Kornimate/medical-research-clean huggingface dataset:
a six-week safety study of an investigational ophthalmic solution

Conditions: Allergic Conjunctivitis

Summary: the purpose of this study was to evaluate the ocular safety of an investigational ophthalmic solution in subjects 2 years of age and older with asymptomatic eyes when administered once daily in both eyes for up to 6 weeks.


Eligibility criteria:
inclusion criteria: * able and willing to comply with study protocol and follow protocol instructions. * adequate birth control methods for the duration of the study. * best-corrected visual acuity (bcva) of 55 or greater in each eye. * willing to avoid contact lens wear during each of the study visits; contact lens wear also should be stable and consistent for 1 month prior to visit 1 and expected to remain the same for the study duration. * willing and able to sign an informed consent form. * other protocol-specified inclusion criteria may apply. exclusion criteria: * women of childbearing potential that are pregnant, breastfeeding, or not in agreement to use adequate birth control methods to prevent pregnancy throughout the study. * evidence of contact lens care solution related ocular surface damage or giant papillary conjunctivitis (gpc). * any ocular infection (bacterial, viral or fungal) or history of ocular herpes (simplex or zoster) or adenoviral infection in either eye or have had any ocular infection within 30 days prior to visit 1. * using systemic medication(s) on a chronic dosing regimen for less than 30 days or changed dosage of this medication within 30 days prior to visit 1. * current or past history of glaucoma or ocular hypertension. * history of retinal detachment, diabetic retinopathy, or progressive retinal disease. * presence of ocular conditions that may affect the study outcomes. * corneal conditions affecting the corneal structure. * history or evidence of any ocular surgical procedure within 1 year prior to visit 1. * current or recent medical conditions that, in the opinion of the investigator, would preclude safe participation in the study. * prior, current, or anticipated use of ophthalmic agents other than investigational product during study participation. * participation in any investigational study within 30 days prior to visit 1 or concomitantly with this study. * known contraindications or hypersensitivities to any of the study medications or their components. * other protocol-specified exclusion criteria may apply.

Keywords: ocular safety allergic conjunctivitis
chemerin and interleukin-6 levels of gingival crevicular fluid in obese individuals following periodontal treatment

Conditions: Obesity; Periodontitis

Summary: the objective in this case-control intervention study, therefore, was to explore the effect of nonsurgical periodontal therapy on the gcf levels of chemerin and il-6 in patients with chronic periodontitis in order to determine the usefulness of chemerin as a diagnostic and prognostic biomarker of periodontal disease.

all individuals underwent a full-mouth periodontal examination, which included probing pocket depth (ppd), clinical attachment level (cal), plaque index (pi), gingival index (gi), bleeding on probing (bop). bmi and whr were used for assessing obesity. in addition, hba1c and fasting plasma glucose levels were used for elimination of diabetes mellitus. based on the periodontal and anthropometric measurements, individuals (n=72) were divided into four groups: the periodontal-healthy group (n=18), chronic periodontitis group (n=18), periodontal-healthy with obesity group (n=18) and chronic periodontitis with obesity group (n=18). periodontitis patients received nonsurgical periodontal therapy. gcf sampling and clinical periodontal parameters were assessed before and 6 weeks after therapy. chemerin and il-6 levels were measured by enzyme-linked immunosorbent assay.

Eligibility criteria:
inclusion criteria: 1. 32-53 years of age 2. had a minimum of 20 natural teeth, excluding third molars 3) glycosylated hemoglobi levels \<6% 4) fasting plasma glucose levels \<100 mg/dl. 5-) criteria for the periodontal healthy group were gi = 0, ppd≤ 3 mm, and no signs of attachment and bone loss by clinical and radiographic examination. 6-) criteria for the chronic periodontitis group were clinical signs of inflammation (red color and swelling of the gingival margin), gi ≥ 2, ppd and cal ≥ 5 mm, and bone loss affecting \>30% of the existing teeth on clinical and radiographic examination. 7-) criteria for obese groups were 30≤ bmi \<40 kg/m2, and concomitant whr ≥0.85 for females and whr ≥0.90 for males. 8-) criteria for normal-weight groups were 20≤ bmi \<25 kg/m2, and whr below that determined for obesity. exclusion criteria: 1. aggressive periodontitis 2. periapical pathologies 3. excessive forces including mechanical forces from orthodontics and occlusion 4. systemic diseases (e.g., diabetes mellitus; cancer; human immunodeficiency virus; or disorders that could affect adipokines levels and the periodontal conditions) 5. chronic high-dose steroid therapy, radiation or immunosuppressive therapy 6. pregnancy, lactation 7. smoking within the past five years, or allergy or sensitivity to any drug 8. had no history of periodontal therapy or drug therapy (e.g., anti-inflammatories, antibiotics, or any other pharmacological treatment) for at least six months

