Kornimate/medical-research-clean huggingface dataset:
technology delivered diabetes-modified behavioral activation treatment

Conditions: Diabetes Mellitus, Type 2

Summary: the overarching goal of this proposal is to test the efficacy of a multi-component, high intensity intervention, technology delivered, diabetes-modified behavioral activation treatment (tech dm-bat) that incorporates: 1) diabetes education; 2) home telemonitoring; and 3) diabetes modified behavioral activation, delivered by nurses via smartphones is effective in improving metabolic control in african americans with poorly controlled type 2 diabetes.

diabetes mellitus is highly prevalent in the united states (cdc 2014) and african americans (aa) are disproportionately affected and have higher prevalence, poorer metabolic control and greater risk for complications and death compared to white americans. evidence from the literature show that effective interventions for aas with type 2 diabetes mellitus (t2dm) have multiple components including: education and skills training, nurse case management, and maintain high intensity. however, few large randomized clinical trials (rct) have tested multi-component interventions that include these key components in aas with t2dm. behavioral activation is a psychotherapeutic process whereby patients are encouraged to identify and schedule structured and enjoyable activities for behavior change that are likely to improve outcomes such as mood, behaviors and quality of life. a brief manualized behavioral activation treatment for depression (batd), has been modified for diabetes. this study tests a multi-component, high intensity intervention that incorporates several strategies that have been shown to be effective in improving diabetes outcomes in aas. nurse case managers will use videoconferencing technology to deliver education, skills training and problem solving for diabetes via smartphones, an approach that has not been used previously in vulnerable and underserved ethnic minority populations.

Eligibility criteria:
inclusion criteria: * age ≥21 years * clinical diagnosis of t2dm and hba1c ≥8% at the screening visit; * self-identified as aa * subject must be willing to use the fora monitoring system for 6 months * subject must be willing to use the study assigned smartphone including videoconferencing, lifestyle monitoring and medication monitoring apps for 6 months * subjects must be able to communicate in english * subjects must have access to a landline or ethernet for fora data uploads for the study period. exclusion criteria: * mental confusion on interview suggesting significant dementia * participation in other diabetes clinical trials * alcohol or drug abuse/dependency * active psychosis or acute mental disorder * life expectancy \<6 months.
comparison of image quality of coronary computed tomography angiography between high concentration and low concentration contrast agents(concentrate trial)

Conditions: Coronary Artery Disease

Summary: according to ct technology development, cardiac ct is very useful examination as noninvasive examination and the accuracy in locating lesions has increased to 95%. specifically, cardiac ct has been performing a gateway role in reducing invasive cardiac angiography implemented solely for the purpose of diagnosis because of the invasive testing of makeshift cardiac angiography. however, cardiac ct also comes with the disadvantage that patients cannot avoid being exposed to radiation, so there has been much effort in appealing to reduce exposed radiation dose. of these methods, the most effective is the method of repeatedly reconstitution by way of synchronized prospective ecg while using low tube-based potential. according to recent studies, the snr(signal noise ratio) and cnr(contrast noise ratio) values representing image quality have been higher compared to the combined method of image reconstruction by makeshift filtered back projection and condition of image acquisition by patient bmi. also, the administered amount of contrast agent can be reduced for achieving the same contrast effect due to the advantage of the increased effect of contrast enhancement by using low tube voltage. therefore, the efficacy studies of using low concentration of contrast agents in conditions of using low tube voltage are being processed. this study intends to prove that image quality does not deteriorate by suitable image reconstruction method with low concentration contrast agent compared to the combined method of the makeshift filtered back projection image reconstruction method and the conditions of image acquisition according to bmi with general amount of contrast agent.


