Kornimate/medical-research-clean huggingface dataset:
study of xl784 in patients with albuminuria due to diabetic nephropathy

Conditions: Albuminuria; Diabetic Nephropathy

Summary: this clinical study is being conducted at multiple sites to determine the activity, safety and tolerability of xl784 when given daily to patients with albuminuria due to diabetic nephropathy. xl784 is a small molecule reno-protective metalloproteinase inhibitor, inhibiting both adams (including adam10, a target of significant interest because of its important role in blood vessel formation and cell proliferation, and adam17/tace, activation of which has been associated with renal deterioration) and mmps (including mmp-2 and mmp-9). xl784 was specifically optimized to be mmp-1 sparing, which may be clinically significant because inhibition of mmp-1 has been hypothesized to be associated with musculoskeletal toxicity.


Eligibility criteria:
inclusion criteria: * type 1 or type 2 diabetes mellitus with albuminuria, observed within 3 months of screening * prior to randomization, subject has a glomerular filtration rate (gfr) \>/= 40 ml/min * prior to randomization, the subject has albuminuria defined as acr \>/= 500 mg/g * stable seated blood pressure at the screening visit and prior to randomization * subject has been on a stable dose and schedule of an angiotension converting enzyme (ace) inhibitor and/or an angiotension receptor blocker (arb) for at least 3 months before first dose of study drug * if on antidiabetic medication, subject has been on a stable dose and schedule for at least 3 months prior to first dose of study drug * sexually active subjects must use an accepted method of contraception during the course of the study and for 3 months after * signed informed consent exclusion criteria: * subject has participated in an investigational study and received an investigational drug within 30 days of the first dose of xl784 * hemoglobin a1c (hba1c) value of \>10% at screening * subject has had either organ transplantation or is currently on immunosuppressive therapy * non-steroidal anti-inflammatory drugs (nsaids) within 5 days of urine screening assessments * current diagnosis of one or more of the following conditions: 1) infection requiring parenteral antibiotics, 2) urinary tract infection, 3) hepatic dysfunction or disease, 4) symptomatic congestive heart failure, 5) unstable angina pectoris, 5) serious cardiac arrhythmia * clinically evident diabetic gastroparesis or motility disturbance * proteinuria not due to diabetic nephropathy * diltiazem or verapamil * ongoing condition where treatment with nsaids is anticipated (aspirin \</= 325 mg/day is allowed) * recent history of drug or alcohol abuse * pregnant or breastfeeding female subjects * known hiv and/or receiving anti-retroviral therapy * known allergy or hypersensitivity to any component of xl784 formulation

Keywords: albuminuria diabetic nephropathy diabetes
efficacy, safety, tolerability and pharmacokinetics of sun13837 to treat acute stroke

Conditions: Stroke

Summary: the purpose of this study is to evaluate the safety and tolerability of sun13837 and to determine whether sun13837 improves the physical performance, relative to placebo, following an acute stroke in adult subjects.


