Kornimate/medical-research-clean huggingface dataset:
pilot testing preschooler care, community resources, advocacy, referral, education (pre-care)

Conditions: Attention Deficit/Hyperactivity Disorder; Inattention

Summary: the goal of this proposed study is to pilot test a novel treatment model (pre-care) addressing unmet social needs for families of preschool-age children with attention deficit/hyperactivity disorder (adhd) symptoms. the investigators will conduct an adaptive, pilot randomized controlled trial (rct) of the intervention with parents of 60 low-income children age 3-5 (36-71 months) with adhd symptoms in order to: optimize intervention delivery; field test study logistics (e.g., recruitment, enrollment, randomization, retention); explore putative intervention mechanisms; and obtain estimates of study parameters to plan an appropriately powered rct of the intervention. the pre-care intervention is adapted from well child care, evaluation, community, resources, advocacy, referral, education (we care), a screening and referral intervention that has been shown to be feasible and effective in addressing the family psychosocial stressors of low-income families seen in pediatric medical homes. given the negative impact that socioeconomic stressors can have on the health and development of young children with adhd symptoms, tailored interventions such as pre-care may serve as a vital early intervention strategy to promote long-term well-being.


Eligibility criteria:
inclusion criteria: * legal guardian and primary caregiver of a child aged 36-71 months * legal guardian or primary caregiver is age 16 years or older * child receives pediatric care at boston medical center or at one of the participating boston healthnet clinics * able to understand informed consent procedures in english or spanish * participant has a child aged 36-71 months with an adhd diagnosis, or one elevated total or subscale score at the 80th percentile on the adhd-rating scale-iv preschool version. 80th percentile cut-offs on the adhd-rating scale-iv preschool version are as follows: * for male children, a total score ≥ 25 or subscale score (inattention and/or hyperactivity) ≥ 12 * for female children, a total score ≥ 13 or subscale score (inattention and/or hyperactivity) ≥ 6 for female children exclusion criteria: * there are no specific exclusion criteria for this study

Keywords: pre-care wecare parent caregiver community health worker
acute unilateral vestibulopathy and corticosteroid treatment

Conditions: Vestibular Diseases; Vestibular Neuronitis

Summary: randomized placebo controlled trial on patients suffering from acute unilateral vestibulopathy. patients will be randomized into 3 arms; 1) placebo only, 2) short corticosteroid treatment (3days) 3) longer corticosteroid treatment (11 days). vestibular function as well as subjective symptoms will be estimated in the acute stage and regularly up to one year after the debut.

randomized controlled trial in 3 arms to see if a short or a even shorter period of steroid treatment on patients diagnosed with vestibular neuritis can be as effective as the only comparable study thus far (strupp et al, nejm 22, 351(4) 354-61). if a shorter treatment with a lower dose has the same outcome, then more patients might be eligible for the treatment as many are excluded due to risk for adverse effects. corticosteroid treatment in acute unilateral vestibulopathy has recently been the subject for a cochrane review with the conclusion of insufficient evidence for treatment effect and recommend studies with subjective symptom based evaluation together with functional testing. patients with acute unilateral vestibulopathy diagnosed within 48hrs after debut. the patients (after acceptance) will be randomized into either of 3 arms and will receive placebo/short treatment (3days)/standard treatment (in sweden 11 days). patients will record subjective symptoms according to liknert scale during the acute stage and fill out enquiries after 3 and 12 months. vestibular function will be assessed with caloric irrigation and video-head-impulse-test (vhit) as soon as possible after the debut and again after 1, 3 and 12 months.

