Kornimate/medical-research-clean huggingface dataset:
ki67 proliferation index of pancreatic neuroendocrine neoplasia

Conditions: Neuroendocrine Tumors

Summary: this is a retrospective, monocentric study involving 50 patients with pancreatic neuroendocrine neoplasia resected between january 2008 and june 2020 at paoli calmettes institute. the primary objective of the study is to evaluate the grade concordance rate, based on ki67 obtained on the pre-operative micro-biopsy and the surgical specimen. based on the histology slides obtained in the course of the treatment, several ki67 recounts will be performed on pre-operative tumor micro-biopsies and on tumors resected after surgery: * a manual count (on photo printed in the hotspot area according to world health organization (who) 2017 recommendations, by an expert pathologist and a junior pathologist. * automated counting using specific software based on artificial intelligence (qpath software). on the other hand, clinical, surgical and anatomopathological data will be collected in order to follow the patient evolution.


Eligibility criteria:
inclusion criteria: * patients with resection of pancreatic neuroendocrine neoplasia by surgery at paoli calmettes institute between january 2008 and june 2020 * patients who had a pre-surgical evaluation of ki67 on micro-biopsy equipment obtained by echo-endoscopy. exclusion criteria: * patient with a mixed tumor of the pancreas. * patient with a pancreas tumor composed of several nodules of similar size without a main mass and for which it is not possible to determine the biopsied nodule during echo-endoscopy. * initial micro-biopsy in a private pathology laboratory * initial subechoendoscopic puncture cytology only (ki67 not possible) * no initial micro-biopsy and surgery

Keywords: pancreatic neuroendocrine tumor ki67 artificial intelligency
safety and efficacy of afq056 in adult patients with fragile x syndrome

Conditions: Fragile X Syndrome

Summary: this phase iib study is designed to assess whether 3 doses of afq056 are safe and effective in treating the behavioral symptoms of fragile x syndrome.


Eligibility criteria:
inclusion criteria: * patients with fragile x syndrome, who are at least moderately ill based on a clinical global impression severity score of at least 4 and have qualifying scores on the abc-c and iq test at visit 1 exclusion criteria: * advanced, severe or unstable disease that may interfere with the study outcome evaluations * cancer within the past 5 years, other than localized skin cancer * current treatment with more than two psychoactive medications, excluding anti-epileptics * history of severe self-injurious behavior other protocol-defined inclusion/exclusion criteria may apply

Keywords: fragile x syndrome martin-bell syndrome genetic diseases x-linked
pre-emptive quadratus lumborum block for laparoscopic bariatric surgery

Conditions: Pain; Postoperative

Summary: the purpose of this study was to determine the effectiveness of pre-emptive quadratus lumborum block on intra, postoperative pain assessment and opioid requirements in laparoscopic bariatric procedures.


Eligibility criteria:
inclusion criteria: patients included in this study are * both genders * age between 18-50 years * those undergoing laparoscopic bariatric surgery (as laparoscopic sleeve gastrectomy or gastric bypass). * bmi ≥ 35 kg/m2 with comorbidity or ≥ 40 kg/m2 without comorbidity. exclusion criteria: patients excluded from this study were * those with obstructive sleep apnoea and/or pickwickian syndrome. * if the laparoscopy procedure was converted to laparotomy. * patients suffering from known coagulation defects. * known hypersensitivity to bupivacaine, or those with contraindication to the use of nsaids. * presence of sepsis at the site of injection.

