Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of paclitaxel-eluting balloon for treatment of lesions in native small coronary arteries

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to evaluate the efficacy and safety of paclitaxel-eluting balloon (sequent® please) for treatment of lesions in native small coronary arteries.

drug-eluting balloon (deb) have emerged as a potential alternative to overcome the limitations of drug-eluting stents such as restenosis or stent thrombosis. deb angioplasty is proven to be effective clinically for the treatment of in-stent restenosis. however, deb for de novo lesions, especially in small vessels is less studied. the purpose of this study is to evaluate the efficacy and safety of paclitaxel-eluting balloon (sequent® please) for treatment of lesions in native small coronary arteries.

Eligibility criteria:
inclusion criteria: * age ≥ 19 years * patients who are appropriate for percutaneous coronary intervention using drug-eluting balloon in native small coronary artery (vessel diameter ≥ 2.25 mm and ≤ 2.75 mm, lesion length \< 25 mm) * informed consent exclusion criteria: * chronic total obstruction lesion * severe calcified lesion * left main coronary lesion * lesion having intravascular thrombus * shock status from any cause including cardiogenic shock * left ventricular ejection fraction \< 30% * need for coronary artery bypass surgery * allergic reaction for paclitaxel * severe allergic for contrast agent (visipaque) or statin * pregnancy, breastfeeding or expectation for pregnancy in women of childbearing age

Keywords: coronary artery disease balloon angioplasty drug-eluting balloon
gut microbial changes after periodontal treatment

Conditions: Periodontitis; Dysbiosis; Intestinal Disease

Summary: periodontitis is a chronic inflammatory disease of the tooth supporting structures induced by a dysbiosis in the oral and subgingival microenvironment of susceptible patients. the long-term swallowing of high doses of periodontal pathogenic microorganisms could induce a dysbiosis of the intestinal microbiota, favouring the establishment of an 'inflamed' microbiome in terms of composition and/or function. the present project is aimed at a better understanding of the etiopathogenetic correlation between periodontitis and intestinal dysbiosis, and aims to explore the hypothesis that non-surgical periodontal treatment may reduce bacterial alpha diversity in stool samples. fifty patients affected by stage iii-iv periodontitis will be recruited, and treated by means of full-mouth scaling and root planing. salivary and stool samples, together with a complete periodontal charting and a food diary will be collected and compared at baseline and 3 months after treatment. age, gender and bmi-matched healthy individuals will be recruited as controls.


Eligibility criteria:
inclusion criteria: * periodontitis stage iii or iv * bmi between 20 and 29 kg/m2 * free diet * presence of at least 20 teeth exclusion criteria: * systemic diseases (including diabetes, thyroid, liver, or kidney diseases) * dietary allergies * use of antibiotics or probiotics during the previous 30 days * pregnancy or breast feeding
accuracy of glomerular filtration rate (gfr) estimation using creatinine and cystatin c and albuminuria

Conditions: Chronic Kidney Diseases

Summary: the egfr-c study will assess the accuracy of current and alternative tests of kidney function against a reference test in people with moderate (stage 3) chronic kidney disease (ckd).

the egfr-c study will assess the accuracy of current and alternative tests of kidney function against a reference test in people with moderate (stage 3) ckd. participants will be recruited from hospital clinics and general practitioner (gp) practices at six major united kingdom (uk) centres. the best measure of kidney function is accepted to be the glomerular filtration rate (gfr), which measures the ability of the kidney to filter blood and is widely used in clinical practice. a low gfr suggests poor kidney function. an estimate of gfr can be obtained from a simple blood test. participants will undergo reference gfr testing at study entry with a second follow-up reference test three years later. the reference test involves injecting a small amount of iohexol into a vein and taking blood samples over the next 4 hours to see how quickly the iohexol disappears from the blood stream as a result of glomerular filtration. the rate at which iohexol disappears is equivalent to the level of kidney function. blood tests for monitoring kidney function, including testing for creatinine and cystatin c, and measurement of urinary albumin will be done every six months during the study period. iohexol measured gfr will be accepted as the reference ('gold standard') measure of kidney function against which each gfr-estimating equations will be compared. the alternative estimated measures of gfr, derived from measuring substances (creatinine and cystatin c) in the blood, will be compared against the reference test. an important outcome is how much the reference test changes over the three years of the study, and how well the surrogate measures reflect this change. the investigators will also collect accurate test cost data for subsequent cost-effectiveness analysis (e.g. do the relative costs of the tests justify any change in practice due to improved performance of one test compared to another?).