Eligibility criteria:
inclusion criteria: * definite unilateral vestibulopathy * no pathological hints (examination criteria in acute vestibular syndrome) * capable of making their own decisions exclusion criteria: * tinnitus or hearing loss with same debut as vertigo * history of bleeding peptic ulcer * glaucoma * pregnancy or non-acceptance to use anticonception measures during 13 days after debut * high blood pressure \>180 systolic, 105, diastolic * ketoacidosis with a base excess \>=2 * psychic disorder (not including mild depression) * serious infection (neutropenia, tuberculosis) * chronic otitis * history of vertiginous disease; ménière, vertiginous migraine, atypical bppv
early detection of myocardial ischaemia in suspected acute coronary syndromes by apo j-glyc

Conditions: Myocardial Ischemia

Summary: the objective of the study is to assess the performance characteristics of apo j-glyc as a novel biomarker for the early detection of myocardial ischaemia in patients with suspected acute coronary syndromes.

this in vitro diagnosis clinical validation will test the performance characteristics of apo j-glyc measured with a novel in vitro diagnostic (ivd) test. blood samples from eligible consenting subjects will be collected at hospital admission, throughout different post admission times (1h, 3h, 24h and 72h or discharge). the quantification of circulating apo j-glyc levels will be analysed in correlation with clinical data providing information about apo j-glyc as an ischaemia biomarker and its diagnostic and 6-months prognostic value.

Eligibility criteria:
inclusion criteria: * age equal or above 18 years old * chest pain of suspected cardiac origin * signature of informed consent * able and willing to comply with study requirements exclusion criteria: * prior inclusion in the same study * life expectancy less than 6 months * previous inclusion in a therapy-related clinical trial (except clinical trials testing medical devices such as stents and/or balloons)

Keywords: acute coronary syndrome myocardial infarction diagnosis prognosis risk stratification
the effect of motivational interviewing in women's health

Conditions: Procrastination; Health Behavior; Cancer

Summary: the behaviour of healthcare demand procrastination constitutes an obstacle for individuals to lead a healthy life, and an example of this is the low participation rate of women in pap-smear screening programs compared to the target population. it is known that motivational interviews are frequently used and effective in studies planned to change health behavior. according to the results of the power analysis, at least 104 women, 52 experimental and 52 control, should be included in the study. data will be collected with the "personal information form", "healthcare demand procrastination scale", "health belief model scale for cervical cancer and pap smear test" and "evaluation form for cervical cancer screening participation". motivational interviews will be given to the women in the experimental group.

the behaviour of healthcare demand procrastination constitutes an obstacle for individuals to lead a healthy life, and an example of this is the low participation rate of women in pap-smear screening programs compared to the target population. it is known that motivational interviews are frequently used and effective in studies planned to change health behavior. this study aims to evaluate the effectiveness of motivational interviewing on behaviour of healthcare demand procrastination, health beliefs regarding cervical cancer screenings, and screening participation in women. according to the results of the power analysis, at least 104 women, 52 experimental and 52 control, should be included in the study. data will be collected with the "personal information form", "healthcare demand procrastination scale", "health belief model scale for cervical cancer and pap smear test" and "evaluation form for cervical cancer screening participation". motivational interviews will be given to the women in the experimental group by the researcher once a week for 4 weeks.

Eligibility criteria:
inclusion criteria: * the ages of 30-65, * having not had cervical cancer screening before, * having not had a hysterectomy operation, * being literate, * volunteering to participate in the study exclusion criteria: * those who have communication problems, * those with psychiatric and mental illnesses, * those who have previously attended any training on cervical cancer screening, * pregnant women

Keywords: cervical cancer screening motivational i̇nterview
acute and chronic pain in lung transplantation: prevalence, associated factors, taken care

Conditions: Pain

Summary: the objective of this project is to estimate the frequency and the characters of the chronic pains by a follow-up which begins during the registration on the waiting list of transplant and which ends at the end of the third year following the lung transplantation. it is a forward-looking study of prevalence entering within the framework of the common care. after lung transplant, pain will be evaluate with questionnaires every day during the hospitalisation, and then after 1 month, 3 months, 6 months, 1 year, 2 years and 3 years.


Eligibility criteria:
inclusion criteria: * patients benefiting from a lung transplant * patients on a list for a lung transplant from may 2010 exclusion criteria: * patients refusing to participate in the study
systemic corticosteroids in treatment of post-covid-19 interstitial lung disease

Conditions: Covid19; COVID-19 Pneumonia; Interstitial Lung Disease

Summary: aim: to investigate the efficacy of systemic corticosteroids in treatment for post-covid-19 interstitial lung disease. method: method: in this multi-centre, prospective, randomised controlled open label clinical trial, patients are divided into two arms: standard treatment arm and standard plus systemic corticosteroid arm. after twelve weeks; clinical, functional, and radiological improvement will being assessed as primary outcomes.


