Kornimate/medical-research-clean huggingface dataset:
evaluation of the efficacy of oc-02 nasal spray on signs and symptoms of dry eye disease (the rainier study)

Conditions: Dry Eye Disease

Summary: the objective of this study is to evaluate the safety and effectiveness of oc-02 nasal spray compared to placebo on signs and symptoms of dry eye disease (ded).

this was a phase 2, multicenter, randomized, double-masked, placebo-controlled study designed to evaluate the safety and efficacy of oc-02 nasal spray in adult subjects with dry eye disease. approximately 45 subjects, at least 22 years of age, with a history of dry eye disease and meeting all other study eligibility criteria were planned to be randomized to receive an application of oc-02 or placebo twice daily (bid) for 4 weeks.

Eligibility criteria:
inclusion criteria: * have used and/or desired to use an artificial tear substitute for dry eye symptoms within 60 days prior to visit 1 exclusion criteria: * have had any intraocular surgery (such as cataract surgery), extraocular surgery (such as blepharoplasty) in either eye within three months or refractive surgery (e.g. laser epithelial keratomileusis, laser-assisted in-situ keratomileusis, photorefractive keratectomy or corneal implant) within twelve months of visit 1 * have a history or presence of any ocular disorder or condition in either eye that would, in the opinion of the investigator, likely interfere with the interpretation of the study results or participant safety such as significant corneal or conjunctival scarring; pterygium or nodular pinguecula; current ocular infection, conjunctivitis, or inflammation not associated with dry eye; anterior (epithelial) basement membrane corneal dystrophy or other clinically significant corneal dystrophy or degeneration; ocular herpetic infection; evidence of keratoconus; etc. blepharitis not requiring treatment and mild meibomian gland disease that are typically associated with dry eye disease are allowed. * have a systemic condition or disease not stabilized or judged by the investigator to be incompatible with participation in the study or with the lengthier assessments required by the study (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction or heart disease, etc.) * have a known hypersensitivity to any of the procedural agents or study drug components * have any condition or history that, in the opinion of the investigator, may interfere with study compliance, outcome measures, safety parameters, and/or the general medical condition of the subject
follow ups of parents with infants with cleft lip and palate

Conditions: Cleft Lip; Cleft Palate

Summary: in norway, 100-120 children are born with clp (1.9 per 1,000 live births) each year. parents of infants with clp need information and support, especially with feeding immediately after birth. these needs are often not met. the purpose of this study is to investigate the effect of systematic follow ups of parents with infants with clp performed by a special trained nurse. parental information needs, parental coping and stress and infant growth and feeding will be explored and compared to a control group receiving standard care. 26 parents (mothers and fathers) or more shall be included in each group according to specific criteria. the control should be examined first. both groups will answer questionnaires 3 times during the child's first year.


Eligibility criteria:
inclusion criteria: * parents of infants with cleft lip and palate (clp); cleft lip, cleft palate or cleft lip and palate * birthplace in south-east region of norway * scandinavian speaking parents exclusion criteria: * parents of infants with clp who are referred to the hospital after the first measure point * birthplace outside south-east region of norway * non-scandinavian speaking parents

Keywords: parents follow-up studies
clinical evaluation on ha coated dynamic hip screws for trochanteric femoral fractures

Conditions: Intertrochanteric Fractures

Summary: evaluated whether ha coated dynamic hip screws can improve fixation of the screw in trochanteric femoral fractures

randomised study to determine the effect of ha coating on the stability of dynamic hip screws used to stabilize femoral neck fractures. stability of the screw will be determined by rsa measurements. additionally the fracture stability will be evaluated by rsa measurements.

Eligibility criteria:
inclusion criteria: * patients with stable intertrochanteric femoral fractures (evans i, ii, iv) * able to speak danish * able to complete the postoperative controls * written consent exclusion criteria: * unable to follow standard hip fracture regime * were breastfeeding * pregnant * terminal disease * in need of open fracture reduction * in need of dhs plate with an angle different from 135 degrees * insertion of fewer than 3 tantalum beads in the femoral head (for rsa) * tad \>20mm in two dimensions in the first postoperative x-ray * fracture displacement \>20mm in two dimensions in the first postoperative x-ray

Keywords: stable fractures (evans i, ii, iv)
helping men adhere to sexual rehabilitation following prostate cancer surgery

Conditions: Prostate Cancer; Erectile Dysfunction

Summary: the purpose of this study is to test two different ways to help men with sexual rehabilitation.


