Kornimate/medical-research-clean huggingface dataset:
a study of imlunestrant versus standard endocrine therapy in participants with early breast cancer

Conditions: Breast Neoplasms

Summary: the main purpose of this study is to measure how well imlunestrant works compared to standard hormone therapy in participants with early breast cancer that is estrogen receptor positive (er+) and human epidermal receptor 2 negative (her2-). participants must have already taken endocrine therapy for two to five years and must have a higher-than-average risk for their cancer to return. study participation could last up to 10 years.


Eligibility criteria:
inclusion criteria: * have a diagnosis of er+, her2- early-stage, resected, invasive breast cancer without evidence of distant metastasis. * participants must have received at least 24 months but not more than 60 months of any adjuvant et, from time of adjuvant et initiation. * participants may have received (neo) adjuvant chemotherapy and/or targeted therapy with a cdk4/6- or parp- inhibitor. * must have an increased risk of disease recurrence based on clinical-pathological risk features. * have a performance status of 0 or 1 on the eastern cooperative oncology group scale. * have adequate organ function. exclusion criteria: * have any evidence of metastatic disease (including contralateral aln) or inflammatory breast cancer at primary breast cancer diagnosis. * participants with more than a 6-month consecutive gap in therapy during the course of prior adjuvant et. * participants who have completed or discontinued prior adjuvant et \>6 months prior to screening. * participants with a history of previous breast cancer are excluded, with the exception of ipsilateral dcis treated by locoregional therapy alone ≥5 years ago. * pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 180 days after the last dose of study intervention. * participant has previously received et of any duration for breast cancer prevention (tamoxifen or ais) or raloxifene. * participants with a history of any other cancer. * have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study.
pharmacodynamic trial, of slow release asa, in platelet functionalism, a long term treatment period

Conditions: Cardiovascular Disease

Summary: evaluation of the pharmacodynamic profile (antiaggregant profile, balance of prostanoids and nitric oxid) of a asa-sr (slow-release)formulation in comparison with a asa nr (normal release), 150 mg, during 12 months of treatment.

* a large clinical trials have established the efficacy of the antiaggregant products in patients with ischemic cardiopathy, stroke and intermittent claudication. * the acetylsalicylic acid (asa) is the most used antiaggregant substance, nevertheless, and spite of being centenarian, it last some questions pending regarding the most appropriate dose, mechanisms of action implicated, the association with oder drugs, and the pharmaceutical fom in order to improve the efficacy and safety of the asa. * some previous studies indicate that the slow release form of asa has a different behaviour in the platelet effect in comparison with plain formulation. * the aim of this study is to demonstrate the best antiaggregant and safety profile of a low dose of a slow release formulation in a long term treatment period of one year.

Eligibility criteria:
inclusion criteria: * previous episodes of myocardial infarction * previous episodes of instable angina pectoris * previous coronary revascularization * significant arterial coronary disease exclusion criteria: * patients with other pathologies that require treatment with other antiaggregants * patients in treatment with low molecular weight heparin or oral anticoagulants * patients with antecedents of hypersensibility to asa

Keywords: slow release asa platelet functionalism secondary cardiovascular prevention
factor analysis of unintended initial dissection of the posterior plane

Conditions: Myopia; Small-incision Lenticule Extraction (SMILE) Surgery

Summary: to explore the potential factors for unintended initial dissection of the posterior plane in a large sample retrospective analysis and surgeons of different levels.

myopia is the most common eye disease in the world. femtosecond laser small incision lens extraction (smile) has increasingly become the first choice in refractive surgery due to its greater biomechanical stability, less impact on the tear film and other advantages. however, because smile surgery is more challenging than flap-based corneal ablative surgery, young surgeons sometimes dissect the lenticule posterior plane first in clinical practice, which will make it more difficult to extract the lenticule or even cause the retained lenticule. the purpose of this study aims to explore the potential risk factors for unintended initial dissection of the posterior plane in large samples and surgeons of different surgical volumes and different surgical habits (different angles of peripheral corneal incision) in multiple scenarios.

