Kornimate/medical-research-clean huggingface dataset:
analysis of the analgesic mechanism of tens-waa during non-anesthetized colonoscopy using eeg-fnirs system

Conditions: Colonoscopy; Pain

Summary: this study is a single-center, randomized controlled trial aiming to evaluate the analgesic mechanism of transcutaneous electrical nerve stimulation based on wrist-ankle acupuncture (tens-waa) during unsedated colonoscopy using eeg-fnirs technology to assess neural activity in brain regions associated with pain perception. sixty patients aged 18-75 years, with stable cardiopulmonary function and a baseline visual analog scale (vas) pain score \<3, will be enrolled and randomly allocated into the intervention and control groups. the intervention group will receive tens stimulation based on the wrist-ankle acupuncture theory 10 minutes before the colonoscopy, with a frequency of 2 hz and adjustable current intensity ranging from 1 to 9 ma. the control group will receive minimal-intensity sham stimulation under identical conditions. all participants will wear eeg-fnirs devices to monitor neural activity in key pain-related brain areas, including the prefrontal cortex, anterior cingulate cortex, motor cortex, and parietal cortex. primary outcomes include eeg-fnirs data, while secondary outcomes are vas scores at the four colonic bends, colonoscopy duration, and the correlation between eeg-fnirs signals and pain perception. statistical analyses will include multivariable linear regression, generalized estimating equations, and mixed-effects models to investigate the analgesic effects and neural mechanisms of tens-waa. this study seeks to provide innovative pain management strategies for patients undergoing unsedated colonoscopy and further explore the neuroregulatory potential of tens-waa technology.


Eligibility criteria:
1. inclusion criteria: * patients undergoing unsedated colonoscopy are eligible for inclusion in this study. * aged 18 to 75 years. * meeting the requirements for colonoscopy, with good cardiopulmonary function and stable vital signs. * a pre-procedural visual analog scale (vas) pain score of less than 3. 2. exclusion criteria: * participants with speech or cognitive impairments. * those with acute anal or rectal stenosis, acute perianal or rectal infections, acute diverticulitis, or active inflammatory bowel disease. * women who are menstruating, pregnant, or breastfeeding. * patients with active tuberculosis, hemophilia, or advanced malignant tumors. * individuals with sensory disturbances, implanted pacemakers or defibrillators, or ankle skin ulcers. * those who have used sedatives or analgesics either long-term or within the past 24 hours. * individuals with any condition that interferes with eeg-fnirs signal acquisition, such as cranial abnormalities, implanted metal or electronic devices, epilepsy, or neurological disorders.
the applicaiton of immune repertoire in the diagnosis and disease monitoring of iga nephropathy

Conditions: IgA Nephropathy

Summary: this prospective study aims to investigate the role of ir-seq in the diagnosis and disease monitoring in patients with iga nephropathy.

autoimmunity may play an important role in iga nephropathy, and previous studies have shown that immune repertoire sequencing (ir-seq) may help elucidate the dynamic changes of immune repertoire (ir) in autoimmune disease states. to further explore the potential application value of this technology, we will conduct a series of prospective studies to investigate the role of ir-seq in the diagnosis and disease monitoring in patients with iga nephropathy.

