Kornimate/medical-research-clean huggingface dataset:
clinical study to evaluate the efficacy, safety and immunogenicity of an mf59-adjuvanted quadrivalent influenza vaccine compared to non-influenza vaccine comparator in adults ≥ 65 years of age

Conditions: Influenza

Summary: a phase iii, randomized, observer-blind, controlled, multicenter clinical study to evaluate the efficacy, safety and immunogenicity of an mf59-adjuvanted quadrivalent influenza vaccine compared to non-influenza vaccine comparator in adults ≥ 65 years of age.


Eligibility criteria:
inclusion criteria: 1. males and females ≥ 65 years old who are healthy or have co-morbidities 2. individuals who or whose legal guardian have voluntarily given written consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. 3. ability to attend all scheduled visits and to comply with study procedures exclusion criteria: 1. hypersensitivity, including allergy to any component of vaccines foreseen in this study 2. abnormal function of the immune system. 3. receipt of any influenza vaccine within 6 months prior to enrolment in this study or who plan to receive influenza vaccine while participating in the study. 4. additional eligibility criteria may be discussed by contacting the site
a study to evaluate patient characteristics and treatment patterns among rheumatoid arthritis patients

Conditions: Rheumatoid Arthritis

Summary: this is a retrospective cohort study to evaluate patient characteristics, treatment patterns including a 6-factor effectiveness proxy measure, health care resource use and associated costs among rheumatoid arthritis patients initiating treatment comparator groups of interest between january 2014 and september 2016 across three united states insurance claims databases.


Eligibility criteria:
inclusion criteria: * first pharmacy claim for tofacitinib and then etanercept or adalimumab between jan 2014 and sep 2016 represents the index claim * first, select patients receiving ≥1 tofacitinib pharmacy claim (jan 2014-sep 2016) who did not have a tofacitinib claim anytime prior to index * patients do have \>1 advanced therapy filled on index date * physician diagnosis of rheumatoid arthritis (in any position) during the 1-year pre-index period, or on the index date * age 18+ years at index exclusion criteria: -none
a trial to increase child vegetable intake through behavioral strategies

Conditions: Obesity, Childhood

Summary: a community nutrition trial among a diverse low-income population that tested the effect of parent-child cooking nutrition intervention on vegetable intake among 9-12 children.

this study was a nonrandomized, controlled trial to determine whether a series of 6 weekly parent-child vegetable cooking skills classes and parent-led strategies informed by behavioral economics (1/week) (intervention group) improved dietary and non-dietary outcomes of a racially and ethnically diverse sample of low-income children (ages 9-12) more than a vegetable cooking skills program alone (control group).

Eligibility criteria:
inclusion criteria: * participant child must be 9-12 years old * parent must be the main food preparer for the household * the family must qualify for some form of public assistance * have a phone * must not have participated in a previous cooking matters for families in the past 3 years * be able to read, speak, and understand english (or spanish for spanish-only courses). exclusion criteria: \*no exclusions other than those that do not meet inclusion criteria

Keywords: child vegetable intake behavioral strategy intervention
comparative study of circulating microrna changes in patients with liver injury and healthy subjects

Conditions: Drug-Induced Liver Injury; Liver Failure

Summary: the objectives are to: 1. validate a panel of tissue-specific mirnas that are differentially expressed in the plasma of patients with and without liver injuries 2. investigate the physiological range of the circulating mirna panel in healthy subjects and under stress 3. investigate the dysregulation of circulating mirna panel and their prognostic and predictive values in clinical outcomes in identifying patients at high risk for mortality and acute liver failure. this trial involves peripheral blood sampling from subjects at their earliest presentation and remaining stays in the hospitalization in the emergency department. the investigators will develop panels of mirnas that are specific indicator of early onset of major organ failures, and correlate clinical outcomes with these mirnas.

