Kornimate/medical-research-clean huggingface dataset:
characterization of metabolic changes in the glioma tumor tissue induced by transient fasting (ergo3)

Conditions: Glioma, Mixed

Summary: nutritional interventions such as ketogenic diet (kd) or fasting are currently under evaluation as anti-cancer treatment. in glioma patient cohorts, the feasibility and safety of fasting in addition to antitumor treatment has been shown. however, it is still unclear whether fasting exerts effects on the glioma tumor tissue at all, and whether fasting causes metabolic or immunological changes in the glioma microenvironment that could be exploited therapeutically. therefore, the central contribution of this study is to characterize metabolic and immunological changes in the glioma tumor tissue induced by a fasting cycle of 72 hours prior to biopsy or resection.


Eligibility criteria:
inclusion criteria: * suspicion of glioma world health organization (who) grade ii, iii or iv as assessed by cerebral imaging (mri) * mri-suspected relapse of previously diagnosed glioma * interdisciplinary recommendation for resection or biopsy * karnofsky performance status \>= 60, eastern cooperative oncology group performance status (ecog) \<= 2 * creatinine \<= 2,0 mg/dl, urea \<= 100 mg/dl * alanine aminotransferase (alat), alanine aminotransferase aspartate transaminase (asat) \<= 7x upper normal limit * international normalized ratio (inr) ≤ 1,5, thrombocytes \> 100000/µl, leukocytes \> 3000/µl exclusion criteria: * bowel obstruction, subileus * insulin-dependent diabetes * dexamethasone \>4mg/day * decompensated heart failure (nyha \> 2) * myocardial infarction within the last 6 months, symptomatic atrial fibrillation * severe acute infection or clinically relevant immunosuppression (hiv infection, granulocytopenia \<1000/ µl, lymphocytopenia \<500/ µl * malnutrition, cachexia (bmi \<18) * other medical conditions that might increase the risk of the dietary intervention * pregnancy * uncontrolled thyroid function * pancreatic insufficiency * dementia or other clinically relevant alterations of the mental status which could impair the ability of the patient to apply to the diet or understand the informed consent of the study * major contraindications to mri scanning (e.g. presence of implanted mri-incompatible cardiac devices)

Keywords: metabolism-nutritional intervention-ketogenic diet-fasting
real-world persistence and adherence of ofatumumab compared to self-injectable and oral dmts in patients with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: this was a retrospective cohort study utilizing the iqvia pharmetrics® plus claims database from 01 august 2019 through 31 may 2022. the database is comprised of fully adjudicated (i.e., paid by the health plan) medical and pharmacy claims and is representative of the commercially insured united states population. adults treated with ofatumumab (omb), oral disease-modifying therapies (dmts) (dimethyl fumarate, diroximel fumarate, monomethyl fumarate, fingolimod, siponimod, ozanimod, ponesimod, teriflunomide, cladribine) or platform self-injectable dmts (glatiramer acetate, interferon beta-1a, peginterferon beta-1a, interferon beta-1b) between 01 august 2020, through 30 november 2021, were identified. the date of the first incident dmt (omb, oral dmt, or injectable dmt) during the identification window served as the index date. the baseline period was the 12 months before the index date, and the follow-up period was at least 6 months after the index date. patients treated with omb were selected first to maximize sample size, and these patients were allowed to have an oral or injectable dmt in the baseline period. patients without omb use during the identification period were categorized into the oral dmt or platform self-injectable dmt cohort based on the first-observed incident dmt during the identification period. for the purpose of this study, platform self-injectable dmts were referred to as 'self-injectable dmts.'


