Kornimate/medical-research-clean huggingface dataset:
a comparison of patients on avamys ® versus nasonex (a trade mark of schering corporation) and flixonase ® on key health outcome measures

Conditions: Rhinitis, Allergic, Perennial

Summary: previous publications have indicated that allergic rhinitis (ar) patients suffering from both ocular and nasal symptoms have a greater burden of illness and lower quality of life than patients suffering from nasal symptoms alone. fluticasone furoate (ff) acts against both nasal and ocular symptoms. the purpose of this study was to evaluate the differences in symptom control (both perceptually and objectively) and resource use for patients with current seasonal ar.

* allergic rhinitis (ar) is a common inflammatory condition of the upper respiratory tract, nasal cavity and eyes affecting up to 20% of the population in the united states and europe. the bothersome nature of ar symptoms can severely affect daily activities including ability to work and examination performance and impact on quality of life (qol) and psychosocial well being. * this study assesses the impact of fluticasone furoate (ff) on the qol of seasonal allergic rhinitis (sar) patients, including the number of symptom-free days (sfd) and quality of life over the last 4 weeks, and compares this with other inhaled nasal steroids (ins): mometasone furate (mf) and fluticasone proprionate (fp). * selected physicians provide information including a range of demographic, symptom and treatment details for a number of their sar patients. the patient themselves are then invited to provide details about their sar including symptoms, the impact of ar upon their lifestyles, attitudes to treatment and completion of health related quality of life (hrqol) instruments.

Eligibility criteria:
patient inclusion criteria: * current seasonal allergic rhinitis sufferer (based on physician judgement) * currently receiving prescribed ins treatment (no other treatment restrictions apply) * have consumed at least one full prescription on the specified ins treatment * no comorbid asthma or copd diagnosis * informed consent exclusion criteria: * none specified

Keywords: ocular symptoms nasal symptoms allergic rhinitis symptom free days quality of life
non-drug study to evaluate the suitability of neurocognitive tests and functioning scales for the measurement of cognitive and functioning changes in children with down syndrome

Conditions: Down Syndrome

Summary: the aim of this study is to assess the suitability of selected scales (floor/ceiling effects, variability, test-retest reliability) to measure cognitive function in children with down syndrome over 6 months, and to evaluate the influence of covariates such as age, gender or language on these neurocognitive scales.


Eligibility criteria:
inclusion criteria: * males and females aged 6 to 11 with diagnosis of down syndrome (trisomy 21). children may have standard trisomy 21, robertsonian translocation, isochromosome 21 (so called 21q21q robertsonian translocation), down syndrome with reciprocal translocation or mosaicism. * down syndrome children meeting clinical diagnostic criteria for generalized anxiety disorders, autism spectrum disorder, attention deficit and hyperactivity disorder, can participate in the study provided they are considered clinically stable or on stable medication for at least 8 weeks prior to the baseline visit. * parent or legal guardian/representative and caregiver willing to give written informed consent. * subjects with sufficient vision and hearing to engage in study evaluations as referred by their parents. mild hearing loss will be allowed. exclusion criteria: * children who may not be able to comply with the protocol or perform the outcome measures due to significant hearing or visual impairment or other issues judged relevant by the investigators * significant sleep disruption or moderate to severe untreated obstructive sleep apnea. * any condition which would make the individual or the caregiver, in the opinion of the investigator, unsuitable for the study.
err 731® formulation evaluation

Conditions: Menopause

Summary: a comparison of an enteric coated and micro-coated formulation of err 731®

current clinical and commercialization experiences have been with enteric-coated formulations of err 731®. with the demonstrated safety of this formulation and the absence of anthraquinones in the extract, there is interest in launching a micro-coated, but not enteric-coated, formulation to broaden the commercial availability of err 731® in new markets. it is proposed that a double-blinded, randomized cross-over design in a peri-menopausal/menopausal and preferably symptomatic group of women (target population for commercialization) is best suited to demonstrate equivalent tolerability.