Eligibility criteria:
inclusion criteria: * adults at least 20 years old * subject who had requested a coronary ct angiography as per a clinical disease exclusion criteria: * subject suspected as having myocardial infarction, unstable angina pectoris, coronary artery disease * subject with heart attack within 40 days prior to the ct scan * subject with diagnosed complicated heart anomaly * bmi (body mass index) \> 35kg/m2 * serum creatinine ≥1.5mg/dl of renal insufficiency * subject with pregnancy or unknown pregnancy * subject with history of hypersensitivity reaction of contrast agents * subject has contraindication of using nitroglycerine * subject has plan to participate or enrolled in other randomized clinical trial for cardiovascular disease. * subject has contraindication of using adenosine (e.g. bronchial asthma, 2-3 degree av block, sick sinus syndrome, sbp (systolic blood pressure) less than 90mmhg, recent prescribed history of dipyridamole, hypersensitivity of adenosine)

Keywords: low concentration contrast agent low dose contrast agent computed tomography
thromboembolic and bleeding risks during anticoagulant treatment in asian patients with atrial fibrillation (target-af)

Conditions: Fibrillation, Atrial

Summary: this study was design to investigate the efficacy and safety of noac therapy in koreans

east asians have demonstrated a higher bleeding tendency compared to western populations during an anticoagulation. consequently, east asians have been prescribed as a relatively weaker treatment regimens based on this evidence. therefore, the target-af study aims to verify the efficacy and safety of noac therapy in koreans

Eligibility criteria:
inclusion criteria: * patients with documented af on 12-lead ecg, holter monitoring, or single-lead ecg recordings are eligible for enrollment. * based on af treatment korean guideline 19, af patients who require noac treatment or are currently on noac treatment (within the past 3 months) * adults aged 18 or above who have provided consent for clinical information exclusion criteria: * patients with moderate or severe mitral stenosis or mechanical prosthetic valve

Keywords: atrial fibrillation stroke bleeding
pegfilgrastim as support to advanced breast cancer patients receiving chemotherapy

Conditions: Neutropenia

Summary: physicians are conducting a clinical trial for patients with advanced breast cancer. breast cancer can be treated with chemotherapy which can affect the bone marrow, where blood cells are produced. neutrophils are a type of white blood cells that fight infection and are produced in the bone marrow. if the neutrophil count becomes low due to chemotherapy, a potentially serious condition called neutropenia occurs. neutropenia is serious because it can affect the body's ability to protect against many types of infections. pegfilgrastim is an investigational drug being evaluated for its potential ability to increase the number of neutrophils. the purpose of this study is to determine the safety and effectiveness of pegfilgrastim in preventing neutropenia following chemotherapy in patients with advanced breast cancer.


Eligibility criteria:
* advanced breast cancer * 18 years of age or older * patients who will be receiving taxotere (docetaxel) chemotherapy

Keywords: breast cancer neutropenia chemotherapy
phase i trial from grid 18f-fdg-pet biological imaging-guided intensitymodulated radiotherapy (bg-imrt) with patients with recurrent or new head or neck tumor in previously radiated area

Conditions: Head and Neck Tumors

Summary: this trials examines the feasibility of grid-therapy combined with biologically imaging based imrt (bg-imrt). within this trial, the strict toxicity parameters of primary treatment of head and neck tumors are used. the grid and bg-imrt technique might be possible to reduce the total radiation dose 2 to 3 times.


Eligibility criteria:
inclusion criteria: * recurrent or new head or neck tumor * 18 years or older

Keywords: recurrent head and neck tumors
platinum-based chemotherapy with or without paclitaxel in treating patients with relapsed ovarian cancer

Conditions: Ovarian Cancer; Primary Peritoneal Cavity Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: randomized phase iii trial to compare the effectiveness of platinum-based chemotherapy with or without paclitaxel in treating patients with relapsed ovarian epithelial cancer.

