Kornimate/medical-research-clean huggingface dataset:
finasteride and flutamide in pre-surgical trial in prostate cancer.

Conditions: Prostate Cancer; Prostatic Intraepithelial Neoplasia

Summary: pre-surgical, window-of-opportunity trials provide a suitable model to assess the activity of preventive interventions in a cost-effective manner using tissue biomarkers as surrogate endpoints. finasteride has been shown to reduce prostate cancer development in a large phase iii trial, and flutamide has a well-known anticancer effect in advanced prostate cancer at the dose of 750 mg/day.

in this randomized, phase iib, double blind, placebo controlled, multicenter, pre-surgical, window-of-opportunity trial we compared the effects of finasteride (5 mg/day) versus low-dose flutamide (250 mg/day) or placebo on tissue biomarkers in patients with prostate cancer who were candidate to radical surgery. specifically, the effects of both drugs on the change in epithelial cell nuclear area in prostate cancer tissue between pre- and post-treatment biopsies was evaluated (primary endpoint). moreover, the changes of the proliferation marker ki-67 and of karyometric parameters in benign, dysplastic (hg-pin) and malignant tissues were evaluated (secondary endpoints). additional endpoints include the changes of serum psa and testosterone, assessment of toxicity, overall survival, recurrence-free survival and event-free (recurrence + death) survival. patients with intracapsular biopsy proven prostate cancer were randomized to either flutamide, 250 mg/day, or finasteride, 5 mg/day, or placebo for 4-6 weeks before radical prostatectomy. blood samples were taken before and after treatment. at surgery, end-of-study ex-vivo biopsies were obtained from the prostatectomy specimens to assess the treatment changes in nuclear area (primary endpoint), ki-67, topoisomerase-ii-α and a 20-feature karyometric discrimant function in normal, high-grade pin and malignant tissue. after surgery patients were followed up for at least 15 years to assess recurrence and/or mortality. we also plan to follow-up patients by telephone interview to assess their vital status for up to 20 years.

Eligibility criteria:
inclusion criteria: * patients aged \> 18 years * patients with a biopsy proven, clinically intracapsular pca who are candidates to radical retropubic prostatectomy * ecog performance status ≤ 2 * satisfactory hematological and biochemical functions: * platelets ≥100 x 10\^9/l * ast and alt in the normal range * able to understand and sign an informed consent exclusion criteria: * previous hormone treatment during the 8 weeks before enrollment * neurologic and psychiatric diseases precluding patient participation in the study * any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the patient from signing or participating in the study and/or comply with the study procedures.

Keywords: prostate cancer prostatic intraepithelial neoplasia chemoprevention flutamide finasteride biomarkers, drug response karyometry
a phase 2a study followed to evaluate the safety, tolerability and levodopa pharmacokinetics in levodopa-treated parkinson's disease patients receiving nd0612

Conditions: Parkinson's Disease

Summary: this phase 2a randomized double blind placebo controlled, in 30 parkinson's disease (pd) subjects who are treated with oral levodopa/carbidopa (ld/cd) and suffer from motor fluctuations. the aim of the study is to determine the safety, tolerability, the levodopa pharmacokinetics, the need for oral ld dose adjustment and the usability of the ambulatory drug delivery pump following repeated dosing of nd0612 in a conventional home setting in parkinson's disease patients. safety and tolerability, pharmacokinetic profile of levodopa and carbidopa, pump usability and the potential clinical effect of nd0612 will be explored in subjects with pd and motor fluctuations.


