Kornimate/medical-research-clean huggingface dataset:
sexual steroids: relationship between serum and prostatic tissue level

Conditions: Urinary Bladder Neoplasms; Prostate Hyperplasia

Summary: patients followed in the foch hospital urology department (suresnes): patients justifying a prostatectomy. * patients justifying prostatectomy together with the bladder (radical cystectomy for bladder cancer). * patients with benign prostate hyperplasia who justified a prostatectomy. compare serum sexual steroid concentrations and intra-tissue on healthy prostates and prostate adenoma, assess concentrations intra-tissue sex steroids on cancer metastasis prostate specific blood sample under study (30ml) will be performed preoperatively in patients followed in foch hospital urology department (suresnes), and a removal of a fragment of prostate tissue or metastasis will be analyze. aim is to compare serum concentrations of sexual steroids and intra-tissue on healthy prostates and prostate adenomas compared to concentrations measured in patients operated for prostate cancer.

steroids concentration will be determined using gas chromatography-mass spectrometry. the analyzed steroids are : fsh :mul/ml lh: mui/ml shbg: µg/ml bt: ng/ml tt: ng/ml dht: ng/ml dhea: ng/ml d5: ng/ml d4: ng/ml e1: pg/ml e2 : pg/ml dhea-s : µg/dl

Eligibility criteria:
inclusion criteria: * men aged over 18 years * surgical indication justifying protatique prostatectomy, or complete prostatocystectomie, or removal of a metastasis of prostate cancer. * patients affiliated to a social security scheme or benefiting from such a regime. * patients who have given their consent to participate in writing exclusion criteria: * patient received local therapy or hormonal treatment (lhrh analogue, therapy blocking androgen receptors) before surgery. * treatment reductase inhibitors 5ari ongoing or stopped for less than 3 months before the intervention. * patient included in another clinical trial inconsistent with the conduct of this research. * patient receiving treatment that could interfere with hormone levels (prednisone, ketoconazole, abiraterone, finasteride, dutasteride).
mindfulness exercises to reduce anxiety and pain during urodynamic testing

Conditions: Stress Incontinence, Female; Overactive Bladder; Lower Urinary Tract Symptoms

Summary: in this pilot study the investigators attempt to answer the question, does mindfulness exercises before urodynamic testing reduce patient's perception of anxiety or pain?

the subjects are being asked to consider participation in this research study. the purpose of this study is to see if incorporating mindfulness exercises prior to urodynamic studies (uds) results in less pain, anxiety and discomfort. the participants will be guided through a mindfulness meditation exercise by a licensed professional. during this exercise participants will be asked to focus attention on breathing, physical sensations, and thoughts. this exercise will last for approximately 10 minutes in which participants will not be asked to engage in any physical activity other than sitting and breathing. the participants will be randomly assigned to one of 2 treatment plans. randomization is a process like flipping a coin and means the chance of being assigned to either of the plans. one treatment plan includes undergoing mindfulness exercises prior to your uds evaluation. the other treatment plan includes simply undergoing the uds evaluation. after the participants uds evaluation, questions will be asked about the urodynamic procedure. the participants will be asked to answer questions on a uds and anxiety questionnaire which pertain to emotional and physical experiences during the procedure.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of urinary symptoms requiring urodynamic testing * stress incontinence * mixed incontinence * urge incontinence * overactive bladder * urinary retention * lower urinary tract symptoms * are department of defense (dod) beneficiaries exclusion criteria: * neurogenic bladder * interstitial cystitis * chronic bladder pain * inability to have urodynamics performed * are not dod beneficiaries * pregnant * lack capacity to consent

Keywords: urodynamics
human subcutaneous inflammatory response to glucose sensors

