Kornimate/medical-research-clean huggingface dataset:
management of post endodontic re-treatment pain with low-level laser therapy

Conditions: Pain

Summary: in this clinical trial investigators aimed to evaluate post endodontic re-treatment pain after irradiation of low level laser therapy

in this clinical trial, 61 patients requiring endodontic retreatments in the posterior teeth were selected. a single visit endodontic retreatment was done. after biomechanical preparation, low level laser was irradiated to the buccal and lingual mucosa overlying the apices of the target tooth in the experimental group. in the control group patients received placebo laser to eliminate the probable psychological effects of laser. laser irradiation was done with a single dose of 808 nm wavelength (whitening lase ii- laser dmc, samsung, korea) with 100 mw power, and dose of 70 j/cm2 for 80 seconds. pain severity was recorded before the treatment, immediately after the treatment and 4, 8, 12, 24 and 48 hours after the treatment by visual analogue scale (vas). the pain scores were statistically analyzed by chi-square test between two groups. the effects of different variables on the post-operative pain experience were also studied by means of logistic regression.

Eligibility criteria:
inclusion criteria: - patients requiring endodontic retreatments in the posterior teeth exclusion criteria: * systemic diseases psychologic disorders

Keywords: endodontic retreatments low level laser pain
switching to e-cigarette after pci

Conditions: Coronary Artery Disease

Summary: despite the increasing popularity of electronic cigarettes (e-cigarettes), the prognostic impact of switching to e-cigarettes in smokers with coronary artery disease (cad) who underwent percutaneous coronary intervention (pci) remains uncertain.

recently, several studies have reported that, although lower than combustible cigarette users, e-cigarette users had a significantly higher risk of future myocardial infarction (mi) or cardiovascular disease compared with non-smokers or quitters. however, because all previous studies has focused on the general healthy population, these results cannot be extrapolated for patients who already proven atherosclerotic cardiovascular disease (ascvd), such as undergoing percutaneous coronary intervention (pci) for coronary artery disease (cad). although busch et al. previously reported that a significant minority of patients are using e-cigarettes post-acute coronary syndrome smokers, a paucity of data exists regarding the impact of such transitions on clinical outcomes in current smoker patients with cad who have undergone pci. in light of these considerations, the current study sought to address this gap in knowledge by evaluating the prognostic implications of smoking habit changes, including e-cigarette use, among cad patients with current smoking status following pci.

Eligibility criteria:
inclusion criteria: * patients who underwent health screening 3 years before and after the pci exclusion criteria: * history of cancer * history of ischemic stroke * died within the first 3 months of follow-up from the index date * newly developed acute mi or received additional pci or cabg from the index pci date to the study index date

Keywords: percutaneous coronary intervention e-cigarette smoking
to compare the pharmacokinetics of avanafil in subjects with mild and moderate renal impairment to subjects with normal renal function.

Conditions: Renal

Summary: the objective of this study is to compare the pharmacokinetics of avanafil in subjects with mild and moderate renal impairment and to assess the safety and toleration of avanafil in subjects with mild and moderate renal impairment.


Eligibility criteria:
inclusion criteria: * adult male subjects, * 21-78 years of age, must be medically healthy with no clinically significant screening results (except for the subjects in groups 2 and 3). * subjects with normal renal function (group 1) must have an estimated clcr of ≥80 ml/min. * subjects with renal impairment (groups 2 and 3) must fulfill the additional following criteria: (a) stable renal impairment; (b) group 2 subjects with mild renal impairment must have a clcr of ≥50 to \<80 ml/min and (c) group 3 subjects with moderate renal impairment must have a clcr of ≥30 to \<50 ml/min. exclusion criteria: * major exclusion criteria include: history or clinical evidence of clinically relevant cardiovascular (including thromboembolic disorders), hepatic, renal (with the exception of renal insufficiency for subjects in groups 2 and 3), hematological, endocrine, pulmonary, gastrointestinal, psychiatric or neurological impairment; any clinically significant laboratory abnormalities as judged by the investigator; systolic blood pressure \ 160 mmhg; diastolic blood pressure \ 95 mmhg; allergy to or previous adverse events with pde5 inhibitors or its constituents; use of prescription or over-the-counter drugs that are known to interfere with metabolism by the cytochrome p450 3a4 enzyme within 30 days prior to day 1; use of any investigational drug within 30 days prior to day 1; use of any prescription or over-the-counter drugs or herbal remedies within 14 days prior to day 1; history of alcohol or drug abuse within 18 months, history of smoking within 6 months; positive breathe alcohol test; positive cotinine test, positive urine drug screen (except in renally impaired subjects following approval by sponsor). additional exclusion criteria are listed in section 4.2.

