Kornimate/medical-research-clean huggingface dataset:
detection of methylated reprimo in plasma for asymptomatic gastric cancer

Conditions: Early Gastric Cancer

Summary: in this proposal the investigators aim to develop a commercial kit to be used in primary screening and non-invasive triage for early detection of gastric cancer. this kit will be cost-effective and more accessible to the general population. in addition, the investigators would like to expand our current patent already submitted to inapi (national institute for intellectual property) and propose royalties to biomedical diagnostic companies for the use of our product at international level.

gastric cancer is the first cause of death in chile and the second worldwide. currently, no screening methods are available for early detection of gastric cancer at population level. the only available test is serum levels of pepsinogen i/ii for gastric atrophy, a precursor lesion only for intestinal type with low risk to progress to gastric cancer. the investigators' previous work, supported by fondecyt (national council for research and technology) and fonis (national council for research and development of human health) both from the government of chile led us to discover a potential biomarker for early detection of gastric cancer, reprimo, a tumor suppressor gene related to p53 in the arrest of g2-m of the cell cycle (clin cancer res. 2008;14:6264-9). here, the investigators propose to evaluate plasmatic detection of reprimo in conjunction with gastric atrophy markers and h.pylori detection to establish a novel screening and triage strategy for early detection of gastric cancer. the aims are i) to determine sensitivity and specificity for reprimo in the detection of gastric cancer in a high-risk population evaluated by upper gastrointestinal endoscopy (1,000 males, 30-74 y.o. low income, symptomatic or asymptomatic) and ii) to characterize at clinical, pathological and molecular level cases of gastric cancer identified and non-identified by direct detection of reprimo along with atrophy, h.pylori and clinical markers. with this information, the investigators will develop an algorithm for screening and triage evaluating predictive values of plasmatic detection of reprimo versus atrophy \& h.pylori detection and clinical data in a general population (3,000 male/female, 40-70 y.o.) from a high-risk area for gastric cancer in chile. in this step the investigators will evaluate also acceptability, efficacy and efficiency of the proposed algorithm. in this proposal the investigators aim to develop a commercial kit to be used in primary screening and non-invasive triage for early detection of gastric cancer. this kit will be cost-effective and more accessible to the general population. in addition, the investigators would like to expand the investigators' current patent already submitted to inapi and propose royalties to biomedical diagnostic companies for the use of the investigators' product at international level.

Eligibility criteria:
inclusion criteria: * male or female * age 40-70 y.o. exclusion criteria: * gastric cancer * dyspepsia * bleeding disorders

Keywords: gastric cancer dna methylation reprimo cell-free dna non-invasive
a study of pembrolizumab plus epacadostat with platinum-based chemotherapy versus pembrolizumab plus platinum-based chemotherapy plus placebo in metastatic non-small cell lung cancer (keynote-715-06/echo-306-06)

Conditions: Lung Cancer

Summary: the purpose of this study was to evaluate the efficacy and safety of pembrolizumab plus epacadostat with platinum-based chemotherapy versus pembrolizumab plus platinum-based chemotherapy plus placebo as first-line therapy in participants with metastatic non-small cell lung cancer (nsclc).


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed diagnosis of stage iv nsclc without epidermal growth factor receptor (egfr)-sensitizing mutation, ros1 and/or anaplastic lymphoma kinase (alk) translocation * measurable disease based on recist 1.1 * life expectancy of at least 3 months. * eastern cooperative oncology group (ecog) performance status of 0 or 1. * adequate organ function per protocol-defined criteria. * provide tumor tissue sample. exclusion criteria: * known untreated central nervous system metastases and/or carcinomatous meningitis * history of (non-infectious) pneumonitis that required systemic steroids or current pneumonitis/interstitial lung disease. * symptomatic ascites or pleural effusion. * known history of an additional malignancy, except if the participant has undergone potentially curative therapy with no evidence of that disease recurrence for 5 years since initiation of that therapy. * active autoimmune disease that has required systemic treatment in past 2 years. * has had an allogeneic tissue/solid organ transplant. * has a known history of human immunodeficiency virus (hiv) infection. hiv testing is not required unless mandated by the local health authority. * has known history of or is positive for active hepatitis b (hbsag reactive) or has active hepatitis c (hcv rna). note: testing must be performed to determine eligibility. * history or presence of an abnormal electrocardiogram (ecg) that, in the investigator's opinion, is clinically meaningful. * use of protocol-defined prior/concomitant therapy.

