Kornimate/medical-research-clean huggingface dataset:
differential mobility spectrometry (dms) based skin tumor analysis

Conditions: Basal Cell Carcinoma

Summary: the trial is a single-center, non-randomized feasibility study aiming to evaluate the feasibility of ex-vivo tissue analysis using differential mobility spectrometry (dms) of tissue smoke generated by the use of an electrosurgical instrument. patients recruited in the trial receive standard-of-care basal cell carcinoma tumor excision surgery.

basal cell carcinoma (bcc) is the most common cancer in caucasians and the average risk of developing bcc is approximately 30% (1,2). in finland, bcc is the most common cancer and the incidence of bcc is approximately 49/100 000 in men and 45/100 000 in women (3). there are several types of bcc (4) of which superficial type can be managed with non-operative treatment. all the other types of bcc (micronodular, nodular, infiltrative) require operative treatment which means surgical removal of the tumor with a few millimeters healthy skin margin (5). the aim of the operative treatment is to remove the tumor entirely so that the healthy skin margins are as sparing as possible and that the functional and cosmetic outcomes are as satisfactory as possible. margin positiveness leads to one or more reoperations which increase the risk of surgical complications. differential mobility spectrometry (dms) based application called automatic tissue analysis (atas) can be utilized to identify tumor cells from healthy tissue. tissue identification is done by analyzing tissue smoke that is generated by the use of an electrosurgical instrument called diathermy (6,7). the objective of the trial is to test whether it is possible to identify bcc from normal skin by using atas. a 4mm punch biopsy of bcc tumor and a control biopsy of healthy skin will be collected from 30 - 40 patients undergoing bcc tumor excision. the biopsies will be examined in the research laboratory with atas to test tissue recognition.

Eligibility criteria:
inclusion criteria: * punch biopsy diagnosed basal cell carcinoma. * tumor diameter of 1,5 cm or larger. * operable patient that is willing to participate in the trial. exclusion criteria: * tumor diameter of less than 1,5 cm. * patient that is unsuitable to take part in the trial, for example, has a tendency to develop keloids. * patient that is unwilling to take part in the trial. * patient that is not able to understand given information concerning the trial or to give consent to take part in the trial.

Keywords: basal cell carcinoma (bcc) differential mobility spectrometry (dms) automatic tissue analysis (atas)
a preemptive epidural ropivacaine for postoperative pain relief in degenerative lumbar spine surgery

Conditions: Postoperative Pain

Summary: this prospective randomized study aims to evaluate the effectiveness of epidural injection of ropivacaine on the relief of pain in patients undergoing laminectomy. total 60 patients will be randomized into one of two groups (groupc or groupi) based on excel number generation. patients in group c will receive no medication intraoperatively, and patients in group i will receive epidural injection of 0.1% ropivacaine 10ml before skin incision. visual analogue scale pain scores, fentanyl consumption and the frequency at which patients pushed the button (fpb) of a patient-controlled analgesia system will be recorded at 4,12,24,48 hour postoperatively.

patients in group i will receive 0.1% ropivacaine 10 ml before skin incision under guide of c-arm.

Eligibility criteria:
inclusion criteria: * laminectomy exclusion criteria: * r/o infection * reoperation * mental change * allergy to local anesthetics

Keywords: pain preemptive postoperative epidural injection laminectomy
treatment for chronic spinal cord injury: surgery with rehabilitation vs rehabilitation

Conditions: Spinal Cord Injuries

Summary: the purpose of this study is to investigate the efficacy of surgical decompression/untethering, combined with weight bearing rehabilitation, on neurological recovery following chronic spinal cord injury.

safety issues: safety issues need to be watched are: occurrence of known and unknown undesirable incidences, moving up injury levels, loss of previously preserved neurological functions, vital physical signs, and worsening of ekg and lab results. if unforeseen issues occur, patients will be consulted to determine whether treatments will be continued. adverse events: adverse events may occur during the trail and these events will be recorded. the severity of the events and their relationship to the experimental therapy will be determined, documented and reported to the data monitoring and safety committee who will determine how these events will be handled if they occur.

