Kornimate/medical-research-clean huggingface dataset:
study evaluating the pk and safety of neratinib in healthy subjects and subjects with chronic liver disease

Conditions: Hepatic Insufficiency

Summary: the purpose of this study is to assess the pharmacokinetics of neratinib and to assess the safety and tolerability of neratinib in healthy subjects and subjects with chronic liver disease.


Eligibility criteria:
inclusion criteria: * men or women of nonchildbearing potential (woncbp) aged 18 to 65 years inclusive at screening. woncbp may be included if they are either surgically sterile (hysterectomy or oophorectomy) or postmenopausal for =1 year (with follicle-stimulating hormone \[fsh\] level =38 miu/ml) and must have a negative serum pregnancy test result within 48 hours before administration of test article. 2-nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. must be able to abstain from smoking during the inpatient stay. 3-have a high probability for compliance with and completion of the study exclusion criteria: * family history of qt prolongation, syncope, seizure, or unexplained cardiac-related death. 2-presence or history of any disorder that may prevent the successful completion of the study. 3-history of drug abuse within 1 year before study day 1.
effect of statins on trained immunity

Conditions: Atherosclerosis

Summary: in this study, the investigators will determine whether patients with elevated levels of ldl are characterized by specific epigenetic changes in circulating cells of the innate immune system, compared to control subjects with healthy levels of ldl and whether regular statin treatment influences these changes.

rationale: the innate immune system plays a pivotal role in the development and progression of atherosclerosis. recently, it was reported that monocytes can develop a long-lasting immunological memory after stimulation with various microorganisms, which has been termed 'trained innate immunity'. this memory is induced by epigenetic reprogramming. here the investigators hypothesize that monocytes of patients with elevated ldl cholesterol levels show epigenetic changes compared to normocholesterolemic subjects and that this can be reversed by treatment with statins. objective: the main objective is to study whether patients with elevated levels of ldl show increased histone 3 lysine 4 trimethylation in the promoter regions of pro-inflammatory cytokines and have an augmented ex vivo toll-like receptor agonist-induced cytokine production in isolated monocytes compared to controls. subsequently the investigators will study the effect of treatment with statins on these responses. study design: observational study study population: subjects aged \>18 years who have been referred to the out-patient clinic and have ldl levels that require lipid lowering treatment and matched normocholesterolemic control subjects.

Eligibility criteria:
inclusion criteria: patients: * 18 years or older * elevated ldl levels (\>4.9 mmol/l) * no previous cardiovascular events controls: * age \> 18 years * ldl cholesterol \< 3.5 mmol/l * no previous cardiovascular events exclusion criteria: * current lipid lowering treatment * known malignant disorders, auto-immune disorder, or diabetes * inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study * clinical signs of acute infection * use of anti-inflammatory medication
advanced diffusion mri to differentiate tumor recurrence from pseudoprogression in patients with glioblastoma and brain metastases

Conditions: Glioblastoma (GBM)

Summary: this pilot study investigates whether advanced diffusion-weighted mri (adw-mri) can differentiate between true tumor progression (tp) and a pseudoprogression (psp) in patients with glioblastoma (gbm) or brain metastases.

advanced diffusion-weighted mri (adw-mri) offer the opportunity of higher sensitivity towards subtle tissue changes associated with increased specificity relating to damage of different tissue components of the central nervous system (cns). within the framework of this study, conventional follow up mri will be complemented by adw-mri in case of suspected tumor recurrence and possible surgical resection of the suspicious tissue. in the case of surgical resection, the histopathological findings will be correlated to the findings of the adw-mri. in the depicted pilot phase, the feasibility of the described protocol will be examined and the data concerning correlations between standard histopathologic and genetic workup of the resected tissue and the results concerning tissue features from adw-mri will be analyzed.

