Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of empagliflozin in hemodialysis

Conditions: End Stage Renal Disease

Summary: a 12-week, phase ii, randomized, double-blind, placebo-controlled, multi-center study to assess the safety, tolerability, and preliminary efficacy of empagliflozin versus placebo among patients initiating hemodialysis (n=60) for the treatment of end-stage kidney disease.


Eligibility criteria:
inclusion criteria: * adults ≥18 years on maintenance hemodialysis (hd) with residual kidney function * thrice-weekly hd * willingness and capacity to provide informed consent * for women of childbearing potential, a negative pregnancy test is required at screening exclusion criteria: * does not have capacity to consent * anuria (daily urine volume \< 200 ml/day) * planned kidney transplant within 3 months * recurrent urinary tract infections (\>2 episodes/year or antibiotic prophylaxis) * new york heart association (nyha) class iv heart failure (hf) * myocardial infarction, unstable angina, revascularization procedure (e.g., stent or bypass graft surgery), or cerebrovascular accident within 12 weeks * history of diabetic ketoacidosis * type 1 diabetes mellitus * hereditary glucose-galactose malabsorption or primary renal glucosuria * liver disease (e.g., acute hepatitis, chronic active hepatitis, cirrhosis); alanine aminotransferase (alt) levels \>2.0 times the upper limit of normal (uln) or total bilirubin \>1.5 times the uln, unless consistent with gilbert's disease * active malignancy (exceptions: squamous and basal cell carcinomas of the skin and carcinoma of the cervix in situ) defined as malignancy under active treatment with chemotherapy, radiation or immunotherapy, or being treated as palliative. * major surgery within 12 weeks * atraumatic amputation within past 12 months of screening, or an active skin ulcer, osteomyelitis, gangrene, or critical ischemia of the lower extremity within 6 months of screening * combination use of angiotensin-converting enzyme inhibitor (acei) and angiotensin receptor blocker (arb) * current use of an sglt2 inhibitor (within 6 weeks prior to randomization) * known allergies, hypersensitivity, or intolerance to sglt2i or its excipients * received an active investigational drug (including vaccines) other than a placebo agent, or used an investigational medical device within 12 weeks before day 1/baseline * pregnant or breast-feeding or planning to become pregnant or breast-feed during the study * women of childbearing potential not willing to use a highly-effective method(s) of birth control, or who are unwilling or unable to be tested for pregnancy. * any condition that in the opinion of the investigator would make participation not in the best interest of the subject
effectiveness of orthokeratology in decreasing myopic progression in a young adult population enrolled in a professional optometric curriculum

Conditions: Myopia Progression

Summary: the high prevalence of myopia - especially in asian countries - is well documented, as are the sight-threatening complications of high or degenerative myopia. retinal detachment, glaucoma, vitreal degeneration and focal retinal changes occur secondary to the progressive axial elongation of the eye with age. specialty rigid lenses have long been shown to lessen this progression in the pediatric population; orthokeratology (ortho-k) lenses are worn at night and change the corneal topography to correct low to moderate amounts of myopia. this same axial elongation has also been shown to occur in young adults with high near demands, however to our knowledge, there are no studies examining the effect of ortho-k lenses in this population. our project seeks to investigate the efficacy of ortho-k in slowing axial elongation and myopic progression in subjects between the ages of 21-30. results will help elucidate what role these specialty lenses may have in the management of the myopic patient throughout their development, as well as what potential they have in prevention of associated degenerative changes.


