Kornimate/medical-research-clean huggingface dataset:
effects of berberine on preventing cardiovascular disease and diabetes mellitus

Conditions: PreDiabetes; Abdominal Obesity; Hypertension; Dyslipidemias

Summary: this multicenter, double-blinded, randomized controlled trial aims to evaluate the effect of berberine on preventing cardiovascular disease and diabetes mellitus among individuals with high cardiometabolic risk in china.

the trial aims to evaluate the efficacy and safety of berberine treatment for individuals with high cardiometabolic risk. potential eligible patients will be recruited from about 100 medical centers in china. after a 4-to-6-week run-in period with berberine, all the eligible participants will be randomized (1:1) to berberine 500mg twice a day plus lifestyle intervention (arm a) or placebo plus lifestyle intervention (arm b). the participants will be followed up at month 3 and month 6, and once every 3 months thereafter, and be followed up for 3 years.

Eligibility criteria:
inclusion criteria: * participants aged ≥45 years (male) or 55 years (female) * participants with abdominal obesity (i.e., waist circumference ≥85 cm in female or waist circumference ≥90 cm in male) * participants with prediabetes, defined as: (a) impaired fasting glucose (ifg) (i.e., 6.1 mmol/l≤fpg\<7.0 mmol/l), or (b) impaired glucose tolerance (igt) (i.e., 7.8mmol/l≤2hpg\<11.1 mmol/l) * participants who meet at least two of four criteria: (a) hypertension, (b) current smoker, (c) hdl-c\<1mmol/l and/or tg≥1.7mmol/l, (d) family history of premature coronary heart disease exclusion criteria: * patients with established atherosclerotic cardiovascular disease, including coronary heart disease, ischemic stroke, and peripheral atherosclerotic diseases * patients diagnosed with diabetes or taking oral glucose-lowering drugs * patients diagnosed with glucose-6-phosphate dehydrogenase (g6pd) deficiency * patients taking berberine or drug containing berberine in the past 1 month * patients with any adverse reaction to berberine * patients with severe constipation, diarrhea, and/or severe chronic intestinal diseases (e.g., ulcerative colitis, crohn's disease, irritable bowel syndrome, etc.) * patients who plan to have weight loss surgery, or are currently taking drugs for weight loss * patients with active liver diseases, or alanine aminotransferase (alt) / aspartate aminotransferase (ast) \> 3 times upper limit of normal * estimated glomerular filtration rate (egfr) \< 45 ml/(min×1.73m2) * women who are pregnant or breastfeeding, or those who plan to be pregnant during the trial * patients with malignant tumors, or other serious diseases with life expectancy of less than 3 years * patients with mental disorders, cognitive disorders, or other serious diseases that could affect study participation * patients who participated or have been participating other trials during the last 3 months * any other conditions that may hinder the compliance to the study intervention or follow-up visit
correlation between cervical spine sagittal alignment and functional disability in preparatory school students with mechanical cervical pain

Conditions: Children, Only

Summary: neck pain is a major public health concern that has been extensively studied in adults but not in children and adolescents. mechanical neck pain became prevalent among children and adolescents, and has its impacts on functional ability. this study is aiming to investigate the correlation between cervical spine sagittal alignment parameter (cranio-cervical angle) and functional disability in preparatory school students with mechanical cervical pain.

* correlational study between cranio-cervical angles and functional disability in students with mechanical cervical pain. * inclusion criteria age between 12 and 15 years, either sex, and cervical symptoms lasting longer than three months. * exclusion criteria spinal pathologies or surgery, or any other deformities or visual or auditory issues, as well as ongoing physical or medical treatment for cervical pain

Eligibility criteria:
inclusion criteria: * age between 12 and 15 years, either sex, and cervical symptoms lasting longer than three months. exclusion criteria: * spinal pathologies or surgery, or any other deformities or visual or auditory issues, as well as ongoing physical or medical treatment for cervical pain

Keywords: cervical spine sagittal alignment functional disability preparatory school children mechanical cervical pain
bioequivalence study comparing artesunate tablet to arsuamoon® tablets (guilin-china) in healthy subjects

Conditions: Falciparum Malaria

Summary: the study will determine if artesunate tablet (pfizer), an antimalarial agent, is pharmaceutically equivalent to arsuamoon® tablets (guilin-china).


