Kornimate/medical-research-clean huggingface dataset:
eus-endodrill vs. eus-fna for diagnosis of submucosal tumors in the upper gi tract

Conditions: Gastrointestinal Neoplasms

Summary: endodrill is a new instrument for biopsy sampling in the gi-channel. the purpose of this study is as follows: - compare eus-guided endodrill biopsies with endoscopic ultrasound guided fine needle aspiration (eus-fna) in terms of ability to establish the correct diagnosis of submucosal tumors in the upper gi tract.

endodrill is a newly constructed biopsy tool for flexible endoscopic use. it uses a drilling motion within a casing to harvest solid biopsies from tissue through the biopsy channel of a conventional flexible endoscope. it was originally designed for sampling of tissue from submucosal lesions. the investigators first study of the instrument is now finished. endodrill is safe to use and generates more submucosal tissue compared to biopsies with a conventional biopsy forceps. in this study the investigators want to compare the endodrill instrument with fna (both modalities eus-guided) in terms of ability to obtain the correct diagnosis of submucosal tumors in the upper gi-tract. patients diagnosed with suspected submucosal tumors in the upper gi-tract will be enrolled to this study. they will first go through examination with eus. if the suspicion of a submucosal tumor is confirmed, the investigator will perform both eus guided fna and endodrill biopsies in the same patient.the harvested tissue will be evaluated by senior pathologists to clarify which method that generates most correct diagnosis.

Eligibility criteria:
inclusion criteria: * all patients with a suspected submucosal tumor in the upper gi tract that are available for both eus-guided fna and endodrill biopsy exclusion criteria: * mental illness * extreme co-morbidity
pc in stance and during functional mobility following big for pd

Conditions: Parkinson Disease

Summary: lsvt big is an intensive, amplitude based rehabilitation program that has been demonstrated to improve one of the hallmark features of parkinson's disease, specifically bradykinesia. we are interested in knowing the effects of this therapeutic approach on postural control and gait parameters.

lsvt big is an intensive, amplitude based rehabilitation program that has been demonstrated to improve one of the hallmark features of parkinson's disease, specifically bradykinesia. postural instability and gait disturbance is another debilitating feature of parkinson's disease. while lsvt big targets postural correction through exercises which challenge balance, the effect of this intervention on stability margins and functional balance assessments have not been well established in the literature. this study includes outcome measures not previously examined with this intervention and may provide valuable evidence regarding the impact of this intervention on postural control, balance and falls risk. alternative amplitude programs have also been designed to meet the needs of patients with pd. these programs adjust frequencies for patients and individualize sessions more than lsvt big. we are interested in knowing if these alternative frequencies and amplitude approaches are similarly as effective as lsvt big in our outcome measures.

Eligibility criteria:
inclusion criteria: * subjects will be included in the study if they have been diagnosed with idiopathic parkinson's disease and are english speaking. exclusion criteria: * exclusion criteria: 1) previous completion of lsvt big or other formal amplitude program training 2) non-idopathic parkinsonism 3) any medical condition that would contraindicate exercise (ie. unstable cardiovascular disease) 4) cognitive impairment that limits ability to follow direction or demonstration

Keywords: postural control gait
beta-blocker discontinuation in heart failure with preserved ejection fraction

Conditions: Heart Failure With Preserved Ejection Fraction

Summary: this is a prospective pilot study to evaluate changes before and 4 weeks after beta-blocker withdrawal in 30 hfpef patients.

this is a prospective pilot study to evaluate changes before and 4 weeks(+/- 1 week) after beta-blocker withdrawal in 30 hfpef patients. the study involves 2 visits that are 4 weeks apart. the first study visit will occur at a standard of care clinic visit and the second visit will be a research visit to fill out questionnaires and perform the limited echocardiogram. no long term follow up beyond the 2nd visit.

