Kornimate/medical-research-clean huggingface dataset:
a study of saxagliptin in subjects with type 2 diabetes who have inadequate blood sugar control with sulfonylureas

Conditions: Diabetes

Summary: the purpose of this trial is to understand if adding saxagliptin to a sulfonylurea is safe and works better than increasing the amount of sulfonylurea a patient takes

all subjects will participate in a lead-in period, and qualifying subjects will continue into a short-term randomized treatment period. subjects who complete the short-term period will be eligible to enter the long term extension period. also, subjects in the short-term period who have an elevated blood sugar that requires additional medication for blood sugar control (defined as rescue) will be eligible to enter the long-term treatment extension period where they will receive metformin.rescue treatment with metformin is also available during the long-term extension period for subjects who meet glycemic criteria.

Eligibility criteria:
inclusion criteria: * type 2 diabetes. * treated with a sulfonylurea for at least 2 months. * inadequate blood sugar control. * are not on any other medications to lower blood sugar. * no major heart, liver or kidney problems. * women not pregnant or breast feeding.
effect of heavy alcohol consumption on farnesoid x receptor (fxr) signaling

Conditions: Alcohol Consumption

Summary: the main purpose of this study is to see whether heavy drinking will interfere with a specific pathway, called fxr signaling in the liver. the abnormality of this pathway may lead to liver injury in some patients who drink heavily.


Eligibility criteria:
inclusion criteria: * individuals ≥ 21 to 65 years old * able to provide informed consent \& negative urine pregnancy test where appropriate * healthy controls must have not consumed any alcohol within 3 months prior to the screening visit * heavy alcohol drinking is defined as \> 40 grams per day on average in women and \> 60 grams per day on average in men for a minimum of 6 months * women of child bearing potential should be willing to practice contraception throughout the treatment period exclusion criteria: * active infection as evidenced by positive urine culture, blood culture, or pneumonia * serum creatinine \> 1.5 mg/dl * known co-existing infection with hepatitis c, hepatitis b, or hiv * significant systemic or major illness including copd, chf and renal failure that in the opinion of the investigator would preclude the patient from participating in and completing the study. * participation in another investigational drug, biologic, or medical device trial within 30 days prior to screening * previous history of jaundice or signs of liver diseases such as spider angiomata, ascites, or history of esophageal varices or hepatic encephalopathy * total bilirubin \> 2 mg/dl and inr \> 1.5 page 20 of 37 * women who are pregnant or nursing * presence of any other disease or condition that is interfering with the absorption, distribution, metabolism, or excretion of drugs including bile salt metabolism in the intestine. patients who have undergone gastric bypass procedures will be excluded (gastric lap band is acceptable). * subjects who are taking warfarin
phase i study of indibulin in patients with solid tumors

Conditions: Solid Tumors

Summary: dose-finding and pharmacokinetic trial of orally administered indibulin to patients with solid tumors.


Eligibility criteria:
inclusion criteria * male or female patient, \>= 18 years of age. * histologically/cytologically proven solid malignant tumor, for which standard treatment of proven efficacy are not or no longer available. * performance status 0-2 ecog/who. * life expectancy \> 3 months. * able and willing to undergo blood sampling for pharmacokinetics. * written informed consent. exclusion criteria * safety concerns: * any non-compensated or uncontrolled non-malignant condition, such as, symptomatic heart failure, active tuberculosis or any other chronic or active infection. * history of allergic reaction to one of the ingredients of the trial medication. * clinically relevant abnormality in organ function as evidenced by any of the following pa¬ra¬meters: * white blood cell count: \< 3.0 x 109/l anc: \< 1.5 x 109/l * thrombocytes: \< 100 x 109/l * hemoglobin \< 6.0 mm * bilirubin (total): \> 1.5 times upper limit of normal range * asat, alat: \> 2.5 times upper limit of normal range unless related to metastases in which case \> 5 times upper normal limit is allowed * creatinine (serum) \> 135 µmol/l (\> 1.5 mg/100ml) or * creatinine clearance: \< 50 ml/min (calculated according to modified cockcroft and gault) * breast feeding, pregnancy or planned pregnancy. a reliable method of contraception must be used in men and in women of childbearing potential during the study and for 3 months after last study drug administration. * lack of suitability for the trial: * concomitant treatment with any other investigational drugs or exposure to another investigational agent within the last 4 weeks prior to study specific screening procedures (period should be extended if the patient has received any drug which is known to have de¬layed toxicity or prolonged half-life). * active peptic ulcer or any gi condition that could alter absorption or motility. * chronic use of h2-antagonists or proton pump inhibitors. * any other cancer treatment during the study or administered within the last 4 weeks (6 weeks for nitrosoureas, mitomycin c, high-dose carboplatin or extensive radiotherapy) before start of study treatment, except irradiation of non-target lesions for symptom relief and bi-phosphonate treatment of bone metastases. * clinically symptomatic brain metastases or leptomeningeal disease. * neurological or psychiatric disease or drug or alcohol abuse which would interfere with the patients proper completion of the protocol assignment. * administrative reasons: * anticipated non-availability for study visits/procedures.
evaluation of metabolism-boosting beverages

