Kornimate/medical-research-clean huggingface dataset:
nutritional therapy for diabetic cardiomyopathy

Conditions: T2DM (Type 2 Diabetes Mellitus)

Summary: the goal of this study is to determine if nutritional therapy can effectively treat/prevent t2dm and its consequent cardiomyopathy.


Eligibility criteria:
inclusion criteria: * subjects must be \>30 and \<65 years of age, in order to limit the confounding affect of age on our endpoints. * subjects must have an ejection fraction \>45% (based on their echocardiogram) * patients with t2dm and nonalcoholic fatty liver disease or steatohepatitis may be included since they have extensive evidence of steatosis. exclusion criteria: * subjects who have had a myocardial infarction or resting ischemia (by history or as evidenced by hypo/akinesis on the pre-intervention echocardiogram) will be excluded because hypo/akinesis would affect our endpoints of lv mass and diastolic function. * subjects who are unstable, not able to lie flat for the imaging studies, unable to give informed consent, pregnant, lactating, with atrial fibrillation (which would compromise measurement of e'), or current smokers will be excluded. * subjects with other major systemic diseases per their clinical charts, history, physical exam, or significant renal insufficiency will also be excluded, as these other system diseases may affect our study endpoints and subject follow-up. * we will exclude patients with significant lv systolic dysfunction (ejection fraction \<45%) * we will not exclude patients with sleep apnea because it does not detrimentally affect lv diastolic function. * subjects will be excluded a priori if they have any history or evidence of liver disease other than nafld, consumed \>20 g alcohol per day.
flash glucose monitoring study for diabetes

Conditions: Diabetes

Summary: on the first of july 2016, the freestyle libre flash glucose monitor (fgm) will be reimbursed in belgium by means of a new diabetes reimbursement program for adults. for children, the freestyle libre fgm is also reimbursed by means of a new reimbursement program from the first of august 2016 onwards. making this the only way to receive the device in belgium. to understand the impact of this new fgm on diabetes patients in uz leuven, olvz aalst, and uz antwerp, we want to study the use of the device by our patients by means of an observational study where patients complete questionnaires at regular time points in the first year of usage and after 24 months clinical data will be gathered during the routine clinical visits as part of the reimbursement program.


Eligibility criteria:
inclusion criteria: * signed informed consent * \>= 4 years * using flash glucose monitoring exclusion criteria: * doesn't want to sign the informed consent * \< 4 years * not using flash glucose monitoring
the effect of hot and cold water application on pregnant women with restless leg syndrome

Conditions: Restless Legs Syndrome; Pregnant; Sleep Disorder

Summary: this study was planned as a randomized controlled study to determine the effect of hot and cold water application on complaints and sleep quality in pregnant women with restless legs syndrome (rls). pregnant women with a total of 90 rls, including 30 people in each group, will be included in the study. the data of this study will be collected by personal information form, rls diagnosis criteria questionnaire, rls severity rating scale, pittsburgh sleep quality index, post application follow-up chart and application satisfaction form. while hot and cold water is applied in the intervention groups in the study, no application other than routine maintenance and follow-up will be done to the control group.data analysis obtained in the research will be performed in turcosa statistical software (turcosa analytics ltd co, turkey, www.turcosa.com.tr).in comparisons, a value of p \<0.05 will be considered statistically significant.in order to conduct the study, the necessary academic committee decision, ethics committee approval (september 09, 2020 and number 2020/445) and institutional permission were obtained. the individuals included in the study will be informed about the purpose of the research, their verbal consent will be obtained and the participant's informed consent form will be signed.


Eligibility criteria:
inclusion criteria: 1. least literate 2. 24-32. between the weeks of gestation 3. having a single pregnancy 4. the presence of rls is detected according to the rls diagnostic criteria questionnaire 5. having rls due to pregnancy 6. uses iron, vitamin d, magnesium and calcium 7. pregnant women who have a severity of 11 or more according to the rls severity rating scale will be included in the study exclusion criteria: 1. those who have a communication disability, 2. risky pregnancy (preterm labor risk, cervical insufficiency, etc.), 3. chronic disease (diabetes, hypertension, thyroid, cardiovascular disease, epilepsy, etc.), 4. with maternal obesity, bmi\> 30 5. he has heirs in his legs, 6. pre-pregnancy sleep apnea, 7. having any psychiatric disease and using antipsychotic, antidepressant medication, 8. using antihistamine, antiepileptic, antiemetic, calcium channel blocker, dextromethorphan and decongestant type drugs, 9. using heparin, 10. pregnant women with a history of deep vein thrombosis, or atherosclerosis history or risk will not be included in the study.

