Kornimate/medical-research-clean huggingface dataset:
evaluation of a telephone follow-up procedure on the quality of life in psychogenic non-epileptic seizures

Conditions: Psychogenic Non Epileptic Seizure

Summary: the goal of this study is to evaluate effectiveness of the phone follow-up method compared to the conventional filler taken one.

this study is a multicenter, non-drug therapy and randomized research trial, comparing a group of patients integrating the phone monitoring device (dst group) to a control group where patients are cared for in the usual way. subject recruiting modalities: the study population represents patients diagnosis, pnes confirmed by following by the video-eeg, recorded in a center of epilepsy and in different chu and informed of the diagnosis of pnes in a standardized manner. patients were recruited during their hospitalization video-eeg is conducted in part of the diagnostic workup of drug-resistant epilepsies, or demonstrations paroxysmal undetermined which may prove to be pnes. usual care: after diagnosis of pnes: orientation psychiatric care or cmp liberal and meeting biannual with the neurologist. in the study: * for patients in both groups: management usual care and, in addition, quotation questionnaires of quality of life and evaluation by a neuropsychologist biannually for 24 months after the appointment with the neurologist. * for patients in the dst group only: phone calls by psychologist at j 15, at 2 months, then every 2 months until m12. the device telephone follow (dst) consists of telephone calls (d15, m2, then every 2 months until m12) of the patient by an external independent psychologist designed to inform the patient about its pathology, promote acceptance of diagnosis, support the patient in his approach to care encouraging psychiatric observation. the device does not replace psychiatric counseling recommended.

Eligibility criteria:
inclusion criteria: * patient above 18 years old * affiliation to social security * evolution disorders for over three months with at least 3 psychogenic non-epileptic seizures spaced over 24 hours and less than two years * diagnosis of pnes (associated or not with epilepsy) or laid confirmed following a video-eeg examination * standardized announcement of the disease made by a neurologist participant / phrc training * good understanding of the french language * patient consented to participate in the study exclusion criteria: * acute psychiatric pathology at the time of inclusion warranting urgent hospitalization (acute suicidal risk, table delusional ...) * progressive neurological pathology intercurrent susceptible to aggravation for the duration of the study (glioma, multiple sclerosis, dementia ...) * a patient who can not physically comply with the six-monthly review at the discretion of the investigator (planned move ...) * simultaneous participation to another therapeutic intervention study during the first 12 months

Keywords: quality of life, pnes, epilepsy,
endocrine determinants of renal function in patients with hypoparathyroidism

Conditions: Hypoparathyroidism

Summary: endocrine determinants of renal function in patients with hypoparathyroidism on conventional treatment: a cross-sectional study (endorse)


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * diagnosis of chronic (≥ 1 year) post-surgical and autoimmune hypoparathyroidism, as established with undetectable or insufficient pth concentration in relation to the presence of hypocalcemia * patients being treated with calcitriol or alfacalcidiol * patients able to sign the written informed consent exclusion criteria: * pregnancy * severe renal failure requiring dialysis treatment * macroproteinuria * use of antihypertensive drugs such as thiazides, ace inhibitors, sartans, beta and alpha blockers, and antialdosterone drugs * pazients affected by diabetes mellitus- insulin-treated
quality of postoperative pain management in cardiac surgical patients

Conditions: Postoperative Pain

Summary: the purpose of this study is to determine the incidence and risk factors of moderate to severe pain after cardiac surgery, and compare the preoperative pain expectation and postoperative pain experience in the same patient.

objectives 1. to study the incidence of moderate to severe pain in cardiac surgical patients 48 hour postoperatively. 2. to study the risk factors of moderate to severe postoperative pain in cardiac surgical patients. 3. to compare the preoperative pain expectation and postoperative pain experience in the same patient.