Keywords: avanafil, renal, impairment, ta-1790
effect of lidocaine spray for pain relief during endometrial biopsy: a randomized, double-blind, placebo-controlled clinical trial

Conditions: Pain

Summary: the effect of lidocaine spray on pain relief during endometrial sampling.

the study population will comprise women with abnormal uterine bleeding who will be scheduled for endometrial sampling or women who will have control biopsies before surgery due to other pathologies. we have two groups; the first group consisted of patients who receive lidocaine spray. the second group consisted of patients who receive placebo spray. patients will be asked to rate their pain level on a standard continuous 100-mm vas to quantify the pain. pain scoring will be performed at 3 different time points: immediately before to the procedure, during the procedure(immediately following the removal of the speculum from the vagina at the end of the endometrial sampling, the patients will be asked to score their pain level experienced during the procedure), and 15 minutes after the procedure. we will document the patients' demographics and medical information. all procedures will be performed by a single operator and the same team to avoid possible operator-dependent pain factors (counseling, patient preparation, attitude and operative steps during operation, moral and psychological support).

Eligibility criteria:
inclusion criteria: * age\>18 years no allergy patients with abnormal uterine bleeding exclusion criteria: * cervical stenosis myoma uteri pregnancy miscarriage chronic pelvic pain dysmenorrhea

Keywords: curettage; pain score
bioequivalence study of crushed sofosbuvir/velpatasvir compared to the whole tablet

Conditions: HCV

Summary: epclusa® is a pan-genotypic, once-daily tablet for the treatment of chronic hepatitis c virus (hcv) infection containing the ns5b- polymerase inhibitor sofosbuvir (sof, nucleotide analogue) 400 mg and the ns5a inhibitor velpatasvir (vel) 100 mg. for patients with swallowing difficulties, administration of whole tablets can be problematic. in addition, hcv patients that are hospitalized (at intensive care units) due to severe illness (co-infections/ liver failure) might not be able to swallow medication. therefore it is useful to know whether it is possible to administer sof/vel through a different route, like a feeding tube. in daily practice, information about the safety and efficacy of crushed tablets is lacking which might result in interruption or discontinuation of expensive hcv therapy. however, it is not recommended to interrupt treatment because there is no evidence about the efficacy of the therapy after discontinuation (and restart). currently, patients and healthcare professionals are crushing sof/vel tablets without information about efficacy and safety. depending on the biopharmaceutical characteristics of a drug formulation, crushing tablets can lead to altered pharmacokinetics of drugs. it is important to know whether pharmacokinetic parameters are influenced by crushing of tablets; both a decrease and an increase in exposure may occur. a decrease of the plasma concentrations of sof and/or vel potentially reduces the therapeutic effect of the drugs. higher doses or switching to other hcv-drugs might be needed. in contrast, in case a higher cmax,ss and/or exposure occurs there might be an increased risk of toxicity. as a result, crushing the drug is a contra-indication based on the available data. therefore this study will be conducted to investigate whether a crushed sof/vel tablet is bioequivalent to sof/vel as a whole tablet.