Keywords: restless legs syndrome pregnant cold water application hot water application quality of sleep
a study of the safety and efficacy of a new treatment for non-infectious intermediate or posterior uveitis

Conditions: Intermediate Uveitis; Posterior Uveitis

Summary: this study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of non-infectious intermediate or posterior uveitis.


Eligibility criteria:
inclusion criteria: * 18 years or older with a diagnosis of chronic intermediate uveitis in at least one eye exclusion criteria: * uncontrolled systemic disease * any active ocular infections
effect of diluent volume on colistin inhalation therapy

Conditions: Inhalation Pneumonia

Summary: the aim of this study is to investigate the impact of different diluent volumes for the same dosage of colistin in mechanically ventilated respiratory patients receiving colistin inhalation therapy. the study aims to determine whether the diluent volume has an effect on clinical outcomes, including icu length of stay, total hospitalization duration, duration of respiratory support within 28 days, mortality rates within 28 days and 90 days, as well as analyze the pharmacokinetic profile of colistin in blood and bronchoalveolar lavage fluid. additionally, the study will evaluate the incidence of nebulizer malfunctions and blockages. the findings of this research will help identify the optimal diluent volume for colistin inhalation therapy in clinical practice.

background： colistin is an antibiotic used to treat infections caused by multidrug-resistant gram-negative bacteria. in recent years, it has been widely utilized as an inhaled antibiotic for the treatment of respiratory infections in critically ill patients on mechanical ventilation. despite the increasing use of colistin inhalation therapy for ventilator-associated pneumonia, the clinical impact of diluent volume on nebulization efficiency remains unclear. study design： a single-center, prospective, randomized controlled trial. methods： the study plans to enroll 60 participants. colistin inhalation therapy will be administered using a blocked stratified random allocation. the control group will receive colistin 6 mu diluted in 6 ml of normal saline (1 mu per 1 ml), while the experimental group will receive colistin 6 mu diluted in 12 ml of normal saline (1 mu per 2 ml). the dosage, frequency, and administration method of colistin inhalation will follow the clinical standard of 6 mu, administered every 8 hours, continuously for 7 days. effect： the investigators anticipate that the clinical outcomes and pharmacokinetics of colistin inhalation therapy will not differ significantly between different diluent volumes. based on comprehensive evaluation, a diluent volume of 12 ml is considered more suitable than 6 ml for the dilution of colistin.

Eligibility criteria:
inclusion criteria: * admitted to the intensive care unit. * age greater than 18 years and using a ventilator due to acute respiratory failure. * requires inhalation colistin treatment as determined by the disease. * sign the written informed consent form. exclusion criteria: * renal failure requiring renal dialysis. * receiving both inhaled colistin and intravenous colistin treatments.

Keywords: colistin antibiotic inhalation therapy diluent volume randomized controlled trial
glycemic effects of morning only, evening only or twice daily insulin glargine in patients with type 1 diabetes

Conditions: Type 1 Diabetes; Hypoglycemia

Summary: this research is a prospective, randomized, cross-over study that is being done to compare the effect of morning only, evening only and twice daily insulin glargine (lantus®) on hypoglycemia (blood glucose level \<70 mg/dl) as measured by continuous glucose monitoring (cgm) in patients with type 1 diabetes.

over the course of the 6 week study, patients will take insulin glargine in each of 3 different times: only in the morning, only at night, and half in the morning, half at night. after 2 weeks taking the insulin in one regimen, patients will be switched to another regimen. through the whole study, patients will be injecting themselves twice daily, and neither the patient nor the treating doctor will know which vials contain the insulin and which have only saline (placebo). the vials will be labeled morning or evening. patients will continue to take their mealtime, short acting insulin doses. additionally, patients will wear a continuous glucose monitor (cgm) which will be masked. before the study, patients will be taught about how to use the cgm, and keep it taped to their abdomen. the site that the cgm inserts into their abdomen will need to be changed every 5 days. we will know if a patients' blood sugar goes low even if the patient did not feel the low. patients will still have to self-monitor their blood sugar levels at-least four times in five days, to calibrate the cgm.

