Kornimate/medical-research-clean huggingface dataset:
a study of the safety and efficacy of mk-3577 in participants with type 2 diabetes mellitus (mk-3577-009)

Conditions: Type 2 Diabetes Mellitus

Summary: this study assessed the safety and efficacy of mk-3577. the primary efficacy hypothesis was that, after 4 weeks of treatment, either the morning (am) administration or the evening (pm) administration of mk-3577 provides superior reduction of 24-hour weighted mean glucose (wmg) levels compared to placebo (pla). the primary safety hypothesis was that mk-3577 is well tolerated compared to placebo.

this was a 4-period/5-treatment crossover study. each period was 4 weeks. the 5 treatments consisted of mk-3577 10 mg once daily (qd) in the am, mk-3577 6 mg qd in the evening (pm), mk-3577 25 mg twice daily (bid), metformin 1000 mg bid, and placebo to mk-3577/placebo to metformin. participants were to be randomized to one of 14 treatment sequence arms. a subset of participants in each group was to domicile (stay overnight) at selected clinical sites at baseline, week 4 (end of period 1), and week 8 (end of period 2) to undergo 24-hr blood sample.

Eligibility criteria:
inclusion criteria: * participant has type 2 diabetes * participant is either not taking antihyperglycemic medications for the last 10 weeks or is taking a single oral antihyperglycemic medication (but not a peroxisome proliferator-activated receptor gamma \[pparg\] agonist) or is taking a low-dose combination oral antihyperglycemic medication (not a pparg agonist) at dose less than or equal to 50% of the maximum dose * female participant is unable to have children exclusion criteria: * participant has a history of type 1 diabetes or ketoacidosis * participant has been treated with a pparg agonist in the last 12 weeks * participant has been treated with insulin in the last 12 weeks * participant has had prescription lipid-modifying drug therapy in the last 12 weeks * participant has a history of coronary artery disease * participant has had a stroke or transient ischemic attack * participant has congestive heart failure
azilsartan in chinese patients with mild and moderate hypertension

Conditions: Hypertension

Summary: a phase 3 clinical study to evaluate the safety and efficacy of azilsartan in chinese hypertension patients


Eligibility criteria:
inclusion criteria: 1. 18-70 years of age (including 18 and 70 years of age), male or female; 2. diagnosed with mild to moderate essential hypertension; 3. clinic diastolic and systolic blood pressure need to meet the following two conditions: 3 times mean sitting diastolic blood pressure measurements at 95mmhg-110mmhg (not including 110mmhg); 3 times sitting systolic blood pressure measured and mean value between150mmhg-180mmhg (not including 180mmhg); 4. understand clearly that voluntary to participate in the study, sign informed consent. exclusion criteria: 1. severe essential hypertension (sitting systolic ≥180mmhg and / or sitting diastolic pressure ≥110mmhg), malignant hypertension, hypertensive emergency, hypertensive crisis and high blood pressure encephalopathy. 2. secondary hypertension. 3. the following hypertension and diseases: acute myocardial infarction within 6 months, the cerebral artery accident, transient ischemic attack; or dissecting aortic aneurysm, angina, ii-ivclass (nyha classification) history of heart failure ⅱ degree atrioventricular block, sick sinus integrated disease, bradycardia (heart rate \<50 beats / min) or other antiarrhythmic drugs needed. 4. significant laboratory abnormalities include: serum potassium\> 5.5mmol / l; blood alt or ast\> 2.5uln; serum creatinine\> 1.5uln. 5. unilateral or bilateral renal artery stenosis. 6. type 1 diabetes and poor glycemic control of type 2 diabetes (hba1c values ≥ 8%). 7. gastrointestinal lesions or gastrointestinal surgery may affect drug absorption or excretion, such as stomach-bowel resection, nearly one year activity of gastrointestinal inflammation, ulcers or gastrointestinal bleeding. 8. azilsartan sheet or olmesartan medoxomil tablets and related drugs (arb, acei and renin inhibitors) allergies. 9. pregnant, lactating female patients, or during the test does not guarantee the effective collision pregnant person. 10. obesity, body mass index (bmi)\> 30kg / m2. 11. import of use in addition to import other types of medication trials of antihypertensive drugs, anti-angina drugs, lithium agents, corticosteroids, licorice, estrogen, digitalis drugs and drugs were potassium. 12. variance of diastolic blood pressure ≥8mmhg. 13. drug or alcohol abuse within 6 months are drinking more than two units of alcohol (1 unit = 360ml or 45ml alcohol content of 40%). 14 patients with malignant tumors. 15. hemodialysis patients or strictly limit salt therapy. 16. participated in other clinical trials within 30 days.
the electroencephalogram and clinical effect of ketamine

