Kornimate/medical-research-clean huggingface dataset:
the 5-fu holter study

Conditions: Gastrointestinal Malignancy

Summary: to assess the feasibility of using ambulatory ecg monitoring (holter monitor) for patients receiving 5-fu chemotherapy

5-fluorouracil (5-fu) is the key chemotherapy component in systemic treatment of colorectal cancer. however, 5-fu treatment is also associated with cardiotoxicity which can have devastating consequences. cardiotoxicity can be both symptomatic (e.g. chest pain, myocardial infarction (heart attack) and/or sudden death) as well as asymptomatic ('silent myocardial ischemia', which is only detectable by ecg). data suggests that asymptomatic cardiotoxicity may be relatively common (\~30% of patients). about 69% of the cardiac events are seen during or within the first 72 hours of the first cycle of 5-fu. the development of cardiotoxicity requires permanent discontinuation of 5-fu chemotherapy. there are no pharmac funded alternatives for patients who discontinue 5-fu due to cardiotoxicity. discontinuation of 5-fu is likely to lead to a worse oncological outcome (survival time) for the patient. one proposed mechanism for 5-fu cardiotoxicity involves fluoro-beta-alanine (fbal), which is a metabolite formed when 5-fu is catalysed by the enzyme dihydropyrimidine dehydrogenase (dpd). the rationale for this feasibility study is to provide preliminary information required to develop a prospective pharmacokinetic study exploring plasma clearance of fbal and 5-fu cardiotoxicity. this study aims to determine i) whether the use of continuous ecg monitoring (ambulatory holter monitoring) in real life conditions (over two days, while at home receiving infusional 5-fu chemotherapy), is able to appropriately assess these types of silent heart attacks (st changes) and ii) the acceptability of this study to both patients and clinicians iii) the excretion rate of fbal over the 48 hour time period \& interpatient pharmacokinetic variability in fbal excretion.

Eligibility criteria:
inclusion criteria: * patients with diagnosis of gastrointestinal malignancy * planned to receive either folfox chemotherapy with any treatment intent * aged ≥ 18 years at time of signing informed consent form exclusion criteria: • ecg with left bundle branch block or left ventricular hypertrophy with strain
a study to evaluate the effectiveness and safety of polatuzumab in real world clinical practice among adult chinese participants with diffuse large b-cell lymphoma

Conditions: Diffuse Large B-Cell Lymphoma

Summary: the purpose of this study is to assess the progression free survival (pfs) in the real-world settings of polatuzumab among chinese diffuse large b cell lymphoma (dlbcl) participants.


Eligibility criteria:
inclusion criteria: * be diagnosed as dlbcl * cohort 1: diagnosed as unfit/frail dlbcl. the unfit/frail is defined as aged 80 years or older, or younger than 80 years but with comorbidity and not tolerant to the standardized dose of cyclophosphamide, doxorubicin, vincristine, and prednisone (chop) therapy according to investigator's judgment * cohort 2: diagnosis as dlbcl but could not be classified into unfit/frail * cohort 3: relapse or refractory to previous treatment exclusion criteria: * participant who currently participates in or with plan to participate in any interventional clinical trial * any other reason that, in the investigator's opinion, makes the participant unsuitable to participate in this study.
micronutrient supplement for nurse burnout

Conditions: Burnout, Professional; Stress, Psychological

Summary: the purpose of this study is to confirm and quantify the ability of an 8-week intervention with a supplement containing magnesium citrate and vitamin b6 to reduce anxiety, stress, and burnout among nurses working full time in hospitals and urgent care centers during the covid-19 pandemic.

after being informed about the study and potential risks, all participants woh meet the eligibility criteria will provide written informed consent. they will then be randomized in a 1:1 ratio to either magnévie b6® or a placebo group. the assigned product will be consumed 3 times daily for 8 weeks.

