Kornimate/medical-research-clean huggingface dataset:
characteristics of popliteal sciatic nerve block in patients with and without diabetic neuropathy

Conditions: Diabetic Neuropathy

Summary: background between 25 and 55% of diabetic patients develop neuropathy secondary to hyperglycemia. high resolution bedside ultrasound has been demonstrated to be a useful tool to detect the presence of neuropathy prior to block performance, by measuring the cross-sectional area of the posterior tibial nerve: a value superior to 19.01 mm2 at a distance of 3 cm above the medial malleolus has an optimal threshold value for identification of diabetic sensorimotor polyneuropathy. animal data showed that duration of sciatic nerve block with local anesthetics is longer in diabetic rats compared with non-diabetic rats. characteristics of a peripheral nerve blockade in humans with diabetic sensorimotor neuropathy are unknown. aim the aim of this study is to compare duration of analgesia and other characteristics of an ultrasound-guided popliteal sciatic nerve block between diabetic patients with neuropathy, diabetic patients without neuropathy and non-diabetic patients without neuropathy, based on the ultrasound-measured cross-sectional area of the posterior tibial nerve. hypothesis we hypothesize that diabetic patients with neuropathy will have a duration of analgesia lasting 50% longer than patients without neuropathy. methods this will be an observational study on diabetic and non-diabetic patients, with and without peripheral neuropathy, based on the ultrasound-measured cross sectional area of the posterior tibial nerve 3 cm above the medial malleolus (cut-off value, 19.01 mm2) all patients will receive ultrasound-guided sciatic nerve block with 30 ml1:1 mixture of lidocaine 1% and bupivacaine 0.5%, with the needle tip positioned at the bifurcation of the sciatic nerve in peroneal and tibial nerve, below the common fascia or paraneurium. block success will be confirmed by loss of sensation to pinprick in the distribution of the common peroneal and tibial nerves 30 minutes following local anesthetic injection. this procedure will be completed by a saphenous nerve block. postoperative pain management will be standardized. pain and block-related endpoints will be collected such as onset time of action of sensory and motor blockades, duration of analgesia, pain scores and opiates consumption among others. relevance defining the duration of analgesia in case of diabetic neuropathy will help regional anesthesiologists to better define the type and doses of drugs that will be injected and to better prescribe the postoperative multimodal analgesic treatment.


Eligibility criteria:
inclusion criteria: * adult patients 18-85 years old * patients scheduled to undergo foot surgery exclusion criteria * patients with neuropathy caused by genetic, metabolic and inflammatory diseases, as well as toxic agents and drugs (eg chemotherapy agents); * patients with chronic pain syndrome; * patients with contraindications for regional anesthesia (e.g., allergy to local anesthetics); * chronic consumption of opioids.

Keywords: regional anesthesia diabetic neuropathy ultrasound
effectiveness of a high-risk diabetic patients program

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to determine whether case management for type 2 diabetic patients with target-organ damage improves quality of care compared to usual care.


Eligibility criteria:
inclusion criteria: * patients with diabetes mellitus * age between 18 and 80 years old * target organ damage (either macrovascular or microvascular) * patient's acceptance to participate exclusion criteria: * moderate to severe dementia * life expectancy lower than one year * justified negative from primary care physician to intervene the patient.

Keywords: diabetes mellitus, type 2 [c18.452.394.750.149] case management [n04.590.233.624.250] disease management [n04.590.607] diabetes complications [c19.246.099]
a comparison of intraocular pressures (iop) during prolonged trendelenburg positioning in morbidly obese and thin patients

Conditions: Intraocular Pressure Disorder

Summary: this study is to determine if there is a rise in eye pressure, when patients are placed in a position where the head is lower than the rest of the body during long surgeries.

eye pressure will be measured at protocol specified intervals.

