Kornimate/medical-research-clean huggingface dataset:
role of granisetron in preventing hypotension after spinal anesthesia with levobupivacaine in rheumatic patients undergoing elective cesarean section

Conditions: Granisetron

Summary: cardiac disease in pregnancy is a high-risk condition and a major cause of maternal mortality and morbidity. although direct or immediate death due to cardiovascular disease is rare, it is an important indirect cause of maternal death worldwide, with an attributable rate of two deaths per 100,000 pregnancies. cardiovascular physiological changes during pregnancy impose an additional load on the cardiovascular system of women with underlying heart disease which increases morbidity and mortality during pregnancy and at the time of delivery. among cardiac diseases, rheumatic heart disease is the commonest cardiac disease complicating pregnancy.

the subarachnoid block is the most used anesthesia technique for conducting a cesarean section. the incidence of hypotension following this procedure is as high as 20-40% in pregnant patients. similarly, bradycardia is also commonly associated with post-sab, and the reported incidence is around 13%. spinal anesthesia results in sympathetic block leading to a decrease in systemic vascular resistance and hypotension. hypotension caused by subarachnoid block is physiologically compensated by an increase in heart rate. however, if vagus nerve-mediated bezold-jarisch reflex gets stimulated, then the cardiac autonomic balance gets shifted towards the parasympathetic nervous system leading to bradycardia, which further precipitates hypotension. levobupivacaine is a highly potent long-acting local anesthetic with a comparatively slow onset of action. compared to bupivacaine, it has a lower tendency to block deactivated cardiac sodium and potassium channels with a more rapid rate of dissociation. it has reduced cardiac toxicity on overdose intravenous administration due to its faster protein binding rate. plain levobupivacaine is isobaric to csf. one of its advantages is that it has a more expectable spread. several studies have revealed the reduced occurrence of various side effects (such as nausea, vomiting, bradycardia, and hypotension) when levobupivacaine compared with bupivacaine for spinal anesthesia used for cesarean delivery. it has been suggested to use 12.5-13.5mg levobupivacaine for effective spinal anesthesia for cesarean delivery.

Eligibility criteria:
inclusion criteria: * rheumatic female patients in the childbearing period scheduled for elective cesarean sections exclusion criteria: * patients with eclampsia and pre-eclampsia history, * uncontrolled diabetes mellitus, morbid obesity, * coagulation abnormalities, * vertebral deformities, also patients who refused regional anesthesia, * having contraindications to spinal anesthesia
pneumothorax after ct-guided lung biopsy: standard vs autologous blood patching

Conditions: Pneumothorax; Biopsy Wound

Summary: the aim of this prospective, randomized study is to compare the rate of postoperative pneumothorax between standard ct-guided core needle biopsy (cnb) versus cnb followed by autologous blood patch injection (abpi).

pneumothorax is the most common complication of percutaneous lung biopsies. reducing this risk is a goal of those who perform these procedures, particularly a reduction in large pneumothoraces requiring intervention (eg, pleural drainage) and hospitalization (clayton et al. 2016). recently, autologous blood patch injection (abpi) inside the biopsy track has been suggested as an effective mean of sealing the punctured lung thus halting air loss and consequently pneumothorax (graffy et al. 2017). the aim of this prospective, randomized study is to compare the rate of postoperative pneumothorax between standard ct-guided core needle biopsy (cnb) versus cnb followed by abpi. in particular, the main objectives are to compare: 1. incidence of immediate pneumothorax 2. incidence of late pneumothorax (2 hrs) 3. incidence of chest tube placement 4. duration of the procedure

Eligibility criteria:
all patients scheduled for lung biopsy will be asked to join this study. after signing the informed consent the subject will be randomized for abpi vs cnb approach. inclusion criteria: 1) patients with pulmonary nodule requiring ct-guided lung biopsy. exclusion criteria: 1. unfit for lung biopsy (inr \>1.5, plt \<50.000, single lung); 2. unavailable venous access.

