Kornimate/medical-research-clean huggingface dataset:
protocol to examine methylation of tumor suppression genes in women at high risk of developing breast cancer

Conditions: Breast Cancer

Summary: a study to examine the correlations between methylation of various genes associated with breast cancer and proliferation and cytomorphology in breast epithelial cells acquired by random periareolar fine needle aspiration of women at high risk for development of breast cancer.

a study to examine the correlation between gene promotor methylation and benign breast tissue proliferation and cytomorphology collected via random periareolar fine needle aspiration in postmenopausal women at increased risk for breast cancer.

Eligibility criteria:
inclusion criteria: * women at high risk of developing breast cancer determined by family or personal history * willing to participate in companion protocol (kumc hsc#4601) for random periareolar fine needle aspiration (rpfna) for correlational studies exclusion criteria: * exclude women who have been on raloxifene, tamoxifen, letrozole, anastrozole or exemestane within the six months prior to rpfna

Keywords: breast cancer prevention tissue sampling polymorphisms steroid and carcinogen metabolism
fish oil as adjunct treatment for major depressive disorder

Conditions: Major Depressive Disorder

Summary: in this proposed study, the investigators will evaluate the effects of fish oil add-on in treatment of major depressive disorder(mdd).

participants are randomly assigned to two groups (n=60): control (placebo, soybean) and fish oil (containing epa 1440mg, dha 960mg). the experimental groups will be compared to placebo to evaluate if it may benefit clinical symptoms, cognitive symptoms and metabolic markers in mdd patients. we also plan to investigate the changes in markers of inflammation at the same time.

Eligibility criteria:
inclusion criteria: 1. able to provide informed consent 2. men or women aged 18-50 years 3. a primary psychiatric diagnosis of major depressive disorder (mdd), by diagnostic and statistical manual-5th ed (dsm-5) using the mini 4. hamd total score≥21 5. no significantly modification of their diet from the time they sign consent to the end of study participation exclusion criteria: 1. suffering from other serious somatic diseases or comorbidities 2. patients with serious nervous system disease 3. patients in accordance with diagnostic standards of other mental illness 4. patients who need to take benzodiazepine every day, and who currently need to be treated by electroconvulsive therapy or have received electroconvulsive therapy in the past 6 months 5. pregnant women or lactating women, women with pregnancy plans during the trial period (12 months), women with a high risk of pregnancy but without taking any contraceptive measures 6. patients with apparent suicide attempt or suicidal behavior 7. any condition or medicines that may have an effect on biomarkers (within 1 week of the screening period or during whole trial period): long-term, regular use of nsaids, cox-2 inhibitors, immunosuppressant, steroids, interferon, chemotherapeutics, anticoagulants, malignancy, active autoimmune diseases, inflammatory bowel diseases, etc 8. allergy history of pufa 9. intake of fish oil more than 3g per day or eat fatty fish more than 3 times a week

Keywords: major depressive disorder,fish oil
effects on clinical and functional outcome of escitalopram in adult stroke patients

Conditions: Stroke

Summary: rehabilitative treatment in stroke survivors has shown to be effective in improving functional outcome and reducing dependency. plasticity of the central nervous system, along with coping strategies and adaptations, seems to play a key role in functional recovery. some data support the hypothesis that drug which improve dopaminergic, serotoninergic and noradrenergic transmission in the central nervous system could improve recovery in stroke patients. in this population, antidepressants as selective serotonin reuptake inhibitors (ssri) are associated to better outcomes, as evidenced by small clinical trials. however, since depression is a common consequence of stroke, observed improvements could be biased by the action of these drugs on depressive symptoms, thus improving participation in rehabilitative treatment. the hypothesis of this study is that ssri could improve functional outcome in stroke survivors not only because of their action on depressive symptoms, but mainly because of a direct effect on neural repair and neuronal growth. the aim of the study is to evaluate the effect of a ssri, escitalopram, on functional outcome of stroke patients.


Eligibility criteria:
inclusion criteria: * both gender * age \> 18 years * first ischaemic and haemorrhagic stroke exclusion criteria: * unstable medical conditions * unable to understand study aims and procedures * severe aphasia * other progressive neurological disease * previous or concomitant psychiatric illness * patients not willing to participate to the study

Keywords: stroke antidepressive agents,second-generation treatment outcome rehabilitation
a study to compare the risk of a major bleeding in participants who received blood thinning medications following a blood clot

Conditions: Venous Thromboembolism (VTE)

Summary: a study to compare the risk of a major bleeding in participants who received 2 different blood thinning medications following a blood clot


