Kornimate/medical-research-clean huggingface dataset:
dapagliflozin cardiovascular effects on patients at end-stage renal disease

Conditions: End-stage Kidney Disease

Summary: treatment with sodium glucose co-transporter type 2 inhibitors (sglt2i) reduced the incidence of cardiovascular death and hospitalization for heart failure by 29% in individuals with moderate chronic kidney disease. recent observations found that beyond its effect on natriuresis, sglt2i directly interacts with cardiomyocytes inducing improvement of myocardial function. this effect is not mitigated as glomerular filtration rate declines. therefore, plausibly treatment with sglt2i may attenuate heart failure in individuals end-stage kidney disease (eskd) requiring dialysis, in whom cardiovascular disease remains the leading cause of death. in this context, this project was designed to estimate the effect of dapagliflozin on myocardial function of dialysis subjects. individuals with diagnosed eskd on dialysis for at least 3 months, from both sexes, aged more than 18 years of age are eligible. exclusion criteria are pregnant woman, hepatic failure, and known allergy to study medications. eligible patients will be recruited from the nephrology division of the clinics hospital of the university of campinas (unicamp). the study was designed as a prospective, randomized, open-label, phase 4 clinical trial. patients will be randomized, 1:1, for a 6-months treatment with either dapagliflozin 10mg/day (n=40) add to standard treatment or standard treatment alone (n=40). at the randomization visit, all patients will undergo a detailed interview and medical examination by the physician-researcher, echocardiogram and blood samples will be collected for further biochemical analysis and follow up visits will be scheduled every month for endpoints disclosure and medications dispensation until the end of study participation at the 6th month visit when echocardiogram and blood sample collection will be repeated. primary goal will be the difference between groups in mean change of ntprobnp levels during treatment. secondary endpoints encompass the mean change in ejection fraction, e/e' ratio, global longitudinal and radial strain and indexed left ventricle mass. changes in bone metabolsm and structure, assessed by serum levels of fgf-23 and α-klotho, and changes in bone mineral density will be compared between groups as an exploratory analysis.


Eligibility criteria:
inclusion criteria: * 18 years or older * on regular dialysis regimen for at least 3 months exclusion criteria: * known allergy to any of the investigational drug components * current use of sodium-glucose co-transporter 2 inhibitors * pregnant woman * myocardial infarction or myocardial revascularization in the past 3 months
study of the safety and efficacy of opc-34712 as a complementary therapy in the treatment of adult attention deficit/hyperactivity disorder

Conditions: Attention Deficit Hyperactivity Disorder

Summary: this study tests the effects of an investigational antipsychotic drug (called opc-34712) in adults with attention deficit hyperactivity disorder (adhd) when taken with an approved stimulant medication to explore a possible impact on sleep, quality of life and cognitive function.


Eligibility criteria:
inclusion criteria: * male and female outpatients 18 to 55 years of age, inclusive, at the time of informed consent. * participants with a primary diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) diagnosis of adhd (including inattentive, hyperactive, and combined subtypes) as confirmed by the conners' adult adhd diagnostic interview (caadid). participants may have received prior treatment for adult adhd, may be currently receiving treatment for adult adhd at screening, or may be treatment-naive. * participants willing to discontinue all prohibited psychotropic medication starting from the time of signing the informed consent and during the study period. exclusion criteria: * females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving study drug. * participants with an adequate response, as determined by the investigator, to any stimulant taken for the treatment of adult adhd after 18 years of age. * participants with a clinically significant current axis ii (dsm-iv-tr) diagnosis of borderline, antisocial, paranoid, schizoid, schizotypal, or histrionic personality disorder. * participants who participated in a clinical trial within the last 180 days or who participated in more than two clinical trials within the past year.