Eligibility criteria:
inclusion criteria: 1. men and women with idiopathic parkinson's disease 2. subjects must experience motor fluctuations associated with ld/cd dosing 3. modified hoehn and yahr stage \< 5 4. subjects must be taking optimized and stable levodopa/dopa decarboxylase inhibitor therapy 5. subjects who are treated with dopaminergic agonists and other anti-pd drugs should be on stable doses 6. women must be postmenopausal, surgically sterilized, or using adequate birth control. women of childbearing potential must have a negative pregnancy test (serum beta-hcg) at screening. 7. subjects must be age 30 or older. 8. subjects must be willing and able to give informed consent exclusion criteria: 1. subjects treated with entacapone, tolcapone, stalevo or controlled release formulation of levodopa/carbidopa. 2. subjects with a clinically significant or unstable medical or surgical condition 3. history of melanoma or significant skin disorders 4. subjects with significant cognitive impairment 5. subjects treated with unstable doses of dopaminergic agonists, anticholinergics, monoamine oxidase (mao)-b inhibitors, or antipsychotics 6. subjects with clinically significant psychiatric illness 7. subjects with a history of alcohol or substance abuse 8. subjects who have taken experimental medications within 60 days prior to baseline. 9. subject who have undergone a neurosurgical intervention for parkinson's disease (e.g., pallidotomy, thalamotomy, transplantation and deep brain stimulation). 10. subjects with severe disabling dyskinesias. 11. subjects with hearing, visual or motor impairments that prevent them from using the pump or reacting effectively to errors

Keywords: motor fluctuations levodopa pharmacokinetics levodopa and carbidopa solution continuous subcutaneous delivery patch-pump
the efficacy of kinesio taping with therapy in the treatment of globus pharyngeus

Conditions: Globus Pharyngeus

Summary: globus pharyngeus or sensation may be defined as a feeling of something a lump in the throat without dysphagia. kinesio tex tape is a medical tap developed by dr. kase for therapeutic purposes and has been widely used in physical therapy applications in recent years. although it is not a treatment with full consensus, the patient's complaints can be corrected with a small number of different therapy techniques or regulations on life.

we conducted a therapy program with kinesio taping on patients who diagnosed with globus pharyngeus for 8 session with sham kinesio taping controlled group. this study aimed to assess of efficacy of the kinesio taping with therapy on patients patients who diagnosed with globus pharyngeus.

Eligibility criteria:
inclusion criteria: * diagnosed with globus pharyngeus * 18 -65 years * give a consent form exclusion criteria: * patients with dysphagia or odynophagia * laryngeal organic pathologies * pharyngeal organic pathologies * epiglottic retroversion * malignancy * pregnancy * mental disorders * neurological disorders * major psychiatric disorders * give not a consent form

Keywords: kinesio taping globus globus pharyngeus sensation therapy
a prospective study of treating duodenal papillary sphincter in different ways during ercp

Conditions: ERCP

Summary: endoscopic retrograde cholangiopancreatography (ercp) is commonly performed to remove bile duct stones.endoscopic sphincterotomy (est), endoscopic papillary balloon dilation (epbd), and endoscopic sphincterotomy plus balloon dilation (sest+epbd) are 3 methods used to enlarge the papillary orifice, but their efficacy and safety remains controversial. this study aimed to compare these methods for treating common bile duct (cbd) stones.

investigators first divided the patients with different sizes of common bile duct stones into two groups. the bile duct stone diameter of group a is less than 1.0cm while group b is more than 1.0cm and less than 1.5cm. each group compared endoscopic sphincterotomy (est), endoscopic papillary balloon dilation (epbd), and endoscopic sphincterotomy plus balloon dilation (sest+epbd) in ercp. through the postoperative comparison of relevant inspection test indicators, the recovery of patients, whether the occurrence of complications, including infection,bleeding,pancreatitis,perforation , and 1 year stone recurrence rate,investigators assess the advantages and disadvantages in three different strategies in different sizes of common bile duct stones , and finally get a relatively objective evaluation to guide our daily ercp work on the choice of duodenal papillary sphincter treatment strategy.