Keywords: quadratus lumborum block laparoscopic bariatric surgery
check it: a new approach to controlling chlamydia transmission in young people

Conditions: Chlamydia Trachomatis Infection; Gonorrhea

Summary: this study, named "check it," is a bundled program for african american (aa) men ages 15-24 that includes community testing for chlamydia and gonorrhea, expedited treatment for subjects who test positive and their female sexual contacts, and rescreening for these two sexually transmitted infections.

participants (n=4854) will be recruited through community partners, at events and using social marketing campaigns including advertisements, referrals from other participants, social media, and a web based educational website (web-ed). after establishing eligibility, written informed consent will be obtained. subjects will complete a survey and provide a urine specimen for chlamydia (ct) and gonorrhea (gc) testing and will provide their preferred contact information in order to be contacted about their test results. the testing laboratory will report positive results per la hygiene code lac 51:ii.105: http://ldh.la.gov/assets/oph/center-phch/center-ch/infectious-epi/surveillance/sanitarycode.pdf. tulane study staff will contact participants to inform them of their results. if the participant tests positive for ct and/or gc, the subject will be offered expedited treatment for the subject and the subject's recent sex partners. the subject may choose to pick up medication at a local pharmacy or medication can be mailed to the subject. staff will also ask the participant to contact his partner(s) and provide them with the check it staff's contact information so that staff can let the partner know that they have been exposed to an infection and offer the subject's sexual partner expedited treatment options if the participant did not already provide the subject's sexual partners with that information. no information provided by the participant will be shared with his partners. the study will cover the cost of the medications for subjects who test positive for either or both organisms and their sexual partners. three months after treatment, male subjects who were positive will be asked to be re-screened and if positive, staff will conduct similar expedited treatment and partner services. any subject who provides consent for annual testing reminders will be reminded using their preferred method of contact.

Eligibility criteria:
inclusion criteria: * identifies as african american or black * identifies as male * 15-26 years of age * lives or spends most of his time in orleans parish * had vaginal sex with at least one woman * has not taken azithromycin in the past 7 days exclusion criteria: * unwilling or unable to provide informed consent * unable to speak or understand english * previously enrolled in the study by self-report

Keywords: screening men expedited treatment
lung function tests in adolescents with anorexia nervosa

Conditions: Anorexia Nervosa

Summary: the investigators hypothesize that lung function would be adversely affected at the hypocaloric stage of adolescents suffering from anorexia nervosa.

anorexia nervosa in adolescents holds adverse effects on different body systems as the cardiovascular, central nervous, endocrine, bone and gastrointestinal systems. there is paucity of information regarding the adverse effects of this tenacious illness on the lungs of adolescents at the hypocaloric stage of their illness. based on previous clinical observations we postulate that lung function tests would be adversely effected by the hypocaloric nutrition of adolescents with anorexia nervosa and that they may improve during short refeeding in an inpatient setting of a general pediatric ward. to examine our hypothesis we would check lung function by various parameters of adolescents suffering from an and a control group of adolescents.

Eligibility criteria:
inclusion criteria: * adolescents with anorexia nervosa * ability to preform lung function tests * parents signing informed concent and adolescents signing informed ascent exclusion criteria: * a history of a lung disease * intercurrent lung illness

Keywords: anorexia nervosa adolescents lung function tests refeeding
certas programmable valve registry

Conditions: Hydrocephalus; NPH (Normal Pressure Hydrocephalus); IIH - Idiopathic Intracranial Hypertension

Summary: post-market clinical follow-up registry of patients with codman certas plus programmable valves.

the codman certas plus programmable valve is a single use implantable device designed for shunting cerebrospinal fluid (csf) for the treatment of hydrocephalus. the clinical investigation specifically aims to collect data on the performance measures outlined below. data will be collected per standard of care, given the nature of the clinical investigation to capture real world data (registry); timing, frequency, and methodology of assessing the performance outcomes may therefore differ per center, subject, and/or visit. 1) improvement of the following symptoms related to hydrocephalus: * gait disturbances; * spatial impairment; * cognitive abilities; * urinary incontinence; * pain caused by headaches; * visual acuity.