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * stated willingness to comply with all study procedures and availability for the duration of the study * woman aged 20-59 * lives in the united states * in good general health as evidenced by medical history * stress subscale score from the dass \> =22 * ability to take oral medication and be willing to commit to taking 3 tablets a day for 8 weeks. * for females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional month after the end of magnévie b6® administration * employed full time as a nurse in a hospital, primary, or urgent care center that treats covid-19 patients. full time is defined as 35 hours or more each week. * agreement to adhere to lifestyle considerations throughout study duration exclusion criteria: * current use of the following pharmaceuticals: bisphosphonates, calcium channel blockers, digoxin, aminoglycoside antibiotics, ketamine, levodopa/carbidopa, gabapentin, potassium sparing diuretics, quinolone antibiotics, skeletal muscle relaxants, sulfonylureas, tetracycline antibiotics, amiodarone, antihypertensives, or antiepileptic drugs (including phenytoin, valproic acid, carbamazepine, phenobarbital). * pregnancy, trying to conceive or breastfeeding * known allergic reactions to any components of the supplement including magnesium citrate anhydrous, pyridoxine hydrochloride, lactose anhydrous, magnesium stearate, hypromellose, macrogol 6000 titanium dioxide, or talc * positive covid-19 test within 60 days of the study period * covid vaccine of any type scheduled during the intervention period or the week prior to the start of the study * current diagnosis or lifetime history of a bleeding disorder, kidney disease, or neuromuscular disease * recent dramatic weight changes (10% change in body weight in the last 6 months) * existing usage of a magnesium or vitamin b6 supplement
comparison of frequency of use of optive and systane

Conditions: Dry Eye

Summary: the purpose of this study is subjectively compare duration of action between optive and systane.


Eligibility criteria:
inclusion criteria: * males or females \> 18 years old * mild to moderate dry eye symptoms * score of at least 2 and no more than 4 on the sesod at the initial screening visit * likely to complete all study visits and able to provide informed consent exclusion criteria: * current use of topical cyclosporine * known contraindications to any study medication or ingredients * active ocular diseases or uncontrolled systemic disease (blepharitis patients that are actively being treated or disease that is uncontrollable) * ocular surgery within the past 3 months, * active ocular allergies
synchro. evaluation of the forecasts parameters of real time-three-dimensional doppler echocardiography in selecting patients with chronic heart failure for cardiac resynchronisation therapy

Conditions: Chronic Heart Failure

Summary: patients showing a normal value of sdi (\< or + 8%) will randomly be assigned to crt in "on" or "off"mode at one month after implantation. in any case of emergency, an automated rescue mode is included in the device for the patients in "off" mode.

patients with a pathological sdi (\> 8%) will as usually be treated by crt and will serve as control group. the study duration for each patient included in the trial is 6 months. patients showing a decreased nyha score by at least one class and an absence of major cardiovascular event during the period will be considered as "good responders". the otherswill be considered as "no responders". based on this composite clinical score, the percentage of good responders in each group at 6 months is the primary endpoint of the study. main secondary endpoints : * evaluation of the left ventricular function * exercice capacity * serious adverse events'frequency * quality of life (sf36) * diagnostic and prognostic value of the "brain natriuretic peptide"(nt pro bnp)evolution.

Eligibility criteria:
inclusion criteria: * both gender * age\>18 years * patients in functional class nyha iii or iv * patient with ejection fraction \ 140msec * interventricular mechanical delay \>40msec * delayed activation of the left ventricular postero-lateral wall * patient under optimal treatment for chronic heart failure for at least one month before inclusion * written informed consentement exclusion criteria: * patient with atrial fibrillation * absence of echogenicity * patient with an indication for pacemaker implantation * patient suffering from arterial pressure disorders, with systolic pressure greater than 170 or lower than 80 mmhg * major cardiovascular event within 6 weeks before inclusion * patient in the exclusion period of any other clinical trial * patient without social insurance policy * drug or alcohol addiction * any psychological disorder * pregnant women * patient with a transplanted organ * hiv positive serology at inclusion