Eligibility criteria:
inclusion criteria: * an acute-care inpatient encounter with a principal or secondarydiagnosis of vte, or an ambulatory-care encounter with any diagnosis of vte * an outpatient pharmacy claim for apixaban or warfarin during the 30-day period following the index encounter * continuous and comprehensive medical/drug coverage for ≥6 months preceding the index encounter exclusion criteria: * evidence of a trial fibrillation/flutter or chemotherapy/radiation therapy for malignancy (other than non-melanoma skin cancer) during 6-month period preceding first receipt of index therapy * evidence of vte(vte event)during 6-month period preceding index encounter * evidence of malignancy (other than non-melanoma skin cancer) during 90-day period preceding first receipt of index therapy other protocol defined inclusion/exclusion criteria could apply
high resolution imaging for early and better detection of bladder cancer

Conditions: Bladder Cancer

Summary: the goal of this study is to develop, optimize, and validate a high resolution imaging system in the bladder that displays images in real-time, providing automated diagnostic criteria for bladder cancer screening. high resolution images of normal bladder tissue and suspicious bladder lesions will be collected from patients who present to the study site for clinical evaluation.


Eligibility criteria:
inclusion criteria: * diagnosed with clinically suspicious bladder lesion or clinical finding; or who are undergoing cystoscopy as part of their routine clinical care. * must be willing and able to participate and provide written informed consent * women of childbearing age who have the possibility of being pregnant must have a negative pregnancy test prior to participation exclusion criteria: * patient with sufficient evidence of cognitive impairment that limits the subject's ability to understand the protocol, provide informed consent, or to comply with the protocol procedures. * women with the possibility of having the pregnancy. * patients having acute infection. * person with lidocaine sensitivity.

Keywords: suspicious bladder lesion, normal bladder tissue
risk factors for atherogenesis in type 1 diabetes

Conditions: Atherosclerosis; Cardiovascular Diseases; Diabetes Mellitus, Insulin-dependent; Heart Diseases; Diabetes Mellitus

Summary: to determine risk factors for atherogenesis in type 1 diabetes.

background: individuals with type 1 diabetes have substantially higher risk for premature atherosclerotic vascular disease (asvd) than the general population. risk factors for the development of asvd have been identified, but linking them to initiation of atherosclerosis was not feasible until recently. advances in non-invasive imaging now permit early detection of changes in blood vessel function and structure. this imaging provides an opportunity to evaluate risk factors for asvd and vascular status in a cohort at a critical time for development and early progression of asvd. design narrative: subjects were enrolled from 1987-1992 and were followed from diabetes diagnosis. standardized protocols for examinations and interviews were implemented and the data base included a valuable longitudinal plasma bank. because incident cases were enrolled, information was collected from diagnosis on children, adolescents and young adults currently without symptoms of atherosclerosis. the existing database was expanded, the existing resources were used including the plasma bank, and promising new and well established clinical research techniques were incorporated by: (i) measuring plasma lipid levels on stored plasma and on newly collected blood samples, (ii) measuring triglyceride levels on newly collected blood samples, (iii) measuring urinary albumin excretion rates on newly collected specimens (already measured from diagnosis to date), and (iv) assessing endothelial function by brachial artery ultrasound, (v) measuring the intima medial thickness (imt) of the carotid artery by ultrasound, and (vi) measuring coronary calcium by computed tomography scanning. these activities allowed pursuit of the following specific aims: 1) to determine the relationship between established risk factors for atherosclerosis and the development of pre-clinical atherosclerosis, 2) to determine the relationship between endothelial dysfunction and carotid imt, and 3) to determine the relationship between coronary artery calcification and carotid imt. such information was critical in directing further efforts toward primary prevention of atherosclerosis in individuals with type 1 diabetes mellitus.

Eligibility criteria:
no eligibility criteria
a study of q-1802 in patients with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: q-1802 is a bispecific antibody targeting both the tumor-specific antigen claudin 18.2 and the immune checkpoint pd-l1. this is a multi-center, single-arm, open-label design to evaluate the safety and tolerance of q-1802 in patients with advanced solid tumors, together with an assessment of pharmacokinetic characteristics and efficacy. the study consisted of two compartments: the dose-exploration stage and the dose-extension stage.


