Kornimate/medical-research-clean huggingface dataset:
prospective registry of eosinophilic esophagitis

Conditions: Eosinophilic Esophagitis

Summary: this is a prospective registry of all the eosinophilic esophagitis (eoe) patients referred to the third level referral centre of san raffaele scientific institute

primary objective of the study is to create a registry of all eoe patients with \> 18 years of age referring to the motility and eoe unit of san raffaele hospital, in order to register clinical, endoscopic and histologic data on the disease, to further design and propose future prospective or retrospective studies to increase disease knowledge and foster collaborations with other centers nationally and internationally

Eligibility criteria:
inclusion criteria: 1. participant is willing and able to give informed consent for participation in the study. 2. the medical product is the standard of care for the patient or the participant is taking the medicinal product according to clinical practice 3. being diagnosed with eoe as per guidelines of the disease exclusion criteria: 1. no clear diagnosis of eoe 2. not willing to provide informed consent to the inclusion in the registry
study evaluating bosutinib-exemestane combination vs exemestane alone in post menopausal women with breast cancer

Conditions: Advanced Breast Cancer

Summary: this is a phase 2, open-label, multicenter, 2-arm study of bosutinib administered in combination with exemestane versus exemestane alone. this is a 2-part study consisting of a safety lead-in phase and randomized phase 2 portion. subjects in part 1 will receive bosutinib and exemestane daily, and will be closely monitored for 28 days. if no safety concerns arise, then future eligible subjects will be randomly assigned to the main phase of the study. they will either receive bosutinib daily combined with daily exemestane, or daily exemestane alone for a specified period of time. subjects will be followed up for survival after treatment discontinuation.

this study was terminated on 19 apr 2010 due to unfavorable risk benefit ratio which did not support continuation in part 2 of the study. even if the safety profile of the combination of bosutinib and exemestane was acceptable 25% of subjects had treatment related liver events including 14% of severe liver events.

Eligibility criteria:
inclusion criteria: * woman aged 18 years or older. * confirmed pathologic diagnosis of breast cancer. * locally advanced, metastatic, or locoregional recurrent breast cancer not amenable to curative treatment with surgery or radiotherapy. * surgically sterile or postmenopausal woman. * documented er+ and/or pgr+ and erbb2- tumor. * progression of locally advanced or metastatic disease during treatment with a nonsteroidal ai or tamoxifen, or progression during treatment with (or within 6 months of discontinuation of) an adjuvant nonsteroidal ai. exclusion criteria: * prior exemestane, prior bosutinib, or any other prior anti-src therapy. * more than 1 prior endocrine treatment for locally advanced or mbc. * more than 1 prior cytotoxic chemotherapy regimen in metastatic setting. * bone or skin as the only site of disease.

Keywords: bosutinib exemestane postmenopausal breast cancer
is lipid mapping an effective early detection tool for breast cancer in high-risk populations?

Conditions: Breast Cancer

Summary: this study aims to investigate if lipid composition mapping using magnetic resonance imaging could improve early and accurate cancer detection in genetic mutation carriers at high risk of breast cancer. it is hypothesised that there is a significant difference in the extent of spatial variation in lipid composition in breast from mri between genetic mutation carriers and patients with breast cancer.

breast cancer is a major and expanding societal challenge despite the significant improvement in survival rate. the current screening method has been shown to lead to overtreatment, prompting the development of accurate early detection approaches targeting underlying clinical features. patients with brca1/2 and tp53 genes are at risk of breast cancer and receive annual surveillance. however, the current diagnostic approach relies on detecting the changes to the growth of tumour only once cancer is well under development. detecting earlier changes to breast fatty tissue may detect patients earlier and more accurately. breast fatty tissue is composed of different fatty acids and a difference in the fatty acid composition has been shown in brca1/2 gene carriers. measurement of lipid composition can be achieved using a specialist magnetic resonance spectroscopy method, but is limited to sampling a small area and is unable to provide the full picture of lipid composition distribution during early cancer growth. recently, magnetic resonance chemical shift imaging, through combining magnetic resonance spectroscopy and imaging approaches, has been developed to provide lipid composition maps of the entire breast. the investigators propose to perform lipid mapping in the breasts of 20 genetic mutation carriers at high risk of breast cancer and 20 patients with newly diagnosed breast cancer to examine the sensitivity of the method. the overarching aim is to improve early and accurate cancer detection in genetic mutation carriers at high risk of breast cancer through the assessment of whole breast lipid composition.

