Kornimate/medical-research-clean huggingface dataset:
study of telmisartanfor the prevention of acute gvhd post allogeneic hematopoietic stem cell transplantation

Conditions: GVHD

Summary: this is single-center, open-label, prospective study of telmisartan for the prevention of acute gvhd in approximately 60 subjects undergoing allogeneic hct for treatment of a hematologic malignancy.

this is single-center, open-label, prospective study of telmisartan for the prevention of acute gvhd in approximately 60 subjects undergoing allogeneic hct for treatment of a hematologic malignancy. subjects will receive 160 mg micardis brand telmisartan once daily, starting 2 days prior to hct (day -2). once the patient is discharged post-hct, treatment will continue through day +98 post-hct for a total of 101 days. after treatment discontinuation on or before day +98 post-hct, subjects will be followed for up to 6 months for primary and secondary endpoints.

Eligibility criteria:
inclusion criteria: * diagnosis of: * acute myeloid or lymphoid leukemia in remission, * myelodysplastic syndrome, * chronic lymphoid leukemia, * non-hodgkin lymphoma, * hodgkin lymphoma, * chronic myeloid leukemia in chronic or accelerated phase, * myeloproliferative disorder, or * multiple myeloma * undergoing allogeneic hsc transplantation from a related or unrelated donor matched at least at 7 of 8 of the hla-a, -b, -c, and dr loci ("8/8" or "7/8" match) * undergoing allogeneic hsc transplantation after a myeloablative tbi-, busulfan-, or (non-myeloablative) melphalan-based pre-transplant conditioning regimen. regimens for transplantation will include at one of the following agents, given in conjunction with fludarabine or cyclophosphamide: * busulfan 130 mg/m2 iv daily x 2 (reduced intensity) or 4 days * tbi 150 cgy bid x8 doses (1200 gy) * melphalan 140 mg/m2. (although melphalan is not a myeloablative regimen, it results in clinically significant mucositis and patients receiving this medication will be of considerable interest in the analysis of these data.) * male or female patient age 18 years or older * karnofsky performance status \> 70% at time of initiation of pre-transplant conditioning * transplantation-specific co-morbidity score of \<5 at time of initiation of pre-transplant conditioning * patients taking antihypertensive medications (including telmisartan) are eligible but the patient must discontinue treatment at least 48 hours prior to first dose of study medication * capable of giving informed consent and having signed the informed consent form exclusion criteria: * inability to provide informed consent * subjects with known heart failure, advanced renal impairment requiring renal replacement therapy, or liver failure although these patients would most likely not be eligible for hct. * subjects taking ace inhibitors, potassium supplements, or spironolactone (or any other potassium-sparing diuretics) who cannot discontinue use prior to initiation of study treatment or who require a high-potassium diet * patient unable to discontinue current hypertension medication for medical or other reasons for two days prior to starting telmisartan * chronic symptomatic hypotension, volume depletion.
rifabutin therapy for the prevention of mycobacterium avium complex (mac) bacteremia in aids patients with cd4 counts = or < 200: a double-blind, placebo-controlled trial

Conditions: Mycobacterium Avium-intracellulare Infection; HIV Infections

Summary: the primary objectives of this trial are: to compare the safety of oral rifabutin versus placebo in the treatment of mycobacterium avium complex (mac) bacteremia in aids patients with cd4 counts less than or equal to 200 cells/mm3. to investigate the incidence of mac in these patients. a secondary objective is to compare clinical response, quality of life (karnofsky), and survival between these two groups.