Eligibility criteria:
inclusion criteria: * post-covid-19 interstitial lung disease (ild) patients who had completed the treatment of acute phase and have recovered, but despite after 90 days from recovery diagnosed as post-covid ild based upon the persistent respiratory symptoms with functional impairment and radiological sequela. * at least 90 days required after discharge for hospitalized patients or termination of isolation for outpatients * confirmation of the diagnosis of covid-19 via real time polymerase chain reaction assay (rt-pcr) or antigen or antibody test in the acute phase of covid-19. * presence of sequelae interstitial changes in follow-up (pre-enrollment) thorax high-resolution computed tomography (hrct)/ct. * presence of persistent respiratory symptoms in the post-covid-19 period or hypoxemia at rest and/or desaturation with exercise. exclusion criteria: * patients who had a normal lung imaging examination (radiography, tomography, etc.) at discharge or enrollment phase * pre-existing diffuse parenchymal lung disease before pandemic * cystic bronchiectasis * presence of contraindications for systemic corticosteroids (uncontrolled diabetes, uncontrolled hypertension, unstable angina pectoris, history of acute coronary syndrome at last month, presence of active infection, active peptic ulcer, presence of uncontrolled psychiatric disease, etc.) * decompensated heart failure * contraindications for pulmonary function tests and those who cannot cooperate with the test * younger than 18 years old * pregnant women * breastfeeding women * those who do not give written consent
effectiveness of a intraoperative blood recovery system in cardiovascular surgery in brazil

Conditions: Cardiovascular Surgery; Blood Loss, Surgical

Summary: randomized trial to evaluate the effectiveness of a intra operative blood recovery system in reducing the need for allogeneic transfusion in cardiovascular surgeries using cardiopulmonary bypass

to evaluate the effectiveness of a intra operative blood recovery system in reducing the need for allogeneic transfusion in cardiovascular surgeries using cardiopulmonary bypass, a randomized clinical trial will be conducted. the study will be conducted at a teaching hospital, which is a reference for major cardiac surgeries and receives patients from the brazilian unified health system (sus). the patients will be randomly assigned to two groups: with and without the use of the system, and allocation concealment will be performed. continuous variables will be analyzed through frequency distributions and appropriate descriptive measures (mean or median), while categorical variables will be presented through frequency distributions. for categorical variables, the confidence interval will be calculated, conventionally set at 95%. for continuous variables, the t-test will be used to measure differences, while for categorical variables, the mcnemar statistical test will be used. for all analyses, a significance level of 5% will be used, and the data will be analyzed according to the intention-to-treat principle.

Eligibility criteria:
inclusion criteria: * all patients undergoing cabg or valve surgery singly. exclusion criteria: * emergency cardiac surgery; * previous heart surgery; * end-stage chronic kidney disease; * inability to receive a blood transfusion (refusal); * anemia (hemoglobin less than 10g/dl); * thrombocytopenia (platelet count less than 100,000/mm3); * coagulopathy (rni \> 1.5);

Keywords: cardiovascular surgery operative blood salvage
antibiotic prophylaxis to prevent post-procedure uti after vcug

Conditions: Antibiotic Prophylaxis; Voiding Cystourethrogram; Febrile Urinary Tract Infection

Summary: the current practice of pre-vcug antibiotic prophylaxis is highly variable. a recent unpublished survey of society of fetal urologists (sfu) completed by this study team found that 87% of respondents reported having patients who develop futi following vcug, with 30% of respondents prophylaxing for futi in patients undergoing vcug. the current lack of best practice guidelines regarding antibiotic prophylaxis prior to vcug due to low quality of current literature, and a growing concern around risks of unnecessary antibiotic exposure suggests the need for an rct. the results of this pilot trial will inform the ability to conduct a definitive rct on this important subject. the results of the definitive trial would have important clinical and economic implications.

