Kornimate/medical-research-clean huggingface dataset:
behavioral economics trial to enhance regulation of blood pressure (better-bp)

Conditions: High Blood Pressure

Summary: better-bp (behavioral economics trial to enhance regulation of blood pressure) is a phase ii, single-center, prospective, pragmatic randomized clinical trial within the new york city health and hospitals (nyc-h+h) system and nyu langone family health centers. the trial will recruit from 3 nyc-h+h ambulatory clinics as well as nyu langone family health centers, and will use a lottery incentive program to promote adherence to antihypertensive medication that will be delivered via smartphone for 6 months. the trial will randomize 435 patients with hypertension determined to have poor adherence (\<80% adherence with antihypertensive medication), in a 2:1 (intervention:control) ratio. baseline enrollment will occur over 36 months with an expected 12 months follow-up per participant.


Eligibility criteria:
inclusion criteria: * a diagnosis of hypertension. * an active prescription for ≥1 antihypertensive medication (any of the following classes: thiazide diuretic, ace inhibitor, angiotensin receptor blocker, beta blocker, calcium channel blocker, centrally acting alpha agonist, direct vasodilator). * 1 ambulatory systolic blood pressure ≥140 mmhg (on therapy). * suboptimal adherence (self-report). exclusion criteria: * incarcerated * pregnant * unable to use study software (way to health) in english or spanish * unable/unwilling to consent * clear barrier to technology use (e.g. visual or hearing impairment) * projected life expectancy \<12 months
implication of two doses of o2-o3 upon the pain alleviation in patients with low back pain

Conditions: Pain, Chronic

Summary: low back pain is very common problem, variable modalities have been introduced to control such problem. one of the emerging modalities is the ozone - oxygen (o2-o3 ) mixture that could reduce the herniation disk size and inflammation.

intervertebral disc herniation is the most common problem which induces low back pain lbp. the number of patients seek surgical and or alternative therapy increases. the rate of re-operation is between 7-9% at 2 years and increases up to 10-25% at ten years postoperative. epidural injections with local anesthetics and steroids are one of the most commonly used interventions in managing chronic low back pain and lower extremity pain of various causes. however, despite their extensive use, debate continues on this medications effectiveness due to the lack of well-designed, randomized, controlled studies to determine the effectiveness of epidural injections in general, and caudal epidural injections in particular. ozone in mixture with oxygen has been justified in multiple studies have been done, this study aims to evaluate variable doses of this mix upon patient satisfaction, pain alleviation over 12 month follow up period .

Eligibility criteria:
inclusion criteria: * all patients suffered radicular leg pain and some reported additional back pain. * all patients are non-responsive to conservative treatment modalities with vas more than 7. exclusion criteria * presence of bleeding disorder * local infection * uncontrolled or degenerative spine disease * pregnancy * multilevel disk involvement * patient refusal.
internet-based treatment of early childhood fecal incontinence

Conditions: Encopresis

Summary: encopresis, also known as fecal incontinence, is the voluntary or involuntary passage of stools causing soiling of clothes by a child over 4 years of age. the purpose of this study is to evaluate an internet intervention for the treatment of encopresis.

an estimated 2.3% of children suffer from encopresis. enhanced toilet training (ett) is one of the most effective ways of treating this disorder. when delivered by skilled and knowledgeable clinicians, ett is twice as effective as intensive medical management alone. although ett is effective in treating encopretic children, there are six major barriers to its implementation: 1) availability of a knowledgeable and skilled clinician; 2) parental acceptance of referral to a mental health professional; 3) expense of service; 4) burden of time and distance to access such specialty services; 5) child resistance to disclosure of embarrassing material; and 6) willingness of the child and parent to follow treatment recommendations. this project will circumvent these barriers by developing an interactive internet-based ett program. the study will then assess the feasibility of the program by determining the acceptance, function, and effectiveness of the intervention. this project will have four phases. phase 1 will identify optimal internet and treatment elements as well as issues in need of experimental investigation. phase 2 will investigate how to enhance internet interventions. phase 3 will evaluate the relative benefit of adding the internet treatment to clinical services provided by clinicians in the fields of medicine and mental health. phase 4 will investigate the relative long-term benefits of adding such an internet-based intervention to professional care to determine its impact on symptom improvement, relapse prevention, quality of life, and its cost-effectiveness. phase 4 will also assess to what extent the program is disseminated worldwide when made available on the internet.

