Kornimate/medical-research-clean huggingface dataset:
effects of peanut consumption on postprandial inflammation, glucose and triglycerides

Conditions: Cardiovascular Disease

Summary: this pilot study will investigate the effects of acute peanut consumption on markers of inflammation, triglycerides and glucose. the hypothesis is that a high glucose/sfa meal will increase postprandial production of the inflammatory marker, c-reactive protein (crp), and that the addition of peanuts to the control meal will reduce the production of crp, as well as triglycerides and glucose.

previous research has demonstrated that a single meal high in saturated fatty acids (sfa) and glucose can induce increases in il-6, tnf-α and crp in abdominally obese and diabetic subjects. as over two-thirds of the u.s. population is overweight or obese, it is important to identify foods that can attenuate postprandial increases in lipids, glucose and inflammation in this population. therefore, the purpose of the pilot study is to determine whether a high sfa / high glucose control meal will induce an acute inflammatory response in overweight individuals, and whether the addition of peanuts to this meal will ameliorate this response. to ensure that these effects are due to peanuts, and not to the increase in total fat, we will compare this response to another test meal that includes an oil blend with a similar fatty acid composition to peanuts.

Eligibility criteria:
inclusion criteria: * bmi \>28 * ldl_c below 130 mg/dl * tg below 350 mg/dl * blood pressure within normal ranges (below 140/90 mmhg) exclusion criteria: * smoking * allergies to peanuts or dairy products * known intolerance for high fat meals * history of cvd, kidney disease, diabetes or inflammatory disease * use of non-steroidal anti-inflammatories or immunosuppressants * conditions requiring the use of steroids * use of medication or supplements for elevated lipids, blood pressure or glucose

Keywords: overweight obese
sympathetic and vascular function in takotsubo syndrome

Conditions: Takotsubo Cardiomyopathy

Summary: the primary objective of this prospective, observational study is to compare muscle sympathetic nerve activity at rest and during stress between female patients with takotsubo syndrome and healthy, matched volunteers. * do takotsubo patients have an increased sympathetic nerve activity compared to controls? * do takotsubo patients have an exaggerated sympathetic nerve activity response to stress? * does the sympathetic nerve activity response to stress in takotsubo change after receiving the beta blocking agent metoprolol? participants will be examined with muscle sympathetic nerve activity recording in the peroneal nerve at rest and during cold pressor test. after intravenous injection with beta blocking agent (metoprolol) or placebo (saline) in a 1:1 randomized fashion, muscle sympathetic nerve recording at rest and during stress will be repeated.

female takotsubo patients included in the saft (sympathetic and vascular function in takotsubo syndrome) study will be invited to undergo microneurography recording of muscle sympathetic nerve activity (msna) at rest and during stress one week to two month after study inclusion. responses to stress with and without the commonly used betablocking agent metoprolol will be compares. microneurography will be performed in the morning after a light caffeine-free breakfast with the subject supine and awake. any medication with a beta blocking agent will be discontinued 24 hours prior to examination. msna will be recorded by inserting a tungsten electrode into the sympathetic nerve fibres of the peroneal nerve, with simultaneous blood pressure and heart rate monitoring. msna recording will then continue during stress induced by placing one of the subjects hand in ice-cold water for 90 seconds (cold pressor test). after intravenous injection with beta blocking agent (metoprolol) or placebo (saline) in a 1:1 randomized fashion, msna recording at rest and during stress will be repeated. age- and gender-matched healthy volunteers will be recruited as controls and examined similarly with microneurography at rest and during stress. msna recordings will be amplified, computerized and saved for further analyses. msna will be quantified as burst incidence (burst per 100 heartbeats), burst frequence (bursts per minute) and relative median burst amplitude (%). msna activity will be compared between takotsubo patients and controls and before and after betablockade in takotsubo patients.