Eligibility criteria:
inclusion criteria: * patients with stage 3 ckd (gfr 30-59 ml/min/1.73 m2) as defined internationally, diagnosed using mdrd/ckdepi egfr (at least two consecutive test results in this range at least 90 days apart, with the most recent test in the last 12 months) * aged 18 years or over * written informed consent exclusion criteria: * history of untoward reactions to iodinated contrast media or allergy to topical iodine * episode of acute kidney injury in previous 6 months (as defined by the acute kidney injury network criteria) * amputation of whole or part-limb * pregnant or breastfeeding * known current alcohol or drug abuse * kidney transplant recipient * any condition with an expected survival of less than study duration * inability to comply with study schedule and follow-up * inability to provide informed consent e.g. due to cognitive impairment

Keywords: egfr ckd cystatin creatinine albuminuria
phytoestrogens and memory decline in menopause

Conditions: Memory Loss; Postmenopause

Summary: the purpose of this study is to investigate whether soy-derived phytoestrogens taken as dietary supplements improve memory function in postmenopausal women who have experienced early memory decline.

accumulating data has indicated that estrogens mediate enhancing effects on cognition and mood and may play a prophylactic role against age- and disease-related cognitive-cerebral decline. phytoestrogens are plant-derived substances that have demonstrated estrogenic activity, but there is little prospective research regarding their effects on mental function. mental health practitioners generally do not prescribe phytoestrogens. however, many women experiencing peri- and post-menopausal symptoms use marketed phytoestrogens under the perception of general health benefits, including presumably enhanced mental function. the purpose of this study is to develop preliminary data regarding the efficacy of isoflavone phytoestrogens in improving cognitive function in late middle-aged and elderly postmenopausal women with symptoms of memory impairment. participants in this study will be randomized to receive either isoflavone supplementation or placebo. the study will last for 16 weeks, during which participants will take the supplement pill or placebo three times a day. participants will be assessed at study entry and at week 16 for changes in basal cortisol levels, mood, and neuropsychological measures of executive function ability and episodic memory.

Eligibility criteria:
inclusion criteria * postmenopausal women * mild memory or cognitive decline that does not meet the criteria for probable dementia exlcusion criteria * hormone replacement therapy within 2 months prior to study entry * psychiatric medications within 30 days prior to study entry

Keywords: postmenopausal memory loss cognition phytoestrogens
chronic obstructive pulmonary disease (copd) in patients hospitalized for acute decompensated heart failure.

Conditions: Disease

Summary: the presence of chronic obstructive pulmonary disease (copd) would confer increased in-hospital mortality and length of hospital stay in patients with acute decompensated heart failure assess the (1) prevalence of copd in patients who are hospitalized for acute decompensated heart failure and (2) the association between copd and in-hospital mortality or length of stay in this cohort.

