Kornimate/medical-research-clean huggingface dataset:
a clinical study to evaluate the efficacy and safety of ckd-351

Conditions: Primary Open-angle Glaucoma; Ocular Hypertension

Summary: the purpose of this study is to evaluate efficacy and safety of ckd-351.

multi center, randomized, double-blind, active controlled, parallel design, phase 3 trial to evaluate the efficacy and safety of ckd-351 in primary open angle glaucoma or ocular hypertension patients.

Eligibility criteria:
inclusion criteria: 1. more than the age of 19 years old 2. subjects who has primary open-angle glaucoma or ocular hypertension 3. subjects who sign on an informed consent form willingly exclusion criteria: 1. subjects with iop(intraocular pressure) ≥35 mmhg at visit 1 and visit 2 (am 09:00) at more than one eye 2. subjects with a maximum corrected visual acuity ≤ 0.3 in the selected evaluation eye at visit 2 3. subjects who were diagnosed as below with monocular or both eye * acute or chronic closed-angle glaucoma * secondary glaucoma * pseudoexfoliation glaucoma * neovascular glaucoma * aphakia * phacocyst capsular torn intraocular lens 4. subjects with significant eye symptoms/signs(abscesses, diplopia) or severe visual field impairment(mean deviation ≥ -25db) 5. subjects with severe dry eye syndrome or progressive retinal disease(retinal degeneration, diabetic retinopathy, retinal detachment, macular edema) 6. subjects with inflammatory/infectious eye disease and active eye disease within the last 3 months 7. subjects who have medical history following * subjects with significant history of ocular trauma during the last 6 months, or who underwent surgical ophthalmic surgery * subjects who received topical or systemic steroids within the last 1 months 8. subjects who wore need to wear contact lenses during the study 9. women who are nursing, pregnant or planning pregnancy during the study 10. subjects with bronchial asthma or history 11. subjects with severe renal impairment (creatinine clearance \<30 ml / min at screening) or hyperchloremic acidosis 12. subjects who have received any other investigational product within 1 month prior to randomization 13. impossible subjects who participate in clinical trial by investigator's decision

Keywords: primary open-angle glaucoma ocular hypertension ckd-351
risk factor control before orthopedic surgery

Conditions: Osteoarthritis; Cardiovascular Disease

Summary: this trial is designed to determine the best preoperative management strategy for patients undergoing orthopedic surgery.

optimize - os (optimization of pre-surgical testing with an intensive multifactorial intervention to minimize cardiovascular events - orthopedic surgery) trial is to determine the best management strategy for patients undergoing orthopedic surgery. optimize will be a prospective randomized trial that will enroll patients during pre-surgical testing before orthopedic surgery. this trial will investigate different strategies aimed at lowering cardiovascular events following orthopedic surgery. the study will compare an intensive multifactorial intervention comprising behavioral modification and polypharmacologic therapy aimed at several modifiable risk factors versus usual care. the trial hypothesis is that a personalized optimization approach is superior to usual care in reducing a composite of death, myocardial infarction, stroke, transient ischemic attack, myocardial necrosis, venous thromboembolism or thrombosis requiring reoperation at 30-days. secondary endpoints include length of stay, major bleeding, each individual endpoint from the primary endpoint, and quality of life.

Eligibility criteria:
inclusion criteria: * • ≥ 21 years of age * subjects undergoing open orthopedic surgery of the hip, knee or spine * surgery is scheduled at least 3 days after pat visit and no more than 14 days. * high risk subject cohort * coronary artery disease, or * cerebrovascular disease (prior stroke, tia or carotid artery disease (\>70% stenosis), or * peripheral artery disease, or * prior venous thromboembolism or arterial thromboembolism, or * age ≥ 60 years and 2 of the following * renal insufficiency (creatinine clearance \< 60ml/min) * diabetes * copd * hypertension * active smoker or stopped less than 30 days prior to consent * cancer (excluding bcc) * heart failure exclusion criteria: * • known intolerance to statins * subject is already on maximum dose statin (atorvastatin/lipitor 80mg daily or rosuvastatin/crestor 40mg daily) * bilateral renal artery stenosis * end stage renal disease (receiving dialysis or crcl \<30ml/min) * known allergy or intolerance to ace-inhibitor (other than cough) or angiotensin receptor blocker (e.g. angioedema, hyperkalemia) * known allergy or intolerance to beta blockers * known sick sinus syndrome not treated with permanent pacemaker * known greater than first degree av block not treated with a pacemaker * excessive alcohol intake * acute coronary syndrome requiring hospitalization within 1 month * stroke within 1 month * known pregnancy * severe co-morbid condition with life expectancy \< 6 months * inability to give informed consent or adhere to follow-up as per protocol * current participation in another investigational drug or device trial