Eligibility criteria:
inclusion criteria: * as per medical record, early stage prostate cancer (pathologic stage 1/2 with gleason score \</=8; or pathologic stage 3 with gleason score =/\< 7) * as per medical record, radical prostatectomy (rp) conducted either at mskcc or at another institution * as per medical record, ≤ 9 months post-rp * as per medical record, moderate erectile functioning pre-surgery (i.e., 15 or greater on the iief erectile function domain (efd) score, or graded their erections as a 1 or 2 on the standard 5 point urology erectile function scale, or have a score of 6 or greater on the 1-10 pre-surgery erectile function scale on the smrp assessment or have a total score of 15 or greater on items 2-7 on the prostrate quality of life survey: sexual domain) * as per self report or as per medical record starting penile injections as part of the erectile rehabilitation program at mskcc * in the judgment of the consenting professional able to communicate, comprehend, and complete questionnaires in english exclusion criteria: * both cavernous nerves fully resected as per surgery report (nerve sparing score of 8 in mskcc surgeon note), or documented in the progress note that the nerves were fully resected. * currently on or has a history of being an androgen deprivation therapy (adt) * has any indication of prostate-specific antigen (psa) * as per self report, specific injection phobia * in the judgment of the consenting professional is unable to provide informed consent and complete study sessions and assessment. * as per self report or as documented in the medical record, current untreated (e.g. no medication no therapy) major psychiatric disorder (schizophrenia, major depression). patients diagnosed with a major psychiatric disorder will be reviewed by the study pi to determine eligibility prior to consent.

Keywords: 15-317
bystander helping behaviour for myocardial infarction following first aid training

Conditions: Acute Myocardial Infarction

Summary: the objective of this study is to measure the effect of an innovative training programme on the help seeking behaviour and helping rates of bystanders in medical emergencies.

a systematic review on the effects of first aid training concluded that training must also include ways to overcome obstacles to bystander intervention. this could lead to better help and higher helping rates in medical emergencies. the objective of this paper is to measure the effect of an innovative training programme on the help seeking behaviour and helping rates of bystanders in medical emergencies. we chose to test the helping behaviour for acute myocardial infarction because it is an important cause of mortality and invalidity. while the victim is urgently in need of help, delay in seeking professional help is an important problem.

Eligibility criteria:
inclusion criteria: * course participants that are 18 years or older exclusion criteria: * course participants that are younger than 18 years * health care students * health care professionals

Keywords: first aid helping behaviour health education myocardial infarction emergencies
clonazepam in children status epilepticus

Conditions: Epilepticus Status

Summary: •background: intravenous clonazepam is the most widely used first-line benzodiazepine in europe for the initial management of status epilepticus in children. the guidelines of the "société de reanimation de langue francaise" (srlf) and the "société française de médecine d'urgence" (sfmu) published in 2018 recommend an initial loading dose of 0.015 mg / kg of clonazepam in this situation (maximum 1.5 mg). to our knowledge, there is no specific study of the efficacy of clonazepam according to the dose used. objective: to compare the effectiveness of the initial loading dose of clonazepam in children treated for status epilepticus •methods: monocentric retrospective study including children \< 16 years who have benefited from an initial loading dose of clonazepam in the context of status epilepticus treated at the montpellier university hospital between january 2016 and june 2019. the investigators collected data from medical records (clinic, treatment , evolution) and compared these according to the dosage of clonazepam used. •discussion: among the benzodiazepines used in the first-line treatment of pediatric status epileptic, lorazepam and midazolam are the most widely used drugs in the world. lorazepam is not so much used in europe because the injectable form is not available for a daily use. conversely, clonazepam is used in a large number of european countries but is rarely used in the united states due to the lack of an injectable form. about the tolerance of treatment, except overdose situations, clonazepam is a drug well tolerated in the pediatric populatin. the main side effects of clonazepam are respiratory depression and impaired alertness. to our knowledge, this study is the first to examine the efficacy depending on the initial loading dosage of clonazepam in children status epilepticus.