Keywords: inattention hyperactivity impulsivity distractibility procrastination disorganized adhd
safety and efficacy study of sebelipase alfa in participants with lysosomal acid lipase deficiency

Conditions: Lysosomal Acid Lipase Deficiency

Summary: this study evaluated the safety and efficacy of sebelipase alfa in a broad population of participants with lysosomal acid lipase deficiency (lal-d).

the primary objective of this study was to evaluate the safety of intravenous (iv) infusions of sebelipase alfa in a more broad population of lal-d participants than previously studied. such participants may have been excluded from enrollment in other studies of lal-d because of age, disease progression, previous treatment by hematopoietic stem cell or liver transplantation, less common disease manifestations, or disease characteristics that would preclude participation in a placebo-controlled study. this open-label study included infants \>8 months, children, and adults. at least 4 participants in the study were to be between the age of 2 and 4 years. eligible participants received sebelipase alfa at a dose of 1 milligram/kilogram (mg/kg) every other week (qow).

Eligibility criteria:
key inclusion criteria: 1. participant was \>8 months of age at the time of dosing. 2. confirmation of lal-d diagnosis as determined by the central laboratory or, for participants with prior hematopoietic stem cell transplant or liver transplant, historical enzyme activity or molecular genetic testing confirming a diagnosis of lal-d. 3. participants \>8 months but \<4 years of age at screening had at least 1 of the following documented clinical manifestations of lal-d: * dyslipidemia * elevated transaminases * impaired growth * suspected malabsorption * other clinical manifestation of lal-d 4. participants ≥4 years of age at screening had at least 1 of the following documented clinical manifestations of lal-d: * evidence of advanced liver disease * histologically confirmed disease recurrence in participants with past liver or hematopoietic transplant * persistent dyslipidemia * suspected malabsorption * other clinical manifestation of lal-d key exclusion criteria: 1. participant had known causes of active liver disease other than lal-d, which had not been adequately treated. 2. participant received a hematopoietic stem cell or liver transplant \<2 years from the time of dosing. 3. participant with co-morbidities other than complications due to lal-d, which were irreversible or associated with a high mortality risk within 6 months or would interfere with study compliance or data interpretation.

Keywords: enzyme replacement therapy (ert) lysosomal storage disease late onset lysosomal acid lipase (lal) deficiency acid cholesteryl ester hydrolase deficiency, type 2 acid lipase disease cholesterol ester hydrolase deficiency lal deficiency lipa deficiency wolman disease additional relevant mesh terms: cholesterol ester storage disease metabolic diseases lipidoses lipid metabolism, inborn errors metabolism, inborn errors genetic diseases, inborn lysosomal storage diseases lipid metabolism disorders infant, newborn, diseases
consolidation therapy with cladribine in relapsing multiple sclerosis patients

Conditions: Multiple Sclerosis

Summary: to investigate the impact on igg and igm concentration, infection risk and effectiveness of switching from anti-cd20 to cladribine compared to continued anti-cd20 treatment over 2 years in relapsing ms patients.


Eligibility criteria:
inclusion criteria: * relapsing ms according to lublin \[23\] edss ≤7.0 - male and female patients with age \>18 years - treatment with ocrelizumab or rituximab for ≥12 months and/or having received ≥ 1.2 / 1.0 gr, respectively - for clad_group: planning to switch to cladribine because of concerns about increased risk of infections related to long term anti-cd20 therapies, defined as at least 3 infectious events/year or a serious infection under anti-cd20 and/or a documented decrease of ≥ 5% igg and/or a level of igg below 7 gr/l compared to pre- anti-cd20 therapy (will be considered as clad_group) - for ocr_group and rtx_group: continuing anti-cd20 therapies (considered as ocr_group and rtx_group with ocrelizumab with rituximab treatment, respectively) - anti-cd20 and cladribine are prescribed according to swiss and european smpc. exclusion criteria: * non-relapsing ms pregnancy or lactation - contraindication to receive cladribine or to continue anti-cd20 therapies according to local label - inability to complete an mri - known presence of other neurological disorders which may mimic ms including but not limited to: neuromyelitis optica, lyme disease, untreated vitamin b12 deficiency, neurosarcoidosis and cerebrovascular disorders - any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study - significant or uncontrolled somatic disease or any other significant disease that may preclude patient from participating in the study - known active bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds infection requiring hospitalization or treatment with i.v. antibiotics within 4 weeks prior to baseline visit or oral antibiotics within 2 weeks prior to baseline visit - history of progressive multifocal leukoencephalopathy (pml) - active malignancy, including solid tumors and hematological malignancies, except basal cell carcinoma, in situ squamous cell carcinoma of the skin, and in situ carcinoma of the cervix of the uterus that have been previously completely excised with documented, clear margins - history of alcohol or drug abuse within 24 weeks prior to baseline - lymphocyte count \< 1000 /μl - ast/sgot or alt/sgpt ≥ 3.0 upper limit of normal (uln)