Eligibility criteria:
inclusion criteria: 1. subjects undergoing prolonged procedures (scheduled \>3hr) in steep trendelenburg position (eg. robotic prostatectomy, hysterectomy, cystectomy) 2. morbidly obese subjects: bmi ≥ 35 kg/m2 3. thin subjects: bmi ≤ 30 kg/m2 4. age 18-70 5. asa (american society of anesthesiologists) physical status classification i, ii, or iii exclusion criteria: 1. known history of glaucoma 2. note:if initial iop is noted to be \>21mmhg (millimeters of mercury), patient will be excluded from study and an ophthalmology consultation will be obtained.surgery will not be postponed. 3. recent use of iop lowering topical ophthalmic agents 4. allergy to latex or proparacaine hydrochloride ophthalmic solution 5. patients with active corneal epithelial defects or history of recurrent corneal erosion 6. patients with underlying disorders that can directly increase intraocular pressure (thyroid eye disease, intra orbital tumors, orbital vascular malformation, sturge-weber disease, carotid or dural cavernous arteriovenous malformation, cavernous sinus pathology) 7. history of corneal surgery, to include lasik (laser-assisted in-situ keratomileusis) 8. any eye surgery within prior 1 month 9. known pregnancy 10. cognitive impairment
the effect of hyaluronic acid intrauterine wash on endometrial receptivity and pregnancy outcome

Conditions: Infertile Patients

Summary: hyaluronic acid intrauterine wash is done for infertile females undergoing intracytoplasmic sperm injection on the day of oocyte retrieval. endometrial receptivity parameters, including the subendometrial vasculature indices were measured before and after the intervention for purpose of studying the effect of hyaluronic acid on improvement of the endometrial receptivity and subsequently the pregnancy outcome


Eligibility criteria:
inclusion criteria: * infertile females aged 18-40 years. * infertile females scheduled for gnrh antagonist protocol of fresh icsi cycle. * females use dual stimulation (gnrh agonist plus ovetrelle) for ovulation triggering. exclusion criteria: * infertile females diagnosed as a poor responder. * infertile females diagnosed with uterine pathology. * infertile females who are scheduled for a frozen icsi cycle. * infertile females diagnosed with endocrine diseases like thyroid disease, diabetes mellitus, and hyperprolactinemia. * infertile females diagnosed with thrombocytopenia.

Keywords: hyaluronic acid intrauterine wash endometrial receptivity pregnancy outcome
the treatment of premature infants with brain injury by autologous umbilical cord blood stem cells

Conditions: Safety Issues; Effect of Drugs

Summary: to study the safety and effect of autologous umbilical cord blood stem cells for treatment brain injury

the purpose of this study is to evaluate the safety and effect of infusions of autologous (the patient's own)umbilical cord blood stem cells in newborn infants with hypoxic-ischemic encephalopathy. for this study, infants who have signs of moderate to severe encephalopathy at birth whose mothers have previously consented to providing cord blood stem cells for the gunagdong cord blood bank,or provided verbal consent for cord blood collection for the possibility of their baby's participation in this trial, can receive their own cord blood stem cells if an adequate number of cells that meet guangdong cord blood bank quality standards are available in the first 14 postnatal days. study activities also include serial blood draws concurrent with clinically indicated blood draws with a total volume of no more than 5 milliliters (1 teaspoon) from all study related tests. babies will be followed for neurodevelopmental outcome at 4 - 6 and 9 - 12 months. mri's will be obtained per clinical routine and results will be analyzed and described in study reports.

Eligibility criteria:
inclusion criteria: * mothers must have consented for cord blood collection at delivery * cord blood must be available for extraction of stem cells. -\>28 weeks gestation,\<37weeks gestation * cord or neonatal ph\ 16 milliequivalents per liter (meq/l) or history of acute perinatal event * either a 10 minute apgar \< 5 or continued need for ventilation. * all infants must have signs of encephalopathy within 6 hours of age. exclusion criteria: * presence of known chromosomal anomaly. * presence of major congenital anomalies. * severe intrauterine growth restriction (weight \<1800g) * infants in extremis for whom no additional intensive therapy will be offered by attending neonatologist. * parents refuse consent. * attending neonatologist refuses consent. * failure to collect the infant's cord blood and/or laboratory unable to process cord blood.

Keywords: autologous umbilical cord blood stem cells safety effect brain injury
elizabeth glaser pediatric aids foundation maternal events and pregnancy outcomes (mep project)a multi-site protocol

Conditions: HIV Infections; HIV Positive; Pregnant Women

Summary: the purpose of this study is to find out if antiretroviral drugs are safe and well tolerated by hiv-positive pregnant women and their infants in south africa and zambia.

although the use of haart in pregnancy has significantly reduced rates of vertical transmission of hiv-1, some questions remain regarding the safety of these therapies and their potential impact on the uninfected infant. the overall goal of the project is to establish a voluntary exposure-registry and perform observational surveillance on hiv - positive pregnant women who are exposed to antiretroviral products during the prenatal period, in order to evaluate the outcome of the pregnancy and safety of the products in hiv-positive pregnant women, and their infants.

