Kornimate/medical-research-clean huggingface dataset:
feasibility study of the intravascular ventricular assist system (ivas)

Conditions: Heart Failure NYHA Class III; Heart Failure NYHA Class IV

Summary: the purpose of this feasibility study is to assess the preliminary safety and clinical performance of the intravascular ventricular assist system (ivas).

this is a single-arm, non-randomized study designed to assess the preliminary safety and clinical performance of the nupulsecv ivas. data obtained from the study will be used to make device modifications, refine the patient population, and inform the design a future clinical trial suitable for assessing longer-term use in heart failure patients.

Eligibility criteria:
main inclusion criteria: 1. at least 18 years of age. 2. if female, are postmenopausal or surgically sterilized, or have a negative pregnancy test within seven (7) days of invasive testing. 3. advanced heart failure (nyha class iii or iv) main exclusion criteria: 1. hypotension treated with the following medications: epinephrine, norepinephrine, vasopressin, methylene blue, phenylephrine, or angiotensin ii. 2. receiving more than two inotropes. 3. subclavian stenosis or stent. 4. currently receiving circulatory support including ecmo, impella, tandemlife or equivalents; or any durable vad. 5. atrial fibrillation without ventricular pacing. 6. concomitant, non-cardiac disease process with life expectancy \< 1 year. 7. significant abnormalities of the aorta, such as aneurysms, coarctation of the aorta, or an extremely tortuous aorta. 8. severe end-organ dysfunction or failure. 9. any other condition the heart team believes inappropriate for this study.

Keywords: heart failure bridge-to-transplant circulatory support vad iabp
fecal microbiota transplantation in decompensated cirrhosis

Conditions: Liver Cirrhosis

Summary: cirrhosis of the liver is the culmination point of long-standing chronic liver disease hallmarked by the cardinal features of liver fibrosis and portal hypertension. the prognosis of patients with cirrhosis is punctuated by the onset of complications which denote the stage of decompensation characterized by ascites, hepatic encephalopathy (he), and variceal bleeding. patients with cirrhosis have been demonstrated to have significant changes in their gut microbiota characterized by alteration in the intestinal microbiome (gut dysbiosis) as well as small intestinal bacterial overgrowth (sibo). gut dysbiosis has been closely linked to the complications associated with decompensated cirrhosis. several studies have documented the alteration of gut microbiota in patients with hepatic encephalopathy. therapeutic modalities that restore normal gut flora and stabilize the gut liver axis are being extensively studied in the management of cirrhosis and its complications. antibiotics, probiotics, and long-chain fatty acid supplementation are being evaluated as methods to restore the gut dysbiosis and consequently limit progressive liver damage. fecal microbiota transplantation (fmt) involves the infusion of intestinal microorganisms by the transfer of stool from a healthy individual into a diseased individual for restoration of normal intestinal flora.the ultimate goal of fmt is to replace aberrant native microbiota with a stable community of donor microorganisms. the treatment is based on the premise that an imbalance in the community of microorganisms residing in the gastrointestinal tract (i.e., dysbiosis) is associated with specific disease states. fmt has been well-established as a treatment modality to stably modify the gut microbiome and has been shown to be safe and efficacious in several disease states resulting from gut dysbiosis. with this background, a trial is proposed to determine whether an fmt from a healthy donor to a patient with advanced cirrhosis improves overall survival and prognosis.


Eligibility criteria:
inclusion criteria: age 18-65 years decompensated cirrhosis (of any etiology) based on clinical, radiological, or histological criteria model for end-stage liver disease (meld scores) between 12-21 were included. exclusion criteria: ongoing bacterial infection requiring antibiotics antibiotics/pre-pro biotics within the last 14 days, t significant alcohol intake in the previous two months, recent (\<14 days) history of spontaneous bacterial peritonitis, he or variceal bleed, history of substance abuse or psychiatric illness, hiv infection, pregnant patients, hepatocellular carcinoma or other known malignancy, t prior liver transplantation or bariatric surgery, immunosuppression, inflammatory bowel disease celiac disease, history of allergy to food substances

Keywords: end-stage liver disease stool therapy microbiota related stool donor prognostic scores complications ammonia cytokines outcomes
etoricoxib with flavoxate for reducing morphine requirement after transurethral prostatectomy (turp)

Conditions: Pain

Summary: the purpose of this study is to determine whether etoricoxib, flavoxate, both are effective in the treatment postoperative pain after turp. the research hypothesis: there is a difference in postoperative morphine consumption in the first 24 hours after transurethral prostatectomy between patients who received etoricoxib or flavoxate or both and placebo.

postoperative pain is still a significant problem for surgical patients. conventional use of narcotics for postoperative pain relief is not without serious side effects such as respiratory depression and sedation.there are other alternatives for postoperative analgesia as nsaids especially cox2-inhibitors. for some specific operation such as turp which foley's catheter needed to be retained for a few days,urinary anti spasmodics may help the patients to be more comfortable. comparison(s): there is a difference in postoperative morphine consumption in the first 24 hours after transurethral prostatectomy between patients who received etoricoxib or flavoxate or both and placebo.

