Kornimate/medical-research-clean huggingface dataset:
impact of bed provision and sleep education

Conditions: Sleep Disturbance; Sleep Deprivation; Sleep; Insomnia

Summary: investigators will recruit up to 100 families (children aged 8-12 years and their primary caregivers) from the philadelphia-area beds for kids charity program, which provides beds, bedding, and sleep education to lower-socioeconomic status (ses) children. the primary objective of this randomized controlled trial is to determine whether bed provision combined with provider-delivered sleep health education can improve sleep in children participating in the beds for kids program.

insufficient and poor-quality sleep impacts more than half of school-aged children, and is associated with significant impairments in child neurocognitive, academic, behavioral, and physical health functioning. lower socioeconomic status (ses) children are at increased risk for poor sleep. compared to their higher-ses peers, lower-ses youth tend to obtain less sleep overall and experience worse sleep quality. many children of lower-ses also may live in noisy or high-violence neighborhoods and in overcrowded homes that lack a child bed or other designated child sleep space. these environmental factors may perpetuate ses-related health disparities in child sleep duration, quality, and poor sleep health behaviors (i.e., bedroom electronics). although there is a robust evidence-base for treating childhood sleep problems, there is a paucity of sleep intervention research focused on lower-ses children. beds for kids is a philadelphia-area program that is part of the larger volunteer organization, one house at a time, that provides lower-ses children with beds, bedding, and a sleep education brochure. to qualify for program participation, youth must be: (1) between the ages of 2 and 20 years, (2) living without an individual bed (e.g., sleeping on the floor, on a sofa, or crowded into one bed with family members), and (3) living in a household whose income is at or below 100 percent of the united states poverty threshold. the program accepts referrals from area social service agencies in the greater philadelphia area.

Eligibility criteria:
inclusion criteria: * caregiver participant is the parent or legal guardian of the child participant. * caregiver/legal guardian is 18 years of age. * child between 8 and 12 years of age. * english-speaking exclusion criteria: * caregiver is not parent or legal guardian of child participant. * presence of a diagnosed child neurodevelopmental (e.g., autism spectrum disorder, trisomy 21) or chronic medical condition (e.g., sickle cell disease, cancer) in which the disorder or treatment of the disorder impact sleep. * caregivers/guardians or subjects who, in the opinion of the investigator, may be non- compliant with study schedules or procedures.
effectiveness and safety of dalteparin in patients with acute coronary syndromes without st elevations in clinical practice

Conditions: Acute Coronary Syndrome

Summary: to collect data on safety and effectiveness of dalteparin in the management of non-st segment elevated acute coronary syndromes in nursing home patients who will be treated conservatively (without percutaneous corornary intervention \[pci\] or coronary artery bypass graft \[cabg\] within 48 hours).

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Eligibility criteria:
inclusion criteria: * male or female patients of 18 years or more presenting with chest pain will be potentially eligible for inclusion in the study if they satisfy the criteria for unstable coronary artery disease per the investigator's routine practice and have received at least one injection of fragmin (dalteparin sodium) as part of routine clinical practice and is expected to be treated conservatively (without pci or cabg within 48 hours) during the index hospitalization. * evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the study. exclusion criteria: * patients who are contraindicated to receive this agent per the local approved prescribing information.

Keywords: dalteparin non-st segment elevated acute coronary syndromes
thyroid cancer and photoacoustic imaging

Conditions: Thyroid Cancer; Thyroid Nodule

Summary: the aim of this study was to evaluate the usefulness of photoacoustic imaging in thyroid nodules. in addition, we would like to confirm the relationship between the results of photoacoustic imaging and histopathologic findings when thyroid nodules were diagnosed as thyroid cancer.


Eligibility criteria:
inclusion criteria: * all thyroid nodule identified as benign or as thyroid cancer exclusion criteria: * patient refuses to participate in the study or withdraws consent

Keywords: thyroid cancer photoacoustic imaging
tvmr with the innovalve system trial - pilot in georgia

Conditions: Mitral Valve Regurgitation (Degenerative or Functional)

Summary: study to evaluate the safety and performance of the innovalve mitral valve replacement system

the study is a multi-center, first-in-human, prospective, single pilot study to evaluate the safety and performance of the innovalve mitral valve replacement system

Eligibility criteria:
inclusion criteria: * clinically significant, symptomatic mitral regurgitation * high risk for open-heart surgery * meets anatomical criteria exclusion criteria: * unsuitable anatomy * patient is inoperable * ef\<25%
oxidative stress and cardiac arrest

Conditions: Heart Arrest

Summary: cardiac arrest is a major health problem reaching 375000 cases in europe each year. only 5 to 31 % survive after an out of hospital cardiac arrest (ohca). the main complication after ohca is the anoxic encephalopathy. recently mild hypothermia has shown a beneficial effect on survival. but the mechanisms underlying these therapy are not clear. cardiac arrest is an example of ischemia reperfusion of the entire body. and it is well demonstrated that reperfusion generates an oxidative stress. but it has never been shown in a clinical setting. the aim of the study is to evaluate oxidative stress after out of hospital cardiac arrest treated with mild hypothermia.


