Kornimate/medical-research-clean huggingface dataset:
open label extension to sre studies in united kingdom and czech republic only

Conditions: Bone Metastases in Men With Hormone-Refractory Prostate Cancer; Bone Metastases in Subjects With Advanced Breast Cancer; Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma

Summary: the purpose of this study is to describe the safety and tolerability of denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received either zoledronic acid (zometa®) or denosumab.


Eligibility criteria:
inclusion criteria: * subjects currently enrolled in study 20050103, 20050136, or 20050244 * subjects must sign the informed consent before any study specific procedures are performed exclusion criteria: * developed sensitivity to mammalian cell derived drug products during the 20050103, 20050136, or 20050244 study * currently receiving any unapproved investigational product other than denosumab * subject is pregnant or breast feeding, or planning to become pregnant within 7 months after the end of treatment * subject (male or female) is not willing to use 2 highly effective contraception during treatment and for 7 months (women) or 10 months (men) after the end of treatment * male subject with a pregnant partner who is not willing to use a condom during treatment and for additional 10 months after the end of treatment * any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures

Keywords: bone metastases hormone-refractory prostate cancer multiple myeloma denosumab breast cancer 20050103 20050136 20050244 advanced cancer tumor prostate cancer zoledronic acid
mrkad5 hiv-1 gag vaccine (v520) in subjects with chronic hepatitis c (v520-022) (completed)

Conditions: Hepatitis C

Summary: a study to assess the general safety and tolerability of the administration of a 3-dose prime/boost regimen of the mrkad5 hiv-1 gag vaccine (v520) in subjects with chronic hepatitis c virus infection.


Eligibility criteria:
inclusion criteria: * subject who is of reproductive potential agrees to use a acceptable method of birth control through week 52 of the study exclusion criteria: * subject weighs less than 110 lbs. * subject has received treatment for hepatitis c virus infection in the 3 months before enrollment in this study or is anticipated to begin treatment with in 1 year after enrollment * subject has any history of anaphylaxis or allergy to vaccine components * subject has any history of anaphylaxis or allergy to tetanus and diphtheria toxoids adsorbed (td) * subject has clinical signs suggestive of cirrhosis * subject has had a liver biopsy showing bridging fibrosis or cirrhosis * subject is hbsag positive * subject has other known chronic liver disease * subject has evidence of hepatocellular carcinoma on liver biopsy * subject has had a liver transplant or is anticipated to have a liver transplant within 1 year of enrollment * subject has been vaccinated with a live virus vaccine in the past 30 days * subject has been vaccinated with an inactive virus vaccine in the past 14 days * female subject is pregnant or breast-feeding, male subject is planning to impregnate * subject has active drug or alcohol abuse * subject is at high risk for hiv infection
effect of inguinal hernia repair on uroflowmetric parameteres

Conditions: Inguinal Hernia; Urinary Retention; Lower Urinary Tract Symptoms

Summary: post operative acute urinary retension or voiding dysfunction are complications after inguinal hernia repair and they cause a great deal of discomfort and stress to patients. furthermore, they can also increase hospital costs by increasing hospital stay, and by growing the need for outpatient appointments after an elective surgical procedure. some studies recommend prophylactic alpha blockers to minimizing these adverse effects. investigators aimed to determine the changes of uroflowmetric values for male patients following elective inguinal hernia repair.

inguinal hernia repair is a common procedure performed in general surgery, with an annual rate of 28 per 100,000 of the population in the usa. the incidence of post operative inability voiding in males following open or laparoscopic inguinal hernia repair varies from 3 to 25%. evaluating risk factors to reduce the occurence of this complications after one of the most commonly performed surgery by general surgeons could help reduce that high rate of that complication. although some authors recommend prophylactic alpha blockers, there is no consensus on whether these can decrease rate of urinary retention or voiding dysfunction in male patients. in current study, investigators aimed to determinate the uroflowmetric parametric changes of patients after elective inguinal hernia repair.

Eligibility criteria:
inclusion criteria: * any type of inguinal hernia exclusion criteria: * active urinary tract infection, * previous bph, neurological disease or significant systemic disease, * medications that could interfere voiding function * history of prostate, bladder or urethral surgery or traumatic urethral catheterisation.