Eligibility criteria:
inclusion criteria: * female over 18 years old * brca1/2 or tp53 gene carriers (high-risk group) * invasive ductal carcinoma of the breast (patient group) * not having any metabolic disorders (e.g., diabetes) * not on any long term medications that may affect lipid metabolism (e.g., statins) exclusion criteria: * female under 18 years old * male * affected by metabolic disorders (e.g., diabetes) * on long term medications that affect lipid metabolism (e.g., statins) * contraindicated for mr investigations (poor renal function and metal implants) * concurrent cancer in other sites * concurrent hormone treatment, chemotherapy or underwent surgery * non-english speakers

Keywords: lipid composition mri
a phase ii clinical study of pdc-748 in patients with acute cough

Conditions: Acute Cough

Summary: the pharmacological effects of pdc-748 were tested in numerous in vitro and in vivo studies. the existing pharmacologic findings suggest that pdc-748 possesses certain inhibitory activity to the citric acid- and capsaicin-induced cough reflex in guinea pigs with a dose-dependent manner. furthermore, a previous phase i/ii uncontrolled, dose-escalating study has shown pdc-748 to be well tolerated and may help to alleviate daytime cough with a dose-responding manner.hence, phytohealth corporation intends to carry out a phase ii investigation to confirm the preliminary findings using placebo in the comparator group, and to further investigate pdc-748 with a dose escalating manner to establish the dose-response range for its antitussive effect, and if possible, to determine the maximal tolerable dose of pdc-748. this is a randomized, double-blind, placebo-controlled, dose escalating study to evaluate the safety and efficacy of the escalating dose levels of pdc-748 in patients with acute cough.


Eligibility criteria:
inclusion criteria: * patients diagnosed with acute cough ; * men or women aged ≥ 20 years old; * patients with cough symptom score(daytime) between 2 and 4, inclusively; * patients are willing and able to comply with the study procedures and sign the informed consent. exclusion criteria: * patients with chronic cough ; * patients with chronic airway disease; * patients with respiratory tract malignancy; * patients with clinically suspected low respiratory tract infection; * patients with abnormal liver or kidney functions * patients taking antitussives, sleeping pills, sedative medications, or herbal products; * pregnant or breastfeeding patients; female patients of child bearing potential who do not agree to practice effective birth control; * patient's symptom of acute cough may be due to heart failure or may be induced by other medications such as ace inhibitor medications, as determined by the investigator; * patients who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with the assessments of safety or efficacy during the course of the trial, including but not limited to hepatic, renal, respiratory, cardiovascular, endocrine, immune, neurological, or hematological disease as determined by the clinical judgment of the investigator; * use of any investigational drug or participation of any clinical trial within 28 days prior to this study.

Keywords: cough antitussive pdc-748 phytohealth
role of social incentives in pro collection

Conditions: Orthopedic Disorder

Summary: value-based healthcare is heavily dependent on the accurate measurement of patient outcomes, both immediately after treatment and at long-term intervals. patient reported outcomes (pros) are often the central component of any quality improvement process as they are patient centered, reflect the ultimate objective of the intervention and are endorsed by many professional societies as the preferred physician performance metric. although high response rates are critical to producing reliable data to support value-based payment models, quality improvement, and stakeholder transparency - especially in arthroscopy in which patients often fare well over time and may be less likely to continue with follow-up - response rates to outcome surveys after initial recovery from treatment are consistently below 50%. monetary incentives offer only minor improvements in response rates against large increases in already rising costs. individually tailored social incentives - as grounded in current behavioral economic practice - offer a potential cost-effective solution to this problem in sports medicine and arthroscopy. the investigators predict that well-constructed, personal social incentives will increase response rates for long-term follow-up of episodic care compared to control. the investigators predict these rates will vary depending on the patient demographics and other characteristics.