Eligibility criteria:
inclusion criteria: * patients scheduled for cardiac surgery in siriraj hospital * age \> 18 exclusion criteria: * unable to communicate with the patient

Keywords: postoperative pain cardiac surgery risk factors
tau/p-tau and neurocognitive outcomes in children

Conditions: General Anesthetics Toxicity; Postoperative Cognitive Dysfunction; Child Development

Summary: the proposed studies are aimed to measure tau and p-tau levels in pre- and postoperative blood, urine, feces and saliva, as well as to assess pre- and postoperative neurocognitive function in children (3 to 5 years old) who will have surgery under general anesthesia (single versus multiple exposures). the studies will establish a system to study biomarkers of the anesthesia/surgery-associated neurocognitive impairment in children and generate hypothesis that tau or p-tau serves as the biomarker of such neurocognitive impairment in children.

this proposed studies have two specific aims: 1. to investigate the relationship between pre-operative or postoperative blood levels of tau or p-tau and neurocognitive outcomes. the working hypothesis is that pre- and postoperative blood tau/p-tau levels are higher in participants who develop neurocognitive impairment than those in the participants who do not develop it. the investigators will perform neurocognitive test before the surgery and then at 12 months after the surgery. the investigators will collect pre-operative and postoperative blood and measure tau/p-tau levels in the blood. finally, the association of the changes in the tau/p-tau levels and neurocognitive scores will be assessed. more importantly, this aim will establish an eligible: recruit ratio, retention rates, safety of the protocol, and power calculation, which will provide crucial information to guide better design of future r01 study. 2. to perform the feasibility studies of measuring tau or p-tau in urine, feces and saliva of the participants. the working hypothesis is that tau/p-tau in urine, feces or saliva of children can be measured. the investigators will use the nanobeam to measure tau/p-tau levels before and after the surgery. the investigators will then determine whether urine, feces and saliva can be used for the future studies to develop tau/p-tau as the biomarker of anesthesia/surgery-associated neurocognitive impairment in children.

Eligibility criteria:
inclusion criteria: 1. between age 3 and 5 at the time of the first neurocognitive test; 2. scheduled for surgery under general anesthesia exclusion criteria: 1. gestational age less than 36 weeks; 2. congenital heart disease that has required surgery or will require surgery or that requires ongoing pharmacotherapy; 3. known chromosomal abnormality or any other known acquired or congenital abnormalities which are likely to affect neurodevelopment; 4. known neurological injury such as cystic periventricular leukomalacia or grade 3 or 4 intra-ventricular hemorrhage (+/- post hemorrhage ventricular dilatation); 5. children for whom follow-up would be difficult for geographic or psychosocial reasons; 6. non-native english speaker (both child and parents); 7. severe visual or auditory disorder.

Keywords: tau/p-tau biomarker neurocognitive outcomes children
phase i, double-blind,placebo, mad study to evaluate the safety, tolerability, pk, and pd of amg 333 in healthy subjects and migraine subjects

Conditions: Migraine

Summary: the primary purpose of this study is to evaluate the safety and tolerability of multiple oral doses of amg 333 for 14 days in healthy subjects and migraine subjects. as part of the secondary objectives, the study will characterize the pharmacokinetic (pk) profile of amg 333 after multiple oral doses in healthy subjects and migraine subjects, as well as characterize the effect of multiple doses of amg 333 on increases in blood pressure (bp) induced by the cold pressor test (cpt) in healthy subjects.

this is a randomized, double-blind, placebo-controlled, ascending multiple-dose study evaluating amg 333 in healthy subjects and subjects with migraines. eight healthy subjects will be enrolled in each of cohorts 1 through 5. study subjects will be randomized such that 6 subjects will receive amg 333 and 2 subjects will receive placebo (3:1 ratio) per cohort. likewise, 8 migraine subjects will be enrolled in cohort 6 and randomized to receive amg 333 or placebo (3:1 ratio). all subjects will be housed for 15 days then allowed to return home. migraine subjects will self-administer the headache diary at least once daily during the screening and out-patient portions of the study, and site personnel will administer the headache diary during the in-house period of the study. healthy subjects will not keep the headache diary during screening and will have the headache diary administered by site personnel at least once daily starting on day 1 through day 14, and will then self administer throughout their participation in the study.

