Kornimate/medical-research-clean huggingface dataset:
studying fibroblast activity in patients with localized pancreatic cancer undergoing surgery

Conditions: Pancreatic Cancer

Summary: rationale: studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. purpose: this research study is assessing fibroblast activity in patients with localized pancreatic cancer undergoing surgery.

objectives: primary * to assess the degree of fibroblast activation protein (fap) enzymatic activity at the tumor site in patients with localized pancreatic cancer. secondary * to explore correlations between tumor stromal fap enzymatic activity and stromal α_2-antiplasmin levels. * to explore correlations between tumor fap enzymatic activity and plasma dipeptidyl peptidase and plasma α_2-antiplasmin converting enzyme activity as potential surrogates. outline: patients undergo fine-needle aspiration of tumor or suspected mass at baseline. tumor samples are analyzed by ihc for fibroblast activation protein (fap) expression, immunocapture assay for ex vivo fap enzymatic activity, and western analysis for fap concentrations. blood samples are collected weekly and analyzed for dipeptidyl peptidase activity by elisa and α_2-antiplasmin converting enzyme.

Eligibility criteria:
disease characteristics: * biopsy-proven adenocarcinoma of the pancreas or pancreatic mass suspicious for pancreatic cancer * localized disease * scheduled to undergo a resection or exploration of their pancreatic tumor patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: adenocarcinoma of the pancreas recurrent pancreatic cancer stage i pancreatic cancer stage ii pancreatic cancer
postpartum weight loss and exercise (pride)

Conditions: Gestational Diabetes; Glucose Intolerance

Summary: the overall objective of this pilot project is to test in 50 women with a history of gestational diabetes mellitus (gdm), the effectiveness and feasibility of an 8 month intensive lifestyle intervention to reduce the rate of metabolic abnormalities within 1 year after delivery.

the objective is in comparison to a group of women not enrolled in the lifestyle intervention, 8 months of intensive lifestyle intervention aimed at promoting 7% weight loss through increased physical activity and dietary modification in women with a history of gdm will: 1. decrease body weight and 2. reduce the rate of metabolic abnormalities, 12 months after delivery

Eligibility criteria:
inclusion criteria: * women are required to be enrolled (provided written consent for participation) in the copss-gdm study and therefore have met the following inclusion criteria: * postpartum women ≥18 years to 45 years (inclusive) of age who experienced gdm during index pregnancy * english-speaking exclusion criteria: * exclusion criteria: * women enrolled in copss-gdm will be excluded if they met the following criteria: medical exclusion criteria * history or clinical manifestation of any other significant metabolic, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, immune, hepatic, renal, urologic disorders, or cancer * regular use of medications for weight control or psychosis * current use of medication to treat diabetes psychiatric and behavioral exclusion criteria * history or clinical manifestation of any eating disorder * smoking * history of drug or alcohol abuse (up to 14 drinks a week are allowed) within the past two years other exclusion criteria * pregnancy or pregnancy planned during the coming year * unwilling or unable to adhere to the clinical evaluation schedule over the twelve -month study period

Keywords: women postpartum gdm
fs-67 in the treatment of pediatric patients with ankle sprain

Conditions: Ankle Sprain

Summary: the objective of this study is assess the efficacy and safety of single and multiple applications of the fs-67 patch in the treatment of ankle sprain in pediatric population (ages 13-17).

a randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of fs-67 patches in adolescent subjects with ankle sprain

Eligibility criteria:
inclusion criteria: * grade 1 or grade 2 ankle sprain exclusion criteria: * pregnancy or lactation

Keywords: ankle sprain
baricitinib plus glucocorticoid for eosinophilia in igg4-rd

Conditions: IgG4-related Disease With Eosinophilia

Summary: evaluation of efficacy and safety of baricitinib combined with glucocorticoid in patients of igg4-related disease with eosinophilia.

this is a multicenter, 52-week prospective, randomized controlled study to compare the efficacy and safety of baricitinib combined with glucocorticoid and glucocorticoid monotherapy in proliferative igg4-rd patients with eosinophilia.

