Kornimate/medical-research-clean huggingface dataset:
canagliflozin treatment and trial analysis-sulfonylurea (cantata-su) sglt2 add-on to metformin versus glimepiride

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to demonstrate the efficacy, safety, and tolerability of canagliflozin (jnj-28431754) compared with glimepiride in patients with type 2 diabetes mellitus with inadequate control despite treatment with metformin.

type 2 diabetes mellitus (t2dm) is well recognized as a major public health problem that presents patients with a significant risk of complications including heart disease, retinopathy, nephropathy, and neuropathy. various classes of orally administered antihyperglycemic agents have been developed for the treatment of diabetes and although individual agents may be highly effective for some patients, it is still difficult to maintain optimal glycemic control in most patients, thereby resulting in high rates of morbidity and mortality in the diabetic population. this is a randomized, double-blind, active comparator-controlled, 3-arm, parallel-group, multicenter study to demonstrate the efficacy, safety, and tolerability of canagliflozin compared with a sulfonylurea (glimepiride) in patients with t2dm, 18 to 80 years of age, inclusive, who are not optimally controlled on metformin monotherapy. the primary study hypothesis is that the study drug will be non-inferior to glimepiride as assessed by the change in hemoglobin a1c (hba1c) from baseline. the patients will receive capsules taken by mouth of canagliflozin (either 100 or 300 mg), or glimepiride with a starting dosage of 1 mg, which will be increased to a maximum dose of 6 or 8 mg once daily for a total duration of 104 weeks.

Eligibility criteria:
inclusion criteria: * patients must have a diagnosis of type 2 diabetes * body mass index (bmi) \>=22 to \<=45 kg/m2, at screening * patients must be taking a stable dosage of metformin as monotherapy at screening * patients must have a hba1c between \>=7% and \<=9.5% at week 2 * patients must have a fasting plasma glucose (fpg) \<=270 mg/dl (15 mmol/l) at week -2 exclusion criteria: * patients having prior exposure or known contraindication or suspected hypersensitivity to jnj-28431754, glimepiride, or metformin * history of diabetic ketoacidosis or type 1 diabetes mellitus * history of pancreas or beta-cell transplantation * history of active proliferative diabetic retinopathy * history of hereditary glucose-galactose malabsorption or primary renal glucosuria * renal disease requiring treatment with immunosuppressive therapy within the past 12 months before screening or a history of dialysis or renal transplant * taken thiazolidinedione therapy in the past 16 weeks before screening

Keywords: diabetes metformin glimepiride hemoglobin a1c type 2 diabetes mellitus canagliflozin
effects of gum chewing on appetite and digestion

Conditions: The Null Hypothesis is That Food Rheology Will Have no Effect on These Indices; The Alternate Hypothesis is That Increased Mechanical Stimulation Will Result in Stronger Satiation/Satiety and Reduced Energy Intake; It is Hypothesized That the Effects of Mastication Will be Less Evident in Obese Compared to Lean Individuals

Summary: one obvious property difference between energy-yielding beverages and solid foods is the oral mechanical processing required to prepare the two food forms for swallowing. considerable human data are consistent with a contribution of mechanical stimulation to appetite suppression. however, no study has isolated this property and assessed its influence on ingestive behavior in humans. this is the aim of the present study. the null hypothesis is that food rheology will have no effect on these indices. the alternate hypothesis is that increased mechanical stimulation will result in stronger satiation/satiety and reduced energy intake. further, it is hypothesized that the effects of mastication will be less evident in obese compared to lean individuals.


