Kornimate/medical-research-clean huggingface dataset:
open label rct for chronic severe ar : entresto vs. ccb/arb

Conditions: Aortic Valve Insufficiency

Summary: the purpose of this study is to assess the efficacy of sacubitril-valsartan compared to the combination of arb/ccb on left ventricular remodeling in patients with chronic aortic valve regurgitation.

after being informed consent about the study and potential risk, all patients giving written informed consent will undergo a 1 month screening period to determine eligibility for study entry. at week 0, patients who meet the eligibility requirements will be randomized in an open-label manner in a 1:1 ratio to sacubitril-valsartan or amlodipine/losartan.

Eligibility criteria:
inclusion criteria: 1. participant over 20 years of age who has not been hospitalized for heart failure 2. participant with hypertension or systolic blood pressure 125 mmhg or higher 3. nyha i 4. participant with chronic severe aortic regurgitation (vcw \>0.6cm) 5. participant with av regurgitant volume ≥ 60ml or effective regurgitant orifice area ≥ 0.3 cm2 6. participant with left ventricular ejection fraction ≥ 55% exclusion criteria: 1. a history of hypersensitivity or allergy to clinical trial drugs or similar compounds or arb/nep inhibitors 2. history of angioedema 3. patients with an ascending aorta dilated by more than 55 mm 4. patients with aortic valve insufficiency due to hereditary aortic disease (marfan syndrome, ehlers-danlos syndrome) 5. patients with moderate to severe aortic stenosis 6. patients with claustrophobia or with metallic implants unsuitable for magnetic resonance imaging 7. history of acute heart failure within 6 weeks and dyspnea of nyha ii or higher 8. symptomatic hypotension or sbp \< 100 mmhg at screening 9. patients with renal failure (estimated gfr \< 30 ml/min/1.73 m2) or on dialysis 10. significant increase in blood potassium level (potassium \> 5 mmol/l) 11. blood ast or alt value is more than twice the upper limit of normal or symptoms and signs of cirrhosis (history of hepatic coma, history of esophageal varices, history of symptomatic ascites) 12. in case of acute coronary syndrome, stroke, thoracic surgery, and percutaneous coronary angioplasty within 3 months 13. if aortic valve surgery is scheduled within the next 6 months 14. in case of severe mitral valve disease 15. patients with primary hyperaldosteronism 16. if a woman of childbearing potential has not used double contraception 17. women who are currently pregnant or lactating 18. when it is judged that there are clinically significant abnormalities in physical examination, diagnostic examination, electrocardiogram, etc. at the time of the screening visit
elda: elderly breast cancer - docetaxel in adjuvant treatment

Conditions: Breast Cancer

Summary: the purpose of this study is to compare disease free survival of elderly breast cancer patients treated with standard adjuvant chemotherapy (cmf) versus experimental adjuvant chemotherapy (weekly docetaxel).

adjuvant combination chemotherapy, given after breast cancer surgery, has been established as the standard approach to reduce the risk of breast cancer recurrence in those patients at intermediate or high risk for recurrence. however, since elderly patients have been underrepresented in past clinical trials, the optimal adjuvant therapy for elderly patients at risk for recurrence has not yet been defined. docetaxel is one of the most active drugs for patients with metastatic breast cancer and several trials are evaluating its efficacy in the adjuvant setting. administration of docetaxel on a weekly schedule is effective and well tolerated in women with metastatic breast cancer. in this study, patients from ages 65 to 80 will be randomized to one of two treatment strategies: * standard adjuvant chemotherapy with cmf (cyclophosphamide, methotrexate, and 5-fluorouracil given intravenously on days 1 and 8 of each cycle) * experimental adjuvant chemotherapy with weekly docetaxel (given intravenously on days 1,8, and 15 of each cycle) in both treatment strategies: * 4 cycles of chemotherapy will administered for patients at least 10% positive for er or pgr, and 6 cycles will administered for patients expressing \< 10% er or pgr * patients with any positive expression of er or pgr will receive adjuvant hormonal therapy with tamoxifen (20mg/day for 5 years) after concluding chemotherapy * adjuvant radiation therapy will be given to patients who are candidates at the conclusion of chemotherapy and within 6 months of surgery.

