Kornimate/medical-research-clean huggingface dataset:
contrast-enhanced ultrasound in patients with crohn´s disease and food allergy

Conditions: Crohn Disease; Food Allergy

Summary: the purpose of this study is to investigate differences of the bowel wall thickness visible in conventional ultrasound and bowel perfusion using quantitative contrast-enhanced ultrasound in patients with crohn´s disease in comparison with healthy controls and patients with food allergy.

after being informed about the study and potential risks, all participants giving written consent will undergo conventional transabdominal ultrasound and contrast-enhanced ultrasound of the bowel wall with measurement of the bowel wall thickness. in addition a continuous video sequence during contrast-enhanced ultrasound is recorded and perfusion kinetics from the video clips are analyzed using a specific quantification software.

Eligibility criteria:
inclusion criteria: * age over 18 * endoscopically and histologically confirmed active crohn´s disease or * previously proven food allergy (double-blind or single-blind food challenge tests with placebo controls previously before the sonographic examination, increased blood and / or intestinal immunoglobulin e levels, elevated methylhistamine values under provocation and with reproducible reactions during food challenge procedures) or * healthy individuals without abdominal complaints exclusion criteria: * age under 18 * intolerance of the ultrasound contrast agent sonovue * refusal of participation in the study * pregnancy or breast-feeding
study in patients with asthma

Conditions: Asthma

Summary: the purpose of this study is to determine which dose of the investigational drug is safest and most effective compared to the control group.


Eligibility criteria:
inclusion criteria: * require the regular use of an inhaled beta-2-selective adrenergic agent. * no clinically significant abnormalities on the medical history, physical examination, and clinical laboratory tests. exclusion criteria: * active acute or chronic disorders of the respiratory system within one month prior to screening. * smoking history within the past 12 months or greater than a lifetime 10 pack-year smoking history. * debilitating systemic and/or life-threatening diseases.

Keywords: asthma pediatric formoterol fumarate foradil
real-world outcomes of patients with metastatic breast cancer after treatment with first-line et+cdk4/6i

Conditions: Advanced/Metastatic HER2-negative Breast Cancer

Summary: this study aims to assess the treatment patterns and real-world outcomes of hr+/her- metastatic breast cancer patients who have progressed on 1l et + cdk4/6i and started a second line (2l) treatment within a real-world cohort in the united states flatiron health database.

this analysis will assess real-world outcomes in hr+/her2- mbc patients who initiated a subsequent line of therapy (lot) (i.e., 2l) after progressing on 1l treatment with et+cdk4/6i. this study will also characterize the treatment patterns, clinical characteristics, and outcomes in this patient population. no study drug was administered in this non-interventional study.

Eligibility criteria:
inclusion criteria * patients with evidence of stage iv or recurrent mbc with a metastatic diagnosis date on or after january 1, 2017 * aged ≥18 years at mbc diagnosis date * received 1l et + cdk 4/6i, with no other systemic agents, in the metastatic setting * had evidence of a rwp event during 1l et + cdk 4/6i * evidence of a subsequent lot following 1l et + cdk 4/6i (start date of subsequent lot = index treatment date) * a record of hr+ status in the closest estrogen receptor (er) or progesterone receptor (pr) test result occurring prior to or within 30 days after the index treatment date * a record of her2- status in the closest her2 test result recorded prior to or on the index treatment date * index treatment date occurring at least 90 days prior to end of study period (30sep2024) exclusion criteria • a record of estrogen receptor 1 (esr1), phosphatidylinositol4,5-bisphosphate 3-kinase catalytic subunit alpha (pik3ca), v-akt murine thymoma viral oncogene homolog (akt1), phosphatase and tensin homolog (pten), or germline breast cancer gene (gbrca) alteration/mutation prior to or within 30 days after index treatment date

Keywords: hr-positive her2-negative metastatic breast cancer
automating breast radiation therapy (rt)

Conditions: Breast Cancer

Summary: breast radiation treatment is planned from a computed tomography (ct) scan. this study is designed to investigate a method to reduce the time between the planning of radiation treatment and its actual start by automating the intensity-modulated radiation therapy (imrt) planning process. the investigators plan to examine data from another scan called cone beam computed tomography (cbct). a cbct scan provides similar information to a conventional ct scan, however the images for cbct are acquired at the treatment unit (linear accelerator used for treatment). using these x-ray pictures of patients, the study team consisting of a radiation oncologist, a medical physicist and a radiation therapist will create a custom treatment plan unique to each patient. by doing this, the investigators hope to reduce the amount of time spent waiting for treatment and the number of hospital visits for patients in the future.