Eligibility criteria:
inclusion criteria: * body mass index 18 -25 or 30-35 kg/ m2 good health not initiating or terminating the use of medications reported to affect appetite or body weight during the proposed study period stable activity level (no deviation \> 1x/wk @ 30 min/session) no eating disorder (score \<20 of the eating attitude test (eat-26) no allergies to test foods. not glucose intolerant or diabetic (based on fasting blood glucose between 70-99mg/dl (3.9-5.5mmol/l as recommended by the american diabetes association.) no history of gi pathology and self-reported consumer of breakfast and lunch. exclusion criteria: -

Keywords: human, chewing, appetite,
repetitive versus deep transcranial magnetic stimulation for major depression

Conditions: Major Depressive Disorder

Summary: the goal of this randomized controlled trial is to he effectiveness of two different tms techniques in trd, repetitive tms (rtms) and deep tms (dtms). the main questions it aims to answer are: type of study: clinical trial participant population/health conditions : major depressive disorder to assess the superiority of dtms over rtms in trd to evaluate the predictive capacity of scalable candidate biomarkers participants will be randomly allocated to one of the two intervention groups (rtms or dtms).

the primary aim of this trial is to compare the effectiveness of two different tms techniques in trd, repetitive tms (rtms) and deep tms (dtms). compared to rtms, dtms delivers a broader magnetic field, which in turn reduces coil positioning error and maximizes the probability of optimal cortical stimulation. a past rct comparing both approaches found a greater depression score decrease and response/remission rates for dtms, but was short of reaching significance for remission rates (primary outcome). critical components of this rct were suboptimal, including too few treatment sessions and insufficient statistical power, both of which could have obscured an actual difference between modalities. proof of a more effective type of tms over another would translate into increased odds of improvement for trd patients who live with a chronic and disabling illness.

Eligibility criteria:
inclusion criteria: * diagnosis of major depressive disorder, at least moderate intensity, single or recurrent episode * hrsd-17 score of at least 18 * no improvement to at least two adequate courses of antidepressants (based on the athf) or were unable to tolerate at least two separate trials of antidepressants of inadequate dose and duration * on a stable antidepressant regimen for the past four weeks before screening * patients with a chronic depressive episode \>2 years and who have previously received ect or ketamine will be eligible to participate exclusion criteria: * having previously received tms; * substance use disorder within the last three months * diagnosis of bipolar or psychosis spectrum disorder * anxiety or personality disorder that is assessed by a study investigator to be the primary cause and causing greater impairment than mdd * concomitant major unstable medical or neurological illness * intracranial implant, cardiac pacemaker or implanted medication pump * significant laboratory abnormality; * active suicidal intent * pregnancy * if participating in psychotherapy, must have been in stable treatment for at least three months before entry into the study, with no anticipation of change * currently taking more than the equivalent of 2 mg of lorazepam of a benzodiazepine daily or any dose of an anticonvulsant due to the potential to limit tms effectiveness

Keywords: mdd tms deep tms
gender differences and snps in asthmatic patients

Conditions: Allergic Asthma; Asthma

Summary: the gina 2020 guidelines suggest that asthma affects approximately 300 million persons worldwide. even if there is a specific drug treatment for each stage of disease (from mild to severe) in some patients it is not efficacy and it culd be reated to the gender difference polymorphisms seems to be involved in asthma (allergic or not) even if no data have been published concerning the role of gender in this clinical manifestation. the aim of this study is to assess whether genetic variations involved in the genes encoding the two key leukotriene enzymes, alox5 and ltc4s, and cysltr1 are implicated in the sex difference of allergic asthma in a well-characterized patient cohort.

the gina 2020 guidelines suggest that asthma affects approximately 300 million persons worldwide. even if there is a specific drug treatment for each stage of disease (from mild to severe) in some patients it is not efficacy and it culd be reated to the gender difference polymorphisms seems to be involved in asthma (allergic or not) even if no data have been published concerning the role of gender in this clinical manifestation. the role of polymorphisms in susceptibility to allergic asthma has been partially investigated but no study has analysed gender subgroups separately, neglecting a their potential predictive role in symptomatological and functional variations in the allergic asthma in both sexes. the aim of this study is to assess whether genetic variations involved in the genes encoding the two key leukotriene enzymes, alox5 and ltc4s, and cysltr1 are implicated in the sex difference of allergic asthma in a well-characterized patient cohort.