Eligibility criteria:
inclusion criteria: * healthy male and/or female subjects between the ages of 21 and 55 years, inclusive. * bmi of 18 to 30 kg/m2; and a total body weight \>45 kg (99 lbs). * an informed consent document signed and dated by the subject or a legally acceptable representative. exclusion criteria: * evidence or history of clinically significant abnormalities. * a positive urine drug screen, history of regular alcohol consumption.

Keywords: bio-equivalence, healthy volunteers
perioperative use of serum creatinine and postoperative acute kidney injury

Conditions: Surgery; Malignancy; Acute Kidney Injury; Cronich Kidney Disease

Summary: the perioperative approach adopted in a cohort of adult oncological patients undergoing major abdominal surgery will be described. in particular, the physician's attitude toward use of scr for identification of patients at risk for po-aki will be described, as well as the patients who should be reassessed in the long term for progression toward ckd. the incidence and risk factors associated with po-aki and renal function deterioration within a year postoperatively will be also evaluated.


Eligibility criteria:
inclusion criteria: * adult patients * scheduled for elective surgery * surgery for oncological disease exclusion criteria: * patients undergoing postoperative chemotherapy * patients who died within 12 month after surgery

Keywords: serum creatinine kidney dysfunction
impact of an educational program on gingival status and oral health related quality of life

Conditions: Gingival Disease; Oral Disease

Summary: this research targets the evaluation of the impact of oral health educational programs on the gingival status and oral health related quality of life in early adolescence of the egyptian population. each participant will benefit from the education of the proper oral hygiene practices under the supervision and follow up of the investigator in addition to the potential improvement of his/ her oral health related quality of life.

the objective of this study is to improve the gingival status and oral health related quality of life in the egyptian population's early adolescence. the intervention is an oral health educational program based on the following: * tooth brushing: the modified bass technique is the method of choice the skill will be taught using a video followed by a model demonstration then a supervised brushing session done by the participants. * dietary recommendations and importance of visiting the dentist will be introduced in the form of power point presentation that will be set according to the american academy of pediatric dentistry (aapd). * participant will be asked to come for 4 visits one for base line data collection and administration of the intervention and another 3 follow up visits once per month.

Eligibility criteria:
inclusion criteria: 1. patients aged from 11-14 years old 2. no reported systemic disease 3. no administration of antibiotics in the last month 4. no fixed or removable appliance 5. absence of acute phase of any oral disease exclusion criteria: 1. patient refuses to participate in the study 2. patient fails to attend follow up sessions
effect of rosiglitazone on myocardial blood flow regulation in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the overall hypothesis to be tested is that increased insulin resistance contributes to abnormal cardiac blood flow regulation in type 2 diabetic patients, which can be reversed by 6 months treatment with rosiglitazone. the planned experimental approach will be to utilize nuclear medicine techniques to evaluate whether the administration of rosiglitazone for 6 months can reverse regional deficits in myocardial blood flow and glucose utilization in type 2 diabetes in a randomized double blind controlled study. these studies will help elucidate the potential of rosiglitazone to correct deficits of myocardial blood flow complicating diabetes with the overall aim being the eventual prevention of sudden cardiac death.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * 30-75 years of age * less than 1% fluctuation in hba1c over 3 months * women must be on contraception * hba1c 6-9% * willingness to sign approved consent form exclusion criteria: * nursing mothers, pregnant women (excluded by a negative pregnancy test). * subjects requiring insulin therapy (\>20 units/day) and can not be converted to sulfonylurea therapy without loss of diabetes control. * patients with a history of drug or alcohol dependence in the last 5 years * patients with pre-existing cardiovascular disease including coronary artery disease, heart attack, heart failure, abnormal heart rhythms, structural abnormalities and valve disease, peripheral vascular disease and uncontrolled high blood pressure. * patients with a history of high cholesterol requiring therapy. * patients with severe systemic disease other than diabetes which has as a recognized complication neuropathy * patients currently taking drugs which act on the blood vessels (for example for hypertension) * patients taking antidepressants, or other drugs or medications known to interfere with the uptake or metabolism of catecholamines (stress hormones) * patients with poor renal function or have significant liver disease * patients with a history of previous kidney, pancreas or cardiac transplantation. * patients with a history of "severe hypoglycemia" which required the assistance of a third party or ketoacidosis requiring hospital admission within the last 3 months. * patients with lung disease for example resulting from chronic obstructive airways disease. * patients with abnormal thyroid function tests. * patients having taken other systemic investigational drugs (especially for neuropathy) or initiating a new or experimental insulin delivery device within 3 months of starting the study. * patients with a history of allergic reactions to multiple drugs or biological products. * obese patients (bmi greater than 35). * patients who refuse to sign the informed consent.

