Kornimate/medical-research-clean huggingface dataset:
study to evaluate the safety, tolerability and efficacy of tocilizumab in participants with rheumatoid arthritis (ra) who have an inadequate response to non-biologic disease modifying anti-rheumatic drugs (dmards) and/or anti-tumor necrosis factor (anti-tnf) therapy

Conditions: Rheumatoid Arthritis

Summary: this observational study will evaluate the safety, tolerability and efficacy of tocilizumab in participants with moderate to severe ra who have an inadequate response to current non-biologic dmard and/or anti-tnf therapy. data will be collected from each participant during tocilizumab therapy and on follow-up for a total of 12 months.


Eligibility criteria:
inclusion criteria: * moderate to severe active ra with an inadequate response to existing therapies (dmards and/or anti-tnfs) * considered eligible for tocilizumab therapy by the treating physician as per routine clinical practice exclusion criteria: * pregnant or breastfeeding females * immunization with live/attenuated vaccine within 4 weeks prior to baseline * participants with clinically significant raised liver enzyme, abnormal lipid profile, platelet count, hemoglobin, white blood cell and neutrophil count * history of severe allergic or anaphylactic reactions to human, humanized or murine monoclonal antibodies * participants with active tuberculosis (tb). participants with latent tb should be treated with standard anti-mycobacterial therapy before initiating tocilizumab and have a negative chest x ray for active tb at enrolment * history of diverticulitis, chronic ulcerative lower gi disease such as crohn's disease, ulcerative colitis or other symptomatic lower gi conditions that might predispose to perforations then the benefit risk ratio should be considered by treating physician * know active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infection * history of or currently active primary or secondary immunodeficiency or known human immunodeficiency virus (hiv) positive status * any other condition which puts the participant to undue risk for tocilizumab therapy as per local prescribing information or investigator's judgement
impact of omalizumab on corticosteroid use, emergency room visits and hospitalizations

Conditions: Asthma

Summary: a retrospective database analysis to evaluate the impact of omalizumab on the use of corticosteroid, emergency-department visits and hospitalizations among patients with uncontrolled asthma and using high-dose inhaled corticosteroids (ics) prior to initiating omalizumab.


Eligibility criteria:
inclusion criteria: * ≥12 years of age with a documented cystic fibrosis (cf) diagnosis, * on long acting beta antagonist- inhaled corticosteroid (laba-ics) at baseline, * uncontrolled asthma at baseline. exclusion criteria: other protocol-defined inclusion/exclusion criteria may apply.

Keywords: asthma omalizumab
aerobic exercise in women with gestational diabetes

Conditions: Gestational Diabetes Mellitus in Pregnancy

Summary: a few, small randomized controlled trials have investigated the effects of exercise on blood glucose levels in women with gestational diabetes (gdm), with inconsistent results. to assess the effects of supervised exercise in women with gdm, 48 women with gestational diabetes, diagnosed between the 18th and 28th week of gestation, will be recruited, after exclusion of subjects with contraindications to exercise. these subjects will be randomly assigned to two groups: structured exercise intervention or standard care. women in the intervention group will perform low intensity aerobic exercise three times per week at 30% hrr (heart rate reserve), under continuous heart rate monitoring. duration of each session will progress from 26 minutes the first week to 40 minutes (increasing 2 min/week). women in the control group will receive standard diet and physical exercise recommendations. in all women, clinical, metabolic and anthropometric features will be assessed before, during and at the end of the study. newborn data will also be collected.