Eligibility criteria:
inclusion criteria * child seen by pediatrician, family physician, or psychologist for the treatment of encopresis * access to the internet, either through a family computer or a community computer exclusion criteria * diagnosis of either mental retardation (iq \< 85) or * a primary illness responsible for fecal soiling (e.g., spina bifida)

Keywords: encopresis internet web treatment intervention
scrub typhus infection induced cardiovascular disease

Conditions: Scrub Typhus; Cardiovascular Complication

Summary: scrub typhus infection has been considered as seasonal and endemic infectious disorder with benign feature. however, the increasing mortality rate of scrub typhus has been recently reported in southeast asia and cause of death could be a fetal complicating cardiovascular disease. therefore, the association and predictors for scrub typhus induced cardiovascular disease should be investigated to provide a timely and appropriate diagnosis and to reduce the mortality rate of complicated scrub typhus infection. therefore, investigators prospectively investigate the association and predictors of cardiovascular disease in the participants with scrub typhus infection.

scrub typhus is a zoonotic disease caused by orientia tsutsugamushi confined to east asia including south korea. it is characterized by fever, headache, rash, and eschar and the majority of patients without complications can recover with an early diagnosis and proper management with antibiotics. however, the increasing mortality rate of scrub typhus has been recently reported in southeast asia. severe complications can be manifested by respiratory distress syndrome, renal failure, hepatic failure, and cardiovascular disease. especially, cardiovascular complications can lead to cardiogenic shock and sudden cardiac arrest. therefore, the association and predictors for scrub typhus induced cardiovascular disease should be investigated to provide a timely and appropriate diagnosis and to reduce the mortality rate of complicated scrub typhus infection. therefore, investigators prospectively investigate the association and predictors of cardiovascular disease in the participants with scrub typhus infection admitted to 3rd referral centers in south korea.

Eligibility criteria:
inclusion criteria: * any participants with scrub typhus infection exclusion criteria: * patients under age of 18 * pregnancy

Keywords: scrub typhus cardiovascular complication
a strength-based intervention to improve job interview skills in young adults in a community setting

Conditions: Autism Spectrum Disorder

Summary: the investigators are looking to evaluate how effective a strength-based intervention may be in improving job interview skills in young adults. the investigators are examining the effects of this intervention in young adults who may have difficulty with job interviews, and who may want to improve these skills.

the investigators have developed kf-stride, a promising web-based intervention which focuses on helping autistic transition age youth improve interview skills by 1) learning to identify their unique employable strengths, and 2) practice speaking about those strengths to potential employers in socially appropriate ways. the inability to express one's strengths to a potential employer can negatively affect interview performance and lead to difficulty with job obtainment. importantly, kf-stride is web-based, so it is highly scalable, and uses well-established principles of positive psychology. the investigators' pilot data evaluating kf-stride in a lab-based setting indicates that after using kf-stride, users experience increased knowledge of their personal strengths and improved job interview skills. however, kf-stride's effectiveness in a real-world setting has not been established. kessler foundation (kf) center for autism research will partner with spectrum works (or other community partner) (see letter of support) to implement and evaluate kf-stride in a real-world setting. spectrum works is a non-profit organization which provides job training and employment opportunities to autistic youth. in the current study, kf-stride will be implemented at spectrum works (or other community partner) by spectrum work staff members (trained by kf staff).