Conditions: Electroencephalogram; Consciousness, Loss of

Summary: the electroencephalography (eeg) is a noninvasive medical technique for monitoring and recording the electrical activity of brain. the hilbert-huang transformation (hht) was proposed to decompose eeg signal into intrinsic mode functions (imf). hht can obtain instantaneous frequency data and work well for nonstationary and nonlinear data. we applied this method in perioperative eeg signal analysis in order to find the energy shift and quantify the energy change during general anesthesia. ketamine was a depolarized sedative which was wildly used in anesthesia. we are trying to find the energy change after ketamine injection, and the interaction between different oscillations in eeg. the whole brain mapping for ketamine and other sedatives interaction is the next step.

method: in the first year, we will record 60 patients who received general anesthesia, their eeg data recorded from bi-spectral index (bis) monitor. under the same anesthesia depth, the experimental group use ketamine 0.5mg/kg; while the control group using alfentanil 0.01mg/kg injection. both perioperative data were recorded included heart rate, blood pressure and surgical time. we decompose the raw eeg data from bis monitor with emd, and we observe difference between imfs, and quantifying energy change. second year: we will extend the eeg monitor to temporal lobe, parietal lobe and occipital lobe. besides the whole brain mapping method for detecting energy change after ketamine injection; we also tried to find the interactions between oscillations. finally, we want to apply the analysis method to pediatric patients, try to find the difference of ketamine reaction between generations. anticipated results: we anticipate that we can quantify the energy of eeg by emperical mode decomposition(emd), and ketamine injection can cause different energy change with other sedatives. we will find the energy traveling in eeg with emd decomposition. we will find that hht is more suitable for eeg analysis in clinical practicing. with the whole brain mapping method, we can understand the electrical activity during general anesthesia.

Eligibility criteria:
inclusion criteria: american society of anesthesiology i-ii not allergic to bis probe do not have wound or scar over forehead area exclusion criteria: patient refuse not suitable for propofol or ketamine injection
patient education program and ehlers-danlos syndrome

Conditions: Hypermobility Type Ehlers-Danlos Syndrome

Summary: the ehlers-danlos syndrome (sed) comprises a group of clinically and genetically heterogeneous, inherited connective tissue diseases. the hypermobility type is the most frequent. it is characterized by a generalized joint hypermobility and a hyperextension skin. chronic pain syndrome is often present. its psychological impact can be significant (anxiety, depression, impact on the quality of life of the patients). the disease also requires changes and a permanent adaptability (coping). it can lead to feelings of isolation and misunderstanding. the french association of the ehlers-danlos syndromes and the rehabilitation center of the 'croix-rouge française des massues' propose a patient education program for the patients with a hypermobility type sed (the predused program). this education program is open to patients and their caregivers located in france. the research hypothesis is that the predused program improves their coping and reduces patient anxiety at 6 months (these are the two clinical criteria on which the predused could have the most impact, given the results of the first sessions).


Eligibility criteria:
inclusion criteria: patients * adults (\>18 years) * hypermobility type ehlers-danlos syndrome * participating to one education session during the study period caregivers * adults (\>18 years) * caregivers of patients with hypermobility type ehlers-danlos syndrome * participating to one education session during the study period

Keywords: hypermobility ehlers-danlos syndrome patient education program
coronavirus disease 2019 (covid-19) pandemic on the oral hygiene status of children

Conditions: COVID-19 Pandemic

Summary: the purpose of this study is to compare oral hygiene status and dietary habits of 3-5 years old children and their parents with a questionnaire and clinic examination between pre- and post-covid-19 period.

