Kornimate/medical-research-clean huggingface dataset:
fluorestradiol (fes) pet/ct for imaging estrogen receptor status

Conditions: Breast Cancer

Summary: these are tumors which expresses estrogen receptors. estrogen receptors are found within breast cancer cells and are an important marker of which medicines may best treat a breast cancer. this study is being performed to imaging the amount of estrogen receptors expressed in the tumor. a research agent named 16α-18f-fluoroestradiol (fes) finds estrogen receptors and binds to them. then tumors with estrogen receptors can be imaged by a pet/ct scanner, a machine that can take pictures of where the fes is and how much fes is present. the results of this study may help researchers know whether fes can be used to monitor changes in estrogen receptors in tumors during treatment.


Eligibility criteria:
inclusion criteria: * patients with histologic/immunochemical proof of er+ primary or metastatic malignancy (positive staining in ≥ 1% of cells by immunohistochemistry). * patients who are to be treated with clinically approved or experimental regimens where er has an important role * ecog performance status of 0-2. * patients must provide written informed consent exclusion criteria: * age \<18 years * patients who cannot undergo pet/ct scanning (i.e. because of weight limits, claustrophobia) * pregnancy or lactation * total serum bilirubin \> 1.5 times upper limit of normal (abnormal hepatic metabolism may interfere with fes hepatic excretion). increased serum bilirubin due to gilbert's syndrome is permitted. * serum creatinine \> 1.5 times upper limit of normal.

Keywords: fluorestradiol (fes) pet/ct scan estrogen receptor 13-071
neuromuscular ultrasound for focal neuropathies

Conditions: Focal Neuropathies; Carpal Tunnel Syndrome; Cubital Tunnel Syndrome; Median Neuropathy; Ulnar Neuropathy; Peroneal Neuropathy; Radial Neuropathy; Sciatic Neuropathy; Tibial Neuropathy

Summary: the purpose of this study is to determine if a new diagnostic technique, called neuromuscular ultrasound, can improve our ability to diagnose focal nerve disease.


Eligibility criteria:
inclusion criteria: * electrodiagnostic finding of focal nerve disease * age 18 and older exclusion criteria: * skin lesions preventing ultrasound * known ultrasound gel allergy * unable to complete 6 months of follow-up
first in human study of azd9592 in solid tumors

Conditions: Advanced Solid Tumours; Carcinoma Non-small Cell Lung; Head and Neck Neoplasms; Colorectal Neoplasms

Summary: this is a first-in-human (fih) phase i, multi-center, open-label, study of azd9592, in patients with advanced solid tumors. the study consists of several study modules, each evaluating the safety, tolerability, preliminary efficacy, pharmacokinetics (pk), pharmacodynamics, anti-tumor activity, and immunogenicity of azd9592, as monotherapy or in combination with anti-cancer agents.


Eligibility criteria:
key inclusion criteria: * age ≥ 18 years * eastern cooperative oncology group (ecog) performance status: 0-1 * life expectancy ≥ 12 weeks * measurable disease per recist v1.1 * adequate organ and marrow function as defined in the protocol additional inclusion criteria for module 1: • histologically or cytologically confirmed metastatic or locally advanced egfrmut., nsclc; metastatic egfrwt. nsclc; recurrent or metastatic hnscc of the oral cavity; metastatic crc. additional inclusion criteria for module 2: • histologically or cytologically confirmed metastatic nsclc egfrmut. additional inclusion criteria for module 3: • histologically or cytologically confirmed metastatic crc. key exclusion criteria: * history of (non-infectious) ild/pneumonitis that required steroids, has current ild/pneumonitis, or where suspected ild/pneumonitis cannot be ruled out by imaging at screening. * spinal cord compression or a history of leptomeningeal carcinomatosis. * active infection including tuberculosis and hbv, hcv or hiv * brain metastases unless treated (prior treatment required only for module 1), asymptomatic, stable, and not requiring continuous corticosteroids at a dose of \> 10 mg prednisone/day or equivalent for at least 4 weeks prior to start of study treatment. * participants with cardiac comorbidities as defined in the study protocol

Keywords: cancer first in human antibody drug conjugate solid tumour phase i
fluticasone in covid treatment (flot)