Eligibility criteria:
inclusion criteria: * histologically confirmed invasive unilateral breast cancer * age \> 65 and \< 80 years * intermediate-high risk of recurrence according to st. gallen criteria: er negative and pgr negative, or axillary lymph node metastasis, or tumor size \> 2 cm, or tumor grade 2 or 3 (intermediate or high) exclusion criteria: * performance status \>1 * distant metastasis * concomitant malignancy or malignancy within previous 5 years (except basal cell or spinocellular skin cancer and in situ cervical cancer if they have been adequately treated * previous breast cancer treatment * neutrophils \< 2000/mm3 or platelets \< 100000/mm3 or haemoglobin \< 10 g/dl * creatinine \> 1.25 the upper normal limit * got and-or gpt and/or bilirubin \> 1.25 the upper normal limit * concomitant conditions that contraindicate the use of the drugs in the protocol * incapacity or refusal to provide informed consent

Keywords: elderly adjuvant therapy intermediate risk high risk
effect of nicorandil on cardiac sympathetic nerve for the patients of acute st segment elevation myocardial infarction

Conditions: Coronary Heart Disease

Summary: the investigators evaluate the effects of intracoronary and intravenous administration of nicorandil on cardiac sympathetic nerve activity and distribution in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention

reperfusion injury might occur in patients with acute st segment elevation myocardial infarction undergoing the primary percutaneous coronary intervention(p-pci),characterized by myocardial stunning, reperfusion-induced arrhythmia, microvascular dysfunction and injury of cardiac sympathetic nerve, etc. nicorandil is an antianginal agent with a dual mechanism of action: nitrate and k+atp channel opener. the nitrate action causes vasodilation of systemic veins and epicardial coronary arteries, while the adenosine triphosphate (atp)-sensitive potassium channel opener action causes vasodilation of peripheral and coronary resistance arterioles. nicorandil not only decreases preload and afterload but also increases coronary blood flow. the study will compare the effectiveness between nicorandil and placebo of preventing the reperfusion injury especially injury of cardiac sympathetic nerve in patients with acute st segment elevation myocardial infarction undergoing the p-pci.it is intended that before reperfusion injury ,nicorandil which was early used by intracoronary injection could prevent and release the microcirculatory spasm, release the coronary microvascular endothelial swelling,decrease embolism of atherosclerotic debris and thrombus formation,moreover,it could reduces the release of norepinephrine from sympathetic endings of the heart directly.so,it could decrease the phenomenon of no-reflow/slow reflow,reperfusion-induced arrhythmia and injury of cardiac sympathetic nerve.

Eligibility criteria:
inclusion criteria: 1. acute st-segment elevation myocardial infarction within 12 hours of symptom onset; 2. age20-80,all genders 3. anterior myocardial infarction 4. the first myocardial infarction 5. the infarct-related artery(ira) is totally occlusive 6. blood pressure is higher than 90/60 millimeters of mercury（mmhg） 7. the time from myocardial infarction onset to reach the hospital is less than 12 hs exclusion criteria: 1. kidney dysfunction (creatinine \>2 mg/dl), 2. history of previous liver disease, 3. cardiogenic shock, 4. history of myocardial infarction (mi) 5. history of coronary artery bypass grafting 6. history of allergic response to drugs 7. severe hypovolemia

Keywords: nicorandil primary percutaneous coronary intervention acute st segment elevation myocardial infarction cardiac sympathetic nerve
wasp classification in diagnosis of diminutive colorectal polyps