Conditions: Energy Expenditure; Appetite

Summary: the purpose of this study is to assess the effect of metabolism-boosting beverages (mbb) containing green tea extract with a standardized amount of epigallocatechin gallate (egcg) and caffeine.

the study will assess the effect of mbb's on 24 hour energy expenditure by performing indirect calorimetry, and on appetite using visual analogue scales (vas). the planned sample size is 54 healthy male and female adults, both lean and overweight. we plan to test 6 metabolism-boosting beverages in the following order: 1) raspberry tea 2) banana shake 3) chai latte 4) strawberry shake 5) cappuccino 6) hot cocoa. in the order that they are screened, each subject will be assigned to receive 1 of 6 metabolism-boosting beverages. each mbb will contain 90 mg egcg and 100 mg caffeine.

Eligibility criteria:
inclusion criteria: * adult males and females (age between 18 and 65) * bmi ≥18.5 - ≤ 40.0 kg/m2 * non-smokers * no known food allergies to wheat, gluten, soy or nuts * ≤ 14 alcoholic beverages per week * no sensitivity to caffeine or green tea * no alcohol or caffeine on days when metabolism is tested * willing and able to give informed consent * not currently using appetite-affecting medications (e.g ssris, steroids, ritalin) * not pregnant or lactating exclusion criteria: * actively dieting * chronic uncontrolled health problems (not including obesity or controlled: type-2 diabetes, hyperlipidemia, hypertension) * history of arrhythmia, or taking anti-arrhythmic medications (e.g. propafenone) * schizophrenia, history of bipolar disorder, current major depressive disorder * dependence on alcohol or sedative-hypnotic drugs (e.g. benzodiazepines) * cognitive impairment severe enough to preclude informed consent * taking weight loss or appetite-suppressant medications * taking appetite affecting medications (e.g. ssris, steroids, ritalin) * food allergies to wheat, gluten, soy, or nuts * sensitivity to caffeine or green tea

Keywords: obesity metabolism weight loss energy expenditure thermogenesis metabolism-boosting beverages effect on ree metabolism-boosting beverages effect on appetite
high-activity natural killer immunotherapy for small metastases of nasopharyngeal cancer

Conditions: Metastatic Nasopharyngeal Cancer

Summary: the aim of this study is the safety and efficacy of high-activity natural killer immunotherapy to small metastases of nasopharyngeal cancer.

by enrolling patients with small metastases of nasopharyngeal cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of high-activity natural killer cells. the safety will be evaluated by statistics of adverse reactions. the efficacy will be evaluated according to local relief degree, progress free survival (pfs) and overall survival (os).