Eligibility criteria:
inclusion criteria: * stable hfpef patients with nyha class ii-iii or elevated bnp ≥100 * n=30 (target: 30). * age: 50 \~ 80 years. * echo evidence of ef ≥50% and grade 2 or 3 diastolic dysfunction. * chronic loop diuretic use * currently on beta-blocker exclusion criteria: * beta blocker was prescribed for treating other cardiac conditions such as atrial fibrillation or coronary artery disease. * heart rate \> 100 bpm * recent hospitalization due to hf within 3 months * non-english speaker

Keywords: hfpef beta-blocker echocardiogram 6mwt
risk and resilience factors in learning disabilities population

Conditions: Learning Disorders

Summary: the purpose of this study is to report preliminary outcomes of executive function and psychopathology symptoms of a manual-based psychological intervention for adolescents diagnosed with learning disorders- i can succeed (ics).


Eligibility criteria:
inclusion criteria: * learning disorder diagnosis * normal range iq * regular class attendance exclusion criteria: * suicidal ideation and psychosis

Keywords: learning disorders
improving detection of atrial fibrillation in primary care with the mydiagnostick

Conditions: Atrial Fibrillation

Summary: atrial fibrillation (af) is the most common arrhythmia and a common cause of stroke. af can be asymptomatic and remain undiagnosed. both the prevalence of af and the proportion of strokes related to undetected af increases with ageing. if af is timely diagnosed and treated accordingly with anticoagulants, disabling strokes can be prevented. in order to help physicians in diagnosing atrial fibrillation, the mydiagnostick was developed. it is a ce certified device that is safe, user friendly and easy to use. this device is capable of detecting or excluding af within one minute by providing a registration of lead i of the ecg. the investigators aim to perform a 2-arm cluster randomized diagnostic trial among patients aged 65 years and over who visit the general practice. in total the investigators will include 42 general practices of which they randomly assign 21 to the mydiagnostick arm and 21 to the control arm. all persons aged 65 years and over who visit the general practice in the mydiagnostick arm will be asked to hold the device every time they visit the surgery during one year. the number of newly detected cases of af with the diagnostic screening strategy with mydiagnostick (mydiagnostick arm) will be compared to care as usual (control arm). also, the number of patients treated with anticoagulants according cha2ds2-vasc score will be compared between both arms. finally, the investigators will assess the number of major adverse cardiovascular events (mace), intracerebral hemorrhages and other major hemorrhages, and all-cause mortality between the arms. end points will be assessed blinded to allocation. the investigators hypothesise that the mydiagnostick improves the diagnosis of atrial fibrillation in primary care and with accordingly treatment will reduce adverse outcomes.

in a recent validation study performed in 200 patients visiting a cardiology outpatient clinic, the sensitivity was 100%, and specificity 96.4% with the mydiagnostics as compared to a 12-lead ecg. adequate comparison of this device with accordingly treatment with care as usual is needed before large scale implementation in the primary care setting can be advocated.

Eligibility criteria:
inclusion criteria: * community dwelling persons visit the gp and aged 65 years of over exclusion criteria: * terminal illness of such severity that anticoagulation is considered to be not appropriate in case of newly detected atrial fibrillation * acute situation in which gp should act instantly * patients with a history of af

Keywords: atrial fibrillation screening primary care diagnostic
evaluation of a novel technique to diagnose carotid artery stenosis

Conditions: Carotid Artery Stenosis

Summary: the purpose of this study is to determine the accuracy of a new non-invasive device, the carotid stenotic scan (css), to check for stenosis of the internal carotid artery (ica) as compared to a carotid ultrasound study.

