Kornimate/medical-research-clean huggingface dataset:
amoxicillin challenge for penicillin allergy diagnosis

Conditions: Penicillin Allergy

Summary: false diagnosis of penicillin allergy are frequently reported, and have been proven detrimental to patients. current guidelines for the assessment of drug allergies recommend that penicillin allergy be evaluated first with prick and intradermal skin tests, and then completed with a graded oral challenge, spread over at least two doses. however, it has been shown that these skin tests, in addition to consuming resources and time, are of limited, or even doubtful validity, given the poor predictive values that have been reported in the modern penicillins era. it now seems unreasonable to continue their use without addressing other, more efficient diagnostic stategies. several groups have now demonstrated the safety, validity, and efficiency of a direct, two-step amoxicillin oral challenge (starting with 10% of the standard therapeutic dose, followed by 90 % of the dose), without prior skin tests, first for any type of reaction in the pediatric population, then for any non-immediate reaction in the adult population. the objective of this study is to demonstrate the safety, efficiency, and validity of direct, two-step graded oral challenge with amoxicillin for the evaluation of any reported penicillin allergy in the adult population, excluding high-risk patients (documented anaphylaxis to a penicillin in the last 5 years). skin tests will first be performed according to the protocol currently in use at the chul, then consented patients will proceed with the graded oral challenge still according to the protocol currently in use at the chul, but regardless of the skin tests results. the results of the two tests will be compared to determine the safety, efficiency and validity of proceeding directly to the graded oral challenge.


Eligibility criteria:
inclusion criteria: * being 18 years of age or older at the time of the test * being referred by a health professional for the evaluation of any allergic reaction to a penicillin, including natural penicillins, anti-staphylococcal penicillins, aminopenicillins, penicillins combined with a beta-lactamase inhibitor, and carboxypenicillins ; or an antibiotic of the beta-lactam family, whose assessment requires testing for penicillins, according to the treating allergist exclusion criteria: * pregnancy * poorly controlled asthma, chronic lung disease or heart disease * failure to stop beta-blockers prior to the test * occurrence of the reaction in the 4 weeks preceding the test (possibility of false negatives) * history of severe delayed hypersensitivity reaction, reaction requiring hospitalization of more than 24 hours, or bullous, pustular, exfoliative or mucosal reaction (excluding angioedema) * recent anaphylaxis (\<5 years), defined as concomitant involvement of at least two systems (respiratory, digestive, mucocutaneous or cardiovascular) within one hour of administration of the drug
randomised placebo-controlled duloxetine-referenced study of efficacy and safety of 5 mg of vortioxetine (lu aa21004) in acute treatment of major depressive disorder in elderly patients

Conditions: Major Depressive Disorder

Summary: to assess the efficacy of vortioxetine (5 mg daily) versus placebo in the acute treatment of depression by means of the change from baseline in the 24-item hamilton depression scale (ham-d24) total score after 8 weeks of double-blind treatment in elderly patients.


Eligibility criteria:
inclusion criteria: clinical diagnosis of recurrent major depressive episode (mde) according the diagnostic and statistical manual of mental disorders, 4th edition, text revision (dsm-iv-tr) criteria with: * reported duration of the current episode of at least 4 weeks * madrs total score \>=26 * at least one previous mde before the age of 60 years exclusion criteria: * mini mental state exam (mmse) \<24 * any current anxiety disorder as defined in the dsm-iv-tr * current or past history of manic or hypomanic episode, schizophrenia, or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the dsm-iv-tr * any substance disorder (except nicotine and caffeine) within the previous 6 months as defined in the dsm-iv-tr * presence or history of a clinically significant neurological disorder (including epilepsy) * neurodegenerative disorder (alzheimer's disease, parkinson disease, multiple sclerosis, huntington disease, etc) * any axis ii disorder that might compromise the study * significant risk of suicide according to the investigator's opinion, or has a score \>=5 on item 10 of the madrs or has made a suicide attempt in the previous 6 months other inclusion and exclusion criteria may apply.

