Kornimate/medical-research-clean huggingface dataset:
miniscrew stability and peri-implant inflammation when precoated k21 vs ethanol control

Conditions: Inflammation Caused by the Placement of a Temporary Anchorage Device

Summary: to determine if coating miniscrews with k21 would increase the success rate of orthodontic miniscrews by reducing adjacent tissue inflammation.

the study design is a split mouth study where 2 miniscrews, one pretreated with k21 the other pretreated (experimental) with ethanol (placebo) are placed in the mouth for orthodontic therapy. all participants will receive 2 or more orthodontic miniscrews with equal numbers of experimental and control pretreatment solutions. mobility will be assessed at the 4 and 8 week follow up appointments by gentle manipulation with cotton pliers. clinical success will be defined as maintenance of stability for a period of 8 weeks. peri-implant inflammation will be assessed at follow up appointments by looking for signs of soft-tissue inflammation (redness, swelling) where possible.

Eligibility criteria:
inclusion criteria: 1. good general health, with no significant medical findings 2. requiring at least two miniscrews in their treatment plans (i.e., most participants will have two miniscrews, but some may receive four or six as indicated by their individual treatment plan) 3. miniscrew pairs indicated with comparable anatomical positions and comparable mechanics (direct vs. indirect anchorage). exclusion criteria: 1. recent or ongoing use of antiresorptive pharmacological agents contraindicating the use of orthodontic miniscrews 2. less than 12 years of age 3. heavy tobacco use (\>10 cigarettes/day) 4. peri-implant tissues must be observable at follow-up appointments 5. being unable or unwilling to consent to the study

Keywords: tad inflammation orthodontics
uterocervical angle in patients with preterm premature rupture of the membranes

Conditions: Preterm Labor

Summary: to evaluate the performance of uterocervical angle (uca) in the prediction of labor timing in patients with preterm premature rupture of the membranes


Eligibility criteria:
inclusion criteria: * no previous systemic illnesses * preterm premature rupture of the membranes exclusion criteria: * abnormal pap smear * previous cesarean section * history of dilatation and curettage (d\&c) * history of loop electrosurgical excision procedure (leep) and cervical conization
multicenter, post-marketing, non-interventional, observational study in ra patients treated with roactemra/actemra (tocilizumab)

Conditions: Rheumatoid Arthritis

Summary: this non-interventional study will observe the usage and efficacy of roactemra/actemra in patients with rheumatoid arthritis (ra) who have recently begun treatment. the treatment regimen will be directed by the treating physician according to clinical practice. patients are expected to be observed for approximately 6 months after beginning treatment.


Eligibility criteria:
inclusion criteria: * patients at least 18 years of age * patients with a diagnosis of moderate to severe ra according to the revised (1987) acr criteria * patient in whom the treating physician has made the decision to commence roactemra/actemra treatment (in accordance with the local label). this can include patients who have received roactemra/actemra treatment within 8 weeks prior to the enrolment visit * patient has given informed consent exclusion criteria: * patients who have received roactemra/actemra more than 8 weeks prior to the enrolment visit * patients who have previously received roactemra/actemra in a clinical trial or for compassionate use * patients who have received treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational agent, whichever is longer) before starting treatment with roactemra/actemra * patients with a history of autoimmune disease or of any joint inflammatory disease other than ra
a study to evaluate solriktug in adult participants with asthma

Conditions: Asthma

Summary: phase 2 study to evaluate the safety, tolerability, pk, immunogenicity, and pharmacodynamics of solriktug with adult participants with asthma.

this is a 12-week randomized, double-blind, placebo-controlled phase 2 clinical study to evaluate the safety, tolerability, pk, immunogenicity, and pharmacodynamics of 3 dose levels of solrikitug versus placebo on top of standard of care in adult participants with asthma. approximately 124 adult participants with asthma will be randomized. participants will receive solrikitug, or placebo, administered via subcutaneous injection at the study site, over a 12-week treatment period. the study also includes a post-treatment follow-up period of 16 weeks.

