Kornimate/medical-research-clean huggingface dataset:
added benefits of lachrymal substitute gel during the night in patients with moderate to severe dry eye syndrome

Conditions: Dry Eye Syndromes

Summary: dry eye syndrome is a highly prevalent ocular disease with an increasing incidence in the elderly population. topically administered lubricants are the basis for treatment of this disease. relief of symptoms in patients with moderate to severe dry eye disease is usually reached by the use of artificial tears during the day. nighttime relief is often achieved by substances known to be more adhesive to the ocular surface, such as gels.


Eligibility criteria:
inclusion criteria: 1. men and women aged over 18 years 2. signed and dated written informed consent. 3. history of dry eye syndrome for at least 3 months 4. tear break up time (but) ≤ 10 seconds or schirmer i test ≤ 5 mm and ≥ 2mm 5. osdi ≥ 22 6. normal ophthalmic findings except dry eye syndrome 7. no administration of topical lubricants 24 hours before the screening examination exclusion criteria: 1. presence of an ocular pathology judged by the investigator as incompatible with the study. 2. any other clinical relevant ocular abnormality except des. 3. history of allergy, known hypersensitivity to one of the components: the administered medical device product, fluorescein or lissamine green 4. history of known clinically relevant allergy 5. medical or surgical history judged by the investigator to be incompatible with the study participation (hepatic or renal insufficiency; all chronic severe organic disease: metabolic, endocrine, neoplastic, hematological disease; severe psychiatric illness, etc.). 6. history of a recent acute illness with a recovery period within the 2 weeks before the inclusion visit (day 0). 7. pregnancy, lactation. 8. pre-menopausal woman who is not using a reliable birth control method (oral contraceptives or coil) or is not surgically sterilized. 9. participation in any high-speed or water-sports during the study without ocular protection (goggles or glasses). 10. subject unable to understand the study instructions or unlikely to comply with the study schedule and treatment. 11. participation in another clinical study in the 4 weeks before the start of the present study or at the same time as the present study.
estimating the global need for palliative care for children

Conditions: Cancer; Congenital Anomalies; Cardiovascular Disease; HIV

Summary: a cross-sectional analysis of prevalence data from a stratified sample of 23 countries used to estimate the global need for palliative care for children aged 0-19 years. prevalence data, from the institute for health metrics and evaluation, was for 12 major diagnostic groups needing children's palliative care according to who and unicef guidelines.

there is growing awareness that there are major gaps in access to children's palliative care (cpc) worldwide. adults have a greater likelihood of receiving palliative care than children. growing access to treatment services, and extended periods of wellness have led to some changes in the nature of the palliative care services required. children are more resilient and more likely to require cpc for longer periods than adults. it is against this background that unicef and the international children's palliative care network (icpcn), in collaboration with national palliative care associations, began a joint analysis to develop methods to assess critical needs and gaps in cpc. the initial assessment, conducted in kenya, south africa and zimbabwe, aimed to analyse existing secondary data on palliative care to estimate the palliative care need amongst children and explore key gaps in the response with service providers. a report on this research, the methods used, and the results for south africa was published in 2014. there is a lack of information regarding the actual need for palliative care for children, and assessment is a complicated process, due to uncertainty about the patient population and the nature of palliative care for children. although there have been some studies focusing on the status of cpc in sub-saharan africa and the united kingdom, there are differences in the scope and approach to the present study. a systematic review of the provision of cpc around the world, noted that over 65% of countries have no recognised cpc service provision, and concluded that service provision for cpc is not meeting the need in the majority of the world. generally, studies estimating need for palliative care for children are based on mortality statistics for chronic, incurable illnesses. estimates focused on end-of-life care, as in the global atlas of palliative care at the end of life do not account for the children that need palliative care well before the last year of life and underestimate the need. the world health organization defines palliative care for children as a special, albeit closely related field to adult palliative care. an effort to define the many diseases and conditions requiring cpc a directory was published in 2013 with 376 potential diagnostic labels though the majority of deaths were from a small number.

Eligibility criteria:
inclusion criteria: * have one of the conditions above exclusion criteria: * greater than 19 years of age

