Kornimate/medical-research-clean huggingface dataset:
natural orifice transluminal endoscopic surgery for colorectal cancer

Conditions: Colorectal Cancer

Summary: the purpose of this study is to assess different hybrid natural orifice transluminal endoscopic surgery techniques in management of colorectal cancer as regard: feasibility of the technique, short term oncologic outcome and functional outcome.

intervention will be done by conventional laparoscopy and transanal endoscopy (teo or gelpoint platform), patients are divided into two arms to compare different natural orifice techniques in resection of colorectal cancer.

Eligibility criteria:
inclusion criteria: 1. medically fit patient. 2. non metastatic pathologically proven sigmoid colon cancer. 3. non metastatic pathologically proven rectal cancer. 4. patient continent for stool. exclusion criteria: 1. patients with american society of anesthesiologist (asa) score 4 and 5. 2. patients with cardiac or chest problems that cannot withstand insufflation. 3. unresectable tumors (defined as those who cannot be resected without a high likelihood of leaving microscopic or gross residual disease at the local site because of tumor adherence or fixation). 4. obstructed or perforated cancer. 5. patients with metastatic colorectal cancer. 6. incontinent patients.

Keywords: natural orifice surgery natural orifice specimen extraction tatme
internet-delivered cbt for asthma-related anxiety: feasibility

Conditions: Asthma

Summary: this is a study to investigate acceptability and feasibility of a novel protocol on exposure-based cbt for asthma-related fear delivered over the internet (internet-cbt).

asthma is one of the most common chronic diseases around the world, with a high prevalence of anxiety disorders. in a prior study (clinicaltrials.gov id: nct03158194) a protocol for exposure-based cbt was developed for asthma-related anxiety. the aim of the current study is to evaluate acceptability and feasibility of our protocol for asthma-related fear when delivered over the internet (internet-cbt). the plan is to include 30 participants that will all receive the intervention in this uncontrolled feasibility study.

Eligibility criteria:
inclusion criteria: * asthma diagnosed by a physician * anxiety or stress related to asthma exclusion criteria: * severe psychiatric disorder * chronic obstructive pulmonary disease (copd) and other chronic airway disorders other than asthma

Keywords: asthma anxiety stress
early recovery outcomes after standardized fast-track whipples procedure

Conditions: Pancreas Cancer

Summary: today the whipple procedure is the preferred operation for malignancy in the pancreas. in abdominal surgery this procedure is known for its high surgical stress-response in the patient, which has been attempted to be resolved with the introduction of preoperative high-dose steroids and goal-directed fluid therapy (gdt). despite this effort, complications still occur regularly (30%) in the first weeks after the operation here at rigshospitalet. therefore there is still a challenge in the patients who have undergone the whipple procedure in the acute postoperative phase. this shows in for example at rigshospitalet, where 50% of the patients continue to be in the need of vasoactive medication the morning after the operation. nevertheless, no studies have in detail described the acute (\<24h) postoperative phase. there is also an importance in the fact that there is often no description or control over other important factors, for example medicine with influence on the circulatory system, fluid treatment and response to this etc.. the purpose of this study is to investigate what issues or complications, in particular those of circulatory matter that occurs in this particular group of patients 24 hours after the operation. furthermore there is lacking a description of which cause-response- link there can be between early and later (30 days) complications, as well as when each of these complications occur. therefore, there will also be collected data on complications within the first 30 days after the operation for the purpose of a later secondary publication with the same authors.