Eligibility criteria:
inclusion criteria: * all standard therapies have failed according to nccn guidelines or the patient refuses standard therapies after cancer recurrence * body tumor 1-6, the maximum tumor length \< 2 cm * kps ≥ 70, lifespan \> 6 months * platelet count ≥ 80×109/l，white blood cell count ≥ 3×109/l, neutrophil count ≥ 2×109/l, hemoglobin ≥ 80 g/l exclusion criteria: * patients with cardiac pacemaker * patients with brain metastasis * patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Keywords: metastatic nasopharyngeal cancer high-activity natural killer
radioembolization with yittrium-90 for intermediate and advanced hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma; Radioembolization

Summary: hepatocellular carcinoma (hcc) is the fifth most-common cancer worldwide and the second most-common cause of cancer mortality. liver resection is the first-line curative treatment for huge hcc. the 5-year overall survival (os) rates after hepatic resection were range from 25% to 45%. transarterial chemoembolization (tace) is the major treatment option for the unresectable primary or secondary liver malignancies. yittrium-90 (y-90) is a pure beta-emitter, without any toxic effect or immune rejection. there are ample data that support the use of y-90 microspheres for primary and metastatic liver tumors. the aim of our study was to compare the clinical outcome of radioembolization with y-90 and tace and provide a new strategy for the treatment of intermediate and advanced hepatocellular carcinoma with portal vein thrombus by conduting a randomized trial.


Eligibility criteria:
inclusion criteria: 1. child-pugh class a or b liver function; 2. preoperative ecog criteria score of 0-2; 3. patients preoperatively diagnosed of hepatocellular carcinoma according to chest computed tomography (ct) and/or magnetic resonance imaging (mri); 4. tumor number ≤5 and the sum of largests tumor diameter ≤15 cm; 5. the expected survival time \>6 months. exclusion criteria: 1. other anticancer treatment before treatment 2. patients with apparent major organs (i.e. cardiac, pulmonary, cerebral and renal) dysfunction, which may affect the treatment of liver cancer 3. patients with other diseases that may affect the treatment of this treatment 4. history of other malignant tumors 5. patients who are participating in other clinical trials 6. pregnant, lactating women

Keywords: yittrium-90 hepatocellular carcinoma
a study of d3l-001 as monotherapy in subjects with her2-positive advanced solid tumors

Conditions: HER-2 Positive Advanced Solid Tumors

Summary: this first-in-human (fih) study, multi-center, open-label, dose escalation and dose expansion phase i study to evaluate the safety, tolerability, pharmacokinetics (pk), pharmacodynamics (pd), immunogenicity, and preliminary anti-tumor activity of d3l-001 in subjects with her2-positive advanced solid tumors.


Eligibility criteria:
inclusion criteria: * subject must have documented her2 positivity (determined by immunohistochemistry \[ihc\], in situ hybridization \[ish\], next generation sequencing \[ngs\] or other analysis techniques as appropriate). * subject must have eastern cooperative oncology group (ecog) performance status of 0 or 1. * subject must have left ventricular ejection fraction (lvef) ≥50% by either echocardiography (echo) or multiple-gated acquisition (muga) within the screening period. * subject must have adequate organ and marrow function within the screening period. exclusion criteria: * subject has any prior treatment with anti-cd47 or sirpα agent. * subject has major surgery or radiotherapy, immunostimulatory agents, investigational agents, or any other anticancer treatment including chemotherapy, targeted therapy, biologics that is not completed 28 days before first dose of study medication. * subject has immunosuppressive medication that is not completed 14 days before the first dose of study medication. * subject has uncontrolled intercurrent illness that would limit compliance with study requirements, substantially increase risk of incurring aes, or compromise the ability of the subject to give written informed consent. * subject has unresolved treatment-related toxicities from previous anticancer therapy of nci ctcae grade ≥2 (with exception of vitiligo or alopecia). * judgment by the investigator that the subject should not participate in the study if the subject is unlikely to comply with study procedures, restrictions, and requirements.

Keywords: her-2 positive advanced solid tumors
effects of moderate intensity intermittent and moderate intensity continuous training on hyperlipdemia

Conditions: Hyperlipidemias

Summary: this project will be a randomized control trial conducted to check the effects of moderate intensity intermittent training versus moderate intensity continuous training on indices of cardio-metabolic health in women with hyperlipidemia, duration will be of 5 weeks, purposive sampling data technique, will be done, subject following eligibility criteria from milestone gym sialkot, will randomly allocated in two groups via lottery method, baseline assessment will be done, group a participants will receive baseline treatment along with moderate intensity intermittent training, and group b participants will receive baseline treatment along with moderate intensity continuous training. pre and post intervention assessment will include lipid profile test and vo2 max rating of perceived exertion (rpe), and post data will be analyzed by using spss version 25.