study rationale and objectives: the primary motivation behind this study lies in understanding the impact of the covid-19 pandemic on oral health behaviors, specifically focusing on children at high risk for dental caries. objectives include assessing changes in tooth brushing habits and dietary patterns among both children and their parents. study design: the study employs a prospective observational design. participants are parents of 155 children aged 3-5 years. data collection occurs at two time points: before and after the covid-19 pandemic. data collection instruments: a structured questionnaire is administered to parents. it covers: children's and parents' dietary habits (frequency of sugary food consumption). oral hygiene practices (tooth brushing frequency). the index of decayed-missing-filled deciduous teeth (dmft) is used to assess dental caries status in children. the covid-19 pandemic had a limited impact on high-caries-risk children's tooth brushing habits. however, increased sugary food consumption by both children and parents exacerbated caries risk. collaborative efforts between healthcare professionals and parents are crucial to mitigate negative oral health effects during such challenging times.

Eligibility criteria:
inclusion criteria: * 3-5 year old children with high caries risk. to identify high caries-risk children, the criteria used by the the american academy of pediatric dentistry (aapd) for assessing a child's dental caries risk were applied. exclusion criteria: * childrens with systemic health problems and childrens with any space maintainers.

Keywords: covid-19 oral hygiene dietary habits parents pediatric dentistry
safety of besivance™ (besifloxacin ophthalmic suspension) 0.6% compared to vehicle

Conditions: Bacterial Conjunctivitis

Summary: the objective of this study is to evaluate the safety of besivance (besifloxacin ophthalmic suspension, 0.6%) compared to vehicle.


Eligibility criteria:
inclusion criteria: * subjects must have a clinical diagnosis of acute bacterial conjunctivitis and exhibit purulent conjunctival discharge (crusty or sticky eyelids) and redness in at least one eye. * subjects who are willing to discontinue contact lens wear for the duration of the study. * subjects who are able and willing to comply with all treatment and follow- up/study procedures. exclusion criteria: * subjects who have any uncontrolled systemic disease or debilitating disease. * subjects with a known hypersensitivity or contraindications to besivance, fluoroquinolones, or any of the ingredients in the study drugs. * subjects who are expected to require disallowed concurrent systemic or ocular therapy(either eye)during or prior to study start. (ie, nsaids, corticosteroids, mast cell stabilizers, antihistamines, decongestants or antimicrobial therapy) * subjects having ocular surgery (including laser surgery) in either eye within six weeks prior to entry into this study. * subjects with suspected viral or allergic conjunctivitis or any other disease conditions that could interfere with the efficacy and safety evaluations of the study medication. * subjects with suspected iritis. * subjects with a history of recurrent corneal erosion syndrome, either idiopathic or secondary to previous corneal trauma or dry eye syndrome. * subjects with any active ulcerative keratitis, specifically any epithelial loss greater than punctate keratitis. * subjects who are immune compromised.
pregabalin on interleukin-6 levels in living donor kidney

Conditions: Pain

Summary: pregabalin, a ligand for alfa2delta subunits of voltage-gated calcium channels, has been shown to be an effective adjuvant therapy for acute postoperative pain, by inhibiting central sensitization. the il-6, is detectable 60 minutes after surgical incision, persisting for until 10 days, with maximal plasmatic level in 4 and 6 hours. the objective of this study is evaluating the analgesic effect of pregabalin and its repercussion on serum levels of il6.

after approved by the ethical committee and signed informed consent, 40 patients aged from 18 until 60 years undergoing nephrectomy will be randomized in two groups. group 1 patients will receive a single dose of 300 mg pregabalin, 1 hour before the surgical incision; group 2 patients will receive a placebo dose. pain intensity will be assessed with the numeric rating scale. the consumption of tramadol in 24 hours after surgery and the time for the first complementation dose will be registered. blood samples will be collected by 6 hours and 24 hours after surgical incision, for il-6 dosage, and maintained at -70 celsus degree. the il-6 dosages will be performed by the elisa (enzyme-linked immunosorbent assay) method. the number of patients was calculated by instat graph® program. to detect difference in pain intensity of 3 between the groups by nrs, with 95% of power (estimated sd= 2.0), when the alpha level is set at 0.05, the sample should be of 20. statistical analyses will be performed with parametric and nonparametric tests, considering the variety studied. the statistical program that will be utilized is instat graph®.