Eligibility criteria:
inclusion criteria: * a condition in which the spherical equivalent refractive error of an eye is ≤ -0.50 d when ocular accommodation is relaxed; * age ≥18 years; * spherical equivalent (se) ≥ -10.0d; * corrected distance visual acuity (cdva) ≥ 16/20; * stable myopia for at least 2 years; * no contact lenses wearing for at least 2 weeks. exclusion criteria: * the presence or history of eye conditions other than myopia and astigmatism, such as keratoconus or external eye injury; * a history of eye surgery; * the presence or history of systemic diseases.

Keywords: femtosecond laser small-incision lenticule extraction (smile) unintended initial dissection of the posterior plane
physical therapists identifying patients with opioid misuse

Conditions: Opioid Misuse; Musculoskeletal Pain

Summary: the purpose of this study is to develop and operationalize key procedures for physical therapists (n = 12) to address patients who are at risk for or have opioid misuse (om). the investigators will train physical therapists in procedures to: 1) engage patients at risk for om in conversations about appropriate opioid use, 2) screen and 3) assess these patients for om and, 4) refer patients for further treatment if om is suspected. the investigators will employ a modified delphi approach to iteratively refine and operationalize the procedures and to arrive at a finalized procedure manual followed by an evaluation of the implementation of these procedures.

the purpose of this study is to develop and operationalize key procedures for physical therapists (n = 12) to address patients who are at risk for or have om. the investigators will train physical therapists in procedures to: 1) engage patients at risk for om in conversations about appropriate opioid use, 2) screen and 3) assess these patients for om and, 4) refer patients for further treatment if om is suspected. the investigators will employ a modified delphi approach to iteratively refine and operationalize the procedures and to arrive at a finalized procedure manual followed by an evaluation of the implementation of these procedures. approximately 4 months following the development of the manual and the distribution of the finalized manual, the investigators will conduct semi-structured interviews to determine the barriers and facilitators to implementing the procedures learned in the training. our aims are: 1. qualitatively evaluate physical therapists' perceptions and recommendations for implementing om procedures. 2. evaluate the implementation of the manualized om procedures.

Eligibility criteria:
inclusion criteria: * university of utah physical therapists with at least 0.5 full-time equivalent * self report managing patients with musculoskeletal pain exclusion criteria: * none

Keywords: opioid misuse physical therapy physical therapist
fmri study of expectancy on acupuncture treatment outcomes in knee oa

Conditions: Osteoarthritis, Knee

Summary: the results of the proposed experiments will directly inform clinicians who treat patients with osteoarthritis of the knee about how to maximize the benefits of acupuncture treatments. and because the experiments specifically asks the question of what is the relation between a patient's expectation of how a treatment will relieve their pain and the outcome of the treatment, the results will potentially inform care givers about all treatments for osteoarthritis and other chronic pain disorders. we hypothesize that acupuncture treatment will produce clinically significant analgesia as indicated by lowered sensory ratings of noxious stimuli and endogenous knee pain.


Eligibility criteria:
inclusion criteria: * volunteers 40-70 years of age. * meet the classification criteria of the american college of rheumatology for osteoarthritis of the right and/or left knee for at least the past 3 months, as determined by the referring physician. * radiographic evidence of grade 2 or 3 knee oa using the kellgren-lawrence scale. * ability to read and understand english; english can be a second language provided that the patients feel they understand all the questions used in the assessment measures. exclusion criteria: * any interventional procedure for knee pain, including corticosteroid injections (within 2 months) to the knee. * prior acupuncture treatment for any condition. because we are using a placebo needle as a control, acupuncture-naive patients are necessary to maximize the benefits of blinding and to control expectancy. * the intent to undergo surgery during the time of involvement in the study. * presence of any illness or medication use that is judged to interfere with the trial. for example: skin irritations around the knee such as psoriasis; bleeding disorders or anticoagulant use that would be contraindications for acupuncture; diabetes due to the increased possibility of sensitivity to heat pain; and use of opiate medications and other substances of abuse that may influence the patient's experience of analgesia. (due to the potential risk that prescription or non-prescription medication use can confound our results, we may perform a urine toxicology screen to verify patient's medication status during session 1.) * knee pain due to other causes, such as inflammation or malignancy, other pain disorders that may refer pain to the leg, oa of ipsilateral hip, diagnosis of rheumatoid arthritis (ra). * non-ambulatory status. * history of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome. for example: asthma or claustrophobia. * presence of any contraindications to fmri scanning. for example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy. * instability of pain rating within session 1 or session 2 of experiment one or visit 1 of experiment two.
evaluation of a ddpcr technology for the sars-cov-2 detection in symptomatic patients with suspicion of covid-19