Eligibility criteria:
each subject must meet all of the following criteria to participate in the study: 1. male or female subjects between 18 and 85 years, inclusive 2. subjects with no prior history of stroke (unless the stroke was not associated with a motor deficit) 3. subjects must score at least 16 points on the standard mmse during baseline assessments 4. subjects must have a total score between 7 and 30, inclusive, out of 35 on the s-stream administered between 24 and 48 hours after the onset of acute stroke 5. subjects must have an estimated pre-stroke mrs of 0 or 1 6. male subjects agree to be heterosexually abstinent or use appropriate contraception 7. female subjects must have undergone menopause or, if premenopausal, must have a negative pregnancy test at baseline. female subjects of childbearing potential agree to be sexually abstinent or must be willing to utilize adequate contraception 8. subjects must be willing to provide verbal/nonverbal informed consent indicating voluntary consent to participate in the study (if a subject is unable to provide informed consent, but able to comply with other study procedures, the subject's lar may provide consent) exclusion criteria: subjects who meet any of the following criteria will be excluded from the study: 1. prior exposure to sun13837 2. history of severe allergic reaction, whether explained or not, requiring a visit to the er and/or medical intervention with epinephrine 3. development of hemodynamic instability following the acute stroke 4. history of dementia, advanced parkinson's disease, other significant movement disorders, or other clinically significant diseases which would jeopardize the safety of the subject or impact the validity of the study results 5. presence of significant global or receptive aphasia 6. presence of clinically significant abnormal laboratory values at the time of presentation in the er 7. history of malabsorption or any gastrointestinal abnormality that could impair oral absorption 8. finding of grade 3 or 4 proliferative retinopathy on routine fundoscopic examination or history of proliferative retinopathy (grade 3 or 4) in subjects with diabetes mellitus 9. unable, as determined by the investigator, or unwilling to discontinue use of potent cytochrome (cyp) p450 3a4/5 inhibitors, potent cyp2d6 inhibitors, cyp3a inducers, or potent p glycoprotein (p gp) inhibitors 10. current participation in another clinical study involving administration of an investigational product or history of such participation within 30 days of acute stroke onset

Keywords: acute stroke outcome measures physical performance
pathological tumor and lymph node responses after neoadjuvant immunochemotherapy in initially-unresectable nsclc

Conditions: Non Small Cell Lung Cancer; Immunotherapy; Chemotherapy; Tumour, Residual

Summary: this is a real-world study with the largest sample size investigating the pathological tumor and lymph node responses to neoadjuvant immunochemotherapy in non-small cell lung cancer to date. patients with initially unresectable nsclc underwent immunochemotherapy and response to treatment was assessed after every two treatment cycles. clinicopathologic features of patients including epidemiological data, clinical manifestations, operation strategies, pathological findings, and prognostic information were recorded and evaluated.


Eligibility criteria:
inclusion criteria: * patients with stage iii nsclc who received neoadjuvant immunochemotherapy. * early-stage nsclc patients who were initially unresectable. * 18 years of age or older. * karnofsky performance status (kps) score of 100 or 90. exclusion criteria: * patients with stage iv nsclc * patients with known alk translocations or egfr mutations. * karnofsky performance status (kps) score \<90.
efficiency of lina libratatm system

Conditions: Menorrhagia

Summary: menometrorrhagia is the first cause of consultation in gynecology. etiology of menometrorrhagia is varied, but in majority of cases no underlying pathology is found, they are said functional idiopathic menometrorrhagia . in case of failure of medical treatment, for women who do not wish to preserve reproduction possibilities, a surgical treatment by endometrectomy (destruction of the uterine endometrial epithelial) can be proposed. currently, a new system, lina libratatm is available on the market. this system allows destructing endometrial membrane with a balloon which offer several advantages compared to present used system. specially, it does not require dilatation of uterus's cervix and it reduces the pain. the investigator make hypothesis that the use of the system lina libratatm does not cause pain and can be thus used under local anesthetic in ambulatory surgery. with the aim of developing ambulatory care, the main objective of this prospective monocentric study is to estimate the efficiency of lina libratatm system in the treatment of functional idiopathic menometrorrhagia. secondary objectives are to estimate the pain during the procedure, the rate of per and post-complications and quality of life.


Eligibility criteria:
inclusion criteria: * women from 40 to 50 years old * not menopausal women * do not want pregnancy * having dysfunctional bleeding * informed and signed consent exclusion criteria: * unacceptable postoperative risk disclosed on interview: coagulation disorder, immune disorder, evolutive disease, etc * pregnancy or wish to have later pregnancy * endometrium cancer (or suspicious of cancer) or precancerous conditions of the endometrium * anatomical conditions (i-e history of caesarian, transmural myomectomy) or pathological conditions (i-e long term treatment) which can weaken myometrium * genital or urinary infection at the time of the procedure * intra uterine device * pelvic inflammation * inability to understand information provided * not covered by a national health insurance scheme, prisoner or under administrative supervision