Keywords: complication uroflowmetry
reflexology versus acupressure on sleep disturbance and hot flashes

Conditions: Postmenopausal Flushing; Hot Flashes

Summary: world health organization (who) estimates that by 2030, 1.2 billion women will be over 50 years old. with a prevalence of 70%, a hot flash is the most distressing symptoms associated with menopause. postmenopausal associated sleep disturbances could affect those women social activities and one's daily positive functioning. therefore, some patients and their providers seek alternative treatments such as relaxation techniques, acupressure, yoga, reﬂexology, regular exercise, balanced nutrition, herbal supplements, appropriate clothing, and frequent showers, have been shown to be effective in reducing symptoms associated with depression. so, this study will be the first one in this issue. therefore, it will have valuable benefits in physical therapy field and scientific research.

fifty-four postmenopausal women suffering from moderate to severe hot flashes diagnosed with hot flashes questionnaire, and sleep disturbances diagnosed with pittsburgh quality sleep index \>5. their age ranged from 45-55 years old with their body mass index ranged from 25 to 30 kilogram per meter square. outcome measures were pittsburgh sleep quality index and hot flashes questionnaire, both were conducted at baseline and after the end of the study program. after recruiting study population, they will be divided into two equal groups randomly. group a; will received foot reflexology (medical border just above the heel, reflex points associated with adrenal, hypothalamus, pituitary glands, heart and lung via manual pressure at reflexology zone), for 15 minutes, 3 sessions per week for 6 weeks. group b; will received acupressure ((shenmen point, sanyinjiao point, fengchi point; yintang point), for 21 minutes, 3 sessions per week for 6 weeks.

Eligibility criteria:
inclusion criteria: * age ranged from 45 to 55 years old. * their body mass index ranged from 25 to 3 kilograms per meter square. * postmenopausal women suffering from moderate to sever hot flashes assessed by hot flashes questionnaire. * postmenopausal women suffering from sleep disturbances more than five assessed by pittsburgh sleep quality index. exclusion criteria: * any emotional stress during at least 6 months. * any pharmacological medicines lead to sleep disturbances. * any mental disorders affect their sleep cycle. * taking hormone replacement therapy for the past six months. * using herbal medicine to improve menopausal symptoms severity. * circular job in particular night shifts. * sensorineural problems in their feet.
increased prevalence of myopia in a ophthalmologic hospital in goiânia - goiás

Conditions: Myopia

Summary: the purpose of this study was to evaluate the increased prevalence of myopia among patients in different periods in an ophthalmologic hospital in goiania. there has been an increase of myopia prevalence around the world especially in some asian countries. the investigators intend to analyze if this growing tendency is also present in our hospital, and if it exist how much is this growth.

there were compared data collected in two scientific studies carried out in the same ophthalmologic hospital in different periods of time, they evaluated among other factors, the refractive errors of the participants, from this data there were compared the percentage of patients with myopia between the two studies. and analysed how much was the grown of myopia

Eligibility criteria:
inclusion criteria: * patients between 2 and 20 years assessment of project "olhar brasil" * patients between 2 and 40 years assessment of project "boa visão" exclusion criteria: * the patients wasn't assessment of project "olhar brasil" * the patients wasn't assessment of project "boa visão"

Keywords: prevalence myopia
choose health: food, fun, and fitness curriculum promotes positive behaviors in 3rd-5th graders compared to control

Conditions: Childhood Obesity; Nutrition Poor

Summary: the choose health: food, fun, and fitness (chfff) curriculum was evaluated in 3rd-5th graders, hypothesizing that change pre- to post- chfff education would be greater than in the same child during a delayed intervention control period.

choose health: food, fun, and fitness (chfff) is a cornell curriculum for 3rd-6th graders targeting behaviors to prevent obesity and chronic disease risk: fewer sweetened drinks; more vegetables, fruits, and whole grains; fewer high-fat and high-sugar foods; and active play. the 6 lessons use experiential learning, food preparation, active games, goal setting, and a family newsletter. it was evaluated in 561 expanded food and nutrition education (efnep) participants in 27 after-school and 28 in-school groups in 5 ny counties in 2015 using a quasi-experimental design, with a delayed-intervention control period prior to chfff. youth completed a self-reported survey 3 times: at initial enrollment, after a 6-week no-intervention control period, and after receiving the 6 weekly chfff lessons. outcome measures included dietary intake scores created based on factor analysis, and related precursors. it was hypothesized that change pre- to post- chfff education would be greater than in the same child during the delayed intervention control period. following chfff, youth improved significantly (p\<.05) compared to their control period in overall diet quality, vegetable intake, fruit intake, soda/fast food intake and choice, and the frequency with which they read nutrition facts labels, shared about healthy eating with their family, and tried a new food.

