Kornimate/medical-research-clean huggingface dataset:
an asian study to evaluate efficacy and safety of oral enzalutamide in progressive metastatic prostate cancer participants

Conditions: Progressive Metastatic Prostate Cancer

Summary: purpose of the study was to assess the effect of enzalutamide on time to prostate specific antigen (psa) progression as compared to placebo in chemotherapy naïve participants with progressive metastatic prostate cancer who have failed androgen deprivation therapy.

the study was a multinational phase 3, randomized, double-blind, placebo-controlled efficacy and safety study of oral enzalutamide (formerly mdv3100) in asymptomatic or mildly symptomatic participants with progressive metastatic prostate cancer who have disease progression despite androgen deprivation therapy. in order to join the study, participants could not have been previously treated with cytotoxic chemotherapy. approximately 30 chinese participants were allocated to the pharmacokinetic (pk) cohort. participants in the pk cohort were required to be hospitalized from day 1 before the randomization date to at least the completion of all the assessments planned on day 3. all participants in the pk cohort underwent blood sampling for the pk analysis. data reported in the results section was based on data cutoff dates of 20 sept 2015 for efficacy and safety data and 20 jan 2016 for pk outcome measures. the study completed double-blind period and is now in the open-label period.

Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features * ongoing androgen deprivation therapy with a gnrh analogue or bilateral orchiectomy * progressive disease despite androgen deprivation therapy as defined by rising psa levels or progressive soft tissue or bone disease * no prior treatment with cytotoxic chemotherapy * asymptomatic or mildly symptomatic from prostate cancer exclusion criteria: * severe concurrent disease, infection, or co-morbidity that, in the judgment of the investigator, would make the patient inappropriate for enrollment * known or suspected brain metastasis or active leptomeningeal disease * history of another malignancy within the previous 5 years other than curatively treated non-melanomatous skin cancer * history of seizure including febrile seizure or any condition that may predispose to seizure (e.g., prior stroke, brain arteriovenous malformation, head trauma with loss of consciousness requiring hospitalization).

Keywords: enzalutamide androgen receptor prostate cancer xtandi
effect of botox before modified lip repositioning repositioning only in relapse of the excessive gingival display within one year

Conditions: Excessive Gingival Display

Summary: the growing interest of patients in esthetic procedures, as well as the development of less invasive protocols in dentistry, has promoted the development of treatment plans that include stability, harmony, and function in orofacial rehabilitation. poor esthetics interfere with an individual's personal, social, and professional relationships and is an individual consideration that varies according to the patient's age, time, region, and culture concerning what is considered beautiful.

people are increasingly being inspired to get more corrective and cosmetic surgeries as an esthetic smile becomes a more fundamental component of what it means to be beautiful. there are several variables that affect how appealing and esthetic a smile is esthetic perception varies according to cultural, societal, environmental, and individual factors like experience and educational level previous studies have shown that a smile with less gingival display (gd) is viewed as more beautiful, with dental professionals being more critical of gingival presentation than laypeople according to research by several authors, the ideal gd ranges from 1 to 3 mm while many factors influence how pleasant a smile is seen, excessive gd (egd), sometimes referred to as a gummy smile, is regarded as a key factor in smile analysis and one of the main issues connected to an unsatisfactory dental smile. to reduce the relapse associated with repositioning surgery and to provide a lasting treatment without the need for reapplication, as in the case of the toxin, a combined treatment using the toxin preoperatively was considered.

Eligibility criteria:
inclusion criteria: * patients that is not satisfied with his smile having excessive gingival display * adult age ≥ 21 years. * systemically and periodontally healthy patients. * had gingival exposure greater than 3 mm when smiling * had a hyperactive upper lip with or without other causes of egd (lip displacement ≥ 9 mm) before botox \& ≥ 3mm after. * cooperative patients able and accept to come for follow up appointments. exclusion criteria: * • smoking * pregnancy or lactation * systemic diseases; neuromuscular,neurological, or psychological disorders or consumption of controlled medication * patients having medical condition or any drugs that could affect healing * patients with systemic condition that can't undergo minor oral surgery * patient allergic to botox or multiple allergic conditions * have history of previous botox injection * periodontal disease * excessive gingival display at rest * those who declined the informed consent or who did not consent to the risks described. * those who have deviate smile
endogenous opioid systems and symptom change in fibromyalgia