Eligibility criteria:
inclusion criteria: * the subject must be in the incoming first year optometry class, with a myopic prescription between -0.50d and -5.00d in at least one eye with refractive astigmatism \<1.50d. visual acuity must be at least logmar 0.10 (snellen 20/25) or better at baseline examination in both eyes. ocular examination must not reveal any strabismus, ocular pathology or contraindications for orthokeratology lens wear. subjects must be in good general health with no systemic conditions that might impact their ocular health or refractive error. they must be willing to sleep a minimum of six hours per night. finally, subjects must be willing and able to present to clinic for all necessary follow-up care. exclusion criteria: * prescription falls outside the refractive guidelines, have a history of any type of trauma or ocular surgery, have a history of prior experience with myopia control treatment, are amblyopic or if they are current gas permeable lens wearers. they will be discontinued from the study if they are non-compliant with the treatment protocol or do not achieve a desirable subjective result,
evaluating commercial anti-plaque products and oral rinse

Conditions: Dental Plaque

Summary: clinical research study to determine the anti-plaque efficacy of commerical dentifrices and an oral rinse.

this clinical research study was to train new examiners for short term plaque clinical methodologies.

Eligibility criteria:
inclusion criteria: * male or female volunteers at least 18 years of age. * good general health. * must sign informed consent form. * minimum of 20 natural uncrowned teeth (excluding third molars) must be present. * no history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study. exclusion criteria: * subjects unable or unwilling to sign the informed consent form. * medical condition which requires pre-medication prior to dental visits/procedures. * moderate or advanced periodontal disease or heavy dental tartar (calculus). * two or more decayed untreated dental sites at screening. * other disease of the hard or soft oral tissues. * impaired salivary function (e.g. sjogren's syndrome or head and neck irradiation). * use of medications that are currently affect salivary function. * use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1. * allergy to chlorhexidine. * pregnant or nursing women. * participation in any other clinical study within 1 week prior to enrollment into this study. * use of tobacco products. * subjects who must receive dental treatment during the study dates. * current use of antibiotics for pre-medication for dental treatment or for any other purpose. * presence of an orthodontic appliance that interferes with plaque scoring. * history of allergy to common dentifrice ingredients. * immune compromised individuals (hiv, aids, immuno suppressive drug therapy).
effect of enzyme replacement therapy on cardiac function in children with gaucher disease type 3

Conditions: Gaucher Disease Type 3

Summary: all cases confirmed diagnosis of gaucher disease type 3 recieving enzyme replacement therapy at assiut university hospital

evaluate cardiac involvement in a group of gd type 3 patients, evaluate pulmonary hypertension and valvular involvement, compare the findings of basic echo before the start of replacement therapy as well as with healthy controls, to assess the effects of enzyme replacement therpay on the cardiac function.

Eligibility criteria:
inclusion criteria: * any sex * no age limit * gaucher disease type 3 * receiving enzyme replacement therapy exclusion criteria: * age18 years old * cases of gaucher type 1 and 2 * other lipid storage disease
gw572016, an oral drug for colorectal cancer patients having prior therapy with 5-fu plus cpt-11 and/or oxaliplatin

Conditions: Colorectal Cancer

Summary: the purpose of this study is to determine the efficacy of an oral investigational drug in patients with refractory metastatic colorectal cancer after receiving prior therapy with 5-fluorouracil in combination with irinotecan and/or oxaliplatin.


Eligibility criteria:
inclusion criteria: * provide signed informed consent. * refractory stage iv metastatic colorectal cancer. * received at least 2 cycles of first-line therapy with intravenous 5-fu (5-fluorouracil) in combination with cpt-11 (irinotecan) and/or oxaliplatin. * no more than one prior therapy. * tumor tissue available for testing. * 4 weeks since first-line cancer regimen. * able to swallow and retain oral medication. * cardiac ejection fraction within the institutional range of normal as measured by muga (multiple gated acquisition scan). * adequate kidney and liver function. * adequate bone marrow function. exclusion criteria: * pregnant or lactating female. * conditions that would affect absorption of an oral drug * first-line regimen did not include 5-fluorouracil with irinotecan and/or oxaliplatin. * serious medical or psychiatric disorder that would interfere with the patient''s safety or informed consent. * severe cardiovascular disease or cardiac (heart) disease requiring a device. * active infection. * brain metastases. * concurrent cancer therapy or investigational therapy. * use of oral or intravenous steroids. * unresolved or unstable, serious toxicity from prior therapy. * prior therapy with an egfr (endothelial growth factor receptor) and/or erbb-2 inhibitor.