Keywords: menorrhagia lina libratatm efficiency menometrorrhagia
toffee full face and toffee nasal mask evaluation in obesity hypoventilation syndrome (nz)

Conditions: Obesity Hypoventilation Syndrome

Summary: this investigation is to evaluate the performance, comfort and ease of use of the toffee full face and toffee nasal mask masks amongst obesity hypoventilation syndrome (ohs) patients in an overnight study.

up to 20 ohs patients who currently use a full face mask or a nasal mask will be recruited. they will be issued a f\&p toffee full face (if they are existing full face users) or f\&p toffee nasal (if they are existing nasal users) for an overnight polysomnography.

Eligibility criteria:
inclusion criteria: * aged 18+ * diagnosed with ohs by a practicing physician * existing full face mask user or a nasal mask user * prescribed pap therapy (bi-level or cpap) exclusion criteria: * inability to give informed consent * pregnant or think they may be pregnant * anatomical or physiological conditions making pap therapy inappropriate * patients requiring supplemental oxygen with their pap device * patients who are in a coma or decreased level of consciousness * existing toffee full face and toffee nasal mask users * no arterial pco2 value from their medical records
impact of perioperative physical activity on postoperative pulmonary complications and quality of life among esophageal cancer patients

Conditions: Esophageal Neoplasms

Summary: this prospective cohort study examines the impact of perioperative physical activity on postoperative pulmonary complications among esophageal cancer patients.


Eligibility criteria:
inclusion criteria: * patients who are diagnosed with esophageal cancer and scheduled to receive curative esophagectomy * patients who are able to read and understand the questionnaire * patients who are able to communicate with research personnel * patients who recognize the purpose of this study and provide written informed consent * patients without treatment for psychiatric disease exclusion criteria: * patients who have difficulty for walking * patients with history of other cancer in the last 3 years * patients with neoadjuvant chemotherapy and/or radiation therapy * patients with recurrent esophageal cancer * patients with multiple cancer * foreigner or overseas patients who were not able to regularly participate this study
effect of terlipressin on the incidence of early postoperative acute kidney injury in liver transplantation patients

Conditions: Acute Kidney Injury; Liver Transplant; Complications

Summary: the goal of this clinical trial is to evaluate the effect of intraoperative terlipressin on the incidence of early postoperative acute kidney injury in deceased doner liver transplantation. patients were randomly divided into experimental group and control group by numerical randomization table. the experimental group was injected with terlipressin perioperative and the control group was injected with placebo

acute kidney injury is a relatively common complication in patients with liver transplantation. most centers have established prediction models for acute kidney injury after liver transplantation, but the incidence cannot be reduced through perioperative anesthesia management. as an vasopressin receptor agonist, terlipressin can increase blood pressure and improve kidney perfusion at the same time, and perioperative application may reduce the incidence of postoperative acute kidney injury

Eligibility criteria:
inclusion criteria: * 1) patients who plan to undergo liver transplantation in our hospital 2) patients or family members sign informed consent exclusion criteria: * patients \<18 years old;② patients undergoing autologous liver transplantation or combined transplantation;③ patients with lower extremity artery stenosis;(4) patients with severe heart disease、lung disease、kidney disease;⑤ patients with severe lung disease;⑥ patients who used renal replacement therapy before surgery;⑦ the depth of one kidney from the body surface is greater than 4cm;⑧ patients treated with terlipressin within 2 weeks before surgery⑨ patients allergic to terlipressin.

Keywords: terlipressin liver transplant
proton beam radiation therapy for early stage adenocarcinoma of the prostate

Conditions: Prostate Cancer

Summary: the primary purpose of this study is to determine if high doses of radiation using proton beam can be given safely with low and acceptable side effects. this study will also gather data to determine the ability of the proton beam to eradicate prostate cancer. proton beam radiation is a very accurate kind of treatment that has been shown to affect less normal tissue than a regular radiation beam.