Keywords: chemerin interleukin-6 gingival crevicular fluid
effect of low glycemic index diet on biochemical parameters and body image in obesity with insulin resistance: a randomized clinical trial

Conditions: Obesity

Summary: to examine how a low glycemic index diet (lgid) changes biochemical parameters, body measurements, and body image perception in obese individuals with insulin resistance. obesity groups with insulin resistance who received a control diet (cd) and a lgid will be compared with each other in terms of biochemical parameters, body image perception and body measurements. in addition, each group will be compared with the start and end measurements over the same values.

the main purpose of this study is to determine the effect of lgid on body image perception, biochemical parameters and body measurements in obese individuals with insulin resistance. sub-objectives of the study; determination of the effect of lgid on fasting blood glucose, fasting insulin level and homa-ir levels compared to cd. determination of the effect of lgid on body weight, fat mass, muscle mass, body muscle ratio and body mass index (bmi) compared to cd. determination of the effect of lgid on body image perception status compared to cd.

Eligibility criteria:
inclusion criteria: * bmi above 24 kg/m2, or the either one (fat mass ≧ 30% or waistline \> 80 cm) * can provide informed consent * can be contacted by telephone * waist circumference \> 90 cm for men and \> 80 cm for women exclusion criteria: * pregnancy or lactation * active or suspected chronic infection * treatment affecting insulin sensitivity * a secondary disease state (cardiovascular disease, cancer, psychiatric, etc.) * any weight loss operation (gastric bypass, gastric balloon, etc.) * a special nutritional program (cancer, kidney disease, etc.) * using any food supplement or medication known to affect whole body metabolism

Keywords: low glycemic load diet obesity
effect of innoslim® on blood sugar and blood lipids regulation in humans

Conditions: Hyperlipidemia

Summary: innoslim® has been studied for enhancing metabolic functions whereas many lab studies have demonstrated the potential efficacy of innoslim® for the blood sugar and blood lipids regulation. there has been no relevant human study on innoslim® on blood sugar and blood lipids regulation. there have reported that 2018 estimating the total costs of diagnosed diabetes have risen to $327 billion in 2017 from $245 billion in 2012. although pharmacological methods have been developed to treat diabetes, these treatments can be costly and are not without potential adverse effects. the development of dietary agents for the prevention of diabetes could represent a cost-effective and safe means to deal with this growing public health crisis.

in this study, the investigators are investigating the effects of innoslim® on blood sugar and blood lipids regulation in humans. the testing sample is orally administrated to participants with pre-diabetes and hyperlipidemia humans, the efficacy parameters of blood sugar, lipid profile and other parameters, as well as adverse effects to the healthy individual, are screened during the trial, the significant difference is shown and no adverse effect reported.

Eligibility criteria:
inclusion criteria: * participants age 20 years and above. * participant has provided written and dated informed consent to participate in the study. * participant is willing and able to comply with the study. * participants blood sugar (100≤ fasting blood glucose ≤ 125 mg/dl and 5.7%≤hba1c ≤ 6.4% ) and total cholesterol ≥200 mg/dl exclusion criteria: * participant is participating in another clinical trial thirty days prior to enrollment. * participant has a significant history or current presence of treated or untreated heart disease, kidney disease, liver disease, muscle disease, bone disease, or a history of surgery. * participant has any medical condition or uses any medication, nutritional product, dietary supplement or program which might interfere with the conduct of the study or place the subject at risk. * participants lost to follow-up, non-compliance, concomitant medication.
biphasic calcium phosphate vs. hydroxyapatite in sinus floor elevation