Keywords: biopsy pneumothorax
trends in risk factors for mother-to-child transmission of hepatitis c among a southern european population

Conditions: Hepatitis C Virus; HIV Infections; Pregnancy

Summary: according to the centres taking part in the alhice survey, the number of hiv-hcv co-infected women is currently decreasing. this drop was first noted in 2006 and persisted in 2007. what might have been considered a chance phenomenon during the first year (2006) was confirmed in the beginning of 2008. in view of this information, the investigators wished to ascertain the reality of this trend and to investigate its causes, by attempting to answer the following questions: - has the prevalence of risk factors for hcv infection changed among the general population over the past 10 years? * has the prevalence of risk factors for hcv infection changed among hiv/hcv co-infected women over the past 10 years? * is the change in the number of co-infected women who gave birth during the past 10 years related to the prevalence of certain risk factors among this population? * is the change in the number of co-infected women who gave birth during the past 10 years related to a decrease in certain risk factors for hcv infection among the general population? * have changes in addictive behaviour among women of child-bearing age played a role in the decreasing number of hcv-contaminated children? furthermore, follow-up data from hcv-infected children born during this period will provide information concerning the course of hcv infection. the objectives are to study trends in numbers of deliveries among hcv/hiv co-infected women as well as trends in risk factors for hcv infection among women of child bearing age and lastly to create a cohort of hcv infected children.

materials and methods: this multi-centre epidemiological study (chu nice, chu toulouse, chu montpellier, h clinic barcelona, h mar barcelona) consists in two parts. our study does not interfere with the usual management of mother and child as laboratory data (virology, immunology, and liver function) are already included in the medical files. data collection will be conducted via an anonymous questionnaire by an only one clinical research assistant who will travel to each participating centre. these data are contained in the mother's and child's medical files. the data concerning the socio-demographic characteristics of mother, the characteristics of hiv and hcv infection with special attention for infection risk factors, and the circumstances of the delivery. the questionnaire among children include laboratory results at birth, m6, and m12, as well as assessment of hepatic fibrosis. data were analysed using spss software. qualitative variables were tested by chi-square and fisher's exact test. for quantitative variables, the non-parametric mann-whitney test was used (median, 25th and 75th quartile). a p-value inferior than 0.05 was considered statistically significant.

Eligibility criteria:
inclusion criteria: * infected hiv/hcv pregnant women * all women to give birth in 1 randomized week each 6 months

Keywords: hcv infected pregnant women
studying the efficacy of aspirin & clopidogrel in healthy subjects with stable coronary artery disease.

Conditions: Coronary Artery Disease

Summary: the investigators will test the hypothesis that aspirin or clopidogrel taken twice daily will augment their antiplatelet efficacy in patients with an elevated platelet turnover (as measured by the proportion of reticulated (young) platelets) compared with once daily dosing.

1. to study whether in healthy subjects with an increased platelet turnover, a twice daily dosing of aspirin 81 mg will be more effective in inhibiting platelets compared with once a day aspirin 81 mg. 2. to study whether in patients with stable coronary artery disease (cad) with an increased platelet turnover, a twice daily dosing of aspirin 81 mg will be more effective in inhibiting platelets compared with once a day aspirin 81 mg. 3. to study whether in healthy subjects with an increased platelet turnover, a twice daily dosing of aspirin 81 mg and clopidogrel 75 mg will be more effective in inhibiting platelets compared with once daily of both aspirin and clopidogrel. 4. to study whether in patients with stable coronary artery disease (cad), increased platelet turnover and aspirin resistance, an oral fatty acid (docosahexaenoic acid (dha) and eicosapentanoic acid (epa), 4 gm/day) supplementation will increase the efficacy of aspirin by modifying platelet function compared to once a day aspirin 81 mg.

