Kornimate/medical-research-clean huggingface dataset:
leukocyte esterase sensor test

Conditions: Prosthetic Joint Infection

Summary: the primary objective of this study is to assess the diagnostic efficacy of the quantitative electrochemical le biosensor for periprosthetic joint infection (pji). the secondary objective of this study is to assess the utility of d-lactase as adjunct biomarker to le in making a diagnosis of pji.


Eligibility criteria:
inclusion criteria: 1: consecutive patients undergoing at least one of the following procedures: presumed aseptic revision arthroplasty, irrigation and debridement, radical resection for periprosthetic joint infection exclusion criteria: 1. known active gout flare 2. existing corrosion or metallosis 3. inflammatory arthritis 4. preexisting diagnosis of infection in the same joint 5. patients undergoing second-stage procedure for infection.
cross-cultural adaptation of the 'cold intolerance severity score' (ciss) to the dutch language.

Conditions: Hand Injuries

Summary: to report cold intolerance by the ciss score in medicolegal patients.

rationale cold intolerance is an important finding in hand trauma patients, nerve injury, crush injury, degloving injury or amputation. cold intolerance as a symptom is probably the least responsive to any known medical treatment. perhaps due to the fact that we have no control over it, the consequences for cold tolerance are seldom researched. patients involved in medicolegal claims report more pain and less function than controls. medicolegal examinations for various indications offer a long-term outcome view for the symptoms of cold tolerance. therefore, together with handcentrum we want to translate, improve and test the current prom for cold intolerance ciss objective to report coldintolerance by the ciss score in medicolegal patients. study parameters / endpoints a validated dutch version of the ciss a report on 100 ciss scores in medicolegal patients examine if a shorter version of the ciss questionnaire is feasible study design 2-3 independent forward translations (e.g. from english into dutch) by native speakers of the target language (e.g. dutch). one of the translators understands the concept, one translator has no knowledge of the concept that the questionnaire measures and no medical background. the translators make a joint forward translation together with an independent person. 2-3 independent back-translations (e.g. from dutch into english) by native speakers of the source language (e.g. english). both translators have no knowledge of the concept the questionnaire measures and have no medical background. ... read more burden and risk these questionnaires are mandatory anyway. so, no additional time for the patients needed. there is no risk involved. there is no alteration in the medical or clinical pathway. recruitment and consent automatically enrolment and permission via medisoft software from handc summary translation and validation of a dutch version of a prom for cold intolerance

Eligibility criteria:
inclusion criteria: * - adult * traumatic hand injury * sufficient knowledge of the dutch language (at least level b1) exclusion criteria: * - definitive total hand amputation

Keywords: ciss, handsurgery, crush, nerve injury , amputation, coldintolerance
prognostic value of heart-type fatty acid-binding protein (h-fabp) in acute pulmonary embolism

Conditions: Pulmonary Embolism

Summary: the patients presenting with acute pulmonary embolism and right ventricular dysfunction are at high risk for life-threatening events and must be identified in the emergency department for adequate care and hospital admission. echocardiography can identify right ventricular dysfunction, but this test is not always available, and echocardiographic criteria of right ventricular dysfunction vary among published studies. the primary purpose of this protocol is to study the prognostic value of a cardiac biomarker, h-fabp (heart-type fatty acid-binding protein) , to identify in the emergency department the patients presenting with high risk pulmonary embolism. as secondary outcomes, h-fabp results will be compared to other cardiac biomarkers (bnp, troponin) and clinical score performances that have been previously studied to stratify the prognosis of patients with pulmonary embolism in the emergency department.


