Kornimate/medical-research-clean huggingface dataset:
conventional bite wing radiography versus stationary intraoral tomosynthesis, a comparison study

Conditions: Dental Caries

Summary: a comparison of caries detection rates between conventional intraoral bitewing radiography and a stationary intraoral digital tomosynthesis (s-iot) using a carbon nanotube x-ray source array. the secondary objective is to assess participants experience with the s-iot device.

the primary purpose of this study is to compare caries detection rates between conventional intraoral bitewing radiography and a stationary intraoral digital tomosynthesis (s-iot) using a carbon nanotube x-ray source array. patient experience with the s-iot device will be assess using a short questionnaire. fifty adult patients who have been referred to the section of oral and maxillofacial radiology (omr) at the university of north carolina (unc) school of dentistry (sod) for horizontal bitewing (bw) radiographs or a full mouth series (fmx) with horizontal bitewing radiographs will be recruited for the study. participants will receive an experimental s-iot bitewing radiograph on each side of their mouth and a visual exam to look for caries. experienced observers will assess the presence or absence of caries using the two imaging modalities. the results of their analysis will be evaluated to determine statistical difference. participants completed questionnaires will be tabulated and the data will be analyzed using descriptive statistics.

Eligibility criteria:
inclusion criteria: * 18 years and older * scheduled for horizontal bw or full (fmx) with horizontal bws * patients who have in the right and left maxilla and mandible at least a canine and two posterior teeth that are in contact * at least one proximal caries lesion in a surface of a posterior tooth (premolar or molar) that is in contact with another tooth. lesion depth can be incipient (outer half enamel), moderate (inner half enamel) or advanced (outer half dentin) as determined by conventional bw radiography. * at least one non-carious proximal surface of a posterior tooth (premolar or molar) that is in contact with another tooth. * patients should be able to provide informed consent exclusion criteria: * institutionalized subject (prisoners, nursing home, etc.) (identified by medical record) * critically ill or mentally unstable patients (identified by medical record) * patients with no radiographic caries of the posterior teeth as determined by conventional bw radiographs * patients with only severe caries lesions as determined by conventional bw radiographs
perioperative intravenous lidocaine in liver surgery

Conditions: Liver Metastases; Liver Cancer; Postoperative Pain; Opioid Use

Summary: this is a randomized double blinded placebo-controlled study, conducted in lund, sweden. patients will be randomized in two groups, with a ratio of 1:1. the experimental arm will receive intravenous lidocaine perioperatively, and the control arm will receive placebo, i.e. normal saline. postoperative both arms will get routine pain control with pca, patient controlled analgesia with an intravenous oxycodone-infusion. outcome-measures will include patients pain intensity scoring, and opioid consumption.

patientes will be randozied in blocks of eight. the experimental arm will receive a bolus of 1,5mg/kg before induction of anesthesia, immediately followed by an infusion of 1,5mg/kg/h until 1 hour post surgery. the placebo arm will receive the same amount of normal saline instead. pain intensity scoring, measured by numerical rating scale, nrs, will be conducted at 1, 2, 4 hour postoperatively, and each morning and night until discharge, or for a maximum 5 days.

Eligibility criteria:
inclusion criteria: * age 18 yy * patient planned for minor hepatectomy * signed informed consent exclusion criteria: * pregnancy * cirrosis * asa\>3 * elevated liver enzymes * av-block \>1, without pacemaker * who class \>2 * allergy against lidocain or other amid-type local anasthesia * heart failure * epilepsy * treatment with class iii anti-arythimic medication * preoperative ongoing opioid usage * use of : erythromycin, clarithromycin, fluvoxamine, cimetidine, ciprofloxacin, antivirala-hiv-läkemedel or imidazol the week before surgery.