Eligibility criteria:
key inclusion criteria: * participant must be aged 18 to 75 years of age. * documented diagnosis of asthma at least 12 months prior to screening. * participants must be on maintenance asthma medications, for at least 3 months prior to screening: inhaled corticosteroid (ics) in combination with long-acting beta agonist (laba), or as part of an approved triple therapy for asthma (ics/laba/long-acting muscarinic antagonist \[lama\]). * participant has an acq-6 score ≥1.5 at screening visit. * participant has fev1 of ≥50% to 90%, inclusive, of predicted normal value at screening visit 1. * evidence of asthma as documented by reversibility in fev1 of ≥12% and ≥200 ml over the pre-salbutamol fev1 at screening visit. key exclusion criteria: * female participant who is pregnant or breastfeeding. * participant is a current smoker, or former smoker with a smoking history of ≥10 pack-years. * participant has a known hypersensitivity to any component of the formulation of solrikitug, including any of the excipients, or a history of anaphylactic reaction to any therapeutic monoclonal antibody. * participant has history or evidence of any clinically significant cardiovascular, hematologic, hepatic, immunologic, metabolic, urologic, neurologic, dermatologic, psychiatric, renal and/or other major disease or malignancy, or any other condition (risks factors of pneumonia) that in the opinion of the investigator might obfuscate the study data. * participant has an exacerbation of asthma requiring use of ocs or hospitalization in the 6 weeks prior to screening or during the screening period. * participant has history or evidence of any clinically significant pulmonary condition, other than asthma. * lower respiratory tract infection within the 6 weeks prior to screening.
sex steroid hormones and risk of chd in women

Conditions: Cardiovascular Diseases; Heart Diseases; Coronary Disease; Postmenopause; Coronary Arteriosclerosis

Summary: to investigate the relationship between endogenous estrogen and androgen levels and risk of coronary heart disease among postmenopausal women in the women's health initiative-observational study (whi-os).

background: the role of endogenous gonadal hormones in the etiology of atherosclerotic disease needs clarification. previous studies of women have been small, rarely prospective, and had other methodological problems. results have been inconsistent. observational and clinical trial data on exogenous hormones, also inconsistent, are probably irrelevant to endogenous hormonal effects. on the other hand, despite hormonal differences being evoked as the reason for women having less atherosclerotic disease than men, it is not apparent from existing data that between-person variability in endogenous hormones is likely to be a strong risk factor for atherosclerotic disease in women. furthermore, the atherosclerotic process begins early in life, and postmenopausal hormone differences are only one aspect of possible hormonal effects on disease. nevertheless, this study has the potential to provide important new information on the role of endogenous hormones on atherosclerotic disease in postmenopausal women. design narrative: the study used a nested-case control design to measure baseline sex steroid hormone levels (serum total and free estradiol, estrone sulfate, total and free testosterone, dehydroepiandrosterone sulfate) and sex hormone binding globulin to determine whether these predicted subsequent risk of coronary heart disease (chd). a total of 350 case subjects and 350 control subjects were selected from women who were free from cardiovascular disease and cancer at study entry and were not using hormone replacement therapy at baseline. cases were those women who subsequently developed a documented myocardial infarction or underwent coronary artery revascularization (n=350), while control subjects were selected from study participants who remained free from chd during follow-up. controls were matched 1:1 for age, ethnicity, smoking and follow-up time. the study also examined correlations between sex steroid hormone levels and other previously funded analyses of biomarkers, including thrombotic and inflammatory markers, lipoproteins, fasting glucose and insulin. detailed baseline data including anthropometrics and behavioral factors allowed control for confounding. 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
safety and efficacy study of lx102-c01 treatment of neovascular age-related macular degeneration (namd)

Conditions: Neovascular Age-related Macular Degeneration

Summary: the goal of this study is to evaluate the safety and efficacy of lx102-c01 treatment of namd. this study will enroll subjects aged ≥ 50 years old to receive a single unilateral intravitreal (ivt) injection of lx102-c01 to evaluate its safety and efficacy.


Eligibility criteria:
inclusion criteria: 1. willing to sign the informed consent, and willing to attend follow-up visits. 1. age ≥ 50 2. diagnosis of active cnv secondary to neovascular amd 3. the study eye must have a best-corrected e-etdrs visual acuity letter score of less than or equal to 63. 4. subjects must have received a minimum of 2 injections within 6 months prior to screening. 5. demonstrated a meaningful response to anti-vegf therapy exclusion criteria: 1. cnv or macular edema in the study eye secondary to diseases other than namd 2. retinal detachment, uveitis, uncontrolled glaucoma in the study eye, or any condition preventing visual acuity improvement 3. acute coronary syndrome, myocardial infarction or coronary artery revascularization, cva, tia in the last 6 months 4. uncontrolled hypertension defined as average sbp ≥160 mmhg or an average dbp ≥100 mmhg 5. uncontrolled diabetes defined as hba1c \>7.5%
evaluation of the safety of relaxin in preeclampsia

Conditions: Pre-Eclampsia

Summary: the purpose of this study is to determine whether different doses of recombinant human relaxin is safe when given to women with severe preeclampsia

the effects of relaxin may be beneficial in the treatment of women with preeclampsia. this study will preliminarily evaluate the maternal, fetal and neonatal safety and tolerability of an iv infusion of relaxin compared with placebo given to women with severe preeclampsia.