the icu patients after surgery or under chemotherapies in sponsor's institutes will be enrolled in this observational cohort of investigation. whole blood samples will be separated immediately into plasma for storage. the participants will have their 2nd and 3rd samples obtained at 24-48 hours and 48-72 hours respectively. the schedule of most of sampling schedule is designed in concordance with the icu routines to avoid extra burdens on patients. the plasma samples will be used as prognostic markers in prognostic and predictive values in identifying patients at high risk for mortality and acute liver failure. patients who are discharged will be tracked for any clinical recurrence of the diseases every 28 days to assess the diagnostic accuracy of the mirna biomarkers that are measured. the 2nd objective will be assessed by measuring the concentration of mirnas in recruited healthy volunteers before and after a brief public speech. the circulating mirnas will be detected directly from 1 - 5 ul of plasma samples with the mirflp assay. this capillary electrophoresis-based mirna quantification method detects multiple mirnas in absolute copy number in smaller sample signature with negligible batch to batch variation, thus providing a standardizable mirna detection method.

Eligibility criteria:
inclusion criteria for healthy controls: adults 18 years and above exclusion criteria for healthy controls: underlying chronic inflammatory condition (e.g. inflammatory bowel disease) underlying autoimmune disease (e.g. rheumatoid arthritis, systemic lupus erythematosus) pre-existent liver disorder user of any prescribed medicine or over the counter drugs in prior 7 days. inclusion criteria for subjects: adults 18 years and above has condition related to icu enrollment cause exclusion criteria for subjects: age below 18 years known pregnancy treating physician deems aggressive care unsuitable unable to provide informed consent or comply with study requirements

Keywords: microrna mir-122 diagnosis prognosis
drugmonitoring of antiinfective drugs in patients receiving continous veno-venous hemodiafiltration (abx-cvvhdf)

Conditions: Need for Renal Replacement Therapy and Anti-infective Therapy Due to Severe Infection

Summary: approximately 300 patients have to be enrolled in the study. they are followed up until the end of icu stay. usually in clinical routine, patients suspected to have infection and simultaneously renal dysfunction making cvvhdf necessary. after enrolment blood and dialysate specimens are drawn and sent for analysis on specific time points. the analysis results are sent back to the study team at the charité - universitätsmedizin berlin and enable them to optimize antiinfectiva treatment of the study patients. data are used to test calculation tools and modify them if necessary.

little data exist whether desired and necessary blood levels of antiinfective drugs are reached during renal replacement therapy. drug producing companies are not able to come forward with appropriate dosing recommendation in patients needing renal replacement therapy. to achieve our study goal we plan: 1. to measure serum-concentrations of antiinfective drugs applied to the patients 2. to measure concentrations of antiinfective drugs in hemofiltration fluids. 3. to compare the actual measured concentrations with concentration predicted in known calculation tools. 4. to modify these calculation tools if necessary for better prediction.

Eligibility criteria:
inclusion criteria: * male and female patients, age ≥ 18 years * patients in the intensive care unit (icu), needing renal replacement therapy due to renal dysfunction and are treated with antiinfective drugs exclusion criteria: * pregnancy and lactation period. * participation in a clinical intervention study * lacking willingness to save and hand out data within the study * accommodation in an institution due to an official or judicial order * the informed consent of the patient or the subject's legally acceptable representative can´t be obtained in time * patient has a power of attorney or patient's provision, where he/she refuses participation in any clinical trial
what concept of manual therapy is more effective?

Conditions: Quality of Life; Self Efficacy; Kinesiophobia; Catastrophizing; Central Sensitisation; Anxiety; Depression; Sleep

Summary: the aim of the study will be to find out which manual therapy approach is most effective for the improvement of symptoms (sensory, cognitive, emotional and social) in people with fibromyalgia.

a randomized clinical trial will be conducted in 52 patients with fibromyalgia who will undergo a myofascial treatment approach or a passive mobilization treatment approach. data will be collected on the improvement of symptom severity, quality of life, self-efficacy, kinesiophobia, catastrophizing, central sensitization, anxiety, depression, and sleep. after the treatments, follow-ups will be made, and the results are expected to be disseminated to the scientific community during and after the end of the study.

