Kornimate/medical-research-clean huggingface dataset:
a study to assess the bioequivalence of darunavir when co-administrated with cobicistat under fed and fasted conditions

Conditions: Healthy Participants

Summary: the purpose of this study is to evaluate the single-dose pharmacokinetics and bioequivalence of darunavir 800 mg when administered as a fixed dose combination relative to 2 x 400 mg tablets of the commercial tablet formulation, in the presence of 150 mg cobicistat, (under fed and fasted conditions) in healthy participants.

this is a randomized (the study drug is assigned by chance), open-label (all people know the identity of the intervention), 3-panel, single-center, single-dose, crossover (method used to switch patients from one treatment arm to another in a clinical trial) study in 134 healthy adult participants. the study consists of 3 phases including a screening phase of approximately 3 weeks (days -21 to -1) followed by an open-label treatment phase consisting of 3 panels with 2 single-dose treatment sessions of 5 days each (days -1 to 4) separated by a washout period of at least 7 days, and a follow-up period occurring 7 to 10 days after last intake of study drugs. the study consists of 3 panels. in each panel participants will be randomly be assigned to 1 of 2 treatment sequences (ab or ba for panel 1; cd or dc for panel 2; and ef or fe for panel 3). participants will receive either single-dose darunavir 800 mg as 2 x 400 mg tablets and cobicistat 150 mg tablet or single-dose darunavir/cobicistat 800/150 mg as tablet in each panel (under fed and fasted conditions).

Eligibility criteria:
inclusion criteria: * participant should be healthy on the basis of physical examination, medical history, vital signs, and electrocardiogram and clinical laboratory tests performed at screening * have a body mass index (bmi, weight in kg divided by the square of height in meters) of 18.5 to 30.0 kg/m2, extremes included * men and women must agree to use a highly effective method of birth control exclusion criteria: * has a positive hiv-1 or hiv-2 test at screening * has a hepatitis a, b or c infection (confirmed by hepatitis a antibody immunoglobulin m (igm), hepatitis b surface antigen (hbsag), or hepatitis c virus antibody, respectively) at screening * has any history of renal insufficiency * has a history of significant skin reactions or any history of allergies to drugs

Keywords: healthy participants darunavir cobicistat bioequivalence fixed dose combination pharmacokinetics human immunodeficiency virus protease inhibitor
pregnancy weight management health literacy questionnaire

Conditions: Gestational Age and Weight Conditions; Health Knowledge, Attitudes, Practice

Summary: worldwide obesity has continued to increase over the past decades. among the adult women, the overweight and obesity rates in taiwan are much higher than that of women in nearby asian countries. in particular, the body mass index of women with low health literacy exceeds the normal range before pregnancy. without proper supervision, the increase in body weight during pregnancy may result in multiple maternal complications, affect the newborn's health, and increase unnecessary medical expenses in taiwan's health care system. thus, assessing pregnant women' s health literacy to manage their body weight is of importance. however, currently, there is no appropriate instrument available in taiwan to assist health practitioners in assessing the health literacy of pregnant women for weight management. the aim of the study is to develop an instrument to measure the health literacy regarding weight management of pregnant women and examine its psychometric properties.

this study will use a multiphase prospective longitudinal design. while developing the items of the instrument based on the review of the literature, five content experts will be invited to participate in the study for examining the appropriateness of the generated items. upon the approval of the institutional review board, a convenience sample will be recruited to establish face validity. then the instrument will be refined according to the report derived from the pretesting. the content experts will then review the revised instrument again, and another 330 primigravida women will be enrolled in the study for assessing the psychometric properties. the validity and reliability of the instrument will be examined through evaluating the internal consistency reliability, split-half reliability, concurrent validity, and predictive validity. health practitioners can use this newly developed instrument to assess pregnant women's health literacy to help manage their weight gain during pregnancy. by utilizing this instrument, health practitioners can provide individually tailored nursing care to improve the effectiveness of their weight management.