Eligibility criteria:
inclusion criteria: * adult men and women above age 18 with a diagnosis of type 1 diabetes mellitus * on multiple insulin injections, including a long acting or intermediate acting insulin preparation and mealtime short acting insulin preparation. * clinical history consistent with hypoglycemia * hba1c \<9.0% exclusion criteria: * patients with type 2 diabetes mellitus * patients on insulin pump * poor control of diabetes (hba1c \> 9.0%) * pregnancy (women of childbearing age will undergo a pregnancy test at the start of the study and will be advised to use birth control methods during the study). insulin glargine has been reported to have teratogenic effects in animal models, and therefore should only be used during pregnancy if clearly needed. * serious co-morbidities that, in clinical opinion of the investigators, could affect pharmacokinetics of glargine (e.g., crf) or safety (e.g., recent cad)

Keywords: hypoglycemia type 1 diabetes split dosing insulin glargine continuous glucose monitoring
role of colonic short chain fatty acids in obesity

Conditions: Obesity

Summary: the excess production of colonic short-chain-fatty-acids (scfa) has been implicated in the promotion of obesity, but colonic fermentation of dietary-fiber to scfa may also play a role in preventing diabetes. the investigators aimed to compare the effects of two fermentable fibers (inulin and resistant-starch) on postprandial scfa, glucose, insulin, free-fatty acids (ffa) and gut hormone responses and to compare the responses in healthy overweight and obese (owo) vs lean (ln) participants. methods: using a randomized, single blind, crossover design, 13 owo and 12 ln overnight fasted participants were studied on 3 separate occasions. on each day they consumed a 300 ml drink containing 75g glucose (control) or 75g glucose plus 24g inulin (in), or 28.2g resistant-starch (rs). a standard lunch was served 4 h after the test drink.


Eligibility criteria:
inclusion criteria: * non-pregnant * body mass index \>=20 and \<=35 exclusion criteria: * history of diabetes mellitus * history of cardiovascular disease * history of bowel disease * history of kidney disease * history of liver disease * use of antibiotics within 3 months of enrolment * unusual dietary habits * fasting glucose \>6.9mmol/l * hematocrit below normal range for age and sex
midline lumbar fusion versus posterior lumbar interbody fusion

Conditions: Degenerative Lumbar Spondylolisthesis

Summary: degenerative lumbar spondylolisthesis is the forward displacement (slip) of one vertebra on an adjacent vertebra resulting in narrowing of the spinal canal or compression of the exiting nerve roots. it is commonly associated with low back and leg pain, and is a frequent reason for spine surgery particularly in individuals over age 65 years. recently novel minimally invasive surgical techniques have heightened public and government interest by touting benefits of reduced approached-related morbidity which in turn leads to quicker recovery, shorter hospital stay, improved short-term clinical outcomes, and reduced health care cost. however, there is no randomized controlled trial evidence to describe the actual advantages and disadvantages associated with minimally invasive spinal fusion. this pilot study is a randomized control trial comparing minimally invasive mid-line lumbar fusion (midlf) to traditional "open" posterior lumbar interbody fusion (plif) with respect to length of stay, approach related morbidity, patient centered outcome measures, and cost-effectiveness in the treatment of degenerative lumbar spondylolisthesis.