Eligibility criteria:
inclusion criteria: 1. male patient asa physical status i-iii. 2. scheduled for an elective turp. 3. body weight \> or = 50 kg 4. can operate a patient-controlled analgesia (pca) device. exclusion criteria: 1. history of asthma, acute rhinitis, nasal polyps, angioneurotic edema or urticaria following the administration of aspirin or other nsaids. 2. known hypersensitivity to morphine. 3. history of hepatic dysfunction. 4. creatinine clearance \< 30ml/min. 5. history of bleeding tendency. 6. history of gastrointestinal bleeding or active peptic ulcer. 7. known case of inflammatory bowel disease. 8. patient with severe heart failure. 9. history of coronary artery disease or cerebrovascular disease.

Keywords: postoperative pain, etoticoxib, etoricoxib pain relief after transurethral resection of prostate.
chronic kidney disease and cardiovascular disease risk assessment

Conditions: Chronic Kidney Diseases; Diabetes Mellitus; Hypertension

Summary: this study will investigate chronic kidney disease (ckd) and cardiovascular disease (cvd) risk factors in a sample population of hispanics/latinos and caucasians in yakima county that are rural dwelling. this investigation is intended to provide information on the impact rural geographical location and social determinants of health (sdoh) have on ckd and cvd risk factors.

yakima county has a large hispanic farmworker population. the peak work times are between may and september. there is a growing body of research that shows the risk of agricultural workers in work environments with extreme heat. the purpose of this pilot study is to look at incidence of non-diagnosed chronic kidney disease within yakima county to inform future studies to examine other factors and unique bio-markers that may help in the early diagnosis of heat related injuries in agricultural workers.

Eligibility criteria:
inclusion criteria: * between the ages of 18 and 75 exclusion criteria: * active malignancy * currently pregnant * end stage renal disease requiring dialysis * current active treatment for diabetes mellitus * current care by a nephrologist for chronic kidney disease
clinical trial to evaluate ant-1207 in participants with primary axillary hyperhidrosis

Conditions: Hyperhidrosis

Summary: the purpose of this study is to establish the therapeutic range of ant-1207 in the treatment of primary axillary hyperhidrosis.


Eligibility criteria:
inclusion criteria: * ages 18 - 70 years of age * diagnosis of primary axillary hyperhidrosis * hdss score of ≥3 * threshold sweat production/axilla in 5 minutes as measured gravimetrically * willingness to shave underarms prior to each study visit exclusion criteria: * botulinum toxin treatment in the prior 6 months * signs of infection in the axilla * skin affliction in the axilla requiring medical treatment * oral anticholinergic treatment * use of antiperspirants, deodorants, powders, or lotions * use of axillary depilatories or axillary epilation * history of surgery or other interventions for axillary hyperhidrosis * female subjects who are pregnant or are nursing a child
a clinical study on exercise guided by cpet to reduce the risk of metabolic cardiovascular diseases（c-met trial）

Conditions: Metabolic Syndrome

Summary: the main purpose of this study is to validate the effect of an individualized exercise prescription developed based on cardiopulmonary exercise testing (cpet) in subjects with metabolic syndrome. this study aims to assess the improvement in cardiovascular metabolic risk associated with the personalized exercise regimen,known as individualized hiit.


Eligibility criteria:
inclusion criteria: 1. age between 30 and 65, for both males and females; 2. inadequate exercise: sedentary lifestyle: sitting for more than 6 hours daily over the past 6 months; insufficient physical activity evaluated by the international physical activity questionnaire (ipaq), with an average weekly duration of moderate-intensity physical activity less than 150 minutes or high-intensity physical activity less than 75 minutes; 3. meeting the criteria for metabolic syndrome according to the 2009 aha/idf definition: must have three or more of the following: abdominal obesity(waist circumference ≥90 cm for males, ≥80 cm for females); elevated fasting blood glucose: ≥5.6 mmol/l; elevated blood pressure: systolic blood pressure ≥130 mm hg, or diastolic blood pressure ≥85 mm hg; elevated fasting triglycerides (tg): ≥1.7 mmol/l (150 mg/dl); reduced fasting high-density lipoprotein cholesterol (hdl-c): \<1.0 mmol/l for males, \<1.3 mmol/l for females. additionally, must meet the following conditions: tg \<500 mg/dl (5.6 mmol/l); fasting blood glucose \<7 mmol/l; baseline blood pressure \<140/90 mm hg; 4. willingness to improve health status through reasonable exercise. exclusion criteria: 1. contraindications to cpet (cardiopulmonary exercise testing); 2. positive results in cpet exercise electrocardiogram; 3. the patient has elevated ldl-c levels and has been indicated for statin therapy. 4. currently undergoing treatment with antihypertensive, antidiabetic, lipid-lowering, or antiarrhythmic medications; 5. the doctor evaluates dietary supplements or over-the-counter medications that may affect the results (such as fish oil products, red yeast rice extract, over-the-counter weight loss drugs, meal replacements, probiotics, berberine, etc.) 6. mental disorders; 7. conditions related to exercise impairment, or occurrence of lower limb exercise-related injuries in the past 6 months; 8. women who are pregnant, breastfeeding, or planning to become pregnant in the near future; 9. other situations deemed unsuitable for participation in this study by the researchers; 10. refusal to sign the informed consent form.

