Kornimate/medical-research-clean huggingface dataset:
study to assess the safety & reactogenicity of gsk biologicals' dtpa vaccine (boostrix) when given at 6-8 years of age.

Conditions: Tetanus; Diphtheria; Acellular Pertussis

Summary: this study will evaluate the safety and reactogenicity of booster dose of gsk biologicals' dtpa vaccine (boostrix) in chinese children at 6-8 years of age.


Eligibility criteria:
inclusion criteria: * a male or female between, and including, 6-8 years of age at the time of vaccination, * written informed consent obtained from the parent or guardian of the subject, * subjects who have received a total of 4 doses of dtp vaccine in the first 2 years of life, exclusion criteria: * subjects who have received previous dtp booster vaccination since administration of the fourth dose of vaccine in second year of life can not participate * subjects with history of diphtheria, pertussis or tetanus diseases can not participate

Keywords: uncontrolled
an observational study to develop algorithms for identifying opioid abuse and addiction based on admin claims data

Conditions: Opioid-Related Disorders; Opiate Addiction; Narcotic Abuse; Drug Abuse

Summary: the purpose of this study is to develop and validate a classification model based entirely on medical claims data that can be used to identify patients experiencing prescription opioid abuse/addiction among patients receiving extended-release (er) and/or long-acting (la) opioids

the most widely available information about patient care and conditions is that contained in medical claims data. if such data can be used to develop a model for identifying patients experiencing prescription opioid abuse/addiction it could be widely applied to patient populations throughout the united states. a study recently conducted at group health comparing international classification of disease, ninth edition (icd-9) coding for opioid abuse/addiction to textual mentions in clinical notes describing abuse/addiction found that icd-9 codes were 64% sensitive and 96% specific in their ability to identify patients experiencing opioid abuse/addiction (compared to evidence from clinical notes). this group health study considered codes for abuse (305.x) and addiction (304.x) equivalent because clinicians' usage of these codes did not differentiate well between abuse and addiction. needed are methods that can accurately identify patients experiencing opioid abuse/addiction based on widely available claims data. this study will not evaluate opioid misuse because this will be captured by instruments in a prospective study of pain patients (study 1a) using a combination of adapted validated instruments, and other new instruments that will be evaluated in post-marketing requirement (pmr) study 2, plus medical record review to supplement questionnaire-based measurement of misuse, abuse and addiction with aberrant behaviors and physician text entries in the medical records.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. receipt of at least a 60 day's supply of er/la opioid analgesics within a 90-day period (including transdermal or oral opioids but excluding buprenorpine) 3. minimum of at least two years continuous enrollment in group health integrated group practice (igp) exclusion criteria: 1. residence in a nursing home at any time during the study period 2. enrollment in a hospice care program at any time during the study period
differential sensory block during labor epidural analgesia: a prospective observational study to investigate the relationship of lower and upper sensory block levels to cold with sensory block to pinprick and light touch

Conditions: Labor Pain

Summary: epidural analgesia remains the gold standard for pain control during labor and delivery. proper assessment of an epidural's level of blockade is important for providing safe and effective analgesia. previous studies have established that the most commonly tested modality for adequacy of epidural blockade is a patient's sensory blockade to cold temperature. in a study performed at our institution, soares et. al. (publication pending) documented two thresholds of sensory block to ice: one defined as the lower sensory block level, in which the patient is able to notice the cold sensation but perceives that it is not as cold as a control dermatome; the other defined as the upper sensory block level, in which the patient perceives that the cold sensation is at approximately the same temperature as if it were applied to a non-anesthetized area such as the neck or face. although this a known finding to nurses and physicians assessing the sensory block to ice, this phenomenon and its magnitude has not been previously reported in epidural anesthesia. the goal of this study is to examine patients with labour epidurals and to determine the dermatomal relationship between the lower and upper sensory block levels to cold when compared with sensory blockade to both pinprick and light touch.


