Kornimate/medical-research-clean huggingface dataset:
clinical performance of thermoviscous bulk fill resin composites in comparison to conventional packable bulk fills

Conditions: Caries,Dental

Summary: this clinical trial will be conducted to compare the clinical performance of the thermo-viscous preheated bulk fill composite in the management of carious lesions in posterior teeth in adult patients over 12 months.


Eligibility criteria:
inclusion criteria: * have at least two molars supported permanent dentition free of any clinically significant occlusal interference and require posterior restoration and fulfilled the inclusion criteria, patients will be informed about the study and will be given an informed consent. * the two studied materials restorations should be used in approximately the same sized lesions or within the same extensions. * the patient will be reimbursed for attending for the clinical evaluation(s) of their restorations. * be a regular dental attender who agree to return for assessments. exclusion criteria: * there is history of any adverse reaction to clinical materials of the type to be used in the study. * there was evidence of occlusal parafunction and/or pathological tooth wear. * patients whose history revealed parafunctional habits or use of medications that potentially could cause hyposalivation.
an open study to evaluate the efficacy, safety of clevudine monotherapy or adefovir and clevudine combination in patients with chronic hepatitis b

Conditions: Chronic Hepatitis B

Summary: this is an open study to evaluate the efficacy, safety of clevudine monotherapy or adefovir and clevudine combination in patients with chronic hepatitis b.


Eligibility criteria:
inclusion criteria: * patient is 18 years and older. * patient is documented to be hbsag positive for \> 6 months. * patient is hbv dna positive with dna levels ≥ 1×10\^5 copies/ml within 30days of baseline. * patient has alt levels ≥ 1×uln * patient who is able to give written informed consent prior to study start and to comply with the study requirements. exclusion criteria: * patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy. * patients previously treated with interferon, peg-interferon or other immunomodulatory within the previous 6 months. * patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine, tenofovir or any other investigational nucleoside for hbv infection. * patient with clinical evidence of decompensated liver disease (total bilirubin \< 2.0mg/dl, prothrombin time \< 1.7(inr), serum albumin≥3.5g/dl) * patient is coinfected with hcv, hdv or hiv. * patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy. * patient with clinical evidence of hepatocellular carcinoma * patient with previous liver transplantation * patient is pregnant or breast-feeding. * patient has a clinically relevant history of abuse of alcohol or drugs. * patient has a significant immunocompromised, gastrointestinal, renal, * hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic gb stone, neurological, cardiac, oncologic(except hcc)or allergic disease or medical illness that in the investigator's opinion might interfere with therapy. * patient has creatinine clearance less than 60ml/min as estimated by the following formula: (140-age in years) (body weight \[kg\])/(72) (serum creatinine \[mg/dl\]) \[note: multiply estimates by 0.85 for women\]
the value of serum microrna-21-5p and lncrnagadd7 expression levels in predicting the severity and prognosis of ards ( acute respiratory distress syndrome )

Conditions: Acute Respiratory Distress Syndrome

Summary: by measuring the expression levels of microrna-21-5p (mir-21-5p) and lncrnagadd7 in the peripheral blood of ards patients, the study aims to explore the correlation between these levels and the severity and prognosis of ards.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years; 2. meets the berlin criteria for ards; 3. diagnosed with ards within 48 hours; 4. signed informed consent. exclusion criteria: 1. immunosuppressed patients: including those on immunosuppressive drugs, history of stem cell transplantation, etc.; 2. patients with malignant tumors; 3. pregnant women; 4. patients discharged from the icu within 48 hours; 5. history of chronic lung diseases.
molecular mechanisms associated with breast implant complications

Conditions: Breast Implant; Complications; Infection or Inflammation

Summary: bacterial biofilms cause implant failures, chronic inflammation, and immune polarization. the study investigates the possible role of bacterial biofilm as a factor in the etiology of breast implant illness. three patient cohorts will be studied (a) subjects with breast implant with bii manifestations (b) subjects with breast implants without bii manifestations (c) subjects without breast implants who underwent breast surgery procedure. blood, surgically discarded tissue, implants, and associated capsules will be collected through this protocol.