Keywords: colorectal cancer egfr inhibitor lapatinib metastatic
lower limb arthroplasty: effects of a tele prehabilitation program with indirect electrostimulation.

Conditions: Osteo Arthritis Knee and Hip; Lower Limb Arthroplasty

Summary: preoperative fitness is known to predict postoperative outcomes following lower limb arthroplasty, but many patients, especially the most fragile, arrive at surgery with reduced mobility and functional capacity. prehabilitation (prehab) encompasses a series of interventions that are intended to help patients improve their physical state and psychological well-being pre-intervention to reduce the days of hospitalization and the number of post-operative complications. patients who participate in prehab require less postoperative care and consequently have less impact on the cost of the healthcare system. however, adherence to a face-to-face program is usually poor and presents both organizational and psychophysical barriers. in the last years, telerehabilitation has proven to be a viable alternative to face-to-face treatment and has already been adopted for the prehab. electrostimulation (esm) is regularly used successfully in clinical settings for the recovery of muscle tone in patients with orthopedic pathologies. in addition, it has already been used for prehab, showing an increase in muscle strength and a decrease in postoperative hospital stay following knee arthroplasty. also exercise offers benefits in the treatment of orthopedic patients because improve: strength, cardiovascular fitness, functional capacities and quality of life. therefore, in a group of patients who are candidates for elective lower limb arthroplasty surgery, it was decided to evaluate the effects of a tele prehab program, based on the esm, and compare them with those of an tele prehab exercise program, equal in dose and duration. the proposal differs from those present in the literature for complete administration in telerehabilitation, including evaluations.


Eligibility criteria:
inclusion criteria: * elective knee or total hip arthroplasty exclusion criteria: * concomitant orthopaedic or neurological pathologies (other than the pathology for which arthroplasty has been indicated) that modify the ability to walk; * pathologies that modify the balance (neurological and/or vestibular); * contraindications to the use of medical equipment used in the study; * inability to understand and sign informed consent.
protecting health care workers during the covid-19 outbreak

Conditions: Covid-19

Summary: preparing to deal with covid-19 outbreak in rajasthan, india, health care workers were given ayurvedic kadha (combination of ayurvedic herbal extracts) starting from the end of february 2020. then, majority of these health care workers were put on front line managing screening, monitoring, quarantine and treating covid 19 patients. this real-life study aimed to determine the experience of health care workers who had ayurveda kadha before starting as front-line workers.


Eligibility criteria:
inclusion criteria: * health care workers posted in covid-19 duties at front line * health workers who had ayurveda herbs combination over for at least 10-days exclusion criteria: * no willing to consent * inability to participate
reducing frailty for older cancer survivors using supplements ii

Conditions: Frailty; Inflammation

Summary: this study is a two-arm placebo controlled randomized clinical trial, to assess the effect of a 12-week egcg intervention on physical frailty compared to placebo in pre-frail older cancer survivors.


Eligibility criteria:
inclusion criteria: 1. be age 65 or over. 2. be diagnosed with stage i-iii cancer 3. have completed curative intent treatment ≤10 years prior to screening patients on the following endocrine therapies are allowed to enroll (anastrozole,leuprolide acetate, and bicalutamide) 4. have a fried's frailty score (ffs) of ≥ 1 5. able to provide informed consent exclusion criteria: 1. have chemotherapy or other systemic cancer treatment planned to occur during the study period. 2. have abnormal liver function tests (alt, ast, and bilirubin) per most recent available lab test (within 3 months of screening) * 3 times institutional upper limit of normal for alt and ast * 1.5 times institutional upper limit of normal for bilirubin 3. have uncontrolled or unmanaged liver disease. 4. consume more than 6 cups of green tea per day. 5. have known allergies to caffeine. 6. be diagnosed with a major psychiatric illness requiring hospitalization within the last year. 7. be diagnosed with dementia. 8. cannot provide informed consent due to lack of decision-making capacity (as determined by the patient's oncologist).
validation of healthcare standards in chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: vesalio is a pilot study aimed at evaluating the feasibility and reliability (time stability and interobserver reliability) of healthcare quality standards in chronic obstructive pulmonary disease (copd) recently outlined by separ (spanish pneumology and thoracic surgery society), and at establishing the foundation for a future validation (construct and criterion validation) of the aforementioned standards.


