Kornimate/medical-research-clean huggingface dataset:
evaluation of oncoxin-viusid® in prostate cancer

Conditions: Prostate Cancer

Summary: a not randomized clinical survey was done in 25 pacients with histological diagnosis confirmed of a prostatic adenocarcinoma and hardy in hormonotherapy at the calixto garcia hospital in habana (2016-2018). researches had as identifying goal the efecctiveness study of oncoxin-viusid® nutritional supplement as a support to convencional treatment. the patient were treated with habitual doses of docetacel and 75 mg per day of supplement during and fiften day after the quimiotherapy. the rest of numbers and severety of adverse reactions were determined as well as its influences on life quality when this co-therapy is performed, the evaluation of progresion spare survival and the porcentage of recurrences.


Eligibility criteria:
inclusion criteria: * masculine \>18 years-old patients * performans status: karnofsky ≥ 70 or (ecog \<2) * hormonal treatment alternatives 6 or 8 weeks before the inclusion ,with resistence to hormonal treatments * normal laboratory tests to onco-specific treatments. * ecocardiogram with a eyección fraction \> 60 %, in patients with history of cardiovascular deseases. * patients with life expectative more than 6 months. exclusion criteria: * patients who are receiving another onco-specific product in research. * patients with known hypersensitivity to anthracyclines and / or mitoxantrone * decompensated intercurrent diseases, including: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, liver damage and psychiatric illnesses that could limit adherence to the requirements of the clinical trial or any other special condition that at the discretion of the physician put your health and life at risk during the study or your participation in the trial. * patients with cerebral metastases. * patients with hiv.
effect of exercise on bowel function in colorectal cancer survivors

Conditions: Colorectal Cancer; Low Anterior Resection Syndrome

Summary: the survival rate of colorectal cancer patients is increasing due to the development of medical technology. however, many colorectal cancer survivors (crcs) have bowel dysfunction unlike other cancer survivors. after bowel dysfunction of crcs was known, many previous studies were conducted to improve bowel dysfunction. medication, probiotics, biofeedback training (bft), kegel exercise, and sacral nerve stimulation were the methods of intervention research to improve bowel movements in crcs. research on randomized control trial of bft and kegel exercise is very insufficient. surgery, chemo, and radiation have a lot of influence on the bowel process of crcs. in particular, damage to the abdominal muscles, pelvic floor muscles, and autonomic nervous system can also be caused by secondary symptoms such as increased fatigue, reduced physical strength, and musculoskeletal diseases. therefore, the investigators examine that exercise which can improve fatigue, physical fitness, and musculoskeletal disease affects bowel symptoms of colon cancer survivors.


Eligibility criteria:
inclusion criteria: 1. adults aged 19 to 70 who have been diagnosed with sigmoid colon cancer or rectal cancer have surgery for 6 months or more to less than 3 years 2. three months after chemo and radiation therapy. 3. six month after stoma take-down 4. colorectal cancer patients with a lars (low anterior reservation syndrome) questionnaire score of 21 or higher exclusion criteria: 1. subjects who have problems reading or understanding korean or who have problems communicating with researchers 2. subjects who plan to undergo surgery at the same time other than colorectal cancer surgery 3. metastatic colorectal cancer patients. 4. subjects who have stoma 5. people who are difficult to exercise in the judgment of the medical staff
detection of occult paroxysmal af in cryptogenic stroke or tia patients using an implantable loop recorder and correlation with genetic markers.

Conditions: Cryptogenic Stroke or TIA; Atrial Fibrillation

Summary: atrial fibrillation (af) is the significant risk factor of ischemic stroke with incidence about 20% of all ischemic strokes. the undiagnosed af in cryptogenic stroke patients could be present but not revealed by rutinne ecg.

the subcutaneous insertable cardiac monitor - reveal® xt icm, which provides long-term monitoring ( for 3 years), in selected stroke and tia population on the basis of age, stroke etiology, and prescreening for cardiac arrhythmias helps to increase a detection of af to 16.7% (range, 14.3% to 20.0%) in compare to ambulatory ecg detection of af 6.4% (range, 5.3% to 9.0%). the af detection after stroke and tia strategically changes the therapeutic approach. in correlation with mentioned above the incidence of both specific genetic markers of af and occurance of af in this population and healthy volunteers are interesting.