Conditions: Inflammatory Response to Glucose Sensors

Summary: the aim of the study is to describe the inflammatory response to enzimatic glucose sensors after 10 days of use and to evaluate the relationship between the magnitude of the fbr (foreign body response) with the accuracy of the sensor (mard)

eighteen type 1 dm patients are going to be included. primary objectives 1. to define the intra-individual and inter-individual variability of the macrophage count around the sensor 2. to assess whether there is a relationship between the number of macrophages, fibrosis and mard of the mcg registry. secondary objectives to describe the histology of tissue response. this description will include: 1. he stain: cell types, arrangement, vascular structures, signs of hemorrhage-clot. giemsa stain: mast cells. masson's trichrome stain: str. vascular. 2. immunohistochemistry: vascular assessment, characterization of macrophages each patient will have 1 glucose sensor inserted in the non-dominant arm. during the useful life of the sensor (10), a minimum of 4 capillary blood glucose determinations/day will be performed the sensor has a length of 8 mm and a diameter of 0.4 mm. all the necessary material will be provided, including a control diary to help the patient remember to carry out the self-control and set its time distribution. on the last day of sensor use, it will be removed and a 4-mm punch skin biopsy will be performed 5 minutes later. tissue samples will be fixed in 4% formaldehyde solution, paraffin blocks made and sectioned. the resulting samples will be stained semiquantitative determination of lymphocytes, neutrophils, mast cells, macrophages will be performed; fibrin, fibrosis, vascular proliferation and karyorrhexis in all cases, a quantitative immunohistochemical study will be performed with x40 field counting with photographs and grid (dako omnis with envision system) for: macrophages the monitor-glucometer will be recovered for download and study of the record. the interstitial glucose - blood pairs will be made with those recorded but not used for callibration. glucose sensor values and insulin doses will be recover from tha medical application

Eligibility criteria:
inclusion criteria: * 1. type 1 diabetes of more than 6 months duration, confirmed by positivity for ab antigad 65 2. be a regular user of a continuous glucose monitoring system 2. to understand the proposed protocol and acceptance of participation. exclusion criteria: * treatment with drugs that could potentially modify the inflammatory response during the 10 days prior to surgery (non-steroidal anti-inflammatory drugs or corticosteroids, antioxidants or platelet antiaggregants).

Keywords: enzymatic glucose sensors, foreign body response
health related quality of life in children with food allergy: comparison to controls and other chronic diseases

Conditions: Children With Food Allergy

Summary: the number of studies concerning health related quality of life (hrql) in children with food allergy is very limited. only one study to date has compared hrql of a group of children with food allergy to data published on general population and other chronic diseases. this study concluded to lowest hrql scores in food allergic children compared to type 1 diabetes mellitus with important impact on scores concerning social activities.

primary aim: to compare generic hrql score in children with food allergy with other chronic diseases and with healthy chidren in an homogeneous socio-cultural context. secondary aims : * to compare generic and specific hrql scores in children with food allergy * identifify in chidren with food allergy, clinical factrors assocated with lowest scores in order to improve our management. methods generic hrql questionnaire (chq-87) will be distributed : * after hospital consultation for patients * in schools for healthy children a specific hrql questionnaire (faqlq-cf or tf) and the " food allergy independent measure " will also distributed to chidren with food allergy.

Eligibility criteria:
inclusion criteria: * age between 8-18 year old * ige mediated food allergy diagnosed by a pediatric allergologist with following criteria: convincing history of allergic reaction with positive prick-test and specific ige or open food challenge associated with positive prick-test and specific ige * signed informed consent of the two parents * signed informed consent of the child * health insurance recipient exclusion criteria: * association with another medical or psychiatric chronic disease (excepted for controlled asthma) * partially or not controlled asthma during last year * no signed consent

Keywords: health related quality of life, food allergy, children, chronic diseases
tenofovir versus lamivudine for patients of chronic hepatitis b with severe acute exacerbation

