Kornimate/medical-research-clean huggingface dataset:
evaluation of the threshold for the interpretation of the results of a method for the blood determination of phosphatidyléthanol

Conditions: Alcohol Abuse

Summary: for an analytical validation of the method for the determination of blood hosphatidylethathanol, it is necessary to: * to compare the results of chronic and excessive ethanol patients with the cut-off proposed in the literature. * also assess the stability of phosphatidylethanol in total blood collected, and in blotted dried blood stains (dbs), depending on temperature (ambient temperature and +4°c)


Eligibility criteria:
inclusion criteria: * person with alcohol consumption ≥ 40g/day (women) and ≥ 60g/day (men) according to who criteria * person hospitalized for a hospital withdrawal in the addiction service of lille's hospital, without other distinctions. exclusion criteria: * patient opposing the use of their personal data in the study * patient subject to protective measures (guardianship or curatorship) * person deprived of liberty
comparison of clinical outcomes in fresh cycle with single blastocyst stage and double cleavage-stage embryos: a single-center, non-blind, randomized controlled study

Conditions: Infertility, Female

Summary: in traditional assisted reproductive technology (art), choosing multiple embryo transfer to get a high clinical pregnancy rate while increasing the risk of multiple pregnancies. research showed that the single-cleavage embryo transfer could not simultaneously meet the dual requirements of maintaining pregnancy rate and reducing the multiple pregnancy rate.the purpose of this study was to observe the clinical outcome between double cleavage embryo transfers and single blastocyst transfers in fresh cycle through rct study with gnrh antagonist protocol.

in traditional assisted reproductive technology (art), choosing multiple embryo transfer to get a high clinical pregnancy rate while increasing the risk of multiple pregnancies. research showed that in the fresh cleavage embryo transfer cycle, the clinical pregnancy rate increased with the increase of the number of high-quality embryos transferred, and so did the multiple pregnancy rate, suggesting that the single-cleavage embryo transfer could not simultaneously meet the dual requirements of maintaining pregnancy rate and reducing the multiple pregnancy rate. compared with the embryo at cleavage stage, blastocyst culture is a process of survival of the fittest, which is physiologically more synchronized with endometrial development and can improve embryo implantation rate. the existing clinical research analysis is mostly limited to the down-regulating regimen, while the rct study of high-quality with gnrh antagonist protocol is few. therefore, the purpose of this study was to observe the clinical outcome between double cleavage embryo transfers and single blastocyst transfers in fresh cycle through rct study with gnrh antagonist protocol.

Eligibility criteria:
inclusion criteria: 1. patients with a diagnosis of primary or secondary infertility with a clinical indication for ivf/intracytoplasmic sperm injection (icsi) 2. under 38 years of age 3. number of afc≥6, amh\>1.1ng/ml 4. no adverse factors of fresh embryo transplantation (evaluation by an experienced reproductive physician) 5. number of available embryos(day 3)≥4 6. informed consent exclusion criteria: 1. pgt 2. with adenomyosis, endometrial compression by uterine fibroids, intrauterine adhesion, endometrial polyps and other factors unsuitable for fresh cycle transplantation
persistent pleural effusion treatment following cardiothoracic surgery by platelet-fibrin glue

Conditions: Pleural Effusion

Summary: persistent pleural effusion is a life-threatening complication after cardiac surgery. the traditional treatment is chest tube drainage, which may not respond to treatment. this study introduces a new noninvasive approach for treating persistent pleural effusion using platelet-rich plasma fibrin glue (prp-fg). this method has been successfully applied for the treatment of postoperative persistent chylothorax and pneumothorax in previous studies, which significantly decreased morbidity, mortality, and hospital stay.

this pilot clinical trial recruited 19 patients at imam reza hospital in mashhad, iran (2023) who had developed unilateral or bilateral refractory postoperative effusion resistant to conventional thoracostomy treatment. treatment success was defined as effusion \<50 ml/day after 48 hours, along with symptomatic improvement and no adverse events.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of pleural effusion after cardiac surgery in open-heart surgery * patients who sign an informed consent form exclusion criteria: * hemodynamically unstable patients * patients who did not sign an informed consent form

