Kornimate/medical-research-clean huggingface dataset:
ckd-828(80/2.5mg) pharmacokinetic study

Conditions: Hypertension

Summary: the purpose of this study is to evaluate the pharmacokinetic characteristics of ckd-828(fixed dose combination tablet; telmisartan and s-amlodipine) in healthy volunteer.


Eligibility criteria:
inclusion criteria: * a healthy volunteer between 20 and 55 years old with body weight within 20% of ideal body weight. * have not any congenital or chronic diseases and medical symptom. * appropriate for the study judging from examinations(interview, vital signs, 12-lead ecg, physical examination, blood, urinalysis result on screening). * able to participate in the entire trial. * signed the informed consent form prior to the study participation. exclusion criteria: * take metabolic enzyme inducing or inhibiting drugs like barbiturates within 28 days prior to the first ip administraion. * the evidence of acute disease within 28 days prior to the first ip administraion. * disease(ex: imflammatory intestinal disease, gastric or duodenal ulcer ,hepatic diseasehistory , gastro intestinal surgery exept for appendectomy)that may influence on the absorption, distribution, metabolism and excretion of the drug(s). * relevant hypersensitivity against drug or clinically significant allergic diseases except mild rhinitis that doesn't need medication. * hypersensitivity telmisartan or amlodipine. * sbp\<90mmhg or dbp\<50mmhg. * abnormal laboratory result(s): ast or alt \> 1.25 times of upper limit / total bilirubin \> 1.5 times of upper limit. * a drug abuse or a heavy caffeine consumer (more than 5 cups per a day) or a heavy smoker(more than 10 cigarettes per a day) or a regular alcohol consumer(more than 30g/day) or drinking within 7days prior to the first ip administration. * diet(especially, grapefruit juice-within 7 days prior to the first ip administraion) that may influence on the absorption, distribution, metabolism and excretion of the drug(s). * donated whole blood within 60 days prior to the first ip administraion. * participated in the other clinical trials within 90days prior to the first ip administraion. * medicine within 10 days prior to the first ip administraion? does the medication affect this trial. * a pregnant or nursing women who does not use medically acceptable birth control. * appropriate for the trial judging from principal investigator.

Keywords: ckd-828 hypertension primary hypertension healthy volunteer s-amlodipine telmisartan amlodipine pharmacokinetic phase 1
a study comparing mircera and epoetin beta for the treatment of anemia in dialysis patients with chronic kidney disease.

Conditions: Anemia

Summary: this 2 arm study will compare the effect on hemoglobin response of mircera and epoetin beta, in patients with chronic renal anemia who are on dialysis. eligible patients will be randomized to receive either mircera (0.4 micrograms/kg i.v. every 2 weeks) or epoetin beta (3 times weekly, according to approved labelling). the anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * chronic renal anemia requiring dialysis; * maintenance hemodialysis or peritoneal dialysis for \>=2 weeks before and during screening; * adequate iron status. exclusion criteria: * previous epoetin treatment within 8 weeks prior to screening; * failing renal graft in place; * bleeding episode necessitating transfusion within 8 weeks prior to screening; * poorly controlled hypertension; * previous treatment with mircera.
the efficacy of an acupuncture protocol and use of taping in the treatment of spastic upper limb after stroke

Conditions: Stroke; Cerebrovascular Stroke

Summary: the purpose of this study is to determine whether acupuncture and taping are effective in the treatment of spastic upper limb after stroke.

acupuncture and taping have emerged as treatment alternatives for many diseases with positive and satisfactory results. thus, acupuncture seeks to balance all physiological systems, using specific points on the body where needles are inserted. in turn, the use of taping is associated to various benefits such as improved blood and lymphatic function. in addition, it assists in the correction of muscle function and in the decrease of pain for neurological suppression. the constant afferent mechanical and somatosensory stimuli are perceived in cortical level and may produce motor unit recruitment and contribute to neuroplasticity of the nervous system. thus, this research aims to analyze the effects of acupuncture associated with functional taping on patients' upper limb with chronic hemiparesis after stroke through a prospective, randomized intervention. seventy-five patients will be evaluated before and after intervention with acupuncture and / or function taping, divided into three groups (acupuncture, functional taping and acupuncture plus functional taping). the evaluation will consist of isokinetic, mini-mental state examination, modified ashworth scale, motor activity log, wolf motor function test and visual analog scale of pain. the results will be analyzed and presented descriptively, as of statistical comparisons of pre- and post-treatment and the relationship between the groups.