Eligibility criteria:
inclusion criteria: * the patient has undergone the whipple procedure * the patient is over 18 years ol * the patient has signed a consent statement from the postoperative therapy ward exclusion criteria: * the patient did not receive 125 mg of methylprednisolone prior to the operation * the patient did only undergo pancreatectomy * the patient wasn't given epidural anesthesia * the patient was given anesthesia through a mask
suicide classification system

Conditions: Suicide and Self-harm

Summary: the purpose of this study is to evaluate whether a new standardized language for categorizing suicidal and self-injury related thoughts and behaviors can be readily adopted for use by mental health clinicians. efforts also include developing a measure that can be used to help clinicians identify appropriate terms (e.g., behaviors) for specific patients.

in recent years, suicide prevention has received increased focus within the va. this is in part related to concerns regarding the mental health and associated suicide risk of operation enduring freedom/operation iraqi freedom military personnel, and a recent study highlighting the increased risk of death by suicide for members of the veteran population. suicide prevention initiatives could be greatly enhanced if a clinically feasible uniform language regarding suicidality and self-injury was readily available and adopted throughout the va system. with this goal in mind, the self-directed violence classification system (sdvcs) and clinical tool were developed based upon the centers for disease control and prevention (cdc) nomenclature and va visn-19 mirecc's work in this area. the purpose of this study is to evaluate whether a new standardized language for categorizing suicidal and self-injury related thoughts and behaviors can be readily adopted for use by mental health clinicians. efforts also include developing a measure that can be used to help clinicians identify appropriate terms (e.g., behaviors) for specific patients.

Eligibility criteria:
inclusion criteria: * suicide prevention coordinator team members at denver or grand junction va medical center * mental health leadership at denver or grand junction va medical center * mental health professionals at denver or grand junction va medical center exclusion criteria: * failure to sign appropriate informed consent * mirecc staff members

Keywords: suicide nomenclature
a study of memory, thinking, and brain imaging in adults with histiocytosis

Conditions: Histiocytosis

Summary: the purpose of this study is to try to understand how histopcytosis can cause symptoms or problems in the brain. the tests being done in the study will look at memory and thinking as well as brain function via mri scan.


Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 years. * fluency in english * diagnosis of a histiocytic disorder as determined, in the opinion of the study pi, by a corroborating constellation of histopathology, clinical, and/or radiologic findings. * will undergo standard of care mri. exclusion criteria: * known intracranial involvement of histiocytosis (including dura, leptomeninges and brain parenchyma) * prior stroke or intracranial hemorrhage * other (non-histiocytic) intracranial neoplasm or neurological disorder deemed by the pi or co-pi to confound neuroimaging studies (e.g., demyelinating disease) * existing diagnosis of a psychiatric disorder or untreated mood disturbance * existing diagnosis of a neurodegenerative disease, such as alzheimer's disease * chronic or daily excessive alcohol consumption as determined by the pi. * history of chronic use of corticosteroids, defined as continuous treatment for six months or longer at any time in the past * history of severe claustrophobia or other contraindications to patient soc brain mri * prior intravenous cytarabine or cladribine * other current or prior treatments (e.g., high-dose chemotherapy for a different cancer) deemed by the pi or co-pi to confound imaging studies or cognitive performance

Keywords: 17-199 histiocytosis
safety and efficacy of the cre8 sirolimus-eluting stent for the treatment of de novo coronary artery lesions

Conditions: Coronary Artery Disease

Summary: the purpose of this study is to evaluate the safety, efficacy and deliverability of the cre8 sirolimus-eluting stent system in the treatment of patients with de novo coronary artery lesions.

this is a prospective, multi-center, single-arm observational registry trial planned to enroll 800 subjects. all 800 subjects enrolled will receive cre8 stents. clinical follow-up will be performed at 1 month, 6 months,12 months and annually up to 5 years after the procedure.