Keywords: switch to cladribine
a study to evaluate the effect of mirabegron + solifenacin in overactive bladder patients

Conditions: Overactive Bladder

Summary: the purpose of this study was to evaluate the safety and efficacy of mirabegron as add-on therapy in patients with oab treated with solifenacin.

the total duration of the study was 18 weeks, comprising a 2-week screening period and a 16-week treatment period. patients meeting the eligibility criteria for provisional enrollment received the study drug for the screening period (solifenacin) at the same dose as that before the start of the study (2.5 or 5 mg), once daily after breakfast orally for 2 weeks. after the screening period, patients meeting the eligibility criteria for formal enrollment received the study drugs for the treatment period (solifenacin 2.5 or 5 mg and mirabegron 25 mg), once daily after breakfast orally for 16 weeks. mirabegron dose could be increased to 50 mg at week 8 visit if the patients met all of the following criteria: (1) had an inadequate response to mirabegron at the dose of 25 mg; (2) was judged by the investigator or coinvestigator to have no safety concerns; and (3) agreed to increase the dose.

Eligibility criteria:
inclusion criteria: * female: postmenopausal oab outpatient * male: oab outpatient who did not wish to have children at all * patient had been treated with solifenacin at a stable dose once daily for at least 4 weeks prior to the study * patient had a total oab symptom score (oabss ) score of ≥3 points and a question 3 score ≥2 points exclusion criteria: * patient had a residual urine volume of ≥100 ml or a maximum flow rate \<5 ml/s, or patients with benign prostatic hyperplasia, or lower urinary tract obstruction * patient had serious heart disease (myocardial infarction, cardiac failure, uncontrolled angina pectoris, serious arrhythmia, use of pacemaker, etc.), liver disease, kidney disease, immunological disease, lung disease, etc. or patient had malignant tumor (except for malignant tumor that has not been treated for at least 5 y before the start of the screening period with no risk of recurrence) * patient had received surgical therapy that may affect the urinary tract function within 24 weeks before the start of the screening period

Keywords: mirabegron solifenacin
prevention of jellyfish stings

Conditions: Bites and Stings

Summary: jellyfish stings are a common occurrence among ocean-goers worldwide with an estimated 150 million envenomations annually. fatalities and hospitalizations occur annually, particularly in the indo-pacific regions. a new topical jellyfish sting inhibitor based on the mucous coating of the clown fish prevents 85% of jellyfish stings in laboratory settings. the field effectiveness is unknown. this is a field test to determine the real world effectiveness.

jellyfish stings are a common occurrence among ocean-goers worldwide with an estimated 150 million envenomations annually. fatalities and hospitalizations occur annually, particularly in the indo-pacific regions. a new topical jellyfish sting inhibitor based on the mucous coating of the clown fish prevents 85% of jellyfish stings in laboratory settings. clown fish inhabit within the tentacles of sea anemones, which have stinging cells similar to those of jellyfish, yet clown fish are not stung by the sea anemones. in controlled laboratory environments, the jellyfish sting inhibitor, safe sea™ when applied to volunteers' arms, prevented 100% of chrysaora fuscescens stings and 70% of chiropsalmus quadrumanus stings. of the c. quadrumanus stings that occurred, their intensity was diminished. the field effectiveness is unknown. this is a field test to determine the real world effectiveness of safe sea to prevent jellyfish stings.

