Kornimate/medical-research-clean huggingface dataset:
molecular classification in mexican patients with endometrial cancer and its impact on prognosis

Conditions: Endometrial Cancer

Summary: endometrial cancer (ec) is one of the most common gynecological neoplasms, being the second in incidence and third in mortality in mexico. recent studies show that ec molecular classification (cancer genome atlas research network, 2013) serves to establish a more accurate prognosis in these patients and regulate therapeutic behavior in a personalized manner. however, there are no studies on ec molecular classification in mexican women or its impact on prognosis and the possible modification of targeted treatment. the investigators will determine the molecular classification in ec by next-generation sequencing (ngs) to detect tp53 and pole somatic mutations, and immunohistochemical detection of microsatellite instability (msh2, mlh1, pms1, pms2, msh6, and msh3) in a cohort of patients with endometrioid-type ec, endometrioid subtype, attended at the instituto nacional de cancerología - mexico (incan) and determine its impact on clinical prognosis.

the investigators will carry out a pilot study on patients with endometrioid type ec treated between 2015-2019. samples of patients over 18 years of age admitted to the cohort with a diagnosis of endometrioid-type ec are already collected and will be evaluated for exome sequencing (n=32) and the detection of pole mutations. dna will be extracted using the "dna/rna allprep" kit (qiagen). verification of adequate dna extraction will be performed by quantifying using tapestation (agilent). exome sequencing (n = 32 tumor samples and 32 somatic samples \[leukocytes\] from the same patient) will be carried out using illumina's nextera rapid capture exome at azenta life science (nj, usa) following preset protocols and with a depth of 100x. the alignment and detection of variants will be done with the gatx-mutect suite (broad institute, usa) and the annotation of variant filtering with annovar. the identification of hotspots will be made according to chen study. the immunohistochemistry (ihc) for microsatellite instability and overexpressed mutant tp53 (n = 94) will be done using established ihc protocols and will include msh2, mlh1, pms1, pms2, msh6, msh3, and tp53.

Eligibility criteria:
criteria: inclusion criteria: * clinical diagnosis of endometrioid-type endometrial cancer with samples available * that the patients have undergone surgery at incan. exclusion criteria: * samples with cee of non-endometroid type. * samples from patients with double primary neoplasm, including carcinoma ductal in situ, squamous cell skin cancers, and cervical carcinoma in situ * history of malignancy \< 5 years prior with no evidence of disease (i.e., remission).

Keywords: endometrial cancer prognostic factors
safety and efficacy of the prepex device circumcision when performed by nurses

Conditions: Circumcision Adult; HIV CDC Category B2

Summary: the protocol, approved by the medical research council, was issued to assess the safety and efficacy of the non-surgical device for applying it to the national scale up of adult male circumcision in zimbabwe

models show that to have the highest impact on the hiv epidemic, circumcision of up to 80% of men in high prevalence countries, where mc rates are low, needs to be achieved (unaids 2009; manicaland hiv/std prevention project, 2008; bollinger, et al, 2009). hallett and colleagues in 2008 showed that for zimbabwe specifically, hiv incidence could be reduced between 25% to 35% if about 50% of men are circumcised. all modelings conducted show that mc programs must be part of a comprehensive hiv prevention package as mc alone will not tip the hiv epidemic into a terminal decline. the prepex device offers hope for rapid scale up of adult male circumcision in resource limited settings. once the safety and efficacy have been established, it is important to conduct operations research to determine how best to implement both device and surgical circumcisions in the national program. thus, the zimbabwe mohcw is planning a three phase trial in order to determine the safety of the prepextm device, its performance and the ease of use in an implementation roll out.

