Kornimate/medical-research-clean huggingface dataset:
machine learning for risk stratification in the emergency department (mars-ed)

Conditions: Acute Pain; Emergencies

Summary: rationale identifying emergency department (ed) patients at high and low risk shortly after admission could help decision-making regarding patient care. several clinical risk scores and triage systems for stratification of patients have been developed, but often underperform in clinical practice. moreover, most of these risk scores only have been diagnostically validated in an observational cohort, but never have been evaluated for their actual clinical impact. in a recent retrospective study that was conducted in the maastricht university medical center (mumc+), a novel clinical risk score, the riskindex, was introduced that predicted 31-day mortality of sepsis patients presenting to an ed. the riskindex hereby also outperformed internal medicine specialists. observational follow-up studies underlined the potential of the risk score. however, it remains unknown to what extent these models have any beneficial value when it is actually implemented in clinical practice. objective to determine the diagnostic accuracy, policy changes and clinical impact of the riskindex as basis to conduct a large scale, multi-center randomised trial. study design the mars-ed study is designed as a multi-center, randomized, open-label, non-inferiority pilot clinical trial. study population adult patients who are assessed and treated by an internal medicine specialist in the ed of whom a minimum of 4 different laboratory results (hematology or clinical chemistry, required for calculation of ml risk score) are available within the first two hours of the ed visit. intervention physicians will be presented with the ml risk score (the riskindex) of the patients they are actively treating, directly after assessment of regular diagnostics has taken place. main study parameters primary - diagnostic accuracy, policy changes and clinical impact of a novel clinical risk score (the riskindex) secondary * policy changes due to presentation of ml score (treatment policy, requesting ancillary investigations, treatment restrictions (i.e., no intubation or resuscitation) * intensive care (icu) and medium care (mc) admission * length of admission * mortality within 31 days * readmission * patient preference * feasibility of novel clinical risk score

see our protocol paper, pmid 38263188

Eligibility criteria:
inclusion criteria: * adult, defined as ≥ 18 years of age * assessed and treated by an internal medicine specialist (gastroenterologists included) in the ed * willing to give written consent, either directly or after deferred consent procedure (see section 11.2). exclusion criteria: * \<4 different laboratory results available (hematology or clinical chemistry) within the first two hours of the ed visit (calculation ml prediction score otherwise not possible) * unwilling to provide written consent, either directly or after deferred consent procedure (see section 11.2).

Keywords: machine learning risk stratification pilot
gallex 6: study to evaluate the safety and tolerability of tesaglitazar in patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: this is a parallel-group, multi-center, long-term extension study from the gallant 6 study to monitor the safety and tolerability of oral tesaglitazar compared with pioglitazone in patients with type 2 diabetes for up to 104 weeks of treatment. the total duration, including treatment and follow-up, is 107 weeks.


Eligibility criteria:
inclusion criteria: * provision of a written informed consent * men or women who are \>= 18 years of age * female patients: postmenopausal; hysterectomized; or, if of childbearing potential, using a reliable method of birth control. * completed the last two visits of the randomized treatment period in gallant 6 exclusion criteria: * type 1 diabetes * new york heart association heart failure class iii or iv * treatment with chronic insulin * history of hypersensitivity or intolerance to any peroxisome proliferator-activated receptor agonist (like actos or avandia), fenofibrate, metformin or 3-hydroxy-3-methylglutaryl coenzyme a reductase inhibitor (statin) * history of drug-induced myopathy or drug-induced creatine kinase elevation, liver enzyme elevations, or neutropenia (low white blood cells) * creatinine levels of above twice the normal range * creatine kinase of above 3 times the upper limit of normal * previous enrollment in this long-term extension study * any clinically significant abnormality identified by physical examination, laboratory tests or electrocardiogram, which, in the judgment of the investigator, would compromise the patient's safety or successful participation in the clinical study

Keywords: patients diagnosed with type 2 diabetes who have participated in and completed the randomized, double-blind, parallel-group, multi-center study gallant 6.
dyadic mindfulness for people with parkinson's disease and their caregivers