Keywords: prevalence epidemiology palliative care pediatric
a dose-finding study of inhaled oligog vs placebo in patients with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: randomized, double blind, placebo controlled study. the study has two parts: dose-finding part, followed by longer term follow-up (6 months)

part 1: randomized, double blind, placebo controlled dose-finding. patients will be assigned to 1 of 3 doses oligog, or to placebo, on top of standard of care. patients will be treated for 12 weeks, followed by 4 weeks washout.the primary endpoint is relative change in % predicted fev1. secondary endpoints include additional spirometry parameters, exacerbation rate, quality of life, sputum rheology and microbiology, safety laboratory tests and adverse event reporting. part 2: randomized double-blind 6 -month study, for longer term follow-up of the dose identified in part 1. new patients will be recruited in part 2, in addition to patients who received placebo in part 1. in addition to the endpoints studied in part 1, part 2 will include lung clearance index (lci), chest imaging by mri or ct, and pharmaco-economic parameters.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of cf * fev1 at screening \>40 and \< 90% of predicted normal * history of pa infection in last 12 m * history of antibiotic treatment due tp pa infection (not for eradication) during last 12 m * concomitant inhaled tobramycin, colistin, aztreonam, or levoflaxin (cycled or continuous) * stable cf disease * willing to remain on stable cf medication (standard of care) * women of child-bearing potential must habe negative urine pregnany test * males \& females must use acceptable contraception * capable of inhaling dry powder * willing to sign informed consent * willing and able to follow study procedures exclusion criteria: * use of hypertonic saline \> twice daily * clinically significant abnormal lab findings, except crp. in case of high ggt values, case will be discussed by experts before deciding * history of comorbidity that may distort results or cause additional risk * pulmonary exacerbation within 28 days prior to randomisation * change in cf therapy within 28 days prior to randomisation * burkholderia spp. finding within 12 m prior to screening * pregnant or breast feeding females * history of allergic reactions to imp ingredients, incl milk protein * inability to perform lung function tests according to ats/ ers criteria * uncontrolled or unstable diseases that might limit compliance * history of, or planned organ transplantation * allergic abpa in the last 12 months prior to the screening visit * requirement for continuous oxygen supplementation * current participation in another clinical study * medical condition, other than cfwhich exposes the patient to an unacceptably high risk * concurrent mlignant disease, except bcc and cervical neoplasia * clinically significant alcohol or drug abuse

Keywords: oligosaccharide
a comparison of clinical outcomes of warmed embryo vitrified at 2pn stage and fresh embryo transfers

Conditions: Infertility, Female; Reproductive Disorder

Summary: the aim of this study was to compare the clinical outcomes between fresh embryo and frozen embryo transfer in in vitro fertilization (ivf). all frozen embryo was vitrified at pronuclear stage (2pn) and cultured to cleavage embryos for transfer. this is a retrospective study. all ivf cycles were included in this study and further divided into fresh and frozen embryo transfer groups. the collection data including: stimulation protocols, medicines, blood test results, pregnancy test and all clinical data. the primary outcome is pregnancy rate and secondary outcome is implantation rate.

study design study progress: stage 1: collection of all data from frozen embryo transfer and fresh embryo transfer groups. stage 2: selection data and check the delivery outcomes stage 3: analysis data and presentation. including criteria: all patients who underwent ivf. excluding criteria: no. statistics analysis: chi-test, t-test assessment point: primary endpoint: pregnancy rate secondary endpoint: implantation rate withdraw criteria: not application. treatments: not application. collection number: 500 patients. scheduled trial period: 2017.05.01\~2018.04.30 expected research results: the implantation rate in frozen embryo transfer group which vitrified at 2pn stage is higher than fresh embryo transfer. the pregnancy rate in frozen embryo transfer group which vitrified at 2pn stage is higher than fresh embryo transfer. this study is only data analysis, no additional collection of samples. this study does not involve vulnerable groups.

Eligibility criteria:
inclusion criteria: * all patients with in vitro fertilization protocols exclusion criteria: * none
appropriateness of angioplasty in patients with chronic coronary syndromes

Conditions: Coronary Artery Disease; Angina Pectoris

Summary: percutaneous coronary intervention (pci) has dramatically changed the treatment of obstructive coronary artery disease patients. pci is indicated in patients with chronic coronary syndrome (ccs) symptoms unresponsive to optimized medical therapy. the american college of cardiology foundation and partners developed in 2009 - and updated them in may 2017 - the appropriateness criteria for pci to support the rational use of pci in chronic patients and to provide patients with high-quality cardiovascular care. since then, these criteria have been applied to guide physicians and serve as metrics of the quality of care based on the best available scientific evidence. countries like the united states and japan already have robust studies on the topic with important repercussions on clinical practice. in brazil, to date, there are no studies on the adequacy of pcis in patients with ccs.

percutaneous coronary intervention (pci) has dramatically changed the treatment of obstructive coronary artery disease patients. pci is indicated in patients with chronic coronary syndrome (ccs) symptoms unresponsive to optimized medical therapy. the american college of cardiology foundation and partners developed in 2009 - and updated them in may 2017 - the appropriateness criteria for pci to support the rational use of pci in chronic patients and to provide patients with high-quality cardiovascular care. since then, these criteria have been applied to guide physicians and serve as metrics of the quality of care based on the best available scientific evidence. countries like the united states and japan already have robust studies on the topic with important repercussions on clinical practice. in brazil, to date, there are no studies on the adequacy of pcis in patients with ccs. the primary goal of the right-pci study is to determine the rate of pci indications categorized as appropriate, possibly appropriate, or rarely appropriate in patients with ccs undergoing elective pci based on criteria established in medical literature at a cardiology reference university hospital. to achieve this objective, we plan to analyze approximately 2,500 consecutive angioplasties performed between 2017 and 2020.

