Kornimate/medical-research-clean huggingface dataset:
toluidine blue versus frozen sections for assessment of tumor margins in oral squamous cell carcinoma

Conditions: Oral Squamous Cell Carcinoma

Summary: the purpose of this study is to test the accuracy of toluidine blue in the assessment of intraoperative tumor margin after excision of oral squamous cell carcinoma(oscc)in comparison to h\&e stain on frozen section.

the incidence of oral cancer remains high, it is ranked to be the sixth most common cancer worldwide, oral squamous cell carcinoma represent more than 90% of all oral malignances. standard treatment for oral squamous cell carcinoma is surgical resection with free margin. negative margin status is an important for control local recurrence and improve outcome in squamous cell carcinoma of the head and neck. hematoxylin and eosin (h\&e) frozen section biopsy is useful tool for intraoperative assessment of resected margins and control of local recurrence, allowing for additional resection intraoperatively in case of positive margins. however in the least developed countries with limited resource, the frozen section is not available in a majority of centers, in addition to that if present in developed countries, it somewhat considered time and cost consumer. toluidine blue(tb) is metachromatic stain, easily available, economical, with high affinity for dna and rna. it is rapidly uptaken by malignant epithelium which contain quantitatively more nucleic acid than normal tissue. it has been widely used as screening tool for malignant and premalignant lesion. the purpose of this study is to test the accuracy of toluidine blue in the assessment of intraoperative tumor margin after excision of oral squamous cell carcinoma(oscc)in comparison to h\&e stain on frozen section.

Eligibility criteria:
inclusion criteria: * patient with biopsy-proven primary oral squamous cell carcinoma undergoing primary excision. exclusion criteria: * patients with prior history of head and neck malignancy * patients with non-squamous cell carcinoma. * patients with previously undergone treatment (surgery and/or radio-/ chemotherapy) for the current oral squamous cell carcinoma.

Keywords: oral squamous cell carcinoma toluidine blue frozen section tumor margin assessment
determinants of depression and its impact on quality of life in patients with chronic pancreatitis

Conditions: Chronic Pancreatitis; Depression; Quality of Life; Chronic Pain

Summary: chronic pancreatitis (cp) is associated with recurrent intractable abdominal pain, pancreatic exocrine insufficiency and endocrine dysfunction. very few studies had evaluated the quality of life in cp, and even a fewer have assessed the mental status in these patients. in the current study, we proposed to evaluate the the relationship between pain, quality of life and depression status in two large independent cohorts of patients with cp. we also proposed to evaluate the brain metabolites in the right and left anterior cingulate cortex, basal ganglia, hippocampus and prefrontal cortex using magnetic resonance spectroscopy. we further proposed to evaluate the pasta metabolites and look for associations with the mental state. finally, we proposed to evaluate how cp related education of the patients could impact on their mental status and response to interventions on pain.


Eligibility criteria:
a. inclusion criteria: * age 18-60yrs * both genders * documented cp for at least 3 years * capable and willing to provide informed consent b. exclusion criteria: * acute exacerbation of pancreatitis * pancreatic malignancy * on anti-depressant and antipsychotic medications * concomitant psychiatric illness (other than depression) * pancreatic malignancy * major co-morbidities * pregnancy and lactation
botulinum toxin treatment in craniofacial, inguinal, palmar, plantar and truncal hyperhidrosis

Conditions: Hyperhidrosis

Summary: hyperhidrosis is defined as excessive sweating and affects about 2.8 % of the population. it has been shown to have a deleterious effect on the quality of life measured using the dermatology life quality index (dlqi) which is one of the most widely used dermatology-specific quality of life instruments. this is comparable to the effect on quality of life in patients with severe psoriasis of the skin as well as to nodulocystic acne patients before treatment with oral isotretinoin. the clinical effect of botulinum toxin (btx) a has been established in three randomized controlled trials (rct) in axillary hyperhidrosis. one rct has indicated a positive effect in palmar hyperhidrosis. although there is increasing evidence that btx a and b have a similar effect on hyperhidrosis of other parts of the body (ie hyperhidrosis of the face, trunk, groin and feet) which is reported in case-reports and open studies there is still a great need for more controlled studies. this is why we will carry out this randomized, double-blind, placebo-controlled study to investigate the clinical effect and safety of btx a in palmar, plantar and inguinal (groins/buttocks) hyperhidrosis and the clinical effect and safety of btx b in craniofacial and truncal hyperhidrosis, respectively. besides using the dlqi instrument we will also study btx a/b to elucidate the impact of this treatment on quality of life using a generic instrument, the effect on anxiety and depressive symptoms, sweating, and patients´global assessment of therapy.