background: the prevalence of mild to moderate copd is \~5%-10% with one-year mortality around 3% while heart failure affects is1%-3% with one year mortality 5-7% in the community. the mortality of copd and heart failure dramatically increase following hospitalization. heart failure and copd are independent predictors of increased morbidity and mortality. copd and heart failure frequently co-exist in an individual patient through the shared risk factors. the prevalence of copd in heart failure patient-population and vice verse varies widely according to patient-selection and age of the population. estimates suggest that copd is present in 10-40% of the patients with heart failure. conversely, unrecognized heart failure is identified in approximately 20% of the patient with copd. the impact of copd on clinical outcome in patients with acute decompensated heart failure is unclear. methods: this is an observational cohort study. per national registry, acute heart failure is defined as either new onset heart failure or decompensation of chronic established heart failure with symptoms sufficient to warrant hospitalization. the data related to the following variables would be collected: age, gender, severity of heart failure (mild, moderate, and severe prior to admission), presence of dyspnea, peripheral edema, crackles, systolic and diastolic blood pressure (on admission and on discharge), heart rate (on admission and on discharge), oxygen saturation (on admission and discharge), blood urea nitrogen (on admission and discharge), serum creatinine (on admission and discharge), serum sodium (on admission and discharge), hemoglobin (on admission and discharge), red cell distribution width (on admission and discharge), electrocardiographic intervals (on admission and discharge), comorbidities (coronary artery disease, chronic kidney disease, atrial fibrillation, diabetes, hypertension, dyslipidemia, peripheral artery disease, copd/asthma, left ventricular ejection fraction \>40%. medication use: angiotensin converting enzyme inhibitors, angiotensin receptor blockers, aspirin, metoprolol tartrate, metoprolol succinate, carvedilol, atenolol, amlodipine, cardizem, clopidogrel, digoxin, diuretics, statins, nitrates, warfarin, non-steroidal anti-inflammatory drugs, hydralazine. end-points: 1) all cause in-hospital death and 2) length of hospital stay between heart failure patients with copd and those with no copd.

Eligibility criteria:
inclusion criteria: * heart failure exclusion criteria: * ambulatory patients

Keywords: copd and heart failure
pilot study to evaluate clinical outcomes with the use of biovance following keloid scar revision surgery

Conditions: Keloid Scar

Summary: the main purpose of this study is to see if there is clinical benefit of using biovance in reduction of the recurrence of keloids when used to revise them. it will also assess the postoperative complications.

to assess the performance of biovance, patients will consulted regarding the history and previous treatment of their keloid. once patients are deemed to be appropriate candidates, they will be enrolled in the study. operatively, the old scar will be completely excised. then the biovance will be laid in the base of the wound. after this is performed, extensive undermining will be done to close the wound in layers. all post-revision complications (including infection, incision dehiscence, hematoma, seroma, and wound necrosis) will be assessed and recorded by the investigator. patients will be reviewed to obtain demographic and risk factor (such as age, body mass index, smoking) data. data on adjuvant therapy use (previous surgeries, treatments for keloid scar) will be collected. surgical technique details (such as incision size and closure technique) will also be recorded for each patient. photographs documenting the pre-, intra- and post-revision clinical course of patients will be collected.

Eligibility criteria:
inclusion criteria: the subject has: 1. been diagnosed with a keloid scar 2. a keloid scar that is located on the face, neck, arm, trunk, or groin area 3. is between the ages of 21 and 80 years old 4. competency as an adult, per applicable state law who is willing to provide written informed consent 5. the intent and ability to return for all scheduled and required visits and follow recommended standard post surgical treatment for keloid scar excision. exclusion criteria: the subject has: 1. clinical evidence of infection of the keloid scar 2. any malignancy or a neoplasm at the keloid scar site 3. any significant comorbid disease that may interfere with wound healing, known active hepatitis a, b, or c or acquired immune deficiency syndrome or is known to be infected with hiv, a known collagen disorder or autoimmune disease \[including systemic lupus erythematosis (sle), rheumatoid arthritis (ra),fibromyalgia, polymyositis, scleroderma, ankylosing spondylitis, dermatomyositis, osteogenesis imperfecta or the inherited disorders of sjogren, larsen, raynaud, ehlers-danlos or marfan syndrome\] 4. received chemotherapy, radiotherapy, immunosuppressives or corticosteroids (greater than 10 mg prednisone-equivalent per day) within the past 30 days. 5. a known history of abuse of alcohol or drugs (prescribed or illegal), significant psychiatric personality or psychotic disorder requiring chronic psychotropic therapy, or gross noncompliance to recommended therapies 6. condition(s) that would adversely affect subject safety by following the protocol 7. any contraindication for use of biovance
a study of ly3437943 in participants with type 2 diabetes mellitus (t2dm)

