Kornimate/medical-research-clean huggingface dataset:
simvastatin in patients with isolated arterial hypertension

Conditions: Hypertension

Summary: the purpose of this study is to determine whether combined therapy with simvastatin and hypotensive drugs (acei or arb) may decrease the blood pressure. moreover, we would like to assess the influence of isolated hypertension on endothelial injury, and on the development of atherosclerosis.

hypertension is one of the most important predictors of cardiovascular diseases (cvd). due to the fact that hypertension frequently coexists with hypercholesterolemia and diabetes which increase the risk of cvds development, it is advisable to use the optimal combined therapy (hypotensive + hypolipidemic + hypoglycemic)in this group of patients. statins are the most effective and widely used drugs for the treatment of hypercholesterolemia. according to the available experimental and clinical data they may decrease the blood pressure (bp) in normotensive and hypertensive patients. however, it is still difficult to determine to what degree the reduction of both blood pressure and cardiovascular risk is due to hypotensive or hypolipidemic/pleiotropic effects of statins.

Eligibility criteria:
inclusion criteria: * isolated hypertension (i or ii class according to esh guidelines 2009) exclusion criteria: * ischemic heart disease, prior percutaneous coronary intervention (pci), prior coronary artery bypass grafting (cabg), heart failure, diabetes, hyperlipidemia, active smokers

Keywords: statins isolated hypertension atherosclerosis lipid profile
histologic diagnoses of incidentally detected lesions on mri

Conditions: Breast Cancer

Summary: patients who received breast mri will be evaluated for a variety of indications including : # each indication : 1) known cancer staging for local exent, 2)high risk, 3)high suspicion clinical finding, 4)questionable mammo finding, 5)silicone leak the number of incidental lesions not detected by any other method that were subsequently subjected to biopsy with the following birads categories 3-# reasons for bx 4-# 5-# of the lesions detected % of each birads category were postive histologies-ductal, lobular, dcis, etc. and negative (fibrosis, hyperplasia, etc.) criteria for classification: morphology, dynamics, clinical significance will be evaluated and a predictive value established.

patients who received breast mri will be evaluated for a variety of indications including ? # each indication : 1) known cancer staging for local exent, 2)high risk, 3)high suspicion clinical finding, 4)questionable mammo finding, 5)silicone leak the number of incidental lesions not detected by any other method that were subsequently subjected to biopsy with the following birads categories 3-# reasons for bx 4-# 5-# of the lesions detected % of each birads category were postive histologies-ductal, lobular, dcis, etc. and negative (fibrosis, hyperplasia, etc.) criteria for classification: morphology, dynamics, clinical significance will be evaluated and a predictive value established. this study is limited to retrospective chart review with the only foreseeable risk being that of disclosure of phi. to minimize this risk, data collection forms will be identified by subject id number. a master list of these id numbers linked to subject medical record number will be maintained in the investigator's file and kept in a secure location accessible only to the study team for purposes of verification of data and validation of results. the medical record number will not be recorded on any other form containing subject phi. the only foreseeable breach of confidentiality would be for the security of the investigator's files to be compromised

Eligibility criteria:
inclusion criteria: * all patients subjected to biopsy as a result of findings seen only on mri exclusion criteria: * none

Keywords: breast cancer
assessment of cmv-specific elispot assay for predicting cmv infection in kidney transplant recipients

Conditions: Kidney Transplantation Recipients

Summary: cmv is one of the most important opportunistic infection in transplant recipients. in south korea, more than 95% of adults reveal sero-positivity for cmv igg. until now, sero-positivity for cmv igg before solid organ transplantation is a laboratory test of choice to stratify the risk of cmv reactivation after solid organ transplantation. theoretically, cmv-specific cell-mediate immune response before solid organ transplantation will further categorize the patients into high or low risk of cmv development after solid organ transplantation. the investigators thus evaluate the usefulness of cmv-specific elispot assay in kidney transplant candidates to predict the development of cmv infection after kidney transplantation.

between mar 2014 and mar 2015, all patients admitted in the kidney transplant unit will be enrolled in this study. all patients will receive cmv-specific elispot assay and be prospectively followed for the development of cmv infection.