Eligibility criteria:
inclusion criteria: * patients with histopathologically proven glioblastoma or brain metastasis and suspected tumor progress on standard mri after first line therapy and who are candidates for elective surgical resection. * able to give informed consent exclusion criteria: * contraindications to mri (e.g. claustrophobia, pacemaker or other implants without mri-approval, pregnancy) * patients in a life-threatening condition * patients in need of emergent surgery * histopathological analyses of insufficient quality * unable to give informed consent * age \<18 years

Keywords: advanced diffusion weighted magnetic resonance imaging (adw-mri) tumor progress (tp) pseudo- progression (psp)
does midazolam affect postoperative pain?

Conditions: Pain, Postoperative

Summary: to investigate whether midazolam has any effect on postoperative pain in outpatient surgery, the investigators will assess the impact of different midazolam doses on pain scores 24h, 7 days and 3 months after open inguinal hernia repair. the investigators hypothesize that patients being administered higher midazolam doses will refer more pain.

systemic midazolam prescribed perioperatively might have impact on pain, with studies suggesting antinociceptive and hyperalgesic effects. anxiety might be a confounder in this association. in order to investigate the effect of midazolam on postoperative pain, a prospective cohort study will be conducted in four portuguese ambulatory surgery units. a convenience sample with consecutive design will include patients admitted for open inguinal hernia repair. after anxiety and pain evaluation, a tailored dose of midazolam will be administered as premedication according to the anesthetist's best judgement within each unit's protocol (routine care; this dose may be null). subsequent anesthesia and analgesia will be standardized. postoperative pain will be blindly assessed by telephone interviews at 24h, 7 days, and 3 months. statistical analysis will be performed separately for each gender, centre and type of anesthesia, adjusting for preoperative anxiety and other confounding variables with multivariate analysis. the investigators intend to clarify the relation between anxiety, preoperative midazolam and postoperative pain.

Eligibility criteria:
inclusion criteria: - adults proposed for open inguinal hernia repair in portuguese ambulatory surgery units exclusion criteria: * psychiatric disorders * alcoholism * illiteracy or poor understanding of the portuguese language * history of chronic pain under opioids * recurrent surgery

Keywords: midazolam inguinal hernia
treatment of urinary incontinence in women with spinal cord injury

Conditions: Spinal Cord Injury; Urinary Incontinence

Summary: the purpose of this study is to determine whether pelvic floor muscle training (pfmt) and intravaginal neuromuscular electrical stimulation (nmes) are effective in reducing urinary incontinence and improving quality of life in women with spinal cord injury (sci).

sci patients often experience neurogenic bladder dysfunction with neurogenic detrusor overactivity or areflexic bladder. due to this, 40-50 % of the sci population suffers from urinary incontinence, which often reduces the patient's quality of life. in order to manage the neurogenic bladder dysfunction, sci patients use specialized bladder emptying methods, most frequently clean intermittent catheterization. to reduce the symptoms of neurogenic detrusor overactivity and urinary incontinence in patients with a sci, medical anticholinergic therapy can be assessed, but the effect is sparse and many adverse effects have been reported. injection of botulinum-a toxin in the bladder has shown great potential in minimizing the symptoms of neurogenic detrusor overactivity and urinary incontinence, though it is an expensive and invasive method that needs to be repeated due to its temporary effect. pfmt and nmes of the pelvic muscles are non-invasive and cheap treatments without side effects and several studies have demonstrated the positive effect of intravaginal nmes and/or pfmt on urinary incontinence in able-bodied women as well as women with neurological disorders like multiple sclerosis. despite the fact that nmes of weak or paralyzed striated muscles has been used for decades in patients suffering from sci, to our knowledge, no study has previously investigated the effect of pfmt and intravaginal nmes in women with sci. the aim of this study is to evaluate the effect of pfmt and intravaginal nmes on urinary incontinence and quality of life in women with sci. in particular, we will investigate the potential additional effect of intravaginal nmes, when nmes is conducted in combination with pfmt. this study is designed as a randomized clinical trial, investigating the effect of pfmt alone and in combination with intravaginal nmes. we will include 40 female patients with an incomplete sci and urinary incontinence. after physiotherapeutic guidance, the patients perform pfmt or pfmt + nmes daily at home for 12 weeks with follow-up evaluations every fourth week.