Eligibility criteria:
inclusion criteria: * diagnosis of preeclampsia * hospital admission for expectant management exclusion criteria: * eclampsia or history of seizures * vaginal bleeding * multifetal gestation * requirement for immediate delivery

Keywords: relaxin preeclampsia
telemedicine approaches to evaluating acute-phase rop erop implementation project

Conditions: Retinopathy of Prematurity

Summary: evaluating retinopathy of prematurity (erop) ancillary study implementation project is a multi-center observational study will focus on feasibility, and relative cost-effectiveness of an retinopathy of prematurity (rop) telemedicine evaluation system to detect eyes of at-risk babies and provide timely feedback to the examining ophthalmologist at the clinical center.

study design: observational cohort study setting/participants: premature babies who are at high risk for rop during their stay in the neonatal intensive care unit (nicu). * the number of sites - 5 centers in the us * the number and description of participants: 500 babies with birth weights of \<1251g study interventions and measures: data from retcam digital images obtained as part of clinical care during the routine diagnostic eye exam for rop will be uploaded and transmitted via secure server to a central reading center. these de-identified images will be graded by certified image readers. results of image gradings will be sent back via secure web-based platform to the clinical center. the primary outcome measure is the turnaround time from uploading the images to feedback to the clinical center. the secondary outcome measure is the time required to obtain retinal images for babies scheduled for rop examination in the nicu (relative cost-effectiveness).

Eligibility criteria:
inclusion criteria: 1. babies with birth weights of \<1251g 2. babies having clinical examinations to screen for rop exclusion criteria: * referral from an outside hospital for treatment of serious rop that is performed before imaging can be obtained. * congenital non-ocular anomalies: babies will be excluded from this study if they have a severe congenital non-ocular anomaly. such exclusions include anencephaly, trisomy 13, trisomy 18, or severe cardiac or pulmonary abnormalities. the neonatologist caring for the baby will determine whether a particular congenital abnormality would exclude the baby from participation in this study. * ocular abnormalities: babies will be excluded from this study if they have major congenital abnormalities in one or both eyes including microphthalmos, anophthalmos, anterior segment dysgenesis, dense corneal opacity, cataract, glaucoma, chorioretinitis, optic nerve hypoplasia, and chorioretinal coloboma. eyelid abnormalities, such as severe blepharoptosis or severe hemangioma, that would likely affect vision, would also exclude a baby from participation. minor abnormalities that would not be expected to affect vision may not be exclusion criteria including mittendorf dot, mild blepharoptosis, limbal dermoid, and iris coloboma.

Keywords: rop retinopathy referral warranted retinopathy
study of the impact of a pain diary in pediatric patients

Conditions: Pain

Summary: the purpose of this study is to show the impact of a pain diary on the communication of pain by pediatric patients. participants will be given a pain diary after consent and asked to complete the record each time they have pain. a survey about the efficacy of the pain diary will be taken prior to discharge by the nurse, physician, patient and parents. the hypothesis is that the pain diary will improve the communication.


Eligibility criteria:
inclusion criteria: * inpatients at the blair e. batson hospital for children 3-19 years of age, receiving regular controlled substance analgesic defined as: codeine with acetaminophen, fentanyl, hydromorphone, meperidine, morphine, oxycodone with acetaminophen, propoxyphene with acetaminophen, and hydrocodone with acetaminophen. exclusion criteria: * admitted to the pediatric intensive care unit * surgical patients, defined as patients having surgery since admission other than minor procedures * patients anticipated to receive pain medication for less than 24 hours * patients unable to verbally communicate their pain

Keywords: pain pediatric pain pain diary pediatric pain measurement pain measurement
prepare-scale: scaling up integrated prep delivery in kenyan maternal and child health clinics

Conditions: Hiv

Summary: this project aims to develop a community of practice; then test a combination of community of practice, quality improvement, and a training toolkit, to enhance implementation and clinical outcomes; and identify patterns attributes associated with successful implementation.

aim 1: to develop and determine the impact of a community of practice (cop) on stakeholder and healthcare worker engagement and knowledge of integrated pre-exposure prophylaxis (prep) delivery. aim 2: to determine the impact of a 3-component scale-up package on implementation outcomes and prep patient outcomes among pregnant and postpartum populations. aim 2a: to determine the impact of the scale-up package on prep implementation outcomes, including reach, service penetration, adoption (primary outcomes), and prep fidelity and maintenance (secondary outcomes). aim 2b: to determine the impact of the scale-up package on prep patient outcomes, including prep initiation and continuation. aim 3: to identify difference-making bundles of facility- and regional-level attributes and implementation processes that influence reach, fidelity implementation, and maintenance.