* radiation therapy to the pelvis and prostate will be given once a day, 5 days a week (monday-friday), for 8 weeks. each treatment takes about 10-20 minutes. * participants will be seen once a week for the entire 8 weeks by their study doctor to monitor and record any side effects. at the end of radiation therapy, participants will have a history and physical examination. follow-up visits with the study doctor will be done at weeks 13 and 26 and then every 6 months for 3 years, then annually to year five.

Eligibility criteria:
inclusion criteria: * patients with previously treated adenocarcinoma of the stages t1c-t2b and gleason of equal to or greater than 5. * psa values of equal to or less than 15 ng/ml must be demonstrated within two months prior to study entry and greater than 3 weeks after prostate biopsy. * zubrod status 0-1. * no evidence of distant metastasis. * no evidence of other cancer. prior malignancy does not exclude the patient if disease free for greater than five years. exclusion criteria: * clinical stages t2c or above. * psa greater than 15. * any patient with t1c disease, a psa less than or equal to 4 and gleason sum less than 6. * evidence of lymph node involvement if lymph node sampling performed. * previous prostate surgery to include: simple prostatectomy, turp, hyperthermia and cryosurgery. * previous prostate radiation. * prior hormonal therapy. * history of inflammatory bowel disease even if currently inactive or controlled on medication. * prior systemic chemotherapy. * history of proximal urethral stricture requiring dilatation. * current and continuing anticoagulation with coumadin or equivalent. * major medical or psychiatric illness

Keywords: proton beam radiation
health after covid-19 in tyrol

Conditions: COVID-19

Summary: the aim of the regional online questionnaire is to better understand the pattern of acute infection and the time of recovery of various symptoms.

the ongoing covid-19 pandemic considerably increases the demand for healthcare and raises concerns on longterm disease outcome. accordingly, to increase the knowledge on recovery from symptoms of acute infection and longterm health effects, a regional covid-19 online survey on the health-status after infection will be performed. this cross-sectional anonymous online survey is initiated and conducted by an interdisciplinary study team of the medical university of innsbruck, austria. for each participant, demographic characteristics (e.g. age, gender, district affiliation, profession), medical history (presence of comorbidities, medication), diagnosis of covid-19, symptoms and their duration, treatments and special conditions will be collected. the aim of the survey is to better understand the pattern of acute infection and the time of recovery of various symptoms. the anonymous online survey is open to individuals after covid-19 infection (proven by sars-cov-2 positive pcr or antibody test) over the age of 16 and living in tyrol (western-austria). the survey takes around 30 minutes to complete.

Eligibility criteria:
inclusion criteria: * status post covid-19 infection, defined by a positive sars-cov-2 pcr or antibody test * age ≥ 16years * resident in tyrol (austria) exclusion criteria:

Keywords: long term sequelae
effects of combined sevoflurane and nitrous oxide inhalation - 14

Conditions: Opioid-Related Disorders; Substance-Related Disorders

Summary: the purpose of this study is to determine the effects of combined sevoflurane and nitrous oxide inhalation on mood, psychomotor performance, and the pain response in humans.


Eligibility criteria:
please contact site for information.

Keywords: nitrous oxide sevoflurane drug interaction subjective effects analgesia healthy volunteers
fgf23 as a marker of acute kidney injury