Keywords: liver surgery postoperative pain lidocaine opioid use
impact of eus guided treatment of gastric varices

Conditions: Gastric Varices Bleeding

Summary: the purpose of the study is to determine the clinical impact of cyanoacrylate tissue adhesive treatment for gastric varices performed by indiana university eus physicians.

using an irb approved database (iu irb#1209009522; nct02037659), data collected from the database will be evaluated to identify complications, risk of rebleeding, death within 1 year of treatment, varices eradication and need for re-intervention associated with cyanoacrylate tissue adhesive (dermabond) treatment performed by indiana university endoscopic ultrasound (eus) physicians.

Eligibility criteria:
inclusion criteria: * any subject enrolled into the existing database (iu irb#1209009522; nct02037659). exclusion criteria: * not enrolled into the database.
efficacy & safety of symbicort® turbuhaler® 160/4.5 µg twice daily & pulmicort® turbuhaler® 200 µg twice daily + theolong® tablet 200 mg twice daily in japanese asthmatic patients

Conditions: Asthma

Summary: the primary objective of this study is to confirm the efficacy (superiority) of symbicort® turbuhaler® 160/4.5 µg twice daily for 8 weeks in comparison to pulmicort® turbuhaler® 200 µg twice daily + theolong® tablet 200 mg twice daily.


Eligibility criteria:
inclusion criteria: * diagnosis of asthma with a documented history of at least 6 months duration prior to visit 1 * prescribed daily use of an igcs for \>=12 weeks prior to visit 1. the dose of igcs must be 400 to 800 µg/day of pulmicort® turbuhaler® or corresponding dose of igcs. the prescribed dose of igcs should be constant for at least 4 weeks prior to visit 1 * prescribed daily use of sustained release theophylline for at least 8 weeks prior to visit 1, or confirmed steady-state blood theophylline concentrations within the effective range (5-15 µg/ml) during 8 weeks prior to visit 1. the prescribed dose of theophylline should be constant (400 mg/day) for at least 4 weeks prior to visit 1 exclusion criteria: * any significant disease or disorder that may jeopardize the safety of the patient * respiratory infection, judged by the investigator(s) as an infection affecting the asthma, within 4 weeks prior to visit 1 * treatment with oral, parenteral or rectal gcs within 4 weeks prior to visit 1 additional inclusion and exclusion criteria will be evaluated by the investigator

Keywords: asthma
post-covid-health study: multidimensional health status of covid-19 survivors one year after a sars-cov-2 infection

Conditions: Covid19

Summary: this study assesses the multidimensional health status of covid-19 survivors one-year post-infection using validated subjective and objective measures.

rationale: within the netherlands, more than 1 million people have been infected with sars-cov-2, also known as covid-19. although the mortality rate is considerable, the vast majority of covid-19 patients survive the infection. preliminary findings show that a majority of covid-19 survivors still experience health problems 3 months after the infection, including reduced lung diffusion capacity, low exercise capacity, muscle weakness, mental problems and reduced cognitive function resulting in a generally poor health status. whether these health consequences persist on the long-term is unknown. objective: to assess the multidimensional health status of covid-19 survivors one-year post-infection using validated subjective and objective measures. study design: a multicenter prospective observational study performed within the mumc+ and viecuri medical center. study population: 200 covid-19 survivors of the mumc+, viecuri medical center or zuyderland medical center, both hospitalized (icu and non-icu admitted) as well as non-hospitalized patients. main study parameters/endpoints: outcome parameters include objectively and subjectively measured multidimensional health outcomes including physiological and metabolic health, physical capability, cognitive function, psychosocial well-being, social well-being, patient reported outcomes as well as potential determinants of these multidimensional health outcomes (e.g. treatment during/after sars-cov-2 infection, vaccination, comorbidities, medication use etc.). outcomes will be measured during a one-day study visit. nature and extent of the burden and risks associated with participation, benefit and group relatedness: subjects will benefit from participating within this study, because their general health will be evaluated in detail and from a multidimensional perspective. furthermore, subjects will be informed on their multidimensional health outcomes and will receive a lifestyle advice tailored to their health status. risks and inconveniences are limited to the time investment associated with the completion of the questionnaires and the study visit. during the study visit various non-invasive measurements as well as minor invasive blood sampling will be performed.