Eligibility criteria:
inclusion criteria: * patients with stroke diagnosis for at least six (06) months, who present hemiparesis in upper limb; * to accept participate in the study by signing theterms of consent; * do not have any cognitive impairment. exclusion criteria: * do not follow the inclusion criteria; * to present shoulder subluxation or dislocation, shoulder pain syndrome or amputations (with or without the use of aids); * to present any allergic reaction due to use of bandage and/or do not adapt to treatment with needles.
effect of preoperative vitamin d supplementation in liver transplant recipients with vitamin d deficiency on post transplant outcomes

Conditions: Post Liver Transplant Infection

Summary: liver transplantation (lt) remains the ultimate option to cure intractable end stage liver disease. vitamin d deficiency is very common in these subsets of patients. vitamin d is involved in calcium metabolism and bone mineralization, regulation of cytokines, immunomodulation, cellular proliferation and differentiation. its deficiency can lead to immune dysregulation, and is associated with the development of viral and bacterial infections, cardiovascular and autoimmune diseases, and several types of cancer. to the best of our knowledge, there are no randomized studies which analyze the effect of vitamin d supplementation preoperatively on post liver transplant outcomes. this double blinded placebo-controlled randomized study aims to analyze the effect of preoperative supplementation of vitamin d in patients with vitamin d deficiency on post liver transplant outcomes. all eligible adult patients with chronic liver disease and vitamin d deficiency undergoing liver transplant during the study period will be included in the study and randomized into two groups. one group will receive oral vitamin d3 - 60000 iu - once a week pre liver transplant for a minimum of 6 weeks and the other will receive placebo once a week for a minimum of 6 weeks in addition to 3 months vitamin d supplementation post liver transplant in both arms. all liver transplant recipients with vitamin d deficiency will be screened in the pre-operative period in the outpatient department. pre-operative, intra-operative and post-operative data will be collected from medical records, electronic hospital information system (his) and radiological images collected from the hospital picture archiving and communication system(pacs). the enrolled subjects will be followed up till for a period of 3 months after the liver transplant and the post transplant bacterial infection rates will be compared between the two groups along with other parameters.


Eligibility criteria:
inclusion criteria: * all adult patients \>18 yrs with cirrhosis of liver and vitamin d deficiency ( defined as levels \< 30 ng/ml) undergoing liver transplant. exclusion criteria: * negative consent pediatric patients infection at the time of liver transplant acute liver failure deceased donor liver transplant patients undergoing re liver transplant patients already receiving vitamin d supplements. patients with hypoparathyroidism/ hyperparathyroidism h/o other solid organ transplantation patients needing urgent liver transplant before 6 weeks of vitamin d supplementation. patients with vitamin d levels \< 10 ng/ml patients with osteoporosis ( dexa bmd t score \<-2.5)
music for anxiety in embryo transfers

Conditions: REPRODUCTIVE TECHNIQUES; Embryo Transfer; Music; Test Anxiety; Patient Satisfaction

Summary: the goal of this clinical trial is to compare if playing music before and during an embryo transfer can make a difference for women who are going through a frozen embryo transfer as part of a medical procedure called assisted reproduction technology (art). the main questions it aims to answer are: * does listening to music before and while having the embryo transfer make patients feel more satisfied and less anxious? * does listening to music before and during the embryo transfer affect how likely it is for the woman to get pregnant? before the embryo transfer, the participants will listen to music through earphones or speakers. during the embryo transfer, the participants will listen to music through speakers. during the embryo transfer, the comparison group will not listen to music and will receive the usual care. the aim is to see if listening to music before and during the embryo transfer can help make the procedure better for women.


