Kornimate/medical-research-clean huggingface dataset:
healthcare decisions on dietary and environmental allergen exposure

Conditions: Dietary Allergy; Environmental Allergy

Summary: design of this study is to collect data and review principal investigators standard operating procedures on allergy testing and changes made to their specific sop.

the purpose of this minimal risk observational study is to increase surveillance for dietary and environmental allergens exposure and to also determine targeted risk reducing and preventative strategies.

Eligibility criteria:
inclusion criteria: * must be a medical practitioner medical doctor (md) doctor of osteopathic (do) physician assistant (pa) advanced practice registered nurse (aprn) nurse practioner (np) must have a current standard operating procedure that includes obtaining/reviewing medical history and family medical history. exclusion criteria: * government funded insurance data cannot be included in the study
the modulatory effect of low-intensity priming intermittent theta burst stimulation on motor cortex poststroke: a concurrent tms-eeg study

Conditions: Stroke

Summary: background: the optimization of the intensity of priming theta burst stimulation increases the probability of success in a randomized controlled trial. we hypothesize that priming intermittent theta burst stimulation (itbs) with a low-intensity continuous theta burst stimulation (ctbs) will yield superior effects than our original priming protocol in healthy adults and patients after stroke. methods: 20 stroke patients will undergo three separate experimental conditions: a low-intensity priming stimulation (55% resting motor threshold \[rmt\] ctbs+70% rmt itbs), a conventional-intensity priming stimulation (70% rmt ctbs+70% rmt itbs), and a nonpriming control. the alterations in cortical excitation/inhibition and its impacts on motor behaviors will be evaluated following stimulation. significance: the findings will inform future clinical trials investigating the optimized priming itbs in promoting poststroke recovery.

background: the optimization of the intensity of priming theta burst stimulation increases the probability of success in a randomized controlled trial. we hypothesize that priming intermittent theta burst stimulation (itbs) with a low-intensity continuous theta burst stimulation (ctbs) will yield superior effects than our original priming protocol in healthy adults and patients after stroke. methods: 20 stroke patients will undergo three separate experimental conditions: a low-intensity priming stimulation (55% resting motor threshold \[rmt\] ctbs+70% rmt itbs), a conventional-intensity priming stimulation (70% rmt ctbs+70% rmt itbs), and a nonpriming control. the alterations in cortical excitation/inhibition and its impacts on motor behaviors will be evaluated following stimulation. significance: the findings will inform future clinical trials investigating the optimized priming itbs in promoting poststroke recovery.

Eligibility criteria:
inclusion criteria: * (1) have a diagnosis of ischemic or hemorrhagic stroke, with time after stroke onset≥6 months; * (2) aged between 18 and 80 years old; * (3) with residual upper limb functions from 2-7 levels in the functional test for the hemiplegic upper extremity, i.e., moderately impaired overall upper extremity functions. * (4) able to give informed written consent to participate in the study. exclusion criteria: * (1) any contraindications to tms (screened by the safety checklist by rossi \[12\]); - * (2) any concomitant neurological disease; * (3) any sign of moderate-to-severe cognitive problems, i.e., montreal cognitive assessment (moca)\<19/30 * (4) modified ashworth score\>2 in hand, wrist or elbow extensor muscle in the hemiparetic upper extremity. in addition, a group of age-matched, right-hand dominant healthy adults without any known neurological diseases will be enrolled. healthy adults with any contraindications to tms will be excluded.

Keywords: stroke transcranial magnetic stimulation theta burst stimulation neuroplasticity motor learning
evaluation of anti-covid 19 pfizer vaccination effect on covid 19 detection using breath analysis

Conditions: Covid19

Summary: the objective of this study will be to evaluate the effect of vaccination on breath voc content. by capturing and analyzing the breath of anti-covid-19 vaccinated subjects during the period of antibody production, the investigators will determine and quantify all the compounds associated with the body reaction to the covid-19 antigen.

the objective of this study will be to evaluate the effect of vaccination on breath voc content. by capturing and analyzing the breath of anti-covid-19 vaccinated subjects during the period of antibody production, the investigators will determine and quantify all the compounds associated with the body reaction to the covid-19 antigen. rapidly growing serological evidence shows that igm, igg, and iga antibodies against the s or n proteins evolve rapidly in the serum of asymptomatic as well as symptomatic covid-19 patients within a week of infection or symptom onset and stay elevated with progressing disease. since the standard serology testing at shamir medical center tracks the presence of igg only, those serologic tests will be conducted before and 48 hours following the second vaccination dose. nevertheless, since igm antibodies are known to be produced by four to seven days following the first dose of vaccination, although igm serology testing cannot be performed, the investigators are interested in sampling breath at this time range, in order for them to correlate it with the changes in the subjects' physiologic condition. since this is an unknown metabolic volatile compound mixture, the goal will be to identify compounds and quantify them with a high level of precision and subsequently correlate them with the disease.

