Kornimate/medical-research-clean huggingface dataset:
association betweenq mafld ( metabolic associated fatty liver disease) and chronic kidney disease

Conditions: Mafld in Ckd Patients

Summary: assess frequency of renal affection in mafld

metabolic dysfunction-associated fatty liver disease (mafld) is a multisystem disorder, but its relationship with kidney injury remains controversial. this study aimed to evaluate mafld effects on the chronic kidney disease (ckd) frequency the association between metabolic dysfunction associated fatty liver disease (mafld) and extrahepatic disease is not known .the aim of this cross sectional study is to compare the frequency of ckd in patients with mafld and examine association between presence and severity of mafld and ckd and abnormal albuminuria. non-alcoholic fatty liver disease (nafld) is characterized by the accumulation of fat in more than 5% of hepatocytes in the absence of excessive alcohol consumption and other secondary causes of hepatic steatosis. in 2020, the more inclusive term metabolic (dysfunction)-associated fatty liver disease (mafld) - defined by broader diagnostic criteria - was proposed to replace the term nafld. the new terminology and revised definition better emphasize the pathogenic role of metabolic dysfunction and uses a set of definitive, inclusive criteria for diagnosis. diagnosis of mafld is based on evidence of hepatic steatosis (as assessed by liver biopsy, imaging techniques or blood biomarkers and scores) in persons who are overweight or obese and have type 2 diabetes mellitus or metabolic dysregulation, regardless of the coexistence of other liver diseases or excessive alcohol consumption. the known association between nafld and chronic kidney disease (ckd) and our understanding that ckd can occur as a consequence of metabolic dysfunction suggests that individuals with mafld - who by definition have fatty liver and metabolic comorbidities - are at increased risk of ckd. mafld appears to be tightly linked to incident chronic kidney disease (ckd). this association may be attributed to multiple shared risk factors including type 2 diabetes mellitus, arterial hypertension, obesity, dyslipidemia, and insulin resistance diagnostic criteria of mafld are ( steatosis with one of the following 1. bmi \>25 2. type ii dm 3. \> 2 metabolic abnormalities \[ 1)waist circumferance \>94 in males or 80 in females 2)bp \>130/85 3) plasma triglycrides \> 150 mg / dl 4) hdl \ 2.5 7)plasma hs crp\> 2 mg/dl \]

Eligibility criteria:
inclusion criteria: 1. ckd patients type ii . iii and type iv not on dialysis 2. patients with mafld 3. patients with type ii dm exclusion criteria: 1. patients with aki 2. patients with nafld 3. patients with alcoholic fatty liver disease 4. patients with type i dm 5. malignancy 6. hbv hcv 7. autoimmune disease 8. liver cirrhosis
safety and short term effectiveness of eea versus pph stapler for iii degree hemorrhoids

Conditions: III Degree Hemorrhoids

Summary: stapled hemorrhoidopexy has gained wide acceptability among colorectal surgeons because of less postoperative pain compared with excisional surgery, however a still relevant percentage of postoperative bleedings and long-term hemorrhoid recurrence are reported. a new stapler device has been designed to overcome these drawbacks by modifying the stapled sutures and by increasing the space for mucosal resection in the case of the stapler. this randomized controlled study was aimed to demonstrate whether the new eea stapler covidien was able to resect more quantity of prolapsed mucosa than the traditional pph 01/03 ethicol endosurgery by measuring the surface of the resected specimen and to demonstrate if the modified stapled sutures can ensure better intraoperative hemostasis by measuring the number of overstitches required to get perfect hemostasis during the operation.


