Kornimate/medical-research-clean huggingface dataset:
external-beam radiation therapy compared with vaginal brachytherapy after surgery for stage i endometrial cancer

Conditions: Endometrial Cancer

Summary: rationale: external-beam radiation therapy uses high-energy x-rays to kill tumor cells. implant radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. giving external-beam radiation therapy or implant radiation therapy after surgery may kill any tumor cells that remain after surgery. sometimes, after surgery, the tumor may not need more treatment until it progresses. in this case, observation may be sufficient. it is not yet known whether radiation therapy is more effective than observation when given after surgery in treating stage i endometrial cancer. purpose: this randomized phase iii trial is studying external-beam radiation therapy or implant radiation therapy to see how well they work compared with observation in treating patients who have undergone surgery for stage i endometrial cancer.

objectives: * compare the rate of 5-year locoregional relapse in patients undergoing external-beam radiotherapy or vaginal brachytherapy vs observation only after surgery for stage i endometrial cancer. * compare 5-year rate of distant metastases in these patients. * determine overall survival rate in these patients. * determine prognostic factors for relapse and morbidity. outline: this is a randomized, multicenter study. patients are randomized to 1 of 2 treatment arms. * arm i: patients undergo either vaginal brachytherapy or external-beam radiotherapy. * arm ii: patients are observed and undergo no further treatment. after completion of study treatment, patients are followed for approximately 83 days. projected accrual: a total of 400 patients will be accrued for this study.

Eligibility criteria:
inclusion criteria: * diagnosis of figo 1988 stage i-iia endometrial cancer, meeting 1 of the following criteria: * age ≥60, stage ic grade 1 or 2 with deep (≥ 50%) myometrial invasion * age ≥60, stage ib grade 2 or 3 (with \< 50% myometrial invasion) * stage iia, any age * no grade 3 endometrial carcinoma with deep myometrial invasion * total abdominal hysterectomy and bilateral salpingo-oophorectomy required prior to randomisation * who performance status 0-2 exclusion criteria: * serous or clear cell histology or uterine sarcoma * staging lymphadenectomy * interval between surgery and radiotherapy \> 8 weeks * history of previous malignant disease (except basal cell carcinoma of skin) * previous radiotherapy, hormonal therapy or chemotherapy * diagnosis of chrohn's disease or ulcerative colitis

Keywords: stage i endometrial carcinoma
neurogenic inflammation in peri-implant and periodontal diseases

Conditions: Neurogenic Inflammation; Periimplant Diseases; Periodontal Diseases; Gingival Crevicular Fluid; Periimplant Sulcular Fluid

Summary: regulatory effects of some neuropeptides substance-p (sp), neurokinin-a (nka), calcitonin gene-linked peptide (cgrp) and neuropeptide-y (npy) )on inflammatory responses in periodontal disease has been described; however, the impact of neuropeptide levels are not clearly defined in healthy and diseased peri-implant tissues.ın order to evaluate the situation, thirty-nine implants that have been loaded over the past 12 months and their symmetrically matching teeth were evaluated using a split-mouth study design. clinical periodontal examinations included the silness-löe plaque index, löe-silness gingival index, bleeding on probing, probing pocket depth and clinical attachment level parameters were determined. gingival crevicular fluid (gcf)/periimplant sulcular fluid (pisf) samples were collected, and the levels of the neuropeptides were determined by enzyme-linked immunosorbent assay. correlations between gcf/pisf neuropeptide levels and the clinical examination parameters were evaluated in the peri-implant/periodontal soft tissues.


Eligibility criteria:
inclusion criteria: the main inclusion criteria for patient selection were as follows: * compliance with systematic maintenance care; * adult, non-smoker, systemically healthy * not using any medicament for the last 6 months ; * partially dentated patient treated with implant-supported metal ceramic full crowns and/or fixed partial dentures * as the study was split-mouth designed, in each individual at least one implant and one matching tooth in the same mouth symmetrically representing the same tooth group (premolars/molars); * a single type of metal ceramic implant restoration that is functional for at least 1 year; and a matching tooth with no dental or endodontic restorations. exclusion criteria: * medical history of cancer, rheumatoid arthritis, diabetes mellitus, or cardiovascular disease and any other systemic disease affecting lipid metabolism (i.e. impaired glucose tolerance, metabolic syndrome); * compromised immune system; * pregnancy, menopause, or lactation; * ongoing drug therapy that might affect the clinical characteristics of periodontitis and lipid metabolism; * dental treatment during the 6 months prior to data collection.
a survey of sleep problems in survivors of breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to gain greater understanding of the problems breast cancer survivors experience related to difficulty sleeping and insomnia. poor sleep can affect a person's mood, increase feelings of fatigue, as well as pain. a greater knowledge and understanding of sleep disturbances can lead to more effective treatment of sleep problems and significantly improve quality of life.