Eligibility criteria:
inclusion criteria: * asa physical status classification ii and iii parturients * requested and received a labour epidural * capable of consenting to the study * have no language barrier which may obfuscate the sensory block assessment * are receiving programmed intermittent epidural boluses (pieb) for maintenance analgesia, which is the mount sinai hospital default maintenance regimen exclusion criteria: * medical comorbidities that could compromise the body's sensitivity to cold, pinprick, or touch * epidurals performed under a combined spinal-epidural (cse) or dural puncture epidural (dpe) technique * epidurals with a documented unintentional dural puncture * inadequate epidural analgesia requiring either manually administered epidural boluses, an increase in the concentration of their maintenance local anesthetic, or a repeat of their epidural

Keywords: sensory block epidural analgesia programmed intermittent epidural bolus
pre-symptomatic studies in amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis

Summary: the goal of press-als is to study the earliest manifestations of disease in people with early als in whom some areas of the body are not yet affected.


Eligibility criteria:
inclusion criteria als group: * subject is a male or female, aged at least 18 years. * subject is affected with als (familial or sporadic). * subject has at least one limb in which there is no symptomatic upper and lower motor neuron dysfunction. * subject is willing and able to comply with all study procedures. * subject agrees to provide signed and dated informed consent form. control group: * subject is a male or female, aged at least 18 years. * subject is not affected with als or an als-related disorder. * subject does not have a family history (i.e., at least 2 biological relatives) of als or an als-related disorder. * subject is willing and able to comply with all study procedures. * subject agrees to provide signed and dated informed consent form. exclusion criterion • any condition or situation which, in the pi's opinion, could confound the biomarker data or may interfere significantly with the individual's participation and compliance with the study protocol, including but not limited to neurological, psychological and/or medical conditions (e.g., multiple sclerosis, neuropathy, myelopathy).

Keywords: disease onset disease progression
factors influencing pediatric asthma

Conditions: Asthma in Children

Summary: asthma is a chronic lung disease with serious morbidity and potential mortality. multiple physiologic, environmental and social conditions impact the prevalence and severity of asthma. even when diagnosed, effective control can be impeded by improper use of medication, not understanding or being unable to avoid environmental triggers, lack of continuity in follow-up care, and lack of an asthma action plan. american indians are especially at-risk for health problems related to asthma. american indians have the highest asthma rate among single-race groups; 18.5% of american indians are diagnosed with asthma, while only 11% are diagnosed with asthma in the general population but little is known about why this is true. asthma is a prototypic example of the interaction of biologic, environmental and psychosocial influences on disease and this study investigated the possible improvement in asthma control from an intensive educational intervention.

the primary aim of this study was to test the hypothesis that intensive patient education regarding self-directed, stepped care will result in reduced morbidity and medical care utilization, while increasing quality of life. one half (54) of the identified cases will be randomized to receive the previously established "breathe" study educational program, emphasizing patient-centered, self management of asthma. periodic follow-up through personal contact and surveillance of ihs rpms or other medical provider records was conducted.

Eligibility criteria:
inclusion criteria: * cases must be "american indian" (eligibile for care within the indian health service); and at least 2 of the following 3 criteria: 1. a diagnosis of asthma on at least 2 occasions by more than one provider during the past 2 years. 2. refills of asthma treatment medications on at least 2 occasions during the past 2 years. 3. improvement of spirometry fev1 of 20% with use of albuterol mdi or nebulizer. * controls meet the same demographic criteria as cases, but must also meet all of the following criteria. 1. no diagnosis of asthma by any provider during the past 2 years. 2. no prescriptions of any asthma meds during the past 2 years. 3. fev1 on spirometry greater than 80% of predicted value exclusion criteria: exclusion criteria: 1. birthweight less than 2500 grams 2. neonatal ventilator treatment 3. hospitalization at birth greater than 15 days. 4. congenital heart anomaly requiring surgery 5. diagnosis of cystic fibrosis 6. congenital lung, diaphragm, chest wall, or airway anomaly 7. diagnosis of pneumonia, pertussis, or tuberculosis within the past year 8. congenital muscular disorder