Eligibility criteria:
inclusion criteria: * informed consent received from patient * informed consent received from patient´s parents (when patient \< 18 years) * hyperhidrosis of the head, trunk, groins/buttocks, hands or feet * age \> 16 years * patients must be previously untreated with btx a/b * if female, patient is post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control (i.e. a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom\*) throughout the study. if male with a female partner of childbearing potential, willing to use an acceptable method of birth control for the study duration of the study, for both female and male, acceptable birth control must be used for at least 3 months after the last dose of study medication. \* a condom alone is not considered an acceptable method for birth control. two barrier methods only are not considered an acceptable method of birth control. * patients must have dlqi-score ≥ 10 and hdss-score ≥ 3 exclusion criteria: * contraindication to btx * use of aminoglycosides, tetracyclines , spectinomycin, lincomycin, polymyxin or muscle relaxants * pregnancy or lactation * patients unwilling to meet the requirements of the protocol * other medical or social reasons for exclusion at the discretion of the investigator

Keywords: palmar hyperhidrosis. plantar hyperhidrosis. inguinal (groins and buttocks) hyperhidrosis. craniofacial hyperhidrosis. truncal hyperhidrosis.
study of prx-03140 monotherapy in subjects with alzheimer's disease

Conditions: Alzheimer's Disease

Summary: a randomized placebo-controlled study to evaluate the efficacy of prx-03140 monotherapy in subjects with alzheimer's disease. the study consists of a 3-month double-blind treatment period and an optional 3-month extension period.


Eligibility criteria:
inclusion criteria: * men or women with a clinical diagnosis of probable ad * mmse score 16 to 24 inclusive * age \>50 and \<90 years * brain ct or mri scan consistent with a primary diagnosis of ad within 12 months * neurological examination without focal deficits (excluding changes attributable to peripheral nervous system disease, trauma or congenital birth deficits) * no history or evidence of any other cns disorder that could be interpreted as a cause of dementia * no diagnosis of vascular dementia * no history of significant psychiatric illness such as schizophrenia or bipolar affective disorder. subjects with major depressive disorder on a stable dose of an antidepressant for \>6 months may be eligible * no evidence of the following: current vitamin b12 deficiency, positive syphilis serology, positive hiv test, or abnormalities in thyroid function * no cognitive rehabilitation within 6 months of the study * subject has a regular caregiver willing to attend all study visits * signed informed consent by the subject (and legal guardian, if applicable) exclusion criteria: * no history of drug or alcohol abuse * no clinically significant laboratory abnormalities or medical history * no investigational drug within 30 days of randomization * intolerance or allergy to cholinesterase inhibitors * cannot have been on cholinesterase inhibitors for ad for \> 2 years * if have been on cholinesterase inhibitors for \ = 2 months prior to randomization * cannot have received memantine within 2 months * no clinically significant ecg abnormalities prior to randomization * no history of uncontrolled seizure disorder within 12 months * cannot be taking mao inhibitors, bupropion,fluoxetine, paroxetine, quinidine * no history of malignancy within 3 years of randomization * women cannot be pregnant or breastfeeding
effectiveness of a tele-rehabilitation evidence-based tablet app for rehabilitation in traumatic bone and soft injuries of the hand, wrist and fingers.