Keywords: hypertension diabetes coronary artery disease peripheral vascular disease
interleukin-7 to improve clinical outcomes in lymphopenic patients with covid-19 infection (brazil cohort)

Conditions: COVID-19; Lymphocytopenia

Summary: comparison of the effects of cyt107 vs placebo administered by intra-muscular route (im) at 10μg/kg twice a week for three weeks on immune reconstitution of lymphopenic covid-19 patients

approximately forty-eight (48) participants will be randomized 1:1 to receive (a) intramuscular (im) administration of cyt107 at 10 μg/kg followed, after 72hrs of observation, by 10 μg/kg twice a week for 3 weeks (maximum 7administrations adjusted to patient's length of stay in the hospital) or (b)intramuscular (im) placebo (normal saline) at the same frequency. the aim of the study is to test the ability of cyt107 to produce an immune reconstitution of these patients and observe possible association with a clinical improvement. this cohort excludes oncology patients on treatment

Eligibility criteria:
inclusion criteria: 1. a written, signed informed consent, or emergency oral consent, by the patient or the patient's legally authorized representative, and the anticipated ability for participant to be re-consented in the future for ongoing study participation 2. men and women aged ≥ 25 - 80 (included) years of age 3. hospitalized patients with two absolute lymphocyte count (alc) ≤ 1000 cells/mm3, at two time points at least 24 hours apart, following hospitalization: 4. hospitalized patients with moderate to severe hypoxemia requiring oxygen therapy at \>4l per minute nasal cannula or greater to keep saturations \>90%, non-invasive positive pressure ventilation (e.g., bipap), or patients intubated / ventilated for respiratory failure 5. confirmed infection with covid-19 by any acceptable test available / utilized at each site 6. willingness and ability to practice contraception regardless of the gender of the patient during 5 months after last drug exposure 7. private insurance or government / institution financial support (through cms or other) exclusion criteria: 1. pregnancy or breast feeding 2. alt and/or ast \> 5 x uln 3. known, active auto-immune disease; 4. ongoing cancer treatment with chemotherapy / immunotherapy or any cancer therapy within last 3 months and/or ongoing 5. patients with past history of solid organ transplant 6. active tuberculosis, uncontrolled active hbv or hcv infection, hiv with positive viral load 7. hospitalized patients with refractory hypoxia, defined as inability to maintain saturation \>85% with maximal available therapy for \>6 hours 8. patients receiving any agent with immune suppressive effects, other than steroids at dosages less than 300 mg/day equivalent hydrocortisone and/or anti-il-6r treatments like tocilizumab or sarilumab or anti-il-1 treatment like anakinra which should preferably be minimized 9. patients with baseline rockwood clinical frailty scale ≥ 6 at hospital admission 10. patients showing an increase of the news2 score by more than 6 points during the screening/ baseline period (48 to 72 hrs prior to first administration) 11. patients under guardianship
adductor canal block versus lumbar plexus block for post operative pain management after total knee replacement

Conditions: Pain Management

Summary: adductor canal block (acb), saphenous nerve block, which is a block of a purely sensory nerve which shares in nerve supply of knee joint has a hypothetical advantage of better pain management with less motor affection. also, it has a clear anatomical landmark that will increase the success rate (femoral artery) (\*).on the other hand, being a branch of the femoral nerve and far distal from the plexus, this can decrease the blocking effectiveness. likewise, the great variation of the knee nerve supply. this prospective double-blinded randomized controlled trial is comparing ultrasound guided adductor canal block (acb) versus ultrasound-guided lumbar plexus block (lpb) in patients undergoing total knee arthroplasty aiming at decreasing post-operative pain, helping in early mobilization and better physiotherapy. this study hypothesizes that acb, compared with lpb, will exhibit less motor, weakness, fewer opioids consumption with the same or better pain score.

this prospective double-blinded randomized controlled trial is comparing ultrasound guided adductor canal block (acb) versus ultrasound-guided lumbar plexus block (lpb) in patients undergoing total knee arthroplasty aiming at decreasing post-operative pain, helping in early mobilization and better physiotherapy. this study hypothesizes that acb, compared with lpb, will exhibit less motor, weakness, fewer opioids consumption with the same or better pain score.