Eligibility criteria:
inclusion criteria: for patients: * diagnosis of takotsubo cardiomyopathy for controls: * matching age with takotsubo patients * signed informed consent exclusion criteria: * coronary anathomy precluding intracoronary investigations * severe obstructive pulmonary disease * kidney failure with estimated glomerular filtration rate \< 30 ml/min/m2 * active malignancy * pericarditis
tilt and tumble vs divide and conquer - a unique comparison of the two cataract surgery methods

Conditions: Cataract

Summary: the purpose of this study is to compare two different methods used during cataract surgery to remove the lens in the eye.

after being informed about the study and potential risks, all participants who have signed the written informed consent will be randomized to undergo cataract surgery with either the method called "divide and conquer" or "tilt and tumble". pre- per- and postoperative measurements from the surgery will be filed and compared later on by the investigator.

Eligibility criteria:
inclusion criteria: * cataract exclusion criteria: * dementia * very narrow anterior chamber * born after 1965

Keywords: divide and conquer, tilt and tumble
comprehensive rimonabant evaluation study of cardiovascular endpoints and outcomes

Conditions: Cardiovascular Disease

Summary: the primary objective is to show whether rimonabant reduces the risk of a heart attack (mi), stroke, or death from an mi or stroke in patients with abdominal obesity with other cardiovascular (cv) risk factors. the secondary objective is to show whether rimonabant reduces the risk of mi, stroke, cv death, or cv hospitalization in these patients.

the estimated study duration per patient is 36 to 53 months. all patients will be followed from randomization until a common study end date, which will occur when the last patient has been followed for 33 months.

Eligibility criteria:
inclusion criteria: waist circumference \>102 cm (40 inches) males, \>88 cm (35 inches) females, with one coronary heart disease (chd) equivalent or two major risk factors for cardiovascular disease. * chd equivalents: * recent (within 3 years)documented heart attack * documented symptomatic coronary artery disease * recent (within 3 years) ischemic cerebrovascular episode (stroke or tia) * documented symptomatic peripheral arterial disease * major risk factors: * documented type 2 diabetes mellitus * metabolic syndrome (ncep criteria) * asymptomatic cerebrovascular, renal, or peripheral arterial disease, or past abdominal aortic aneurysm repair * elevated high-sensitivity c-reactive protein * age \> or = 65 years for males, age \> or = 70 years for females exclusion criteria: * obesity of known endocrine origin * pregnant or breastfeeding women * very low calorie diet or weight loss surgery within past 6 months * presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation, including uncontrolled serious psychiatric illness * likely cardiovascular intervention within next 1 month * allergy to rimonabant or excipients, or prior participation in a rimonabant trial * receipt of investigational product within past 30 days

Keywords: myocardial infarction cerebrovascular accident obesity
expanded access rbs2418 treatment

Conditions: Expanded Access in Pancreatic Cancer

Summary: this is an expanded access treatment protocol designed to provide access of rbs2418 to a single patient with pancreatic cancer.

given lack of any therapeutic options such as standard of care chemotherapy for this single patient owing to lack of tolerability and opportunity to enroll in any clinical trial due to extent of disease, patient desires to try compassionate use protocol with rbs2418, an oral immunotherapeutic agent that is currently in clinical trials and is well tolerated by patients. furthermore, patient's tumor has been shown to express enpp1, the protein targeted by rbs2418

Eligibility criteria:
inclusion criteria: * the patient is willing and able to provide informed consent. only the patient for whom this clinical study/experimental treatment was designed will be given the investigational drug under the treatment of the pi. no other patient is authorized to participate in or to receive treatment under this treatment protocol. exclusion criteria: * not applicable
comparison of epicardial versus conventional lead placement in cardiac resynchronization therapy

Conditions: Cardiac Resynchronization Therapy; Heart Failure

Summary: the primary goal of this study is to evaluate the use of robotically -assisted device leads as a primary strategy for heart resynchronization.this trials aims to compare transvenous lead placement with robotic lead placement for cardiac resynchronization therapy.

a secondary goal is to explore the link between efficacy of crt and inotropic contractile reserve as measured by dobutamine stress echocardiography.