Eligibility criteria:
inclusion criteria: * asthma (allergic or not) diagnosed according to global initiative for asthma guidelines (gina 2020). * signed informed consent exclusion criteria: * • infectious diseases * neurodegenerative diseases * autoimmune diseases * neoplasms * progressive serious medical conditions (such as cancer, aids or end-stage renal disease) * alcohol consumption (\>3 alcoholic beverages daily) * substanceabuse * inability to give written informed consent * those who will not sign the consent to the processing of personal data

Keywords: asthma allergy gender polymorphism
study of mr-107a-02 in the treatment of post surgical dental pain.

Conditions: Acute Pain; Post Operative Pain; Pain

Summary: mr-107a-02 is being studied to investigate its efficacy, safety and dose-response after dental surgery.


Eligibility criteria:
inclusion criteria: 1. males and females ≥18 years of age. 2. requirement for dental surgery for extraction of ≥2 third molars, at least 1 of which involves partial or complete mandibular bony impaction. 3. pain intensity (pi) using a numeric pain rating scale (nprs) ≥5 during the 5 hours following the end of surgery in the eligibility assessment as well as in the baseline assessment immediately pre-dosing. 4. rating of moderate or severe pain on a 4-point categorical pain rating scale (i.e., none, mild, moderate, severe) during the 5 hours following the end of surgery. exclusion criteria: 1. previously dosed with mr-107a-02. 2. subject with known hypersensitivity to nonsteroidal anti-inflammatory drugs (nsaids). 3. active gi bleeding or a history of peptic ulcer disease, active inflammatory bowel disease, e.g., crohn's disease or ulcerative colitis,or bleeding disorders that may affect coagulation. 4. moderate or severe hypertension, prior stroke or transient ischemic attack. 5. use of any investigational drug within 28 days, or 5 half-lives, prior to consent whichever is longer. 6. use of medications with the potential to interact with mr-107a-02. 7. other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator.
effect analysis of neoadjuvant chemoradiotherapy combined with surgery in laparoscope for advanced colon cancer

Conditions: Colon Neoplasm

Summary: in this study, a randomized controlled trial was conducted on advanced colon cancer patients with preoperative tumor staging t1-4/n1-2/m0 or t4/n0/m0 to determine the effectiveness of preoperative short-term radiotherapy combined with chemotherapy and whether it can effectively reduce the postoperative local recurrence rate, so as to provide better treatment for colon cancer patients and improve the oncological treatment effect of colon cancer.

this is prospective,a single-arm, single center, clinical trail study.the patient entered the study after meeting that criteria.the orr, r0 resection, os and dfs of patients and neoplasm down-staging status,etc would be compared.

Eligibility criteria:
inclusion criteria: * diagnosis of colon neoplasm * 18 years to 70 years * preoperative abdominal enhanced ct or mri showed ct4, cn0-2 * ecogs score≤2 * thoraco-abdomina ct showed no obvious metastasis（the ct of liver and lung show uncertainty tubercle,suggestive performed pet-ct) ct4,cn0-2,m0 radiography inclusion criteria（according postoperative enhanced ct or mri） * progress tubercle penetrate peritoneotome base * progress tubercle penetrate serous surface of neighboring organ * progress tubercle development by late mesentery or side abdominis exclusion criteria: * appeared other system cancer * patient with postoperative recurrent of colon cancer * patient with malignancies history in recent 5 years * pregnant or female of suckle period * the patient have adjuvant radiotherapy record in other system cancer before this time treatment，and patient with surgical contraindications. * the patient have accepted adjuvant chemoradiotherapy before this time treatment. * distant metastasis found during surgery * patients with poor radiotherapy compliance and difficulty in coordination * patients with mental disorders
factors associated with pain during unsedated colonoscopy

Conditions: Colonoscopy; Unsedated; Pain

Summary: colonoscopy is the gold standard in the diagnosis and treatment colorectal disease, but due to the uncomfortable or even painful procedure, a part of people unwilling to undergoing the examination and giving analgesic agents were recommended in several guidelines. however, use of analgesic agents have their own drawbacks, and nearly 70% patients felt no pain or only mild discomfort with the unsedated colonoscopy, routine administration of sedative or analgesic agents to all patients was considered as unnecessary. however, unsedated colonoscopy was thought to be an option for some but not for all, therefore a method to identify which patients at high risk for painful colonoscopy in preoperational stage is necessary.