Conditions: Covid19

Summary: a multicenter, open-label, randomized controlled trial to evaluate the efficacy of fluticasone propionate (metered dose inhaler - mdi) added to standard care at early stage of covid-19 in reducing the incidence of adverse outcomes (any of those following: oxygen therapy, systemic corticosteroids, hospitalization, mechanical ventilation, and mortality) in symptomatic patients either from 18 to 49 years of age with risk factors or older than 50 years.

this study has 2 arms: the standard care group followed the covid-19 guidelines of the ministry of health of vietnam and the interventional group: fluticasone propionate mdi with spacer, twice a day for 14 days. the study participants will be monitored via video call from day 1 to day 14, day 21, and day 28 after randomized.

Eligibility criteria:
inclusion criteria: 1. signing consent to participate in the study 2. having covid related-symptoms within 5 days prior to randomization 3. confirmed diagnosis of covid-19 by rapid antigen test or polymerase chain reaction (pcr) test within 5 days prior to randomization 4. over 50 years old or 18-49 years old and have one or more of risk factors for severe covid-19 exclusion criteria: 1. pregnant or breastfeeding woman 2. allergy and/or contraindications to inhaled fluticasone 3. current or previous administration of inhaled corticosteroids within the 15 days prior to randomization 4. current or previous administration of high dose systemic corticosteroids (higher than 3.75 mg dexamethasone/day or equivalent doses of other corticosteroids) and/or anticoagulants etc.. more than or equal to 2 days within 15 days prior randomization, or taking any other antiviral drugs (such as remdesivir, favipiravir, etc..) 5. indication for start of systemic corticosteroids or oxygen therapy or hospitalization dut to covid-19 within next 24 hours 6. already participated in other interventional covid studies 7. any conditions for which the investigator believes that the patient should not participate for the benefit of the patient or that would prevent, limit, or distort the evaluation of the study procedure

Keywords: covid19 fluticasone propionate inhaled corticosteroid ics
a trial of vertebroplasty for painful chronic osteoporotic vertebral fractures (vertos v)

Conditions: Osteoporosis; Vertebral Fracture

Summary: background the standard care in patients with a painful osteoporotic vertebral compression fracture (vcf) is conservative therapy. percutaneous vertebroplasty (pv), a minimally invasive technique, is a relatively new treatment option. recent randomized controlled trials (rct) provide conflicting results: two sham-controlled studies showed no benefit of pv while an unmasked but controlled rct (vertos ii) found effective pain relief at acceptable costs in patients with acute vcfs. a still ongoing masked rct (vertos iv) focuses on acute vcfs defined as ≤ 6 weeks. vertos iii focused on conservative treatment and found that half of patients still had disabling pain after 3 months or longer. these patients with sustained pain after 3 months may benefit from pv. objective to compare pain relief after pv with a sham intervention in selected patients with a chronic osteoporotic vcf ( three months or longer) using the same strict inclusion criteria as in vertos ii an iv. secondary outcome measures are back pain related disability and quality of life. methods the vertos v study is a prospective rct with pain relief as primary endpoint. inclusion criteria are a vcf of thoracic level 5 or lower with focal tenderness at fracture level, assessed by an internist on physical examination and a visual analogue scale (vas) score ≥ 5 for three months or longer, decreased bone density defined as t score ≤ -1 and age 50 years or older. 94 patients will be included, 47 in each arm. crossovers are not allowed. follow-up is at regular intervals during one year period with vas score for pain as primary endpoint. secondary endpoints are back pain related disability and quality of life measured with the quality of life questionnaire of the european foundation for osteoporosis and physical function measured with the roland morris disability questionnaire. conclusion vertos v is a methodologically sound masked randomised sham controlled trial of vertebroplasty in patients with sustained pain 3 months or longer after a vertebral compression fracture.