Eligibility criteria:
inclusion criteria: * asa i-ii * age more than 25 and less than 80 were included exclusion criteria: * patients with known allergy to the medications to be given * asa iii, iv * age less than 25 or more than 80 * dementia * deafness * psychological disease * difficult to communicate * cannot lay flat * inr more than 1.5 * low platelets (less than 100000/ml3) or with significant coagulopathy
dose-escalating safety study in subjects on stable statin therapy

Conditions: Hypercholesterolemia

Summary: the aim of this study is to assess the safety of varying doses of isis 301012 in subjects on stable statin therapy.


Eligibility criteria:
inclusion criteria: * on a stable dose of \>/= 40 mg simvastatin or atorvastatin daily for \>/= 3 months prior to baseline and expected to remain on this dose for the remainder of the study * ldl-cholesterol between 2.60 and 5.70 mmol/l (100 and 220 mg/dl), inclusive at screening * females not of childbearing potential. exclusion criteria: * history of chd or chd-equivalent (such as diabetes mellitus, or another clinical form of atherosclerotic disease, e.g., peripheral arterial disease, abdominal aortic aneurysm, or symptomatic carotid artery disease) * fasting triglyceride \>2.26 mmol/l (200 mg/dl) at screening * any uncontrolled medical/surgical/psychiatric condition, including conditions that may predispose to secondary hypercholesterolemia * current diagnosis or known history of complement deficiency or abnormality * a positive hepatitis b surface antigen or hepatitis c antibody, or a known positive hiv status * current diagnosis or known history of liver disease, or has an alt \>uln at screening * known history of fibromyalgia, myopathy, myositis, rhabdomyolysis, any unexplained muscle pain, or has a cpk \>uln at screening * malignancy within 5 years, except for basal or squamous cell carcinoma of the skin that has been adequately treated * the advisability of a subject taking any prescription medication (apart from simvastatin or atorvastatin) within 6 weeks prior to screening should be discussed with the isis medical monitor * subject unwilling to discontinue taking alternative/herbal medication for the duration of the study * history of drug abuse within 2 years of screening * subject unwilling to limit alcohol consumption for the duration of the study: male subjects to a maximum of 3 drinks (30 g) per day, and \<12 drinks (120 g) per week; female subjects to a maximum of 2 drinks (20 g) per day, and \<8 drinks (80 g) per week * known allergy or hypersensitivity to simvastatin * undergoing or has undergone treatment with another investigational drug, biologic agent, or device within 3 months, or 3 half lives, prior to screening, whichever is longer

Keywords: ldl-cholesterol apob-100 apob-48
effect of 37℃ non-ionic contrast agent during ercp procedure in hilar cholangiocarcinoma

Conditions: Cholangitis

Summary: the purpose of this study is to determine the effect of normal temperature and 37℃ non-ionic contrast agent acting on ercp-related cholangeitis after endoscopic retrograde cholangiopancreatography (ercp) in the treatment of hilar cholangiocarcinoma.

at present, the common used contrast agent in ercp is composed of ionic and non-ionic type, and the latter's advantages lie in its slighter toxic-and-side effect and favorable security. when heated to 37℃, the 20 ℃ contrast agents would be diluted to 50% consistency, then a shorter time period of its intravascular and other intracavitary stay would add to less cell damage. and the applications of heated non-ionic contrast agents could be found in computed tomography angiography(cta), hysterosalpingography (hsg) and cystourethrography, and consequently the patients with the intervention of heated non-ionic contrast agents felt more comfortable and fewer adverse reactions could be observed. nevertheless, heated contrast agent was rarely reported to act in ercp. it's theoretically possible that its heat-reduced lower mucosity could help the contrast agent itself to drainage, so that the incidence of cholangeitis could be under control.