Conditions: Bone Substitutes; Calcium Phosphates; Hydroxyapatite; Rhodophyta; Sinus Floor Augmentation

Summary: twenty patients scheduled for lateral-window sinus floor elevation (sfe) are randomized into two groups: use of symbios® biphasic bone graft material (group 1) or of algipore® bone substitution material (group 2). biopsies are taken 3 months after sfe and during implant surgery after 6 months. one ground section per biopsy (n=40) is stained, scanned, and histomorphometrically analyzed for new bone, old bone, soft tissue, graft, bone infiltration of graft, bone-to-graft contact, and penetration depth.


Eligibility criteria:
inclusion criteria: 1. capability of giving an informed consent 2. good health as defined by the subject's medical history 3. patients age 20-75 years 4. fully edentulous or partially edentulous patients with unilateral or bilateral missing teeth in the maxillary premolar or molar areas with severe alveolar atrophy and a residual alveolar ridge height of maximal 5 mm requiring a two-staged sinus floor elevation and implant placement. exclusion criteria: 1. patients without detailed baseline medical data 2. patients with medical history of local inflammations in the posterior maxilla 3. skeletal immaturity 4. patients with osteoporosis in their medical history 5. patients with severe illnesses, malignant diseases, radiotherapy or chemotherapy in their medical history 6. patients with pathological fractures 7. patients treated with bisphosphonates 8. uncontrolled diabetes mellitus 9. uncontrolled periodontal diseases 10. smoking 11. pregnancy
diabetes in the perioperative period

Conditions: Hyperglycemia; Diabetes

Summary: high blood glucose levels in surgical patients with and without diabetes are associated with increased risk of medical complications and death. over the short-term, high blood glucose can adversely affect fluid balance, impair immunologic response to infection, and promote inflammation and endothelial dysfunction (blood vessel function). blood glucose control with intensive insulin therapy in patients with critical illness (very sick patients in intensive care unit) reduces the risk of multiorgan failure and systemic infections, and decreases short- and long-term mortality. high blood glucose has also been associated with poor outcome in non-critically ill patients admitted to general surgical and medical wards; however, intensive glycemic control is not aggressively pursued because of fear of hypoglycemia. a computerized search of biomedical journal literature from medline, pubmed, and ovid from 1966 to 2008 provided very little information on the prevalence and outcome of high blood glucose during the perioperative period (before and after surgery) in non-critically ill patients. therefore, the present study aims to evaluate the impact of high blood glucose, in large number of subjects with and without diabetes, during general (non-cardiac) surgery.

we will perform a retrospective chart review of all patients who underwent non-cardiac surgery from 01/01/07 to 06/30/07 at emory university hospital as inpatient.

Eligibility criteria:
inclusion criteria: * patient undergoing non-cardiac surgery (inpatient only) exclusion criteria: * outpatient procedures, cardiac surgery

Keywords: non-cardiac surgery mortality morbidity perioperative period
expression levels of microrna processing enzymes dicer and drosha in epithelial skin cancer

Conditions: Skin Cancer

Summary: micrornas (mirnas) are very small endogenous rna molecules about 22-25 nucleotides in length, capable of post-transcriptional gene regulation. mirnas bind to their target messenger rnas (mrnas), leading to cleavage or suppression of target mrna translation based on the degree of complementarity. mirnas have recently been shown to play pivotal roles in diverse developmental and cellular processes and linked to a variety of skin diseases and cancers. in the present study the expression profiles for the two most important mirna processing enzymes dicer and drosha of actinic keratoses, basal cell carcinoma and squamous cell carcinoma are compared to healthy skin tissue.