Conditions: Chronic HBV With Severe Exacerbation

Summary: in taiwan, 15% of general population had hepatitis b virus (hbv) infection, hbv is the leading cause of liver cirrhosis and hepatocellular carcinoma in taiwan. after entering immune clearance, 10-30% of patients of chronic hbv develop acute exacerbation (ae) , some are mild but some developed hepatic decompensation or even death. previous study found that early use of lamivudine before bilirubin level is above 20 mg/dl can improve survival in chornic hbv with severe ae. from the study from hongkong, lamivudine was found to have better survival than entecavir in chronic hbv with severe ae. recent study from india found that tenofovir is able to improve survival in chronic hbv with severe ae. the aim of this study is to compare the effect of lamivudine and tenofovir for chronic hbv with severe ae. the study aims to enroll 120 patients with chronic hbv defined as persistence of hbsag for more than 6 months. severe ae was defined as alt \> 400 u/l, prolongation of prothrombin time \> 3 seconds, bilirubin \> 2 mg/dl. patients with hepatitis a, c, d or hiv infection, drug or alcoholic liver disease, hepatocellular carcinoma, under immuno-suppressive agents use, or previous use of anti-hbv agents are excluded. all enrolled patients are randomized into group a who received tenofovir 300 mg qd for 3 years and group b who received lamivuidne 100 mg qd for 6 months, followed by tenofovir 300mg qd for 30 months. mortality rate and virological, biochemical and serological response were evaluated at 1,2,4,48,96 and 144 weeks. the values are expressed as mean + sd. categorical variables were analyzed with chi-square test or fisher's exact test as appropriate and continuous variables were analyzed by mann-whitney test. logistic regression test was applied to analyze the independent association of various variables with outcome. a p value \< 0.05 was regarded as significant.


Eligibility criteria:
inclusion criteria: * hbsag (+) \> 6 months * alt \> 5x uln * prolongation of prothrombin time \> 3 seconds and bilirubin level \> 2 mg/dl * 20-75 years old exclusion criteria: * hav, hcv, hdv and hiv co-infection * concurrent hepatocellular carcinoma * drug, metabolic or alcohol as cause of hepatitis * anti-viral treatment in recent 6 mnths * pregnant woman

Keywords: tenofovir, lamivudine, hepatitis b, acute exacerbation
chemotherapy in treating patients with sarcoma of the uterus

Conditions: Endometrial Cancer; Sarcoma

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase ii trial to study the effectiveness of liposomal doxorubicin in treating patients who have advanced or recurrent sarcoma of the uterus.

objectives: i. estimate the antitumor activity of doxorubicin hcl liposome in patients with recurrent or advanced uterine sarcoma. ii. determine the nature and degree of toxicity of this drug in this patient population. outline: patients receive doxorubicin hcl liposome iv over 1 hour. treatment continues every 4 weeks in the absence of unacceptable toxicity or disease progression. patients are followed every 3 months for 2 years and then every 6 months for 3 years. projected accrual: a total of 20-30 patients will be accrued for this study within 1-1.5 years.

Eligibility criteria:
disease characteristics: histologically confirmed advanced, persistent or recurrent uterine sarcoma with documented disease progression after appropriate local therapy leiomyosarcoma malignant mixed mullerian tumor (mixed mesodermal tumor, mixed heterologous mesenchymal sarcoma) mixed malignant muellerian tumor (carcinosarcoma, homologous mesenchymal sarcoma) endometrial stromal sarcoma other uterine sarcomas considered incurable bidimensionally measurable disease consisting of abdominal, pelvic, chest, or other masses by palpation, x-ray, computed tomography, or ultrasound patient characteristics: age: over 21 performance status: gog 0-2 life expectancy: not specified hematopoietic: absolute neutrophil count at least 1,500/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin no greater than 1.5 times upper limit of normal (uln) sgot no greater than 3 times uln alkaline phosphatase no greater than 3 times uln renal: creatinine no greater than 1.5 mg/dl cardiovascular: lvef normal by muga scan other: no clinically significant infection no other malignancy within the past 5 years except nonmelanoma skin cancer prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior therapy with cytotoxic drugs no prior doxorubicin hcl liposome no prior doxorubicin greater than 360 mg/m2 no other concurrent antineoplastic agents endocrine therapy: not specified radiotherapy: recovered from prior radiotherapy no prior radiotherapy for any other malignancy surgery: recovered from prior surgery other: no other concurrent investigational agents

Keywords: stage iv uterine sarcoma recurrent uterine sarcoma uterine carcinosarcoma uterine leiomyosarcoma endometrial stromal sarcoma
effectiveness of smartconsent in improving understanding of informed consent