Eligibility criteria:
inclusion criteria: * male or female, age ≥18 years and ≤75 years. * patients with at least one measurable lesion per recist (v1.1) (applicable to the dose-extension stage). * eastern cooperative oncology group (ecog) performance status score 0 or 1 at screening and no deterioration occurs within two weeks before enrollment. * life expectancy period ≥ 12 weeks. * patients who have sufficient baseline organ function and whose laboratory data meet the following criteria (receiving no treatment of blood transfusions, albumin, recombinant human thrombopoietin, or colony-stimulating factor within 14 days before the first dose of this study). * patients with advanced gastric mucinous adenocarcinoma, advanced ovarian mucinous carcinoma or other dominant tumors participating in the dose-extension stage must provide eligible tumor tissue samples for biomarker detection; if subjects agree, tumor tissue samples should also be provided during the dose-exploration stage. exclusion criteria: * patients who have received any prior pd-1/pd-l1 antibody therapy (applicable to the dose-exploration stage). * patients with uncontrolled blood pressure (systolic blood pressure ≥ 150 mm hg and/or diastolic blood pressure ≥ 100 mm hg) or previous hypertensive crisis or hypertensive encephalopathy. * patients with active peptic ulcer, gastric outlet obstruction or persistent recurrent vomiting. * patients with a history of monoclonal antibody allergic reaction. * patients who are considered ineligible by the investigator due to any other severe, acute or chronic disease or other causes that the investigator considers could affect the patient's participation or assessment in the study.
brief mindful meditation practice in improving quality of life in patients with cancer undergoing radiation therapy

Conditions: Malignant Neoplasm

Summary: this pilot clinical trial studies how well brief mindful mediation practice works in improving quality of life in patients with cancer undergoing radiation therapy. brief mindful mediation practice may improve the well-being and quality of life of patients with cancer who are undergoing radiation therapy by increasing levels of mindfulness and reducing stress, anxiety/depression, and fatigue.

primary objectives: i. to investigate the feasibility of a clinical trial using a brief mindful meditation practice during radiation therapy. secondary objectives: i. to explore the measurable changes in quality of life, fatigue, and mindfulness while using a brief mindful meditation practice during radiation therapy. outline: patients use brief mindful meditation practice (sitting meditation in which the mind is guided to focus in the present, thinking of your existence, and allowing sensations to arise with an openness and curiosity) over 12 minutes daily for 14 days during radiation therapy. after completion of study, patients are followed up 4-12 weeks after completion of radiation therapy.

Eligibility criteria:
inclusion criteria: 1. pathologically proven diagnosis of cancer any stage, based upon the following minimum diagnostic workup: history \& physical examination, including documentation of karnofsky performance status of 70 - 100% for at least 60 days prior to study entry 2. patients who are receiving a course of radiation therapy for curative or adjuvant intent 3. patient who have reported fatigue moderate or higher fatigue (based on the 0-10 fatigue scale, a fatigue score of 5 or; see appendix iii) while on radiation treatment 4. the patient must be an adult male or female 18 or older 5. patient must be capable to read and speak english and provide study specific informed consent prior to study entry 6. no prior history of radiation therapy 7. no history of or current active drug/alcohol dependence 8. no patients being decisionally impaired 9. patients who have home access to a computer, or compact disc audio player exclusion criteria: 1. patient is under the age of 18 2. diagnosis of a non-malignant disease and receiving radiation for a pathological diagnosis that is non-cancer 3. patient who have reported less than moderate fatigue (based on the 0-10 fatigue scale, a fatigue score less than 5; see appendix iii) 4. karnofsky performance status of less than 70% within the last 60 days prior to study 5. prior history of radiation therapy 6. history of or active drug/alcohol dependence or abuse 7. decisionally impaired patients 8. no access to a computer, or compact disc audio player 9. patient who are unable to read and speak english
comparative evaluation of herbal and allopathic drugs for the treatment of chronic diarrhea

Conditions: Chronic Diarrhea

Summary: revival of significance and the emergent market of herbal medicinal products necessitate strong commitment by the stakeholders to safeguard the end users. the variability in the concentrations of constituents of plant material, coupled with the variety of extraction techniques and processing steps used by different manufacturers, results in distinct inconsistency in the quality of herbal products. the present study will be directed to a polyherbal formulation entoban which integrates an outstanding blend of herbs that have been used for decades to eradicate microorganisms and worms from gastrointestinal tract. it is the combination of holarrhena antidysenterica, berberis aristata, symplocos racemosa, querecus infectoria and helicteres isora. the current study would target the chemical assessment, pharmacological and comparative clinical evaluation of entoban to assure its safety and efficacy.

the study will be adopted to compare the efficacy, tolerability, and safety of entoban using metronidazole ds as a comparator. the study was carried out in xyz hospital from jan 2015 to dec 2015. the participants will be selected on the basis of inclusion and exclusive criteria.

Eligibility criteria:
inclusion criteria: * male or female adults between the age of 18-60 years who were suffering from diarrhea of presumed infectious origin and willing to participate were eligible for inclusion in the study. exclusion criteria: * exclusion criteria were the presence of chronic * iatrogenic, or bloody diarrhea, having received antibiotic treatment for other medical or surgical problems * having a history of renal or hepatic dysfunction * having a concomitant infection. * patients receiving treatment with an anti-diarrheal drug in the five days prior to the study were also excluded. * pregnant or lactating women and women planning pregnancy were also ineligible for study participation.

