Kornimate/medical-research-clean huggingface dataset:
a randomized study evaluating the incidence of post lumbar puncture headache with atraumatic needles in hematology

Conditions: Leukemia; Lymphoma

Summary: lumbar punctures are implemented for the diagnosis of patients with hematologic symptoms as well as for the intrathecal chemotherapy injections. post lumbar puncture headache is a common complication for patients and is characterized by the occurrence of a headache with an orthostatic component, with additional symptoms such as nausea. some studies in neurology, anesthesia and gynecology have previously shown a decreased incidence for post lumbar puncture headache while using atraumatic needles as compared to standard needles. in this context, it is necessary to better document the incidence of post lumbar puncture headache with the use of atraumatic needles in hematologic patients.

lumbar punctures (lp) are implemented for the diagnosis of patients with hematologic symptoms as well as for the intrathecal chemotherapy injections. post lumbar puncture headache (plph) is a common complication in around 30% of patients. plph is characterized by the occurrence of a headache with an orthostatic component within 12-72 hours after lp with additional symptoms such as nausea. even if this phenomenon spontaneously resolves within 3 to 5 days, symptoms can immobilize the patient and can interfere with his daily activities. technical procedures largely influence the incidence of plph. indeed, some studies in neurology, anesthesia and gynecology have previously shown a decreased incidence for plhp while using atraumatic needles as compared to standard needles. so far, few data are available for hematology. in this context, it is necessary to better document the incidence of plph with the use of atraumatic needles in hematologic patients.

Eligibility criteria:
inclusion criteria: * patients with hematologic syndromes undergoing a diagnostic lumbar puncture * signed written informed consent form * patient affiliated to a social security regimen or beneficiary of the same exclusion criteria: * any known contraindication for the lumbar puncture procedure: increased intracranial pressure, blood clotting disorder, thrombocytopenia * any known infection * patient with a body mass index \ 40 * any patient that requires an ultrasound guided lumbar puncture * patient that underwent a lumbar puncture within 6 months * patient under guardianship or deprived of his liberty or any condition that may affect the patient's ability to understand and sign the informed consent (art. l.1121-6, l.112-7, l.1211-8, l.1211-9) * refusing participation * pregnancy or breastfeeding women

Keywords: lumbar puncture post lumbar puncture headache atraumatic needle haematology
development of a predictive model for sexually transmitted infections in individuals using pre-exposure prophylaxis for hiv in spain

Conditions: Sexually Transmitted Infections (STIs); HIV; PrEP

Summary: objective: to develop and validate a predictive model for acquiring sexually transmitted infections (stis) in individuals using hiv pre-exposure prophylaxis (prep) within the national program providing this strategy. methods: ambispective cohort study, multicentric (23 spanish hospitals). all prep users, with follow-up within the program, will be included. entry into the program will be considered as the baseline visit. from there, patients are followed quarterly, following the national protocols for monitoring prep users in spain. at each visit, diagnosis of different stis (serum, pharyngeal swab, urethral or urine sample, rectal swab, endocervical/vaginal swab, ulcer) is performed. primary outcome variable: development of an sti (yes/no). the following stis will be considered: syphilis, neisseria gonorrhoeae (ng) infection, chlamydia trachomatis (ct) infection, lymphogranuloma venereum (lgv), mycoplasma genitalium (mg) infection, genital herpes, hepatitis a, hepatitis b, hepatitis c, hiv infection, and mpox. secondary outcome variable: number of diagnosed stis. in order to determine factors associated with acquiring an sti, multivariate analyses will be conducted using logistic regression. the best models will be analyzed in the validation population. to compare the models, we will follow the bayesian approach suggested by benavoli et al.


