Kornimate/medical-research-clean huggingface dataset:
the use of paravertebral block for cardiac surgery

Conditions: Mitral Valve Insufficiency

Summary: pain after robotic cardiac surgery is a known problem and is often difficult to manage. paravertebral nerve blocks are a proven method of pain relief following thoracotomy. a paravertebral block has been shown to provide good pain relief with minimal side effects, however, paravertebral blocks for robotic surgery have not been well studied. currently the investigators routinely perform pvb on this patient population (of 50 mv robotic cases done between january and october 2012, 36 received paravertebral blocks with no adverse events noted). the investigators believe this should be studied further and that paravertebral blocks will reduce the amount of additional pain medication patients require in the first 24 hours after surgery, decrease intubation time and improve pacu and hospital discharge times.

pain after robotic cardiac surgery is a known problem and is often difficult to manage. paravertebral nerve blocks are a proven method of pain relief following thoracotomy. a paravertebral block has been shown to provide good pain relief with minimal side effects, however, paravertebral blocks for robotic surgery have not been well studied. currently we routinely perform pvb on this patient population (of 50 mv robotic cases done between january and october 2012, 36 received paravertebral blocks with no adverse events noted). we believe this should be studied further and that paravertebral blocks will reduce the amount of additional pain medication patients require in the first 24 hours after surgery, decrease intubation time and improve pacu and hospital discharge times.

Eligibility criteria:
inclusion criteria: * patients over the age of 18 years of age undergoing robotic mitral valve surgery. * have capacity to understand and sign consent form exclusion criteria: * patients that are not candidates for paravertebral block as per asra guidelines (horlocker, reg anesth pain med, 2010). in short, this includes patients taking specific anti platelet agents such as clopidigrel, anticoagulants such as heparin or low molecular weight heparin, or patients with an inr of greater than 1.5. -patients with a history of copd or other respiratory diseases that would confound data on time to extubated will be excluded. * patients that with a diagnosis of chronic pain, or patients currently taking narcotics are excluded, as this would confound data on postoperative narcotic requirements.
a placebo-controlled study of ins117548 ophthalmic solution in subjects with glaucoma (p08650)

Conditions: Glaucoma

Summary: the purpose of this study is to evaluate the safety and tolerability of ins117548 ophthalmic solution.


Eligibility criteria:
inclusion criteria: * have a diagnosis of bilateral ocular hypertension or early primary open angle glaucoma * have best corrected visual acuity in both eyes of at least +0.5 or better exclusion criteria: * are diagnosed with closed angle glaucoma, exfoliation syndrome or exfoliation glaucoma, and pigment dispersion or secondary glaucoma * have a history of any type of intraocular surgery, except for cataract surgery * have had cataract surgery within three months
iv acetaminophen and post-tonsillectomy pain

Conditions: Tonsillectomy; Adenoidectomy

Summary: this study is a randomized prospective study to compare the post-operative analgesic efficacy of intravenous acetaminophen 15 mg/kg to an equal volume of 0.9% normal saline when all other analgesic interventions have been standardized for all patients enrolled.


Eligibility criteria:
inclusion criteria: 1. the subject is age 3 to 10 years (inclusive) 2. the subject weighs more than 10.0 kg (inclusive of the tenth kilogram) 3. the subject is scheduled for the following: elective tonsillectomy or tonsillectomy with adenoidectomy scheduled on an outpatient basis, with acceptable inclusion of patients also having pets and/or eua of ear 4. the subject is asa patient classification i-ii 5. the subject's legally authorized representative has given written informed consent to participate in the study and when appropriate, the subject has given assent or consent to participate. exclusion criteria: 1. additional surgical procedures are being performed concurrently; 2. the subject is asa classification \> ii; 3. the subject has pre-existing allergy or known hypersensitivity to acetaminophen; 4. the subject receives midazolam as a premedication; 5. the subject has a history of chronic malnutrition; 6. the subject has any other condition, which in the opinion of the principal investigator, would not be suitable for participation in the study

Keywords: tonsillectomy intravenous acetaminophen pediatric
ceftaroline diffusion into cerebrospinal fluid of children

