Kornimate/medical-research-clean huggingface dataset:
sentinel lymph node total tumoral load as a predictor of non sentinel node involvement in early breast cancer

Conditions: Breast Cancer

Summary: this is a retrospective, multicentric cohort study of patient cases with ct1-3, n0 early breast cancer, who previously had intraoperative sentinel lymph node (sln) evaluation by one-step nucleic acid amplification (osna) assay with a complete axillary dissection. the aim of the present study is to assess the intraoperative positive sln total tumor load (ttl) obtained from the osna assay and to determine whether this ttl predicts non-sln metastasis in patients with clinically node-negative early-stage breast cancer.


Eligibility criteria:
inclusion criteria: * pathologically confirmed invasive breast carcinoma * stage t1-3,n0 evaluated by physical exam or imaging according to ajcc v.7 and best clinical local practices * intraoperative evaluation of sentinel lymph node (sln) by osna * complete dissection of axillary lymph nodes after the evaluation of the slns by osna * pathology report of the tumor and dissected lymph nodes that includes the following information: * primary tumor size (mm), tumor grade (scarff-bloom richardson), estrogen receptor status * progesterone receptor status * her2 status (asco/cap guidelines) * ki67 index * presence/absence of lymphovascular invasion * total number of sentinel and non-sentinel lymph nodes dissected during surgery * total number of positive and negative sentinel and non-sentinel lymph nodes, \*size of the metastasis in both sentinel and non-sentinel lymph nodes * total tumoral load in each sentinel lymph node, expressed as number of ck19 mrna copies per microliter. exclusion criteria: * patients who underwent neoadjuvant chemotherapy * ck19-negative breast tumor * alnd with \<10 lymph nodes * in situ carcinoma only * metastatic breast cancer at time of diagnosis

Keywords: breast cancer osna sentinel lymph node
comparison of pulmonary function, exercise capacity, and physical activity level between children with hemophilia and healthy controls

Conditions: Hemophilia; Healthy Children

Summary: hemophilia is a rare x-linked congenital bleeding disorder characterized by deficiency of clotting factor viii (hemophilia a) or deficiency of factor ix (hemophilia b) with complex diagnosis and management. participation in physical activity is still limited in children with hemophilia, probably due to protective attitudes of families/patients and avoidance of activity, and possibly also as a result of chronic pain. exercise capacity has been identified as a protective factor against joint problems in hemophilia. aerobic fitness is associated with better pulmonary function in children. chronic pain and decreased range of motion due to recurrent bleeding in joints and muscles in hemophilia may indirectly affect posture and respiratory mechanics, leading to impaired pulmonary function. this study aims to compare pulmonary function, exercise capacity, posture, and physical activity level between children with hemophilia and healthy controls and to investigate the relationship between these parameters.


Eligibility criteria:
hemophilia group inclusion criteria: * having been diagnosed with hemophilia and being clinically stable, * being between the ages of 8-18, * being on prophylaxis treatment (a routine treatment), * being 125 cm or taller, * being inhibitor negative at the time of enrollment, * to be able to cooperate with the tests to be performed, * being willing to participate in the study. exclusion criteria: * being inhibitor positive at the time of enrollment, * having a history of acute joint bleeding, * being unable to bear weight on the extremities, * having a history of acute intramuscular bleeding, * having undergone radionuclide synovectomy, * having a history of surgery on any of the lower extremity joints, * having a severe cardiovascular, orthopedic or neurological problem that may affect the assessments. control group inclusion criteria: * not having any known internal or chronic disease * being male between the ages of 8-18 * having full range of motion in the upper extremity * having full range of motion in the lower extremity * not having any history of injury or surgery in the lower extremity * being 125 cm or taller * being willing to participate in the study exclusion criteria: * having any problem that may affect the tests * not having full range of motion in the upper extremity * having a history of injury or surgery in any of the lower extremity joints * having a neurological deficit * having pain or movement limitation in the lower extremity

Keywords: hemophilia exercise capacity pulmonary function
a study to evaluate available treatment information of ponatinib, bosutinib, imatinib, dasatinib and nilotinib in adults with chronic myeloid leukemia

