Kornimate/medical-research-clean huggingface dataset:
skin biopsies and dna analysis in patients receiving irinotecan or gemcitabine for advanced solid tumors

Conditions: Breast Cancer; Colorectal Cancer; Pancreatic Cancer

Summary: rationale: studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. purpose: this laboratory study is collecting skin biopsy specimens from patients receiving irinotecan or gemcitabine for advanced solid tumors and using them to study change in dna due to this treatment.

objectives: primary * determine the level of p-chk1 and phospho-histone 2ax (p-h2ax), an indicator of dna damage, and possibly downstream pathway markers in hair follicles from skin biopsies of patients treated with gemcitabine hydrochloride or irinotecan hydrochloride for advanced solid tumors. secondary * characterize the method for measurement (immunohistochemistry). * measure inter- and intra-patient variability for the biomarker. * partially characterize the dynamic time course of p-chk1 and p-h2ax after administration of a dna-damaging agent. outline: this is a multicenter study. patients undergo collection of 2 skin biopsies with hair follicles at 4 and 8 hours or at 4 and 6 hours after the start of irinotecan hydrochloride or gemcitabine hydrochloride treatment on day 1 of course 1. repeat biopsies will be taken at 4, 6, or 8 hours after the start of irinotecan hydrochloride or gemcitabine hydrochloride on day 1 of 2 successive courses. tissue is examined by immunohistochemistry and possibly other methods for changes in p-chk1 and ph2ax. projected accrual: a total of 60 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of advanced solid tumor malignancy (preferably colorectal, pancreatic, or breast cancer) * scheduled to receive a standard dose, weekly regimen of either irinotecan hydrochloride or gemcitabine hydrochloride patient characteristics: * not specified prior concurrent therapy: * no dna-damaging agent within the past 13 days

Keywords: recurrent colon cancer stage iii colon cancer stage iv colon cancer recurrent rectal cancer stage iii rectal cancer stage iv rectal cancer recurrent pancreatic cancer stage ii pancreatic cancer stage iii pancreatic cancer stage iv pancreatic cancer recurrent breast cancer stage iiia breast cancer stage iiib breast cancer stage iiic breast cancer stage iv breast cancer
conditioned pain modulation in patients with hemophilia

Conditions: Hemophilia

Summary: introduction: hemophilic arthropathy is characterized by functional alterations, disabling physical sequelae, and chronic pain. conditioned pain modulation describes the net effect of endogenous pathways that enhance or diminish the effects of afferent noxious stimuli. objectives: to describe conditioned pain modulation in patients with hemophilia and identify the best predictive model of conditioned pain modulation in these patients methods: cross-sectional cohort study. 51 patients with hemophilic arthropathy will be recruited in 3 regions of spain. the main study variable will be the conditional pain modulation (conditioned pain modulation index, using an ischemic technique of the arm using the pain pressure threshold as a test stimulus), with age being the dependent variable. the secondary variables, estimated as modifying or confounding variables, will be kinesiophobia (tampa scale for kinesiophobia), catastrophizing (pain catstrophizing scale), trait and state anxiety (state-trait anxiety inventory) and the main clinical, anthropometric, and sociodemographic. expected results: identify the degree of modulation conditioned by pain in patients with hemophilic arthropathy. identify the best predictive model for conditioned pain modulation in these patients based on the study variables


Eligibility criteria:
inclusion criteria: * patients diagnosed with hemophilia a or b. * patients over 18 years of age. * persons with a medical diagnosis of bilateral hemophilic ankle arthropathy. * patients with clinical assessment by hemophilia joint health score (\>4 points). * persons with hemophilia on prophylactic treatment with fviii / fix coagulation concentrates or monoclonal antibodies. * have signed the informed consent document. exclusion criteria: * patients with neurological or cognitive alterations that prevent the comprehension of the questionnaires and physical tests. * patients who have had an ankle hemarthrosis in the 6 months prior to the start of the study. * patients who have taken analgesic or anti-inflammatory drugs in the 30 days prior to the study. * patients who are undergoing an intervention (physiotherapeutic or orthopedic) at the time of the study.