Eligibility criteria:
inclusion criteria: * covid-19 positive based on: * confirmed rt-pcr; * proven serology for sars-cov-2 with clearly associated complaints for a sars-cov-2 infection; * co-rads score of 4 or more with a proven serology for sars-cov-2 afterwards. * age of ≥18 years; * able to provide informed consent; * understanding of dutch language. exclusion criteria: * patients not willing to participate; * investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements.

Keywords: multidimensional health covid-19 long-term consequences
[18f]-fluoro-2-deoxy-d-glucose and -[18f] dihydro-testosterone pet imaging in patients with progressive prostate cancer

Conditions: Prostate Cancer

Summary: this study will use pet scans, which is a type of x-ray test that uses a radiotracer, to see whether these scans may be better able to find places in the body where your prostate cancer may have spread.

our preliminary studies have shown that whole body fdg-pet imaging identifies areas of abnormal metabolism in a majority of tumor sites in patients with progressive disease and that changes in fdg accumulation parallel changes in psa after treatment. this suggests that changes in fdg metabolism may provide an early assessment of treatment outcomes. in previous work we established a methodology to examine a radiotracer in patients with progressive disease and abnormal imaging studies, which we have applied to the clinical states of non-castrate and castrate metastatic disease. this design is characterized by: 1) evaluation of uptake on a site-by-site basis in relation to conventional studies 2) standardization of uptake values in tumor relative to a normal organ 3) controlling for progression using standard measures of progression including a rising psa, new or enlarging lesions on bone or transaxial imaging, and new symptoms of disease. in the present study we are evaluating fluorinated dihydrotestosterone (fdht) in addition to fdg. fdht is targeted to the ar and has been shown in preliminary studies to visualize prostate cancers in man. this study will apply our established methods to investigate fdht imaging in patients with progressive prostate cancer. in the selected cases where tumor is available, we will study associations between fdht accumulation and ar expression.

Eligibility criteria:
inclusion criteria: * patients with histologically confirmed prostate cancer. * progressive disease manifest by either: * imaging modalities: * bone imaging: new osseous lesions on bone imaging (bone scintigraphy or naf pet scan) and/or mri or ct: an increase in measurable soft tissue disease, or the appearance of new sites of disease. or * biochemical progression: a minimum of three rising psa values from a baseline that are obtained 1 week or more apart, or 2 measurements 2 or more weeks apart. * visible lesions by either ct, bone imaging, or mri consistent with disease. * informed consent. exclusion criteria: * previous anaphylactic reaction to either fdht or fdg * hepatic: bilirubin \> 1.5 x upper limit of normal (uln), ast/alt \>2.5 x uln, albumin \ 2.5 x uln if alkaline phosphatase \> 2.5 x uln * renal: creatinine \>1.5 x uln or creatinine clearance \< 60 ml/min

Keywords: progressive prostate cancer [18f]-fluoro-2-deoxy-d-glucose [18f] dihydro-testosterone pet imaging pet scan 00-095
total knee arthroplasty with vitamin e polyethylene

Conditions: Knee Osteoarthritis

Summary: the aim of this observational study is to investigate if there is any difference in survival rate, clinical and radiological results after total knee replacement with vitamin e-blended polyethylene in comparison to conventional polyethylene at minimum 7-year follow-up


Eligibility criteria:
inclusion criteria: * patient who received primary cemented total knee arthroplasty with gks prime flex mobile knee by permedica orthopaedics with vitamin e polyethylene bearing or with conventional polyethylene bearing. * minimum 7-year follow-up; * age ≥ 18 and \< 85 years; * patient who signed informed consent. exclusion criteria: * patient who received primary cemented total knee arthroplasty with a different knee prosthetic design; * patient already enrolled in other clinical studies.

Keywords: total knee arthroplasty vitamin e polyethylene aseptic loosening osteolysis
effect of perioperative gabapentin on postoperative opioid requirements

Conditions: Postoperative Pain

Summary: the purpose of this study is to determine if preoperative gabapentin is noninferior to preoperative and postoperative gabapentin for pain control in patients undergoing surgery for pelvic organ prolapse.