Conditions: Cancer; COVID

Summary: evaluation of the ddpcr ability to detect the sars-cov-2 in nasopharyngeal samples of symptomatic patients with suspected covid-19 infection using an igg serological assay (euroimmun anti-sars-cov2 elisa ig) as gold/reference standard (fda validated commercial serologic test).

the bio-rad sars-cov-2 ddpcr test is a reverse transcription (rt) droplet digital polymerase chain reaction (ddpcr) test designed to detect rna from sars-cov-2 in specimens (mainly nasopharyngeal, anterior nasal, oropharyngeal and mid-turbinate swab but also nasopharyngeal wash/aspirate and nasal aspirate specimens) collected from individuals who are suspected of covid-19 infection. this single assay multiplex test enables a one-well reaction with three sets of the oligonucleotide primers and probes which were reported by cdc. two were selected from regions of the virus nucleocapsid (n) gene. an additional primer/probe included in the panel is set to detect the human rnase p gene (rp) in control samples and clinical specimens. rna isolated and purified from swab specimens is added to the mastermix comprised of reverse transcriptase whereby rna is converted into cdna and then amplified, using the bio-rad one-step rt-ddpcr advanced kit for probes. briefly, the sample and mastermix rt-ddpcr mixtures are fractionated into up to 20,000 nanoliter-sized droplets in the form of a water-in-oil emulsion. the 96-well rt-ddpcr ready plate containing droplets is sealed with foil using a plate sealer. the emulsions are then thermocycled to achieve reverse transcription to generate cdna followed by target amplification plus probe hydrolysis in each droplet. after thermocycling is complete, the 96-well rt-ddpcr ready plate is loaded into the droplet reader. the droplet reader singulates the droplets and flows them past a two-color fluorescence detector (fam and hex) in order to determine which contain target (positive) and which do not (negative) for each of the targets identified with the sars-cov-2 ddpcr test: n1, n2 and rp. the ddpcr system uses the quantasoft 1.7 and quantasoft analysis pro 1.0 for analysis software.

Eligibility criteria:
1. age ≥ 18 years on the day of signing informed consent. 2. confirmed diagnosis of any type of solid or hematologic tumor. 3. ongoing anticancer treatment at the time of inclusion or within the last 3 months prior to inclusion (last treatment administration or last loco regional procedure). 4. suspicion of covid-19 infection. patients must not have underwent diagnostic test and/or chest imaging before inclusion. 5. covered by a medical/health insurance. 6. signed and dated irb/ice approved informed consent form.

Keywords: covid-19, sars-cov-2, ddpcr, cancer, serology
complications and adverse effects in continuous peripheral regional anesthesia

Conditions: Infection; Inflammation; Adverse Effects

Summary: the investigators prospectively document infectious, neurological, and other complications or adverse events occurring during peripheral regional anesthesia via a catheter using computer-based data recording.

perineural blocks with catheter placement are more and more frequently used. few data dealing with infectious complications of perineural catheters exist. we assess incidence and localization of infectious complications of perineural catheters by means of computerized data acquisition. we prospectively evaluate perineural catheters placed at different sites for regional anesthesia and postoperative analgesia. the catheters were placed under standardized sterile conditions by using the nerve stimulator technique. local inflammation is defined as the presence of at least two of the three signs: redness, pain on pressure or swelling. infection is defined as the presence of at least two of the following criteria: pus at the catheter insertion site, fever, increased crp and/or leukocytes requiring antibiotic therapy.