Eligibility criteria:
inclusion criteria: * iii degree hemorrhoids * written informed consent * mental ability to understand the procedure exclusion criteria: * previous treatments for hemorrhoids or other proctological diseases * fecal incontinence * chronic inflammatory bowel disease * anal sphincter lesions * coagulative defects * obstructed defecation

Keywords: hemorrhoids circular staplers mucosal resection hemostatic suture
effectiveness of medical therapy, endovascular therapy, and surgery for peripheral arterial disease

Conditions: Peripheral Arterial Disease

Summary: this study is designed to develop a clinical registry of peripheral arterial disease (pad) patients undergoing lower extremity revascularization to describe the population and assess comparative effectiveness of endovascular therapy versus surgery. in addition, this study will conduct a prospective cohort study of patients treated medically or undergoing lower extremity revascularization at the va and kaiser colorado to compare changes in health status.

using electronic medical records, a registry of patients undergoing lower extremity revascularization therapy will be identified. chart reviews with be done by an expert panel. the prospective cohort study will ask participants to complete health status surveys before they begin therapy for pad and again 6 months later.

Eligibility criteria:
inclusion criteria: * presents with pad, * \> 18 years of age, * can complete a questionnaire, and * has either had a change in pad lower extremity intervention or start of a new intervention (surgical, endovascular, or medical therapy (cilostazol or exercise regimen) exclusion criteria: * dementia, * inability to consent, * pregnancy, * limited life expectancy (\< 6 months), * previous endovascular or surgical revascularization within the previous 12 months, * non english speaking
fixed versus flexible dosing of pregabalin in patients with fibromyalgia

Conditions: Fibromyalgia

Summary: a 9-week randomized double-blind, multi-center study of 172 patients, who after 1 week baseline evaluation are randomized to either fixed dose pregabalin starting at 75 mg bid for one week and increased to 150 mg bid for 7 weeks or flexibly dosed pregabalin given bid (75-300 mg/d) increased gradually over 4 weeks then maintained at that same dosing for 4 weeks.it is proposed that use of flexible dosing combined with nightly dosing would have similar pain relief to fixed dosing, would improve adherence, would have less side effects and would be more likely to improve sleep.


Eligibility criteria:
inclusion criteria: * diagnosis of fibromyalgia by acr criteria * ambulatory patients * complete of 5 pain diaries during 1 week evaluation * other inclusion criteria may apply exclusion criteria: * pregnant or of childbearing potential not using contraceptives * use of pregabalin in the past * concomitant use of opioids or gabapentin * estimated creatinine clearance less than 60 * other criteria may apply

Keywords: fibromyalgia lyrica pregabalin
prevention and early detection and intervention of post-coronary artery bypass grafting surgery (cabg) acute kidney injury (aki)

Conditions: Acute Renal Injury; Preventive Measures

Summary: nephrology participation in care of patients undergoing cabg could reduce aki through correction of modifiable risk factors and early detection and intervention of post-op aki.


Eligibility criteria:
inclusion criteria: * adult patients (age \>18 years) * elective cabg at mayo clinic rochester and shanghai zhongshan hospital from 7/1/2016 to 6/30/2017 exclusion criteria: * non-elective cabg * renal failure on dialysis * renal transplantation
clinical effectiveness, security and radiological changes in epiduroscopy for lumbar stenosis

Conditions: Spinal Stenosis, Lumbar Region, With Neurogenic Claudication

Summary: it will be done a prospective study involving 38 patients with lumbar stenosis. a magnetic resonance (mr) imaging study and a electromyographic study will be done previously and 3 months after the epiduroscopy to confirm radiologic or neurophysiological changes. during the technic it will be used different instruments, an endoscope developed for its use in the epidural space (resascope), a fogarty balloon (resaloon) to dilate the space near the epidural recess where it will be try to decrease the ligamentum flavum using the resaflex, an instrument with quantum molecular resonance for tissue coablation, in order to get less symptomatic lumbar stenosis. the investigators will compare qualitative and quantitative variables at baseline and 1, 3, 6, ant 12 months after the epiduroscopy.

the investigators perform the interventional endoscopic spinal surgical (iess) ,with the different instruments mentioned above. the resaflex wich use quantum molecular resonance, through combination of different frequencies in the range of the radio-frequency, emit quantum in resonance and produce lesion and coagulation; the objective is to reach the ligamentum flavum doing lesions to diminish the stenosis caused by hypertrophic ligamentum over all in the recess area near the radicular nerve. to increase the security of the procedure the investigators introduce for the first time , neurophysiological monitoring.