Keywords: pleural effusion persistent cardiac surgery prp fibrin glue
evaluation of high speed laser doppler imaging technology

Conditions: Hay Fever

Summary: skin prick tests (spt) are commonly used in daily allergological practice to assess skin reactivity to allergens. multiple factors can contribute to non-optimal results of conventional wheal and flare measurement (cwfm) of spt such as inaccurate measurements, observer-dependency and absence of traceability. this study aims to evaluate the quantification of spt by a novel high speed laser doppler imaging (hsl-di) and to compare it with cwfm. first, spt with birch and/or grass pollen extracts as well as positive and negative controls will be performed in 20 volunteers (11 atopics, 9 non-atopics) to establish the characteristics (cut-off, optimal reading time and allergen concentration) of hsl-di analysis based on two parameters ("area" and "flow" measurement). in a second step, fifty patients will be tested with birch and grass pollen extracts at optimal allergen concentration and time window. analysis of spt by hsl-di and cwfm will be compared.


Eligibility criteria:
inclusion criteria: * age 18 to 65 years * history of allergic rhinitis to birch pollen and/or grass pollen. exclusion criteria: * any medical condition (including pregnancy) that could influence the study (viral or bacterial airway infection, active allergic rhinitis) * uncontrolled asthma (peak expiratory "flow" \<80% of volunteer's best personal value) * treatment with antihistamine medication less than two weeks before enrolment or during the trial.
flexibility: a study to assess the impact of darbepoetin alfa in subjects withnon-myeloid malignancies with anemia due to chemotherapy

Conditions: Anemia; Cancer

Summary: this study will compare the efficacy (non-inferiority) of darbepoetin alfa (aranesp®) extended dose schedule administration (eds) versus darbepoetin alfa administered once per week (qw) in the treatment of anemia in subjects with non-myeloid malignancies receiving multi-cycle chemotherapy.


Eligibility criteria:
inclusion criteria: - subjects with active non-myeloid malignancy(ies) including lymphocytic leukemias - receiving chemotherapy and expected to receive at least 8 additional weeks of cyclic cytotoxic chemotherapy anticipated to be on a qw, every other week (q2w) or every three weeks (q3w) schedule - anemia due to cancer and/or chemotherapy (screening hb less than 11.0 g/dl) - eastern cooperative oncology group (ecog) performance status of 0 to 2 exclusion criteria: - subjects with acute myelogenous leukemia (aml), chronic myelogenous leukemia (cml), or myelodysplastic syndromes (mds) - other underlying hematologic disorder, which could cause anemia, other than a non-myeloid malignancy - active bleeding - severe, unstable, active chronic inflammatory disease (e.g., ulcerative disease, peptic ulcer disease, rheumatoid arthritis) - active, unstable systemic or chronic infection - planned elective surgery during the study where significant blood loss is expected - known iron deficiency (to be considered iron deficient a subject must have both of the following: a saturated transferrin less than 15% and ferritin less than 10 ng/ml at screening) - unstable angina, or uncontrolled cardiac arrhythmia - hypertension (diastolic blood pressure greater than 100 mmhg) - inadequate renal and/or liver function (e.g., creatinine greater than 2 x upper limit of normal (uln) and/or transaminase greater than 5 x uln) - history of pure red blood cell aplasia - known positive human immunodeficiency virus (hiv) test or acquired immune deficiency syndrome (aids) status - known positive antibody response to any erythropoietic agent - subject has known sensitivity to any erythropoietic agents, the study drug, or its excipients to be administered during this study

Keywords: chemotherapy, anemia aranesp®, rhuepo chemotherapy induced anemia non-myeloid malignancy non-myeloid malignancies chemotherapy
effect of strength training on the quality and duration of sleep and daytime sleepiness of institutionalized adolescents

Conditions: Adolescent Behavior; Sleep Disorder

Summary: the aim of this study was to analyze the effects of strength training on sleep quality and daytime sleepiness in institutionalized adolescents (14 to 19 years of age). thirty-one adolescents were randomly assigned in two sample groups: intervention group (ig, n = 19) and control group (cg, n = 12). anthropometric measures were performed (height and body mass) and bmi was determined. sleep quality and daytime sleepiness were assessed using the questionnaires, pittsburgh sleep quality index (psqi) and epworth sleepiness scale (ese), and total sleep time by accelerometer. physical training (2x / week) was performed for 12 weeks. the omni perceived exertion scale for resistance exercise (omni-res) scale was used to control the effort intensity and the exercises followed an alternate pre-follow-up.