Eligibility criteria:
inclusion criteria: * vcf on x-ray of the spine (minimal 15% loss of height) * level of vcf th5 or lower * back pain ≥ 12 weeks at time of x-ray * ≥ 50 years of age * bone edema on mri of the fractured vertebral body * focal tenderness on vcf level * decreased bone density t-scores ≤ -1 exclusion criteria: * severe cardio-pulmonary condition * untreatable coagulopathy * systemic or local infection of the spine (osteomyelitis, spondylodiscitis) * suspected alternative underlying disease (malignancy) * radicular and/or cauda compression syndrome * contra-indication for mri
monitoring of 5% treatment naïve intravenous immunoglobulin (ivig) primary immunodeficiency disease (pidd) patients using the careexchange® system: a pilot study using 5% gammaplex® ivig in the home setting

Conditions: Primary Immunodeficiency Disease (PIDD)

Summary: the purpose of this study is to demonstrate the utility of measuring outcomes in 5% treatment naïve intravenous immunoglobulin (ivig) primary immunodeficiency disease (pidd) patients using infusion nurse and patient measured physical, quality of life (qol), respiratory, and disability assessments using careexchange in the home setting.


Eligibility criteria:
inclusion criteria: * diagnosis of any form of primary immunodeficiency disease * males and females * ≥ 15 and ≤ 85 years of age * 5% treatment naïve ivig for the treatment of pidd * ability to have gammaplex® ivig prescribed under the discretion of the patient's treating physician in accordance with standard treatment practices for the entire duration of the study * ability and willingness to provide informed consent and comply with study requirements and procedures * ability to read and write english * understanding of study procedures and ability to comply with study procedures for the entire length of the study * eligible for infusion services by axelacare health solutions, llc, in collaboration with the subject's prescribing physician and insurance provider exclusion criteria: * the presence of any medical condition that the investigator and/or prescribing physician deems incompatible with participation in this trial. * prisoners, and other wards of the state * determined to have non-competency of data collection requirements (physical assessments and use of an ipad™) by either the home infusion nurse and/or caregiver. * receiving subcutaneous immunoglobulin (scig) therapy during study participation.
efficacy and safety of bf2.649 in excessive daytime sleepiness (eds) in parkinson's disease

Conditions: Parkinson's Disease

Summary: to compare the efficacy of bf2.649 over placebo (12 week double-blind phase) and assess the long term safety and the efficacy maintenance(9 months open-label extension phase) of bf2.649 in the improvement of excessive daytime sleepiness in patients diagnosed with parkinson's disease.

as measured by the change from baseline in the epworth scale scores (ess) at week 12 and at week 51, in patients diagnosed with eds in parkinson's disease.

Eligibility criteria:
inclusion criteria: * patients with a documented history of parkinson's disease according to updrs,fluctuating and non-fluctuating patients, hoehn and yahr score \<5; * stabilized on optimal antiparkinsonian treatments unmodified for 4 weeks prior to study entry; * presenting an excessive daytime sleepiness as indicated by an ess\>or=12 exclusion criteria: * patients with a known diagnosis of other degenerative parkinsonian syndromes (e.g. progressive supra-nuclear palsy, multisystemic atrophy, corticobasal degenerescence, diffuse lewy's body dementia) * patients who have shift work, chronic or occasional sleep deprivation, circadian rhythm disorders * patients with a severe depression indicated by (bdi\>= 16)or at suicidal risk (bdi item g\>0) or depression treated for less than 8 weeks * patients with a cognitive impairment

Keywords: eds in parkinson's disease
corona virus disease 2019 cohort study

Conditions: COVID-19 Pneumonia; COVID-19 Pandemic; COVID-19

Summary: the goal of this observational study is to learn about the influence of corona virus disease 2019 on obstetric outcome and offspring development.

the main questions it aims to answer are: * collect the information about corona virus disease 2019 infection and medication of pregnant women to establish a birth cohort, and analyze the correlation between corona virus disease 2019 infection during pregnancy and adverse pregnancy outcomes and birth outcomes. * the offspring born in this cohort were followed up to analyze the effects of corona virus disease 2019 infection during pregnancy on the nervous system development of the offspring. researchers will compare corona virus disease 2019 infection group and uninfected group during pregnancy to see if corona virus disease 2019 infection has adverse effects on pregnant women and their offspring.