Eligibility criteria:
inclusion criteria: * all individuals with documented initiation of oral prep (daily or event-driven regimens), who have collected the medication at least once and have taken at least one pill, will be included in the study. the approved criteria for the use of oral prep in spain, as recommended by the spanish gesida guidelines (gesida. recomendaciones sobre la profilaxis pre-exposición para la prevención de la infección por vih en españa. marzo 2023. available at http://.gesida-seimc.org/category/guias-clinicas/otras-guias-vigentes/), are as follows: * people without hiv infection at the time of cohort inclusion * age ≥ 16 yr who meet the following criteria: * msm and transgender women with at least two of the following criteria during the last year: \> 10 sexual partners; condomless anal sex; chemsex; pep; ≥ 1 sti * sex worker women who report non-habitual use of condoms. * cisgender males/females, who report condomless and present at least two of the same criteria as msm and transgender. * pwid with unsafe injection practices exclusion criteria: none -

Keywords: sti hiv prep modelling machine learning adherence persistence
direct and indirect protection by influenza vaccine given to children in india

Conditions: Influenza

Summary: the study described here will immunize children with trivalent influenza vaccine (tiv) and determine whether this reduces influenza illness among the immunized children and their older family members. the comparison or control group for the children receiving influenza vaccine will be children immunized with inactivated poliovirus vaccine (ipv). the study will also provide information on the amount of disease produced by influenza in the study population.

influenza is an important cause of illness among children and adults in the united states. influenza is likely also an important cause of illness in india, but published data on influenza infections in india are limited, especially for children. although influenza vaccines are used routinely in the united states, including in young children, influenza vaccines have not seen widespread use in india. this is likely due to the lack of information from india about disease burden due to influenza and because the influenza vaccines have never been tested for efficacy in india. in addition, because young children are thought to be important in the spread of influenza in families, it is possible immunization of children against influenza will reduce influenza infections among older children and adults in the home.

Eligibility criteria:
inclusion criteria: * inclusion in either vaccine group (tiv or ipv) will require ages 6 months through 10 years of age. * all individuals in enrolled households will be eligible for enrollment into surveillance arm. exclusion criteria: * exclusion criteria from the vaccine groups includes known allergy to eggs, or hypersensitivity to other components of a vaccine (streptomycin, neomycin, and polymyxin b)

Keywords: influenza india children trivalent influenza vaccine (tiv) inactivated poliovirus vaccine (ipv) direct vaccine effectiveness indirect vaccine effectiveness
post marketing observational study in patients with pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: to investigate the long-term safety and effectiveness of adcirca (tadalafil) in pulmonary arterial hypertension (pah) patients in the clinical practice -focused topics- 1. to evaluate the incidence of adverse events for the patients with long-term use 2. to evaluate the incidence of adverse events of decreased blood pressure, bleeding (including uterine hemorrhage), visual disturbance and sudden hearing loss.


Eligibility criteria:
inclusion criteria: * patients with pah receiving adcirca exclusion criteria:patients who meet the criteria of contraindication * patients with hypersensitivity to tadalafil * patients who are using any form of organic nitrate * patients with severe renal impairment * patients with severe hepatic impairment * patients taking strong inhibitors of cyp3a4 * patients taking strong inducers of cyp3a4
platelet activation by a collagen analogue in hemorrhagic situations

Conditions: Collagen Analog; Platelet Activation; Hemorrhage

Summary: dijon university hospital and the dijon-based nvh medicinal company have developed a recombinant mini-collagen nvh020b with platelet and willebrand factor binding activity. its small size and granular, non-fibrillar presentation make it suitable for use as an injectable hemostat in patients with a hemorrhage or other emergency under antiplatelet therapy.


Eligibility criteria:
inclusion criteria: * - person who has given their non-opposition to inclusion * adult * healthy volunteers or controls (patients seen in consultation, without history of hemmorhage, etc.). or * patients with acute bleeding: polytraumatized, or hemorrhage or intracerebral haemorrhage, or bleeding complications at the end surgery (in particular cardiac surgery with ecmo) or * patients with antiplatelet therapy or * patients with thrombocytopenia/thrombopathy exclusion criteria: * protected adults (curatorship, guardianship) * person deprived of their liberty by judicial or administrative decision * pregnant, parturient or breastfeeding woman * person unable to express their non-opposition * platelet transfusion on initial management
research study evaluating cinacalcet for patients with end stage renal disease (esrd)

Conditions: End Stage Renal Disease

Summary: the purpose of this study is to observe the effects of a treatment strategy that incorporates cinacalcet hcl into the management of secondary hyperparathyroidism (hpt) in subjects with esrd receiving hemodialysis, on bio-intact parathyroid hormone (bipth), corrected serum calcium, serum phosphorus, and calcium phosphorus product.