Eligibility criteria:
inclusion criteria: * age 16 or more * agree with written informed consent exclusion criteria: * donor cmv igg (+) and recipient cmv igg (-)
observational program to assess use of intermittent adjuvant deprivation therapy with leuprorelin (lucrin depot) in patients with advanced prostate cancer (pca) in russia

Conditions: Prostate Cancer

Summary: the objective of this study was to describe treatment patterns of leuprorelin over 2 years using an intermittent, adjuvant regimen in participants with advanced prostate cancer (pca)

participants started hormone treatment with leuprorelin 3.75 mg once every 28 days, subcutaneously (sc) or intramuscularly (im). duration of induction therapy was at least 6 months (6-9 months) during which psa and testosterone levels were measured every 3 months. when psa decreased by greater than 90% from baseline (psa less than 10 ng/ml) or became lower than 4.0 ng/ml (for 2 consecutive measurements made at least 2 weeks apart) the participants were included into intermittent hormone therapy regimen group (iad). participants with psa decrease not achieved greater than 90% or less than or equal to 4.0 ng/ml were given either continuous hormone therapy (cad) or chemotherapy. therapy was stopped if participants had psa decrease greater than 90% from baseline or values less than 4.0 ng/ml after 6-9 months of continuous hormone therapy. psa and testosterone were measured every 4 weeks. if psa became greater than or equal to 10.0 ng/ml, hormone therapy was resumed until psa was less than 4.0 ng/ml for 2 consecutive measurements made at least 2 weeks apart. duration of hormonal therapy cycle was at least 3 months. then intermittent treatment was performed according to a similar scheme. psa and testosterone levels were determined every 12 weeks when hormone therapy was administered and every 4 weeks after it was stopped. the treatment was carried out for 2 years or until hormone refractory prostate cancer (hrpc) developed.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed advanced pca meeting the following criteria: 1. any tumor, node 1, metastasis 0 2. any tumor, node 0, metastasis 1 \[according to tumor node metastasis classification 2009\] 2. participants planned for administration of leuprorelin 3. world health organization status 0-1 4. life expectancy at least 2 years exclusion criteria: 1. contraindications to administration of leuprorelin: 1. hypersensitivity to leuprorelin similar products of protein origin or any of the excipients in drug product composition 2. surgical castration 2. hormone-refractory pca 3. presence of another malignant tumor (except skin cancer) 4. previous administration of hormone therapy with gonadotropin-releasing hormone agonists or antiandrogens 5. previous administration of radiotherapy or chemotherapy course within 1 month 6. testosterone level less than or equal to 50 ng/dl (less than or equal to 1.7 mmol/l) at time of inclusion 7. extremely high level of psa (greater than or equal to 1000 ng/ml) 8. other severe diseases in stage of decompensation 9. other contraindications, that make the participant's participation impossible (by investigator judgment) 10. previous enrollment in the present program

Keywords: lucrin depot intermittent adjuvant regimen advanced prostate cancer leuprorelin
effectiveness of midodrine as an adjuvant to norepinephrine in weaning critically ill patients from vasopressors

Conditions: Shock

Summary: this study aims to evaluate the effectiveness of midodrine as an adjuvant to norepinephrine in weaning critically ill patients from vasopressors


Eligibility criteria:
inclusion criteria: * patients with refractory hypotension on an intravenous vasopressor for more than 24 h but deemed clinically stable. * patients on noradrenaline support \<10 μg/min exclusion criteria: * known allergy to midodrine. * severe shock state, as evidenced by multiple vasopressor infusions or high vasopressor requirement (i.e. noradrenaline \>10 μg/min) * patients with severe organic heart disease (e.g., heart failure, sever aortic stenosis), pregnancy, thyrotoxicosis or pheochromocytoma. * those with no enteral route available.
effects of sevoflurane and propofol on optic nerve sheath diameter during laparoscopic gynecologic surgery