Eligibility criteria:
inclusion criteria: * institutionalized adolescents (14 to 19 years of age) exclusion criteria: * refuse to participate, * incomplete evaluation
serum irisin in myocardial infraction and following percutaneous coronary intevention

Conditions: Myocardial Infarction; Coronary Artery Disease

Summary: the investigators aim to evaluate circulating irisin levels alterations in patients with acute myocardial infraction and in patients with coronary artery disease subjected to percutaneous coronary intervention.

irisin is a newly discovered myokine induced in exercise. there is evidence that cardiac muscle produces more irisin than skeletal muscle in response to exercise. furthermore, irisin has been associated with isoproterenol-induced myocardial infarction (mi) in rats while it has been reported to decrease after acute myocardial infarction in humans. the investigators aim 1) to investigate circulating irisin levels in patients at the time of acute myocardial infarction and after reprefusion \[primary percutaneous coronary intervention (pci)\] 2) to compare irisin' s diagnostic and prognostic value and specificity value in myocardial infarction with known markers of cardiac injury such as creatine kinase-mb isoenzyme (ck-mb) and troponin 3) to evaluate irisin as an early necrosis biomarker 4) to evaluate irisin's sensitivity as a biomarker to detect minor myocardial necrosis after elective percutaneous coronary intervention

Eligibility criteria:
inclusion criteria: * patients with acute myocardial infraction (mi) or with coronary artery disease without myocardial infraction who need percutaneous coronary intervention exclusion criteria: * age \< 20 years old * diseases or medications that could affect cardiac muscle or skeletal muscle metabolism * musculoskeletal injury of surgery 6 months prior to recruitment * severe liver or kidney disease (creatinine clearance \< 60ml/min/1.73m2) or liver or kidney transplantation

Keywords: irisin myocardial infarction coronary
use of autobiographical and interest assessment for a better stimulation of patients in nursing home

Conditions: Alzheimer's Disease

Summary: the purpose is to evaluate patients' interests (patients in nursing home). moreover the study aims to evaluate whether an activity for which the patient is interested in, allows a better involvement and stimulation.

context : behavioral and psychological symptoms of dementia (bpsd) arouse researchers' interest because they are frequent manifestations responsible for a large share of the suffering of patients and caregivers. apathy is the most frequent of them. systematic literature reviews on non-pharmacological treatment for bpsd indicates that some technique and more particularly residential care staff training program appear to have promising results, even if the level of evidence of efficacy remains moderate partly because of the paucity of scientific quality research in this area. the most of them comes from anglo-saxon country. in france, the tnm en ehpad study demonstrated the staff training program efficacy regarding to the management of behavioral positive symptoms such as agitation or aggressiveness compared to a control group aims of the study : the aims of the study is to evaluate the short and medium term effectiveness of staff training program to manage and stimulate patients with a diagnosis of alzheimer's disease or associated disorders and presenting bpsd of the apathy type and living in nursing homes. description : a randomized controlled trial (randomization by nursing home) presents as a routine clinical procedure according to the french regulation. raters and our statistician are unaware and blind to the randomization. the trial takes place in 4 nursing homes. to be included, patients are older than 65 years with a diagnosis of alzheimer's disease or associated disorder and present the diagnostic criteria of apathy, within a moderate to severe stage of the disease. data are collected at baseline, month 1 and at month 4, namely 3 months after the end of the training programme thanks to the apathy inventory clinician version (ai-c), the neuropsychiatric inventory for the staff members (npi-es), the ad qol, an observation scale and a qualitative analysis of the official caregiver's knowledge and perception about bpsd especially apathy and their expectations concerning the training program.