Conditions: Fibromyalgia

Summary: this study is designed to study brain mechanisms associated with symptoms and severity of fibromyalgia. this will be accomplished by relating results from pet scans to self-reported and objective measures of disease severity.

the purpose of this study is to examine µ-opioid receptor (µor)-mediated neurotransmission in patients diagnosed with persistent pain, fibromyalgia (fm), and its relationship with pain and affect measures. µor activation is expected to take place in the following brain regions: rostral and dorsal anterior cingulate (racc, dacc), orbitofrontal cortex (ofc), thalamus (tha), nucleus accumbens (nac), amygdala (amy), periaqueductal gray (pag). greater regional activation is expected to be associated with improvements in clinical pain ratings and affective state. the endogenous opioid system and µ-opioid receptors (µors) play a central role in the regulation of pain, the pathophysiology of chronic pain syndromes, mood and emotion; this system is dysregulated in persistent pain syndromes. a substantial body of literature addressing these mechanisms has been developed in our laboratory, including recent data on the cognitive and molecular mechanisms associated with reductions in pain, as well as trait personality and genetic predictors of emotional effects in the context of pain. eighty individuals who have been diagnosed with fm and who fit the inclusion and exclusion criteria will be enrolled in this 14-week protocol. an initial visit for informed consent procedures and baseline characterization will then be scheduled, as well as the visits for positron emission tomography (pet) and magnetic resonance imaging (mri) procedures. subjects will return for testing after 6 and 14 weeks. volunteers will undergo imaging with structural and functional mri and pet with \[11c\]carfentanil to determine baseline µor non-displaceable binding potential (bpnd) and changes in those bpnd measures coinciding with symptom severity at the time of scanning.

Eligibility criteria:
inclusion criteria: * have met american college of rheumatology (acr) criteria for fibromyalgia for at least 1 year; * willing to limit introduction of new treatments during the study; * use of sleep aids no more than twice per week * 18-55 years of age * right handed * capable of providing written informed consent exclusion criteria: * concurrent untreated medical illnesses, autoimmune, or inflammatory disease; * routine daily use of narcotic analgesics or history of substance abuse; * concurrent participation in other therapeutic trials; * pregnancy/ nursing; * ongoing psychiatric illness; * contraindications to pet or mri methods; * impairments that would prevent completion of the study protocol; * use of sleep aids at frequency of more that twice per week; * allergy to fentanyl
evaluating impact of systane ilux on dryness symptoms and wearing time in contact lens users

Conditions: Meibomian Gland Dysfunction; Dry Eye

Summary: to evaluate dry eye symptoms and contact lens wearing times after a single ilux treatment by evaluating change from baseline in osdi scores, subjective cldeq8 and cl wearing time questionnaires, and meibomian gland secretion scores.

a single arm, single center phase 4 study to evaluate impact of a single systane ilux mgd treatment device thermal pulsation treatment on contact lens wearing time and tolerability, meibomian gland secretion scores, and subjective dry eye symptoms in soft contact lens wearing subjects with meibomian gland dysfunction.