what are the study objectives? the primary objective of this pilot trial is to determine the feasibility of conducting a definitive trial investigating whether pre-vcug antibiotic prophylaxis, when compared to placebo, decreases the risk of futi in infants undergoing vcug for genitourinary abnormalities. the pilot trial will address specific feasibility outcomes including process, resources, management and scientific domains. the pilot will lay the groundwork for the eventual full trial. funding for the full trial will be sought after preliminary data is collected from the pilot study. the primary objective for the definitive trial is to determine whether single-dose, preprocedural antibiotic prophylaxis compared to placebo lowers the risk of futi in children \< 3 years of age who are undergoing vcug for the following indications: high-grade (sfu classification iii, iv/utd 2,3) hn, ureteral dilatation, or bladder abnormalities found during renal ultrasound. the secondary outcomes of the definitive trial will include assessment of adverse event outcomes related to antibiotic prophylaxis administration, including antibiotic resistant uti pathogens, episodes of antibiotic associated diarrhea, and c. difficile.

Eligibility criteria:
inclusion criteria: 1. children \<3 years of age undergoing vcug for the following indications: high-grade sfu/utd hydronephrosis, ureteral dilatation, or bladder abnormalities found during renal ultrasound 2. parent or legal guardian able to provide informed consent exclusion criteria: 1. chronic antibiotic use 2. allergy to trimethoprim or trimethoprim-sulfamethoxazole
bioequivalence study (candesartan 16 mg and amlodipine 5 mg) - b

Conditions: Hypertension

Summary: the purpose of this study is to compare the safety and pharmacokinetics of ckd-330 (fixed-dose combination of candesartan 16 mg and amlodipine 5 mg) with coadministration of the two separate drugs in healthy male volunteers.


Eligibility criteria:
inclusion criteria: 1. healthy male volunteer in the age between 19 and 45 years old. 2. body weight ≥ 55 kg and body weight in the range of calculated ibw ±20%. 3. subjects without a hereditary problems and chronic disease. 4. subjects whose clinical laboratory test values are inside the accepted normal range. 5. understand the requirements of the study and voluntarily consent to participate in the study. exclusion criteria: 1. previous history or present of clinically significant hepatobiliary, nephrological, neurologic, respiratory, hemato-oncological, endocrine, urogenital, psychiatric, musculoskeletal, immune, otorhinolaryngological, cardiovascular system. 2. history of gastrointestinal disease or gastrointestinal surgery to affect drug absorption. 3. history of clinically significant allergies of amlodipine or candesartan or ccb or arb or aspirin or antibiotic. 4. subjects with galactose intolerance. 5. sbp ≥ 140 mmhg or\< 90 mmhg, dbp ≥ 95 mmhg or \< 60 mmhg, pulse ≥ 100 bpm. 6. ast or alt \> 2\*uln, total bilirubin \> 2\*uln 7. serum creatinine \> uln 8. previous history or present of drug abuse. 9. subjects treated metabolizing enzyme inducers or inhibitors such as barbitals within 1 month prior to the first dosing. 10. subjects treated ethical drug or herbal medicine within 2 weeks, otc or vitamin within 1 week prior to the first dosing. 11. subjects treated ip within 2 months prior to the first dosing. 12. subjects with whole blood donation within 2 months or component blood donation within 1 month or blood transfusion within 1 month prior to the first dosing. 13. alcohol \> 21 units/week or cannot stop drinking. 14. cigarette \> 10 cigarettes/day. 15. subjects with the plan dental treatment(extraction, orthodontic, nerve treatment) or any surgery(plastic surgery, eye surgery - lasik, lasek). 16. not eligible to participate for the study at the discretion of investigator.
clinical trial to evaluate the efficacy and safety of pulsed electric field ablation devices in the treatment of lung tumors

Conditions: NSCLC

Summary: the goal of this clinical trial is to verify the efficacy and safety of pulsed electric field (pef) treatment of early-stage unreseectable non-small cell lung cancer(nsclc) patients. the main questions it aims to answer are: * safety of pef treatment of early-stage unreseectable nsclc patients. * locoregional control of ablated lesions. * survival and quality of life assessment of early-stage unreseectable nsclc patients.