Eligibility criteria:
inclusion criteria: * women undergoing a frozen embryo transfer as a consequence of an art technique exclusion criteria: * gestational carriers * hearing-impaired or deaf persons * fresh embryo transfers

Keywords: music embryo transfer randomized controlled trial anxiety satisfaction
effect of alkali therapy on vascular and graft function in kidney transplant recipients

Conditions: Metabolic Acidosis; Kidney Transplant; Complications; Vascular Diseases

Summary: lower serum bicarbonate levels, even within the normal laboratory range, in kidney transplant recipients (ktrs) are associated with an increased risk of graft loss, cardiovascular events and mortality. because acid retention is common in ktrs, it is plausible that alkali therapy in ktrs may also result in improved vascular and graft function. the investigators will perform a randomized, double-blinded, placebo-controlled, 12 month study in 120 ktrs to examine the effect of sodium bicarbonate therapy on surrogate markers of cvd and graft function. the overall hypothesis is that treatment with bicarbonate will improve indicators of vascular and graft function in ktrs by decreasing complement activation.


Eligibility criteria:
inclusion criteria: * age 18-80 years * serum bicarbonate 16-24 meq/l on 2 separate measurements (at least 1 day apart) * kidney transplant received 1 year prior to randomization * egfr ≥ 45 ml/min/1.73m2 by ckd-epi equation * blood pressure \<130/80 mm hg prior to randomization * bmi \< 40 kg/m2 (fmd measurements can be inaccurate in severely obese patients). * able to provide consent * immunosuppression regimen consisting of tacrolimus, mycophenolate mofetil and prednisone (95% of patients at university of colorado are on this regimen) * stable immunosuppression regimen for at least three months prior to randomization * stable anti-hypertensive regimen for at least one month prior to randomization * not taking medications that interact with agents administered during experimental sessions (e.g. sildenafil interacts with nitroglycerin). exclusion criteria: * significant comorbid conditions that lead the investigator to conclude that life expectancy is less than 1 year * use of chronic daily oral alkali within the last 3 months (including sodium bicarbonate, calcium carbonate or baking soda) * uncontrolled hypertension * serum potassium \< 3.3 or ≥ 5.5 meq/l at screening * new york heart association class 3 or 4 heart failure symptoms, known ef ≤30%, or hospital admission for heart failure within the past 3 months * nephrotic range proteinuria (urine complement activation fragment measurements may not be accurate with severe proteinuria) * factors judged to limit adherence to interventions * current participation in another research study * pregnancy or planning to become pregnant or currently breastfeeding * chronic use of supplemental oxygen * use of anticoagulants
powerassert radio-frequency (rf) guidewire coronary in-stent chronic total occlusion (cto)

Conditions: Coronary Artery Disease

Summary: a single center pilot clinical registry study of the" acute procedural" safety and efficacy of stereotaxis powerassert(tm)rf coronary total occlusion system assisted angioplasty in the treatment of refractory coronary total occlusions

determine the safety and efficacy of the stereotaxis powerassert™ 18 rf wire system: primary - of recanalizing (crossing) coronary total occlusions within a stent. secondary - facilitated angioplasty at hospital discharge represented by * event free survival * anginal status, and * target vessel patency * minimal luminal diameter (mld).

Eligibility criteria:
inclusion criteria: * patient eligible for elective revascularization of a native coronary vessel * patient has refractory coronary total occlusion (thrombolysis in myocardial infarction (timi) 0 flow) within a stent * written informed consent obtained exclusion criteria: * under 18 years of age * current participation in another study with any investigational drug or device -\>timi 0 flow at target lesion site * lesion \>40mm. in length * factors making follow-up or repeat angiography difficult or unlikely * acute myocardial infarction less than 1 month before angioplasty * contra-indication to emergency coronary artery bypass surgery * no access to cardiac surgery * contra-indication to treatment with aspirin, ticlopidine, clopidogrel or heparin * angiographic evidence of thrombus (filling defect proximal to or involving the occlusion) * occluded ostium of the right coronary artery or stem of left main coronary artery as target lesion * totally occluded bypass graft as target vessel * occlusion in an unprotected left main coronary artery * ejection fraction less than 30% * lesion beyond acute bends or in a location within the coronary anatomy where the catheter cannot traverse * lesion within a bifurcation with a significant sidebranch \>1.5mm in diameter

Keywords: coronary artery chronic total occlusion in-stent
the impact of inhalation vs total intravenous anesthesia on the immune status and mortality in patients undergoing breast cancer surgery: a prospective double-blind randomized clinical trial.