Eligibility criteria:
inclusion criteria: 1. eligible subjects must be 18 years of age or older 2. eligible subjects must be willing and able to provide an english language written informed consent form 3. be a current soft contact lens wearer for at least 2-18 hours a day 4-7 days a week but experiencing contact lens discomfort that limits the number of hours of comfortable contact lens wear. 4. have worn the same commercially available soft contact lens (material, base curve, diameter) for the previous 90 days 5. have new contact lens to wear starting the first day after ilux treatment 6. have an osdi score greater than ≥ 12 7. have a cldeq8 score ≥ 12 8. have a minimum meibomian gland expression score ≤ 12 (using mgd scoring system: apply pressure with korb expressor to 15 glands of lower lid (5 nasal, 5 central, 5 temporal): each gland will be scored from 0 to 3 (0 = no secretion, 1 = inspissated, 2 = cloudy, 3 = clear liquid), sum of score from each gland with equal total score, total score will range from 0-45. 9. be able and willing to follow instructions and participate in all trial assessments and visits 10. eligible subjects must be fully vaccinated against covid-19 exclusion criteria: 1. have any clinically significant slit-lamp findings at visit 1 that in the opinion of the investigator may interfere with trial parameters 2. have abnormal lid anatomy eg. entropion, ectropion or active lid lesion eg. hordeolum, chalazion that may interfere with administering ilux treatment 3. had lipiflow, ilux, tear care or manual meibomian gland expression in the last 30 days 4. be a woman who is pregnant, nursing, or planning a pregnancy 5. had ocular surgery within the last 90 days 6. have used topical cyclosporine, lifitegrast, topical or facial steroids, serum tears, or oral doxycycline or tetracycline within the last 30 days before visit 1 7. had intense pulsed light (ipl) treatment within last 30 days 8. have active ocular infection or inflammation 9. be a current wearer of extended wear contact lenses

Keywords: dry eye disease meibomian gland dysfunction ilux thermal pulsation contact lens
influence of two paraffin wax chewing gums of different consistency on the stimulated saliva flow rate

Conditions: Xerostomia

Summary: the study examines two different chewing gums with regard to consistency and its influence on the result of sialometry

the examination (sialometry) is performed on healthy volunteers. the volunteers must chew on a paraffin gum for seven minutes. after each minute, the amount of secreted saliva is spat into a designated cup and evaluated. this test is performed with aurosan chewing gum and later with gc europe chewing gum.

Eligibility criteria:
inclusion criteria: * healthy volunteers * non-smoker * no medication exclusion criteria: * physical or mental illnesses * smokers * regular medication intake * pregnant women * dementia or persons who are unable to judge or persons with guardianship * minor test persons

Keywords: paraffin chewing gum sialometry salivary flow rate mouth dryness
perioperative immunonutrition intervention and oral decontamination in elderly surgical patients

Conditions: Postoperative Complications

Summary: elderly patients are vulnerable to postoperative complications. preoperative malnutrition and poor oral hygiene are risk factors for postoperative complications especially pulmonary complications. this study aims to investigate the feasibility and efficacy of perioperative oral decontamination and immunonutrition supplement on reducing postoperative complications in elderly surgical patients.

this study is a prospective, single center, two-by-two factorial randomized controlled trial to evaluate the feasibility and efficacy of perioperative oral chlorhexidine decontamination and immunonutrition supplementation on postoperative complications in elderly surgical patients. patients aged 65 years and older who are scheduled for elective non-cardiac surgeries will be recruited and randomized into four groups in 1:1:1:1 ratio (oral decontamination vs routine oral care with/without immunonutrition supplementation).

Eligibility criteria:
inclusion criteria: 1. age≥65 years; 2. undergoing non-cardiac surgery (expected duration \>2 hours); 3. scheduled for general anesthesia and endotracheal intubation; 4. asa classification i-iv; 5. with intermediate to high risk of respiratory complications assessed by ariscat score (assess respiratory risk in surgical patients in catalonia); 6. inform consent obtained exclusion criteria: 1. emergency surgery; 2. preoperative pneumonia; 3. allergic to chlorhexidine; 4. severe hepatic/renal dysfunction, incapable of oral feeding, with autoimmune diseases, taking immunosuppressant or immunoregulation medications, or with other contraindication to immunonutrition supplementation; 5. expected intervention of immunonutrition\<3 days.
gsk618334 repeat dose study

Conditions: Substance Dependence

Summary: the proposed study will evaluate the safety, tolerability, pharmacokinetics (pk) and pharmacodynamics of repeated oral doses of gsk618334 in healthy male and female volunteers.

gsk618334 strongly binds to dopamine type 3 receptors in the human brain and is being developed as an innovative treatment for substance dependence. this study will evaluate the safety, tolerability, blood concentrations and effect following repeated oral doses of gsk618334 in healthy male and female volunteers. the effect of food on a single oral dose of gsk618334 will also be evaluated. another portion of this study will investigate dopamine type 3 receptor binding in the human brain by pet scan before and after repeated doses of gsk618334.