Conditions: Diminutive Colorectal Polyps

Summary: adenomas, serrated adenomas and hyperplastic polyps are polypoid lesion in the colorectum. at the present moment, all polyps should be resected endoscopically, although only adenomas and serrated adenomas, but not hyperplastic polyps have the potential to develop colorectal cancer. some studies have investigated the value of the narrow-band imaging (nbi) on histological prediction of the polyp. this method is conducted in real time during colonoscopy, which leads to simplification of diagnostic procedures. for instance, it would be conceivable to resect diminutive polyps and discard them without further assessment by a pathologist. one problem in this context is a correct differentiation between hyperplastic polyps and serrated adenomas. these two polyp entities are known to show similar optical features. however, while serrated adenomas are premalignant lesions hyperplastic polyps have benign histology and never develop into cancer. it is therefore important to sufficiently distinguish hyperplastic polyps from serrated lesions. in this study the investigators want to investigate whether the use of nbi would be capable to get accuracy of optical polyp predictions by more than 90% using the wasp (workgroup serrated polyps and polyposis) classification. nbi is a light filter tool which can be activated by pressing a button at the endoscope. the use of nbi leads to an endoscopic picture which appears blue and enables endoscopists to better assess surface structures and vascular patterns. all polyps will be resected and send to pathology for further microscopic assessment. after completing the trial the investigators aim to compare accuracy of the optical diagnosis.


Eligibility criteria:
inclusion criteria: * patients aged more than 18 years old * patients with at least one diminutive colorectal polyp exclusion criteria: * patients with poor bowel preparation * paitents with history of colorectal surgery, familial adenomatous polyposis or inflammatory bowel disease * patients with advanced colorectal cancer * patients with missed histology information of resected polyps or missed resected specimen * patients with emergency operation during colonoscopy * patients with unfinished colonoscopy due to any reason

Keywords: narrow band imaging wasp classification diminutive colorectal polyps
mtor and adipose tissue inflammation

Conditions: Obesity

Summary: the target of rapamycin complex 2 (torc2) is an evolutionarily conserved serine/threonine protein kinase that controls growth and metabolism. in mammals (including humans), mammalian tor complex 2(mtorc2) contains mammalian tor (mtor), rictor, msin1 protein, and mlst8 gene. in an animal model, the adipose-specific rictor knockout (adriko) mouse, systemic insulin resistance, hepatic steatosis, and cardiovascular dysfunction develop upon high fat diet (hfd)-induced obesity or aging. to find a molecular link between adipose mtorc2 and systemic insulin resistance, investigators have already performed transcriptomics and proteomics analysis on visceral white adipose tissue in a mouse model. the aim of the study is to confirm a molecular link between adipose mtorc2 and systemic insulin resistance in humans.


Eligibility criteria:
inclusion criteria: * obese volunteers (bmi \> 35kg/m2) aged 18 to a maximum of 60 years, males and females; insulin-resistant, scheduled for elective bariatric surgery. * normal weight patients (bmi \< 27kg/m2) aged 18- max. 60 years, males and females; insulin-sensitive, scheduled for elective surgery. exclusion criteria: * known diabetes mellitus * chronic inflammatory disease (inflammatory bowel disease, rheumatoid disease, cancer) * acute inflammatory disease * known renal disease: kidney failure * pregnancy: * history of gastrointestinal surgery with major changes to the gastrointestinal tract (removal of stomach, any gi-bypass) * substance abuse, alcohol abuse * inability to follow procedures due to psychological disorders, dementia * insufficient knowledge of project language (german)
safety and efficacy study of different dose levels of exc 001 to improve the appearance of scars in subjects undergoing elective abdominoplasty

Conditions: Scar Prevention

Summary: this study will compare how well exc 001 works versus placebo in reducing the appearance of scars in subjects undergoing elective abdominoplasty. the study will also evaluate the safety of exc 001 in healthy adult subjects.