Keywords: insulin resistance type 2 diabetes myocardial perfusion nitrosative stress thiazolidinediones
the safety of nafamostat mesylate for patients with high risk bleeding undergoing hemodialysis: a pilot study

Conditions: Dialysis; Complications; Bleeding

Summary: comparison nafamostat and low molecular weight heparin among dialysis patients


Eligibility criteria:
inclusion criteria: * platelet below 10k ptt above 60 second inr above 20 patient with bleeding (epistaxis, orbital bleeding, hematuria) recent brain hemorrhage (within 6 months) receiving anticoagulant therapy (coumadin or noac) dual antiplatelet agent users received major surgery within one month exclusion criteria: * cancer liver cirrhosis pregnancy drug allergy current bleeding on major organ (brain, gastrointestinal)

Keywords: dialysis bleeding nafamostat heaprin
vaginal dinoprostone prior to diagnostic office hysteroscopy in primarily infertile patients

Conditions: Hysteroscopy

Summary: to compare the effectiveness of vaginal dinoprostone with placebo in minimizing the pain experienced by primarily infertile patients during diagnostic ofﬁce hysteroscopy and to assess the ease of insertion of hysteroscope as reported by the hysteroscopist.

hysteroscopy is commonly used in the diagnosis and treatment of intrauterine lesions such as polyps, ﬁbroids, septa, and adhesions, and in the presence of abnormal bleeding and during the removal of an intrauterine device or foreign body. cervical ripening is made possible by the use of medication through different routes. the most commonly used agent is misoprostol, a synthetic prostaglandin e1 (pge1) analog that is frequently administered in off-label use in obstetrics and gynecology for medical abortion, labor induction, endometrial biopsy, dilatation and curettage, intrauterine device insertion, myomectomy, postpartum haemorrhage, and cervical ripening. in contrast, dinoprostone, a natural pge2, is mostly used in obstetrics for cervical ripening and the stimulation of uterine contractions to induce labor.

Eligibility criteria:
inclusion criteria: * nulliparous women with primary infertility requiring a diagnostic hysteroscopy as a part of an infertility diagnosis workup exclusion criteria: * • women with suspected pregnancy * heavy vaginal bleeding * recent pelvic infection * those known to have hypersensitivity or contraindication to dinoprostone * those who received analgesics prior to oh * a concomitant neurologic disease that could affect the correct evaluation of pain
evaluation of a cognitive remediation program for mood disorders

Conditions: Taking Charge of Cognitive Impairment in Patients With Mood Disorders

Summary: psychotherapeutic management of cognitive disorders in patients suffering from a mood disorder