Eligibility criteria:
inclusion criteria: - men and women must agree to use highly effective contraceptive measures throughout the study - prescribed hemodialysis for at least 3 months before study day 1 - cohort 1: the mean of 2 bipth determinations obtained from the central laboratory must be greater than 160 pg/ml and less than or equal to 430 pg/ml - the mean of 2 corrected serum calcium determinations obtained from the central laboratory must be greater than or equal to 8.4 mg/dl exclusion criteria: - have an unstable medical condition, defined as having been hospitalized, other than for dialysis vascular access revision, within 30 days before day 1, or otherwise unstable in the judgment of the investigator - subjects receiving oral vitamin d - pregnant or nursing females - parathyroidectomy in the 12 weeks before day 1 - received, within 21 days before day 1 of the dose titration phase, therapy with medications that are predominantly metabolized by the enzyme cyp2d6 and have a narrow therapeutic index (e.g., flecainide, vinblastine, thioridazine and most tricyclic antidepressants). the antidepressant amitriptyline is permitted - received, within 21 days before day 1, therapy with medications that are potent inhibitors (e.g. ketoconazole, itraconazole and erythromycin) or inducers (e.g., rifampin and st. john's wort) of the enzyme cyp3a4. phenytoin, phenobarbital and carbamazepine are also potent inducers of this enzyme. however, subjects on a stable dose of any of these anti-convulsants at baseline, with no evidence of seizure activity in the past 2 months may be eligible for the study - experienced a myocardial infarction within 12 weeks prior to day 1 - other investigational procedures are excluded - currently enrolled in, or have not yet completed at least 30 days since ending other investigational device or drug trials, or are receiving other investigational agents (experimental dialysis machines are acceptable) - current gastrointestinal disorder that may be associated with impaired absorption of orally administered medications or an inability to swallow tablets - participated in other studies with cinacalcet hcl - disorder that would interfere with the understanding and giving of informed consent or compliance with protocol requirements

Keywords: end stage renal disease (esrd) secondary hyperparathyroidism hemodialysis, bipth amg 073, amgen
evaluating adenoma recurrence after endoscopic mucosal resection with margin marking or post treatment with snare tip soft coagulation

Conditions: Adenoma Colon Polyp

Summary: non-inferiority trial comparing the recurrence rate of adenomas in non-pedunculated colonic lesions following endoscopic mucosal resection with margin marking (emr-mm) and endoscopic mucosal resection with thermal margin ablation (emr-stsc)


Eligibility criteria:
inclusion criteria: 1. age 18 years or older 2. ability to provide informed consent 3. patient scheduled to undergo colonoscopy for the evaluation and removal of colon polyps 4. non-pedunculated polyps ≥ 20 mm size exclusion criteria: 1. pedunculated polyps 2. inflammatory bowel disease 3. inability to provide informed consent 4. lesions \< 20 mm in size (largest dimension) 5. lesion involves the lips of the ileocecal valve, is located at the appendiceal orifice and/or is fully circumferential. 6. any standard contraindication, including pregnancy, to anesthesia and/or colonoscopy
early abdominal wall prosthesis infections: epidemiology, risk factors and factors linked to recovery

Conditions: Abdominal Wall Prosthesis Infections

Summary: abdominal wall prosthesis infections are among the complications most feared by digestive surgeons. indeed, this complication is associated with high morbidity and is difficult to manage (antibiotic therapy? surgical revision?). much data is missing in the literature because there are many types of prosthesis, implemented in patients with very varied conditions and the treatment is not strictly speaking codified. the investigators wish to carry out a retrospective study on approximately 500 patients and research the main characteristics of the different infections (which microorganism? which site? what time of appearance), the factors linked to the appearance of these infections and above all how to optimize their management. charge.