Eligibility criteria:
inclusion criteria: * symptomatic nyha class iii or iv heart failure from idiopathic or ischemic heart failure * qrs interval greater than or equal to 130 msec * left ventricular end diastolic diameter greater than or equal to 55 mm * left ventricular ejection fraction less than or equal to 35 * willingness to participate exclusion criteria: * acute renal failure; active gi bleeding; unexplained fever which may be due to an infection * untreated active infection * acute stroke * severe uncontrolled systemic hypertension * severe systemic electrolyte imbalance * severe concomitant illness that drastically shortens life expectancy * severe coagulopathy * history of severe copd and inability to tolerate single lung ventilation * history of prior left sided thoracotomy * history of recent intravenous drug use * concomitant psychiatric diagnosis that impairs patient's ability to comply with study protocol * participation in another investigational protocol

Keywords: biventricular pacing
cohort study for atrial fibrillation risk stratification

Conditions: Atrial Fibrillation

Summary: afhri is planned as a prospective, single-center cohort study in patients at high risk of af.

the primary aim of the study is to evaluate and improve atrial fibrillation risk prediction, which takes into account clinical, psycho-social, environmental and lifestyle-risk factors, protein patterns and genetic variability in addition to the classical risk factors with respect to the primary endpoint, af (paroxysmal or permanent).

Eligibility criteria:
inclusion criteria: * age 18 to 85 years; * personally signed informed consent exclusion criteria: * insufficient knowledge of the german language, in order to understand study documents and computer assisted interview without translation; * physical or psychological incapability to cooperate in the investigations
electrical stimulation of accessory spinal nerve in cortical activation and autonomic response in healthy subjects

Conditions: Pain

Summary: this randomized, crossover sham controlled trial with sham intended to study the effect of electrical stimulation on peripheral nerve (spinal accessory nerve) with acupuncture needle in healthy subjects aims to access the effect o electrical stimulation of accessory spinal nerve in cortical activation, muscular perfusion and autonomic response in healthy subjects. participants will be assessed through measure changes in cortical activation, local muscular peripheral perfusion and autonomic responses before and after intervention and intervention-sham, and crossed after a period of wash-out. the design aims to contribute to assessment of one electroacupuncture's techniques by measuring some of the physiological effects caused by peripheral stimulation.

in recent years, there are growing evidence that many diseases such as chronic pain and psychiatric disorders can be managed with non-pharmacological techniques. the possibility of inducing central neuroplastic responses through transcranial magnetic stimulation (tms) and transcranial direct current stimulation (tdcs) has been widely studied, as well as peripheral stimulation techniques such electroacupuncture (ea) and intramuscular stimulation (ims). however, there are few studies on physiological mechanisms, indications and limitations of each technique. thus, this randomized, crossover sham controlled trial, where sham intended to study the effect of electrical stimulation on peripheral nerve (spinal accessory nerve) with acupuncture needle in healthy subjects aims to access the effect o electrical stimulation of accessory spinal nerve in cortical activation, muscular perfusion and autonomic response in healthy subjects. participants will be assessed through measure changes in cortical activation, local muscular peripheral perfusion and autonomic responses before and after intervention and intervention-sham, and crossed after a period of wash-out. the design aims to contribute to assessment of one electroacupuncture's techniques by measuring some of the physiological effects caused by peripheral stimulation.

Eligibility criteria:
inclusion criteria: * healthy male subjects * right handed * basic education exclusion criteria: * contraindication to infrared technology nirs * brain stimulator device * drug and alcohol abuse * chronic disease (any); * chronic pain condition * tobacco use * psychiatric disorders * beck depression inventory higher then score 12 * psychotropic drugs * use of pain-killers or anti-inflammatories 12h previous experiment

Keywords: pain mechanisms cortical activation fnirs accessory spinal nerve autonomic response muscular perfusion
intersept: in-tunnel septrx european pfo trial

Conditions: Foramen Ovale, Patent; Heart Defects, Congenital; Heart Septal Defects

Summary: the objective of this study is to determine the safety, performance, and effectiveness of the septrx ipo pfo closure system in the treatment of patent foramen ovale (pfo) in patients who are amenable to percutaneous closure of their pfo defects.


