Kornimate/medical-research-clean huggingface dataset:
simple technique to improve diagnostic yield in eus-fna

Conditions: Lesion Sampled for Cytology

Summary: endoscopic ultrasound and fine needle aspiration are useful tools for the diagnosis and staging of pancreatic cancer. one potential limitation is contamination when needle traverses the gastrointestinal tract under continuous negative pressure. gastrointestinal tract contamination can lead to misinterpretation of fna specimens. we propose a technique to eliminate any remaining negative pressure during eus-fna and therefore decrease gastrointestinal tract contamination. our hypothesis is that briefly untwisting the syringe from the biopsy channel after a specimen is obtained eliminates any remaining negative pressure in the fna needle and therefore reduces gi tract contamination of eus-fna specimens, and will lead to improved diagnostic accuracy of this important clinical technique.

endoscopic ultrasound (eus) has evolved into a minimally invasive diagnostic and staging method. the addition of fine needle aspiration (fna) increases the accuracy of eus in the diagnosis and staging of pancreatic malignancies. an ultrasound probe attached to the end of the endoscope allows real-time direct visualization by means of ultrasound transmission. during the fna process a needle is advanced through the biopsy channel of the endoscope and into the target lesion. in order to obtain a tissue specimen of a suspicious pancreatic lesion, an fna needle must traverse either the stomach or duodenum to access the pancreatic mass. once the needle has entered the target lesion a syringe is exchanged for the needle stylet and negative pressure is applied allowing acquisition of a cytology specimen. negative pressure is released from the syringe and the stop cock is closed to the syringe. however, due to the relatively long length of the needle there is is significant remaining negative pressure at the needle tip. this leads to aspiration of surrounding material including gi mucosal contamination into the needle while removing it from the target lesion. contamination of the fna specimen from gastric or duodenal epithelium can occur with continued negative pressure at the needle tip upon withdrawal of the needle out of the target lesion. while eus-fna has a high specificity (96%), sensitivity (87%), and accuracy (94%), gastrointestinal tract contamination can lead to misinterpretation of fna specimens. based on clinical experience, we propose a technique to eliminate any remaining negative pressure during eus-fna and therefore decreasing gastrointestinal tract contamination.

Eligibility criteria:
inclusion criteria: * age \> 18 * not pregnant * can give consent * patients with suspicious gi lesions in need of tissue diagnosis by means of eus/fna exclusion criteria: * pregnant * age \< 18 * cannot give consent * eus not technically possible

Keywords: eus pancreatic cancer cytology fine needle aspiration
prevention of severe acute respiratory failure in patients with proofcheck

Conditions: Respiratory Failure; Multiple Organ Failure

Summary: severe acute respiratory failure (arf) requiring prolonged mechanical ventilation is the most common form of acute organ dysfunction in the hospital, and is often associated with multiple organ failure (mof), high mortality, and functional impairment. most studies on arf have focused on patients in the intensive care unit (icu) after they have been on mechanical ventilation for days and end organ damage is already established. the overall goal of this proposed project is to improve the outcomes of patients at high risk for developing severe arf and prolonged mechanical ventilation in and outside of the icu. the project aims to intervene early in high risk patients with an electronic medical records (emr)-based, patient-centered checklist of common critical care practices aimed at preventing lung injury and hospital acquired adverse events that commonly lead to organ failure (prevention of organ failure checklist -proofcheck). this application proposes a stepped-wedge, clustered randomized control trial to determine the utility of proofcheck to improve survival and reduce the duration of mechanical ventilation and multiple organ failure in patients identified as high risk for progressing to severe arf and prolonged mechanical ventilation. the aims in the uh2 phase are: 1) to refine a previously validated lung injury prediction score into a pragmatic, emr-based early prediction model to accurately predict prolonged ventilation (approve), which will automatically identify patients anywhere in the hospital who are at high risk for developing severe arf requiring mechanical ventilation \>48 hours; 2) to incorporate proofcheck into the emr to prompt clinicians on care practices to limit lung injury, prevent adverse events, and avoid additional organ failure; and 3) to establish the infrastructure for the proposed trial. the proposed pragmatic trial will harness the hospital-wide emr to identify patients at high risk for prolonged mechanical ventilation with approve for intervention with proofcheck. as such, the proposed trial aims to break out of the clinical silos by which care is currently organized in the hospital and bring patient-centered, context appropriate care to the acutely ill patient wherever and whenever the patient's condition requires it.


