Kornimate/medical-research-clean huggingface dataset:
non-invasive neustimulation and respiratory rehabilitation

Conditions: Lung Diseases

Summary: introduction: respiratory diseases are associated with high rate of morbidity and mortality in brazil. cardiopulmonary rehabilitation through respiratory muscle training, aerobic training and strengthening of upper and lower limbs emerges as one of the resources available for the treatment and monitoring of patients with respiratory diseases. to add in this perspective, the application of hd-tdcs induces significant neurophysiological and clinical effects in several body systems. objective: to identify the chronic effects of non-invasive neurostimulation associated with the rehabilitation of patients with respiratory disorders. material and methods: this is a pilot study, quantitative, clinical trial type, randomized and controlled, double blind. the sample will be composed by patients with respiratory diseases, aged above 18 years old. the study will consist of two groups: (1) hd-tdcs will be applied - anodic current + respiratory rehabilitation with respiratory muscle training (rmt) and (2) sham - only respiratory rehabilitation with rmt without any type of cortical stimulation. the chronic effects of neurostimulation by hd-tdcs associated with cardiopulmonary rehabilitation, with tmr, during 12 sessions will be evaluated. patients will be evaluated, before and after the protocol, in relation to cortical activation function, pulmonary function, subjective perception of effort, respiratory muscle function, functional capacity, sensation of dyspnea and quality of life. for statistical analysis, intention-to-treat analysis will be used and groups will be compared using student's t-test, for continuous variables, or chi-square, for categorical variables. anova split-plot, repeated measures for primary outcomes. analyzes of covariance to identify differences between groups using baseline scores as covariates. effect sizes and confidence intervals will be calculated using eta squared (η²). expected results: neurostimulation would enhance the effects of respiratory rehabilitation and reduce the symptoms of patients with these diseases.


Eligibility criteria:
inclusion criteria: * confirmed clinical diagnosis for respiratory disease; * stable disease exclusion criteria: * develop disabling condition that prevents the implementation of the protocol; * join another rehabilitation program

Keywords: brain stimulation performance exercise
long-term follow-up study of participants exposed to renal autologous cell therapy frozen product

Conditions: Diabetic Kidney Disease; Chronic Kidney Disease

Summary: the purpose of this study is to evaluate the long-term safety, efficacy, and durability in participants with chronic kidney disease (ckd) who received up to four react injections, delivered percutaneously into either the same or bilateral kidneys in previous studies.

this observational extension study is a multi-center, prospective, non-therapeutic study, where up to 50 participants who have been enrolled and dosed with renal autologous cell therapy in previous interventional clinical studies (regen-007, regen-006, regen-015) will be monitored for up to five years with alternating in clinic and phone visits.

Eligibility criteria:
inclusion criteria: * the participant must have received react in a previous trial (regen-006, regen- 007, and regen-015) for the treatment of chronic kidney disease and completed an end of study visit in their previous trial per protocol. * the participant is willing and able to cooperate with all aspects of the protocol. * the participant is willing and able to provide signed informed consent. exclusion criteria: • participant did not receive react in a previous trial for the treatment of chronic kidney disease
validation of vital signs and symptoms for the diagnosis of serious infections in children in the paediatric a&e.

Conditions: Community-Acquired Infections; Respiratory Tract Infections; Sepsis; Urinary Tract Infections; Meningitis; Gastroenteritis

Summary: validation of vital signs and symptoms for the diagnosis of serious infections in acutely ill children in a high prevalent setting: the paediatric accidents \& emergencies through prospective observational data collection concerning specific items from the clinical and technical examination in diagnosing serious infections, such as meningitis, sepsis, pneumonia, pyelonephritis, bronchiolitis with hypoxia. eventually we will attempt to validate a vital signs and symptoms rule derived from multiple low to high prevalent settings of acutely ill children.


Eligibility criteria:
inclusion criteria: * children aged 1 month to 16 years * acute illness episode of maximum 5 days exclusion criteria: * recent trauma * neurological conditions * intoxication * psychiatric of behavioural disorders without a somatic cause * acute exacerbation of a chronic condition (asthma, known immunodeficiency, diabetes, cystic fibrosis, etc)

Keywords: serious infections meningitis
a major determinant focused on the ecg or echocardiogram for picm and its clinical outcome (picm syndrome)

Conditions: Pacemaker Complication

Summary: chronic right ventricular pacing has a deleterious effect on left ventricular (lv) function, namely pacing-induced cardiomyopathy (picm). several parametes make difference of effect on the occurrence of picm and its subsequent clinical outcomes. in particular, recognition of a major determinant focused on the ecg or echocardiographic parameters including strain or genetic factor for occurrence of picm may lead to better identification of patients at high risk. investigators prospectively enroll a participant with documented high risk of picm and clinically follow-up to idenify clinical impact of picm (picm syndrome) over a long period of time.