Eligibility criteria:
inclusion criteria: * incomplete sci graded c, d og e on asia impairment scale, sustained minimum 3 months ago * urinary incontinence, corresponding to a total iciq-ui-sf score ≥ 8 exclusion criteria: * regular treatment with botox bladder injections or \< 1 year since last botox injection * lack of urodynamic investigation after the sci * pregnancy * pacemaker * lack of ability to contract the pelvic floor muscles during objective clinical examination

Keywords: pelvic floor muscle training neuromuscular electrical stimulation urinary incontinence spinal cord injury
benefits of icd for the primary prevention in patients with valvular cardiomyopathy

Conditions: Valvular Heart Disease; Implantable Cardioverter Defibrillator; Sudden Cardiac Death; Primary Prevention

Summary: the prevalence of valvular heart disease is on the rise along with the aging society and the generalization of echocardiography. furthermore, the rheumatic valvular heart disease is much more prevalent in asia than in western countries, and the frequency of valve disease is higher in asia. the effect of an implantable cardioverter defibrillator (icd) in the primary prevention of sudden cardiac death in ischemic cardiomyopathy is well established and has become a standard of care. however, there is limited research on the effect of icd implantation for primary prevention in patients with heart failure due to valvular heart disease. in a small study, the incidence of fatal cardiac arrhythmia was lower in patients with valvular cardiomyopathy (5%) who received icd implantation for primary prevention than in those with ischemic cardiomyopathy. but there is also a report that the appropriate icd treatment is not different from that of ischemic heart disease in valvular heart disease patients. therefore, it is necessary to study the primary prevention effect of icd on valvular cardiomyopathy in a larger number of patients. the purpose of this study was to investigate the effect of icd on the prevention of sudden cardiac death in patients with heart failure due to valvular heart disease through prospective, multicenter, and observational studies.


Eligibility criteria:
inclusion criteria: * patients who meet one of the following criteria: * patients who have undergone surgery for aortic valve or mitral valve disease for more than 12 months * patients with severe aortic valve or mitral valve disease * patients with left ventricular ejection fraction ≤ 35% by echocardiography or other imaging methods * us, european practice guidelines class i indication for icd implantation * patients without evidence of ischemic heart disease (who meet one of the following criteria): * stress test negative * significant stenosis was not observed in coronary artery images: epicardial coronary stenosis \<70%, left main stenosis \<50% * history of heart failure symptoms * patients who have received medication for more than 3 months according to the heart failure treatment guideline recommendation exclusion criteria: * patients with left ventricular dysfunction without valvular heart disease * patients who require cardiac pacing therapy due to bradycardia * heart transplant scheduled * life expectancy is less than one year
high potassium diet with spices and herbs as salt substitute for lowering blood pressure in older adults: study protocol

Conditions: Hypertension; Older Adults Institutionalized in Residential Homes

Summary: this clinical trial aims to evaluate the high potassium diet rich in spices and herbs-salt substitution (hpsh-ss) for reducing blood pressure in older adults. the study has two phases: the first focuses on developing a high-potassium, low-sodium diet, while the second involves a 14-day randomized controlled trial. participants are divided into two groups: the intervention group (ig) receives an 1800 kcal daily diet with 3500 mg potassium and 1500 mg sodium, while the control group (cg) receives a diet with 1500 mg potassium and 2000 mg sodium. key outcomes include changes in blood pressure, serum potassium, aldosterone, nitric oxide, and oxidative stress markers. the results could provide new dietary strategies for managing blood pressure in the elderly.


Eligibility criteria:
inclusion criteria: * older adults aged ≥60 years residing in the nursing * active and not bedridden * without infectious disease, taste disorders, or dementia * have blood pressure measurements indicating a systolic blood pressure (sbp) ≥130 mmhg and/or diastolic blood pressure (dbp) ≥85 mmhg exclusion criteria: * individuals with impaired kidney function (creatinine serum levels \>1.2 mmol/l) * uncontrolled diabetes mellitus (fasting blood sugar \>126 mg/dl) * obesity (bmi ≥30 kg/m2 ) * active smokers * have memory impairment and depressive conditions * participants declining continued participation, requiring intensive hospital care, or experiencing persistent vomiting and diarrhea were excluded from the intervention.