Eligibility criteria:
inclusion criteria: * all patients within the age range who underwent elective pci defined as a procedure indicated in an outpatient scenario or an inpatient in a non-acute setting when the heart team was called to evaluate the patient and agreed with the indication for pci exclusion criteria: * history of acute coronary syndrome \< 30 days of the referral for pci

Keywords: coronary artery disease angina pectoris angioplasty appropriateness prognosis treatment
passive versus active educational interventions for melanoma recognition

Conditions: Educational Problems; Melanoma (Skin)

Summary: this study evaluates the efficacy of a passive versus an active educational intervention in increasing the ability of laypersons at low risk for melanoma development, in recognizing atypical skin melanocytic lesions. patients will be randomized (1:1) to receive the active or the passive intervention.

almost 60-70% of primary melanomas are first detected by patients or their relatives and not by physicians. then, it appears imperative to promote public campaigns in order to increase the awareness of laypersons on the most important rules for early identification of atypical skin lesions. the two main clinical rules are: 1. abcd rule. according to this rule, lesions characterized by one of more of the following features: asymmetry, irregular borders, color variegation and diameter larger than 6 mm, should be considered at risk for malignancy. in order to evaluate evolution, monitoring strategies have been implemented; 2. "ugly duckling" sign. according to this rule, a suspicious lesion tends to be different from the general nevus pattern of a given patient. the passive intervention will consist in the administration of a booklet containing the explanation of this two previous clinical rules for early detection of atypical melanocytic lesions. in the active intervention a standardized explanation will be given to the patient by a dermatologist, together with the administration of the booklet. efficacy will be evaluated through the completion of a specific test before, immediately after and after one month the administration of the educational intervention.

Eligibility criteria:
inclusion criteria: * no personal or family history for melanoma; * first visit for skin examination exclusion criteria: * patients referring to know and to be already confident in the use of at least one of the tested rules.

Keywords: educational intervention melanoma clinical trial
chronic infections on articular prostheses with c. acnes diagnosed by specific pcr

Conditions: Bone and Joint Infection

Summary: osteaoarticular infection due to c. acnes are known to be of late onset, causing chronic infection possibly pauci-symptomatic. osteaoarticular infection due to c. acnes represents a diagnostic challenge, since c. acnes is slow and difficult to grow, and can also be considered a contaminant.a 16s universal pcr bacteriological diagnosis has been proposed but is lacking of sensitivity. a specific c. acnes pcr was developed in 2010, but is not used routinely.


Eligibility criteria:
inclusion criteria: * patients having had infection prothesis vith c. acnes identified by pcr exclusion criteria: * none

Keywords: bone and joint infection propionibacterium acnes cutibacterium acnes
the effect of intraoperative ephedrine use on the incidence of hypothermia after major surgery

Conditions: Ephedrine Usage and Hypothermia Incidence; Effects of Ephedrine on Thermogulation

Summary: intraoperative hypothermia is a common and potentially severe complication during major surgical procedures. the consequences of intraoperative hypothermia can be far-reaching, affecting patient outcomes, recovery times, and overall healthcare costs. therefore, strategies aimed at preventing hypothermia are of paramount importance in modern surgical practice. however, despite all the measures taken, some patients may still become hypothermic at the end of surgery. understanding these factors can enhance the quality of daily practice. medications used intraoperatively can decrease the threshold for vasoconstriction, and some of them have been reported to influence thermoregulation. for example, ephedrine is a sympathomimetic amine used to maintain hemodynamic stability, but there is a report about its thermogenic effect. one study found that patients who received an intraoperative infusion of ephedrine had a significantly lower decrease in core temperature and these patients had a more stable hemodynamic profile. it was employed in obese patients for its thermogenic and appetite-suppressing effects until its adverse effects prevented its use. ephedrine has an unintended yet significant effect on body temperature regulation, which has raised questions about its role in contributing to the incidence of hypothermia in the postoperative period. the purpose of this study is to investigate the potential relationship between the intraoperative use of ephedrine and the incidence of hypothermia following major surgery.

this study aims to investigate the potential relationship between the intraoperative use of ephedrine and the incidence of hypothermia following major surgery. the primary goal is to determine the effect of intraoperative ephedrine use on the incidence of hypothermia after major surgery. the secondary goal is to identify patient characteristics associated with an increased risk of hypothermia despite all measures taken. the results of this study could have important implications for the quality of care for patients undergoing major surgery.