Eligibility criteria:
inclusion criteria: * patients with breast cancer who will receive standard two-field tangential whole breast radiation therapy with dose prescription of 4240 cgy in 16 fractions, 5000 cgy in 25 fractions or 4000 cgy in 16 fractions. * patients with any stage of breast cancer. * patients with prior treatment such as surgery or chemotherapy for any type of cancer. * able to provide a written informed consent. * 18 years of age or older. exclusion criteria: * \< 18 years of age. * unable to provide informed consent. * males. * patients who received partial breast radiation and not the standard dose. * patients who will not receive 4240 cgy in 16 fractions, 5000 cgy in 25 fractions, or 4000 cgy in 16 fractions.

Keywords: cbct breast cancer
studying tumor tissue samples from patients with early-stage non-small cell lung cancer

Conditions: Lung Cancer

Summary: this research trial studies biomarkers in predicting the risk of cancer returning after surgery in tissue samples of patients with early-stage non-small cell lung cancer. studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer and predict how well patients will respond to treatment.

primary objectives: i. to develop and validate a clinically useful molecular prognostic signature based on ribonucleic acid (rna)-expression arrays to accurately distinguish between good and poor outcome in patients with stage 1b non-small cell lung cancer (nsclc) (t2an0m0) by predicting the risk of cancer recurrence after surgery. secondary objectives: i. to develop and validate a clinically useful prognostic signature for stage 1a nsclc (t1a-bn0m0) that accurately predicts the risk of post-operative cancer recurrence and is part of a prognostic classifier, which also includes histological, pathological, and demographic parameters as in the primary objective. ii. to determine the effects on test accuracy of the histological subtype (adenocarcinoma \[ac\] vs squamous cell \[sqa\]) for each of the stage specific prognostic classifiers. iii. to determine the relevant statistical features, including accuracy of predicting overall survival, cancer specific survival, and disease free survival at 3 and 5 years, for each of the prognostic classifiers validated. iv. to utilize the validated prognostic signatures and classifiers in stage 1b nsclc to determine whether these can reliably predict good outcome among stage ii nsclc patients. outline: rna extracted from archived tumor tissue samples are analyzed for whole-genome expression by affymetrix microarrays (gene profiling array cgmp u133 p2) and reverse transcriptase-polymerase chain reaction (rt-pcr).

Eligibility criteria:
inclusion criteria: * registration to calgb-140202 * the subject population to be studied in this protocol includes patients selected from calgb-140202; all such patients have signed a written informed consent document meeting all federal, state and institutional guidelines as part of entry into that trial; the calgb does not require that a separate consent form be signed for this study * all samples to be studied were obtained and stored as part of calgb-140202; the material and data obtained from the patient's protocol record will be used to obtain appropriate clinical information; in no instance will the patient be contacted directly * tumor specimens need to have 40% tumor content to be included

Keywords: stage ia non-small cell lung cancer stage ib non-small cell lung cancer adenocarcinoma of the lung squamous cell lung cancer
autonomous digital cbt intervention for opioid use disorder in individuals with co-occurring internalizing disorders

Conditions: Opioid Use Disorder; Anxiety; Depression

Summary: the primary objective of this protocol is to implement the ug3 phase (phase 1) of a national institute on drug abuse (nida) ug3/uh3 grant (rfa-da-23-049). this phase is dedicated to the pilot testing of neat-o, a digital cognitive behavioral therapy (cbt) program tailored for individuals with opioid use disorder (oud) and concurrent anxiety or mood disorders - collectively referred to as internalizing disorders (intds). neat-o is based on an empirically supported cbt framework, specifically modified to address the complexities of comorbidity in substance use disorders (suds). this pilot study will evaluate the usability and acceptability of neat-o in 15 participants with oud, with the goal of refining the program\&#39;s content and delivery methods. the results of the pilot study will inform a comprehensive rct in the uh3 phase (phase 2) (n=300). progression to the uh3 phase, with its funding, depends on meeting milestones in phase 1 including demonstrating protocol adherence and the program\&#39;s acceptability and usability.