Eligibility criteria:
inclusion criteria: * conduct regular prenatal examinations in the hospital and establish a pregnancy and childbirth health manual, planning for pregnant women who are hospitalized for delivery; * conduct regular physical examinations in the hospital and establish a children's health manual for infants. * age ≥ 18 years old exclusion criteria: * concomitant tumor related diseases; * individuals with severe mental disorders.

Keywords: pregnant woman birth cohort infant nervous system development
a study of al-38583 ophthalmic solution 0.05%, 0.010% versus al-38583 vehicle for dry eye

Conditions: Dry Eye

Summary: the purpose of this study is to determine whether al-38583 ophthalmic solution is effective for treatment of signs and symptoms of dry eye.


Eligibility criteria:
inclusion criteria: * composite corneal staining score of greater than 5 in one or both eyes. * schirmer ii score of greater than 4 mm. * osdi score of greater than 23. * other protocol-defined inclusion criteria may apply. exclusion criteria: * any medical condition (systemic or ophthalmic) that may, in the opinion of the investigator, preclude the safe administration of the test article or safe participation in this study. * other protocol-defined exclusion criteria may apply.

Keywords: dry eye
human-centered injury thrivorship pathway for survivors of physical trauma

Conditions: Injury Traumatic; Survivorship; Trauma Injury

Summary: the goal of this clinical trial is to pilot and evaluate a human-centered injury thrivorship pathway in injury survivors. the main question it aims to answer is: • is the pathway appropriate, acceptable, and feasible to meet the medical and social needs of injury survivors? injury survivors will be purposively sampled to enroll in the pathway and asked to participate in in-depth interviews and their use of pathway resources will be tracked.


Eligibility criteria:
inclusion criteria: * patient ≥ 18 years old presenting with a physical injury to zuckerberg san francisco general hospital * admitted to the hospital ≥ 24 hours * discharged from the hospital alive * san francisco resident or unhoused in san francisco * capacity for informed consent exclusion criteria: * patient \< 18 years old * deceased during index hospitalization * unable to provide informed consent

Keywords: social determinants of health community-engaged research unmet needs
stand community trial

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the proposed study evaluates the effectiveness of a family-based psychosocial treatment program for teens with adhd (supporting teens' academic needs daily; stand) developed to be delivered in community settings. stand is bt enhanced by motivational interviewing (mi) that was developed (r34 mh092466) for teens with adhd through a stakeholder informed process. stand consists of ten 50-minute sessions delivered by therapists with community-typical levels of training and supervision. across randomized controlled pilot (n=28; n=36) and efficacy trials (n=128), stand demonstrates medium to large effects on adhd and odd symptoms and indices of academic and family impairment. in the proposed study, 300 adolescents with adhd who present for treatment at one of four community mental health agencies in miami-dade county, fl will be randomly assigned to stand or agency usual care (uc). participating agency therapists also will be randomly assigned to deliver stand or uc. stand therapists will receive a comprehensive treatment manual, three-day training, and weekly supervision from a project psychologist. participants will be screened by research staff in the community setting and enrolled on a rolling basis over 30 months. participants will be assessed at baseline, post-treatment, and three-month follow-up. in line with rdoc, multi-method measures will be obtained for treatment outcome (family and academic impairment), treatment mediators (executive functioning, parent academic involvement, parent-teen communication, parent/adolescent motivation, adhd symptoms), and moderators of effectiveness (patient, practitioner, service delivery, and organization characteristics). additional consumer perspective (satisfaction, therapeutic alliance) and agency fit (therapist competence, treatment fidelity, need for additional treatment, attendance, therapist attitude toward treatment, cost effectiveness) measures will also be obtained to evaluate effectiveness. we will recruit an ethnically diverse sample (65% hispanic, 19% african-american, 16% non-hispanic white) that is historically underrepresented in research, but ideal for evaluating therapy effectiveness.


Eligibility criteria:
inclusion criteria: * adhd diagnosis * iq of at least 70 * enrollment in sixth through twelfth grade exclusion criteria: * history of autism spectrum disorder * not attending a miami-dade county public school * a primary presenting problem other than adhd, requiring immediate treatment of a different domain
yag laser vitreolysis for vitreous floaters

Conditions: Posterior Vitreous Detachment; Myopic Vitreopathy; VISION DEGRADING MYODESOPSIA

Summary: the purpose of this study is to measure how the quality of life, the structure of eye, and vision change after treatment for the opacities in the gel (vitreous) that fills the center of eye which cause vision disturbances commonly called "floaters". in this study the vitreous floaters are treated using a neodymium-doped yttrium-aluminum-garnet (nd:yag) laser. the fda has approved the use of this laser to treat membranes in the eye.


