Kornimate/medical-research-clean huggingface dataset:
regulation of placental vascular reactivity in pregnancy-induced hypertension

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension; Pregnancy Toxemias

Summary: to elucidate the role of an imbalance in vasodilator prostacyclin (pgi2) and vasoconstrictor thromboxane (txa2) in pregnancy-induced hypertension

background: pregnancy-induced hypertension (pih) is associated with increased fetal and neonatal morbidity and mortality possibly resulting from hypoxia in utero. the primary pathology of pih involves a reduction in uteroplacental blood flow but modern imaging techniques have now shown that increased impedance of the fetal-placental circulation and hence reduced blood flow can also be found in pih. this may represent a direct effect of hypoxia or be a fetal adaptation to increase placental oxygen extraction to relieve hypoxia. the fetal-placental circulation is regulated by humoral agents and vascular pressure. an imbalance of vasodilator prostacyclin (pgi2) and vasoconstrictor thromboxane (txa2) production is reported to underlie the vasoconstriction seen in pih. the study resulted from the 1986 release of a request for applications for research on hypertension in pregnancy by the national heart, lung, and blood institute and the national institute of child health and human development. design narrative: the fetal-placental circulations of perfused human placental cotyledons from normotensive and pregnancy-induced hypertensive pregnancies were used to determine if an imbalance in pgi2/txa2 production existed and its relationship to the responses of the fetal-placental circulation to vasoconstriction. studies were also conducted on the effects of hypocalcemia and hypomagnesemia, hypoxia, and drugs. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
this is a study to get more information about non ambulatory boys & men with duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy

Summary: many therapeutic trials in dmd exclude non-ambulatory boys and men. rate of progression in these non-ambulatory patients has been studied but consensus has not been reached for what measures are most reliable and reproducible. furthermore, any treatment trial would be expected to demonstrate improved function and improvement in quality of life. therefore, function, strength, and quality of life must be understood and standardized. while the goal of this proposal is to standardize clinical outcomes for therapeutic trials, careful understanding of the progression of dmd in non ambulatory boys may also lead to better medical treatment.

for non-ambulatory study, boys must be unable to walk without assistive devices for greater than or equal to one year. age at onset of study for non-ambulatory boys and men: greater than or equal to 7 years through age 22 years. genetic or biopsy confirmation of dystrophinopathy or clinical diagnosis of dmd with biopsy/genetic confirmation in a primary relative.

Eligibility criteria:
inclusion criteria: 1. for non-ambulatory study, boys must be unable to walk without assistive devices for greater than or equal to one year. 2. age at onset of study for non-ambulatory boys and men: greater than or equal to 7 years through age 22 years. 3. genetic or biopsy confirmation of dystrophinopathy or clinical diagnosis of dmd with biopsy/genetic confirmation in a primary relative. exclusion criteria: 1. for non-ambulatory study, the inability to understand and cooperate with the testing would exclude a subject. -

Keywords: dmd non ambulatory
trial to evaluate radiotherapy followed by endocrine therapy vs endocrine therapy alone for psa failure after radical prostatectomy

Conditions: Prostate Cancer

Summary: the purpose of this study is to evaluate radiotherapy followed by endocrine therapy in comparison with endocrine therapy alone for psa failure after radical prostatectomy.

a randomized controlled trial is conducted in japan to evaluate radiotherapy followed by endocrine therapy for psa failure after radical prostatectomy. patients who have psa failure after radical prostatectomy under a diagnosis of localized prostate cancer (t1-2 n0m0) are randomized into treatment group of either radiotherapy followed by endocrine therapy or endocrine therapy alone. urologic oncology study group (uosg) in the jcog composed of 36 specialized institutions will recruit 200 patients. the primary endpoint is time to treatment failure (ttf) of bicalutamide and secondary endpoints are ttf of protocol treatment, progression free survival, overall survival, adverse events and quality of life (qol). the clinical trial review committee of the japan clinical oncology group (jcog) approved the protocol on april 13, 2004, and the study was activated on may 17, 2004.