Eligibility criteria:
inclusion criteria: * adults ages 18 to 65 * current dsm-5 diagnosis of oud (confirmed during mini 7 interview) * current dsm-5 diagnosis of panic disorder with or without agoraphobia (pd/ag) generalized anxiety disorder, social anxiety disorder, or major depression (confirmed during mini 7 interview) * currently in treatment for oud using moud * access to an internet-enabled smartphone for the duration of the study * currently residing in the united states * provision of informed consent exclusion criteria: * current diagnosis of psychosis * current institutionalization (e.g., jail, hospital) * self-reported pregnancy * non-english speakers
safety and efficacy of a flavonoids- and omega3s-based compound for the treatment of muscular dystrophies

Conditions: Muscular Dystrophies; Muscle Inflammation

Summary: the study aimed to assess the safety and, partially, the efficacy of dietary supplementation of a flavonoids-, dha- and epa-based natural supplement in non-ambulant dmd boys and in a cohort of lgmd and fshd patients to compare its effect in mds of different aetiology and to eventually highlight any differences in inflammatory involved pathways. to assess safety, patient's laboratory parameters were monitored and adverse events recorded, while efficacy was evaluated through performance scale questionnaire and strength measurement (6 minute walking test and biodex system 4 dynamometer parameter evaluation). this study was conceived as proof of principle for the safe use of flavonoids/omega3s-based compound as an adjuvant in the management of neuromuscular disorders; besides, its efficacy in alleviating symptoms linked to secondary effects of genetic mutation as inflammation, muscular pain and weakness was assessed.


Eligibility criteria:
inclusion criteria * documented genetic and histological diagnosis of dmd, fshd and lgmd; * absence of severe cardiac and pulmonary disease; * age superior to 9 years for dmd, between 9 and 70 years for lgmd and between 20 and 70 years for fshd; * glucocorticosteroid treatment for 6 or more months (stable dose and regimen for ≥3 months before screening) and for the duration of the study; * adhesion to inform consent by same patients or parents/tutors for minors. exclusion criteria * severe cardiac and pulmonary disease; * positive hepatitis b surface antigen (hbsag) test, positive hepatitis c and hiv tests; * low kidney and liver functionality; * autoimmune disorders; * mental retardation (iq via wechsler intelligence scale \< 70); * psychological-psychiatric disorders; adverse psychosocial conditions; * known allergies to some of compounds to be used in the trial; * pathologies occurring just before or during the trial (fever, metabolic disorders, drug abuse); * enrollment to other trials (steroids regime won't be considered in this list)

Keywords: dietary supplementation flavonoids omega 3
snuff use, smoking, periodontal health and premature death: 30-year study

Conditions: Tobacco Use; Periodontitis

Summary: snuff use and smoking associated with poor periodontal health, especially if used together.

aim: the investigators investigated how snuff use and smoking affect periodontal health parameters and mortality in a swedish cohort, hypothesizing that snuff use increases the risks. material and methods: study cohort of 1 532 subjects aged 30 to 40 (758 men and 774 women) from stockholm area was clinically examined and followed up from 1985 to 2015. associations were analysed between periodontal health parameters, snuff use, smoking and age of death. for analyses, all subjects were classified into four groups: "dual-users" (current and ex-snuffers, current and ex-smokers); "pure snuffers" (current and ex-snuffers); "pure smokers" (non-snuffers, current and ex-smokers) and "non-users" (non-snuffers and non-smokers). cross-tabulation, chi-square and fisher's exact tests were used.