Eligibility criteria:
inclusion criteria: * english speaking * orthopedic patient * 6-24 months post-operative exclusion criteria: * non-english speaking

Keywords: patient reported outcomes (pro) social incentives
a randomized study to compare the safety and immunogenicity of fluviral® made with new versus aged bulk

Conditions: Influenza Vaccines

Summary: vaccination is currently the most effective means of controlling influenza and preventing its complications and mortality in persons at risk. once a year, a meeting of world health organization (who) experts takes place, leading to a recommendation on the influenza a and b strains that should be used for the production of vaccine for the coming influenza season. for the strains which do not change from the previous year, the vaccine can be formulated from the old mono bulk from the previous year. bulks as old as 12 months may be blended to make trivalent inactivated vaccine (tiv) under the current canadian and us licenses. this study is conducted to evaluate safety and immunogenicity of fluviral vaccines made with the aged bulk material compared with the new bulk material. this protocol posting has been updated in order to comply with the fda amendment act, sept 2007.


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes can and will comply with the requirements of the protocol should be enrolled in the study. * male and female adults, 18 to 60 years. * written informed consent obtained from the subject. * if the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for the duration of the study. exclusion criteria: * acute disease at the time of enrollment. * any confirmed or suspected immunosuppressive condition * presence of blood dyscrasias, including hemaglobinopathies and myelo- or lymphoproliferative disorder. * chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. * a history of any demyelinating disease including guillain-barré syndrome. * presence of an active neurological disorder. * any significant disorder of coagulation that increases the risk of intramuscular injections or treatment with coumadin derivatives or heparin. * receipt of an influenza vaccine within 6 months prior to study enrollment. * administration of any vaccines within 30 days prior to study enrollment or during the study period. * use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period. * administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study. * any known or suspected allergy to any constituent of fluviral and/or a history of anaphylactic type reaction to consumption of eggs, and/or reactions to products containing mercury. * a history of severe adverse reaction to a previous influenza vaccination. * lactating/nursing female. * any condition which, in the opinion of the investigator, prevents the subject from participation in the study.

Keywords: influenza
enhancing outcomes, reducing costs: evaluating peer support for mood disorders

Conditions: Depression; Bipolar Disorders; Mood Disorders

Summary: the purpose of this study to evaluate peer-led mutual help organizations (mhos) that target individuals with psychiatric diagnoses such as mood disorders, and provide evidence either supporting the expansion of such groups and the development and testing of clinical procedures, or point toward reevaluation and development of alternative low-cost, community based approaches to promoting recovery among individuals suffering from these disorders.

participants will include up to 200 participants from the depression and bipolar support alliance (dbsa) for aim 1. aim 1 will measure characteristics of current dbsa members through cross-sectional surveys of demographics, clinical use history, and involvement in dbsa. 60 new dbsa members who began attending in the past month will be enrolled for aim 2. aim 3 will consist of 100 matched controls of people who have never attended a dbsa meeting. assessments will be completed at mclean hospital, in which a study staff member will thoroughly explain the study to participants. if participants are eligible for aim 2, study staff will receive written consent from the participant.