Eligibility criteria:
inclusion criteria: * singleton pregnancy, * gestational diabetes diagnosis between 18th and 28th week of gestation, * caucasian. exclusion criteria: * hemodynamically significant heart disease, * restricted lung disease, * incompetent cervix/cerclage, * persistent second or third trimester bleeding, * placenta previa, * threatened preterm labor, * ruptured membranes, * preeclampsia, * hypertension, * severe anemia, * cardiac arrhythmias, * history of epilepsy, * chronic bronchitis, * orthopedic limitations, * overt hyperthyroidism/ hypothyroidism, * type 1 diabetes mellitus, * drugs that interfere with metabolic control (such as cortisone)
metformin hydrochloride and empagliflozin tablets in the treatment of type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the main objective of this study is to evaluate the efficacy and safety of metformin hydrochloride and empagliflozin tablets in the treatment of type 2 diabetes in real-world clinical settings. a total of 2,600 type 2 diabetes patients were included in the study. the study observed the clinical glycemic control rate and adverse events over a period of at least 6 months from the prescription date to the end of continuous clinical follow-up.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years, gender unrestricted; 2. clinically diagnosed with type 2 diabetes; 3. first-time treatment with metformin and empagliflozin tablets; 4. hba1c test results within 2 weeks prior to enrollment (rapid fingertip test results are acceptable); 5. voluntary participation in the study and signing of informed consent form. exclusion criteria: 1. moderate to severe renal impairment (egfr \< 45 ml/min/1.73 m²), end-stage renal disease, or dialysis; 2. acute or chronic metabolic acidosis, including diabetic ketoacidosis; 3. a history of severe allergy to empagliflozin, metformin, or any excipient in this product; 4. currently or within the past month, participation in any other clinical trials; 5. judged by the investigator to be unsuitable for participation in this study.
sonication of explanted breast implants for detection of subclinical infection

Conditions: Implants, Breast

Summary: objective. capsular contracture is a frequent complication after breast implantation with unclear etiology. summary background data: microorganisms may trigger chronic periimplant inflammation with subsequent capsular fibrosis. study hypothesis: the investigators hypothesize that with sonication adherent microorganisms can be detected on removed implants . methods: in a prospective multicentre study all breast implants explanted are collected to be analyzed by sonication. the resulting culture results are correlated with patient, surgical and implant characteristics.

the study is performed in order to find a correlation between the degree of capsular fibrosis and presence of biofilm bacteria on the surface of the implant.

Eligibility criteria:
inclusion criteria: * patients aged 18 years or more * undergoing breast implant removal for any reason at one of the participating center * explantation of breast implant performed between february 2006 and march 2009 exclusion criteria: * obvious contamination of the breast implant in the operating room or during transportation.

Keywords: breast implants capsular contraction sonication biofilm complications surgery
creating an artificial night on physiological changes in preterm infants

Conditions: Physiologic Changes

Summary: effects of creating an artificial night on physiological changes, weight and feeding tolerance in preterm infants. introduction:nowdays,with medical advances in intensive care increased chance of survival in premature infants.one of the major concerns exposure to high light levels in neonate \& subsequent it is increase in metabolism rate.so,this study was conducted to determine the effect of creating an artificial night on physiological changes, weight and feeding tolerance in preterm infants. methods: this is a randomized clinical trial dual group study, 38 preterm infants (gestational age of 30-34weeks)due to prematurity hospitalized at ghaem nicu,were evaluated within 10 days. infants were divided into two groups of 1200-1700 and 1701-2200g based on the weight and the weight of each group were randomized into artificial night(dark period was from 19 to 7 during incubator was covered with linen cloth \& light period was from 7 to 19 removed the cover) and control groups(continuous lighting). mothers \& infants through questionnaires,interviews,observation \& document completion, changes in physiologic \& weight befor entering the study \& then physiologic changes twice a day,weight \& feeding tolerance were collected daily.data were analyzed using spss v.16 software.


Eligibility criteria:
inclusion criteria: premature newborn infants with gestational age of 30-34 weeks birth weight of 1200-2200g taking care and supervision in the incubator to measure weight and grow up keeping the axillary temperature in the range of 36-37° c keeping the heart rate in the range of 100 to 160 beats per minute breast feeding through a nasogastric tube or gastric orally healthy infants without congenital anomalies no history of taking specific drugs or alcohol by mother during the pregnancy. mother's lack of addiction exclusion criteria: illness of the infant (affecting with secondary sepsis, seizures; increased or decreased blood pressure, successive apnea, feeding intolerance or feeding stoppage) starting phototherapy discharge of the infant earlier than 10 days parents' lack of consent with the study
study of free dna content of embryo culture medium as a non-invasive tool for embryo assessment