currently, carotid duplex ultrasound is used for screening for ica stenosis and must be performed by a trained and certified vascular technologist using advanced duplex imaging equipment and with subsequent interpretation by a trained physician. it would be of value to develop an accurate, reliable, low-cost, and easily accessible tool to screen for extra-cranial ica disease in an office based setting. however, such a tool would require novel technology that allows for quick, accurate, reproducible, and safe evaluation. this study will evaluate a new technology called the carotid stenotic scan (css) developed by cvr global. the css instrument uses principles of cardiovascular resonance to detect low frequency pressure fluctuations associated with flow disturbances in areas of significant arterial narrowing. subjects will undergo a clinically ordered clinical carotid duplex ultrasound as part of standard of care. subjects will have a noninvasive css assessment before or after the carotid duplex ultrasound. within 3 months following the date of the initial study visit, the electronic medical record will be queried for any interval correlative imaging studies (cta, mra, or angiography) and reports performed up to 1 month prior and 3 months after the duplex examination date. report of findings will be documented (i.e., % ica stenosis by cta/mra).

Eligibility criteria:
inclusion criteria: * outpatients age \> 18 years sent to the vascular laboratory for carotid duplex examination for initial carotid ultrasound study or for follow-up of known carotid disease. * enrolled patients will include at least 100 subjects with at least moderate known stenosis (50-69% or greater, psv \> 125 cm/sec) or occlusion of one or both icas * up to 25 patients with known fibromuscular dysplasia (fmd) of the internal carotid arteries. exclusion criteria: * age \< 18 years. * hospitalized inpatients. * inability to provide informed consent. * prior history of carotid endarterectomy or carotid artery stent. * prior neck surgery * known prosthetic heart valve, known critical aortic stenosis, or study indication "preop" open heart or aortic surgery.

Keywords: carotid artery stenosis plaque carotid duplex ultrasound fibromsucular dysplasia carotid atherosclerosis
a comparison of fidaxomicin and vancomycin in patients with cdi receiving antibiotics for concurrent infections

Conditions: Clostridium Difficile Infection (CDI)

Summary: administration of concomitant antibiotics (ca) is a known risk factor for treatment failure in the treatment of cdi, as well as for recurrence of cdi. recent data suggested that among patients receiving ca, fidaxomicin is superior to vancomycin. while these data are encouraging, many clinicians remain unclear on how to apply these data to patient care. additionally, patients were excluded from the trials presented to the fda if it was expected that they would require ≥ 7 days of ca. therefore, the clinical question still remains of how to apply these data to the real world patient who requires a long course of ca and develops cdi while on therapy. we therefore propose an open label, comparative and prospective study of fidaxomicin 200 mg twice daily vs oral vancomycin 125 mg four times daily for the treatment of cdi among patients who are receiving a long course of ca. we hypothesize that fidaxomicin will be superior to vancomycin with respect to clinical cure for patients with cdi.


Eligibility criteria:
inclusion criteria: * patients 18 years of age or older with \>3 unformed stools/24 hours with positive stool test for c. difficile. * patients receiving ≥ 1 high or medium risk antibiotic for treatment of an infection other than cdi, for an anticipated duration of ≥ 5 days from the time of enrollment. * high risk: carbapenems, 2nd-4th generation cephalosporins, fluoroquinolones, clindamycin, and beta-lactam/beta-lactamase inhibitor combinations * medium risk: 1st generation cephalosporin, macrolides\*, and aztreonam * \*the macrolide would be considered to be low risk if patients are receiving intermittent macrolides for prophylaxis only and not for treatment of an acute infection exclusion criteria: * patients with severe-complicated disease that would compromise oral therapy (hypotenstion or shock, ileus or bowel obstruction, megacolon). * patients with an allergy to oral vancomycin or fidaxomicin. * patients anticipated to receive metronidazole after enrollment. * patients who already received oral vancomycin or metronidazole (either oral or intravenous) for \> 24 hours within the preceding 72 hours at the time of enrollment. * patients anticipated to receive adjunctive c. difficile therapy (rifaxamin, nitazoxanide, tigecycline) after enrollment. * patients who are on laxatives before they are enrolled into the study, such as lactulose, if: * patients have had a recent dose adjustment; * baseline number of bowel movement while on laxatives is unknown. * number of bowel movements and/or consistency has not changed from baseline. * patients who have had colostomy or ileostomy * patients who will have colostomy or ileostomy after enrollment and before study ends * patients who are or will be on long-term (\>12 weeks) medium or high-risk antibiotics prophylaxis after enrollment