Conditions: Cerebrospinal Fluid Shunts; Ventriculoperitoneal Shunt

Summary: ceftaroline fosamil is an intravenous (iv) drug that belongs to a group of antibiotics called cephalosporins . antibiotics are drugs used to treat infections. clinical studies in adults patient shave shown ceftaroline fosamil to be effective against many bacteria that are resistant to other currently approved antibiotics. some of these bacteria may be responsible for infections in the central nervous system.the main aim of this study is to gather information to determine how much of a single iv dose of ceftaroline fosamil will enter into a child's csf so that the benefit of giving ceftaroline fosamil to children with infections can be better determined.

children 6 months to 17 years of age admitted to the hospital because of infected vps (ventriculitis) will be eligible for the study. a total of twelve eligible patients will be included in the study. eligible study subjects would be patients who have undergone vps removal and placement of evd tubing and are being treated with standard iv antibiotics for ventriculitis. csf cultures are obtained before antibiotics treatment is initiated. standard initial antibiotics regimen is usually iv ceftriaxone and vancomycin. the antibiotics regimen is subsequently adjusted based on the pathogen recovered from the csf culture. total iv antibiotic treatment is usually 14 days. following clearance of the infection the patient undergoes new vps insertion by neurosurgery service.

Eligibility criteria:
inclusion criteria: * age 6 months - 17 years * ventriculitis due to vps infection (abnormal csf parameters consistent with meningeal inflammation and/or positive csf culture) * vps is externalized and external ventriculostomy drain (evd) is in place * patient has iv access and is receiving antibiotic treatment for vps infection * parent/guardian signed written informed consent * negative urine or serum pregnancy test for females of child-bearing potential exclusion criteria: * known allergy to beta-lactam antibiotics * moderate to severe renal impairment (creatinine clearance \< 50ml/minute) * parent/guardian written consent cannot be obtained * positive urine or serum pregnancy test
3d pet myocardial blood flow and rb82 infusion profiles

Conditions: Normal Healthy Volunteers Without Chronic Medical Conditions; Coronary Artery Disease; Cardiac Risk Factors; Myocardial Infarction

Summary: the investigators seek to test bolus infusions (50ml/min) vs. slow infusions (20 ml/min) of rb-82 on metrics of coronary blood flow assessed on a modern 3d pet/ct.

as perfusion metrics in the healthy volunteers, patients with risk factors and/or coronary artery disease and in tissue with transmural myocardial infarctions has been well defined and same day test-retest variability minutes apart using a bolus infusion is ±10%, the investigators shall test 3 hypotheses. the first hypothesis is repeated same day test-retest coefficient of variation (cov) of whole heart rmbf and smbf acquired using a bolus infusion profile (50 mls/min) on a modern 3d pet scanner falls within ± 10%. the second hypothesis is repeated same day test-retest cov of whole heart rmbf and smbf acquired using a slow infusion activity profile (20 mls/min) on a modern 3d pet scanner falls within ± 10%. the third hypothesis is cov of whole heart rmbf and smbf between bolus and slow activity profiles is ± 10% where the bolus is considered the standard on a modern 3d pet scanner. the investigators will test the different activity profiles on 3 distinct populations: 1. healthy volunteers 2. clinical volunteers with risk factors and/or cad 3. volunteers with clinical infarcts.

Eligibility criteria:
inclusion criteria: normal volunteers * adults ≥18 and \<40 years old able to give informed consent. * ability to abstain from caffeine for 48 hours the "clinical" population * adults ≥18 years old able to give informed consent. * any cardiac risk factor including hypertension, hyperlipidemia, diabetes mellitus or tobacco use or * cad defined by with history of pci or cabg, coronary ca score\>400, or dense coronary calcifications noted on chest ct * ability to abstain from caffeine for 48 hours the "infarct" population * adults ≥18 years old able to give informed consent. * prior cardiac pet scan demonstrating a fixed defect ≥ 15% of the lv myocardium with relative uptake ≤60% maximum uptake. * in addition, to the perfusion defect, each volunteer requires either: * fdg pet or mri viability studies confirming infarct or * akinesis and wall thinning on echo within the same territory as the pet defect in addition to q-waves on ecg * ability to abstain from caffeine for 48 hours exclusion criteria: normal volunteers * any chronic cardiac disease or condition (e.g., hypertension, hyperlipidemia) * any chronic systemic disease or condition (e.g., diabetes, systemic lupus, rheumatoid arthritis) * tobacco use * family history in a first degree relative with clinical cad (h/o pci, mi or cabg) in men \<55 or women \<65 * severe claustrophobia * positive urine pregnancy test * inability to give informed consent * bmi ≥ 30 or bmi\>25 and \ 0.80 in women or 0.90 in men. the "clinical" and "infarct" populations * severe claustrophobia * hemodynamic instability or unstable symptoms * positive urine pregnancy test * inability to give informed consent
comparing pressure based and dilution based total lung capacity measurements in copd patients for lung function diagnostics

