Kornimate/medical-research-clean huggingface dataset:
emotion recognition in benign epilepsy of childhood with centro-temporal spikes (bects)

Conditions: BECTS; Epilepsy, Rolandic

Summary: the social processes depend on complex cognitive mechanisms, which involve mainly the frontal and temporal lobe regions. patients with early onset frontal and temporal lobe lesions might later develop important deficits in social integration. accordingly, children with early onset temporal lobe epilepsy (tle) demonstrate altered emotion recognition.

study design: multicentre, case-control study. emotion recognition is a first step for the development of the capacity to judge the thoughts, intentions, and desires of others. in infants, the capacity to identify, distinguish, and interpret emotions is limited, but these processes are developing rapidly and innately during the first years of life, on the same neural bases as those described in adulthood. children with bects show altered social behavior. in fact, deficit in social cognition could derive from brain dysfunction in the frontotemporal regions primarily affected in bects, since these regions are also viewed as playing an important role in social cognition and development of social skills. the investigators hypothesized that children with bects might have altered social cognitive skills and underlying neural networks.

Eligibility criteria:
inclusion criteria: * children diagnosed with active bects (e.g. having at least one seizure with epileptiform abnormalities at eeg) * treated or not with anti-epileptic drugs; age range between 6 and 11 * infants who have not presented an epileptic seizure within 48 hours before the psychodiagnostic evaluation * patients with a sleep eeg recording; mmspe (mini mental state pediatric examination) ≥23.3 exclusion criteria: * mental retardation * presence of other neurological or severe neuropsychiatric disorders * atypical eeg pattern (awake or asleep)

Keywords: emotion social cognition childhood epilepsy
validation and clinical utility of the lung sliding index (lsi) for differentiating pulmonary diseases

Conditions: COPD; ILD; Bronchiectasis; Pneumothorax; Pneumonia; Pleural Effusion Disorder; Pulmonary Oedema

Summary: this upcoming case-control study aims to confirm the lung sliding index (lsi), a new ultrasound score that measures how well the pleura moves, in various lung diseases. the study will check how well the lsi can tell apart different lung diseases (like pneumothorax, interstitial lung disease, copd, pneumonia, and pulmonary edema), how it relates to signs of disease severity, and how consistent the results are between different operators who have received the same training. secondary objectives include assessing patient and operator satisfaction and feasibility using validated likert scales.

* the study will enroll adults with various pulmonary pathologies and healthy controls. lung ultrasound will be performed on all subjects using a standardized 12-zone protocol; each zone will be scored for pleural sliding using the lsi (0-3 per zone; total 0-36). operator training and calibration will precede enrollment to ensure scoring consistency. * a subset of patients will undergo repeat assessments to evaluate intra- and interobserver reliability, using independent, blinded raters. * for correlation with lsi, we will collect clinical data, including spirometry, blood gases, symptom scores, and 6-minute walk tests. diagnostic utility will be evaluated using roc curves. satisfaction and feasibility will be assessed via likert questionnaires, with validation analyses (internal consistency, test-retest reliability). * all data will be de-identified and securely stored. written informed consent will be obtained from all participants. * the study groups will include: 1- pneumothorax 2. interstitial lung disease (ild/ipf) 3. copd/emphysema 4. bronchiectasis 5. community-acquired pneumonia 6. pulmonary edema 7- pleural effusion 8. healthy controls * data collection methods: * standardized data entry forms for clinical, imaging, and outcome data. * centralized digital storage with access limited to study personnel. statistical methods: - descriptive statistics for baseline data anova or kruskal-wallis for group comparisons; post hoc testing as appropriate roc analysis for diagnostic cut-offs pearson/spearman correlation for clinical associations intraclass correlation coefficients (icc) for reliability cronbach's alpha for likert scale validation multivariable regression for confounder adjustment

Eligibility criteria:
inclusion criteria: * age 18 years and older. * diagnosed with one of the specified pulmonary diseases, or a healthy control * able to provide written informed consent exclusion criteria: * inability to tolerate or undergo a lung ultrasound * extensive chest wall pathology precluding assessment * unscorable \>2 zones per protocol * withdrawal of consent * mechanically-ventilated patients
evaluation of 5 days holter and 30 days thumb-ecg for detection of atrial fibrillation in stroke patients