Eligibility criteria:
inclusion criteria: * age 18 to 75 years at the time of consent * capable of understanding written and/or spoken language * able to provide informed consent * assigned to undergo anti-covid-19 vaccination exclusion criteria: * age under 18 years old * under guardianship or deprived of liberty * pregnant or lactating woman * not eligible for anti-covid-19 vaccination
the effect of 0.05% csa eye drops on post-refractive surgery dry eye

Conditions: Dry Eye

Summary: the purpose of this study is to observe the effect of 0.05% cyclosporine eyedrops combined with artificial tears in patients with dry eyes after corneal refractive surgery and to observe the changes in ocular surface characteristics and tear inflammatory cytokines before and after treatment.

the purpose of this study is to observe the effect of 0.05% cyclosporine eyedrops combined with artificial tears in patients with dry eyes after corneal refractive surgery and to observe the changes in ocular surface characteristics and tear inflammatory cytokines before and after treatment. at the same time, this study further observed whether 0.05% cyclosporine eyedrops combined with artificial tear eyedrops were more beneficial to ocular surface repair and tear film homeostasis compared with traditional artificial tears alone.

Eligibility criteria:
inclusion criteria: * patients who suffering from dry eye after refractive surgery with age between 18 and 45 years old. * any gender. * provision of written informed consent. exclusion criteria: * active ocular infection, ocular inflammation, active ocular allergy, severe blepharitis or obvious inflammation of the eyelid margin. * pregnant and lactating women, or those planning a pregnancy over the course of the study. * uncontrolled systemic disease. * suffer from diseases that may affect corneal nerves, such as keratoconus, trigeminal neuralgia, allergic conjunctivitis, etc.

Keywords: dry eye, refractive surgery, 0.05% cyclosporine
pulmonic valve replacement multi-discipline emea registry

Conditions: Pulmonary Regurgitation; Pulmonary Insufficiency; Pulmonary Stenosis

Summary: the purpose of this registry is to retrospectively and prospectively obtain clinical data in consecutively treated patients, in order to demonstrate that the commercially available edwards sapien valve with the rf3 delivery system is a safe and effective treatment for patients with pulmonary regurgitation or stenosis.

consecutive patient data should be collected at discharge, 6 months, 12 months and 2-5 years post-implant.

Eligibility criteria:
inclusion criteria: - symptomatic with a regurgitant or stenotic pulmonary valved conduit. exclusion criteria: * angiographic evidence of coronary artery compression. * rv-pa pulmonary conduit size that is either too large or too small to accommodate the sapien thv. * thrombus or intracardiac mass in the right atrium, right ventricle, and/or pulmonic valve. * severe coagulation problems and/or unable to tolerate anticoagulation/antiplatelet therapy. * active bacterial endocarditis or other active infections. * illeofemoral venous stenosis that may prevent the placement of the introducer sheath and/or central venous vascular tortuosities that may prevent advancement of the delivery system to the heart or into the pulmonary artery. * presence of any prosthetic valve in the tricuspid position. * unstable coronary artery disease-related angina. * placement of the sapien thv in pregnant females.

Keywords: conduit pulmonic stenosis regurgitation dysfunctional
validation of the wisconsin stone-qol

Conditions: Urolithiasis; Nephrolithiasis; Kidney Stones

Summary: the overall purpose of this study is to evaluate criterion-related validity of a newly-developed disease-specific instrument to assess the health-related quality of life (hrqol) of patients who have had kidney stones. specific aims of this study are: 1. aim 1. evaluate the population/external validity (generalizability) of the wisconsin stone-qol by answering the question, "is the wisconsin stone-qol useful for assessing the hrqol of patients who form kidney stones from a broad region of north america?" 2. aim 2. assess the ability of the wisconsin stone-qol to detect changes within patients related to stone interventions and other disease-specific outcomes by answering the question, "is the wisconsin stone-qol sensitive to changes in stone-related outcomes within individuals?"