Eligibility criteria:
inclusion criteria: 1. iga nephropathy: 1. age: 18-80 years. 2. patients diagnosed with primary iga nephropathy by renal biopsy. 3. estimated glomerular filtration rate (using the 2009 ckd-epi formula) ≥30ml/min/1.73/m\^2. 4. obtain informed consent from patients. 2. healthy control: gender, age and ethnicity matched health volunteers. 3. igan patients were further divided into 4 groups, as defined below: 1) long-term stable patients: follow-up for at least 15 years and meet at least one of the following: 1. annual egfr loss rate \<3ml/min/1.73m\^2. 2. egfr\>90ml/min/1.73m\^2. 2) non-progressive igan patients: meet at least one of the following: 1. egfr decrease of more than 50% from baseline (in the absence of other possible causes of kidney damage). 2. annual egfr loss rate \>5ml/min/1.73m\^2. 3. progress to esrd. 3) igan patients at low risk of disease progression: proteinuria ≤ 1g/24h after 3 months of optimized supportive care. 4) igan patients at high risk of disease progression: proteinuria \> 1g/24h despite 3 months of optimized supportive care. exclusion criteria: 1. kidney biopsy shows crescentic igan or mcd-igan.; 2. patients with secondary igan; 3. during pregnancy or lactation; 4. after kidney transplantation; 5. more than one serious acute infection in the psat 12 months; 6. chronic infection; 7. use of glucocorticosteroids and other immunosuppressive drugs within the last 6 months; 8. incomplete medical history or clinical data.

Keywords: iga nephropathy ir-seq biomarker
pilot study of the multisense patch to record cardiopulmonary data during sleep and wake cycles

Conditions: Obstructive Sleep Apnea of Adult

Summary: the investigators are proposing to use a wearable device, multisensetm, developed by rhythm diagnostic systems, inc. which has many sensors inside in a "band-aid" like strip in order to see if it can help diagnose capabilities in individuals suspected of having obstructive sleep apnea. the multisensetm sensor is a self-contained, reusable, rechargeable, battery-powered, flexible strip, measuring 4 x 1.2 inches that simultaneously tracks and records a number of physiological health related parameters such as ecg, heart rate, pulse synchronized oxygen saturation, temperature, respiratory rate, depth of respiration and motion/position. one advantage of this device over current home diagnostic systems is the capability for recording over several nights. the objective is to compare multiple biometric parameters tracked by the multisensetm to gold standard monitoring in an accredited sleep lab using polysomnography. home monitoring will explore potential findings supportive of sleep apnea while monitoring at home during routine sleep over 5 to 7 nights. enrolling 10 adults already scheduled for a medically indicated sleep study will help us to make these determinations. subjects will wear the device, which is the size of a band-aid, via adhesive to their chest over a period of 10 days. subjects will go about their normal daily activities and return the device via mail once completed.


Eligibility criteria:
inclusion criteria: * adults over age 18 * considered to be at high likelihood for sleep apnea and already scheduled for a formal sleep study. exclusion criteria: * congestive heart failure or other major medical illness that would complicate the diagnosis of osa. * psychological or social situation that would make the study difficult for the patient.
utility of whole-body mri in the detection of traumatic injuries of undetermined origin in children

Conditions: Traumatic Injuries

Summary: the diagnosis of abuse in children relies heavily on the presence of skeletal and extraskeletal injuries. however, some lesions are not seen by initial skeletal survey. and the investigators have to complete the skeletal survey with either bone-scan or ct scan or whole-body mri. whole-body mri has proved its worth in the pediatric population for the evaluation of skeletal and extraskeletal lesions in children with cancer or infectious diseases. thus, whole-body mri would allowed to have total picture of children without ionising radiation exposure.


Eligibility criteria:
inclusion criteria: * infant hospitalised for sub-dural hematoma or skeletal injuries due to non accidental traumatism or skin lesions or abdominal injuries of undetermined origin exclusion criteria: * sub-dural hematoma of accidental origin or skeletal injuries of accidental * origin or known origin of lesions. * subject already included in the study

Keywords: traumatic injuries whole-body mri skeletal survey children diagnostic
the real-life efficacy and safety of telmisartan in patients with arterial hypertension

Conditions: Hypertension

Summary: the main purpose of this study is to asses the efficacy and safety of telmisartan, with the special attention on the influence of telmisartan on selected metabolic parameters of patients.


