneous image-guided gastrostomy performed in the interventional radiology suite. exclusion criteria: 1. pregnancy; or 2. established pharyngeal obstruction and/or presence of an enteral feeding device.

Keywords: head and neck cancer percutaneous image-guided gastrostomy pain quality of life complication
i-zip ocular bandage pivotal study

Conditions: Cataract

Summary: to evaluate the safety and performance of the i-zip ocular bandage in subjects undergoing uneventful unilateral clear corneal phacoemulsification with foldable monofocal intraocular lens (iol) implantation compared with the oasis 24-hour soft shield collagen corneal shield (oasis medical, inc. glendora, california) for providing ocular protection and relief of pain or discomfort in the acute post-operative period.


Eligibility criteria:
inclusion criteria: * subject has a cataract and is expected to undergo unilateral clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber monofocal intraocular lens through an incision ≤ 3.5mm in width measured after iol implantation using internal calipers. exclusion criteria: * any intraocular inflammation in the study eye that was present during the screening slit-lamp examination or presence of ocular pain in the operative eye as rated on the pre-operative nrps * previous surgery (laser or incisional) or ocular trauma to the operative eye or planned multiple procedures during cataract/iol implantation surgery * potential bcva in fellow eye worse than 20/40 as assessed by the clinical investigator * active or history of chronic or recurrent inflammatory eye disease (iritis, scleritis, uveitis, iridocyclitis, rubeosis iritis), evidence of acute external ocular infections, intraocular infection, dysthyroid ophthalmopathy, nasolacrimal duct obstruction, active chalazion, uncontrolled blepharitis, uncontrolled and clinically significant dry eye syndrome, anything more than trace guttata (\>10 guttae in the central 6 mm of cornea), evidence of glaucoma/glaucoma suspect, corneal dystrophy or other ocular disease that would interfere with study evaluations * subject is currently receiving antineoplastic therapy * use of topical ocular steroids within 14 days and/or systemic steroids (excluding inhalants) within 30 days prior to surgery. * subject is an insulin-dependent diabetic or has background diabetic retinopathy (bdr), proliferative diabetic retinopathy (pdr) or compromised macular function

Keywords: cataract or intraocular lens placement surgery