Eligibility criteria:
inclusion criteria: * aged 18-80 years * underwent unsedated colonoscopy exclusion criteria: * no bowel preparation or colon cleansing by enema only * no need to reach cecum * prior finding of severe colon stenosis or obstructing tumor * history of colectomy * unstable hemodynamics * pregnant * unable to give informed consent.
low dose of metronomic cyclophosphamide and capecitabine in pretreated her2-negative metastatic breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to evaluate the role of low dose metronomic cyclophosphamide and capecitabine in pretreated metastatic breast cancer.

metronomic chemotherapy has been considered as an effective strategy in metastatic breast cancer. this trial is designed to evaluate the role of low dose metronomic cyclophosphamide and capecitabine in pretreated metastatic breast cancer.

Eligibility criteria:
inclusion criteria: 1. females with age between 18 and 80 years old 2. ecog performance between 0-3 3. life expectancy more than 3 months 4. histological proven unresectable recurrent or advanced her2-negative breast cancer 5. at least one previous therapy regimen (including endocrine therapy) for metastatic breast cancer;suitable for monotherapy (neoadjuvant or adjuvant docetaxel should be completed at least one year). 6. at least one measurable disease according to the response evaluation criteria in solid tumor (recist1.1) 7. no anticancer therapy within 4 weeks 8. adequate hematologic, hepatic, and renal function,no serious medical history of heart, lung, liver and kidney 9. provision of written informed consent prior to any study specific procedures 10. previous capecitabine is permitted, however, it should be completed at least 6 months. exclusion criteria: 1. pregnant or lactating women (female patients of child-bearing potential must have a negative serum pregnancy test within 14 days of first day of drug dosing, or, if positive, a pregnancy ruled out by ultrasound) 2. women of child-bearing potential, unwilling to use adequate contraceptive protection during the course of the study 3. treatment with an investigational product within 4 weeks before the first treatment 4. symptomatic central nervous system metastases 5. other active malignancies (including other hematologic malignancies) or other malignancies, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia. 6. patient having a history of clinically significant cardiovascular, hepatic, respiratory or renal diseases, clinically significant hematological and endocrinal abnormalities, clinically significant neurological or psychiatric conditions 7. uncontrolled serious infection 8. patients with bad compliance 9. patients lack of dihydropyrimidine dehydrogenase(dpd)

Keywords: metronomic cyclophosphamide metronomic capecitabine her2-negative breast cancer
treatment of mitral regurgitation using a minimally invasive approach with the harpoon device.

Conditions: Mitral Regurgitation

Summary: to evaluate the long-term safety and performance of the harpoon™ mvrs for use in patients presenting with severe degenerative mitral regurgitation due to posterior leaflet prolapse in the post-market phase.

this trial is a single arm, prospective, multi-center, non-randomized and open-label post-market study that will evaluate subjects for up to 5 years post treatment.

Eligibility criteria:
inclusion criteria: 1. subject is \> 18 years old 2. presence of severe mr as read on a transthoracic echocardiographic study 3. mitral leaflet coaptation surface is sufficient to reduce mitral regurgitation without undue leaflet tension (approximate leaflet to gap ratio of 2:1) based on the judgment of the patient eligibility committee and the operating surgeon 4. degenerative mitral valve disease with mid-segment p2 prolapse 5. patient is able to sign informed consent and able to return for follow-up and is capable of participating in all testing associated with this clinical investigation exclusion criteria: 1. patient is of the age where further growth is expected 2. active endocarditis 3. left ventricular or left atrial appendage thrombus 4. severe mitral annular and/or leaflet calcification 5. cannot tolerate procedural anticoagulation or post-procedure antiplatelet regimen 6. mitral stenosis 7. functional mitral valve disease 8. previous mitral valve replacement surgery 9. fragile or thinning apex 10. contraindications to transoesophageal echocardiography (atlantoaxial disease, severe generalized cervical arthritis, upper gastrointestinal bleeding, significant dysphagia and odynophagia, has received extensive radiation to the mediastinum) 11. patient is pregnant or lactating
prophylactic cd45ra-depleted dli after haploidentical transplantation/ric