Eligibility criteria:
inclusion criteria: * aim 1: * 18 years of age or older * self-report a diagnosis of any type of mood disorder * attend dbsa meetings * aim 2: * 18 years of age or older * self-report a diagnosis of any type of mood disorder * have attended their first meeting in the past month * aim 3: * 18 years of age or older * self-report a diagnosis of any type of mood disorder * have never attended a dbsa meeting exclusion criteria: * aim 1: * do not report a diagnosis of any type of mood disorder * have not attended a dbsa meeting * aim 2: * do not report a diagnosis of any type of mood disorder * have not attended a dbsa meeting * have attended their first meeting prior to a month before their assessment * aim 3: * do not report a diagnosis of any type of mood disorder * have attended a dbsa meeting
hypoxic changes in hepatocellular carcinoma (hcc) following trans arterial chemo embolization and stereotactic radiation: fluorine18 (18f) fluoromisonidazole (fmiso) imaging

Conditions: Hepatocellular Carcinoma

Summary: \[18f\] fmiso positron emission tomography (pet) to determine hypoxia in patients with hcc treated with tace.

this phase ii study will investigate the utility of \[18f\] fmiso in patients with hepatocellular carcinoma (hcc). this trial is designed to test the hypothesis that pet determined \[18f\]fmiso uptake will indicate tumor hypoxia in patients with hcc treated with trans-arterial chemo-embolization (tace). we anticipate that \[18f\] fmiso pet/ct will advance our understanding of the role of hypoxia in hcc prior to treatment and that this knowledge will help design newer combination therapeutic trials for better treatment outcomes. \[18f\] fmiso pet/ct provides three parameters, tissue hypoxic volume (hv), maximum tissue to blood uptake ratio (t:bmax) and tumor blood flow. both pre-and post-therapy images will be examined to investigate changes in these parameters during the course of tace treatment.

Eligibility criteria:
inclusion criteria: * adult (\> 18 years of age) patients with documented hcc tumor mass \>3cm, who are scheduled to undergo tace with additional selective internal radiation therapy (sirt) * the appropriate criteria for inclusion for this patient population are: * biopsy or radiological diagnosis of hcc (defined as organ procurement and transplantation network (optn\*) category 5 lesion either on ct or mri) * scheduled for tace (using doxorubicin-eluting beads) + sbrt * willingness to undergo pet/ct * able to lie on the imaging table for up to 1 hour. * able to provide signed informed consent. * women with childbearing potential must have a negative urine beta-human chorionic gonadotropin (β-hcg) test day of procedure exclusion criteria: * estimated life expectancy \<12 months or serious medical co-morbidities that would preclude definitive local therapy * unable to lie on the imaging table * age less than 18 years. * pregnancy or lactation * inability or unwillingness to provide informed consent. * weight \>500 lbs (the weight limit of the tomograph gantry table)
poc sars-cov-2 diagnostic pcr device comparison to fda approved reference pcr test

Conditions: Covid19

Summary: study will assess sensitivity and specificity of anavasidx poc pcr device for detection of covid-19 in patients presenting for testing a clinical sites.

study will assess sensitivity and specificity of anavasidx poc pcr device for detection of covid-19 in patients presenting for testing a clinical sites using a national laboratory pcr covid-19 test as reference. this study is following fda eua molecular test approval criteria. study will be conducted in 3 or more geographically diverse clinical sites.

Eligibility criteria:
inclusion criteria: * subjects presenting to clinical site for covid-19 testing. completion of signed written informed consent process. exclusion criteria: * inability to complete signed written informed consent process. younger than 2 years of age. any contraindication to covid-19 swab testing
effect of nilotinib in cerebellar ataxia patients

Conditions: Ataxia, Cerebellar; Ataxia, Progressive

Summary: this is an institutional cohort study. patients confirmed with spinocerebellar ataxia (sca) and taking or planning to take nilotinib (tasigna®) are enrolled in this study. the daily dose of nilotinib is 150mg-300mg and the patients will be followed up at 1, 3, 6, and 12 months. rating scale for friedreich's ataxia i and ii and barthel index are used as general function and daily living performance index. scale for assessment and rating of ataxia (sara) are used as an objective measure of cerebellar function. adverse drug reactions are evaluated based on ctcae version 4.0.