Eligibility criteria:
inclusion criteria: * less than 62 years old * medical diagnosis of fibromyalgia * the individuals included in the study had a minimum one-year history of symptoms * to confirm the medical diagnosis of fibromyalgia, the physical therapists and study investigators used the 2010 american college of rheumatology (acr) diagnostic criteria. -since 2 of the measurement variables used in the study (wpi and ss-score) match the protocol when determining these criteria, this procedure was facilitated. the diagnostic criteria establish the diagnosis of fibromyalgia when12 : idg/wpi ≥ 7 and ss ≥ 5 or idg/wpi 4-6 and ss ≥ 9. exclusion criteria: * intolerance to touch * a change of medication in the last 2-3 months * agree not to change their medication during the study exclusion criteria: -

Keywords: manual therapy chronic pain fibromyalgia passive mobilizations myofascial approach symptom severity
retrospective study of positive biopsy specimens on patients undergoing a prostatectomy

Conditions: Prostate Cancer

Summary: this is a review of prostate biopsy specimens which show capsular penetration or positive surgical margins. patients had surgery performed at william beaumont hospital-royal oak, michigan.


Eligibility criteria:
inclusion criteria: * males having undergone surgery for prostate cancer at william beaumont hospital-royal oak, michigan

Keywords: prostate prostate cancer surgical margins gleason score positive lateral biopsies
point - preventing an opioid epidemic in norway: focusing on treatment of chronic pain

Conditions: Chronic Pain; Opioid Use

Summary: the investigators do research on chronic pain treatment to minimize the risks associated with opioids.

the investigators know that patients suffering from chronic pain need good treatment. the use of opioids for chronic, non-cancer related pain may seem appropriate in the short term, but can often have negative consequences for both the individual and society in the long term. several factors-the escalating use of opioids to chronic pain patients, the increasing use of strong opioids in particular, and the increasing number of overdoses caused by prescription opioids-point to the start of an opioid epidemic in norway. objectives the overall goal of the point project is to provide knowledge to optimize treatment of patients with chronic pain in order to avoid unnecessary escalation of opioid treatment, improve their quality of life and reduce the burden of disease. in the long run our objective is to prevent the unwanted consequences of opioid treatment and improve patients' quality of life. ultimately, through this project the investigators hope to prevent an opioid epidemic in norway. to achieve the main goal, the investigators will focus on pain patients and their doctors, as increasing opioid use may occur through the patient-doctor interaction. methods the project will develop and test a non-drug interventions that consist of an interdisciplinary group treatment . financing the research council of norway cooperation st. olavs hospital stavanger hospital trust city of stavanger national institute of public health (fhi) alcohol and drug research western norway (korfor) foreningen for kroniske smertepasienter (fks) norwegian forum of disabled peoples' organizations (safo) cooperation with other projects injury prevention and outcomes following trauma

Eligibility criteria:
inclusion criteria: * non-malignant, chronic pain * registered in stavanger municipality * consent to participation. * age 18 - 67 years * pain duration \<10 years exclusion criteria: * malignant pain condition
genotypic resistance-guided versus empirical therapy for h. pylori eradication.

Conditions: Helicobacter Pylori Infection

Summary: this study aims to investigate the efficacy of a 7-day genotypic resistance-guided triple therapy, compared with empirical concomitant therapy, for first-line eradication of h. pylori.

empiric eradication of h. pylori becomes steadily more challenging because of increasing antibiotic resistance. in high-resistance countries where bismuth and/or tetracycline are unavailable (eg; greece), non-bismuth quadruple therapies are currently recommended as first-line therapeutic options; however, eradication rates \>95% are infrequently achieved and even \>90% are disputed. antimicrobial susceptibility-guided therapy is a promising alternative in order to maintain high therapeutic efficacy. however, traditional culture-based susceptibility testing methods have several shortcomings, including they are time-consuming and they do not 100% reflect in vivo eradication. recent guidelines also recommend the use of molecular testing for evaluation of h. pylori antibiotic susceptibility. nevertheless, the efficacy of genotypic resistance-guided treatment of h. pylori has been seldom appraised. therefore, the investigators conducted this prospective randomized controlled trial aiming to investigate the efficacy of a 7-day genotypic resistance-guided triple therapy, compared with empirical concomitant therapy, for first-line eradication of h. pylori.