Eligibility criteria:
inclusion criteria: * a diagnosis of localized prostate cancer (clinical stage t1-2n0m0) which is treated by radical prostatectomy * pathological stage: pt0/2/3 and pn0/x * serum level of psa once reached \< 0.1 ng/ml after radical prostatectomy and then increased 0.4 ng/ml * serum level of psa 1.0 ng/ml at entry * no clinical recurrence based on abdominal and pelvic computed tomography, and a bone scan * no history of chemotherapy or radiation therapy or endocrine therapy for any cancer * ages 20 to 79 years * eastern cooperative oncology group (ecog) performance status of 0 or 1 * no blood transfusion within 28 days of entry * sufficient organ function within 28 days of entry * provided written informed consent exclusion criteria: * synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ * mental disease or mental symptoms which would affect participant's decision to participate * continuous medication with steroids (exclude external use of steroids for skin) * ischemic heart disease or arrhythmia which needs medical treatment * poorly controlled hypertension * poorly controlled diabetes mellitus * history of cerebral infarction or myocardial infarction within 6 months * liver cirrhosis * interstitial pneumonia which requires ventilation assistance, oxygen inhalation, steroids, or diuretic medicine

Keywords: prostate cancer radical prostatectomy psa failure rct radiation endocrinotherapy
comparative effectiveness of decision aids for stable chest discomfort

Conditions: Coronary Artery Disease; Stable Angina

Summary: the purpose of the study is to compare two different types of decision support materials for patients considering treatment for chest pain or chest discomfort from heart disease.

the purpose of the project is to compare the effectiveness of a detailed, video patient decision aid and an online, interactive patient decision aid for treatment of stable chest discomfort. the study will randomly assign eligible participants to receive either the online decision aid or the video decision aid. participants will complete a survey after reviewing the decision aid that will examine decision quality, use of the intervention, and satisfaction with the intervention.

Eligibility criteria:
inclusion criteria: * adults 18 and older * english speaking * current diagnosis of stable angina * ability to access online material and willing to provide an email address exclusion criteria: * coronary bypass surgery and/or percutaneous coronary intervention within 6 months * diagnosis of unstable angina, acute coronary syndrome, stemi, non stemi within 6 months * scheduled for nonelective catheterization * significant cognitive deficit such that participant is unable to consent for self * serious comorbidities or other conditions that make revascularization inappropriate

Keywords: decision making decision aids shared decision making stable angina cardiology
systemic effects of lidocaine infusion for tap block catheter

Conditions: Nephrectomy

Summary: lidocaine is a local anesthetic that is usually used for nerve blocks to sensory/motor blockade. however, lidocaine can also been given intravenously, and it has been shown that this method can be used to help alleviate chronic pain. we wish to investigate if lidocaine is infused via the transversus abdominis plane (tap) block catheter will exert systemic effect, hence reduce opioid consumption and pain score in patients compared with using local anesthetic such as ropivacaine.

following irb approval and written consents, patients undergoing nephrectomy were randomized into 2 groups: standard 0.2% ropivacaine infusion (control) and 0.4% lidocaine infusion for tap catheter. the tap catheters were placed by the surgeons under direct vision at the end of surgery before wound closure. all subjects had a general anesthetic in accordance to the discretion of the anesthesiologist in the operating room. at the end of surgery, all patients received a patient-controlled analgesia (pca) in recovery for 48 hours. the primary outcome was the total opioid consumption at the first 27 hours post-operatively. the secondary outcomes were the total opioid consumption at 4/12/24/36/48/60 hours after the initiation of local anesthetic infusion, the numerical rating scale (nrs) at rest and on movement at 4/12/24/36/48/60 hours after the initiation of the local anesthetic infusion, the incidence of nausea and vomiting, and adverse effects. the sample size calculation for this non-inferiority trial is based on our previous retrospective study on tap in nephrectomy patients. a sample of 80 patients is needed, using a power of 90% with the two-sided significance level of 5%. all parametric data will be analyzed using mean and standard deviation. non-parametric data will be analyzed using median and interquartile range. student's t-test or mann-whitney u test will be used to compare between groups.

Eligibility criteria:
inclusion criteria: * elective nephrectomy * patients consent to study * asa i to iii exclusion criteria: * patient refusal * allergy to lidocaine, * patients with cardiac arrhythmias or on anti-arrhythmics or propranolol * wolf-parkinson white syndrome * hepatic disease

Keywords: lidocaine tap block nephrectomy acute pain
to study the role of liquid based cytology (lbc) for diagnosis and characterization of biliopancreatic tumor s compared with standard cytology and on-site evaluation.