Eligibility criteria:
inclusion criteria: * age 20-80 years old * ct or mrcp diagnose the patients with common bile duct stones * the diameter of the stone is less than or equal to 1.5cm * patients with the indications for ercp * patients and their families agree to participate in the trial exclusion criteria: * stones are too large (\> 1.5cm) * a history of gastrointestinal surgery * ercp and est or epbd surgery history * patients generally poor, total bilirubin\> 200umol / l or pt time extension\> 3s * patients with mental illness or other serious heart and lung disease
analgesic effects of caudal s-ketamine for supplementation of ropivacaine caudal analgesia in children with hypospadias

Conditions: Postoperative Analgesia; S-ketamine; Pediatrics; Caudal Block; Hypospadias

Summary: caudal analgesia with ropivacaine is commonly used in sub-umbilical pediatric surgery. however, increasing the dosage of ropivacaine has not been found to prolong the action significantly while complications will be serious. ketamine as an additive to caudal administration had been shown to prolong the duration of postoperative analgesia, while the analgesic effectiveness of s-ketamine, the s(+)-enantiomer of ketamine with less possibility to induce psychomotor disturbances, is not clear. in this prospective randomized double-blind clinical trial , the investigators aimed to study the effect of s-ketamine as additive on the duration of caudal analgesia.

forty-four children scheduled for hypospadias randomize into 2 groups. group e (n=22) (0.2% ropivacaine 0.7 ml／kg and s-ketamine 0.5 mg/kg), group c(n=22)( 0.2%ropivacaine 0.7ml／kg and equivalent saline) intraoperative and postoperative hemodynamics will be recorded. postoperative pain is assessed using an established 6-item flacc score at 1h,3h,6h,12h,24h,48h, or the time when children complain of pain after surgery. a score of more15μg/kg is administered.investigators propose to compare the duration of caudal analgesia provided by plain ropivacaine and by a mixture of ropivacaine and s-ketamine.

Eligibility criteria:
inclusion criteria: * informed parent consent, asa i or ii children, between 3months and 18 years of age,and weighing \<28kg, scheduled for elective hypospadias surgery with general anesthesia will be recruited. exclusion criteria: * patients who have congenital abnormalities of lower spine and meninges. * patients with hypersensitivity to any local anesthetics * children with coagulation disorders * presence of infections at puncture sites * preexisting neurological disease * refusal to consent by parent/guardian
mindfulness training in nurses and its effect on work stress

Conditions: Nursing Caries; Consciousness, Level Altered

Summary: the aim of the study, which was planned in the experimental design type, was to determine the effect of the mindfulness-based stress reduction training on nurses' job stress. the sample of the study consisted of 70 nurses (35 in the experimental group, 35 in the control group) working in a university hospital in çanakkale. the mindfulness-based stress reduction training was carried out as a group, once a week, for 8 weeks in total.

one of the most important problems of nurses in turkey is the stress they experience at work. this stress experienced in the workplace is accompanied by consequences such as depression, anxiety, and decreased job satisfaction. therefore, it is clear that addressing the stress associated with the nursing profession is an urgent problem. the aim of the study, which was planned in the experimental design type, was to determine the effect of the mindfulness-based stress reduction training on nurses' job stress. the sample of the study consisted of 70 nurses (35 in the experimental group, 35 in the control group) working in a university hospital in çanakkale. the mindfulness-based stress reduction training was carried out as a group, once a week, for 8 weeks in total. the personal information form, the job stress scale, the mindful attention awareness scale, and the rosenbaum's learned resourcefulness scale were used for data collection. a total of three follow-ups were conducted to the nurses before the training, at the end of the training, and 3 months after the training. descriptive analysis, chi-square test, independent samples t-test, dependent samples t-test, and one-way analysis of variance were used in the analysis of the research data.

Eligibility criteria:
inclusion criteria: * working as a nurse in the relevant health practice and research hospital * not having participated in any mindfulness-based training program before exclusion criteria: * working as an executive nurse * not attending any session of the 8-week training

Keywords: nurse work stress awareness
ptk787 in patients with advanced metastatic pancreatic adenocarcinoma

Conditions: Neoplasm

Summary: the purpose of this research study is to find out if an experimental drug called ptk787/zk222584 might be effective against advanced or metastatic pancreatic cancer. in order for tumors to grow and spread to other parts of the body, they need to have a growing blood supply. tumor cells have been shown to produce substances that stimulate the abnormal growth of new blood vessels that allow the tumor to grow. in adults, blood vessel cells normally divide very rapidly. it is thought that ptk787/zk222584 may interfere with the growth of new blood vessels. a drug that interferes with the growth of new blood vessels might stop tumor growth, and possibly shrink the tumor by keeping it from receiving nutrients and oxygen supplied by the blood vessels. since normal blood vessel cells divide very rarely, it might be possible to stop tumor growth without harming normal tissues.