Eligibility criteria:
inclusion criteria: * group a: healthy subjects aged 18-64 years with no evidence of coronary artery disease or any major risk factors for cad including smoking, diabetes mellitus, hyperlipidemia, hypertension and obesity. * group b: patients with known cad aged 18-64 years taking aspirin 81 mg daily as the only antiplatelet therapy. patients should be in stable condition and at least one month post myocardial infarction. * group c: patients with known stable cad aged 18-64 years taking aspirin 81 mg and clopidogrel 75 mg daily. patients should be in stable condition and at least one month post myocardial infarction. exclusion criteria: * subjects will be excluded if they used nsaid's within one week prior to the study, have renal insufficiency, inflammatory disorders such as rheumatologic conditions, autoimmune disorders, active infections, malignancy or if they are undergoing chemotherapy. * other exclusion criteria include contraindications to aspirin including active bleeding, hypersensitivity, thrombocytopenia (platelet count \< 50,000) and anemia (hemoglobin \< 10.0 gm/dl). * we will also exclude patients with unstable angina and recent (less than a month) cabg or pcta.

Keywords: cad
safety demonstration of microneedle insertion

Conditions: Allergic Reaction to Nickel

Summary: hypodermic needles are conventionally used to deliver drugs and vaccines into the muscle of humans and animals. side effects of these needle injections are pain, bleeding, and anxiety in patients. an alternative drug and vaccine delivery method is the use of hollow microneedles, which are sub-millimeter needle-like structures. microneedles are pain- and bleeding-free, as they do not reach the nerve-endings and blood capillaries in the skin. as a result, they are better received by patients and do not induce needle anxiety. as the investigators' microneedles are made of gold- or silver-coated, as well as uncoated nickel, the purpose of this study is to observe their biocompatibility and inertness.


Eligibility criteria:
inclusion criteria: * proven nickel allergy exclusion criteria: * pregnancy

Keywords: microneedles biocompatibility allergy metal nickel contact dermatitis
ftih - single and repeat oral doses of fdl169 in healthy volunteers

Conditions: Cystic Fibrosis

Summary: to determine the safety and tolerability of single and multiple escalating doses of fdl169 in healthy male subjects.

this study is the first time in human study and consists of two parts. part 1a: part 1 of the study is a randomised, double-blind, placebo-controlled, dose-escalation, first-time-in-human study to assess the safety, tolerability and pk profiles following single oral administrations of fdl169 to healthy male volunteers. sixty-four (64) male subjects (8 per cohort) will be included in part 1 of the study. up to eight dose levels of fdl169 are planned to be tested in part 1 of the study. part 1b: open label. following completion of part 1a of the study, an additional cohort of 8 subjects will receive a single dose of fdl169 in both fasted and fed states part 2: part 2 of the study is a randomised, double-blind, placebo-controlled, dose-escalation study to assess the safety, tolerability and pk profiles following multiple oral administrations of fdl169 to healthy male subjects. forty-eight male subjects, in cohorts of twelve, will be included in part 2 of the study. it is planned to test up to four dose levels of fdl169 in part 2.

Eligibility criteria:
inclusion criteria: healthy male subjects aged 18 to 45 years who fulfil standard safety screening assessments for the study (haematology/biochemistry, urinalysis, 12-lead electrocardiogram (ecg), vital signs and oral temperature) and who in the opinion of the investigator, are medically suitable to participate in the study. male subjects and their partners must be willing to use an effective method of contraception from first dose of investigational medicinal product (imp) and for 3 months after the last dose of imp. exclusion criteria: 1. participation in a new chemical entity clinical study within the previous 4 months or a marketed drug clinical study within the previous 3 months. 2. subjects who have history or presence of clinically significant cardiovascular, pulmonary, renal, hepatic, haematologic, gastrointestinal (endocrine or immunologic disease), at screening. 3. donation of 500 ml or more blood within the previous 3 months. 4. use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 21 days (or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the investigator and flatley discovery labs medical monitor the medication will not interfere with the study procedures or compromise subject safety. 5. smoking or use tobacco products or substitutes equivalent to \> 15 cigarettes/day. 6. any subject attempting to father a child within 3 months of their follow-up visit.
the effect of clove oil on labor pain

Conditions: Labor Pain

Summary: the study has two groups. one of them is experimental group that is given massage with clove oil. the other one is control group that is given standard midwifery care. each group consists of 30 women. we will evaluate their labor pain scores by using visual analogue scale before and after massage application.

labor is a painful process. that's why there are lots of nonpharmacological methods to reduce labor pain. especially most clinical guide suggests giving massage to pregnant who has labor pain. in the literature, there are a lot of study examining effectiveness of massage techniques. however there is no study about massage application with clove oil on labor pain. the investigators would like to give a massage with clove oil to pregnants to reduce their labor pain. hereby the investigators will evaluate effectiveness of clove oil.