Conditions: Atrial Fibrillation; Stroke

Summary: this study will compare the two methods 5 days holtermonitoring and 30 days thumb electrocardiogram for detection of atrial fibrillation in stroke patients

patients with a newly stroke will be examined with both 5 day holter monitoring and 30 days thumb ecg at the same time. the detection rates of the two methods will be compared

Eligibility criteria:
inclusion criteria: * stroke or tia within the last 3 months verified by a ct or a mr scan or unequivocal symptoms and old infarcts visualised on ct or mr * age 65 or above * patients able to handle the thumb-ecg * written informed consent exclusion criteria: * earlier diagnose of atrial fibrillation * pacemaker or icd device * stroke induced by trauma, infection or surgery procedure * carotid stenosis of more than 60%
perineal massage combined with hip joint training

Conditions: Pelvic Floor Disorders

Summary: the goal of this clinical trial is to learn if perineal massage combined with hip joint training works to improve pelvic function (urinary incontinence, constipation and hip motion) in pregnant women. the main questions it aims to answer are: does the perineal massage combined with hip joint training lower the prevalence of participants who have urinary incontinence and constipation? does the perineal massage combined with hip joint training improve the flexibility of the hip joint? researchers will compare an intervention (perineal massage combined with hip joint training) to a comparison(regular training and treatment) to see if the intervention (perineal massage combined with hip joint training) works to improve pelvic function. participants will: receive the intervention (perineal massage combined with hip joint training ) or regular training and treatment fifth a week at 36 weeks gestation before participants receive first-time intervention, they complete demographic sociological , ici-q-lf, wexner constipation and hip motion questionnaires

women experience varying degrees of damage to the female reproductive and urinary muscle groups during pregnancy and delivery, which can lead to a series of pelvic floor disorders, for example, pelvic organ prolapse (pop), urinary incontinence(ui), chronic constipation (cc) and other syndrome, reducing the quality of life. this study examined the effect of perineal massage combined with hip joint training on pelvic floor function, especially on ui, cc and hip motion. this is a parallel randomised control trial. the researchers will recruit participants from the obstetrics outpatient ward. pregnant women attending the maternity clinic who met the inclusion and exclusion criteria will be randomly selected and sign informed consent, then the enrolled population was randomly assigned to each group using sealed envelopes. the intervention group will receive perineal massage combined with hip joint training; the comparison group will receive regular training. the primary outcome is the ici-q-lf score; wexner constipation score; and the secondary outcome is hip motion.

Eligibility criteria:
inclusion criteria: * singleton pregnant women * primipara; * signed informed consent voluntarily * 36 weeks gestation; * no pregnancy complication exclusion criteria: * pluripara; * multiple pregnancies; * pregnant women with mental or cognitive disabilities; * scarred uterus; * pelvic surgery history; * urinary incontinence before pregnancy history; * obstipation before pregnancy history
study of gore® bio-a® fistula plug for use in anal fistula repair

Conditions: Anal Fistula

Summary: primary outcome variable is healing at the final follow up visit.

the primary purpose of this prospective, multicenter, observational, single arm study is to further substantiate efficacy of the gore® bio-a® fistula plug when used as a soft tissue reinforcement of anal fistula repair and healing.

Eligibility criteria:
inclusion criteria: * transsphincteric fistula consisting of 1 tract(defined as a fistula which would not be amenable to fistulotomy); determined during operative procedure * likely cryptoglandular origin * must be at least 18 years of age * patients informed about the study, and will have read, understood and signed the patient informed consent and authorization to use phi data, as applicable * patients willing and able to submit to postoperative follow-up evaluations exclusion criteria: * crohn's disease * evidence of on-going local infection * history of more than 2 prior definitive repair attempts; repair attempt is defined as any of the following: advancement flap, cutting seton, fistulotomy, fistulectomy, fibrin glue, anal fistula plug, lift * superficial fistulas without any muscle involvement * fistulae of traumatic origin, including obstetric * intersphincteric fistulas that would be candidate for fistulotomy * horseshoe or multi-tract fistulas * ano-vaginal or recto-vaginal fistulas * anastomotic fistulas (ileo-anal, colo-anal) * a wound-healing or autoimmune disorder (including insulin-dependent diabetics) * subjects who are immunocompromised such as, with hiv, or currently receiving chemo or radiation therapy * subjects who are immunosuppressed, e.g. transplant patients, patients taking steroids, tnf agents, methotrexate * history of prior or current pelvic radiation * difficulty comprehending or complying with the study (in surgeon's opinion)
effect of paricalcitol on markers of inflammation in hemodialysis patients