Eligibility criteria:
inclusion criteria: * diagnosis of alzheimer's disease * mmse score between 12 and 24 * patient involved in organized activities in nursing home exclusion criteria: patients: * who are not able to understand and answer to questions for the study * \< 60 years of age * who are not able to sit * aphasic
computer vision system for the blind veteran

Conditions: Blindness

Summary: this is a feasibility study involving a small number of blind subject to evaluate the effectiveness of using a software and associated hardware components to assist the blind in identifying and locating objects of interests and to assist in way finding tasks. after the system has been successfully tested by the blindfolded engineers, it will be evaluated in a small number of blind subjects.

this is primarily an engineering project to develop computer vision algorithms for an integrated system comprising of a laptop computer, webcam, gps, digital compass, microphone, and stereo earphones. the system will be voice controlled. the algorithm will be trained to identify and located objects and navigationally landmarks in real-time, previously selected by sighted developers. after the system has passed objective engineering milestones, blind subjects will be tested to determine whether the novel system will improve the ability of the blind to travel over a test course in a hospital setting.

Eligibility criteria:
inclusion criteria: * age 18 and over * legally blind exclusion criteria: * decreased hearing * unable to understand or follow instructions * inability to walk and stand for 10 minutes
open-label study of ard-0403 in testosterone deficient men

Conditions: Hypogonadism

Summary: male hypogonadism, a disorder associated with testosterone deficiency, is frequently seen in clinical practice and has significant effects on patient well-being. the purpose of this study is to investigate the efficacy and safety of ard-0403 as a testosterone replacement therapy in testosterone deficient men.


Eligibility criteria:
inclusion criteria: * testosterone deficiency * completed study ard-0403-004 exclusion criteria: * previous treatment with testosterone replacement therapy within 4 weeks * moderate-severe benign prostatic hypertrophy or prostatic cancer * haematocrit \>50%
treatment with investigational convalescent plasma and measure antibody levels in patients hospitalized with covid-19

Conditions: COVID-19

Summary: this is an open label pilot study designed to provide access to treatment with investigational convalescent plasma and assess the relationship between nab titers in the investigational convalescent plasma compared to changes in nab levels in the recipient in hospitalized patients with covid-19.

primary objectives are as follows: 1. to provide access to treatment with investigational convalescent plasma to inpatients with documented coivd-19 infection 2. to measure nab titers in an aliquot of the cp administered, to measure the volume of cp administered, and determine whether there is a correlation between the nab dose (in nab units/kg body weight, where a unit is the reciprocal of the endpoint nab titer in the cp multiplied by the volume in ml) and change or lack of change when comparing pre-treatment and day one nab titers. secondary, exploratory objectives are as follows: 1. to evaluate the safety of convalescent plasma (cp) administration in hospitalized covid-19 patients 2. to evaluate viral shedding of sarscov-2 in nasopharyngeal or nasal samples before and on days 3, 7, and 14 after cp transfusion 3. to perform genomic analysis of the sars-cov-2 from patients before and after treatment with cp transfusion 4. determine cumulative incidence of disease severity (transfer to icu, type of respiratory support, los, and mortality)

Eligibility criteria:
inclusion criteria: 1. patients must be 18 years of age or older. 2. hospitalized with covid-19 respiratory symptoms and confirmation via covid-19 sars-cov-2 rt-pcr testing. if covid-19 test results are pending or done at enrolment, test results must be positive prior to administration of convalescent plasma. 3. patient (or legally authorized representative, lar) is willing and able to provide written informed consent and comply with all protocol requirements. 4. for patients unable to consent, consent by the legally authorized representative (lar) may be obtained by phone. exclusion criteria: 1. female subjects with positive pregnancy test or breastfeeding. 2. receipt of pooled immunoglobulin in past 30 days. 3. contraindication to transfusion or history of prior severe allergic reactions to transfused blood products. 4. on ecmo or in refractory shock at entry
intracranial distal access catheter in neurointerventional therapy

Conditions: Acute Ischemic Stroke; Intracranial Aneurysms

Summary: the study objective is to evaluate the safety and effectiveness of intracranial distal access catheter in neurointerventional therapy.

patients with mechanical thrombectomy for acute ischemic stroke, treatment of intracranial aneurysms and other ischemic and hemorrhagic diseases, requiring the use of intracranial distal access catheter to complete the procedure were eligible. at last, 124 retrospective and prospective subjects in 6 centers were screened in this trial, and 114 subjects were successfully enrolled.