Keywords: asthma pediatric american indian children
vitamin k to slow progression of dyslipidemia and diabetes risk (vita-k 'n' kids study ii)

Conditions: Obesity; Insulin Resistance; Obesity in Diabetes; Nutritional and Metabolic Diseases; Hyperlipidemia; Hyperglycemia; Cardiovascular Diseases

Summary: animal studies have found that vitamin k-dependent proteins matrix gla protein and osteocalcin beneficially influence lipid and glucose metabolism, respectively. however, this concept has not been tested in humans at risk for dyslipidemia and diabetes risk. vitamin k supplementation presents an opportunity to test the hypothesized link between the vitamin k-dependent proteins and markers of lipid and glucose metabolism. the investigators will conduct an 8-week vitamin k intervention (to manipulate carboxylation of matrix gla protein and osteocalcin) and determine its effects on markers of dyslipidemia and diabetes risk. sixty obese children will be randomly allocated to either the control group receiving placebo or the low-dose (45 mcg/d) or high-dose group (90 mcg/d) receiving vitamin k (menaquinone-7).


Eligibility criteria:
inclusion criteria: * age 8 to 17 years * body mass index equal to or greater than 85th percentile for age and sex * subject and parent/guardian understands the study protocol and agrees to comply with it * informed consent form signed by the parent/guardian and assent signed by the subject exclusion criteria: * subjects using vitamin supplements containing vitamin k * subjects with (a history of) metabolic or gastrointestinal diseases including hepatic disorders * subjects presenting chronic degenerative and/or inflammatory diseases * subjects receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters (salicylates, antibiotics) * subjects receiving corticosteroid treatment * subjects using oral anticoagulants * subjects with a history of soy allergy * subjects who have participated in a clinical study more recently than one month before the current study

Keywords: g01 [biological sciences] g02.513 [nutrition] g06.696.259 [child nutrition] g07.553.481.398.571 [obesity] g06 [biochemical phenomena, metabolism, and nutrition] g12.392.617 [insulin resistance] g06.696.259.500 [adolescent nutrition] a06 [endocrine system] a07 [cardiovascular system] c18.452.297.681 [obesity in diabetes] c18.452.555 [insulin resistance] c18 [nutritional and metabolic diseases] c18.452.494 [hyperlipidemia] c18.452.460 [hyperglycemia] c14 [cardiovascular diseases] d11.786.875.844 [vitamin k 2] d02.806.550.750 [vitamin k 2] e02.293 [diet therapy] e02 [therapeutics] f04.096.544.215.508.428 [primary prevention] n01.224.425.525 [nutritional status]
a comparative study between postextubation of preterm infants into high-flow nasal cannulae v.s nasal continuous positive airway pressure

Conditions: Neonatal Respiratory Distress

Summary: the investigators hypothesize that there is a growing trend of the feasibility of hfnc as an alternative to other forms of non-invasive ventilation mechanism to provide continuous distending pressure to preterm infants. however, there remains uncertainty about the efficacy and safety of hfnc in this population.

our primary outcome is to determine whether postextubation respiratory support via heated humidified high-flow nasal cannula results in a greater proportion of infants younger than 34 weeks gestation being successfully extubated after a period of endotracheal positive pressure ventilation compared with conventional (ncpap). the following study will be conducted in the neonatal intensive care unit (nicu) of gynecology and obstetric department of kasr el aini hospital and neonatal intensive care unit of military hospital throughout a time interval of at least 6 months for a minimum of 100 preterm infants. infants will be eligible for the study if they born at less than 34 weeks' gestation, required endotracheal intubation and positive pressure ventilation, and considered ready for extubation by the clinical team. the investigators will assign extubation of preterm ventilated infants (50 preterm infant) in nicu of military hospital into hhfnc and extubation of preterm ventilated infants (50 preterm infant) in (nicu) of gynecology and obstetric department of kasr el aini hospital into ncpap (50 preterm infant).