Eligibility criteria:
inclusion criteria: * men and women 40 years of age or older * diagnosis of copd at hospital discharge * hospitalization for a copd exacerbation exclusion criteria: * patients hospitalized for the first time at the participating site without a documented history of copd * patients currently participating of having ever participated in a copd-related clinical trial * patients with a serious disease that might affect the measured outcomes (terminal oncologic disease, neoplastic disease for which the patient is receiving chemo/radiotherapy, terminal renal insufficiency, aids)

Keywords: copd
perception of cardiovascular risk

Conditions: Cardiovascular Diseases; Heart Diseases

Summary: the aim of the study is to describe the association between the perception of cardiovascular (cv) risk and the actual cv risk and, secondarily, to detect the actual cv risk to assess the prevalence of clinical risk factors, determined by means of appropriate instruments.

cardiovascular (cv) disease is the major cause of premature death in adults that carries serious economic consequences. risk perception for cv disease has been reported as the subjective judgment of the likelihood of having a cv event. risk perception is an important precursor to adopting a healthy lifestyle. however, both overestimation and underestimation of actual risk due mostly to poor health literacy are common. for these reasons, cv prevention services of health care professionals (e.g., nurses, physicians) should, on the one hand, include screening for the presence of risk factors, and on the other hand, know the cv risk perceptions of those being cared for. the aim of the study is to describe the association between the perception of cardiovascular (cv) risk, investigated by means of the perception of risk of heart disease scale and a likert-5 scale question, and the actual cv risk according to the score2 and, secondarily, to detect the actual cv risk ascertained by the score2 and to assess the prevalence of clinical risk factors (alterations in the lipid, glucose, or anthropometric profile) determined by means of appropriate instruments.

Eligibility criteria:
inclusion criteria: * an age between 18 and 69 years of age * subscription to informed consent. exclusion criteria: * patients with a positive history of hospitalization due to cv pathology at the time of enrollment; * patients with ongoing relevant cognitive debilitation (six item screener score \< 4)
pharmacy implementation trial: adherence to antihypertensive therapy

Conditions: Hypertension

Summary: the purpose of this study is to determine the effectiveness of maximal support of community pharmacies to implement a pharmaceutical care model for establishing and - if necessary - improving adherence to antihypertensive medication in patients with medication-resistant hypertension.

cardiovascular disease is the main cause of death in large parts of the world. hypertension is an important risk factor for cardiovascular disease. although hypertension treatment has improved in the last decade, the effectiveness of antihypertensive therapy still needs attention. adherence to medication appears to play an important role in that. pharmacists can support the general practitioners in their efforts to optimize antihypertensive therapy, by establishing adherence to medication of patients with hypertension in spite of the use of one or more antihypertensive drugs. this is performed with the electronic medication event monitoring system (mems®). registered adherence and accompanying blood pressure are discussed with the patient by the gp. implementation of the above-mentioned intervention is studied in two randomized groups of pharmacies. one group receives minimal support in the intervention, the other group also receives interactive educational meetings, reminders and feedback, and support of multiprofessional cooperation.

Eligibility criteria:
inclusion criteria: * pharmacies: resident in the south of the netherlands * patients: * 18 years or older * diagnosis of hypertension * systolic blood pressure between 150 and 180 mm hg despite the use of antihypertensive drug(s) * indication for treatment escalation exclusion criteria: * patients: * impossibility to establish blood pressure properly * patient treated by medical specialist * change of antihypertensive therapy because of adverse effects of current medication * insisting on using dose organisers * not managing their drug intake themselves * not able to come to the pharmacy

Keywords: patient non-adherence antihypertensive agents community pharmacy services professional roles
the life and care of patients with colorectal cancer before age 65 and their kindred