Eligibility criteria:
inclusion criteria: * male or female adult subjects, 18-60 years of age * have a clinical diagnosis of chronic spinal cord injury (≥ 12 months after traumatic spinal cord injury). * neurological examination: asia-a * injury levels: t1-t12 spinal levels * the diagnosis of spinal cord injury is confirmed by mri * subjects must be able to read, write and complete visual analogue scale * voluntarily signs and dates an informed consent form, approved by an institutional review board (irb)/independent ethics committee (iec), prior to any study-specific procedures. if a subject consents to participation but is not in a position to personally sign and date the informed consent form because of his or her physical condition, the consent must be confirmed at the time of consent orally, signed on behalf by the subject's relative, and by an impartial witness who is present throughout the whole informed consent process. exclusion criteria: * severe head injury * subjects with severe osteoporosis or joint diseases * subjects with severe pressure sore * sign of kidney, cardiovascular, liver disorders * subjects with internal medical and/or infectious diseases (including but not limited to hepatitis b and hiv carriers) * pregnant women or women at lactation stages * medically or mentally unstable according to the judgment of the investigator * history of multiple sclerosis or peripheral demyelination * any criteria which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol

Keywords: spinal cord injury kunming locomotor scale surgical decompression untethering weight bearing rehabilitation
an extension study of v203-ad study to evaluate the safety, tolerability, immunogenicity, and efficacy of ub-311

Conditions: Alzheimer's Disease

Summary: to evaluate the long-term safety, tolerability and potential efficacy, patients who previously participated in v203-ad study (nct02551809) will be eligible to participate in the extension study and will receive 3 or 5 doses of ub-311 within a 96-week treatment period followed by a 12-week follow-up period.


Eligibility criteria:
inclusion criteria: * patients who participated in v203-ad trial without major safety concerns; * stable doses of permitted medications for 3 months before screening; * with a caregiver; * other inclusion criteria apply exclusion criteria: * clinically significant neurological disease other than alzheimer's disease * major psychiatric disorder * severe systemic disease * serious adverse reactions to any vaccine * other exclusion criteria apply
clinical application study of pet/ct for differential diagnosis of non-small cell lung cancer

Conditions: Lung Cancer; Lung Diseases; Lung Neoplasms; Lung Cancer Metastatic; Lung Inflammation

Summary: this study aims to explore the efficacy of trop2, epcam-specific pet/ct imaging for noninvasive visualization of trop2 or epcam expression levels in non-small cell lung cancer; and to explore the differences between novel target-specific pet/ct examinations and conventional 18f-fdg pet/ct in the diagnosis and differential diagnosis of solid lung nodules.

a solid lung nodule was initially diagnosed as non-small cell lung cancer by chest ct. patients with lung nodules subjected to 18f-fdg pet/ct with surgical resection/biopsy. patients will also be included for routine follow-up, surveillance, and treatment efficacy evaluation.enrolled patients will undergo whole-body immunopet/ct scans 1-2 hours after tracer injection (0.05-0.1 mci/kg). the uptake of imaging tracers in tumors and normal organs/tissues will be scored visually and quantitatively.tumor uptake will be quantified by the maximum standard uptake value (suvmax). the sensitivity, specificity, positive predictive value (ppv), negative predictive value (npv), and accuracy will be calculated to assess the diagnostic efficacy. the correlation between lesion uptake and trop2 and epcam expression level determined by immunohistochemistry staining will be further analyzed. the primary exploration endpoint will be the tracers' imaging feasibility and preliminary diagnostic value compared to conventional imaging approaches like 18f-fdg pet/ct.

Eligibility criteria:
inclusion criteria: 1. age 18-80 years; 2. imaging studies suspecting non-small cell lung cancer; 3. solid lung nodules (≥8 mm in diameter) diagnosed by chest ct, which are subject to 18f-fdg pet/ct and surgical resection/biopsy of lung nodules according to the nccn guideline specifications for nsclc in the 2024 edition; 4. patients or family members agreed to participate in this clinical study and signed an informed consent form. exclusion criteria: 1. women during pregnancy and lactation; 2. persons with a history of surgery and trauma that significantly affects metabolic distribution and anatomical structure; 3. persons with severe other systemic diseases or known hypersensitivity to humanized monoclonal antibody products; 4. patient is unable to cooperate in completing the pet/ct examination; 5. patient has participated in other clinical studies within the past year that have resulted in radiation exposures in excess of an effective dose of 50 msv, in addition to the radiation exposures anticipated from participation in this clinical study; 6. patient should not participate in this clinical trial in the opinion of the investigator.