Eligibility criteria:
inclusion criteria: * patients with 1 claim or more for ofatumumab, a newly initiated oral dmt (dimethyl fumarate, fingolimod, teriflunomide, cladribine, siponimod, ozanimod, diroximel fumarate, monomethyl fumarate, ponesimod) or a newly initiated self-injectable dmt (daclizumab, glatiramer acetate, interferon beta-1a, peginterferon beta-1a, interferon beta-1b) occurring during the index window. * patients with 12 months or more of pre-index continuous enrollment \[ce\] with medical and pharmacy benefits. * patients with 6 months or more of post-index ce with medical and pharmacy benefits. * patients with 2 or more non-ancillary outpatient medical claims (at least 30 days apart) with a diagnosis code for ms (international classification of diseases, 10th revision, clinical modification \[icd-10-cm\] code: g35) in any position or 1 or more inpatient claims with a diagnosis of ms in the first position during pre-index period. * no data quality issues (defined as missing age or sex). * having two dmts on the same day was very rare in ms patients per clinician's inputs, but if it happened, those patients were excluded from analysis.
thromboelastography (teg) and clopidogrel withdrawal time in elderly patients with hip fracture

Conditions: Hip Fracture

Summary: in the elderly patients with hip fracture, some often take antiplatelet drugs such as clopidogrel due to the ischemic cardiovascular or cerebrovascular diseases. in traditional practice, these patients often need to stop medication for 5-7 days before surgery. but on the other hand, delayed surgery will lead to a significant increase in fracture related complications. therefore, the appropriate time for drug withdrawal is particularly important in this population. thromboelastography is a monitoring method that can accurately judge the anticoagulation status of patients. we hope to use thromboelastography to guide the time of drug withdrawal, shorten the time of drug withdrawal as much as possible, and reduce the incidence of fracture related complications without increasing the risk of massive hemorrhage.


Eligibility criteria:
inclusion criteria: * hip fracture and operation * taking clopidogrel for more than one week before injury, with or without taking aspirin at the same time exclusion criteria: * high energy injury (such as traffic accident, falling from height), bilateral hip fracture, multiple fractures or injuries, pathological fracture * malignant tumor patients * hormone users * patients with recent active bleeding or bleeding ulcer * primary or secondary coagulation dysfunction or depression caused by other reasons than taking antiplatelet drugs (for example, taking warfarin) * patients with other acute or unstable diseases requiring delayed surgery (acute heart failure, myocardial infarction, cerebral infarction, cerebral hemorrhage, severe pulmonary infection, deep vein thrombosis or pulmonary embolism, etc.)

Keywords: hip fracture clopidogrel withdrawal surgical timing thromboelastogram
a prospective comparison of cardiac troponin t and troponin i in the diagnosis of myocardial infarction

Conditions: Myocardial Infarction

Summary: the rising number of patients with chest pain without myocardial infarction has made accurate diagnosis important. unnecessary invasive coronary angiographies are increasingly prevalent. these are both costly and lead to rare but serious adverse events. recent studies suggest cardiac troponin i is more cardiac specific than cardiac troponin t. in this study we will investigate whether using cardiac troponin i lead to fewer unnecessary procedures in clinical practice (i.e. invasive coronary angiography and non-invasive tests)


Eligibility criteria:
inclusion criteria: * admitted to either herlev-gentofte or amager-hvidovre hospital * clinically suspected of nstemi * referred to invasive coronary angiography (ica) * recieved at least one measurement of either troponin exclusion criteria: -

Keywords: troponin
evaluation of two different designs of bausch & lomb contact lenses

Conditions: Myopia

Summary: the objective of this one month study is to evaluate the product performance of a redesigned purevision contact lens compared to the purevision contact lens when worn on a daily wear basis by wearers of contact lenses.


Eligibility criteria:
inclusion criteria: * subjects must have clear central corneas and be free of any anterior segment disorders. * subjects must be adapted wearers of one of the listed contact lenses * subjects must be myopic * subjects must use a lens care system on a regular basis. exclusion criteria: * subjects who have worn gas permeable (gp) contact lenses within the last 30 days of polymethylmethacrylate (pmma) lenses within the last 3 months. * subjects with any systemic disease affecting ocular health. * subjects using any systemic or topical medications that will, in the investigator's opinion, affect ocular physiology or lens performance. * subjects with an active ocular disease or are using any ocular medication. * subjects with any "present" finding during the slit lamp examination that, in the investigator's judgment, interferes with contact lens wear. * subjects who have had any corneal surgery (eg, refractive surgery). * subjects who have participated in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation.