Eligibility criteria:
inclusion criteria: * in 1985-1986 a sample was selected from the registry file of all inhabitants of the stockholm area, of people born on the 20th of any month from 1945 to 1954.the sample comprised 3200 people. they were informed about the purpose of the study and called for clinical investigation. 1681 (52.5%) individuals, 840 men and 841 women, participated in the study. from the remaining 1519 non-respondents to the initial call, 100 randomly selected subjects, 45 men and 55 women, were reinformed and persuaded and finally agreed to participate in this investigation. they were used as a drop-out control sample. exclusion criteria: * other people

Keywords: tobacco calculus gingiva oral hygiene periodontitis biofilm
glucose control by empc algorithm in peri- and postoperative period in cardiac surgery patients

Conditions: Cardiac Surgery Patients; Blood Glucose

Summary: randomized controlled trial to compare blood glucose control by the model predictive control algorithm with variable sampling rate (empc) with routine glucose management protocol (rmp) in peri- and postoperative period in cardiac surgery patients.

context. increased blood glucose levels frequently occur in critically ill patients and its normalization by intensive insulin treatment markedly improves clinical outcome. objective and design: randomized controlled trial to compare blood glucose control by the model predictive control algorithm with variable sampling rate (empc) with routine glucose management protocol (rmp) in peri- and postoperative period in cardiac surgery patients. setting: department of cardiac surgery, university hospital. patients. 60 cardiac surgery patients. interventions. elective cardiac surgery and treatment with continuous insulin infusion to maintain euglycemia (target range 4.4 - 6.1 mmol/l). 30 patients were randomized for empc and 30 for rmp treatment. blood glucose was measured in 1-4 hour intervals depending on request of each algorithm during surgery and post-operation period for 24 hours. main outcome measures. mean blood glucose, percentage of time in target range. results. mean blood glucose was 6.15 ± 1.11 mmol/l in empc vs. 7.21 ± 1.08 mmol/l in rmp group (p\<0.05); percentage of time in target range was 60.4 ± 22.8% for empc vs. 27.5 ± 16.2% for rmp group (p\<0.05). no severe hypoglycemia (blood glucose bellow 2.9 mmol/l) was observed during the study. average insulin infusion rate was 4.67 ± 3.34 in empc vs. 2.57 ± 1.66 iu/h in rmp (p\<0.05), average sampling interval was 1.46 ± 0.31 vs. 2.10 ± 0.22 hours (p\<0.05). conclusions. empc algorithm was more effective and comparably safe as compared to rmp in maintaining euglycemia in cardiac surgery patients.

Eligibility criteria:
inclusion criteria: * elective cardiac surgery exclusion criteria: * allergy against insulin * mental incapacity * language barrier

Keywords: critically ill insulin resistance intensive insulin therapy computer algorithm
molecular characterization of candida auris

Conditions: Oral Fungal Infection

Summary: candida auris is emerging fungal opportunistic pathogen in developing countries. much studies has been conducted on candida albicans. there was a dire need to investigate this alarming threat. our hypothesis is that by recording the patients diagnosed with oropharygneal candidiasis and collecting clinical swab samples from these patients will be fruitful if microbiological isolation, identification and molecular characterization will be done. so this is the first study on c. auris in south punjab, pakistan. aim of this study is to collect epidemiological data of c. auris.


Eligibility criteria:
inclusion criteria: * pre-diagnosed patients of both gender from pre-selected localities exclusion criteria: * healthy individuals or individuals having no oral fungal infection individuals above 100 years of age

Keywords: candida auris oral fungal infection candidiasis
ultrasound-guided percutaneous neuromodulation versus dry needling in shoulder pain treatment

Conditions: Shoulder Pain

Summary: background: nonspecific shoulder pain is very common and the symptoms can persist for 6 to 12 months in half of patients. ultrasound-guided percutaneous neuromodulation (us-guided pnm) is an intervention based in an electrical stimulation of a peripheral nerve through a needle located close to the target nerve by the use of an ultrasound guidance. objectives: the primary aim is to determine changes in strength after us-guided pnm or ultrasound-guided dry needling (us-guided dn) intervention in the suprascapular nerve (sn) as well as its effectiveness in changes of muscle function, pain and disability. methods: randomised clinical trial (ratio 1:1), single-blind (examiners), parallel, with assessment of third parties. 62 adult participants with unilateral mechanical chronic nonspecific shoulder pain with at least 3-month evolution and shoulder muscle weakness will randomised to one of two procedures: us-guided pnm or us-guided dn. it will be assessed muscle strength, muscle function, pain and disability before, just after, a week and a month after the intervention.