Keywords: trophoblast cell surface antigen 2 (trop2) epithelial cell adhesion molecule(epcam) immunopet lung tumor
the efficacy of liposomal bupivacaine in ultrasound guided supraclavicular nerve blocks for hand and wrist surgery

Conditions: Hand Surgery; Wrist Surgery; Elbow Surgery; Fracture Fixation; Dupuytren Contracture; Finger Fracture; Wrist Arthropathy; Distal Radius Fracture

Summary: patients undergoing hand, wrist, and elbow surgery may experience pain after surgery. the orthopedic surgeon may provide prescription pain medications after surgery to assist with pain control. however, with concern of the opioid epidemic, many patients would rather minimize the use of narcotic pain prescriptions after having surgery. as an alternative, ultrasound guided regional nerve blocks can assist with postoperative pain control. patients consented to this study will be randomized into three groups: 1) will receive an ultrasound guided nerve block with local anesthesia only, 2) will receive an ultrasound guided nerve block with local anesthesia and a steroid dexamethasone, 3) will receive an ultrasound guided nerve block with liposomal bupivacaine. our study team will make phone calls after surgery to the patient to determine how long the block lasted for, and how many opioid pain pills were taken up to 3 days after surgery.

our study team predicts that the ultrasound guided nerve block with liposomal bupivacaine can last approximately 48 hours, while the block with local anesthesia and dexamethasone will last approximately 30 hours, and the block with local anesthesia only may last up to 24 hours

Eligibility criteria:
inclusion criteria: * patients scheduled to undergo finger, hand, wrist, elbow surgery with a hand surgeon at st. luke's university hospital in bethlehem, pennsylvania * patients greater than 18 years of age, able to provide written consent for surgery and study exclusion criteria: * patients that cannot provide written consent for finger, hand, wrist, elbow surgery * patients with known allergies to local anesthetics * patients with severe liver disease * patients with a condition known as methemoglobinemia

Keywords: liposomal bupivacaine supraclavicular nerve block ultrasound guided nerve block hand, wrist, elbow surgery local anesthetic dexamethasone perineural injection
p75ntr, diagnostic biomarker for alzheimer's disease: quantification study in cerebrospinal fluid

Conditions: Alzheimer Disease

Summary: this research will be achieved by the assessment of p75ntr-ecd expression (total and linked to different species of aβ (aβ1-40 and aβ-1-42)) within the cerebrospinal fluid (csf) of patients with ad dementia, mild cognitive impairment (mci) due to ad, frontotemporal dementia and non-neurodegenerative dementia.

alzheimer's disease (ad) is a dementia which is clinically characterized by cognitive impairments with early memory loss and neuropathologically by two main lesions, amyloid deposits and tau protein accumulation. presently, early diagnosis of ad relies on clinical symptoms, imaging techniques with recently introduced radio-tracers and analysis of cerebrospinal fluid biomarkers. all these tools are efficient when patients are already symptomatic and it is presently known that the lesions that might be reversible appear early in the time life of patients, several decades before the onset of clinical signs. to find a biomarker which would be detected early and tested in peripheral fluids is our challenge. according to updated physiopathology of the disease and referring to previous work on sphingolipid pathway in ad, precedent study focused attention on an original protein, p75ntr and particularly its extracellular domain (ecd). this protein is involved in the physiopathology of ad in several ways (apoptosis, survival). p75ntr-ecd interacts with aβ, increases its solubility and accelerates its clearance. the hypothesis of the present study is that p75ntr-ecd could be expressed differentially according to the category and stage of dementia. more precisely, this new biomarker could help for the diagnosis of ad and could also be used as an early marker of ad when tested in peripheral fluid.

