Kornimate/medical-research-clean huggingface dataset:
comets - compare the efficacy of rosuvastatin with atorvastatin and placebo in the treatment of non-diabetic, non-atheroscleric, metabolic syndrome subjects

Conditions: Metabolic Syndrome

Summary: the purpose of this study is to compare the efficacy of treatment with rosuvastatin with atorvastatin in reducing low density lipoprotein cholesterol over 6 weeks of treatment in subjects with metabolic syndrome.


Eligibility criteria:
inclusion criteria: * presence of 3 or more coronary heart disease risk factors as defined by the protocol. * fasting low density lipoprotein cholesterol level of \> 130 mg/dl. * documented history of, or high risk of coronary heart disease or other established atherosclerotic disease. * not previously taken statins. exclusion criteria: * the use of lipid lowering drugs or dietary supplements after visit 1 * active arterial disease eg unstable angina, or recent arterial surgery * blood lipid levels above the limits defined in the protocol * uncontrolled hypertension, hypothyroidism, alcohol or drug abuse

Keywords: cholesterol hypercholesterolemia low density lipoproteins metabolic syndrome rosuvastatin
safety and feasibility of dasatinib and quercetin in adults at risk for alzheimer's disease

Conditions: Aging

Summary: the purpose of this pilot study is to demonstrate the safety and feasibility of administering intermittent doses of dasatinib and quercetin (d+q) in older adults at risk of alzheimer's disease (ad). the study will evaluate whether giving d+q may improve cerebral blood flow regulation, mobility, and cognition in older adults, and thus may prevent progression to alzheimer's disease.

the investigators will conduct a 12-week single arm, open label, pre-post pilot study in 12 adults aged 65 or older with slow gait speed (\<1.0 m/sec) and mild cognitive impairment (mci, defined as a telephone montreal cognitive assessment score (moca) \<19). participants will be asked to take 100mg of dasatinib and 1,250mg of quercetin for 2 consecutive days, every two weeks over a period of 12 weeks (12 doses in total, given over 6 cycles). at baseline, enrolled participants will undergo gait speed and neurocognitive testing, and provide blood and urine to evaluate biomarkers of senescence. at visits 3,4, 6, and 7, participants will have safety labs drawn, and the study team will assess medication adherence and adverse events. at visits 2, 5, and 8, participants will undergo cognitive assessments, gait speed testing, cerebral blood flow and neurovascular coupling testing. at the final study visit, participants will again provide blood and urine to assess biomarkers of senescence.

Eligibility criteria:
inclusion criteria: * men and women \>/= 65 years * ambulatory, * community dwelling, * slow gait speed (\<1 m/second), * mild cognitive impairment (telephone moca score \<21, which is indicative of cognitive impairment) exclusion criteria, or as per clinical judgment: * telephone moca score \<10 points * unwilling to take study medications or follow study protocol * inability to independently perform katz activities of daily living (adls), * allergies to dasatinib or quercetin, * hospitalization within 6 months, * unstable coronary artery disease (myocardial infarction within 6 months or angina), * stroke or transient ischemic attack in the past 6 months, * chronic heart failure, * current or chronic history of liver disease, * neurodegenerative disease including parkinson's disease, * anemia, * chronic renal disease, * drug or alcohol abuse in the last 5 years, * qtc prolongation, * thrombocytopenia, * neutropenia, * prolonged prothrombin time or inr, * indications of current fluid retention, * history or current diagnosis of pulmonary hypertension, * inability to insonate the middle cerebral artery through a temporal bone window on at least one side using transcranial doppler ultrasound, or * chronic use of any of the following medications: anti-arrhythmic medications, antipsychotics, anxiolytics, anti-platelet or anti-coagulant medications other than aspirin, quinolone antibiotics, or drugs metabolized by the same liver enzymes as quercetin or dasatinib.