Eligibility criteria:
inclusion criteria: * healthy males and females between the ages of 18-50 years old * male and female subjects must agree to use protocol specified contraceptive methods. * male subjects only in pet parts of the study. * capable of providing written informed consent. exclusion criteria: * a positive test for hepatitis b or hepatitis c within 3 months of screening. * current or chronic history of liver disease, or known liver/bile/gallbladder abnormalities. * personal or family history of heart disease (such as irregular heart beats, a history of sudden unexplained death in a first degree relative, or unexplained fainting). * screening ecg parameters outside the protocol specified parameters. * pulse rate \ 100 bpm or a systolic blood pressure \>140 or \ 90 or \<50 mmhg at screening and/or baseline. * pregnant or lactating females. * exposure to more than four new chemical entities within 12 months prior to the first dosing day. * where participation in the study would result in donation of blood or blood products in excess of 500 ml within a 56 day period. * previous inclusion in a research and/or medical protocol involving nuclear medicine, pet or radiological investigations with significant radiation burden. * significant suicidal risk.

Keywords: compulsive discorders addiction
therapy in stable coronary artery disease patients according to clinical guidelines (align)

Conditions: Stable Ischemic Heart Disease

Summary: the aim of this prospective cohort study is to assess the quality of therapy in patients with stable ischemic heart disease (ihd) who had never applied for specialized medical care for the last 3 years and try to accord their treatment with current clinical guidelines.

the purpose of this study is to assess the quality of therapy in patients having come for the first time consultation to the specialized cardiology department of the scientific research centre within the profile registry and to try to correct therapy according to current clinical guidelines paying particular attention to reaching target blood pressure (bp), low-density lipoprotein cholesterol (ldl-c), glycosylated haemoglobin - hba1c (in patients with diabetes mellitus) levels, improving exercise tolerance and quality of life. the first visit (v0) is an inclusion in the study. during this visit, an attempt to correct or start (if it had not been started before) antiplatelet, hypolipidemic, antihypertensive and antianginal therapy will be made. the second visit (v1) is planned for each patient three months after the first visit (v0). during the second visit number of patients who reached target levels of bp, ldl-c, frequency of angina attacks will be assessed. if necessary, correction of therapy will also be made. the third visit (v2) is planned for each patient one year after the first visit (v0). during the third visit reaching target bp, ldl-c levels, frequency of angina attacks will be assessed. if necessary, therapy correction will be recommended. the last visit - telephone contact with patients - is expected in 2 years after the first visit. during that visit it is planned to assess life status, complications and current medical treatment.

Eligibility criteria:
inclusion criteria: all patients with documented ihd having consequentially come for the first time for consultation to the specialized cardiology department of the scientific research center from december 31, 2017 to december 31, 2022. documented ihd: 1. positive results of the angina questionnaire (typical angina) 2. positive exercise electrocardiography or stress echocardiography, plus one of the following criteria: * ischemia documented by scintigraphy study * invasive coronary angiography data (stenosis of at least 75% in at least one main coronary artery) * previous coronary revascularization (percutaneous coronary intervention (pci), coronary artery bypass graft surgery (cabg)) * previous myocardial infarction * patients who had elective pci or cabg exclusion criteria: * patients with acute ihd (less than 30 days since the last ischemic event with or without invasive procedures for the treatment of the event) * patients' refuse to follow the study's graphic of doctors' visits

Keywords: quality of therapy current clinical guidelines
new strategies of genetic study of patients with oculocutaneous albinism

Conditions: Oculocutaneous Albinism; Mutation

Summary: the oculocutaneous albinism is an autosomal recessive condition associated with mutations in 4 genes. in 20% of patients no mutation is identified. the optimization of genetic analysis methods and the search for new genes involved will help improve the diagnosis in these patients.

the oculocutaneous albinism is an autosomal recessive condition associated with mutations in 4 genes. in 20% of patients no mutation is identified. the optimization of genetic analysis methods and the search for new genes involved will help improve the diagnosis in these patients. .