Eligibility criteria:
inclusion criteria: * patients with ad * patients with mci due to ad, * patients with frontotemporal dementia * patients with non-neurodegenerative dementia, according to dsm-v and updated national institute on aging (nia) recommendations exclusion criteria: * patients with parkinson disease or lewy body dementia

Keywords: alzheimer disease alzheimer's disease, biomarkers p75ntr-ecd
age gender left ventricular mass and cardiac troponin t

Conditions: Heart Failure

Summary: the purpose of this study is to determine the influence of functional or anatomic cardiac parameters, age and gender on high sensitivity ctnt (tnths) levels in healthy individuals.

we sought to investigate the relative contribution of functional or anatomic parameters as assessed by cardiac magnetic resonance tomography (cmri, 1.5 tesla), and clinical variables including increasing age and gender on high sensitivity ctnt (tnths) levels in healthy individuals. therefore we measured tnths in serum samples of 120 healthy volunteers aged between 20 and 70 years. all individuals underwent cmri including stress testing using dobutamine or adenosine.tnths concentrations were related to cmri and clinical findings. partial correlation, as well as linear and hierarchical regression analyses were used to identify independent predictors and their relative contribution for prediction of tnths values.

Eligibility criteria:
inclusion criteria: * agreement, age \> 18 years, men and women exclusion criteria: * measurable heart disease, any chronic or acute disease, intake of meds, hypertension, diabetes

Keywords: age gender left ventricular mass high sensitive troponin t
preoperatively orientation in cardiac surgery: nurses intervention on patients recovery

Conditions: Coronary Artery Bypass Graft Triple Vessel; Heart Valve Diseases

Summary: the purpose of this study is to determine whether the guidelines preoperative performed by a nurse contribute to the recovery of the patient submitted to cardiac surgery compared with the guidelines for routine.

this is a randomized clinical trial, which included patients submitted to cardiac surgery on both sexes. they are divided in two groups: control group and intervention group.

Eligibility criteria:
inclusion criteria: * primary elective cardiac surgical procedures * age above 18 years old * at least 24 hours of hospitalization before the procedure exclusion criteria: * patients who do not accept and do not signed a consenting term

Keywords: cardiac surgery orientation nursing
single dose study of the fluticasone/salmeterol (500/50 μg) administered with elpenhaler® versus diskus®

Conditions: Asthma

Summary: the aim of this study is to establish the therapeutic equivalence between the test (fluticasone/salmeterol administered with elpenhaler®, rolenium®) and the reference formulation (seretide®, administered with diskus®), both containing 500/50μg of the fluticasone/salmeterol combination. the study will be conducted in a randomized, double-blind, double-dummy, 2x2 crossover fashion.

in case of inhaled products, it is not possible to follow the classic scheme, based on similarity of plasma concentration-time behavior of parent drug in assessing bioequivalence. for this reason, a pharmacodynamic study was designed in order to assess the therapeutic equivalence of the new formulation of fluticasone/salmeterol with the innovative one. the test and reference fluticasone/salmeterol formulations will be compared in terms of their bronchodilator effects in lung function. forced expiratory volume in 1 second (fev1) will be the primary efficacy measure and will be measured in such a way that a similar time-dependent increase in pulmonary function can be demonstrated for both fluticasone/salmeterol formulations in patients with asthma. in terms of safety comparison, repeated measurements of adverse events, vital signs, heart rate, blood hematology and biochemistry as well as ecg changes will enable the establishment of the similar safety profile of the test and reference fluticasone/salmeterol combinations.

Eligibility criteria:
inclusion criteria: * age 18-65 years, * diagnosis of asthma of 6 months, * fev1 ≥ 50% and ≤ 80% predicted, * reversibility of at least 12%, * stable asthma for at least 4 weeks, * inhaled steroids (ics) at a stable dose within the previous 30 days, * pif 30 - 90 lt/min and * informed consent. exclusion criteria: * history of other pulmonary disease, * asthma exacerbation or respiratory infection within the previous 4 weeks, * hospitalization for acute asthmatic symptoms requiring parenteral steroids or oral steroid dose increase, within the previous 30 days, * heavy smokers, * change of asthma medication within the previous 4 weeks, * seasonal asthma alone, * history of severe heart disease, * pregnancy or lactation, * use of a β-blocker, of a nsaid or an antiallergic/antihistaminic medication within 2 weeks prior to screening visit.
gamma knife radiosurgery on tectal plate gliomas

Conditions: Gamma Knife Radiosurgery; Tectal Plate Gliomas

Summary: this study aimed to assess the impact of gamma knife radiosurgery on tectal plate gliomas (tpgs).

tectal plate gliomas (tpgs) represent a subset of brainstem gliomas that are predominantly slow-growing, low-grade tumors and rarely produce neurological deficits. viable options include biopsy and monitoring with serial neuroimaging, surgical resection, radiotherapy (either early following surgery or late on evidence of disease progression), chemotherapy, and stereotactic radiosurgery (srs). srs using gamma knife radiosurgery (gkrs) has been identified in small case series as a safe and promising approach for managing tpgs that necessitate intervention beyond mere observation.