Eligibility criteria:
inclusion criteria: * healthy male and female subjects (cohorts 1 through 5) and male and female subjects with migraines (cohort 6), who are ≥ 18 and ≤ 55 years of age at the time of screening, and have no history or evidence of clinically-relevant medical disorders as determined by the investigator in consultation with the amgen physician. exclusion criteria: * history or evidence of a clinically significant disorder, condition, or disease that in the opinion of the investigator and amgen physician, would significantly impair pain perception (eg, history of stroke, history of neuropathy), would pose a risk to subject safety or interfere with evaluation, procedures, or study completion.

Keywords: migraine
effectiveness new health care organization model in primary care for chronic cardiovascular disease patients based

Conditions: Ischemic Heart Disease

Summary: the purpose of this study is to determine whether a multifactorial primary care intervention based on chronic models can improve the level of control and reduce the number of hospital admissions in patients with ischemic heart disease.


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of ihd of any site (icd-10 codes from 410 to 414 inclusive. * signed written informed consent exclusion criteria: * lack of consent * immobilized patients * patients with serious health problems or with a low life expectancy

Keywords: health services research cardiovascular diseases primary care secondary prevention.
the effect of antihypertensive drugs on severity of anaphylaxis and side-effects during venom immunotherapy

Conditions: Hymenoptera Venom Allergy; Antihypertensive Treatment

Summary: there is an ongoing debate whether antihypertensive treatment with beta-blockers and/or angiotensin converting enzyme (ace)-inhibitors comprises a risk factor for more severe and more frequent side-effects during venom immunotherapy (vit). in the literature, data are controversial and originate from case reports or statistically underpowered studies; the number of included patients was usually high but the proportion of patients on antihypertensive treatment was low ranging from 2-11%. the study was conducted as a prospective, observational, european multicenter study. 1425 patients, aged from 35 to 85 years, with a history of an anaphylactic reaction due to bee or wasp stings, were included. the medical history was recorded as well as laboratory parameters and data of the vit-updosing phase. one year after reaching the maintenance dose, possible side-effects during vit as well as the outcome of field stings or sting challenges were documented.


Eligibility criteria:
inclusion criteria: * history of systemic sting reaction (≥ grade i according the classification by ring and messmer) * age 35 to 85 years exclusion criteria: * absolute contraindications for vit * pretreatment with omalizumab
comparison of anti-coagulation and anti-platelet therapies for intracranial vascular atherostenosis- magnetic resonance imaging

Conditions: Stroke; Intracranial Atherosclerotic Stenosis (ICAS)

Summary: captiva-mri is an observational multimodal mr imaging study that is ancillary to the captiva trial \[a 3-arm, double-blind phase iii trial conducted at approximately 115 strokenet sites randomizing patients with stroke attributed to 70-99% intracranial atherosclerotic stenosis (icas) to aspirin plus ticagrelor, clopidogrel, or rivaroxaban.\] the primary goal of this ancillary study is to determine if mri biomarkers can potentially identify icas patients who fail best medical management. the captiva-mri study leverages the captiva trial design and implementation to capture information that will inform and facilitate the next generation of icas trials and the management of patients with icas.