Keywords: alzheimer's disease senescence
self-management interventions after an icd shock

Conditions: Implantable Defibrillator User; Stress Reaction; Ptsd; Stress Management; Social Cognitive Theory

Summary: this study, "biobehavioral intervention to reduce ptsd symptoms after an icd shock," addresses a critical need in cardiology care by describing the feasibility and acceptability of a timely, highly promising, electronically-delivered intervention for patients who have recently received an icd delivered shock. the study intervention and outcomes are designed to reduce anxiety, enhance return to activities of daily living (adls), and prevent the development of severe distress and post-traumatic stress disorder (ptsd), and ultimately promote quality of life. the study is a two-arm, embedded mixed methods, randomized trial (n=60, 30/group). the purpose is to determine feasibility and potential effects of a self-management intervention (spsm) plus usual care (uc) compared to uc alone, delivered during the critical 1 month period after an icd shock when distress is high. the intervention will be delivered over 1 month following an icd shock; a 6-month follow-up will be used to assess the sustainability of intervention effects and determine if the incidence of ptsd is reduced. spsm includes: 1) training in heart rate (hr) self-monitoring; and 2) individualized learning through 4 self-paced, web-based modules. the study interventions are delivered at a crucial time, closely after an icd shock when stress is high, but ptsd has not yet developed. the specific aims are to: 1) examine the effects of the spsm intervention plus uc vs. uc alone on the primary outcome of icd shock anxiety at 1 and 6 months post-shock event, 2) describe the impact of spsm plus uc compared to uc alone on the secondary outcomes of total daily physical activity, depression, ptsd symptoms, qol, salivary cortisol levels, and self-efficacy and outcome expectations at 1 and 6 months post-shock event, and 3) assess feasibility, acceptability, and safety of the spsm intervention, sdoh will be used to describe differential responses to the spsm intervention. this study fills a significant gap in the care of patients with an icd, through the systematic testing of a brief, novel and cost-effective intervention that provides the knowledge and skills to improve quality of life. study findings will be used to design future larger rcts to test intervention effectiveness for more diverse samples and settings.


Eligibility criteria:
inclusion criteria: 1. icd implant for primary or secondary prevention of sudden cardiac arrest (sca), 2. receipt of at least 1 icd shock, appropriate or inappropriate, one week prior to enrollment; 3. able to read, speak and write english; 4. access to online resources and telephone for study duration. exclusion criteria: 1. current diagnosis of ptsd, schizophrenia or bipolar disorder; 2. short blessed score \>6 indicating cognitive dysfunction \[73\]; 3. age \<18 years; 4. audit-c score ≥4 for alcohol use; 5. regular non-medical use of illicit drugs

Keywords: implantable cardioverter defibrillator ptsd stress management
efficacy of a lipolytic cream in an overweight and obesity treatment

Conditions: Lipolysis; Overweight and Obesity; Diet Modification; Physical Activity

Summary: the coadyouvant efficacy of a combination of cosmetics ingredients in the form of a lipolytic cream with hypocaloric diet and physical activity were assessed and compared with with hypocaloric diet and physical activity for overweight and obesity treatment in patients.

the coadyouvant efficacy and safety of a combination of cosmetics ingredients in the form of a lipolytic cream with hypocaloric diet and physical activity were assessed and compared with with hypocaloric diet and physical activity for overweight and obesity treatment in patients of both gender and different age groups. design: in a monocenter, open-label, randomized, parallel-group study of 102 patients that consulted for overweight and obesity treatment were analyzed in perimeters and body composition for 12 consecutive weeks that were medically prescribed a weekly hypocaloric diet and physical activity for one group of 51 patients, and hypocaloric diet, physical activity and the lypolitic cream at least twice per day for the other group of 51 patients. efficacy was evaluated by comparing intial and final of all values in both groups. safety was monitored by the incidence of adverse events. patients also assessed the acceptability of the cream presentation.