Eligibility criteria:
inclusion criteria: 1. patients with sof/vel treatment for the treatment of chronic hcv genotype 1 through 6. 2. patient is at least 18 at the day of screening. 3. patient is able and willing to sign the informed consent form. 4. patient is able and willing to follow protocol requirements. exclusion criteria: 1. pregnant female (as confirmed by an hcg urine test performed at screening) or breast-feeding female. 2. relevant history or current condition that might interfere with drug absorption, distribution, metabolism or excretion. 3. inability to understand the nature and extent of the study and the procedures required. 4. clinically relevant low hemoglobin concentration at screening judged by the patient's own hepatologist.

Keywords: epclusa pharmacokinetics crushing
identification of risk factors and construction of prediction model for postoperative intestinal anastomotic leakage in ovarian cancer

Conditions: Ovarian Cancer

Summary: this study was a multicenter, retrospective cohort study. although advancements in surgical techniques have mitigated the incidence of intestinal anastomotic fistula, complete avoidance remains elusive. anastomotic leakage (al) complications directly impinge on postoperative quality of life and pose life-threatening risks if inadequately managed. given al's adverse prognostic implications and the financial strain on patients' families, identifying its risk factors aids in perioperative risk assessment, enabling timely clinical decisions on interventions to enhance prognosis and curtail adverse outcomes and economic investments.

optimal cytoreduction, particularly in advanced cases, significantly extends 5-year survival compared to cases with residual disease exceeding 1 cm. consequently, ultra-radical tumor cytoreduction procedures, commonly performed in advanced ovarian cancer, entail the excision of abdominopelvic tissues affected by the primary ovarian malignancy, including segments of the bowel, bladder, spleen, gallbladder, diaphragm, and other organs. rectosigmoid resection (rsr) emerges as the predominant bowel resection, followed by colon and small bowel resections. intestinal anastomosis post-rsr is indispensable for bowel reconstruction but bears a notable risk of postoperative anastomotic fistula (al), a major complication. al incidence rates fluctuate over time, reported between 8-14% in oc surgery patients undergoing rsr. al imposes considerable burdens, encompassing elevated hospital costs, prolonged stays, heightened rates of secondary admissions and surgeries, and mortality rates ranging from 3% to 21%. furthermore, al delays the commencement of adjuvant chemotherapy, detrimentally impacting overall survival and representing a significant consequence of colorectal surgery.

Eligibility criteria:
inclusion criteria: 1. patients with postoperative pathological diagnosis of primary ovarian, fallopian tube or peritoneal cancer 2. patients undergoing tumour cytoreductive surgery combined with colorectal resection and stage i intestinal anastomosis 3. no history of other malignant tumours 4. complete case data exclusion criteria: 1. previous combination of malignant tumours of other organs 2. comorbidities with serious diseases related to other organs 3. patients undergoing secondary tumour cytoreduction

Keywords: anastomotic leakages risk factors ovarian cancer
inflammatory response in laparoscopic and open colectomy

Conditions: Colorectal Cancer

Summary: this study is designed to measure and compare the inflammatory response in laparoscopic and open colon cancer surgery


Eligibility criteria:
inclusion criteria: * colorectal cancer exclusion criteria: * metastases * stage 4 colorectal cancer * recurrent disease * chronic diseases * obvious inflammatory condition

Keywords: a-defensins tlrs inflammatory cytokines crp no metastases no other obvious inflammation no chronic diseases
sorafenib plus hepatic arterial infusion versus sorafenib for hcc with major portal vein tumor thrombosis

Conditions: HepatoCellular Carcinoma; Portal Vein Thrombosis

Summary: according to the barcelona clinic liver cancer (bclc) staging treatment guideline, sorafenib is recommended for hepatocellular carcinoma (hcc) with portal vein tumor thrombosis (pvtt), but hcc with major pvtt (in the main trunk or 1st-order branches of the portal vein) did not benefit much from sorafenib in previous studies. there is no established standard treatment for hcc patients with major pvtt, the investigators conducted a randomized, phase 2 study to investigate the survival benefit of sorafenib plus hepatic arterial infusion chemotherapy (haic) with oxaliplatin and fluorouracil versus sorafenib for hepatocellular carcinoma with major portal vein tumor thrombosis.


