Kornimate/medical-research-clean huggingface dataset:
the association between non-vitamin k antagonist oral anticoagulant concentration and clinical outcomes.

Conditions: Atrial Fibrillation

Summary: introduction: non-vitamin k antagonist oral anticoagulants (noac) is the first line therapy to prevent ischemic stroke or systemic thromboembolism among atrial fibrillation (af) patients. since 2016, our study team enrolled patients under noac therapy in national taiwan university hospital, and measured their noac concentration to develop a cohort of noac treatment and noac concentration. study purpose: based on the cohort of noac therapy, we aim to investigate factors driving high or low noac concentration, and link noac concentration to clinical outcomes. methods: for all the participants in the cohort, we will retrieve their basic characteristic, concurrent medications, laboratory tests and clinical outcomes such as ischemic stroke, systemic thromboembolism, intracranial hemorrhage, major bleeding and death from the electronic medical records. the noac concentration will be compared to the expected range reported in clinical trials to define higher, within or lower than expected range. univariate logistic regression will be used first, followed by multivariate logistic regression to investigate factors associated with high or low noac concentration. the relationship between noac concentration and clinical outcomes will be investigated by using the cox proportional hazard model.


Eligibility criteria:
inclusion criteria: * age more than 20 years. * under noac therapy. exclusion criteria: * failed to provide at least one blood sample for noac concentration measurement. * declined to provide informed consent
oral care with breast milk in preterm newborns fed by tube

Conditions: Breastmilk; Oral Care

Summary: it was conducted to evaluate oral care with breast milk in preterm newborns fed by tube

newborns selected according to the randomization group will receive nursing care, including oral care and feeding, from the same person twice a day, at 09:00 in the morning and 15:00 in the afternoon. breast milk (bm) will be used for oral care. at each treatment, two ml bm should be dropped onto sterile gauze to clean the cheeks, tongue and palate. process steps; after hand hygiene is achieved, it will be done using disposable gloves.

Eligibility criteria:
inclusion criteria: * -staying in the neonatal intensive care unit * being fed by gavage * babies with no oral intake (nonperoral-npo) * babies fed with breast milk and/or formula exclusion criteria: * babies who are exclusively breastfed * cleft palate/lip * major congenital anomaly * intubated babies

Keywords: breastmilk oral care newborn
does undercorrection of myopia retard myopia progression among kindergarten children?

Conditions: Refractive Error - Myopia

Summary: the purpose of this study is to find out if undercorrection of myopia slow down the progression of myopia in kindergarten children.


Eligibility criteria:
inclusion criteria: 1. children of chinese descent aged 5 - 6yrs 2. refractive error of -1.00 to -3.00ds 3. less than 1.50 astigmatism in each eye. (no oblique axis) 4. visual acuity is 6/6 or better in both eyes. 5. no binocular problems, no anisometropia \>1.50d 6. will be staying in s'pore for at least 2 years. exclusion criteria: -
study of dht-gel to treat the symptoms of low testosterone in men 55-80

Conditions: Hypogonadism; Late Onset Hypogonadism; Low Testosterone

Summary: the purpose of this study is to evaluate whether dht-gel, when applied daily to the skin, can relieve the symptoms of low testosterone in men aged 55-80. these symptoms include reduced muscle strength, increase fat mass, low libido, feeling blue or moody