Eligibility criteria:
inclusion criteria: * only one eye per patient will be included in this study * able and willing to give informed consent * age ≥18 years * suffering from symptomatic vitreous floaters * floaters arising from either/both: * myopic vitreopathy * posterior vitreous detachment * floaters meeting the following characteristics: * present for ≥3 months * one single or more dense and well-defined vitreous opacities, * a weiss ring or opacities which are within the safety area, at least 3mm away from the retina and 6mm away from the lens * visible on contact lens biomicroscopy exclusion criteria: * patient presenting with vitreous opacities outside of the described safety area (within 3mm of the retina or 6mm from the lens) * have clinically significant cataract (lens opacification) in one or both eyes which are in the opinion of the examining doctor more significant in impacting vision as compared to that caused by vitreous opacities; or cataract expected to need cataract surgery during the duration of the study * present with untreated retinal tears or retinal holes requiring treatment at the discretion of the study investigator * have high risk of peripheral lesions requiring treatment at the discretion of the study investigator * have synchysis scintillans (unusual vitreous opacities from old blood) * have asteroid hyalosis (unusual vitreous opacities from cholesterol) * have vitreous hemorrhage (fresh blood in the center of the eye) * have active photopsia (flashing lights) * history of previous yag laser vitreolysis treatments, or vitrectomy for any condition (retinal detachment, proliferative diabetic retinopathy, etc.) * have posterior vitreous detachment (separation of vitreous away from the retina lining the inside of the back of the eye) within the past 3 months * are unable to attend study appointments * have any other significant ocular or non-ocular condition that, at the discretion of the study investigator, puts the subject at risk or influences the results of the study * history of intraocular surgery within 6 months from study entry * history of retinal laser within 2 months from study entry
midazolam sedation for neonatal lumbar puncture

Conditions: Pain; Anxiety

Summary: lumbar puncture is one of the most common painful procedures performed on neonates in the emergency department (ed). the investigators will study in a randomized controlled trial, the efficacy of intravenous administration of a single dose of midazolam in reducing pain and anxiety in neonates undergoing lumbar puncture in the ed, as well as the rate of adverse sedation reactions. the investigators hypothesize that compared with placebo, single dose midazolam would significantly decrease pain and anxiety and will have low rate of adverse reactions.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) score i, ii * post natal age ≤ 30 days * fasting of at least 2 hours before the procedure exclusion criteria: * american society of anesthesiologists (asa) score iii or greater * gestational age of 37 weeks or younger * congenital disease or defect * any medication provided by the caregiver prior ed admission * fasting of less than 2 hours

Keywords: neonates
to compare the efficacy of i.v 200 mg iron sucrose and 500 mg iron sucrose to treat anemia in pregnancy

Conditions: Pregnancy

Summary: this study is aimed to compare the efficacy of 2 doses of iron sucrose given intravenously - 200 mg versus 500 mg.

anemia is common during pregnancy. it is associated with maternal and neonatal complications. it is acceptable to prescribe oral iron supplements. however, gastrointestinal side effects are very common and those lead to patient's intolerance as well as low patient's compliance. in those cases, as well as in severe anemia it is recommended to give iron sucrose. this drug is administered intravenously is effective to treat iron deficiency anemia with a minimal adverse effect profile. the two methods of giving iron sucrose is (1) to give i.v 200 mg iron sucrose 2-3 times/week or (2) to give i.v 500 mg iron sucrose once a week in the present study we aim to compare between the efficacy of those 2 protocols.

Eligibility criteria:
inclusion criteria: * singleton pregnancy * iron deficiency anemia * intolerance or low compliance for oral iron exclusion criteria: * known allergy for iron supplements * anemia not due to iron deficiency * acute infection * liver failure or viral hepatitis * thalassemia or hemoglobinopathies * asthma * multiple pregnancy