Conditions: Leukemia

Summary: the aims of this study are to learn out about treatment information (including amongst others treatment patterns, safety, development of a participant's condition) ponatinib, bosutinib, imatinib, dasatinib and nilotinib using already available data. no new data will be collected from participants as part of this study and no study medicines will be provided in this study.

this is a retrospective cohort analysis study in participants with chronic phase chronic myeloid leukemia (cp-cml). this study will use humedica electronic medical record (emr) data to evaluate the real-world treatment patterns, safety, and efficacy of ponatinib and other tyrosine kinase inhibitors (tkis) among cp-cml participants. the study will enroll approximately 1769 patients. based on the tki drug used on index date, stratified by prior tki use, participants will be classified into the following cohorts - * ponatinib cohort * bosutinib cohort * other tki cohort this is a multicenter study conducted in the united states (us). the overall duration for data collection in this trial will be approximately 5 years.

Eligibility criteria:
inclusion criteria: participants will be included in the study if they: 1. had ≥1 prescription for tki (imatinib, dasatinib, nilotinib, bosutinib, or ponatinib) from april 1, 2013-march 31, 2017; * for participants with ponatinib use, the first ponatinib prescription date will be defined as the index date; for participants with bosutinib but not ponatinib use, the first bosutinib prescription date will be defined as the index date; and for participants without ponatinib and bosutinib use, the first imatinib, dasatinib, nilotinib prescription date will be defined as the index date. * participants with \>1 type of tki on the index date will be dropped. 2. had ≥1 medical diagnosis for cml (international classification of diseases, ninth revision, clinical modification \[icd-9-cm\]: 205.1; icd-10-cm: c92.1) any time prior to the index date or within 6 months post-index date; diagnosis codes in the primary or secondary position will be used; the first cml diagnosis date will be designated as the initial cml diagnosis date; 3. were aged ≥18 years on the index date; 4. were active in the humedica emr data 6 months pre- and post-index date, indicated by the first and last healthcare activity in the data; * participant data will be assessed until the earliest of switch to another tki, disenrollment, death, or study end date. the minimum required duration of follow-up can be further revised based on the average duration of first-line treatment. * participants who died in 6 months will be included. exclusion criteria: participants will be excluded from the study if they: 1. had ≥1 prescription for their index tki (imatinib, dasatinib, nilotinib, bosutinib, or ponatinib) any time prior to the index date. 2. this will allow ≥6-month wash-out period, and ensure we are capturing second line participants.

Keywords: drug therapy
study comparing two different tablet formulations of bosutinib under fed conditions

Conditions: Healthy

Summary: study comparing 2 formulations of bosutinib in healthy subjects.


Eligibility criteria:
inclusion criteria: * men or women of nonchildbearing potential age 18 to 50 years exclusion criteria: * any clinically significant medical condition
incidence, risk factors, and risk model of acute kidney injury after liver transplantation

Conditions: Renal Function; Liver Transplantation

Summary: the incidence of acute kidney injury after liver transplantation has been reported to be 17 to 95 percent, but no definite treatment has been reported yet. therefore, it is important to identify and prevent reversible risk factors for acute kidney injury after liver transplantation. previous studies have reported several preoperative clinical risk factors, but preoperative medication and intraoperative colloid administration and hemodynamic parameters have not been evaluated. therefore, we attempt to evaluate perioperative risk factors and develop simplified clinical risk scoring model.

ischemia/reperfusion injury occurs during graft harvesting, cold storage, and surgical procedures in liver transplantation. ischemia/reperfusion injury in liver graft results in major organ damage including kidney, lung and heart as well as graft dysfunction. graft dysfunction and renal injury after liver transplantation are major clinical issues and are associated with prognosis and low survival rate. the incidence of acute kidney injury after liver transplantation has been reported to be 17 to 95 percent, but no definite treatment has been reported yet. therefore, it is important to identify and prevent reversible risk factors for acute kidney injury after liver transplantation. previous studies have reported several preoperative clinical risk factors, but perioperative medication, metabolic variables (albumin, glucose, uric acid), intraoperative colloid administration and hemodynamic parameters have not been evaluated. in addition, a neutrophil-lymphocyte ratio (nlr), which has been reported to be related to systemic inflammation and associated with prognosis of cardiac and cancer patients, might be related to the development of aki after ldlt. therefore, we attempt to evaluate these perioperative risk factors and develop simplified clinical risk scoring model.