background - in the context of hypogonadism, androgen supplementation is clearly beneficial, particularly in younger males. the benefits of therapy in men with milder degrees of hypogonadism, and elderly males with testosterone deficiency, are less clear-cut. several options are available for androgen replacement in adult men. oral testosterone, intramuscular injections, subcutaneous implants and transdermal therapy have all been used. each mode of delivery has advantages and drawbacks. several alkylated derivatives of t are available for oral or sublingual use, including methyl testosterone and fluoxymesterone. however, they are not recommended for use as replacement therapy because of their associated adverse effects. study design - this is a multi-center, double-blind, placebo-controlled, parallel group, randomized study of dht-gel versus placebo gel in male subjects ages 55-80 years inclusive with low serum testosterone and symptoms compatible with the clinical diagnosis of hypogonadism. total enrollment for this study will be approximately 120 subjects (40 subjects for each treatment group). subjects will be treated with 35 mg/day dht, 70 mg/day dht, or placebo gel for 6 months. all subjects will apply the gel once daily. up to 9 months of study participation, including up to 2 months of screening and a 1-month follow-up period, will be required by the protocol. the primary efficacy endpoint in this study is change in body composition as determined by dexa scan. secondary endpoints in this study include change in sexual libido, and overall function and mood, and normalization of serum androgen levels. a subset of sites will perform strength assessments, which will include handgrip dynamometry, and upper and lower body strength tests.

Eligibility criteria:
inclusion criteria: * men aged 55-80 serum testosterone \< 275 symptoms of hypogonadism as determined by ams scale in good overall health exclusion criteria: * abnormal prostate exam for age prostate or breast cancer significant illness weight \>300lbs generalized skin disease unstable sleep apnea

Keywords: libido depression strength testosterone dihydrotestosterone
clinical study, non inferiority between noex® 32µg versus budecort aqua® 32µg in treatment of alergic rhinitis

Conditions: Rhinitis, Allergic, Perennial

Summary: this study is to evaluate non inferiority of eurofarma budesonide nasal spary x referral astrazeneca budesonide. half patients will receive eurofarma medication and half patients will receive astrazeneca medication. there is no placebo group.

budesonide is a medicine already very used and registered about 20 years. eurofarma has the intention to collect more data about safety and efficacy and present them to local authority. this study was draw to treat patients with persisntent rhinits moderate to severe in sites localted locally in brasil.

Eligibility criteria:
inclusion criteria: 1. age ≥ 12. 2. history of alergic persistent rhinitis moderate to severe at least 2 years. 3. proved alergic using prick or rast test. 4. nasal symptoms (nis) \> 3 and nasal obstruction \>1. 5. indication of nasal corticorteroids use.. 6. washout of nasal corticorteroids for 14 days. 7. icf. exclusion criteria: 1. other types of rhinitis; 2. asthma non controled 3. use of oral/injectable corticoids 30 days before screening. 4. patients not eligible to complete diaries. 5. patients with alergy to any substance of medicines. 6. non controlled desease.
laboratory study of lymphoblasts in young patients with high-risk acute lymphoblastic leukemia

Conditions: Leukemia

Summary: rationale: collecting and storing samples of bone marrow and blood from patients with cancer to study in the laboratory may help doctors learn more about changes that may occur in dna and identify biomarkers related to cancer. purpose: this laboratory study is looking at lymphoblasts in young patients with high-risk acute lymphoblastic leukemia.

objectives: * identify regions of copy number abnormalities (cna) and uniparental disomy in leukemic lymphoblasts from pediatric patients with high-risk acute lymphoblastic leukemia (all) using affymetrix genechip mapping 500k array sets. (pilot project) * identify regions of cna and loss-of-heterozygosity using affymetrix snp 6.0 microarrays. (expansion project) * define gene expression profiles for leukemic lymphoblasts using affymetrix u133 plus 2.0 arrays. * assess the global expression of micrornas in leukemic lymphoblasts using microrna gene chips. * utilize array-generated gene expression data and data for cnas and uniparental disomy to prioritize candidate genes and genomic regions for resequencing. * characterize epigenomic profiles using the hpaii tiny fragment enrichment by ligation-mediated pcr (help) assay. (expansion project) * discover candidate therapeutic targets for these patients by identifying genes that are consistently mutated in leukemic lymphoblasts using high-throughput focused gene resequencing. (pilot project) * discover candidate therapeutic targets for these patients by next generation sequencing technologies, including whole genome, whole transcriptome, and whole exome. (expansion project) outline: this is a multicenter study. banked biological samples (bone marrow and peripheral blood) are analyzed using gene expression profiling, single-nucleotide polymorphism and genotyping assays, dna copy number and loss of heterozygosity estimates, epigenetic profiling, and gene resequencing. projected accrual: a total of 150 patient samples will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of b-cell precursor acute lymphoblastic leukemia (all) * high-risk disease * participation in clinical trial cog-p9906 required (pilot project) * in complete remission * consented to future studies using banked tissue specimens * participation in clinical trial and cog-aall03b1 and linked therapeutic studies cog-aall0232 and cog- aall0331(expansion project) * experienced a bone marrow relapse within 36 months of initial diagnosis * consented to future studies using banked tissue specimens * have matched all blast and germline specimens * demographic, clinical and pathologic data elements for these biospecimens available patient characteristics: * not specified prior concurrent therapy: * not specified