Eligibility criteria:
inclusion criteria: * all patients receiving perineural blocks via catheter exclusion criteria: * none

Keywords: complications adverse events regional anesthesia adverse effects
cxcr4 targeted pet imaging in the diagnosis and identification of primary aldosteronism

Conditions: Primary Aldosteronism

Summary: this study aimed to prospectively evaluate the utility of c-x-c chemokine receptor type 4 (cxcr4) positron emission tomography (pet) imaging in patients with clinical suspected primary aldosteronism (pa), with postoperative pathological or follow-up results as reference standards.

1. record the course of disease, the laboratory examination (e.g., potassium, aldosterone, aldosterone-to-renin ratio, intravenous salt-loading test or captopril test) and the results of adrenal vein sampling in patients with clinically suspected pa. 2. pet image analysis: record and evaluate the following indicators: the maximum standardized uptake value (suvmax) of lesions, the mean standardized uptake value (suvmean) of normal liver, the suvmean of adjacent normal adrenal tissue, the ratio of the lesional suvmax to the normal liver suvmean (llr), and the ratio of the lesional suvmax to the adjacent adrenal tissue suvmean (lar). 3. pathological analysis: hematoxylin and eosin staining and immunohistochemical analyses will be performed. immunohistochemical analysis will be used to investigate the expression of aldosterone synthase (cyp11b2) and cxcr4.

Eligibility criteria:
inclusion criteria: 1. persistent hypertension with blood pressure \> 150/100 mmhg, refractory hypertension (blood pressure \>140/90 mmhg with combined use of three types of antihypertensive medications, including diuretics), or with hypokalemia of blood pressure \>140/90 mmhg; 2. refractory hypertension with an aldosterone-to-renin ratio (arr) ≥ 2.0 (ng/dl)/(mu/l); 3. positive intravenous salt-loading test or captopril test; 4. hypertension and adrenal lesions; 5. patient ≥18 years of age at the time of consent; 6. provided written informed consent authorisation before participating in the study. exclusion criteria: 1. refusal by the patients to undergo cxcr4 pet imaging, adrenal vein sampling, superselective adrenal arterial embolization or adrenalectomy; 2. suspicion of familial hyperaldosteronism type 1 (fh-1) or type 3 (fh-3)； 3. suspicion of adrenocortical carcinoma； 4. severe comorbidity potentially interfering with treatment or hrqol； 5. requirement of medication interfering with the study protocol； 6. pregnancy or lactation； 7. estimated glomerular filtration rate \<40 ml/min/1.73 m².
pharmacokinetic study of clarithromycin in very low birth weight (vlbw)

Conditions: Very Low Birth Weight Infant; Ureaplasma/Mycoplasma Positive

Summary: the purpose of this study is to investigate the pharmacokinetics of clarithromycin which is used for premature infants with ureaplasma.


Eligibility criteria:
inclusion criteria: * birthweight \< 1500gm or ga \< 32 weeks * transtracheal aspirate/gastric juice ; ureaplasma/mycoplasma(+) exclusion criteria: * sepsis, hypotension, shock * major congenital anomaly
biobehavioral predictors of coronary angioplasty outcome

Conditions: Cardiovascular Diseases; Heart Diseases; Coronary Disease

Summary: to examine some of the psychosocial predictors of poor outcome among revascularized coronary artery disease patients.