Eligibility criteria:
inclusion criteria: * primigravida women * fluent in writing, reading and speaking mandarin exclusion criteria: * non-pregnant * can't fluent in writing, reading and speaking mandarin * cognitive dysfunction

Keywords: primigravida women weight management health literacy
evaluation of group health teaching with video in diabetic patients

Conditions: Diabetes Mellitus

Summary: objective:health videos and group education to allow patients to a correct understanding of diabetes and insulin treatment. method: standards and number of patients: the patients received subcutaneous insulin injection, estimated 30 people enrolled. experimental design and methods: 1. screening out-patient treatment with insulin use, hba1c\> 8% or poor postprandial glucose (ppg) 2. at the time of the visits, invite the patient to participate in the video group education on insulin therapy by answering some questions about insulin injections, such as: do not know how to perform; afraid of the pain; fear of inconvenience, give patients time to complete the questionnaire.

diabetes is a long-term chronic disease. the patients need to correct "knowledge and action" lifestyle in order to achieve effective blood glucose control. upon the general control of diabetic patients in taiwan, however, glycosylated hemoglobin (hba1c) is not satisfactory. one of the important reasons is the low rate of insulin injection. for the use of insulin, the patient has many misconception. the patients in the clinic need to spend a lot of time to explain and description, but the results are not necessarily good. so we hope that in this part of the health education activities through organized groups videos to assist doctors and patients as a bridge of communication, to enhance diabetes doctor thus contributing to glycemic control results.

Eligibility criteria:
inclusion criteria: 1. willing to sign the informed consent 2. age over 20 years old 3. hba1c\>8% or ppg) \> 200 mg/dl even under insulin therapy exclusion criteria: 1. vegetation status 2. inability of visual or hearing contact with the video program
management of obstructive sleep apnea (osa) in children and maxillary and mandibular development

Conditions: Obstructive Sleep Apnea Syndrome

Summary: assessment of the association of maxillary expansion using a rapid palatal expansion, use of a mandibular advancement appliance (mga™) and of a device allowing sleep in a semi-seated position (yoobreath™) in patients with obstructive sleep apnea (oas). mga™ and yoobreath™ constitute the yookid system™.

obstructive sleep apnea syndrome (osa) shows a 10% morbidity rate in children with a higher rate between the ages of 3 and 5. generally speaking, its prevalence is underestimated. furthermore, detecting osa remains difficult due to its particular physiopathology. the decrease in nasopharyngeal airway dimensions is the most common etiology. this decrease is related to soft tissues as well as maxillomandibular abnormalities. the aim of the study is to show that reducing sleep apnea in children remains possible when inducing rapid palatal expansion and mandibular advancement using the yookid™ system. the yookid™ system associates a mandibular advancement appliance and repositioning of the patient during sleep.

Eligibility criteria:
inclusion criteria: * 5 to 7 year-old children * children with american society of anesthesiologists score (asa) of 1 and 2 * children with signs of osa during examination and clinical exam * children with apnea-hypopnea index (ahi) from 1 to 5 (one to five sleep apnea / hour during psg) * children with a class ii division 1 angle malocclusion (at the canines level rotation center) and skeletal class ii according to delaire analysis exclusion criteria: * osa associated to syndromic disorder and/or syndrome * body/mass index (bmi) \> 97ème percentile according to development curves (obese children) * central sleep apnea * respiratory allergy * previous ear, nose and throat (ent) surgery * hypertrophic tonsils needing surgery * adenoid hypertrophy needing surgery * patients with ankyloglossia

Keywords: osa polysomnography rapid palatal expansion mandibular advancement sleep position
a study to assess dystrophin levels in participants with nonsense mutation duchenne muscular dystrophy (nmdmd)

Conditions: Duchenne Muscular Dystrophy

Summary: this study is designed to evaluate the ability of ataluren to increase dystrophin protein levels in muscle cells of participants with nmdmd. the study will evaluate the levels of dystrophin before and after 40 weeks of ataluren therapy using muscle biopsies and 2 validated assay methods, electrochemiluminescence (ecl) and immunohistochemistry.