Eligibility criteria:
inclusion criteria: -oculocutaneous albinism (diagnosis validated by a clinician at the initial genetic consultation and did not show mutations of the tyr, oca2, tyrp1, slc45a2 genes) exclusion criteria: none

Keywords: cgh array chip homozygosity mapping
a study of the inflammatory pathways associated with chronic obstructive pulmonary disease exacerbations

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to observe how the inflammatory pathways differ in subjects with chronic obstructive pulmonary disease (copd) during an acute exacerbation of copd (aecopd).

this is an observational study in adult male and female subjects with copd to collect blood, endobronchial tissues and bal to investigate the inflammatory genes/pathways associated with aecopd at the time of exacerbation (ie, active disease) and at 6 weeks later (ie, stable disease).

Eligibility criteria:
inclusion criteria: * physician-diagnosed acute exacerbations of chronic obstructive pulmonary disease * current or ex-smoker with a tobacco history of 15 or more pack years * females of childbearing potential must use birth control for the duration of the study. exclusion criteria: * evidence or history of clinically significant disease * subjects with asthma * subjects taking anti-leukotriene medications

Keywords: chronic obstructive pulmonary disease copd acute exacerbation of copd aecopd
study of codivir in patients with covid-19

Conditions: Covid19

Summary: this is an open-label study to evaluate the safety and preliminary efficacy of codivir in 12 mild or moderate covid-19 patients and onset of symptoms within 72h prior to their inclusion. treatment will begin in the hospital, participants will be discharged at day 4 and continue the treatment up to day 10 at home and followed up to day 28.

eligible participants who agree to participate will be submitted to safety assessments, an rt-pcr and a quick test for covid-19. everyone will receive the treatments indicated for their case, except for other investigational medications. codivir will be administered in addition to these treatments at a dose of 20 mg sc twice daily for 10 days. participants will remain hospitalized for the first 3 days. if they have progressed well, they will continue the treatment up to day 10 at home, receiving a nurse's home visit twice a day to administer codivir and collect vital signs. participants will be followed up to day 28 by telemedicine. a doctor will call them periodically to monitor the clinical evolution, collect adverse events, concomitant medication and instruct the participants. in case of unfavorable evolution, the participants will remain hospitalized receiving the appropriate care. the investigator will decide whether or not the investigational medication will continue, considering the participant's health and well-being.

Eligibility criteria:
inclusion criteria: 1. age between 18 and 60 years; 2. male or female; 3. sars-cov-2 infection indicated by rapid test and confirmed by rt-pcr. 4. mild or moderate covid-19: * the oxygen saturation in room air \>93%; * \<30 breaths per minute; 5. no signs of hemodynamic decompensation. 6. absence of pregnancy in women of childbearing age. 7. able to understand and comply with the requirements of the protocol. 8. consent to participate exclusion criteria: 1. participants in need of o2 supplementation by catheter or mask, invasive mechanical ventilation, or vasopressors. 2. onset of symptoms or rapid test or positive rt-pcr for more than 72 hours of inclusion. 3. participants in use or expected to use within 24 hours prior to the inclusion of drugs that are under clinical investigation as a therapeutic option for the treatment of covid-19 (eg hydroxychloroquine, chloroquine, ivermectin, nitazoxanide, among others) during the study period; 4. body mass index less than 19.9 or greater than 35; 5. comorbidities such as: other serious infections, active malignancies, autoimmune diseases, liver, kidney or heart failure; another systemic disease and / or laboratory abnormality, which, in the investigator's opinion, prevent the patient from participating in the study; 6. concomitant hiv, hbv or hcv infection. 7. pregnancy or lactation; 8. participation in another clinical trial in the 12 months preceding inclusion; 9. anti-covid-19 vaccination at any time; 10. vaccination for any other infection in the 4 weeks prior to inclusion; 11. any condition that increases the risk of participating in the study, in the opinion of the investigator.

Keywords: corona coronavirus covid-19 sars-cov-2