Conditions: Hematologic Malignancy; Haplo-identical Stem Cell Transplantation

Summary: to assess safety of prophylactic escaladed dose of t naïve depleted (cd45ra depleted donor lymphocyte infusion, in patients with malignant hemopathie who received an allogeneic stem cell transplant from an haplo-identical donor, after a reduced intensity conditionning regiment.

primary objective is to determine whether the administration of prophylactic cd45raneg (cd45raneg) memory/effector t lymphocytes is feasible and safe in the early post-transplant period for patients with haploidentical transplant and ric conditioning. donor lymphocytes are isolated from the original donor by non-mobilized mononuclear cell leukapheresis. repetitive intravenous infusions (up to 3) of escalating doses of cd45raneg cells, prepared from the leukapheresis by clinimacs® technology (cd45ra-depletion), storage in vapor nitrogen. escalating doses of cd45raneg cells, for patients with haploidentical graft, intervals of 6-8 weeks, if gvhd is absent starting ≥ 4 weeks from the day of transplantation.

Eligibility criteria:
inclusion criteria: * patients who received a stem cell graft from a haploidentical donor after ric for hematologic malignancies * written informed consent of patient and donor obtained exclusion criteria: * participant taking prednisone (or equivalent steroid) * participant taking prednisone (or equivalent steroid) * participant taking mycophenolate mofetil * participant taking cyclosporine/tacrolimus at therapeutic blood levels * progressive hematologic malignancy before transplant * second allogeneic transplant * acute gvhd ≥ grade 2 * chronic moderate or severe gvhd (nih consensus criteria) * hematologic or molecular relapse of the primary malignancy requiring chemotherapy or unmanipulated dli (receiving prophylactic antileukemic agent, eg tki, is not an exclusion criteria) * donor aberrant cd45ra expression due to a polymorphism in cd45 gene * participation in another interventional clinical trial within 30 days prior to inclusion * pregnant or nursing women. sexually active women with childbearing potential as well as sexually active male patients who are unwilling to use an effective method of contraception during participation in the study from time of inclusion until 2 months after last dose of cd45raneg dli infusion * inability to follow the procedures of the study, including, but not limited to, language problems, psychological disorders, dementia
smoking cessation in subjects with mild-to-moderate chronic obstructive pulmonary disease (copd).

Conditions: Smoking Cessation

Summary: this study is to be conducted in subjects with mild-to-moderate copd who are cigarette smokers with the intent of demonstrating differences in smoking cessation between varenicline and placebo.


Eligibility criteria:
inclusion criteria: * subjects will be current cigarette smokers who have smoked an average of at least 10 cigarettes per day during the past year and during the month prior to the screening visit. * mild to moderate copd confirmed by spirometry * subjects must have a clinical diagnosis of copd. exclusion criteria: * subjects who have made a serious attempt to quit smoking in the past 3 months. * subjects who have been previously randomized in a study that has included varenicline.

Keywords: smoking cessation smoking cessation in copd
co-administration study in patients with elevated cholesterol and coronary heart disease (0653-802)(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 who have cholesterol levels within normal ranges as identified by the study

Keywords: elevated cholesterol
adverse drug reactions with fatal outcome

Conditions: Adverse Drug Reaction

Summary: the purpose of this study is to determine the incidence of drug-related deaths in a university hospital during the year 2015

the investigators aimed to determine the incidence of drug-related mortality of admitted patients in a university hospital during the year 2015

Eligibility criteria:
inclusion criteria: * inpatients deaths and drug-related deaths. exclusion criteria: * death patients in the emergency room, patients with a death diagnosis not available, and dead patients due to other causes non-drug related.

Keywords: adverse drug reaction hospital mortality incidence