Eligibility criteria:
inclusion criteria: •infants born at a gestational age of less than 34 weeks, receiving mechanical ventilation through an endotracheal tube. exclusion criteria: * full term neonates or large for gestational age. * preterm neonates not supported primarily by invasive ventilation. * infants with suspected upper airway obstruction, congenital airway malformations or major cardiopulmonary malformations.
smell, voice and nasal swabs as markers for neuro-degenerative disorders

Conditions: Alzheimer Disease; Neurodegenerative Diseases

Summary: degenerative dementias including alzheimer's disease (ad), parkinson's disease with dementia (pdd), dementia with lewy bodies (dlb), frontotemporal dementias (ftld), corticobasal degeneration (cbd) and progressive supranuclear palsy (psp) constitute a significant, and growing burden with an estimated cost to the us healthcare system for 2016 of $236 billion (1). definitive diagnosis of these dementias is based on pathological criterion upon autopsy, which presents a significant challenge to establish diagnosis in living patients. although clinical diagnostic criteria have been developed for several of these disorders, including for alzheimer's disease (ad) by the national institute of neurological and communicative disorders and stroke and alzheimers disease and related disorders association (nincds-adrda) , parkinson's disease (pd) by the united kingdom parkinson disease brain bank diagnostic criteria (ukpdbb) diagnostic criteria for parkinson disease(4) and others, the currently available tests, including the use of imaging markers and cerebrospinal fluid (csf) biological markers do not provide a definite diagnosis since this requires the observation of characteristic neuropathological changes in specific regions of the brain.


Eligibility criteria:
inclusion criteria: * diagnosed with idiopathic parkinson's disease, progressive supranuclear palsy, alzheimer's disease or mild cognitive impairment based on consensus criteria, or suspicion of presbylarynx based on clinical evaluation. * require evaluation of voice dysfunction by an ent doctor given symptoms of impaired voice volume or quality * age ≥ 18 years-old to ≤ 90-years old. * ability to understand and the willingness to sign a written informed consent. exclusion criteria: * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * active nose bleeds, or abnormal anatomy of the nose that prevent safe nasal swabs, or active oropharyngeal disease that prevents laryngoscopy or voice assessments.
double-lumen tube intubation technique to reduce laryngeal injuries

Conditions: Laryngeal Injuries

Summary: the purpose of this study is to devise the method to reduce laryngeal injuries during double-lumen tube intubation.


Eligibility criteria:
inclusion criteria: * patients undergoing thoracic surgery that require the placement of left-sided double-lumen tubes exclusion criteria: * preoperative hoarseness or sore throat * history of upper airway diseases * anticipated difficult airway * operation time longer than 6 hours

Keywords: during double-lumen tube intubation
comparative study of two multifocal intraocular lens with different add power

Conditions: Cataract

Summary: this study will compare cataract patients with implantation of diffractive multifocal iol with an additional power of +2.75 diopters (group 1) and with +3.25 diopters (group 2). evaluations will be performed 1 and 3 months following cataract surgery, including measurement of uncorrected distance visual acuity (udva), refractive error (manifest refraction \[mr\]), and uncorrected near visual acuity (unva) at 33, 40, and 50 cm. at 3 months, internal aberrations and contrast sensitivity will be evaluated and subjects will complete a questionnaire on outcomes satisfaction, visual symptoms, and spectacle use.