investigators investigate a major determinant focused on the ecg or echocardiogram or genetic factor to predict the picm after implantation of pacemaker. not only qrs duration and mechanical strain but also genetic factor could be also investigated to predict the occurrence of picm before diagnosis fo picm

Eligibility criteria:
inclusion criteria: mandatory (1 and 2) and optional (3 or 4) 1. willng to participate in the study and able to sign informed consent 2. undertaken ecg and echocardiogram including strain before and after device implantation 3. below preserved left ventricular dysfunction in the echocardiogram 4. above 15% pacing-rhythm in the device interrogation exclusion criteria: 1. less than 18 years of age 2. being pregnant or plan to become pregnant 3. advanced heart failure waiting in heart transplantation 4. have a life expectancy of less than 1 year
audiological and quality of life outcomes of anatomy based fitting in patients implanted by robot assisted cochlear implant surgery (racis)

Conditions: Cochlear Implants; Sensorineural Hearing Loss, Bilateral

Summary: severe to profound hearing loss affects 0,8% of the global population. for these people, a conventional hearing aid often does not provide sufficient benefit. however, these people can benefit from a cochlear implant (ci). a ci needs to be individually programmed (fitted) for each recipient. a fitting "map" is defined as a set of electrical parameters that are individually adapted to a recipient's needs to achieve optimal sound perception. at present, most ci recipients are fitted with a default frequency allocation map that doesn't take individual variability in size and shape of the cochlea into account. in this study, a fitting strategy based on the post-operative ct scan, that will allow the audiologist to set a frequency-band distribution for ci fitting that may be more closely aligned to the natural tonotopic frequency distribution of a normal hearing cochlea, will be evaluated. this study will focus on patients that are already implanted with the hearo robotic system.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * post-lingual onset of severe to profound sensory-neural hearing loss in the implanted ear(s) * subject implanted by robot assisted cochlear implant surgery (racis) * subject implanted with med-el cochlear implant(s) with flex28, flex 26 or flexsoft electrode to obtain maximum cochlear coverage * subject planned to receive a med-el sonnet 2 or rondo 3 audio processor on the newly implanted side * subject is either a user with unilateral implantation, bilateral implantation or a bimodal ci user (unilateral ci user with contralateral ear adequately fitted with a hearing aid) * pre- operative and post-operative ct scan of the temporal bone available * pre-operative result of pure-tone audiometry, speech test in quiet and in noise available * audio processor not yet activated on the newly implanted side * minimum of 10 active channels can be activated * fluent in the language of the test centre (dutch or french) * signed and dated icf before the start of any study-specific procedure exclusion criteria: * subject is a single-sided deafness (ssd) ci user * subject is an electric acoustic stimulation (eas) user (with an eas audio processor) * lack of compliance with any inclusion criteria * anything that, in the opinion of the investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study
an observational post-marketing study using commercially approved biosense webster (bwi) medical devices for the treatment of participants with cardiac arrhythmias

Conditions: Cardiac Arrhythmias

Summary: the purpose of this study is to prospectively collect clinical data evaluating the ongoing safety and performance during routine-use standard cardiac arrhythmia mapping and/or ablation procedures while using commercial biosense webster inc. (bwi) medical devices. data generated from the study will be used to confirm safety and performance of bwi medical devices in the marketed phase and to expand the body of evidence on the use of these devices and techniques in treatment of cardiac arrhythmias.


Eligibility criteria:
inclusion criteria * diagnosed with paroxysmal or persistent atrial fibrillation (af) or supraventricular tachycardia (svt) or ventricular tachycardia (vt) and scheduled to undergo an ablation procedure for management of their arrhythmia with a per-protocol defined bw therapeutic catheter * able and willing to comply with all pre, post and follow-up testing and requirements as per hospital standard of care * signed patient informed consent form (icf) as applicable per local regulation exclusion criteria: * currently participating in an interventional (drug, device, biologic) clinical trial * life expectancy of less than 12-months * presenting any contraindication for the use of bwi commercially approved medical devices, as indicated in the respective user manuals
functional magnetic resonance imaging study of the central auditory system after single sided deafness

Conditions: Unilateral Hearing Loss

Summary: the objective is to study the relation between the reorganization of the central auditory system, and the psychophysical deficits in binaural hearing in subjects with single sided deafness.