Eligibility criteria:
inclusion criteria: * patients with acute pulmonary embolism diagnosed in the emergency departement exclusion criteria: * patient under guardianship * patient without social insurance * pregnant women * refusal to sign the consent * myocardial infarction in the 10 days before pulmonary embolism

Keywords: pulmonary embolism heart-type fatty acid-binding protein cardiac biomarkers risk stratification
head position after endovascular therapy

Conditions: Stroke, Acute; Endovascular Therapy

Summary: the aim of this trial is to investigate whether head elevation position after endovascular treatment can improve the 90-day functional outcome of acute large vessel occlusion in the anterior circulation.

the optimal head position for patients with acute ischemic stroke (ais) remains uncertain. the headpos study revealed that there is no significant difference in disability outcomes between patients who are placed in a lying-flat position for 24 hours and those who are placed in a sitting-up position with the head elevated to at least 30 degrees for 24 hours. however, this study included both patients with ischemic and hemorrhagic strokes, and most of the patients had mild strokes (median national institutes of health stroke scale score of 4). it is unclear how to arrange the patient's head position after endovascular treatment. the hypothesis of this trial: compared with the lying flat head positioni, the head elevation position after endovascular treatment can significantly improve the 90-day functional outcome of acute large vessel occlusion in the anterior circulation.

Eligibility criteria:
inclusion criteria: 1. clinical signs consistent with acute ischemic stroke; 2. age ≥ 18 years old; 3. proved anterior circulation large vessel occlusion on digital subtraction angiography (ica, m1, m2) with/without cervical lesion (tandem); 4. nihss score ≥ 8 points before endovascular treatment; 5. aspects score ≤ 7 points before endovascular treatment; 6. successful vessel recanalization after endovascular treatment (defined as an etici score of 2b, 2c, or 3) ； 7. the time from onset to randomization ≤ 24 hours (the onset time is defined as the last normal time); 8. written informed consent is obtained from patients and/or their legal representatives. exclusion criteria: 1. pre-stroke mrs score\>1 point; 2. patients with acute occlusions in multiple vascular territories (e.g. bilateral anterior circulation, or anterior/posterior circulation); 3. currently in pregnant or lactating or serum beta hcg test is positive on admission; 4. contraindications to a flat head position; 5. any terminal illness with life expectancy less than 6 months; 6. participating in other clinical trials; 7. patients with a preexisting neurological or psychiatric disease that would confound the neurological functional evaluations; 8. unlikely to be available for 90-day follow-up.
effect of natalizumab on infarct volume in acute ischemic stroke

Conditions: Acute Ischemic Stroke

Summary: the primary objective of the study is to determine whether one 300 mg dose of intravenous (iv) natalizumab reduces change in infarct volume from baseline to day 5 on magnetic resonance imaging (mri) in participants with acute ischemic stroke when given at ≤6 hours or at \>6 to ≤9 hours from when they were last known normal (lkn). the secondary objectives of this study in this study population are as follows: to assess the efficacy of natalizumab on change in infarct volume from baseline to day 30; to assess efficacy of natalizumab on change in infarct volume from 24 hours to day 5 and day 30; to assess the efficacy of natalizumab on clinical measures of stroke outcome; to assess the safety of natalizumab in participants with acute ischemic stroke.


Eligibility criteria:
key inclusion criteria: * diagnosis of acute ischemic stroke. * score of ≥6 points on the national institute of health stroke scale (nihss) at screening. * at least 1 acute infarct with largest diameter of more than 2 cm on baseline brain diffusion-weighted imaging (dwi). * participants who have received reperfusion therapy may be eligible to participate but must meet all eligibility criteria and perform the baseline study magnetic resonance imaging (mri) after reperfusion therapy has been completed. * subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for at least 3 months after their dose of study treatment. key exclusion criteria: * presence of any intracranial hemorrhage (ich) on head computed tomography (ct) or non-petechial ich on screening mri. * stroke isolated to the brainstem. * presence of coma * expected to die or unable to be evaluated within 5 days. * hypotension requiring the use of intravenous (iv) vasopressor support or systolic blood pressure \<90 mmhg at the time of randomization. * known prior treatment with natalizumab. * immunocompromised subjects, as determined by the investigator. * history of progressive multifocal leukoencephalopathy (pml). * contraindications to mri, e.g., implanted pacemaker or other contraindicated implanted metal devices, history of or risk for side effects from gadolinium, or claustrophobia that cannot be medically managed. note: other protocol-defined inclusion/exclusion criteria may apply.
the effect of the hand massage a women undergoing brachytherapy