Eligibility criteria:
inclusion criteria: * ages 18 - 30 years * uncircumcised * wants to be circumcised * agrees to be circumcised by any of the study methods ,prepex or surgical as appropriate * hiv sero-negative * able to understand the study procedures and requirements * agrees to abstain from sexual intercourse and to keep caution not to directly rub the cut area if masturbating, for 8 weeks post removal (9 weeks total) * agrees to return to the health care facility for follow-up visits (or as instructed) after his circumcision for a period of 8 weeks post removal (9 weeks total) * subject able to comprehend and freely give informed consent for participation in this study and is considered by the investigator to have good compliance for the study * subject agrees to anonymous video and photographs of the procedure and follow up visits * agrees to stay overnight at the hospital in order to follow pain measurements in the first 16 hours exclusion criteria: * active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the subject from undergoing a circumcision * hiv sero-positive * subject with the following diseases/conditions: phimosis, paraphimosis, warts under the prepuce, torn or tight frenulum, narrow prepuce, hypospadias, epispadias * known bleeding / coagulation abnormality * uncontrolled diabetes * subject that to the opinion of the investigator is not a good candidate * subject does not agree to anonymous video and photographs of the procedure and follow up visits * refusal to take hiv test.

Keywords: male circumcision hiv zimbabwe
study of zoledronic acid administered monthly versus every 3 months in multiple myeloma and breast cancer patients who were treated with zoledronic acid the prior year

Conditions: Multiple Myeloma; Breast Cancer

Summary: the primary objective of this study is to investigate the repeat-dose pharmacokinetic (pk) profile of zoledronic acid when administered every 4 weeks versus every 12 weeks, in patients treated with 9-20 infusions of zoledronic acid during the previous 10-15 months.


Eligibility criteria:
inclusion criteria: * male or female between 18-75 years of age * multiple myeloma or breast cancer with bone involvement * treatment with zoledronic acid for bone lesions between 10-15 months prior to entry into study with a total of 9-20 infusions received. exclusion criteria: * current active dental problems or recent (within 8 weeks) or planned dental or jaw surgery * active or uncontrolled infection, liver, or renal disease * history of treatment with intravenous bisphosphonates * diagnosis of metabolic bone disorders other than osteoporosis (e.g. paget's disease) other protocol-defined inclusion/exclusion criteria may apply.

Keywords: multiple myeloma breast cancer zoledronic acid pharmacokinetics
the efficacy and safety of low-level tragus stimulation on heart rate variability, neutrophil-lymphocyte ratio, and major adverse cardiovascular events in patients with st-segment elevation myocardial infarction (tesla-stemi)

Conditions: ST Elevation Myocardial Infarction

Summary: the goal of this clinical trial is to learn the effect of low level tragus stimulation (llts) on heart rate variability (hrv), neutrophil-lymphocyte ratio, and major adverse cardiovascular events in patient with st-segment elevation myocardial infarction (stemi). it will also learn about the safety of llts in such setting. the main questions, it aims to answer are compared with sham control: 1. does llts could alter low frequency/high frequency ratio in patients with stemi? 2. does llts could alter neutrophil-lymphocyte ratio in patients with stemi? 3. does llts could decrease mortality in patients with stemi? 4. does llts could decrease reinfarction event in patients with stemi? 5. does llts could decrease stroke event in patients with stemi? 6. does llts could decrease lethal arrhythmia event in patients with stemi? 7. does llts could decrease acute lung oedema event in patients with stemi? 8. does llts could decrease cardiogenic shock event in patients with stemi? researchers will compare llts to sham llts control to see if llts have benefit in participants with stemi participants will divided into two group i.e. treatment group vs control (sham/placebo) group, then both of them: 1. undergo laboratory examination before primary percutaneous coronary intervention (ppci) 2. undergo hrv measurement using wecardio device before primary percutaneous coronary intervention (ppci) 3. undergo llts (treatment group will have stimulation) for 60 minutes, however, sham control will not have stimulation, before ppci 4. undergo ppci 5. undergo laboratory examination after primary percutaneous coronary intervention (ppci) 6. undergo hrv measurement using wecardio device after primary percutaneous coronary intervention (ppci)