Conditions: Kidney Failure

Summary: studies have shown that patients with esrd on hemodialysis have high levels of inflammatory markers which may contribute to the high rates of cardiovascular disease and mortality seen in these patients. vitamin d use in dialysis patients has been shown to have a survival benefit, with paricalcitol at advantage over calcitriol. since there is some evidence for involvement of the vitamin d receptor in inflammation, this study is designed to look for an effect of paricalcitol on markers of inflammation in hemodialysis patients.

patients with esrd have a high incidence of acute phase inflammation. studies have shown that c-reactive protein (crp) and interleukin-6 (il-6) are excellent biomarkers for inflammation, and high levels are predictive of cardiovascular morbidity and mortality in this population. both uremia and the dialysis process itself contribute to this inflammatory state. it is our hypothesis that paricalcitol therapy decreases the biomarkers of inflammation which may have implications for future studies of morbidity and mortality in this population.

Eligibility criteria:
inclusion criteria: 1. ckd and receiving hemodialysis for greater than or equal to 3 months 2. age greater than or equal to 18 years 3. medically stable 4. avf or ptfe dialysis access 5. no acute inflammatory disease within 4 weeks prior to study 6. on an average dose of 3 - 7 mcg of paricalcitol three times per week for 4 weeks prior to the study 7. two consecutive ipth of 150-400 (bipth 75 - 200) =/- 30% one week apart 8. ca \<10.2 mg/dl; po4 \<7.0 9. kt/v greater than or equal to 1.2 10. on no other interventional drugs/devices in the past 30 days exclusion criteria: 1. currently receiving dialysis using a venous catheter access 2. currently receiving high dose immunosuppressive therapy (greater than or equal to 10 mg prednisone) 3. pregnancy 4. hospitalization within the last 4 weeks. -

Keywords: end stage renal disease inflammation
a study in patients with neovascular age related macular degeneration or macular edema secondary to retinal vein occlusion to evaluate usability of the ranibizumab (lucentis®) prefilled syringe (pfs)

Conditions: Macular Edema

Summary: this is a multicenter study designed to evaluate usability of ranibizumab pfs in patients with neovascular age related macular degeneration or macular edema secondary to retinal vein occlusion.

the purpose of this study is to assess the ability of hcps to follow the instructions for use (ifu) to prepare and administer a ranibizumab pfs itv injection dose to patients.

Eligibility criteria:
inclusion criteria: ocular * study eye deemed to be indicated for ranibizumab itv therapy at the discretion of the retina specialist exclusion criteria: concurrent ocular conditions * patients legally blind in one or both eyes * history of or any current clinically relevant intraocular inflammation or ocular inflammatory reaction (any grading from trace and greater is excluded), including non-infectious uveitis or uveitis, or sterile inflammatory reaction after the past itv injections with any agent * active disorder of ocular adnexa and skin in the study eye, including ocular surface infections * history of or any current indication of excessive bleeding and recurrent hemorrhages, including any prior excessive intraocular (including subconjunctival) bleeding or hemorrhages after itv injection or intraocular procedures * uncontrolled intraocular pressure greater than (\>) 25 millimeters of mercury (mmhg) in the study eye (uncontrolled means that it occurs even with intraocular pressure-lowering therapy) * use of therapies that are known to be toxic to any ocular tissues within the 6 months prior to enrollment prior ocular therapies * treatment with any itv injection within the 27 days prior to day 1 * any invasive intraocular surgery, prior long-acting therapeutic agent, or ocular drug release device implantation (approved or investigational) in the study eye at any time during the past 3 months general * receipt of any systemic (non-ocular) investigational drug within 3 months prior to day 1 * current systemic coagulation or bleeding disorders and history of recurrent hemorrhages * intolerance or known reaction to prior biological therapies * history of other diseases or physical or laboratory examination findings that per the retina specialist represent a contraindication to ranibizumab use in the patient or may represent an unwarranted patient risk. * uncontrolled hypertension (systolic \>160 mmhg and/or diastolic \>100 mmhg while sitting) * current systemic infectious disease or a therapy for active infectious disease * pregnant or lactating
a clinical trial assessing the impact of inhaled insulin on glucose disposition

