Kornimate/medical-research-clean huggingface dataset:
a 12-week treatment study to evaluate the effectiveness of albuterol multidose dry powder inhaler with integrated electronic module digital system (emdpi ds) in participants13 years or older with asthma

Conditions: Asthma

Summary: this is a 12-week treatment, multicenter, open-label, randomized, parallel group comparison feasibility study to evaluate the effectiveness of the albuterol emdpi digital system (ds), including inhaler, app, digital health platform (dhp) (cloud solution), and dashboard, to optimize outcomes in participants at least 13 years of age or older with asthma. the study will consist of a screening visit, a 12-week open-label treatment period, and a follow-up telephone call (2 weeks following treatment completion). participants with suboptimal asthma control will be enrolled in the study and randomized in a 1:1 ratio to 1 of 2 parallel groups stratified by investigational center: ds group participants utilizing the albuterol emdpi ds, including inhaler, app, dhp (cloud solution), and dashboard, and cc group participants who will be treated with their standard of care albuterol-administering rescue inhalers and will not use the ds during the treatment period.


Eligibility criteria:
inclusion criteria: * the participant has a documented diagnosis of asthma * the participant is currently on treatment with an inhaled corticosteroid (ics) with a long-acting beta2 antagonist (laba). * the participant is currently using inhaled albuterol sulfate as rescue medication and is willing to discontinue all other rescue medications and replace them with the study provided albuterol emdpi. * the participant can read and communicate in english and is familiar with and is willing to use his/her own smart device and download and use the app. * additional criteria apply, please contact the investigator for more information exclusion criteria: * the participant has any clinically significant uncontrolled medical condition (treated or untreated) other than asthma. * the participant was hospitalized for severe asthma in the last 30 days. * the participant has a diagnosis of chronic obstructive pulmonary disease (copd) or asthma-copd overlap (aco). * the participant is a current smoker or has a greater than 10 pack-year history of smoking. * the participant is currently being treated with systemic corticosteroids (oral, intramuscular, or intravenous) or has been treated within the last 30 days. * the participant has any treatment with biologics for asthma (for example, omalizumab, anti-il5, anti-il5r, anti-il4r), or has had such treatment within the last 90 days. * additional criteria apply, please contact the investigator for more information
understanding immune-related toxicities by multifacet profiling

Conditions: Oncology

Summary: a prospective observational cohort study of patients undergoing cpi therapy in which translational research is the fundamental aspect of the study.

the study aims to enroll and obtain samples of investigational interest from 200 patients over a 36-month recruitment period. blood and/ or stool samples will be taken at baseline, in context of irae development / during cpi treatment and during follow-up. skin samples may also be taken upon development of organspeciifc iraes. further assessments at baseline or during the course of or following treatment will be conducted in accordance with standard institutional practice and will be clinically driven. clinical data, samples and results from archival, current or prospective diagnostic or therapeutic procedures will be used for research purposes within exact. irae clinical monitoring will be conducted in accordance with standard institutional practice and will be clinically driven.

Eligibility criteria:
inclusion criteria: * written informed consent * age 18 years or older * confirmed diagnosis of any form of solid malignancy with a clinical indication and appropriate treatment plan to commence immune checkpoint inhibitor therapy exclusion criteria: * medical or psychological condition that would preclude informed consent * planned participation in a drug trial receiving investigational agents * subjects who have previously commenced immune checkpoint inhibitor therapy prior to study entry. * subjects unable to comply with the study or sample schedule.
repetitive position change improves gastric cleanliness for mce

Conditions: Stomach Diseases

Summary: by comparing dimethicone administration with/without subsequent repetitive position change before magnetically controlled capsule endoscopy (mce) examination, the investigators aim to determine the efficacy of repetitive position change in improving gastric cleanliness for mce examination.

this is a single-blind, randomized controlled trial. subjects receiving magnetically controlled capsule endoscopy at the institution will be randomly allocated into positional change group and conventional group before the procedure. right after ingesting 5 g dimethicone mixed with 100 ml water, subjects in the position change group will be instructed to repeatedly change the body position according to a pre-specified protocol for a period of 15 min: in the order of supine to the left lateral position to prone, left lateral, supine, right lateral, and repeat last four positions twice, each for 1 min; finally supine for 1 min. thirty and 40 min after dimethicone administration, subjects in both groups will additionally take 200 ml and 800 ml water, respectively, and undergo mce examination. gastric cleanliness will be rated by two physicians independently.