Keywords: haemophilia joint pain conditioned pain modulation kinesiophobia catastrophism anxiety
enhancing juvenile drug court outcomes with evidence-based practices

Conditions: Adolescent Substance Use

Summary: juvenile drug courts were developed in response to a perceived need to intervene more effectively with youth with substance abuse problems. close collaboration between the court and substance abuse treatment provider is a defining component of the drug court model and is critical to helping youth achieve positive outcomes. despite the proliferation of juvenile drug courts in recent years, however, evaluation of their capacity to reduce offender substance use and criminal activity has lagged. moreover, the institute of medicine (iom, 1998) and leading experts (mclellan, carise, \& kleber, 2003) have presented a bleak picture of the nation's capacity to meet the treatment needs of substance abusing individuals. although community-based programs provide the backbone of substance abuse treatment in the nation, their capabilities have not kept up with major scientific advances in the development and validation of evidence-based substance abuse interventions. building on our research findings and experience regarding juvenile drug court outcomes as well as the transport of evidence-based practices to community treatment settings, the purpose of this study is to develop and test a relatively flexible and low cost strategy for enhancing the outcomes of juvenile drug courts by integrating components of evidence-based treatments into existing substance abuse services. specifically, this project aims to: aim 1: adapt existing intervention and training protocols from evidence-based practices (i.e., contingency management for adolescent substance abuse; family engagement strategies from evidence-based treatments of juvenile offenders) for integration into juvenile drug court sites. aim 2: conduct a study to examine youth (e.g., substance use and criminal behavior) and system level (e.g., intervention adherence, feasibility, retention and completion rates, consumer satisfaction, cost estimates) effects of implementing the intervention protocols in juvenile drug courts. aim 3: revise the intervention and training protocols in preparation for a stage ii study if findings are supportive.


Eligibility criteria:
inclusion criteria: * juvenile drug court-involved youth * fluency in english exclusion criteria: * none

Keywords: substance use delinquency juvenile drug court contingency management family engagement
to study the effects of cordyceps cicadae on vision care

Conditions: Myopia

Summary: cordyceps cicadae is a traditional asian herbal medicine with a variety of bioactive substances and curative effects similar to cordyceps cicadae, and it has been reported that anti-dry eye and eye protection ingredients can be extracted. with the advancement of civilization, the number of patients with high myopia is increasing year by year and suffers from complications of dry eye or other eye diseases. in this study, the subjects were provided with cicadae extract or placebo in a double-blind manner, tracked the degree of visual fatigue by regular questionnaires, and measured for visual acuity, axial length and diopter. the purpose of this study is to investigate the effect of cicadae extract on visual acuity and visual fatigue, and to evaluate its potential as a health food ingredient.

1. visual acuity measurement: snellen's chart was used to measure visual acuity. 2. refractive examination: measure binocular refraction with open field computer refractor (shin-nippon nvision k5001 wide view). 3. measuring the axial length of the eye: use the multifunctional optical eyeball length measuring instrument (lenstar) to measure the distance from the instrument to the optical paths such as the cornea, lens, and retina, and then convert to the axial length of the eye. 4. corneal radian measurement: use a keratometer (bausch \& lomb keratometer) to measure the corneal radian and curvature, and estimate the degree of corneal astigmatism. 5. visual fatigue questionnaire survey: a visual fatigue scale questionnaire was designed using ocular surface disease index (osdi) and computer vision syndrome (cvs).

Eligibility criteria:
inclusion criteria: 1. adults aged 20 or over 2. willing to participate in this study and sign the subject's consent form 3. myopia less than 700 degrees exclusion criteria: 1. have consumed related eye care products in past 3 months 2. those who have eye infection in the past 3 months 3. people who have been diagnosed with any eye diseases in past 3 months 4. those who are allergic to cicadae
effects of recruitment maneuvers in early acute lung injury (ali) and acute respiratory distress syndrome (ards) patients