breast implants were first introduced in 1962. it is estimated that 10 million women worldwide, including three million americans have breast implants. there has been increased identification of patients experiencing a constellation of symptoms related to their implants. for breast implants, these symptoms are often associated with autoimmune and connective tissue disorders (ctd) and have been referred to as breast implant illness (bii). a growing number of patients 30,000 annually are seeking to have their breast implants removed. in view of the implant associated complications, the us food and drug administration (fda) has placed a black box warning on breast implants. limited research has resulted in a void in the prognosis of this surgical problem. bacterial biofilms are becoming a major concern for medical device implants. bacterial biofilms cause implant failures, chronic inflammation, and immune polarization. the study investigates the possible role of bacterial biofilm as a factor in the etiology of bii. this research studies oxilidized lipids (oxylipins). these are metabolities formed as a result of host-biofilm interaction. the presence of oxylipins will be studied in peri-prosthetic tissue post-biofilm infection and in systemic circulation. oxylipins are immunogenic. hence, the investigators will also study the abundance of immune cells t cells and macrophages (types and subtypes) and associated cytokines.

Eligibility criteria:
inclusion criteria for breast implant subjects: * age greater than or equal to 18 years * undergoing removal of breast implant * willing and able to comply with protocol instructions inclusion criteria for subjects undergoing breast surgeries (other than implant removal) * age greater than or equal to 18 years * undergoing breast surgery * willing and able to comply with protocol instructions exclusion criteria: * individuals who are deemed unable to understand the procedures, risks, and benefits of the study, (i.e., unable to provide informed consent) * pregnant females * immunodeficiency (hiv/aids, scid) * currently on immunosuppressive medications * prisoners
adjuvant pd-1 inhibitor for patients with early-stage hepatocellular carcinoma following microwave ablation

Conditions: Hepatocellular Carcinoma

Summary: for early-stage hepatocellular carcinoma, i.e. barcelona clinical liver cancer stage 0, ablation is the standard treatment with a comparable prognosis and less risk of ablation compared with liver resection. however, ablation is demanding on the surgeon and patients often face early recurrence if ablation is not complete. therefore, it is necessary to find reasonable adjuvant treatment to consolidate the effect of microwave therapy.

for early-stage hepatocellular carcinoma, i.e. barcelona clinical liver cancer stage 0, ablation is the standard treatment with a comparable prognosis and less risk of ablation compared with liver resection. however, ablation is demanding on the surgeon and patients often face early recurrence if ablation is not complete. therefore, it is necessary to find reasonable adjuvant treatment to consolidate the effect of microwave therapy. there is no consensus on postoperative adjuvant therapy, especially for the management of early-stage hcc. most scholars believe that hcc in this period does not have high-risk factors for tumor recurrence, thus neglecting the role of adjuvant therapy. early studies have found that microwave ablation can alter the tumor microenvironment, which is conducive to the action of immune checkpoint inhibitors such as pd-1 inhibitors and even has a synergistic anti-tumor effect. we therefore designed this prospective cohort study to explore the efficacy and safety of adjuvant pd-1 inhibitors after microwave surgery.

Eligibility criteria:
inclusion criteria: * aged 18-75 years * pathological type is hcc, bclc stage 0-a * no extrahepatic hcc * no radiographic recurrence at 2-4 weeks after ablation * eastern cooperative oncology group (ecog) performing status of 0-1 * child-pugh grade a or b and adequate hematologic and organ function exclusion criteria: * any history of other malignant tumors or recurrent hcc * any preoperative treatment for hcc including local and systemic therapy * any acute active infectious diseases, active or history of autoimmune disease, or immune deficiency * any persistent serious ablation-related complications * esophageal and/or gastric variceal bleeding within 6 months * inability or refusal to comply with the treatment and monitoring * participation in other clinical trials

Keywords: hepatocellular carcinoma adjuvant therapy microwave ablation pd-1 inhibitor
autologous fibroblast grafts in facial skin regeneration

Conditions: Skin Aging

Summary: the purpose of this study is to evaluate the presence of skin changes after grafting of autologous fibroblasts by means of biophysical, histological, immunohistological, gene expression, glycosaminoglycan, and sensitivity analyses.