Eligibility criteria:
inclusion criteria: * consecutive outpatients aged ≥18 years with documented h. pylori infection. mental and legal ability to provide written informed consent. exclusion criteria: * previous history of h. pylori eradication therapy * history of allergies to the medications used * previous esophageal or gastric surgery * serious systemic disease * pregnancy or lactation.

Keywords: h. pylori genotypic resistance tailored therapy concomitant therapy
impact of probiotics bifilact® on diarrhea in patients treated with pelvic radiation

Conditions: Cancer; Diarrhea; Abdominal Pain; Quality of Life

Summary: in this double-blinded randomized clinical trial study, investigators assessed probiotic used to prevent or delay radiation induced grade moderate to severe diarrhea with patient treated for pelvic cancer.

this study was prospective, unicentric, controlled with comparison to a placebo, randomised and double-blinded. patients were stratified into three groups: prostatic cancers, gynecologic cancers without chemotherapy and gynecologic or rectal cancers with chemotherapy. patients were block-randomized by the research nurse and received a standard dose of bifilact® probiotics or placebo according to the random list generated by blocks of 2, 4, or 6 patients according to random permutations. a preliminary internal pilot study was performed when the half of the expected sample size were recruited. the goal of this analysis was to test assumptions that lead to chosen sample sizes (n0) and thus, validate the feasibility of the study. following preliminary results, the sample size re-calculated at the interim analysis is similar to that originally intended. it would be advisable to continue the recruitment as planned. no adjustment to the critical level of the test would be required in analyzes carried out at the end of study. however, another random block using higher probiotics dosage to the randomization was added with preservation of double bind. new random list were generated for each strata with a 3:1:1 ratio (higher dose, standard dose, placebo) to compensate for the starting of the latest higher dose group. all the bottles had a similar aspect, they were all identified by the commercial brand bifilact. also the group, either a, b or c, was circled on that bottle, depending on if that bottle belong to the placebo group, standard dose group, or high dose group. only the nurse knew the coding system, it was also her who would assign the patient to a group, according to the randomization list. she would also hand out the bottle to the patient every week. the two registered dietician, caregivers, were totally excluded of this processes (preliminary study and randomisation) to preserve the double blind.

Eligibility criteria:
inclusion criteria: * they had a pelvic cancer: gynecologic, rectal, or prostatic,they were to receive radiotherapy treatments for a minimum of 40 gy at the pelvic level , with or without chemotherapy and they had eastern cooperative oncology group(ecog) performance status of 0 or 1 exclusion criteria: * they had previous radiotherapy treatments in the pelvic or abdominal region, medical history of gastro-intestinal inflammation, malabsorption syndrome or inflammatory bowel disease or coeliac disease, ileostomy, daily use of anti-diarrheal medication before radiotherapy, pregnancy or breastfeeding, neutropenia or probiotics intolerance

Keywords: probiotics radiation-induced enteritis radiation-induced diarrhea radiation, diarrhea, enteritis diet nutrition
better evidence and translation for calciphylaxis

Conditions: Calciphylaxis

Summary: this global platform study will evaluate multiple interventions, across several domains of therapeutic care, in adult patients with kidney failure and newly diagnosed calciphylaxis.

beat-calci is a randomized, adaptive, multi-center, platform trial that will evaluate multiple interventions, across several domains of therapeutic care. the objective of the study is to establish high-quality evidence on the effect of a range of interventions in patients with kidney failure and newly diagnosed calciphylaxis. calciphylaxis is a rare disease affecting 1-2 people in 10,000. the trial will commence with a dialysis membrane domain and pharmacotherapy domain. the pharmacotherapy domain of beat-calci is a placebo-controlled, double blind, response adaptive, randomised controlled trial that will investigate whether any of the pharmacotherapeutic agents is superior to placebo in improving outcomes. the dialysis membrane domain of beat-calci is an open-label, randomised controlled two-way comparison between two different dialysis technologies. the beat-calci wound assessment scale (bcwas) is the primary endpoint for the trial. it is an 8-point ordinal categorical scale of disease outcomes and will be used to determine each participant's outcome. the trial will utilise a bayesian adaptive sample size re-estimation approach for sample size calculations. the trial will continue to recruit until predefined superiority or futility rules are met. as the trial progresses, in response to information accumulating during the trial, there are various adaptations that can occur, including addition or removal of an intervention arm, response adaptive randomisation and addition of new therapeutic domains.

