Kornimate/medical-research-clean huggingface dataset:
cardiovascular outcomes and mortality in vascular surgical patients

Conditions: Perioperative Complication; Cardiovascular Complication

Summary: this is a registry-based study of elective vascular surgical patients undergoing intermediate or high-risk vascular surgical interventions at groote schuur hospital, a tertiary academic center, over a 12 month period.


Eligibility criteria:
inclusion criteria: - all patients undergoing vascular surgery: 1. 18 years and older 2. elective procedures 3. moderate- to high-risk surgical interventions exclusion criteria: 1. emergency vascular procedures 2. low risk vascular surgery, i.e. venous stripping 3. all non-vascular surgical interventions
risk stratification for coronary artery disease with type 2 diabetic patients

Conditions: Coronary Arteriosclerosis

Summary: diabetic type 2 patients (db2) has a higher prevalence of coronary artery disease (cad) than non-diabetic persons. presence of cad results in murmurs arising from the filling of the arteries and can be detected by the cadscor system and can together with biological patient profile indicate the risk of presence of cad in the patient. in the pilot study 100 asymptomatic db2-patients examined with cadscor system and biomarkers will be compared with computed tomography (ct) cardiography and single-photon emission computed tomography (spect) for assessing if combination of patient profile (gender, age etc) combined with above measures may give rise to new improved risk scoring method for he db2-patient.

the study is intended as a pilot observational study for evaluation of a new risk scoring method, cadscor system, is relevant for assessment of cad in the db2-patient. the primary end point will be to document that the hypothesis of combining the cadscor system measure with other patient profile data will increase the accuracy of the method for determination of risk of presence of cad. the secondary endpoint will be to show that a receiver operating characteristic curve (roc) of \> 80% for correct determination of presence of cad will be achieved. the further objective of the study will be to confirm the relevance of performing a large scale study with equivalent objectives. as controls in the study will be applied ct angiography, ct-calcium and resting and drug induced ct-scintigraphy. it is assumed that 15-20 of enrolled patients in the study will suffer from cad.

Eligibility criteria:
inclusion criteria: * patients suffering from diabetes type 2 * both sexes * patients between 40 and 80 years * patients without chest pain at rest and labor * patients having a normal electrocardiogram (ecg, i.e. without q-peaks/ t-peak abnormalities in sinus rhythm) * patients having intact skin over sternum exclusion criteria: * patients suffering from a heart disease * patients already having received heart surgery * patients with pacemaker or other implanted electronic device * patients suffering from allergy against iodine and iodine containing substances * patients with estimated gfr below 50 ml/min/1.73 sqm m * patients suffering from adenosine intolerance or known allergic asthma * patients not being capable of understanding the patient information of the study * patients who are pregnant * patients suffering from allergy to adhesives
effect of wet clothing removal compared to use of a vapor barrier in accidental hypothermia

Conditions: Accidental Hypothermia; Emergencies

Summary: the optimal method of prehospital insulation and rewarming of hypothermic patients have been subject of debate, and there is a substantial lack og high-quality evidence to guide providers. one question concerns whether or not the patients clothing should be removed prior to being wrapped in an insulating model with a vapor barrier. evaporative heat loss is one of four mechanisms of heat loss, and preventing evaporative heat loss should be a prioritized task for providers. removal of wet clothing usually means subjecting the patient to the environment, but will reduce the evaporative heat loss considerably. an other alternative is to encapsulate the patient in a vapor barrier. evaporative heat loss will stop when the humidity inside the vapor barrier reaches 100%. we aim to investigate whether it is recommended to removed wet clothing or encase the patient in a vapor barrier.


Eligibility criteria:
inclusion criteria: * age \<18 * american society of anaesthesiologists class 1 * no nicotine use exclusion criteria: * acute illness on study day, fever or malaise

Keywords: accidental hypothermia mountain medicine
pilot study on gastro-intestinal (gi) enteral nutrition (en) tolerance in intensive care unit patients

Conditions: Critically Ill

Summary: specifically designed enteral formulations may improve the gastrointestinal tolerance during early enteral nutrition in the critically ill patient. this pilot trial will permit testing the design of the full-scale study providing valuable data on the expected effect of the formulation, the variability, thus helping to better estimate the required sample size.