Conditions: Diabetes Mellitus

Summary: to assess the impact of inhalation of insulin on glucose disposition in patients with type 1 diabetes

the study was terminated on oct. 28, 2007. the protocol was undergoing implementation and methodological issues with major revisions that qualified this trial as a new trial. pfizer decided to cancel new trials because of the decision to withdraw exubera due to lack of market performance and not for safety reasons.

Eligibility criteria:
inclusion criteria: * diabetes mellitus type 1 exclusion criteria: * asthma, copd * smoking
verification of the efficacy of npc-15 for sleep disorders of children with autism spectrum disorders

Conditions: Sleep Disorders; Autism Spectrum Disorder

Summary: the purpose of this study is to verify the efficacy of npc-15 (melatonin 1 mg/d or 4 mg/d) versus placebo to sleep latency with electronic sleep diaries.

this study will be a multicenter, double-blind, randomized, placebo-controlled parallel group trial. the trial has five phases; the pre-screening phase, the screening phase, double-blinded treatment phase, open label treatment phase and post-treatment phase. the screening phase comprises a screening visit where subject's initial eligibility will be evaluated. during double-blinded treatment phase, patients who meet all entry criteria for the trial will be randomized into three groups, and they will be assigned npc-15 1 mg, 4 mg or placebo before going to bed for 2 weeks. during open label treatment phase, all patients will be administered npc-15 1 mg, 2 mg or 4 mg on the basis of their doctors' judgements.

Eligibility criteria:
inclusion criteria: * female or male patients aged 6 to 15 years. * patients with "autism spectrum disorder" diagnosed by using dsm-5. * patients with average of daily sleep latency persisted over 30 min and the condition is continuous over 3 months * patients who are out-patient, not hospitalized patient. * signed informed consent obtained from rearer(s)/parent(s)/guardian(s) of the patient, or signed ic or informed assent obtained from the patient themselves. exclusion criteria: * patients with at least severity in either conceptual area, or social area, or practical area of intellectual disability have judged more than "severe" by using dsm-5. * patients who took melatonin (including supplement) in history. * patients who had taken ramelteon within 4 weeks before clinical study starts.

Keywords: melatonin npc-15 sleep disorders autism spectrum disorders dsm-5
multimodality imaging and functional lesion assessment in intermediate coronary stenosis in chronic coronary syndrome

Conditions: Chronic Coronary Syndrome

Summary: the aim of this prospective, investigator-initiated study is to evaluate the diagnostic accuracy and correlations between functional indices (fractional flow reserve, ffr) and morphometric indices: luminal and qualitative parameters assessed by optical coherence tomography (oct) including minimal lumen area, plaque type, presence of thin cap fibroatheroma among patients with chronic coronary syndrome identified with intermediate grade coronary stenosis.

this is a prospective, single center, non-randomized, single-arm, investigator-initiated study evaluating diagnostic accuracy and correlations between functional indices (fractional flow reserve, ffr) and morphometric indices: luminal and qualitative parameters evaluated by oct including minimal lumen area, plaque stratification into fibrotic, calcific, lipidic plaque, or thin cap fibroatheroma) among patients with chronic coronary syndrome identified with intermediate grade coronary stenosis. the additional objectives include: evaluation of the impact of age, sex, diabetes mellitus, renal dysfunction on the assocation between functional and morphometric indices of coronary stenosis. we hypothesized that in patients with intermediate grade coronary stenosis in chronic coronary syndorme there is a positive correlation between the functional parameters and the morphometric parameters of cornary stenosis.