Conditions: Acute Respiratory Distress Syndrome; Lung Injury, Acute

Summary: the purpose of this study is to evaluate the effect of lung recruitment maneuver in patients with early ali/ards

the acute respiratory distress syndrome (ards) was first described in the medical literature in 1967. patients with ards mostly require mechanical ventilatory support due to hypoxic respiratory failure. mechanical ventilation can induce lung injury (ventilator-induced lung injury, vili) by causing overdistention and repetitive opening and closing of unstable lung units. data from a number of randomized controlled trials indicate that a lung protective ventilatory strategy with small tidal volume and low plateau pressure reduces mortality in acute lung injury (ali) and acute respiratory distress syndrome. lung recruitment maneuvers are being used in the management of ali and ards, but recruitment maneuvers are still controversial. lung recruitment maneuver is aimed to open the collapsed lung and keep the lung open. the maneuver briefly increases the alveolar pressure to open recruitable lung, sustained with adequate positive end-expiratory pressure(peep) after lung recruitment, to avoid derecruitment. we want to enroll 120 patients with early ali/ards in this randomized controlled study. the study group use recruitment maneuver and lung protective ventilatory strategy, and the control group use lung protective ventilatory strategy only. concerning about both safety and efficacy, we design a modified recruitment maneuver protocol which has never been published in previous medical literature. the primary outcome is ventilator-free days and icu-free days, and secondary outcomes include ventilator weaning rate, and 28-day mortality and cost effectiveness analysis. since no randomized controlled trials clearly establish benefit from recruitment maneuvers, we hope this study would be able to provide some evidence on whether lung recruitment should be used in the routine management of ali/ards.

Eligibility criteria:
inclusion criteria: * met criteria of ali/ards * pao2/fio2 less than or equal 250 mmhg after standard ventilator setting (fio2 more than or equal 0.5 and peep more than or equal 10 cmh2o)at least 30 mins exclusion criteria: * age less than 18 years * duration of mechanical ventilator more than 72 hours * pneumothorax or subcutaneous emphysema or bullous lung disease * severe chronic respiratory disease * intracranial hypertension or received craniotomy surgery * longterm dependent ventilator * neuromuscular disease * premorbid conditions with an expected 6 month mortality risk exceeding 50%

Keywords: recruitment maneuvers ards lung protective strategy ards, human
clinical evaluation of beta-lacta ™ test in urinary infections

Conditions: Urinary Infection

Summary: 3rd generation cephalosporins (c3g) are the antibiotics recommended in probabilistic in most enteric infections in france including pyelonephritis and bacteraemia. however, the prevalence of resistance of enterobacteriaceae including e. coli to c3g is continuously increasing for several years. in 2012, in france, the proportion of e. resistant or intermediate coli categorized to c3g is 10 to 25% (earss data). antibiotics not adapted early in severe sepsis is responsible for worse prognosis for patients in terms of morbidity and mortality and unnecessary prolongation of the dms. at st. joseph's hospital on enterobacteria levels of resistance to c3g is 15.4%. to avoid overuse of carbapenems for probabilistic antibiotic and to quickly prescribe antibiotics adapted to the resistance of the bacteria, it is interesting to use a rapid test for detection of resistance to c3g. the lacta ™ test could be used in this indication. this is a rapid test diagnostic orientation detecting hydrolysis of a substrate (chromogenic cephalosporin) by the enzymatic action of esbl, camp-type cephalosporinases and carbapenemases. this test was initially marketed for rapid detection of resistance to c3g enterobacteria from isolated bacterial colonies in culture.

main objective / secondary: the investigators propose to conduct a study with a double objective: 1. to assess the analytical performance and its positioning relative to all the tests available to us in urine samples, 2. to evaluate prospectively the clinical impact test in urinary infections expected results and prospects: this study will define the performance and limitations of this test in the most difficult situations (low number of bacteria / ml, haematic urine, ...) and will specify its indications and its place among all other tests before implanting it in our routine, as appropriate. the clinical impact study will provide medical and economic analysis data including shortening time to adapt antibiotic therapies and put in septic isolation to argue the implementation of this test routinely.