Keywords: metabolic syndrome insufficient exercise
comparing brief behavioral therapy (bbt-ci) and healthy eating education learning (heal) for cancer-related sleep problems while receiving chemotherapy

Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Summary: this phase iii trial compares bbt-ci to heal for the reduction of insomnia in patients with stage i-iv cancer who are receiving cancer treatment. cancer treatment can cause side effects such as sleep problems. sleep problems such as insomnia, are common for cancer patients. insomnia can be described as difficulty falling asleep, waking up many times during the night or waking up earlier than patient would like. insomnia can increase fatigue and worsen quality of life. this trial may help researchers determine which treatment works better in reducing insomnia, bbt-ci or heal.

primary objective: i. determine the efficacy of bbt-ci compared to heal for treating insomnia as measured by the insomnia severity index (isi) at post-intervention. secondary objective: i. determine the efficacy of bbt-ci compared to heal for improving sleep efficiency as measured via actigraphy at post-intervention. mechanistic objectives: i. examine the efficacy of bbt-ci compared to heal for regulating circadian rhythms as measured via actigraphy (i.e., mesor, acrophase, amplitude, i\<o dichotomy index). exploratory objectives: i. examine potential moderators of bbt-ci effects on insomnia (isi). ii. examine potential mediators of bbt-ci effects on insomnia (isi). iii. determine the efficacy of bbt-ci compared to heal for treating insomnia as measured by the insomnia severity index at the 6-month follow-up. iv. determine the efficacy of bbt-ci compared to heal for improving sleep efficiency as measured via actigraphy at the 6-month follow-up. outline: patients are randomized to 1 of 2 groups. group i (bbt-ci): patients complete face to face/video sessions with a trained staff member. patients also complete phone sessions. group ii (heal): patients complete face to face/video sessions with a trained staff member. patients also complete phone sessions. after completion of study, patients are followed for up to 6 months.

Eligibility criteria:
inclusion criteria: * be at least 18 years of age * be diagnosed with cancer (stage i, ii, iii, or iv) with a life expectancy of at least 12 months * be currently receiving any cancer treatment (surgery alone is excluded) * report sleep disturbance of 3 or greater on the sleep disturbance question: "rate your sleep disturbance in the past 2 weeks on a scale from 0-10, 0 is no problems and 10 is having the most severe problems" * have a score of 2, 1, or 0 on the eastern cooperative oncology group (ecog) performance status scale * be able to speak, understand and read english to participate in the study assessments and interventions exclusion criteria: * have a clinical diagnosis of obstructive sleep apnea or restless leg syndrome (even if controlled) * be engaged in a formal cognitive behavioral therapy for insomnia program presently or in the past 30 days. use of psychotropics and sleep medication are allowed
study comparing the safety and efficacy of idp-120 gel and idp-120 vehicle gel in the treatment of acne vulgaris

Conditions: Acne Vulgaris

Summary: study designed to assess the safety, tolerability, and efficacy of idp-120 gel and idp-120 vehicle gel

this is a multi-center, randomized, double-blind, vehicle-controlled, 12-week study designed to assess the safety, tolerability, and efficacy of idp-120 gel and idp-120 vehicle gel at weeks 2, 4, 8, and 12. to be eligible for the study subjects must be at least 9 years of age and have a clinical diagnosis of moderate to severe acne

Eligibility criteria:
inclusion criteria: 1. male or female at least 9 years of age and older; 2. written and verbal informed consent must be obtained. subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit); 3. subject must have a score of 3 (moderate) or 4 (severe) on the evaluator's global severity score (egss) assessment at the baseline visit; 4. subjects with facial acne inflammatory lesion (papules, pustules, and nodules) count no less than 20 but no more than 50; 5. subjects with facial acne non-inflammatory lesion (open and closed comedones) count no less than 25 but no more than 100; 6. subjects with two or fewer facial nodules exclusion criteria: 1. use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study; 2. any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gram-negative folliculitis, dermatitis, eczema; 3. any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive; 4. subjects with a facial beard or mustache that could interfere with the study assessments; 5. subjects with more than two (2) facial nodules; 6. evidence or history of cosmetic-related acne
non-interventional observational study with viramune® in hiv to evaluate gender specific data

