Kornimate/medical-research-clean huggingface dataset:
ertugliflozin in chronic heart failure

Conditions: Heart Failure

Summary: the purpose of this study is to determine the effects on heart failure signs and symptoms of the use of either ertugliflozin, metolazone or placebo, in conjunction with intravenous loop diuretic use in acute settings and chronic oral loop diuretic therapy. there are two general purposes for this study. the proposed study is both larger and more rigorous than essentially all pk/pd studies that form the basis of current practice with loop diuretics as well as all studies looking at add-on thiazide therapy (current guideline-recommended adjuvant). the second is to generate a mechanistic understanding of the pleotropic cardio-renal factors with chronic therapy that differentiate ertugliflozin from traditional diuretics particularly in how they maintain reduced blood volume without the complication of over-diuresis and volume depletion.

this is a randomized placebo controlled mechanistic study to understand the utility of ertugliflozin in acute and post-acute hospitalized heart failure patients with or without diabetes, compared to both placebo and the active control metolazone. the broad study design will be designed around evaluation of change in gold standard determined body fluid spaces (blood volume, extracellular fluid, total body water), administering a sodium chloride challenge, and collecting the necessary biospecimens to test our hypotheses. the general study design will randomize to ertugliflozin vs. placebo early during iv diuretic therapy with continuation post discharge for a total therapy of 6 weeks.

Eligibility criteria:
inclusion criteria: 1. a clinical diagnosis of adhf with at least one objective sign of volume overload (rales, edema, elevated jvp, or preadmission weight gain) 2. as judged by the treating physician, a projected need and ability to tolerate treatment with an extended need for iv diuretics with the goal of significant fluid removal (i.e., goal \>1l/day net fluid loss) 3. chronic daily oral loop diuretic dose \> or equal to 20mg furosemide equivalents for at least one month prior to admission 4. egfr 30 ml/min/1.73 m2 5. signed informed consent exclusion criteria: 1. current use or plan to initiate renal replacement therapy or ultrafiltration this hospital admission 2. significant bladder dysfunction or urinary incontinence 3. inability to comply with the serial urine collection procedures 4. current use of a thiazide or thiazide like diuretics or use within 5 half-lives of the drug, including metolazone 5. prior heart transplant, critical stenotic valvular disease or complex congenital heart 6. history of type 1 diabetes, diabetic ketoacidosis, "brittle" diabetes or frequent hypoglycemia or severe hypoglycemic episodes requiring emergent intervention (er visit or ems response, glucagon administration or forced oral carbs) in the last 3 months 7. history of or current urosepsis or frequent urinary tract infections 8. anemia with hemoglobin \<8g/dl (due to required phlebotomy for the study) 9. pregnancy or breastfeeding

Keywords: ertugliflozin metolazone
immuno-oncology drugs gls-012 alone & in combination gls-010 treating with advanced patients solid tumors

Conditions: Solid Tumor

Summary: this is a phase i/ii study to investigate the safety, tolerability, and preliminary efficacy of gls-012 monotherapy and in combination with gls-010 in subjects with advanced solid rumor after progression on standard treatment.