Eligibility criteria:
inclusion criteria: 1. all patients must meet the following diagnostic criteria of igg4rd (2020): 1) and radiological features: one or more organs show diffuse or localized swelling or a mass or nodule characteristic of igg4-rd. in single organ involvement, lymph node swelling is omitted. 2) serological diagnosis: serum igg4 levels greater than 135 mg/dl. 3) diagnosis diagnosis: positivity for two of the following three criteria: a. dense lymphocyte and plasma cell infiltration with fibrosis. b. ratio of igg4-positive plasma cells /igg-positive cells greater than 40% and the number of igg4-positive plasma cells greater than 10 per high powered field. c. typical tissue fibrosis, particularly storiform fibrosis, or obliterative phlebitis. patients fulfill (1) + (2) + (3) are diagnosed as definite igd4rd; (1) + (2): possible igg4rd; (1) + (3): probable igg4rd. exclusion of other diseases. 2. active igg4-rd (responder index ≥ 2 points for each involved organ) 3. the counts of peripheral blood eosinophil cells ≥0.75×109/l exclusion criteria: 1. patients who is not able to discontinue gc 2. pregnancy or breastfeeding or planning to get pregnant within 2 years 3. received glucocorticoids, immunosuppressants, biological agents or jak inhibitors within 3 months 4. allergic to baricitinib 5. concomitant other autoimmune diseases 6. malignancy 7. chronic hbv infection, latent tuberculosis, or active infection 8. server liver or renal dysfunction, or heart failure.

Keywords: igg4-related disease eosinophilia
spironolactone plus metformin in polycystic ovary syndrome

Conditions: Polycystic Ovary Syndrome

Summary: the investigators examined whether a combined therapy with low-dose spironolactone plus metformin is more effective than metformin alone in 52 overweight/obese polycystic ovary syndrome (pcos) patients.

in the present prospective, randomized study, we evaluated the efficacy of a combined therapy with metformin and low-dose spironolactone as compared to metformin alone on the clinical and endocrine-metabolic alterations of pcos patients.

Eligibility criteria:
inclusion criteria: * overweight/obese patients with pcos exclusion criteria: * other causes of hyperandrogenism and * use of drugs including: * oral contraceptive * anti-hypertensive agents * anti-diabetic drugs * agents for weight loss

Keywords: pcos metformin spironolactone metabolic syndrome hyperandrogenism
assessment of quality of life, bone density and safety in postmenopausal breast cancer patients with letrozole therapy

Conditions: Breast Cancer

Summary: to compare the overall qol (quality of life) using trial outcome index (toi) of fact-b questionnaire for 3 years from baseline.

1. toi is the sum of the scores from the physical and functional well-being and the breast cancer subscales. 2. to assess incidence of adverse events (including cardiovascular, cerebrovascular, and endocrine, musculoskeletal) in korean postmenopausal breast cancer patients in early adjuvant setting. 3. to assess the effect of letrozole (femara) on bmd in early adjuvant setting. 4. to assess the effect of letrozole (femara) on total cholesterol in early adjuvant setting.

Eligibility criteria:
inclusion criteria: 1. patients have undergone surgery of the breast cancer and proven histologically to be breast cancer with postmenopausal women older than 45 years. postmenopausal state was defined the following conditions, at least one of a, b, c. 1. serum fsh ≥ 30 miu/ml 2. amenorrhea ≥ 1 year 3. oophorectomy 2. patients with estrogen receptor(+) and/or progesterone receptor(+) 3. who(ecog) performance status 0-2 4. adequate haematological function, renal function, hepatologic function. 5. no evidence of metastasis. exclusion criteria: 1. patient with hormone receptor negative. 2. patients with malignancies (other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell / squamous cell carcinoma of the skin. 3. other hormone therapy given within the previous 4 weeks. 4. patients with other aromatase inhibitor and chemotherapy 5. uncontrolled infection, medically uncontrollable heart disease 6. other serious medical illness or prior malignancies 7. patients with bmd t-score ≤-2.5 8. patients who were treated with bisphosphonate 9. patients with postmenopausal state induced chemotherapy 10. estimated life expectancy of \<12 months