Keywords: childhood acute lymphoblastic leukemia in remission b-cell childhood acute lymphoblastic leukemia
utilization of the biowave device to treat overactive bladder

Conditions: Overactive Bladder

Summary: demonstrate a response to stimulation of the posterior tibial nerve using the biowave device and a microneedle patch electrode in patients with overactive bladder symptoms. the investigators hypothesize that after at least 6 weekly treatments there will be modest improvements in overactive bladder symptoms trending toward more improvement.

women 18 years old and over with a score of equal to or greater than 4 on the oab-q short form for urgency and average daily urinary frequency equal to or greater than 10 times based on a 3-day voiding diary plus other inclusion criteria will be reviewed for possible enrollment in this study. outcomes measured include global response assessment (gra) for overall bladder symptoms, a change in the 3-day voiding diary parameters and adverse events.

Eligibility criteria:
inclusion criteria: * women \>18 years of age * a score of \> 4 on the oab-q short form for urgency (question 1) * average daily urinary frequency \> 10 times based on a 3-day voiding diary * self-reported bladder symptoms present \> 3 months * self-reported failed conservative care (i.e., dietary restriction, fluid restriction, bladder training, behavioral modification, pelvic muscle training, biofeedback, etc.) * off all antimuscarinics for at least 2 weeks prior to enrollment * capable of giving informed consent * ambulatory and able to use a toilet independently, without difficulty * capable and willing to follow all study-related procedures exclusion criteria: * pregnant as confirmed by urine pregnancy test, or plans to become pregnant during the study period * neurogenic bladder * botox® use in bladder or pelvic floor muscles in the past year * pacemakers or implantable defibrillators * primary complaint of stress urinary incontinence * current urinary tract infection (uti) * current vaginal infection * current use of interstim® * current use of bion® * previously been treated with percutaneous tibial nerve stimulation (ptns) * use of investigational drug/device therapy within the past 4 weeks. * participating or have participated within the past 4 weeks in any clinical investigation involving or impacting gynecologic, urinary or renal function. * deemed unsuitable for enrollment in study by the investigators based on subjects' history or physical examination (including skin disorders at the treatment site or peripheral neuropathy). * subjects with nerve damage that would impact either percutaneous tibial nerve or pelvic floor function.

Keywords: frequency urgency incontinence
assessment of qsant™ for underlying allograft rejection

Conditions: Kidney Transplant Failure and Rejection

Summary: the aqua registry is a multi-center observational study to assess the clinical management of kidney transplant recipients (ktrs) with use of the qsant test. qsant is a test based on 6 urinary biomarkers including cell-free dna, that is used for the evaluation and management of acute rejection in renal allograft recipients with clinical suspicion of rejection, as well as subclinical rejection.

the aqua registry is a multi-center observational study to assess the clinical management of kidney transplant recipients (ktrs) with use of the qsant test. each participant will be tracked for 24 months. qsant testing will be performed according to the intended use guidelines specified in "lcd - moldx: molecular testing for solid organ allograft rejection (l38671)", along with all standard of care testing, such as serum creatinine/ estimated glomerular filtration rate (scr/egfr) as described in the study schedule. participants will be compared to a site-specific retrospective cohort of ktrs without qsant testing having received a kidney transplant no more than 5 years prior to study initiation as well as the national cohort derived from unos (united network for organ sharing) data.