Conditions: Pancreatobiliary-Type Carcinoma

Summary: liquid based cytology is a method of preparing samples for examination in cytopathology.liquid-based cytology (lbc), enables cells to be suspended in a monolayer. lbc makes better cytological assessment possible with improved sensitivity and specificity, since fixation is better and nuclear details are well preserved in the technique. conventional cytology is gold standard for biliopancreatic malignancy examination. this method is operator depended and have high inter observer variation . on site evaluation increases the sensitivity of conventional cytology but requires the presence of pathologist at the time of sampling . our study will compare lbc with conventional cytology ,if found to be non inferior will be great help in centre were on site evaluation cannot be carried out . it will further reduce the interobserver variation


Eligibility criteria:
inclusion criteria: * consenting patients (or guardian) undergoing eus guided sampling of suspected pancreato-biliary tumors exclusion criteria: * patients on anti-platelet agents(including aspirin). * patients with deranged coagulation parameters, defined by platelet counts \ 1.8
comparison of electrodessication, potassium titanyl phosphate (ktp) laser and pulsed dye laser for treatment of cherry angiomata

Conditions: Cherry Angioma

Summary: the primary objective of this study is to determine whether laser treatments over 6 weeks using the pulsed dye laser system or the potassium titanyl phosphate (ktp) laser are effective in patients with cherry angiomas as observed by a physician provider and the subject. the investigators hypothesize that the two laser treatments will be an effective tool for treating cherry angiomas. the investigators aim to compare these modalities to electrodessication, as all three modalities are considered the current standard of care. electrodessication can result in atrophic lesions at the site of the treated cherry angiomas. in summary, the goal of this project is to compare the non-ablative pulsed dye laser and the auratm potassium titanyl phosphate (ktp) laser to each other and to the current standard of care, electrodessication.


Eligibility criteria:
inclusion criteria: * age 18 to 95 years. * have at least 12 cherry angiomas (4 per each third of the torso) that have been documented. * the subjects are in medically stable condition. * the subject has willingness and the ability to understand and provide informed consent for the procedure and is able to communicate with the investigator. * must be willing not to employ other treatment options for cherry angiomas during the course of this study. exclusion criteria: * under 18 years of age and over 95 years of age * pregnancy or lactation. * subjects who are unable to understand the protocol or to give informed consent. * subjects cannot have had previous laser treatment in the last 6 months before enrollment. * subjects have a cardiac defibrillator or pacemakers that may interact with the electrodesiccation technique. * subjects have no serious medical conditions that would contradict participation in the research.
safety of ginkgo biloba leaf extract

Conditions: Healthy

Summary: primary objective: the primary objective of this study is to assess the effect of ginkgo biloba l. leaf extract (idn 5933) in comparison to placebo in human subjects treated at therapeutic doses for 6 months on the level of dna damage and genomic instability, measured with the comet assay and the micronucleus assay, respectively . secondary objective: the secondary objective of this study is to provide a preliminary assessment of the safety of ginkgo biloba l. leaf extract (idn 5933) in human subjects treated at therapeutic doses in term of adverse drug reaction, hepatotoxicity, genotoxicity.

the study will be a randomised clinical trial comparing subjects receiving twice-daily doses of either 120-mg of ginkgo biloba l. leaf extract (idn 5933) or placebo for a 6 months period. primary endpoints: * dna damage assessed with the comet assay as proportion of dna in the tail. * micronucleus frequency (mn) in peripheral blood lymphocytes (frequency per 1000 binucleated cells). secondary endpoints: * complete clinical assessment at the beginning and at the end of the study. * occurrence of adverse drug reactions in individuals treated with gbe or placebo. * liver functions will be monitored according to biological laboratory examinations and clinical symptoms. a subgroup of individuals will be monitored also for genetic parameters concerning expression patterns of genes putatively associated to early events of hcc carcinogenesis clinical and biological parameters will be measured in the study groups at the beginning (t0) and at the end of the study (t2).

Eligibility criteria:
inclusion criteria: * male and female senior, residents of nursing homes, with no known clinically significant pathology as assessed by the investigator * life expectancy of greater than 1 year * subjects must have given written informed consent in accordance with ich-gcp (international conference on harmonization - good clinical practice) and local laws and regulations to perform the experiment in a typical population treated with ginkgo biloba l. leaf extract ( idn 5933) the study will be performed among the residents of nursing homes among the structures of the san raffaele network, i.e., the san raffaele montecompatri, the san raffaele rocca di papa and the san raffaele sabaudia . the use of institutionalised subjects will allow a good compliance to the treatment, which will be administered by the nursing homes nurses. subjects meeting inclusion criteria and signing the informed consent will be randomised to receive 120-mg/twice per day of ginkgo biloba l. leaf extract ( idn 5933) or placebo. exclusion criteria: * life expectancy of less than 1 year * treatment with anticoagulant and antiplatelet drugs in subjects with previous report of increased bleeding tendency * cognitive impairment * refuse to sign the informed consent

Keywords: ginkgo biloba extract safety genomic stability dna cell maintenance
lumbar proprioception in patients with lumbar spinal stenosis