Eligibility criteria:
inclusion criteria: * the patient must be ≥ 18 years of age and ≤ 70 years of age * the patient is willing to comply with specified follow-up evaluations * the patient or legally authorized representative has been informed of the nature of the study, agrees to its provisions and has been provided written notice of informed consent, approved by the appropriate ethics committee (ec) * pfo flat width of 4-14mm (approximate pfo balloon diameter of 2.5-9mm) and pfo length of 4-20mm exclusion criteria: * pregnant or nursing subjects and those who plan pregnancy in the period up to 1 year following index procedure * other medical illness (e.g., cancer, known malignancy, congestive heart failure, organ transplant recipient or candidate) or known history of substance abuse (alcohol, cocaine, heroin etc.) * known hypersensitivity or contraindication to aspirin, heparin, clopidogrel/ticlopidine, nitinol, and/or contrast sensitivity that cannot be adequately pre-medicated * currently participating in another investigational study, or participation in another clinical trial in the previous 3 months * pfo flat width \ 14mm to begin the trial. pfo flat width \ 19mm when the second size device is ready * pfo length \ 20mm * active endocarditis, active bacterial infection, or other infection producing bacteremia or sepsis * history of chronic or sustained arrhythmia * congenital or structural heart disease other than pfo * thrombus at the intended site of implant or documented venous thrombosis in venous access * severe pulmonary hypertension * vascular anatomy unable to accommodate the appropriate-sized sheath for device introduction * acute appendicitis * confinement to bed (increased risk for clot formation) * prior cardiac surgery, including implantation of active cardiac devices

Keywords: patent foramen ovale pfo
u/s guided oblique subcostal transversus abdominis plane block versus erector spinae plane block as preemptive analgesia

Conditions: Pain; Hernia, Umbilical

Summary: administration of opioids for the treatment of acute pain after open umbilical hernia repair is associated with many side effects. erector spinae plane (esp) block is a novel inter-fascial plane block used in postoperative pain and chronic neuropathic pain relief of the thoracoabdominal region.tap block is a regional injection of local anaesthetic between the transversus abdominis and internal oblique muscle planes. tap block affects the sensory nerves of the anterolateral abdominal wall (t6-l1) that innervate the abdomen.

tap block is a regional injection of local anaesthetic between the transversus abdominis and internal oblique muscle planes. tap block affects the sensory nerves of the anterolateral abdominal wall (t6-l1) that innervate the abdomen. tap block is an easy technique and decreases postoperative pain and opioid consumption. erector spinae plane (esp) block is a novel inter-fascial plane block used in postoperative pain and chronic neuropathic pain relief of the thoracoabdominal region. however, its first use was for the treatment of chronic pain, but recently it has been used as a postoperative regional analgesia technique in different surgeries from the shoulder to hip regions (3-4) the present study will be carried out to compare the preemptive analgesic efficacy between the ultrasound-guided bilateral esp block versus bilateral oblique subcostal tap block on patients undergoing open umbilical hernia repair.

Eligibility criteria:
inclusion criteria: 1. american society of anesthesiologists i-ii, scheduled for open umbilical hernia repair. 2. age range of 18-65 years. exclusion criteria: 1. patient refusal. 2. patients belonging to asa grade iii and grade iv. 3. extreme obesity (bmi \>35). 4. hepatic or renal insufficiency. 5. preoperative cognitive dysfunction or communication disorder. 6. allergy to amide-type local anaesthetics. 7. back puncture site infection. 8. coagulation disorders, pregnancy, drug abusers.