Keywords: hormonal therapy(letrozole) postmenopausal breast cancer quality of life
drug-drug interaction study of aripiprazole and lamotrigine in patients with bipolar type i disorder

Conditions: Bipolar Disorder

Summary: the purpose of this clinical research study is to learn if aripiprazole has a drug-drug interaction with lamotrigine.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) of 18 to 40 kg/m2 * subjects with bipolar i disorder who are clinically stable on a stable dose of at least 100 mg lamotrigine for at least 4 weeks prior to study entry * men and women, ages 18 to 65 exclusion criteria: * women who are pregnant or breastfeeding * patients with any significant acute or chronic medical illness, other than bipolar i disorder * subjects with active psychotic symptoms * history of head trauma within the past 2 years * history of akathisia requiring treatment * history of tardive dyskinesia or abnormal involuntary movements * subjects with a predisposition to orthostatic hypotension * positive urine screen for drugs of abuse * use of narcotic-containing agents, amphetamines, or hormonal contraceptives within 4 weeks of study start

Keywords: bipolar type i disorder
phase ii study of asp3550 in patients with prostate cancer

Conditions: Prostatic Neoplasms

Summary: to assess the effect of asp3550 on the maintenance of serum testosterone suppression in patients with prostate cancer

two doses of asp3550 were administered to patients with prostate cancer. the primary efficacy variable was the effect of asp3550 on the maintenance of serum testosterone suppression. in addition, the safety and pharmacokinetics of asp3550 will be investigated.

Eligibility criteria:
inclusion criteria: * is a male patient with histologically proven prostate cancer (adenocarcinoma) of all stages * is a patient in whom endocrine treatment is indicated. patients with rising serum psa after having prostatectomy or radiotherapy performed with curative intention may be included * has a serum testosterone level above 1.5 ng/ml at screening * has an ecog (eastern co-operative oncology group) p.s. (performance status) score of 0 to 2 exclusion criteria: * previous or present endocrine treatment for prostate cancer. however, patients who have undergone neoadjuvant/adjuvant endocrine therapy for a maximal duration of 6 months and in whom prostatectomy or radiotherapy was terminated at least 6 months preceding screening visit may be included * is being treated with a 5α-reductase inhibitor * is a candidate for curative therapy, i.e., radical prostatectomy or radiotherapy within 12 months * has concurrent or a history of severe asthma (defined as a need for daily treatment with inhalation steroids), anaphylactic reactions, severe urticaria and angioedema

Keywords: asp3550 degarelix prostate cancer prostatic neoplasms
a study of atezolizumab in participants with programmed death-ligand 1 (pd-l1) positive locally advanced or metastatic non-small cell lung cancer (nsclc) [fir]

Conditions: Non-Small Cell Lung Cancer

Summary: this multicenter, single-arm study will evaluate the efficacy and safety of atezolizumab (mpdl3280a) in participants with pd-l1-positive locally advanced or metastatic nsclc. participants will receive an intravenous (iv) dose of 1200 milligrams (mg) atezolizumab (mpdl3280a) on day 1 of 21-day cycles until disease progression. eligible participants will be categorized in to three groups as follows: 1. participants with no prior chemotherapy for advanced disease; 2. participants who progress during or following a prior-platinum based chemotherapy regimen for advanced disease (2l+participants); 3. participants who are 2l+ and previously treated for brain metastases.


