Kornimate/medical-research-clean huggingface dataset:
a study of the effect of tocilizumab on markers of atherogenic risk in patients with moderate to severe rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this 2 arm study will investigate the effects of tocilizumab on lipids, arterial stiffness, and markers of atherogenic risk in patients with moderate to severe active rheumatoid arthritis. in part 1 of the study, patients will be randomized to receive either tocilizumab 8mg/kg intravenously or placebo every 4 weeks, in combination with methotrexate 7.5-25 mg weekly. in part 2, all patients will receive open-label treatment with tocilizumab plus methotrexate.


Eligibility criteria:
inclusion criteria: * adult patients, 18-75 years of age * rheumatoid arthritis (ra) of \>6 months duration * able to receive outpatient treatment * on methotrexate for at least 12 weeks before entering study, at a stable dose of 7.5-25 mg/week for the last 8 weeks * oral corticosteroids and non-steroidal anti-inflammatory drugs (nsaids) permitted, if at a stable dose for 4 weeks before study start exclusion criteria * major surgery (including joint surgery) within 8 weeks prior to screening, or planned surgery within 6 months after entering study * history of, or current inflammatory joint disease or rheumatic autoimmune disease other than ra * inadequate response to anti-tumor necrosis factor (tnf) agent during the 6 months prior to baseline, or inadequate response to \>2 anti-tnf agents * initiation of treatment with lipid lowering agents within 12 weeks prior to baseline
a randomised, double-blind, placebo-controlled study assessing the effect of fenofibrate, coenzyme q10 and their co-administration on ventricular diastolic function in patients with type 2 diabetes

Conditions: Patients With Type 2 Diabetes

Summary: the purpose of this study was to study the effect of different combinations of fenofibrate and coenzyme q10 on ventricular diastolic function in patients with type ii diabetes


Eligibility criteria:
inclusion criteria: * men or women aged from 40 to 79 years * patients with pre-existing t2dm * hba1c \<9% * written informed consent exclusion criteria: * unable to comply with the protocol, likely to leave the trial before completion * having participated in an another trial 3à days before v1 * pregnant or childbearing potential not using birth control method * type 1 diabetic patients, t2dm insulin therapy patients with one of the following pathology: * with muscular disorders known or increase ck , or hepatic deficiency or transaminase increase * with symptomatic gall-bladder disease or/and renal insufficiency * with abnormal thyroid function * with proliferative retinopathy * with recent cardiovascular event, uncontrolled hypertension * with known chronic alcohol intake * with other severe pathology * with tc\>= 7.0 mmol/l and/or tg\>= 4mmol/l at v1 * patients treated with warfarin * patients with specific ecg dysfunction

Keywords: ventricular diastolic function diabetes
myeloid-derived suppressor cells (mdscs) in oscc patients

Conditions: Squamous Cell Carcinoma of the Oral Cavity

Summary: oral squamous cell carcinoma (oscc) has the highest annual increase in the rate of death among the top 10 leading cancers in taiwan. this research aimed to explore whether increased anti-tumor immunity for osccs reduces the recurrence rate or improves survival. we first identified cd33+/cd11b+/hla-dr-/low/cd14+/- as myeloid-derived suppressor cell (mdsc) surface markers by using flow cytometry to compare the mdsc frequency of osccs with blood samples from healthy donors (hds). we then re-confirmed the suppression of t cell proliferation and function achieved by co-culturing with oscc-educated mdscs. we subsequently explore whether using particulate β-glucan as a food-grade supplement promotes the human immune system via subversion of immune modulatory mdscs. lastly, we correlated clinicopathological parameters with mdscs and β-glucan administration to examine anti-tumor immunity, and to predict the therapeutic effect and prognosis in oscc patients..