Conditions: Benign Prostatic Hyperplasia

Summary: the general objective of the study is to assess whether the new smartconsent tool improves patients' understanding of the intervention to be performed, compared to standard practice. a randomized clinical trial will be conducted in 50 patients who will undergo laser prostatic enucleation.

male patients aged between 50 and 70 years, belonging to the hospital universitario araba who are going to undergo prostatic laser enucleation, and who attend urology consultation between december 2019 and december 2020, and who meet the inclusion criteria and none of the exclusion criteria. inclusion criteria: * patients willing to receive information via tablet. * patients who know how to and can read. exclusion criteria: -not applicable. main variable: score on the multiple choice test questionnaire (designed specifically for each type of procedure, following the recommendations proposed by kehoe, jerard and fathelrahman et al. and developed on the basis of the information that an informed consent should provide (1, 2), with 4 response options and only one correct answer. an average score will be calculated for each patient. this test evaluates the comprehension of the information provided through the informed consent.

Eligibility criteria:
inclusion criteria: * patients willing to receive information via tablet. * patients who know and can read. exclusion criteria: * not applicable
fruit and vegetable juice concentrate effects on rbp4 and antioxidant capacity in lean and overweight 6-10 year old boys

Conditions: Obesity

Summary: our study aims to evaluate if the consumption of a fruit and vegetable juice concentrate (fvjc) vs. placebo can exert changes in the serum levels of retinol binding protein 4 (rbp4), carotenoids, tocopherol, antioxidant capacity, pro-inflammatory markers, insulin sensitivity in conjunction with weight management in a cohort of lean as compared to overweight healthy six to ten year-old boys. the boys will undergo a detailed medical and family history and a complete physical examination during the screening visit. careful anthropometric measures and body composition by dexa will be performed. nutritional and exercise counseling will be given at the start of the study. the outcome measures will include differences in serum rbp4, antioxidant levels, inflammatory markers and insulin sensitivity at baseline and six months after consumption of fvjc in a randomized double blind placebo control manner.


Eligibility criteria:
inclusion criteria: * 6-10 year old healthy boys * lean or overweight * have not started puberty exclusion criteria: * chronic illness, asthma, or gi disorder * vegan diet * use of routine medications or vitamins 4 weeks before study

Keywords: nutrition oxidative stress insulin resistance whole food supplement pediatric retinoids antioxidants dietary supplements
effect of pelvic organ prolapse surgeries on female sexual function in egyptian women

Conditions: Female Sexual Dysfunction

Summary: study on female sexual function after different prolapse surgeries


Eligibility criteria:
inclusion criteria: * sex active prolapse surgery exclusion criteria: * not sex active any psychiatric problem
complete functional assessment of intermediate coronary artery stenosis before and after transcatheter aortic valve implantation (tavi) in patients with severe symptomatic aortic valve stenosis

Conditions: Coronary Artery Stenosis; Transcatheter Aortic Valve Implantation

Summary: the purpose of the current study is to assess complete coronary physiology (ffr, rfr, cfr, imr, and ct-ffr) in tavi candidates with intermediate coronary artery stenosis before and 6 months after tavi. this aims to determine how tavi affects coronary blood flow and coronary microcirculatory function after longer-term follow-up, and how these effects influence ffr and rfr values. in addition, it is aimed to correlate invasive functional testing (ffr and rfr) with non-invasive ct-ffr before and 6 months after tavi.

prospective, single center, open-label study to 1. compare coronary flow reserve (cfr), index of microvascular resistance (imr), fractional flow reserve (ffr) and resting full cycle ratio (rfr) values before tavi and 6 months after tavi 2. correlate testing of microcirculatory function (imr) with measurements of functional testing (ffr and rfr) before and six months after tavi 3. correlate functional testing (ffr and rfr) with computed tomography (ct) derived fractional flow reserve (ct-ffr) before and six months after tavi.