Eligibility criteria:
inclusion criteria: * 18 years or older * chronic coronary syndrome defined as presence of chest pain ranked 2-3 in the canadian cardiovascular society classification or positive ischemia test (exercise test, single photon emission tomography (spect) * intermediate grade coronary stenosis of 40-80% assessed visually in coronary angiography * ffr and oct examination of the same lesion * the patient is willing to participate in the study and has provided a written informed consent exclusion criteria: * acute coronary syndrome * proximal left main lesion * ostial right coronary artery lesion * bypass of the assessed vessel * contraindications for adenosine administration * hemodynamic instability * heart insufficiency in new york heart association (nyha) class iv scale * acute renal insufficiency * pregnancy

Keywords: ffr oct ivus ccs
a study of efinopegdutide in participants with hepatic impairment (mk-6024-014)

Conditions: Non-alcoholic Steatohepatitis; Hepatic Impairment

Summary: the purpose of this study is to evaluate the pharmacokinetics of efinopegdutide in participants with hepatic impairment compared to healthy participants, and to examine the safety and tolerability of efinopegdutide.


Eligibility criteria:
the main inclusion and exclusion criteria include but are not limited to the following: inclusion criteria: * a participant assigned female at birth is eligible to participate if not pregnant or breastfeeding, is not a participant of childbearing potential (pocbp), or is a pocbp and agrees to follow contraceptive guidance during the study intervention period and for at least 35 days after the last dose of study intervention. * for participants with moderate or severe hepatic impairment: have a diagnosis of chronic (\>6 months), stable, hepatic impairment with features of cirrhosis due to any etiology (stability of hepatic disease should correspond to no acute episodes of illness within the previous 2 months due to deterioration in hepatic function). exclusion criteria: * history of cancer (malignancy). * had major surgery and/or donated or lost 1 unit of blood (approximately 500 ml) within 4 weeks prior to the prestudy (screening) visit. * participants with moderate or severe hepatic impairment who are positive for human immunodeficiency virus (hiv)-1 or hiv-2 at the prestudy (screening) visit. * participants with moderate or severe hepatic impairment who received antiviral and/or immune modulating therapy for hepatitis b virus (hbv) or hepatitis c virus (hcv) within 90 days prior to study start. * healthy participants who are unable to refrain from or anticipate the use of any medication, including prescription and nonprescription drugs or herbal remedies beginning approximately 2 weeks (or 5 half-lives) prior to administration of the initial dose of study intervention, throughout the study (including washout intervals between treatment periods), until the poststudy visit.
pulmonary artery denervation clinical study using the gradient denervation system in heart failure patients with pulmonary hypertension

Conditions: Heart Failure Patients With Pulmonary Hypertension

Summary: prospective, single-arm, multicenter first in human study to characterize the impact of pulmonary artery denervation on the quality of life in heart failure patients with pulmonary hypertension


Eligibility criteria:
inclusion criteria: * heart failure with ef ≥ 40% (by tte within last 3 months) * mean pulmonary artery pressure (mpap) \>20 mmhg at rest * pulmonary vascular resistance (pvr) ≥ 3wu at rest * pulmonary capillary wedge pressure \> 15 mmhg (at rest) or \> 18 with passive leg raise * cardiac index (ci) ≥ 1.7 l/min/m2 * nyha class ii or iii * glomerular filtration rate (gfr) ≥ 25 ml/min * n-terminal pro-b-type natriuretic peptide (nt-probnp) ≥ 400pg/ml * stable, guideline directed medical treatment, including controlled volume status for a minimum of 3 months prior treatment exclusion criteria: * inability to take dual antiplatelet or anticoagulants, hypersensitivity or allergy to aspirin or clopidogrel * pulmonary artery aneurysm, moderate or greater pa stenosis or other pa anatomy that would prevent safe or proper use of the study device * systemic infection or localized infection/rash at planned access site at time of procedure * myocardial infarction, unstable angina pectoris, or a cerebrovascular accident in the previous 3 months * crt or other interventional cardiac procedure (except rhc) within last 3 months * any planned cardiac procedure or inpatient procedure within the next 30 days