Eligibility criteria:
inclusion criteria: * stage iiib (not eligible for definitive chemoradiotherapy), stage iv, or recurrent nsclc * pdl1-positive status as determined by an immunohistochemistry assay performed by a central laboratory. a positive result in chemotherapy, chemoradiation of the tumor sample biopsy will satisfy the eligibility criterion * eastern cooperative oncology group performance status of 0 or 1 * life expectancy greater than or equal to 12 weeks * measurable disease, as defined by response evaluation criteria in solid tumors version 1.1 * adequate hematologic and end organ function exclusion criteria: * any approved anti-cancer therapy, including chemotherapy, or hormonal therapy within 3 weeks prior to initiation of study treatment; the following exceptions are allowed. hormone-replacement therapy or oral contraceptives, and tyrosine kinase inhibitors approved for treatment of nsclc discontinued greater than 7 days prior to cycle 1 day 1 * treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment * known central nervous system disease, including treated brain metastases in the following participants: 1. who will not receive prior chemotherapy for advanced disease 2. who progress during or following a prior-platinum based chemotherapy regimen for advanced disease (referred as 2l+ participants) * participants with a history of treated asymptomatic brain metastases are allowed in the 2l+ participants and previously treated for brain metastases. * leptomeningeal disease * uncontrolled tumor-related pain * uncontrolled hypercalcemia
[18f]flt pet/ct in rb+ metastatic breast cancer

Conditions: Breast Neoplasm; Metastatic Breast Cancer; Rb+ Breast Cancer

Summary: in this study positron emission tomography (pet/ct) imaging will be used to evaluate proliferative activity in sites of metastatic disease using the investigational radiotracer \[18f\]fluorothymidine (flt).

this protocol is designed to develop relationships between parameters determined from imaging biomarker studies and ones used for determination of therapeutic response to combined cdk4 inhibitor and chemotherapy regimens. imaging will occur prior to starting therapy on the separate therapeutic protocol upcc 06115. patients may undergo a second flt pet/ct scan following a 3-day run of ribociclib (lee011) (day -6 to -4) and a third flt pet/ct scan on cycle 1 day 12 following two treatments of weekly paclitaxel to compare changes in flt uptake measures.

Eligibility criteria:
inclusion criteria: 1. at least 18 years of age 2. history of histologically or cytologically confirmed breast cancer, any er, pr or her2 status is allowed as long as it expresses the rb protein. 3. at least one site of metastatic breast cancer that is outside of the liver and bone that is identified by standard imaging (e.g. ct, mri, fdg pet/ct, ultrasound, x-ray) 4. participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures. 5. patients must be candidates to receive treatment on the therapeutic trial upcc06115, a phase i study of ribociclib (lee011) and weekly paclitaxel. exclusion criteria: 1. females who are pregnant at the time of screening will not be eligible for this study, urine pregnancy test will be performed at screening in women of child-bearing potential. 2. inability to tolerate imaging procedures in the opinion of an investigator or treating physician 3. serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study. 4. ineligible for the therapeutic trial upcc 06115
the evaluation of consistency by finger stick blood glucose or venous blood glucose of flash glucose monitoring in different infiltration time

Conditions: Type 2 Diabetes; Flash Glucose Monitoring; Conscience

Summary: this is a prospective randomized controlled study to evaluate consistency by finger stick blood glucose or venous blood glucose in different infiltration time (including the time between activation of the sensor and storage of the first blood glucose value) of flash glucose monitoring(fgm). in this study, the relationship between the dynamic blood glucose and finger stick blood glucose or venous blood glucose in type 2 diabetes mellitus patients(t2dm), was explored. and the investigators also analyzed the deviation and accuracy of fgm in practical application,so as to provide a good reference for clinical application.


Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes fit the 1999 who diagnostic criteria for diabetes * aged 18 or above * without serious complications, such as diabetic ketoacidosis, severe infection,severe cardiac insufficiency, severe liver and kidney diseases * voluntary and signed informed consent to participate * be able to read and understand chinese, perform all research visits and tasks, and follow research instructions exclusion criteria: * patients with known allergy to medical grade adhesive or isopropanol used for skin disinfection, edema, skin damage, scar, redness, infection, etc. during pregnancy or preparation of pregnancy or at the sensor application site (dorsal side of upper arm). * the examinee took drugs such as ascorbic acid (vitamin c) and salicylic acid (an ingredient in aspirin and many painkillers) that affected the accuracy of the sensor. * mri is required during the study. * the examinee had poor compliance and could not continue to complete the study.
performance evaluation of diagnostic accuracy of pantum detect test for detection of solid tumours in known cancer population and in cancer free population.