Conditions: Hand Massage

Summary: background gynecologic cancers are among the ten most common cancers among women. during brachytherapy, women can have pain and situational anxiety due to the treatment. methods this parallel-group randomized controlled study evaluated the effect of the hand massage practiced using baby oil, with lavender oil, on reducing operational pain and situational anxiety in women with brachytherapy. the study was completed with 36 patients. the treatment group included 18 patients, and the control group had 18. the data were collected through patient information form, visual analog scale, and state anxiety inventory. before the brachytherapy, three sessions of hand massages, each lasting 10 minutes (5 minutes for each hand), were performed using baby oil with lavender. data collection forms were repeated after each session. the control group received routine treatment. p\<0.05 was accepted as significant.

therefore, the impact of hand massage applied with lavender baby oil on women with gynecologic cancer having brachytherapy for three sessions on the pain and state anxiety experienced during the intervention was evaluated in this study.

Eligibility criteria:
inclusion criteria: * verbal communication * to be at the age of 18 and above * to be diagnosed with gynecologic cancer and receive bt three days a week regularly * to be aware that she has a gynecologic cancer disease and to be a volunteer to participate in the study exclusion criteria: * the patients who had metastasis, bleeding or coagulation disorder * received complementary and integrated treatment * had edema or lesion on hand, had a psychiatric disease * had communication problems * did not want to have a massage * were under general anesthesia during the intervention

Keywords: hand massage pain state anxiety brachytherapy
postoperative results of incisional endometriosis

Conditions: Endometriosis; Pain

Summary: the primary aim is to determine the endometriotic foci formed in the incision line after surgical operations, and the medical treatment approach is the primary objective. medical treatment was initiated and the patients who did not benefit from the treatment would be operated and postoperative pain scores would be compared with the medical treatment. it will be tried to determine which treatment is more effective in pain control. in addition to removing the symptoms and providing therapeutic methods in patients, it is aimed to help in differential diagnosis of dermatological diseases and malignancy and thus to prevent anxiety in patients. it is also aimed to evaluate the pathology results in the most appropriate way to eliminate the symptoms (severe pain, bleeding, etc.) that occur in accordance with the menstrual cycle every month.


Eligibility criteria:
inclusion criteria: * patients who have undergone surgery previously and who have an incision in the abdominal region and who applied with a complaint of mass in the incision and who were primarily considered endometrial focus in the diagnosis, * patients who were diagnosed with endometriotic foci in the incision line and used medical treatment for a while, but who did not benefit because of surgical excision. exclusion criteria: * dermatologically diagnosed patients * follow-up patients with malignancy diagnosis * patients who have responded to medical treatment

Keywords: incisional endometriosis scar endometriosis
an emergency department (ed) provider centered intervention for non-traumatic dental condition management (ntdc)

Conditions: Emergency Department Visit; Odontalgia

Summary: the overall objective of this proposal is to understand the barriers and facilitators to non-traumatic dental condition (ntdc) management in the emergency department (ed) through quantitative and qualitative methods. the first aim will determine the national variation in ntdc prescribing in the ed and subsequent ed/urgent care revisits and hospitalizations within 30-days of an index ed visit. using national electronic health records and integrated claims datasets and a random effects model, we will identify factors associated with prescribing for ntdc and variation at the patient, provider, hospital and state levels. the second aim identifies ed providers' perceived barriers and facilitators to the management of ntdc in the ed. using individual in depth interviews, ed providers (physicians, advanced practice providers) will identify the facilitators and barriers to management and prescribing for ntdc in the ed.