Eligibility criteria:
inclusion criteria: * adult patients aged \> 18 in the hospital * identified as being at high risk for developing severe arf requiring prolonged mv exclusion criteria: * patients who are chronically ventilated * patients who have dni orders on hospital admission * patients in areas of the hospital that are unable or unwilling to participate
cost-effectiveness of the single-implant mandibular overdenture versus mandibular conventional denture

Conditions: Mouth, Edentulous; Complete Edentulism

Summary: this is a randomized clinical trial designed to assess the 1-year effectiveness of two treatment modalities for the mandibular edentulists: conventional complete dentures and single-implant mandibular overdenture.

this randomized clinical trial alongside a cost-effectiveness analysis will include edentulous individuals who meet eligibility criteria. new maxillary and mandibular dentures will be fabricated for all participants following a standardized protocol. then, participants will be randomized into one of the treatment groups: conventional complete denture group or single-implant mandibular overdenture group. each participant allocated to the overdenture group will then receive an implant (titamax ti cortical - neodent, brazil) in the mandibular midline followed by the immediate connection of an o-ring/ball attachment with intra-oral incorporation of the retention system in the mandibular denture. direct costs related to therapies in both groups will be identified, measured and valuated for one year after treatment and patient-reported outcomes will be assessed. incremental cost-effectiveness ratios will be estimated and graphically presented on cost-effectiveness planes. a markov decision tree will be constructed to set out the consequences of the competing alternatives. sensitivity analysis on the most important assumptions will be performed in order to assess the robustness of the model.

Eligibility criteria:
inclusion criteria: * to present favorable general health and the need to be rehabilitated with a new set of complete dentures * to agree to be randomly assigned to one of the two study groups * to be able to comprehend and answer the data collection instruments. exclusion criteria: * presence of general health conditions that may contraindicate implant surgery (such as uncontrolled type ii diabetes mellitus or uncontrolled cardiovascular conditions) * insufficient height and volume in the midline region to receive an implant of at least 3.75mm x 9.0mm * presence of evident signs of cognitive impairment and/or oral conditions requiring additional treatments, such as oral lesions and temporomandibular disorders * inability to attend to the scheduled appointments and follow-up visits

Keywords: overdenture edentulism dental implant cost-effectiveness economic analysis effectiveness
improving the management of drug resistant tuberculosis in the uk

Conditions: Tuberculosis

Summary: the 'rising tide' of antimicrobial resistance is a source of concern across most infectious diseases. in the uk, for example, 6.8% of the \~8,500 tuberculosis patients seen in 2012 were resistant to the cheap and effective first-line drug isoniazid. it is of great importance to prevent the loss of current anti-tuberculosis drugs and preventing the spread of resistance by treating such patients as well as possible. currently, guidance on the best treatments for isoniazid resistant tuberculosis is inconsistent globally. data from randomised controlled trials, the peak quality of evidence, is sparse. it is thus important that studies using pre-existing observational data are undertaken. the investigators aim to use data and samples collected from public health england and national health service hospitals to determine a) the best treatments for patients with isoniazid resistant tuberculosis disease (cohort study) and b) how different causes of drug resistance in the infecting bacteria influence a) (nested case-control study). eligible participants will have had isoniazid resistant tuberculosis (without associated rifampicin resistance) in england between 2009 and 2013 and will have been notified to public health england. the study will be conducted at university college london, national health service hospitals and public health england and will last until december 2017. patient hospital records and disease surveillance records will be accessed and cultured bacteria from previously stored samples sequenced.


Eligibility criteria:
inclusion criteria: * isoniazid resistant non-multidrug resistant tuberculosis patients. * notified to public health england's enhanced tuberculosis surveillance system between 2009-2013. * adults aged 18 years and over. * patients not treated at private hospitals. exclusion criteria: * non-notified patients. * individuals where the site of disease required more than 12 months of treatment. * individuals diagnosed post-mortem.

Keywords: isoniazid drug resistance
investigation of the relationship between core muscles functions and symptoms of patients with abdominal bloating/distension

Conditions: Bloating; Distension

Summary: the aim of this study is to investigate the relationship between core muscle functions (strength, endurance, thickness) and symptoms in individuals with abdominal bloating/distension. the main questions it aims to answer are: does symptoms in individuals with abdominal bloating/distension have an effect on core muscles? how do core muscles change based on an increase or decrease in these symptoms?

in studies on individuals with abdominal bloating/distension in the literature, the diaphragm, abdominal muscles, and pelvic floor muscles have been examined separately. there is no study that examines all core muscles together in such cases. additionally, there is no study examining the relationship between core muscle function and symptoms. therefore, the aim of our study is to investigate the relationship between core muscle functions (strength, endurance, thickness) and symptoms in individuals with abdominal bloating/distension.