Eligibility criteria:
inclusion criteria: * onset stemi less than 12 hours * participant agreed to be included in this study * killip class i - ii on presentation * sbp \>90 mmhg and/or map \>65 mmhg * sinus rhtyhm exclusion criteria: * history of myocardial infarction, stroke, heart failure with reduce ejection fraction, chronic total occlussion on prior coronary angiography, chronic kidney disease (egfr \< 30) or on hemodyalisis, malignancy, hematology disease, autoimmune, or other chronic diseases * on permanent pacemaker * acute infection * pregnant woman

Keywords: st segment elevation myocardial infarction low level tragus stimulation heart rate variability neutrophil-lymphocyte ratio major adverse cardiovascular events
efficacy and safety of inetetamab combined with pyrotinib and vinorelbine in abc

Conditions: HER2-positive Advanced Breast Cancer

Summary: this is a prospective, no interventional, single arm cohort study, which aims to study the efficacy and safety of inetetamab combined with pyrotinib and vinorelbine in the treatment of her2 positive advanced breast cancer in the real world. the study will be conducted by signing an informed consent form for study enrollment, collecting patient case information, and conducting observation and follow-up.

this is a prospective, no interventional, single arm cohort study, which aims to study the efficacy and safety of inetetamab combined with pyrotinib and vinorelbine in the treatment of her2 positive advanced breast cancer in the real world. the study will be conducted by signing an informed consent form for study enrollment, collecting patient case information, and conducting observation and follow-up.the research process is divided into screening period, treatment period, and survival and follow-up periods.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years; 2. the her2 positive advanced breast cancer confirmed by cytology or histology must meet the following conditions at the same time: (1) her2 positive is defined as\>10% of immunoreactive cells with an immunohistochemical (ihc) score of 3 or an in situ hybridization (ish) result of her2 gene amplification (2) advanced breast cancer is defined as locally advanced breast cancer or metastatic breast cancer that cannot be removed by radical surgery confirmed by researchers; 3. the functional level of the main organs has been evaluated by the researchers to withstand chemotherapy, anti her2 monoclonal antibodies, and anti her2 tki drugs. the lvef and qt intervals measured by echocardiography or muga are within a clinically acceptable safety range. if the survival benefits of the treatment value are assessed by the researcher to be greater than the risks faced, the admission conditions for the specific organ function level can be appropriately relaxed by the researcher, but the reasons need to be explained in the medical record; 4. ecog score: 0-2 points; 5. voluntarily sign the informed consent form for this study. 6. contraception during the study period and within 6 months after treatment, non lactation. exclusion criteria: 1. pregnant or lactating women; 2. at the same time or in the past five years, patients with one or more malignant tumors with metastatic capacity or potential other than her2 positive breast cancer, but not including cured cervical carcinoma in situ, thyroid cancer, skin basal cell carcinoma or squamous cell carcinoma. for other malignant tumors occurring within a period of more than 5 years from this treatment, if only cured by surgery, they are allowed to be included. 3. persons with a known history of allergy to the drug components of this protocol; 4. have a history of immunodeficiency, including hiv testing positive, or have other acquired or congenital immunodeficiency diseases; 5. the researcher believes that it is not suitable for inclusion.

Keywords: advanced breast cancer，her2-positive
quality of life in patients who are receiving either vinorelbine, gemcitabine, and docetaxel or paclitaxel and carboplatin for advanced non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: studying quality-of-life in patients undergoing cancer treatment may help identify the intermediate and long-term effects of treatment on patients with cancer. purpose: this clinical trial is studying quality of life in patients who are receiving either vinorelbine, gemcitabine, and docetaxel or paclitaxel and carboplatin for advanced non-small cell lung cancer.