Eligibility criteria:
inclusion criteria: * major subject (≥18 years old) * subject operated on at the hus in the department of pr. rohr between january 1, 2017 and july 26, 2023 * operation of an incisional hernia cure with installation of an abdominal wall prosthesis * absence of written opposition in the subject's medical file to the reuse of their data for scientific research purposes. exclusion criteria: * subject having expressed his opposition to the reuse of his data for scientific research purposes.

Keywords: abdominal wall prosthesis antibiotic therapy surgical revision abdominal wall
positive affect as a source of resilience for adults in chronic pain

Conditions: Geriatric; Chronic Pain

Summary: fibromyalgia syndrome (fms) is a chronic musculoskeletal condition characterized by widespread pain and tenderness, and often accompanied by impaired physical functioning, depressed mood, as well as deficits in positive affect (pa).standard behavioral therapies typically focus on minimizing negative thoughts and emotions associated with pain and yield only modest treatment effects. efforts are therefore needed to develop more effective psychological treatments for chronic pain by identifying new targets for intervention. the objectives of this stage i randomized pilot trial are to evaluate the feasibility, acceptability, and the impact of a previously developed online positive affect (pa) skills intervention -larkspur (lessons in affect regulation to keep stress and pain under control)-in a sample of hispanic, non-hispanic other, and non-hispanic african american patients with fibromyalgia syndrome (fms).

specific aims: aim 1: to maximize relevance and acceptability of content and delivery of larkspur intervention among patients with fms, a chronic pain population with known deficits in pa. this aim will establish the feasibility (recruitment and retention) and acceptability (helpfulness, satisfaction, and impact) of the multicomponent larkspur intervention in hispanic, non-hispanic african american and non-hispanic other patients with fms. aim 2: to conduct a randomized pilot trial to evaluate the impact of the larkspur intervention in fms pain (primary outcome), as well pa, depressive symptoms, physical functioning, and stress appraisals (secondary outcomes) and aim 2a: explore racial/ethnic disparities. for aim 1, the study team will pilot larkspur to examine feasibility and acceptability of the intervention framework by conducting frequency and descriptive statistics for enrollment rates, number of sessions completed, number of weeks required to complete the intervention, and likert-scale items assessing satisfaction with the intervention and perceived helpfulness. for aims 2, fms patients (target n=90) will be randomized to receive the larkspur content online or to complete daily emotion reports online (control). the researchers hypothesize that intervention participants will report more frequent pa, decreased depressive symptoms, enhanced physical functioning, improved stress appraisals, and reduced fms pain (intensity and interference) immediately following the intervention (approximately 6-8 wks) and at 1-month post-intervention.

Eligibility criteria:
inclusion criteria: * access to daily internet * ≥ 50 years of age * able to read and understand english * physician diagnosis confirmation of fms and/or score ≥ 13 on the 6-item, self-report fibromyalgia screening tool * report having pain for at least the last three months exclusion criteria: * cognitive impairment * current behavioral treatment for pain * enrolled in another pain study
the impact of covid-19 among obese patients

Conditions: Obesity, Morbid

Summary: background: stay-at-home orders in response to the coronavirus 2 (sarscov-2) have forced abrupt changes to daily routines. the aim of our study is to evaluate the impact of the stay-at-home orders on the waiting list for bariatric surgery in our department of medical and surgical during covid-19 pandemic. materials and methods: in this observational retrospective study, from the 9th of march to 18th may 2020, the patients of our department were invited to answer to a 14-questions multiple-choice questionnaire relative to weight changes, working activity, daily exercise, dietary behaviors, and conditions potentially impacting the nutritional choices


Eligibility criteria:
inclusion criteria: - alle obese patients on the waiting list for bariatric surgery in our department of medical and surgical during covid-19 pandemic from march to may 2020 exclusion criteria: - patients underwent bariatric surgery
effect of positive airway pressure therapy on hospitalization and mortality in sdb patients with comorbid chronic obstructive pulmonary disease (copd) or/and heart failure (hf)