Keywords: contact lens
investigation of the efficacy of pnf and schroth treatment

Conditions: Scoliosis; Adolescence

Summary: our study was to compare the advantages of schroth and pnf methods used in ais treatment

there are studies showing that schroth and pnf are effective on ais seperately. while there are studies showing that schroth is particularly effective on ais, the number of studies on pnf is insufficient. however, no evidence was found comparing the efficacy of schroth and pnf. therefore, the aim of our study was to compare the advantages of schroth and pnf methods used in ais treatment

Eligibility criteria:
inclusion criteria: * participants were between ages 10-18 * volunteered for the study. * diagnosed with adolescent idiopathic scoliosis * cobb angle between 10-30 degrees * 0-3 risser sign * lenke curve type 1 exclusion criteria: * non-idiopathic scoliosis * previous spinal surgery * who had exercise contraindications who had rheumatological disease who had mental handicap and who another neuromuscular problem
patient and caregiver attitudes and beliefs regarding prescription of intranasal naloxone spray for opioid overdose

Conditions: Caregiver; Patient

Summary: this trial studies the attitudes and beliefs of high risk patients and caregivers regarding the prescription of intranasal naloxone spray for opioid overdose. knowledge regarding high risk patients' and caregivers' beliefs and attitudes regarding co-prescription of naloxone spray with opioids may help to identify barriers to prescribing and helping tailor the education to better meet the needs of patients and caregivers.

primary objective: i. to determine the proportion of high risk patients who perceive receiving a prescription of intranasal naloxone to be beneficial for them. secondary objectives: i. to determine the proportion of caregivers who perceive receiving a prescription of intranasal naloxone to be beneficial for the patient. ii. to determine the association between high risk patients' and their caregivers' characteristics (this includes cut-annoyed-guilty-eye \[cage\], screener and opioid assessment for patients with pain \[soapp\], age, gender, ethnicity, education, employment status, presence of caregiver, cancer type, cancer stage, reason for narcan prescription, health insurance, and setting of narcan prescription) and their perception that a prescription for intranasal naloxone is beneficial for patients. exploratory objective: i. to conduct an exploratory analysis of high risk patients' and caregivers' attitudes and beliefs regarding prescription of intranasal naloxone spray. outline: participants complete a survey over 30 minutes.

Eligibility criteria:
inclusion criteria: * patients must have been prescribed intranasal naloxone in the past 1 year * patients and caregivers must be able to understand, read, write, and speak english * patients must have no clinical evidence of cognitive impairment, as determined by the palliative care provider (memorial delirium assessment scale score of \>= 7) * patients must sign an informed consent * caregivers may sign an informed consent if available during the visit * caregivers may verbally consent over the phone if not present during the visit * caregiver must be a friend, significant other or family member * caregivers must have no evidence of cognitive impairment, as determined based on orientation questions pertaining to the date, day of the week, time, and place exclusion criteria: * patient: emotional or psychosocial distress as identified by the patient's palliative care * patient: participants with edmonton symptom assessment system (esas) anxiety score of \> 6
an investigational drug study in patients with elevated cholesterol and coronary heart disease (0653-804)(completed)

Conditions: Hypercholesterolemia; Coronary Disease

Summary: the purpose of this study is to investigate additional cholesterol lowering effects in patients with coronary heart disease by giving an investigational drug with a patient's current approved cholesterol lowering medication.

the duration of treatment is 10 weeks.