Eligibility criteria:
inclusion criteria: * hiv positive pregnant woman on antiretroviral treatment * able and willing to participate and provide informed consent * be at least 18 years of age or older than legal age to provide consent * if under legal age, must have legal guardian who is able to give consent * be an emancipated minor exclusion criteria: * history of mental illness * history of condition that would preclude provision of consent * inability to provide consent

Keywords: hiv pregnancy antiretrovirals hiv seronegativity treatment experienced
cla metabolism and effects on human health

Conditions: Dietary Modification; Inflammation; Body Composition, Beneficial

Summary: the purpose of the study is to investigate the effects of conjugated linoleic acid (cla) from dairy products on fatty acid metabolism and human health. a cla depletion-repletion study was carried out with healthy volunteers. cla depletion was achieved through an eight-week dairy fat restriction, followed by an eight-week repletion period consisting of intake of a butter naturally enriched with cla. changes in body composition, fasting glucose and insulin, inflammatory mediators, cell membranes' stability, plasma lipid levels and fatty acid composition of lipid classes are evaluated after depletion and repletion phases.

after collecting baseline blood samples, cla-depletion phase started with dietary orientation, by a registered dietitian, to the study subjects (n=29) to exclude from their diets any type of dairy fat for the following 8 weeks. blood samples were taken at the end of cla-depletion, and cla-repletion phase was initiated by dietitians' instructions: volunteers returned to their regular diets, and additionally consumed a cla-enriched butter for another 8-week period. blood samples were taken at the end of the cla-repletion phase. the effects of cla on the following parameters were evaluated: inflammatory mediators; fatty acid composition of erythrocytes, plasma phospholipids and cholesterol esters; body composition; clinical factors associated with the metabolic syndrome and indicators of cell membranes' stability.

Eligibility criteria:
inclusion criteria: * healthy volunteers; * 20 to 40 years; * bmi between 18.0 and 29.9 kg/m2. exclusion criteria: * use of dietary supplements; * smoker; * alcoholic; * under medication; * history of chronic disease

Keywords: cla-enriched butter cla metabolism inflammation
platelet reactivity and clinical thrombotic events study

Conditions: Acute Coronary Syndrome; Antiplatelet Therapy; Platelet Reactivity

Summary: platelet function testing has been considered for dapt strategy adjustments to reduce the patient's risk of ischemia and bleeding. although several previous rct studies did not find any benefit in the detection of platelet function， the previous studies were mostly low-risk populations, and the p2y12 receptor antagonists were simply clopidogrel, and the detection methods were relatively simple. therefore, the need for platelet monitoring in high-risk acs patients receiving new potent p2y12 inhibitor ticagrelor, as well as the diagnostic threshold for different platelet function assays needs further study. in addition, due to the differences on the response to anti-platelet drugs between the east and the west, it is not appropriate to simply refer to the conclusion of the other party. however, as of now, there is no large sample randomized controlled study systematically focused on the applicability and status of platelet function tests in east asian populations, especially chinese populations.


Eligibility criteria:
inclusion criteria: 1. age 18-80 years old; 2. there was a history of at least one acute coronary syndrome (acs) attack within 14 days before enrollment, including unstable angina, non-st elevation myocardial infarction, or st-elevation myocardial infarction; 3. being treated with aspirin and a p2y12 inhibitor (clopidogrel or ticagrelor); 4. plan to apply dual antiplatelet drugs (dapt, aspirin + p2y12 inhibitor) for at least 12 months; 5. voluntary signature of informed consent exclusion criteria: 1. in combination with other anti-platelet drugs, such as cilostazol; 2. have received glycoprotein iib/iiia inhibitor within 72 hours before enrollment; 3. receving a p2y12 inhibitor loading does less than 72h or maintenance (unloaded) less than 5d; 4. plan to perform any coronary revascularization within 30 days; 5. the need for oral anticoagulants (warfarin, factor ii or factor x inhibitors); 6. predicted survival time \<12 months for patients with known severe progressive disease (such as malignancy) or extreme depletion of the disease; 7. pregnant women or pregnant people; 8. any situation that may interfere with the research process, such as dementia, delirium, alcoholism, etc.; 9. expected to undergo surgery within 1 year; 10. patients participating in other ongoing clinical studies