Keywords: safety efficacy
predictive factors for response to new oral anticoagulants in the treatment of non-valvular atrial fibrillation..

Conditions: Atrial Fibrillation

Summary: post-authorization observational, prospective, follow-up study of a cohort of patients with non-valvular atrial fibrillation who are treated with direct oral anticoagulants (doacs) to evaluate the clinical course (occurrence of stroke, major bleeding and mortality) and its correlation with clinical, pharmacokinetic (plasma concentrations), pharmacodynamic (haemostatic) and pharmacogenetic factors.

post-authorization observational, prospective, follow-up study of a cohort of patients with non-valvular atrial fibrillation treated with direct oral anticoagulants (dabigatran, rivaroxaban, apixaban and edoxaban) to assess the clinical course (occurrence of stroke, other ischemic or bleeding events and mortality) and its correlation with clinical, pharmacokinetic (plasma concentrations), pharmacodynamic (haemostatic) and pharmacogenetic factors. patient selection and follow-up will be performed in 6 public spanish hospitals: hospital universitario de la princesa, hospital universitario la paz, hospital universitario ramón y cajal, fundación jiménez díaz, hospital gómez ulla (madrid) and hospital universitario de burgos (burgos). to reduce variability, the determination of anticoagulant activity will be performed in the hematology service of the hospital universitario de burgos and the measurement of plasma concentrations and genotyping of all patients in the clinical pharmacology service of the hospital universitario de la princesa. patients who are to receive or are receiving one of the four doacs currently available in spain will be informed about the characteristics of this study and will be asked to sign the consent form for their participation. the treatment or clinical management of these patients at each centre will not be modified. they will be asked three blood samples, coinciding with other tests that will be carried out to monitor their pathology (one blood sample for the study of the effect on coagulation, another for drug quantification in plasma and another for genetic studies) with the only requirement that they must have been treated with the drug for at least one week so that they have spent more than 5 half-lives and are in steady state. the samples will be extracted in the morning, before medication intake (trough concentrations).

Eligibility criteria:
inclusion criteria: 1. men or women over 18 years of age 2. patients with non-valvular atrial fibrillation (nvaf). 3. patients who are going to receive or are receiving treatment with any of the doacs (dabigatran, rivaroxaban, apixaban or edoxaban) for the prevention of stroke and systemic embolism in adult patients with nvaf, according to the drug label. 4. patients who agree to participate in the study and give their written consent. exclusion criteria: 1. patients on treatment with other anticoagulants. 2. patients suffering from a malignant or terminal disease whose life expectancy is less than 6 months.
risk prediction of bleeding in liver cirrhosis by combi-elastography

Conditions: Liver Cirrhosis; Gastroesophageal Varices; Variceal Hemorrhage

Summary: through the parameters of liver stiffness and spleen stiffness obtained by combi-elastography technique, summarize and analyze the warning index of esophagogastric variceal bleeding in patients with cirrhosis, so as to provide a new and valuable technique for clinical diagnosis.

firstly,the combi-elastography technique developed by hitachi uses the method of multi-index and multi-parameter to evaluate the liver stiffness and spleen stiffness comprehensively. and then,this prospective study is designed to follow up patients with cirrhosis for a period of 12 months, summarize and analyze the warning index of bleeding in patients with cirrhosis,so as to provide a new and valuable technique for clinical diagnosis.

Eligibility criteria:
inclusion criteria: * 18-80 years old, no gender limit; * the clinical diagnosis is in line with patients with liver cirrhosis caused by chronic hepatitis b, and the gastroscopy is in line with the indications of portal hypertension; * gastroscopy needs to provide the degree of gastroesophageal varices; * sign the informed consent form. exclusion criteria: * patients with cirrhosis and portal hypertension because of other causes or combined with other causes(such as viral hepatitis other than hepatitis b,autoimmune liver disease, alcoholic liver disease, metabolism-related fatty liver disease, etc.) * patients with a history of spleen-related operations, such as splenectomy, splenic embolism; * patients undergoing portosystemic shunt or tips; * isolated esophageal venous tumor and its bleeding patients; * history of upper gastrointestinal tumor or bleeding from gastric ulcer , etc; * those with serious diseases of other systems that cannot cooperate with elastography examination, such as heart failure, renal failure, mental illness, etc; * ascites before liver and spleen result unable to complete elasticity examination; * pregnant patients.

Keywords: elasticity imaging techniques ultrasound