Eligibility criteria:
inclusion criteria: 1. age between 18 and 65 years old 2. the patient's previous diagnosis of bipolar-related disorder or depressive disorder according to the dsm-5 criteria. 3. mood stabilized with respect to depressive symptomatology (absence or presence of residual mild depressive symptoms (hdrs-17 ≤ 18)) 4. mood stabilized with respect to manic symptomatology (absence or presence of residual mild manic symptoms (ymrs ≤ 8)) 5. stable and effective treatment at minimum dose for at least 2 months 6. cognitive complaint expressed by the patient, and detected by the patient's referring psychiatrist 7. free and informed consent form read, initialled and signed 8. patient affiliated to a social protection scheme or beneficiary of state medical aid 9. patient knowing how to speak french - exclusion criteria: 1. presence of a dsm-5 disorder, other than a mood, anxiety or personality disorder 2. substance addiction or abuse (alcohol, psychoactive substances) in the past 12 months 3. manic, hypomanic or major depressive episode in the last 2 months 4. somatic or neurological disorder which may lead to cognitive impairment 5. current or less than one month's commitment to another research protocol 6. a neuropsychological assessment prior to 6 months. 7. patient under protective custody, guardianship or reinforced guardianship
physiological assessment of the endothelium - circadian rhythm and role of the sympathetic nervous system

Conditions: Endothelial Function

Summary: the purpose of this study is to determine whether interventions aimed at increasing sympathetic tone modify endothelial function measures as assessed by the measurement of flow-mediated dilation (fmd) and constriction (fmc). the investigators hypothesize that the three interventions under study will increase fmc while causing a blunting in fmd. further, the investigators plan to study the circadian variability of fmc and fmd. the investigators hypothesize a peak of fmd in the late hours of the day and a peak of fmc in the early hours.


Eligibility criteria:
inclusion criteria: * healthy volunteers with no cardiovascular risk factor, no current disease, normal laboratory parameters and ecg. exclusion criteria: * any active disease

Keywords: endothelial function sympathetic nervous system
testing effect and schizophrenia

Conditions: Schizophrenia; Episodic Memory Deficits

Summary: when people are tested on a previously learned material, they will latter remember it better even when compared to a condition where they can re-study it. this phenomenon is called retrieval practice and is supported by an extensive research literature mostly carried out in normal students. this paradigm begins to be used in cognitive remediation programs in patients suffering from memory difficulties. the objective of this study is to investigate whether retrieval practice is spared in patients with schizophrenia. if effective, this method could be used in cognitive remediation programs. since episodic memory difficulties are supposed to be secondary to deficits in the initiation/elaboration of efficient encoding and retrieval strategies our hypothesis is that retrieval practice is spared in schizophrenia


Eligibility criteria:
inclusion criteria: * french is the native language, or acquired before 5 years old * people must be able to understand and follow the trial instructions specific inclusion criteria (for patients) : * diagnostic of schizophrenia, according to the dsm -5, clinically stable * the treatment must remain unchanged during the trial exclusion criteria: * severe or acute cerebral disease * other actual psychiatric disorder * use of drugs with high anticholinergic effect * irregular use of benzodiazepines medication, or high dose of benzodiazepin (more than 2 mg of lorazepam per day or equivalent) * inappropriate use of drugs specific exclusion criteria (for healthy subjects) : - diagnostic of schizophrenia of a relative up to the third degree

Keywords: schizophrenia episodic memory deficits
genesearch™ breast lymph node (bln) assay china registration study

Conditions: Breast Cancer

Summary: the primary objective of this trial is to compare genesearch™ breast lymph node (bln) test kit to permanent pathological section, so as to evaluate the clinical sensitivity and specificity of genesearch™ breast lymph node (bln) test kit in detecting axillary sentinel lymph node metastases in breast cancer patients. the secondary objective of this trial is to evaluate the positive predictive value and negative predictive value of genesearch™ breast lymph node (bln) test kit when used in the detection of axillary sentinel lymph node metastases in breast cancer patients. prospective and multi-center clinical trial


Eligibility criteria:
inclusion criteria: * diagnosed previously as breast cancer * patient scheduled for sentinel lymph node dissection * 18 years or older * female or male, and * able and willing to give consent to participate in the study exclusion criteria: * patients taking part in other research studies that would interfere with their full participation in this study, or * prior sentinel or partial axillary lymphadenectomy on the same body side

Keywords: genesearch breast cancer
mmp-9 expression in permanent mature teeth with symptomatic pulpitis

Conditions: Pulpitis

Summary: matrix metallopeptidase-9 (mmp-9) expression was compared in healthy and inflamed pulp and the outcome of coronal pulpotomy in teeth with symptomatic pulpitis was assessed. after procedure blood samples were examined using elisa kit.