Eligibility criteria:
inclusion criteria: 1. kidney transplant recipient, ≤ 90 days post kidney transplant of any age, solitary or combined multi-organ solid transplants which includes a kidney transplant. 2. able to understand risks and requirements of participation and provide informed consent 3. willing and able to comply with the study requirements exclusion criteria: 1. inability to provide a voided urine sample per collection protocol 2. urological abnormalities such as augmented bladder, ileo-conduits, mitrofanoff, and vesicostomy.

Keywords: kidney transplant kidney biopsy allograft rejection subclinical allograft rejection kidney kidney health kidney function urine sample urine test kidney disease
impact of rotavirus vaccination on hospitalisations for rotavirus gastroenteritis in children aged <5 years in australia

Conditions: Rotavirus Gastroenteritis; Gastroenteritis

Summary: this study aims to monitor the incidence rates and duration of hospitalisations for rotavirus gastroenteritis (rv ge) and all cause ge, compared to bronchiolitis from 1998 to 2009, in children \< 5 years of age after the introduction of rotarix in 2006 by year, both inside and outside rotavirus season in australia. it further aims to compare the two dose regimen of rotarix with the three dose regimen of rotateq from 2007 to 2009.


Eligibility criteria:
inclusion criteria: * children \<5 years of age; * children with a diagnosis of all-cause gastroenteritis, rotavirus gastroenteritis or bronchiolitis in the australian institute of health and welfare (aihw) database in new south wales, australian capital territory, tasmania and northern territory, from 1998 to 2009; * children who were vaccinated with rotarix or rotateq in new south wales and queensland, registered in the australian childhood immunisation register (acir) database in queensland and new south wales, from 2007 to 2009. exclusion criteria: no exclusion criteria will be applied.

Keywords: rotavirus gastroenteritis rotarix rotateq gastroenteritis
effect of ketamine intranasal spray in treatment of chronic cluster headache

Conditions: Cluster Headache

Summary: ketamine has been used clinically iv in a very safe manner by a very small number of clinicians, to treat migraines and ch, and various other rarer pain disorders, including mixed headache and neuropathic pain clinical syndromes. in 5 cases taken from krusz j.c. headache clinic data in dallas, texas us, an intranasal spray of ketamine aqueous solution of 100 µl in one nostril were dosed in treatment of patients with refractory chronic cluster headache as an alternative to iv-treatment (data not published).the net conclusion, at this point, is that intranasal ketamine is a legitimate pharmacologic treatment and is safe and has in one case series proven effective for ch rescue. the cch patients will be dosed with an intranasal spray containing 172.5 mg ketamine hydrochloride (150 mg ketamine base) per ml in an aqueous solution. the individual dosing includes 15 mg ketamine in an intranasal sprayed volume of 100 µl given in one nose nostril under supervision of a nurse. the treatment is initiated at t0 under a ch attack when the headache pain exceeds nrs = 6 on an nrs pain scale. the first intranasal dose of 15 mg is given at time 0 and at time intervals of 6 minutes. at 15 minutes after 3 doses (45 mg) it is decided to evaluate whether the patient is sufficiently pain relieved (e.g. nrs \< 4) or wants to receive rescue medications instead or if pain is not sufficiently relieved wants to continue until 5 dosing's (75 mg) are received at timepoints t24. the final evaluation of the treatment is performed at t30. participants are followed up after 1-2 weeks by telehone


Eligibility criteria:
inclusion criteria: * signed informed consent * age between 18 and 60 years * diagnose: chronic cluster headache according to ichd-3 criteria (1) * body weight ≥50 kg and bmi ≤30 exclusion criteria: * conditions that result in the participant being unable to complete the experiment * medical history with elevated intraocular pressure (e.g. glaucoma) * medical history with severe heart or liver disease * aneurysmal vascular disease or arteriovenous malformations * medical history with severe neurological disease except of headache * bp measured at baseline before ch attack (systolic\> 140 mmhg or / and diastolic blood pressure\> 90 mm hg) * medical history with severe depression or psychosis * a previous history of drug abuse * consumption of illegal drugs within the last 6 months * medical history of nasal abnormality or dysfunction (e.g. rhinitis) * high disposition for larynges or apnea * positive pregnancy test before treatment and breastfeeding * known hypersensitivity to ketamine
micisport survey : questionnaire