Eligibility criteria:
inclusion criteria: * male or female older than 18 years of age * all icu patients * expected icu stay superior or equal to 5 days * anticipated to receive tube feeding for at least 3 days * informed consent obtained from patient or close relative exclusion criteria: * contraindication to enteral nutrition or to the placement of an enteral feeding tube * on enteral nutrition with superior or equal to 75% of caloric goal administered * restriction in full intestinal support including protein administration * parenteral nutrition of any kind unless due to enteral nutrition intolerance * history of allergy or intolerance to the study product components (test or control product) * currently under therapeutic limitations. non functional gi tract * unwilling or unable to comply with study treatments * currently participating or having participated in another clinical, interventional trial during the last month

Keywords: enteral nutrition, critically ill patients
aprevent vocal implant system (vois) for adjustable treatment of unilateral vocal fold paralysis (uvfp)

Conditions: Paralysis, Unilateral, Vocal Cord

Summary: the objective of this study is to evaluate pre- and intraoperative voice quality, the degree of vocal fold closure and the maximum phonation time (mpt), first determined after temporary aprevent® vois implantation and then after permanent existing product implantation.


Eligibility criteria:
inclusion criteria: * male and female patients between 18 and 80 years * diagnosed with permanent uvfp and insufficient glottal closure and planned type i thyroplasty with conventional implant * ability to co-operate with the investigator and to comply with the requirements of the entire study exclusion criteria: * any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the clinical investigation may influence the result of the clinical investigation, or the participant's ability to participate in the clinical investigation * scheduled elective surgery or other procedures requiring general anaesthesia during clinical investigation * had medialization thyroplasty before * had injection medialization laryngoplasty in the past two years. * presence of structural vocal fold lesions such as polyp or nodules * status post total cordectomy * previous laryngeal framework surgery (any type of thyroplasty, arytenoid adduction) * significant non-laryngeal speech abnormality (severe dysarthria determined by a panel of trained speech therapists) * severe coagulopathy

Keywords: unilateral vocal fold paralysis type i thyroplasty
a pilot with interactive computer-assisted screening for mental health in primary care

Conditions: Mental Health Disorders

Summary: the current protocol pertains to the evaluation of the interactive computer-assisted screening (icas) tool through a pilot randomized control trial. the purpose of this evaluation is to determine the efficacy of the icas tool in improving clinician's detection of common mental health conditions (i.e. major depression/generalized anxiety/post-traumatic stress disorder/alcohol dependence), and patients' discussion on mental health.

the icas tool is a health-risk assessment survey that is completed by adult patients using touch-screen ipad device in their waiting time before seeing their clinician (family physician or nurse practitioner). the computer program generates tailored risk-report for the clinician and a simple recommendation sheet for the patient, with community resources and health information, at the point of care. the icas tool currently includes validated screening scales for depression, generalized anxiety, posttraumatic stress disorder and alcohol abuse. there are some questions on the social determinants of mental health as well. the current versions of the tool are in english and spanish; a chinese language version will also be developed.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * speak/read spanish * speak/read english * visiting the consenting clinician exclusion criteria: * patient accompanied by a family member for interpretation * new patients coming for first visit * patients feeling unwell (self-report) * inability of the research staff to offer study details in privacy

Keywords: interactive health-risk assessment primary care randomized open label efficacy study
a study to determine the tissue properties, vascular physiology and biochemical milieu of myofascial trigger points

Conditions: Myofascial Pain

Summary: determine the effect of dry needling using a 32 gauge needle on active trigger points in subjects with chronic myofascial pain. participants will receive treatment for active trigger points (3 on successive weeks) and will have pain, status of the trigger point and functional measures assessed at baseline, after treatment and eight weeks later.

chronic myofascial pain syndromes, such as pain associated with myofascial trigger points (mtrps), are prevalent yet poorly understood. our long-term goal is to determine the pathogenesis and pathophysiological mechanisms of chronic pain associated with trigger points, eventually leading to the development of objective diagnostic criteria and effective pain management strategies. we propose to achieve this goal using a new and unique integrative methodology combining microanalytic biochemical assays, ultrasound technology (imaging) and mathematical modeling. an additional component of the study plan is to learn if a standard treatment for mtrps is associated with the biochemical and ultrasound changes we will be measuring this project has the following specific aims: 1) to understand the viscoelastic soft tissue neighborhood and vascular physiology of affected muscle at a macroscopic level using ultrasound imaging, elastography and doppler blood flow imaging; 2) to understand the pathophysiology of myofascial trigger points at a nanotechnological level through assays of biochemical milieu using a microdialysis technique; 3) to develop mathematical models of underlying pathophysiological mechanisms based on experimental observations for quantitative hypothesis testing; 4) to determine if dry needle therapy, a standard of care for mtrps, changes the macroscopic and/or microscopic measurements and leads to resolution of the trigger point and secondarily associated pain symptoms.. our hypothesis is that pathogenesis of myofascial pain syndrome involves local trauma to the muscle fibers, and the biochemical response to the injury leads to sustained muscle contracture, compression of blood vessels and a local energy crisis that causes tissue hypoxia and the expression of pain-producing substances at myofascial trigger points. relieving the trigger point through dry needle therapy

Eligibility criteria:
inclusion criteria: * spontaneous soft tissue pain in shoulder and neck region exclusion criteria: * recent fracture, neurological injury or history of stroke, use of opioids

Keywords: active trigger points
state anxiety levels of pregnant women to inform about fetus with ultrasound images during detailed ultrasound.