Keywords: non-small cell lung cancer programmed cell death 1 (pd-1) inhibitor indoleamine 2 3-dioxygenase 1 (ido1) inhibitor chemotherapy
effect of prophylactic tranexamic acid on bleeding outcomes for dilation and evacuation

Conditions: Abortion; Dilation and Evacuation; Hemorrhage; Blood Loss

Summary: prophylactic tranexamic acid has shown been shown to reduce maternal mortality from postpartum hemorrhage with no adverse effects, but has not been studied to reduce bleeding complications with dilation and evacuation (d\&e). we propose a randomized, double-blinded, placebo-controlled pilot study to determine whether routine use of intravenous (iv) tranexamic acid will decrease the need for interventions to control bleeding at the time of d\&e at 16 to 24 weeks gestation.


Eligibility criteria:
inclusion criteria: * requesting pregnancy termination * intrauterine pregnancy at 16 to 24 weeks gestation * participants must be willing and capable of giving informed consent and able to understand and sign written consents in english. exclusion criteria: * history of thromboembolic events (i.e. deep vein thrombosis, stroke, pulmonary embolism)
effect of mutations in t2dm susceptibility genes on the expression of susceptibility genes in patients with t2dm and controls

Conditions: Type 2 Diabetes Mellitus; Gene Polymorphisms; Genetic Mutations; Susceptibility, Genetic

Summary: in this study, investigators wanted to determine the effect of t2dm susceptibility gene mutations on self-expression. participants (t2dm patients and controls) were recruited to identify genotypes and detect the levels of t2dm susceptibility genes expression in the fresh peripheral plasma. the normal pancreatic tissues or adjacent tissues of pancreatic cancer were also collected to identify the expression differences of t2dm susceptibility genes under different genotypes.

the primary objective of this study was to investigate the changes of the expression of t2dm susceptible genes (nos1ap, kcnq1, tcf7l2, wsf1, glp-1r, etc.) in participants (newly diagnosed t2dm patients and controls) after gene mutation. secondly, the expression differences of t2dm susceptible genes in t2dm patients with different genotypes were compared, and the relationship between the expression differences and clinicopathological characteristics of t2dm patients was analyzed. participants (newly diagnosed t2dm patients and healthy subjects) were screened from the department of endocrinology and health management center, whose fresh peripheral blood were collected. the normal pancreatic tissues or adjacent tissues of pancreatic cancer were collected in the department of general surgery. the dna genome was extracted for genotyping, and then the expression levels of t2dm related susceptibility genes under different genotypes were detected by elisa kits, pcr, wb,he staining, ihc staining, ect. the basic information of t2dm patients was collected, including demographic characteristics, physiological and biochemical data.then investigators further compared the differences in the expression of susceptible genes between newly diagnosed t2dm patients and controls.

Eligibility criteria:
inclusion criteria: 1. no drug therapy; 25 to 70 years old; hemoglobin a1c (hba1c) 7%-12%; bmi 20-35 kg/m2; stable body weight (≤10% change within 3 months)（for newly diagnosed patients with t2dm）. 2. 25 to 60 years old; bmi 19-26 kg/m2; in good health, with no abnormalities of motor system, digestive system, respiratory system, urogenital system, blood system, circulatory system, nervous/mental system, endocrine system, etc（for healthy subjects）. 3. 20-80 years old; surgical resection of part or all of the pancreas; pancreatic lesions confirmed by enhanced ct or magnetic resonance (mr) examination or confirmed by intraoperative and postoperative pathology（for the patients in general surgical）. exclusion criteria: 1. had taken antidiabetic drugs; 2. had a history of pancreatic surgery; 3. complicated with severe organ lesions; 4. long-term use of drugs that affect pancreatic function.

