Kornimate/medical-research-clean huggingface dataset:
a multicenter prospective study to assess the effects of adjuvant icotinib in egfrm stage i nsclc with high-risk of disease recurrence after complete resection

Conditions: Non-Small Cell Lung Cancer

Summary: this is a multicenter single arm study, with an aim to assess the effects of adjuvant icotinib among egfr mutant stage i lung adenocarcinoma patients, who have high-risk pathological features of recurrence.


Eligibility criteria:
inclusion criteria: * male or female, at least ≥ 18 years，and ≦ 80 years * lung adenocarcinoma. * stage i disease(ia or ib), based on tnm8 classification. * there is at least one of the following high-risk factors: 1. pathologically confirmed vascular invasion positive; 2. pathologically confirmed lung adenocarcinoma containing solid or micropapillary or complex gland histology, with a percentage \> 20%; 3. pathologically confirmed invasive tumor size \> 2 cm; 4. pathologically confirmed visceral pleural involvement (t2a). * started adjuvant therapy in this study 4-6 weeks after complete resection without any previous antitumor therapy. * a tumour which harbours one of the 2 egfr mutations (ex19del, l858r) ,without kras mutation * world health organization performance status of 0 or 1. * bood routine: hb \> 80g/l; anc \> 1.0x109/l; plt \> 50x109/l.blood biochemistry： alt and ast \< 2.5 times the upper limit of normal; crea \< 1.5 times the upper limit of normal. * good adherence to follow-up. * during the trial and for 3 months after the trial，participants must be using highly effective contraceptive measures. exclusion criteria: * prior treatment with any anticancer therapy for nsclc (including chemotherapy, radiotherapy, immunotherapy, and egfr-tkis). * local radiotherapy. * patients with cancers other than nsclc (except cured cervical carcinoma in situ, cured basal cell carcinoma and bladder epithelial tumors) within 5 years prior to the start of treatment in this study. * any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, angina pectoris beginning within the last 3 months, congestive heart failure, myocardial infarction occurring within 6 months prior to enrollment, severe arrhythmia requiring medication, liver, kidney or metabolic disease). * any clinical evidence suggestive of active interstitial lung disease. * an eye inflammation or eye infection that is not fully controlled, or any condition that could lead to one of these eye conditions. * known human immunodeficiency virus (hiv) infection. * known hypersensitivity to egfr-tki drugs or related components. * mixed small cell and non-small cell cancer history. * substance abuse, or illnesses such as psychological or psychiatric disorders that may interfere with study compliance. * patients with epilepsy requiring medication (e.g. steroids or anti-epileptic drugs). * other conditions deemed unsuitable for enrollment by the investigator.
the ita model of integrated treatment of eating disorders

Conditions: Eating Disorders; Anorexia Nervosa; Bulimia Nervosa; Binge Eating; Eating Disorders in Adolescence; Eating and Feeding Disorders

Summary: this is a naturalistic study implementing a routine assessment to monitor the evolution of the patients with eating disorders being treated in various centers of "ita salud mental" in spain.

"ita salud mental" offers integrated treatment for eating disorders including outpatient, inpatient and day hospital care. the routine assessment implemented to this aim includes both general measures to gauge the therapeutic progress (core system) and measures specific for eating disorders (eat, bite), which are administered from the beginning to the end of treatment in different time points combined with clinical data included in the patients' health record such as diagnosis, body mass index, previous treatments, and chronicity. according to its naturalistic nature, this study will accept all participants who are admitted into the care system offered by "ita salud mental" between november 2, 2017 and october, 2nd., 2020, meeting the inclusion/exclusion criteria and signing informed consent (n = 800 is an estimation). these patients will be followed on three-week bases until october, 30th., 2020, and less intensively on three-month bases until october 2025 to monitor symptoms and to record possible adverse effects. the analysis of these data will permit to evaluate the therapeutic effects of this integrated treatment and the factors which might influence the outcomes.