oral squamous cell carcinoma (oscc) has the highest annual increase in the rate of death among the top 10 leading cancers in taiwan. this research aimed to explore whether increased anti-tumor immunity for osccs reduces the recurrence rate or improves survival. we first identified cd33+/cd11b+/hla-dr-/low/cd14+/- as myeloid-derived suppressor cell (mdsc) surface markers by using flow cytometry to compare the mdsc frequency of osccs with blood samples from healthy donors (hds). we then re-confirmed the suppression of t cell proliferation and function achieved by co-culturing with oscc-educated mdscs. clinically, we enrolled 100 oscc patients and 30 hds to demonstrate a significantly higher mdsc frequency in oscc candidates than hds. to determine whether using β-glucan as a food-grade supplement promotes the immune system of oscc patients, we further allocated oscc patients with and without pre-surgical administration of whole glucan particle β-glucan to groups ii and iii, respectively (with group i being the hds). we will explore whether using particulate β-glucan as a food-grade supplement promotes the human immune system via subversion of immune modulatory mdscs. lastly, we correlated clinicopathological parameters with mdscs and β-glucan administration to examine anti-tumor immunity, and to predict the therapeutic effect and prognosis in oscc patients.

Eligibility criteria:
inclusion criteria: * oral squamous cell carcinoma (oscc) subjects without other cancer diagnosis * healthy donors (hds) exclusion criteria: * pregnant woman

Keywords: myeloid-derived suppressor cell (mdsc) oral squamous cell carcinoma (oscc) whole glucan particle (wgp) β-glucan flow cytometry recurrence prognosis
circulating endothelial progenitor cells and aortic aneurysm

Conditions: - Aortic Aneurysm

Summary: we aimed to see if aortic aneurysms could be followed-up by circulating endothelial progenitor cells cd34+144+cd14- and cd34+vegf-r2+cd14- blood level.

circulating endothelial progenitor cells cd34+144+cd14- and cd34+vegf-r2+cd14- have been shown to be inversely correlated to aortic aneurysm size. we aimed to see if aortic aneurysms could be followed-up by circulating endothelial progenitor cells cd34+144+cd14- and cd34+vegf-r2+cd14- blood level. 40 patients followed for known aortic aneurysm \>30mm and \<50mm will be followed up every 6 months during 2 years. each 6 months they will have a consultation by their physiologist with an echo or a ct-scan. at the same time, a 10ml blood sample will be taken to assess the circulating endothelial progenitor cells cd34+144+cd14- and cd34+vegf-r2+cd14- blood level.

Eligibility criteria:
inclusion criteria: * aortic aneurysm size \>30mm and \> 50mm exclusion criteria: * infectious disease * inflammatory disease * liver insuffisency * cancer evolutive * pregnant women

Keywords: aortic aneurysm circulating endothelial progenitor cells
ocular penetration of 1.5% levofloxacin and 0.5% moxifloxacin during corneal transplant surgery

Conditions: Corneal Transplantation

Summary: compare the corneal penetration of levofloxacin 1.5% and moxifloxacin 0.5% in patients undergoing penetrating keratoplasty (pk)


Eligibility criteria:
inclusion criteria * man or woman 18 years of age or older * scheduled for corneal transplant surgery * patients must be healthy enough to undergo surgery * women must be postmenopausal for at least 1 year or surgically sterile incapable of pregnancy * women must be abstinent at the discretion of the investigator * women practicing an effective method of birth control * women agree before entry to continue to use the same method of contraception throughout the study * women of childbearing potential must have a negative urine pregnancy test at screening exclusion criteria * presence of an active ocular infection or positive history of ocular herpetic infection * history of severe dry eye syndrome * use of contact lenses in the 2 weeks prior to the study and for the duration of the study * received an experimental drug or used an experimental medical device within 30 days before the planned start of treatment * pregnant or breast feeding * employees of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center as well as family members of the employees or the investigator

Keywords: corneal penetration of levofloxacin and moxifloxacin
non-invasive ventilator modems: a qualitative study

Conditions: Ventilatory Failure

Summary: advances in technology has meant that domiciliary non-invasive (niv) devices can be remotely monitored via modems in patients' homes. possible benefits and challenges of modem technology have yet to be established. this study explored the perspectives and experiences of patients, their carers' and health care professionals (hcps) on the addition of modem technology in managing home niv patients.