Eligibility criteria:
inclusion criteria: * 1. cryptogenic stroke or tia within 72 h of onset symptoms according to the criteria for the trial of org 10172 in acute stroke treatment (toast ) 2. national institute of health stroke scale (nihss ) score ≤ 15 3. modified rankin scale (mrs ) score ≤ 3 4. ability and willingness of patients or their relatives or legal representatives to understand study instructions both verbal and written in accordance with ich gcp and legislation applicable in the slovak republic exclusion criteria: * 1. known etiology of stroke or tia 2. untreated hyperthyreosis 3. myocardial infarct within 1 month of onset stroke or tia 4. coronary bypass within 1 month of onset stroke or tia 5. valvular disease requiring urgent surgery 6. documented atrial fibrillation or flutter . 7. patent foramen ovale (pfo) 8. permanent indication to oral anticoagulation therapy 9. long-term steroid therapy \> 30 days 10. participation in another clinical trial oriented to experimental pharmacologic therapy . 11. chronic inflammatory disease ( rheumatoid arthritide, ibd (inflammatory bowel diseases ), lupus, vasculitis) 12. severe co-morbidity not likely to complete to follow-up one year 13. pregnant and breastfeeding women 14. indication to pacemaker implantation, implantable cardioverter defibrillator (icd) or cardiac resynchronization therapy ipg or icd implantation 15. unabillity provide or unconsent with requiring protocol procedures

Keywords: cryptogenic stroke /tia atrial fibrillation implantable loop recorder genetic mutation
study of aro-rage in healthy subjects and patients with inflammatory lung disease

Conditions: Asthma

Summary: the purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of aro-rage in normal healthy volunteers (nhvs) and in participants with inflammatory lung disease (asthma). in part 1 of the study, nhvs will receive a single dose of aro-rage or placebo. in part 2 of the study, adult participants with asthma will receive 2 doses of aro-rage or placebo. additional nhvs may be randomized to receive 1 or 2 doses of aro-rage or placebo at sponsor discretion. dose levels in part 2 will be determined based on cumulative safety and pharmacodynamic data from part 1.


Eligibility criteria:
inclusion criteria: * normal pulmonary function tests at screening (nhvs only) * confirmed diagnosis of asthma based on source verifiable medical record (asthma patients only) * no abnormal finding of clinical relevance at screening (other than asthma for asthma patients) * stable dose of asthma controller medications prior to screening (asthma patients only) * if on allergen-specific immunotherapy, participants must be on a stable maintenance dose * non-smoking * women of childbearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception. males must not donate sperm during the study and for at least 12 weeks following the last dose of study drug * willing to provide written informed consent and to comply with study requirements exclusion criteria: * acute lower respiratory infection or asthma exacerbation within 30 days prior to first dose * positive covid-19 test during screening window * use of immunosuppressive medication within 90 days prior to first dose * receipt of any intranasal vaccine within 30 days prior to first dose * use of systemic corticosteroid therapy within 90 days prior to first dose * clinically significant health concerns (other than asthma in asthma patients) * human immunodeficiency virus (hiv) infection, seropositive for hepatitis b virus (hbv), seropositive for hepatitis c virus (hcv) * uncontrolled hypertension * unwilling to limit alcohol consumption to within moderate limits for the duration of the study * use of illicit drugs * use of an investigational agent or device within 30 days prior to first dose note: additional inclusion/exclusion criteria may apply per protocol
evaluation of 18f-fluciclovine (facbc) pet/mr uptake in participants with glioma