Eligibility criteria:
inclusion criteria: an individual must fulfill all of the following criteria in order to be eligible for study enrollment: * aged under 16 years * status epilepticus taken care of at the chu de montpellier exclusion criteria ● no loading dose of clonazepam
the effect of dexmedetomidine on emergence agitation in children undergoing a surgery under desflurane anesthesia

Conditions: Psychomotor Agitation

Summary: after genernal anesthesia using sevoflurane or desflurane, the investigators can observe many cases of agiation (over 80%) and despite of no report of long-term complication, agitation is a big issue in pacu for doctors and nurses. the investigators use dexmedetomidine for prevention of agiation of preschool aged children. the investigators expect single injection of dexmedetomidine lead to decrease postoperative agitation and pain without any complication like oculocardiac reflex requiring atopine for treatment.

there are four groups accoding to dosage of dexmedetomidine. dexmedetomidine 0.25 microg.kg(-1),(group d0.25), dexmedetomidine 0.5 microg.kg(-1),(group d0.5), dexmedetomidine 1 microg.kg(-1) (group d 1) and normal saline(group p) is administered ivs. for 10mins when we are inducing each patient.

Eligibility criteria:
inclusion criteria: * physical status classification of american society of anesthesiologist 1-2, * healthy, normal * 2-6 years old * elective operation exclusion criteria: * lack of consent * known adverse effects to dexmedetomidine, mental retardation * developmental delay, or neurological or psychiatric illness that may associate with agitation (cerebral palsy, seizure, etc) * no cardiac disease
evaluation of pericapsular nerve group block on positioning pain for spinal anesthesia in hip fracture patients

Conditions: Pain, Acute

Summary: the purpose of this study is to evaluate of analgesic effects of pericapsullar nerve group block which is performed preoperatively to assist positioning patients for performance of spinal anesthesia.


Eligibility criteria:
inclusion criteria: * hip fracture * aged between 35 and 90 years old exclusion criteria: * contraindications for spinal anesthesia and peng block * impaired cognition or dementia * multiple fractures * any previous analgesic administration during the last 12 hours

Keywords: hip fracture, postoperative analgesia, positioning pain
access to chiropractic care during the covid-19 healthcare emergency in spain

Conditions: Musculoskeletal Pain; Disability Physical; Psychological Distress

Summary: this is a pragmatic controlled clinical trial taking place in the first phase of covid-19 lockdown re-opening in spain. patients of 52 chiropractic clinics were invited to participate in a pseudo-random order (one out of every three contacted patients) as they were contacted to either schedule an appointment with their current chiropractor or not, depending on the clinic's and the patient's availability. patients would receive chiropractic in-person care (one or more than one visits) or no care at all, for a two-week period. according to the care received, they were assigned to one of three groups (receiving no care, receiving care once, and more than once). participants filled an online questionnaire with self-reported outcome-measures at the beginning of the two week period. a follow-up questionnaire was completed 14 days after.


Eligibility criteria:
inclusion criteria: * chiropractic patients active when lockdown was declared, over the age of 14 exclusion criteria: * new patients in the clinic, patients with no current pain at the time of the trial
combination chemotherapy plus radiation therapy in treating patients with primary cns lymphoma

Conditions: Lymphoma

Summary: rationale: drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. radiation therapy uses high-energy x-rays to damage tumor cells. combining radiation therapy with chemotherapy may kill more cancer cells. purpose: phase ii trial to study the effectiveness of methotrexate and cytarabine plus radiation therapy in treating patients who have primary cns lymphoma.

objectives: i. determine the efficacy of methotrexate and cytarabine chemotherapy in combination with whole-brain radiation therapy for patients with non-aids related primary central nervous system lymphoma. ii. assess the response rate and safety of this chemotherapy regimen. outline: patients receive the first course of chemotherapy as soon as possible after diagnosis and staging. methotrexate (mtx) iv is administered over 40-60 minutes on days 1 and 15. cytarabine (arac) is administered intrathecally on days 1 and 15. the second course of chemotherapy begins on day 29 or after bone marrow recovery. radiation therapy begins no later than 3 weeks after completing chemotherapy. patients are followed until death. projected accrual: a maximum of 50 patients will be accrued.