the aim of this study is to consider the opinions of patients, their carers' and health care providers on the addition of using modem technology in the management of patients with hypercapnic respiratory failure receiving domiciliary niv. objectives 1. to investigate the experience of patients receiving domiciliary niv with modem technology and how this compares to niv treatment without a modem 2. to investigate the experience of carers' of patients receiving domiciliary niv with modem technology and how this compares to niv treatment without a modem 3. to gain opinions of health care providers on the use of modem technology in caring for patient with ventilatory failure and how this compares to delivering home niv treatment without a modem 4.2 outcome the outcome of this study will inform future service development of home niv services to ensure they are designed with service users' preferences in mind.

Eligibility criteria:
inclusion criteria: patients and carers •patients and their carers who received treatment from the royal free london (rfl) domiciliary niv service both pre and post modem installation will be eligible to be included in the study. hcps •staff who have experience of looking after patients with niv both with and without modems will be able to take part in the study. staff recruited will be currently working at rfl. we have been using modems for all of our patients with niv since december 2014. therefore rotational staff (e.g. registrars) working rfl will only have experience of looking after patients with modems on their niv. to allow for this factor staff will be allowed to join the study even if their experience of looking after patients with niv without modems is at other hospitals. exclusion criteria: * patients under the care of the rfl domiciliary niv service who have only had experience of treatment with a modem in situ will be excluded from the study. * patients who are unable to verbally communicate * patients who cannot have an "everyday" level conversation in english

Keywords: technology modems qualitative research
use of picco system in critically ill patients with septic shock and acute respiratory distress syndrome

Conditions: Septic Shock; Acute Respiratory Distress Syndrome

Summary: picco has been widely used in critical care settings for several decades. together with pulmonary artery catheter, it is regarded as the important tool for guiding fluid management in patients with shock or acute respiratory distress syndrome. however, its effects on patients' outcome remain untested. the investigators study is a pilot study that is designed to test whether the use of picco will improve patients' outcome, as compared to those without picco monitoring.

picco comprises techniques of pulse contour analysis and transpulmonary thermodilution, and can provide important information on hemodynamics and pulmonary functions. it has been widely used in critical care settings for several decades. together with pulmonary artery catheter (pac), it is regarded as the important tool for guiding fluid management in patients with shock or acute respiratory distress syndrome. during last two decades, many well designed clinical trials have been conducted to see whether the use of pac would benefit patient outcome. the result consistently showed that pac added no benefit in terms of mortality, icu length of stay, organ failure free survival days, and the length of mechanical ventilation. since picco is relatively new to pac, and its effects on patients' outcome remain untested. the investigators study is a pilot study that is designed to test whether the use of picco will improve patients' outcome, as compared to those without picco monitoring.

Eligibility criteria:
inclusion criteria: patients were included if they were diagnosed with shock, acute respiratory distress syndrome (ards), or both. shock was defined by the presence 4 criteria: * heart rate of at least 90/min; * a respiratory rate of at least 20/min or a paco2 of 32mmhg or lower or the use of mechanical ventilation; * the use of vasopressors to maintain a systolic blood pressure of at least 90mmhg despite fluid resuscitation, low dose of dopamine (≤ 5 μg/kg per minute), or dobutamine; * at least 1 of 3 signs of hypoperfusion (urine output \< 0.5ml/kg of body weight per hour for 1 hour or more; neurologic dysfunction defined by confusion, psychosis, or a glasgow coma scale score of ≤ 6; plasma lactate higher than the upper limit of the normal value). acute respiratory distress syndrome： * the presence of acute decrease in pao2/fio2 to 200mmhg or lower, * bilateral pulmonary infiltrates or a chest radiograph consistent with edema; * no clinical evidence of left atrial hypertension; and requirement for positive pressure ventilation. exclusion criteria: * patients were moribund. * signed do-not-resuscitation odor.