Eligibility criteria:
inclusion criteria: health care workers: * work at a facility involved in study * involved in prep service delivery * \>=18 years clients: * female clients seeking health services at study facilities * pregnant or postpartum * \>15 years (includes emancipated minors) exclusion criteria: * n/a
epidemiology study on insulin-like growth factor-1 in children with idiopathic short stature (epigrow study)

Conditions: Idiopathic Short Stature

Summary: the purpose of the protocol is to describe the distribution of igf-1 deficiency in the studied population of idiopathic short children without growth hormone deficiency or any other identified cause of short stature and not treated with recombinant growth hormone or igf-1


Eligibility criteria:
inclusion criteria: * short children, height ≤ -2.5 sds * age ≥ 2 years * with at least one normal or elevated peak gh response to a stimulatory test (peak gh ≥ 7 ng/ml) at the time of the study and/or at a given time-point during the last 12 months * pre-pubertal * signed informed consent, including agreement to have blood samples taken for hormonal measurement and genetic analysis, by both parents or by legally acceptable representatives when applicable and the child when applicable exclusion criteria: * the following identified causes of short stature: * gh-deficient short stature * other endocrine causes (hypothyroidism, cushing's syndrome, parathyroid or vitamin d disorders, hypogonadism) * identified syndromes with genetic abnormalities (including turner, noonan and russell-silver syndromes) * chronic diseases including malnutrition, coeliac disease, chronic inflammation, muscular dystrophy, thalassaemia, blood disorders, severe liver or kidney disease and severe cyanotic heart disease * chronic diseases requiring treatment with chronically administered corticosteroids * skeletal dysplasia * psychosocial short stature * patients having received irradiation, including total body irradiation * patients currently on gh or igf-1 therapy or having received gh or igf-1 therapy in the last 12 months * patients likely to require gh, igf-1 or chronic corticosteroid treatment during the study * any mental condition that prevents both parents or legally acceptable representatives and the child when applicable from understanding the nature, scope and possible consequences of the study, or any evidence of an uncooperative attitude
wearable device and self-regulation strategies to promote physical activity among children with cancer: a pilot study

Conditions: Cancer

Summary: this is a clinical trial that tested whether a 12-week exercise program using smart wristbands and personalized goal-setting could help children with cancer become more active, feel more confident about exercising, and improve their quality of life. the study included 72 children and teenagers (ages 6-18) receiving cancer treatment at two hospitals in china. they were divided into two groups: intervention group (33 children): used a smart wristband to track daily steps, followed a personalized exercise plan, and received weekly guidance. control group (39 children): continued with usual care (no special exercise program). the main questions it aims to answer are: 1. does the exercise program help children with cancer move more and sit less; 2. can it boost their confidence to stay active and improve their physical and emotional well-being?

what did the study find? * children in the exercise group: * increased active time: they did more moderate-to-vigorous exercise (like brisk walking or playing) by the end of the program. * walked more steps daily: from about 2,200 steps/day at the start to over 6,300 steps/day after 12 weeks. * felt more confident: they believed they could keep exercising even during treatment. * improved well-being: parents and children reported better physical energy, mood, and social interactions. * comparison with the control group: * the exercise group showed much greater improvements than the group without the program. what does this mean for families? this study suggests that combining wearable devices (like step trackers) with simple goal-setting and family support may help children with cancer stay active during treatment. staying active could reduce fatigue, improve mood, and support recovery. what's next? while these results are promising, larger studies are needed to confirm the long-term benefits and safety of such programs.

Eligibility criteria:
inclusion criteria: * age between 6 and 18 years old; * children diagnosed with leukemia, lymphoma, or solid tumor confirmed by pathology or bone marrow examination; * obtaining informed consent from the child and their guardian; * approval from the attending physician for participation in physical activity interventions. exclusion criteria: * children diagnosed with mental health disorders; * individuals with severe physical disabilities incompatible with physical activity participation; * cases involving metastasis to bone tissue that would restrict movement.

Keywords: physical activity childhood cancer quality of life physical activity self-efficacy integrated theory of health behavior change