Kornimate/medical-research-clean huggingface dataset:
a randomized trial of low-dose bevacizumab vs laser for type 1 rop

Conditions: Retinopathy of Prematurity

Summary: this randomized clinical trial will compare retinal outcomes with low-dose intravitreous bevacizumab (0.063 mg) versus laser photocoagulation as treatment for infants with type 1 retinopathy of prematurity (rop). the study also will assess neurodevelopment, refractive error, visual acuity, and peripheral visual fields.

infants with type 1 rop and no prior treatment for rop will be randomly assigned (1:1) to treatment with either intravitreous bevacizumab 0.063 mg or peripheral retinal laser ablation. study exams will be at weeks 1, 2, and 4 weeks, and at 2 and 4-months post-treatment (and re-treatment when indicated). additional study exams will occur at adjusted age 6 months, 1 year, and then annually for 5 more years. non-study examinations will be at clinician discretion and are likely to occur more often. the primary outcome will be treatment success, defined as no worsening of rop 5-13 days after treatment (or re-treatment if indicated), no plus disease or severe neovascularization 2 weeks to 6 months after treatment (or re-treatment if indicated), and no unfavorable structural outcome (or prior scleral buckle or vitrectomy) at 6 months adjusted age. important secondary outcomes include the number of re-treatments, extent of retinal vascularization, refractive error, neurodevelopment assessed by the bayley-4 test, iq and neuropsychiatric testing, visual acuity, visual fields, and systemic morbidities.

Eligibility criteria:
inclusion criteria: * birth weight \< 1251 grams * newly diagnosed (within 2 days) type 1 rop in one or both eyes; meeting the following criteria: * zone i, any stage rop with plus disease, with retinal vessels or rop in zone ii in any quadrant, or * zone i, stage 3 rop without plus disease, with retinal vessels or rop in zone ii in any quadrant or * zone ii, stage 2 or 3 rop with plus disease exclusion criteria: * previous treatment for rop * stage 4 or 5 rop in either eye * all rop in zone i in either eye (no retinal vessels or rop extend into zone ii in any quadrant) * either treatment could not be done within 2 days of diagnosis of type 1 rop * investigator unwilling to randomize or parent unwilling to accept random assignment to either treatment * transfer to another hospital not covered by study-certified examiners anticipated within the next 4 weeks * active ocular infection or purulent nasolacrimal duct obstruction in either eye one eye will be excluded, and other eye may be eligible, if either of the following are present: * visually significant ocular anomaly (e.g., cataract, coloboma) * opacity that precludes an adequate view of the retina
right versus left apical transvenous pacing for patients with preserved left ventricular systolic function study

Conditions: Bradyarrhythmia

Summary: the purpose of this study is to compare chronic (1-year) effects on left ventricular ejection fraction resulting from transvenous pacing of the right ventricular apex (rva) versus the left ventricular apex (lva) in patients with preserved or mildly reduced left ventricular systolic function (\>= 45%).

it is well established that chronic right ventricular apical pacing has an adverse effect on left ventricular systolic function. an alternative is pacing the left ventricular apex, which has shown more favourable results in terms of left ventricular pump function than the rva in small series. the left ventricular apex may be paced via the coronary sinus tributary (e.g. in the anterior cardiac vein). our study will compare effects of these two pacing sites on left ventricular ejection fraction measured by 3d-echocardiography.

Eligibility criteria:
inclusion criteria: * requirement for ventricular pacing according to current guidelines (including chronic atrial fibrillation) * anticipated \>=50% daily ventricular pacing * lvef \>=45% as evaluated by 2d-echocardiography, 3d-echocardiography, magnetic resonance imaging or by radionuclide/contrast ventriculography * minimum age of 18 years, and at least 1 year life expectancy exclusion criteria: * prior tricuspid valve replacement (annuloplasty is permitted) * intrinsic rhythm \< 30bpm * patients with permanent atrial fibrillation who undergo ablation of the atrioventricular node. * echocardiographic window of insufficient quality for measuring lvef * life expectancy of \< 1year * pregnancy (women of childbearing potential will undergo pregnancy testing) * unable of unwilling to sign a patient informed consent form
effective training models for implementing health-promoting practices afterschool