Eligibility criteria:
inclusion criteria: * all of volunteer and pregnant women is 18-35 years old. exclusion criteria: * the pregnant women has any obstetrical complications.

Keywords: labor pain midwifery pregnant women massage
reducing alcohol dependence among hiv-positive individuals

Conditions: Alcohol Dependence

Summary: the purpose of this study is to compare the effects of interventions for drinking-reduction and antiretroviral therapy (art) adherence among hiv-positive primary care patients. the interventions consist of brief meetings to discuss drinking and art adherence enhanced with daily self-monitoring through the use of a smart phone application that tracks drinking and other aspects of health. these meetings will either be based on the clinician's guide, a brief intervention for heavy drinking in primary care settings advocated by the national institute on alcohol abuse and alcoholism, or motivational interviewing. participants will be assessed at baseline, 30, 60, 90 days, 6 and 12 months after baseline. by the end of treatment (60 days) and throughout the follow-up period, alcohol use is expected to highest among participants who receive the clinician's guide alone, intermediate among participants who receive the enhanced clinician's guide, and lowest among participants who receive enhanced motivational interviewing.

hiv infection is a widespread health problem in the u.s. antiretroviral (art) therapy has increased longevity and changed the nature of risk factors for morbidity and mortality. alcohol consumption has become an increasingly serious health issue among hiv primary care patients. drinking is a key factor in progression to severe liver damage (especially those co-infected with hepatitis), and liver disease is now one of the most common causes of death among those with hiv. excess drinking is also associated with medication noncompliance, reduces the effect of antiretroviral treatment, and is linked to other health problems. therefore, helping hiv patients reduce unsafe drinking is crucial to their long-term health. this study aims to evaluate two evidence-based approaches when combined with an innovative smart phone application designed to help users track drinking and other aspects of health. an effective, easily implemented alcohol-reduction intervention could be incorporated into standard care in hiv clinics to help prevent or slow the progress of some medical problems in hiv-infected individuals, improve medication compliance, prolong lifespan and decrease risk behavior associated with alcohol use.

Eligibility criteria:
inclusion criteria: * age 18 and older * patient had 4 or more drinks on any day in prior 30 days * patient meets criteria for dsm-iv current alcohol dependence * hiv+ exclusion criteria: * patient is psychotic, suicidal, or homicidal * patient has gross cognitive impairment * patient does not speak english or spanish * patient has plans to leave the greater new york metropolitan area within the study period * patient has vision/hearing impairment that would preclude participation

Keywords: human immunodeficiency virus unsafe drinking antiretroviral therapy (art)
evaluation of the triage risk screening tool

Conditions: Elderly Subject Fragility

Summary: this study tried to describe diagnostic properties of trst completed by an emergency doctor, for screening process for fragility of elderly subjects admitted at the accident and emergency department.

a constant increase of emergencies admission of elderly subjects is registered. the current problem is the identification and early screening of these patients upon admission at the accident and emergency department for early tracking in geriatric network. this early assessment could allow a shorter waiting time, a better orientation of patients and a decrease in the number of re-hospitalization. there are many screening process for fragility tests but there seem to be nonspecifically. the advantage of trst is its simplicity and speed of filling. in 2015, duc et al. have found that trst may be a screening instrument for elderly subject and is going to require geriatric mobile team (gmt) for evaluation. unfortunately, the threshold may be too sensitive and gmt solicitation is too high.