Conditions: Glioma

Summary: this is a pilot study to assess the ability of \[f-18\]fluciclovine to differentiate pseudoprogression from progression in participants after therapy, at imaging time points within the 12 week interval post chemoradiation. \[f-18\]fluciclovine. pet will be obtained at the time point in the 12 week interval in which mri demonstrates increase in enhancing volume with the differential diagnosis of pseudoprogression versus tumor progression. at the same time point (at least 6 hours after \[f-18\]fluciclovine or up to 3 days) f-18 fdg will also be performed consistent with standard clinical practice. the verification of pseudoprogression versus tumor progression will be determined by the regression of enhancing lesion on subsequent mri imaging obtained as part of standard care.

in this pilot study the investigators propose to image 10 participants who have been previously diagnosed by resection or biopsy with grade 3 or 4 glioma. all glioma cases undergoing resection at upmc are evaluated by immunohistochemistry for mutations in p53, nuclear localization of atrx, and the presence of idh1r132h mutation as part of standard neuropathologic integrated diagnosis using the who 2016 diagnostic criteria. all glioma cases resected at upmc undergo genetic profiling using next generation sequencing. mri imaging will be obtained as part of standard clinical care. the mri sequences include t1 pre and post contrast, t2 flair, dwi, adc and perfusion sequences using the imaging algorithm for evaluating treatment response in glioma treatment trials. radiogenomic analysis will be performed using the mri imaging sequences obtained as standard clinical care.

Eligibility criteria:
inclusion criteria: * 1. age ≥ 18 years old. 2. been previously diagnosed by resection or biopsy with grade 3 or 4 glioma. 3. agree to use adequate contraception as indicated in this protocol. 4. consent to pet scanning and receipt of one injection of 18f-fluciclovine. 5. able to comply with study procedures. 6. able to give written consent. 7. subject has had a standard of care, diagnostic mri study which was indeterminate due to the inability to differentiate pseudoprogression versus tumor progression. exclusion criteria: * 1. are a pregnant or breastfeeding female. 2. are participating in a clinical trial of another unlicensed product. 3. are undergoing 18f-fluciclovine pet for reason(s) other than newly diagnosed or recurrent glioma. 4. have a hypersensitivity to 18f-fluciclovine. 5. have acute renal failure or moderate/severe renal impairment, according to local clinical guidelines. 6. have a non-mri compatible implantable device or another contraindication for mri scan. 7. are deemed ineligible to participate for other reasons by an investigator.
the time-2b study: a study of akb-9778 (razuprotafib), a novel tie 2 activator, in patients with non-proliferative diabetic retinopathy (npdr)

Conditions: Nonproliferative Diabetic Retinopathy

Summary: the purpose of this study is to evaluate the safety and efficacy of subcutaneously administered akb-9778 15mg once daily or 15mg twice daily for 12 months in patients with moderate to severe non-proliferative diabetic retinopathy (npdr).


Eligibility criteria:
key inclusion criteria: * adults 18 through 80 years of age (inclusive) * subjects with moderate to very severe npdr (etdrs level 43 - 53 inclusive) * no evidence of central involved diabetic macular edema * etdrs best-corrected visual acuity letter score ≥ 70 (snellen 20/40 or better) key exclusion criteria: * ocular disease other than dr that may cause substantial reduction in visual acuity, including iris neovascularization, retinal detachment, visually significant epiretinal membrane, vitreous hemorrhage or fibrosis, ocular inflammation (uveitis), other retinal inflammatory or infectious diseases * evidence of neovascularization on clinical examination or imaging * hemoglobin a1c (hba1c) ≥ 12.0% at screening * severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation
the impact of cytochrome p450 abnormalities in patients with delirium.

Conditions: Delirium, Cytochrome P-450 Enzyme System

Summary: objectives: 1. to examine whether patients with delirium have higher prevalence of cytochrome-p450 abnormalities compared to patients without delirium. 2. to examine whether the severity of delirium is related to a specific cytochrome p450 genotype. 3. to examine the persistence of delirium at 6-8 weeks stratified by presence of cytochrome p450 abnormalities 4. to examine whether delirium persistence is impacted by types of medications administered during their hospital stay.

delirium is a costly and devastating illness affecting older patients in the hospital. its prevalence increases as patients get older and sicker. there is scientific evidence that delirium affects cognitive function for a prolonged period of time and in many cases irreversibly. the economic burden on health care and emotional burden on the caregivers of patients with delirium is tremendous. we think that our study may contribute to developing prevention strategies for delirium in the hospital. we propose genetic testing of older patients to determine their ability to metabolize commonly used medications in the hospital. this will give medical professionals and pharmacists an ability to adjust dosages of medications based on the patient's genetic profile.