Eligibility criteria:
inclusion criteria: * all adult patients (age 18 years) who received ephedrine during general anesthesia undergoing major surgical procedures exclusion criteria: * patients undergoing minor surgical procedures * patients scheduled for day surgeries * patients patients (those under the age of 18) * patients with a history of thyroid disease * patients undergoing brain surgery * patients undergoing radiological interventions, * trauma patients * patients directly transferred from the intensive care unit to the operating room * patients with preoperative fever (either low or high) * patients who have received vasoactive agents within 24 hours before surgery * patients with sepsis and/or septic shock, or fever within a week before surgery * patients who have received vasoactive agents

Keywords: ephedrine usage intraoperative hypotension intraoperative hypothermia; major surgery
relationships between physical activity and different measures of fatigue in cancer survivors

Conditions: Cancer Remission

Summary: this is an investigation of possible relationships between daily physical activity (pa) and different measurements of fatigue in cancer survivors participating in a cancer exercise program.

this is an investigation of possible relationships between daily physical activity (pa) and different measurements of fatigue in cancer survivors participating in a cancer exercise program. results will inform exercise prescription and timing to best reduce fatigue, as well as methodology for measuring fatigue. participants will answer several daily questions on fatigue using a smartphone application during the 3 month exercise program and wear a pa monitor for 10 days during the first month and last month of the program.

Eligibility criteria:
inclusion criteria: * be an active participant in the bfitbwell cancer exercise program * criteria for this program include: * adult (\>= 18 years old) * being a patient seen at the university of colorado cancer center * currently receiving cancer therapy or be within 6 months of completing cancer therapy * have a signed physician clearance form to participate in an exercise program * have a smartphone (necessary for the ema assessments) * a score of 48 or less on the facit-fatigue (completed during the initial bfitbwell program assessment) * the minimally important difference of the facit-fatigue is 3 points, suggesting that a score of at most 48 indicates the presence of crf and allows for meaningful change in both directions. exclusion criteria: * none
the parkinson's disease neurogenebank at scripps clinic registry

Conditions: Parkinson's Disease

Summary: by creating a neurogenebank from parkinson's disease patients' blood donations we will ultimately be able to define genes for parkinson's disease and other neurological conditions.


Eligibility criteria:
inclusion criteria: * is age 30 years or older at the time of onset of parkinson's * has been diagnosed with idiopathic parkinson's disease by a scripps neurologist * is reliable, cooperative and willing to comply with all protocol-specified procedures and/or sub-study if consented or have legal representative/guardian willing to do so * able to understand and grant informed consent or have a legal representative/ guardian who is able to do so exclusion criteria: * patient has been previously enrolled in the parkinson's disease neurogenebank at scripps clinic registry * if a blood draw would be contraindicated for any reason * has a significant chronic medical condition (i.e. cva, hepatic encephalopathy) which, in the investigator's option, may interfere with the patient's optimal participation in the study * treatment with any investigational agents or devices within 30 days preceding enrollment in the study * has undergone ect within 90 days preceding enrollment in the study
a global, multicenter study to assess maternal, fetal and infant outcomes of exposure to palynziq® (pegvaliase) during pregnancy and breastfeeding

Conditions: Phenylketonuria, Maternal

Summary: this is a phase 4 observational study designed to assess the impact of palynziq ® (pegvaliase) treatment in pregnant women with pku and on their offspring who were exposed to pegvaliase at any time during pregnancy and breastfeeding.

women prescribed pegvaliase by their healthcare provider (hcp) who become pregnant during treatment may decide to participate in the study and enroll via a centralized call center model. upon consent, data will be collected from the patient's hcp(s) retrospectively for at least 3 months prior to last menstrual period (lmp). data will be collected during pregnancy and throughout the infant's first year of life. pegvaliase exposure will be recorded during pregnancy and breastfeeding including exposure during each trimester of pregnancy. duration of individual subject participation will be up to approximately 21 months.

Eligibility criteria:
inclusion criteria: * subject (or a legally authorized representative) consent obtained prior to enrollment. consent will be obtained in compliance with any country-specific regulations or requirements * confirmation of ongoing pregnancy. subjects with unknown outcomes will be classified as prospective pregnancies; subjects who have undergone prenatal testing (eg, targeted ultrasound, amniocentesis) regardless of findings will be classified as retrospective pregnancies * diagnosed with pku per local standard of care * documentation that the subject was treated with pegvaliase at any point starting from 2 weeks prior to the date of lmp * agrees to permit the investigator (ie, crp, cca, pi) to contact the subject's hcps (eg, pcp, pku-treating physician, ob, nurse, midwife) and the infant's hcp (eg, pediatrician, neonatologist) for medical information exclusion criteria: • currently participating in a biomarin sponsored interventional study of any investigational product, device, or procedure

Keywords: phase 4 observational maternal pregnancy outcomes exposure breastfeeding outcomes