Eligibility criteria:
inclusion criteria: * age \>= 18 * cataract patients with lens opacities classification higher than grade iii * patients who desire to be spectacle indepence for distance and near vision exclusion criteria: * previous ocular surgery or trauma * presence of corneal opacities * fundus abnormalities * glaucoma * uveitis * amblyopia * systemic disease * posterior capsule rupture during cataract surgery
multicenter, interdisciplinary national vexas registry with accompanying biomaterial collection

Conditions: VEXAS Syndrome

Summary: the aim is rapid collection of real-life data on the epidemiology, treatment and disease course in patients with vexas syndrome during routine clinical practice and collect biomaterials to evaluate genotype-phenotype associations, determine optimal treatment schedule, identify diagnostic features and biomarkers

see brief summary

Eligibility criteria:
inclusion criteria: * patients with established or suspected (clinical and hematological criteria) vexas syndrome * age ≥18 years * signed informed consent form exclusion criteria: * patients who are not in a position to understand the nature and scope of participation in this register

Keywords: vexas
study to compare the efficacy and safety of two cc-5013 dose regimens in subjects with metastatic malignant melanoma

Conditions: Melanoma; Neoplasm Metastasis

Summary: subjects are randomized to one of two treatment arms. all subjects are screened for eligibility within 28 days prior to randomization. the study consists of a treatment phase and a follow-up phase. subjects will be treated in repeating 4 week cycles.


Eligibility criteria:
* understand and voluntarily sign an informed consent form. * able to adhere to the study visit schedule and other protocol requirements. * metastatic malignant melanoma now stage iv, relapsed or refractory to standard metastatic therapy. * women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of starting study drug. * patients with active brain disease, or newly diagnosed brain metastases, within 4 weeks prior to the start of study treatment are excluded.

Keywords: metastatic melanoma metastatic malignant melanoma revimid cc5013
the combination of pharmacotherapy and cognitive behavioral psychotherapy under the recovery perspective.

Conditions: Anxiety; Depression; Obsessive-compulsive Disorder; Personality Disorder; Bipolar Disorder; Schizophrenia; Psychotic Disorders; PTSD

Summary: the combination of pharmacotherapy and individual cognitive behavioral therapy in a private practice.

reintegration into society and good functional outcome by people with mental health disorders is frequently the result of the combination of pharmacotherapy and individual cognitive behavioral psychotherapy. the effectiveness and efficacy of this combination of treatments under the recovery perspective by anxiety disorders, depressive disorders, ptsd, bipolar disorders, schizophrenia and psychotic disorders, by obsessive-compulsive disorders and by personality disorders presents the main goal of this research protocol. recovery means that people learn through the trherapy to be responsible towards their own problems.

Eligibility criteria:
inclusion criteria: * age 18-65, * iq ≥ 80, * diagnosis: anxiety disorders, depression, obsessive-compulsive disorders, ptsd, personality disorders, bipolar disorders, schizophrenia and psychotic disorders. exclusion criteria: \*substance abuse and head injury.

Keywords: pharmacotherapy cognitive behavioral psychotherapy recovery
a study of mirikizumab (ly3074828) in participants with ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to evaluate if study drug mirikizumab is safe and effective compared to vedolizumab and placebo in participants with moderately to severely active ulcerative colitis (uc).


Eligibility criteria:
inclusion criteria: * participants must have a diagnosis of uc for at least 3 months prior to baseline * participants must have a confirmed diagnosis of moderately or severely active uc, as assessed by the modified mayo score (mms) * participants must have demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic therapy for uc * participants must, if female, meet the contraception requirements exclusion criteria: * participants must not have a current diagnosis of crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis) * participants must not have had a previous colectomy * participants must not have current evidence of toxic megacolon * participants must not have prior exposure to anti-il-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab), vedolizumab, or natalizumab * participants must not have prior clinical failure or intolerance to anti-il12p40 antibodies (e.g. ustekinumab), anti-integrin antibodies other than vedolizumab and natalizumab (e.g. etrolizumab) or anti-integrin ligand antibodies (e.g. ontamalimab) within 4 weeks prior to screening endoscopy

Keywords: interleukin-23 (il-23) antibody il-23p19