Conditions: Laparoscopic Gynecologic Surgery

Summary: intracranial pressure（icp) increases during laparoscopic gynecologic surgery increase (icp) and may alter optic nerve sheath diameter(onsd).this study measures onsd in different team because sevoflurane and propofol have different effects on icp.half of participants will receive sevoflurane anesthesia,while the other half undergo propofol anesthesia.

due to the anatomical and physiological characteristics of optic nerve sheath ,onsd increases when icp rises. sevoflurane and propofol have different effects on icp.when sevoflurane concentration \>1.1 minimum alveolar concentration（mac),icp increases because of cerebral vasodilatation；on the other hand ,propofol constricts the blood vessels and icp decreases. icp increases during laparoscopic gynecologic surgery because of steep trendelenburg position and pneumoperitoneum . meanwhile,sevoflurane affects self regulation of cerebral blood flow on the way of dose dependent,but propofol has no effects on self regulation of cerebral blood flow.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists physical status diagnosed as i or ii exclusion criteria: * neuromuscular diseases;laboratory abnormalities in electrolytes; liver and kidney dysfunction;allergy to general anesthetics;pregnancy;ocular lesions including ocular trauma, optic neuritis, optic nerve tumor.

Keywords: sevoflurane propofol intracranial pressure optic nerve sheath diameter
a setting focus overdose prevention intervention

Conditions: HIV Infections; HCV; Drug Overdose

Summary: a pilot injection-setting targeted peer-driven intervention to reduce hiv and hepatitis c virus transmission and overdose risk behaviors among people who inject drugs (pwid).

this is a pilot of an injection setting targeted peer-driven intervention to reduce hiv/hcv transmission and overdose risk behaviors. participants will be randomized to conditions: 1) peer education and stocking of semi-public injection settings (spis) with risk reduction materials, and the standard of care. based on their spis use, 120 index pwid participants will be selected. a conceptual model for the intervention: the conceptual model is based on social influence, social network, and social cognitive theory. the prior work delineated social influence mechanisms. it is expected that training and modeling of effective communication skills will increase the occurrence of conversations on hiv/hcv and overdose prevention. these conversations will then alter perceived descriptive and prescriptive social norms of risk behaviors. the prior work is being enhanced by increasing the availability of risk reduction materials as well as the cuing and modeling risk reduction behaviors in risk settings. it has been found that pwid are motivated to conduct peer education; it enhances their status and provides them a prosocial role in the community. it is hypothesized that peer outreach and supply of materials to spis will lead to reduced sharing of injection equipment and increased naloxone availability.

Eligibility criteria:
inclusion criteria: * current drug user (opioid use in the prior two weeks) exclusion criteria: * any mental or physical health impairment that impedes ability to participate
niv and glottis-diaphragm synchrony

Conditions: Noninvasive Ventilation; NAVA Catheter; Hypercapnic Exacerbation COPD

Summary: noninvasive ventilation (niv) can provide ventilatory support in selected patients with acute respiratory failure, for instance due to acute exacerbation of copd and acute heart failure. advantages of noninvasive ventilation compared to invasive mechanical ventilation include absence of complications associated with endotracheal intubation, lower risk of pneumonia, lower level or even absence of sedation and the ability of the patient to verbally communicate. however, in approximately 30% of patients niv fails and endotracheal intubation is needed to provide optimal ventilatory support. surprisingly, very few studies have investigated why patients fail on niv. clinical observations indicated that agitation, delirium and most importantly asynchrony between patient and ventilator play a role in unsuccessful support with niv. the upper airways are bypassed during endotracheal intubation. however, with niv the upper airways may play a role in the efficiency of ventilatory support. in normal breathing the upper airways actively dilate before initiation of inspiratory flow. this is a highly appropriate response as it prevents narrowing of the upper airways during inspiration, which would result in elevated inspiratory resistance. experiments in newborn lambs have shown that niv has profound effects on physiology of the upper airways. positive pressure during inspiration results in constriction of upper airway muscles in the early phase of inspiration. this results in elevated upper airway resistance with lower tidal volume delivered to the lungs. subsequent studies revealed that reflexes that mediate this response originate in vagal afferences located in the lower airways. from an evolutionary point of view this might be an appropriate response, as high pressure delivered to the lungs may induce barotraumas. however, these responses may negatively affect the efficiency of ventilatory support delivered during niv. the understanding of upper airway constriction and dilation during niv is rudimentary. this study aims at determining the effect of niv on regulation of upper airway patency in patients with copd.