Keywords: open umbilical hernia transversus abdominis plane block erector spinae plane block
finnprostate study vii: intermittent versus continuous androgen deprivation in patients with advanced prostate cancer

Conditions: Patients With T1-4 Advanced Prostate Cancer

Summary: to compare intermittent androgen deprivation (lhrha treatment) with continuous androgen deprivation (lhrha treatment or orchidectomy)


Eligibility criteria:
• inclusion criteria (run-in period): t1-t4, metastatic (m1) prostate cancer t1-t4, non-metastatic (m0) prostate cancer with psa \> 60 ng/ml t3-t4, non-metastatic (m0) prostate cancer with psa \> 20ng/ml t1-t4, n+ prostate cancer who performance status 0-2 written informed consent • inclusion criteria to the randomised period: patients who fulfilled all entry criteria of the run-in period patients who completed the 24-week run-in period patients who responded to the 24-week run-in period with a decrease of psa to \< 10 ng/ml. if the baseline was \< 20ng/ml, at least 50% decrease from the baseline measurement is required exclusion criteria (run-in period): any previous or concurrent treatment of prostate cancer, except turp, 5-alpha reductase inhibitor, radical prostatectomy or radiotherapy any medication/treatment affecting sex hormone status -
range of neutrophil response to 20,000 eu of clinical center reference endotoxin in otherwise healthy smokers

Conditions: Healthy Smokers

Summary: endotoxin is a component of outdoor air pollution, an air contaminant found in a number of different workplaces, and is even found in homes. the endotoxin used for this study is obtained from the national institutes of health, and is called "clinical center reference endotoxin", or ccre. the purpose of this phase 1 research study is to identify a dose of inhaled endotoxin that is safe (does not cause prolonged cough, shortness of breath or other problems), but causes changes in sputum cell samples that the scientists can measure. phase 1 research studies like this one are not intended to be a treatment, but are a scientific investigation. eventually, with these types of studies we will be able to examine why some people are more sensitive to endotoxin. scientists at other universities have found that while most people do not have a considerable lung response to endotoxin at doses as high as 60,000 eu (endotoxin units), a few respond to as little as a total dose of 4500 eu. our study is designed to identify if using a dose of 20,000 eu causes changes in the lung cells but does not cause symptoms in our study subjects. in our previous studies in our lab, using an endotoxin from another source, we have used higher doses (15,000 eus) in subjects with asthma with no major problems, and we have used 10,000 eus of ccre in subjects who are current smokers without seeing any problems.

we are looking for people who currently smoke a minimum of a half a pack of cigarettes each day. you must not have any other health problems, be pregnant or nursing a baby, or actively trying to become pregnant or to father a child.

Eligibility criteria:
inclusion criteria: * current smoker * healthy exclusion criteria: * no asthma * no chronic health conditions * no daily cough * not pregnant or nursing a baby * not actively trying to get pregnant or father a child

Keywords: current no health problems no daily cough from smoking
to describe the effect of rhlh supplementation in women with hyporesponse to rhfsh after pituitary downregulation

Conditions: Infertility

Summary: primary objective: to evaluate the efficacy in terms of oocyte retrieval number of rlh supplement in women with hyporesponse to rfsh after pituitary downregulation. secondary objective: to further explore the efficacy of rlh supplement in women with hyporesponse to rfsh after pituitary downregulation to evaluate the safety of rlh supplementation in hyporesponse women

primary endpoint: number of oocyte retrieved secondary endpoints: 1. oestrodial on hcg day (pg/ml) 2. number of embryos 3. implantation rate (%) 4. clinical pregnancy rate (%) 5. ongoing pr per ivf cycle (%) 6. abortion rate (%) 7. ampoules of rfsh 8. fertiqol score safety endpoint: adverse events

Eligibility criteria:
inclusion criteria: 1. 20-40 years old women 2. with menstrual cycles ranged 24-35 days, intraindividual variability±3 days 3. basal fsh \<10 iu/l at cycle d2-d5 4. 18 \< bmi \< 30 5. presence of two ovaries 6. no ovarian stimulation over the past 3 months 7. signed inform consent form. exclusion criteria: 1. polycystic ovarian syndrome 2. rafs stage ⅲ-ⅳ endometriosis 3. chromosomal abnormalities, endocrinological and/or autoimmune disorders. 4. more than two previously unsuccessful ivf.

Keywords: luveris hyporesponse pituitary downregulation ivf infertility women