Eligibility criteria:
inclusion criteria: * ed providers (physicians, nurse practitioners, physician assistants) * working full-time in the ed exclusion criteria: * part-time ed providers

Keywords: non-traumatic dental conditions emergency department opioid antibiotic
stroke treatment with acute reperfusion and simvastatin

Conditions: Stroke, Acute

Summary: the purpose of this study is to determine whether simvastatin treatment started within the first 12 hours from stroke onset improves neurological and functional outcomes, evaluated at seventh day/discharge or at the third month. also, to demonstrate that simvastatin is safe and not associated with higher rates of hemorrhagic transformation in patients who receive thrombolysis.


Eligibility criteria:
inclusion criteria: * patients older than 18 years acute ischemic stroke (less than 12 hours from stroke onset). * stroke involving mca-aca-pca. * nihss score 4 to 22. * previous modified rankin scale score of 1 or 0. * patient or proxy informed consent. * patients not taking statins for the past six months. exclusion criteria: * pregnancy or breastfeeding. * clinical or radiological evidence on admission of intracranial hemorrhage, hemorrhagic infarction or tumor. * seizures at the time of inclusion. * complete or substantial recovery prior to randomization. * patients with ipsilateral neurological deficit that may mask the evaluation of the current event. * liver disease (ast or alt more than twice upper normality limit). * cardiogenic shock or relevant cardiac failure. * patients with more than five times upper normality limit of cpk. * myocardial infarction or any other thromboembolic event within the previous 30 days. * active infection by the time of inclusion. * documented hypersensibility to statins. * drug abuse. * expected short life-expectancy related to other systemic diseases.

Keywords: acute stroke tissue plasminogen activator simvastatin
ic14 antibodies to treat individuals with acute lung injury

Conditions: Respiratory Distress Syndrome, Adult; Lung Diseases

Summary: this is a phase ii, randomized, double-blind, placebo-controlled, safety and efficacy study of a recombinant chimeric monoclonal antibody against cd14 (ic14) in hospitalized patients with acute lung injury (ali).

background: this study will use ic14, a recombinant chimeric monoclonal antibody (mab) recognizing cd14, to block cd14 medicated cellular activation in patients with sepsis-induced ali. research results of antibody interaction with cd14 suggest that cd14 has a central role in the recognition of bacterial products and the induction of innate immune responses. although beneficial, when this response is combined with a component of alveolar stretch it may induce an exaggerated response that can be harmful. this study will implement strategies to block cd14-mediated cellular activation and will evaluate whether this strategy has a beneficial effect in reducing alveolar inflammatory response, mechanical ventilation days, multiple organ failure, and severity of organ dysfunction in patients with sepsis-induced ali. design narrative: the primary outcome of this study will be alveolar lavage concentrations of interleukin-8 that will be measured post-treatment at days 2 and 3, and days 6 to 8. the key secondary outcomes of this study will be: 1) worst murray lung injury score (measured at days 1 through 7, and day 28); 2) worst multiple organ dysfunction (mod) score (marshall) (measured at days 1 through 7, and day 28); 3) infections-nosocomial and/or surgical site infections (measured at day 28); 4) ventilator-free days (measured at day 28); and 5) mortality (measured at day 28).

Eligibility criteria:
inclusion criteria: * presence of ali, defined as the following: 1. acute onset (less than 28 days from study entry) 2. pao2/fio2 of less than 300 3. bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph (infiltrates may be patchy, diffuse, homogeneous, or asymmetric) 4. requirement for positive pressure ventilation via endotracheal tube 5. no clinical evidence of left atrial hypertension * clinical indication for antimicrobial therapy at the time of randomization * anticipated duration of mechanical ventilation greater than 48 hours exclusion criteria: * treatment with a drug or device within 30 days prior to study entry that has not received regulatory approval at the time of study entry * does not meet safety criteria for bronchoscopic alveolar lavage either at baseline or is anticipated to be too high a risk for lavage on day 1 of the study * intubation for cardiopulmonary arrest * intubation for status asthmaticus, pulmonary embolus, or myocardia infarction * anticipated survival less than 48 hours from intubation * anticipated survival less than 28 days due to pre-existing medical condition
a trial to compare antibacterial vs. placebo mouthwash to reduce the incidence of sexually transmitted infections (stis) in men who have sex with men (msm) taking hiv pre-exposure prophylaxis (prep)