Eligibility criteria:
inclusion criteria: * age \>18 years * willing to participate and able to understand, read and sign the informed consent document before the planned procedure * severe symptomatic aortic stenosis with indication for tavi according to current guidelines deemed by the heart team * patients who have undergone coronary ct angiography before tavi in which cad could not be ruled out * cad in one or more native major epicardial vessels or their branches by coronary angiogram with visually assessed coronary stenosis, in which the physiological severity of the lesion is in question (typically 40-90% diameter stenosis). * eligible for invasive coronary angiography and functional assessment (ffr, rfr, cfr and imr) * eligible for coronary ct-angiography and functional assessment (ct-ffr) exclusion criteria: * patients whose ct-angiography was determined to be non-diagnostic/unreadable during its evaluation * previous coronary artery bypass grafting with patent grafts to the interrogated vessel * patients with severe lesions with a diameter stenosis ≥ 90%, flow-limiting lesions, or a significant left main coronary artery stenosis * critical coronary artery disease deemed by the heart team to require immediate revascularization * contraindication to adenosine (e.g. bronchial asthma) * chronic renal impairment with severe reduction of glomerular filtration rate (egfr \<30 ml/min) * presence of cardiogenic shock * participation in another interventional study involving the left heart or coronary arteries

Keywords: coronary artery stenosis transcatheter aortic valve implantation coronary physiology coronary blood flow coronary microcirculatory function non-invasive ct-ffr fractional flow reserve resting full cycle ratio
the effect of 10 cm catheter mount on malfunction of capnometers under the conditions of water

Conditions: Cardiopulmonary Resuscitation; Pulmonary Edema; Hemorrhage

Summary: capnometer has been used to assess the success of intubation and the quality of cardiopulmonary resuscitation. however, capnometers can malfunction under the conditions such as pulmonary edema and hemorrhage due to the vulnerability of capnometers for water. investigators hypothesized that the use of 10cm catheter mount will reduce the malfunction of capnometers under the conditions of water.


Eligibility criteria:
inclusion criteria: * healthy adults without underlying disease exclusion criteria: * lung and heart disease * drinking carbonated beverages

Keywords: capnography catheters intubation
cardiotoxicity of targeted therapy for her-2 positive breast cancer patients at high altitude

Conditions: HER2-positive Breast Cancer; Targeted Therapy; Cardiac Toxicity; High Altitude

Summary: this is a prospective, multicenter, cohort study aiming to explore the cardiotoxicity of targeted therapy for her-2 positive breast cancer patients who lives in high altitude area. one hundred and thirty two her-2 positive breast cancer patients who will receive neoadjuvant, adjuvant, or palliative targeted therapy will be enrolled. the cardiotoxicity of targeted therapy will be observed and recorded during the treatment and one year after the end of treatment. the subjects will be stratified by age, baseline cardiac risk factors, and anthracyclines.

her-2 positive breast cancer patients who live at high altitudes greater than 2000 meters for long periods of time and will receive trastuzumab-based targeted therapy will be enrolled. the subjects included early and advanced patients. treatment regimens includes chemotherapy combined with trastuzumab, chemotherapy combined with trastuzumab and pertuzumab, trastuzumab alone, and trastuzumab plus pertuzumab. electrocardiogram, cardiac ultrasound, nt-probnp, and tni will be tested every 3 months when the treatment begins. the primary endpoint is cardiotoxity. the second endpoints is pathologic complete response (pcr) rate in neoadjuvant therapy, objective remission rate (orr) and disease control rate (dcr) in neoadjuvant and palliative therapy.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed invasive her2-positive breast cancer. 2. the baseline left ventricular ejection fraction \>55%. 3. living at high altitude area （\>2000 meters）for at least 10 years. 4. ecog score 0-2. 5. expected survival time ≥ 12 months. exclusion criteria: 1. patients with previous breast cancer or other malignant tumor within 5 years. 2. patients who had accepted previous anti-her2 or anthracyclines-based therapy. 3. patients with severe heart disease or discomfort. 4. patients who are pregnant. 5. patients with other conditions considered not suitable to be enrolled by the investigator.

Keywords: her2-positive breast cancer targeted therapy cardiotoxicity high altitude