- analytical prospective autocontrolled study

Eligibility criteria:
inclusion criteria: * women, aged between 50 to 70 years with facial wrinkles (rhytides), * fitzpatrick iii skin type, and * who had reached menopause at least 3 years before entering the study were eligible for participation. exclusion criteria: * women with uncontrolled comorbid conditions, * smokers, * alcohol and corticosteroid users, * who had undergone chemical peeling or skin filling in the face or neck at least 12 months prior to the study, * who had a keloid scar, * who scored below 18 on the mini-mental state examination, * who had any psychiatric disorder or those undergoing orthodontic treatment were excluded from the study.

Keywords: skin aging fibroblasts transplantation autologous
clinical trial of a computer-driven weaning system for patients requiring mechanical ventilation

Conditions: Respiratory Insufficiency

Summary: the purpose of this study is to compare the efficacy of a computer-assisted ventilator weaning system (drager smartcare) to our current standard of care in the medical intensive care unit.


Eligibility criteria:
inclusion criteria: * age greater than 18 years * initiated on mechanical ventilation via endotracheal tube * admitted to medical intensive care unit and medical intensive care unit team (harrison avenue campus, menino pavilion) * requiring mechanical ventilation for more than 48 hours * meets prespecified weaning criteria exclusion criteria: * do not resuscitate/do not intubate order * pregnancy * mechanical ventilation initiated at another hospital * cardiac arrest for more than 5 minutes with poor neurologic prognosis * tracheostomy

Keywords: respiratory insufficiency ventilators, mechanical ventilator weaning therapy, computer-assisted
prevention of prostate cancer with dutasteride in case of high grade pin neoplasia

Conditions: Prostate Cancer

Summary: patients with diagnosis of hpin were enrolled. patients were randomized into two groups: dutasteride treatment group and watchful waiting strategy group. according to the study protocol the subjects would undergo 10 core biopsies after 6, 12, 24, and 36 months after randomization. there are assessed the rate of prostate cancer at repeated transrectal ultrasound guided biopsies and the effect of 5 alfa reductase inhibitor (dutasteride) on prevention of prostate cancer development for patients with high grade intraepithelial neoplasia (hpin).


Eligibility criteria:
inclusion criteria: 1. age - 40-80 years 2. hpin on prostate biopsy specimens 3. psa below 20ng/ml 4. no hormone therapy or radiation in pelvic region 5. no previous treatment with 5alfa reductase inhibitors 6. signed subject information and informed subject consent form. exclusion criteria: 1. not compensate cardiovascular, pulmonary, hepatic or renal functions, neurological, psychiatric disease, sepsis, etc.

Keywords: prostate cancer chemoprevention dutasteride
comparison of skin incision closure material for the transobturator suburethral sling procedure

Conditions: Pain, Postoperative; Irritation (Physical); Pelvic Pain

Summary: the purpose of this study is to compare different skin closure materials for the transobturator suburethral sling procedure. currently the investigators are using monocryl suture material as the standard for skin closure. this material has anecdotally show to be very irritating to patients who have had this type of surgery. our study will compare the monocryl suture material with vicryl (polyglactin 910) and dermabond (2-octyl cyanoacrylate) skin glue. the investigators believe that vicryl suture material will be superior in comfort when compared to monocryl and dermabond for this type of procedure.


Eligibility criteria:
inclusion criteria: * those patients receiving a transobturator suburethral sling procedure. * adults (\>= 18years). exclusion criteria: * non-english speaking. * allergy to monocryl, vicryl, or dermabond.