Conditions: Soft Tissue Injuries; Distal Radius Fracture; Metacarpal Fracture; Carpal Fracture; Carpal Tunnel Syndrome; Thumb Osteoarthritis; Dupuytren's Disease

Summary: trauma and soft injuries of the wrist, hand and fingers have a high incidence, and large social and healthcare costs are generated, mainly due to productivity loss. therapeutic exercises must be part of the treatment and in the last 10 years the scientific literature highlights the need for the inclusion of the sensorimotor system in both surgical and rehabilitative approaches. current methods as leaflets or videos lacks of adherence control, evolution control and knowledge of how the patient do the exercises which compromise the expected results. touch-screens of tablet devices have showed a large potential to cover these needs and for the retraining of sensorimotor system. rehand is a tablet digital tool (android and ios) to prescribe and monitor exercise programs based on sensorimotor approach and developed under the guidelines of various healthcare professionals (hand surgeons, physiotherapists, rehabilitators and occupational therapists) to implement home exercise programs and monitor patients. subjects are selected by emergency, hand surgery, rehabilitation and physiotherapy services of six hospitals from andalusian public health service through consecutive sampling. concretely, patients over 18 years of age with trauma and soft injuries of the wrist, hand and fingers, no more than 10 days after surgery or removal of immobilization. experimental group will receive access to rehand app to perform a monitored home exercises program. control group will receive the conventional method employed: a home exercise program in paper with recommendations. clinical variables will be assessed at baseline before group allocation, 4 weeks, 3 months and 6 months. at the end of the study, cost-utility variables will be analyzed.


Eligibility criteria:
inclusion criteria: * age over 18 * patients with trauma or soft tissue injuries of the wrist, hand and fingers. dupuytren, carpal tunnel syndrome, rizarthrosis, distal radius fracture, carpal fracture or metacarpal fracture. exclusion criteria: * neurological pathology that affects the upper limb. * non-cooperative. * psychiatric illness.
efficacy and safety study of roactemra (tocilizumab) in participants with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this is an open-label, non-interventional study to evaluate efficacy and safety in rheumatoid arthritis participants receiving tocilizumab as per the product label.


Eligibility criteria:
inclusion criteria: - participants with rheumatoid arthritis receiving tocilizumab as per product label exclusion criteria: - no specific exclusion criteria were specified for this non-interventional trial

Keywords: rheumatoid arthritis roactemra tocilizumab
retinal neurodegeneration in type 2 diabetes mellitus detected by optical coherence tomography

Conditions: Retinal Neuropathy; Neurodegeneration

Summary: evaluation of retinal neurodegeneration in patients with type 2 diabetes mellitus (dm2) without diabetic retinopathy or with mild non proliferative diabetic retinopathy

retinal complications in diabetes mellitus (dm) patients were typically considered part of a vascular process. however, recent studies suggest that ocular degeneration in dm might be caused by 2 different conditions: vasculopathy and neuropathy . for some authors, neuropathy observed in the retina of dm patients might be a part of an underlying polyneuropathy ; for others, however, neuropathic changes might precede microvascular alterations . axons of retinal ganglion cells compose the retinal nerve fiber layer (rnfl) in the retina and then form the optic nerve connecting the eyeball and brain. retinal nerve fiber layer (rnfl) loss is recognized as an important neurodegenerative sign in glaucoma. thinning of the rnfl has also been found in multiple sclerosis, parkinson's disease and alzheimer's disease, indicating neurodegeneration of the retina. if rnfl thinning is significant in diabetic patients with preclinical diabetic retinopathy, evaluation of peripapillary rnfl thickness would be very important, because early detection and treatment of diabetic retinopathy is critical to reduce the risk of blindness optical coherence tomography (oct) has been introduced into clinical practice as the most noninvasive and objective method to visualize the retina, showing an amount of detail that resembles histological specimens. initially, oct was applied to detect complications of dr (edema macular or epiretinal membrane). later on, it allowed quantitative and qualitative measurements of retinal thickness and segmentation of all intraretinal layers. oct might detect early retinal neurodegenerative changes, and thus help define which diabetic patients may be at risk to develop dr.

