Kornimate/medical-research-clean huggingface dataset:
steri-strip tape use in unilateral ectropion surgery

Conditions: Ectropion

Summary: currently, the incidence of involutional and chronic eyelid disorders, such as ectropion, has been increasing, as human life expectancy has risen worldwide (more than 600 million people are aged ≥ 60 years). ectropion is a common eyelid malposition that causes visual morbidity. it is characterized by eversion of the eyelid margin and has multiple etiologies. steri-strip tapes have been used in some ophthalmologic procedures, such as blepharoplasties, where they help prevent infections by acting as a barrier method, are resistant enough to reduce the risk of wound dehiscence, simplify postoperative care, and allow for proper eyelid fissure closure. their use has been recommended in patients with facial paralysis to prevent keratitis or exposure ulcers. however, current evidence is limited, as their use has only been documented in case series and letters to the editor. therefore, a randomized controlled clinical trial is proposed to evaluate the postoperative outcomes of steri-strip tape use in unilateral ectropion surgery compared to standard postoperative management.

this study will compare the use of steri-strip tape in unilateral ectropion surgery with standard postoperative care to assess cosmetic and functional outcomes in the adult population. participants will be followed up at 8 and 30 days after surgery.

Eligibility criteria:
inclusion criteria: * patients aged 18 years or older who are scheduled to undergo unilateral ectropion surgery. exclusion criteria: * underlying conditions associated with skin hyperlaxity, such as cutis laxa and ehlers-danlos syndrome. * skin diseases that predispose to cicatricial ectropion, such as ichthyosis, scleroderma, and psoriasis. * paralytic ectropion. * current use of oral isotretinoin.
extracorporeal shockwave therapy for the treatment of refractory angina pectoris

Conditions: Refractory Angina Pectoris

Summary: low intensity shockwaves have been proven in animal studies to induce local growth of new blood vessels from existing ones. the hypothesis of this study is that shockwave therapy could improve the symptoms of patients with refractory angina not amenable to revascularization with angioplasty or bypass surgery.

low intensity shockwaves (1/10 the ones used in lithotripsy) are delivered to myocardial ischemic tissue. shockwaves are created by a special generator and are focused using a shockwave applicator device. the treatment is guided by standard echocardiography equipment. the shockwaves are delivered in synchronization with patient r-wave to avoid arrhythmias. the treatment is painless. at first, the patient undergoes stress- spect testing to identify the ischemic areas. following that, the same area is localized by the ultra-sound device and the shockwaves are focused to the ischemic area. several treatments are required for optimal results.

Eligibility criteria:
inclusion criteria: * diagnosed with chronic stable angina pectoris. * documented myocardial segments with reversible ischemia * ap ccs class of iii-iv. * stable dosage of medication used to treat angina for at least 6 weeks prior to enrollment. * exercise tolerance time \< 10 min (modified bruce) * two ett tests results (within two weeks) averaging no more than 25% of their mean * documented epicardial coronary artery disease not amenable to angioplasty or cabg. * signed an irb approved informed consent form. * life expectancy of \>12 months. exclusion criteria: * intraventricular thrombus * malignancy in the area of treatment * severe copd * no smoking during the study procedure * mi less \<3 months prior to treatment * severe valvular disease * child bearing potential

Keywords: extracorporeal shockwave therapy myocardial ischemia refractory angina
web-based guided self-help cbt-e vs online g-cbt-e for binge eating behavior

Conditions: Feeding and Eating Disorders

Summary: eating disorders with binge eating as the core feature include bulimia nervosa (bn) and binge eating disorder (bed). in recent years, the prevalence rate has increased rapidly, mostly among women, accompanied by emotional problems, physiological complications and increased risks of obesity and depression, which bring great pain to patients. enhanced cognitive behavioral therapy (cbt-e) for eating disorders is an evidence-based and effective first-line psychotherapy for bn and bed. cbt-e is implemented in various forms. in addition to face-to-face therapy, online group cbt-e and guided self-help cbt-e can significantly reduce binge eating in bn and bed patients. however, there are no relevant clinical studies in china. since 2008, the applicant has carried out cbt treatment and research on eating disorders, translated and published the self-help book "overcoming overeating", and accumulated rich clinical research experience. this study intends to establish a set of cbt-e self-help therapy courses suitable for chinese binge eating patients, and conduct a randomized controlled study of web-based guided self-help cbt-e and online group cbt-e to compare the effectiveness of the treatment modalities in the treatment of binge eating and the feasibility of online guided self-help cbt-e and online group cbt-e in the treatment of binge eating.