Eligibility criteria:
inclusion criteria: * informed consent * copd * hypercapnic respiratory acidosis * clinical need of niv ventilation on the intensive care * nava catheter in situ exclusion criteria: * pre-existent muscle disease (congenital or acquired) or diseases / disorders known to be associated with myopathy including auto-immune diseases. * diabetes * upper airway/esophageal/mouth or face pathology (i.e. recent surgery, esophageal varices, diaphragmatic hernia) * recent (\< 1 month) nasal bleeding * allergic to xylocaïne

Keywords: glottis respiratory muscles upper airway noninvasive ventilation
olanzapine given in combination with zonisamide sr to prevent weight gain in schizophrenic subjects

Conditions: Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder

Summary: the purpose of this study is to determine if zonisamide sr will prevent weight gain in schizophrenic subjects who take olanzapine (zyprexa)


Eligibility criteria:
inclusion criteria: * male or female subjects,18-55 years of age * outpatients diagnosed with schizophrenia, schizoaffective disorder, or schizophreniform disorder * body mass index (bmi) between 22-35 kg/m2 (inclusive) * negative serum pregnancy test in women of child-bearing potential * if women of child-bearing potential, must be non-lactating and agree to use an acceptable form of contraception, which in all cases, includes one type of barrier method, throughout the study period and for 30 days after discontinuation of study drug * subject requires a change in antipsychotic treatment and olanzapine is deemed by the investigator to be a reasonable antipsychotic treatment choice * no clinically significant abnormality on ecg * no clinically significant laboratory abnormality * negative urine drug screen * must be considered reliable and possess a level of understanding that enables the subject to provide written informed consent and to comply with protocol procedures and schedule * must be able to read and understand english exclusion criteria: * diagnosis of substance dependence within the 6 months prior to randomization * diagnosis of substance abuse (except for nicotine and caffeine) within the 3 months prior to randomization * suicidal behavior or ideation within 3 months prior to randomization, or any current suicidal ideation or intent * presence of dementia or other organic brain syndrome * serious or unstable medical illnesses * known, uncorrected narrow-angle glaucoma * diagnosis of eating disorder as defined by dsm-iv within 6 months prior to randomization * require treatment with any typical or atypical antipsychotic in addition to olanzapine

Keywords: schizophrenia schizophreniform schizoaffective disorder zyprexa olanzapine
cryoablation of venous vascular malformations

Conditions: Venous Vascular Malformation

Summary: to now, two alternatives for the management of venous vascular malformations are recognized, appropriate to the location, size and patients: sclerosis and surgery. however, sclerosis is effective on symptoms in 80% of cases and excision removes the malformation completely or partially, but it is aggressive and recurrences are common.

in order to propose an additional alternative option, cryoablation has been recently tested with promising results. therefore, the purpose of this study is to evaluate the safety and efficacy of cryotherapy on venous vascular malformations. fourteen patients will be included after discussion in multidisciplinary meeting. patients will be follow until 6 months to evaluate the safety and the 6 months efficacy on symptoms. a mri will be perform at 6 months to evaluate the size of ablated zone following recist criteria.

Eligibility criteria:
inclusion criteria: * patient over 18 years, * initial radiological diagnosis of venous or glomovenous vascular malformation proved by doppler ultrasound and mri, * recurrence of symptoms after initial treatment, * symptomatic deformation :pain, tangible mass,functional discomfort * recurrence after treatment by surgery or sclerosis * cryotherapy considered technically feasible after discussion in multidisciplinary committee, * localization at distance from the skin and major neurovascular structures, * absence of contra-indication of anaesthesia, * signed informed consent, * coverage by french social security exclusion criteria: * localization of the lesion does not allow the implementation of cryotherapy in adequate conditions: ablation zone too close to the major anatomic structures (nerve), * tp \ 1.5 x control, anticoagulation * platelets \<90000/mm3, * progressive infection * patient included in another clinical study, * unable to undergo medical tests for geographical, social or psychological, * adult under a legal guardianship or unable to consent, * pregnancy and breastfeeding.