Eligibility criteria:
inclusion criteria: * diagnosis of an eating disorder: anorexia nervosa, bulimia nervosa, binge and other eating disorders not otherwise specified. * treated in one of the centers of "ita salud mental". exclusion criteria: * not willing to participate (not signing informed consent).

Keywords: eating disorders anorexia nervosa bulimia nervosa binge eating routine outcome monitoring psychological interventions integrated treatment effectiveness
cutaneous hydration assessment in scd

Conditions: Sickle Cell Disease

Summary: this study will validate the diagnostic accuracy of a cutaneous hydration sensor. this sensor will also be evaluated for its feasibility as a point-of-care device for the assessment of hydration status and its potential to guide hydration therapy in patients with sickle cell disease (scd).

vaso-occlusive episodes (voe) are the leading cause of hospitalization for patients with scd. intravenous fluid replacement is one of the cornerstones of management of voe in the emergency department and throughout hospitalization. however, there are no evidence-based guidelines specifying the optimal administration of maintenance fluids. overly aggressive hydration therapy imparts the risk of hypervolemia and pulmonary edema, which may lead to acute chest syndrome and death. thus, a reliable biomarker is needed to gauge hydration status and guide fluid replacement strategies with the goal of achieving euvolemia. the investigators propose a point-of-care test that may inform management (e.g., bolus vs. continuous infusion of maintenance intravenous fluid), and prevent over- or under-hydration. for this purpose, investigators seek to validate the diagnostic accuracy of a cutaneous hydration sensor, delfin moisturemeterepid (a non-significant risk device) and evaluate its feasibility as a point-of-care device for the assessment of hydration status and potentially guide hydration therapy in patients with scd. investigators will measure skin hydration in the clinic when participants are at baseline state of health. skin hydration before and after fluid resuscitation therapy in patients with vaso-occlusive crisis (voc) or voe will also be assessed. blood and urine will be collected to compare assessments of skin hydration with laboratory biomarkers of hypertonicity and red blood cell dehydration.

Eligibility criteria:
inclusion criteria: * diagnosis of sickle cell disease (genotypes ss, sc, sß-thalassemia, sd, soarab) * participants must be ≥12-years old * participants that provide legally effective consent to all study procedures exclusion criteria: * participants under 12-years old * participants being treated with experimental therapies in clinical trials
a study to evaluate the effects of lci699 on cortisol in participants with hypertension

Conditions: Hypertension

Summary: this study determined the maximum dose of lci6999 with respect to effect on the acth-stimulated cortisol response in participants with hypertension.


Eligibility criteria:
inclusion criteria: * diagnosis of hypertension with blood pressure ≥ 140/90 millimeters of mercury (mmhg) and \< 180/110 mmhg on current antihypertensive treatment * male and female participants 18-75 years of age * participants must weigh at least 50 kilograms (kg) exclusion criteria: * recent history of myocardial infarction, heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebral accident or transient ischemic attack * clinically significant electrocardiography (ecg) findings related to cardiac conduction defects * type 1 diabetes or uncontrolled type 2 diabetes (haemoglobin a1c \[hba1c\] \> 9%) * malignancies within the last 5 years (excluding basal cell skin cancer) * liver disease other protocol-defined inclusion/exclusion criteria may apply.

Keywords: blood pressure hypertension cortisol
the effect of nursing care with peri-natal loss

Conditions: Perinatal Loss; Perinatal Grief

Summary: this study was planned to evaluate the effect of standardised nursing care given to women with perinatal loss using the nursing process on perinatal grief, posttraumatic stress and postpartum depression. h01: there is no difference between pre-test, post-test and follow-up tests in terms of perinatal grief scale mean scores in the intervention group. h02: there is no difference between pre-test, post-test and follow-up tests in terms of ies-r mean scores in the intervention group. h03: there is no difference between pre-test, post-test and follow-up tests in terms of epds mean scores in the intervention group. h04: there is no difference between the pre-test post-test and follow-up tests in terms of the mean scores of the complicated grief scale in the intervention group. * at the first encounter with women, the mean scores of pmi, iesr and epds will be evaluated. * the mean epds score will be evaluated on the 10th postpartum day, 1st, 3rd and 6th month. * the mean i-esr scale score will be evaluated at postpartum 1st, 3rd and 6th month. * at postpartum 1st and 3rd month, the mean score of pms will be evaluated. * at the postpartum 6th month, the mean score of the pbi scale will be evaluated.