Eligibility criteria:
inclusion criteria: * age from 5 to 55 years. * both sexes. * patients underwent gamma knife radiosurgery (gkrs) for tectal plate gliomas (tpgs). exclusion criteria: * high-grade glioma. * tumor extension beyond the tectal region.
probiotics for irritable bowel syndrome

Conditions: Functional Gastrointestinal Disorders; Irritable Bowel Syndrome

Summary: this randomised, double blind, cross-over study compares the effect (symptoms, fecal bacterial growth, gas production) of three weeks' treatment with lactobacillus plantarum mf 1298 with placebo in patients with irritable bowel syndrome. the results are related to dietary habits, food intolerance and food allergy.


Eligibility criteria:
inclusion criteria: * irritable bowel syndrome according to the rome ii criteria * regular symptoms exclusion criteria: * use of probiotics last three weeks * pregnancy * lactation * co-existing other gastrointestinal disorders * use of laxatives and antibiotics within last 5 weeks.

Keywords: probiotics
acute feasibility investigation of a new s-icd electrode

Conditions: Ventricular Fibrillation

Summary: this is an early-stage feasibility study. this study seeks to characterize the performance of the new electrode shock configuration with the s-icd

background: the subcutaneous implantable cardioverter-defibrillator (s-icd, emblem®, boston scientific corp) delivers 80 j shocks from an 8 cm left-parasternal coil (lpc) to a 59 cc left lateral pulse generator (pg). a system that defibrillates with lower energy could significantly reduce pg size. computer modeling and animal studies suggest a 2nd shock coil either parallel (p) to lpc or transverse (t) from xiphoid to pg pocket would significantly reduce shock impedance and defibrillation threshold (dft). objective: acutely test defibrillation efficacy of p and t configurations in patients receiving an s-icd. methods: testing was performed in patients receiving a conventional s-icd system (c) for standard indications. patients at risk for conversion failure, stroke or infection were excluded. a 65 j success with the conventional s-icd was required prior to investigational testing. a second electrode was temporarily inserted from the xiphoid incision using the same introducer and sheath tools and connected to the pg with an investigational y-adapter (model 3598, boston scientific). phase 1 (n=11) tested only p at a starting energy of 50 j with subsequent tests at 65 or 30 j then 40 or 20 j depending upon outcome. phase 2 (n=21) tested both p and t in random order, starting at 30 j then either 40 or 20 j.

Eligibility criteria:
key inclusion criteria: 1. subject is scheduled to receive a de novo s-icd system implant per labeled indication. 2. passing s-icd screening ecg performed per applicable user's manual. 3. subject is willing and capable of providing informed consent specific to local and national laws. 4. subject is age 18 or above, or of legal age to give informed consentspecific to local and national law. key exclusion criteria: 1. subject has an unusual chest anatomy (eg. pectus excavatum and pectus carinatum) that might impede the ability to temporarily insert a second s-icd electrode. 2. subject has a left ventricular ejection fraction ≤ 20% within 3 months prior to enrollment. 3. subject has nyha class iv or unstable class iii heart failure. 4. subject that, in the opinion of the investigator, cannot tolerate the dft testing required by this protocol. 5. subject is morbidly obese, defined as bmi ≥ 35. 6. subject has an active infection or has been treated for infection within the past 30 days. 7. subject that, in the opinion of the investigator, has an increased risk of infection. 8. subject is currently requiring/receiving dialysis. 9. subject has insulin-dependent diabetes. 10. subject had/has any prior or planned other surgical procedure within ±30 days of enrollment. 11. subject that, in the opinion of the investigator, has an increased risk for thromboembolic event. 12. subject that, in the opinion of the investigator, has an increased risk of excessive bleeding. 13. subject is currently on an active heart transplant list.