Keywords: septic shock acute respiratory distress syndrome transpulmonary thermodilution technique mortality
effects of antenatal education on fear of birth, depression, anxiety, childbirth self-efficacy, and mode of delivery in primiparous pregnant women

Conditions: Fear of Childbirth; Antenatal Education; Depression, Anxiety; Stress; Childbirth Self Efficacy; Mode of Delivery

Summary: background: caesarean delivery rates are quite high, especially in primipara, in turkey. fear of birth, low childbirth self-efficacy, and psychological factors may be among the primary causes. since antenatal educations are not universal and there are differences in educational contents, there is not sufficient evidence on this topic in international studies. objective: to investigate the effects of antenatal education on birth fear, depression, anxiety, stress, childbirth self-efficacy, and mode of delivery in primiparous pregnant women.

background: caesarean delivery rates are quite high, especially in primipara, in turkey. fear of birth, low childbirth self-efficacy, and psychological factors may be among the primary causes. since antenatal educations are not universal and there are differences in educational contents, there is not sufficient evidence on this topic in international studies. objective: to investigate the effects of antenatal education on birth fear, depression, anxiety, stress, childbirth self-efficacy, and mode of delivery in primiparous pregnant women. design: a single-blind, prospective, randomized controlled trial. setting and participants: the study was conducted in a province in central anatolia region in turkey, and the data were collected between april 2019 and september 2019. randomized block assignment was used to assign 120 primiparous pregnant women to either the antenatal education group (n = 60) or the control group (n = 60). at the end of the study, 112 women were evaluated. measurements: those in the antenatal education group received two-hour (240 min) educational sessions, twice a week, for 4 weeks. data were collected by demographic and labor outcomes information form, the wijma delivery expectancy/experience questionnaire (version a and b), childbirth self-efficacy inventory, and the depression, anxiety and stress scale.

Eligibility criteria:
inclusion criteria: * pregnant women (between 20 and 32 gestation weeks), * healthy, * nulliparous with singleton pregnancies, * older than 18 years. * involved giving birth at full term, * having a healthy newborn (born at 38-42 weeks of gestation) exclusion criteria: * women taking medication for a diagnosed mental illness (e.g., antidepressants, antianxiety or antipsychotic medication), * women with complicated or high- risk pregnancies, * anticipating or experiencing a perinatal death (e.g., congenital abnormality incompatible) or stillbirth, * having experienced no postnatal complications (hemorrhage, puerperal infection, mastitis, thromboembolic disease or postpartum psychiatric disorder).

Keywords: antenatal education fear of childbirth depression anxiety stress childbirth self-efficacy mode of delivery
safety and efficacy of two artificial tears in dry eye subjects

Conditions: Dry Eye Syndrome

Summary: this study will evaluate the safety, efficacy, and acceptability of two artificial tears compared to a currently available artificial tear in subjects with dry eye.


Eligibility criteria:
inclusion criteria: * current use of an artificial tear at least twice daily, for at least three months prior to day 1, on average * ability/agreement to wear habitual correction (glasses) during study period exclusion criteria: * known allergy or sensitivity to the study product(s) or its components * anticipate contact lens wear during the study, or subject has worn contact lenses in the last six months * chronic use of systemic medications which may affect a dry eye condition * active ocular allergy or infection * use of restasis® or other topical cyclosporine products within 3 months prior to day 1 * current use of any topical ophthalmic medications, have used within 2 weeks prior to day 1, or are likely to use during study.
cytomegalovirus infection after hsct and pt-cy as gvhd prophylaxis >> gvhd prophylaxis era

Conditions: CMV Infection

Summary: multicentre, observational, retrospective study to analyze the differences in cmvi pattern and recurrences between two groups of allogeneic hsct patients (haplo vs no haplo hsct), with intervention both postransplant cyclophosphamide as gvhd prophylaxis, using a database with information from historical clinic data.