Conditions: Crohn's Disease

Summary: this study offers a questionnaire to patients with crohn's disease in order to assess their physical activity and / or sport as well as their eating habits in order to assess the impact of these lifestyle habits on activity and the symptoms of the disease.

this questionnaire, validated with doctor pineton de chambrun, is set up within the framework of an exercise thesis in pharmacy focusing on the impact of physical activity and diet on the evolution and patients' crohn's disease (cd) experience. along with ulcerative colitis (uc), crohn's disease belongs to chronic inflammatory bowel disease (ibd), which is a major public health concern. these pathologies currently affect 2.5 million patients in europe (1 million of cd versus 1.5 million of uc). more specifically, in france in 2015, there were 212,700 patients with ibd, with a proportion of 60% cd and 40% rch1. these pathologies have a major impact on patient's lifes, both in terms of quality of life and the therapeutic course (efficacy and side effects). physical activity and diet are other important concerns of health authorities. they are the subject of numerous recommendations based on age and health status. the world health organization (who), for example, recommends that adults between the ages of 18 and 64 should practice endurance physical activity of moderate intensity lasting at least 150 minutes per week or 75 minutes per day, sustained intensity endurance activity, or a combination of these two types of activity. epidemiological data show that the lack of physical activity and a sedentary lifestyle favor the increase of the prevalence of diseases, such as cancer and diabetes, but also the increase in cardiovascular risk factors, such as hypertension, obesity and hyperglycemia. a sedentary lifestyle is also considered to be the fourth risk factor for mortality worldwide. therefore, it appears interesting to study the potential impact of physical activity and exercise as well as food consumption on the activity of crohn's disease. this impact felt by patients will be assessed by means of a questionnaire which will be offered to them after their medical consultation. the hypothesis of this work is that physical activity and / or sports and diet control improve the quality of life for patients with crohn's disease.

Eligibility criteria:
inclusion criteria: - crohn's disease patients exclusion criteria: - patients without crohn's disease

Keywords: disease activity eating habits sport physical activity
a clinical study to investigate the long-term use of lacosamide as monotherapy in subjects who completed study sp0994

Conditions: Epilepsy

Summary: study is conducted to evaluate the long-term safety and tolerability of lacosamide (lcm) in patients receiving lcm in sp0994 \[nct01465997\]. the study will enable collection of additional monotherapy safety data, and will facilitate access to treatment until commercial availability for monotherapy use.


Eligibility criteria:
inclusion criteria: * an institutional review board /institutional ethics committee approved written informed consent form (icf) is signed and dated by the subject or by the parent(s) or legal representative. the icf or a specific assent form, where required, will be signed and dated by minors * subject/legal representative is considered reliable and capable of adhering to the protocol, visit schedule, and medication intake according to the judgment of the investigator * subject has completed the termination visit of sp0994 \[nct01465997\] and has been treated with lacosamide monotherapy exclusion criteria: * subject is receiving any investigational drugs or using any experimental devices in addition to lacosamide (lcm) * subject experienced a seizure at the 3rd target dose (i.e. lcm 600 mg/day) during sp0994 * subject required another anti epileptic drug (aed) for the treatment of seizures * subject meets a "must" withdrawal criteria for sp0994 * subject is experiencing an ongoing serious adverse event from sp0994 * female subject who is pregnant or nursing, and/or a woman of childbearing potential who is not surgically sterile, 2 year postmenopausal or does not practice one highly effective method of contraception, unless sexually abstinent, for the duration of the study

Keywords: lacosamide vimpat epilepsy partial onset seizures tonic-clonic seizures monotherapy aed