Kornimate/medical-research-clean huggingface dataset:
optimizing sleep health in nurses

Conditions: Circadian Rhythm Sleep-Wake Disorders, Shift Work Type; Sleep Initiation and Maintenance Disorders

Summary: the aim of the proposed study is to pilot test two behavioral sleep intervention strategies for improving insomnia among night shift working nurses.

night shift nurses with insomnia who meet all study criteria will receive one of two insomnia therapies. the specific therapy for insomnia will be determine by chance (like a flip of a coin), with an equal chance to receive either cognitive-behavioral therapy for insomnia or multicomponent relaxation therapy for insomnia, both modified for shift workers. both therapies will be conducted over telehealth by interventionists trained in behavioral sleep medicine.

Eligibility criteria:
inclusion criteria: * current shift working nursing staff in oregon * expect to continue on shift work schedule during the study * meets criteria for an insomnia disorder * elevated insomnia symptoms * have daily access to internet on a smartphone, tablet, or computer; and * can read and write in english exclusion criteria: * people with uncontrolled medical conditions * presence of safety risk or condition in which study participation may be ineffective or result in increased risk to safety * some current treatments for insomnia * permanent day, evening, or rotating shift schedule * history of seizures or manic episode; or * current/expected pregnancy during the study period

Keywords: insomnia shift work circadian rhythm sleep psychology behavioral sleep medicine
pilot study of iliade : exploring health literacy within patients hospitalized for acute cardiovascular events

Conditions: Acute Myocardial Infarction; Chronic Heart Failure

Summary: health literacy (hl) is the ability to access, understand, evaluate and apply information in order to communicate with health professionals and understand health instructions but also, promote, maintain and improve health throughout life. health literacy is known as a health determinant. an association has been shown between low health literacy and low health outcomes such as increased number of unscheduled hospitalization or emergency visits, low medication adherence and poor health status. these have been particularly demonstrated with cardiovascular diseases, which combine risk factors (emergency hospitalization, reduction in the length of hospital stays, and complex secondary preventive drug treatments). despite many scientific international literature about health literacy and health outcomes, no information is available in france on the prevalence of low health literacy level of patients, notably cardiovascular patients. the investigating team's hypothesis is that knowing the prevalence of low hl levels in cardiovascular patients would help to better tailored a communication intervention dedicated to the needs of these low-hl patients with the final aim of increasing their adhesion to preventive drugs and behavioural recommendations. the first aim of the present study is to estimate the prevalence of low hl level among patients discharged after acute myocardial infarction or acute decompensation of chronic heart failure. secondary aims are to assess factors associated with the level of hl and identify barriers and facilitators of low hl patients to understand medical information on their disease. the results of this study will guide the design of the intervention of an interventional study on hl of cardiovascular patients.


Eligibility criteria:
inclusion criteria: - patient * age greater than or equal to 18 years * hospitalization for acute coronary syndrome (acs) (myocardial infarction with or without st segment elevation) or acute attack of heart failure (systolic or diastolic) * able to communicate in french and/or helping to communicate in french * return home after hospitalization health professional * voluntary and available for the entire interview * having participated in the management of the patient screened on the day of the consultation * cardiologist, intern or emergency department nurse * attached to the participating service exclusion criteria: - patient * short-term vital prognosis * severe dementia * inability to manage drug treatment alone * institutionalization at the end of hospitalization health professional * health professional working in the department only one or two days a week * health professional who is not specialized in diseases of interest
effects of fortified complementary foods on vitamin a status and body pool size in ghanaian infants.

Conditions: Malnutrition

Summary: this study tried to prove that children given food supplements containing vitamin a would have better liver vitamin a stores than children given food supplements without vitamin a over a 5 month period.

the study wanted to assess the effect of fortification of home based complementary foods on vitamin a status in ghanaian children who receive food supplements known as sprinkles. the study assessed the vitamin a status and body pool size in children using a test known as the modified relative dose response test (mrdr) tests and stable 13c2 retinol as a tracer, among those who receive sprinkles with or without vitamin a through home fortification of complementary foods.