Eligibility criteria:
inclusion criteria: * patient must have histologically or clinically confirmed hepatocellular carcinoma. * hcc with major pvtt (in the main trunk or 1st-order branches of the portal vein) * child a class * patient's eastern cooperative oncology group (ecog) performance status must be =\ = 60%) * absolute neutrophil count \>= 1,500/mcl * platelets \>= 100,000/mcl * hemoglobin \>= 90g/l * total bilirubin =\< 2 x institutional upper limit of normal * aspartate aminotransferase (ast) (serum glutamic oxaloacetic transaminase \[sgot\])/alanine aminotransferase (alt) (serum glutamic pyruvate transaminase \[sgpt\]) =\< 2.5 x institutional upper limit of normality * creatinine =\< 1.5 x institutional upper limit of normal * albumin \>= 30g/l * patient must be able to understand and willing to sign a written informed consent document exclusion criteria: * patients who have had prior chemotherapy with oxaliplatin or fluorouracil or sorafenib. * patient who is receiving any other investigational agents * patient who have a diagnosis of hepatic encephalopathy * patients who have a diagnosis of sclerosing cholangitis. * patients who have a diagnosis of gilbert's disease. * patients who have clinical ascites * patient must not have any uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled diabetes mellitus and hypertension, or psychiatric illness/social situations that would limit compliance with study requirements * no other malignancy except localized basal cell or squamous cell skin cancer in the past 5 years * patient who is pregnant or lactating * patient allergic to iodine contrast medium * uncontrolled severe coagulation disorders (inr \< 1.5 in patients not on warfarin therapy)

Keywords: hepatocellular carcinoma portal vein tumor thrombosis hepatic arterial infusion chemotherapy sorafenib
a randomized double-blind study testing the effects of pregabalin on diabetic neuropathy

Conditions: Diabetic Neuropathy

Summary: this study is designed to examine how pregabalin affects parameters of autonomic nerve regulation in correlation with change in pain, anxiety, and depressive symptoms in patients with diabetic neuropathy.

this study is designed to primarily examine how pregabalin affects the autonomic nerve or sympathetic-parasympathetic regulation in patients with diabetic neuropathy and its relationship to neuropathic pain. the goals of this study include (1) assessing the change of parameters of autonomic nerve function such as heart rate variability (hrv), respiratory sinus arrhythmia (rsa), minute ventilation, and changes in objective sleep parameters measured by means of the lifeshirt, upon treatment of pregabalin in comparison to placebo; (2) assessing the symptom change of neuropathic pain upon treatment of pregabalin in comparison to placebo; (3) assessing the change of anxiety symptoms upon treatment of pregabalin in comparison to placebo; (4) assessing the change of depressive symptoms upon treatment of pregabalin in comparison to placebo; (5) assessing the relationship of autonomic nerve function with neuropathic pain at baseline prior to treatment and the correspondences to the study drug; (6) assessing the relationship of autonomic nerve function with anxiety and depressive symptoms at baseline prior to treatment and their correspondences to the study drug; (7) identifying sensitive and reliable parameters of autonomic nerve regulation as predictor(s) of the severity and improvement of neuropathic pain and/or anxiety; and (8) to assess the change in objective sleep parameters (eeg/eog) by means of the lifeshirt, upon treatment of pregabalin in comparison to placebo