Eligibility criteria:
inclusion criteria: * women \> 18 years old * english-speaking * stage \> 2 pelvic organ prolapse * undergoing pelvic organ prolapse procedure (including native tissue vaginal procedure, native tissue laparoscopic procedure, mesh-augmented laparoscopic procedure, obliterative procedure) * planning overnight stay exclusion criteria: * renal dysfunction (creatinine clearance \<60 ml/min) * allergy to acetaminophen and ibuprofen * allergy to gabapentin * patients on a controlled substance agreement or opioid contract from another provider. this information is available in the iu health electronic medical record, cerner.
synera™ for epidural needle insertion

Conditions: Pain Associated With Epidural Needle Insertion

Summary: we hypothesized that the analgesic effect of synera™ analgesic patch would be superior to traditional infiltration with lidocaine for pain of epidural needle insertion in laboring parturients.


Eligibility criteria:
inclusion criteria: * older than 18 years, body mass index less than 45 kg•m-2, requesting a labor epidural exclusion criteria: * hypersensitivity to any study medications
a study comparing combination clindamycin phosphate/tretinoin gel alone versus with benzoyl peroxide foaming cloths for facial acne

Conditions: Acne Vulgaris

Summary: there are many different factors that cause acne. so combination treatment using different medications that can address these different factors is commonly used to treat acne. fixed-dose combination clindamycin phosphate 1.2% and tretinoin 0.025% gel and benzoyl peroxide 6% foaming cloths are both used to treat acne. this study will evaluate the use of the medications when used together.


Eligibility criteria:
inclusion criteria: * males and females ≥ 12 years old. * subjects must be in good general health as confirmed by medical history and physical examination. * females of child-bearing potential must have a negative urine pregnancy test at the baseline visit and agree to use adequate birth control during the study (barrier, oral, injection, intrauterine or abstinence). * clear diagnosis of facial acne vulgaris for at least 3 months. * subject must have a static physician's global assessment (pga) of at least 2 (mild severity), but no more than 4. * disease must be stable or slowly worsening for more than one week prior to entering the study. * subjects or their guardians must be able to read, sign, and date the informed consent, and abide by study restrictions for its duration. exclusion criteria: * females who are pregnant, attempting to conceive, or breastfeeding. * subjects with known hypersensitivity to study drug. * subjects with very severe acne (pga score of 5) * subjects with overt signs of skin atrophy, telangiectasias or other skin findings that would affect efficacy evaluation. * subjects with a current active skin malignancy or infection. * subjects requiring the use of medications known to alter the course of acne vulgaris during the study treatment. * subjects who have received systemic antibiotics within 2 weeks. * subjects using systemic corticosteroids or immunosuppressants within 28 days of entering the study. * subjects who have received any topical therapies for acne vulgaris within 2 weeks of entering the study. * subjects taking birth control pills for less than 3 months or solely for the prevention of acne. * subjects who are currently participating in or, within the previous 28 days, have participated in another study for the treatment of acne vulgaris. * subjects with clinical conditions that may post a health risk to the subject by being involved in the study or detrimentally affect regular follow-up of the subject.

Keywords: acne vulgaris
selenoprotein p and non-alcoholic fatty liver disease

Conditions: Non-alcoholic Fatty Liver Disease; Insulin Resistance

Summary: the pathogenesis of nonalcoholic fatty liver disease has not been fully elucidated. the most widely supported theory implicates insulin resistance as the key mechanism leading to hepatic steatosis, and perhaps also to steatohepatitis. selenoprotein p(sep) is a secretory protein primarily produced by the liver. previous studies demonstrated that sep, a liver-derived secretory protein, causes insulin resistance. therefore, the purpose of this study is to determine the different sep levels between healthy normal group and nafld group.