Conditions: Diabetes Mellitus, Type 2

Summary: the main purpose of this study is to learn about the side effects of ly3437943 when given to participants with type 2 diabetes. blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. each enrolled participant will receive injections of ly3437943, dulaglutide, or placebo given just under the skin. for each participant, the study will last up to about 5 months and will include 16 visits to the study center.


Eligibility criteria:
inclusion criteria: * have t2dm for at least 3 months before screening and are without advanced known possible complications of diabetes mellitus * have a glycated hemoglobin (hba1c) value at lead-in and screening of ≥7.0% and ≤10.5% and treated with diet and exercise alone or a stable dose of metformin for at least 3 months prior to screening * have had a stable body weight for the 3 months prior to randomization (\<5% body weight change) * have a body mass index of 23 to 50 kilograms per square meter (kg/m²), inclusive * male participants agree to use an effective method of contraception for the duration of the study plus 90 days, which corresponds to 4 months after the last investigational product dose * women not of childbearing potential may participate and include those who are: infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as mullerian agenesis; or those who are postmenopausal exclusion criteria: * have type 1 diabetes mellitus or latent autoimmune diabetes in adults * have uncontrolled diabetes, defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening * have a known clinically significant gastric emptying abnormality * have had an episode of severe hypoglycemia * have a history of acute or chronic pancreatitis or fasting serum triglyceride level of \>500 milligrams per deciliter (mg/dl) at screening and/or day-2. if participant is on lipid-lowering therapies, doses must be stable for 30 days prior to screening * have known liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or have elevations in aminotransferases (alanine aminotransferase \[alt\] and aspartate aminotransferase \[ast\]) greater than 3x upper limit of normal (uln) at screening and/or day -2
extracellular vesicles in fibrin gel for cartilage repair

Conditions: Joint Disease

Summary: this project aims to produce and study in vitro/ex vivo a platelet rich plasma (prp)-derived fibrin gel loaded with mesenchymal stromal cells (msc)-extracellular vesicles (evs), to combine the positive results on cartilage growth of prp growth factors and the hyaline cartilage stimulating activity of msc-evs. therefore, the project goal is to provide an advanced option for orthopedic patients with an innovative evolution of a gold standard procedure, making it easy to translate into daily clinical practice for physicians, healthcare professionals and patients.


Eligibility criteria:
inclusion criteria: * males and females ≥ 18 * patients undergoing plastic surgery procedures; * patients undergoing elective joint surgery with a diagnosis of knee or hip osteoarthritis (any kellgren-lawrence grade); * patients undergoing regenerative medicine treatments with prp with a diagnosis of knee or hip osteoarthritis (any kellgren-lawrence grade; * signed informed consent for the study exclusion criteria: * positive virological test (hiv, hcv, hbv, tpha) * pregnancy or breastfeeding by self-declaration * other conditions that, at the discretion of the investigator or the physician

Keywords: cartilage mesenchymal stromal cells extracellular vesicles platelet rich plasma
activated vitamin d for the prevention and treatment of acute kidney injury

Conditions: Critically Ill; Acute Kidney Injury

Summary: the purpose of this study is to assess the efficacy of calcifediol (25-hydroxyvitamin d) and calcitriol (1,25-dihydroxyvitamin d) in preventing and reducing the severity of acute kidney injury (aki) in critically ill patients.

decreased circulating levels of active vitamin d metabolites, including 25-hydroxyvitamin d (25d) and 1,25-dihydroxyvitamin d (1,25d), are common in critically ill patients, and lower levels are independently associated with a higher risk of acute kidney injury (aki). further, administration of 25d and 1,25d attenuates aki in animal models. the purpose of this study is to assess if administration of 25d and 1,25d decreases the incidence and severity of aki in critically ill patients.