the wisconsin stone-qol was developed as the only known hrqol instrument designed specifically for patients with kidney stones. its development has been published. internal and other validity tests on the instrument have been conducted and reported. further validity testing of the instrument is needed to confirm its broader utility in the context of surgical and medical management of patients with kidney stones. upon enrollment at each site, patients will be asked to complete a medical history form and the wisconsin stone-qol. to supplement the information provided in the medical history forms, patients' medical records will be reviewed in order to collect and enter approved data into a spreadsheet. further patient interventions include completion of the wisconsin stone-qol at 3 months, 12 months, 24 months, and 36 months post-enrollment. these post-enrollment surveys will usually be mailed to patients to the addresses they provide. alternatively, patients may be provided the surveys at a urology encounter if it falls on or near the intervention time points. at each time point, patients' medical records will also be searched to document any changes in the data entered at enrollment.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of kidney stones, either in the past or currently * 18 years of age or older exclusion criteria: * under 18 years of age * no previous or current diagnosis of kidney stones

Keywords: quality of life qol urolithiasis nephrolithiasis kidney stones patient-reported outcomes
zinc sulphate vs. zinc amino acid chelate

Conditions: Diarrhea; Acute Respiratory Infection

Summary: acute respiratory infection and acute diarrhea are among the most prevalent diseases of childhood increase the burden of morbidity and mortality in children under 5 years. among the possible strategies for its prevention is important to count on good nutritional status for use in developing a good immune response to infections. zinc deficiency has been shown to favor the development of infections and has been considered a real public health problem. within the zinc compounds used are zinc amino acid chelate and zinc sulphate, the first that has shown evidence of being better absorbed and tolerated. we propose a study showing the effectiveness of zinc amino acid chelate and zinc sulphate in the prevention of acute diarrheal disease and acute respiratory infection.


Eligibility criteria:
inclusion criteria: children who * belong to institute fan in medellín * attend full time to institute fan (eight hours) * have 2 to 5 years exclusion criteria: children who * children at the began of the study are with acute diarrheal disease and acute respiratory infection. * recurrent pneumonia, cystic fibrosis, gastrointestinal malformations, persistent diarrhea of any cause, inflammatory bowel disease. * failure to attend the educational institution for more than 10 days * no consumption of zinc supplementation for more than 10 days, because of insistence to the school

Keywords: child, preschool dietary zinc zinc sulfate zinc-glycine chelate
carbohydrates distribution in pregnancy study

Conditions: Gestational Diabetes Mellitus in Pregnancy

Summary: hypothesis: patients with gestational diabetes mellitus (gdm) have a high risk to develop complications during pregnancy, puerperium and in the newborn. at present there are not scientific evidences about the optimal distribution of meals in the medical nutrition therapy (mnt) and their relationship with glycemic control. aim: to explore and compare ketonemia and glycemic profile in patients with gdm that follow a mnt distributed in 6 or 3 meals. besides, we want to explore the differences between both treatments in glucose dynamics. methods: the study design is a randomized, crossover and multicentric trial. a sample of 10 patients with gdm will be recruited in the department of endocrinology and nutrition from both centres. in a randomized manner patients will follow the conventional treatment (a carbohydrate-controlled diet distributed in 6 meals: 3 main meals and 3 snacks) and the intervention treatment (a carbohydrate-controlled diet distributed in 3 meals: breakfast, lunch and dinner). they will be randomized to begin with one of the two treatments, and after two weeks they will be switched to the other treatment. patients will wear a blinded continuous glucose monitoring device (ipro2-tm, medtronic) during the entire study period. inclusion criteria: * women with gdm diagnosed in 24-28 weeks. * age 18-40 years. * pregnancy age of 28-32 weeks. * caucasian. * body mass index ≤ 35 kg/m2. exclusion criteria: * unability to understand the dietary recommendations and/or to perform self-management of glycemia, ketonuria or ketonemia. * a low adherence to mnt. * problems with written and/or oral communication. * presence of comorbidities other than obesity, hypertension and dyslipidemia. * insulin-need criteria within 3 first days of the beginning of the study (fasting glucose ≥90mg/dl, postprandial glucose 1-hour ≥140mg/dl). clinical and sociodemographic variables will be assessed. dietary records and blood samples will be collected. daily basal ketonuria and ketonemia before each meal will be assessed. glycemic profile will be collected with a blind-sensor during the four weeks of the intervention study. generalized linear model analysis will be performed. statistical power will be 80% and significance level will be set at 0.05. written informed consent will be collected from all participants.


Eligibility criteria:
inclusion criteria: * women with gdm diagnosed in 24-28 weeks. * age 18-40 years. * pregnancy age of 28-32 weeks. * caucasian. * body mass index ≤ 35kg/m2. * firs-time mother. exclusion criteria: * disability to understand the dietary recommendations and/or to perform self-management of glycemia, ketonuria or ketonemia. * a low adherence to mnt. * problems with write and oral communication. * other comorbidities differed of obesity, hypertension and dyslipidemia. * insulin criteria within 3 first days of study (fasting glucose ≥90mg/dl, postprandial glucose 1-hour ≥140mg/dl).