Eligibility criteria:
inclusion criteria: * out of hospital cardiac arrest exclusion criteria: * refractory shock * moribund patient * resuscitation \> 60 minutes * hypothermia \< 30 degrees

Keywords: heart arrest oxidative stress lactic acid outcome
study of pregabalin therapy for pain relief in subjects with post-herpetic neuralgia

Conditions: Post-Herpetic Neuralgia

Summary: the purpose of this study is to measure how rapidly pregabalin treatment can relieve pain in patients with post-herpetic neuralgia


Eligibility criteria:
inclusion criteria: * diagnosis of phn with pain present for at least three months after the healing of a herpes zoster skin lesion. * subjects must have completed the daily pain rating scale in the electronic diary at least 4 times during screening and have an average daily pain rating score of greater than or equl to 4 during the 7 +/- 3 days prior to randomization (visit 2). exclusion criteria: * history of neurolytic or neurosurgical therapy for phn. * presence of any severe pain associated with conditions other than phn that may confound the assessment or self-evaluation of the pain due to phn.
a global prospective observational study of women with fabry disease and their infants during pregnancy and breastfeeding

Conditions: Fabry Disease

Summary: this is a global prospective observational study of women with fabry disease and their infants during pregnancy and/or breastfeeding. the study will evaluate outcomes of pregnancy and/or breastfeeding in women and infants exposed to migalastat.

this is a global prospective observational study of women with fabry disease and their infants during pregnancy and/or breastfeeding. the study will evaluate outcomes of pregnancy and/or breastfeeding in women and infants exposed to migalastat. all pregnant women with fabry disease are eligible to enroll, an unexposed cohort potentially can be used for comparisons. cases will be reported voluntarily to the pregnancy coordinating center (pcc) from any country by healthcare providers (hcps), by patients and secondary contacts. the pcc will follow patients throughout their pregnancies and/or breastfeeding and infant through 1 year of age. there will be 2 cohorts enrolled in the study. cohort 1 will be pregnant and/or breastfeeding patients who have fabry disease, and have been exposed to at least 1 dose of migalastat during pregnancy and/or breastfeeding. cohort 2 will be pregnant and/or breastfeeding patients who have fabry disease, who were not exposed to migalastat during pregnancy and/or breastfeeding. this is an observational study, it will enroll patients and collect data as described in this protocol for a minimum of 10 years.

Eligibility criteria:
inclusion criteria: female patients meeting the following criteria will be eligible for study enrollment: 1. patients with fabry disease who are pregnant and/or breastfeeding, whether or not they are exposed to migalastat 2. able and willing to provide informed consent or assent, if applicable. 3. able and willing to provide hcp contact information. exclusion criteria: none

Keywords: migalastat fabry disease women with fabry disease
metal contamination after minimally invasive repair of pectus excavatum (mirpe)

Conditions: Congenital Funnel Chest

Summary: the purpose of this study is to determine whether there is a metal wear debris after minimally invasive repair of pectus excavatum and if there's a clinical relevance. our hypothesis is that the metal bar after minimally invasive repair of pectus excavatum leads to a locally and systemic immune reaction due to elevated metal contamination.


Eligibility criteria:
inclusion criteria: * mirpe exclusion criteria: * none
observational study of the use of pegloticase (krystexxa®) in refractory chronic gout

Conditions: Refractory Chronic Gout

Summary: the primary purpose of this study is to observe patients being treated with pegloticase in a standard healthcare setting in order to evaluate the frequency and severity of infusion reactions, anaphylaxis and immune complex related events. additionally, serious adverse events associated with pegloticase therapy will be identified.

this was a phase 4, multicenter, open-label, single-arm observational study of pegloticase 8 mg administered intravenously every 2 weeks in adult hyperuricemic patients with gout refractory to conventional therapy. study duration is approximately 63 weeks, including 51 weeks of treatment and 12 weeks of follow-up. the design of this study follows the fda-approved full prescribing information for the use of pegloticase and allows for capturing additional data related to the safety and efficacy of pegloticase within the standard healthcare setting.