Eligibility criteria:
inclusion criteria: * age over 18 * untreated or ineffectively treated arterial hypertension exclusion criteria: * cholestatic disorders and severe hepatic failure * allergy to telmisartan * pregnancy and lactation period

Keywords: hypertension
prospective study of urinary markers of fibrosis in kidney transplants

Conditions: Kidney Failure

Summary: the purpose of this study is to determine whether urinary connective tissue growth factor (uctgf) can predict the onset of fibrosis in transplanted kidneys.

since march 2004, and as part of routine clinical practice, protocol renal allograft biopsies are routinely performed at implantation and at 3, 12 and 24 months after transplantation, in all patients who receive a kidney transplant at the university hospitals leuven, unless there is a medical contra-indication or patient refusal to undergo this procedure. the biopsies are scheduled using a dedicated microsoft access database ("biopsy database"), that is maintained on the central servers of the university hospitals leuven. patients who have an unexplained change in renal allograft function, undergo additional clinically indicated indication biopsies. these biopsies are also recorded in the aforementioned microsoft access database. all clinical data, including pretransplant donor and recipient characteristics, and post-transplant follow-up data are directly stored and maintained in a prospectively collected electronic database (ccl database until 06/2012, transferred to the central kws database in 2012). this electronic database is the only existing clinical database for these patients, and contains all clinical patient charts. no written records are collected. all renal allograft biopsies will be scored by a single renal pathologist according to the most recent banff classification, blinded for the clinical parameters and timing of the biopsy. these rescoring data are directly entered in the dedicated microsoft access database ("biopsy database").

Eligibility criteria:
inclusion criteria: * patients who receive a primary or secondary single cadaveric or living donor renal allograft. * signed informed consent exclusion criteria: * patients receiving a combined renal allograft.

Keywords: kidney transplantation connective tissue growth factor fibrosis
comparison of blood product use and bleeding events during and after endoscopic or neurosurgical procedures in patients with cirrhosis and coagulopathy

Conditions: Cirrhosis; Coagulopathy

Summary: a prospective, randomized clinical trial comparing blood product use and bleeding events during and after endoscopic or neurosurgical procedures in patients with cirrhosis and coagulopathy: rotational thromboelastometry (rotem) vs. conventional therapy (scarlet).

orthotopic liver transplantation (olt) can be associated with significant bleeding requiring multiple blood product transfusions, especially in patients with severe liver dysfunction. rotational thromboelastometry (rotem) is a point-of-care device that has been used successfully to monitor coagulation on whole blood samples during olt. whether it allows blood loss and transfusion to be reduced during olt remains controversial. rotem or conventional coagulation tests were used in this study to guide transfusion of platelets, cryoprecipitate, and fresh frozen plasma (ffp) during olt. patient characteristics as well as pre- and post- transplant laboratory data were collected. intra-operative blood loss, type and amount of blood products transfused, and cost were compared between the two groups.

Eligibility criteria:
inclusion criteria: * patients 18 and older, admitted to the hospital * patients who have clinically documented cirrhosis * patients who are coagulopathic (inr \> 1.5 and/or platelets \< 50,000) * patients undergoing an endoscopic procedure or neurosurgical procedure exclusion criteria: * patients must not be pregnant * patients must not be taking any anticoagulant or antiplatelet medication (with the exception of asa 81 mg or heparin for dvt prophylaxis) * patients must not have an active infection (per pi discretion) * patients must not have any known hemostatic disorder
the roles of tissue factor in malignant gliomas

Conditions: Venous Thromboembolism; Brain Tumors

Summary: to explore the relationship between tissue factor levels, tumour progression, activation of blood coagulation and venous thromboembolism with malignant glioma

to explore the relationship between tissue factor levels, tumour progression, activation of blood coagulation and venous thromboembolism with malignant glioma

Eligibility criteria:
inclusion criteria: * participation in prodige * adult patients * newly diagnosed, biopsy-confirmed grade iii/iv malignant gliomas * undergone craniotomy or stereotactic biopsy \> 2 days and \< 4 weeks before exclusion criteria: * have known hereditary thrombophilia * are receiving experimental antiangiogenic therapy

Keywords: venous thromboembolism brain tumours glioma tissue factor blood coagulation tumour progression low molecular weight heparin
feasibility study of cortical recording depolarizations in brain-injured patients, and their use as biomarkers of new lesions.