Conditions: Infertility

Summary: study of cell free dna content of human embryo culture medium as a non-invasive tool for embryo assessment in intra cytoplasmic sperm injection treatment cycles.

the aim of the present study is to determine whether cell free dna content of the culture medium of the human embryo correlates with the quality and reproductive potential of embryos in icsi cycles and, thus, to look for a new non invasive tool of assessing embryo quality beside morphological assessment. determining a rapid, noninvasive method for the assessment of the developmental potential of embryos may be a great achievement

Eligibility criteria:
inclusion criteria: * third day embryos exclusion criteria: * less than third day embryos
longitudinal cohort study in participants with severe asthma to assess biomarkers

Conditions: Asthma

Summary: prospective, single-arm, longitudinal, international, multicenter study in a real-world cohort of adult severe asthma participants being conducted to assess the relationships between asthma biomarkers and asthma-related health-outcomes for a period of 52 weeks.


Eligibility criteria:
inclusion criteria: * asthma diagnosed by a respiratory physician greater than or equal to (\>/=) 12 months prior to study enrolment * pre-bronchodilator fev1 of 30 percent (%) to 85% at baseline/visit 1 * documented bronchodilator response defined as \>/=12% relative improvement in fev1 after bronchodilator administration or a positive methacholine bronchial challenge test with provocative concentration causing a 20% fall in fev1 (pc20) less than (\<) 8 milligrams (mg) at study baseline/visit 1 or within 24 months prior to baseline * current treatment with a total daily dose of \>/= 500 micrograms (mcg) of fluticasone propionate (fp) dry powder inhaler (dpi) (or equivalent ) and at least one of the following controller medications: long-acting beta-agonist (laba), leukotriene receptor antagonist (ltra), long-acting muscarinic antagonists (lamas), theophylline or oral corticosteroids, with a continued duration of three months prior to baseline/visit 1 exclusion criteria: * acute or chronic parasitic, bacterial, fungal or viral infections that required, or currently require, hospitalization or antimicrobial treatment during the last four weeks prior to participant eligibility * acute asthma exacerbation or any other medical event treated with increased doses of oral, or any dose of intramuscular (im) or intravenous (iv) corticosteroids within six weeks prior to study * other relevant pulmonary diseases (e.g. chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, cystic fibrosis, pulmonary arterial hypertension, tuberculosis) requiring treatment within 12 months prior to baseline/visit 1 * ex-smokers with \>/=10 pack-year smoking history * prior treatment with bronchial thermoplasty * participation in any clinical trial of an investigational agent or procedure within six months prior to baseline/visit 1 or during the study * pregnancy prior to participation or during the study
effects of wb-ems and specific dietary supplements on cancer patients

Conditions: Cancer; Cancer Cachexia; Weight Loss; Muscle Loss; Muscle Weakness

Summary: patients suffering from cancer often experience a loss of muscle mass and strength during disease and its therapy. muscle wasting is the main characteristic of the so-called cancer cachexia syndrome and responsible for many therapy-related complications and a poorer prognosis of the patient. stabilizing muscle mass should therefore be a great goal in cancer care. physical exercise and nutrition are promising measures to combat cancer-related muscle atrophy but conventional exercise programs may not always be suitable for physical-weakened patients and increased catabolic processes are difficult to overcome by normal nutrition - especially in advanced cancer. therefore, the present study aims to test a combined approach of specific nutritional supplementation and exercise using the novel strength training method of whole-body electromyostimulation (wb-ems). the study investigates the effect of a 12-week wb-ems training combined with a dietary supplementation of β-hydroxy-β-methylbutyrate (hmb), l-carnitine (lc) or the omega-3-fatty acid eicosapentaenoic acid (epa) on skeletal muscle mass, body composition, physical function, nutritional and inflammatory status, fatigue and quality of life in cancer patients undergoing oncological treatment. the results of this study may help to clarify the effectiveness of those combined interventions to counteract muscle wasting and other symptoms of cancer cachexia.