Conditions: Obesity, Childhood

Summary: this study of the dissemination of the out-of-school nutrition and physical activity initiative will utilize a 3-arm group-randomized control trial to establish the effectiveness of two learning collaborative training models (e.g. train-the-trainer in-person vs. online) for an evidence-based out-of-school time (ost) nutrition and physical activity intervention. the study will compare sites that receive the training models with a control group. investigators will work with ymca leadership to recruit 45 demographically diverse ymca ost sites from across the country. sites will be matched on racial/ethnic composition, proportion of students eligible for free or reduced price meals, program enrollment, urban/rural/suburban setting, and physical activity and food service facilities available. one-third of the sites will be randomized to participate in the online training over the school year, one-third will participate in the in-person train-the-trainer model, and one-third will serve as controls. after randomization, in fall 2016, teams of ymca ost directors and line staff will be invited to participate in the osnap learning collaborative trainings. the intervention follows the social ecological model with activities targeting multiple levels of change-school district/program sponsor, ost site, interpersonal, and individual-and emphasizing on adoption of the following osnap goals: ban sugar-sweetened drinks from snacks served and brought in from outside the snack program; offer water as a drink at snack every day; offer a fruit or vegetable option every day at snack; ban foods with trans fats from snacks served; serve whole grains; offer 30 minutes of physical activity to all children daily; offer 20 minutes of vigorous physical activity to all children 3 times per week; and eliminate television, movies, and non-educational screentime. sessions are designed consistent with the institute for healthcare improvement breakthrough series collaborative model and use constructs from social cognitive theory-knowledge and skill development coupled with action planning-to drive environmental and behavior change. teams of afterschool staff will use the out-of-school nutrition and physical activity observational practice assessment tool (osnap-opat), decision aids, policy writing guides, and other resources available at www.osnap.org to set data-driven goals and implement discrete practice, policy, and communication action steps throughout the year. staff will also receive training on the food \& fun after school curriculum available at foodandfun.org.


Eligibility criteria:
inclusion criteria: * staff from afterschool sites that are run by the ymca * staff from afterschool sites that serve elementary age children * staff from afterschool sites that run programming for the duration of the school year exclusion criteria: - staff from afterschool sites that have already had experience implementing the osnap intervention

Keywords: nutrition physical activity
evaluating the safety and tolerability and determining the pk and pd of single dose ub-221 in chronic spontaneous urticaria

Conditions: Chronic Idiopathic Urticaria

Summary: the study is to evaluate the profiles of safety, tolerability, pharmacokinetics, and pharmacodynamics of ub-221. in this study, safety profile of ub-221 and maximum tolerated dose (mtd) is to be investigated using sentinel dosing strategy. the starting dose of 0.2 mg/kg is selected based on the evaluation and comparison of various approaches including noael, mabel (minimum anticipated biological effect level), and experiences from other anti-ige mab drugs in development.

this is a phase i, randomized, single-blind, placebo-controlled, parallel group, single ascending dose study to evaluate the safety, tolerability, pharmacokinetics (pk), and pharmacodynamics (pd) of a single dose of ub-221 as an add-on therapy in chronic spontaneous urticaria (csu) subjects who fail to respond to the first line h1-antihistamine treatment. only the qualified subjects will be blinded to receive treatment. each subject will receive only one dose of ub-221 or placebo.

Eligibility criteria:
inclusion criteria: * subjects aged ≥ 18 years * subjects who are able and willing to provide the informed consent * subjects diagnosed with chronic spontaneous urticaria (csu) for more than six weeks prior to the screening visit as confirmed by investigators based on medical history. exclusion criteria: * history of significant diseases (other than csu) or major clinical conditions by the investigator's judgment, such as auto-immune disease or psychiatric and behavioral conditions from which the investigator considers the subject not suitable to participate in this study.
chronic low back pain and meditation

Conditions: Pain

Summary: the purpose of this research study is to see if and how mindfulness meditation affects pain. specifically, we are interested in assessing if mindfulness is associated with the release of naturally occurring opiates in the body, in response to intravenous (iv) administration of the opioid antagonist naloxone during a chronic low back pain provoking procedure.

the purpose of this psychophysical and pharmacologic study is to determine if meditation induced pain relief is mediated by endogenous opioids in response to intravenous (iv) administration of the opioid antagonist naloxone during a pain evoking straight leg raise test in response to double-blind intravenous administration (iv) of naloxone/placebo-saline. the aim of this study is to determine if mindfulness-based analgesia is associated with the release of endogenous opioids.

Eligibility criteria:
inclusion criteria: * participants must have a medical evaluation that demonstrates chronic low back pain that is evoked by lifting the legs. existing medical records, per physician discretion and low back examinations will confirm diagnosis * participants must be between 18 and 65 years of age * participants must rate their daily chronic pain intensity at a 3 or higher on 0-10 visual analog scale * participants must have experienced their chronic low back pain for at least 3 months * participants must have no prior meditative experience * participants must be straight leg raise test positive exclusion criteria: * participants must not be participating in any new (within 2 weeks prior or anytime after enrollment) pain management procedures during the study period * participants must not be taking opioids * participants must not be pregnant or nursing mothers * participants must have not had back surgery within the last year before their enrollment into the study * participants must have not had any other sensory or motor deficits that preclude participation in this study * participants must not have known anomalies of the central nervous system including: stroke, dementia, aneurysm, and a personal history of psychosis * participants must not have any known allergies to naloxone or similar drugs * participants must not have a history of syncope and/or fear of needles/blood