Keywords: depression elderly acute treatment
evaluation of nasal biomarkers for objective assessment of disease severity in respiratory disorders

Conditions: Chronic Obstructive Pulmonary Disease (COPD); Asthma Patients; Asthma and Rhinitis; Asthmatic Patients; Asthma, Chronic Obstructive Pulmonary Disease (COPD); Rhinitis Allergic; Rhinitis, Allergic, Perennial and/or Seasonal; Non-allergic Rhinitis; Chronic Sinusitis With or Without Nasal Polyps; Healthy Volunteers

Summary: this research study is an observational, single site study quantifying expression of biomarkers of respiratory disease in nasal fluid using the abel microsampler device. the primary objective of this study is to compare biomarker expression between healthy controls and participants with respiratory disorders such as chronic obstructive pulmonary disorder (copd), hayfever, chronic sinusitis, asthma and rhinitis.


Eligibility criteria:
inclusion criteria: * all participants: * 18 years of age or older * the participant must be able to comprehend and sign an approved informed consent form and other applicable study documents. * healthy volunteers: * no significant sinonasal/pulmonary symptoms or prior diagnoses of sinonasal/pulmonary conditions as determined by pre-enrolment questionnaires. * case goup: * participants must be previously diagnosed with rhinitis, chronic sinusitis, asthma, or copd by a medical professional. exclusion criteria: * less than 18 years of age at the time of enrolment. * volunteers who are actively pregnant * prior history of adverse reaction or contraindicated to diagnostic testing including fingerprick blood sampling, pulmonary testing, nasal swab/sampling. * any other conditions limiting the volunteer's ability to complete study requirements in the judgement of the investigator/clinician * any nasal anatomical issue or finding which may limit the safe insertion of the abel collection device, as determined by investigator/clinician * history of nasal surgery or trauma within the last 3 months

Keywords: nasal biomarker nasal fluid asthma biomarker copd biomarker rhinitis biomarker chronic sinusitis biomarker allergy respiratory disease
study of cardiopulmonary exercise testing in women who have her2-positive breast cancer with mild cardiotoxicity

Conditions: Breast Cancer; HER2-positive Breast Cancer; HER2-positive Metastatic Breast Cancer; Breast Cancer Stage I; Breast Cancer Stage II; Breast Cancer Stage III; Breast Cancer Stage IV; Cardiotoxicity

Summary: the purpose of this study is to find out how much oxygen is used during a cardiopulmonary exercise test (cpet) in women who have mild cardiotoxicity after standard treatment for her2-positive breast cancer, and to see whether the results of this test can be used to predict how well participants' heart and lungs will work if they continue to receive this kind of treatment.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * female * diagnosed with a her2-positive solid tumor (stage i-iv) * left ventricular dysfunction prior to the start of her2-targeted therapy, defined by a lvef \< 53% (or lower limit of normal), or diagnosed with mild cardiotoxicity associated with her2-targeted therapy, defined by an absolute decrease in lvef ≥ 10% from pre-treatment to \< 53% * planning to undergo treatment with her2-targeted therapy (e.g. trastuzumab, pertuzumab, or ado-trastuzumab) for a minimum of 3 months (i.e. 4 cycles administered every 3 weeks). * willing and able to comply with the requirements of the protocol exclusion criteria: * symptomatic heart failure (new york heart association class iii or iv) * subjects must not have any of the following absolute contraindications to cardiopulmonary exercise testing: * acute myocardial infarction (within 30 days of any planned study procedures), * unstable angina * uncontrolled arrhythmias causing symptoms or hemodynamic compromise, * symptomatic severe aortic stenosis * recurrent syncope * active endocarditis * acute myocarditis or pericarditis * acute pulmonary embolus or pulmonary infarction (within 3 months of any planned study procedures) * thrombosis of lower extremities (within 3 months of any planned study procedures) * suspected dissecting aneurysm * uncontrolled asthma * pulmonary edema * room air desaturation at rest ≤ 85% * respiratory failure * acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise (i.e., infection, renal failure, thyrotoxicosis) * mental impairment leading to inability to cooperate. * enrollment onto any other interventional investigational study * inability to provide informed consent