Conditions: COPD

Summary: total lung capacity (tlc) of the lungs can be determined using a pressure based method (i.e. by body plethysmography) or it can be determined using a dilution based method (i.e. by single breath dilution during a co diffusing capacity test). the results of the two methods differ, especially in patients with higher grades of copd. the study investigates an improved analysis for the determination of tlc using the dilution method; this method has been suggested in the new ats/ers dlco (diffusion capacity of lung for carbon monoxide) standard published in 2017. this study is based on approx. 120 participants. so far, there has not been a study using commercially available equipment. spirometry, lung volume measurement by body plethysmography and dlco measurements will be performed on reference device (masterscreen body/diff, vyaire, usa), spirometry and dlco will also be performed on the device under test (easyone pro lab, ndd medizintechnik ag, switzerland) in a crossover design. both devices are ce marked and fda approved. the tests performed on both devices are standardized tests performed routinely with patients.


Eligibility criteria:
inclusion criteria: 3 groups * healthy subjects, fev1/fev1(pred) \> 80% * copd gold classification 1 or 2, fev1/fev1(pred) ≥ 50% * copd gold classification 3 or 4, fev1/fev1(pred) \< 50% exclusion criteria: * smoked during 2 hours prior to measurements additional exclusion criteria for healthy subjects: * bmi \> 30 * any relevant concomitant diseases (investigators decision) * any relevant concomitant medication (investigators decision) * fev1/fev1(pred) \<= 80%

Keywords: copd dlco spirometry alveolar volume body plethysmography
does meal replacement with a carbohydrates and protein supplement induce weight loss in overweight and/or obese adults?

Conditions: Weight Loss

Summary: participants will be randomized into two groups, one group will be the control (no intervention at all) and the other will be cho-pro (meal replacement, generation ucan supplement, 400ml, 20% solution). prior to the start of the experiment, all participants will be asked to record their satiety ratings, appetite and desire to eat (10-point visual analogue scale) 30, 60 and 120 minutes after their regular dinner for 3 days. on the first day of the experiment, all participants will be asked to measure their waist and hip circumferences, fasting blood glucose level, maximal number of pushups and body weight using a scale at home prior to breakfast. instructions on how to do the measurements properly will be recorded in a video and distributed to the participants. participants in the control group will not receive any intervention. participants in the cho-pro group will be provided with the supplement and they will be asked to consume the cho - protein supplement (generation ucan supplement, 250ml, 10% solution) 6 to 7 hours after lunch, in place of their dinner for 6 weeks. they will also be asked to record their satiety ratings, appetite and desire to eat (10-point visual analogue scale) 30, 60 and 120 minutes after each meal replacement drink. all participants will be required to complete a dietary record, prior to, and during (at weeks 2 and 4) intervention. to track adherence of the cho-pro group, participants will be asked to check off the calendar that they did not consume the meal replacement due to various reasons. on day 43, all participants will be asked measure again waist and hip circumferences, fasting blood glucose level, maximal number of pushups and body weight using a scale at home prior to breakfast again.


Eligibility criteria:
inclusion criteria: * sedentary (\<2 moderate exercise bouts/wk) * between the ages of 18 to 40y * body mass index (bmi) between \>25 exclusion criteria: * do not eat three meals a day typically * taking medication that affects their eating patterns * have metabolic and gastrointestinal diseases
bioequivalence study of pravastatin sodium tablets 80 mg under fed conditions

Conditions: Healthy

Summary: this is a single dose two-way crossover fed bioequivalence study of pravastatin 80 mg tablets of dr.reddy's laboratories limited with pravachol 80mg, bristol myers squibb in healthy volunteers.