shoulder pain is the third reason for medical consultation in the world. many treatment techniques have been proposed. neuromodulation techniques through the application of an analgesic electric current using a needle as an electrode, are increasingly used in the treatment of pain. in this study, the investigators will compare whether the application of a neuromodulation technique is more effective than applying the dry needling technique in isolation.

Eligibility criteria:
inclusion criteria: * chronic mechanical unilateral shoulder pain of non-specific origin of at least 3 months of evolution * weakness in the abduction force and / or external rotation of the shoulder. exclusion criteria: * previous shoulder surgery. * previous history of shoulder dislocation * whiplash. * cervical radiculopathy. * total rupture of the rotator cuff. * adhesive capsulitis. * fibromyalgia diagnosis. * diabetes. * needle phobia or some contraindication for dry needling (anticoagulants or psychiatric disorders). * bilateral shoulder pain. * pregnancy or having received a dry puncture in the shoulder region in the last 6 months

Keywords: electric stimulation therapy dry needling
soberlink within in-home addiction treatment program

Conditions: Alcohol Use Disorder

Summary: the purpose of this study is to evaluate the impact of use of soberlink on treatment experience for individuals with alcohol use disorder while enrolled in an in-home addiction treatment program. treatment engagement, feelings related to autonomy and empowerment, and overall quality of life will be evaluated. although not the primary focus, recidivism and relapse will be measured.

the study will include 30 clients with a primary or secondary diagnosis of alcohol use disorder (aud) and who are enrolled in aware recovery care's in-home addiction treatment program where care teams will monitor cloud-based breathalyzer results. soberlink's cloud-based breathalyzer system will provide data to care team if the client has relapsed or is not compliant with testing through the soberlink system. clients will use soberlink for 180 days within context of routine alcohol use disorder treatment at aware recovery care.

Eligibility criteria:
inclusion criteria: * male or female subject between ages of 21-75 years old * subject active in in-home addiction treatment program (aware recovery care) * subject admitted to program with american society of addiction medicine (asam) assessment score 1.5-2.5 * primary or secondary diagnosis is alcohol use disorder * subject is willing to use soberlink device to provide blood alcohol content (bac) * subject is willing to discuss soberlink test results with care team * subject is willing to sign soberlink client agreement * subject is english speaking and reading exclusion criteria: * alcohol use disorder is not a primary or secondary diagnosis * subject is not between ages of 21 and 75 years old * subject is currently taking anti-alcohol/craving medications (antabuse, campral, vivitrol) * subject will not be in the united states through duration of study * subject is unwilling to properly use the device * subject is non-english speaking and reading * subject is a child, adolescent, cognitively impaired, diagnosed with a mental disorder involving depersonalization or active psychotic symptoms * active withdrawal/alcohol use within 72 hours of start of participation * subject is using soberlink data for a child custody or legal consequence
prospective evaluation of a smartphone application, gocheckkids™, to detect amblyopia risk factors in young children

Conditions: Amblyopia

Summary: the objective is evaluation of gocheck kids, a smartphone application ('app'), for use as a photo screening device in a pediatric population to detect amblyopia risk factors (arfs).

detection of amblyopia risk factors using photo screening app in children of ages from 12 months to 8 years

Eligibility criteria:
inclusion criteria: * age 12 months to 8 years inclusive. * informed consent given by parent or legal guardian. exclusion criteria: - history of ocular surgery and any condition that would preclude the ability of the investigator to obtain a reliable image and measurement

Keywords: amblyopia myopia hyperopia risk factors amblyopia risk factors smartphone application (app) photoscreening vision screening mobile vision screening vision screening app preschool children objective vision screening