Conditions: Ultrasound; Perinatal Care; Anxiety

Summary: the aim of the study is to determine the state anxiety levels of the pregnant women who were given and not given information about the fetus with usg images during the detailed ultrasound (usg) and to compare them in both groups. this research is in the design of pre-test-post-test applied and randomized controlled research. dependent variables: state anxiety levels independent variables: being informed during ultrasound control variables: socio-demographic variables and obstetric variables.

the research population will be composed of pregnant women who applied to the perinatology polyclinic of the fırat university hospital, department of obstetrics and gynecology for detailed usg. the sample size was calculated using the g\*power v. 3.1.9.7 program. according to the results of 95% confidence (1-α), 95% test power (1-β), d=0.72 effect size and two-way independent samples t test power analysis, 51 in each group, a total of at least 102 people were sampled. was calculated (ekrami et al., 2019). randomization pregnant women who are suitable for the sample selection criteria, using the random integer generator method under numbers sub-title from random.org, for the numbers distributed in 2 columns consisting of 1-102 numbers. which column would be the experiment and which column would be the control was determined by drawing lots. pre-test-post-test application before starting the detailed usg examination for the experimental group, personal information form and state-anxiety inventory (dci) will be filled. while informing about the fetus during the usg examination, the pregnant woman will be informed by using the physical images of the fetus (hand, arm, face, heartbeat, information about the internal organs, etc.) using the usg screen. after the usg is completed, the state-anxiety inventory (dci) will be filled again as a final test. in the control group, the personal information form and state-anxiety inventory (dci) will be filled before the usg procedure, and only the state-anxiety inventory (dci) after the usg procedure. after the data collection process is completed, the pregnant woman will be informed about the usg results.

Eligibility criteria:
inclusion criteria: * 18-23. in gestational week * not carrying any risk factors (pre-eclampsia, iugg, premature rupture of membranes, getational diabetes, etc.) during pregnancy, * pregnant women who did not have any diagnosed problems related to the health of the fetus (such as fetal anomaly, intrauterine growth retardation) were included in the study. exclusion criteria: -

Keywords: ultrasound perinatal care to inform consultancy anxiety
efficacy and safety of bufy02 versus trb02 in the treatment of dry eye disease

Conditions: Dry Eye Disease

Summary: the goal of this interventional investigation is to compare bufy02 with trb02 in the treatment of patients with dry eye disease. the main questions it aims to answer are: * is bufy02 non-inferior to trb02 in terms of signs of ded? * is bufy02 non-inferior to trb02 in terms of symptoms of ded? participants will be asked to: * visit the trial site at 4 different timepoints * use the allocated study treatment everyday until the end of the study (during 3 months) * be examined by the investigator * complete several questionnaires * return unused study treatment. researchers will compare bufy02 to trb02 to see if both study treatments provide similar effects on signs and symptoms of the disease, together with comparable safety.


Eligibility criteria:
inclusion criteria include: * at least a 3-month documented history of bilateral dry eye syndrome needing artificial tears; * at least one eye with oxford score ≥ 4 and ≤ 9; * at least one objective sign of tear deficiency (in at least one eligible eye); * having a health insurance. exclusion criteria include: * wear of contact lenses starting within the last 2 months; * best-corrected visual acuity (bcva) \< 1/10; * severe ded with one of the listed conditions: * severe blepharitis; * seasonal allergy; * any issues of the ocular surface not related to ded; * history of ocular trauma, infection or inflammation not related to ded; * history of ocular surgery, including laser surgery; * unstable glaucoma; * use of artificial tears with preservative within the last 2 weeks; * systemic (enteral or parenteral) or local (topical) use of one of the listed medications: * known hypersensitivity to any constituent of the study treatments; * pregnancy or breastfeeding; * participation in another clinical study within the last 90 days; * legally restricted autonomy, freedom of decision and action.
3d/4d ultrasound contrast enhanced imaging (ceus) for carotid plaque vulnerability