Eligibility criteria:
inclusion criteria: * enrollment in the captiva trial: nondisabling symptomatic ischemic infarct stroke within 30 days secondary to 70-99% stenosis of the intracranial ica, mca, ba or va * ability to obtain baseline study mri within 14 days of captiva enrollmen exclusion criteria: * unable or unwilling to undergo mri, including pacemaker or other mri contraindications per american college of radiology guidelines62 * gadolinium contrast allergy or acute or chronic kidney disease with egfr\<30 ml/min/1.73m2

Keywords: mri stroke intracranial atherosclerotic stenosis (icas)
exoluminate study for early detection of pancreatic cancer

Conditions: Pancreas Cancer; Exosomes; Extracellular Vesicles; Pancreatic Neoplasms

Summary: exoluminate is a nationally-enrolling registry study designed for earlier detection of cancer in patients at elevated risk or clinically-suspicious for pancreatic ductal adenocarcinoma (pdac). those with elevated risk for pdac can include individuals with intraductal papillary mucinous neoplasms, family history of pancreatic cancer, germline mutations in genes known to be associated with cancer, and a personal or family history of pancreatitis. the goal of the study is to compare the performance of exoverita™ assay in early detection of pdac to current standard-of-care methods of surveillance.

biological dynamics, inc. has developed a non-invasive blood test ("liquid biopsy") that can identify early-stage disease with high sensitivity and specificity. the proprietary exoverita™ assay uses alternating current electric (ace) field to isolate extracellular vesicles (evs) for differentiated multiomics applications and includes an optimized machine learning algorithm to identify a panel of ev-bound protein biomarkers in patient's plasma in order to detect pdac at earlier stages. exoluminate is a prospective, multi-center, observational registry study designed to evaluate the non-inferiority of the performance of the exoverita™ assay in detecting pancreatic ductal adenocarcinoma (pdac) in high-risk or clinically-suspicious populations in comparison to standard-of-care methods. the study is planned to recruit a minimum of 1000 u.s. adults over 3-years (with a 2-year follow-up for data collection). eligible subjects will be evaluated using the exoverita™ assay through blood donation(s) at specified time intervals. overall, this study poses minimal risk to subject.

Eligibility criteria:
inclusion criteria: * ≥18 years old. * meeting criteria for one of the study cohorts. * capable of giving informed consent. * able to provide a blood sample. exclusion criteria: * \< 18 years old. * pregnancy. * active cancer (other than pancreatic cancer) and/or undergoing treatment for an active cancer diagnosis (except for skin malignancies). * prior organ transplant or bone marrow transplant. * history of fainting or other adverse effects when blood is drawn. * any condition that, in the opinion of the investigator, should preclude enrollment.

Keywords: early detection exosomes extracellular vesicles ipmn pdac pancreatic cancer
johnston county adhd study: environmental, reporductive, and familial risk factors for attention-deficit hyperactivity disorder (adhd)

Conditions: Attention-Deficit Hyperactivity Disorder

Summary: we propose a population-based case-control study among 7000 elementary school children in semi-rural johnston county, nc. teachers will complete a screening form on each child. controls will be randomly selected. mothers of potential cases and controls will be interviewed by telephone about their child's symptoms of adhd and exposure history, their family history of adhd, and their reproductive and exposure history. children's shed baby teeth will be analyzed for lead. mothers will complete brief parenting scales and the child behavior checklist. school records will be collected. the study goals are to identify risk factors for adhd including preterm delivery and childhood lead exposure.

we propose a population-based case-control study among 7000 elementary school children in semi-rural johnston county, nc. teachers will complete a screening form on each child. controls will be randomly selected. mothers of potential cases and controls will be interviewed by telephone about their child's symptoms of adhd and exposure history, their family history of adhd, and their reproductive and exposure history. children's shed baby teeth will be analyzed for lead. mothers will complete brief parenting scales and the child behavior checklist. school records will be collected. the study goals are to identify risk factors for adhd including preterm delivery and childhood lead exposure.

Eligibility criteria:
* inclusion criteria: during the first phase of the study, all children will be screened by the homeroom teacher, except for those students in certain self-contained classrooms. self-contained classrooms for students with an iq less than 70 or autism will be omitted from the screening. in the second phase of the study, children designated as "lep", or low english proficiency, will be excluded from the study.