Eligibility criteria:
inclusion criteria: * all patients with confirmed type 2 dm diagnosis of at least 6 months * best-corrected visual acuity (bcva) of 6/12 or higher (using a snellen chart) in each eye * intraocular pressure (by applanation) less than 21 mmhg. * healthy controls had no record nor evidence of ocular or neurologic disease of any kind; their bcva is \> 6/9 based on the snellen scale. exclusion criteria: * presence or past history of moderate or severe non proliferative diabetic retinopathy or proliferative diabetic retinopathy , confirmed by indirect funduscopy or retinography images. * presence of significant refractive errors (≥5 diopters of spherical equivalent refraction or 3 diopters of astigmatism) * intraocular pressure ≥21 mmhg * media opacifications * concomitant ocular diseases, including history of glaucoma or retinal pathology * systemic conditions that could affect the visual system, including neurodegenerative disorders such as parkinson's disease, multiple sclerosis, or dementia.
be study of albuterol sulfate inhalation aerosol 90 mcg per actuation in patients with stable mild asthma

Conditions: Bronchial Asthma

Summary: the purpose of this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product, using bronchoprovocation (methacholine challenge testing) in adult patients with stable mild asthma.

this study is to demonstrate the pharmacodynamic bioequivalence of the test product to the reference product in terms of fev1 measured at different time-points, using bronchoprovocation (methacholine challenge testing) in adult patients with stable mild asthma.

Eligibility criteria:
inclusion criteria: 1. subject must have a ≥6-months diagnosis of stable mild asthma based on national asthma education and prevention program expert panel report 3 (naepp epr3) guidelines (naepp epr3, 2007) 2. subject must demonstrate an fev1 ≥1.5l and ≥80% of predicted based on nhanes iii predicted values at the pre-challenge/pre-saline stage of the first screening mbpc a. if a subject's fev1 at the pre-challenge (baseline/pre-saline) spirometry is \<80%, but ≥70%, the screening visit may be rescheduled one time (visit must take place within 7 days) 3. subject must demonstrate airway responsiveness to methacholine at baseline (pre-albuterol dose) pc20 at ≤8 mg/ml concentration of methacholine (equivalent to pd20 of ≤513 µg) at the first screening mbpc 4. subject must have a bmi of ≥18 kg/m2 and ≤35 kg/m2 at screening. exclusion criteria: 1. subject has a fall in fev1 at the saline stage ≥10% at the screening mbpc. 2. subject having fev1 of less than 1.5l at pre-challenge or saline stage of mbpc at any visit. no re-screening/re-scheduling is allowed for such subjects. -
endocrown restorations longevity compared with post retained restorations

Conditions: Endodontically Treated Teeth

Summary: caries disease is still the leading cause of severe tooth decay. since this can lead to tooth loss, it is important that appropriate treatment is advised to help prevent damage and maintain tooth health. faced with major coronary destruction, several times it becomes necessary to perform the endodontic treatment, aiming to maintain the element in the buccal cavity for longer. it is known that an excellent restorative treatment with poor endodontic treatment and the inverse has a direct impact on the (in) success of the treatment. in this context, the proper cleaning of the root canals is highlighted, aiming the removal of bacteria and toxins. acceptable restorations are those that provide adequate reestablishment of anatomy, function, proximal contacts, and occlusal stability. traditionally, indirect restorations would be indicated in cases of extensive coronary destruction, because it was believed that they would present greater resistance and longevity when compared to direct restorations. however, contemporary dentistry admits that, thanks to adhesive and conservative principles, this difference between direct and indirect procedures in terms of longevity is not significant. the classic restorative procedure in cases of endodontically treated teeth with great loss of coronary structure involves the use of intraradicular retainers, followed by the creation of core and restoration through total crowns. removal of healthy tissue for the use of posts can weaken the remaining dental structure and increase the risk of root perforations. in this sense, endocrown restorations show superiority when compared to those made with intraradicular retainers. although the indications are favorable for the use of endocrown restorations, the clinical evidence available on the subject is still scarce. in this double-blind randomized clinical trial, patients who need and meet the inclusion criteria will will be allocated to one of the three restorative groups available, being endocrown restoration in semi-direct composite resin, direct restoration in composite resin retained on the post and ceramic crown retained in the post. patients will be monitored annually after completion of restorative treatment outcome. in addition to treatment longevity, other secondary outcomes will be evaluated, such as patient satisfaction, impact on quality of life and cost-effectiveness of the proposed treatments.