Conditions: Mindfulness; Caregivers; Movement Disorders; Neurodegenerative Disease; Dyadic Intervention; Psychosocial Health; Parkinsons Disease

Summary: the proposed two-arm randomized waitlist-controlled trial will use a mixed-methods design to investigate the effects of dyadic mindfulness on physio-psycho-spiritual outcomes in people with parkinson's disease (pwpd) and their family caregivers. one hundred chinese patient-caregiver dyads will be randomized to receive eight weekly 90-minute dyadic mindfulness sessions or usual care. outcome measures include negative emotions (primary outcome), patient-caregiver relationship, mindfulness, hrqol, gut microbiome, pd-related symptoms, and caregiving burden. an actor-partner interdependence model will be used to explore the interactions of treatment effects within the dyads. the dyads will be assessed at baseline(t0), post-intervention(t1), and 4-months post-intervention(t2). the investigators will also invite 25 dyads to attend in-depth interviews exploring their experiences, perceived changes, and factors attributable to the effectiveness/ineffectiveness of the intervention. generalized linear mixed-effects (glme) with intention-to-treat analysis will be used to compare the changes in outcomes over time within and between the two arms. the findings will be triangulated to provide a comprehensive evaluation of the intervention's effectiveness. this study will generate rigorous scientific evidence to inform the application of dyadic mindfulness as a public health practice preventing the progression of psychological distress in pwpd and caregivers to clinically severe levels. its self-help nature also enriches the primary care for this clinical cohort.


Eligibility criteria:
inclusion criteria of pwpd: * chinese patients with idiopathic mild-moderate pd (as indicated by the hoehn and yahr scale stages i-iii: those with unilateral/bilateral symptoms, with/without postural instability who are able to walk/stand unassisted) * aged 50-80 * experience at least mild negative emotions (as indicated by the 21-item depression, anxiety and stress scale \[dass21\] score of depression subscale ≥10, anxiety subscale ≥8, or stress subscale ≥15) inclusion criteria of caregivers of pwpd: - self-identified as the primary caregivers of their patient both need to be able to communicate in cantonese and provide written consent. exclusion criteria: * engage in regular supervised mind-body practices such as tai chi, yoga, or other forms of mindfulness training (\>2 times per week) * have a pre-existing acute psychotic disease * currently participating in any other behavioral or pharmacological trial * have significant cognitive impairment, as indicated by an abbreviated mental test score≤ 6 * have other contraindications that may limit their full participation (e.g., severe hearing/vision impairment)

Keywords: parkinsons disease mindfulness dyadic care
the effect of a newly designed presurgical orthopedic appliance

Conditions: Cleft Lip and Palate

Summary: a randomized clinical trial to compare the effectiveness of newly designed active type of presurgical orthopedic appliances on maxillary arch dimensions in infants with bilateral cleft lip and palate.

it is a multicenter randomized clinical trial with two parallel arms. the patients will be randomly divided into two groups, group one: a passive orthopedic appliance will be used, and group two a new designed active orthopedic appliance will be used. impressions will be taken before starting the treatment (t1) and at the end of treatment (t2) three months later. the effectiveness of the two appliances will be assessed and measured on digital models of the maxillary arch before and after the treatment.

Eligibility criteria:
inclusion criteria: * 1. healthy new born infants with complete bilateral cleft lip, alveolus and palate. 2. non-syndromic. 3. non-operated cases. exclusion criteria: * 1. infants with systemic syndromes. 2.facial deformities.

Keywords: cleft lip and palate bilateral presurgical orthopaedic appliance
observational study of the prognosis in treated arterial hypertension

Conditions: Hypertension

Summary: observational study of life time prognosis for persons medically treated for arterial hypertension, according to current who-guidelines.