Eligibility criteria:
inclusion criteria: * patients who underwent living donor liver transplantation between 2010 and 2013 in samsung medical center exclusion criteria: * incomplete data regarding pre- and postoperative creatinine and estimated glomerular filtration rate * patient who underwent retransplantation

Keywords: risk factor acute kidney injury liver transplantation postoperative renal function
study to assess safety and tolerability of g17dt in patients with colorectal adenocarcinoma.

Conditions: Colorectal Cancer

Summary: pancreatic, gastric, and colorectal cancers have all been shown to overexpress the gastrin gene and to be sensitive to the trophic effects of the gastrin in animal models. the hypothesis of this study is that g17dt will elicit specific and high-affinity antibodies that will bind gastrin-17, thus preventing the trophic activity of cancer cells.


Eligibility criteria:
inclusion criteria: * histologically verified adenocarcinoma of the colon or rectum * recurrent/ metastatic disease not amenable to curative surgery and/or radiotherapy * measurable/ evaluable lesions * life expectancy \> 3 months * karnofsky index \> 50% or who performance rating of 0-2 * biochemical markers: * renal function \< 25% above upper limit of normal range (creatinine, 140 imol/1 unless malignant involvement proven) * liver function \< 25% above upper limit of normal range (bilirubin \~25 mcmol/1 unless malignant involvement proven) * haematological status: * haemoglobin, 11 g/ dl * wbc, 4 x 109/1 * platelets, 100 x 109/l * written consent exclusion criteria: * other concomitant malignant disease except treated basal cell carcinoma of the skin or cancer of the uterine cervix stage 0-1 * h 2 receptor antagonist or proton pump inhibitor therapy * previous gastric surgery (including vagotomy) * active uncontrolled infection * autoimmune disorders * anticancer treatment within the last three months unless progression of the disease occurred in the interim * women of child-bearing age * patient is a poor medical risk because of non-malignant systemic disease * previous radiotherapy to all measurable or evaluable lesions.
clonal hematopoiesis and therapy-emergent myeloid neoplasms in patients with cancers, chances study

Conditions: Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma; Recurrent Malignant Solid Neoplasm; Clonal Cytopenia of Undetermined Significance; Clonal Hematopoiesis; Idiopathic Cytopenia of Undetermined Significance; Non-Neoplastic Hematopoietic and Lymphoid Cell Disorder; Ovarian Carcinoma; Myeloid Neoplasm Post Cytotoxic Therapy

Summary: this study is being done to investigate clonal hematopoiesis and therapy-emergent myeloid neoplasms in patients with ovarian or other solid cancers. researchers want to identify risk factors for developing these blood cancers as well as if there is/are a genetic/environmental component(s) to developing blood cancer.

outline: this is an observational study. patients undergo blood sample collection and complete surveys on study. patients' medical records are also reviewed.

Eligibility criteria:
inclusion criteria: * subjects who have or have had ovarian, peritoneal, or fallopian tube carcinoma who have a life expectancy of greater than 6 months and: * have completed or plan to complete at least 5 cycles of platinum-based chemotherapy or * subjects who have or have had a solid tumor diagnosis and any of the following: * at least 4 months of exposure to a parp inhibitor * diagnosis of a blood disorder including, but not limited to, clonal hematopoiesis of indeterminate potential, cytopenia of unknown significance, or therapy-related myeloid neoplasm exclusion criteria: * individuals with a life expectancy of less than 6 months
study compare adjuvant chemotherapy, chemoradiotherapy and surgery alone for pn1-2(pt1b-3n1-2m0) esophageal carcinoma

Conditions: Esophageal Squamous Cell Carcinoma

Summary: a multi-center prospective randomized controlled study was conducted to compare the effects of adjuvant chemotherapy, chemoradiotherapy and surgery alone for the patients with esophageal cancer.

a multi-center prospective randomized controlled study was conducted to compare the effects of adjuvant chemotherapy, chemoradiotherapy and surgery alone on the overall survival rate (os) and disease-free survival (dfs) of patients with pn1-2 (pt1b-3n1-2m0) thoracic esophageal squamous cell carcinoma, and to observe the safety, side effects of adjuvant therapy and the impact on the quality of life of patients after operation.