Conditions: Brain Lesion; Head Trauma; Subarachnoid Hemorrhage

Summary: the progression of brain lesions after severe head trauma or subarachnoid hemorrhage results from extra cranial aggression which is well controlled in intensive care and intracranial aggression which is less well known and therefore less well managed. the detection of events that can generate new lesions from intracranial monitoring is limited and late once the lesions are irreversible. invasive cortical depolarizations (sd) can be observed using cortical electrodes and an acquisition system having access to the usually filtered dc signal (0 to 1 hz). sd are observed at the onset of a new attack of the cortex and spread widely away from the site of aggression. during their propagation, sd generate a significant metabolic demand, and can cause ischemic injury, particularly after meningeal or post-traumatic hemorrhage. sds are therefore both a marker of new lesion and a mechanism of progression of primary lesions. yet this type of monitoring is only performed in some expert centers around the world. the analysis of the feasibility and safety of the placement of cortical electrodes in this indication is therefore an essential step to study the clinical benefit of individualized management on the basis of this monitoring.


Eligibility criteria:
inclusion criteria: * patient \> 18 year old * patients admitted in neurological reanimation unit for brain lesions after severe head trauma or subarachnoid hemorrhage and requesting a intracranial monitoring or a surgery (evacuation of a hematoma, treatment of an aneurysm, external ventricular bypass). * patients affiliated to a social security system * patient having been informed and having signed the consent form or close to the patient who has been informed and signed the consent form or third party certificate then close consent for further study. exclusion criteria: * patient with scalp acute infection * pregnant or nursing women * contre-indication to intracranial surgery * patient with not corrected coagulation disorder * patient treated with nsaids * patient treated with under platelet antiaggregants * patient under legal protection, guardianship, curators * patients under legal protection * patient participating in a study who may interfere with this study. * people under duress psychiatric care,

Keywords: subdural or intra cortical implanted electrodes cns monitor brain lesions
study in patients with moderated to severe rheumatoid arthritis who have failed to combination therapy of conventional disease-modifying antirheumatic drugs (cdmards) to cdmard plus anti-tnf versus cdmards in real world

Conditions: Arthritis, Rheumatoid

Summary: this study will be conducted to observe the disease activity change of conventional disease modifying anti-rheumatic drugs (cdmard) plus anti-tumour necrosis factor (anti-tnf) from baseline to 6 months compared with cdmards, as measured by the disease activity score with the erythrocyte sedimentation rate (das28-esr).


Eligibility criteria:
inclusion criteria: * diagnosed with rheumatoid arthritis within 3 years * participants who have no experience with anti-tumor necrosis factor (anti-tnf) * participants who have experienced two or more conventional disease modifying anti-rheumatic drugs (cdmards) of a stable dose for at least 3 months prior to informed consent * participants who change the treatment regimen to one of the following according to the opinion of the investigator: 1. one cdmard plus anti-tnf 2. two or more cdmards: modifications or additions of cdmards that have been treated prior to informed consent exclusion criteria: * participants who may be pregnant or lactating women * participants who have contraindication to anti-tnf * participants who had participated in this study

Keywords: joint pain joint stiffness joint redness loss of joint function swollen joints
safety study of rp-1127 (glyburide for injection) in healthy volunteers

Conditions: Traumatic Brain Injury; Stroke

Summary: the primary objective of this study is to evaluate the safety and tolerability of different dose levels of glyburide for injection, administered as a bolus dose followed by a 3-day continuous infusion. the secondary objectives are to assess the pharmacokinetics (pk) of glyburide and blood glucose and serum insulin pharmacodynamic (pd) responses to glyburide.

this study was previously posted by remedy pharmaceuticals, inc. and has since been acquired by biogen.