Eligibility criteria:
inclusion criteria patients must have the following: * diagnosis of aids with a case defining infection other than mycobacterium avium complex (mac). * written informed consent. * females of childbearing potential must also sign a special informed consent. exclusion criteria co-existing condition: patients with the following conditions or symptoms are excluded: * known hypersensitivity to rifabutin, rifampin, other rifamycins, zidovudine or didanosine (ddi). * previous or current infection due to mycobacterium avium complex (mac) disease as evaluated by two successive blood cultures and two successive stool cultures taken within 14 days prior to study initiation. concurrent medication: excluded: * antiretroviral agents other than zidovudine (azt). * didanosine (ddi). * antimycobacterial therapy. * rifampin. * isoniazid. * clofazimine. * ethambutol. * cycloserine. * ethionamide. * amikacin. * ciprofloxacin. * streptomycin. * other investigational drugs. * if antimicrobial therapy is required to treat bacterial infections (= or \< 14 days), adria laboratories must be contacted prior to initiation of therapy. patients with the following are excluded: * known hypersensitivity to rifabutin, rifampin, other rifamycins, zidovudine (azt), or didanosine (ddi). * previous or current mycobacterium avium complex (mac) infection. * perceived patient unreliability or unavailability for frequent monitoring. prior medication: excluded within 4 weeks of study entry: * antiretroviral agents other than zidovudine (azt) or didanosine (ddi). * antimycobacterial therapy. * rifampin. * isoniazid. * clofazimine. * ethambutol. * cycloserine. * ethionamide. * amikacin. * ciprofloxacin. required: * zidovudine (azt). * antipneumocystis prophylactic therapy. required for at least 4 weeks prior to study entry: * zidovudine (azt) or didanosine (ddi). * antipneumocystis prophylaxis.

Keywords: rifabutin aids-related opportunistic infections mycobacterium avium-intracellulare infection acquired immunodeficiency syndrome antitubercular agents
efficacy and safety of azilsartan in participants with mild to moderate uncomplicated essential hypertension

Conditions: Essential Hypertension

Summary: the purpose of this study was to evaluate the dose-response relationships of azilsartan, once daily (qd) in participants with mild to moderate uncomplicated essential hypertension.

hypertension is known to cause multiple organ damage by being combined with not only blood pressure but also other hemodynamics, endocrinological/metabolic abnormalities and genetic factors. this becomes a medically and medical-economically significant problem in japan the significance of early treatment of hypertension and of long-term control of blood pressure has been increasing year by year. takeda pharmaceutical company limited invented tak-536 (azilsartan), an angiotensin ii receptor blocker for decreasing blood pressure. this study investigating the efficacy and safety of azilsartan using candesartan cilexetil, a widely used antihypertensive drug, as a reference control.

Eligibility criteria:
inclusion criteria: * has mild to moderate uncomplicated essential hypertension. * has a sitting diastolic blood pressure between 95 and \<110 mmhg and sitting systolic blood pressure between 150 and \<180 mmhg at placebo run-in period (week -2) or randomization visit. exclusion criteria: * has a cardiovascular disease or symptoms * has been treated with more than 3 different antihypertensives within 27 days prior to placebo run-in period. * has a significant hepatic disorder, hyperkalemia, malignant tumor or significant renal impairment.

Keywords: drug therapy
extracellular matrix marker of arrhythmia risk (emma)

Conditions: Myocardiopathies; Ischemia, Myocardial; Arrythmia; Death, Sudden, Cardiac

Summary: assess whether serum levels of mmp 2 and or mmp 9 correlate with episodes of ventricular tachycardia or fibrillation in patients who have implantable cardioverter defibrillator devices.