Eligibility criteria:
inclusion criteria: * age ≥ 18 * admitted to the icu within 48h prior to enrollment * likely to remain in the icu (alive) for ≥72h * naso/orogastric tube or ability to swallow * high risk of severe aki exclusion criteria: * serum total calcium \> 9.0 mg/dl or phosphate \> 6.0 mg/dl within previous 48h * currently receiving oral calcium supplementation * ingestion of vitamin d3 \>1,000 iu/day or any 25-hydroxyvitamin d or 1,25-dihydroxyvitamin d during the previous 7 days * aki stage 2 or 3 (based on kdigo serum creatinine and/or urine output criteria) * history of transplantation or receiving chronic (\>7days) of immunosuppressive medications (not including glucocorticoid steroids at a dose less than or equivalent to prednisone 20 mg/day) * neutropenia in the previous 48h * active primary parathyroid disease, active granulomatous disease, or symptomatic nephrolithiasis in the previous 3 months * receiving cytochrome p450 inhibitors * chronic kidney disease stage v or end stage renal disease * hemoglobin \< 7 g/dl * gi malabsorption * prisoner * pregnancy or breast feeding
a placebo controlled trial of l-tryptophan in post-operative delirium

Conditions: Post-operative Delirium

Summary: post-operative delirium is a common and deleterious complication in elderly patients. the investigators have previously found lower levels of serum tryptophan in post-operative elderly patients who developed delirium in comparison to post-operative elderly patients who did not develop delirium. the investigators hypothesize that post-operative supplementation of l-tryptophan will reduce the duration and incidence of post-operative delirium. this study is a double-blinded placebo controlled trial of l-tryptophan supplementation in post-operative icu patients 60 years and older. the primary outcome measure is the comparison of duration of post-operative delirium in subjects who receive l-tryptophan supplementation versus a similar appearing control.

the sudy will compare rates and duration of postoperative delirium in groups that receive l-tryptophan supplementation compared to placebo.

Eligibility criteria:
inclusion criteria: * included subjects will be 60 years and older undergoing an operation with a planned icu admission post-operatively. exclusion criteria: * medications that, when combined with tryptophan, increase the risk of serotonin syndrome. the classes of medications include: * monoamine oxidase inhibitors * selective serotonin reuptake inhibitors * serotonin-norepinephrine reuptake inhibitors * triptans * opioids * central nervous system stimulants * bupropion * st. john's wort * patients who undergo an operation on their brain. * factors which prevent delirium assessment with the cam-icu: vision impairment or non-fluent english speakers. * a lowered seizure threshold including: * history of seizure disorder * alcohol abuse defined by a high audit score (\>8 females and \>13 males) * benzodiazepine or barbiturate abuse within three months of the study * or a positive urine toxicology screen for alcohol, benzodiazepines or barbiturates. * significant liver disease (child's class b or greater) or significant renal disease (creatinine ≥2.0). * history of huntington's or addison's disease. (as requested by the fda) * history of bipolar disorder or a psychotic disorder (such as a psychotic major depression, schizophrenia, schizoaffective disorder, or psychosis in alzheimer's disease or other dementia). (as requested by the fda) * women who are not post-menopausal. (as requested by the fda)

Keywords: delirium surgery operation geriatric complication
study to evaluate the impact of anti-cyclic citrullinated peptide(anti-ccp) for management with enbrel in patients with psoriatic arthritis(psa)

Conditions: Psoriatic Arthritis

Summary: this study is to evaluate the local data in iraqi patients with psoriatic arthritis on enbrel treatment with positive anti-cyclic citrullinated peptide using data from the rheumatologist in baghdad teaching hospital registry.


Eligibility criteria:
inclusion criteria: * diagnosed psa patients. * ≥18 years of age * have not received previous biological treatment exclusion criteria: * previous use of other biological treatments. * etanercept use for less than 1 year duration.