Eligibility criteria:
inclusion criteria: lives in the united states of america between the ages of 14-26 speaks english well and at a 4th grade reading level exclusion criteria: had a stroke, traumatic brain injury, or neurological injury or disease in the past(like brain tumor or epilepsy) has a history of significant psychiatric illness(like schizophrenia or psychosis) has uncontrolled seizures or other unstable medical complications
effect of exenatide monotherapy on glucose control in subjects with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to evaluate the safety and efficacy of a 28-day regimen of exenatide (ac2993), given as a monotherapy to subjects with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * subject has type 2 diabetes mellitus treated with diet and exercise modification alone or in combination with one oral antidiabetic agent for no longer than 4 years. exclusion criteria: * subject has a clinically significant history or presence of any of the following conditions: (a) hepatic disease, (b) renal disease, (c) central nervous system disease, (d) gastrointestinal disease (e) pulmonary disease (f) hematologic disease. * subject is currently treated with any of the following excluded medications: (a) metformin/sulfonylurea combination therapy (b) thiazolidinediones (c) insulin as outpatient therapy (d) regular use of drugs that directly affect gastrointestinal motility (e) regular use of systemic corticosteroids by oral, intravenous (iv), or intramuscular (im) route, or potent, inhaled, intrapulmonary, or intranasal steroids known to have a high rate of systemic absorption (f) regular use of medications with addictive potential such as opiates, narcotics and tranquilizers (g) antineoplastic agents (h) transplantation medications (i) prescription weight-loss medications.

Keywords: diabetes exenatide amylin lilly
maturational changes in cardiac structures -- blood pressure relationship -- scor in hypertension

Conditions: Cardiovascular Diseases; Heart Diseases; Hypertension

Summary: to examine a school-based population of children for maturational changes in blood pressure and cardiac structures.

background: although excessive left ventricular mass has been viewed as an adaptation to increased blood pressure, it can precede the rise in blood pressure in hypertensive models. excessive growth of the heart may reflect additional factors contributing to eventual level of blood pressure. in children, rapid heart growth may be predictive of subsequent high childhood blood pressure level and greater incidence of cardiovascular disease in adult relatives. these studies had the potential of defining maturational changes in known risk factors which might help predict future hypertensive disease. the study was a subproject within a specialized center of research (scor) in hypertension. the request for applications for the scor was released in october, 1988. design narrative: a total of 124 prepubertal males and females were followed longitudinally for five years. yearly examinations defined the stages of sexual maturation. on four occasions each year, subjects were studied for resting and ambulatory blood pressure, echocardiography, anthropometry and activity assessment. once yearly, each subject had blood drawn for hormone analyses and whole blood viscosity estimate. from these data, growth velocities of the heart and rate of change of blood pressure were determined. these parameters were analyzed to determine if rapid growth of the heart preceded or followed the rise in blood pressure observed during puberty and body size and composition, sexual maturation and hormone changes, and sympathetic activity. the study was a subproject within a scor in hypertension. approximately 7 percent of total dollars were awarded for this subproject. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
lasertherapy for vulvodynia

Conditions: Vulvodynia

Summary: the study aims to assess the efficacy, acceptance and safety profile of vulvovaginal laser therapy in women with vulvodynia.

randomized double blinded sham-controlled clinical study main hypothesis: laser therapy will be more effective than sham laser therapy in vulvar pain reduction measured by q-tip test and tampon test secondary study hypotheses laser therapy, in comparison to sham laser therapy * will lead to more improvement of sexual health and hrqol * will have similar rates of side effects

Eligibility criteria:
inclusion criteria: * women with vulvodynia (diagnosed according to the 2015 consensus terminology) * multidisciplinary treatment for at least 3 months * informed consent exclusion criteria: * current genital infection (i.e. candidiasis, herpes ) * inflammatory vulvar disease/ dermatosis (i.e. lichen sclerosus, lichen planus) * neoplastic vulvar disease (e.g. hsil vulva, paget disease) * recent vulvar trauma (i.e. bleeding, erosion or ulceration) * pudendal neuralgia * pregnancy, delivery \<6 months * epilepsy or major neurologic or psychiatric morbidity * active systemic infection * previous treatment with ionizing radiation in the area to be treated * history of wound healing disorders (i.e. hyperpigmentation, abnormal scarring) * fever * systemic or local autoimmune disorders * history of photosensitivity disorder