sudden cardiac death (scd) is responsible for 300,000-450,000 deaths per year in the united states. while it is well known that patients with both ischemic and non-ischemic cardiomyopathy (icm, nicm) are at increased risk for scd, there is little beyond ejection fraction which has proven useful as a noninvasive predictor to risk stratify these patients. myocardial scar has been validated as an arrhythmic substrate in ischemic populations; the majority of successful ablations for lethal ventricular arrhythmias are performed on tissues in peri-infarct regions. scar provides an anatomic electrical boundary where peri-infarct zones may lead to areas of slow conduction due to the disruption of inter-myocyte electrical conduction. myocardial scar is a less organized collagen deposition which disrupts the typical cardiac extracellular matrix. the collagen matrix provides mechanical support to the myocardium dictating ventricular shape, size and stiffness. while typically relatively dormant, the fibrillar collagen matrix reflects a dynamic relationship between collagen synthesis mediated by fibroblasts and collagen degradation performed by matrix metalloproteinases (mmp). a marker for scar burden or a marker which could assess a patient's predilection to form scar after either an ischemic or non-ischemic insult may be useful in further risk stratifying this population. since mmp levels may fluctuate in the course of ischemic or nonischemic injury a static promoter sequence which confers a higher level of mmp expression to an ischemic or nonischemic insult may prove to be a reliable marker. functional polymorphisms of the mmp-9 gene promoters have been shown in multivariate analysis to be an independent predictor of cardiac mortality regardless of the mechanism of heart failure.

Eligibility criteria:
inclusion criteria: * lvef of ≤ 35% measured within 6 months of icd implantation * nyha class ii-iv at the time of icd implantation * icd implantation at least 1 year prior to enrollment exclusion criteria: * status post heart transplant * known malignancy in the past 2 years. * recent procedure, intervention or surgery within the past 90 days * acute mi, cabg, or ptca/stent within the past 2 months. * active rheumatoid arthritis or pulmonary or hepatic fibrosis. * taking chronic steroid therapy for a medical condition * currently pregnant * enrolled in a concurrent study that may confound the results of this study

Keywords: cardiac ischemia cardiac arrhythmia defibrillator matrix metalloproteinase genetic polymorphism
a study of moxr0916 in combination with atezolizumab versus atezolizumab alone in participants with untreated locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-based therapy

Conditions: Urothelial Carcinoma

Summary: this is a phase ii, multicenter, randomized, placebo-controlled, double-blind study to evaluate the safety and efficacy of moxr0916 in combination with atezolizumab versus placebo and atezolizumab in participants with locally advanced or metastatic urothelial carcinoma (uc) who have not received prior systemic therapy in the locally advanced/metastatic setting and who are ineligible to receive cisplatin-based therapy.

the study design has been amended after the decision to prematurely stop patient accrual due to enrollment challenges. as only 5 participants were enrolled, the study blinding will not be maintained, and placebo infusions will not be administered. patients assigned to the moxr0916 arm may continue study treatment with the combination of atezolizumab and moxr0916 or with atezolizumab alone based on a discussion of benefit and risk with the treating investigator.

Eligibility criteria:
inclusion criteria: * age \>= 18 years * eastern cooperative oncology group (ecog) performance status of \<= 2 * life expectancy \>= 12 weeks * histologically or cytologically confirmed locally advanced or metastatic urothelial carcinoma (uc) * availability of a representative formalin-fixed paraffin-embedded tumor specimen * no prior systemic therapy for inoperable locally advanced or metastatic uc * ineligible for cisplatin-based chemotherapy as defined by any one of the following criteria: impaired renal function (glomerular filtration rate \[gfr\] \> 30 but \ = 2 audiometric hearing loss (of 25 decibel at two contiguous frequencies or more severe); nci ctcae v 4.0 grade \>= 2 peripheral neuropathy; ecog performance status of 2 * measurable disease according to response evaluation criteria in solid tumors v1.1 * adequate hematologic and end-organ function exclusion criteria: * significant cardiovascular disease * known clinically significant liver disease * any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment * prior treatment with cd137 or ox40 agonists, anti-cytotoxic t-lymphocyte-associated protein (ctla4), anti-programmed death-1 (pd-1), anti- programmed death-ligand 1 (pd-l1), anti-cd-27, anti- glucocorticoid-induced tumor necrosis factor receptor (gitr) therapeutic antibody or pathway-targeting agents * untreated central nervous system (cns) metastases or active (progressing or requiring corticosteroids for symptomatic control) cns metastases * any history of leptomeningeal disease * malignancies other than uc within 5 years prior to cycle 1, day 1 * history of autoimmune disease * history of idiopathic pulmonary fibrosis, pneumonitis, organizing pneumonia, or evidence of active pneumonitis on screening chest computed tomography scan * active hepatitis b and c virus infection * positive hiv test at screening * active tuberculosis * prior allogeneic stem cell or solid organ transplantation
transcranial magnetic stimulation for visual snow syndrome