Keywords: her2-positive breast cancer cardiotoxicity her2-targeted therapy breast cancer 21-271 memorial sloan kettering cancer center
application of pet/mri in the evaluation of the efficacy of neoadjuvant therapy for locally advanced rectal cancer

Conditions: Locally Advanced Rectal Cancer (LARC)

Summary: this study plans to include larc patients receiving neoadjuvant therapy at this center, conducting pet/ct and pet/mr examinations before treatment, and pet/mr examinations before surgery after neoadjuvant therapy. the changes in the lesion before and after treatment will be compared to evaluate the efficacy of neoadjuvant therapy, including: the relief situation of the rectal primary lesion ; lymph node metastasis; local infiltration around the tumor; peritoneal and other distant metastases , etc. the pathological relief diagnosed by surgical pathology is the gold standard, and the predictive efficacy of pet/mr will be evaluated, comparing the advantages and disadvantages of 18f-fdg and 68ga-fapi pet/mr, and comparing with traditional pet/ct and rectal mri to explore the value of pet/mri in predicting the efficacy of neoadjuvant therapy in larc patients.


Eligibility criteria:
inclusion criteria: * (1) age 18-75 years old; (2) ecog score 0-2; (3) pathologically confirmed as rectal adenocarcinoma; (4) the lower edge of the tumor is within 12cm from the anal edge; (5) clinically staged as ct3-4n0m0 or ctanyn+m0; (6) untreated patients who have not received radiotherapy, chemotherapy, and surgery, etc.; (7) good liver and kidney function, can tolerate radiotherapy and surgery; (8) patients and their families can understand the research plan, voluntarily participate in this research and sign the informed consent form. exclusion criteria: * (1) ecog score \> 2; (2) patients with multiple primary colorectal cancers; (3) patients with a history of other malignant tumors within the past 5 years (except for cured basal cell carcinoma, cervical carcinoma in situ, surgically treated localized prostate cancer, or surgically removed breast ductal carcinoma in situ); (4) patients with intestinal obstruction, intestinal perforation, gastrointestinal bleeding, and other emergencies requiring emergency surgery; (5) pregnant or lactating women; (6) patients with a history of severe mental illness, immune diseases, and hormone medication; (7) patients with contraindications for mri, pet examination, radiotherapy, immunotherapy, or surgical treatment; (8) patients who have participated in other clinical studies within the last 3 months; (9) any other conditions deemed unsuitable for inclusion by the researcher.
safety and tolerability of inhaled chf 6001 in healthy volunteers (hv)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: this study is designed to investigate the safety, tolerability and pharmacokinetics of inhaled chf 6001 after single and multiple doses in healthy volunteers.

the study will be conducted in a single centre and will consist of a single dose part and a multiple dose part. seven single doses of chf 6001 will be administered according to an escalation, alternate cross over scheme. five multiple doses of chf 6001 will be administered for 7 days according to a sequential escalation scheme.

Eligibility criteria:
inclusion criteria: * subject's written informed consent obtained prior to any study-related procedure * male healthy volunteers aged 18-55 years; * able to understand the study procedures, the risks involved and ability to be trained to use the devices correctly. * body mass index (bmi) between 18.0 and 28.0 kg/m2; * non- or ex-smokers who smoked \ 1 year; * results of laboratory tests within the normal ranges. minor deviations are acceptable provided that they are not judged clinically significant by the investigator. * a reliable method of contraception for the subjects and their partner. exclusion criteria: * blood donation or blood loss less than 8 weeks before inhalation of the study medication; * positive hiv1 or hiv2 serology; * positive results from the hepatitis serology which indicates acute or chronic hepatitis b or hepatitis c; * history of substance abuse or drug abuse within 12 months prior to screening visit or with a positive urine drug screen at screening; * clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical investigation; * clinically significant and uncontrolled cardiac, hepatic, renal, gastrointestinal, endocrine, metabolic, neurologic, or psychiatric disorder that may interfere with successful completion of this protocol; * treatment within the previous 3 months with any drug known to have a well defined potential for hepatotoxicity (e.g. isoniazide, nimesulide, ketoconazole). * subjects who refuse to abstain from alcohol or caffeine containing foods or beverages or grapefruit containing foods or beverages from 48 hour prior to each intake of study medication until the end of confinement at the clinical centre. * heavy caffeine drinker (\> 5 cups or glasses of caffeinated beverages e.g., coffee, tea, cola per day).
optical coherence tomography of the irido-corneal angle before and after goniotomy and trabeculotomy in primary congenital glaucoma