Eligibility criteria:
inclusion criteria: * han nationality, aged 18-35 years old; * students with junior high school education or above; * meet the diagnostic criteria of bn or bed in dsm-5, body mass index (bmi)≥18.5 kg/m2; * no systematic nutritional treatment, psychiatric drug treatment or any form of psychological treatment was received within 1 month before enrollment; * each patient must understand the nature of this study and sign informed consent. exclusion criteria: * persons meeting other dsm-5 diagnoses other than bn and bed, such as substance abuse/dependence, depression, bipolar disorder, anxiety disorder, obsessive-compulsive disorder, etc., persons at high risk of suicide, persons with strong destructive impulses or antisocial behaviors; * the patient has severe primary or secondary physical disease or cognitive impairment, which makes the patient unable to complete the required symptom assessment and psychological tests; * have received systematic nutritional therapy, individual and group psychotherapy; * those who have taken neuroblockers, antidepressants, lithium salts, stimulants, antiepileptics and other psychotropic drugs within the past 1 month; * participation in this clinical trial was deemed inappropriate by the investigator for other reasons.
a study of the pharmacology of tamiflu in pregnancy

Conditions: H1N1 Influenza Treatment During Pregnancy

Summary: the purpose of this study is to determine the pharmacokinetics (pk) of the anti-flu medication, tamiflu during pregnancy and to determine to what extent pregnancy may affect the currently recommended dosage of this medication.

the emergence of the novel h1n1 influenza virus has raised concern among public health officials and the public alike. although initial reports suggested that the risk of serious disease or death was less than initially feared, continued experience suggests that the disease will have a major impact on the public's health. to address this urgent public health challenge, the centers of the obstetric-fetal pharmacology research units network (opru) will recruit a total of 75 pregnant women (25 per trimester with singletons pregnancies) who are receiving oseltamivir for supposed influenza infection. when possible, we will recruit women with twin gestation to determine if fetal number affects the drugs pharmacokinetics. we do not anticipated a significant number of multi-fetal gestations (\< 10) but even limited data might prove useful in this population given the tremendous change in renal drug clearance that is normally seen in this group of women. an additional 25 healthy non-pregnant women will be studied to define pregnancy- related changes in the pk of oseltamivir and the carboxylate. we will study each woman once during therapy, performing steady state pharmacokinetic analyses. this study will be performed after 3 days of oral therapy to optimize the possibility that steady state concentrations have been achieved. we will: 1. collect biological fluids (plasma and urine) to further characterize the pharmacology of the drug; 2. collect a check swab for dna to allow study of the impact of single nucleotide polymorphisms on drug handing and disease expression; 3. develop an assay or partner with others to develop an assay for oseltamivir and the primary metabolite, oseltamivir carboxylate; 4. compare the pharmacokinetics of oseltamivir and its metabolite in each trimester of pregnancy to evaluate whether gestational age has an impact on the drug's pharmacokinetics; 5. assess the impact of fetal number on the drug's pharmacokinetics; 6. ask all participants about gi tolerance to the drug and any side effects they may be experiencing, especially related to mood and psychiatric well being; and 7. on all pregnant subjects studied, when possible, we will obtain at delivery maternal and umbilical cord blood to evaluate placental transport especially in those who deliver proximate (within 3 days) to drug treatment.

Eligibility criteria:
inclusion criteria: 1. taking or about to start oral oseltamivir for presumed influenza viral infection or for prophylaxis 2. able to give informed consent 3. pregnant female with singleton or multifetal gestation or healthy non-pregnant female (ancillary study) exclusion criteria: 1. unable to take medication orally 2. renal failure - creatinine \> 1.5 3. hct \<28

Keywords: h1n1 influenza swine flu oseltamivir tamiflu pregnancy
the effect of citrate dialysate on clot formation and anemia in hemodialysis patients

Conditions: Hemodialysis; Citrate; Heparin

Summary: acetate-free citrate containing dialysate is expected to be clinically effective in maintaining hemodynamic stability during hemodialysis (hd). it has been demonstrated that citrate dialysate help produce a local anticoagulant effect by chelating ionized calcium. moreover, citrate can improve phosphate and beta2 macroglobulin and better control of arterial hypertension and hemoglobinemia. we therefore would like to study the effect of citrate dialysate on clot formation and anemia while reducing heparin in chronic hemodialysis patients.