the overall aim of the study is to to analize cmvi after ptcy for gvhd prophylaxis, with a detailed description of cmvi and recurrences, direct and indirect consequences, in a hsct population comparing two cohorts: haploidentical hsct vs no haploidentical hsct

Eligibility criteria:
inclusion criteria: 1. age \> 18 years. 2. period of hsct: january 1st 2013 to december 31th 2018. 3. gvhd prophylaxis: post-transplantation cyclophosphamide (50 mg/kg on days +3 and +4 or +3 and +5) and calcineurine inhibitors as gvhd prophylaxis. 4. conditioning chemotherapy regimen and source of stem cells: myeloablative or reduced intensity tbf (thiotepa 5 mg/kg d -7-6, fludarabine 50 mg/m2 d -5-4-3, busulfan 3,2 mg/kg d -4-3-2) starting on d-7 followed by peripheral blood or bone marrow infusion on day 0. exclusion criteria: 1. cord blood hsct. 2. antilymphocytic or anti thymocytic thymoglobulin as gvhd prophylaxis. 3. alentuzumab as gvhd prophylaxis. 3. sirolimus as gvhd prophylaxis. 4. hiv positive, hvc, hvb active or latent at hsct. 5. cmv prophylaxis with letermovir. -

Keywords: cmv pt-cy allogeneic stem cell transplantation
doxycycline treatment in mild thyroid-associated ophthalmopathy

Conditions: Graves Ophthalmopathy; Graves Disease; Thyroid-associated Ophthalmopathy; Thyroid Diseases; Endocrine System Diseases; Eye Diseases, Hereditary; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Summary: the aim of this study is to evaluate the effects of subantimicrobial dose doxycycline (50 mg/d), administered for 12 weeks, on patients with mild thyroid-associated ophthalmopathy (tao).

thyroid-associated ophthalmopathy is an autoimmune disease that can be treated by corticosteroids and surgery. but they often cause severe side-effects and are usually used for treating moderate-sever and sight-threatening tao. wait and see will be the first choice for the patient with mild tao. subantimicrobial dose (sd) doxycycline displays a strong anti-inflammatory and immunomodulatory function, which is independent of its antibiotic properties. data from clinical trials demonstrated that sd doxycycline was effective in moderating inflammation in a variety of autoimmune diseases, such as rheumatoid arthritis, multiple sclerosis, rosacea and periodontitis. we propose to test the effect of subantimicrobial dose doxycycline for mild tao.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of thyroid-associated ophthalmopathy * mild tao * normal serum free thyroxine and free triiodothyronine concentrations * no previous specific therapy for tao, except for local measures * written informed consent is obtained exclusion criteria: * pregnant females as determined by positive (serum or urine) hcg test at screening or prior to dosing, or lactating females * uncontrolled diabetes or hypertension * history of mental / psychiatric disorder * hepatic dysfunction (alb, ast, alt and alkaline phosphates levels must be within normal range for eligibility) * renal impairment (urea and creatinine levels must be within normal range) * tetracycline allergy or intolerance

Keywords: graves' orbitopathy graves´ ophthalmopathy thyroid eye disease thyroid-associated ophthalmopathy doxycycline eugogo cas
efficacy of a propolis-based denture cleanser

Conditions: Dental Plaque; Denture Stomatitis; Oral Candidiasis; Oral Hygiene

Summary: the purpose of this study is to assess if a propolis solution is able to remove plaque and kill microbes from complete dentures. the investigators will compare the results of the propolis-based denture cleanser with those obtained with an inactive solution.


Eligibility criteria:
inclusion criteria: * good general health * patients requesting new complete dentures * regular wearing of the same maxillary and mandibular complete dentures for at least one year * both denture bases and artificial teeth should be composed by acrylic resin exclusion criteria: * unsatisfactory complete dentures in use (i.e. with poor fitting, relining or fractures) * pathologic changes in the oral cavity

Keywords: candida complete denture dental plaque index denture bases denture cleansers edentulous mouth mutans streptococci oral health propolis streptococcus mutans