Eligibility criteria:
disease characteristics: histologically proven non-hodgkin's lymphoma of the central nervous system (cns) including leptomeninges and the spinal cord no burkitt's lymphoma or low grade t-cell lymphoma must have at least 1 measurable lesion no aids-related primary central nervous system lymphoma (pcnsl) no disease confined to the eye without other localization in the cns patient characteristics: age: 16 to 60 performance status: karnofsky 40-100% neurological functional status 0-3 life expectancy: not specified hematopoietic: not specified hepatic: no serious impairment of hepatic function renal: no serious impairment of renal function creatinine no greater than 1.5 mg/dl or creatinine clearance no less than 50 ml/min cardiovascular: no serious impairment of cardiac function other: hiv negative no congenital or acquired immunodeficiency syndrome no prior/concurrent systemic lymphoma no prior malignancy except: adequately treated non-melanoma skin cancer carcinoma in situ of the cervix uteri not pregnant no severe uncontrolled infection prior concurrent therapy: biologic therapy: no concurrent treatment with immunosuppressive drug chemotherapy: no prior chemotherapy endocrine therapy: corticosteroid use for less than 3 weeks allowed radiotherapy: not specified surgery: no prior organ transplantation

Keywords: primary central nervous system non-hodgkin lymphoma
methods for nutritional assessment in cirrhosis

Conditions: Liver Cirrhosis; Cachexia; Malnutrition

Summary: nutritional status in patients with cirrhosis has been shown to have a direct influence on the prognosis of these patients, it is related to higher mortality and it has been linked to the developement and perpetuation of certain complications such as hepatic encephalopathy, ascites and spontaneous bacterial peritonitis. despite the importance of nutritional status in this patients, most of the methods for its assessment are still not completely reliable or not easily accessible; therefore, evaluating nutritional status in the daily clinical practice is still a complex task.


Eligibility criteria:
inclusion criteria: * diagnosis of cirrhosis * no restriction of etiology * 18-75 years * child-pugh stage a/b/c * signed informed consent exclusion criteria: * pregnancy * extremity amputation * malignancy different from hepatocellular carcinoma
dose ranging study of slit tablets of house dust mite allergen extracts (hdm) in adults with hdm-associated allergic asthma

Conditions: Asthma; House Dust Mite Allergy

Summary: the purpose of this study is to investigate the efficacy and safety of different doses of sublingual tablets of house dust mite allergen extracts as compared to placebo in adults with house dust mite-associated allergic asthma.


Eligibility criteria:
inclusion criteria: * written informed consent. * male or female from 18 to 50 years of age. * diagnosed asthma and rhinitis with medical history consistent with hdm-induced allergic asthma and rhinitis. * positive spt to hdm and and hdm-specific ige serum value ≥ 0.7 ku/l. * stable asthma therapies. * spirometry (pre-bronchodilator) with best fev1 ≥ 70% of the predicted value. * spirometry with reversibility in fev1 of ≥ 12% and ≥ 200 ml. * asthma control test™ (act) score ≤ 19. exclusion criteria: * former smoker with \> 10 pack year history or current smoker. * patient with a urine level of cotinine ≥ 500 ng/ml. * co-sensitisation to any allergen possibly leading to clinically relevant symptoms likely to significantly change the asthma symptoms of the subject during the study. * patient who received allergen immunotherapy for hdm within the past 10 years. * ongoing immunotherapy for an aeroallergen other than house dust mite. * patient with any oral condition that could confound the safety assessments or planning to have a dental extraction during the study. * patient treated with beta-blockers, tricyclic antidepressants or monoamine oxidase inhibitors (maois). * pregnant women or breast-feeding/lactating. * women with childbearing potential who are not using a medically accepted birth control method. * patient with a past or current disease, which as judged by the investigator, may affect the patient's participation in, or the outcome of this study.
glucosamine and chondroitin in preventing inflammation in overweight patients