Conditions: Visual Snow Syndrome

Summary: this study aims to investigate the feasibility of the use of repetitive transcranial magnetic stimulation (rtms) for symptoms associated with visual snow syndrome (vs).

the study will gather information about the treatment of up to 10 people with vs using rtms. treated participants will undergo 10 sessions of rtms administered 5 times a week over 2 weeks. all visits will take place in the university of colorado school of medicine neuromag/transcranial magnetic stimulation laboratory on university of colorado anschutz medical campus. the specific aims for this feasibility study include: 1. determine whether any participant experiences untoward effects of rtms in the setting of visual snow syndrome and determine the potential drop-out rate of larger study. 2. determine the performance of a novel scale (colorado visual snow scale) and two three psychophysical visual processing tasks 1. determine the standard deviation and test-retest reliability for the novel scale and two visual processing tasks 2. determine whether the visual processing tasks perform similar to performance found by the developer 3. describe changes in outcome measures between pre- and post-treatment with rtms

Eligibility criteria:
inclusion criteria: * a diagnosis of vs that meets international headache society criteria * able to provide meaningful informed consent * visual snow must be present for more than three months and must be persistent (i.e. continuous) * a prior clinical brain mri with and without contrast done in the past 3 years that does not show signs of clinically significant brain lesions (no evidence of multiple sclerosis, stroke, brain tumor, cortical heterotopia or other cortical developmental abnormalities, arteriovenous malformation, etc...) exclusion criteria: * syndrome meeting criteria for hallucinogen-persisting perception disorder * prior treatment with tms for any disorder * epilepsy, family history of epilepsy, or personal history of seizure * any medical condition or medication that increases the risk of seizure * pacemaker or other implantable medical device * metal in the skull, not including the mouth * unstable cardiac, pulmonary, or other systemic illness * pregnancy * bipolar disorder * history of suicidality

Keywords: repetitive transcranial magnetic stimulation
the clinical efficacy of robotic and laparoscopic radical total gastrectomy in locally advanced middle and upper gastric cancer

Conditions: Gastric Cancer; Robotic Gastrectomy

Summary: to evaluate the clinical efficacy (safety, feasibility and long-term efficacy) of robotic radical total gastrectomy and laparoscopic radical total gastrectomy in patients with locally advanced middle and upper gastric adenocarcinoma (ct2-4a, n-/+, m0) .

in the field of gastrectomy, hashizume et al. first reported robotic gastrectomy in 2002. since then, reports on the safety and feasibility of the application of robotic surgical system in the treatment of gastric cancer (gc) have gradually increased. reports of robotic surgery for gc are increasing, especially in asia. several studies confirmed the advantages of robotic gastrectomy when compared with laparoscopic gastrectomy. however, whether robotic radical total gastrectomy is noninferior to laparoscopic radical total gastrectomy remains unclear. the investigator first carried out this study in the world to evaluate the efficacy of robotic radical total gastrectomy versus laparoscopic radical total gastrectomy for gc.