Eligibility criteria:
inclusion criteria: * participants in efnep nutrition education in schools and in after-school programs in 5 counties in ny during the 2014-2015 school year exclusion criteria: * younger than 3rd grade (n=3) * those with fewer than 4 lessons (n=9)

Keywords: nutrition education evaluation child diet efnep
comparison of recovery from general anesthesia in remimazolam with flumazenil vs. propofol

Conditions: Recovery

Summary: this prospective randomized trial aims to compare recovery time from discontinuation of remimazolam followed by flumazenil administration vs. propofol-based total intravenous anesthesia in patients undergoing breast cancer surgery.

adult patients undergoing breast cancer surgery are randomized to receive either remimazolam with flumazenil or propofol-based total intravenous anesthesia. when the surgery is ended, anesthetic agents are discontinued. the study's primary outcome is a comparison of the time to the first eye-opening response to the doctor's command from the discontinuation of anesthetic agents between the groups. secondary outcomes include the time from anesthetics off to extubation/discharge from operating room (or), bis score at eye-opening/extubation/discharge from or, the incidence of emergence agitation at or, the pat score, the modified aldrete score, modified oaa/s (observers assessment of alertness/sedation scale) after pacu administration. in addition, the investigators investigate postoperative pain score at 10/20/30 minutes and postoperative nausea and vomiting after pacu administration, korean version of quality of recovery-15 in postoperative 24 hours, postoperative pain score and postoperative nausea and vomiting, postoperative opioid consumption in postoperative 24 hours.

Eligibility criteria:
inclusion criteria: * adult patient, age \>19, scheduled for breast cancer surgery under general anesthesia exclusion criteria: * patients who are not alert before procedure * day surgery * bmi ≥35 * hemodynamicaly unstable patients before procedure * patients with history of neromuscular disease or drug use affecting neuromuscular function. * patients with history of adverse reaction of allergic reaction to study drugs * patients who are anticipated to be unable to remove supraglottic airway or endotracheal tube due to severe dyspnea or need for mechanical ventilatory support * use of sedatives (anxiolytics, psychoactive medication, antidepressants, hypnotics) within 24 h * known galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption * alcohol or drug dependence * organic brain disorder * patients with hypersensitive to beans or peanut * patients who refuse to participate

Keywords: recovery remimazolam flumazenil propofol safety
versatile ampification single-molecule detection in liquid biopsy

Conditions: Liquid Biopsy; Melanoma (Skin); Melanoma Stage III; Melanoma Stage IV

Summary: the trial will test a paradigm-changing in vitro diagnostic device for liquid biopsy enabling facile simultaneous detection of protein and nucleic acid analytes with sensitivity at single-molecule level, e.g. not achievable with any alternative technology. a novel affinity-mediated transport amplification (amt) method will be tested allowing for the multiplexed quantification of rare biomarkers circulating in blood. the versilib amt photonic biosensor will test two analytes: the known actionable dna mutation braf p.v600e, and a melanoma-restricted protein antigen. the results will be compared to digital pcr and elisa methods.


Eligibility criteria:
inclusion criteria: * age: ≥ 18 * pfs≤2 * patients willing to sign an informed consent; * confirmed (cytologically or histologically) cutaneous melanoma diagnosis * confirmed braf p. v600e tumor status * eligible for brafi/meki treatment or immune checkpoint blockade in either the adjuvant or advanced settings (the latter typically stages iii/iv, high risk). exclusion criteria: * life expectancy \<8 weeks * other clinical conditions preventing blood drawing compliance, as per physician's choice.

Keywords: brafv600e
assessment of autonomic regulation during the listening of mother heart beat in newborns

Conditions: Premature Birth

Summary: prematurity birth lead to an early breaking link with the in utero environment. a special attention is brought in the neonatal intensive care units to reduce noise and lighting surrounding aiming to protect the newborn. during the uterine life fetus benefits previously of several auditory stimulations by the maternal voice, the mother's heartbeat. after birth the auditory environment is dramatically modified. aim of this study is to submit to the newborn an audio recording of his mother's heart beat to analyze the comfort, stress and autonomic response. heart rate variability (hrv) analysis is a non-invasive tool able to consider autonomic nervous system activity. previous studies have shown that pleasant feelings are associated with an increase of high frequencies variations index (hfnu index) reflecting a prevalence of parasympathetic activity in the sympathetic-parasympathetic balance. this one can be simply assess by a monitor named nipς and can provide a comfort index by quantifying the parasympathetic tone.

the study will imply 40 preterm and term newborns hospitalized in neonatal intensive care units of the university hospital of saint-etienne (france).