Conditions: Solid Tumor

Summary: performance evaluation of diagnostic accuracy (sensitivity and specificity) of pantum detect test for detection of solid tumours in known cancer population (sick population) and in cancer free (healthy) population.

pantum detect is a simple blood test that can detect presence of solid tumors using two important tumor biomarkers - apo 10 and tktl-1. most tumors develop slowly and gradually. from the first tumor cell, to the identification of the tumor itself, there can be a timespan of many years. the turning point where a locally growing tumor develops into an invasive, metastasizing cancer is paramount for curability. it is the objective of pantum detect to detect a tumor in time before this critical turning point. such locally growing tumors can often easily be removed by surgery or treated successfully

Eligibility criteria:
inclusion criteria: 1. written informed consent 2. sick population with hiostopathology proven diagnosis 3. age 30-75 years 4. newly diagnosed case of solid tumor. exclusion criteria: 1. history of past surgery within 8 weeks. 2. history of any chemotherapy, vaccination etc
assessing mechanisms of anxiety reduction in animal-assisted interventions

Conditions: Social Anxiety Disorder; Social Anxiety; Social Anxiety Disorder of Childhood

Summary: adolescence and young adulthood is a critical period for the development of social anxiety, which is often linked to other mental health challenges such as depression, mood disorders, and substance abuse. initial evidence suggests that interacting with animals can reduce stress and anxiety, but no research has tested whether this benefit extends to adolescents at risk for social anxiety disorder. additionally, researchers and clinicians do not understand what mechanism is responsible for anxiety reduction in animal-assisted interventions (aais). therefore, the objectives of this study are to explore the specific mechanisms by which interacting with a therapy dog reduces anxiety, and to test whether such an interaction reduces anxiety in adolescents with varying levels of social anxiety.

the specific aims of this project are to (1) test the mechanisms by which aais reduce anxiety, and (2) determine if the anxiolytic effect of social and physical interaction is moderated by level of pre-existing social anxiety. to achieve these aims, 75 adolescents (age 13-17) will undergo a well-validated laboratory-based social evaluative stressor, the trier social stress task for children, and be randomly assigned to one of three conditions: 1) no interaction with a dog (control condition), 2) social interaction only (no physical interaction) with a therapy dog; or 3) social interaction plus physical interaction with a therapy dog. using a multivariate approach, three levels of outcome data will be collected: a) self-reported experience (anxiety), b) autonomic physiology (heart rate), and c) behavioral performance (error rates on mental math task). in addition, the interactions will be videotaped and behavioral coding will be used to explore the specific social behaviors between the participant and the dog that may predict anxiety reduction (such as frequency or type of social referencing or physical contact).

Eligibility criteria:
inclusion criteria: - low, mid-range, and high levels of social anxiety exclusion criteria: * fear of dogs * allergy to dogs

Keywords: human-animal interaction animal-assisted intervention
parasternal block combined with rectus sheath block for cardiac surgery under sternotomy

Conditions: Cardiac Disease; Surgery; Analgesia; Acute Pain; Postoperative Pain

Summary: the aim of this randomized controlled trial is to examine the effect of ultrasound guided bilateral parasternal nerve block combined with rectus sheath block on preoperative analgesia, opioid consumption and respiratory function in patients undergoing cardiac surgery via sternotomy. half of participants will receive general anesthesia combined with bilateral parasternal block and rectus sheath block while the other half receive general anesthesia combined with bilateral parasternal block and infiltration of drainage exits sites with local anesthetic (without performing rectus sheath block)


Eligibility criteria:
inclusion criteria: * patients undergoing elective cardiac surgery under median sternotomy * age \>= 18 years * american society of anesthesiologists (asa) status i-iv * approval and sign of the informed consent exclusion criteria: * allergy to local anesthetics * puncture site infection * lack of signing of informed consent * age \<18 years * emergency surgery * asa \> iv * preoperative acute respiratory failure