Eligibility criteria:
inclusion criteria: * patient with indication for epiduroscopy in the usual clinical practice * neurogenic claudication * lumbar pain for more than 6 months * numerical rating scale \>6 * no response with medical treatment * no response with other interventional treatment: epidurolysis exclusion criteria: * psychiatric disorders * opioid addiction * acute organic disease * severe chronic organic disease * vasculo-cerebral disease * coagulation alterations * ofthalmologic disease * allergic * infections * impossibility to understand the procedure

Keywords: lumbosacral epiduroscopy spinal stenosis magnetic resonance imaging intraoperative neurophysiological monitoring neurogenic claudication
study of patient use and perception of the travatan dosing aid

Conditions: Glaucoma

Summary: the primary objective of this study is to determine the opinions of patients who are given the travatan compliance monitoring dispenser to use to dispense their travatan glaucoma drops.

patients enrolled in this study will use the new travatan compliance monitoring dispenser for 6 weeks. patients will be informed that some, but not all, patients' compliance will be monitored by the device. patients are randomly assigned to one of three groups (proportionally in a 2/2/1 ratio): 1. fully functional travatan compliance monitor 2. travatan compliance monitor with lcd display and alarms disabled, but compliance monitoring intact 3. travatan compliance monitor with lcd display, alarms and compliance monitor disabled. at end of study, patients fill out questionnaire assessing 1. patient opinion regarding device: ease of use of new device; preference vs travatan use without device, etc 2. patient's belief as to whether their compliance was monitored or not rates of adherence are compared across groups and with regard to patients' reported beliefs as to whether they were monitored. the design of this study should allow the clinicians to ethically monitor compliance in patients who do and do not believe that they are being monitored. the use of monitoring devices without a functioning display and alarm should lead to some patients believing that they are not being monitored. as patients are told at the outset that they may or may not be monitored, this should be an ethically acceptable design. however, the collected data will allow a preliminary assessment of the impact of the patients' beliefs as to whether they are being monitored on their actual compliance, and hence an additional potential value of the device.

Eligibility criteria:
inclusion criteria: * open angle glaucoma or ocular hypertension * presently using travatan eye drops exclusion criteria: * allergy to prostaglandin

Keywords: travatan dosing aid compliance monitoring dispenser
patient navigation program to improve clinical trial enrollment in cancer patients

Conditions: Prostate Cancer; Kidney Cancer

Summary: the goal of this clinical trial is to test the utility of patient navigation by comparing high intensity patient navigation to low intensity navigation approaches to improving cancer trial enrollment of patients treated in academic and community cancer centers. patient navigation is a strategy for increasing patients access to cancer care by helping the participant overcome barriers in the participants communities and within the health care system by providing a bridge between the patient and the health care system. the primary objective of this study is to determine if a high intensity patient navigation program will improve patients enrollment on clinical trial in comparison to a low intensity patient navigation. participants who agree to participate and are eligible will be randomly assigned to either the high intensity or low intensity approach.

this study is a pilot randomized two arm prospective study of a high versus low intensity patient navigation program with the primary endpoint of clinical trials enrollment rate between the 2 arms. the hypothesis of the study is that a high intensity patient navigation program will improve the enrollment rates on clinical trials. candidates for this study will already have been identified by the patient navigator as being potentially eligible for a clinical trial. randomization will be stratified by the type of site: community versus academic. there will be a single futility analysis after approximately 50% of the patients have been randomized and offered a clinical trial. randomization and data capture will be via redcap. the primary endpoint of the study is the enrollment rate on clinical trials. with a sample size of 90 and conservatively assuming a clinical trial enrollment among clinical trial eligible patients of 50%, simulations show the investigators would be able to detect a 25% minimum difference (alternative 75% enrollment) in enrollment rates between the two groups with 84% power using a z test of proportions with a one-sided alpha level of 0.10.