hyperlipidemia is a condition with high levels of fat in the blood, such as cholesterol and triglycerides. hyperlipidemia is most commonly associated with high-fat diets, sedentary lifestyle, obesity and diabetes. the aim of the current study is to find the effectiveness of moderate intensity intermittent training and moderate intensity continuous training in women with hyperlipidemia. it will be a randomized control trial and screening will be done as per the inclusion criteria of women having 30-40 years of age with hyperlipidemia. participants with the history of any serious cardiac condition, musculoskeletal injury, and any type of systemic issue will be excluded. participants will be randomly allocated into two groups, group a will receive moderate intensity intermittent training consist of running for 5 km with 1-min at 70% of maximal aerobic speed with interval of 1-min passive recovery and group b will receive moderate intensity continuous training consist of running continuously for 5 km at 70% of maximal aerobic speed for 5 weeks including exercise training of 3 days/week. participants in both groups will be assessed with lipid profile (fasting triglycerides, high density lipoproteins, low density lipoproteins) before and after the intervention. vo2 max, rating of perceived exertion (rpe) step test: the step test is designed to measure a person's aerobic fitness. participants step up and down, on and off an aerobic- type step for three minutes to increase heart rate and evaluate the heart's recovery rate during the minute immediately following the step test exercise. modified borg scale: mbs is a 0-10 rated numerical score used to measure dyspnea as reported by the patient during submaximal exercise and is routinely administrated during six-minute walk testing.

Eligibility criteria:
inclusion criteria: * women. * age 30-40 years. * hyperlipidemia exclusion criteria: * with another serious cardiac condition. * with any musculoskeletal injury. * with any systematic condition.

Keywords: cholesterol hyperlipidemia mict miit
neuropeptide y regulates neurogenic pulp inflammation

Conditions: Neurogenic Inflammation; Dental Pulp Disease

Summary: objective. this study assessed the neuropeptide y (npy) expression in healthy human dental pulp following tooth bleaching with three in-office hydrogen peroxide-based systems: opalescence boost© (ultradent products, south jordan, ut), pola office© (sdi, victoria, australia), and zoom© (zoom! bleaching system; discuss dental, culver city, ca). materials and methods. forty dental pulps were collected from healthy premolars scheduled for extraction for orthodontic reasons. teeth were divided into four groups containing ten healthy premolars each: control group (n= 10): the teeth were not exposed to dental bleaching agents (healthy pulps assessed for normal/basal npy values). pola office system group (n= 10): application of pola office (35% h2o2) for 8 minutes. opalescent boost system group (n= 10): application of opalescent boost (40% h2o2) for 20 minutes. zoom system group (n= 10): application of zoom! (25% h2o2 + cold blue light) for 15 minutes. the investigators rigorously followed the manufacturer's instructions for all bleaching systems. following the extractions, the pulpal tissue was collected, placed in a 4% formaldehyde solution in eppendorf tubes, and processed. npy levels were measured using enzyme-linked immunosorbent assay (elisa).


Eligibility criteria:
inclusion criteria: * dental pulps were collected from non-smoking donors * patients who need premolar extractions for orthodontic purposes. * these premolars must meet the following requirements: * caries and restoration-free, * complete root development (visually and radiographically confirmed), * normal response to sensitivity testing. exclusion criteria: * evidence of periodontal disease, * traumatic occlusion * previous orthodontic force application.

Keywords: npy dental pulp dental bleaching neurogenic inflammation
a study of ono-1110 in patients with major depressive disorder

Conditions: Major Depressive Disorder (MDD

Summary: to evaluate the efficacy and safety of ono-1110 in patients with major depressive disorder