Eligibility criteria:
inclusion criteria: * age ≥18 years and ≤ 75 years, male or female without pregnancy; * patients with clinical evidence of asymptomatic heart disease, stable or unstable angina, or old myocardial infarction; * de novo lesions of native coronary arteries; * target vessel diameter between 2.25mm and 4.5 mm, and target lesion length ≤ 60mm by visual estimation; * target lesion diameter stenosis ≥ 70% by visual estimation; * each target lesion must be implanted the same stent (cre8); * patients is eligible for percutaneous coronary intervention (pci) and is an acceptable candidate for surgical revascularization (cabg); * patients with left ventricular ejection fraction ≥40%; * patients who can understand the nature of the study, agree to participate and accept angiographic and clinical follow-up, and have provided written informed consents. exclusion criteria: * patients with acute myocardial infarction (ami) within 72 hours; * chronic total occlusion lesion (timi flow 0 before procedure), left main disease and/or triple-vessel lesion that might require treatment; * heavily calcified or tortuous lesions which cannot be successfully pre-dilated, and lesions which are not suitable for stent delivery and deployment; * in-stent restenosis; * thrombotic lesions; * patients who had received any other stent in the past one year; * patients with acute or chronic renal dysfunction (defined as creatinine greater than 2.0 mg/dl); * patients with cardiogenic shock, acute infection, known bleeding or coagulation disorder, or with a history of active gastrointestinal bleeding, ulcer, cerebral hemorrhage or subarachnoid hemorrhage and stroke within 6 months; * patients who allergic to aspirin, clopidogrel, ticagrelor, ticlopidine, heparin, contrast agent, sirolimus, polymer, co-cr alloy, or with contraindication to aspirin or clopidogrel or ticagrelor; * patients with life expectancy less than 1year; * patients who had participated in another investigational drug or device trial that has not completed the primary endpoint; * patient is in the opinion of the investigator, unable to comply with the requirements of the study protocol; * patients who had underwent heart transplant surgery.
real-world resource use and costs of car-t therapies in diffuse large b-cell lymphoma (dlbcl): inpatient and outpatient settings

Conditions: Diffuse Large B-cell Lymphoma

Summary: a retrospective, non-interventional cohort study was used to address the study objectives. this study aimed to provide a better understanding of real-world healthcare resource utilization (hru) and healthcare reimbursement costs associated with chimeric antigen receptor modified t cell (car-t) therapy among patients with dlbcl.


Eligibility criteria:
inclusion criteria: car-t cohort: * patients had at least one international classification of diseases, tenth revision (icd-10) diagnosis code for dlbcl. * patients received car-t therapy following dlbcl diagnosis. the administration date of car-t therapy was defined as the index date. patients who received both car-t therapy and allo-hsct were classified based on the first treatment that the patient received. * patients were at least 18 years of age as of the index date. * patients had at least three months of continuous eligibility in the medicare part a and part b data before the index date. since 2020 part d data is not available in the current data cut; eligibility requirement in the part d data was not required. * patients were further classified into car-t ip and car-t op cohorts depending on where the administration occurred. allo-hsct cohort: * patients had at least one icd-10 diagnosis code for dlbcl. * patients received allo-hsct following dlbcl diagnosis. the date of allo-hsct procedure was defined as the index date. patients who received both car-t therapy and allo-hsct were classified based on the first treatment the patient received. * patients were at least 18 years of age as of the index date. * patients had at least three months of continuous eligibility in the medicare part a and part b data before the index date. since 2020 part d data is not available in the current data cut; eligibility requirement in the part d data was not required. exclusion criteria: • patients had a medical claim associated with a clinical trial (icd-9 cm code v70.7; icd-10 cm code z00.6) during one month before and after the index date.
using virtual reality for patients with gastrointestinal disease

Conditions: Gastrointestinal Disease; Inflammatory Bowel Diseases

Summary: the primary aim of this study is to evaluate the effect and impact of a technology which creates a virtual reality (vr), personalized representation of a patient's endoscopic findings in comparison our standard practice (sp). our study will compare the level of knowledge, understanding and satisfaction the patient and family have between those receiving sp and those receiving both sp and vr.