Eligibility criteria:
inclusion criteria: informed consent of mother of eligible children aged 6-12 months. willingness to remain in the study area for entire duration of the study. willingness to agree to feed the child with supplied micronutrient supplements for duration of study. the child should have started taking complementary foods in addition to breast milk. child's haemoglobin level of at least 70 g/l. exclusion criteria: child's haemoglobin level less than 70 g/l. unable to give informed consent

Keywords: vitamin a, complementary foods, malnutrition, children
same-visit hepatitis c testing and treatment (the quickstart study)

Conditions: Hepatitis C

Summary: the quickstart study aims to assess the impact of three models of hcv care on hcv treatment uptake and cure among people who inject drugs. rapid point-of-care (poc) hcv testing and test-and-treat strategies will be utilised in primary health care settings across australia.

the quickstart study will explore models of point-of-care hcv testing and a same-day test and treat model to determine the impact of these models on hcv treatment initiation and cure. the study is a cluster cross-over randomised controlled trial. sites are primary care services in australia who provide services to people who inject drugs (pwid) and who routinely prescribe treatment for hepatitis c. clinical services with a primary care practitioner and/or nurse experienced in providing daa treatment to high numbers of pwid will be recruited to the study. a total of 30 services will be recruited with each service enrolling approximately 60 participants across an intervention and control period. key participant eligibility include a history of injecting drug use and no previous treatment for hcv with direct acting antivirals. each site will participate in a control comparison period in addition to one of three interventions. the three interventions involve: a) a rapid hcv antibody test using a fingerprick sample and for anybody subsequently diagnosed with hepatitis c, management and treatment will be according to standard of care. b) a rapid hcv antibody test followed by a poc hcv rna test for those who return a reactive antibody result. both these will use a fingerprick sample and for anybody diagnosed with hepatitis c, management and treatment will be according to standard of care. c) a rapid hcv antibody test using a fingerprick sample and for participants who return a reactive result, an initial starter pack of daa prior to a confirmed hcv rna diagnosis.

Eligibility criteria:
inclusion criteria: * current or former pwid (i.e., injected drugs at least once) * aged 18 years or over * attending a participating phc for any reason * no previous treatment with daas for hcv * failed interferon based treatment for hcv in the past (i.e., did not achieve cure) * medicare eligible * able to speak and understand english exclusion criteria: * women known to be currently pregnant or who are breastfeeding * individuals self-reporting to be currently engaged in treatment for hcv * unable to provide informed consent * tested for hcv in the past 3 months
observational study of an electronic questionnaire in patients with chronic obstructive pulmonary disease (copd)

Conditions: Pulmonary Disease, Chronic Obstructive; Infections, Bacterial

Summary: the aim of the study is to develop a new patient-reported outcome (pro) questionnaire measuring the impact of an acute exacerbation on daily lives of patients with chronic obstructive pulmonary disease (copd). this questionnaire will aim to detect an acute exacerbation and resolution of exacerbation from the patient's perspective. at a later stage of development, this questionnaire will be able to measure the effect of anti bacterials in the treatment of acute exacerbations of copd (aecopd). this study will evaluate the factor structure, validity, reliability, and responsiveness of the gsk questionnaire in subjects who experience acute exacerbations of their copd.


Eligibility criteria:
inclusion criteria: * 15 pack-year smoking history. * confirmed diagnosis of copd. * have two documented episodes of acute exacerbation in past 12 months. exclusion criteria: * clinical diagnosis of asthma. * subjects not literate in the language of the questionnaire (e.g. us english).

Keywords: patient reported outcomes copd acute exacerbation of chronic obstructive pulmonary disease (aecopd)
immune mediated disorders after allogeneic hematopoietic cell transplantation

Conditions: Graft vs Host Disease; Cutaneous Sclerosis; Bronchiolitis Obliterans

Summary: the purpose of this research study is to better understand the onset and course of graft versus host disease (gvhd)and other immune-mediated disorders after stem cell transplant.

allogeneic hematopoietic cell transplantation (hct) is the only known curative option for many hematologic disorders. after transplantation, many patients develop immune mediated disorders that may be life-threatening such as graft versus host disease (gvhd). the morbidity and mortality associated with hct-associated immune mediated disorders are major barriers to successful use of transplantation to cure rare hematologic malignancies such as leukemia, lymphoma, multiple myeloma, myelodysplastic/myeloproliferative syndromes amongst other diseases. with this study, the investigators will investigate the biologic basis for immune mediated disorders after allogeneic hct, focusing on those developing cutaneous sclerosis, bronchiolitis obliterans syndrome, late acute gvhd and chronic gvhd. the study will enroll 1118 (1018 adults and 100 children) allogeneic hct patients over a three year period. subjects will be followed for two years and monitored closely for development of immune mediated disorders. this study will have 5 study visits at day 1, 100, 180, 365, and 730. during these visits, a physical assessment, medication review, blood and urine collection will occur. if a subject develops an immune mediated disordered, they will be monitored at 3 months, 6 months, 1 year and then annually from the date of diagnosis. during these study visits, a physical assessment, imd status, and medication review as well as blood and urine collection will occur.