Keywords: skin closure dermabond vicryl monocryl suburethral sling transobturator sling pain discomfort skin irritation
aronia and cognitive fitness

Conditions: Brain Vascular Function; Cognition

Summary: previously, beneficial effects of aronia melanocarpa extract (ame) supplementation on cognitive performance has been observed in healthy middle-aged adults. however, underlying mechanisms have not yet been addressed. in addition, effects of ame are unknown in subjects at increased risk of cognitive impairment. it is hypothesized that supplementation with ame enhances (regional) brain vascular function and brain insulin-sensitivity, thereby improving cognitive function of subjects at increased risk of cognitive impairment. the primary objectives are to investigate effects of ame intake on brain vascular function and insulin-sensitivity in cognitive-control brain areas, while we will also evaluate changes in cognitive function (secondary objective). the present study is a randomized, double-blind, placebo-controlled, cross-over trial consisting of two study groups and a pre- and post-test day in both study arms.


Eligibility criteria:
inclusion criteria: * men and women, aged between 55-75 years * bmi between 25-35 kg/m2 * fasting plasma glucose \< 7.0 mmol/l * fasting serum total cholesterol \< 8.0 mmol/l * fasting serum triacylglycerol \< 4.5 mmol/l * systolic blood pressure \< 160 mmhg and diastolic blood pressure \< 100 mmhg * stable body weight (weight gain or loss \< 3 kg in the past three months) * willingness to give up being a blood donor from 8 weeks before the start of the study, during the study and for 4 weeks after completion of the study * no difficult venipuncture as evidenced during the screening visit exclusion criteria: * smoking or smoking cessation \< 12 months * presence of diabetes mellitus * active cardiovascular disease like congestive heart failure or cardiovascular event * severe medical conditions, including asthma, chronic obstructive pulmonary disease (copd), kidney failure, auto-inflammatory diseases or rheumatoid arthritis * unstable body weight (weight gain or loss \> 3 kg in the past three months) * use of dietary supplements or medication affecting the main outcomes of the study * use of an investigational product within another biomedical intervention trial within the previous month * contra-indications for mri imaging (e.g., pacemaker, surgical clips/material in body, metal splinter in eye, claustrophobia) * left-handedness * familial hypercholesterolemia * abuse of drugs * more than 3 alcoholic consumptions per day * use medication to treat blood pressure, lipid or glucose metabolism
relevance of an adapted and supervised physical activity program in fibromyalgia patients. the fimouv 1 study.

Conditions: Fibromyalgia; Physical Activity

Summary: fibromyalgia affects 2 to 5% of adults in the general population. patients describe a combination of symptoms centred around fatigue not induced by exercise and not relieved by rest. the diagnosis of fibromyalgia is self-perpetuating by the deconditioning, consequence of a reduced muscle mass due to inactivity and periods of prolonged rest. thus, it seems fundamental to develop other non-drug approaches: among them, adapted physical activity is recommended by most learned societies because of a good level of evidence (level 1, grade a). the question remains, however, whether simple advice to resume physical activity is sufficient (routine care with medical assessment at 3 months) or whether a physical activity supervised inside and outside the hospital is not more relevant.


Eligibility criteria:
inclusion criteria: * patient lived in t loire (42) or haute-loire (43) * patient diagnosed with fibromyalgia according to acr (american college of rheumatology) criteria (total score wpi (widespread pain index) + ss (severity scale) ) ≥ 13 * french writing and speaking * sedentary or low level of activity (less than 2 hours of regular physical activity per week at the time of inclusion) * signature of informed consent exclusion criteria: * cardiac or respiratory diseases that contraindicate the practice of physical activity * significant co-morbidities that contraindicate the practice of physical activity: associated cardiac pathologies (severe rhythm disorders such as rapid atrial fibrillation), respiratory pathologies (severe obstructive or severe respiratory insufficiency), disabling joint pathologies (knee osteoarthritis or osteoarthritis of the hip) training on a treadmill or on a high intensity bike). * impossibility of submitting to the medical monitoring of the program for geographical, social or psychological reason