Eligibility criteria:
inclusion criteria: * 1.age between 18 and 75 years 2.the primary gastric lesion was histopathologically diagnosed as middle and upper gastric adenocarcinoma (papillary adenocarcinoma pap, tubular adenocarcinoma tub, mucinous adenocarcinoma muc, signed-ring cell carcinoma sig, poorly differentiated adenocarcinoma por) by endoscopic biopsy. 3.preoperative clinical stages were ct2-4a、 n-/+、and m0 (according to ajcc-8th tnm tumor staging) 4.excepting to perform radical total gastrectomy and d2 lymph node dissection can achieve r0 resection. 5.american society of anesthesiology (asa) score class i, ii, or iii 6.written informed consent exclusion criteria: 1. preoperative examination suggested disease staging ct1, n-/+, and m0 (according to ajcc-8th tnm tumor staging ) 2. women during pregnancy or breast-feeding 3. severe mental disorder 4. history of previous upper abdominal surgery (except laparoscopic cholecystectomy) 5. history of previous gastrectomy(except for esd/emr for gastric cancer ) 6. enlarged or bulky regional lymph node over 3 cm by preoperative imaging 7. history of other malignant disease within the past five years 8. history of previous neoadjuvant chemotherapy or radiotherapy 9. history of unstable angina or myocardial infarction within past six months 10. history of cerebrovascular accident within past six months 11. history of continuous systematic administration of corticosteroids within one month 12. requirement for simultaneous surgery for other disease(except laparoscopic cholecystectomy) 13. emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer 14. fev1 (forced expiratory volume in one second)\<50% of predicted values

Keywords: robotic radical total gastrectomy gastric cancer laparoscopic radical total gastrectomy
endosonographic shear wave elastography for liver stiffness

Conditions: Liver Cirrhosis

Summary: this is a single-center, prospective, non-randomized, comparative study which will compare the diagnostic accuracy and safety of endosonographic real-time elastography and shear wave elastography with the current standards of care, i.e. liver biopsy and vibration-controlled transient elastography (fibroscan). subjects who are referred for an endoscopic ultrasound (eus) guided liver biopsy will be prospectively enrolled to undergo liver biopsy, elastography and/or vibration-controlled transient elastography.


Eligibility criteria:
inclusion criteria: * patients referred for eus guided liver biopsy * elevated liver enzymes without obvious etiology, thus necessitating liver biopsy or clinical concern for cirrhosis or nash requiring histological confirmation * ability to provide informed consent and willing to participate exclusion criteria: * clinical evidence of cirrhosis which obviates need for liver biopsy * noninvasive lab testing which confirms presence of cirrhosis * surgically altered foregut anatomy which precludes safe endoscopic liver biopsy * coagulopathy with inr greater than 1.6 in patients on anticoagulant therapy * thrombocytopenia with platelet count less than 50,000/ml * pregnancy (positive urine pregnancy test in females of childbearing age) * lack of consent
multi-parameters'change process during dehydration therapy on brain edema patients.

Conditions: Hemodynamic Instability; Water on the Brain; Intracranial Pressure Increase

Summary: this study aims to investigate the inner mechanism during different dehydration therapies such as mannitol injection and hypertonic saline. the investigators used a self-made near infrared spectroscopy (nirs) instrument to monitor the physiological changes noninvasively including oxyhemoglobin (\[hbo2\]), deoxy-hemoglobin (\[hb\]), the derived change in blood volume (\[thb\]) and water concentration on the forehead of brain edema patients.

cerebral edema, as an acute head injury along with high intracranial pressure, has been of great interest over decades in clinical neurosurgery research. dehydration therapy is a common clinical method to decrease intracranial pressure. this study aims to investigate the inner mechanism during different dehydration therapies such as mannitol injection and hypertonic saline. the investigators used a self-made near infrared spectroscopy (nirs) instrument to monitor the physiological changes noninvasively including oxyhemoglobin (\[hbo2\]), deoxy-hemoglobin (\[hb\]), the derived change in blood volume (\[thb\]) and water concentration on the forehead of brain edema patients. then the investigators compared the changes process of multiple physiological parameters during different dehydration therapies.

Eligibility criteria:
inclusion criteria: • patients who had brain edema and need dehydration therapy to decrease intracranial pressure. exclusion criteria: * aids, active hepatitis, tuberculosis, syphilis * patients who regularly take anticoagulants, antiplatelet drugs * anemia, thrombocytopenia * hemorrhagic disease like hemophilia

Keywords: brain edema dehydration noninvasive optical method