background: percutaneous coronary revascularization procedures are increasingly used in the treatment of coronary artery disease, with approximately 300,000 interventions performed each year. despite new developments in cardiology such as intra-coronary stents and anticoagulant pharmacological treatments, a major problem remains the frequent occurrence of coronary restenosis and new cardiac events within six months after the intervention. these adverse outcomes occur in one out of four patients and have substantial impact on the costs of medical care and patients' quality of life. research indicated that hemostatic factors (e.g., fibrinogen, von willebrand factor, and plasminogen activator inhibitor) promote the formation of blood clots and that these factors predict coronary restenosis. moreover, prior longitudinal studies have also demonstrated that the psychosocial traits of hostility and depression affect clinical progression of coronary disease. these psychosocial factors significantly predict adverse long-term outcome after revascularization and both hostility and depression are known to affect blood clotting factors. in addition, acute mental and physical stress are reported to affect blood clotting factors (coagulation and fibrinolysis) and responses to stress are reported to be more pronounced in hostile individuals. however, previous research on predictors of adverse clinical outcome after percutaneous coronary revascularization has not examined stress-induced changes in hemostatic factors and the consequences of these responses for progression of coronary artery disease. therefore, the study investigates whether psychosocial factors and responses to acute mental stress affect measures of the blood clotting process that are involved in progression of coronary disease, thereby increasing the risk of an adverse prognosis following percutaneous coronary revascularization. this study may improve the identification of patients at risk for recurrent cardiac events and provide further understanding of the pathophysiological mechanisms involved in the progression of coronary artery disease. design narrative: the study investigated whether psychosocial factors and responses to acute mental stress affected measures of the blood clotting process that are involved in progression of coronary disease, thereby increasing the risk of an adverse prognosis following percutaneous coronary revascularization. this study helped to improve the identification of patients at risk for recurrent cardiac events and provided further understanding of the pathophysiological mechanisms involved in the progression of coronary artery disease. 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
telehealth as a modality to increase the uptake of prep services in black and latino: "e-prep"

Conditions: HIV Prevention

Summary: to evaluate if utilizing telehealth medicine for access to hiv prep will engage more black and latino men who have sex with men (msm)

the goal of this study is to determine whether incorporating a telehealth model that allows for same-day appointments for prep delivery with the support of navigation leads to increased uptake and persistence of prep in young msm/transgender of color and individuals in rural communities that have disproportionately not used prep. the investigators will accomplish this by using an effectiveness-hybrid design that will allow us to both evaluate the interventions impact on relevant clinical outcomes as well as the effectiveness of the implementation strategy. our hypothesis is that by removing some of the barriers to care such as transportation, childcare, work schedule and potentially stigma with repeated clinic visits, the investigators will increase the uptake and persistence of prep amongst communities who historically have had many barriers to care and have not started prep.

Eligibility criteria:
inclusion criteria: 1. hiv negative on any fda approved hiv test within 10 days of starting prep 18 years and older 2. no medical or mental health comorbidity that would preclude participating in a clinical study as deemed by the study investigator 3. able to understand and sign consent in english or with other language interpreter 4. able to stay in the state catchment area of the license health care provider 5. no use of prep for more than 30 days in the last year exclusion criteria: 1. hiv positive 2. if greater and equal to 50 years of age and renal glomerular filtration rate (gfr) \<30 mg/g 3. \<18 years of age 4. no access to internet or devise for telehealth 5. cis-gender women

Keywords: hiv
effect of post-operative brace on pain and patient outcomes following hip arthroscopy for fais

Conditions: Hip Arthroscopy

Summary: the routine application of hip brace following hip arthroscopy for femoroacetabular impingement syndrome (fais) has no proven clinical benefits. this study will investigate whether the application of hip brace affects the post-operative course and patient reported outcomes in patients undergoing hip arthroscopy for fais.


Eligibility criteria:
inclusion criteria: * patient age of 18 years or older * patients with femoroacetabular impingement syndrome (fais) and who are candidates for surgical treatment with hip arthroscopy exclusion criteria: * patient age \< 18 years * patients with fais who are not surgical candidates (surgical therapy is not indicated) * patients with previous, ipsilateral hip procedures