1. patients taking nilotinib 1-1.baseline information: demographics, genetic type of sca, brain mri, electrocardiography, routine blood evaluations 1-2. time point of evaluation: at initiation of taking nilotinib, 1, 3, 6, and 12 months 1-3. evaluation items (at each time point) routine check-up: electrocardiography, routine blood evaluations adverse events: ctcae version 4.0 daily living performance: barthel index general function: friedreich's ataxia i and ii 1-4. change of drug dose based on the attending physician's decision 2. patients planning to take nilotinib 2-1.baseline information: demographics, genetic type of sca, brain mri, electrocardiography, routine blood evaluations 2-2. time point of evaluation: baseline, 1, 3, 6, and 12 months 2-3. evaluation items (at each time point) routine check-up: electrocardiography, routine blood evaluations adverse events: ctcae version 4.0 cerebellar function: scale for assessment and rating of ataxia (sara) daily living performance: barthel index general function: friedreich's ataxia i and ii 2-4. change of drug dose based on the attending physician's decision

Eligibility criteria:
inclusion criteria: * diagnosed as chronic cerebellar ataxia * confirmed as spinocerebellar ataxia by gene test exclusion criteria: * laboratory abnormalities that could interfere with the proper use of nilotinib qtc interval \>450ms on initial electrocardiograph, hb \ 200, alt\>200, alp\>575, positive hiv serology, active hepatitis b * unstable mental or physical status that could interfere with precise evaluation and proper management of sca heart failure (nyha grade iii or iv), history of major heart disease pregnancy, on breast feeding

Keywords: spinocerebellar ataxia treatment nilotinib bcr-abl receptor-tyrosine-kinase-inhibitor
dose low dose ketamine in casesarian

Conditions: Postoperative Pain; Postpartum Depression

Summary: the results of ketamine, ketamine and midazolom and placebo can be copied after birth in cesareans subjected to spinal anesthesia.

postpartum depression will be evaluated by dividing the patients into 3 groups: group 1 as ketamine, group 2 as ketamine and midasom, and group 3 as placebo group.

Eligibility criteria:
inclusion criteria: american society of anesthesiologists 2-.3 18 -45years old patients planned to be born by cesarean section the patient requests a cesarean section with spinal anesthesia exclusioncriteria: pathological obstetric complications hypertension contraindication for ketamine contraindication for spinal

Keywords: midazolam with low dose ketamine low dose ketamine postoperatıve analgesıc need postpartum depression
celgosivir as a treatment against dengue

Conditions: Dengue Fever

Summary: this is a randomized, double-blind, placebo-controlled, phase 1b clinical study to evaluate the activity, pharmacokinetics, safety and tolerability of celgosivir in adults with confirmed dengue fever.

patients with confirmed dengue fever who meet all inclusion and exclusion criteria will be enrolled and admitted to the investigational medicine unit. patients will be randomized 1:1 to celgosivir or placebo. capsules of placebo or celgosivir will be administered for 5 days. while in hospital, daily clinical exams will be conducted, and blood samples will be collected for viral load, quantitative ns1, hematology, clinical chemistry, cytokine levels and pharmacokinetics (pk). safety assessments will be conducted. at discharge on study day 5, patients will be asked to return on study days 7, 10, and 15 for blood sampling and safety assessments.

Eligibility criteria:
main inclusion criteria: * fever of ≥ 38°c of ≤ 48 hr duration. * at least two of the following criteria indicating probable dengue infection: * live or work in or recent travel to dengue endemic area * nausea and vomiting * presence of rash * aches and pains, including headache, or retro-orbital, muscle or joint pain * positive ns1 strip assay main exclusion criteria: * clinical signs and symptoms for severe dengue * patients with certain abnormal laboratory values * history of presently active intestinal disorders * severe diarrhea * current usage of anticoagulant drugs * other clinically significant acute illness * history of severe drug and/or food allergies * exposure to investigational agent within 30 days prior to study drug administration * clinically significant abnormal physical exam unrelated to dengue fever * pregnancy