Conditions: Sleep-Disordered Breathing; Pulmonary Disease, Chronic Obstructive; Heart Failure

Summary: the aim of the study is to test the hypothesis that treatment of sleep disordered breathing (sdb) in patients with comorbid chronic obstructive pulmonary disease (copd) and/or heart failure (hf) with positive airway pressure (pap) is associated with reduced risk for hospitalizations and death, lower health care utilization, and greater cost-effectiveness.

in this retrospective analysis the health care utilization in patients with copd and hf will be quantified. data of patients who additionally underwent a polysomnography or polygraphy between 2012 and 2015 are taken into consideration. the data (risk for hospitalization and death, comorbidities, diagnosis and therapy of sdb, costs of health care utilization) will be collected 12 months before and 12 months after diagnosis of sdb. the patients' medical records will also be reviewed for compliance to treatment for sdb, and the patients will be classified as treated or untreated. the treated group will be divided into two subgroups: those with "good adherence" to pap therapy (≥ 4 hours pap use per night) and those with "poor adherence" to pap therapy (\< 4 hours pap use per night). healthcare utilizations, hf or copd exacerbations and mortality will be identified by reviewing medical records, national database when available, or self-reported by patient or patient's family through phone interview or questionnaire.

Eligibility criteria:
inclusion criteria: * subjects between 21 to 75 years; * consecutive patients who underwent polysomnography or polygraphy during the period of 01/01/2012 to 31/12/2015. * diagnosis of copd and/or hf exclusion criteria: * age \ 75 years
cross sectional study to evaluate the acceptability of oral solution of levetiracetam

Conditions: Epilepsy

Summary: phase iv, observational, post-authorization, cross sectional, open-label, multicenter study to evaluate the acceptability of oral solution of levetiracetam in patients with partial epilepsy as assessed by a questionnaire.


Eligibility criteria:
inclusion criteria: * patients 16 years old or older diagnosed with partial epilepsy with or without generalization receiving levetiracetam oral solution for at least 28 days before the study exclusion criteria: * patients with disturbances of the sense of taste and smell that can interfere with the assessment of the parameters of the study

Keywords: cross sectional study acceptability levetiracetam oral solution keppra
auditory plasticity training

Conditions: Mild Traumatic Brain Injury

Summary: the investigators are working on a project to help people who have had mild brain injuries hear better. sometimes, these injuries can make it hard for people to hear clearly, especially in noisy places or when trying to tell where sounds are coming from. the project is testing special training exercises that have helped healthy people improve their hearing in these situations. the goal is to see if these exercises can also help people with mild traumatic brain injuries (mtbi). if these exercises work, they could help doctors give better treatment to people with hearing problems after a brain injury. this would be especially helpful for soldiers who need to stay ready for duty. it could also make life better for veterans who struggle with hearing issues and help lower the cost of healthcare.

the study has two aims: 1. aim 1 - speech in noise (spin) training: the training group will receive the spin training, while the active control group will play a variation of the main listen game (frequency discrimination) that is not expected to improve speech recognition in noise. participants will receive a tablet and earphones. the instructions will be explained, and they will practice and work with the experimenter to verify they understand how to run the training at home. participants will do spin and active control training at home over 8 days, with up to two, 10 min sessions each day, for a total of 15 training sessions. 2. aim 2 - spacial hearing training: two groups will be tested: training and control, and participants will be randomly assigned to one of two groups. the training group will receive spatial hearing training, which will be compared to no-contract controls. the study team will avoid withholding training from the controls by considering them a waitlist control group, which will then be offered the training after completing the study as a control participant.the training group does the same spatial hearing task on two days, but on every trial they are given feedback about how the location they thought the sound came from differed from the actual sound location.

Eligibility criteria:
inclusion criteria: * age 18-55 years * english is the primary language * history of mtbi by self report exclusion criteria: * pure tone threshold (mean of 0.5-4.0 khz) \> 40db hl * major neurological or psychiatric conditions besides mtbi

Keywords: auditory plasticity hearing training