Eligibility criteria:
inclusion criteria: * subjects must have sufficient excess abdominal tissue to qualify for a standard elective abdominoplasty * subject has chosen to have an elective abdominoplasty * medically healthy with normal screening results * subjects must not be pregnant or lactating exclusion criteria: * subjects with existing scars or significant striae on the abdominal pannus * females who are currently pregnant or pregnant during the 12 months prior to inclusion in the study, or lactating * participation in another clinical trial within 30 days prior to the start of the study * any other condition or prior therapy, which, in the opinion of the pi, would make the subject unsuitable for this study

Keywords: scarring
auburn university research on olive oil for alzheimer's disease (au-rooad)

Conditions: Alzheimer Disease; Cerebral Amyloid Angiopathy

Summary: until now there is no medical treatment and/or intervention that can slow, stop or reverse the underlying neurodegenerative of alzheimer's disease (ad). the goal of this study is to demonstrate "oleocanthal rich-extra-virgin olive oil (evoo) consumption stops or delay mild cognitive impairment conversion to ad by restoring the blood-brain barrier (bbb) function in humans". specific aims: 1. evaluate effect of evoo on the brain function by functional mri (fmri) imaging, and bbb function by dynamic contrast-enhanced mri (dce-mri). 2. evaluate effect of evoo on cognitive function and on selected biomarkers


Eligibility criteria:
inclusion criteria: men and women, experiencing mild cognitive impairment with: 1. mini-mental state exam (mmse) scores between 18-30 (based on education level 2. memory complaint, have objective memory loss measured by education adjusted scores on wechsler memory scale logical memory vi 3. clinical dementia rating (cdr) score 0.5. exclusion criteria: 1. subjects with contradictions for mri include: the presence of metal or electronic devices such as metallic joint prostheses, artificial heart valves, an implantable heart defibrillator, a pacemaker, metal clips, cochlear implants, a bullet, shrapnel or any other type of metal fragment; breathing problems or disorders, claustrophobia, inner ear disorders, vertigo or dizziness, tattoos or permanent makeup that contains metal, and body piercing jewelry that cannot be removed. 2. subjects will be excluded if they are smokers 3. subjects who have have clinically important medical or neuropsychiatric comorbidity. 4. subjects who have renal problems or are allergic to the mri contrast agent.
the effect of virtual reality on women undergoing endometrial biopsy

Conditions: Endometrial Biopsy

Summary: the aim was to determine the effect of nature sounds and images that will be shown to women who underwent endometrial biopsy by using virtual reality glasses on pain and anxiety. hypotheses h0: virtual reality glasses have no effect on women's pain and anxiety during endometrial biopsy. h1: virtual reality glasses have an effect on women's pain and anxiety during endometrial biopsy. the study will be carried out in two different groups. the practice will start with meeting the women who apply to the radiology clinic for an endometrial biopsy. after the women are evaluated in terms of eligibility criteria for the research, the women who are eligible will be informed about the research and written informed consent will be obtained from the women who accept. the random distribution of women to the study groups will be carried out using the block randomization method. the following applications will be made to the groups. virtual reality group in addition to the routine procedure, virtual reality glasses will be applied to the women in the virtual reality group of the research. virtual reality glasses is a device that works on compatible smart mobile phones. after being taken to the gynecological table for the hsg procedure, the women included in the experimental group will be made to watch a video lasting an average of 15 minutes with virtual reality glasses until the procedure is completed. while watching the video, the relaxing nature sounds music of the video will be played in the practice room with a bluetooth speaker. control group patients in the control group of the study will not be subjected to any treatment other than the routine procedure.


Eligibility criteria:
inclusion criteria: * \*being over 18 years old * speaking and understanding turkish * being willing to participate in the research exclusion criteria: * not volunteering to participate in research \* not speaking or understanding turkish
bli400-302: a safety and efficacy evaluation of bli400 laxative in constipated adults

Conditions: Constipation; Chronic Idiopathic Constipation; CIC

Summary: the objective of this study is to evaluate a daily dose of bli400 laxative for safety and efficacy versus placebo in constipated adults.