objectives: * compare the quality of life of patients with advanced non-small cell lung cancer treated with vinorelbine, gemcitabine, and docetaxel vs paclitaxel and carboplatin on protocol jmto-lc00-03. outline: this is a multicenter study. patients receive treatment on protocol jmto-lc00-03. quality of life is assessed using the functional assessment of cancer therapy-lung (fact-l), fact-taxane, and functional assessment of chronic illness therapy-spirituality (facit-sp) questionnaires at baseline, weeks 9 and 18, and at the completion of treatment. projected accrual: a total of 80 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed primary non-small cell lung cancer, including any of the following: * newly diagnosed selected stage iiib (t4 lesion due to malignant pleural effusion) disease * newly diagnosed stage iv disease * recurrent disease after prior surgery and/or radiotherapy * any of the following cellular subtypes are allowed: * adenocarcinoma * large cell carcinoma * squamous cell carcinoma * unspecified carcinoma * enrolled on protocol jmto-lc00-03 patient characteristics: performance status * zubrod 0-1 life expectancy * not specified hematopoietic * not specified hepatic * not specified renal * not specified prior concurrent therapy: radiotherapy * see disease characteristics surgery * see disease characteristics

Keywords: adenocarcinoma of the lung large cell lung cancer recurrent non-small cell lung cancer squamous cell lung cancer stage iiib non-small cell lung cancer stage iv non-small cell lung cancer
the role of micro nutrient supplement in improvement of the sperm dna fragmentation

Conditions: Infertility, Male

Summary: male from infertile couples are tested for semen analysis and sperm dna fragmentation. any case with high dna fragmentation index (dfi) will be randomized indicated for multi-micro nutrient supplement (profortil™) in 3 months and then checked again post-treatment for (dfi). the ivf/icsi cycles will be analyzed for pregnancy outcomes

higher dfi is correlated with poor embryo development, lower implantation rate in intracytoplasmic sperm injection (icsi) cycles and higher miscarriage rate. the effectiveness of micro nutrients (profortil™) has been proven in improving sperm quality including sperm cell density, progressive motility and normal morphology. this randomized controlled trial includes male from infertile couples treated at the center for reproductive endocrinology and infertility, hue university hospital, vietnam from november 2019 to november 2020. the semen samples were collected from the husband after 3-5 days of abstinence and then evaluated for sperm motility, vitality, concentration and morphology by the guideline of world health organization (who) 2010. sperm dna fragmentation (sdf) was measured using a sperm chromatin dispersion (scd) test (halosperm® kit, halotech, madrid, spain). a total of 500 sperms were examined by only one highly trained technician to decrease variability. dfi was expressed as the percentage of sperms with small halo, without halo and degraded sperms over total of 500 sperms. any case with high dna fragmentation index (dfi \>=30%) will be randomized indicated for (group 1) micro nutrient supplement (profortil™, twice daily) plus vitamin e (enat 400, once per day) in 3 months and (group 2) only vitamin e (enat 400 once per day) then checked again post-treatment for (dfi). the ivf/icsi cycles will then be analyzed for embryo quality, pregnancy outcomes including biochemical pregnancy rate, clinical pregnancy rate, on-going pregnancy, miscarriage.

Eligibility criteria:
inclusion criteria: - male from infertile couples exclusion criteria: * men with acute systemic diseases * acute urinary tract infection * hepatic function disorders * malignant diseases * retrograde ejaculation * azoospermia

Keywords: sperm dna fragmentation micronutrient in vitro fertilization
phase 2 safety and efficacy study of zilucoplan (ra101495) to treat pnh patients who have an inadequate response to eculizumab

Conditions: Paroxysmal Nocturnal Hemoglobinuria (PNH)

Summary: the purpose of the study is to evaluate the safety and efficacy of ra101495 in patients with paroxysmal nocturnal hemoglobinuria (pnh) who have an inadequate response to eculizumab. patients will be treated with ra101495 for 12 weeks.