Eligibility criteria:
inclusion criteria: * ages 35-64, inclusive, preference given to subjects ages 45-54, inclusive * preference given to symptomatic subjects; symptoms including vasomotor symptoms, mood disturbances, fatigue, myalgias and arthralgias. exclusion criteria: * a serious, unstable illness including cardiac, hepatic, renal, gastrointestinal, respiratory, endocrinologic, neurologic, immunologic/rheumatological, or oncological/hematologic disease. * history of breast or uterine cancers. * known infection with hiv, tuberculosis or hepatitis b or c. * hormone replacement therapy: all formulations of synthetic estrogens, natural estrogens (estrone, estradiol and estriol) and progestins (including natural progesterone) * hormonal contraceptives: all formulations of synthetic estrogens and progestins * botanical formulations - including phytoestrogens and progesterone-mimetic botanicals (rhapontic rhubarb, soy phytoestrogens, hops (8-prenyl naringin) red clover, kudzu, chaste tree berry, licorice, resveratrol, black cohosh, dong quai, etc.) * use of narcotics during the last 30 days * use of anticoagulants during last 30 days * use of corticosteroids during the last 30 days * use of controlled substances (other than marijuana or cbd) on a recreational basis during the last 30 days. * consumption of more than 3 alcoholic beverages per day (one beverage is a 5-ounce glass of wine, 12 ounces of beer, or one ounce of hard liquor) * pregnancy * breast feeding

Keywords: botanical supplement formulation rhapontic rhubarb
remote ischemic preconditioning during lower limb revascularization

Conditions: Ischemic Preconditioning; Acute Kidney Injury; Limb Ischemia

Summary: the aim of this study is to evaluate the role of remote ischemic preconditioning (ripc) in preventing acute kidney injury after lower limb revascularization. remote ischemic preconditioning(ripc) is a simple, cost-free and non invasive procedure (transient upper limb ischemia/reperfusion) that could provide organ protection (heart, brain and kidney) following ischemia injuries.


Eligibility criteria:
inclusion criteria: * patients scheduled for open limb revascularization exclusion criteria: * peripheral vascular disease affecting upper limbs * chronic kidney disease in stage 4 or 5 (egfr\<30 ml/min/1,73m2) * patients underwent contrast-enhanced radiological exams in the previous 7 days * treatment with glibencamide or prostaglandins

Keywords: remote ischemic preconditioning lower limb revascularization timp-2 igfbp-7
study of autologous stem cell transplantation for patients with ischemic stroke

Conditions: Infarction, Middle Cerebral Artery

Summary: this is a open label study to assess the safety of autologous bone marrow transplantation in patients with a ischemic stroke in the middle cerebral artery territory within 90 days from symptoms onset.

objective: the purpose of this study is to evaluate the safety and feasibility of intra-arterial and intravenous injection of autologous bone marrow mononuclear cells in patients in the acute and sub-acute phase (\> 3 and \< 90 days after symptoms onset) of ischemic cerebral infarct in the middle cerebral artery territory. methods: 15 patients with cerebral infarct within the middle cerebral artery territory will be enrolled in this prospective, nonrandomized, open-labeled study. up to 10 patients will receive up to 500x 10 6 autologous bone marrow cells injected intra-arterially into the middle cerebral artery through percutaneous approach. the procedure is monitored by transcranial doppler (tcd) and electroencephalogram (eeg). other 5 patients will receive up to 500x 10 6 autologous bone marrow cells injected intravenously. changes in neurological deficits and improvements in functions will be evaluated at baseline and at regular intervals during follow-up ( 4 months). eeg and neuroimaging exams will be performed at baseline and at regular intervals during the follow-up period.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of ischemic stroke lasting for more than 3 hours and less than 90 days from symptoms onset * neuroimages exams showing ischemic cerebral infarct in the middle cerebral artery territory * age between 18 and 75 years old * nihss between 4 and 20 * spontaneous re-canalization of the middle cerebral artery documented by tcd or mri * signed informed consent exclusion criteria: * difficult in obtaining vascular access for percutaneous procedures * vascular impossibility to reach the middle cerebral artery through percutaneous approach * severe carotid stenosis( \>70%, by doppler) related to the severe stroke * neurological worsening (\>4 points in the nihss ) due to edema or intracerebral hemorrhage * primary hematological disease * neurodegenerative disorder * previous stroke with mrs \> 2 * intracardiac thrombosis * auto-imune disorders * osteopathies that could increase the risk of bone marrow harvesting procedure * thrombophilias * liver failure * chronic renal failure (creatinine \> 2mg/ml) * life support dependence * lacunar stroke * pregnancy * history of neoplasia or other comorbidity that could impact patient's short-term survival * any condition that in the judgment of the investigator would place the patient under undue risk