Eligibility criteria:
inclusion criteria: * patients with actinic keratoses, squamous cell carcinoma or basal cell carcinoma of the skin exclusion criteria: * patients under 18 years of age * patients with other forms of cancer in previous medical history
effect of intravenous metoprolol combining ric on myocardial protection in stemi patients

Conditions: Anterior Myocardial Infarction; Heart Failure

Summary: the main purpose of this study is to compare the myocardial protection effect of intravenous metoprolol combined with remote ischemic conditioning (ric) and single treatment before reperfusion in chinese patients with anterior stemi. this study sought to find possible strategies to further improve myocardial protection in chinese patients with anterior stemi.

this study is a prospective, multi-center, randomized controlled study. it is planned to enroll 1200 patients with anterior stemi. immediately after the first medical contact, the patients who were determined by the investigator to meet the inclusion/exclusion criteria were randomized through the interactive web response system (iwrs) and received different pre-reperfusion treatments. the four groups were placebo group, metoprolol group, remote ischemic conditioning (ric) group and metoprolol \& ric group. subsequently, the investigator conduct diagnosis and treatment according to the patient's specific conditions and check the serum level of myocardial damage markers (i.e. ck and ck-mb) at the time of admission, 12, 24, 36, 48, 60 hours, respectively. if the patient undergoes pci treatment, additional detection of myocardial damage markers immediately after pci is also required. all patients were followed for 1 year with an office visit or a telephone call at 1, 3, 6, 9 and 12 months to evaluate the health status and adverse clinical events of patients.

Eligibility criteria:
inclusion criteria: 1. ages 18 to 80 years; 2. presenting within 12 h of symptoms onset, with anterior stemi and planned for ppci; anterior stemi was defined as the occurrence of \>20 min of chest pain and st-segment elevation (\>2 mm) in at least 2 contiguous precordial leads; 3. sign informed consent; exclusion criteria: 1. systolic blood pressure \< 110mmhg; 2. cardiogenic shock or with heart failure symptoms, killip iii\~iv; 3. allergic history of metoprolol; 4. history of asthma or the need for bronchodilators; 5. pr interval \> 240ms, ii\~iii atrioventricular block； 6. heart rate \< 60 beats/min; 7. unable to consent; 8. pregnancy and lactation women; 9. life expectancy for diseases (i.e. cancer) \< 1 year.

Keywords: anterior myocardial infarction intravenous metoprolol ric myocardial protection
characterization of cutaneous microbiota in the psoriasis pathogenesis

Conditions: Psoriasis

Summary: the skin harbors a complex and dynamic microbiota constituted by numerous microorganisms that live in symbiosis with the host. the specific etiology of psoriasis is still not-well understood; nonetheless several studies highlighted that that the skin microbiota could have a pivotal role in the maintenance and/or progression of the disease, acting as microbial predictor of psoriasis however. the aim of the present study was to characterize the microbiota of cutaneous biopsies associated to guttate and vulgaris psoriasis, both considering lesion and healthy skin belonging to the same psoriatic subject.

twelve individuals with guttate psoriasis and 12 individuals with vulgaris psoriasis have been enrolled at dermatological unit of irccs galeazzi institute, milan. patients selected for the psoriasis vulgaris group had a course of disease stable for at least 1 month before collection. the second group presented guttate psoriasis, defined as "eruptive", that is characterized by a rapid appearance and worsening of the clinical presentation within the month preceding the visit. from each participant, a punch was used to obtain a cutaneous sample from both a lesion and healthy skin area of 2 mm2 belonging to the left gluteus, for a total of 48 biological samples. participants were selected and included in the study according to the following criteria: i) over 18 years of age; ii) use of a free-preservatives soap with moisturizing function; iii) no use of probiotics; iv) no use of antibiotics; v) no treatment with corticosteroids, biological drugs, methotrexate or retinoids in the month prior the sampling; vi) no use of topical corticosteroids, vitamin d derivatives or phototherapy; vi) no chronic or systemic infections; vii) no cutaneous acute infections; viii) no allergy to pollen, food and drugs ix) no pets. informed consent was obtained from all subjects. a metagenomics approach, performed by the use of ion torrent personal machine, were used to investigate the bacterial composition of the skin microbiota associated to each samples collected. after sequencing, the data analysis were focused on the bacterial biodiversity and microbial networks existing in the skin microbiota to evaluate a hypothetical role of bacteria in the complex pathophysiological mechanisms involved in psoriasis.