Eligibility criteria:
inclusion criteria: 1. adult patients (18-80 years old at time of enrollment) undergoing implantation of the codman certas plus programmable valve according to the device label. 2. patients willing and able to understand and sign informed consent. exclusion criteria: n/a
pharmacological penile rehabilitation in the preservation of erectile function following bilateral nerve-sparing radical prostatectomy

Conditions: Penile Cancer; Erectile Dysfunction; Radical Prostatectomy

Summary: when a bilateral nerve-sparing radical prostatectomy (rp) is performed, recovery of erectile function (rigid erections) is reported for up to 80% of patients, who are less than 60 years old. erectile function recovery is also impacted by patient age, erectile function before surgery, and the length of time after surgery. current evidence from studies suggests that developing erections is important, however, these studies have been small, and the evidence is not definite. animal studies suggest that erection medication (viagra, levitra, cialis) may protect erection tissue, even in the absence of erections. however, the correct treatment plan is unknown. for example, how often does a man need to take sildenafil (viagra®) to protect his erectile function or to maximize his erectile function recovery? is only using erection medication enough for erectile function recovery? would penile injections, which almost ensure production of an erection, be better than using sildenafil (viagra®), or might a combination be even better at helping recovery of erections? these are types of questions this study might answer.


Eligibility criteria:
inclusion criteria: * male, must be ≥ 18 years of age, with histologically confirmed prostate adenocarcinoma, that is clinically localized to the prostate gland * stable sexual relationship for ≥ 6 months * open or laparoscopic bilateral nerve-sparing radical prostatectomy * baseline score of ≥ 22 on the international index of erectile function domain (appendix a) * able to speak, read and write in the english language * calculated creatinine clearance using the 4 variable mdrd equation based on serum creatinine, age, race, and gender of \> 60 cc/min * patient is able to walk up two flights of stairs briskly without chest pain * patient needs to have their baseline sitting and standing blood pressure and pulse done at the time of consent exclusion criteria: * preoperative or planned postoperative pelvic radiation therapy * preoperative or planned postoperative androgen deprivation * presence of peyronie's disease at baseline * presence of a penile prosthesis at baseline * resection of one or both nerve bundles at surgery * any contraindications to sildenafil: * patient is currently using nitrates; * presence of retinitis pigmentosa; * presence macular degeneration; * mi or cva within 3 months; * patient is currently using maoi medications * patient is currently using penile self injection medication (trimix, bimix, or pge-1) * patient requiring sildenafil for penetration * use of sildenafil within 30 days of consent

Keywords: penis placebo sildenafil citrate trimix bimix viagra 09-005 erectile dysfunction following bilateral nerve-sparing
nmes during the day and prior to sleep

Conditions: Sarcopenia

Summary: in the present study, the effect of a bolus of intrinsically labeled milk directly after one-legged nmes (neuromuscular electrical stimulation) will be studied under two conditions: during the day and prior to sleep

in the present study, the effect of a bolus of intrinsically labeled milk directly after an hour of one-legged nmes (neuromuscular electrical stimulation) will be studied under two conditions: during the day and immediately prior to sleep

Eligibility criteria:
inclusion criteria: * age 65-85 years * male * 18.5 ≤ bmi ≤ 30.0 exclusion criteria: * type ii diabetes * all co morbidities interacting with mobility and muscle metabolism of the lower limbs (e.g. arthrosis, arthritis, spasticity/rigidity, all neurological disorders, paralysis, hip/knee surgery). * use of anticoagulants, blood diseases, allergy for lidocaine * use of nsaids (non-steroidal anti-inflammatory drugs) and acetylsalicylic acid * patients suffering from pku (phenylketonuria) * presence of implantable cardioverter defibrillator and/or pacemaker * performed regular resistance type exercise in the past 6 months * use of any tools to assist during walking (cane/ crutches/ walker) * (partial) foot/ leg amputation

Keywords: neuromuscular electrical stimulation ageing protein ingestion
replication of the poet-copd trial in healthcare claims data

Conditions: Chronic Obstructive Pulmonary Disease

Summary: investigators are building an empirical evidence base for real world data through large-scale replication of randomized controlled trials. the investigators' goal is to understand for what types of clinical questions real world data analyses can be conducted with confidence and how to implement such studies.

this is a non-randomized, non-interventional study that is part of the rct duplicate initiative (www.rctduplicate.org) of the brigham and women's hospital, harvard medical school. it is intended to replicate, as closely as is possible in healthcare insurance claims data, the trial listed below/above. although many features of the trial cannot be directly replicated in healthcare claims, key design features, including outcomes, exposures, and inclusion/exclusion criteria, were selected to proxy those features from the trial. randomization is also not replicable in healthcare claims data but was proxied through a statistical balancing of measured covariates according to standard practice. investigators assume that the rct provides the reference standard treatment effect estimate and that failure to replicate rct findings is indicative of the inadequacy of the healthcare claims data for replication for a range of possible reasons and does not provide information on the validity of the original rct finding.