Keywords: acute stroke middle cerebral artery autologous transplantation bone marrow cells stem cells cell therapy
an investigational drug study in patients with type 2 diabetes mellitus (mk0431-023)

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * patients at least 18 years of age and not older than 75 who have a specific type of diabetes called type 2 diabetes mellitus exclusion criteria: * younger than 18 years of age or older than 75 * any condition, which in the opinion of the investigator, may not be in the patient's best interest to participate
novel approaches of advanced neuroimaging based on mri fiber tracking to detect early signs of vascular cognitive impairment in hypertensive patients

Conditions: Hypertension

Summary: hypertension is the major risk factor for vascular cognitive impairment (vci). one of the main limitations in the clinical approach to vci is that, by the time that it is manifested, it might be too late to reverse the neurodegenerative process. thus, early identification of predictive signs of later dementia is demanding for management of hypertensive patients (ht).this aim claims for new methods that compute in a cloud all possible data sources coming from patients (brain imaging, cognitive profile, clinical data), to extract discriminative aggregate biomarkers. thus, this study aims at: 1) characterizing the predictive potential of an aggregate biomarker for dementia in ht, based on brain imaging, clinical and cognitive assessment; 2) evaluating the impact of blood pressure variability, besides systolic/diastolic blood pressure, on the progression of the aggregate biomarker; 3) assessing whether specific classes of antihypertensive drugs differently affect the progression of the aggregate biomarker. in order to do this, this study proposes to evaluate advanced brain imaging and cognitive profile in a cohort of hypertensive patients, at baseline and after a 1 year follow up, to identify an innovative signature for the development of cognitive dysfunction in hypertension. in particular, the effects of blood pressure variability and of different classes of antihypertensive drugs will be evaluated.


Eligibility criteria:
inclusion criteria: * age ≥ 40 and ≤ 70 years * patients with moderate hypertension * written informed consent exclusion criteria: * previous ima, stroke or tia * arrhythmia or severe cardiac disease * diabetes or renal disease * psychiatric disease * neurological or neurodegenerative disease * dementia * assumption of drugs known to interfere with cognitive function * inability to be subjected mri analysis * participation to other clinical trial, ongoing or terminated less than one month before enrolment in this study.

Keywords: vascular cognitive impairment magnetic resonance imaging blood pressure variability
effect of insulin degludec versus insulin glargine on glycemic variability in patients with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: type 2 diabetes mellitus (t2dm) is characterized by wide fluctuations of glucose. the long-acting insulin has showed to improve glycemic variability however the behavior of insulin glargine versus insulin degludec is unknown.

cross-over, double dummy, randomized, clinical trial was carried out. the sample size was calculated using the formula for clinical trials of mean differences with an "n" of 6 patients per group was obtained. patients between 30 and 65 years of age will be included with t2dm, without hyperglycemic drugs, hemoglobin a1c (a1c) 6.5 to 11.0 % and with written signature consent. they were assigned randomly by sealed envelope either to received insulin degludec (novo nordisk a/s. bagsvaerd, denmark) or insulin glargine (sanofi-aventis deutschland gmbh. frankfurt, germany) \[10 international units (iu) subcutaneous (sc) every 24 hours for six days\], patients who were administered initially insulin degludec corresponded then insulin glargine and vice versa, with a washout period of 14 days between each intervention. the clinical findings and laboratory tests included a metabolic profile and biosafety, which will be made at baseline. body weight, body mass index and blood pressure were performed during the initial visit, likewise, interstitial glucose concentrations by ambulatory continuous glucose monitoring system (guardian®, medtronic minimed, northridge), through which the mean amplitude of glucose excursions (mage) and area under the curve of glucose were calculated, which served to assess the glycemic variability. adverse events and adherence to treatment are documented. statistical analysis: mann-whitney u test, chi2, fisher exact test. it is considered with significance at p \<0.05.