Eligibility criteria:
inclusion criteria: * have a diagnosis of abdominal bloating/distension made by a physician according to the rome iv criteria * be female between 18 and 65 years of age * volunteer to participate\&#34; exclusion criteria: * having a serious neurological, pulmonary, systemic, orthopedic, or metabolic disease accompanying bloating-distension * being under 18 or over 65 years of age * being pregnant * having any organic cause for bloating and distension (such as celiac disease or other absorption disorders, intestinal dysmotility, and chronic intestinal pseudo-obstruction) * having alarm symptoms (weight loss, rectal bleeding, or anemia) * having a body mass index (bmi) ≥40 * having a history of gastrointestinal (gi) or abdominolumbopelvic surgery

Keywords: abdominal bloating/distension core muscles electromyography
a research study comparing how well different doses of the medicine nnc0487-0111 lower blood sugar in people with type 2 diabetes

Conditions: Type 2 Diabetes (T2D)

Summary: the study will look at how well different doses of a new medicine called nnc0487-0111 help lower the blood sugar and body weight in people with type 2 diabetes. nnc0487-0111 is a new medicine which cannot be prescribed by doctors but has previously been tested in humans. participants will either get nnc0487-0111, which is given as tablets or as injections, or placebo. which treatment the participant get is decided by chance.the study will last for about 43 weeks.


Eligibility criteria:
inclusion criteria: * male or female, aged 18-75 years (both inclusive) at the time of signing the informed consent. * diagnosed with type 2 diabetes mellitus greater or equal to 180 days before screening. * stable daily dose(s) greater or equal to 90 days before screening of the following antidiabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose as judged by the investigator: metformin with or without sglt2 inhibitor. * hba1c of 7.0-10.0 procent (53-86 mmol/mol) (both inclusive) as assessed by central laboratory at screening. * body mass index between greater or equal to 23.0 and below 50.0 kg/m\^2. * able and willing to adhere to the protocol including wearing a continuous glucose monitoring (cgm) device provided for the study, as judged by the investigator. exclusion criteria: * treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. however, short term insulin treatment for a maximum of 14 consecutive days and prior insulin treatment for gestational diabetes are allowed. * uncontrolled and potentially unstable diabetic retinopathy or maculopathy. verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. * known hypoglycaemic unawareness as indicated by the investigator according to clarke's questionnaire question.
thrive intervention in schools

Conditions: Childhood Mental Disorder

Summary: this study is designed to test the effectiveness and implementation of an early intervention therapy for children and their primary caregivers by using existing school counselors across several school districts. the intervention is a 6-8 week caregiver-child intervention (thrive) which will be conducted via video conference in the family's home (i.e., zoom), or within the school setting (or a combination of those 2 modalities depending upon feasibility for the family). thrive will be compared to an asynchronous on-line parenting education program, parenting wisely (pw). this online parenting course will be accessed at www.parentingwisely.com. existing school counselors will be trained in the delivery of thrive to 3-7 year old children (in preschool, kindergarten and first grade) and their primary caregivers. in addition to testing the effectiveness of thrive compared to pw, we will also compare two implementation strategies: thrive-coached and thrive-low coached (lc). we will assess ongoing coaching of thrive trainees to increase therapist efficacy and adherence to the intervention (thrive-coached). this will be compared to implementation of thrive with low supports (e.g. weekly supervision) provided only for the first case following the initial training (thrive-lc\]. compared to those randomized to pw, we expect children who receive thrive will have significantly better behavioral and socio-emotional outcomes. caregivers who receive thrive will experience less parenting stress and depression, more optimism and will show more nurturing, emotional tolerance, and supportive caregiving. therapists in the thrive-coached condition will deliver the intervention with higher achieved outcomes and find the intervention to be more acceptable than therapists in the thrive-lc condition. therapists in the thrive-coached condition will be more likely to plan to sustain the intervention following the completion of the study than those in the thrive-lc condition. parents and children receiving thrive from therapists in the thrive-coached condition will have better socio-emotional outcomes than those in the thrive-lc and pw conditions.


Eligibility criteria:
inclusion criteria: * near the clinical threshold on the teacher or parent report form * an active primary caregiver can be identified and is available to participate in the intervention (mother, father, grandparent or any adult in this role) exclusion criteria: * autism * major neurological disorder * participating in active weekly individual or family therapy

Keywords: preschool parent-child relationship emotion development therapy prevention
a randomized evaluation of first-dollar coverage for post-mi secondary preventive therapies

Conditions: Myocardial Infarction; Coronary Artery Disease

Summary: the objective of this randomized trial is to evaluate the effect of providing full prescription drug coverage (i.e. no co-pays, co-insurance or deductibles) for statins, beta-blockers, angiotensin converting enzyme inhibitors and angiotensin ii receptor blockers to patients recently discharged from hospital after acute myocardial infarction.