Conditions: Acute Kidney Injury; Kidney Ischemia

Summary: a partial nephrectomy (pn) preserves renal parenchyma with a proper oncology outcome. pn is performed during transitory ischemia to avoid massive bleeding during tumor resection. nevertheless, the transitory ischemia might cause an acute kidney injury(aki). aki diagnose is based on the increase in plasma creatinine concentration and a decrease in urine output. however, both plasma creatinine concentration and diuresis are useful for the diagnose, but not in the detection of the risk patients. therefore, there is considerable interest to find a biomarkers of kidney injury that allow clinicians to predict the development of aki. hence, we propose fibroblastic growth factor-23 (fgf23) as a novel early biomarker to detect patients in risk to develop postoperative aki after a pn. we will conduct an observational and prospective study in three different groups of patients: pn gropup, patients who underwent pn with a transient and controlled renal ischemia injury using a renal artery clamping; hemicolectomy (hc) group, patients as non-renal ischemia surgery controls, with similar demographic characteristics, but submitted to hc; and nephrolithotomy (nl) group, patients who underwent nl, as a control of kidney surgery with physical injury. in each patient, a time curve of plasmatic creatinine, blood urea nitrogen (bun), and fgf23 were measure. our study aims to describe the role of fgf23 as an early biomarker of aki after pn, where patients are exposed to a controlled ischemic injury.


Eligibility criteria:
inclusion criteria: * american society of anesthesiology physical status (asa) i or ii. * normal preoperative plasma creatinine level * baseline estimated glomerular filtration rate (egfr) \> 60 ml/min per 1.73 m2. exclusion criteria: * history of chronic kidney disease * anemia * alterations in the parathormone or vitamin d axis * pregnant women * subjects with concomitant use of nephrotoxic drugs.

Keywords: acute kidney injury creatinine fibroblast growth factor-23
study of the effect of adjunctive vivomixx® in patients with cirrhosis and spontaneous bacterial peritonitis (sbp)

Conditions: Spontaneous Bacterial Peritonitis

Summary: study design: double-blind placebo-controlled clinical trial study duration:2 years study center: hospital de la santa creu i sant pau, barcelona (single center) objectives: to assess the effect of adjunctive vivomixx® on bacterial translocation in patients with cirrhosis and sbp number of subjects: 30 main inclusion criteria: patients with cirrhosis hospitalized with an episode of sbp at hospital de la santa creu i sant pau study product, dose, route, regimen: vivomixx ® sachets containing 450 x 109 bacteria, 2 every 12 hours during hospitalization (n=15), or placebo (n=15) duration of administration: during hospitalization due to sbp episode hypothesis: the adjunctive treatment with vivomixx® in patients with cirrhosis and sbp could decrease bacterial translocation and systemic and cerebral proinflammatory state. this would result in a faster sbp resolution, a decrease in the incidence of complications and an improvement in cognitive function.


Eligibility criteria:
inclusion criteria: * patients with cirrhosis hospitalized with an episode of sbp at hospital de la santa creu i sant pau. cirrhosis will be diagnosed by clinical, analytical and ultrasonographic findings or by liver biopsy. sbp will be diagnosed by an ascitic fluid neutrophil count \> 250/mm3 with or without positive culture . exclusion criteria: * advanced hepatocellular carcinoma (beyond milan's criteria) or any other malignancy. * advanced liver insufficiency \[meld (model for end-stage liver disease) \>25\]. * active alcohol intake (in the previous 3 months). * neurological disease. * marked symptomatic comorbidities (cardiac, pulmonary, renal, untreated active depression, hiv infection). * previous antibiotic treatment, including norfloxacin and rifaximin. * septic shock, ileus, need for tracheal intubation or intensive care unit. * immunomodulatory drugs.
artificial intelligence enhanced ecg to detect cardiac amyloidosis

Conditions: Cardiac Amyloidosis

Summary: the purpose of this study is to assess a novel artificial intelligence (ai)-enabled electrocardiogram (ecg)-based screening tool for improving the diagnosis of cardiac amyloidosis (ca).

this pragmatic trial will be the first study to prospectively evaluate the use of the ai ecg dashboard along with an augmented report in everyday practice. the findings will also guide future implementation strategies and inform the translation of many of the current and future ai algorithms into the clinical setting. the participants are the providers. basic demographic information about the providers will be collected as well as their reactions to the trial based educational guidance supplied to them. patient health information will be collected on their patients using a hippa waiver. there will be no patient contact.

Eligibility criteria:
inclusion criteria: * mayo clinic cardiology or hematology providers who care for adult patients * mayo clinic providers who consent to participate on this study exclusion criteria: - none