Eligibility criteria:
inclusion criteria: 1. participants volunteer to participate the study and signed the informed consent. 2. surgical methods: radical resection of tumors (r0) was performed, and pathological examination confirmed the diagnosis of thoracic esophageal squamous cell carcinoma. 3. no antineoplastic treatments before operation. 4. according to the 8th edition of ajcc staging, pn1-2 (pt1b-3n1-2m0) stage of esophageal cancer; 5. who ps score: 0-1; 6. age and gender: 18-75 years old, male and female unlimited; 7. laboratory examination within one week before the adjuvant treatment confirmed that the cardiac, hepatic and renal functions met the requirements. exclusion criteria: 1. the surgical approach is left thoracic approach; 2. patients with severe postoperative complications who cannot receive adjuvant therapy; 3. received other anti-tumor treatment before enrollment; at the same time, patients with malignant tumors of other sites were excluded, except non-melanoma skin cancer, in-situ cervical cancer or cured early prostate cancer. 4. abnormal coagulation function, bleeding tendency (such as active gastrointestinal ulcer) or receiving thrombolytic or anticoagulant treatment; 5. patients with original severe heart disease, including congestive heart failure, uncontrollable high-risk arrhythmia, unstable angina pectoris, myocardial infarction within half a year, severe heart valve disease and intractable hypertension; severe hepatic and renal insufficiency; 6. patients with uncontrollable neurological, mental illness or mental disorder, poor compliance, and inability to cooperate or describe treatment response; 7. known or suspected allergy to chemotherapeutic drugs.

Keywords: esophageal squamous cell carcinoma adjuvant chemotherapy adjuvant chemoradiotherapy surgery
glycemic response of co-ingesting carbohydrate and amino acids

Conditions: Metabolic Diseases

Summary: the study will investigate if consumption of amino acid mixtures results a change in glycemic response of carbohydrate (white rice) and insulinemic response at different doses and timing (before consumption of carbohydrate).

healthy male subjects will be served with amino acid mixtures in combinations of two doses and three time points along with white rice as control. the combinations were either low or high levels of amino acid mixtures. this was consumed together or 15 min, 30 min before consumption of white rice. postprandial blood glucose and plasma insulin concentrations were measured at fasting and every 15 min after consumption of treatment meal until 60 min after the consumption of white rice. subsequent blood sample were taken at 30 min interval until 210min. the glucose and insulin in the blood will be analysed.

Eligibility criteria:
inclusion criteria: * male * chinese ethnicity * age between 21-50 years * body mass index (bmi) between 18-24.9 kg/m2 * waist circumference ≤ 90 cm for men * normal blood pressure (\<120/80 mmhg) * fasting blood glucose \< 6 mmol/l exclusion criteria: * dislike the consumption of essence of chicken * participating in competitive sports * allergic to amino acids and rice * metabolic diseases (such as diabetes, hypertension and the metabolic syndromes) * glucose-6-phosphate-dehydrogenase (g6pd) deficiency * on prescription medication * smokers
tolerability, acceptance, and utility of intermittent cgm use in youth with prediabetes

Conditions: PreDiabetes; Obesity; Insulin Resistance

Summary: we are evaluating whether intermittent use of continuous glucose monitors (cgms) in addition to standard nutritional counseling and physical activity counseling is associated with improved metabolic health for youth with pre-diabetes (pd).

the purpose of this research study is to test if cgms are tolerable to youth with pre-diabetes (pd) and their caregivers. we are also evaluating if cgms add benefit to standard treatment in youth with prediabetes. the cgm in question, abbott freestyle libre 2 is approved by the food and drug administration (fda) to treat patients aged 4 and up with diabetes. we want to determine if this cgm may benefit people who have pd. people who enter the study will either receive standard medical care for prediabetes or receive standard medical care for prediabetes plus use a cgm for 2 weeks each month to receive real-time biofeedback on their glucose levels during the day. there will be 3 visits over a 6-month period, baseline, 3-month, and 6-month visits. at each visit fasting labs will be obtained including: complete metabolic panel, lipid panel, pro-insulin, c-peptide, insulin. anthropomorphics including body mass index, waist circumference, and hip circumference will be monitored.