Keywords: platelet reactivity thrombotic events
influence of lipid lowering on impaired coronary flow

Conditions: Coronary Artery Disease

Summary: this study assess in patients with stable chest pain and coronary artery disease (cad) determined by coronary cta whether cholesterol lowering with regression of coronary adverse plaque characteristics is associated with recovery of impaired flow

multicenter, prospective study. 105 patients with stable chest pain, and moderate cad, statin naive (and ldl cholesterol \>2 mm), and at least one translesional ffrct value \<0.81 are randomized (patients with significant cad in the left main or other proximal segments are excluded from the study) to either "atorvastatin 40 mg daily" or "rosuvastatin 40 mg + ezetimibe 10 mg daily" treatment. patients are followed for 18 months with 2 ct scans performed at 9 months and one at 18 months. at each 4 ct scans blinded corelab analyses of plaque characteristics and volumes as well as ffrct calculation (heartflow) are performed. the primary endpoint is changes in ffrct values from 0 to 18 months. secondary endpoints are 1 changes in ffrct values from 0 to 9 months of follow-up, and changes in low density plaques volumes and number of lesions with positive remodeling over time relative to changes in ldl cholesterol.

Eligibility criteria:
inclusion criteria: * age ≥35 y * symptoms suggestive of stable cad * no pre-cta known cad * at least one lesion with ffrct \<0.81 * sinus rhythm * ldl cholesterol \>2.0 mm * statin use \>2 months * life expentancy \< 3 years * signed informed consent exclusion criteria: * known cad * poor cta image quality inadequiate for ffrct analysis (determined by corelab) * significant cad in the left main or proximal coronary segments * referral to invasive catheterization * statin intolerance * bmi \>40 * allergy to ionidated contrast * pregnancy

Keywords: fractional flow reserve ct derived fractional flow reserve coronary artery disease ischemic heart disease stable chest pain statin blood cholesterol level
evaluation of pain in urinary collections in pediatric emergencies in children who have not acquired cleanliness

Conditions: Urinary Tract Infections in Children

Summary: observational study.

febrile urinary infections account for 5% of unexplained causes of fever in children up to 2 years of age. urinary samples are therefore very common in pediatric emergencies. in children who have not acquired cleanliness, the most used method of collection is the placement of a sterile urine bag on the perineum. it allows a noninvasive urinary collection. however from a bacteriological point of view this method is debatable because the rate of contamination of the collections is important. this mode of collection is of interest only to exclude a urinary infection, by the realization of a urinary strip. pocket-collected urine is not reliable for bacteriological analysis in culture. for example, if the urine strip is positive, the american academy of pediatrics recommends urine sampling by urine sampling (or other invasive methods) for culture. the urine bag should be changed every 30 minutes to avoid the risk of contamination. the technique is wait-and-see, the installation of several pockets is often necessary before obtaining urine. a study carried out in 2014 shows that in 39.4% of the cases the withdrawal of the urinary pouch was as much more painful than the urinary sounding, in the same patient. to our knowledge there is no other study dealing with the difference in pain engendered by these two methods. since the urinary catheterization is faster, bacteriologically justified and necessary if the pocket collection is positive, it seems legitimate to ask ourselves if we should not aim at a generalization of the urinary catheterization, as first intention, having not acquired cleanliness, requiring a withdrawal of urine for suspicion of urinary infection. many centers continue to use urinary pocket collection mainly, as the survey technique seems too invasive and painful.