Conditions: HIV Infections

Summary: the question that prompted this study is the extent to which results from clinical trials can be translated into everyday practice (external validity). first and foremost are questions about tolerability and the efficacy of an antiretroviral combination treatment with viramune and other antiretroviral partners. in particular, adverse events will be recorded depending on gender and the therapeutic effect will be monitored via the course of viral load and improvement of the immune system, based on the cd4 cell count.

time perspective: retro- and prospective

Eligibility criteria:
inclusion criteria: the inclusion criteria for treatment with viramune plus other antiretroviral combination drugs are to be based on the current information for healthcare professionals/spc exclusion criteria: the inclusion criteria for treatment with viramune plus other antiretroviral combination drugs are to be based on the current information for healthcare professionals/spc
drug interaction study between dorzagliatin and sitagliptin

Conditions: Patients

Summary: this is a phase 1, open-label, sequential, multiple-dose, drug interaction study of glucokinase activator dorzagliatin and sitagliptin in subjects with t2dm. pharmacokinetics and pharmacodynamics when dorzagliatin and sitagliptin given alone and in combination will be studied.


Eligibility criteria:
inclusion criteria: 1. subjects diagnosed with t2dm within at least 3 months prior to screening 2. male and/or female subjects between the ages of 30 and 65 years, inclusive; 3. body mass index (bmi) of 19 to 38 kg/m2, inclusive; 4. fasting c-peptide test result \>0.3 nmol/l (\>0.90 ng/ml); 5. hba1c ≥7% and ≤10.5%; exclusion criteria: 1. fasting blood glucose at screening or day -1 ≤110 or ≥270 mg/dl; 2. type 1 diabetes mellitus; 3. reported incidence of severe or serious hypoglycemia within 3 months prior to screening; 4. known contraindications to sitagliptin; 5. clinically significant gastrointestinal disorder; 6. history or symptoms of clinically significant cardiovascular disease within one year prior to screening; 7. history of more than three urinary tract infections and/or more than three genital fungal infections in the last 12 months; 8. reported history of clinically significant central nervous system disease; 9. reported history of liver disease; 10. reported history of clinically significant renal disease; 11. estimated glomerular filtration rate (egfr) ≤60 ml/min/1.73m2; 12. acute or chronic metabolic acidosis, including diabetic ketoacidosis; 13. known or suspected malignancy; 14. any reported hypersensitivity or intolerance to sitagliptin; 15. antidiabetic treatment with insulin, sulfonylureas, thiazolidinediones or glp-1 agonist within 3 months prior to screening; 16. systolic blood pressure \ 160 mmhg or diastolic blood pressure \ 100 mmhg at screening; 17. a hospital admission or major surgery within 90 days prior to screening; 18. uncontrolled hypertriglyceridemia \>500 mg/dl; 19. positive blood screen for hiv, hhbsag, or hepatitis c antibody; 20. positive pregnancy test result; 21. female is breast-feeding or planning to become pregnant; 22. treated with any investigational drugs within 6 weeks prior to screening; 23. reported history of prescription drug abuse; 24. reported history of alcohol abuse; 25. reported history of donation or or acute loss of blood during the 90 days prior to screening;
marginal periosteal pedicle flap - platelet rich fibrin barriers in treating periodontal intrabony defects

Conditions: Periodontal Pocket

Summary: the use of autogenous graft materials has been recorded to be a gold standard in regenerative therapy. this study directed toward evaluation of two autogenous regenerative materials, marginal periosteal pedicle graft (mpp) and platelet rich fibrin (prf) as membrane barriers for treating intrabony defects. in spite of its reported significant clinical outcomes, the limited availability of the periosteum makes it necessary to evaluate other autogenous alternatives such as prf that could offer predictable outcomes.

material and methods: 10 patients with sever chronic periodontitis and at least single ≥4 mm intrabony defect had participated in this randomized clinical study. subjects were randomly divided into2 groups, group 1(mpp) defect coverage with xenograft defect fill(10 patients),group 2(prf) defect coverage with xenograft defect fill(10 patients).clinical and radiographic measurements were carried out at 3,6 and 9 months postoperatively.

Eligibility criteria:
inclusion criteria: * no systemic diseases that could influence the outcome of therapy * good compliance for plaque control instructions after initial therapy * vital teeth * had contralateral matched pair of 2- or 3-walled intrabony interproximal defects in premolar or molar teeth * probing pocket depth (ppd)≥6 mm and clinical attachment level (cal) ≥4mm 6) selected 2- or 3-wall intrabony defect depth ≥ 3 mm as detected in diagnostic periapical radiographs, exclusion criteria: * pregnant females and patients presented with opened interproximal contact