Conditions: Optical Coherence Tomography; Anterior Chamber Angle; Goniotomy; Trabeculotomy; Primary Congenital Glaucoma

Summary: the research aimed to improve surgical techniques and long-term outcomes by utilizing this advanced imaging technology to illuminate the structural abnormalities of the anterior segment in eyes with primary congenital glaucoma.

primary congenital glaucoma (pcg) is a rare disease, but it is responsible for 2.5%-15% of all documented cases of pediatric blindness. the main target of the treatment of pediatric glaucoma is to control the iop surgically. however, medical treatment could be instituted as a temporary and/or adjunctive option to maximize intraocular pressure (iop) control. initial goniotomy or trabeculotomy have been detected to have high success rates. trabeculotomy has a comparable long-term success rate in most patients of pcg. the success rate of trabeculotomy is lower in advanced or late-presenting patients.

Eligibility criteria:
inclusion criteria: * age from 1 to 72 weeks. * both sexes. * infants with primary congenital glaucoma. exclusion criteria: * eyes in which the angle could not be visualized by the handheld anterior segment optical coherence tomography (hh as-oct). * eyes with previous intraocular surgery.
testing home-based exercise strategies in underserved minority cancer patients undergoing chemotherapy: the thrive study

Conditions: Breast Cancer; Colorectal Cancer; Prostate Cancer

Summary: the purpose of this research is to determine whether a 16 week, home-based, aerobic and resistance exercise intervention will increase physical activity levels in black and hispanic breast, colorectal, or prostate cancer patients. the names of the study interventions involved in this study are: * supervised aerobic and resistance exercise (sup) - virtually supervised 16- week aerobic and resistance exercise performed at home via zoom. * unsupervised aerobic and resistance exercise (unsup) - home-based 16- week aerobic and resistance exercise. * attention control (ac) - 16-week home-based stretching.

this is a randomized control trial of black and hispanic patients who have been newly diagnosed with breast, colorectal, or prostate cancer and are being prescribed chemotherapy to determine the effects of home-based exercise on levels of physical activity. it will also evaluate the impact of home-based exercise on cardiovascular (heart health) risk factors. the research study procedures include: screening for eligibility and study treatment including evaluations of body composition, blood tests, fitness and strength assessments, and surveys at study entry and follow-up visits. participants in this study will be randomly assigned to one of three groups: 1) supervised aerobic and resistance exercise (sup), 2) unsupervised aerobic and resistance exercise (unsup), or 3) attention control (ac). participation is expected to last for 8 months. it is expected that about 135 people will take part in this research study.

Eligibility criteria:
inclusion criteria: * over 18 years old; children under the age of 18 will be excluded due to rarity of disease * newly diagnosed with stage i-iii breast, colorectal or prostate cancer * self-identify as hispanic or black * are within 4 weeks of initiating chemotherapy * overweight or obese (bmi \>25kg/m2 or body fat percent \>30) * physician's clearance to participate in moderate-vigorous intensity exercise * speak english or spanish * engaging in less than 90 minutes of moderate-or-vigorous physical activity per week * willing to travel to dana-farber cancer institute for necessary data collection * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * pre-existing musculoskeletal or cardiorespiratory conditions * patients should not have any uncontrolled illness including ongoing or active infection, uncontrolled diabetes, hypertension, or thyroid disease * patients with other active malignancies * patients with metastatic disease * participate in more than 90 minutes of structured exercise/week * unable to travel to dana-farber cancer institute for necessary data collection * subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.