Conditions: Sexually Transmitted Diseases

Summary: the study involves a randomized placebo controlled trial that aims to assess if a mouthwash (listerine cool mint, lcm) is able to reduce the cumulative incidence of gonorrhoea (ng), chlamydia (ct) and syphilis in men who have sex with men and receiving preexposure prophylaxis (prep) at the institute of tropical medicine (itm).

the study aims to assess if there is a difference in the incidence rate of gonorrhea, chlamydia and syphilis detected at any site whilst individuals are on daily and pre/post sex listerine cool mint (lcm) vs. placebo mouthwash. the study has a double-blind, cross-over design, in which subjects will be screened at the itm and, if eligible, will be enrolled and randomized to group 1 (lcm) or group 2 (placebo). after 3 months, a crossover will occur and subjects will switch to the other intervention. each participant will therefore be enrolled for 6 months (2 x 3 months, no wash out period). subjects will be recruited from the existing prep cohort at the institute of tropical medicine antwerp. a total of 320 subjects will be recruited (160 in each arm).

Eligibility criteria:
inclusion criteria: * men aged 18 or more * enrolled in belgian prep program at itm * has had sex with another man in the previous year * has had a symptomatic or asymptomatic sti (ct/ng/syphilis) in the previous 2 years * willing to be enrolled in the cohort for 6 months and attend 3 monthly follow up visits * willing to comply with the mouthwash study schema and willing to ask their casual partners to mouthwash pre- and post-sex * prepared to fill out the online diary once a week * able and willing to provide written informed consent exclusion criteria: * currently using a mouthwash and unwilling to cease use of this mouthwash * enrolment in another interventional trial * tests hiv positive at screening

Keywords: gonorrhea syphilis chlamydia listerine sti
evaluation of emotion management skill strengthening in chronically ill patients, benefiting from creative and physical activities

Conditions: Emotion Management Skill; Educational Therapy; Creative and Physical Activities

Summary: there are very few studies on emotion management in chronically ill patients. they usually include small sample size (less than 30 persons) and are not randomized controlled trials. however, emotion management is an essential coping skill in mental well-being and quality of life and is the subject of numerous studies in psychology.the investigators hypothesized that a creative and physical activities combination in chronically ill will promote the strengthening of emotion management skill. the investigators will conduct an innovating study combining quantitative and qualitative variables in a randomized controlled trial to confirm our hypothesis.

1. surveyors will conduct a first interview with patients (within an association "la fabrique créative de santé" that provides free activities to chronically ill) , in order to collect data on emotion management and quality of life perception and to assess expectations regarding the activities. at the end of the interview, patients will be randomized in two groups. 2. in arm 1, patients choose one creative activity (evolutive art-therapy, writing workshop, theatre, singing) and one physical activity (pilates, mindfulness meditation, shiatsu, ayurvedic massage) that they will practice during the following six months. 3. in arm 2, patients will follow the same pattern but will start activities 6 months later. 4. after 6 months data on patients emotion management and quality of life perception will be collected again and interviews will be conducted regarding their overall satisfaction of the activities. 5. every six months during one year, data will be collected by mail or e-mail.

Eligibility criteria:
inclusion criteria: * 18 years old and over * chronical illness * followed by a physician from nantes university hospital exclusion criteria: * having already taken part in activities within the association "la fabrique créative de santé" * mental illness

Keywords: chronic ill patients emotion management skill quality of life