Keywords: chronic heart failure real time three-dimensional echocardiography cardiac resynchronization therapy ventricular asynchrony systolic dysynchrony index
a study of dulaglutide in japanese participants with type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the main purpose of this study is to evaluate the efficacy and safety of combination therapy with dulaglutide and insulin in japanese participants with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * participants who have had a diagnosis of type 2 diabetes mellitus * participants who have been treated with insulin therapy (basal insulin, premixed insulin, or basal/mealtime insulin regimen) with or without 1 or 2 oral antidiabetics (oads) at stable dose for at least 3 months before screening * participants who have an hba1c value ≥7.0% and ≤10.5% at screening if the participant is washing out oads (dipeptidyl peptidase-4 \[dpp-4\] inhibitors, sulfonylurea \[su\], or glinides) or ≥7.5% and ≤10.5% at screening if the participant is not washing out oads * participants who have stable weight (±5%) ≥3 months prior to screening * participants who have a body mass index (bmi) of 18.5 to 35.0 kilograms per meter squared (kg/m\^2) exclusion criteria: * participants who have a diagnosis of type 1 diabetes * participants who have previously received therapy with a glucagon-like peptide-1 receptor agonist within 3 months prior to screening * participants who have been previously treated with dulaglutide prior to screening * participants who have been treated with 2 of the following at screening: dpp-4 inhibitor, su, and glinide (ie, dpp-4 inhibitor and su, or dpp-4 inhibitor and glinide) * participants who have been treated with continuous subcutaneous insulin infusion (csii) at screening * participants who have clinically significant gastric emptying abnormality, hepatitis, pancreatitis, renal dysfunction, or thyroid abnormalities * participants who have a history of clinically significant cardiovascular disease, transplanted organ, or active or untreated malignancy
nafld in diabetes type 2 in primary care

Conditions: NAFLD

Summary: the epsonip (evaluating prevalence and severity of nafld in primary care) trial is a longitudinal cohort study of patients with t2dm recruited from primary health care centers in östergötland, sweden. the latest mri techniques will be used to quantify the amount of hepatic fat, inflammation, liver fibrosis and body composition. each patient will be investigated twice with three years apart to determine patients with progressive disease.


Eligibility criteria:
inclusion criteria: * diabetes type 2 * age 35-75 year exclusion criteria: * contraindication to mr * alcohol dependance * previously diagnosed liver cirrhosis * previously known liver disease (other than fatty liver)
analyses of existing framingham data

Conditions: Eye Diseases

Summary: since 1948, the framingham study has examined a group of men and women every two years for the primary purpose of studying the incidence and prevalence of cardiovascular disease and its risk factors. in 1971 the framingham study began a study of the offspring of the original group, including data collection on blood pressure, cigarette smoking, weight, and other factors that are of interest to studies of eye disease. researchers gave eye exams to some of the original group and to the offspring group. data from these eye exams have been used to examine risk factors for cataracts, diabetic retinopathy, myopia, and glaucoma. the purpose of this study is to use the previously collected data for continued research on eye-related disorders. no new eye examinations will be conducted. ...

we propose to continue to analyze existing framingham eye and heart study data to identify possible risk factors for various eye diseases. originally begun in 1948 by the national heart, lung and blood institute (nhlbi), the framingham heart study has been examining a population-based cohort of men and women biennially since 1948 for the primary purpose of studying the incidence and prevalence of cardiovascular disease and its risk factors. in 1971 the heart study began a prospective study of the offspring of the original cohort. the heart study has collected data on blood pressure, cigarette smoking, weight and many other factors of interest for epidemiologic studies of eye disease. eye examinations were conducted on the survivors of the original cohort in a collaborative effort between the nei and the nhlbi between 1973 and 1975 (framingham eye study i; fes i) and then again between 1986 and 1989 (framingham eye study ii; fes ii). eye examinations were conducted on the offspring cohort from 1989 to 1991 (framingham offspring eye study; foes). the framingham data are unique in allowing epidemiologic studies with both cross sectional and longitudinal designs. over the years, data from the heart study and the various eye studies have been used to examine demographic and risk factor characteristics for cataract, diabetic retinopathy, myopia, and glaucoma. to date this collaborative effort has yielded 31 publications by the national eye institute's division of epidemiology and clinical research; rita hiller is an author of 11. this proposal is for the continued use of the previously collected framingham data. all studies will be done in collaboration with heart study investigators from boston university which manages the study and conducts annual irb reviews. no new eye examinations will be done.