Conditions: Anesthesia; Breast Cancer

Summary: even decade ago it was believed that the choice method of anesthesia did not affect the course of the oncological process, but recent evidence has begun to emerge that inhalation anesthesia vs tiva is associated with a higher number of adverse outcomes. apparently, it makes sense to conduct mrct in order to assess the effect of ia on immune system in patients operated on for breast cancer comprehensively. the results of that kind of rct may finally give us an answer whether the choice of anesthesia affects the immune status of patients undergoing surgery for breast cancer. the evaluation of complications and long-term survival will allow to recommend to use or not to use ia for this type of surgery. objective: the impact of inhalation vs total intravenous anesthesia on the immune status and mortality in patients undergoing breast cancer surgery

the power calculation for this study was based on an assessment of neutrophil-lymphocyte ratio (nlr) in patients undergoing breast cancer resection with total intravenous and inhalation anesthesia in two studies: 1. cho j.s. et al., 2017 - 48 patients (pmid: 28924368, tiva group: nlr = 3.37 ± 1.27; inhalation group: nlr = 3.85 ± 1.46) 2. ní eochagáin a. et al., 2018 - 116 patients (pmid: 29457215, tiva group: nlr = 3.20 ± 1.37; inhalation group: nlr = 4.10 ± 1.90). the pooled mean nlr in the tiva group is 3.25±1.34, in the inhalation anesthesia group: 4.03±1.78. difference in means (effect size): 0.78, for level α=0.05, power 1-β=80% and expected standard deviation of 1.5, 65 patients in each group should be recruited, taking into account a 10% margin (total number of patients: 130).

Eligibility criteria:
inclusion criteria: * the age of the patients is from 45 to 74 years; * primary operable breast cancer (bc) without prior chemotherapy; * cytologically confirmed breast malignant tumor of ia-iia stages (t1-2, n0, m0); * signed informed consent. exclusion criteria: * acute cerebrovascular accident (cva) occurred in the previous 6 months; * myocardial infarction (mi) occurred in the previous 6 months; * acute arterial thrombosis occurred in the previous 6 months; * acute venous thromboembolism occurred in the previous 6 months; * subarachnoid hemorrhage occurred during the previous 3 months; * chronic kidney disease (ckd) stage 3b-5; * сhronic heart failure (nyha) class 3-4; * pregnancy; * history of another location cancer; * history of drug addiction; * autoimmune diseases in history; * post-randomization: withdrawal of informed consent (refusal to continue participating in the study); * post-randomization: surgical intervention, performed not in full (verified non-resected lesions in the early p/o period, 2 weeks p/o).

Keywords: anesthesia breast cancer phagocyte cell dysfunction immune suppression inhalation anesthesia volatile anesthesia total intravenous anesthesia interleukins phagocytosis neutrophil-lymphocyte ratio natural killers oncology
the supraspinal control of lower urinary tract function in patients with orthotopic sigmoid neobladder.

Conditions: Orthotopic Neobladder

Summary: orthotopic sigmoid neobladder surgery is one of the ideal urinary diversion methods after radical cystectomy.in recent years, functional imaging studies have revealed brain regions related to urinary system function, but brain activity of lower urinary tract function in neobladder patients is still unclear.the aim of this study is to explore the brain activity of urination intention and self-controlled urination behavior in patients with orthotopic sigmoid neobladder by task-state functional magnetic resonance imaging (fmri).


Eligibility criteria:
inclusion criteria: 1. being right-handed; 2. 3 months or more after operation; 3. no contraindications to fmir examination; 4. voluntarily sign informed consent. exclusion criteria: 1. history of bladder radiotherapy; 2. history of prostate cancer; 3. suffering from diseases affecting abdominal pressure; 4. history of abnormal brain anatomy, craniocerebral surgery, craniocerebral tumor, and craniocerebral radiotherapy; 5. history of mental disorders, parkinson's disease, alzheimer's disease, epilepsy, cerebral infarction, cerebral hemorrhage; 6. claustrophobia or carrying metal implants that are not suitable for fmri examination; 7. diseases affecting lower urinary tract function (such as spinal cord injury, diabetic peripheral neuropathy, etc.); 8. urethral stricture; 9. refusing to sign the informed consent form for clinical projects; 10. other conditions that were not suitable for inclusion according to the investigator's judgment.