this is the prospective comparison study. this study enrolled chronic hemodialysis patients age more than 18 who undergo hemodialysis 3 times per week for at least 3 months. all the patients should have serum ferritin 200-1000 ng/l and tsat of 15-50%. the investigators exclude patients with age more than 70 years, comorbidities influencing citrate metabolism (hepatic failure,liver transplantation,cancer with bone metastasis), patients using heparin free protocol, hyperkalemia worsened by hypocalcemia, contraindication to heparin, treatment with cinacalcet or oral anticoagulant, patients using central venous catheter with blood flow less than 300 ml/min, and patients using low molecular weight heparin. the study will be conducted in three phases over a period of 4 months. after run-in period for 2 weeks using acetate dialysate, the heparin dose will be titrated to lowest effective dose. during the first phase, citrate was replaced for acetate and heparin will be reduced to 50%. the second and third phase will be performed by reducing heparin doses to 25 % and heparin free consecutively. each phase lasts for 4 weeks. washout period for 2 weeks will be alternated after each phase. data collection: the investigators measure blood chemistries such as cbc, bun creatinine electrolytes calcium phosphorus and kt/v at the beginning and at the end of each session. ionized calcium will be monitored pre and post dialysis in each session. in addition, the investigators record clot score and erythropoietin dosage in each session and each phase.

Eligibility criteria:
inclusion criteria: * this study enrolled chronic hemodialysis patients age more than 18 who undergo hemodialysis 3 times per week for at least 3 months. * serum ferritin 200-1000 ng/l and tsat of 15-50%. exclusion criteria: * age more than 70 years, * comorbidities influencing citrate metabolism (hepatic failure,liver transplantation,cancer with bone metastasis), * patients using heparin free protocol,hyperkalemia worsened by hypocalcemia * contraindication to heparin, * treatment with cinacalcet, or oral anticoagulant * patients using central venous catheter with blood flow less than 300 ml/min * patients using low molecular weight heparin
safety, efficacy and pharmacokinetic behavior of leuprolide injectable emulsion for premenopausal breast cancer subjects.

Conditions: Breast Cancer Subjects

Summary: the study is to assess the safety, efficacy and pharmacokinetic behavior of leuprolide injectable emulsion for premenopausal breast cancer subjects.

this is a multicenter, randomized, open-label , non-inferiority phase iii study . all premenopausal women breast cancer subjects were randomly allocated to either the study group or control group in a 1:1 ratio. furthermore, all subjects received tamoxifen citrate treatment throughout the entire duration of the study. the efficacy of maintaining serum e2 levels ≤30 pg/ml at 4-48 weeks post-treatment will be assessed in both groups.

Eligibility criteria:
inclusion criteria: * premenopausal female subjects aged 18 to 55 years old. * histological or cytological confirmation of hr+，her2- premenopausal breast cancer. * subjects have any breast cancer surgery before informing, and no clinical residual local regional lesions were found after the surgery. * life expectancy is not less than 12 weeks. * eastern cooperative oncology group (ecog) performance status of 0 or 1. * adequate function of major organs. exclusion criteria: * history of evidence of distant metastatic lesions; * subjects have the history of new adjuvant or adjuvant endocrine treatment for breast cancer ( excluding subjects receiving tamoxifen citrate tablets treatment for less than 12 weeks before informing). * active hepatitis b, hepatitis c or hiv in screening.
effects of cord blood 25-hydroxy-vitamin d level on early neonatal morbidities

Conditions: Neonatal Hypocalcemia; Neonatal Sepsis

Summary: cholecalciferol (vitamin d3) is a prohormone and its active form is 1,25 dihydroxycholecalciferol. this hormone has effect on both calcium, phosphorus and bone metabolism and also bone morrow, muscle, heart and immune system. for a long time, maternal low vitamin d level is a well known problem for our country and the level was reported as \<10 ng/ml for 46-80% of mothers.the most prominent risk factor was determined as low socioeconomic status. therefore, the level of 25-hydroxy-vitamin d is supposed to be in relation with several neonatal morbidities and maternal complications of pregnancy.


Eligibility criteria:
inclusion criteria: * term or preterm newborns which are hospitalized in the neonatal intensive care unit of our hospital exclusion criteria: * preterm babies born before the 24. gestational week * babies with complex cardiac anomalies and/or dysmorphic features

Keywords: vitamin d cord blood neonatal sepsis neonatal morbidity
evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of icp-248 in mature b-cell malignancies

Conditions: Mature B-cell Malignancies

Summary: evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of icp-248 in mature b-cell malignancies