Eligibility criteria:
inclusion criteria: hypertension according to who-defined criteria exclusion criteria: age \< 18 years pregnancy
relationship between hyperventilation syndrome and sars-cov-2 infection

Conditions: COVID-19; Hyperventilation Syndrome

Summary: following an acute covid-19 infection, many patients suffer from long lasting physical symptoms that may greatly impair quality of life. persisting dyspnea and other functional respiratory complaints could evoke hyperventilation syndrome (hvs) as a putative contributor of the long-covid presentation in covid-19 survivors. we aimed to assess the possible relationship between a hvs and previous acute sars-cov-2 infection.


Eligibility criteria:
inclusion criteria: * read and speak french * perform a pulmonary function test exclusion criteria: - incomplete questionnaire or inability to obtain an interpretable lung function assessment

Keywords: covid-19 dyspnea hyperventilation syndrome
ultrabrief right unilateral and brief pulse bitemporal electroconvulsive therapy

Conditions: Depression; Depressive Disorder; Treatment Resistant Depressive Disorder; Bipolar Disorder; Major Depressive Disorder

Summary: to evaluate the equivalent efficacy of ultrabrief pulsewidth right unilateral electroconvulsive therapy versus bitemporal brief pulse electroconvulsive therapy in the treatment of depression and to evaluate the cognitive effects of ultrabrief right unilateral electroconvulsive therapy versus bitemporal brief pulse electroconvulsive therapy.

patients will be randomized to either bitemporal brief pulse electroconvulsive therapy ( 0.5 ms pulse width) or right unilateral ultrabrief pulse electroconvulsive therapy for the first six treatments. if further treatment is necessary, electrode placement will be chosen by the treating psychiatrist. all electroconvulsive therapy treatments will be performed with a thymatron system iv instrument. (somatics, llc, lake bluff, illinois, usa) pre- electroconvulsive therapy testing will occur within one week of beginning treatment. post-electroconvulsive therapy testing will occur within 48 hours of the 6th treatment.

Eligibility criteria:
inclusion criteria: * all patients age 18 and above referred for electroconvulsive therapy will be screened for eligibility for participation in this study. * basic competency in english * diagnosis of either of the following: 1. major depressive disorder, single episode 2. major depressive disorder, recurrent 3. bipolar disorder, currently depressed exclusion criteria: * pre-existing cognitive impairment with an initial mini mental status exam score of 24 or lower * major neurological disease * other medical conditions making electroconvulsive therapy an excessive risk to be completed safely in an outpatient surgery center and anticonvulsant therapy. * pregnancy

Keywords: depression depressive disorder treatment resistant depressive disorder bipolar disorder major depressive disorder electroconvulsive therapy
pregabalin for opiate withdrawal syndrome

Conditions: Opioid Withdrawal

Summary: it is a single blind randomized symptom triggered study to assess efficacy and safety of pregablin combined with the symptom triggered treatment for opiate withdrawal syndrome vs. clonidne with the same with the symptom triggered treatment for opiate withdrawal syndrome.

study design: single-blind randomized symptom-regulated protocol with an active control. eighty patients admitted to an inpatient addiction treatment program will be randomly assigned to two groups. the first group (n=40) receives up to 600 mg a day of pregabalin for six days along with symptomatic therapy that is divided into basic treatment that is given to all patients (doxylamin 30 mg/day) and additional medications based on patients' needs as determined by a psychiatrist using the opioid withdrawal scale and included ketorolac, loperamide, metoclopramide, nefazolin and phenazepam (benzodiazepine). the second group (n= 40) receives up to 600 micrograms of clonidine a day as the main treatment along with the same basic and symptomatic regimen. opiate withdrawal severity, craving, sleep disturbance, anxiety and depression, as well as general clinical impressions and side effects are assessed daily by psychiatrists who are blind to patients' group assignment using internationally validated quantitative psychometric instruments.