Eligibility criteria:
inclusion criteria: * patients attending victoria hospital * degenerative spondylolisthesis in the lumbar spine at one level * medically suitable for surgical management * able to consent for surgery exclusion criteria: * lytic spondylolisthesis * non degenerative stenosis: tumor, trauma * active infection * on long term disability or workers compensation claims * drug or alcohol misuse * lack of permanent home residence * previous surgery in the lumbar spine at the surgical level * previous fusion in the lumbar spine * contraindication to surgery: medical co morbidities * unable to complete questionnaire: eg dementia * unable to give voluntary consent * pregnant
study to evaluate the efficacy and safety of tamsulosin in children with neurogenic bladder

Conditions: Bladder, Neurogenic

Summary: aim of this study is to evaluate the efficacy and safety of a range of doses of tamsulosin hydrochloride as treatment in children with an elevated detrusor leak point pressure associated with a known neurological deficit


Eligibility criteria:
inclusion criteria: * neuropathic bladder secondary to a known neurologic deficit (e.g. spina bifida) * elevated detrusor leak point pressures (lpp) ≥40 cm h2o confirmed by two measurements exclusion criteria: * clinically significant abnormalities as determined by the investigator * a history of relevant orthostatic hypotension, fainting spells or blackouts

Keywords: tamsulosin pediatric neurogenic bladder
long term extension study is designed to monitor long-term efficacy and safety of miravirsen sodium in combination with telaprevir and ribavirin in subjects with chronic hepatitis c virus genotype 1 infection

Conditions: HCV

Summary: long term observational extension study designed to monitor long-term efficacy and safety of miravirsen sodium in combination with telaprevir and ribavirin in subjects with chronic hepatitis c virus genotype 1 infection


Eligibility criteria:
inclusion criteria: - participated in study spc3649-205 (this would include those who completed study spc3649-205, those who discontinued or terminated the study early for whatever reason (including treatment failure) and those who opted to receive approved therapy for the treatment of hcv infection). exclusion criteria: * those unwilling to provide informed consent for participation in this study. * subjects who have received investigational drug therapy after discontinuation, termination, or successful completion of study spc3649-205.
technology-based distractions for minor procedures

Conditions: Anxiety; Procedural Anxiety

Summary: the purpose of this study is to determine if non-invasive distracting devices (virtual reality headset, augmented reality headset) are more effective than the standard of care (i.e., no technology-based distraction) for decreasing anxiety and pain scores in pediatric patients undergoing various minor procedures (i.e lumbar punctures and cardiac catheterization). the anticipated primary outcome will be a reduction of overall cumulative medication and secondary outcomes include but are not limited to: physician satisfaction, discharge time, pain scores, anxiety scores, and procedure time.


Eligibility criteria:
inclusion criteria: * pediatric patient age between 4-17 * english speaking * parental consent/patient assent * undergoing minor procedure(s) at lpch or stanford hospital exclusion criteria: * patient does not consent * legal guardian not present to obtain consent * patient with a significant neurological condition or major developmental disability * patient experiencing nausea * patient with active infection of the face or hand * a history of severe motion sickness * a history of visual problems * a history of seizures caused by flashing light * major surgery within the last 48 hours * patients who are clinically unstable or require urgent/emergent intervention * patient or parental preference for general anesthesia

Keywords: pain
clinical cohort study in patients with different subtypes of primary sjogren syndrome related dry eye

Conditions: Dry Eye

Summary: primary sjögren's syndrome is a chronic autoimmune disease that primarily involves exocrine glands, most commonly manifested in dry eye, dry mouth, and in other systems of the body.

patients usually first seek for the ophthalmologist for severe dry eye symptoms, and most clinicians are ill-informed about sjögren's syndrome dry eye disease (ss-ded), which can lead to missed diagnoses and misdiagnoses. clinically, there are not many types of patients with pss and the number of in-depth studies is small. meanwhile, there are no specific drugs for the treatment of ss-ded, and most patients need to be treated with multiple methods to understand which methods are most effective. in this study, by establishing a clinical cohort of patients with different subtypes of dry eye with pss, we explored the association between the primary organs affected by pss and various biomarkers related to tear fluid and blood, and the association between the primary organs affected by pss, tear components and blood markers and the severity of ocular involvement, symptom progression and prognosis. this study initially constructs a special cohort of patients with pss ocular involvement, which may explain its pathogenesis from a new perspective in diagnose, classification and treatment.