Keywords: vancomycin fidaxomicin cdi diarrhea
phase i nicotinic agonist treatment trial for autism

Conditions: Autism

Summary: this study plans to learn more about whether a nicotine-like investigational new drug, dmxb-a \[3-(2,4-dimethoxybenzylidene) anabaseine\] may have positive effects on mental focus and may help us to find new types of treatment for autism spectrum disorder. subjects will come in for a screening visit and three more drug visits. there will be at least one week between each drug visit to allow the drug to be eliminated from your system completely. during each drug visit subjects will receive either a placebo (a capsule that looks like medicine but is not real), 75 mg of dmxb-a, or 150 mg of dmxb-a. during the drug day vital signs and well being will be monitored by the study physician. subjects will complete some paper and pencil tasks to test memory, attention, speed, and problem solving, some rating scales and questionnaires, and the study team will record brain wave patterns with an electroencephalogram (eeg) .


Eligibility criteria:
inclusion criteria: * age 18-50 * meet dsm-5 criteria for autism spectrum disorder, levels 1 or 2, as defined by autism diagnostic observation schedule * non-smoking persons * in good health exclusion criteria: * persons with estimated verbal and nonverbal iq \< 70. * abuse of other substances. * persons not sufficiently fluent in english to permit testing * those with history of severe head injury * fragile x syndrome * rett syndrome

Keywords: autism nicotinic agonist cognition p50 alpha 7
rct on the combined modality treatment of squamous cell carcinoma of the esophagus

Conditions: Esophageal Neoplasms; Squamous Cell Cancer

Summary: the purpose of the study was to test a null hypothesis that a combined modality treatment of esophageal cancer with neoadjuvant chemotherapy or chemoradiotherapy is equivalent to surgery alone and what are the benefits from adding irradiation to chemotherapy in neoadjuvant treatment of esophageal cancer.

the choice of the most beneficial method of treatment in esophageal cancer remains controversial and is the subject of vigorous debate. surgery is still regarded as the principle modality among treatment strategies, with longterm survival achieved mainly in less advanced cases. more advanced cases, diagnosed more frequently, are more problematic in selection of the optimal therapeutic method. one of the options for improving treatment outcome in patients with advanced esophageal cancer is combined modality treatment with chemo- and chemoradiotherapy. currently available rcts have tested preoperative chemotherapy or chemoradiotherapy separately in comparison to surgery alone. moreover, we do not know from these trials what is the added value of irradiation in a combined modality therapy over a preoperative chemotherapy. another drawback of available rcts is combining 2 different biological cancer entities: adenocarcinoma and squamous cell carcinoma of the esophagus as well as carcinoma of the esophagus and gastro-esophageal junction. that were the reasons for designing our trial testing 3 principal modes of esophageal cancer therapy: surgery vs. chemotherapy + surgery vs. chemoradiotherapy + surgery on homogenous population of esophageal cancer patients with single pathological type - squamous cell carcinoma affecting thoracic esophagus.

Eligibility criteria:
inclusion criteria: * informed consent * histopathologically proven, clinically stage ii-iii (ctnm according to ajcc/uicc classification), primary squamous cell carcinoma of the thoracic esophagus * patients' age above 18 years * general condition with karnofsky performance status of \>70 * circulatory and pulmonary capacity at normal range (fev1 \>60%; fvc \>60%, nyha i-ii, cardiac output \>40%) * normal function of the bone marrow (rbc \>3,5 t/l; plt \>100 g/l) * normal renal (creatinine \<1.5 of the upper limit) and liver (ast or alt \<2,5 of the upper limit or bilirubin \<1,5 of the upper limit) function exclusion criteria: * metastatic disease * synchronous malignancy * history of other cancer within 5 years prior to esophageal cancer treatment * history of allergic reaction to cisplatin of 5-fluorouracil * systemic infection * pregnancy or female patients in childbearing age without proper contraceptives.