Eligibility criteria:
inclusion criteria: * diagnosis of pnh by flow cytometry * inadequate response to eculizumab defined as having received eculizumab for at least 6 months plus a documented ldh level ≥ 1.5 x the upper limit of normal (uln) and/or the presence of a known c5 mutation conferring resistance to eculizumab exclusion criteria: * history of meningococcal disease * current systemic infection or suspicion of active bacterial infection

Keywords: pnh
predictors of readmission in patients undergoing pnl

Conditions: Kidney Stone

Summary: to identify predictors of patients postoperative readmission after pnl

percutaneous nephrolithotomy (pcnl) is a minimally-invasive procedure to remove stones from the kidney by a small puncture wound (up to about 1 cm) through the skin. it is usually done under general anesthesia or spinal anesthesia. despite the advancements in endoscopic technologies technique and training, the procedure is still associated with complications, which can occur during the intervention or in the early or late postoperative period. known complications to pcnl are fever (2.8-32.1%), bleeding requiring transfusion (0- 45%), organ injury (0-1.7%) and sepsis (0.3-1.5%) these complications consider life threatening and increase risk of patient readmission readmission is defined as a state when the patient is admitted to the same or a different hospital after being discharged from the applicable hospital to a non-acute setting, such as his home within a specified time period . hospital readmissions are frequent and costly, and are estimated to cost the us health care system \> $12-17 billion annually . readmissions occurring within the first week after discharge are often related to the stress of acute illness as well as heightened self-care needs, new medications, and impaired function while those occurring later reflect chronic illness nurses could play a pivotal role in preventing readmissions through appropriate discharge teaching and following up with the patients after discharge through telephone conversations. early identification of patients' problems and taking appropriate measures to handle these problems at an early stage helps to prevent further post-discharge complications and improves patient outcomes. nurse should emphasize to the patient the importance of reporting symptoms to physician immediately. postoperative care should include: close monitoring of vital signs, close observation of urine output and color changes, wound care and careful observation for dressing and tube drainage. many studies have been found in the literature on readmissions after urological surgeries and their causes in recent years . these studies include general urological surgical procedures, and there are limited studies examining potential predictive factors for endourology and stone surgery

Eligibility criteria:
inclusion criteria: * adult male and female patients * patients shechedled for pnl * age range from)18-65(years exclusion criteria: * failed pnl * psychiatric patients * coagulopathy * patients refused to participate in the study

Keywords: predictors, percutaneous nephrolithotomy, readmission
scripted sexual health informational intervention in improving sexual function in patients with gynecologic cancer

Conditions: Anxiety Disorder; Cervical Cancer; Endometrial Cancer; Female Reproductive Cancer; Gestational Trophoblastic Tumor; Ovarian Epithelial Cancer; Ovarian Germ Cell Tumor; Sexual Dysfunction; Uterine Sarcoma; Vaginal Cancer; Vulvar Cancer

Summary: this randomized pilot clinical trial studies the feasibility of a pre-operative and/or post-operative scripted sexual health informational intervention and how well it works in improving sexual function in patients with gynecologic cancer. discussing sexual outcomes and counseling options with patients may help improve sexual outcomes and/or anxiety after primary gynecologic cancer treatment.

primary objectives: i. to evaluate the feasibility of patient recruitment, including time required to consent, enroll and retain the necessary number of participants. ii. to determine the distribution of candidate primary patient-reported outcome measures, including time to resumption of sexual activity, global satisfaction with sex life, sexual function and anxiety in this particular population. iii. to establish the prevalence of patient recall of the intervention to determine the most effective time at which to deliver the intervention. outline: patients are randomized to 1 of 4 treatment arms. arm i: patients receive standard counseling at both the pre-operative and 2-4 week post-operative visit. arm ii: patients receive standard counseling at the pre-operative visit and the scripted sexual health intervention at the 2-4 week post-operative visit. arm iii: patients receive standard counseling and the scripted sexual health intervention at the pre-operative visit and standard counseling at the 2-4 week post-operative visit. arm iv: patients receive standard counseling and the scripted sexual health intervention at both the pre-operative and 2-4 week post-operative visit.

Eligibility criteria:
inclusion criteria: * patients with a new suspected or confirmed gynecologic malignancies * patients plan to have primary surgery at either the university of chicago hospital or the university of wisconsin hospital * patients must be english speaking exclusion criteria: * previous treatment of any cancer excluding skin cancer * patients with a suspected benign gynecologic process * patients who are prisoners or incarcerated