Eligibility criteria:
inclusion criteria: * outpatients aged 18 years or older * meet criteria for diagnosis of diabetic neuropathy * average daily pain scores greater than or equal to 4 by visual analog scale * ability to give informed consent * no pregnancy exclusion criteria: * patients with clinically significant psychiatric disorders requiring vigorous interventions, i.e., moderate to severe depressive disorder, psychotic disorders, ptsd, obsessive compulsive disorder, panic disorder, substance abuse, or personality disorders, or active suicidal/homicidal ideations, or past history of active suicidal ideation and/or attempts * patients on gabapentin which cannot be discontinued, meaning a dose greater than 1200mg. if a patient is on a dose of gabapentin that is less than 1200mg and he or she is willing to stop taking the medication, he or she can participate in the study. these patients must take the last dose of gabapentin the night before starting the study. * patients being non-compliant with diabetic control * inability to wear the lifeshirt * unable to participate or answer questions using a personal digital assistant input device

Keywords: diabetic neuropathy pregabalin lyrica
mtx hold during covid-19 booster

Conditions: Rheumatoid Arthritis

Summary: to investigate the effect of mtx discontinuation for 1 week on vaccination response to covid-19 booster vaccination in ra patients.


Eligibility criteria:
inclusion criteria: * males or females ≥ 19 years of age at time of consent * have a diagnosis of ra per acr criteria * require methotrexate for ra treatment * subject to a covid-19 booster vaccination * must understand and voluntarily sign an informed consent form including writing consent for data protection exclusion criteria: * pregnant or lactating females * previous anaphylactic response to the vaccine components * any other rheumatic disease such as systemic lupus erythematosus, mixed connective tissue disease, dermatomyositis/polymyositis, and vasculitis except for secondary sjogren's disease * any condition including laboratory abnormality which places the subject at unacceptable risk * subjects who decline to participate
corticolimbic degeneration and treatment of dementia

Conditions: Dementia

Summary: the overall purpose of this research is to determine if there is a relationship between your symptoms of dementia of the alzheimers type and changes in the size and shape of certain brain structures during combined donepezil (aricept®) and memantine (namenda®) treatment.

in this study we will be using memantine (namenda®) in an investigational fashion with individuals with very mild to mild dementia. donepezil (aricept®) is approved by the food and drug administration for the treatment of alzheimers disease. memantine (namenda®) is currently approved by the food and drug administration for moderate and severe dementia only. this study may be instrumental in the development of a new therapy for others with similar conditions, and to determine whether memantine (namenda®) will be helpful to individuals with very mild to mild dementia. specific aim 1. to determine what neuroanatomical measures are most strongly correlated with the progression of clinical and cognitive deficits in patients with dementia of the alzheimer type (dat). to accomplish this aim, we will use high-resolution magnetic resonance (mr) imaging and the tools of computational anatomy to assess changes in the structure of selected subcortical (e.g., hippocampus) and cortical (e.g., parahippocampal gyrus and cingulate gyrus) structure along with clinical and cognitive measures of dementia severity in subjects with very mild-to-mild dat. specific aim 2 - to determine whether cholinesterase inhibitors and memantine can slow disease progression in dat subjects. to accomplish this aim, we will use mr imaging and the tools of computational anatomy to compare the rate of change in the neuroanatomical measures listed above in 1) untreated dat subjects, 2) dat subjects treated with donepezil alone, and 3) dat subjects treated with the combination of donepezil and memantine.

Eligibility criteria:
inclusion criteria: 1) meets national institute of neurological and communicative disorders and stroke and the alzheimer's disease and related disorders association(nincds-adrda) alzheimer's criteria for dementia of the alzheimer's type (dat), 2) clinical dementia rating (cdr) score of 0.5 or 1, 3) 50-80 years of age, 4) able to give informed consent or has a primary caregiver or legal guardian, who can give informed consent. exclusion criteria: 1) other psychiatric (e.g., depression) or neurological (e.g., cva) disorders that would confound the assessment of dementia symptoms, 2) history of loss of consciousness, and 3) unstable or severe medical illness (e.g., hepatotoxicity) that would make donepezil or memantine treatment or participation in other aspects of the study unsafe.

Keywords: dementia of the alzheimer type