Eligibility criteria:
inclusion criteria: * adult patients aged more than 18 years, who were scheduled to undergo a magnetically controlled capsule endoscopy, were eligible for this study. exclusion criteria: * dysphagia or symptoms of gastric outlet obstruction, suspected or known intestinal stenosis, overt gastrointestinal bleeding, history of upper gastrointestinal surgery or abdominal surgery altering gastrointestinal anatomy, or postabdominal radiation; * congestive heart failure, renal insufficiency, under therapeutic anticoagulation, in poor general condition (american society of anesthesiologists class iii/iv), claustrophobia, metallic parts, a pacemaker or other implanted electromedical devices, artificial heart valves; * pregnancy or suspected pregnancy; * exclusion criteria for standard magnetic resonance imaging (mri) examination such as the presence of surgical metallic devices, even though its low magnetic field would technically not interfere with such devices; * currently participating in another clinical study.

Keywords: position change gastric cleanliness magnetically controlled capsule endoscopy
effect of the consumption of a lactobacillus strain on the incidence of covid-19 in the elderly

Conditions: SARS CoV-2 Infection; Elderly

Summary: the objective of this trial is to evaluate the effect of the consumption of a probiotic strain on the incidence and severity of covid-19 in elderly population living in a nursing home. in addition, it will be evaluated if the probiotic strain have some effect on the immune response generated by the covid-19 vaccine inthis population.

the working hypothesis is that the administration of a lactobacillus strain improves the immune response in the elderly population, improving the immune response to a possible covid-19 infection. the strain would act as an adjuvant that contributes to developing an effective response against the virus, and therefore there are fewer infectious symptoms due to this virus or, if it appears, it occurs in a milder way among the subjects who take the probiotic strain. also,the investigators hypothesizes that the administration of the lactobacillus may improve the immune response generated by the covid-19 vaccine in this elderly population.

Eligibility criteria:
inclusion criteria: 1. person over 60 years of age. 2. intern in residence for the elderly. 3. sign informed consent. exclusion criteria: 1. person who at some previous time has tested positive for detection of covid-19 by pcr or serology. 2. person who at the time of starting the intervention presents symptoms compatible with covid-19. 3. person with concomitant disease type hiv, transplant, active cancer or other type of active immunosuppression.

Keywords: probiotics covid19
a study comparing the response of patients with hypertension to amlodipine or amlodipine plus benazepril.

Conditions: Hypertension

Summary: comparison of the safety and efficacy of the combination of amlodipine/benazepril to amlodipine monotherapy in patients with non-essential hypertension, not controlled on amlodipine alone.


Eligibility criteria:
inclusion criteria: * outpatients 18 years of age or older. * male or female patients are eligible. female patients must be either post-menopausal for one year or surgically sterile, or using effective, contraceptive methods such as barrier method with spermicide, or an intrauterine device. * patients with essential hypertension as measured by a validated device exclusion criteria: * severe hypertension (dbp \> 115 mmhg diastolic and/or sbp \> 180 mmhg systolic). other protocol-defined exclusion criteria may apply.

Keywords: amlodipine benazepril hypertension diastolic
optiflow in sequential non-invasive ventilation

Conditions: Respiratory Failure

Summary: background : patient with hypoxemic respiratory failure treated with niv receive between niv session oxygen therapy. gaz exchange disorder with a decrease of the ratio between partial pressure of arterial oxygen (pao2) and inspired fraction of oxygen (fio2) are noticed when niv is stopped at the end of the session du to alveolar derecruitment optiflow is a high flow oxygen delivery system used a heated humidifier and heated breathing circuit. in observational studies, optiflow increase oxygenation of patients with hypoxemic respiratory failure. oxygenation is better than under high-concentration mask and work of breathing is reduced. the aim of the study is to compare in acute hypoxemic respiratory failure, optiflow to oxygen therapy under high-concentration mask, on patients oxygenation between niv sessions (measured as the difference between pao2/fio2 ratio at the beginning and at the end of the session), during the first two niv sessions study design : prospective, randomized, controlled, multicentric, open clinical trial with two groups: * control group with conventional clinical management, oxygen therapy and sequential used of niv * optiflow group with high flow oxygen delivery system, conventional clinical management and sequential used of niv for a period of 36 hours at least. number of subjects: 100 (50 patients per group) patients admitted in intensive care unit for hypoxemic respiratory failure.