Eligibility criteria:
inclusion criteria: * age 14 or older * english-speaking * stable metformin dose for 1 month prior to enrollment or no metformin use * baseline a1c of 5.7-6.4% * tanner stage 3 or above * bmi \> = 85% for age exclusion criteria: * bmi \< 85% for age * chronic steroid use * diagnosis of type 1 diabetes, type 2 diabetes, other forms of diabetes * current or history of malignancy

Keywords: pediatrics prediabetes obesity
comparison between isotretinoin, silymarin and both in the treatment of acne vulgaris

Conditions: Acne Vulgaris

Summary: this study aims to compare the effects of isotretinoin and silymarin or both in treatment of acne and their effects on the level of igf-1, saa1 and malondialdehyde (mda) in acne patients.

acne vulgaris, a common and chronic disorder of the pilosebaceous unit, affects up to 85% of adolescent and young adults. the pathogenesis of acne is multifactorial. traditionally, four distinct processes were believed to play critical roles: increased sebum production, alteration of keratinization processes leading to comedone formation, follicular colonization by propionibacterium acnes (p.acnes) and inflammatory mediators around pilosebaceous unit. orally administered isotretinoin is currently the only agent that can affect all four main factors implicated in acne. serum insulin-like growth factor -1(igf)-1 is a polypeptide hormone that has effects on sebocyte differentiation and proliferation. it leads to lipogenesis, and synthesis of inflammatory cytokines. igf-1 also stimulates androgen synthesis leading to overproduction of sebum. propionibacterium acnes can increase the release of serum amyloid a1 (saa1) .there is significant elevation of saa1 in patients with acne, with a positive correlation with its severity. oxidative stress plays a role in the pathogenesis of acne in part due to the generation of reactive oxygen species (ros) in response to infection by the bacterium propionibacterium acnes, which colonizes the skin and grows in plugged hair follicles, thus attracting inflammatory cells, mainly neutrophils. these in turn secrete inflammatory mediators and generate ros, which augments the inflammatory response and tissue damage. silymarin, the main active component of milk thistle consists of a mixture of flavonolignans and flavonoid taxifolin. silymarin acts as a hepatoprotective, anticancer, anti-inflammatory and immunomodulatory agent. silymarin acts as a free radical scavenger, stabilizes the plasma membrane and reduces the production of inflammatory mediators produced by p. acnes, and scavenges the released free radicals.

Eligibility criteria:
inclusion criteria: * age: 16 years or more. patient with moderate or severe acne. not receiving acne treatment in the last month. exclusion criteria: * pregnancy or lactation. patients with known hypersensitivity to isotretinoin or silymarin. patients with depression, liver diseases or high cholesterol. patients with acromegaly. patients with chronic inflammatory, infective or neoplastic disorders.
effect of cauti prevention alert - a randomized control trial

Conditions: Infection Due to Indwelling Urinary Catheter

Summary: this study proposes to expand upon previous research by studying the effects of a urinary-catheter removal alert on duration of urinary catheter use and frequency of cautis with a large, randomized controlled trial within a three-hospital academic medical center. hypothesis the proposed urinary-catheter removal alerts will decrease the number of catheter days and decrease the number of catheter associated urinary tract infections (cautis), but will not affect the catheter re-insertion rate.

primary objectives * specific aim 1: investigate the effect of a urinary-catheter removal alert on the rate of catheter associated urinary tract infections (cautis). * specific aim 2: investigate the effect of a urinary-catheter removal alert on the number of catheter days. * specific aim 3: evaluate the effect of a urinary-catheter removal alert on the rate of catheter re-insertion. * specific aim 4: evaluate the effect of a urinary-catheter removal alert on overall mortality in patients with indwelling catheters.

Eligibility criteria:
inclusion criteria: * all admissions with an indwelling urinary catheter will be randomly assigned to intervention vs. control (usual care) conditions. exclusion criteria: * neonatal intensive care unit and pediatric patients

Keywords: urinary catheter urinary tract infection