Keywords: t2dm gene polymorphism susceptibility gene genetic mutations
use of gerikit to better phenotype older adults with ischemic heart disease

Conditions: Ischemic Heart Disease

Summary: this study seeks to expand the use of the nyu gerikit mobile application ("app") in a diverse range of settings to better phenotype older patients, which will enhance both research and patient care.

this is a single-center proof of concept study of geriatric impairments and feasibility metrics through the use of the gerikit software application in older adults with ischemic heart disease at the nyu langone medical center. the gerikit mobile application was developed to make geriatric assessment instruments easily accessible to clinicians who do not have subspecialty training in geriatrics. the gerikit app has been used clinically but is untested in research settings.

Eligibility criteria:
inclusion criteria: 1. age ≥ 75 2. currently hospitalized for acute mycardial infarction (ami), percutaneous coronary intervention (pci), or coronary artery bypass grafting (cabg); or hospitalized for ami, pci, or cabg within the prior 4 weeks 3. capable of self-consent 4. understand and are able to perform study procedures in english exclusion criteria: 1. non-ambulatory 2. moderate or severe cognitive impairment (operationalized as known diagnosis of dementia) 3. unable or unwilling to consent 4. incarcerated 5. unable to use complete assessments in english 6. unable to complete geriatric assessment for other reasons

Keywords: gerikit comprehensive geriatric assessment (cga)
understanding fabry disease therapy choices through the eyes of the patients

Conditions: Fabry Disease

Summary: the objective of this study is to increase the understanding surrounding the choices presented to patients and families impacted by fabry disease.

this will be a cross-sectional study conducted in approximately 130 individuals (or representative parents/caregivers of patients) living with fabry disease. all study participants will complete the rsvp followed by a structured interview conducted by trained interviewers. it is estimated that each respondent will need up to 60 minutes for the entire process; 10 minutes to complete the rsvp including uploading the proof of fabry disease diagnosis or verifying membership with fabry groups, including but not limited to: fabry support and information group, national fabry disease foundation, mps society uk, morbus fabry selbsthilfergruppe, fabry international network, or others, and approximately 50 minutes to complete the interview.

Eligibility criteria:
inclusion criteria: * participant must be a person with fabry disease who is 18 years or older or the parent/legal guardian of a living person with fabry disease who is under the age of 18 years or who are 18 years and older who are unable to answer for themselves. * confirmed diagnosis of fabry disease with written proof of disease provided * must have a genetic mutation that is amenable to oral therapy * resident of germany, the u.k or the u.s. * able to read, write and communicate in german, or english. * able to grant informed consent * willing to participate in a 50 to 60-minute telephone interview, including follow up questions (if necessary) and information regarding adverse events (if necessary). exclusion criteria: * inability to meet any of the inclusion criteria

Keywords: hypohidrosis proteinuria angiokeratoma
acupuncture for acute viral lower respiratory infection in hospitalized children

Conditions: Viral Respiratory Tract Infection

Summary: acute viral respiratory infections are among the most common causes of hospitalization in the pediatric population. the usual presentation of viral respiratory tract infections (vrti) includes fever, malaise, wheezing and or coughing, rhinorrhea and loss of appetite. up to 50% of children will have at least one viral-induced wheezing illness by school age. currently treatment of vrti is essentially supportive and no specific and efficient treatments are known. given the lack of effective medications, current treatment for severe viral lower respiratory tract infection (lrti) in infants relies on supportive measures only. these measures include supplementation of oxygen, monitoring of apnea, nasal/gastric tube feeding or intravenous fluids, and, if required, respiratory support with nasal bi-level positive-airway pressure. vtri therefore represent an important unmet need for improved treatment strategies. acupuncture's effect on has also been studied. acupuncture has been shown to be a safe and effective in various respiratory tract inflammations. a review published in 2011 have found that acupuncture is safe for pediatric patients. acupuncture's effect on acute viral induced wheezing and cough in hospitalized children has yet to be studied. since the current standard of care is supportive care only, using acupuncture as an additional treatment may provide benefit in reducing wheezing, respiratory distress, and shorten hospitalization.