Eligibility criteria:
inclusion criteria: * planned or completed first allogeneic stem cell transplant (any conditioning regimen, graft source, donor type and gvhd prophylaxis regimen) * signed, informed consent and, if applicable, child assent exclusion criteria: * inability to comply with study procedures * anticipated survival less than 6 months due to co-morbid disease * autoimmune disorder or inherited immunodeficiency before hct * diagnosis of late acute or chronic gvhd prior to study enrollment * hematologic relapse or chemotherapy refractory disease at restaging within 1 month of hct or at the time of enrollment (e.g., \> 5% blasts for leukemia; poorly responsive lymphoma)

Keywords: graft vs host disease allogeneic hematopoietic cell transplantation bone marrow transplantation peripheral blood stem cell transplantation umbilical cord blood stem cell transplantation
evaluating celecoxib activity in mycobacterium tuberculosis: a whole blood bactericidal activity study in healthy volunteers

Conditions: Tuberculosis

Summary: the purpose of this study is to evaluate the bactericidal activity against mycobacterium tuberculosis of celecoxib in combination with established drugs used to treat tuberculosis (tb). pharmacokinetics (pk) and whole blood bactericidal activity (wba) will be measured in healthy volunteers following administration of the study drugs alone and in combination.

the whole blood bactericidal activity (wba) assay is an ex vivo model for measuring the combined effects of administered drugs, host factors and strain factors on mycobacterial sterilisation. if performed in parallel with pk measurements, the method can be used to evaluate the effect of drugs throughout the dosing cycle. celecoxib is a cox-2 inhibitor with immuno-modulatory properties important in the host defence against tuberculosis (tb). the aim of this trial is to investigate the effect on wba of manipulation of the host response to tb using celecoxib, in combination with established tb drugs.

Eligibility criteria:
inclusion criteria: 1. aged over 21 years and below 60 years old 2. male or female willing to comply with the study visits and procedures 3. willing and able to provide written informed consent exclusion criteria: 1. women who are currently pregnant or breastfeeding 2. body weight below 50kg 3. clinical signs of active tb in the opinion of the investigator 4. previous hypersensitivity, intolerance or allergy to rifampicin, pyrazinamide, cox-2 inhibitors, non-steroidal anti-inflammatory drugs or sulfonamides 5. current use of any drugs or medication known to have an interaction with rifampicin, pyrazinamide or celecoxib 6. current use or use in the last 2 weeks of non-steroidal anti-inflammatory drugs or cox-2 inhibitors 7. current use or use in the last 2 weeks of any drugs, over the counter or herbal preparations that are known or potential inhibitors or inducers of cytochrome p450 enzymes 8. evidence of renal or hepatic dysfunction or any clinically significant deviation from normal during screening including laboratory determinations 9. known hepatic disease, recent hepatitis (within last 6 months) or alcohol abuse 10. known cardiovascular disease, heart failure, stroke or current cardiovascular risk factors 11. known peptic ulcer disease, previous gastrointestinal bleed or current risk factors for gastrointestinal events 12. acute or previous gout, acute porphyria 13. any other significant condition that would, in the opinion of the investigator, compromise the volunteer's safety or outcome in the trial 14. current participation in other clinical intervention trial or research protocol
protein molecular characteristics and prognosis of cervical neuroendocrine tumors

Conditions: Neuroendocrine Neoplasm; China; Women; Cervical Cancer; Cervical Lesion

Summary: the clinical diagnosis and treatment data of 300 cases of cervical neuroendocrine tumors were collected, including age, preoperative biopsy pathology results, postoperative histopathological results, tct results, and colposcopy biopsy pathology results. at the same time, paraffin tissue specimens (remaining specimens after pathological diagnosis) from 100 cases of cervical neuroendocrine tumors from multiple centers across the country were collected to establish a cervical neuroendocrine tumor data follow-up database. protein concentration and omics analysis were performed on the data results, to evaluate the molecular characteristics and prognosis of cervical neuroendocrine tumor proteins, and to preliminarily explore its clinical application value.

1. the clinical diagnosis and treatment data of 300 cases of cervical neuroendocrine tumors were used for prognostic analysis. (1) the diagnosis and treatment information of cervical neuroendocrine carcinoma in multiple hospitals was collected, including clinical and medical data such as age, preoperative hpv genotyping, preoperative biopsy pathological results, postoperative histopathological results, figo staging, prognosis and survival information, and follow-up of patients. 2. protein and other omics analysis was performed on paraffin tissues of 100 cases of cervical neuroendocrine tumors paraffin samples collected from 100 cases of cervical neuroendocrine tumors were identified, processed and segmtioned, and protein concentration and proteome were determined to establish the molecular characteristics and prognostic targets of cervical neuroendocrine tumors.