Eligibility criteria:
inclusion criteria: * healthy volunteers planning on snorkeling for 30 to 45 minutes. exclusion criteria: * pregnancy * severe allergy to jellyfish * allergy to any topical dermatologic product

Keywords: jellyfish stings marine envenomation jellyfish stings
glucosamine and chondroitin effects

Conditions: Inflammation

Summary: a common starting dose of glucosamine and chondroitin will reduce inflammation as reflected by a reduction in serum c-reactive protein.

use of glucosamine and chondroitin have been associated with reduced cancer and overall mortality. the aim of this study is to determine whether a common starting dose of glucosamine and chondroitin (1500 mg/d + 1200 mg/d, respectively) reduces systemic inflammation as reflected by a reduction in high sensitivity c-reactive protein.

Eligibility criteria:
inclusion criteria: * healthy * overweight (body mass index kg/m2 (bmi) between 25 and 32.5) * non-smoking men and women * aged 20-55y exclusion criteria: * chronic medical illness, history of gastrointestinal, hepatic, or renal disorders, or inflammatory conditions (including autoimmune and inflammatory diseases) * pregnancy or lactation * currently on a weight-loss diet * bmi (body mass index) \ 30 * alcohol intake of greater than 2 drinks/day * current use of prescription or over-the-counter medications, (excluding oral contraceptives and hormone-secreting iuds), including use of aspirin or nsaids more than 2 days per week * abnormal renal, liver or metabolic test * inability to swallow pills * known allergy to shellfish * not willing to take pills made from shellfish or animal sources * intention to relocate out of study area within next 4 months
impact of probiotics on oral microbiota in older adults with dysphagia

Conditions: Dysphagia

Summary: the overall purpose of this study is to characterize the effect of probiotics on the oral microbiota in older adults with dysphagia at risk for pneumonia.

the goal of this pilot study is to characterize the effects of probiotics on the oral microbiota in older patients with dysphagia at risk for pneumonia. a total of 20 participants will be recruited from the uw health inpatient swallowing consult service. participants will have a dysphagia diagnosis along with documented aspiration on videofluoroscopy. each participant will receive a once daily vsl#3 probiotic blend (dissolved in thickened liquid as applicable) for 28 days. a baseline assessment will be completed to collect data on demographics, health history and behaviors, usual diet, level of oral intake, and patient-reported swallow function. oral swab (buccal mucosa and tongue dorsum) as well as saliva sample collections will be completed. data on adherence and adverse events will be collected weekly. bacterial dna will be extracted from oral samples and 16s rrna sequencing techniques will be used to identify contents of oral microbiota at baseline, week 2, and week 4. oral microbial composition will be compared between the time points, and treatment feasibility (recruitment and retention rates) in this population will be evaluated.

Eligibility criteria:
inclusion criteria 1. 65 years of age or older 2. dysphagia diagnosis based on videofluoroscopic swallow study with observed airway invasion (penetration-aspiration scale score of 3 or higher) 3. ability to provide consent 4. ability to submit oral samples 5. ability to swallow sachet of probiotic (dissolved in thickened liquid, as needed) 6. ability to return to uwhc for week 2 and week 4 visits. exclusion criteria 1. currently taking antibiotics or probiotics 2. actively receiving immunosuppressive therapy 3. non-oral feeding with inability to swallow probiotic 4. diagnosis of head and neck cancer or upper airway disease 5. prior surgery to the head and neck region that would have affected the muscles of swallowing or the salivary glands 6. history of chemotherapy or radiation to the head and neck region 7. severe periodontal disease. 8. currently pregnant or planning to become pregnant

Keywords: probiotics oral microbiome dysphagia
phase ii study of maintenance treatment of nimotuzumab for advanced esophageal carcinoma

Conditions: Stage IV Esophageal Squamous Cell Carcinoma

Summary: there have been reports suggesting that anti-epidermal growth factor antibody nimotuzumab is advantageous for advanced esophageal cancer patients in combination with chemotherapy or radiotherapy. however, whether maintenance therapy of nimotuzumab provides benefit to advanced esophageal cancer patients is not known.

we design this clinical trial to confirm the efficacy of maintenance treatment of nimotuzumab after initial treatment.