introduction: widely used diagnostic tests do not provide information to distinguish the pulp inflammation stage while improvement of materials, techniques and vital pulp therapy have received a wider acceptance in symptomatic pulpitis treatment. the aim of this clinical study was to compare mmp-9 expression in healthy and inflamed pulp and to assess the short-term outcome of coronal pulpotomy in mature permanent teeth with symptomatic pulpitis. methods: patients diagnosed with symptomatic pulpitis were included in this clinical study. coronal pulpotomy was performed using calcium-silicate based material and blood samples were taken. initial and postoperative pain was recorded by heft-parker visual analog scale at 24 hours and 72 hours after the procedure. in control group teeth with healthy pulp were used. during follow-up visits after three and six-months, patients were examined clinically and radiographically. the elisa kit was used to determine the levels of mmp-9 in inflamed and healthy coronal pulp tissue.

Eligibility criteria:
inclusion criteria: * teeth diagnosed with symptomatic pulpitis * patients who did not use any nsaids before the treatment * positive cold test of investigated teeth * clinically dental caries in contact with pulp chamber * permanent teeth with radiographically closed root apex exclusion criteria: * patients who refuse to participate in the study * medically compromised patients (with immunosuppressive/systemic diseases, patients on medications) * teeth with periapical radiolucency or clinical signs of apical periodontitis * periodontological compromised teeth (probing depth ≥4mm) * internal/external root resorption in periapical radiograph * pulp chamber and/or root canal calcification in periapical radiograph * teeth with unrestorable crown * teeth with a negative response to cold test

Keywords: calcium-silicate, coronal pulpotomy, mmp-9, symptomatic pulpitis.
medi9447 alone and in combination with medi4736 in adult participants with select advanced solid tumors.

Conditions: Solid Tumors

Summary: the purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and antitumor activity of medi9447 alone and in combination with medi4736 in adult participants with select advanced solid tumors


Eligibility criteria:
inclusion criteria: * adult participants; age ≥ 18 * written and signed informed consent must be obtained * have histologic or cytologic documentation of solid tumor including egfrm nsclc * participants must have at least 1 lesion that is measurable using recist guidelines * participants must consent to provide archived tumor specimens or tumor biopsies for correlative biomarker studies. * eastern cooperative oncology group performance score of 0 or 1 * adequate organ function exclusion criteria: * prior treatment with tumor necrosis factor receptor superfamily agonists including ox40, cd27, cd137 (4-1bb), cd357 (gitr). one cohort also excludes anti ctla-4, pd-l1, and anti pd-l1. * participants who have received prior therapy with regimens containing ctla-4, pd-l1, or pd-1 antagonists may be permitted to enroll under certain conditions * cardiac or peripheral vascular disease meeting any of the following criteria: * past history of myocardial infarction in the prior 12 months * past history of stroke or transient ischemic attack requiring medical therapy * congestive heart failure ≥ class 3 based on new york heart association functional classification * grade 3 or greater edema (eg, peripheral, pulmonary) * history of grade 3 or greater thromboembolic events in the prior 12 months * participants with active tuberculosis are ineligible. in settings where there is clinical or radiographic evidence of tuberculosis, active disease must be ruled out * active or prior documented autoimmune or inflammatory disorders * untreated central nervous system (cns) metastatic disease * known positive for human immunodeficiency virus (hiv), chronic or active hepatitis b or active hepatitis a or c * other invasive malignancy within 2 years except for noninvasive malignancies such as cervical carcinoma in situ, in situ prostate cancer, non-melanomatous carcinoma of the skin, ductal carcinoma in situ of the breast that has been surgically cured * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, active peptic ulcer disease or gastritis, uncontrolled hypertension, uncontrolled diabetes, or psychiatric illness/social situations that would limit compliance with study requirement

Keywords: solid tumors, medi9447, oleclumab, medi4736, durvalumab, cd73, programmed death ligand-1 (pd-l1), epidermal growth factor receptor mutant (egfrm) non-small cell lung cancer (nsclc), immunotherapy, pancreatic, colorectal