Conditions: Spinal Stenosis Lumbar

Summary: the primary aim of this study was to compare spinal proprioception in patients with lumbal spinal stenosis (lss) (with or without surgery) and healthy controls. a secondary aim was to investigate the effect of pain at target positions where repositioning error (re) was assessed and tlf flexibility on spinal proprioception deficiency.this cross-sectional and healthy controlled study was conducted in patients with lss. participants will be grouped as: healthy control (group i), chronic low back pain due to lss (group ii) and undergoing surgery due to lss (group iii). reposition error (re), pain at target positions of re and flexibility of the tlf were assesed with iphone tiltmeter app, vas and goniometric platform, respectively. target positions of reposition error were: 30º forward bending and 15º backward bending in sitting and standing.

this cross-sectional and healthy controlled study was conducted in patients with lss. participants will be grouped as: healthy control (group i), chronic low back pain due to lss (group ii) and undergoing surgery due to lss (group iii). reposition error (re), pain at target positions of re and flexibility of the tlf were assesed with iphone tiltmeter app, vas and goniometric platform, respectively. target positions of reposition error were: 30º forward bending and 15º backward bending in sitting and standing. the general study inclusion criteria were as follows: age between 20 and 50 years and not having had lower extremity surgery. in addition to the general inclusion criteria, the inclusion criteria for the control group were as follows: not having a chronic spinal disorders and not having low back pain in the last week. group ii consisted of patients diagnosed with lss and confirmed by mri findings. in addition to the general inclusion criteria, the inclusion criteria for the lss group were as follows: having low back pain for more than 3 months and having low back pain intensity of 4 or more assessed with vas. there was not any additional inclussion criteria for group iii. the exclusion criteria of current study are; having any previous inner ear inflammation or vestibular disorders, having diabetes and being pregnant.

Eligibility criteria:
inclusion criteria: * age between 20 and 50 years * not having had lower extremity surgery * not having a chronic spinal disorders * not having low back pain in the last week * having low back pain for more than 3 months * having low back pain intensity of 4 or more assessed with vas exclusion criteria: .having any previous inner ear inflammation or vestibular disorders .having diabetes and being pregnant.

Keywords: lumbar spinal stenosis proprioception reposition error
mitra v fingerprick tacrolimus creatinine

Conditions: Transplant;Failure,Kidney

Summary: patients with kidney transplant have blood tests very often. this is normally done in hospital and using a needle inserted into the vein. two tests are important for kidney transplant patients - creatinine to monitor the health of the kidney; and tacrolimus to measure the level of the medicine which prevents rejection. the investigators would like to compare a fingerprick microsampling method to the standard venous blood. the fingerprick test is the same done by patients with diabetes and we use a microsampling tip which looks like a cotton bud to draw up a small amount of blood. each tip draws up exactly 10 microlitres which is two drops. the investigators want to compare the results of creatinine and tacrolimus done through the two methods. in the future, this would allow patients to do their creatinine and tacrolimus test at home. the tips dry completely and can be posted to a laboratory. we hope this will make life easier for transplant patients and also help them engage more with the care of their condition.


Eligibility criteria:
inclusion criteria: kidney transplant recipients. taking tacrolimus exclusion criteria: unable to consent
the effect of bariatric surgery on metabolism, the metabolome and microbiome in patients with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus; Obesity

Summary: what are the benefits of undergoing roux-en-y gastric bypass surgery in improving type 2 diabetes outside of weight loss alone?

roux-en-y gastric bypass (rygb) surgery leads to improvements in diabetes that occurs even before any significant weight loss is seen. what are the reasons for this? there is evidence in animals that changes in the composition of gut bacteria after rygb may be responsible for improvements in how glucose is metabolized in the body. the study aims to correlate changes in the bacterial composition of the gut that occurs after surgery with improvements in glucose metabolism in people with type 2 diabetes. the investigators will do this by using validated methods to measure glucose metabolism and cutting edge technology to analyze the gut microbiome. a parallel group of patients with similar weight, height and age will undergo caloric restriction alone to mimic weight loss seen after rygb. participants will also undergo similar glucose metabolism studies and analysis of their gut bacterial composition. thus, any difference seen between groups can be attributed to the surgery itself and may lead to identification of novel therapeutic options for diabetes.

Eligibility criteria:
inclusion criteria: * age 20-65 years of age. * seen at mayo clinic nutrition clinic and have received authorization for rygb surgery. * type 2 diabetes mellitus or impaired fasting glucose with bmi \>35 and not interested in surgery but are interested in supervised caloric restriction. exclusion criteria: * previous treatment with thiazolidinediones. * chronic antibiotic therapy. * active microvascular or macrovascular complications of diabetes.

Keywords: bariatric surgery weight loss