Eligibility criteria:
inclusion criteria: * patients with t2dm without treatment for at least 3 months body mass index (bmi) from 25.0-34.9 kg/m2 diagnosis of t2dm * fasting plasma glucose ≤300 mg/dl at the time of scrutiny * a1c between 6.5 and 11% * written informed consent exclusion criteria: * women pregnant or breastfeeding * untreated thyroid disease and/or uncontrolled hypertension \[≥150 systolic and diastolic ≥90\] * consumption of oral agents or other medications or supplements with proven properties that modify the behavior of glucose. in the case of antihypertensives, these may be included if treatment was not modified previous 3 months and no change during the study. * total cholesterol \>240 mg/dl * triglycerides ≥400 mg/dl * alanine aminotransferase (alt) and aspartate aminotransferase (ast) more than twice the normal range * glomerular filtration rate \<60 ml/min \[cockcroft-gault\]
sad/mad study in healthy subjects and adults with uc to evaluate safety, tolerability, pk, pd of amt-101

Conditions: Ulcerative Colitis

Summary: a randomized, double-blind placebo-controlled first in human study in approximately 36 male healthy subjects and approximately 20 male and female patients with active uc who have had an inadequate response to or demonstrated intolerance to 5-asa.

a randomized, double-blind placebo-controlled first in human study in approximately 36 male healthy subjects and approximately 20 male and female patients with active uc who have had an inadequate response to or demonstrated intolerance to 5-asa. subjects may but are not required to have been exposed to corticosteroids, or immunosuppressive agents. in case the subject has been exposed to any of these treatments, he/she must have had either an inadequate response, failed response or demonstrated intolerance. patients may be 1. naïve to anti-tnfα therapy or 2. have failed or demonstrated intolerance to anti-tnf-α therapy.

Eligibility criteria:
inclusion criteria: part a (healthy volunteers) * male subject in good health as determined by past medical history, physical examination, vital signs, ecg, and laboratory tests at screening * between 18 and 45 years of age, inclusive. * body mass index (bmi) between 18 and 30 kg/m2 (inclusive). part b (adult ulcerative colitis) * male and female patients 18 years and older * documented diagnosis of uc for at least 3 months duration * stable mild to moderate uc, as defined by the following criteria: total mayo score (excluding pga) at least 3 but not greater than 7: * patients must have failed or demonstrated intolerance to aminosalicylates (e.g., 5-aminosalicylic acid, mesalamine) exclusion criteria: part a and part b * known hypersensitivity or allergy to amt-101 or excipient contained in the drug formulation. * clinically significant abnormalities in laboratory test results (including complete blood count, chemistry panel including kidney panel, and urinalysis). part b * clinical findings of crohn's disease * a prior history of surgery for uc * prior use of integrin antagonists (vedolizumab, natalizumab), jak kinase inhibitors (tofacitinib), cyclosporin or tacrolimus
covid-19 in patients with anosmia in egypt

Conditions: Anosmia; Covid19; Dysgeusia

Summary: the study aims to test the frequency of severe acute respiratory syndrome new corona virus sars-cov-2 or other respiratory viruses in patients presenting with anosmia or dysgeusia to ain shams university hospitals, cairo, egypt.

fifty patients presenting to triage and/or ear, nose and throat (ent) clinics in ain shams university hospitals with the chief complaint of anosmia/ dysgeusia in the period july- september 2020; will undergo thorough history taking, clinical assessment and polymers chain reaction rt-pcr to sars-cov2; and if proven negative to covid 19, pcr to other respiratory pathogens will be tested. covid-19 patients will be managed according to the standard protocol of ain shams university hospitals. follow up after 3 weeks for the outcome of recovery of the smell sense and seroconversion by rapid test for immunoglobulins igm/ igg of covid 19, for the probability of a false negative pcr at initial visit. ethical committee approval for the current study protocol was obtained. patients will be invited to participate and the informed consent will be signed.