Keywords: sedentary time
gentamicin treatment prior to schwannoma surgery - residual function

Conditions: Vestibular Schwannoma

Summary: the purpose of the study is to determine whether vestibular and postural compensation following schwannoma surgery is improved by ablating remaining vestibular function prior to surgery, through gentamicin injections in the middle ear.

the residual function of the vestibular system before surgery differs considerably between patients, due to extent and influence of tumor growth, resulting in varying spectra of post-surgery illness as well as vestibular symptoms. an acute unilateral vestibular deafferentation (uvd) (if significant vestibular function remains prior to surgery) invariably results in severe nausea and vertigo. the nausea/vertigo induced by surgery and sudden uvd both can impede vestibular compensation processes and in extension, also the need for rehabilitation. the vestibular prehab protocol was developed in order to address this problem and to ensure an enhanced and sufficient rehabilitation. the protocol encompass treating patients that have measurable vestibular function before surgery with intratympanic gentamicin injections, thus producing gradually a uvd over a period of 3-4 weeks, whilst performing daily vestibular exercises before and after the gentamicin treatment. through this procedure the sensory trauma is separated from the surgical trauma, making it possible for vestibular compensation to ensue as the vestibular function gradually decline from gentamicin toxicity, unencumbered by any depression of central nervous function that might result from schwannoma surgery or the acute stages of an uvd.

Eligibility criteria:
inclusion criteria: * diagnosed with vestibular schwannoma and surgical treatment is advised * remaining vestibular function exclusion criteria: * impaired decision making * no remaining vestibular function * signs of central nervous dysfunction * neurofibromatosis * patients are advised not to participate in the gentamicin arm but encouraged to participate in the 'non-gentamicin' arm: * when hearing is better than 30decibel (db) i pure tone average (500, 1000, 2000, 3000/4000 hz) and speech discrimination better than 70% -when the neurosurgeon aim at hearing preservation surgery and do not want to risk gentamicin- associated hearing loss

Keywords: vestibular schwannoma acoustic neuroma cerebellopontine angle tumour gentamicin rehabilitation postural balance
sound check-correlation between transperineal and digital cervical exam in 3rd trimester pregnancy

Conditions: Cervix; Pregnancy

Summary: the primary purpose of this study is to compare the accuracy of the butterfly iq pocket ultrasound with the digital cervical examination in the third trimester cervix. the secondary aim of this study is to compare discomfort or the two cervical exam methods and determine if patients have a preference for one over the other.

patients in the 3rd trimester that require a digital cervical exam (dce) for assessment of labor will be approached. after informed consent is obtained, one of two study investigators will perform a transperineal ultrasound (tpus) using the glove-covered butterfly iq+ probe. the butterfly iq+ does not have a transperineal probe or setting, therefore, the "bladder" preset setting will be used. the "bladder" setting has been predetermined to provide the best cervical images. this pocket ultrasound is fda-approved and is the standard of care for point of care ultrasounds in many institutions and is already used in our department. the tpus will be performed by 1 of the 2 investigators with digital calipers. there will be 3 measurements: dilation, effacement, and station. the dilation measurements with be made from the inside margins of the cervix . effacement will be measured by marking the thinnest and most easily imaged lip of the cervix. zero station will be assumed to be 5 cm above the perineum, with distances from 6-10 cm corresponding to -1 to -5 station clinically. an independent, blinded examiner will then perform a traditional digital cervical exam, which will be recorded in epic. the study investigators will be blinded to the dce measurement until the end of the study. the patient will act as their own control. additionally, the investigators will collect ega, race, ethnicity, age, bmi, and indication for assessment of the cervix.

Eligibility criteria:
inclusion criteria: * pregnant women in the third trimester presenting for assessment of labor or admitted for labor and delivery. exclusion criteria: * second trimester (less than 28 weeks) * bmi\>50 * does not wish to participate

Keywords: transperineal ultrasound cervix labor