Eligibility criteria:
inclusion criteria: * patient at least 18 years old * patients affiliated to or benefiting of the french social welfare system * patients with ards on previously healthy lung. acute respiratory insufficiency, defined as the pao2/fio2 ratio less than 200 mm hg associated with the presence of lung infiltrates on chest radiograph * free and informed consent of patient * hospitalized in one of involved icu exclusion criteria: * existence of criteria for intubation. * refusal to participate in the study. * pregnancy * patient under guardianship or trusteeship * patients for whom a decision of non intubation has been decided. * patients who have received one or several niv session for ards before hospital admission * home noninvasive ventilation * tracheostomy * hemodynamic instability * hypercapnia (paco2\>45 mm hg). * left ventricular failure (cardiogenic pulmonary acute edema). * ineffective coughing. * recent gastric or oesophageal surgery * severe ventricular rhythm disorder * high digestive haemorrhage * lack of collaboration * pernicious vomiting * upper airway obstruction * severe sepsis. * undrained pneumothorax.
neoadjuvant combination chemotherapy of dcs and dcf in patients with locally advanced gastric adenocarcinoma

Conditions: Gastric Cancer

Summary: number of patients planned the study adopted two parallel phase ii studies, with the same p1 and p0 in each arm, suggested by logan. the investigators hypothesized a target orr of interest, p1=50, and a lower orr, p0=25 with the treatment of dcs and dcf, respectively. under the assumption of α-error=0.05 and β-error= 0.2, using sample size tables of a'hern, 26 patients were required per arm to achieve the desired statistical power. finally, taking a 20% drop-out rate into consideration, the overall number of enrolled patients was 62.

treatment scheme * screening period: d-21 to d1 (treatment day) * preoperative screening includes eus, laparoscopy (optional), egd and abd-pelvic ct scan. * preoperative clinical staging is based on the guideline of japanese gastric cancer association (jgca, 1998) * tumor response is assessed every 2 cycles (6 weeks) * treatment is repeated until,. * 4 cycles * progressive disease * unacceptable toxicity * patient's withdrawal * gastric surgery should be performed within 4\~6 weeks of the last dose of chemotherapy * gastric surgery is for curative aim and should include ≥ d2 ln dissection. * patients who received r0 resection should receive at least 4-cycled adjuvant chemotherapy with 5-fu and cisplatin. * palliative chemotherapy should be indicated for inoperable progressive disease or who failed curative resection. 5-fu and oxaliplatin combination is recommended as first-line therapy. * follow up for survival is repeated every 3 months for 2 years study period patient enroll period for 12 months., and follow-up duration for further 12 months., resulting total study period of 24 months

Eligibility criteria:
inclusion criteria: * histologically/cytologically confirmed gastric adenocarcinoma * age 18 to 70 years old * ecog performance status 0\~1 * preoperative clinical staging by japanese gastric cancer association (jgca): ct3n2 (iiib), ct4n0-3 (iiia\~iv), m0, p0, h0, cy0 * no pretreatment (radiotherapy or chemotherapy) for gastric cancer * adequate organ function * hb ≥ 9.0 g/dl * wbc ≥ 4,000/µl * anc ≥ 2,000/µl (\*anc = neutrophil segs ＋ neutrophil bands) * platelet ≥ 100 × 103/ µl * total bilirubin: ≤ 1.5 × unl * ccr ≥ 60 ml/min (by laboratory or cockcroft-gault formula) * ast/alt, alp: ≤ 2.5 × unl * written informed consent exclusion criteria: * distant metastasis on diagnosis * ct1-2 * cancer of gastroesophageal junction (gej) * poor oral intake or absorption deficiency syndrome * gastric outlet obstruction, perforation or bleeding * medically uncontrollable chronic illness or infection * pregnant or lactating women, women of childbearing potential not employing adequate contraception * history of clinically significant cardiac disease * past or concurrent history of neoplasm last \< 5 year other than gastric cancer * prior gastrectomized patients * concomitant administration of any other experimental drug under investigation * peripheral neuropathy ≥ nci-ctc grade 2

Keywords: unresectable locally advanced
a study to assess the feasibility of screening for sars-cov-2 among healthy workers

Conditions: COVID-19

Summary: this is a prospective, epidemiological, cohort study to assess the feasibility of screening healthy asymptomatic workers for the presence of severe acute respiratory syndrome sars-cov-2 by pharyngeal swaps and serology at baseline, day 21 and day 40.

this study has been designed to assess the feasibility of screening asymptomatic workers and to investigate the extent of infection, as determined by pharyngeal swaps analysis and immune response against the virus and virus specific cd4+ and cd8+ t-cell analysis. furthermore, the extent to which virus-specific cd4+ and cd8+ t-cells are induced is investigated as well as the persistence of virus-specific memory cd4+ and cd8+ t-cells -especially in asymptomatic infected persons. in total, approximately up to 500 workers will be enrolled into the trial to have 450 evaluable subjects at the end of the study. there will be three individual cohorts of workers working in different departments: workers from the production area (cohort 1), workers from the laboratory area (cohort 2) and workers working in other areas (cohort 3). the fraction of asymptomatic or subclinical infections should be determined as well as the kinetics of the immune responses. for each timepoint the difference between the cohorts is investigated. this study also aims to evaluate the impact of sanitary and preventive measures taken within the company during the pandemic situation. epidemiological exposure data and biological samples will be systematically collected. the present study is being conducted in line with world health organization recommendations to help understanding the epidemiology of sars-cov-2.