Eligibility criteria:
inclusion criteria: * opioid use disorders; opioid withdrawal syndrome exclusion criteria: * severe psychiatric and somatic disorders, other substance use disorders (except tobacco)
benefits of exergames on neurocognitive functions in adults suffering from depression

Conditions: Depression

Summary: the purpose of this study is to analyse the changes derived from exergames (videogames that include cognitive and physical stimulation simultaneously), in terms of cognitive functioning, psychomotor abilities, and its neural substrate, in adults suffering from depression.

the experiment will consist in a randomized three-arms controlled study. after being informed about the study and potential risks, and given written informed consent, adult participants with depression will be randomly distributed into three experimental groups: an intervention group that will train with exergames, an active control group that will train only with cognitive games, and a passive control group or wait-list. cognitive functions will be evaluated in three different moments: before the training intervention, after the intervention, and three months after finishing the training intervention. researchers will collect cognitive-behavioral and neural information (event-related potentials), and performing analysis of variance to compare the outcomes of the diverse groups at the three different time points, scientists will analyse the benefits of exergames on cognition.

Eligibility criteria:
the inclusion and exclusion criteria for persons suffering from depression, will be validated by a professional (psychologist), through an interview and the use of reliable and valid psychological assessment tools. inclusion criteria: * using the beck depression inventory-second edition (bdi-ii), a scored considered for inclusion criteria where depression (≥ 28 points on bdi-ii), confirmed by psychological interview. * a sufficient level of education to understand study procedures and be able to communicate with site personnel exclusion criteria: * participants suffering from depression with comorbidities (bipolar disorder, obsessive-compulsion disorder, neurological disorder, or traumatic brain injury) will be excluded. * \<20/60 vision with or without correction * inability to complete the activities * communication problems

Keywords: cognition neuropsychology neuroplasticity event related potentials exergames video games
evaluation of icotinib in metastatic triple-negative breast cancer after second-line therapy

Conditions: Metastatic Breast Cancer

Summary: evaluating the safety and efficacy of icotinib administered in 2-month treatments, in patients with metastatic triple-negative breast cancer that have received at least two prior treatments.

this is a phase ii, multi-center study. sixty-seven patients are planned to be enrolled. all patients will receive icotinib 125 mg bid administered for 8 weeks. patients with a complete response, partial response or stable disease at that time may continue to be treated based on physician discretion. follow up is then required until resolution or stabilization of any treatment-related toxicity, and patients with stable disease or objective responses must also continue evaluations until survived.

Eligibility criteria:
inclusion criteria: * age 18 years or older * ecog 0 or 1 * primary or metastatic tumor onfirmed as triple negative * measurable disease per recist version 1.1 * normal organ function, including bone marrow function, renal function, liver function, and cardiac function * two or more prior chemotherapy * signed and dated an informed consent form * life expectancy of at least 12 weeks exclusion criteria: * pregnant or breast feeding * ecog score ≧2 * uncontrolled medical problems * hepatic, renal, or bone marrow dysfunction as detailed above * concurrent malignancy or history of other malignancy within the last five years except as noted above * patients were unable or unwilling to comply with program requirements
does the recall by the general practitioner improve patients' participation in colorectal cancer screening?

Conditions: Colorectal Cancer

Summary: the propose of this study is to assess the effect of general practitioner's involvement in the stimulus invitation letter in colorectal cancer screening compared to sending the patient home test (stimulus 2 of reference as contained in the specifications).


Eligibility criteria:
inclusion criteria: * age : 50 to 74 years. * not having answered the first two solicitations of adeca75 to participate in screening for colorectal cancer exclusion criteria: * patients who have a fecal occult blood test for less than 2 years or a colonoscopy within the past 5 years or excluded for medical reasons (according to information known from adeca).

Keywords: colorectal cancer screening general practitioner fecal occult blood tests
intermittent caloric restriction in patients with mild to moderate crohn's disease

Conditions: Crohn's Disease

Summary: crohn's disease (cd) is a chronic inflammatory disease of the gastrointestinal (gi) tract. cd is a common inflammatory bowel disease (ibd), frequent (150,000 patients in france and 1.5 million in europe), disabling and incurable. the environmental factors, and in particular diet, play a major role in the pathogenesis of cd. the prevalence of cd is steadily increasing in highly industrialized countries, where the western diet rich in saturated fats and refined sugars, is blamed for this to explain this true pandemic. on the other hand, enteral nutrition, exclusive or partial, is known to be effective in the initial treatment of cd, especially in pediatrics. there are a number of evidence in favor of a nutritional management nutritional management of caloric restriction during inflammatory diseases such as psoriasis and rheumatoid arthritis,whose physiopathology is similar to that of ibd. to date, and despite patient concern, there is no consensus nutritional in the management of cd to influence the natural course of the disease. the investigators have decided to initiate a clinical study to evaluate for the first time the efficacy, acceptability and safety of intermittent caloric restriction in patients with cd.