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 and ≤ 80 years. 2. subjects with histopathologically and/or flow cytometry-confirmed diseases according to the 2016 world health organization (who) classification criteria for lymphohematopoietic neoplasms or meeting the international workshop on chronic lymphocytic leukemia (iwcll) criteria 3. relapsed disease 4. for subjects with r/r mcl: patients must have measurable disease 5. patients with an eastern cooperative oncology group (ecog) performance status (ps) score of ≤ 1 and a life expectancy of ≥ 6 months. 6. adequate hematologic function 7. patients with basically normal coagulation function 8. patients with adequate hepatic, renal, pulmonary and cardiac functions 9. subjects are able to communicate with the investigator well and to complete the study as specified in the study. exclusion criteria: 1. known central nervous system involvement by lymphoma/leukemia. 2. known or suspected history of richter's transformation. 3. prior autologous stem cell transplant (unless ≥ 3 months since transplant); or prior chimeric cell therapy (unless ≥ 3 months since cell infusion). 4. a history of allogeneic stem cell transplantation. 5. an interval of less than 5 half-lives from the last dose of a strong cyp3a or cyp2c8 inhibitor or inducer (chemical agent, herbal medicine and dietary supplement) to the first dose of the investigational product, or a plan to use concurrently medications, dietary supplements or food (e.g., grapefruit or grapefruit juice) with strong cyp3a or cyp2c8 inhibitory or inductive effect during study participation 6. presence of active infection that currently requires intravenous systemic antiinfective therapy. 7. history of immunodeficiency, including a positive human immunodeficiency virus (hiv) antibody test. 8. history of significant cardiovascular disease 9. patients with previous or concomitant central nervous system disorders 10. known alcohol or drug dependence 11. female patients who are pregnant or lactating. 12. unable to swallow tablets or presence of disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, bariatric surgery procedures, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
preventing youth substance use with family talk

Conditions: Substance Use Disorders

Summary: family talk, an evidence-based parent-youth dyadic intervention, is a promising approach to improving substance use outcomes for high-risk families, and its structure lends itself to delivery by existing personnel within an office-based addiction treatment (obat) model of care. the investigators propose a single-arm pilot study with 25 parent-youth dyads through which a rapid cycle performance improvement approach will be employed to adapt and optimize the content and delivery of the embedded family talk prevention strategy. the investigators will field-test relevant baseline and outcome measures and will use qualitative methodology to identify key modifications to the intervention and generate hypotheses for how the prevention strategy may impact youth and family outcomes and prevent youth substance use. information from this study will inform a subsequent pilot randomized controlled trial of the intervention to prevent substance use for youth whose parents are in recovery from sud (substance use disorder).


Eligibility criteria:
inclusion criteria: * participating parent is receiving treatment for substance use disorder * participating youth is between the ages of 12-25 * participating youth has no diagnosis of substance use disorder * parent and youth are both comfortable communicating in english or spanish exclusion criteria: * acute family crisis, such as recent or current incarceration, divorce, adult return to substance use, or traumatic event * adult or youth with cognitive limitation or intellectual disability

Keywords: parent-youth dyads modules prevention of adolescent sud (substance use disorder) family talk
feasibility study of metronomic chemotherapy for locally advanced her2-negative breast cancer

Conditions: Locally Advanced HER2-negative Breast Cancer

Summary: the purpose of this study is to determine whether weekly paclitaxel followed by weekly doxorubicin plus daily oral cyclophosphamide without granulocyte colony-stimulating factor (g-csf) is feasible in the treatment of locally advanced her2-negative breast cancer.


Eligibility criteria:
inclusion criteria: * locally advanced breast cancer diagnosed by guided core biopsy * t \> 2 cm (any n), or any t and node positive (needle biopsy is required) * non-metastatic disease assessed by computed tomography and bone scintigraphy * histological grade 2 and ki67 \> 15% or * histological grade 3 or * any triple negative (tn) or * inflammatory breast cancer (ibc) * normal left ventricular ejection fraction (lvef) * her2-negative disease exclusion criteria: * another malignancy within the last 5 years (except curatively treated skin carcinoma, in situ cervix carcinoma, in situ ductal carcinoma of the breast, or in situ lobular carcinoma of the breast) * clinically significant comorbidities as cardiovascular diseases, chronic obstructive pulmonary disease (copd), renal or liver failure, psychiatric disorders * lvef value below institutional limits of normal * predominant lobular carcinoma histology * grade 1 tumors * detected or suspicious distant metastasis * neutrophils less than 1,500/µl, platelets less than 100,000/µl, hemoglobin less than 10 g/dl, ast more than 2.5x upper limit of normal (uln), total bilirubin more than uln, alkaline phosphatase more than 1.5x uln * male sex * her2-positive breast cancer
cytometric immunodiagnostics of latent tuberculosis infection (ltbi)

Conditions: LTBI; BCG Vaccination Reaction; TB

Summary: tb-reactive immune cells will be tested in a multiparametric flow cytometry to distinguish an immune response for antigens of mycobacterium spp. in tb disease/latent infection or a reaction after bcg vaccine.

the goal of this project is the verification of current cytometric panel of detection antibodies in a wider panel of stimulative immunodominant antigens for cd4+ and cd8+ t cells in combination with adjuvants 2 in a in vitro activating test.

Eligibility criteria:
inclusion criteria: active tb, contact with tb infection in previous 3 months before the study - exclusion criteria: * hiv positive patients