Eligibility criteria:
inclusion criteria: * overweight and obesity treatment voluntary assistance exclusion criteria: * hearth disease

Keywords: obesity overweight fat percentage body fat lipolytic cream
use of curcumin for treatment of intestinal adenomas in familial adenomatous polyposis (fap)

Conditions: Familial Adenomatous Polyposis

Summary: familial adenomatous polyposis (fap) is an autosomal dominant disorder characterized by the formation of multiple adenomatous colorectal polyps usually in the teenage years. virtually, all patients with fap will develop colorectal cancer on average by the 5th decade of life if prophylactic surgery is not performed. besides, these individuals must have lifelong cancer surveillance of the remaining colorectum or ileum. use of nonsteroidal anti-inflammatory drug (nsaid), such as sulindac, or celecoxib, which selectively inhibits prostaglandin synthesis primarily via the inhibition of cyclogenase-2 (cox-2) have been shown to reduce the incidence and induce regression of adenomas in the rectum of patients with fap. however, use of nsaids and cox-2 inhibitors is associated with significant comorbidity including renal and gastric toxicity and increased risk of vascular events. therefore, identification of a chemopreventive agent that would have similar efficacy but less toxicity would enhance our ability to treat these patients. therefore the following specific aim has been proposed:to determine in a randomized, double-blinded, placebo-controlled study the tolerability and efficacy of curcumin to regress intestinal adenomas by measuring duodenal and colorectal/ileal polyp number, and polyp size in patients with fap.

patients will be randomized to curcumin (2 curcumin pills twice a day for 12 months) or placebo (2 pills twice a day for 12 months). besides, blood samples, risk factor questionnaire,and biopsies (upper endoscopy and sigmoidoscopy) will be obtained.

Eligibility criteria:
inclusion criteria: * 21-85 years with fap (with an intact colon or who have had surgery) exclusion criteria: * mentally incompetent * female patients of childbearing age not on effective birth control * patients with wbc \ 25mg%, creatinine \> 1.5mg% * patients unable to stop nsaids or aspirin use for the duration of the study * malignancy other than nonmelanoma skin cancer * active bacterial infection * patients with gerd (gastro esophageal reflux disease) * patients with a history of peptic (stomach or duodenal) ulcer disease * patients on warfarin or anti-platelet drugs

Keywords: familial adenomatous polyposis (fap) curcumin colorectal polyps duodenal polyps
treating pediatric nafld with nutrition

Conditions: Non-Alcoholic Fatty Liver Disease; Liver Diseases; Liver Fat; Hepatic Steatosis; Nutritional and Metabolic Disease

Summary: this is a proof of concept clinical trial to compare daily intake of at least 20 grams of whole dairy fat vs habitual diet on hepatic steatosis in children with nafld.

nonalcoholic fatty liver disease (nafld) is the most common chronic liver disease in children, estimated to be present in 5-10% of all children in the united states. nafld is a growing cause of cirrhosis and liver cancer. there is not yet an fda approved treatment for nafld. guidelines recommend improvement in diet at the first line of treatment; however, there is no consensus as to what that diet should be. general health guidelines recommend nonfat or low fat dairy over whole dairy after age 2. limited studies have suggested that whole dairy may be better for people with nafld. this study will test the effect of whole dairy on liver fat in children age 10-17 with nafld. as a baseline, the investigators will measure liver fat (using mri) at 2 time points separated by 12 weeks to establish the current amount of liver fat. the children will be instructed to incorporate 2 ½ servings of whole dairy (as milk and/or yogurt provided by the study will provide) into their daily diet. after 12 weeks, the investigators will measure liver fat with mr and labs to assess safety and further evaluate the liver.

Eligibility criteria:
inclusion criteria: * age 10 through 17 years * nafld * alt of ≥ 40 u/l * mri-pdff ≥ 8% * ability and willingness of legal guardian and participant to provide written, informed consent exclusion criteria: competing health conditions * participants with a history of health issues that make it unsafe for them to participate in the opinion of the investigator * type 1 or type 2 diabetes * ldl-cholesterol \> 160 mg/dl * evidence of other chronic liver disease (alcohol liver disease, alcohol related liver disease, hepatitis c, chronic hepatotoxic drug use, mitochondrial diseases, autoimmune liver disease, wilson's disease) * history of bariatric surgery or planning to undergo bariatric surgery during the study duration * participant with a history of conditions affecting digestion and/or absorption intervention * inability or refusal to consume dairy * cow's milk protein allergy * lactose intolerance

Keywords: child adolescent nutrition liver
low-dose lidocaine infusion for acute pain management pilot study

Conditions: Postoperative Pain Management

Summary: the purpose of this study is to evaluate the safety and efficacy of lidocaine infusion in acute pain management following open abdominal surgery, including opiate use after surgery and the incidence of postoperative nausea and vomiting, ileus, length of stays (icu/hospital), and improvement in patient satisfaction.