Eligibility criteria:
inclusion criteria: * all enrolled ded participants met the criterion of tfos dews ii definition and classification report and pss-ded group also met 2016acr/eular pss diagnosis and classification consensus. exclusion criteria: * (1) patients were diagnosed as any rheumatic or systematic diseases that would probably affect tear function except for pss and ded. (2) had a history of ocular trauma or surgery. (3) had a history of wearing contact lens. (4) had concomitant ocular lesions such as acute inflammation or infection, glaucoma or eyelid abnormalities. (5) cannot cooperate properly or finish related examinations.
vt art consortium: radioablation for ventricular tachycardia

Conditions: Ventricular Tachycardia (VT)

Summary: the overall objective of the study is to evaluate the efficacy and safety of stereotactic radiation therapy in the non invasive ablation of ventricular tachycardia refractory to any other type treatment.

by agreeing to participate in this study, the patient will undergo an initial evaluation to verify that his or her condition meets the inclusion criteria required for participation. at that visit, * 12-lead ecg will be performed * echocardiography * ct scan of the chest * laboratory tests: nt probnp, hs troponin i * pmk device evaluation the study will have a duration of 60 months and will involve 52 patients with the same disease from which one is affected. specifically, the total expected duration of individual subject participation in the study will be 60 months. participation in the study does not involve any expense for the patient or any compensation. participation in the study may involve some risks such as :: pericarditis, actinic pneumonia, worsening heart failure, exitus. the following benefits can be expected from participation in this study: reduction of vt episodes compared to the pre-treatment period, reduction/total discontinuation of antiarrhythmic drugs compared to baseline (before radioablation), improvement of cardiac parameters compared to baseline : lvef, left ventricular end-diastolic volume/diameter, end-systolic volume/diameter, rvef and tapse for right ventricular function, improvement of patient's quality of life (sf-36) compared to baseline. no direct benefits may also emerge from the study, but still significant for research.

Eligibility criteria:
inclusion criteria: 1. patients with refractory vt 2. age \> 18 years 3. patients with icds for follow-up 4. ineligible for heart transplantation. 5. prognosis of not less than 1 year 6. ability to express autonomous consent to therapies or (in case of inability due to clinical condition) deferred consent (first indicated by the referring clinician, later expressed by the patient once recovered to autonomous condition exclusion criteria: 1. evaluation of icd demonstrating polymorphic vt; 2. patients with intermacs class greater than 4; 3. patients with lvad; 4. patients with active neoplastic disease undergoing oncological treatment.

Keywords: radioablation ventricular tachycardia star
is barium enema an adequate diagnostic test for patients with positive fobt?

Conditions: Colorectal Cancer

Summary: the research protocol aim is to compare diagnostic tools for the proper evaluation of patient with fecal occult blood test positive (fobt +), a routine screening test for colorecatl carcinoma. the purpose of this study is to determine if double contrast barium enema (dcbe), a specialized radiographic exam of the colon, is a reasonable alternative for the evaluation of patients with positive fecal occult blood as compared to colonoscopy, which is considered the best evaluation method. colonoscopy involves the direct visualization of the colon using a flexible instrument. this permits the removal of polyps and to obtain biopsies. it involves additional risks, discomfort and costs. in fact the dcbe is the experimental procedure in this protocol. additional aims of this study are: to determine the localization, number, size and pathologic characteristics, if applicable, of findings in colonoscopy and/or dcbe and to determine the patient preference between both studies. this study is limited to those patients 50 years or older who are at average risk for colon cancer and who had a positive fecal occult blood screening test.


Eligibility criteria:
inclusion criteria: * asymptomatic patients older than 50 years of age, with at least one positive fobt * without history of colon cancer and/or polyps * gross gastrointestinal bleeding or prior colonoscopy or dcbe * who were willing to participate in the study * were included in the investigation. exclusion criteria: * patients with poor cardio-respiratory condition * coagulation deficiency, use of anticoagulants or other drugs affecting coagulation * severe renal or liver disease * hospitalized patients and palpable abdominal or rectal mass were excluded from the study.

Keywords: colon polyps fecal occult blood test double contrast barium enema colonoscopy