individuals who consent to participate in this study will be asked to complete a battery of questionnaires that will take approximately 1 hour. based on answers they give to the questionnaires, 45 patients will be asked to participate in a sleep study done at a sleep lab. if you choose to take part, then you will be asked to do the following: spend approximately 1 hour answering questionnaires either at the breast cancer center with a research assistant, at home on the phone with a research assistant, or by completing the questionnaires at home and returning them by mail. you will only be asked to complete questionnaires one time. the questionnaires will ask you questions about your: * past medical history * demographics * sleep quality * sleep habits * energy level, pain, daytime sedation * quality of life * menopausal symptoms * depression * fears if you are then selected to participate in the sleep study, further information will be provided for you. after you are finished with the questionnaires, the research assistant will provide you with any necessary further information and feedback. the research assistant will also be able to put you in contact with a study doctor should you require any further assistance. after you are finished with the study, the study doctor may contact you for clarification of your answer on a question, or for an answer if you have by any chance missed a question.

Eligibility criteria:
inclusion criteria: subject inclusion criteria for questionnaire portion of study * women with a diagnosis of stage i, ii, or iii breast cancer who are one year posttreatment, but not more than 10 years post-treatment (surgery, chemotherapy, and/or radiation) prior to entrance into the study. use of biological and/or hormonal therapy is acceptable. * greater than 18 years of age. * able to speak and read english. exclusion criteria: subject exclusion criteria for questionnaire portion of study •evidence of acute or chronic encephalopathy or psychiatric disease severe enough to compromise data collection. exclusion criteria for sleep lab study •women who are unable or unwilling to avoid alcohol, caffeine consumption or cigarette smoking as of 3 p.m. on the day of the sleep study.
post-market surveillance study to evaluate the long-term safety and effectiveness of the lvis device

Conditions: Intracranial Aneurysms

Summary: the proposed study is a multi-center single arm retrospective and prospective data collection, of patients treated with the lvis device of specific sizes of 3.5mm, 4.0mm, 4.5mm, 5.5mm with up to 5 years follow-up. information collected during the study will be standardized across centers to include pre-treatment baseline characteristics of patients including aneurysm(s) symptoms, procedural information, prespecified clinical safety events of interest, and follow-up imaging, clinical visits or telephone calls.


Eligibility criteria:
inclusion criteria: the following criteria match the fda-approved indications for use per pma (p170013) * subjects treated with the lvis® device in accordance with currently approved indications for use; * treatment of wide-necked (neck ≥ 4mm or dome to neck ratio \< 2) intracranial saccular aneurysm arising from a parent vessel with a diameter ≥ 2.0 mm and ≤ 4.5 mm who underwent treatment with lvis device of researched sizes within the last 5 years. (device models: 212517-lvis, 212525-lvis, 213015-lvis, 213025-lvis, 213041-lvis, 214035-lvis, 214049-lvis; 212912-lvis, 212917-lvis, 212922-lvis, 212928-lvis, and 212931-lvis); * availability of medical health records; * subject whose age is ≥ 18; * appropriate or waived consent: 1. for retrospective review: local institutional review board approves the research as exempt, allowing an all-inclusive retrospective examination of medical records documenting treatments using the study devices and available clinical and imaging follow up; 2. for prospective follow up: subject or his/her legally authorized representative consents to participation in the study follow up visits up to 5 years, and provides a signed informed consent form as applicable;. exclusion criteria: * subjects not treated according to the currently approved indications for use
meditative neurofeedback for depression

Conditions: Depression - Major Depressive Disorder; Depression Disorders

Summary: the goal of this open-label single-arm study is to test a meditative neurofeedback intervention for depressed mood.

the goal of this open-label single-arm study is to test whether a 10-session meditative neurofeedback intervention significantly alleviates depressive symptons as well as improves secondary outcomes of rumination and mindfulness.