Eligibility criteria:
inclusion criteria: * adults (age 18 years or more) with chronic gout refractory to conventional therapy, defined as patients who have failed to normalize sua and whose signs and symptoms are inadequately controlled with xanthine oxidase inhibitors at the maximum medically appropriate dose, or for whom these drugs are contraindicated. * patients who have made the decision, along with their treating physician, to begin treatment with krystexxa. * patients who are willing and able to give informed consent and adhere to visit/protocol schedules. exclusion criteria: * glucose-6-phosphate dehydrogenase (g6pd) deficiency * non-compensated congestive heart failure * pregnancy or breast feeding * prior treatment with pegloticase or another recombinant uricase * known allergy to urate oxidase * prior treatment or concomitant therapy with a polyethylene glycol (peg)-conjugated drug * recipient of an investigational drug within 4 weeks prior to study drug administration or plans to take an investigational agent during the study
comparison of efficacy of naproxen versus ibuprofen

Conditions: Pain, Postoperative

Summary: comparison between naproxen and ibuprofen in management of post operative endodontic pain was done.total 116 patients were selected and divided in to two groups.one group was given naproxen and other was given ibuprofen.

this randomized controlled trial was carried out in outpatient department of operative dentistry, fatima memorial hospital, lahore, pakistan and was completed in six months from september 2nd,2019 to february 25th,2020. sample size of 116 cases(58 in each group) of irreversible pulpitis was calculated with 80% power of test, 5% level of significance, p1(prevalence) for naproxen was 61.53% and p2 for ibuprofen is 38.46%. estimation of p (prevalence) as 90% is based on pilot study carried in our department. the patients were randomly allocated into two groups, a and b, by random number table. in both groups teeth were anaesthetized using 1.8ml of 2% lignocaine containing 1:100,000 epinephrine and isolated with rubber dam. an access cavity was prepared with round bur and pulpectomy was done using hand files. working length was determined using an electronic apex locator and confirmed with periapical radiograph. canals were prepared with step back technique. canals were then dried with paper points and the access cavities were restored temporarily with cavit(cavit3m espe).visual analogue scale for pain score was measured for both groups before initial endodontic procedure . group a was given (naproxen 550 mg b.d), while group b was given (ibuprofen 400mg b.d).post-operative pain was measured subjectively after 24 hours with standard visual analogue score (vas) scored on a 10 cm scale, with markings at every 1 cm anchored by the end points of "no pain" on the left and "worst pain" on the right. patient were asked to point the number most precisely describing the amount of pain he or she experienced after 24 hours. all this data was recorded in a specially designed proforma (attached).efficacy was labelled as per operational definitions. data was analyzed using spss version 20. for descriptive analysis, mean and standard deviation were reported for age, bmi and vas score, whereas frequency and percentages were calculated for categorical variables like gender and educational status. a chi square was used to determine the significance of the difference between the efficacy of naproxen and ibuprofen. data was stratified for age, gender, bmi and educational status .this comparison also included feelings of patients in terms of side effects. a p value 0.05 or less was taken as significant. post stratification chi-square was applied with p value ≤0.05 considered as significant.

Eligibility criteria:
inclusion criteria: * • age range 20-40 years * gender- either * teeth with acute irreversible pulpitis assessed by electric pulp tester lasting more than 30 seconds * one tooth per arch with no opposing tooth involved exclusion criteria: * patients who reported to have any systemic disease while taking history e.g. diabetes, hypertension * during pregnancy * history of taking analgesics 12 hours prior to treatment
effects of curcumin supplementation in patients with chronic kidney disease on peritoneal dialysis

Conditions: Chronic Kidney Diseases; Peritoneal Dialysis; Hemodialysis

Summary: the objective of this study is to assess whether supplementation with curcumin could modulate the intestinal microbiota, reducing levels of inflammatory markers of oxidative stress, uremic toxins and inflammasome, in patients with chronic kidney disease in peritoneal dialysis.

curcumin is a chemical compound of the curcuminoids class found in the root of curcuma (curcuma longa), and due to its potential antioxidant and anti-inflammatory, has been suggested as a nutritional strategy to reduce oxidative stress and inflammation present in several chronic diseases. although it is a promising therapy, there are no studies evaluating the effects of curcumin in patients with chronic kidney disease (ckd) in peritoneal dialysis (pd). the aim of this study is to evaluate the effect of curcumin supplementation on inflammatory markers and oxidative stress in patients with ckd in pd. methods: this is a longitudinal randomized clinical double-blind crossover study, with a washout period and placebo-controlled, where patients will be randomized into two groups: turmeric and placebo. after the 12-week supplementation period, a washout (12 weeks) will be performed for subsequent crossover of the patients. mononuclear cells will be extracted from whole blood and the expression of m ribonucleic acid from transcription factors (nrf2 and nf-kb), antioxidant enzymes (nqo1, ho-1), as well as nlrp3 inflammasome will be analyzed by real-time polymerase chain reaction and protein expression by western blotting. inflammatory cytokine levels will be assessed by elisa, also, plasma levels of tbars, routine laboratory parameters, as well as food intake and nutritional status.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of chronic kidney disease * peritoneal dialysis patients for more than 6 months * aged from 18 to 60 years * must be able to swallow tablets exclusion criteria: * patients pregnant * smokers * using antibiotics in the last 3 months * using antioxidant supplements in the last 3 months * usual intake of turmeric * usual intake autoimmune * clinical diagnosis of infectious diseases * clinical diagnosis of cancer * clinical diagnosis of aids