Eligibility criteria:
inclusion criteria: 1. patients age 18 and older admitted to the algh (advocate lutheran general hospital) rehabilitation unit 2. one or more of the following principle diagnosis: principle stroke diagnosis principle cardiac-post cardiac surgery principle spinal surgery 3. non-english speakers are not anticipated. however, there is an available interpreter services already on the unit and this interpreter's services will be utilized. https://www.languageline.com/ however, we will utilize that ahc irb approved short forms if a potential subject presents itself. exclusion criteria: 1. stroke patients with any diagnosed aphasia 2. spinal surgery, as a result of trauma 3. pregnant women 4. prisoners 5. patients with dementia (score of greater than 3.3 on short iqcode questionnaire) (long term cognitive impairment after critical illness, nejm, 2013, pandharipande et al.) 6. patients with cirrhosis and liver failure 7. patients with renal failure requiring dialysis 8. recent blood transfusion
gargling with green tea for prophylaxis of influenza infection in teenagers

Conditions: Influenza Infection

Summary: experimental and clinical studies in adults have reported that green tea catechins prevent influenza infection. in this clinical randomized study, the investigators aimed to determine the effects of gargling with green tea on the prophylaxis of influenza infection among high school teenagers.

influenza infection is the principal cause of acute respiratory illnesses and occurs in epidemic or pandemic worldwide. it spreads easily among high school students and from them to the rest of the community; therefore the prevention of influenza is very important. experimental studies have revealed that some components of green tea can prevent influenza infection in vitro. in clinically, gargling with green tea catechins has been reported to have possibilities to preventing influenza infection in adults; however, little clinical evidence in teenagers has so far been existed. based on this background, the investigators designed a randomized study to evaluate the clinical efficacy of gargling with green tea in preventing influenza infection among high school students.

Eligibility criteria:
inclusion criteria: * aged from 15 to 20 years * obtained written informed consent from both the student and parent before participation * possible to gargle during 90 days * possible to fill in questionnaire exclusion criteria: * possessing allergy to green tea * possessing history of influenza infection within 6 months before entering the study * possessing severe immune disease or whole body infection * severe cardiac, respiratory, renal, or hepatic dysfunction * diagnosed as inadequate to participate in the study by student doctor

Keywords: green tea gargling prophylaxis influenza respiratory tract infections high school students
advanced surface ablation (asa) vs laser-assisted in situ keratomileusis (lasik)

Conditions: Nearsightedness; Farsightedness; Astigmatism

Summary: the purpose of this combined retrospective and prospective chart review analysis is to investigate the safety, efficacy, and predictability obtained via laser-assisted in situ keratomileusis (lasik) and advanced surface ablation (asa) over a wide range of refractive errors the working hypothesis is that there will be no difference in clinical outcomes between patients treated with lasik or asa.

excimer laser vision correction (lvc) is a widely used procedure to correct nearsightedness, farsightedness, and astigmatism by reshaping the surface of the eye (cornea). laser-assisted in situ keratomileusis (lasik) and advanced surface ablation (asa) and are techniques currently used to prepare the cornea for excimer lvc. this review is intended to study whether lasik is equal in visual outcome (null hypothesis), more effective (alternate hypothesis 1) or less effective (alternate hypothesis 2) than asa in clinical outcome up to one year.

Eligibility criteria:
inclusion criteria: * eyes that were treated for lasik or asa excimer laser vision correction before december 1st 2006 and newly recruited eyes that qualify for lasik or asa excimer laser vision correction may be enrolled in this study. exclusion criteria: * there are no exclusion criteria; all patients that went forward with excimer laser vision correction may be included.
bioactive glass as bone graft substitute in operative treatment of bone - a 10 years follow-up study

Conditions: Depressed Lateral Condyle Fracture; Benign Bone Tumour Cavity; Spinal Fusion

Summary: the main aim is to evaluate the long-term safety and bone healing in the operated area and to compare bioactive glass granules with autogenous bone as a filler material.