Eligibility criteria:
inclusion criteria: * type ⅰ、ⅱ、ⅲ、ⅳ of hilar cholangiocarcinoma; * age: 18\~90 years old; * underwent diagnostic and therapeutic ercp; exclusion criteria: * coagulation dysfunction(inr\>1.3) or/and low peripheral blood platelet count （plt \<50x10\^9/l）; * preoperative acute cholangitis; * preoperative acute pancreatitis; * preoperative hemobilia or hemorrhage of digestive tract; * preoperative liver failure; * combined with mirizzi syndrome and intrahepatic bile duct stones; * preoperative malignant tumor of biliary system such as carcinoma of head of pancreas, gallbladder carcinoma; * biliary-duodenal fistula confirmed during ercp; * a history of reconstructive surgery for upper digestive tract except billroth ⅰand a history of cholangioenterostomy including cholangio-jejunostomy and side to side anastomosis of the bile duct and duodenum; * previous ercp; * pregnant women

Keywords: ercp contrast agent hilar cholangiocarcinoma cholangitis nonionic
a phase 1 safety study of the intravenous administration of thymosin beta in healthy volunteers

Conditions: Myocardial Infarction; Myocardial Ischemia

Summary: the purpose of this study is to determine whether the intravenous administration of single- and multiple-ascending doses of thymosin beta 4 is safe and tolerable in healthy volunteers.

the cardio-protective effect of tβ4 treatment was shown in a permanently ligated mouse model.the authors demonstrated that systemic tβ4 treatment (intraperitoneal, intracardiac, or i.p. plus intracardiac) every third day enhanced early myocyte survival and significantly improved cardiac function. several weeks after the heart attack, it was evident that mice treated with tβ4 had less muscle damage and stronger hearts compared with mice treated with placebo. specifically, tβ4 treatment significantly improved fractional shortening by about 60% and ejection fraction by about 100% and myocardial salvage by about 53% when compared with controls.

Eligibility criteria:
inclusion criteria: * in good health with no underlying medical condition that, according to the investigator, would place a subject at risk * having given written informed consent exclusion criteria: * evidence of any malignancy * use of any tobacco product within 7 years of study entry * pregnant or lactating women * history of drug abuse * clinically significant abnormal screening ecg * abnormal vital signs * use of systemic steroidal therapy), immunotherapy, cytotoxic, chemotherapy or any investigational drug or device within 30 days of study entry. topical steroids are allowed * women, 40 years of age and above, who have not had a mammography within one year of study entry * men and women, 50 years of age and above, who have not had a sigmoidoscopy within 5 years and colonoscopy within 10 years of study entry

Keywords: myocardial infarction myocardial ischemia myocardial diseases infarction
function of regulatory t cells improved by dexamethasone in graves' patients

Conditions: Graves' Disease

Summary: antithyroid drugs is the first choice treatment of graves' disease in china and europe. however,the relapse rate is very high (40-60%) after therapy withdrawal, and many patients need further treatment. in our previous study, a new treatment strategy for gd has been introduced. after methimazole (18 months) combined with intrathyroid injection of dexamethasone (dex) (3 months) treatment, the relapse rate of hyperthyroidism was markedly reduced compared with methimazole treatment alone (7.4% versus 51%) during the 2-year follow-up period. the results have been published in the 'j clin endocrinol metab, 2009,94:4984-4991'. however, the mechanism by which the dex reduces the relapse rate of gd is not fully understood. in vitro study, we have proven that dex could effectively improve the function of regulatory t (treg) cells and set up a new balance of t helper 1(th1)/th2 in gd patients(this results have been in press in the eur j endocrinol). in order to elucidate mechanism of this treatment strategy in vivo, we plan to recruit 20-30 patients with gd and treat those patients by intrathyroid injection of dex combined with methimazole, and the function of treg cells and balance of th1/th2 will be evaluated.


Eligibility criteria:
inclusion criteria: * gd patients will have been trated with methimazole and serum levels of tsh and ft4 should be in the normal range. exclusion criteria: * pregnancy * allergy to antithyroid drugs (atd) * alanine aminotransferase (alt) or aspartate aminotransferase (ast) levels more than two times the upper normal range * patients with coexistent endocrine or organ-specific autoimmune diseases (such as those with atopic dermatitis or bronchial asthma) * patients taking medications that could affect the immune system (such as corticosteroids), noncompliance because of psychiatric or other serious diseases * unwillingness to participate in the study.