Eligibility criteria:
inclusion criteria (all requirements must be met at the same time): 1. age ≥ 18 years old; 2. pathological diagnosis of non-small cell lung cancer, with the maximum diameter of the tumor ≤ 3 cm and the number ≤ 3; 3. ecog score ≤ 2 points; 5. according to the evaluation of the researcher, it is technically feasible to perform ablation treatment on the lesion; 6. the subject agrees to receive ablation treatment and signs the informed consent form. exclusion criteria (if any of the above conditions are met, the patient will be excluded): 1. the subject cannot tolerate or refuses general anesthesia; 2. has a history of severe allergic reactions; 3. has contraindications to bronchoscopy or refuses bronchoscopy; 5. has active implants in the chest cavity or metal implants in the lung to be treated; 6. uncorrectable coagulation abnormalities (inr\>1.5 or aptt\>1.5 uln), with bleeding tendency; anticoagulant therapy and/or antiplatelet drugs are discontinued before ablation for no longer than the prescribed safety period; platelets \<50×10\^9/l; 7. severe liver and kidney dysfunction, assessed by the researchers as unsuitable for inclusion; 8. accompanied by infectious diseases that cannot be effectively controlled; 9. subjects with other severe lung diseases (including severe interstitial pneumonia, pulmonary fibrosis, pulmonary fibrosis combined with emphysema, atelectasis, etc.), assessed by the researchers as unsuitable for inclusion 10. acute cardiovascular and cerebrovascular accidents such as acute cerebral infarction, acute coronary syndrome, etc. within 3 months; 11. subjects with severe cardiac dysfunction; history of severe arrhythmias in the past 2 years, including rapid atrial arrhythmias, any rapid ventricular arrhythmias; history of ii degree type ii or iii degree atrioventricular block; and sinus bradycardia with a heart rate of less than 45 beats per minute, etc.; 12. subjects have participated in or are participating in other clinical trials within three months; 13. pregnant, lactating women, or women who plan to become pregnant during the study; 14. subjects determined by the researchers to have other conditions that are unsuitable for inclusion.
nasal high frequency ventilation in preterm infants: a pilot study

Conditions: Infant Respiratory Distress Syndrome; Respiratory Insufficiency; Apnea of Prematurity

Summary: the purpose of this study is to test whether application of high frequency ventilation through a nasal tube can lower blood carbon dioxide levels in stable preterm infants.

prolonged mechanical ventilation is frequently needed to treat respiratory insufficiency and apnea in very low birthweight (vlbw, \<1500 g) preterm infants. endotracheal intubation and mechanical ventilation carry many risks including potentially fatal air leaks and ventilator-associated pneumonias. less-invasive methods of respiratory support are needed to minimize these risks while supporting the convalescing preterm infant. we propose to test the effectiveness of nasal high-frequency ventilation (nhfv) in stable neonates with mild respiratory acidosis who are dependent on nasal continuous positive airway pressure for respiratory support (cpap). nasal high frequency ventilation may be effective in decreasing rates of reintubation for apnea or respiratory insufficiency in vlbw infants. we will enroll 60 stable vlbw infants who are currently being treated with nasal cpap and who have mild respiratory acidosis. twenty patients will be assigned to each ventilator under investigation. nasal high frequency ventilation will be applied at the same mean airway pressure as the patients' previous cpap support. the amplitude on nasal high frequency ventilation will be adjusted to achieve adequate shaking of the chest wall. blood gas measurements, transcutaneous continuous pco2 monitoring, continuous pulse oximetry, and chest x-rays will be used to assess safety and efficacy. study power has been calculated to detect a difference (drop or rise) in partial pressure of co2 (pco2) equal to two-thirds of the standard deviation of pco2 change reported in another study (van der hoeven et al., 1998), which is a clinically relevant difference.

Eligibility criteria:
inclusion criteria: * birthweight less than 1500 g * age \>7 days * free of severe intraventricular hemorrhage (grade iii-iv) * requiring nasal continuous positive airway pressure with a stable compensated respiratory acidosis (ph 7.25 - 7.45, pco2 \> 43 mm hg), * medically stable. exclusion criteria: * major congenital anomalies

Keywords: premature infants very low birthweight infants high frequency ventilation nasal ventilation