Eligibility criteria:
inclusion criteria: * neonates between 28 and 40 weeks of gestational age (wga) * hospitalized in the neonatal intensive care units of the university hospital of saint-etienne (france) exclusion criteria: * respiratory or hemodynamic instability * uncontrolled sepsis * sedation on going * treatment known to modify the sympathetic or parasympathetic activity of the autonomic nervous system * congenital disease * congenital ear pathology

Keywords: premature maternal heart beat newborn heart rate variability autonomous nervous system
treatment of chronic itch in patients under arsenic exposure with naloxone

Conditions: Chronic Pruritus

Summary: the purpose of this study is to assess the efficacy and safety of sublingual naloxone in the treatment of chronic itch in patients under arsenic exposure.

this study aims to determine the efficacy and safety of sublingual naloxone in the treatment of chronic, refractory itch in patients under long-term arsenic exposure. in this study, 120 subjects with a moderate-to-severe symptom of itching (numeric rating scale, nrs≥3) will be recruited and randomly treated with either sublingual naloxone (60 subjects) or placebo (60 subjects). the severity of itching will be evaluated in the wash out phase, baseline, and one week after the treatment through reporting of subjective symptomatology (itch nrs) via the interview. quality of sleep measured by the pittsburgh sleep quality index (psqi) and dermatology life quality index (dlqi) will serve as the secondary outcome.

Eligibility criteria:
inclusion criteria: 1. aged 18 years or over and without diseases except arsenic-related pruritus 2. ability to study protocol and to give informed consent by himself/herself voluntarily 3. the number of male or female subjects is required more than 1/3 of the total number of subjects 4. numeric rating sscale≥3 at the baseline 5. subjects taking hormone-containing medications must be on a stable dose for 6 months prior to study start to avoid any confounding influence on sensory and pain perception exclusion criteria: 1. use of oral anti-inflammatory medications for 2 weeks prior to the study start. 2. use of oral anti-histamines for 2 weeks prior to the study start. 3. use of topical or oral anti-pruritic agents for 2 weeks prior to the study start. 4. use of oral neuromodulatory agents for 2 months prior to study start. 5. current use of chronic pain medications (including opioids, antidepressants and anti-epileptic drugs). 6. use of nicotine-containing products for the past 6 months prior to study start. 7. history of basic itchy dermatological diseases before such as eczema wich may influence the judgement of drug efficacy. 8. unstable thyroid function within the past 6 months prior to study start to exclude thyroid-related neuropathy. 9. known history of central or peripheral nervous system dysfunction. 10. history of acute hepatitis, chronic liver disease or end stage liver disease. 11. history of human immunodeficiency virus (hiv) or acquired immune deficiency syndrome. 12. history of neuropathy associated with chronic obstructive pulmonary disease, diabetes mellitus, documented exposure to organophosphates or heavy metals or polychlorinated biphenyls. 13. known nutritional deficiency (vitamin b12, vitamin d, iron or zinc) within 3 months prior to the study start. 14. use of illicit drugs within the past 6 months prior to study start. 15. lyme disease, porphyria, rheumatoid arthritis, hansen's disease (leprosy) or use of antineoplastic chemotherapeutic agents. 16. patients considered by researchers that are not suitable to the study.

Keywords: arsenic exposure naloxone placebo single-blind randomized trial
a real-world study of trifluridine/tipiracil containing regimen for the treatment of patients with mcrc (reflect study)

Conditions: Metastatic Colorectal Cancer

Summary: a real-world study of trifluridine/tipiracil containing regimen for the treatment of patients with metastatic colorectal cancer. a total of 200 patients planned to be enrolled.

this is a non-randomized, uncontrolled, multicenter real-world study. the total number of subjects is 200. the objective is to observe and evaluate the efficacy and safety of trifluridine/tipiracil alone or in combination with other therapies in the treatment of metastatic colorectal cancer in real-world environment. the primary endpoints is progression-free survival (pfs). secondary endpoints are overall survival (os), objective response rate(orr), disease control rate(dcr), progression-free survival (pfs), and quality of life (qol).

Eligibility criteria:
inclusion criteria: patients eligible for inclusion in this study have to fulfill all of the following criteria at enrollment: * male and female patients with ≥18 years of age; * patients with metastatic colorectal cancer confirmed by histopathology; * be willing to use reliable contraceptive methods and refrain from sperm donation throughout the study period and within 3 months after the last dose; * voluntarily join the study and provide written informed consent to participate in the study; * have traceable medical history during the treatment; * doctor believe the patients can benefit from the study. exclusion criteria: patients fulfilling any of the following criteria at enrollment are not eligible for inclusion in this study: * failure to sign informed consent; * patients with contraindications to trifluridine/tipiracil; * female subjects who have a positive pregnancy test or are breastfeeding; * any medical or psychological condition in the treating physician's opinion which may prevent the patient from the study participation.