Eligibility criteria:
inclusion criteria: * written informed consent obtained; participation of previous clinical investigation with bioactive glass exclusion criteria: * the subject is unlikely to adhere to study procedures * concurrent disease or condition that in the opinion of the investigator is contraindicating participation * simultaneous participation in another medical device or investigational drug trial
treatment of orthostatic intolerance

Conditions: Tachycardia; Chronic Orthostatic Intolerance

Summary: this trial is designed to study the effects of various mechanistically unique medications in controlling excessive increases in heart rate with standing and in improving the symptoms of orthostatic intolerance in patients with this disorder.


Eligibility criteria:
inclusion criteria: * chronic symptoms (\> 6 months) with standing upright exclusion criteria: * obvious cause of hypovolemia or drugs that could worsen tachycardia * chronic severe medical conditions such as cancer or ischemic heart disease

Keywords: tachycardia sinus tachycardia postural tachycardia syndrome (pots)
soy polysaccharide fiber for the treatment of chronic constipation in children: a randomized, double-blind trial

Conditions: Constipation

Summary: the study tested the hypothesis that soy polysaccharide fiber reduces clinical symptoms of chronic constipation.

the study was performed out at outpatient clinic of pediatric gastroenterology at the federal university of são paulo (são paulo, brazil), located in the southeastern region of brazil. it is a public referral hospital for pediatric gastroenterology attendance in the metropolitan area of the são paulo and in brazil. in general, the patients go to consultation after a referral from a primary care center. study design and sample size the design was a randomized double-blind trial, placebo-controlled study. sample size was calculated by the formula of comparison of two proportions, using clinical improvement as a primary outcome. it had been previously calculated that a minimum of 14 patients in each group will give a power of 80% to detect a effect size of 50% with significance at the level of 5% (one-sided).

Eligibility criteria:
inclusion criteria: * patients over two years of age at first consultation and chronic functional constipation were included. chronic constipation was defined by the occurrence of any of the following, for at least 2 weeks, independently of stool frequency: passage of hard, scybalous, pebble-like or cylindrical cracked stools, straining or painful defecation, passage of large stools that may clog the toilet, or stool frequency less than 3 per week. exclusion criteria: * the exclusion criteria applied were organic constipation, regular use of dietary fiber in the preceding 30 days or drugs causing constipation.

Keywords: clinical trial dietary fiber constipation children
mk0476 study in adult patients with acute asthma (0476-322)

Conditions: Asthma

Summary: this study evaluates the efficacy and safety of mk0476 intravenous administration in adult patients with acute asthma.


Eligibility criteria:
inclusion criteria: * adult patients with acute asthma attacks exclusion criteria: * patient has any known or suspected, acute or chronic cause for their pulmonary symptoms other than asthma (e.g., copd, chronic heart failure, etc.) * patient has a smoking history (20 cigarettes per day) of more than 15 years * patient has a disease of the cardiovascular, hepatic, renal, hematologic systems, or other severe disease
a study to investigate the potential for azd5672 to affect the electrical conduction pathways in the heart

Conditions: Rheumatoid Arthritis

Summary: this study is being performed to investigate the potential for azd5672 to affect the electrical conduction pathways in the heart. azd5672 will be compared against a drug (moxifloxacin - a licensed antibiotic) known to have a detectable but safe change on the electrical conduction of the heart.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) between 18 and 30 kg/m2 and a minimum weight of 50kg. * non-smoker exclusion criteria: * marked qtc prolongation at baseline e.g. repeated demonstration of qtc interval \>450ms or marked shortening of qtcf \<350ms * any clinically important abnormalities in rhythm, conduction or morphology of resting ecg that may interfere with the interpretation of the qtc interval changes * use of concomitant medications that prolong qt/qtc interval

Keywords: qtcf crossover ich e14 qt/qtc prolongation moxifloxacin qt/qtc interval