Eligibility criteria:
inclusion criteria: * patients between 18 to 65 years old * established diagnosis of crohn's disease with a minimum disease duration of 3 months * patient with mild to moderate crohn's disease defined by a fecal calprotectin ≥ 250 μg/g and a cdai score between 150 to 300 * medical treatment of crohn's disease stable for at least 3 months * patient compliant with an intermittent caloric restriction during 16 weeks * person affiliated to or beneficiary of a social security plan * person informed about study organization and having signed the informed consent exclusion criteria: * patient with a bmi \< 18.5kg/m2 * patient having a weight loss of 5% the first month and 10% during the first 6 months * patient with active ano-perineal lesions * patient with an ostomy * patient with eating disorders (anorexia, bulimia) * person referred in articles l.1121-5, l. 1121-7 and l.1121-8 of the public health code: * pregnant, parturient or breastfeeding woman * minor person (non-emancipated) * adult person under legal protection (any form of public guardianship) * adult person incapable of giving consent and not under legal protection * person deprived of liberty for judicial or administrative decision, person under psychiatric care as referred in articles l. 3212-1 and l. 3213-1.

Keywords: intermittent caloric restriction crohn's disease
retinavue diabetic screening

Conditions: Diabetic Retinopathy

Summary: the purpose of this study is to examine whether the deployment of a non-mydriatic color fundus camera in a rural prime care setting is feasible and improves the detection rate of diabetic retinopathy in patients where adherence rates with recommended ophthalmology screening is low.

the centers for disease control and prevention (cdc) have estimated that 25.6 million americans aged 20 years or older have either been diagnosed or undiagnosed with diabetes mellitus. as such, it is crucial for patients to receive routine eye exams during their annual health assessment or diabetes follow-up visit with their primary care physician to check for diabetic retinopathy (dr). of those type 2 patients with a known duration of diabetes of less than 5 years, dr was diagnosed in 40% of patients taking insulin and 24% of patients not taking insulin. these percentages are especially concerning since data presented by schoenfeld and colleagues indicates that approximately 35% of americans with diabetes mellitus do not receive timely and recommended eye care to detect and treat their dr.10 reasons for noncompliance include transfer to a retinal specialist, limited personal mobility, and insurance. in addition, patients regularly fail to follow-up with their ophthalmologist or optometrist due to the lack of visual symptoms-the lack of symptoms does not exclude the possibility of early diabetic retinopathy. per the american diabetes association (ada) guidelines, it is recommended that all type 2 patients receive annual dilated eye exams. these eye exams must be completed by a knowledgeable and experienced eye care professional (i.e. ophthalmologist or optometrist). early detection of dr and the preventative effects of therapy is an important aspect for long term vision outcomes. the long-term goal is to improve the detection of diabetic retinopathy through better-quality measures of patient compliance and screening protocols in the prime care clinic. it is hypothesized that in type ii diabetic patients without documented retinal pathology, a hand-held non-mydriatic fundus camera is superior to a referred dilated eye exams for the screening and detection of dr.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. type ii diabetes without documented diabetic retinopathy exclusion criteria: 1. documented ocular pathology that may interfere with image acquisition (i.e. high grade cataract) 2. macular pathology (i.e. macular degeneration, cystoid macular edema, central serous retinopathy) 3. inability to attain analyzable retinavue image due to ocular pathology or other conditions (such as tremors limiting ability to maintain stable head for image) 4. acute or emergent ocular pathology that requires urgent assessment by an eye care professional as identified by the retinavue camera interpretation report 5. seen within the last 11 months for a diabetic eye exam.