Eligibility criteria:
inclusion criteria: * patients aged 8-25 years of age who are willing and able to participate * patients who recently had an endoscopic procedure at boston children's hospital exclusion criteria: * patients who are unable to provide consent due to age or developmental status

Keywords: crohns disease patient education ulcerative colitis celiac ulcer polyp gastrointestinal bleeding inflammatory bowel disease virtual reality
understanding needs

Conditions: Caregivers

Summary: the "understanding needs" project is designed to gain an understanding of the needs of informal caregivers. researchers have designed a survey to highlight activities of daily living involved in the caregiving role, pain related to caregiver, and potential services desired. the initial phase of the study will consist of a focus group of informal caregivers to discuss current needs. the survey will then be refined based on knowledge gained from the focus group, and feedback from expert researchers. the refined survey will then be disseminated to caregivers throughout the country. please click on the following anonymous link to participate: https://chhscolostate.co1.qualtrics.com/jfe/form/sv_54j83bqsitmuoub

the "understanding needs" project highlights the needs of informal caregivers. an informal caregiver is defined as a person who regularly provides unpaid care to another adult. the survey will ask about pain intensity, pain interference, and relation of pain to the caregiving role. the survey will also address which activities the caregiver assists with, and activities now lacking since becoming a caregiver. one focus group will be completed to refine the contents of the survey prior to dissemination. the results will be analyzed by an occupational therapist, with a focus on how pain may connect to assistance with daily living activities provided to the care recipient. the needs of caregivers within the community will be compiled to inform future involvement in remediation of needs.

Eligibility criteria:
inclusion criteria: * at least 18 years old * informal caregivers (unpaid) * have been a caregiver for \> 6 months * provide at least 8 hours of care/week * able to read english exclusion criteria: * less than 18 years old * paid caregivers * not able to read english * caregiver or care recipient has a terminal diagnosis with a life expectancy of less than one year

Keywords: caregivers chronic pain
validation of lower body negative pressure (lbnp) model of human hemorrhage in trauma patients

Conditions: Physical Trauma

Summary: lower body negative pressure (lbnp) is a laboratory model used to study hemorrhage in humans. the investigators hypothesize that the physiologic changes that occur with application of lbnp mimic those observed in bleeding and hemodynamically unstable trauma patients, and that lbnp is a truly valid model of human hemorrhage.

specific aims: 1. compare physiologic waveform data obtained from bleeding and hemodynamically unstable trauma patients to existing data collected from lbnp subjects. 2. determine the accuracy of lbnp in approximating the physiologic changes that occur in bleeding and hemodynamically unstable trauma patients.

Eligibility criteria:
inclusion criteria: * age: 31 days - 89 years * patients cared for in the emergency department (ed), operating room (or), or the intensive care unit (icu) at denver health medical center, children's hospital colorado and san antonio military medical center * patients with report of physical trauma within 24 hours of presentation at the hospital. exclusion criteria: * pregnant patients * incarcerated patients * patients who object at any time to participating in the study

Keywords: physical trauma
digital radiography in detection of recurrent caries underneath chlorhexidine containing adhesive versus conventional adhesive after one year follow up: randomized clinical trial

Conditions: Recurrent Caries Incidence

Summary: this study will be conducted to compare the effect of chlorexidine containing adhesive versus conventional one in prevention of secondary caries lesion underneath composite restoration over one year follow up null hypothesis

each patient will have at least 2 class ii cavities.one will be restored using the intervention and the other using the control. digital radiographs will be taken and the images will be processed using a digital system. then the teeth will be evaluated by expert in dental radiology who had no awareness of the results of the visual inspection. the examiner will use a radiograph viewer and a radiographic film magnifier to determine the presence or absence of radiolucency underlying the restoration. the clinical and radiographic examination will be assessed according to the fdi world dental federation clinical criteria for the evaluation of direct and indirect restorations the aim of this equivalent trial is to examine if the chlorhexidine containing adhesive is effective as the conventional adhesive in prevention of recurrent caries under resin composite restoration after one year follow up in high caries risk patients with class ii cavities. based on the previous papers by papagiannoulis et al .,1999 and kohler et al.,2000, the success rate reported was about 95% (absence of caries). if there is truly no difference between the standard and experimental treatment, then 37 patients are required to be 80% sure that the limits of a two-sided 90% confidence interval will exclude a difference between the standard and experimental group of more than 15 %. the sample size was calculated by sealed envelope online. data will be analyzed using ibm spss advanced statistics (statistical package for social sciences), version 21 ( spss inc. chicago , il). numerical data will be described as mean and standard deviation or median and range. categorical data will be described as numbers and percentages. comparisons between categorical variables will be performed using the chi square test. an equivalent limit will be tested. a p -value less than or equal 0.05 will be considered statistically significant. all tests will be two tailed