Eligibility criteria:
inclusion criteria:- to be over 18 years old * being married (according to the woman's declaration) * not having an existing psychiatric illness (according to the woman's declaration) * not having communication problems (knowing turkish, being literate, not having vision, speech or hearing problems, etc.) * spontaneous conception * singleton pregnancy * no substance addiction exclusion criteria:women who agreed to participate in the study but did not want to receive post-discharge care, who were hospitalised for any reason, who became pregnant again, who did not want to complete the last tests or who wanted to leave the study at any stage of the study will be excluded from the sample.

Keywords: perinatal grief, perinatal loss, postpartum depression post-traumatic stress disorder
effect of gualou xiebai banxia decoction with danshen decoction in treating unstable angina.

Conditions: Unstable Angina

Summary: this study evaluates the clinical efficacy of gualou xiebai banxia decoction compounded with danshen decoction in the treatment of unstable angina pectoris. all of the patients will be divided into 2 arms randomly. one of the arms will be treated by conventional western medicine, the other one will be treated by gualou xiebai banxia decoction compounded with danshen decoction at the base of conventional western medicine.

gualou xiebai banxia decoction compounded with danshen decoction has the effect of promoting blood circulation and resolving phlegm, so it will be used for patients taht belong to phlegm and blood stasis type.

Eligibility criteria:
inclusion criteria: * participants diagnosed with coronary heart disease through coronary angiography or coronary cta; patients have at least one of these symptoms: 1. the stability of the nature of angina pectoris changes, that is, frequent attacks of angina pectoris, serious degree and prolonged duration; 2. angina pectoris during rest; 3. the recent occurrence of angina pectoris caused by mild physical activity in the last month. exclusion criteria: * patients diagnosed with stable angina; patients with acute myocardial infarction; chest pain caused by congenital heart disease, valvular heart disease, severe neurosis or arrhythmia; the heart function grade is iii or iv; patients with acute cerebral infarction; patients complicated with other serious primary diseases; patients with acute infection in recent 2 weeks; uncontrolled hypertension (the resting blood pressure \>160/95mmhg within one week); diabetics emerged with serious diabetic complications; patients can't finish the questionnaire due to abnormal mental and nervous or mental disorders; pregnant or lactating women.

Keywords: unstable angina gualou xiebai banxia decoction danshen decoction
validity reliability of 3 meter backward walk test in stroke patients

Conditions: Stroke Syndrome; Balance; Distorted; Walking, Difficulty

Summary: the 3 m walk-back test is used to assess neuromuscular control, proprioception, protective reflexes, fall risk, and balance. in a study of healthy elderly adults, a 3-m walk-back test showed better diagnostic accuracy compared to the most commonly used measurement methods for falls in the past year. reliability is extremely important, especially for research and clinical applications. in order to assess the risk of falling, measurement methods need to be reliable and change accurately over time. 3 m walk back test was found to be reliable in healthy elderly individuals. however, there are no studies investigating the validity and reliability of this test in stroke patients.

balance; within the limits of the stability of the center of gravity can be controlled on the surface. balance can be affected due to muscle weakness after stroke, abnormal muscle tone, loss of deep sensation and disturbances in vestibular mechanisms. among all sensorimotor results of stroke, it is stated that the balance of postural control has the greatest effect on daily living activities and gait. accurate assessment of balance in stroke patients is important in identifying appropriate aids for mobility, choosing an effective treatment program, determining safe and unsafe activities, and setting rehabilitation goals. the most common risk factor for falls is one of the most important risk factors for stroke. therefore, reliable and accurate measurement of dynamic gait balance is an important issue in stroke patients.the 3 m walk-back test is used to assess neuromuscular control, proprioception, protective reflexes, fall risk, and balance. in a study of healthy elderly adults, a 3-m walk-back test showed better diagnostic accuracy compared to the most commonly used measurement methods for falls in the past year. reliability is extremely important, especially for research and clinical applications. in order to assess the risk of falling, measurement methods need to be reliable and change accurately over time. 3 m walk back test was found to be reliable in healthy elderly individuals. however, there are no studies investigating the validity and reliability of this test in stroke patients.