Keywords: sodium potassium spices and herbs blood pressure hypertension elderly protocol study gerontology dietary anti-hypertensive oxidative stress
a substudy of investigational agents in programmed cell death-1/ligand 1 (pd-1/l1) refractory locally advanced or metastatic urothelial carcinoma (muc) (mk-3475-04a)

Conditions: Urothelial Carcinoma

Summary: this substudy is part of an umbrella platform study which is designed to evaluate investigational agents with or without pembrolizumab in participants with urothelial carcinoma who are in need of new treatment options. substudy 04a will enroll participants with locally advanced or muc whose disease is resistant to treatment with programmed cell death-1/ligand 1 (pd-1/l1) inhibitors. the protocol infrastructure will enable the rolling assignment of investigational treatments.


Eligibility criteria:
inclusion criteria: the main inclusion and exclusion criteria include but are not limited to the following: * histologically or cytologically confirmed diagnosis of locally advanced/unresectable or muc of the renal pelvis, ureter (upper urinary tract), bladder, or urethra. * pd-1/l1 refractory locally advanced or muc as evidenced by: either disease progression while on treatment or after treatment with an anti-pd-1/l1 monoclonal antibody (mab) for locally advanced/unresectable or muc administered either as monotherapy, or in combination with other checkpoint inhibitors or other therapies or disease recurrence while on treatment or after treatment with an anti-pd-1/l1 mab for muscle-invasive urothelial carcinoma (miuc) administered as monotherapy. * participants must provide an archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion demonstrating uc, not previously irradiated, and adequate for biomarker evaluation. exclusion criteria: * known additional nonurothelial malignancy that is progressing or has required active treatment within 3 years prior to study randomization/allocation. * received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization/allocation. * active infection requiring systemic therapy. * received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. administration of killed vaccines are allowed. * known history of human immunodeficiency virus (hiv). * known history of hepatitis b or known hepatitis c virus infection.
omalizumab in severe and refractory solar urticaria

Conditions: Solar Urticaria

Summary: solar urticaria is a rare disease, with a usual favourable outcome with photoprotection and with anti h1 histamines. nevertheless, some cases can be severe and refractory to this usual treatment, leading to a large impact on quality of life. new treatment options are warranted. the investigators aim to test the efficacy and the safety of omalizumab, an anti-ige antibody recently approved in chronic spontaneous urticaria, in this setting.

this is an open-labelled multicentric phase ii study testing the efficacy and the safety of omalizumab 300 mg (w0, w4 and w8) in patients affected with severe and refractory solar urticaria.

Eligibility criteria:
inclusion criteria: * age \> or equal to 18 years, * appearance of wheals within 15 min after sun exposure and lasting \< 2 hr in the shade, * wheals reproducible with phototesting: appearance after exposure to uvb, uva or visible light less than 30 min after exposure and lasting \< 2 hr, * severity criteria: * very large effect on quality of life, with dermatology life quality index (dlqi) \> 10, and * at least 1 of the following: involvement of the face, per annual eruption, extension of wheals on the non-photoexposed skin, su triggered by artificial light, su flares accompanied by bronchospasm or syncope. * refractory criteria: * resistance to photoprotection with sunscreen with sun protection factor ≥ 50, and * resistance to administration of an association of 2 different antihistamines during 3 months or to photodesensitization. exclusion criteria: * contra indication to omalizumab * previous treatment with omalizumab

Keywords: omalizumab efficacy safety
efficacy and safety study of elnd005 as a treatment for agitation and aggression in alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the primary purpose of this study is to determine whether elnd005 is effective in treating symptoms of agitation and aggression in patients with alzheimer's disease