Eligibility criteria:
inclusion criteria: * age = 18-80 years old. * patients with mechanical thrombectomy for acute ischemic stroke, treatment of intracranial aneurysms and other ischemic and hemorrhagic diseases, requiring the use of intracranial distal access catheter to complete the procedure (such as poor vascular access conditions, lesions located in secondary or higher branches of cerebral vessels, inability of conventional guiding catheters in place and providing effective support. treatment with flow-divert devices, covered stents, stent grafts, etc.) * patients agree to participate in the study and sign the informed consent form.（only prospective enrolled patients) exclusion criteria: * intracranial distal access catheter is used during the interventional therapy of non-neurovascular diseases, such as peripheral vascular and coronary artery diseases. * interventional procedure is performed with other distal catheters or devices with the same function before using intracranial distal access catheter. ordinary guiding catheters can be used to establish access to complete the procedure without the use of intracranial distal access catheter.
immune durability after vsv-ebov vaccination

Conditions: Immune Response; Vaccination; Durability

Summary: this prospective observational cohort study will follow the roughly 100 adults who received the vsv-zebov vaccine in the geneva phase 1 randomized controlled trial in 2014-2015 in order to determine their long-term (5-year) immune response to vaccination.

background: during the ebola epidemic of 2014-5, there was no proven therapy or prevention available beyond horizontal infection control measures. after the canadian government donated 800 vials of the vaccine candidate vsv-ebov to world health organization (who), the university hospitals of geneva agreed to perform a who-coordinated phase i/ii double-blind, placebo-controlled randomized trial to assess the candidate's safety and immunogenicity healthy adult volunteers. the doses of 10 e7 pfu and 5 x 10 e7 pfu were tested in 35 and 16 volunteers, respectively, before a safety-driven study hold in late 2014. at trial resumption in early 2015, the remaining volunteers (n=51) received 3 x 10 e5 pfu. thirteen volunteers received placebo. among vaccinees, early immune responses were impressive, even at the lowest dose of 3 x 10 e5 pfu, and persisted well up to 6 months (last time point assessed). the trial successfully ended 12 months after injection. this prospective observational study will assess immune durability in this group of vaccinees at yearly time points up to five years post-vaccination.

Eligibility criteria:
inclusion criteria: * participated and was vaccinated with a single injection of vsv-ebov at a dose of either 3 x 10e5 pfu, 10e7 pfu or 5 x 10e7 pfu in the geneva phase i vsv-ebov vaccine trial (nct02287480). * able to provide written, informed consent for this observational study. exclusion criteria: * received additional vaccination with vsv-ebov at similar or differing doses. * was lost to follow-up in the geneva phase i vsv-ebov vaccine trial
effectiveness of buddhist monks in providing cognitive behavior therapy

Conditions: Major Depressive Disorder

Summary: this research is to study the effectiveness of cognitive behavioral therapy-cbt and psychotherapy by trained buddhist monks. there are generally accepted that both cognitive and buddhist concepts are related. this randomized controlled trial is to study the elderly participants who suffer major depressive disorder according to dsm-iv. the subjects will be divided into two groups. the experimental group will receive 12 sessions of cbt 2 times per week for 6 weeks in addition to usual treatment. the control group will receive treatment as usual and general conversation (non-cbt) with monks. pretreatment factors (such as attachment style, interpersonal factors) of both therapist monks and patient participants will be studied.


Eligibility criteria:
inclusion criteria: * meet criteria for major depressive disorder * receiving antidepressant exclusion criteria: * presence of intense suicidal intent behaviors that require inpatient admission * history of alcohol or drug dependence * presence of hallucinations or delusions * currently receiving electroconvulsive therapy or repetitive-transcranial magnetic stimulation, * patients' involvement in other clinical trials.

Keywords: buddhist monks cbt elderly depression