Eligibility criteria:
* this study is of existing ocular data from the framingham eye study. since the participants have already been recruited, there are no further exclusions from the study.

Keywords: eye diseases
ang1005 in patients with recurrent high-grade glioma

Conditions: Glioma; Glioblastoma; Brain Tumor, Recurrent

Summary: this is a phase 2 study to see if an investigational drug, ang1005, can shrink tumor cells in patients with high-grade glioma. another purpose of this study is to assess the efficacy, safety, tolerability, and pharmacokinetics (pk) of ang1005 in patients.

see above.

Eligibility criteria:
inclusion criteria: 1. ≥ 18 years old 2. gbm and gbm variants, who grade iii anaplastic glioma diagnosis confirmed 3. radiologically confirmed recurrent and bi-dimensionally measurable disease per response assessment in neuro-oncology (rano) criteria 4. neurologically stable 5. for bevacizumab-refractory patients, radiologic demonstration of tumor progression during bevacizumab therapy 6. karnofsky performance status (kps) ≥ 80 7. expected survival of at least 3 months exclusion criteria: 1. more than three relapses 2. previous ang1005/grn1005 treatment 3. radiotherapy within 3 months. 4. therapy with bevacizumab within 4 weeks prior to day 1 of treatment for recurrent who grade iii anaplastic glioma patients (arm 3) 5. evidence of significant intracranial hemorrhage 6. previous taxane treatment 7. prior therapy with bevacizumab for bevacizumab-naïve patients (arm 1) 8. nci common toxicity criteria for adverse effects (ctcae) v4.0 grade ≥ 2 neuropathy 9. inadequate bone marrow reserve 10. any evidence of severe or uncontrolled diseases 11. participants with the presence of an infection including abscess or fistulae, or known infection with hepatitis c or b or hiv 12. known severe hypersensitivity or allergy to paclitaxel or any of its components

Keywords: glioma glioblastoma brain cancer brain tumor recurrent
vitamin d effect on calcium absorption on persons on hemodialysis

Conditions: Chronic Kidney Disease; End Stage Renal Disease; Vitamin D Deficiency

Summary: the assumption has been that 1,25(oh)2d is solely responsible for calcium absorption. that has been one of the presumed causes of hyperparathyroidism in chronic kidney disease (ckd) (low 1,25(oh)2d leads to decreased calcium absorption, which increases parathyroid hormone release in compensation). replacing 1,25 d directly has been the goal with using 1,25d or its analogues in ckd. there is very little data concerning use of native vitamin d or 25(oh)d in ckd, although autocrine functions in extrarenal tissues would use 25(oh)d. the latest kdigo guidelines do recognize the autocrine role of vitamin d, but have no data on outcomes or doses or optimal levels to guide them and so have made a blanket recommendation to treat 25d levels in ckd by general healthy population guidelines. 1. this project focuses on an outcome (calcium absorption) that may be impacted by optimizing 25d status in renal patients. the investigators will assume for this project that a level of 25d \> 32 ng/ml is optimal in ckd patients as in a healthy population. 2. a secondary outcome is to quantify calcium absorption in ckd patients with and without vitamin d repletion and to quantify systemic 1,25d levels. this may clarify the roles 25d and 1,25d play in calcium absorption.