Eligibility criteria:
inclusion criteria: * patients should be 20-25 years of age with high caries risk. patients should have an acceptable oral hygiene level. patients must have at least two proximal lesions to be restored. exclusion criteria: patients with a compromised medical history. severe or active periodontal disease. heavy bruxism or a traumatic occlusion. lack of compliance
an open-label, randomized, parallel-arm study investigating the efficacy and safety of intravenous administration of pamrevlumab versus standard of care in patients with covid-19

Conditions: COVID-19 Respiratory Infection; COVID-19 Pneumonia; Covid19

Summary: this is a randomized, open-label, parallel-arm study to investigate the efficacy and safety of pamrevlumab in patients with documented sars-cov-2 infection. the study consists of screening, a treatment period, and a follow-up period. the study will enroll patients who have been hospitalized and who are not currently on invasive mechanical ventilation. the treatment period is open ended, and patients will be randomized to treatment with pamrevlumab or standard of care in a 1:1 ratio according to a pre-generated randomization list. pamrevlumab dosing, 30 mg/kg iv, will be administered at day 1, day 7 and day 14. based on investigator's decision, treatment may be continued every 3 weeks after day 14, up to 11 weeks. a follow-up by visit or phone call will be performed 8 and 12 weeks after the end of the last dose of treatment. the treatment period for an individual patient will not exceed 11 weeks.


Eligibility criteria:
inclusion criteria: * documented covid-19 infection * age \>=18 to \<=80 years * interstitial pneumonia (findings of consolidation or ground glass opacities as assessed by chest hrct) * respiratory distress, defined as pao2/fio2 ratio of \>=100 \<=300 mmhg, requiring supplemental oxygen and hospitalization exclusion criteria: * invasive mechanical ventilation at screening * pregnancy * incapacity to express a valid informed consent * known hypersensitivity to monoclonal antibodies used as experimental drugs for any clinical indication
ykl -40 as new biomarker in covid -19 patients

Conditions: COVID-19

Summary: the coronavirus disease-2019 (covid-19)is a pandemic disease caused by sars -cov-2 which belongs to the β-coronavirus family . the majority of affected individuals exhibit no or mild to moderate symptoms, but up to 15% of patients develop severe pneumonia with approximately 6% progressing to acute respiratory distress syndrome and multiorgan failure. biomarkers are needed to identify patients will suffer rapid disease progression to severe complications and death. preliminary studies describe vasculitic processes underlying organ damage in seriously ill patients, induced by the activation of inflammatory cascades, complement activation and pro-inflammatory cytokines (i.e. interleukin). the severity of vasculitic damage is unfortunately not easily predictable through currently used laboratory biomarkers such as d-dimer or prothrombin time/activated partial thromboplastin time. the severity of the disease is mainly driven by diffuse interstitial lung diseases. ykl-40 has a pro mitogenic action on pulmonary fibroblasts, increases the activity of macrophages and is associated with inflammatory disorders. in ild, ykl-40 has been described to be associated with the severity of lung diseases and with the risk of death. ykl-40 serum levels could therefore be of interest for diagnosis and prognosis since it is at the cross-link between vascular and epithelial lung damage. .


Eligibility criteria:
inclusion criteria: * • group one should be diagnosed by rt-pcr (reverse transcriptase polymerase chain reaction). * healthy individual must be without a prior history of chronic inflammation in the lung. exclusion criteria: * patients with acute renal failure (arf) or multiple organ damage (mof).