Eligibility criteria:
inclusion criteria: * the presence of acute viral respiratory disease exclusion criteria: * evidence of chronic cardio-pulmonary disease, immune-suppression or any chronic systemic disease or disability
study comparing the pharmacokinetics of ftd as a component of tas-102 with ftd alone

Conditions: Advanced Solid Tumors

Summary: the purpose of this study is to compare the pharmacokinetics of trifluorothymidine (ftd) as a component of tas-102 with ftd alone.

this is a phase 1, open-label, randomized, parallel, 2-group study evaluating the pk of ftd as a tas-102 component compared with ftd alone in patients with advanced solid tumors (excluding breast cancer). patients will be randomized to receive a single dose of tas-102 or ftd during the pk contribution phase and will receive continuing cycles of tas-102 during the extension phase.

Eligibility criteria:
inclusion criteria: 1. has provided written informed consent 2. has advanced solid tumors (excluding breast cancer) for which no standard therapy exists 3. ecog performance status of 0 or 1 4. is able to take medications orally 5. has adequate organ function (bone marrow, kidney and liver) 6. women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. males must agree to adequate birth control. exclusion criteria: 1. has had certain other recent treatment e.g. anticancer therapy, received investigational agent, within the specified time frames prior to study drug administration 2. certain serious illnesses or medical condition(s) 3. has had either partial or total gastrectomy 4. has unresolved toxicity of greater than or equal to ctcae grade 2 attributed to any prior therapies 5. known sensitivity to tas-102 or its components 6. is a pregnant or lactating female 7. refuses to use an adequate means of contraception (including male patients)

Keywords: advanced solid tumors (excluding breast cancer) for which no standard therapy exists
epidemiological characteristics and prediction system of acute respiratory distress syndrome

Conditions: Acute Respiratory Distress Syndrome

Summary: this project intends to adopt the multicenter prospective real-world study method to conduct a preliminary study on the incidence, grading, risk factors, respiratory support strategies, in-hospital mortality, 3-month mortality, 6-month mortality, 1-year mortality, quality of life, lung function and limb function recovery, cognitive function, return to work and other conditions of ards patients in ricu. by collecting 1,000 patients, a clinical database related to ards in china was established to provide essential data and ideas for promoting standardized diagnosis and treatment technology for ards patients and further clinical intervention research. at the same time, ards biobank was established in china-japan hospital and xiangya hospital to realize the integration of clinical data and sample resources, and the prediction model of ards survival and complications of tuberculosis clinical data and biological samples was established by using big data and ai technology.


Eligibility criteria:
inclusion criteria: * new or worsening respiratory symptoms less than 7 days after the acute blow. * ct/x-ray: double lung infiltration that cannot be fully explained by pleural effusion, lobar/whole atelectasis, and nodule. * respiratory failure that cannot be explained by heart failure or fluid overload * after 15min assisted ventilation (peep or cpap ≥ 5cmh2o) or hfnc with flow≥30l/min, pao2/fio2≤300mmhg * classification of ards: mild (200mmhg \< pao2/fio2 ≤ 300mmhg), moderate (100mmhg \< pao2/fio2 ≤ 200mmhg), and severe (pao2/fio2 ≤ 100mmhg) and 4 ancillary variables for severe ards exclusion criteria: * younger than 18 years old * patients or family members refused to participate in the study

Keywords: ards; mortality; incidence; prognosis; predictive model; ai
testing integrative smoking cessation for hiv patients

Conditions: Smoking; Smoking Cessation; HIV Infections

Summary: the purpose of this study is to examine the feasibility, acceptability and effect of a combined smoking cessation intervention integrating contingency management (reward-based) strategies with mindfulness training to identify the optimal dynamic strategy to promote smoking cessation among hiv patients.