Keywords: mindfulness opioids pain naloxone
effectiveness of tu and mrt to release trigger points to increase rom and pain relief in upper tt

Conditions: Pain

Summary: to find out the effectiveness of therapeutic ultrasound and myofascial release technique to release trigger points to increase range of motion and pain relief in upper trapezius tightness


Eligibility criteria:
inclusion criteria: * 1. age between 20-40years. * 2. male and female both are included. * 3. those having tenderness on a taut muscle band, rise in regular pain, local twitching response, and restricted range of motion of cervical region. exclusion criteria: * 1. those having referred pain due to any pathology of cervical. * 2. those having any healing fractures over upper back and in neck region. * 3. those who have dermatitis over upper back or any clotting disorder. * 4. any related wound in neck region or any pathology of shoulder. * 5. those who has any degenerative cervical spine disease. (2)
evaluation of the effectiveness of the power through choices program

Conditions: Pregnancy; Sexually Transmitted Infections

Summary: the purpose of this study is to evaluate the effectiveness of the power through choices (ptc) curriculum in increasing contraceptive use and delaying sexual initiation among youth living in group foster care homes.

youth in foster care are at especially high risk for teen pregnancy and associated sexual risk behaviors. the power through choices (ptc) program is a 10-session sexuality curriculum that aims to increase contraceptive use and delay sexual initiation by empowering youth to make healthy, positive choices about their sexual behaviors. this study uses a cluster randomized design to compare the effectiveness of ptc to usual programs and services provided to youth living in group foster care homes. study participants will be youth living in group foster homes recruited in four locations: kern county, ca; cook county, il; baltimore county, md; and oklahoma (statewide). the study is being conducted as part of the national evaluation of adolescent pregnancy prevention approaches funded by the office of adolescent health in the u.s. department of health and human services.

Eligibility criteria:
inclusion criteria: * resident of group foster care home exclusion criteria: * pregnant or parenting

Keywords: teen pregnancy sexually transmitted infections sexual risk behaviors
bringing the diabetes prevention program to geriatric populations - pilot

Conditions: Diabetes

Summary: the purpose of this pilot study is to test the feasibility of implementing a telehealth adaption of the diabetes prevention program (dpp) intervention among 30 nyc senior center members. the intervention will be conducted through 6 weekly webinars with a certified dpp coach. participants will receive a binder and physical activity tracker to complete self-monitoring of diet and physical activity. the primary outcome is feasibility and acceptability of the intervention measured by workshop attendance and focus group feedback. secondary outcomes include changes in diet, physical activity, and weight.


Eligibility criteria:
inclusion criteria: * men and women age ≥ 60 years * diabetes risk score \>=5 exclusion criteria: * decisional incapacity to consent
electroacupuncture for diminished ovarian reserve

Conditions: Irregular Menses

Summary: diminished ovarian reserve (dor)is a disease can not be cured. medicine for dor includes dehydroepiandrosterone (dhea), hormone replacement therapy (hrt), immunosuppressive agents and alternative therapy, etc. electroacupuncture (ea) can help patients regain regular menses, increase the estradiol (e2) level and decrease the follicle-stimulating hormone (fsh) and decrease fsh/luteotropic (lh) ratio. in this cohort study, we aim to observe the effect of ea versus other therapies for dor.


Eligibility criteria:
inclusion criteria: * age younger than 40 yr * 10iu/l ≤ fsh ≤ 40iu/l * volunteer to join the research and give the informed consent exclusion criteria: * a history of ovariectomy, receiving cytotoxic chemotherapy or irradiation * reproductive system infection or tumor * autoimmune disease * amenorrhea due to reproduction abnormality or pregnancy * patients can not adhere to treatment due to personal situation * patients have taken immunosuppressive agents in past 6 months * receive treatment for less than 1 week before withdrawal

Keywords: electroacupuncture diminished ovarian reserve cohort study
the effect of chronic nitrate supplementation on acute mountain sickness and exercise performance in hypoxia

Conditions: Hypoxia

Summary: the study will aim to describe and evaluate the effect of chronic beetroot juice supplementation on acute mountain sickness symptoms and exercise in a hypoxic environment. it is hypothesized that beetroot supplementation will decrease acute mountain sickness and increase exercise performance.


Eligibility criteria:
inclusion criteria: * women only: regular menstrual cycle or post-menopausal exclusion criteria: * stayed at altitude above 2500m in the last 6 months * traveled to altitude above 2500m in the last 2 months * unable to give informed consent * unstable medical condition.
comparison of the detection rates of 50 gr-100 gr ogtt and 75 gr ogtt that require medical treatment of gdm

Conditions: Gestational Diabetes; Glucose Intolerance During Pregnancy

Summary: both 50 gr ogtt-100 gr ogtt and 75 gr ogtt are used for detecting gestational diabetes mellitus. two approaches are approved by obstetricians. with this study, we aim to compare the gestational diabetes mellitus detection rate of these different tests.