Eligibility criteria:
inclusion criteria: * age greater or equal than 40: days \[0,0\] * diagnosis of copd: days \[-all data, 0\] * history of at least 1 copd exacerbation within the past year requiring treatment with antibiotics and/or systemic steroids and/or requiring hospitalization: days \[-365, -28\] exclusion criteria: * patients with 3 diagnosis of asthma: days \[-180, 0\] * patients with current severe cardiovascular disorders (heart transplantation, lvad/implantable heart, pulmonary hypertension/other pulmonary disease) and use of systemic corticosteroid medication at unstable doses: days \[-365, 0\] * patients with any respiratory infection (acute respiratory infections, pneumonia and influenza) or copd exacerbation: days \[-28, 0\] * exclude use of salmeterol or tiotropium containing inhaler use \[-180, 0\]
evaluation of nicom (bioreactance) for the non-invasive determination of cardiac output

Conditions: Cardiac Disease

Summary: cardiac output (co) is an important parameter in the diagnosis and therapy of cardiac diseases. the current standard methods for the determination of co, however, are either invasive (e.g. right heart catheterization) or technically expendable and expensive (magnetic resonance tomography, mrt). therefore, the aim of the study at hand was to evaluate nicom (bioreactance) as a new method for determinion of co and to compare this new technique to mrt.


Eligibility criteria:
inclusion criteria: * indication for cardiac magnetic resonance imaging exclusion criteria: * pace maker * patient unwilling to participate

Keywords: accuracy of nicom precision of nicom
sprint - randomized trial of tibial fracture fixation

Conditions: Tibial Fracture

Summary: the purpose of this study is to determine if there is a difference in the rate of healing of a tibia fracture treated with an intramedullary nail based on whether or not the bone was reamed prior to nail insertion.

patients with tibia fractures that are amenable to being treated with both a reamed and an unreamed nail will be randomized via telephone to one of the two groups. these patients then will be followed for a year with clinical, as well as subjective, outcome follow-up questionnaires. time to healing, as well as repeat interventions and adverse events, will be tracked. the rationale for doing a large sample size multi-center trial is the hope that a clear answer to whether or not one of these two methods is significantly better than the other will become apparent and thus aid surgeons in making a more informed operative treatment choice.

Eligibility criteria:
inclusion criteria: * fractured tibia requiring fixation using an intramedullary nail
feasibility of stereotactic image guidance on the lateral skull base

Conditions: Otologic Disease

Summary: a clinical trial to asses the accuracy, usefulness and usability of a stereotactic image-guidance system during lateral skull base surgery.

stereotactic image guidance aims to provide for accurate and precise instrument localization in patient-specific image data. image guidance is effectively used in various surgical domains such as neurosurgery, nose-surgery and orthopaedic surgery with benefits for patients such as less invasiveness and reduced surgery time. its application for lateral skull base surgery was proposed and is considered an unmet clinical need. however, the small geometric scale (\~0.5 mm) of the anatomical structures within the lateral skull base prevents the effective application of commercially available systems due to their insufficient guidance accuracy. within the context of robotic cochlear implantation, stereotactic image guidance technology with a guidance accuracy \<0.5 mm was developed. the aim of this study is to apply the developed technology in lateral skull base surgery other than robotic cochlear implantation. this study primarily seeks to determine the effective end-to-end image guidance accuracy of the investigational device at predefined artificial landmarks on a task-specific registration device attached to the skull. the main secondary objective is to qualitatively assess the available accuracy at predefined anatomical landmarks by visual inspection through surgeons in the absence of quantifiable ground truth information.