Eligibility criteria:
1. age ≥ 18 years 2. patient with a current diagnosis of a primary solid tumor including: prostate cancer and kidney cancer 3. being seen at the sidney kimmel comprehensive cancer center (skccc) at johns hopkins university (jhu) or wellspan health center 4. available therapeutic trial for the patient as determined through pre-screening/medical record review

Keywords: clinical trials enrollment rate
intergroup trial for children or adolescents with primary mediastinal large b-cell lymphoma: da-epoch-rituximab evaluation

Conditions: Primary Mediastinal Large B Cell Lymphoma

Summary: phase ii trial to determine the efficacy of dose adjusted-epoch-rituximab regimen in children and adolescent with primary mediastinal large b cell lymphoma in terms of event free survival.


Eligibility criteria:
inclusion criteria: * histologically proven primary mediastinal large b-cell lymphoma (pmlbl). * pmlbl without central nervous system (cns) involvement. * 6 months to less than 18 years of age at the time of consent. * males and females of reproductive potential must agree to use an effective contraceptive method during the treatment, and after the end of treatment: during twelve months for women, taking into account the characteristics of rituximab * complete initial work-up within 8 days prior to treatment that allows definite staging. * able to comply with scheduled follow-up and with management of toxicity. * signed informed consent from patients and/or their parents or legal guardians exclusion criteria: * follicular lymphoma, mucosa-associated lymphoid tissue (malt) and nodular marginal zone * pmlbl patients with cns involvement * patients with congenital immunodeficiency, chromosomal breakage syndrome, prior organ transplantation, previous malignancy of any type, or known positive hiv serology. * evidence of pregnancy or lactation period. * there will be no exclusion criteria based on organ function. * past or current anti-cancer treatment except corticosteroids during less than one week. * tumor cell negative for cd20 * prior exposure to rituximab. * severe active viral infection, especially hepatitis b. * hepatitis b carrier status history of hepatitis b virus (hbv) or positive serology. * participation in another investigational drug clinical trial. * patients who, for any reason, are not able to comply with the national legislation.
acute gastric variceal bleeding: endoscopic treatment versus brto

Conditions: Gastric Varices

Summary: the purpose of this study is to study the efficacy of endoscopic cyanoacrylate injection versus balloon-occluded retrograde transvenous obliteration in the management of acute gastric bleeding.


Eligibility criteria:
inclusion criteria: 1. cirrhosis 2. active bleeding from gastric varices (gov2 or igv1) 3. presence of gastrorenal shunt exclusion criteria: 1. previous pharmacologic therapy combined with endoscopic treatment to prevent rebleeding 2. previous use of tips or surgical shunt 3. non-cirrhotic portal hypertension 4. contraindications to cyanoacrylate injection or brto 5. portal cavernoma 6. hepatorenal syndrome 7. proven malignancy including hepatocellular carcinoma 8. end-stage renal disease under renal replacement therapy; 9. cardiorespiratory failure 10. pregnancy or patients not giving informed consent for endoscopic procedures
effects of vitamin d on gut microbiota, intestinal barrier in ibs-d patients

Conditions: Diarrhea-predominant Irritable Bowel Syndrome

Summary: irritable bowel syndrome (ibs) is a common functional gastrointestinal disease. evidence suggests that the concentration of serum vd is decreased in ibs patients, particularly in ibs-d. after giving a supplementation of vd, some symptoms of these patients were relieved to a certain degree. however, the specific mechanism still remains unclear.