Keywords: chronic kidney disease peritoneal dialysis curcumin hemodialysis
development and feasibility testing of a lung cancer screening decision aid

Conditions: Lung Neoplasms

Summary: this study evaluates the feasibility and acceptability of lucas choices, a web-based decision aid designed to facilitate informed decision making about participation in lung cancer screening among individuals at high risk of lung cancer due to heavy cigarette smoking.

the proposed project will develop an innovative web-based decision aid (da) to improve decision making for lung cancer screening (lcs) among individuals at high risk for lung cancer due to cigarette smoking. recent national lung screening trial (nlst) data demonstrated a 20% relative reduction in lung cancer mortality for low dose computed tomography screening as compared to chest x-ray among individuals at high lung cancer risk. given that lung cancer is the leading cause of cancer death in the united states with an estimated 160,340 deaths predicted for 2012, the new data have reinvigorated interest in lcs. however, lcs carries substantial risks including a high false positive rate, over-diagnosis, adverse psychosocial consequences, and increased radiation exposure. further, it is unknown whether lcs would reduce lung cancer mortality among individuals who smoke but do not meet nlst eligibility criteria. therefore, there is currently no clear best choice for whether a given individual should be screened or not. decisions about participating in lcs should be well informed and consistent with individual preferences. however, previous data indicate that individuals who do undergo lcs rarely have a thorough understanding of the risks or benefits. to address this rapidly emerging public health challenge, this research has developed a web-based decision aid (da) to facilitate informed decision making regarding lcs in individuals at high risk for lung cancer (i.e., cigarette smokers), and will assess feasibility of da administration and proposed methods for conducting a future randomized clinical trial (rct) of da effectiveness. the content of the da will be based on the investigators previous studies exploring lcs decision making and other recent research. the specific aim of the currently proposed research are to conduct a feasibility trial of the da among individuals at high risk of lung cancer due to heavy cigarette smoking. investigators will recruit participants to assess feasibility of: 1) delivering the da intervention in a community setting, and 2) conducting research procedures and assessment tools as planned for a future rct.

Eligibility criteria:
inclusion criteria: * be at least 40 years of age * history of 20 or more pack years of smoking * ability to read and understand english * must have a personal phone * must have internet access exclusion criteria: * reporting or demonstrating significant psychological distress

Keywords: decision aid informed decision making shared decision making screening
visual training for improving intermittent exotropia visual function

Conditions: Intermittent Exotropia; Visual Functions

Summary: the goal of this clinical tral is to investigate that if vr/ar visual training can improve the visual function in children with intermittent exotropia. the main question it aims to answer is : does the vr/ar visual training can enhance stereoscopic vision function in children with intermittent exotropia. researchers will compare intervention group to control group to see if vr/ar visual training could enhance stereoscopic vision function in children with intermittent exotropia. participants will: the intervention group will receive 20 minutes of vr/ar visual training once a day for a period of one year. follow up check ups at the hospital every 3 months. keep a diary of the values of stereoscopic vision function and newcastle control score.


Eligibility criteria:
inclusion criteria: aged 6 to 14 years. intermittent exotropia meeting all of the following criteria: exodeviation at least 10δ at distance measured by the prism and alternate cover test, near deviation does not exceed distance deviation by more than 10δby prism and alternate cover test, mean distance newcastle control score (ncs)≥2 points (mean of 3 assessments during the examination). refractive error between -5.00 d \< spherical equivalents (ses) ≤ -1.00 d, astigmatism ≤1.50d, anisometropia ≤1.5d, best visual acuity in each eye of 1.0. not receiving any other form of strabismus or myopia treatment within 3 months. willing to follow the research plan and participate in the entire research process. participants and guardians agree to be randomly assigned and sign an informed consent form. exclusion criteria: vertical strabismus; diagnosed with other eye diseases or visual abnormalities such as strabismus, amblyopia, etc; existence of cognitive or learning disabilities that may affect the effectiveness of training; patients with neurological disorders; unable to cooperate with eye examination and follow-up work.

Keywords: visual training visual function intermittent exotropia