Keywords: graves' disease dexamethasone function of regulatory t cells the proportion of th1 and th2 cells
oral and jaw health in bipolar patients

Conditions: Bipolar Disorders; Oral Health

Summary: the assessment of oral health, jaw health and related problems in bipolar patients is important to provide a holistic approach to patients in terms of physical, mental and psychosocial aspects and to improve quality of life. in this study, oral health, temporomandibular dysfunction (tmd) and oropharyngeal dysphagia (od) were investigated in patients with bipolar disorder (bd).

during the remission period, 70 individuals aged 20-60 years with bd were divided into two groups according to the duration of diagnosis as under ten years (group 1=33) and over ten years (group 2=37). oral and dental health-related quality of life was assessed with the oral health impact profile-14 (ohip-14), tmj pain was assessed with the numeric pain scale (nps), the presence of tmj discomfort was assessed with the fonseca anamnestic questionnaire (faq), chewing functionality was assessed with the jaw function limitation scale-8 (jfls-8), and oropharyngeal dysphagia was assessed with the eating assessment tool (eat-10).

Eligibility criteria:
inclusion criteria: * patients between 20 and 60 years of age who volunteered to participate in the study and signed the informed consent form, * diagnosed with bd at the outpatient department of bakırkoy prof. dr. mazhar osman mental health and neurological diseases training and research hospital, * in remission for at least 3 months, * had a history of regular lithium use for at least 1 year in any phase of the disease were included in the study. exclusion criteria: * being in a manic or depressive episode (young mania rating scale score greater than 7, hamilton depression rating scale score greater than 7) * history of comorbid psychiatric illness, * alcohol and substance use disorder, * cancer, neurological problems, congenital anomalies, musculoskeletal problems, systemic illness, * facial paralysis, * spinal, abdominal and/or tmj surgery, * and having received any spinal or tmj treatment in less than 6 months.

Keywords: bipolar disorders oral health temporomandibular disorders
long-term outcomes with abatacept in biologic treatment-naive rheumatoid arthritis patients in japanese clinical practice settings

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to examine the effectiveness and safety of the abatacept administration in biologic-naïve rheumatoid arthritis patients who have moderate disease activity despite treatments with conventional synthetic disease modified anti-rheumatic drugs.


Eligibility criteria:
inclusion criteria: * patients with ra who meet the 2010 american college of rheumatology / european league against rheumatisms (acr/eular) ra classification criteria * patients with ra with a moderate disease activity (sdai: \> 11 and 26) * biologic-naive patients with treatment history csdmards * patients who meet the following criteria by hematological examination: * peripheral white blood cell count: 4,000/mm3 * peripheral lymphocyte count: 1,000/mm3 * blood β-d-glucan negative * patients who understand the investigator's explanation of study procedures and have given voluntary written consent to participate in this study * patients initiated with abatacept at per their physician's therapeutic decision exclusion criteria: * past history of hypersensitivity to the components of the abatacept preparation * disease complications from a comorbidity * active infectious disease * been judged by the investigator or the co-investigator as being inappropriate other protocol defined inclusion/exclusion criteria could apply
arthroscopic versus conservative treatment of degenerative meniscal tear in middle aged patients in regard to pain & knee function

Conditions: Knee Pain Chronic

Summary: the study is prospective comparative study, conducted in erbil teaching hospital on 60 patients, their age ranging between 40 and 60 years. all were clinically diagnosed to have degenerative medial meniscal tear then confirmed by mri. thirty patients were treated conservatively, thirty patients were treated arthroscopically.


Eligibility criteria:
inclusion criteria: 1. atraumatic continuous pain in medial aspect of knee affecting daily activities, for more than one month despite the treatment of general physician. 2. grade 3 degenerative tear of medial meniscus approved on mri. exclusion criteria: 1. meniscal tear due to trauma. 2. any rheumatologic knee disease. 3. mri showing ligament injury, loose bodies, tumors and osteochondral defects. 4. former surgery of knee and lower limb fractures in the last year. 5. knee joints with osteoarthritis graded 2 or more according to kellgren-lawrence scale (kellgren and lawrence, 1957) on weight-bearing knee x-ray. 6. lateral meniscus tear.

Keywords: degenerative meniscal tear arthroscopic partial meniscectomy conservative treatment medial meniscal tear