Eligibility criteria:
inclusion criteria: * 40 years or older, * getting a diagnosis of stroke, * not having cooperation and communication problems * to be able to walk 10 m independently with or without device exclusion criteria: 1. have a neurological or orthopedic problem other than stroke that will affect functionality and balance 2. individuals with contraindications for advanced cardiovascular disease and mobilization will not be included in the study.
clinical investigation of the tecnis® next-generation intraocular lens

Conditions: Cataracts

Summary: prospective, multicenter, bilateral, interventional, controlled, masked (sponsor, subjects, and evaluators), randomized clinical trial.


Eligibility criteria:
inclusion criteria to be considered for enrollment in this study, patient must: * be at least 22 years old * have cataracts in both eyes * sign the written informed consent * be willing and able to comply with examination procedures * understand, read and write english to complete informed consent and questionnaires * be available for study follow-up visits exclusion criteria patient will not be eligible to take part in the study if: * currently participating in any other clinical study or have participated in a clinical study during the last 30 days * have a certain disease/illness, such as poorly controlled diabetes * have certain ocular conditions, such as uncontrolled pressure in the eye * taking medication that may affect vision * pregnant, plan to become pregnant during the study, or are breastfeeding
discovering the antecedents of rheumatoid arthritis flare

Conditions: Rheumatoid Arthritis

Summary: longitudinal study of patients with rheumatoid arthritis comparing measures of disease activity with blood samples.

80% of patients living with rheumatoid arthritis can expect fluctuations in their symptoms over time. dramatic increases in disease activity are considered flare. this study will follow patients with increased risk for flare prospectively for one year. serial questionnaires and disease activity scores will be compared to blood samples to better understand the molecular phenotype of rheumatoid arthritis flares.

Eligibility criteria:
inclusion criteria: * 2010 criteria for rheumatoid arthritis * swelling of at least one joint and or elevated acute phase reactants * greater than or equal to 40 years old or less than or equal to 65 year old female sex * cyclic citrullinated peptide antibody + in the past 12 months exclusion criteria: * hemoglobin \< 9 * white blood cell count \< 3.5 * diagnosis of any active malignancy within the last 3 years besides non-melanomatous skin cancer * diagnosis of diabetes and requires insulin * hiv+, hep b s ag+, hep c polymerase chain reaction + * untreated latent tuberculosis * diagnosis of any additional systemic autoimmune connective tissue disease * inability to reliably complete study requirements * history, physical, social or laboratory findings suggestive of any other medical or psychological condition that would, in the opinion of the principal investigator, make the candidate ineligible for the study

Keywords: rheumatoid arthritis
novel 3d hematological malignancy organoid to study disease biology and chemosensitivity

Conditions: Hematologic Malignancy

Summary: the objective of this project is to compare chemosensitivity between chemotherapy combinations in bone marrow aspirates using 3d organoid models. the investigators overarching hypothesis is that 3d organoids are ideal to test chemosensitivity in real time, to provide personalized medicine and guidance in the setting of relapsed hematologic malignancy and potentially other cancers.