Conditions: Colorectal Cancer

Summary: in a context the respect of the autonomy of the patients is important, it is necessary to pay a sustained attention to the experiences and the lived experience as well of the patients suffering or in remission of cancer as of their family. it is therefore, for the family, to deepen the synthesis carried out by the societal cancer observatory which is a societal observatory of cancer


Eligibility criteria:
inclusion criteria: patients will be * over 18 years old * with a diagnosis of crc before 65 years. * able to give their non-opposition and to nominate at least 2 family members who would be willing to participate in the study the spouse and / or children and / or parents will be eligible: if they are at least 18 years old, if they can be considered a caregiver or are first-degree relatives of the index patient for whom a diagnosis of crc has been made. . exclusion criteria: * patients under 18 years of age or with a diagnosis of crc after 65 years. * near a deceased patient or under 18 years old.
registry (prospective cohort) for heart failure in korea (korahf)

Conditions: Acute Decompensated Heart Failure

Summary: korahf is a multi-center registry (prospective cohort) for acute decompensated heart failure patients in korea. the aim of this registry is to analyze several causes affecting prognosis and survival and to develop new strategies for managing acute decompensated heart failure.


Eligibility criteria:
inclusion criteria: all consecutive hospitalized adult patients who have 1 and (2 and/or 3) 1. symptom and/or sign of heart failure 2. lung congestion 3. objective finding of lv systolic dysfunction (lvef), or structural heart disease exclusion criteria: * n.c.

Keywords: heart failure registry cohort heart disease cardiovascular diseases
laparoscopic versus open liver resection for hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: the purpose of the study is to observe the curative effect and safety of laparoscopic versus open liver resection for hepatocellular carcinoma.

liver resection is the most important treatment of hepatocellular carcinoma (hcc). open hepatectomy was regarded as a giant surgery because of its big incision, influence of the liver function, and long hospital stay. laparoscopic hepatectomy was widely used since it was reported by reich in 1991. with the constant innovation of laparoscopic technique and equipment, there is no penalty area in laparoscopic hepatectomy. the louisville consensus proposed that the best indication for laparoscopic hepatectomy was the tumor diameter \< 5cm, located in segment ii-vi. previous studies shows that compared with the open surgery, laparoscopic hepatectomy has the advantages of shorter operation time, less bleeding, shorter hospitalization time. the mortality, mobility, the overall survival and the disease-free survival was same in these two groups. so far, however, the curative effect and safety research of laparoscopic versus open liver resection for hcc is limited to retrospective study and case-control study. a prospective, randomized, controlled study is urgently needed. this study was proceeded to observe the curative effect and safety of laparoscopic versus open liver resection for hcc.

Eligibility criteria:
inclusion criteria: 1. diagnosis was hcc 2. the tumor was located in segment: ii, iii, ivb, v, vi 3. the tumor diameter \< 5cm 4. without thrombosis in the portal vein, hepatic vein or bile duct 5. without intrahepatic and systemic metastasis 6. the child-pugh score was a-b7 7. the asa（american society of anesthesiologists） score was i-iii 8. the patient age was between 18-75 9. sign the informed consent, and can fully understand the research content exclusion criteria: 1. have surgery contraindications 2. pregnant or lactating women 3. the child-pugh score was b8-c 4. the asa（american society of anesthesiologists） score was iv-v 5. with other malignant tumor 6. with mental illness 7. participated in other clinical trials in the last three months 8. underwent other treatments(chemotherapy or radiotherapy) before operation
dose confirmation efficacy study (v260-007)

Conditions: Rotavirus Infections

Summary: this study was designed to evaluate the safety of the investigational rotavirus vaccine and the efficacy to prevent rotavirus gastroenteritis.

the duration of treatment is 10 months.

Eligibility criteria:
inclusion criteria: * healthy infants exclusion criteria: * history of abdominal disorders from a birth defect, intussusception, or abdominal surgery * known or suspected problems with immune system * fever at time of immunization * prior administration of a rotavirus vaccine * history of known prior rotavirus disease * chronic diarrhea, or failure to thrive