this is an open-label, phase ii multi-center therapeutic trial investigating the efficacy and tolerability of ptk787/zk222584 in patients with metastatic or advanced pancreatic cancer who failed first line gemcitabine-based therapy. the primary objective of this study is to evaluate the 6-month survival rate, time to progression, and tolerability of the regimen in pancreatic cancer patients treated with ptk787/zk222584 as second-line therapy.

Eligibility criteria:
inclusion criteria: * age \> 18 * zubrod performance status of 0 - 2 * histological or cytological diagnosis of pancreatic adenocarcinoma * measurable or evaluable disease determined as per recist criteria * life expectancy \> 12 weeks * written informed consent * patients must have failed or progressed on prior gemcitabine-based therapy for advanced or metastatic disease. exclusion criteria: * islet cell or neuroendocrine carcinomas of the pancreas. * history or presence of central nervous system disease. * patients with a history of another primary malignancy \< 5 years * prior chemo therapy \< 21 days prior to registration. * prior biologic or immunotherapy \< 14 days prior to registration * prior full field radiotherapy \< 28 days or limited field radiotherapy \< 14 days prior to registration. * major surgery \< 28 days prior to registration. * patients who have received investigational drugs \< 28 days prior to registration. * prior therapy with anti-vegf agents. * pleural effusion or ascites that causes respiratory compromise. * female patients who are pregnant or breast feeding.

Keywords: pancreas adenocarcinoma cancer metastatic advanced cancer phase ii growth factor vegf angiogenesis
intralymphatic immunotherapy in increasing doses, after subcutaneous immunotherapy

Conditions: Rhinitis, Allergic

Summary: the study evaluates the safety and effect of intralymphatic allergen specific immunotherapy in increasing doses. patients that have already undergone subcutaneous immunotherapy will be treated with three intralymphatic injections in increasing doses; 1000 sq-u, 3000 sq-u and 10 000 sq-u, or placebo.

38 patients with seasonal allergic rhinitis that have recently (within 20 months) ended a full subcutaneous immunotherapy protocol with birch or grass allergen with improvement but not full symptom relief are recruited. study subjects are randomized to intralymphatic injections with placebo or alk alutard 5-grasses or birch.

Eligibility criteria:
inclusion criteria: * age 18-55 * accepted and signed informed consent. * recently (within 20 months) ended a full 3 year program with subcutaneous immunotherapy (scit) with amelioration of symptoms but not full symptom relief. exclusion criteria: * previously subcutaneous immunotherapy (scit) with total symptom relief. * previously scit but no symptom improvement at all. * sensitizations to house dust mite or furry animals, with symptoms. * severe atopic dermatitis. * patients with significant diseases other than allergic rhinitis. a significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study. * patients with a respiratory tract infection in the past 4 weeks prior to visit 2. * pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices, diaphragm, or subdermal implants). * known autoimmune or collagen disease * cardiovascular disease * perennial pulmonary disease including asthma * hepatic disease * known renal insufficiency * cancer * hematologic disease * chronic infectious disease * any medication with a possible side-effect of interfering with the immune response * previous immuno- or chemotherapy, apart from scit * disease or conditions rendering the treatment of anaphylactic reactions difficult (symptomatic coronary heart diseases, severe arterial hypertension and treatment with β-blockers) * major metabolic disease * known or suspected allergy to the study product * obesity with bmi \> 30 since subcutaneous fat makes ultrasound imaging of lymph nodes harder which may risk the correct placement of injection. * patients who, in the opinion of the investigator, abuse alcohol or drugs within 2 years prior to visit 1. * patients who have taken an investigational drug within 1 month or six half lives, whichever is greater, prior to visit 1. * mental incapability of coping with the study * withdrawal of informed consent
data analysis for drug repurposing for effective alzheimer's medicines (dream) - methotrexate vs hydroxychloroquine