optimize the novel 3d organoid technique already used to recreate myeloma tumors in the regenerative medicine laboratory. optimize cell viability of myeloma organoids to extend available time in culture by screening cell culture media cytokines and 3d extracellular matrix composition (current environment is able to maintain cells alive for up to 5-7 days to allow testing). evaluate myeloma tumor markers at different time points of organoid life to confirm accurate tumor representation, identify genetic expression characteristics, unique mutations, and tumor-stroma interaction. this will give information of the tumor characteristics to learn about tumor biology and correlate with responses. evaluate chemosensitivity on patient derived 3d organoids. using myeloma patients marrow aspirate, evaluate live/kill rates of myeloma cells after being exposed to established regimen combinations after 24 and 36 hours of exposure at pre-determined concentrations. using patient samples, evaluate differences in gene expression and cell markers of the myeloma cells that remained alive after chemotherapy exposure to better understand mechanisms of resistance. validate the predictive value of the 3d organoid chemobiogram results compared with retrospective data of the donor s responses to the treatment used at that time point. this will compare in vivo/ex vivo responses and facilitate future personalized medicine. chemobiogram is the report on chemosensitivity from the combinations tested much like an antibiogram.

Eligibility criteria:
inclusion criteria: * patients with suspected or confirmed hematologic malignancy undergoing a bone marrow biopsy as part of their care. * the ability to understand and willingness to sign an irb approved informed consent document.

Keywords: 3d organoid technique
allonk®, an allogeneic non-genetically modified, cord blood-derived nk cell therapy, in combination with rituximab, studied in relapsing forms of b-cell dependent rheumatologic diseases.

Conditions: Refractory Rheumatoid Arthritis (RA); Idiopathic Inflammatory Myopathies (IIMs); Systemic Sclerosis (SSc); Rheumatoid Arthritis (RA; IIM; Myositis; Scleroderma; Sjogren Syndrome; Sjogrens Disease

Summary: a basket trial of refractory rheumatoid arthritis (ra), sjögren's disease (sjd), idiopathic inflammatory myopathies (iims) and systemic sclerosis (ssc) subjects to evaluate the safety and efficacy of allonk, a non-genetically modified allogeneic nk cell, in combination with rituximab.

an open-label phase 2a study to evaluate the safety and efficacy of allonk®, an allogeneic cord blood-derived nk cell therapy, in combination with rituximab in relapsing forms of b-cell dependent rheumatologic diseases. allonk® (also known as ab-101) is a non-genetically modified, allogeneic, off-the-shelf, cryopreserved cord blood-derived nk cell therapy.

Eligibility criteria:
for subjects with refractory rheumatoid arthritis (ra): * documented diagnosis of ra, meeting the 2010 acr/eular classification criteria. * rheumatoid factor (rf) or anti citrullinated protein antibody (acpa) positive. * high-sensitivity c-reactive protein (hs-crp) \> 3 mg/l or erythrocyte sedimentation rate (esr) \> 28 mm/hr. * have had prior treatment for a period of at least 12 weeks with a biologic disease modifying anti-rheumatic drug and were deemed refractory by the treating physician. * minimum of six swollen joint counts (sjc) and six tender joint counts (tjc) according to joint assessment. for subjects with sjögren's disease (sjd) * prior diagnosis of primary sjd as per 2016 acr/eular criteria with confirmatory diagnosis in the 24 weeks preceding screening. * total clinical european league against rheumatism sjogren's syndrome disease activity index (clinessdai) \> 6. * salivary flow rate \> 0.1 ml/min on stimulation. for subjects with idiopathic inflammatory myopathies (iims) * presence of a positive autoantibody (ana \>1:80 or rnp or ssa/ssb or other myositis specific autoantibodies. * refractory iim as defined by inadequate response/intolerance to at least 3 months of glucocorticoids and/or at least one other immunosuppressive. * muscle biopsy or muscle mri to confirm iim diagnosis, where applicable, within 12 months prior to enrollment. for subjects with systemic sclerosis (ssc) * diagnosis of ssc in accordance with the acr/eular 2013 classification. * modified rodnan skin score (mrss) \> 10. * initial confirmatory diagnosis within 8 years of screening. * refractory ssc as defined by inadequate response/intolerance to at least 3 months of glucocorticoids and/or at least one other immunosuppressive.

Keywords: refractory rheumatoid arthritis allonk idiopathic inflammatory myopathies systemic sclerosis sjögren's disease refractory ra cell therapy allogeneic nk cells allogeneic cell therapy non-genetically modified rituximab cord blood cells adcc enhancement outpatient community