objectives: * compare survival of patients with relapsed ovarian epithelial or peritoneal cancer treated with paclitaxel and either carboplatin or cisplatin vs conventional platinum-based chemotherapy. * compare the quality of life and health economics of these regimens in these patients. outline: this is a randomized study. patients are randomized to one of two treatment arms. * arm i: patients receive platinum-based chemotherapy (that is familiar to the oncologist and used routinely by the center) comprising either cisplatin or carboplatin alone or cisplatin in combination with other drugs. * arm ii: patients receive paclitaxel iv over 3 hours followed by either carboplatin or cisplatin. treatment for both arms continues every 3 weeks for up to 6 courses in the absence of unacceptable toxicity. quality of life is assessed. patients are followed at 6 months, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. projected accrual: a maximum of 800 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * ovarian epithelial cancer or serous peritoneal carcinoma that has relapsed after prior chemotherapy * progression-free interval (from end of last treatment) of at least 6 months * measurable disease not required patient characteristics: age: * not specified performance status: * not specified life expectancy: * not specified hematopoietic: * not specified hepatic: * bilirubin less than 2 times normal renal: * not specified other: * no sepsis * no contraindication to chemotherapy prior concurrent therapy: biologic therapy * not specified chemotherapy * see disease characteristics endocrine therapy * not specified radiotherapy * not specified surgery * not specified

Keywords: recurrent ovarian epithelial cancer primary peritoneal cavity cancer
evaluation of the quantiferon-tb test.

Conditions: Tuberculosis

Summary: to compare the results of the investigational test to the currently approved quantiferon-tb gold in-tube test.

the objective of the study was to enroll patients who have clinical signs/symptoms strongly indicating tb and who are receiving of have to start the treatment for active tb, and test the variants of the cst001 assay to support the evaluation of clinical sensitivity.

Eligibility criteria:
inclusion criteria: * clinical symptoms consistent with a high probability of having tb disease * receiving, or are likely to receive, therapy for active tb * confirmed tuberculosis by either afb smear and culture testing, or nucleic acid amplification methods and culture testing. * between 18 and 70 years of age. exclusion criteria: * taken therapy for active tb or latent tb for more than 14 days * culture confirmation of m. tuberculosis not obtained

Keywords: tuberculosis tb
individualized fortification of breast milk

Conditions: Postnatal Growth Disorder; Neurodevelopment

Summary: the proposed research will investigate individualized fortification of breast milk based on daily milk analysis of carbohydrate, protein, and fat content in a randomized double blind controlled trial. the combination of additional fat, carbohydrate and protein and commercial fortifier will be added to ensure that the milk contains the target amounts of nutrient. growth and development of these infants will be compared with that of infants fed mother's milk that has been supplemented with the current standard amounts. the postnatal growth of the infants will be assessed by measuring weight, length and head circumference and fat and lean mass using highly accurate, non-invasive methods throughout the intervention period and at the first follow-up visit after discharge at 3 months. neurological development will be analyzed at the age of 18 months. the investigators hypothesize that individualized fortification of breast milk improves the nutritional intake of preterm infants, optimizing growth, and thus this will positively impact neurodevelopment and health.


Eligibility criteria:
inclusion criteria: 1. gestational age \< 32weeks (maternal dates or early fetal ultrasound); 2. tolerating an enteral intake of ≥ 100 ml/kg/d for ≥ 24h; 3. subject is anticipated to receive the intervention for ≥ 3 consecutive weeks after full enteral feeding (≥ 150 ml/kg/d) has been achieved; and 4. written informed consent has been obtained from the infant's legal representative. exclusion criteria: 1. infants with intrauterine growth restriction, small for gestational age defined by a weight less than 3rd percentile using sex specific reference data for birth weight 2. gastrointestinal malformation, major congenital anomalies and chromosomal abnormalities; 3. babies with enterostoma or short gut syndrome; 4. necrotizing enterocolitis, defined by feeding intolerance associated with positive x-ray findings (pneumatosis intestinalis - bell stage 2; air in the biliary tract or free air in the peritoneum - bell stage 3); 5. renal disease, defined by symptoms (oliguria, anuria, proteinuria, hematuria) associated with an increased blood urea nitrogen 10 mmol/l79 and creatinine of 130 mmol/l80; 6. hepatic dysfunction, defined by jaundice (direct bilirubin \>1.0 mg/dl) that is associated with one or more abnormal liver function tests (ast, alt or ggt); 7. participation in another clinical trial that may affect outcomes of this study; or 8. probability of transfer to another nicu or level ii nursery outside the mcmaster children's hospital before the minimum period of three weeks is completed. post-randomisation exclusion criteria: 1. infants fed more than 25% of mean caloric intake for a consecutive week with formula milk; 2. fluid restriction \< 140ml/kg/d for ≥ 3 consecutive days; 3. sepsis - all infants with gram-negative sepsis will be removed from the study.