single dose two-way crossover fed bioequivalence study of pravastatin 80 mg tablets of dr.reddy's laboratories limited with pravachol 80 mg, bristol myers squibb in healthy volunteers. a total of 24 non-smoking subjects (18 men and 6 women) were included in this study, of which 23 finished the study according to the protocol. the washout period (7 days) between the two periods of the study and with an equal number of subjects randomly assigned

Eligibility criteria:
inclusion criteria: * healthy males and females at least 18 years of age inclusive. * informed of the nature of the study and given written informed consent. * have a body weight within 15% of the appropriate range as defined in the 1983 metropolitan life company tables and weighing at least 100 lbs. (appendix i and ii). exclusion criteria: * hypersensitivity to pravastatin (pravachol®), or similar compounds. * any history of a clinical condition which might affect drug absorption, metabolism or excretion. * recent history (within 1 year) of mental illness, drug addiction, drug abuse or alcoholism. * donation of greater than 500 m1 of blood in the past 4 weeks prior to study dosing or difficulty in donating blood. * received an investigational drug within the 4 weeks prior to study dosing. * currently taking any prescription medication, except oral contraceptives, within the 7 days prior to study dosing or over-the-counter medication within 3 days of study dosing. this prohibition does not include vitamins, or herbal preparations taken as nutritional supplements for non-therapeutic indications as judged by the attending physician. * tobacco use (\>5 cigarettes per day) in the 3 months prior to study dosing. * if female, the subject is lactating or has a positive pregnancy test at screening and prior to each of the two treatment periods. females of child bearing potential must use a medically acceptable method of contraception throughout the entire study period and for one week after the study is completed. medically acceptable methods of contraception that may be used by the subject and/or her partner are: oral contraceptives, progestin injection or implants, condom with spermicide, diaphragm with spermicide, iud, vaginal spermicidal suppository, surgical sterilization of their partner(s) or abstinence. females taking oral contraceptives must have taken them consistently for at least three months prior to receiving study medication.
improved hrv, inflammation markers and endothelial function after tavi

Conditions: Severe Aortic Stenosis; TAVI

Summary: severe aortic valve stenosis is known to affect heart haemodynamics, endothelial function and body inflammation markers. our aim is to investigate the weather transcatheter aortic valve implantation in patients with severe aortic stenosis affects heart rate variability, inflammation markers and endothelial function.


Eligibility criteria:
inclusion criteria: * tavi exclusion criteria: * stage v chronic kidney disease * active malignancies
study of niacin and rosiglitazone in dysmetabolic dyslipidemia

Conditions: Metabolic Syndrome X; Insulin Resistance

Summary: lipid abnormalities in people with the metabolic syndrome (the insulin resistance syndrome) are characterized by elevations in triglycerides and ldl cholesterol; low levels of hdl cholesterol; and small, dense ldl particles. statins generally do not change ldl particle size, so often fenofibrate is added. this combination may still not be sufficient. niacin is a common third drug added to the treatment regimen, but niacin can increase insulin resistance. this study compares niacin as a third drug to rosiglitazone, an insulin sensitizer.

the metabolic syndrome is characterized by an atherogenic dyslipidemia consisting of hypertriglyceridemia, modest elevations of ldl cholesterol, low levels of hdl cholesterol, and ldl phenotype pattern b (small, dense ldl particles). statins are first line therapy, and reduce ldl cholesterol levels without affecting ldl particle size. fenofibrate addresses the triglycerides, hdl cholesterol levels, and ldl phenotype, so is recommended as second level therapy. the third element is niacin, but for insulin resistant patients, a question has been whether niacin might be exacerbating the underlying pathophysiology of metabolic syndrome patients. in snared, niacin was compared to the insulin sensitizer rosiglitazone in study subjects already on statin and fenofibrate. all volunteers participating in snared exhibit ldl phenotype pattern b despite statin therapy at the time of recruitment. comparisons of ldl phenotype at baseline are to be compared to measurements made after 4 months of statin + fenofibrate. if the ldl phenotype converts to pattern a (large ldl particles), this is a study endpoint. otherwise, study subjcts are randomized to receive statin+fenofibrate+niacin, or statin+fenofibrate+rosiglitazone for six months, at which time lipid phenotype will again be determined..