Eligibility criteria:
inclusion criteria: 1. a healthy male or a healthy nonpregnant, nonlactating female. 2. capable of understanding and complying with the protocol and has signed the informed consent form before the screening procedures begin. 3. have a body mass index of between 18.0 and 30.0 kg/m², inclusive. 4. a clinically normal physical examination, 12-lead electrocardiogram (ecg), screening laboratory studies and urinalysis. 5. a negative urine or saliva test for selected substances of abuse and cotinine. exclusion criteria: 1. clinically significant history of hypoglycemia as assessed by the investigator. 2. history of seizure disorder, even if currently not receiving anticonvulsant medications. 3. history of adverse reaction to glyburide, other sulfonylurea class of anti-diabetic medications, or other sulfa drugs. 4. glucose-6-phosphate dehydrogenase (g6pd) deficiency as determined by g6pd enzyme testing at screening. 5. be an active smoker or user of other forms of tobacco. former smokers or tobacco users must have refrained from smoking or using other forms of tobacco for at least 6 months prior to dosing on study day 1. 6. a history or clinical manifestations of significant metabolic (including diabetes mellitus, hypercholesterolemia, or dyslipidemia), hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urologic, immunologic, or psychiatric disorders (a history of mild depression, currently not receiving therapy, is acceptable). 7. use any prescription medication within 14 days prior to randomization, or nonprescription drugs within 7 days. exceptions may be made by the medical monitor on a case-by-case basis. 8. received another investigational drug within 30 days prior to randomization. 9. a positive hepatitis virus test (hepatitis b virus surface antigen or hepatitis c virus antibody) or a positive human immunodeficiency virus (hiv) antibody test at screening. if the hiv test is positive, the subject will be informed privately and referred for additional counseling.
dna-damage pathways in workers exposed to silica (caesar stone)

Conditions: Silicosis

Summary: silicosis is well-known occupational disease caused by free crystalline silica (silicon dioxide) and is marked by inflammation and pulmonary fibrosis. there are cumulative evidences that exposure to caesar stone (quartz surface products that manufactured from up to 93% quartz, polymer resins and pigments) is particularly dangerous to exposed workers. goals: to examine correlation between disease and exposure to caesar stone and genetic differences regarding genes involved in oxidative stress to understand genetic susceptibility

it is a sub-study of "dna-damage biomarkers to monitor and early detect health impairment in workers exposed to silica (caesar stone)" study. study participants would be recruited during two years of the study. they will be asked to come to a single visit at pulmonary laboratory of tel aviv medical center. during the meeting, participants will be given a precise explanation about the tests they will perform and after signing the informed consent will perform following tests: 1. induced sputum (is) 2. exhaled breath condensate 3. pulmonary function tests (pfts) 4. participants will be asked to complete occupational questionnaire genetic studies (dna) will be done from peripheral blood samples (20 ml) to study differences in heme oxygenase 1 (ho-1) gene sequencing between participants with evidences of clinically definite silicosis according to american thoracic society/european respiratory society (ats/ers) guidelines and participants without evidences of clinically definite silicosis.dna samples will be obtained and coded in the same day of a participant visit and after collecting reasonable amount of samples examination of genes of interest will be done.analysis of data will be done after the completion of data collection and laboratory tests. each sample will be given specific code to protect confidentiality of participants. blood samples, test results and the code key will be kept in different places and only few research staff will have the accessibility to genetic information. in any case employers or any other persons that not included in research staff will not have any accessibility to this information. in this study genetic analysis is not connected to gender, nationality or any other social feature.

Eligibility criteria:
inclusion criteria: 1. male 2. 18-70 years old 3. at least six months of professional exposure to caesar stone exclusion criteria: 1. other occupational exposure (welding of any kind) 2. chronic obstructive pulmonary disease (copd), tuberculosis, asthma, autoimmune disease in healthy exposed workers 3. interstitial lung disease in exposed workers with clinically approved silicosis

Keywords: silicosis