Eligibility criteria:
inclusion criteria: 1. patients diagnosed with cervical neuroendocrine carcinoma by histopathology 2. clinical data were complete exclusion criteria: 1. patients who are not being treated in our hospital 2. patients with lack of follow-up data, unable to obtain survival information 3. patients call to refuse to participate in this project 4. the quality of paraffin specimens can not meet the requirements of proteome concentration determination
wound inflammatory cells after cardiac surgery

Conditions: Sternotomy Wound

Summary: one hundred patients, aged from 41 to 78 years, underwent open heart surgery in the years 1998-1999 and were studied by using the cellstick device for harvesting wound inflammatory cells during the first 24 hours after surgery. the results of the differential count were computerized by using artificial neural network for obtaining wound inflammatory cell node (wicn). the patients were followed up for sixteen years or to the death. wicn values were compared with the patients´ survival.


Eligibility criteria:
inclusion criteria: * elective operations exclusion criteria: * urgency operations
accelerated brachytherapy forward chemo radiation therapy (abc-rt) for locally-advanced cervical cancer

Conditions: Locally Advanced Cervical Carcinoma

Summary: the standard treatment for locally advanced cervical cancer is well established as a combination of chemotherapy and radiation, typically over 25-28 daily fractions with the addition of a brachytherapy boost to the primary tumor. an important component to treatment efficacy is overall treatment time. prolongation of overall treatment time has been shown to lead to worse local control and overall survival; thus, strategies to effectively deliver radiation efficiently is required. this is a pragmatic feasibility study to determine the impact of upfront brachytherapy combined with hypofractionated external beam radiation for patients with locally advanced cervical cancer (figo 2018 stage ib3-iva) on late gastrointestinal and genitourinary toxicity, oncologic outcomes including recurrence free survival, and systemic and local immune response.


Eligibility criteria:
inclusion criteria: * newly diagnosed biopsy proven figo (2018) clinical stage ib3-iva cervical carcinoma. * histological diagnosis of squamous cell carcinoma, adenocarcinoma, or adenosquamous cell carcinoma of the cervix * candidate for definitive radiation therapy as determined by treating radiation oncologist. * at least 18 years of age. * ecog performance status ≤ 2 * ability to understand and willingness to sign an irb approved written informed consent document. legally authorized representative may sign and give informed consent on behalf of study participants. exclusion criteria: * any prior pelvic radiotherapy. * any prior gynecologic or other pelvic malignancy. * any prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational regimen. patients with prior or concurrent malignancy that does not meet that definition are eligible for the trial. * evidence of metastatic disease outside of the pelvis or para-aortic nodes. * previous hysterectomy or planned hysterectomy as part of initial cervical cancer therapy; this includes patients with a prior history of supracervical hysterectomy. * pregnant and/or breastfeeding. women of childbearing potential must have a negative pregnancy test day of or within 7 days prior to simulation. * major surgery ≤ 3 weeks prior to initiating protocol therapy; if a patient has had major surgery prior to 3 weeks, they must have recovered from any surgical effects. * serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection. examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled chronic obstructive pulmonary disease, uncontrolled major seizure disorder, unstable spinal cord compression, or superior vena cava syndrome.

Keywords: cervical cancer hypofractionated rt brachytherapy pembrolizumab
acquisition of portal venous ctcs and exosomes from patients with pancreatic cancer by eus

Conditions: Pancreatic Cancer

Summary: the investigators are going to explore the diagnostic and prognostic value of circulating tumor cells and exosomes extracted from the portal venous blood obtained with endoscopic ultrasound in pancreatic cancer patients.

as the prognosis of pancreatic cancer, a kind of malignant tumor, remains poor due to the low diagnostic rate at the early stage, there is still a significant clinical need to determine individualized tumor molecular profiles and personalized risk for recurrence. circulating tumor cells (ctcs) and exosomes from patients with primary tumors may hold promise in serving as an informative biomarker to address this clinical need. here in this study, the investigators are going to explore the feasibility and safety of sampling portal venous blood via endoscopic ultrasound (eus), and detect portal venous ctcs and analyze mrna markers of exosomes by rna-seq. the investigators aim to explore the potential molecular mechanisms in tumor microenvironment and mechanisms of drug resistance.

Eligibility criteria:
inclusion criteria: 1. aged from 18 to 80 years-old 2. suspected pancreatic masses and referred for eus-fna for pathology diagnosis 3. written informed consent exclusion criteria: 1. patients who have received adjuvant chemotherapy and other anti-tumor treatments 2. severe heart, lung, liver, kidney insufficiency, or severe bleeding disorders, severe coagulopathy or local/systemic infections, other critical illnesses 3. women who are planning to become pregnant or are pregnant or breast-feeding

Keywords: pancreatic cancer portal venous blood circulating tumor cells exosome