Eligibility criteria:
inclusion criteria: 1. currently receiving haemodialysis, or peritoneal dialysis that can be converted to haemodialysis, with planned ongoing haemodialysis a minimum of three times per week for at least the duration of the protocolised calciphylaxis treatments within this trial 2. have a new calciphylaxis ulcer present for less than 10 weeks 3. age ≥ 18 years 4. eligible for randomisation in at least one recruiting domain 5. the participant and treating physician are willing and able to perform trial procedures exclusion criteria: nil
the 3d stent study

Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention (PCI)

Summary: the goal of this observational study is to assess the diagnostic performance of 3d stent to detect stent under-expansion in patients undergoing percutaneous coronary intervention. the main question it aims to answer is: the study hypothesis is that 3dstent technology will offer a comparable assessment of stent expansion compared to intravascular imaging.


Eligibility criteria:
inclusion criteria: * patient presenting with chronic or acute coronary syndromes (acs) with a clinical indication for pci guided by ivus. exclusion criteria: 1. age \<18 years 2. coronary lesions requiring total stent length \> 48 mm. 3. body mass index \>35 kg/m2 4. uncontrolled recurrent ventricular tachycardia 5. cardiogenic shock 6. unable to provide written informed consent (ic).
cardiotoxicity of carbon monoxide in patients treated with hyperbaric oxygen therapy

Conditions: Carbon Monoxide Poisoning

Summary: carbon monoxide poisoning is a frequent domestic accident and the leading cause of death from unintentionnal poisoning. its toxicity is based on the co binding to hemoglobin and myoglobin, inhibition of mitochondrial cytochrome oxidase, resulting in tissue hypoxia and reduced adenosine triphosphate synthesis and ischemia-reperfusion injury. this study aims to investigate the early and late cardiologic effects of co in patients treated with hyperbaric oxygen (hbot) for co poisoning

this is a single-center retrospective study on health data. the methodology includes a collection of data on health and history data of patients treated by hbot fo co poisoning between 01/01/2015 and 31/12/2021 and carrying out a telephone interview of patients who have had early cardiovascular manifestations of co poisoning. one month between the start of theses interviews, an information letter on the study is sent by post, giving the possibility of opposing it.

Eligibility criteria:
inclusion criteria: patients treated for co poisoning with hbot in the hyperbaric and underwater medicine department of the brest university hospital from 2015/01/01 to 2021/12/31 exclusion criteria: * refusal

Keywords: cardiac injury cardiac toxicity
hemodynamic effects on cerebral autoregulation in acute stroke

Conditions: Ischemic Stroke

Summary: this study investigates if there are hemodynamic alterations in acute stroke that predispose patients to impaired perfusion and regulation of cerebral blood flow. to test this, we will target recruitment of acute ischemic stroke patients who present to the ed within 12 hours of symptoms onset. enrolled subjects will receive continuous noninvasive hemodynamic monitoring contemporaneous with measurements of cerebral blood flow velocities and cerebral oximetry.


Eligibility criteria:
inclusion criteria: * suspected ischemic stroke within 12 hours of symptom onset * nihss ≥ 4 * age 18 to 90 years exclusion criteria: * baseline modified rankin scale \> 3 * pregnancy * intracranial hemorrhage on head ct * mechanical ventilation prior to enrollment * inadequate temporal windows for tcd analysis

Keywords: stroke transcranial doppler cerebral blood flow cardiac output non-invasive hemodynamic monitoring