Eligibility criteria:
inclusion criteria: children under 3 years of age who have not acquired the cleanliness present at the pediatric emergency department in rennes, where urine sampling is necessary in case of suspected urinary tract infection.
safety study for the use of rapamycin in children with familial adenomatous polyposis

Conditions: Familial Adenomatous Polyposis

Summary: the hypothesize of this research is that rapamycin is effective and well-tolerated in teenagers with familial adenomatous polyposis (fap). rapamycin could be effective in blocking the formation of adenomas and/or their evolution by decreasing their size and number. researchers aim to assess the safety profile of rapamycin in fap adolescents using a 2 low dose regimen.

fap is a rare genetic disease linked to mutations of apc gene. adenomatous polyps appear around the age of 10 and will evolve into colic adenocarcinoma. to date, there is no effective treatment; 100% of patients will develop colorectal cancer before 40 years. this risk is addressed by regular colonoscopy monitoring, in order to propose a timely prophylactic colectomy. rapamycin (sirolimus) is a drug that targets the mtor (mammalian target of rapamycin) protein involved in the pi3k-akt signalling pathway downstream of pi3k. there are interactions between the pi3k-akt pathway and the wnt/apc/-catenin pathway that is hyperactivated in fap. rapamycin was used out of indication with efficacy and good tolerance in 2 adolescents whose parents had refused colectomy. researchers recently demonstrated its effectiveness in a child with very severe juvenile polyposis. data are also available in animals, but no proof-of-concept studies have been conducted in humans. in france, rapamycin use is allowed in adults with kidney transplantation and pulmonary lymphangioleiomyomatosis. however, it is used on children over the market. according to the literature and the field experience, the hypothesize is that a through level of 3-8 ng/ml should be effective in children with fap, with a lower rate of adverse events.

Eligibility criteria:
inclusion criteria: * children aged 12 to 17 at time of inclusion. * patients with colonoscopy for diagnosis or follow-up of fap. * ≥ 5 polyps (\> 2 mm) at initial colonoscopy (v1). * free and informed consent, signed by both holders of parental authority/legal representative, with the accord of the minor patient. * affiliated with a social security scheme. * patients of childbearing potential must agree to the use of a method of contraception during the study. exclusion criteria: * inability to understand the nature and goals of the study and/or communication difficulties observed by the investigator. * contraindication to performing a colonoscopy. * \ 2 mm) registered during initial colonoscopy (v1). * advanced disease with high-grade dysplasia adenoma or even adenocarcinoma in situ that should required colectomy * signs of primary tuberculosis infection or respiratory infection * any other medical or psychological condition deemed incompatible with the proper conduct of the study according to the investigator. * contraindications to rapamycin use * participation in other biomedical research * deprivation of liberty of the legal guardians by judicial or administrative decision. * pregnancy, breastfeeding

Keywords: safety use rapamycin prophylaxis teenager
a study to evaluate the safety and potential efficacy of lt3001 drug product in subjects with ais

Conditions: Acute Ischemic Stroke

Summary: this is a multicenter, double-blind, single-dose, randomized, and placebo-controlled prospective phase iia clinical study, designed to evaluate lt3001 drug product versus placebo/control in subjects with ais.


Eligibility criteria:
inclusion criteria: * 18 to 90 years * nihss of 4 to 30 * diagnosis of ais within 24 hours after stroke symptoms onset exclusion criteria: * treatement with approved drug during the current ais * pre-stroke disability * imaging evidence of acute intracranial hemorrhage, intraparenchymal tumor, arteriovenous malformations, other central nervous system lesions that could increase bleeding risk, or aneurysm requiring treatment * suspected subarachnoid hemorrhage * seizure * uncontrolled hypertension * inr \>1.7 and/or abnormal aptt or platelet count \<100,000/mm3 * blood glucose concentration \ 400 mg/dl * lactating or pregnant subjects or those planning to become pregnant during the study * received anticoagulants and/or antiplatelet therapy and glycoprotein iib/iiia inhibitors within 48 hours * ais, myocardial infarction, serious head trauma or major surgery within 90 days * bleeding event within 21 days * puncture of noncompressible vessels within 7 days * severe hepatic, renal, and/or infectious disease
a long-term study of aripiprazole in patients with major depressive disorder

Conditions: Major Depressive Disorder

Summary: this trial is a 52-week safety study to evaluate the safety of adjunctive aripiprazole in outpatients with major depressive disorder who have experienced an incomplete response to an ongoing antidepressant trial.


Eligibility criteria:
inclusion criteria: * men and women, 18 years or older * experiencing major depressive disorder with a duration of minimally 8 weeks. * treatment history of an inadequate response to at least one and no more than four antidepressants