Eligibility criteria:
inclusion criteria: * moderate depression per phq9 symptom ratings exclusion criteria: * active substance abuse/dependence * psychotic disorders * bipolar disorder * displaying acutely suicidal behaviors

Keywords: meditation neurofeedback rumination eeg anxiety depression
motivational interviewing to address suicidal ideation for veterans at high risk for suicide

Conditions: Suicide, Attempted; Suicidal Ideation

Summary: the purpose of this project is to conduct a randomized control trial with 470 veterans to examine the impact of a revised version of motivational interviewing to address suicidal ideation (mi-si-r) on risk for suicide attempts and suicidal ideation when compared to high quality usual care.

research suggests that treatments to reduce suicidal behavior may need to focus on both the motivation to live and the motivation to die to obtain optimal effects. the pi developed a revised version of motivational interviewing to address suicidal ideation (mi-si-r) to help veterans resolve ambivalence about living by increasing the motivation to live, that consists of three sessions delivered in-person, virtually, or by telephone. enhanced usual care (euc) for high-risk veterans includes safety plans administered or reviewed by research therapists, care coordination, and access to a 24-hour crisis hotline. in a preliminary randomized controlled trial (rct) in psychiatrically hospitalized veterans, mi-si-r plus euc was associated with 50% fewer suicide attempts and 41% lower likelihood of suicidal ideation compared to euc alone. the investigators are proposing an rct comparing mi-si-r plus euc (mi-si-r+euc) to euc alone in a sample of 470 high-risk veterans with recent suicidal crises from three vha medical centers, with "high-risk" defined as a suicide attempt within a month or suicidal ideation \> 5 on the beck scale for suicidal ideation. half (n = 235) will be randomized to mi-si-r+euc (three sessions in-person, via video connect, or telephone) and the remaining participants (n = 235) will receive euc alone. all participants will be asked to complete telephone follow-up assessments at 1, 3, 6, and 12-months after randomization. this will allow the investigators to determine the efficacy of mi-si-r+euc in reducing risk for suicide attempts (aim 1) and reducing overall suicidal ideation (aim 2) when compared to euc alone.

Eligibility criteria:
inclusion criteria: * veteran status, * admitted to an inpatient unit, referred by a suicide prevention coordinator, or identified as high-risk via data extraction, * age 18 and over, * english speaking and reading, and * ability to understand the study and provide informed consent, * high-risk status confirmed by suicide attempt within a month on the columbia- suicide severity rating scale or a score \> 5 on the scale for suicidal ideation exclusion criteria: * current psychosis, * active mania, * dementia, * impaired decision making capacity, and * institutionalization due to hospitalization in a non-va facility, jail, or prison.

Keywords: veterans motivational interviewing
clinical study of 18f-fapi-rgd in interstitial lung disease associated with connective tissue disease

Conditions: Interstitial Lung Disease

Summary: the goal of this observational study is to examine clinical utility of 18f-fapi-rgd pet/ct imaging in evaluating connective tissue disease-associated interstitial lung disease. participants will undergo clinical evaluation and 18f-fapi-rgd pet/ct examination.

interstitial lung disease is an overarching term for a wide range of disorders characterized by inflammation and/ or fibrosis in the lungs. interstitial lung disease associated connective tissue diseases(ctd-ild) is one of the most common types.the goal of this study is to explore the feasibility of using 18f-fapi-rgd, a dual-targeting heterodimeric pet tracer that recognizes both fibroblast activation protein (fap) and integrin αvβ3 for detecting connective tissue disease associated interstitial lung disease (ctd-ild), and analyze the relationship between 18f- fapi-rgd pet/ct images and related parameters of lung function, clinical laboratory indicators and hrct scores.

Eligibility criteria:
inclusion criteria: * age 18 and above * patients who have been diagnosed with, or are clinically highly suspected of ild * patients who have been diagnosed with, or are clinically highly suspected of ctd-ild exclusion criteria: * pregnant or breastfeeding * patients with tumor, other respiratory diseases, and lung surgery * abnormal cardiopulmonary function or mental state, unable tolerate pet/ct
prevalence of fuctional heartburn in patients with ibs .

Conditions: Heartburn

Summary: the purpose of this study is to assess prevalence of functional heartburn in ibs patients.

functional heartburn (fh) and ibs are functional digestive disorders that may occur in the same patients (1). heartburn is a burning sensation in the chest, radiating toward the mouth, as a result of acid reflux into the esophagus. however, only a small percentage of reflux events are symptomatic. heartburn is also often associated with a sour taste in the back of the mouth with or without regurgitation of the refluxate.(2) definition of fh has been greatly modified from the rome ii criteria (in which the definition of fh included all nerd patients with negative ph-manometry) to the rome iii criteria (in which fh is defined as a functional esophageal disorder unrelated to gerd and characterized by negative ph-manometry, the lack of a relationship between symptoms and reflux events, and the lack of symptom improvement after a trial of ppi therapy)(2). however, data establishing a solid link between fh and ibs are lacking, because the clinical definition of fh has undergone substantial changes over the years(3). the prevalence of ibs varied from 5 to 65% and the incidence varied from 1 to 36% , its frequency in women is more than men.(4). psychological problems were strongly associated with prevalence and incidence of ibs. (5) distinguishing between irritable bowel syndrome (ibs) and functional dyspepsia can be challenging because of the variations in symptom patterns, which commonly overlap.(6) currently, the criteria for diagnosis of functional heartburn (fh) rest not only on compatible symptoms but also on exclusion of structural and metabolic disorders that might mimic the functional disorders, patients have to have a normal x_ray ,normal upper endoscopy and 24-hour ph monitoring test that is normal, and the absence of any evidence of a correlation between physiologic reflux events, either weakly acidic or acidic, and heartburn symptoms.(7,8)