Eligibility criteria:
inclusion criteria: * malignant disease (solid or hematological cancer) e.g. head and neck cancer, colorectal carcinoma, small intestinal cancer, gastric cancer, oesophageal cancer, pancreas carcinoma, liver cell carcinoma, cholangiocarcinoma,lung cancer, breast cancer, cervix cancer, ovarian cancer, prostate cancer, renal cell carcinoma, malignant melanoma, patients with leukaemia and malignant lymphomas * ecog performance status ≤ 2 exclusion criteria: * simultaneous participation in other nutritional or exercise intervention trials * acute cardiovascular events * use of anabolic medications * epilepsy * severe neurological diseases * skin lesions in the area of electrodes * energy active metals in body * pregnancy * acute vein thrombosis

Keywords: cancer cachexia wb-ems skeletal muscle mass exercise nutrition dietary supplements
differential expression and analysis of peripheral plasma exosome mirna in patients with myocardial infarction

Conditions: Myocardial Infarction

Summary: the aim of this study is to determine the mirna expression profile in peripheral blood exosomes of patients with myocardial infarction and to investigate its relationship with myocardial infarction.

collect exosomes in peripheral blood of patients with myocardial infarction, compare the expression of mirna with healthy volunteers, find out the mirnas with significant differences, and explore its relationship with the development of myocardial infarction.

Eligibility criteria:
inclusion criteria: * age \> 18 years st elevation by ecg diagnostic of stemi evidency of coronary occlusion in coronariography signed informed consent exclusion criteria: * patients who will undergo immediate pci pregnant and lactating women patients with mental disorders patients are using other experimental drugs; refusal to provide informed.
a study to determine the degree of additional reduction in cv risk in lowering ldl below minimum target levels

Conditions: Cardiovascular Disease; Cerebrovascular Accident; Coronary Heart Disease

Summary: the primary objective of this study is to determine the degree of additional reduction in cardiovascular risk that was accrued to patients by lowering their ldl-c beyond the currently accepted minimum target level for patients with pre-existing chd. secondary objectives include the safety profile of this treatment strategy, its cost-effectiveness, effect on other atherosclerotic-related events and procedures, and total mortality.


Eligibility criteria:
inclusion criteria: men and women age 35-75 who have evident chd exclusion criteria: known hypersensitivity to hmg co-a reductase therapy, liver disease, evidence of secondary hyperlipidemia

Keywords: major cardiovascular event major coronary event revascularization
evaluation of daily disposable lenses with multi-purpose solution (mps)

Conditions: Myopia

Summary: the purpose of this study is to evaluate daily disposable lenses inserted out of the blister package versus daily disposable lenses inserted after a pre-soak in multi-purpose solution fid 107027.

corneal staining and subjective responses for ocular redness and comfort will be compared.

Eligibility criteria:
inclusion criteria: * 18 years of age or older. * visual acuity correctable to 20/30 (snellen) or better in each eye at distance with contact lenses. * successfully wearing hydrogel or silicone hydrogel contact lenses on a daily wear basis for at least two weeks prior to study. * other protocol-defined inclusion criteria may apply. exclusion criteria: * history of hypersensitivity to any components of the multi-purpose solution. * evidence or history of ocular conditions as prescribed in protocol. * one functional eye or a monofit lens * any slit-lamp finding score equal to 1 at visit 1 of each study period. * significant corneal staining at visit 1 of each study period as prescribed in protocol. * other protocol-defined exclusion criteria may apply.

Keywords: daily disposable contact lenses multi-purpose disinfecting solutions
ranolazine for the prevention of atrial fibrillation after electrical cardioversion

Conditions: Atrial Fibrillation

Summary: the investigators hypothesize that ranolazine would decrease the incidence of recurrence of atrial fibrillation (af) after electrical cardioversion of persistent af. patients with persistent af who are candidates for electrical cardioversion will be randomized to either placebo or ranolazine after successful electrical cardioversion.