Eligibility criteria:
inclusion criteria: * over 18 years of age; * use of a free-preservatives soap with moisturizing function, applied once a day;pets. exclusion criteria: * no use of probiotics in the month prior the sampling; * no use of antibiotics in the month prior the sampling; * no treatment with corticosteroids, biological drugs, methotrexate or retinoids in the month prior the sampling; * no use of topical corticosteroids, vitamin d derivatives or phototherapy in the month prior the sampling; * no chronic or systemic infections; * no cutaneous acute infections during sampling; * no allergy to pollen, food and drugs * no pets.

Keywords: psoriasis guttate, psoriasis vulgaris
diagnostic capacity of keratoconus match index and keratoconus match probability in forme fruste keratoconus

Conditions: Forme Fruste Keratoconus (FFK)

Summary: primary objective of this study was to evaluate the diagnostic capability of keratoconus match index (kmi) and keratoconus match probability (kmp) indexes in forme fruste keratoconus (ffk), and their association with a series of pentacam-derived keratconus (kc) indexes. kmi and kmp parameters are kc-specifc indexes that are measured by ocular response analyzer (ora), based on the distinct ora-derived waveform characteristics of kc eyes. study participants were recruited from the cornea outpatient service in a consecutive if eligible basis. two study groups were formed: a) ffk group (ffkg) that included patients diagnosed with ffk, and, b) control group (cg) was formed by refractive surgery candidates. all ora (reichert ophthalmic instrument, buffalo, ny, usa, software version: 3.01)and pentacam (pentacam hr, oculus optikgerate gmbh, heidelberg, germany)measurements were performed by the same experienced operator in a consistent way


Eligibility criteria:
inclusion criteria: * diagnosis of keratoconus kc in the fellow eye according to the amsler-krumleich criteria (ffkg) * kisa index between 60 and 100% in the ffk eye (ffkg) * lack of any kc-related findings / signs in the slit-lamp biomicroscopy (ffkg) * uneventful ophthalmologic history (cg) * no indications of corneal pathology in slit-lamp biomicroscopy and placido disk-based videokeratography (cg) * kisa index value less than 60% (cg) exclusion criteria: for both study groups: * previous incisional eye surgery * corneal scars and opacities * history of herpetic keratitis, severe eye dryness * pregnancy or nursing * current corneal infection * glaucoma * suspicion for glaucoma * iop lowering treatment * underlying autoimmune disease

Keywords: keratoconus match index keratoconus probability index ocular response analyzer pentacam forme fruste keratoconus
effects of neuromuscular electrical stimulation in patients with congestive heart failure

Conditions: Heart Failure

Summary: this study intends to treat patient with congestive heart failure that are maximized their pharmacological treatment and at heart transplant wait list. all patients in the treatment arm will receive electric muscular stimulation with a russian current protocol twice a week for 7 weeks. the outcome will be assessed by the improvement in quality of life and functional capacity.

the neuromuscular electrical stimulation (nmes) has been used as adjuvant treatment in patients with end-stage congestive heart failure. those patients are limited to perform conventional physical activity and adherence to any every day protocols frequency. the aim of this study was evaluated the effect on functional status and quality of life after nmes treatment using russian stimulation wave solely twice a week during five weeks period in patients waiting for a heart transplant. inclusion criteria: age between 30 to 80 years old congestive heart failure in nyha class iii or iv ejection fraction lower than 35% stable clinical status full pharmacologic treatment exclusion criteria: unstable angina ventricular arrhythmia intermittent lameness inferior limb amputation protocol design: patients at waiting list for heart transplant will be invited to participate on protocol of nmes using russian stimulation wave (2.5 khz, burst at 50hz, on/off: 3/9 sec), named nmes group or sham stimulation, named control group. the nmes will be applied for 50 minutes, twice a week on both quadriceps femoral muscles during 7 weeks. the patients will be evaluated every week for distance walked during six minutes walk test (6mwt), heart rate variability, and functional status according to new york heart association. all patients were evaluated at the beginning and after completion of the protocol for quality of life with minnesota living with heart failure questionnaire (lhfq).

Eligibility criteria:
inclusion criteria: * patients on waiting list for heart transplant exclusion criteria: * patients that won't accept to participate in the protocol

Keywords: heart failure, heart transplant, electrical stimulation