background single sided deafness (ssd) and asymmetrical hearing loss are common hearing impairments, and their social consequences are well established. at the central auditory system level, the single sided deafness is associated with a reorganization of auditory temporal cortices that leads to a reduction of inter hemispheric asymmetry. purpose : our main objective is to study the relation between the reorganization of the central auditory system, namely the inter hemispheric asymmetry, and the psychophysical deficits in binaural hearing in subjects with ssd. abstract : binaural hearing enables spatial localization of the sound source and improves speech recognition in a competing noise. ssd and asymmetrical hearing loss are common hearing impairments, which affect 0.3 to 1/1000 children. in the adult population, this prevalence increases with age. the impact of ssd and asymmetrical hearing loss on quality of life indices is well established and some reports underline its consequences in children scholarship. previous neuro-imaging and electro physiological studies highlighted the reduction of normal inter hemispheric asymmetry in subjects with ssd. to the best of our knowledge, there is no report about the relation between the central auditory system reorganization and its behavioural deficits. the investigators propose to conduct a study which analyzes the relationship between the reduction of inter hemispheric asymmetry and performance in binaural hearing tests. thus, the auditory plasticity will be studied using functional magnetic resonance imaging and more specifically bold variations in auditory temporal cortices. a set of binaural hearing assessments will be performed, including speech recognition in noise and localization abilities. the correlation between the lateralization ratio and binaural measurements (speech reception threshold (srt) in dichotic hearing, diotic hearing, reverse dichotic hearing) will be estimated. likewise, the impact of ssd duration on cortical reorganization and binaural tests will be studied.

Eligibility criteria:
inclusion criteria: * right-handed subjects * ssd confirmed using evoked auditory potentials exclusion criteria: * associated neurological disorder

Keywords: single sided deafness. auditory plasticity asymmetrical hearing loss cochlear implants inter hemispheric asymmetry lateralization index dichotic hearing
tumor metabolism of head and neck cancer in patients who underwent radiation therapy measured with f-18-fdg-pet

Conditions: Head and Neck Cancer

Summary: the purpose of the study is to describe the regional and global fdg-kinetics in head and neck cancer during percutaneous radiation therapy.


Eligibility criteria:
inclusion criteria: * histologically confirmed head and neck cancer not curable by surgery * karnofsky \> 70% * tumor volume and localization allow curative radiotherapy * written consent exclusion criteria: * metastases * earlier radiotherapy of head or neck * pregnancy * secondary malignancy excluding dermal carcinoma t1 and tis-carcinoma of cervix uteri * psychiatric impairment

Keywords: radiation therapy f-18-fdg
long-term safety study of glycopyrronium in subjects with primary axillary hyperhidrosis

Conditions: Hyperhidrosis

Summary: this is an open-label, long-term safety study of glycopyrronium topical wipes, enrolling up to 660 subjects with primary axillary hyperhidrosis who participated in either the drm04-hh04 or drm04-hh05 studies.

safety will be assessed through adverse events, blood and urine laboratory tests, physical examination, pulse and blood pressure. local skin reactions will be assessed including burning/stinging, pruritus, edema, erythema, dryness and scaling.

Eligibility criteria:
inclusion criteria: * completed day 28 of either the drm04-hh04 or drm04-hh05 study with at least 80% treatment compliance * male or females exclusion criteria: * subject has a clinically significant abnormality on physical exam, vital signs or ecg at the week 4 visit of drm04-hh04 or drm04-hh05 study that would make further treatment with glycopyrronium contraindicated * male with a history of urinary retention requiring catheterization due to prostatic hypertrophy or severe obstructive symptoms of prostatic hypertrophy * any other condition which, in the judgement of the investigator, would put the subject at unacceptable risk for participation in the study
pd-1/pd-l1 pathway study on septic patients

Conditions: Sepsis

Summary: the investigators want to identify that whether pd-1/pd-l1 pathway will change in human sepsis, and whether pd-1/pd-l1 pathway play an important role in sepsis induced immunosuppression.

first, we will detect pd-l1 expression on pbmc of septic patients and healthy controls. second, blockade of pd-1/pd-l1 pathway in vitro and stimulate with some biomolecules and then analyze the pbmc function and apoptosis by flow cytometry. then, compare with healthy controls and find the differences.

Eligibility criteria:
inclusion criteria: * patients who develop sepsis exclusion criteria: * patients with cirrhosis or renal dysfunction * patients with dyscrasia * patients with autoimmunity diseases * patients with severe cardiac and pulmonary diseases * patients with hematological diseases * patients with diabetes mellitus * patients with malignant tumors

Keywords: sepsis
microcirculatory alteration and biomarkers: new approach for early assessment of septic multi-organ dysfunction

Conditions: Sepsis; Multiple Organ Failure

Summary: the aim of this study is to investigate associations between early structural cellular injury and microvascular alteration with progression of septic organ dysfunction according to total sofa-score (an icu-scoring system - the sequential organ failure assessment score). patients will be monitored for renal (timp-2, igfbp7), and intestinal biomarkers (plasma i-fabp) in conjunction with kidney and muscle vascular bed microvascular perfusion analysis assessed by contrast-enhanced ultrasonography (ceus). in parallel, a comprehensive analysis of patients' immunological status will be conducted using an established, on-site immune monitoring panel. the ultimate goal of this study is an early identification of septic patients developing multiorgan dysfunction which may facilitate a timely novel intervention in the future to improve outcome.