Eligibility criteria:
inclusion criteria: * living donor kidney exclusion criteria: * myocardial ischemia * psychiatric disease * absence of chronic pain * absence of drugs dependency * don´t use of opioid medication 1 week before surgery

Keywords: pregabalin postoperative pain control interleukin-6 acute pain
the preoperative health & body study

Conditions: Breast Cancer

Summary: this study is designed to look at the changes that occur in women who take part in exercise and mind-body programs between breast cancer diagnosis and breast surgery. the investigators will look at changes in stress, anxiety, mood and quality of life, to see if these types of short programs can make women feel better during this time. the investigators are also interested in looking at whether a short exercise or mind-body program leads to any changes in markers in breast cancer cells, such as their growth and death rates, or in blood hormones such as insulin, which have been linked to breast cancer development. since the investigators do not know if these blood or tumor tests have any relationship to cancer recurrence, the investigators do not plan to share the results of these tests with you or your physician.


Eligibility criteria:
inclusion criteria: * newly diagnosed, histologically confirmed stage i-iii breast cancer * planning to undergo definitive surgical management with lumpectomy or mastectomy with in the next 8 weeks. * willing and able to participate in the intervention for at least 3 weeks prior to surgery. * ecog performance status of 0 or 1 * approval by oncologist or surgeon * willingness to be randomized. * english speaking and able to read english exclusion criteria: * concurrent other malignancy or history of other malignancy treated within the past 3 years (other than non-melanoma skin cancer or in situ cervical cancer) * presence of metastatic disease * scheduled to receive any form of neoadjuvant cancer therapy * locally advanced breast cancer not amenable to primary surgery * history of prior ipsilateral breast cancer * taking tamoxifen, raloxifene or an aromatase inhibitor at the time of breast cancer diagnosis * absolute contraindications to maximal exercise testing as recommended by the american thoracic society * any condition which in the investigator's opinion makes the subject unsuitable for study participation * participating in another clinical study with competing study outcomes * pregnant (i.e., positive beta-hcg) or breast feeding * unable to comply with protocol and/or not available for follow-up assessments * participation in more than 90 minutes a week of moderate-intensity recreational activity (not including activities such as gardening, bowling, golfing with a cart) as assessed by the leisure score index of godin leisure- time exercise questionnaire (lsi) (appendix i) or recent participation (past 6 months) in two or more strength training sessions per week. * diabetes mellitus requiring insulin or oral agents; patients with diet-controlled diabetes will be allowed to participate

Keywords: stage i-iii breast cancer
post-operative constipation following total knee arthroplasty

Conditions: Constipation

Summary: postoperative constipation, defined as no fully satisfying bowel movement within the first three postoperative days, is a common occurrence with some researchers estimating that between 41 and 85% of postoperative patients experience symptoms. causes include intraoperative medications, postoperative opioid analgesics, decreased mobility, and decreased oral intake. constipation significantly impacts quality of life following surgery. current standard of care for preventing postoperative constipation for patients having a single total knee arthroplasty at cleveland clinic is discharge on postoperative day one with either a prescription to be filled for docusate sodium (brand name colace®) 100 mg to be taken two times a day by mouth for twenty eight days or the filled prescription, plus discharge instructions on ways to avoid and treat constipation. research results show that docusate sodium is ineffective for preventing postoperative constipation in orthopedic surgery patients, and anecdotal reports confirm this finding. the proposed study uses a 2-group non-equivalent cohort design to evaluate the effect of one standard dose (17 grams) of an over-the-counter osmotic laxative (propylene glycol (peg 3350), brand name miralax) by mouth prior to discharge to the current standard of care. the primary outcome measure is whether patients report of a fully satisfying, normal for them, bowel movement within the first three postoperative days. patient reported data will be collected by phone call four to seven days following surgery. pertinent patient characteristics will be abstracted from the electronic medical record. the sample will consist of patients over twenty years old having a single total knee arthroplasty by drs. stearns, molloy, or murray who are admitted to unit 5d at cleveland clinic lutheran hospital postoperatively. intent to treat analysis will be performed using logistic and linear regression models, adjusting for differences between groups on patient and surgical characteristics. based on use of a two-sided pearson chi-square test with 80% power and significance level of 0.05, 49 patients per group are required to detect a 25% decrease in constipation rate. to account for attrition we will over sample by 50% for a total of 74 per group or 148 total participants.