Eligibility criteria:
inclusion criteria: * patients with elevated cholesterol and coronary heart disease exclusion criteria: * patients whose cholesterol levels measure within acceptable ranges as specified by the study requirements

Keywords: elevated cholesterol
longitudinal pancreatic cancer study

Conditions: Pancreatic Cancer

Summary: to obtain sufficient specimens and correlating clinical data from a well-controlled prospective clinical trial collecting longitudinal specimens from subjects diagnosed with any stage of pancreatic cancer.

the study objectives are described below: 1. obtain serum and plasma specimens longitudinally collected from approximately 140 subjects diagnosed with pancreatic cancer and are about to or are currently undergoing treatment and follow-up. specimens will be used to evaluate ca 19-9 assays, currently under development, as an aid for monitoring recurrence or progressive disease. 2. to store any remaining specimens for use in future cancer research and to evaluate as yet undetermined biomarkers for the development of ivds, including additional ca 19-9 assays, for monitoring the course of disease and therapy in subjects diagnosed with pancreatic cancer.

Eligibility criteria:
inclusion criteria: * males and females, age≥ 18 years * histologic/pathologic confirmation of exocrine pancreatic cancer * any stage of disease: newly diagnosed, stable, disease progression * any treatment time point: treatment naïve, currently receiving or completed therapy for pancreatic cancer including active monitoring. * individuals with a history of malignant disease other than pancreatic cancer that was resected greater than 5 years ago and are currently in remission are eligible. * life expectancy greater than 6 months * able to understand and willing to provide informed consent exclusion criteria: * males and females, age \<18 years * no histologic/pathologic confirmation of exocrine pancreatic cancer * life expectancy less than 6 months * any concurrent malignancy other than basal or squamous cell skin cancers or in-situ cervical cancer. * unable to provide informed consent
exclusive intraoperative radiation therapy for breast cancer

Conditions: Breast Neoplasms; Toxicity

Summary: aim of the study is to evaluate toxicity in breast cancer patients treated with two different doses of intra operative radiotherapy


Eligibility criteria:
inclusion criteria: * non lobular epithelial breast carcinoma, excised with standard quadrantectomy * age ≥ 45 and \< 85 * tumor major diameter ≤ 2.5 cm * negative surgical margins (≥ 5 mm) * willingness to undergo follow up examinations * willingness to undergo imaging examinations (mri, mammograms, ultrasonography) * signed informed consent exclusion criteria: * ductal carcinoma in situ or lobular carcinoma * extensive intraductal component (greater than 25%) or intraductal carcinoma with microinvasion * serious concomitant disease or any disorder or condition (such as psychiatric or addictive disorders) that, in the opinion of the investigator, would preclude the patient from meeting the study requirements * pregnancy or lactation at the time of enrolment proposal (if necessary, during the trial patients must use effective contraceptive device) * collagen vascular disorders

Keywords: breast cancer intra operative radiation therapy toxicity
an observational cohort study in patients with chronic hepatitis b receiving pegasys

Conditions: Hepatitis B, Chronic

Summary: this observational, non-interventional cohort study will evaluate predictors of response in patients with chronic hepatitis b receiving standard of care pegasys therapy. efficacy and safety parameters will also be evaluated. patients included in the study will be followed for the duration of their treatment and for up to 3 years thereafter.


Eligibility criteria:
inclusion criteria: * adult patient, \>/= 18 years of age * chronic hepatitis b * treatment with peginterferon alfa-2a exclusion criteria: * coinfection with hav, hcv and hiv
study of losartan in pediatric patients with hypertension (mk-0954-337)

Conditions: Hypertension

Summary: this study will explore the dose-response of losartan as well as the safety and tolerability in children from 6 months to 6 years of age.