Eligibility criteria:
inclusion criteria: * patient who was confirmed stage iv esophageal carcinoma by pathologic histology or cytology. * the sample size estimate: 20 cases per arm. * males or females aged ≥18 years, \< 75 years. * eastern cooperative oncology group (ecog) performance status 0-2. life expectancy ≥12 weeks. * males and females should be contraceptive during the period of the trial until 8 weeks after the last administration of the drug. * adequate bone marrow, renal, and liver function are required. * able to comply with the required protocol and follow-up procedures, and able to receive oral medications. * institutional review board-approved informed consent will be obtained for every patient before initiation of any trial-specific procedure or treatment. exclusion criteria: * any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous year, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease). * allergy to anti-egfr antibody. * female subjects should not be pregnant or breast-feeding. * adequate hematological function: absolute neutrophil count (anc) ≥1.5 x 109/l, and platelet count ≥100 x 109/l. adequate renal function: serum creatinine ≤ 1.5 x uln, or ≥ 50 ml/min. adequate liver function: total bilirubin \< 1.5 x upper limit of normal (uln) and alanine aminotransferase (alt) and aspartate aminotransferase (ast) \< 2.5 x uln in the absence of liver metastases, or \< 5 x uln in case of liver metastases. * patient assessed by the investigator to be unable or unwilling to comply with the requirements of the protocol.
peroperative administration of tranexamic acid in roux-en-y gastric bypass and one-anastomosis gastric bypass

Conditions: Hemorrhage; Bleeding

Summary: the incidence of bleeding after metabolic surgery seems to increase. the administration of a drug (tranexamic acid) that can reduce bleeding could possibly also reduce bleeding after metabolic surgery. objective: this study aims to determine whether administration of tranexamic acid before surgery can reduce postoperative bleeding in patients undergoing gastric bypass.


Eligibility criteria:
inclusion criteria: * primary metabolic procedure; * gastric bypass: roux-en-y gastric bypass or one-anastomoses gastric bypass; * ≥18 years; * good command of the dutch or english language. exclusion criteria: * patients unwilling to give informed consent; * patients with a medical history of bleeding or vte (defined as, pulmonary embolism (pe) or deep vein thrombosis (dvt)); * patients who use anticoagulants; * arterial bleeding or (iatrogenic) bleeding during the procedure coming from surrounding organs or vascular structures such as the liver or the spleen.

Keywords: gastric bypass tranexamic acid
navigation invitations liver surveillance uptake

Conditions: Hepatocellular Carcinoma; Liver Cirrhosis; Chronic Hep B

Summary: this study aims to evaluate the efficacy of patient navigators and mailed surveillance invitations on attendance of hepatocellular carcinoma (hcc) ultrasound surveillance appointments. the investigators hypothesise that mailed invitations and patient navigators will improve attendance at hcc surveillance appointments and increase the proportion of patients diagnosed at an early stage, compared with a control group receiving usual care.

hepatocellular carcinoma (hcc) is the third leading cause of cancer-related death worldwide. despite advances in treatment options, prognosis remains worrying, with 5-year survival rates remaining less than 20%. surveillance for hcc involves six-monthly ultrasounds (us) of the liver and has been demonstrated to increase rate of early diagnosis, which translates to improved survival. however, the uptake of hcc surveillance is low internationally; in western countries, only 20% of patients eligible for hcc surveillance receive a surveillance test. the current provision of hcc surveillance in the uk is ad hoc: eligible patients have six-monthly ultrasound requested by their clinician (usually a gastroenterologist, hepatologist or hepatology clinical nurse specialist). patients receive an ultrasound appointment in the post with no formal invitation or information about the surveillance test. work with focus groups suggests lack of knowledge and fear are barriers to hcc surveillance attendance. previous research has shown that patient navigation increased hcc surveillance uptake in an american population. however, there has been no research on interventions aimed at improving surveillance uptake in the uk population. the study predicts that the mailed invitations and patient navigators will improve patient attendance at hcc surveillance and increases the number of patients diagnosed with early-stage hcc, compared with usual care.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * ecog performance status of 0-2 * eligible for hcc surveillance as defined by nice and easl criteria * child pugh a or b cirrhosis * child pugh c cirrhosis and on liver transplant waiting list * high risk chronic hepatitis b exclusion criteria: * previous or current diagnosis of hcc * child pugh c cirrhosis * frailty (clinical frailty scale \>7) * previous liver transplant