Eligibility criteria:
inclusion criteria: * diagnosis of probable ad according to the national institute on aging- alzheimer's association (nia-aa) guidelines (mckhann et al 2011). * mmse score of 5 to 24 (inclusive) at the screening visit. * has clinically significant agitation/aggression defined as neuropsychiatric inventory (npi)-agitation/aggression subscore of ≥4. * no response or suboptimal response to standard nonpharmacological interventions. exclusion criteria: * the agitation/aggression is attributable to concomitant medications, environmental conditions, or active medical or psychiatric condition. * current diagnosis of major depressive disorder according to the criteria of the diagnostic and statistical manual of mental disorders fourth edition text revision (dsm iv tr). * has persistent and distressing psychotic symptoms (delusion and/or hallucinations) that require psychiatric hospitalization.

Keywords: agitation aggression patients
3d custom plate vs. standard titanium plates for mandibular sub-condylar fractures fixation

Conditions: Mandibular Sub-condylar Fracture

Summary: this randomized clinical trial aims to conduct a comprehensive clinical and radiographic evaluation by comparing the efficacy of standard titanium fixation plates with three dimensional custom plate in the management of sub-condylar fractures. by assessing the clinical outcomes, accuracy of reduction of the fracture segments, and bite force promoted by both fixation modalities.


Eligibility criteria:
inclusion criteria: * displaced sub condylar fractures, requiring open reduction and rigid internal fixation * age ranges from 18 to 60 years * fracture duration less than 2 weeks * patients with adequate follow up duration for outcome assessment exclusion criteria: * comminuted sub condylar fractures * patients with severe systemic diseases that may affect fracture healing * presence of any pathology at the fracture site * patients with previous history of mandibular surgery * medically compromised patients who are not fit to undergo surgery under general anesthesia * patients with in complete medical records or missing follow up data

Keywords: mandibular fracture 3d custom plate titanium miniplates sub-condylar fractures
"sveat" chest pain scoring system

Conditions: Chest Pain

Summary: this is a prospective, observational study to assess the efficacy of the newly developed sveat scoring system in identifying low-risk patients who may be eligible for early discharge. various elements of clinical information including symptoms, vascular history, ekg, age and troponin values will be checked and entered on the scoring form to calculate the sveat risk score. additionally, heart score and timi risk score will be calculated for the same subjects. the primary aim is to assess the positive and negative predictive values for the sveat index for cardiovascular events and compare it to the heart and timi scores.

this is a prospective, observational study in patients presenting to the emergency department or admitted to clinical decision unit at renown regional medical center with a primary complaint of chest pain in a period of 12 months. all patient \>24 years will be recruited. exclusion criteria include patients with clear-cut acute st-segment elevation myocardial infarction, traumatic non-cardiac chest pain, life-expectancy less than 90 days, hemodynamic instability or inability to provide informed consent. data and scores based on commonly known timi\* risk score, heart score and a newly developed sveat index ( symptoms, vascular disease, ekg, age, troponin) will be obtained by primary investigator trained physicians or advanced nurse practitioners as earliest as possible after their initial presentation. the care of the patients will be left to the discretion of the treating physician. the outcome of each patient will be determined by either chart review, telephone contact or office visit as appropriate in 30 days post presentation. the sensitivity, specificity, positive and negative predictive value of sveat index will be calculated using standard statistical analysis. the receiver operating characteristic (roc) curves of sveat index, timi risk score and heart score will be generated and compared using commercially available software. p value of 0.05 or less will be considered statistically significant difference. the primary hypothesis of the study is that scoring systems that better incorporate useful clinical information such as the sveat score may improve our ability to accurately identify low-risk acute chest pain patients presenting to the ed.

Eligibility criteria:
inclusion criteria: * any patient \> 24 years old presenting to the emergency room or admitted to the clinical decision unit with chest pain. exclusion criteria: * patient with clear-cut acute st-segment elevation myocardial infarction, traumatic non-cardiac chest pain, life-expectancy less than 90 days, hemodynamic instability or inability to provide informed consent.

Keywords: acute coronary syndrome heart diseases cardiovascular diseases vascular diseases