Eligibility criteria:
inclusion criteria: * participant is determined to be hypertensive exclusion criteria: * participant has a history of severe or symptomatic hypertension * participant has history of heart failure, rhythm disturbance or cardiomyopathy, or obstructive valvular disease * participant has started taking hypertensive medications within the past 30 days * participant has a known sensitivity to losartan or history of angioneurotic edema
a trial of rehabilitation therapy in older acute heart failure patients

Conditions: Acute Decompensated Heart Failure

Summary: rehab-hf: a trial of rehabilitation therapy in older acute heart failure patients, is a multicenter, randomized, attention-controlled, single-blind trial designed to examine the hypothesis that, in addition to standard care, a novel, tailored, progressive, multi-domain rehabilitation intervention administered to older patients with acute decompensated heart failure (adhf) beginning early during hospitalization and continuing for 12 weeks will improve physical function and key clinical outcomes, including the rate of rehospitalization.

there will be three lead centers, wake forest baptist health along with thomas jefferson university and hospital-co-investigator dr. david whellan, and duke university medical center-co-investigator dr. christopher o'connor. each center may recruit up to 3 geographically close, tightly affiliated 'satellite' sites under their management and budgetary control. together, these sites will recruit a total of 352 consenting patients ≥ 60 years old hospitalized with adhf. following informed consent and baseline testing, the participants will be randomized in a 1:1 fashion to receive a 12-week novel, progressive, multi-domain rehabilitation and exercise training intervention or attention control. the multi-domain rehabilitation intervention will include endurance, mobility, strength, and balance training and will be tailored based on participant performance in each of these domains. it will begin upon randomization during the hospitalization and will continue 3 times per week in an outpatient setting. participants randomized to the attention control arm will receive all services ordered by their primary physician and will be contacted bi-weekly by study staff. all participants will undergo measures of physical function and quality of life at baseline, 1 month, and 3 months. clinical events will be monitored for 6 months following the index hospitalization.

Eligibility criteria:
inclusion criteria: * age ≥ 60 years old * in the hospital setting \>24 hours for the management of adhf, or diagnosed with adhf after being hospitalized for another reason. adhf will be confirmed by the study physician, and will be defined according to the food and drug administration definition of hospitalized heart failure as a combination of symptoms, signs, and hf-specific medical treatments. exclusion criteria: * acute myocardial infarction * planned discharge other than to home or a facility where the participant will live independently * already actively participating in formal, facility-based cardiac rehabilitation

Keywords: heart failure
effectiveness of fluoride varnish in the prevention of early childhood caries: a randomized controlled trial

Conditions: Dental Caries

Summary: triple-blind randomized controlled trial with two parallel arms conducted between 2012 and 2014. children 2-3 years old, from 28 rural public preschools, located in low socioeconomic areas of chile were invited to participate. oral health education component was given to children, parents and educators, twice yearly. a new toothbrush and toothpaste for each child was delivered to the parents at baseline and in each of the follow-up visits. the experimental group was treated with fluoride varnish every six months while the control group received placebo applications. 277 preschoolers (2 to 3 years) main outcome: number of caries incident cases, increment dmft index

triple-blind randomized controlled trial with two parallel arms conducted between 2012 and 2014. children 2-3 years old, from 28 rural public preschools, located in low socioeconomic areas of chile were invited to participate. oral health education component was given to children, parents and educators, twice yearly. a new toothbrush and toothpaste for each child was delivered to the parents at baseline and in each of the follow-up visits. the experimental group was treated with fluoride varnish every six months while the control group received placebo applications. a trained, calibrated dentists blinded to treatment arm performed a visual-tactile dental assessment at 6, 12, 18 and 24 months. the number of incidents children with caries were recollected as the number of caries during the follow-up visits. nº of participant/ centres: 277 preschoolers (2 to 3 years) of 28 public preschools in non-fluoridated areas. main outcome: number of caries incident cases, increment dmft index

Eligibility criteria:
inclusion criteria: * children between 24 an 47 months, free of caries, preschooler of a public centre and living in a non-fluoridated community. exclusion criteria: * children compromised medically, or with developmental or learning disabilities, or with a temporary residence or with dental developmental anomalies.