the management of acute pain remains challenging for the physicians, with many patients suffering from inadequate pain control following surgery. evidence has shown that 90% of patients in the intensive care unit usually treated with opioids for pain. poorly controlled pain and opioid-related adverse events have several negative consequences for critically ill patients during the postoperative period, including delay in functional recovery and hospital discharge, increased length of stay, development of chronic postsurgical pain, reduced patient satisfaction, and increased total healthcare cost. the reported incidence of postoperative ileus varies with the procedure, ranging from 14.9% for large-bowel resection and 19.2% for small-bowel resection). although many analgesic therapies are available, the high incidence of postoperative pain among patients indicates that there are still significant treatment challenges. recently, there has been much interest in using low-dose lidocaine infusion for acute pain management in the operating room or/and pacu. lidocaine is a drug with multiple effects, including anti-arrhythmic, local, topical, and injectable anesthetics. lidocaine is also used for uncontrolled and chronic pain. however, this is an off-label use. additionally, i.v. lidocaine is a potent anti-inflammatory, anti-hyperalgesic, and gastrointestinal pro-peristaltic drug. there is a lack of data on low dose lidocaine infusion for acute postoperative pain management in surgical critical care patients.

Eligibility criteria:
inclusion criteria: * males or females age \> 18 years admitted to surgical icu. * severe acute pain with pain scale \> 7, following open exploratory laparotomy for bowel, gall bladder, and pancreatic surgeries. * women of childbearing age must have a negative urine/serum pregnancy test. exclusion criteria: * regional anesthesia during surgery * heart failure with ejection fraction \< 20%. * allergy to amide local anesthetics * neuraxial anesthesia during surgery * post-liver transplant patients * hemodynamically unstable patients on two or more vasopressors * child-pugh class c or meld \>20 * any investigational drug use within 30 days before enrollment * pregnant or lactating females * patients with chronic opioid-dependence * intubated and mechanically ventilated patients on intensive care unit analgo-sedation * subjects who do not agree to participate or may be non-compliant with study schedules or procedures.
understanding and addressing rejection of personalized breast cancer risk information: administrative supplement study

Conditions: Breast Cancer Female

Summary: the understanding and addressing rejection of personalized cancer risk information study is a longitudinal study conducted to understand the nature of phenomenon of personalized cancer risk rejection in the context of mammography screening.

the understanding and addressing rejection of personalized cancer risk information study seeks to understand the nature of the phenomenon of personalized cancer risk rejection in the context of mammography screening by testing hypotheses about why women reject their risk estimate and the influence of rejection on screening intentions. the breast cancer risk assessment tool (bcrat) will be used to asses participant's breast cancer risk. this model is designed to estimate breast cancer risk in women 35-84, and uses the following predictors: 1) age, 2) age at first menstrual period, 3) age at first live birth, 4) first-degree relatives with breast cancer, 5) previous breast biopsy with atypical hyperplasia, and 6) race/ethnicity. participants will be required to complete a survey in which they receive their bcrat model risk estimate and respond to that risk estimate.

Eligibility criteria:
inclusion criteria: 1. female sex 2. age 39-74 (i.e., people who are eligible for routine breast cancer screening and for whom guidelines recommend an informed, risk-based decision) 3. english literacy 4. black or african american race exclusion criteria: 1. prior diagnosis of 1. breast cancer 2. ductal carcinoma in situ (dcis) 3. lobular carcinoma in situ (lcis) 4. known brca1/2 gene mutation 5. cowan syndrome 6. li-fraumeni syndrome 7. having received previous chest radiation for treatment of hodgkin's lymphoma.

Keywords: breast cancer risk risk perceptions screening intentions
d-chiro inositol in prevention of gestational diabetes mellitus in china

Conditions: Gestational Diabetes Mellitus in Pregnancy

Summary: inositol is a type of food additives, which plays an important role in insulin signal pathway and is related to insulin sensitivity. our randomized, double-centered, placebo-controlled study is planned to recruit 360 pregnant women who is in high risk for gestational diabetes. they will be assumed randomly 1 g of d-chiro inositol per day or placebo from 12-16th gestational weeks until oral glucose tolerance test (ogtt) at 24-28th gestational weeks. perinatal outcomes about delivery time, neonatal weight will be registered.