Keywords: cryoablation venous vascular malformation mri safety pain
maternal self-efficacy and motor development in premature infants: clinical trial protocol

Conditions: Premature Birth; Mothers of Newborn Infants

Summary: mothers of premature newborns face special home care situations due to the conditions of their children after hospital discharge; this requires promoting the positive perception of maternal self-efficacy and thus achieving the reinforcement of behaviors related to the demand for care in relation to motor development. * objective: determine the effect of an interdisciplinary intervention program on maternal self-efficacy and motor development of premature children in the cities of bogotá and tunja in comparison with the traditional kangaroo program. * methodology: experimental study, with pretest/posttest design, with experimental and control group, which determines the baseline. with initial evaluation of the groups, randomized assignment, and post-intervention evaluation at 4 weeks and flow-up at 8 weeks. the intervention will be developed in two scenarios, in the outpatient kangaroo plan consultation and at home. the experimental group will receive an intervention based on the promotion of maternal self-efficacy and the motor development of the premature baby. the control group will have traditional kangaroo program care. the sample calculation is 92 participants, 46 in the experimental group and 46 in the control group. the intervention, evaluations and data analysis will be developed by blinded professionals. an analysis of the data will be done by intention to treat. * type of results expected to be obtained: it is expected to obtain an intervention that promotes maternal self-efficacy for the adequate stimulation of the motor development of the premature baby. it is expected to enhance the confidence and empowerment of the maternal role, the motor development of children in accordance with the corrected age and the incorporation of ict for monitoring at home.


Eligibility criteria:
inclusion criteria: * mothers of a child born prematurely who attend the outpatient kangaroo mother program in bogotá, tunja and zipaquirá in the period between 2024 and 2025. * premature children between 32 to 36.6 weeks who participate in the outpatient kangaroo mother program in bogotá, tunja and zipaquirá in the period between 2024 and 2025. exclusion criteria: * mothers who manifest any diagnosed mental limitation to participate in the study. * premature children with hemodynamic alterations, congenital malformations, chromosomal syndromes, esophageal atresia, ductus arteriovenosus, heart disease and neurological pathologies.

Keywords: premature newborn mothers self-efficacy motor skills motor praxis outpatient care information and communication technologies kangaroo mother care nursing physical therapy
an observational study to evaluate effectiveness and safety of amosartan plus tablet

Conditions: Hypertension,Essential

Summary: this study was to evaluate the therapeutic effect and safety of amosartan plus tablet administration in uncontrolled essential hypertension patients. during the routine medical visit, amosartan plus tablets were administered to patients in need of blood pressure control according to the investigator's judgment. in this study, effectiveness and safety information of treatment of amosartan plus tablets was followed for 6 months (up to 12 months), and observation of the target patients was terminated after collecting relevant data. as this study was a non-interventional observational study, all patients received prescriptions according to the routine treatment procedure, and there were no visits or procedures required according to the observational study protocol.

this study was a multi-center, prospective, non-interventional, observational study of factors affecting blood pressure after treatment with amosartan plus tablet in uncontrolled essential hypertension patients. data was collected from patients receiving routine treatment at hospitals in south korea. each patient visited the institution according to the protocol that designed the follow-up visits for six months to examine the effectiveness and safety of amosartan plus tablet. this study approved by the institutions' irbs and was conducted in compliance with clinical research ethics regulations.

Eligibility criteria:
inclusion criteria: * uncontrolled essential hypertension patients * those who have already decided to administer amosartan plus tablet under the medical judgment of the researcher * those who voluntarily decided to participate in this study and consented in writing to the consent form exclusion criteria: * patients for whom use of amosartan plus tablet is prohibited