Keywords: postnatal development breast milk fortification composition of breast milk
pilot biomarker trial to evaluate the efficacy of itraconazole in patients w/ basal cell carcinomas

Conditions: Basal Cell Carcinoma (BCC); Skin Cancer

Summary: basal cell carcinomas (bccs) are the most common human cancer in the us and affect over 1 million people. there is no effective drug to prevent basal cell carcinomas of the skin. we hope to learn if an oral anti-fungal drug, itraconazole, might inhibit a marker of proliferation and a biomarker (tumor signaling pathway) of bcc development. itraconazole is an fda-approved drug for the treatment of fungal infections of the skin, and has been used for the past 25 years with relatively few side effects. it has been shown in mice to reduce a bcc biomarker and to reduce growth of bccs. thus, it may reduce bcc growth in humans.

participants with at least one bcc tumor measuring 4 mm or greater in diameter will be enrolled onto 1 of 2 treatment cohorts to receive oral itraconazole. * cohort a - 400 mg itraconazole (as 200 mg twice daily for 30 days), stratified by: * cohort a1 - participants are vismodegib-naive. * cohort a2 - participants had received prior vismodegib treatment. * cohort b - 200 mg itraconazole (as 100 mg twice daily, for up to 4 months). the objective of this cohort is to assess the anti-cancer efficacy of lower-dose extended treatment. * control group - tumors from untreated participants.

Eligibility criteria:
inclusion criteria * at least one bcc tumor (greater than 4 mm in diameter) at any skin location, to be biopsied and surgically removed. * had at least one liver function test \[eg, aspartate aminotransferase (ast), alanine aminotransferase (alt)\] with normal results in the last year. * consent to research use of their bcc tissue. * cohort a or b: willing to take itraconazole during the 2 to 3 weeks between biopsy and surgical removal of bcc exclusion criteria * history or current hepatitis or other liver disease. * currently taking systemic medications that would affect bcc tumors (oral retinoids) or metabolism of itraconazole (anti-convulsants, corticosteroids) * history or current evidence of malabsorption or liver disease within the one year prior to enrollment. * history or current evidence of hyperthyroidism increasing metabolism of itraconazole * unable to attend to 2nd study visit at stanford for mohs surgical excision * current immunosuppression disease (cancer, autoimmune disease) * receiving immunosuppressive drugs * pregnant * lactating * any female actively trying to become pregnant
neoadjuvant treatment of triple-negative breast cancer with stereotactic radiotherapy, pd-1 monoclonal antibody, and chemotherapy

Conditions: Breast Cancer Invasive

Summary: the primary aim is to evaluate the efficacy of neoadjuvant sbrt combined with pd-1 monoclonal antibody and chemotherapy in patients with triple-negative breast cancer, with the endpoint being the pcr rate-defined as the proportion of patients with no residual invasive cancer in the breast and no axillary lymph node metastasis after treatment. this is a single-arm study. eligible participants will receive : neoadjuvant treatment consisting of sbrt followed by envafolimab (pd-1 inhibitor), chemotherapy and immunotherapy (envafolimab). surgery will be performed after the last chemotherapy cycle. pathological evaluation will assess the treatment response. patients will receive adjuvant immunotherapy (envafolimab) up to 1 year post-surgery.