Keywords: orthotopic neobladder functional magnetic resonance imaging neuroimaging study lower urinary tract function bladder cancer
erythropoietin effect on ischemic_ reperfusion injury in coronary artery bypass graft surgery

Conditions: Myocardial Ischemic Reperfusion Injury

Summary: the aim of this trail is to assess the safety and therapeutic effects of single epo intervention in different times during coronary surgery in changes of inflammatory response.

in addition to well-known effect of erythropoietin (epo) on erythropoiesis in hypoxic conditions, some lines of evidence suggest its protective effects against reperfusion injury in several tissues by its specific receptor. preclinical studies have indicated a broad variety of cardioprotective actions for epo. it improves cardiac function and exercise capacity in congestive heart failure, angiogenesis, limit myocardial inflammatory response, cardiac remodeling, infarct size and apoptosis extension induced by reperfusion injury. activation of epo receptor in endothelial and cardiac cells is suggested to attenuate proinflammatory cytokines production and inflammatory cells infiltration, and increasing nitric oxide production through possible mechanisms. reperfusion injury is unavoidable event during cardiac surgery using cardiopulmonary bypass.it is associated with inflammation, cell injury and attenuate contractility property. although it is an area of concern and many clinical studies have been designed by different interventions, it remains a major challenge. epo intervention during heart reperfusion (surgery/ percutaneous angioplasty) as a new promise of cardioprotection strategy is the main design of several studies with conflicting results .

Eligibility criteria:
inclusion criteria: * revascularization requirement according to angiographic evidence * elective coronary artery bypass graft surgery * first time coronary artery bypass graft surgery * on-pump coronary artery bypass graft surgery exclusion criteria: * history of myocardial infarction in the past 3 months * previous myocardial trauma or major surgery in the past 3 months * cr\>2mg/dl * receiving streptokinase or previous reperfusion treatments * erythropoietin intake in the recent 6 months * known thromboembolic disorder and malignant disease * uncontrolled hypertension * polycythemia * previous valvular surgery

Keywords: coronary artery bypass erythropoietin inflammation il-6 reperfusion injury ykl- 40
a study of orforglipron (ly3502970) in participants with type 2 diabetes and inadequate glycemic control with insulin glargine, with or without metformin and/or sglt-2 inhibitor

Conditions: Type 2 Diabetes

Summary: the main purpose of this study is to determine the safety and efficacy of orforglipron. participants will have type 2 diabetes (t2d) and have inadequate glycemic control with insulin glargine with or without metformin and/or sglt-2 (sodium-glucose cotransporter-2) inhibitor. the study will last about 46 weeks and may include up to 20 visits.


Eligibility criteria:
inclusion criteria: * have type 2 diabetes (t2d) * have hba1c ≥7.0% \[53 mmol/mol\] to ≤10.5% \[91 mmol/mol\] * have been treated with stable doses of the same formulation of the following for ≥90 days prior to screening visit 1 and have maintained the same doses through randomization: * insulin glargine u-100 (100 u/ml) ≥0.25 u/kg/qd (units per kilogram per day) or ≥20 u/qd alone, or * insulin glargine u-100 (100 u/ml) ≥0.25 u/kg/qd or ≥20 u/qd in combination with * metformin, or * sglt-2 inhibitor, or * both metformin and sglt-2 inhibitor. * are of stable body weight (±5%) for at least 90 days prior to screening visit 1 and agree to not initiate an intensive diet or exercise program during the study with the intent of reducing body weight, other than the lifestyle and/or dietary measures for diabetes treatment. * have a body mass index (bmi) ≥23.0 kg/m\^2 at baseline. exclusion criteria: * have new york heart association functional classification iii-iv congestive heart failure. * have had any of the following cardiovascular conditions within 60 days prior to baseline. * acute myocardial infarction * cerebrovascular accident (stroke), or * hospitalization for congestive heart failure. * have acute or chronic hepatitis, including a history of autoimmune hepatitis, signs or symptoms of any other liver disease other than nonalcoholic fatty liver disease * have had chronic or acute pancreatitis any time.