Eligibility criteria:
inclusion criteria: * admission to cleveland clinic lutheran hospital surgical unit 5d * single total knee replacement surgery by orthopedic surgeons stearns, murray, or molloy * age greater than 20 * discharge to home on postoperative day one exclusion criteria: * known allergy to peg 3350 * unable to complete a follow up phone call in english * known renal disease, irritable bowel syndrome, or inflammatory bowel disease (crohn's disease or ulcerative colitis)

Keywords: constipation postoperative total knee arthroplasty
observational study on patients with chronic hepatitis b

Conditions: Chronic Hepatitis B

Summary: the study was conducted to evaluate the effect of anti-viral treatment on long-term outcome on patients with chronic hepatitis b.


Eligibility criteria:
inclusion criteria: * male or female, aged over 30 (inclusive) years of old * patients has a history of diagnosis of chronic hepatitis b (ie. hbsag positive for more than 6 months) * for patients with hbsag positive, patients should be undergoing anti-viral treatment * for patients with hbsag negative, a documented evidence of previous anti-viral treatment should be provided. * life expectancy is more than 1 year * good treatment compliance. exclusion criteria: * patients has a history of diagnosis of hepatocellular carcinoma * patients with child pugh c * coinfected with hcv, hdv and hiv * suffering from other serious disease * taking part in other clinical trial
clinical study of high concentration ganciclovir eye drops in the treatment of cytomegalovirus retinitis

Conditions: Cytomegalovirus Retinitis; Ganciclovir Eye Drops

Summary: clinical study of high concentration ganciclovir eye drops in the treatment of cytomegalovirus retinitis

approval of the study was obtained from the hospital's ethical committee. the study design and methodology followed the tenets of declaration of helsinki. all patients were provided with written informed consent and received a thorough explanation of the use of 2% ganciclovir eye drops, its potential risks and benefits. this is a monocencer, single arm, prospective study. the experimental group is: 2% ganciclovir eye drops therapy group. administration method and dose adjustment: 2% ganciclovir eye drops, 10 times / day for two weeks, 8 times/day for two weeks, 6 times/day for two weeks, 4 times/day for more than six weeks. according to best corrected visual acuity (bcva), intraocular pressure, corneal abrasion, anterior chamber and vitreous inflammation, optical coherence tomography (oct), ultra wide angle fundus image and so on. the investigators evaluate the effects of 2% ganciclovir eye drops in treatment of cytomegalovirus retinitis.

Eligibility criteria:
inclusion criteria: 1. patients voluntarily participate in studies and sign informed consent forms 2. ages 2-80 years (with cut-off values) male and female 3. one of the following is true （1）in patients with cytomegalovirus retinitis after hematopoietic stem cell transplantation/cord blood transplantation, the white blood cell count is less than 4× 10\^9/l, and the platelet count ranges are 25× 10\^9/l≤ plt\<100×10\^9/l，intravitreal injection carries a greater risk of infection and bleeding, and is unable to administer systemic medication due to the bone marrow suppression of antiviral drugs, or systemic medication for severe cmv retinitis cannot be well controlled; （2）in patients with cmvr with aids, the cd4+ t cell count is less than 100/μl, there is a great risk of infection with intravitreal injection, and the systemic medication of severe cmv retinitis cannot be well controlled. exclusion criteria: * eye condition 1. the presence of refractive interstitial opacification affects fundus observation; 2. intravitreal ganciclovir or sodium phosformate injections were performed within 1 week prior to baseline; 3. other diseases that can affect visual function such as syphilis-related eye diseases, acute retinal necrosis, congenital glaucoma, congenital corneal lesions, congenital macular degeneration, etc. * general condition 1. severe neutropenia (\<0.5×10\^9) or severe thrombocytopenia (\< 25× 10\^9/l); 2. other investigators judged patients who were not suitable for enrollment;