Conditions: Rheumatoid Arthritis

Summary: this study aims to evaluate the comparative risk of dementia/alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication.

this is a non-randomized, non-interventional study that is part of the dream study of brigham and women's hospital. dream is led by dr. madhav thambisetty, md, phd, chief of the clinical and translational neuroscience section, laboratory of behavioral neuroscience, national institute on aging (nia) intramural research program. this study aims to evaluate the comparative risk of dementia/alzheimer's disease onset between patients treated with medications that target specific metabolic pathways and patients treated with alternative medications for the same indication using healthcare claims data.

Eligibility criteria:
please see https://docs.google.com/spreadsheets/d/14hjn7w3nfpfcaowvdnici9ullrkrn2fn2jyejjggtzc/edit?usp=sharing or appendix a for full code and algorithm definitions. medicare timeframe: 2007 to 2017 (end of data availability). inclusion criteria: * 1. no prior use of methotrexate or hydroxychloroquine anytime prior to cohort entry date * 2. enrollment in medicare part a, b, and d with no hmo coverage for 365 days prior to and including cohort entry date exclusion criteria: * 1. prior history of dementia measured anytime prior to cohort entry date * 2. no prior history of rheumatoid arthritis recorded in the 365 days prior to cohort entry date * 3. prior history of nursing home admission in the 365 days prior to the cohort entry date * 4. prior history of dmard use measured anytime prior to cohort entry date
short-term effects of transdermal estradiol on female covid-19 patients

Conditions: COVID-19; Hormone Replacement Therapy

Summary: the goal of this randomized placebo-controlled study is to investigate the short-term effects of transdermal estrogen therapy on postmenopausal women with covid-19 disease. the main question\[s\] it aims to answer are: * the clinical outcomes with adding estrogen treatment to conventional therapy of covid-19 disease * the biochemical outcomes with adding estrogen treatment to conventional therapy of covid-19 disease all participants received favipiravir for a week according to the national guidelines published by the health ministry of turkish republic at that time. as an intervention, transdermal estradiol patch (7.8 mg patch/week) was applied for 14 days on the upper buttock of the patients in experimental arm. as a placebo, hydrogel patch (adhesive hydrogel patch/week) was applied to the female patients for 14 days. researchers compared experimental and control groups to see if the impact of adding estrogen on the clinical course of covid-19 disease

the risk of severe acute respiratory syndrome coronavirus 2 (sars-cov-2) infection, morbidity and mortality from covid-19 disease were higher among men compared to women. this is caused by the differences in immunological response and viral pathogenesis between men and women. it is theoretically assumed that estrogen has a positive impact on female covid-19 patients. in this randomized placebo-controlled study, we aimed to investigate the short-term effects of transdermal estrogen therapy on postmenopausal women with covid-19 disease. female patients diagnosed with covid-19 disease were examined and only postmenopausal women were included into the study. the covid-19 diagnosis was made with a positive reverse transcription-polymerase chain reaction (rt-pcr) test given with nasal and oral swabs. all participants received favipiravir for a week according to the national guidelines published by the health ministry of turkish republic at that time. as an intervention, transdermal estradiol patch (7.8 mg patch/week) was applied for 14 days on the upper buttock of the patients in experimental arm. as a placebo, hydrogel patch (adhesive hydrogel patch/week) was applied to the female patients for 14 days. our primary outcome was to achieve better clinical and biochemical outcomes with adding estrogen treatment to conventional therapy of covid-19 disease. the epidemiological and clinical data, the results of biochemical analysis, the information regarding the treatment and outcomes and serum estradiol levels were determined.

Eligibility criteria:
inclusion criteria: * female patients diagnosed with covid-19 disease * postmenopausal women (who had 12 months of amenorrhea after their final menstrual period) * positive reverse transcription-polymerase chain reaction (rt-pcr) test given with nasal and oral swabs exclusion criteria: * negative rt-pcr test * female patients at reproductive stage

Keywords: covid-19 hormone replacement therapy