Eligibility criteria:
inclusion criteria: * during 12-16 weeks gestation * meet any of the following: prepregnancy bmi \> 24, family history of diabetes (type 1 or 2), gdm history, history of delivering macrosomia, gestational history of stillbirth; * willing to participate exclusion criteria: * type 1 or type 2 diabetes mellitus diagnosed before pregnancy * multiple gestation * mental or cognitive impairment cannot complete the study
study of lamotrigine to treat ménière's disease

Conditions: Meniere's Disease; Ménière's Vertigo; Vertigo, Intermittent; Vertigo, Aural

Summary: this double-blinded study evaluates the frequency of vertigo attacks and the quality of life of patients diagnosed with ménière's disease after being randomly assigned to take a placebo or lamotrigine.


Eligibility criteria:
inclusion criteria: * male and female participants aged 18 years or older * diagnosed with unilateral definite ménière's disease according to the aao-hns 1995 criteria, confirmed by an ent * active vertigo: at least two ménière's vertigo attacks (defined as lasting 20 minutes or longer and associated with tinnitus, ear fullness, or low frequency hearing loss and nausea/vomiting) every four weeks during the eight-week qualification period and at least two more ménière's vertigo attacks during the lead-in phase prior to randomization * documented unilateral lower frequency hearing loss defined as the four-tone average (arithmetic mean rounded to the nearest whole number) of the pure-tone thresholds at 0.25, 0.5, 1 and 2 kilohertz (khz) more than or equal to 25 decibels (db) of the worse audiogram during the six months before screening * have tried diuretics for at least one month and discontinued treatment due to continued vertigo attacks * all other co-existing medical or psychiatric conditions are stable, and no greater than moderate severity * willing to avoid pregnancy during the entirety of the study (abstinence or two forms of acceptable birth control, such as condoms and oral contraceptives) exclusion criteria: * bilateral ménière's disease * current or past history of migraine * any other neuro-otologic disease or major vestibular abnormality found during screening that could confound the evaluation of ménière's symptoms * previous intolerance or sensitivity to lamotrigine * on any prohibited medication within four weeks prior to the study * history of tympanostomy tubes with evidence of perforation or lack of closure * it gentamicin injections or endolymphatic sac surgery within the last year * history of or current immunodeficiency disease, nephrolithiasis, hypertension, cardiac disease, arrhythmia, hypercholesterolemia, hemiplegic/basilar migraine, stroke, diabetes, vascular disease or kidney disease * family history of unexplained deafness * pregnant or breastfeeding * current diseases or conditions that may be associated with an altered perception of processing stimuli * current severe medical condition(s) that in the view of the investigator prohibits participation * previously used the investigational drug * current non-vertiginous dizziness (orthostatic or panic disorder) unless it could be clearly differentiated from ménière's attacks by the participant

Keywords: lamotrigine lamictal anticonvulsant ménière's disease vertigo attack dizziness vestibular disorder
the effect of transcutaneous electrical nerve stimulation on people with muscle fatigue due to training, sports

Conditions: Muscle Fatigue

Summary: the objective is to assess if tens will improve the muscle recovery rate from post-exercise fatigue.


Eligibility criteria:
inclusion criteria: * no phobia of electrical stimulation * no pain or anti-inflammatory medication will be taken during study * english speaking exclusion criteria: * pregnancy * diabetes mellitus * neuropathy * smoker * uncontrolled hypertension * past surgery in the region to be treated by tens or had received an intra-articular corticosteroid or hyaluronic acid injection within 6 months prior to enrollment * rhumatoid arthritis (ra) in the area to be treated by tens * allergic to tape/electrodes * dementia * history of knee joint replacement or tibial osteotomy * undergoing physical therapy * any major joint pain (e.g., back, hip, or ankle) that could limit functional ability * contraindications to tens such as having a pacemakers, dermatological conditions, and abnormal sensation of the lower extremity.

Keywords: tens, doms, soreness, fatigue