Eligibility criteria:
inclusion criteria: * discharged alive from hospital after acute mi * receive health services and prescription drug benefits through aetna, inc. exclusion criteria: * enrollment in a health savings account (hsa) plan * age ≥ 65 years of age at the time of hospital discharge * plan sponsor has opted out of participating in the study * receive only medical services or pharmacy coverage but not both through aetna

Keywords: myocardial infarction secondary prevention health insurance cost-sharing
hm vs fibreglass cast immbolization for supracondylar fractures

Conditions: Pediatric Supracondylar Humeral Fracture

Summary: supracondylar humeral fractures are the most common elbow fractures in children and cast immobilization continues to remain as the recommended treatment for modified gartland's classification type i and type iia injuries. apart from plaster of paris and fibreglass casts, the use of waterproof, tubular hybrid mesh (hm) casts have been gaining traction for cast immobilization. although the use of hm cast has been reported to have similar clinical outcomes and overall patient satisfaction scores to the fibreglass cast, the results of the recent studies are only limited and generalizable only to paediatric distal radius fractures. as the application method of hm and fibreglass casts are fundamentally different, it has not been reported if the difference in application duration between the cast materials is significant and its potential implications in outpatient clinic operation. hence, through a randomized controlled trial, this study primarily aims to investigate if the clinical outcomes, patient satisfaction and duration of cast application with the hm casts would be comparable with fibreglass casts in children with supracondylar humeral fractures. through this study, the investigators hope to evaluate the advantages and disadvantages of the respective casting material which may better aid physicians in deciding a more appropriate cast material for treating paediatric supracondylar humeral fractures with cast immobilization and the implications of casting duration on clinic operations.


Eligibility criteria:
inclusion criteria: * first presentation of supracondylar humeral fracture (type i and iia modified gartland's classification) exclusion criteria: * prior treatment of supracondylar humeral fracture * previous elbow injuries * open fractures * polytrauma * neurovascular injuries

Keywords: supracondylar humeral fracture pediatric fracture hybrid mesh cast fibreglass cast
gait and posture analysis in hemiparetic patients through optoelectronic systems, "smart" tools and clinical evaluation

Conditions: Stroke Sequelae; Hemiparesis; Gait Disorders, Neurologic

Summary: the purpose of the study is to validate the use of smart and widespread instruments to detect kinematic, kinetic and spatio-temporal parameters in gait and postural analysis in hemiparetic and healthy individuals. device as single microsoft sensor kinect v2, wearable sensorized clothing and/or smartphone-type devices will be used; it is also planned to analyze and compare such parameters with those obtained through a technique of manual palpatory analysis. finally the obtained measures will be compared with the corresponding ones obtained with three-dimensional instrumented gait analysis (3d-ga).


Eligibility criteria:
inclusion criteria: * patient with post-stroke chronic hemiparesis (at least 6 month post-acute event) * ability to stand erect for 30 seconds * ability to walk with or without aids for 10 meters exclusion criteria: * moderate/severe cognitive impairment (mmse \< 22) * moderate/severe depression (hamilton depression scale \> 20) * severe spasticity
clinical trial of miltefosine to treat mucosal leishmaniasis

Conditions: Leishmaniasis; Leishmaniasis, Mucocutaneous

Summary: the purpose of this study is to determine whether miltefosine is effective in the treatment of mucosal leishmaniasis compared to meglumine antimoniate, the standard treatment.

mucosal leishmaniasis is a rare form of the disease, that affects only 6% of the patients with cutaneous leishmaniasis in the new world. it causes deformities and may be lethal if not treated. it is part of the neglected tropical diseases because on the past sixty years there was few progress regarding other treatment options or improvement at quality of life of its patients. also, there was little interest from the pharmaceutical industry and government authorities to develop new researches. the standard treatment, meglumine antimoniate, is toxic, invasive, requires trained personnel and has many adverse effects and restrictions. on the other hand, miltefosine is the first oral drug to demonstrate efficacy against mucocutaneous leishmaniasis. few clinical trials have being performed in central and south american countries, but so far, just one involved mucosal leishmaniasis patients, and compared miltefosine to amphotericin b. none studies comparing its efficacy to the standard treatment have being done.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of mucosal leishmaniasis * not previously treated, or last treatment must have occurred more than 6 months before the enrollment on the study * use of contraceptive method, if female on child bearing age * sign the agreement and consent form exclusion criteria: * previous leishmanicidal treatment on the past 6 months before the enrollment on the study * electrocardiogram abnormalities on the pretreatment exams * previous kidney, liver and/or heart diseases * diabetes mellitus * hypersensitivity to miltefosine or meglumine antimoniate * pregnant women or breastfeeding mothers * hiv patients

Keywords: leishmaniasis mucocutaneous leishmaniasis therapeutics meglumine antimoniate miltefosine