Eligibility criteria:
inclusion criteria: 1. japanese (sex not specified) 2. participants who, in the opinion of the principal (or sub-investigator), are capable of understanding the content of the clinical trial and complying with its requirements 3. participants diagnosed with major depressive disorder based on dsm-5-tr (diagnostic and statistical manual of mental disorders, fifth edition, text revision) criteria, as determined through an interview using the m.i.n.i. (mini-international neuropsychiatric interview) 4. outpatients 5. participants whose current depressive episode has lasted for at least 2 months but no more than 12 months 6. participants with a ham-d17 (hamilton depression rating scale 17 items) total score of 18 or higher and a cgi-s (clinical global impression-improvement) score of 4 or higher exclusion criteria: 1. participants with a current or past history of psychiatric or neurological disorders that meet any of the following criteria: * participants with a comorbid psychiatric disorder other than major depressive disorder as defined by dsm-5-tr (diagnostic and statistical manual of mental disorders, fifth edition, text revision) (assessed using the m.i.n.i.(mini-international neuropsychiatric interview)) * participants with major depressive disorder with mixed features, psychotic features, or catatonia as defined by dsm-5-tr (diagnostic and statistical manual of mental disorders, fifth edition, text revision) * participants with a current or past history of schizophrenia or other psychotic disorders as defined by dsm-5-tr (diagnostic and statistical manual of mental disorders, fifth edition, text revision) * participants with neurodevelopmental disorders or personality disorders as defined by dsm-5-tr (diagnostic and statistical manual of mental disorders, fifth edition, text revision) * participants with a current or past history of clinically significant neurological disorders (including epilepsy) * participants with neurodegenerative diseases (such as alzheimer's disease, parkinson's disease, multiple sclerosis, etc.) 2. participants who, in the opinion of the principal (or sub-investigator), have not responded to at least two different antidepressants, each administered at an adequate dose for at least 6 weeks, during the current or past depressive episode. 3. participants who have used adjunctive treatments such as lithium, triiodothyronine/thyroxine, lamotrigine, valproate, carbamazepine, or atypical antipsychotics, or who have used combination therapy with antidepressants for the current depressive episode.
a biomarker study in patients getting regorafenib for metastatic colorectal cancer

Conditions: Colon Cancer

Summary: this is an exploratory biomarker study. patients with metastatic colorectal cancer will receive regorafenib, which is fda approved in this setting, on day 1-21 of every consecutive 28 day cycle. patients will be asked to undergo tumor biopsy at baseline and 2 weeks after starting regorafenib. peripheral blood samples will be collected at baseline 2 weeks after starting regorafenib, after initiation of cycle 3, and every 4 weeks thereafter.

tumor tissue collected at baseline and 2 weeks after starting regorafenib will be analyzed for phosphoproteins and rna. peripheral blood samples will be collected and banked for protein, mirna, and mutated dna analysis.

Eligibility criteria:
inclusion criteria: * metastatic colorectal cancer suitable for regorafenib treatment * life expectancy of at least 12 weeks * able to understand and willing to sign written informed consent form * adequate bone marrow, liver, and renal function * glomerular filtration rate \>/= 60 according to the modified diet in renal disease abbreviated formula * women of childbearing potential must have a negative serum pregnancy test * subject able to swallow and retain oral medication exclusion criteria: * previous assignment to treatment in this study * uncontrolled hypertension * active or clinically significant cardiac disease * evidence or history of bleeding diathesis or coagulopathy * any hemorrhage or bleeding even grade 3 or higher within 4 weeks prior to start of study medication * subjects with thrombotic, embolic, venous or arterial events * subjects with any previously untreated or concurrent cancer * pheochromocytoma * known history of human immunodeficiency virus infection or current chronic or active hepatitis b or c infection requiring treatment with antiviral therapy * ongoing infection grade 2 or higher * symptomatic metastatic brain or meningeal tumors * presence of a non-healing wound, non-healing ulcer, or bone fracture * renal failure requiring dialysis * dehydration grade 1 or higher * seizure disorder requiring medication * persistent proteinuria grade 3 or higher * interstitial lung disease with ongoing signs and symptoms at the time of informed consent * pleural effusion or ascites that causes respiratory compromise * history of organ allograft including corneal transplant * known or suspected allergy or hypersensitivity to the study drug * any malabsorption condition * women who are pregnancy or breast-feeding * substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study results * concurrent anticancer therapy * concurrent use of another investigational drug or device therapy during or within 4 weeks of trial entry * major surgical procedure, open biopsy, or significant traumatic injury within 28 days before start of study medication * therapeutic anticoagulation with vitamin-k antagonists or with heparins and heparinoids * use of any herbal remedy