Keywords: medical therapy nutrition meal carbohydrates intervention food intake
bnt001 digital therapeutic feasibility pilot study

Conditions: Cancer

Summary: this single arm phase ii trial focused on cancer patients and cancer survivors in the veterans health administration will gather data on feasibility, acceptability, ease of clinical implementation, and preliminary efficacy of bnt001, a prescription digital software application. bnt001 delivers a 10-session digitally administered version of a published manualized therapy for stress management in adult cancer patients that has established efficacy in improving quality of life and mood.

this pilot will study specific implementation barriers and facilitators, procedures that are necessary to ensure adherence to utilization of the digital program, as well as any potential safety issues associated with recruiting and offering an intervention to cancer patients with moderate anxiety or mild depressive symptoms. data relating to patient experience, adherence, satisfaction and pre-post intervention outcomes will also be tracked. the study will run in two distinct phases to first assess the process of clinical implementation by prescribing oncology clinicians, and in a second more expanded phase, further assess the clinical implementation and impact on enrolled patients. study phase 1: we aim to identify promoters and barriers to the clinical implementation of bnt001, a software application that delivers a 10-session digitally administered version of a published manualized therapy for stress management in adult cancer patients that has established efficacy in improving quality of life and mood. study phase 2: we aim to further identify promoters and barriers to provider clinical implementation of bnt001, assess patient acceptability and feasibility including patient adherence to bnt's 10-sessions, and obtain preliminary data on bnt001's impact on cancer-related distress.

Eligibility criteria:
inclusion criteria: * diagnosis or history of invasive cancer (excluding non-melanoma skin cancer). * patients showing mild to moderate anxiety or depression on the veteran system assessment screen (vsas), with anxiety or depression scored as 1-6 on a 0-10 scale. * fluent in english. * has access to ios or android smartphone, or tablet and capable of receiving text messages. * has an e-mail address. exclusion criteria: * endorses thoughts of self-harm, history of suicidality. * currently participating in investigative behavioral intervention trial for treatment of anxiety or depression. * participant is unable to complete training, has cognitive deficits, major psychiatric conditions, psycho-social conditions; lack of access to reliable internet and accessible device; other social conditions that would interfere with adherence to self directed care, such that in investigator's opinion the participant would be unable to complete the study. * recently completed use of blue note therapeutics covid cancer care program or other blue note therapeutics sponsored study.
metabolic changes in patients with chronic cardiopulmonary disease

Conditions: Heart Failure; Chronic Obstructive Pulmonary Disease; Malignancy; Chronic Kidney Disease

Summary: this study aims to evaluate prevalence of sarcopenia and cachexia in patients with chronic cardiopulmonary disease. the investigators will also investigate metabolic disorders like glucose metabolism, presence of metabolic syndrome, body composition and histological changes in skeletal muscle and body fat. finally, patients will be followed for clinical endpoints.


Eligibility criteria:
inclusion criteria: * diagnosis of chronic disease (heart failure, copd, malignancy, ckd) or no diagnosis (controls) exclusion criteria: * refuse to participate
preoperative inspiratory muscle training in esophageal resection

Conditions: Esophageal Resection Candidates

Summary: the prepare study is the first multicenter randomized controlled trial to evaluate the hypothesis that preoperative inspiratory muscle training leads to decreased pulmonary complications in patients undergoing esophageal resection.

rationale: esophageal resection is associated with high incidences of postoperative pulmonary pneumonia. numbers of 30% are reported in literature. postoperative complications can result in prolonged hospital stay and increased health care costs. in cardiac surgery patients a reduction of postoperative pneumonia of 50% is reported as a result of a preoperative inspiratory muscle training program. while in some surgical centers imt is already used in the preoperative phase in patients undergoing esophageal resection, the effect of this promising intervention has not yet been investigated in a randomised and controlled study design in large surgical populations other than cardiac surgery. primary objective: investigate the effect of a preoperative inspiratory muscle training program on the incidence of postoperative pneumonia in patients undergoing esophageal resection. study design: prospective multicenter randomised controlled clinical trial. main study parameters/endpoints: a significant reduction in incidence of postoperative pneumonia.

Eligibility criteria:
inclusion criteria: * (cognitively) capable to understand and perform a preoperative imt program * surgery is scheduled at least 2 weeks after signing informed consent, since the patients need to be able to follow the intervention program for at least 2 weeks * willing to sign the informed consent form exclusion criteria: * unable to communicate in dutch language * age \< 18 years * participating in a conflicting trial concerning esophageal resection

Keywords: esophageal cancer surgery