Eligibility criteria:
inclusion criteria: * diagnosed with hiv (based on self-report). * be 18 years and older * have smoked ≥ 5 cigarettes/day in the past year * be interested in making a quit attempt in the next 30 days * own a smartphone (apple/android), and plan to keep it active for the next 6 months * able to consent * have no plans to move in the next 6 months * are not pregnant or planning to be pregnant in the following 6 months * have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements exclusion criteria: * have contraindication to nrt (past month myocardial infarction, history of serious arrhythmias/or unstable angina pectoris, dermatological disorder) * are currently being treated for a psychiatric condition. * are currently being treated for smoking cessation, alcoholism, or illicit drug use * are adults unable to consent * are individuals who are not yet adults * are pregnant women * are prisoners

Keywords: mindfulness training contingency management
molecular breast imaging: a novel technology for detection of malignant breast lesions

Conditions: Small Breast Lesions; Dense Breast Tissue; Discrepancy With Clinical Examination; Equivocal Mammographic, Sonographic or MRI Lesion

Summary: detection of breast cancer as early as possible is an ongoing imaging challenge.the purpose of the current study is to assess the clinical performance of the new scintigraphic technology, a dedicated breast gamma camera composed by the new generation of czt detectors,for assessment of breast pathology specifically in women where current imaging techniques, mainly mammography are suboptimal. these cohort are patients with dense breast tissue and patients who are at high risk for breast cancer by a combination of other metrics, including family history and genetic testing. brca (breast cancer susceptibility gene), is particularly a relevant health problem among ashkenazi jews in israel.

recently, a breast-dedicated gamma camera has been used for assessment of breast malignancy in over 1000 women in mayo clinic, rochester, usa. molecular breast imaging (mbi), which utilizes a cadmium-zinc-telluride (czt) gamma camera for scintimammography, has been shown to have a high sensitivity (91%) for the detection of breast lesions \> 5 mm in diameter and 69% for tumors smaller than 5mm. in israel , genetic high- risk for breast cancer is highly relevant. we will offer the new imaging technology, to a wide patients population/group from all over israel , in which the referring physician and/or the breast-imaging physician will look for additional imaging modality. therefore this stage will include: * women with equivocal findings on mammography, us and/or mri * women with discrepancy between cbe(clinical breast examination)and breast imaging * women with dense breast * women in high risk for breast cancer before the imaging procedure each woman will need to fill detailed questionnaire, specific for the study, that will include information on her medical history, family history, gynecology information, menstrual phase, use of hormones etc. the images will be correlated with other imaging tests including mammography, us and mri. we will follow up the women for at least 6 months, including biopsy findings and or other clinical and imaging exams. this phase will include 500 women.

Eligibility criteria:
inclusion criteria: * age over 25. * equivocal breast lesions. * dense breast tissue. * high-risk for breast cancer exclusion criteria: * age under 25. * pregnancy. * patients unable to understand and sign an informed consent

Keywords: breast cancer scintimammography czt high-risk
assessing the safety and performance of the endoscopic linear cutter stapler and reloads (frankenman) in colectomy

Conditions: Colon Cancer

Summary: the purpose of this observational study is to evaluate the safety and performance of the single use endoscopic linear cutter stapler and reloads from frankenman used in (hemi)colectomy to remove tumors and create anastomoses in patients with cancer in the ascending colon. the goal of the study will be achieved by assessing the device performance and reporting of peri- and postoperative complications in a prospectively maintained database.


Eligibility criteria:
inclusion criteria: * age at study entry is at least 18 years. * patient must sign and date the informed consent form prior to the index-procedure. * patient has a tumor in the ascending colon. exclusion criteria: * patient is pregnant. * patient has inflammatory bowel disease (ulcerative colitis, crohn's disease). * patient has symptomatic diverticulitis. * patient has bowel trauma. * patient has peritoneal carcinomatosis. * patient is known to be, or suspected of being unable to comply with the study protocol or proposed follow-up visits.

Keywords: ascending colon