Eligibility criteria:
inclusion criteria: patients ≥18 years of age with severe sepsis and fulfill the following criteria at the admission to icu: * peritonitis (abdominal infection) and performed source control (either surgically or interventionally) * 2 or more criteria for systemic inflammatory response syndrome (temperature \>38° or\ 90 beats per minute; respiratory rate \>20 breaths per minute or paco2 \ 12,000/mm3, \ 10% immature forms) and serum lactate level of 4mmol/l and more or refractory hypotension - mean arterial pressure \<65mmhg or systolic blood pressure \<90mmhg after fluid challenge of 1000ml or more /30min * absence of any familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule * written informed consent prior to any study procedures exclusion criteria: * pre-existing renal-replacement therapy in the pre-operative course * pre-existing shock * acute coronary syndrome * active hemorrhage * trauma * known allergy to ultrasound contrast media * anemia with hemoglobin concentration \< 7g/dl * patients not able to give written informed consent

Keywords: biomarkers sepsis multi organ dysfunction immunomonitoring ceus
hepatitis c in severe mental disorders: nursing programme

Conditions: Hepatitis C; Severe Mental Disorder

Summary: it has been described in the scientific literature that people diagnosed with serious mental disorders, such as psychosis and schizophrenia, have difficulties to access medical treatments for their physical illnesses, which produces excess mortality in this population. this project will consist of three different parts. the first will be the detection and accurate diagnosis of hepatitis c (hcv) in the population diagnosed with a severe mental disorder (smd). it will find the prevalence of people with infection who have not been diagnosed, as well as that of people diagnosed but who have not completed treatment. likewise, the characteristics of the sample obtained and the risk factors associated with positive cases will be analyzed. the second part of the study will consist of comparing the effectiveness of an individualized monitoring programme (nurse-navigation programme), carried out by the specialist mental health nurse, during the treatment of hepatitis c versus the usual health care. in order to fulfill these first two objectives, a clinical pathway will be opened in which the microbiology, gastroenterology, pharmacy and mental health services of the regional university hospital of malaga will participate. the third objective of the project will be to study how the presence of hepatitis c influences psychotic symptoms, mainly negative ones, changes in daily functioning and changes in quality of life . for these purposes we will use the panss scale, a quality of life scale (the life skill profile) and the euroqol5d health questionaire before treatment and after verifying the effective cure of hcv. a third and final evaluation with all the study variables will be carried out 6 months after starting the treatment. in addition, the disappearance of the viral load and, therefore, the patient's cure will be determined with a new blood test.

the objective of this study is to compare the effectiveness of a nurse-navigation program developed by specialist nurses on mental health, for patients with hcv and smd, against the usual standard care, regarding the detection of the disease, facilitation of access and adherence to treatment, guides through the healthcare system, and cure from hcv. the null hypothesis that this study will test is that there are no differences in the hcv cure rate in smd subjects who receive the nurse-navigation model versus those who receive usual care. additionally, a second hypothesis will be tested regarding to the differences in the adherence to hcv treatment.

Eligibility criteria:
inclusion criteria: * severe mental disorder * hepatitis c positive with viral load exclusion criteria: * patients who have contraindicated hcv treatment for any reason * patients in a clear situation of psychopathological decompensation (until recovery) * patients does not agree to participate

Keywords: clinical paths patient care planning hepatitis c severe mental disorders
using sensors to measure drug concentrations in exhaled breath

Conditions: Mental Disorder

Summary: the use of blood tests to measure drug concentrations in psychiatric patients is often a crucial part of monitoring and evaluating the course of treatment. such tests are commonly conducted as part of official protocols, and patients are often tested on a weekly basis. the current study aims to examine the possibility of using a novel, non-invasive device to measure drug concentrations in exhaled breath as an alternative to blood tests. the device, sniffphone, uses sensors to detect and measure volatile organic compounds (vocs) in exhaled breath, and features a small and portable design. sniff phone has been previously approved for use in clinical trials and has been used successfully to screen for particular types of cancer and other diseases.


Eligibility criteria:
inclusion criteria: * proper ability to give informed consent * psychiatric patients undergoing treatment at sheba medical center * patients with treatment plans that require therapeutic drug monitoring exclusion criteria: * involuntary psychiatric hospitalization * pregnancy