Eligibility criteria:
inclusion criteria: * patients may have a urinary infection esble * patients accepting the use of their result for analysis. exclusion criteria: * no exclusion criteria

Keywords: beta-lactamine β-lactamine
amyloid imaging and cognitive impairment after intracerebral hemorrhage

Conditions: Intracerebral Hemorrhage

Summary: to evaluate pet av-45 amyloid imaging in the etiological diagnosis of primary non traumatic intracerebral hemorrhage (cerebral amyloid angiopathy and hypertension related hemorrhage).we hypothesize that patients with lobar hemorrhage (probably related to cerebral amyloid angiopathy) will have a greater av45 cortical binding than patients with deep hemorrhage (probably related to hypertension).

cerebral amyloid angiopathy (caa) and hypertension related hemorrhage are the main causes of non traumatic primary intracerebral hemorrhage. in vivo diagnosis of these two cerebral diseases may be difficult and is based on hematoma location and pattern of cerebral microbleeds (cmb) distribution. we aimed to evaluate a multimodal approach including brain mri, pet av-45 amyloid imaging and neuropsychological assessment to improve etiological diagnosis of primary intracerebral hemorrhage. 70 patients with acute primary non traumatic intracerebral hemorrhage will be prospectively included and two groups will be compared: lobar hemorrhage group and deep hemorrhage group. brain mri, pet av-45 cerebral amyloid imaging (during the first month) and neuropsychological assessment (three months later) are performed. differences between the two groups are evaluated for av45 cortical binding, cmb distribution, white matter lesions and cognitive profile.

Eligibility criteria:
inclusion criteria: * age : 40-90 years, * non traumatic primary intracerebral hemorrhage during acute phase (less than 30 days from hemorrhage onset) confirmed on brain imaging (ct and/or mri). * correct visual, hearing and language functions to perform neuropsychological tests. * written consent of patient exclusion criteria: * secondary causes of intracerebral hemorrhage : vascular malformations (arteriovenous malformation, intracranial aneurysm, cavernous angioma, dural arteriovenous fistula), cerebral venous thrombosis, intracranial neoplasm, coagulopathy, vascularitis, cocaine or alcohol use, hemorrhagic ischemic stroke. * pregnancy * contraindication to mri * progressive neoplasm * cognitive impairment secondary to progressive neurological disease * depression, * drug addiction

Keywords: intracerebral hemorrhage cerebral amyloid angiopathy amyloid imaging 18f-av-45
closed loop auditory stimulus in sleep and epilepsy

Conditions: Temporal Lobe Epilepsy

Summary: this is a single-centre pilot study of a non-invasive auditory stimulation during sleep in participants with temporal lobe epilepsy.

the primary objectives will be to pilot the use of home-based auditory stimulation during sleep in 10-20 participants with temporal lobe epilepsy using wireless devices.

Eligibility criteria:
inclusion criteria: 1. participant is willing and able to give informed consent 2. participant diagnosed with temporal lobe epilepsy 3. will have had fewer than three generalized tonic clonic seizures per month in the last three months 4. will be taking 3 or fewer anti-seizure medications. 5. will have access to a computer or cellphone with an internet connection exclusion criteria: 1. abnormal hearing that cannot be corrected to normal overnight. 2. abnormal vision that cannot be corrected to normal during the day. 3. unwilling to abstain from caffeine, alcohol, daytime naps and extreme physical exercise in the 12 hours prior to the study. 4. cannot read english 5. engaged in night work in the previous 2 months 6. any history of seizures triggered by music or sounds 7. travelled across more than 2 time zones in the last 2 months 8. prescribed/taking sleeping tablets other than clobazam 9. cannabis use \>4 joints/day.