Eligibility criteria:
inclusion criteria: * age \>= 18 years fasting triglycerides \> 100 mg/dl fasting plasma glucose 110-128 mg/dl non-pattern a ldl phenotype exclusion criteria: * overt diabetes mellitus current therapy with hypoglycemic agents secondary causes of dyslipidemia (e.g. hrt, thyroid disease) serum creatinine \> 2.5 mg/dl or nephrotic syndrome ast/alt \> 3x upper limits of normal known gallbladder disease history of gout or hyperuricemia history of peptic ulcer disease hypersensitivity or intolerance to any of the study drugs women who are pregnant or nursing

Keywords: fenofibrate niacin rosiglitazone ldl phenotype pattern b small, dense ldl insulin resistance metabolic syndrome
radiofrequency ablation in thyroid nodules

Conditions: Thyroid Nodules

Summary: thyroid nodules are common problems and although \> 95% are stated to be benign, they may cause some problems like hyperthyroidism, compression symptoms, and cosmesis associated with their function, size and localization. especially for these nodules, patients undergo surgery and face up with the problems associated with surgical complications although they are not cancer. in some studies, radiofrequency ablation previously used for intrabdominal tumors like hepatic metastasis...,was stated to be efficient in the treatment of benign thyroid nodules and in some recurrent thyroid cancer cases. therefore, the investigators decided to use this method in our patients having nodules like previously mentioned and see the efficacy and safety of the technique.


Eligibility criteria:
inclusion criteria: 1. the presence of subjective symptoms (foreign body sensation, neck discomfort or pain, compressive symptom) or cosmetic problems; 2. a poor surgical candidate or refusal to undergo surgery; 3. fine-needle aspiration cytology and us findings that were compatible with a benign nodule; 4. anxiety about a malignancy. exclusion criteria: 1. a nodule less than 5 mm in size; 2. follicular neoplasm or malignancy on fine needle aspiration cytology (fnac); 3. a nodule with the sonographic criteria for a malignancy (taller than wide, marked hypoechoic, microcalcifications, ill-defined margins), although fnac was a benign result; 4. previous radiation or operation history to the head and neck; (5) previous sclerosing therapy.

Keywords: radiofrequency thyroid nodule
clinical effect observation for electrical pudendal nerve stimulation in treating urethral pain syndrome

Conditions: Pelvic Pain Syndrome

Summary: in this randomized controlled trial, we intend to determine whether electrical pudendal nerve stimulation is more effective than intravesical instillation in urethral pain syndrome.

according to the 2017 edition of european association of urology guideline, there is no specific treatment for urethral pain syndrome (ups), and it is recommended this type of patients should be treated in a multi-disciplinary and multi-modal program. since some mechanisms for the development of ups suggest it may be a form of bladder pain syndrome (bps) due to the intimate relation of the urethra with the bladder (both covered with urothelium), a combination of intravesical hyaluronic acid and lidocaine plus sodium bicarbonate, the more widely used regimen for bps in china, is also applied to ups here in china. however, the symptom relief of the intravesical irrigation won't last long and patients usually report recurrence in 2-3 weeks. hence, the purpose of this study is to explore whether the electrical pudendal nerve stimulation（epns）, which has been proven effective in treating bps, is more effective than intravesical instillation (intravesical hyaluronic acid and lidocaine plus sodium bicarbonate) in patients with ups.

Eligibility criteria:
inclusion criteria: 1. male or female patients aged 18 - 75 2. occurrence of chronic or recurrent episodic pain perceived in the urethra, especially related to micturition, for more than 3 months; accompanied by other symptoms such as increased daytime and night-time frequency, in the absence of proven infection or other obvious urethral pathology such as urethral diverticulum. 3. negative in urine routine test or urine cultivation. 4. agreement to sign the written informed consent. exclusion criteria: 1. symptoms relieved by anti-inflammatory drugs, α-blockers, muscle relaxants. 2. a diagnosis of bacterial cystitis or prostatitis within a 3-month period; bladder or ureteral calculi; active genital herpes; any type of cystitis; vaginitis. 3. life threatening complication such as uterine, cervical, vaginal, or urethral cancer, bladder tumor, heart failure, cardiovascular disease, hemorrhagic disease, uncontrolled diabetes, and/or factors that can affect hemostasis. 4. female patients with pregnancy or lactation. 5. serious mental disorders.

Keywords: urethral pain syndrome electrical pudendal nerve stimulation intravesical instillation