Keywords: children behavior epidemiology lead learning disorder
study of normal conditions of use, dosing, and safety of intravenous (iv) administration of vernakalant (mk-6621-049)

Conditions: Atrial Fibrillation

Summary: this non-interventional prospective study is a post-authorization safety study (pass) of vernakalant conducted to collect information about normal conditions of use and appropriate dosing, and to quantify possible medically significant risks associated with the use of vernakalant in real-world clinical practice.


Eligibility criteria:
inclusion criteria: * to be treated with intravenous vernakalant, independently of this study * participant and/or legal guardians willing to provide informed consent and/or informed assent according to local regulations exclusion criteria: - enrollment in an investigational drug or device clinical trial in the 30 days prior to study enrolment. participation in another non-interventional drug or device study or registry is permitted.

Keywords: atrial fibrillation cardioversion
urdu version of fonseca anamnestic index: reliability and validity study

Conditions: Temporomandibular Disorder

Summary: the aim of study is to translate and culturally adapt fonseca anamnestic index into urdu language and to investigate the reliability and validity in pakistani population over the age 18 years.

the english version of the fonseca anamnestic index will be translated and culturally adapted as per previous recommendation. in pakistani general population, urdu version of fonseca anamnestic index will distributed among 140 participants choose by random sampling technique based on pre-defined inclusion and exclusion criteria. to test inter and intra-observer reliability of the final urdu version of fonseca anamnestic index questionnaire will be filled on the same day, by two observers, and for the inter-observers assessment, with an interval of 30 minute between the first and the second application. third assessment will carried out after 7 days by observer-1, for intra-observer assessment. data will be entered and analyzed using statistical package of social sciences version 24. internal consistency will be analyzed with cronbach alpha value. test- re-test reliability will be assessed using an intra-class correlation coefficient. the urdu version of fonseca anamnestic index will be evaluated for content validity, construct validity, criterion validity and responsiveness.

Eligibility criteria:
inclusion criteria: * patient with the age of 18 years. * having any previous history of temporo-mandibular joint pain * having any current condition of temporo-mandibular disorders. * both genders are included equally. exclusion criteria: * inability to understand or follow the instructions of the fonseca anamnestic index. * suffering from any neurological condition. * suffering from any unstable medical condition. * patients with rheumatoid arthritis were also excluded

Keywords: fonseca anamnestic index urdu version reliability validity temporomandibular disorder general population
comparison of temporomandibular joint arthroscopy with botulinum toxin injection versus placebo

Conditions: Temporomandibular Joint Disorders

Summary: there are several studies that have considered botulinum toxin a (bont-a) injections are effective in treating symptoms for temporomandibular joint (tmj) disorders. bont-a injections improve the hyper-tonicity of mandibular muscles and its consequent joint load reduction. also injections of bont-a, for patients with articular disc displacement, resulted in pain relief and return of the normal movements of the mandible. the main goal of this study is to test the beneficial impact of bont-a injections in the masticatory muscles of patients submitted to tmj surgical arthroscopy.

study objective: to investigate the potential performance of incobotulinumtoxin-a (btxa) in patients submitted to tmj surgical arthroscopy. besides the acceptable good outcomes of tmj arthroscopy, the authors believe that using a single injection of btxa into the temporalis and masseter muscles could reduce joint loading and pain, improving tmj arthroscopy results. the proposed explanation for this study: tmj arthroscopy is a minimal invasive surgical technique for different types of temporomandibular joint (tmj) internal derangements. besides the acceptable outcomes of tmj arthroscopy, the authors believe that adding to this treatment a single injection of btxa into the temporalis and masseter muscles could reduce joint loading, improving tmj arthroscopic results.

Eligibility criteria:
inclusion criteria: * patients with tmj with indication for arthroscopy * age between 12-60 years old * minimum level of pain for inclusion should be 5/10 (on a 0-10 vas scale) exclusion criteria: * previous treatment to tmd * previous use of facial botulinum toxin * any contraindication for the use of btxa according to xeomin smpc

Keywords: incobotulinumoxina temporomandibular joint disorder temporomandibular joint arthroscopy randomized clinical trial