Eligibility criteria:
inclusion criteria: * adult (\>18 years) patients presented with acute-onset anosmia. exclusion criteria: * patients with anosmia or gustatory dysfunctions before the epidemic; patients with previous history of chronic sinusitis or previous sinus surgery.

Keywords: corona virus sars-cov-2 olfactory disturbance taste disturbance
performance of a new glucose meter system in children and young adults

Conditions: Diabetes

Summary: the purpose of this study is to evaluate the performance of a new blood glucose meter in the hands of children, teens, young adults.


Eligibility criteria:
inclusion criteria: * type 1 or type 2 diabetes * age 4 to 24 years * routinely performs blood glucose testing at home * if age 18 or older at time informed consent is signed, subject must be able to speak, read, and understand english. * if younger than age 18, subject's parent/guardian must be able to speak, read, and understand english, and is able to provide appropriate supervision. * is willing to complete all study procedures, with or without parent / guardian supervision, if appropriate exclusion criteria: * currently pregnant * hemophilia or any other bleeding disorder * taking prescription anticoagulants (such as warfarin or heparin) or has clotting problems that may prolong bleeding. taking plavix or aspirin daily is not excluded * infection with a blood borne pathogen (e.g., hiv, hepatitis) * subject or parent/guardian is employee of competitive medical device company * cognitive disorder or other condition, which in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study
incidence of rhabdomyolysis among patients admitted with jimsonweed ingestions

Conditions: Rhabdomyolysis; Myoglobinuria; Hemoglobinuria

Summary: retrospective chart review to determine the presence of rhabdomyolysis among patients admitted to chmca from 1997-2007 with jimsonweed ingestions and to define possible risk factors predisposing patients to the developement of jimsonweed-associated rhabdomyolysis.


Eligibility criteria:
inclusion criteria: * admitted to chmca between 1/1/1997 to 12/31/2007 with a qualifying icd-9 diagnosis code for rhabdomyolysis, myoglobinuria, and hemoglobinuria (728.88, 791.2, 791.3)or other icd-9 codes identified during the study * between the ages of 0-21 years at diagnosis exclusion criteria: * rhabdomyolysis or serum ck concentrations not actually documented * patient admitted to the burn center * patient \> 21 years of age

Keywords: retrospective chart review jimsonweed ingestion
brazil nuts effects on selenium status and cognitive performance

Conditions: Mild Cognitive Impairment

Summary: some studies reported that selenium status is associated with cognitive function. however only a few reports have investigated whether selenium supplementation can benefit cognitive performance and in most of them selenium supplementation was not exclusive. also, none of those reports have used foods rich in selenium as a source of supplementation. thus, the aim of our study was to investigate whether the consumption of brazil nuts improves cognitive function. we hypothesized that the daily consumption of brazil nuts would have benefits on selenium status, increase antioxidant enzyme activity and improve cognitive function in older adults with mci.

we enrolled older patients with mci who attended the memory and aging unit of the geriatrics division, university of são paulo medical school (brazil). all participants fulfilled the criteria proposed by the international working group on mild cognitive impairment (winblad et al., 2004), which include the following: (1) the person is neither normal nor demented; (2) there is evidence of cognitive deterioration shown by subjective report in conjunction with objective cognitive deficits; and (3) activities of daily living are preserved and complex instrumental functions are either intact or minimally impaired. the diagnosis of mci was based on a comprehensive neuropsychological assessment which included the consortium to establish a registry for alzheimer's disease (cerad) neuropsychological battery (welsh et al., 1994; bertolucci et al., 2001). participants were recruited from may 2011 to august 2012. eligible subjects were aged 60 years or older, fluent in portuguese, and free of any other significant neurologic or psychiatric diseases. none of them presented major depression or psychosis, had a regular intake of brazil nuts, used supplements with selenium, or had intolerance to oleaginous food. an informed consent was obtained before the interview from all participants. the research protocol was approved by the research ethics comittee of the faculdade de ciências farmacêuticas da universidade de são paulo.

Eligibility criteria:
inclusion criteria: * aged 60 years or older, * fluent in portuguese, * free of any other significant neurologic or psychiatric diseases exclusion criteria:

Keywords: cognitive performance selenium brazil nuts oxidative stress