nonalcoholic fatty liver disease (nafld), a disease spectrum that includes simple steatosis, nonalcoholic steatohepatitis (nash) and cirrhosis, has been increasingly recognized as the hepatic manifestation of metabolic syndrome. both inflammation and insulin resistance are considered to be pivotal pathogenic mechanisms of nafld, as well as metabolic syndrome, type 2 diabetes, and atherosclerosis. there is mounting evidence implicating adipokines secreted from adipose tissue in the pathogenesis and progression of nafld, in addition to the development of insulin resistance and inflammation. selenoprotein p (sep) has recently been reported as a novel hepatokine that regulates insulin resistance and systemic energy metabolism in rodents and humans. although previous studies have shown a close relationship among insulin resistance, inflammation, and nafld, as far as we know, there is no previous report evaluating the association between sep and nafld. in the present study, we examined serum sep levels in subjects with increased visceral fat area (vfa) or liver fat accumulation measured with computed tomography (ct). we evaluated the relationship between sep levels and cardiometabolic risk factors.

Eligibility criteria:
inclusion criteria: * healthy volunteers for visiting routine medical check in our clinic exclusion criteria: * history of cardiovascular disease(myocardial infarction, unstable angina, or cardiovascular revascularization) * diabetes * hypertension * malignancy * severe renal or hepatic disease * subjects taking medications that might affect body weight or body composition
comparison of vasopressin and other pressors in septic shock

Conditions: Shock, Septic

Summary: the purpose of this study is to compare the classical tactics in the treatment of septic shock (dopamine, noradrenalin and dobutamine) to the use of vasopressin as first choice pressor. vasopressin seems to be an interesting alternative in the treatment of septic shock. to this date, available studies have showed that it could correct hyperkinetic syndrome and vasoplegia in septic shocks without noticeable side effect. it as been demonstrated that vasopressin improves renal function, as no effect on digestive organs and as no metabolic effect.


Eligibility criteria:
inclusion criteria: * legally major patient presenting a septic shock. the time window between beginning of symptoms and onset of treatment is established at 12 hours. the patient must be intubated and mechanically ventilated. patient presenting a mean arterial blood pressure of less than 60 mm hg after adequate fluid resuscitation (at least 1 l of colloid or crystalloid) and 10 ug/kg/min of dopamine. patient presenting a cardiac index of at least 3 l/min/m2 exclusion criteria: * shock other than septic * cardiac hypokinesia * a pre-existing organic renal failure that needs hemodyalisis * oesophagal or gastric phatology that would lead to a naso-gastric tube contraindication

Keywords: septic shock catecholamine vasopressin tonometria lactate
axis(tm) solvent-dehydrate dermal allograft in the treatment of pelvic organ prolapse.

Conditions: Pelvic Organ Prolapse

Summary: the goal of this study is to assess improvement in subjects who have undergone axis dermis, biologic mesh for pelvic organ prolapse repair. \[describe participant population/health conditions\]. the main question\[s\] it aims to answer are: * is the leading edge of the prolapse above the hymen * does subject notice a bulge participants will undergo axis dermis pelvic organ prolapse repair procedure.

this is a prospective single-arm study of 50 subjects undergoing pelvic organ prolapse repair using the axis™ dermis biologic mesh. they will be followed for a period of 3 years. a subgroup analysis is for patients with uterine prolapse and vaginal mesh hysteropexy. clinical examination including vaginal wall retraction with or without pelvic ultrasound, pop-q, and also specific validated questionnaires at baseline, 1 month, 6 month, 12 month, 24 month and 36 month visits will be assessed.

Eligibility criteria:
inclusion criteria: * subjects with preoperative stage ii or greater prolapse on the pelvic organ prolapse quantification system assessment (pop-q) * subjects who have bothersome vaginal bulge based upon symptoms. * subjects who undergo any type of axis dermis surgery (anterior, posterior, total, with or without a uterus). exclusion criteria: * subjects who are unable to follow-up. * subjects who cannot complete the validated questionnaires. * subjects that lack competency of the english language. * subjects who decline to be part of the clinical trial. * subjects who do not sign an informed consent.