Conditions: Atherosclerosis; Stroke

Summary: contrast enhanced 3d/4d (3 dimension/4 dimension) ultrasound (ceus) provides visualization of the dynamic vascular features of the plaques, in a unique spatial format using three orthogonal planes and angiogram-like images. therefore, the observer can utilize the entire vascular system in a volumetric manner (3d). the rotation of the intra-plaque neovasculature as viewed in various angles provides a realistic representation that is more easily appreciated. inter-observer variability for individual plaques has been assessed and inter-observer variability and inter-scan variability (the analysis of multiple images from single patients in longitudinal studies) were dependent on plaque size, with larger plaques showing lower variability. therefore, the proposed 3d/4d vs. 2d ceus imaging of the carotid plaque will provide added value for the depiction of the and quantification of intra-plaque blood vessel density by providing a true volumetric viewing area. this data will be correlated to the subsequent surgical specimens. the goal of the protocol is to investigate the correlation of intra-plaque blood vessel density and hemorrhage to 3d/4d ceus vasa vasorum using quantitative software analyses. the histology methods used for quantification of hemorrhage and vessel density analyses.


Eligibility criteria:
inclusion criteria: * adult subjects with known carotid artery disease will be included. * subject must be able and willing to comply with study procedures and provide a signed and dated informed consent including consent for 3 year annual follow up. * subjects will be screened by asking each study subject if they have known or suspected hypersensitivity to any of the components of optison, blood, blood products of albumin. in addition, each study subject will be asked if they have a right to left or bi-directional or transient right to left cardiac shunts. if any of the above questions are answered in the positive, the patient will not be eligible for inclusion in the study. exclusion criteria: * female subjects of child bearing potential will be excluded. * the subject presents any clinically active, serious, life-threatening disease, with a life expectancy of less than 1 month or where study participation may compromise the management of the subject or other reason that in the judgment of the investigator makes the subject unsuitable for participation in the study. * history of acute occlusion requiring medical intervention of any artery (including aorta) within 6 months of consent. * has a known or suspected hypersensitivity to any of the components of optison, blood, blood products, or albumin. * has known right to left, bi-directional or transient right to left cardiac shunts. * any known contra-indications as listed on the current optison package insert.

Keywords: carotid arteriosclerosis contrast-enhanced ultrasound neovascularization quantitative analysis 3d/4d imaging ceus vasa vasorum
somatosensory dysfunction as the underlying mechanism of upper limbs motor blocks in people with parkinson's disease

Conditions: Parkinson's Disease; Somatosensory Disorders

Summary: motor blocks during gait and upper limb movements (fouls) are a disabling and common motor impairment in mild to severe stages of parkinson's disease (pd). however, the main mechanism underlying these phenomena is still an open debate. apart from the motor correlates, cognitive-attentional impairment and somatosensory deficits (especially in the proprioceptive system) may underlie these motor blocks. the current study aims to unravel whether the proprioceptive system is involved by manipulating task-relevant or non-relevant proprioceptive stimuli. hence, the main aims of this study are: (i) to assess the somatosensory function in people with pd that experience freezing of gait fog and (ii) to investigate the effects of manipulating both proprioception and attentional resources on foul severity. forty-five people will be assigned to three age-matched groups (n=15 each): healthy elderly, pd patients that experience fog (fog+) and pd patients that do not experience fog. cutaneous sensory function and kinesthetic ability will be assessed by means of standardized user-friendly methods and precise repositioning measures using the vicon motion analysis. additionally, participants will perform a newly developed task that can successfully elicit fouls (a handwriting freezing-provoking task) on a custom tablet (heremans et al 2015). the task will be performed without and with the use of muscle vibration (a well-known method to stimulate the proprioceptive system). the investigators will manipulate both the timing of vibration (relevant - after foul onset; or non-relevant: before foul onset) and the region of stimulation (neutral: on a bone-mark where there is little if any proprioceptive stimulation; and on a non-neutral spot: on the forearm muscles). it is believed that fog+ will present with worse somatosensory function than those who do not experience motor blocks (especially in the proprioceptive system). additionally, the investigators expect a reduction in foul severity (e.g. foul duration) when vibration is applied in a task-relevant way, independently of the region stimulated. in contrast, it is also expected that when vibration is applied in a non-relevant way and it may act as a distractor, foul duration will increase. this study will thus be able to distinguish between the contribution of attentional and proprioceptive resources to the mechanism of motor blocks in pd.


Eligibility criteria:
inclusion criteria: * pd patients (n=30): * diagnosis of pd based on the uk pd brain bank criteria * hoehn \& yahr stage ii-iii (on-medication) exclusion criteria: * cognitive dysfunction score on the mini mental state examination (mmse) \< 23/30 * medication change in the past 1 month * other neurological disorders * vestibular disorder * uncontrolled diabetes * cutaneous diseases * left-handedness

Keywords: parkinson's disease freezing of gait motor blocks somatosensory proprioception muscle vibration handwriting