Keywords: closed loop auditory stimulus sleep memory
preliminary efficacy and safety study of oral nepadutant in infant with colic not responding to conventional treatment

Conditions: Infantile Colic

Summary: this phase iia study is designed as a multi-centre, single country, randomised, double-blind, placebo controlled study in three parallel groups, with the aim to evaluate the efficacy and safety of nepadutant given at two oral doses once daily for seven days in comparison to placebo in the treatment of infantile colic.

infant colic is a functional gastrointestinal disorders which affects up to the 30% of the infant population; it is primarily characterised by excessive inconsolable crying starting without any apparent cause and lasting for several hours per day. current non pharmacological interventions (e.g. message, restriction in maternal diet in breast-feeding infants) and pharmacological treatments (simethicone, antimuscarinic drugs) are largely unsatisfactory. in animal models, nepadutant reverse the exaggerated intestinal motility and sensitivity, induced by different stimuli, without producing inhibitory effects on these functions at baseline, suggesting that nepadutant could have a therapeutic effect with no interference on physiological gastrointestinal transit. this phase iia study is designed to evaluate the efficacy of nepadutant paediatric oral solution given once daily at two doses in comparison to placebo. the experimental clinical phase encompasses the following periods: * screening period (no study medication) to be done 7 to 4 days prior to randomisation * treatment period, lasting seven days with once daily administration * post treatment period, lasting seven days a safety follow-up visit will be performed approximately 1 month after the first administered dose.

Eligibility criteria:
inclusion criteria: * healthy infants with diagnosis of infant colic according to the following modified wessel criterion "paroxysm of irritability, fussing or crying that start and stop without obvious cause for \>3h/day, \>3 days/week for one week" * age ≥ 6 weeks and \< 4 months * no adequate response to conventional pharmacological or non-pharmacological treatment alternatives for infant colic * infants exclusively breast-fed. * normal growth * willingness to refrain from use of antimuscarinic drugs, simethicone, dimethicone or antiacids during the study period exclusion criteria: * clinical evidence of allergies or other diseases which may cause crying and/or fussiness or may interfere with absorption or clearance of the drug. * suspect of gastroesophageal reflux disease (gerd) * formula fed or mixed fed infants.

Keywords: infantile colic tachykinin antagonist nepadutant
effect of multiple micronutrient fortified bread consumption on iron deficiency anemia in women of reproductive age

Conditions: Iron Deficiency Anemia

Summary: the project aims to assess if consuming two slices of multi-fortified bread daily for 120 days is effective in reducing iron deficiency anemia in women of reproductive age through a three-arm randomized trial.

iron deficiency anemia (ida) continues to be a public health priority in peru and the world. the prevalence of the condition is high in women of reproductive age regardless of geographic area and socioeconomic status. fortification of staple foods is recognized as a cost-effective strategy to reverse iron deficiency. in peru, iron fortification of wheat flour and derived products is mandatory, but to date its effect on the ida has not been evaluated. in recent years, evidence has been generated on the positive effect of zinc, vitamin a and vitamin b12 supplementation on hemoglobin (hb) levels. this project is a three-arm randomized clinical trial that seeks to evaluate the effect of consuming two slices of bread fortified with a multivitamin premix (iron, folic acid, vitamin a, vitamin b12 and zinc) daily on iron deficiency anemia in non-pregnant women of reproductive age. as a control, one group will receive standard bread fortified according to peruvian legislation and a third group will not receive treatment.

Eligibility criteria:
inclusion criteria: * ferritin levels \< 13 ng/ml, * hemoglobin levels between 8 g/dl and 11.9 g/dl, * no plans to move during the duration of the study, * commitment not to become pregnant during the duration of the study, * signed informed consent. exclusion criteria: * pregnancy, * amenorrhea not related to pregnancy, * breastfeeding, * chronic diseases (active tb, hiv, cancer, asthma, liver disease, coronary heart disease, chronic renal disease), * hemoglobin levels \< 8 g/dl, * bleeding in the 3 months prior to recruitment, * smoking, * inability to sign informed consent, * consumption of nutritional supplements.

Keywords: iron deficiency anemia hemoglobin iron status hematological parameters
phase ii trial of neoadjuvant[fec100]/cisplatin-docetaxel ± trastuzumab in women with over expressed or amplified her2/neu with locally advanced breast cancer

Conditions: Breast Cancer

Summary: phase ii trial of neoadjuvant \[fec100\]/cisplatin-docetaxel ± trastuzumab in women with over expressed or amplified her2/neu with locally advanced breast cancer


Eligibility criteria:
inclusion criteria: * patients with locally advanced breast cancer