Eligibility criteria:
inclusion criteria: 1. patients who are willing to sign the informed consent form; 2. aged 18-75 years, male or female; 3. histologically confirmed diagnosis of a solid tumor; 4. patients with advanced solid tumors after progression on standard treatment; 5. subjects must have at least 1 measurable target lesion according to recist version 1.1； 6. eastern cooperative oncology group (ecog) performance status 0 or 1； 7. life expectancy more than 12 weeks; 8. adequate organ function and bone marrow function as indicated by the screening assessments in the screening period; 9. women of childbearing potential must use highly effective contraception during the study period and at least 6 months after the last study drug administration, and must have a negative blood pregnancy test within 3 days before study enrollment. exclusion criteria: 1. patients with iraes of grade ≥ 3 in the previous immunotherapy, and the aes of the last anti-tumor treatment have not recovered to grade ≤ 1, except for hypothyroidism/hyperthyroidism and dermatitis that have recovered to grade ≤ 2, and aes with no safety risks judged by the investigators, for example, alopecia. 2. patients with primary or secondary immunodeficiency, or patients who are receiving long-term systemic steroid therapy or any other form of immunosuppressive therapy within 7 days before randomization. 3. use of corticosteroids or other immunosuppressants for systemic treatment within 14 days before the first study drug administration; 4. known central nervous system (cns) metastases; 5. patients with severe hypersensitivity to macromolecular protein preparations/monoclonal antibodies in the past. 6. patients with other malignant tumors within 5 years before screening, except cured cervical carcinoma in situ and cured skin basal cell carcinoma. 7. cardiac clinical symptoms or diseases that are not well controlled. 8. known hereditary or acquired bleeding and thrombosis tendency. 9. patients with congenital or acquired immunodeficiency disorders (such as hiv-infection), or a history of organ transplantation. 10. patients complying with any of hepatitis b surface antigen (hbsag) positive and hbv-dna copies being more than 2500 copies/ml (or 500 iu/ml); or positive hcv-rna; 11. patients with poor compliance or other conditions that are not suitable to participate in the clinical trial, as considered by the investigator.
the best dosage and timing of polyethylene glycol for bowel preparation before capsule endoscopy

Conditions: Small Bowel Disease

Summary: the aim of this study is to evaluate the ideal dose of peg and timing of bowel preparation in patients referred for ce examination.


Eligibility criteria:
inclusion criteria: * patients aged between 18 and 75 years and referred to capsule endoscopy because of suspected small-bowel disease are prospectively eligible for entry into the study. exclusion criteria: * age \ 75 years * known or suspected gi stricture or fistula * a history of gi tract resection * swallowing disorders * intensive therapy with fasting and parenteral nutrition;with a disease that may reduce movement of the gi tract, such as diabetes mellitus * medications that could affect gastrointestinal movement within one week * implanted with a medical electronic device * active inflammatory bowel disease, toxic megacolon, toxic colitis * severe pulmonary, cardiac, renal, or hepatic disease * uncontrolled hypertension (systolic blood pressure\>170 mm hg, diastolic blood pressure\>100 mm hg); * disturbance of electrolytes * pregnancy or lactation * patients inability to provide written voluntary informed consent * participation in another clinical study

Keywords: capsule endoscopy polyethylene glycol bowel preparation solutions
a study to evaluate the safety and efficacy of d-1553 combined with in10018 in kras g12c mutant solid tumors

Conditions: Solid Tumor

Summary: this is a phase 1b/ii, open-label study to evaluate the safety, tolerability, pharmacokinetics and antitumor activities of d-1553 in combination with in10018 in subjects with locally advanced or metastatic solid tumor with kras g12c mutation.

this study includes 2 phases: phase ib-dose escalation and phase ii-dose expansion. phase ib-dose escalation part will enroll at least 6 subjects to identify the safety and rp2d of d1553 in combination with in10018 in kras g12c mutant solid tumors. phase ii-dose expansion part contains 3 cohorts with cohort a to enroll advanced colorectal cancer (crc) with kras g12c mutation, cohort b to enroll advanced non-small cell lung cancer (nsclc) with kras g12c mutation, and cohort c to enroll other advanced solid tumors with kras g12c mutation. phase ii study is to evaluate the safety and antitumor activities of d-1553 in combination with in10018 in kras g12c mutant solid tumors. the sample size in each cohort is estimated per simon's 2-stage design. in cohort a, when simon's 2-stage study achieved statistical hypothesis, an open-label, randomized study will be conducted for factorial analysis to evaluate the contribution of in10018 in the combination regimen.