Keywords: erbium:yag laser
comparison between two strategies for the diagnosis of tb

Conditions: Pulmonary TB

Summary: tuberculosis (tb) is a major cause of death among the "communicable" diseases in the world. pulmonary tb, the main localization, leads to the dissemination of cases. an earlier diagnosis of contagious pulmonary tb is a cornerstone to stop the air transmission. the aim of the study will be to compare two strategies, in patients with a chest-x-ray in favour of contagious pulmonary tb: the classical strategy of sputa collection during three consecutive early mornings, versus the studied strategy of sputa collection at hour h, hour h+1, hour h+2 during the first early morning.

tuberculosis (tb) is a major cause of death among the "communicable" diseases in the world. pulmonary tb, the main localization, leads to the dissemination of cases. an earlier diagnosis of contagious pulmonary tb is a cornerstone to stop the air transmission by starting earlier treatment. the aim of the study will be to compare two strategies, in patients with a chest-x-ray in favour of pulmonary tb: the classical strategy of sputa collection during three consecutive early mornings, versus the studied strategy of sputa collection at hour h, hour h+1, hour h+2 during the first early morning.

Eligibility criteria:
inclusion criteria: * all adult patients suspected of pulmonary tb (symptoms: lost weight, hemoptysis, chronic cough or fever, or a chest-x-ray (cxr) evocative of pulmonary tb) exclusion criteria: * patients who refused or were unable to give written consent
a study to evaluate the rna signature of rheumatoid arthritis from synovium and whole blood

Conditions: Rheumatoid Arthritis

Summary: rheumatoid arthritis is a systemic disease, it is not clear whether the gene expression profile exhibited by circulated peripheral blood cells and that expressed by the inflamed synovium mirror one another. understanding this relationship would be useful not only in potentially having a relatively non-invasive means to predict response to therapy but it might be useful in better understanding differences in ra expression amongst patients with this disease, thus perhaps assisting in target identification through a better understanding of disease processes.

rheumatoid arthritis (ra) is a chronic systemic inflammatory disease affecting approximately 1% of the adult population. the disease is characterised by inflammation of synovial tissue (st) in multiple joints, which often leads to destruction of joint integrity, contributing to serious functional impairment and disability. the contributors to its pathology include joint inflammation, abnormal cellular and humoral responses, and synovial hyperplasia. ultrasonography is a powerful, non-invasive, and feasible way to evaluate synovial hyperplasia and guide its collection by biopsy.

Eligibility criteria:
inclusion criteria * adult men and non-pregnant, non-lactating women between 18 and 75 years of age. sexually active females must be of either non-childbearing potential or willing to comply with the contraceptive requirements * body weight greater \>40 kg and \<120 kg with a body mass index (bmi) between 19-31 kg/m2 * clinical history of rheumatoid arthritis as defined by acr criteria * negative urine pregnancy test for women of child bearing age (except those with documented proof of hysterectomy or bilateral oophorectomy) for populations b and c only * currently on a stable dosing regimen of methotrexate 7.5 to 25 mg once weekly, as their only dmard (no changes in dosing regimen for 4 weeks prior to screening). exclusion criteria * history of an acute illness within 2 weeks prior to the study * history of drug abuse within 2 years * donation of blood in excess of 500 ml within 56 days prior to the first dose of study medication for group a only * prior treatment with disease modifying anti-rheumatic agents or biologicals.