Conditions: Healthy Subject; Overweight

Summary: this trial studies glucosamine and chondroitin in preventing inflammation in overweight patients. chronic inflammation contributes to cancer formation, and biomarkers of inflammation have been associated with cancer risk. glucosamine and chondroitin may prevent inflammation and this trial may help identify the bacteria that help process them in the gut.


Eligibility criteria:
inclusion criteria: -individuals from the greater seattle area who are overweight (body mass index \[bmi\] of 25-32.5 kg/m\^2) exclusion criteria: * chronic medical illness, history of gastrointestinal, hepatic, or renal disorders, or inflammatory conditions (including autoimmune and inflammatory diseases) * pregnancy or lactation * currently on a weight-loss diet * bmi (body mass index) \ 32.5 kg/m\^2 * alcohol intake of greater than 2 drinks/day (2 drinks being equivalent to 720 ml beer, 240 ml wine or 90 ml spirits) * current use of prescription or over-the-counter medications other than oral contraceptives and hormone secreting intrauterine device (iud)s, multivitamin pills or infrequent use of aspirin and nonsteroidal anti-inflammatory drugs (nsaids), or use of aspirin or nsaids more than 2 days per week * abnormal renal, liver or metabolic test * inability to swallow pills * known allergy to shellfish * not willing to take pills made from shellfish or animal sources * intention to relocate out of study area within next 2 months * any antibiotic use in the past 6 months
a multi-center, prospective evaluation of infants and children with congenital ichthyosis

Conditions: Ichthyosis

Summary: this project will follow babies with ichthyosis over time in order to better understand the natural course of ichthyosis in infants and children and to examine how specific genetic mutations affect clinical characteristics.

the investigators hypothesize that early complications and comorbidities in infants with congenital ichthyosis are genotype-dependent, such that clinical standards of care can be tailored to the genetic diagnoses. definition of clinical groups based upon phenotype may also provide useful predictors of outcome. information gained from this study will provide the basis for the development of rational standards of care for the future management of children with congenital ichthyosis.

Eligibility criteria:
inclusion criteria: * one parent must be able to understand and sign an informed consent document. * newborns who present at or within 2 months of birth with a clinical diagnosis of ichthyosis. * families must consent to providing dna for genetic analysis * families must agree to the intake evaluation followed by 10 follow-up evaluations, which will occur at ages 1, 2, 3, 6, 9, 12, 18, 24, and 36 months. exclusion criteria: * subjects with non-english speaking parents * patients with a family history of ichthyosis vulgaris * patients with x-linked ichthyosis
nanopore sequencing in ophthalmology

Conditions: Endophthalmitis

Summary: in this pilot study, the feasibility of the oxford nanopore minion to identify pathogens from vitrectomy samples in eyes with endophthalmitis shall be assessed. the minion is a low cost commercially available device for dna/ rna analysis that, in studies, has been used for pathogen determination in various infectious diseases as well as for the genetic characterization of hematologic tumors.

vitreous samples and anterior chamber taps from eyes with endophthalmitis are taken during routine vitrectomy. the gathered samples are divided in half to undergo routine culture for microbial growth and nanopore sequencing with the minion mk1b, a commercially available device for dna/rna sequencing. base reads from nanopore sequencing are then compared with available libraries for pathogen identification. the nanopore sequencing results for pathogens are compared versus the results of the microbiological culture of the same eye as the gold standard. clinical features and visual function before and after vitrectomy are gathered from patient charts. treatment is not altered due to results of the nanopore sequencing.

Eligibility criteria:
inclusion criteria: * eyes of patients with endophthalmitis exclusion criteria: * no informed consent possible * participation in other studies

Keywords: endophthalmitis nanopore sequencing next generation sequencing