Eligibility criteria:
inclusion criteria: * on hemodialysis * \> 19 years of age exclusion criteria: * pregnancy or planned pregnancy * hypercalcemia (\> 10.2 mg/dl) at baseline * chronic gi disease * liver dysfunction * taking steroids * received any investigational drugs within 4 weeks * any allergy to vitamin d3 * chronic vitamin d intake \> 1,000 iu daily * dialysate concentration (calcium 2.5mg/l) which is to remain constant during rx

Keywords: vitamin d kidney renal
gsk1120212 rollover study

Conditions: Cancer

Summary: this was an open-label study to permit subjects with solid tumors or leukemia, who were clinically benefitting on another gsk sponsored trial with gsk1120212 either monotherapy or in combination continued access to gsk1120212.


Eligibility criteria:
inclusion criteria: 1. has provided signed informed consent for this study. 2. has demonstrated compliance during the parent study with study treatment(s), treatment visit schedules, and the requirements and restrictions listed in the consent form. 3. is currently participating in gsk1120212 study and is receiving treatment with gsk1120212. 4. is currently receiving clinical benefit as determined by the investigator from previous treatment with gsk1120212 either as monotherapy or as part of a combination treatment regimen. 5. continued ability to swallow and retain orally administered study treatment(s) and does not have any clinically significant gi abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach or bowels. 6. female subjects of childbearing potential, as defined in the parent study, must be willing to continue practicing the same acceptable method of contraception as used in the parent study during the rollover study and for at least 4 months after the last dose of gsk1120212. 7. female subjects of childbearing potential, as defined in parent study, must have negative serum pregnancy tests at the time of transition to this study. 8. subjects enrolled in france: in france, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category. exclusion criteria: 1. permanent discontinuation of gsk1120212 in the parent study due to toxicity or disease progression. 2. current use of a prohibitive medication(s) as listed in section 6.2. note: use of anticoagulants such as warfarin is permitted; however, the international normalization ratio (inr) must be monitored in accordance with local institutional practice. 3. any unresolved toxicity that meets the study treatment discontinuation or study withdrawal criteria from the parent study at the time of transition to this study. 4. bazett-corrected qt (qtcb) interval ≥501 msec at the time of transition to this study 5. left ventricular ejection fraction (lvef) \< institutional lower limit of normal (lln) by echo (preferred) or muga scan at the time of transition to this study. 6. nursing female. 7. any serious and/or unstable pre-existing medical, psychiatric disorder or other conditions at the time of transition to this study that could interfere with subject's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator or gsk medical monitor. -
effect of need to void on parkinsonian gait

Conditions: Lower Urinary Tract Symptoms; Parkinsonism; Gait Disorders, Neurologic

Summary: this study evaluates the effect of the need to void on parkinsonian gait

parkinsonian syndromes are common causes of gait disorders, associated with hypometria, bradykinesia or rigidity. if motor disorders are the most visible part, lower urinary tract dysfunction is one of the most prevalent dysautonomic disorder (27-80%), especially over active bladder syndrome (oab). if it seems evident that gait and urinary disorders are linked, because of similar anatomic pathways and control processes, no studies have investigated their association in extrapyramidal patients. the aim of this study is to assess the effect of the need to void on the walking speed in this particular population. this prospective study inclues all parkinsonian syndromes who had a follow-up for oab. they must have a security delay over five minutes, no severe cognitive, motor or psychiatric disorders. we invite them to drink until a need to void (or equivalent). bladder filling is measured by bladder scan, then they performe gait tests in a specific place, with calm and no passage : patient can use their habitual walking device. speed walk asking is comfortable for the two test. three ten-meter tests, one double-task ten-meter test, one timed-up-and-go test, one timed raise of the floor (gmt). we repeat the same tests after voiding or self-catheterization. toilets are just next to the hall where they realize the tests. a clinical examination assesses urinary dysfunction (usp, ipss), motor score (updrs-iii, hoehn and yahr scale, daily equivalent of levodopa), history of falls and comorbidities.

Eligibility criteria:
inclusion criteria: * parkinsonian syndromes * follow in neurourology for lower urinary tract symptoms * able to walk 50 meters without human assistance * able to hold voiding for more than 3 minutes exclusion criteria: * actual urinary tract infection * montreal cognitive assessment \< 20/30 * acute psychiatric or neurologic disorders who can interfer with walking tests