Keywords: rheumatoid arthritis rna synovium peripheral blood mononuclear cells
paracetamol hypothermia children

Conditions: Safety Issues

Summary: transient acetaminophen induced hypothermia in pediatrics population undergoing general anesthesia


Eligibility criteria:
inclusion criteria: - exclusion criteria: -
efficacy and safety of short course antibiotic therapy in preterm neonates with early onset sepsis

Conditions: Early-Onset Neonatal Sepsis; Antibiotic Stewardship

Summary: objective of the study is to compare the efficacy and safety of 'short duration antibiotic' (72hrs) and 'standard duration antibiotic'(5 - 7days) in preterm neonates ( \>28weeks and \>1000grams ) with culture negative early onset sepsis.

enrolled participants will be randomly allocated to one of two study groups: 1) short duration antibiotic' (72hrs), 2) standard duration antibiotic'(5 - 7days) short duration antibiotic group: antibiotic therapy stopped at the time of randomization i.e. 72 hours after starting antibiotics standard duration antibiotic group: antibiotics therapy continued for 5-7 days further after 72 hrs of starting antibiotics.

Eligibility criteria:
inclusion criteria (all must be present) * all preterm neonates (gestational age \>28weeks and \>1000grams) * age less than 72hours of life * started on antibiotic therapy based on presence of symptoms attributable to sepsis and /or positive sepsis screen but sterile blood culture * symptoms resolved at time of randomization exclusion criteria: * antibiotics started based on risk factors * infants with major congenital anomalies or syndromes. * presence of site specific infections including meningitis, pneumonia * neonates suspected to have inborn errors of metabolism * neonates with severe birth asphyxia, (apgar score at 5min \<4 and cord ph\< 7.0,base excess \<-16) * neonates underwent major surgery in 1st week of life * deemed by doctor in charge to be sick enough to be continued on antibiotics
hormone replacement therapy and insulin action: a double-blind, parallel, placebo-controlled hormone intervention study in postmenopausal women

Conditions: Menopause

Summary: considerable controversy exists regarding the effect of estrogen and progesterone on insulin sensitivity in postmenopausal women. thus, the goal is to examine the effect of estradiol and progestin on in vivo insulin sensitivity and pathways of intracellular glucose metabolism in postmenopausal women. this will be accomplished by examining the effects of unopposed estrogen (cee) or combination estrogen and progestin (cee/mpa) versus placebo therapy in 30 early menopausal women (defined from 6 months to 3 years post-cessation of menses). women will be treated for 16 weeks and the outcome measures will be: 1) insulin sensitivity and glucose oxidation as determined by euglycemic clamp, 2) assessments of insulin sensitivity on muscle biopsy cultures with the primary endpoints being glucose uptake and glycogen accumulation/synthesis, 3) protein levels of insulin action cascade steps based on muscle biopsy western blots.


Eligibility criteria:
inclusion criteria: * 6 months to 3 years since cessation of menses * bmd 24-33 * no surgically induced menopause
phase iii study of topical gel for treatment and prevention of raynaud's phenomenon

Conditions: Raynaud's Disease

Summary: the purpose of this study is to investigate the efficacy and safety of a topical gel formulation of nitroglycerin, in comparison to a matching placebo, for patients with moderate to severe primary raynaud's phenomenon or patients with raynaud's phenomenon secondary to autoimmune diseases, such as scleroderma.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of raynaud's phenomenon * 2 or more raynaud's events on a typical winter day * agree to discontinue current treatments for raynaud's * negative pregnancy test and agree to use effective contraception during study exclusion criteria: * current use of nitrate medications or medications known to interact with nitroglycerin * patients who currently use medications, like calcium channel blockers, that might interfere with study medication * patients with a known allergy to nitroglycerin or common topical ingredients * patients with a history of migraine headaches * patients with a history of unstable medical problems * patients with cognitive or language difficulties that would impair completion of assessment instruments * patients with lab screening values more than 20% outside normal range * patients with non-epithelialized skin lesions, in the area where the gel is to be applied, at the time of screening * pregnant or nursing women * women of child-bearing potential who are unwilling to comply with the contraceptive requirements

Keywords: raynaud's phenomenon raynaud's disease scleroderma raynaud's disease secondary to scleroderma raynaud's disease secondary to other autoimmune disease