atrial fibrillation (af) is the most common clinically significant cardiac arrhythmia and is associated with increased cardiovascular morbidity and mortality. although a rhythm control strategy offers no survival benefit over a rate control strategy, elective electrical cardioversion is still recommended in patients without hemodynamic instability for symptomatic relief. however, recurrences are frequent after cardioversion and antiarrhythmic medications are required to maintain sinus rhythm. nonetheless, the use of antiarrhythmic medications is problematic because of the risk of serious potential adverse effects, including drug-induced ventricular arrhythmias. ranolazine is a novel antianginal agent, which inhibits the late inward sodium current and produces antiischemic effects without reducing heart rate or blood pressure. additionally, recent preclinical as well as preliminary clinical data suggest that ranolazine exhibits distinct antiarrhythmic properties. however, there is no controlled data for the use of ranolazine to prevent recurrence of af after electrical cardioversion of persistent af. the investigators hypothesize that ranolazine would decrease the incidence of recurrence of af after electrical cardioversion of persistent af. patients with persistent af who are candidates for electrical cardioversion will be randomized to either placebo or ranolazine after successful electrical cardioversion. they will be followed at 2 weeks, 1, 3 and 6 months for clinical evaluation and electrocardiography for the detection of recurrence of af.

Eligibility criteria:
inclusion criteria: * male or female with persistent atrial fibrillation, aged 21 or older * duration of atrial fibrillation less than one year * the patient does not have any contraindications for anticoagulation * the patient is willing to participate in the study for a total of 6 months with 3 outpatient office visits * the patient has provided written informed consent during the screening visit to any test or procedure being performed, or medication being changed, for this study. * the patient has no clinically significant abnormal clinical laboratory values, which in the investigator's opinion precludes the patient from safely participating in the study. exclusion criteria: * any contraindication for anticoagulation * new york heart association class iv heart failure * currently taking anti-arrhythmic drugs * chronic kidney disease (serum creatinine less than 2.5mg/dl) or severe liver dysfunction * pregnancy/nursing * prolonged qt interval (\>500ms) * taking other medications known to prolong the qt interval * taking other medications known to affect the metabolism of ranolazine

Keywords: atrial fibrillation ranolazine
bioequivalence study of capsule and tablet formulations of ta-8995

Conditions: Dyslipidaemia

Summary: the purpose of this study is to compare the pharmacokinetics of capsule and tablet formulations of ta-8995 in healthy male subjects aged 18 to 55 years.


Eligibility criteria:
inclusion criteria: * healthy males aged 18-55 * body mass index (bmi) between 18.0 and 32.0 kg/m2, inclusive exclusion criteria: * subject has a known hypersensitivity to any of the inactive ingredients of the study treatments. * subject has any other condition which, in the investigator's opinion will interfere with the study. * subjects who are still participating in another clinical study (eg, attending follow-up visits) or who have participated in a clinical study involving administration of an investigational drug (new chemical entity) within 3 months or 5 half-lives (whichever is longer) prior to the first dose in this study.
comparative study of maxillary and mandibular splints used for the treatment of masticatory muscle parafunction (fea)

Conditions: Jaw, Edentulous; Mouth, Edentulous

Summary: the purpose of this study is to clarify the rationale for the choice of the upper or lower jaw for positioning the occlusal splint

after being informed about the study and potential risks, all patients are giving written informed consent. occlusal splints for the upper and lower jaws are made for each of the patients. an assessment is made of the relative values and distribution of chewing forces in two cases: 1. "maxillary occlusal splint - lower dentition"; 2. "mandibular occlusal splint - upper dentition". the obtained values are used in the final elemental analysis of the stress-strain state and the degree of displacement of the dentition in both indicated cases.

Eligibility criteria:
inclusion criteria: * continuous dentition * diagnosis (by icd\*-10): k03.0 excessive attrition of teeth * diagnosis (by icd-10): k07.6 temporomandibular joint disorders * complaints of nocturnal bruxism * complaints of discomfort in the area of the chewing muscles * no history of orthopedic and / or orthodontic treatment * absence of concomitant general somatic pathologies in the stage of decompensation * no history of psychogenic and psychosomatic disorders * no history of cancer \*icd - classification of diseases exclusion criteria: * refusal of the patient during the clinical trial from further treatment

Keywords: denture, complete technology, dental biomedical and dental materials