Eligibility criteria:
inclusion criteria: * patients which are regularly scheduled for an otologic surgical procedure * informed consent as documented by signature * age \>= 18 years exclusion criteria: * other clinically condition or disease that would (as deemed by the operating surgeon) significantly increase the risk of surgery

Keywords: image-guidance lateral skull base surgery
a comparison of patient perceptions undergoing manual cataract surgery (mcs) vs refractive laser-assisted cataract surgery (relacs) in first and second eyes

Conditions: MCS vs ReLACS; Pain Perception Postoperatively First Eye vs Second Eye; Early Anesthesia vs Standard Anesthesia

Summary: the focus of this study is to assess how pain can be mitigated for patients undergoing cataract surgery through the early application of anesthesia prior to the surgery as compared to the standard timing, and by using the relacs cataract surgery technique compared to the standard mcs technique.


Eligibility criteria:
inclusion criteria: 1. patients undergoing uncomplicated cataract surgery with either surgical technique (mcs or relacs) 2. patients who require surgery in both eyes by same surgeon 3. able to understand english and complete a pain assessment exclusion criteria: 1. deafness or communication disorder, known dementia, severe copd/asthma (severe lung disorder), severe osa, psychiatric or anxiety conditions, involuntary movement disorders, allergy to the anesthesia, any conditions requiring intraoperative iris manipulation, any prior ocular surgery 2. pre-existing chronic eye pain or uveitis, or complicated cataracts (dislocation, zonulopathy) 3. pre-existing uncontrolled glaucoma/high iop 4. intraoperative complications or non-routine cataracts (eg. sutures, excessive time of surgery) 5. any patient who requires deep sedation (propofol), ga or preop ativan 6. patients under 40, severe obesity (bmi \>35) 7. chronic pain/narcotics/recreational/medical marijuana
honey and a mixture of honey, beeswax and olive oil-propolis extract in treatment of chemotherapy-induced oral mucositis

Conditions: Oral Mucositis

Summary: although, oral mucositis has been studied for many years, no available treatment has been shown to be effective in preventing or treating mucositis. based on the observations that honey and other products of honeybees have anti-inflammatory, anti-oxidant, anti-microbial and wound healing effects, the present study aims at evaluation of the effect of topical application of honey and a mixture of honey, beeswax and olive oil-propolis extract, as natural products, in treatment of chemotherapy-induced oral mucositis in children with acute lymphoblastic leukemia (all). this is a randomised controlled clinical trial in which eligible patients were randomly assigned into three equal treatment groups. group 1 received 15 gm honey applied topically to the affected oral mucosa three times daily. group 2 received 5 gm of a mixture of honey, olive oil-propolis extract and bees wax (hope) applied topically to the oral mucosa three times daily. group 3 served as control and received a 7.5% benzocaine gel applied to the areas of ulcers three times daily.

all patients with all during the consolidation phase of treatment, and with chemotherapy-related oral mucositis grades 2 and 3 were candidates for this trial.exclusion criteria included the presence of any of the following: (1) coexisting diabetes mellitus, (2) administration of antiviral, antifungal therapy and / or any other treatment for oral mucositis before enrollment in the study, (3) presence of neutropenia (absolute neutrophilic count \[anc\] ≤ 1500/mm3), (4) presence of advanced or severe periodontitis (patients with periodontal pockets of 6 mm or more. the primary outcome measure was the "recovery time", defined as the number of days from initiation of treatment to when complete healing of all ulcers occurred.

Eligibility criteria:
inclusion criteria: * all patients with all during the consolidation phase of treatment, and * with chemotherapy-related oral mucositis grades 2 and 3 exclusion criteria: 1. coexisting diabetes mellitus, 2. administration of antiviral, antifungal therapy and / or any other treatment for oral mucositis before enrollment in the study, 3. presence of neutropenia (absolute neutrophilic count \[anc\] ≤ 1500/mm3), 4. presence of advanced or severe periodontitis (patients with periodontal pockets of 6 mm or more)