Eligibility criteria:
inclusion criteria: 1. men or women aged ≥ 18 years at the time of signing the informed consent form. 2. subjects with pathologically confirmed locally advanced or metastatic solid tumors. 3. confirmed positive kras g12c mutation in tumor tissue or other biospecimens (only for phase1b) containing cancer cells or dna. 4. tumor types in different phases and cohorts: 1) phase 1b: subjects with locally advanced or metastatic solid tumors who have progressed on or failed in standard therapy, and no standard treatment is available. 2) phase ii cohort a: subjects with locally advanced or metastatic crc. 3) phase ii cohort b: subjects with locally advanced or metastatic nsclc. 4) phase 2 cohort c: subjects with other locally advanced or metastatic solid tumors. 5. has measurable lesions at baseline according to recist 1.1 criteria. 6. has an eastern cooperative oncology group (ecog) performance status of 0 or 1. 7. adequate bone marrow, liver, renal, and coagulation function within 7 days prior to the first dose. exclusion criteria: 1. prior kras g12c inhibitors treatment. 2. have known symptoms of spinal cord compression, instable or symptomatic central nervous system (cns) metastases, and/or carcinomatous meningitis. 3. have a history of stroke or other serious cerebrovascular diseases within 12 months prior to the first dose. 4. have had interstitial lung disease or any active infection requiring systemic treatment within 14 days prior to the first dose. 5. has a history of severe cardiovascular disease such as acute myocardial infarction, severe/unstable angina, qtc prolongation, or poorly controlled hypertension. 6. haven't recovered from toxicity due to prior antitumor therapy 7. pregnant or lactating women. 8. malignant neoplasms other than study disease within 5 years prior to enrollment.
the safety and immunogenicity of haemophilus influenzae type b vaccine in different injection site

Conditions: Healthy

Summary: the objective of this study was to evaluate the safety and immunogenicity of haemophilus influenzae type b vaccine in different injection site.

a randomized trial was conducted in 680 healthy infants with hib vaccine of two brands. the different sub-groups were selected randomly based on the plan to inoculate vaccines in the upper arm deltoid or vastus lateralis muscle. the safety and immunogenicity were assessed after three or two doses.

Eligibility criteria:
inclusion criteria: * participants were under 1 years old, and were in good healthy * participants were full-time pregnancy and birth weight were more than 2.5 kg exclusion criteria: * current infectious fever or acute disease * a history of hypersensitivity to study vaccine components especially tetanus toxoid * a history of allergy, autoimmune, convulsions, seizures heredity disease * a history of hib vaccination or hib disease * a history of congenital deformity, developmental disorders or serious chronic diseases, muscle injection contradiction, and immunosuppressive agents, hormone or immunoglobulin received.
minor troponin elevations in patients with atrial fibrillation

Conditions: Atrial Fibrillation; Myocardial Ischemia

Summary: this study aims at identifying the etiology of troponin-t elevations in patients with atrial fibrillation visiting the emergency department.

the aim of this study is to identify the factors associated with minor cardiac troponin-t elevations in patients presenting in emergency department (ed) with atrial fibrillation (af) diagnosis , and the possible implications it has on the patients prognosis. data on 3394 patients from the turku university hospital catchment area with diagnosis of af on admission to ed and minor troponin-t elevation were analyzed. patients were classified into three groups according to the troponin-t value: troponin \<15ng/l, 15-50ng/l and 51-100ng/l. individual patient records were reviewed.

Eligibility criteria:
inclusion criteria: * two troponin t tests within 72 hours of ed admission * prior diagnosis of af or af at admission exclusion criteria: * age \< 18 years
add-on complex ayurvedic treatment in fibromyalgia-syndrome compared to standard care alone

Conditions: Fibromyalgia Syndrome

Summary: the aim of this study is to evaluate the effectiveness of an additive complex āyurvedic diagnosis and treatment compared to conventional standard care alone in stationary patients with fibromyalgia syndrome.


Eligibility criteria:
inclusion criteria: * informed consent * age between 18 and 70 years * fms according to current guidelines exclusion criteria: * change of pharmacological fms treatment \>= 6 weeks before inclusion * pregnancy or breat feeding * acute psychiatric condition * severe acute somatic disease * severechronic comorbidity * obesity who \>= ii degree * bloodcoagulation-disease * intake of opiods * current treatment with hyperthermia * simultaneous participant in other trial * praticipation in other trial during 6 month before inclusion

Keywords: fibromyalgia syndrome fibromyalgia ayurveda traditional indian medicine cam pain chronic widespread pain
impact of c-arm ct in patients with hcc undergoing tace: optimal imaging guidance