Eligibility criteria:
inclusion criteria: * 18 years old or more; * healthy volunteers; * molars or premolars with endodontic treatment and large coronal destruction; * at least 20 teeth; exclusion criteria: * abutment of removable partial denture ; * tooth with mobility higher than 1; * more than 1/2 bone loss height;
is one pass enough for the diagnosis of the pancreatic masses during eus-fnb?

Conditions: Pancreatic Cancer

Summary: endoscopic ultrasonography (eus) with tissue acquisition (ta) is nowadays a well-established technique for the sampling of solid lesions pancreatic and non-pancreatic lesions. major complications after eus-ta of solid masses are rare. several studies have been published in the last recent years aimed to identify factors related to a non-diagnostic or false-negative eus-fna, and to improve its diagnostic yield using different needle gauge and different tissue acquisition technique as fanning technique, slow-pull stylet extraction or suction technique. to overcome this problem, new eus-ta needles entered in clinical practice to obtain histological specimens increasing the accuracy of the eus-ta. preliminary result with these new needles, called eus-fine needle biopsy (fnb) are promising with an accuracy rate more than 90%. recently, leungh et al. conducted an observational study to evaluate the role of macroscopic on-site evaluation (mose) on the diagnostic accuracy of 22g franseen-tip needle. the study demonstrated that mose using the 22g franseen tip needle could limit needle passes by accurately estimating histologic core fragments. however, the study limitations such as the small sample size and the lack of control group, hampered the value of the conclusions. so, nowadays, no definitive data regarding how many needle passes need to be performed with fnb needles, neither regarding the use of mose to evaluate the specimens obtained with fnb needle. the mose technique of the acquired tissue was proposed for the first time by iwashita et al, using a 19g needle and is nowadays a well-established technique with high accuracy in the final diagnosis. the aim of our study is to evaluate if during eus-fnb of pancreatic masses only one needle pass with mose evaluation can be satisfactory to obtain a correct diagnosis.


Eligibility criteria:
inclusion criteria: * age greater than 18, both genders. * both in-patient and out-patients. * presence of a solid lesion. in the presence of a cystic component, the solid part of the lesion should be more 75% of the total. * fnb performed by a 22g needle acquire® (boston scientific). * tissue acquisition with fanning technique. * able to obtained informed consent. exclusion criteria: * patients underwent eus-fna with or without rose * patients underwent eus-fnb plus rose. * previous biopsy of the lesion with diagnosis of malignancy * presence of an uncorrectable coagulopathy as defined by abnormal prothrombin time (pt) or partial thromboplastin time (ptt) that does not normalize after administration of fresh frozen plasma. * pregnancy or breast-feeding. * patients unable to understand and/or read the consent form.
single-anastomosis duodeno-ileal bypass with sleeve gastrectomy (sadi-s) for the treatment of morbid obesity and its metabolic complications

Conditions: Morbid Obesity; Diabetes

Summary: single-anastomosis duodeno-ileal bypass with sleeve gastrectomy is a modified and simplified duodenal switch. it is performed on morbid obese patients and severe t2dm patients with obesity, and a proper weight loss is expected as well as a decrease in the cardiac risk and a remission of t2dm. a lower complication rate than for duodenal switch is expected.

a sleeve gastrectomy over a wide bougie is performed. then the proximal duodenum is divided and anastomosed to the ileum 250 cm from the cecum. the preoperative studies and postoperative follow up is similar to those performed before and after other bariatric procedures.

Eligibility criteria:
inclusion criteria: * bmi \> 30 with t2dm or bmi \> 40 exclusion criteria: * oncologic patients, alcoholic patients, mentally retarded

Keywords: morbid obesity duodenal switch diabetes decrease in cardiac risk remission of t2dm
effects of nintendo wii balance board in children with cerebral palsy

Conditions: Balance Problem; Cerebral Palsy

Summary: i wan to check the effects of nintendo wii balance board therapy in children with cp.

evaluate the effects of nintendo wii balance board therapy in combination with conventional physical therapy.

Eligibility criteria:
inclusion criteria: * children with age of 7-14 years. no history of falls. children able to stand independently. delays in gait development. exclusion criteria: * children with hemiplegic cp. comorbidities. children with lower limb contractures. hearing disorders. children with epilepsy.