Eligibility criteria:
inclusion criteria: * healthy workers asymptomatic for sars-cov-2 * ability to consent with the study and its procedures * age above 18 years old * full time employee on site at least 3 full working days a week * working in a shared office/lab/manufacturing environment where at least 3 employees are present and/or having frequent contact with others i.e reception area, transportation and delivery areas. exclusion criteria: workers presenting symptoms that could be signs of a sars-cov-2 infection such as: * fever ≥38°c * chills * fatigue * muscle ache (myalgia) * sore throat * cough * runny nose (rhinorrhea) * shortness of breath (dyspnea) * wheezing * chest pain * other respiratory symptoms * headache * nausea/vomiting
accuracy of the association between the "pa-r" and "act" questionnaires in asthmatic pediatric patients

Conditions: Asthma in Children

Summary: a patient with asthma requires daily and long-term pharmacological treatment when symptoms are frequent and/or severe. international guidelines suggest increasing or reducing pharmacological therapy based on the individual's needs. on average, follow-up visits for a child with asthma treated with maintenance pharmacological therapy should be every 3 months. this period is often challenging to meet in clinical practice because of long waiting lists. an alternative solution could involve the use of structured questionnaires that the patient should fill out on their own (if aged 12 or older) or with the help of parents (if younger than 12). a similar solution is also suggested by international asthma guidelines. the doctor, upon receiving the questionnaire, for example through email, could make the appropriate management decisions and communicate them to the patient, again through email. for remote use, the test should have optimal sensitivity and specificity, otherwise, there is a risk of either underestimating or overestimating the need for adjustments to the maintenance therapy. the most commonly used is the asthma control test (act), which did non demonstrate an elevated sensibility and specificity as revealed by different studies. tripoli et al., for example, reported that 22% of children aged 12 or older with an act score = 25 have asthma and a fall in fev1 \>12% after physical exertion. considering the information above, we considered combining the act with the physical activity-rating (pa-r), a validated questionnaire for measuring the level of physical activity. it is possible that one of the issues lies in the lack of quantification of the patient's physical activity level when administering the act. through an interventional study, our intention is to assess the diagnostic accuracy of the act + pa-r combination (test under experimentation) compared to act (traditional test) and compared to reference standard (spirometry before and after exertion). the goal of the study is to evaluate whether the combination of a high score in both the pa-r (\>7) and act (\>21) can accurately identify patients with well-controlled asthma, i.e., those with normal spirometry after physical exertion.


Eligibility criteria:
inclusion criteria: * correctly diagnosed asthma; * age between 6 and 15 years; * understanding and signing of the informed consent by the parent/guardian; * understanding and signing of the assent by the minor. exclusion criteria: * inability to correctly perform spirometry; * inability to correctly perform the exercise test; * unwillingness to sign the informed consent by the parent/guardian; * unwillingness to sign the assent by the minor.
study of the effect of magnetic stimulation repetitive transcranial on impulsivity in cocaine dependence

Conditions: Cocaine Dependence

Summary: in a randomized, double-blind controlled trial the investigators will evaluate the efficacy of rtms in reducing impulsivity for cocaine addicts through - quantitative and qualitative analysis - such behavior and possible behavioral consequences related.

reduction of the rating impulsivity

Eligibility criteria:
inclusion criteria: 1. diagnosis of the cocaine dependence syndrome, alone or in combination with abuse of alcohol and nicotine dependence (dsm iv, 1994; scid-p, 1994). 2. 20 days or less withdrawal 3. 18-35 years old. 4. if female, to be using contraception (barrier, oral contraceptive, iud, surgical sterilization). 5. fixed residential address in sao paulo exclusion criteria: 1. other mental disorders (dsm iv, 1994; scid-p, 1994). 2. organic brain disease, neurosurgery to implant metal clip or epilepsy. 3. severe uncontrolled clinical comorbidity. 4. use current or within last six months of psychotropic drugs in general, except for clonazepam dose of up to four mg / day. 5. changes clinically significant laboratory findings. 13 6. condition or situation to which in the opinion of the investigator put the patient at risk significant, which may confound the results, or interfere substantially in individual's participation in the study. 7. mandate that mandating the judicial treatment for cocaine dependence

Keywords: transcranial magnetic stimulation cocaine impulsivity rating scale