Eligibility criteria:
inclusion criteria signed written informed consent prior to enrollment age ≥ 18 years ecog ps score 0-1 newly diagnosed t1c n1-2 or t2-3 n0-2 breast cancer triple-negative breast cancer with pd-l1 cps \< 10 hemoglobin ≥ 10.0 g/dl, neutrophils ≥ 1.5 × 10⁹/l, platelet count ≥ 100 × 10⁹/l bun ≤ 1.5 × upper limit of normal (uln), creatinine ≤ 1.5 × uln serum bilirubin ≤ 1.5 × uln, alkaline phosphatase (akp), ast, and alt ≤ 2.5 × uln women of childbearing potential must be willing to use contraception during the study negative serum or urine pregnancy test within 7 days prior to treatment exclusion criteria occult breast cancer bilateral breast cancer breast tumor unsuitable for sbrt unable to undergo mri scanning history of other malignancies that may affect survival active autoimmune disease or history of autoimmune disease current use of immunosuppressants or systemic steroids (within 2 weeks prior to enrollment) known allergy to any component of the investigational drugs uncontrolled cardiac symptoms or diseases active infection or unexplained fever \> 38.5°c during screening/before first dose other factors likely to cause early study termination (e.g., serious concurrent illnesses, significant lab abnormalities, or social/family circumstances affecting safety/data collection)

Keywords: preoperative radiothrapy immunotherapy triple-negative breast cancer
treatment of gingival recession using mesenchymal stem cells

Conditions: Gingival Recession

Summary: treatment of patients with gingival recession by injection of autologous adipose-derived mesenchymal stem cells mixed with collagen gel

treatment of patients with gingival recession by injection of autologous adipose-derived mesenchymal stem cells mixed with collagen gel (1×106cells/0.2 ml). the volume of the mixture is divided into 4 equal injections in the gingival region of one tooth (one place injection volume is 0.05 ml of mixture).

Eligibility criteria:
inclusion criteria: -gingival recession exclusion criteria: * pregnancy * breast-feeding * acute and chronic infectious diseases: hiv, viral hepatitis, tuberculosis * mental disorders

Keywords: gingival recession
tace combined with lenvatinib for unresectable hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: it is an exploratory clinical study aimed to evaluate the efficacy and safety of tace combined with lenvatinib in the treatment of patients with bclc stage b and c hcc.treatment will continue until the death or intolerable toxicity or patients withdrawal of consent,and the target sample size is 54 individuals.

this is a prospective, single-center and single-arm exploratory clinical study designed to evaluate the efficacy and safety of tace combined with lenvatinib in the treatment of patients with bclc stage b and c hepatocellular carcinoma.treatment will continue until the death or intolerable toxicity or patients withdrawal of consent,and the target sample size is 54 individuals.

Eligibility criteria:
inclusion criteria: - 1. histopathologically or clinically confirmed unresectable hepatocellular carcinoma. 2. age ≥ 18 years at time of study entry. 3. child-pugh scores \<7. 4. performance status (ps) ≤ 2 (ecog scale). 5. bclc stage b, some patients in stage c (vp2-3). 6. the patient and/or his family agreed to join the clinical trial and sign the informed consent form. exclusion criteria: * 1. have received tace or other local treatment for liver cancer (except bridged liver transplantation). 2. main portal vein tumor thrombus or complicated with extrahepatic metastasis. 3. tumor burden≥70% , diffuse liver cancer or tumor is not suitable for mrecist standard evaluation. 4. have received systemic chemotherapy, sorafinib or other targeted therapy or immunotherapy. 5. estimated life expectancy of \ 2.3. 7. renal dysfunction：serum creatinine (scr) \>176.8 μmol/l（2 mg/dl）or creatinine clearance rate (ccr) \<30 ml/min. 8. serious heart, lung, brain or other important organ diseases. 9. pregnant or lactating women. 10. cannot cooperate with tace operation and sign informed consent form.

Keywords: hepatocellular carcinoma transarterial chemoembolization lenvatinib