Eligibility criteria:
inclusion criteria: * patients who are more than 75 years old * admitted to the emergency department for medical or surgical reason * admitted from monday to friday (8h30 am- 6h pm) exclusion criteria: * patient with specific care (vital emergency, urgent surgery) * patient or his support person opposing the use of data

Keywords: screening instrument
prediction model based on computed tomography liver volume for the short-term mortality in hepatitis b related acute-on-chronic

Conditions: Acute-on-Chronic Liver Failure; Hepatitis B, Chronic

Summary: hbv-related acute-on-chronic liver failure (hbv-aclf) deteriorates rapidly with a high short-term mortality. early identification and accurate prognostic prediction was critical to improve survival rate. this study was sought to determine the liver volumetry as predictor for short-term mortality in hbv-aclf and develop a simpler prognostic model based on liver morphology. liver volumetry were determined from ct at admission. univariate and multivariate logistic regression were used to identify the optimum prognostic indicators and develop prognostic model. additionally, receiver operating characteristic curves were analyzed to evaluate the predictive ability of the model.

hbv-aclf deteriorates rapidly with a high short-term mortality and early identification and accurate prognostic prediction may be the key to make clinical decision and improve survival rate. liver volume, non-invasively reflects the balance of structural collapse with hepatic regeneration, predicting the prognosis of liver diseases. however, there is no idea whether the liver volume is an indicator to predict the mortality of hbv-aclf patients. the present study evaluated the difference of liver volume between 28-day survival group and non-survivals and developed a new prognostic model based on liver volume . this study highlighted the significance of liver morphology in predicting the outcome of hbv-aclf for the first time.

Eligibility criteria:
inclusion criteria: 1. age 18-70 years, male or female. 2. acute hepatic insult manifesting as jaundice and coagulopathy, complicated within 4 weeks by ascites, and/or encephalopathy in a patient with chronic hbv infection 3. abdominal ct examination was performed within 3 days after admission 4. biochemical examinations were available within 3 days before or after ct scan exclusion criteria: 1. patients with evidence of non-b hepatitis virus: alcohol abuse leads to liver failure, autoimmune leads to liver failure, oxic or other causes that might lead to liver failure 2. past or current hepatocellular carcinoma 3. serious diseases in other organ systems 4. chronic liver failure 5. there was no ct imaging data or the interval between ct scan and diagnosis of liver failure \>3 days

Keywords: hepatitis b acute-on-chronic liver failure liver volume prognostic model
ventricular pace suppression versus intrinsic rhythm support study

Conditions: Sick Sinus Syndrome

Summary: the objective of this study is to intra-individually compare the performances of two pacemaker algorithms designed to reduce unnecessary right ventricular pacing: intrinsic rhythm support plus (irsplus) and ventricular pace suppression (vps). the study will compare ventricular pacing percentage, long-term atrio-ventricular conduction time, occurrences of atrial tachyarrhythmic events and atrial fibrillation burden percentage in patients implanted with a pacemaker for sick sinus syndrome.


Eligibility criteria:
inclusion criteria: * patients over 18 years of age; * patient has proven informed consent; * subject with indication of dual chamber pacemaker due to sinus node dysfunction; * subjects with a dual chamber pacemaker already implanted within six months from enrollment, provided that ventricular pacing percentage ≤ 40% and with the right ventricular lead in the apical position; * stable medical situation; * stable geographical situation; exclusion criteria: * permanent or paroxysmal av block ≥ ii; * permanent atrial fibrillation/atrial flutter; * device replacement; * patient with a poor echocardiographic window; * patient already implanted with the right ventricular lead not in the apical position; * subjects with a dual chamber pacemaker, implanted later than six months; * subjects with a dual chamber pacemaker with ventricular pacing percentage ≥ 40%; * contraindication for ddd(r)-adi(r) or ddd(r) pacing modes; * vps or irsplus algorithm contraindications; * age \< 18 years; * life expectancy \< 12 months; * cardiac surgery planned within the fu period; * participation to another clinical investigation;

Keywords: sick sinus syndrome ventricular pacing minimal ventricular pacing ventricular pacing suppression intrinsic rhythm support long term av