irritable bowel syndrome (ibs) is a common functional gastrointestinal disease, which is due to the gut microbiota disturbances, intestinal mucosal barrier dysfunction, and brain-gut axis dysfunction. vitamin d (vd), a fat-soluble vitamin, has been found to be associated with gut microbiota, intestinal mucosal barrier and nlrp3 in inflammatory bowel disease, nonalcoholic fatty liver disease and other diseases. the concentration of serum vd is decreased in ibs patients, particularly in ibs-d. and the symptoms of ibs patients seems to be connected with the level of serum vd. after giving a supplementation of vd, some symptoms of these patients were relieved to a certain degree. however, the specific mechanism still remains unclear.we designed a study to figure out the effects of serum vd on gut microbiota, intestinal mucosal barrier and in patients with ibs-d.

Eligibility criteria:
inclusion criteria: * ①ibs-d patients meeting the roman iv diagnostic criteria: recurrent abdominal pain, averaging at least 1 day per week in the last 3 months, with 2 or more of the following: associated with defecation, accompanied by changes in defecation frequency, accompanied by changes in fecal properties or appearance. (symptoms have been present for at least 6 months before diagnosis, and meet the above diagnostic criteria in the last 3 months; \>1/4 (25%) stools were bristol stool scale type 6 or 7, and \<1/4 (25%) stools were bristol stool scale type 1 or 2); ② the age ranged from 18 to 65. exclusion criteria: * ① history of other gastrointestinal diseases, such as inflammatory bowel disease, infection, cancer, abdominal radiation or surgery, hepatobiliary and pancreatic diseases; ② taking vitamin d drugs, calcium, contraceptives, glucocorticoids, probiotics, antibiotics, antidepressants, etc.; ③ pregnancy and lactation; ④ diabetes mellitus, thyroid disease, osteoporosis, etc.; ⑤ complicated with serious heart, liver, lung, kidney, blood, serious mental diseases and other systemic diseases; (6) boston intestinal preparation scale score \<6; the cecum was not detected by endoscopy. ⑦ unwilling to participate or unable to give informed consent.

Keywords: ibs-d; vitamin d; gut microbiota; intestinal barrier;
mean percentage of levothyroxine dosage increase in patients with hypothyroidism started on enteral feeding

Conditions: Hypothyroidism

Summary: the study aims to describe the changes in levothyroxine dosage requirements in patients with hypothyroidism started on enteral feeding, and assess whether giving levothyroxine on empty stomach affects the mean percentage increase expected in levothyroxine dosage in these patients.

the study will be a randomized controlled trial comparing the mean percentage of levothyroxine dosage change in hypothyroid patients after the starting of enteral feeding in an inpatient setting in two different groups: a control group where levothyroxine will be administered with continuous enteral nutrition, and an intervention group where enteral nutrition will be held for two hours before and two hours after the levothyroxine administration. the enrollment of eligible patients will be over two to three years and follow up will continue for the duration of the hospital stay or 12 weeks, which ever occurs earlier. eligible patients will have thyroid function tests at enrollment (within three days of the starting of the tube feeding) and afterwards weekly. levothyroxine dosage will be adjusted by the endocrinology research team according to the thyroid function results. initial levothyroxine dosage and subsequent dosages will be recorded and the mean percentage decrease or increase of levothyroxine dosage required will be measured in each group. an eventual difference between the two groups mean percentage change will be tested for statistical significance.

Eligibility criteria:
inclusion criteria: * adults admitted to maimonides medical center * started on enteral feeding within 3 days of enrollment: tube feeding, percutaneous endoscopic gastrostomy or peg tube feeding, or jejunostomy tube feeding. * history of hypothyroidism on a stable dose of levothyroxine for at least four weeks prior to enteral feeding * tsh 0.2-10 miu/ml at enrollment exclusion criteria: * concomitant administration of medications that affect thyroid function test including cholestyramine, sucralfate, amiodarone, lithium, dopamine, dobutamine and dilantin at enrollment. * pregnancy * known untreated disease or surgery of the small intestine specifically the jejenum.

Keywords: hypothyroidism tube feeding