Conditions: Carcinoma, Hepatocellular

Summary: patients will be enrolled based on presence of hcc and eligibility for tace. they will be randomized to one of two arms for imaging navigation to the optimal catheter location for chemotherapy injection to treat the first (possibly sole) tumor target. the two arms will be: tace using c-arm ct supplemented by dsa or dsa only (only dsa images will be used for navigation and tumor vessel tracking). navigation to subsequent treatment targets in all patients will be done with fluoroscopy, cact, and dsa, as is standard of care at stanford university medical center, and is not part of the study. vascular complexity, which affects navigation difficulty and thus the need for imaging, will be assessed separately for use in data analysis by two radiologists on a four-point scale.

we hope to learn more about the utility of c-arm ct in patients undergoing tace for hcc. data will be evaluated with regards to: 1. sensitivity and specificity to diagnose additional tumors and its impact on transplantation criteria. 2. the ability to decrease procedural time by aiding navigation through complex arterial anatomy. 3. impact on radiation dose. although the patient would receive the radiation during c-arm ct, overall the number of dsa angiograms and fluroscopy may decrease, potentially negating any effect of the additional dose from c-arm ct

Eligibility criteria:
inclusion criteria: patients must be affected by hcc patients must be 18 years old or older patients must have received an abdominal ct, pet/ct scan or mri, completed prior to the tace procedure. ability to understand and the willingness to sign a written informed consent document. exclusion criteria: subjects under the age of 18 pregnant women
sex and exercise-mode differences in post exercise blood pressure and heart rate variability responses during workday

Conditions: Hemodynamic; Exercise

Summary: the present study compared the acute effects of sex and exercise mode on subsequent blood pressure (bp) and heart rate variability (hrv) responses during daily work in healthy adults. all subjects did 3 sessions: aerobic exercise on a treadmill, resistance exercise at the gym and a seated control session.

resting blood pressure and heart rate variability are simple and non-invasive methods to evaluate cardiovascular risk after different exercise sessions. thus, exercise can reduce these risk factors in the short and long term, but these responses can be different between sex in different exercise sessions.

Eligibility criteria:
inclusion criteria: * able to practice aerobic and resistance exercise at moderate intensity; * men and women; * normotensive, pre-hypertensive or hypertensive stage 1. exclusion criteria: * renal pathologies; * using beta blockers; * history of stroke or acute myocardial infarction; * smokers.

Keywords: post-exercise hypotension aerobic exercise resistance exercise autonomic stress heart rate variability sex difference
horizant (gabapentin enacarbil extended-release tablets) for the treatment of alcohol use disorder

Conditions: Alcohol Use Disorder

Summary: the purpose of this study is to determine whether gabapentin enacarbil is effective in the treatment of problems with alcohol.


Eligibility criteria:
inclusion criteria: subjects must meet each one of the following inclusion criteria in order to be eligible for participation in the study: 1. be at least 21 years of age. 2. have a current (past 12 months) dsm-5 diagnosis of aud. 3. have a bac by breathalyzer equal to 0.000 when s/he signed the informed consent document (either just prior to or immediately after signing consent). 4. be seeking treatment for problems with alcohol. additional will be evaluated in clinic. exclusion criteria: evaluations will be conducted in clinic.

Keywords: alcohol use disorder alcoholism alcohol dependence drinking alcohol
allopurinol and quality of life in liver cirrhosis

Conditions: Cirrhosis, Liver

Summary: the study aims to evaluate the impact of allopurinol on patients' related quality of life.

cirrhosis is the late stage of liver damage and possess two phases:. the shift from compensated to decompensated cirrhosis is characterized by the onset of complications) which are associated with substantial morbidity and negative impact on quality of life (qol)cirrhosis and its complications have a substantial economic, social, and personal impact on affected patients, as well as their families and caregivers

Eligibility criteria:
inclusion criteria: cirrhosis adult both sex exclusion criteria: * renal insufficiency
pharmacofmri of anxiolytic medications (pregabalin)

Conditions: Anxiety Disorders

Summary: the purpose of this study is to use functional magnetic resonance imaging (fmri) in healthy controls to examine the acute effects of certain anxiolytic medications on brain function. in this case, the medication pregabalin will be used. the investigators hypothesize that pregabalin (at doses of 50 mg and 200 mg, versus placebo) will yield a reduction in amygdala and insula activity (in a dose-dependent fashion) during emotion processing using fmri.

increased amygdala and insula activity have been implicated in neurobiological models of anxiety. using fmri, the anxiolytic medication, lorazepam, has previously been found to decrease activation in these areas during the processing of emotional stimuli. this study aims to replicate those results but by using a different medication, pregabalin. an eventual aim of this study, in combination with future studies, is to evaluate the utility of fmri as a tool to identify anxiolytic function in both established and novel compounds that may be used to treat anxiety.