Eligibility criteria:
inclusion criteria: * pregnant women exclusion criteria: * already diagnosed by diabetes mellitus * multiple pregnancy
developing dual-channel transcranial alternating current stimulations targeting negative symptoms in schizophrenia

Conditions: Schizophrenia; Transcranial Alternating Current Stimulations; Negative Symptoms

Summary: negative symptoms are core symptoms in schizophrenia which play an important role in clinical outcomes and impede patients to return to society. anti-psychotic medicines have shown limited effect in improving negative symptoms and cognitive functioning, whereas non-invasive neuromodulations, i.e. , transcranial alternating current stimulation (tacs), have shown promising potentials. recently new evidence of brain structural and functional alterations has been provided by neuroimaging studies. brady ro et al. found cerebellar-prefrontal network connectivity was related to negative symptoms in schizophrenia. it provides clues for developing a new tacs protocol targeting improving negative symptoms, in which dual-channel high-density alternating current stimulations were delivered over both the right dorsolateral prefrontal cortex and cerebellum simultaneously.


Eligibility criteria:
inclusion criteria: * meet the dsm-v diagnostic criteria for schizophrenia; * present with prominent negative symptoms with panss-negative scores \>20, at least one score of panss n1-n7 \>3, and reductive ratio of panss-negative in the past two weeks before recruitment \<10%; * stable usage and dosage of anti-psychotic medicines in the past two weeks and during the tacs intervention. * age within 18-60; * illness duration \>1year; * education at least 6 years; * written consent of receiving tacs intervention. exclusion criteria: * meet any dsm-v diagnostic criteria of any other psychiatric disorders besides schizophrenia ; * any history of alcohol or substance dependence in the past 3 months; * any other major physical disease (i.e., sensorimotor disorder, neurological disease); * any metal implants or any other tacs contraindication.
early detection of primary antibody deficiencies in primary care facilities by an algorithm driven selection of serologic testing in individuals at risk.

Conditions: Primary Antibody Deficiencies

Summary: rationale: primary antibody deficiencies (pad) encompass a group of rare heterogeneous diseases. the clinical presentation may vary widely, including infectious and autoimmune symptoms and increased risk of malignancy. due to the rarity of the diseases and this wide array of symptoms there is often a delay in diagnosis, of up to 12 years on average1-4. timely diagnosis of pad reduces morbidity, mortality and health care costs as effective therapies are available. the currently available screening systems for the broader group of primary immunodeficiencies (pid) have been shown to have poor diagnostic performance5-10 and are time consuming. we have thus developed an algorithm to screen patient records in a primary care setting for risk factors specifically for pad. patients with a high risk may undergo a laboratory assessment and referral if necessary, thus reducing the diagnostic delay of pad. the aim of the current study is to validate this algorithm. objective: main objective: to validate a screening algorithm for pad in a primary care setting in the netherlands. study design: mono-centre cohort study based on regular care data study population: primary care patients aged 12-70 years with the 100 highest scores based on our algorithm.


Eligibility criteria:
inclusion criteria: * age between 12 and 70 years * a total algorithm score that is within the highest 0.66% of the algorithm scores within a single general practitioner's clinic * signed informed consent * did not meet exclusion criteria during manual evaluation of the health care record exclusion criteria: * secondary causes of immunodeficiency as registered by icpc codes for: multiple myeloma, hiv-infection, anorexia nervosa, bulimia, cystic fibrosis. * the presence of one of the following during manual screening of the health care record: nephrotic syndrome, current systemic chemotherapy and stage 3-4 liver cirrhosis will be excluded. this could not be done by the algorithm as there is no icpc code available.
prediction of pain in total knee arthroplasty

Conditions: Pain, Postoperative

Summary: in this consecutive, prospective cohort study trial the investigators evaluate if preoperative pain response upon heat stimulation is predictive for acute and subacute postoperative pain after total knee arthroplasty.

the preoperative heat stimulation consists of short and long tonic heat stimulation. pain response is evaluated with an electronic visual analog scale. furthermore the investigators evaluate other factors possibly predictable for acute and subacute postoperative pain after total knee arthroplasty - demographic factors, preoperative pain related factors, psychosocial factors (hospital anxiety and depression scale and pain catastrophizing scale).

Eligibility criteria:
inclusion criteria: * ethnic danes, above 18 years and able to give informed consent scheduled for primary, unilateral total knee arthroplasty. exclusion criteria: * bilateral / revision arthroplasty * disease affection central or peripheral nerve function * alcohol and medical abuse * daily use of opioids or glucocorticoids * malignancy * bmi \> 40 * depression * dementia or other cognitive dysfunction