Eligibility criteria:
inclusion criteria: 1. male or female subjects at least 18 years of age 2. constipated, defined by the following adapted rome ii definition fewer than 3 spontaneous defecations per week and at least one of the following symptoms for at least 12 weeks (which need not be consecutive) in the preceding 12 months: * straining during \> 25% of defecations * lumpy or hard stools in \> 25% of defecations * sensation of incomplete evacuation for \> 25% of defecations 3. if female, and of child-bearing potential, is using an acceptable form of birth control 4. negative serum pregnancy test at screening, if applicable 5. in the investigator's judgment, subject is mentally competent to provide informed consent to participate in the study exclusion criteria: 1. report loose (mushy) or water stools in the absence of laxative use for more than 25% of bms during the 12 weeks before visit 1 2. meet the rome ii criteria for irritable bowel syndrome. 3. subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon 4. subjects who have had major surgery 30 days before visit 1; appendectomy or cholecystectomy 60 days before visit 1; abdominal, pelvic, or retroperitoneal surgery 6 months before visit 1; bariatric surgery or surgery to remove a segment of the gi tract at any time before visit 1 5. subjects with hypothyroidism that is being treated and for which the dose of thyroid hormone has not been stable for at least 6 weeks at the time of visit 1 6. subjects taking laxatives, enemas or prokinetic agents that refuse to discontinue these treatments from visit 1 until after completion of the study 7. subjects who are pregnant or lactating, or intend to become pregnant during the study 8. subjects of childbearing potential who refuse a pregnancy test 9. subjects who are allergic to any study medication component 10. subjects taking narcotic analgesics or other medications known to cause constipation 11. subjects with clinically significant cardiac abnormalities identified at the visit 1 ecg 12. subjects with clinically significant laboratory abnormalities, deemed as a potential safety issue by the investigator 13. subjects who, in the opinion of the investigator, should not be included in the study for any reason, including inability to follow study procedures 14. subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days 15. subjects with an active history of drug or alcohol abuse 16. subjects have been hospitalized for a psychiatric condition or have made a suicide attempt during the 2 years before visit 1 17. subjects who withdraw consent at any time prior to completion of visit 1 procedures
safety and pharmacokinetic study of mm-302 in patients with advanced breast cancer

Conditions: Breast Cancer

Summary: this study is a phase 1 and pharmacologic open-label dose-escalation trial using a "3+3" design. successive cohorts of three or more patients will be treated at escalating doses until a maximum tolerated dose is identified. once the maximum tolerated dose is identified, an expansion cohort will be enrolled at that dose to further characterize safety and pharmacologic endpoints. additional arms will be enrolled to explore the combination of mm-302 with trastuzumab or trastuzumab plus cyclophosphamide in patients with advanced her2 positive breast cancer.


Eligibility criteria:
inclusion criteria: * locally advanced/unresectable or metastatic breast cancer * eighteen years of age or above * able to understand and sign an informed consent (or have a legal representative who is able to do so) * measurable disease according to recist v1.1 * ecog performance score of 0 or 1 * adequate bone marrow, hepatic, renal and cardiac function * willing to abstain from sexual intercourse or to use an effective form of contraception during the study and for 90 days following the last dose of mm-302 exclusion criteria: * patients for whom potentially curative anticancer therapy is available * active infection or fever \> 38.5°c during screening visits or on the first scheduled day of dosing * symptomatic cns disease * known hypersensitivity to any of the components of mm-302 or who have had hypersensitivity reactions to fully human monoclonal antibodies * received other recent antitumor therapy * pregnant or breast feeding * patients with any other medical or psychological condition, deemed by the investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results

Keywords: mm302 breast cancer locally advanced/unresectable metastatic