Eligibility criteria:
inclusion criteria: 1. age above 18 years. 2. patients diagonsed as ibs (according to the rome criteria of the lv revision) and presented with heartburn with a normal x_ray, normal upper endoscopy and normal 24-hour ph monitoring. exclusion criteria: 1. patients who refuse to contribute in this study. 2. presence of duodenal or gastric ulcer or cancer on upper endoscopy. 3. cardiac patients. 4. pregnancy and breastfeeding
esomeprazole for relief of upper gastrointestinal symptoms associated with continuous use of nsaids

Conditions: GERD

Summary: this study is a randomised, double-blind, parallel-group and placebo controlled study comparing the efficacy of esomeprazole 40 mg orally qd vs. placebo and esomeprazole 20 mg orally qd vs. placebo when given to patients on continuous use of nsaids, including cox-2 selective nsaids, for a period of 4 weeks in treatment of relief of upper gi symptoms.


Eligibility criteria:
inclusion criteria: * 18 years of age, or older. * capable of completing the diary card. * ability to complete the hrql questionnaires. * a clinical diagnosis of a chronic condition (e.g., osteoarthritis or rheumatoid arthritis) that requires continuous daily nsaid treatment for at least 7 months. * daily nsaid treatment is defined as taking the prescribed dose for at least 5 of 7 days in any given week and can include cox-2 selective nsaids, multiple nsaids, and high-dose aspirin (\>325 mg/day). * daily nsaid treatment dose and type: (must have been stable for at least 4 weeks prior to baseline endoscopy and; are expected to remain stable for the duration of the study. and; must be administered orally for the duration of the study. if more than one type of nsaid treatment is used, at least one type must be given orally). exclusion criteria: * current, or history of, gastric or duodenal ulcer * current, or history of, esophageal, gastric or duodenal surgery. * history of gerd, not associated with nsaid use. * pain, discomfort or burning in the upper abdomen precipitated by exercise or relieved by defecation. * pain, discomfort or burning in the upper abdomen not associated with the use of nsaids, including cox-2 selective nsaids, as judged by the investigator. * endoscopic barrett's esophagus(\>3 cm) or significant dysplastic changes in the esophagus

Keywords: nsaids upper gi symptoms
pre-recovery bedside liver biopsy in brain death organ donors

Conditions: Brain Death; Liver Disease

Summary: this study's objective is to obtain preliminary data to test the hypotheses that percutaneous liver biopsy in brain death donors is safe and provides reliable histological information. furthermore, that information when disseminated fully and widely many hours before organ recovery would not only decrease economic costs of wasteful recovery of livers that are not ultimately transplanted but also increase transplantation and decrease cold ischemia times of recovered livers.


Eligibility criteria:
inclusion criteria: * neurological death donors in whom brain death determination is imminent * first person or next of kin consent for research becomes available * high risk donor, as defined by the following criteria i) known liver disease ii) hepatitis bsag, bcab, b dna, hepatitis c ab or hepatitis c rna positivity iii) age \>= 50 iv) any of the following risk factors for fatty liver disease a) bmi \>= 30 b) history of type 2 diabetes mellitus c) ultrasound, computerized tomography or other imaging modalities suggesting steatosis v) any of the following risk factors for chronic liver disease 1. greater than 2 drinks of alcohol daily currently or in their history 2. current iv drug use 3. ultrasound, computerized tomography or other imaging modalities suggesting cirrhosis exclusion criteria: * donation after cardiac death donors * live organ donors * no first person consent and next of kin decline research consent * donors in whom it has been established the liver will not be shared * donors in whom percutaneous liver biopsy has been performed within the past month for any indication and the biopsy results are available and considered reliable. * donor with a contraindication to liver biopsy, including inr \> 2, ptt \> 75, platelets \< 70,000, history of coagulopathy, current or recent use (within 7 days) of antiplatelet agent such as aspirin or plavix, and hemodynamic instability defined as a map less than 65mmhg. * inability to position donor appropriately for performance of ppb * unavailability of pathology staff to analyze specimen in a timely manner

Keywords: liver biopsy organ donation donor management