Keywords: breast cancer colorectal cancer prostate cancer
cryptococcal optimal art timing trial

Conditions: Cryptococcal Meningitis; HIV Infections; AIDS

Summary: the cryptococcal optimal art timing (coat) trial seeks to determine after cryptococcal meningitis (cm) whether early initiation of antiretroviral therapy (art) prior to hospital discharge results in superior survival compared to standard initiation of art started as an outpatient.

after 7-11 days of amphotericin b therapy, subjects will be randomized in a 1:1 allocation to: * early initiation of art (experimental group) = art initiated within 48 hours after study entry, or * standard initiation of art (control group) = art at \>=4 weeks after study entry hiv therapy will be with efavirenz plus nucleoside backbone per national guidelines for first line therapy.

Eligibility criteria:
inclusion criteria: * hiv-infection, documented by elisa * antiretroviral medication naïve (excluding mother-to-child transmission therapy) * age \>14 years * cryptococcal meningitis diagnosed by either culture or csf cryptococcal antigen (crag) * ability and willingness of the participant or legal guardian/representative to give informed consent. * receiving amphotericin-based anti-fungal therapy exclusion criteria: * study entry prior to receipt of \ 11 days of amphotericin therapy * history of prior, known cryptococcal meningitis * inability to take enteral medication * receiving chemotherapy or other immunosuppressant medications * cannot or unlikely to attend regular clinic visits * contraindication to immediate or delayed hiv therapy based on serious co-morbidities or co-infections, or laboratory values * pregnancy or breastfeeding * female participants of childbearing potential who are participating in sexual activity that could lead to pregnancy must agree to use two reliable methods of contraception

Keywords: cryptococcal meningitis cryptococcus cryptococcosis hiv aids strategy
using an iphone ecg to monitor the qt interval on dofetilide and sotalol patients

Conditions: Cardiac Arrhythmia; Qt Interval, Variation in

Summary: this study will validate the recording accuracy of a specific electrical interval of the heart, the qt interval, between an iphone rhythm strip recording and a traditional 12-lead electrocardiogram (ecg). these measurements will occur in hospitalized patients that are starting either sotalol or dofetilide, since both of these medications can prolong the qt interval.

patients that were already selected to begin either dofetilide or sotalol in the hospital, will be included in the study. patients will receive an ecg before and 2 hours after each dose of the medication, which is done to monitor the qt interval. in addition, patients that consent to participate in the study will have an iphone ecg recording taken in lead positions that correspond to leads i,ii, and iii. these recordings will be compared and analyzed to assess the accuracy of the qt interval recordings between the two methods.

Eligibility criteria:
inclusion criteria: * initiation of sotalol or dofetilide * inpatient at university hospital exclusion criteria: * none

Keywords: ecg qt interval sotalol dofetilide iphone
phase 2 study to evaluate rpt193 in adults with moderate to severe t2-high asthma

Conditions: Asthma

Summary: randomized, multi-center, double-blind, placebo-controlled, parallel group, proof of-concept study with rpt193 in subjects with t2-high, moderate-to-severe asthma who are partially controlled on medium or high doses of inhaled corticosteroids (ics) in combination with long-acting beta 2 agonist (laba).

randomized, multi-center, double-blind, placebo-controlled, parallel group, proof of-concept study with rpt193 in subjects with t2-high, moderate-to-severe asthma who are partially controlled on medium or high doses of inhaled corticosteroids (ics) in combination with long-acting beta 2 agonist (laba). after a screening period subjects will receive standardized, inhaled therapy during a run-in period. subjects will be randomized to receive rpt193 or placebo through week 14. all enrolled subjects will receive background inhaled therapy with ics and laba.

Eligibility criteria:
inclusion criteria: * physician diagnosis of asthma for ≥6 months * pre-bronchodilator fev1 of \>40% and \<80% * history of treatment with corticosteroid or hospitalization for worsening asthma * medium- or high-dose inhaled corticosteroid use exclusion criteria: * history of smoking/vaping * history of severe covid * serious and/or uncontrolled pulmonary, cardiac, immune system conditions * requires systemic oral or iv corticosteroids in the month prior to screening

Keywords: asthma