Eligibility criteria:
inclusion criteria: * male, or female (not pregnant or intending to become pregnant during the study) * between the ages of 18-30. * in good general health. * no specific contraindications to the drug being administered exclusion criteria: * subjects with a history of dsm-iv depressive disorder, psychotic disorder, anxiety disorder * subjects who meet criteria for substance abuse or dependence within the last 6 months * subjects with an positive urine screen for illicit drugs having clinically significant abnormal laboratory, ecg or physical examination findings not resolved by the baseline visit * patients who have taken psychotropic drugs or antidepressants (including monoamine oxidase inhibitors, maoi's) within the last year * subjects who are left-handed. * subjects suffering suffers from claustrophobia, or phobia for injections or blood * magnetic resonance imaging related exclusion criteria: cardiac pacemaker, metal fragments in eyes/skin/body (shrapnel), subjects who have ever been a metal worker/welder; history of eye surgery/eyes washed out because of metal, aortic/aneurysm clips, prosthesis, by-pass surgery/coronary artery clips, hearing aid, heart valve replacement, subjects who are in the first trimester of pregnancy, subjects with an i.u.d. (birth control device), a shunt (ventricular or spinal), electrodes, metal plates/pins/screws/wires, or neuro/bio-stimulators (tens unit).

Keywords: anxiety functional magnetic resonance imaging fmri pregabalin lyrica
choline nutritional status of children with cystic fibrosis x-sectional study

Conditions: Cystic Fibrosis

Summary: cystic fibrosis (cf) is the most common lethal, inherited disorder among caucasians. choline is an essential vitamin and as a methyl donor is critically needed to support the normal metabolism. our previous studies have demonstrated that children with cf have depleted levels of choline. the purpose of this study is to gather data on the status of choline and related metabolites in children with cystic fibrosis by age and gender. the hypothesis for this study is that in children with cf, deficiency of choline and related metabolites will increase with increasing age.

the objective of this clinical project is to determine the status of choline and related metabolites in a large group of children with cystic fibrosis (cf). based on the results it will be possible to determine which children are deficient or at risk for choline deficiency, and might benefit most from supplementation to sustain improvement in the plasma choline, and its metabolites. this will be a cross-sectional study that will, over a 6 month period, look to enroll as many patients as possible from 140 children with cf who are seen regularly at the cf clinic at b.c.'s children's hospital. the study will involve the collection of blood and urine at the time of a scheduled appointment. all procedures for enrollment, collection of chart data and blood samples will follow procedures used in our previous studies. body weight and height will be measured and routine blood work including liver enzymes, hematology, serum zinc, selenium and vitamins a and e will be completed as part of the clinic appointment. cf genotype, gender, birth date, hematology, clinical chemistry, anthropometric and nutritional measures, liver ultrasound, biopsy reports where available, pancreatic function (elastase, chymotrypsin/secretin-cck) and all medications including mineral, vitamin and nutritional and enzyme supplements will be recorded from chart data. blood samples will be used for analyses of choline and its metabolites and various biomarkers in redox pathways. a urine sample will be collected and used to assay excretion of related metabolites. creatine will be analyzed to avoid the need for quantitative 24 hour urine collection.

Eligibility criteria:
inclusion criteria: * children with proven cf and known genotype. * age 0-17 yr. * outpatients of the cf clinic at the british columbia (b.c.) children's hospital. * children without cf or any other known disease. exclusion criteria: * children with cf receiving parenteral nutrition during the previous week. * children who are hospitalized. * children with any health problems other than cf that might in the opinion of the investigators influence dietary choices, growth, choline or methyl metabolites.

Keywords: choline cystic fibrosis methyl metabolism oxidative stress