Keywords: esophagectomy chemotherapy chemoradiotherapy combined modality therapy
covid-19 pandemic induced stress and symptoms

Conditions: Stress Reaction; Stress, Emotional; Stress; COVID-19 Pandemic

Summary: the previous survey of oncology patients at university of california, san francisco in 2020-2021 found an alarmingly high symptom burden and high levels of stress and loneliness among respondents. this is a follow-up study with the same sample of oncology patients and survivors who participated in the previous study

objectives: 1. evaluate for associations among general and disease-specific measures of stress and measures of social isolation and loneliness. 2. evaluate for associations between general and disease-specific stress and common symptoms associated with cancer and its treatments. 3. evaluate for associations between social isolation and loneliness and common symptoms associated with cancer and its treatments. 4. evaluate for associations between social isolation and loneliness and health behaviors and quality of life (qol) as compared to our last survey. as a baseline. 5. evaluate for changes in stress, social isolation, loneliness and symptom burden between the two time points. outline: patients will be asked to complete self-report questionnaires online. questionnaires will take approximately 60 minutes to complete. and directed to take rest periods at 20 minute intervals. participants will be given two weeks to complete the instruments.

Eligibility criteria:
inclusion criteria: * current/previous diagnosis of cancer * able to read, write, and understand english * able to complete the study questionnaires on line * able consent to participate. exclusion criteria: * participants of our previous covid survey study who opted out of future research.

Keywords: follow-up study
quadratus lumborum block vs tranversus abdominis plane block for cesarean section

Conditions: Postoperative Pain

Summary: the quadratus lumborum block (qlb) was first described by blanco in 2007. the main advantage of qlb compared to the transversus abdominis plane block (tap) is the extension of local anesthetic agent beyond the tap plane to the thoracic paravertebral space. the wider spread of the local anesthetic agents may produce extensive analgesia and prolonged action of the injected local anesthetic solution. previous studies showed that both tap block and qlb may reduce morphine requirements in the postoperative period in patients who had cesarean section under spinal anaesthesia. however there are no published reports comparing the 2 techniques. the aim of this randomised controlled, double blinded study is to compare the analgesic efficacy of qlb compared to tap block in patients who had cesarean section under spinal anesthesia.

after ethical committee approval, informed written consent will be obtained from all patients. a sample size of 72 patients (36 per group) was calculated based on 15% reduction in morphine consumption with 0.05% significance and a power of 0.8. consenting patients scheduled to have elective cesarean section under spinal anesthesia will be randomised to receive bilateral qlb or tap at the end of surgery.the dose of local anaesthetic in both groups will be 0.2 ml/kg 0.125% bupivacaine. allocation to either group will be done using closed envelope technique. all the blocks will be performed in operation theatre after the end of cesarean section with intravenous access, ecg, bp, oxygen saturation by pulse oximetry monitoring and full resuscitation equipment and medication ready. all patients will be in the supine position . under ultrasound guidance a 22 gauge, two inch pajunk sonoplex needle will be used for both techniques. the calculated dose of local anaeshetic will be injected bilateraly with intermittent aspiration. the spread of injectate will be seed on ultrasound. all patients will receive the routine postoperative analgesia, comprising patient-controlled iv morphine analgesia and regular diclofenac and paracetamol. all patients will be assessed postoperatively by a blinded investigator: in the postanesthesia care unit and at 2, 4, 6, 12, 24, 36, and 48 h postoperatively.

Eligibility criteria:
inclusion criteria: elective caesarean sections asa 1 to 3 written informed consent. exclusion criteria: patient refusal local infection at the site of injection allergy to study medications sepsis anatomic abnormalities systemic anticoagulation or coagulopathy inability to comprehend or participate in pain scoring system inability to use intravenous patient controlled analgesia