Eligibility criteria:
inclusion criteria: * evidence of signed and dated informed consent/assent document(s) indicating that the participant (and/or his parent/legal guardian) has been informed of all pertinent aspects of the trial. * phenotypic evidence of duchenne muscular dystrophy (dmd) based on the onset of characteristic clinical symptoms or signs (for example, proximal muscle weakness, waddling gait, and gowers' maneuver) and an elevated serum creatine kinase (ck). medical documentation of phenotypic evidence of dmd needs to be provided upon request by the sponsor's medical monitor. * documentation of the presence of a nonsense point mutation in the dystrophin gene as determined by gene sequencing. review and approval of documentation by sponsor or designee is required prior to enrollment. * willing to undergo muscle biopsy. exclusion criteria: * ongoing intravenous (iv) aminoglycoside or iv vancomycin therapy. * known contra-indication to muscle biopsy (such as bleeding or clotting disorders). * prior or ongoing therapy with ataluren. * known hypersensitivity to any of the ingredients or excipients of the study drug (for example, refined polydextrose, polyethylene glycol 3350, poloxamer 407, mannitol 25c, crospovidone xl10, hydroxyethyl cellulose, colloidal silica, magnesium stearate). * exposure to another investigational drug within 2 months prior to start of study treatment, or ongoing participation in any interventional clinical trial. * requirement for daytime ventilator assistance or any use of invasive mechanical ventilation via tracheostomy. evening non-invasive mechanical ventilation such as use of bilevel positive airway pressure (bi-pap) therapy is allowed. * elevated serum creatinine or cystatin c levels at screening. * prior or ongoing medical condition (for example, concomitant illness, psychiatric condition, behavioral disorder), medical history, physical findings or laboratory abnormality that, in the investigator's opinion, could adversely affect the safety of the participant, makes it unlikely that the course of treatment or follow-up would be completed, or could impair the assessment of study results.
implementation program to improve screening and management for ckd in diabetes (program 1) (iris-ckd)

Conditions: Chronic Kidney Disease(CKD); Type 2 DM; Type 2 Diabetes Mellitus (T2DM)

Summary: iris-ckd is an implementation study to improve guideline-recommended screening of chronic kidney disease (ckd) in individuals with type 2 diabetes (t2d) in the united states.

iris-ckd screening program: will focus on ckd screening in t2d. we will identify patients with t2d that have not received appropriate screening for ckd within the last 15 months and randomize patients to receive either a home kit to complete ckd screening ("home kit") versus a standard laboratory order ("laboratory order"). the primary objective is to evaluate whether delivery of home testing kits versus standard laboratory testing influences the degree to which patients receive guideline-recommended ckd screening. patients will complete approximately 3 months of follow-up.

Eligibility criteria:
screening program- inclusion criteria: * adults with type 2 diabetes (t2d) * receiving primary care within the healthcare system, primary care provider (pcp) visit within the past 24 months (any pcp provider, including app). * lack of estimated glomerular filtration rate (egfr) and/or urine albumin- creatinine ratio (uacr) measurement in the prior 15 months within the ehr exclusion criteria: • chronic kidney disease (ckd) diagnosis

Keywords: ckd t2dm t2d type 2 diabetes chronic kidney disease
wrist extension dynasplint (wed) distal radius fracture

Conditions: Distal Radius Fracture; Wrist Contracture

Summary: the purpose of this study is to evaluate the effectiveness of a dynamic splinting system for wrist extension contracture following a distal radius fracture.


Eligibility criteria:
inclusion criteria: * distal radius fracture treated with surgical management and wrist flexion contracture upon follow up exclusion criteria: * carpal fractures (scaphoid, lunate, hamate, and trapezium) * radial nerve entrapment * arthrodesis * traumatic dislocation of the distal ulna

Keywords: distal radius fracture wrist contracture dynasplint
rna disruption assay (rda) response prediction in neoadjuvant chemotherapy breast cancer treatment

Conditions: Invasive Breast Cancer

Summary: the purpose of this study is to determine the optimal time to use the tumor rna disruption assay (rda) as a predictor of pathological complete response (pcr) in patients with breast cancer treated with neoadjuvant chemotherapy. this is important because the earlier non-responders are identified, the greater is the impact of reducing side effects of ineffective treatments. the study hypothesis is that the rda score will accurately predict for tumor response after one cycle of chemotherapy.

this prospective clinical trial will determine if the tumor rda score can predict for pcr after the first, second, and third cycles of chemotherapy in women with breast cancer treated with neoadjuvant therapy. tumor rda score will also be measured after the first dose of any new chemotherapy agent if residual palpable disease is present. data will be collected until accrual target of 30 patients is met. all patients will undergo core needle biopsy of the breast tumor and analysis of er, pr, and her-2-neu receptors. patients will receive neoadjuvant therapy as recommended by their treating physicians. all chemotherapy regimens will be acceptable for participation in this study. usually, these regimens are between 6 to 8 cycles, often with a switch of chemotherapy regimens after 3 to 4 cycles. evaluation of tumor size will be determined by 2 axis tumor measurement performed prior to, and after each chemotherapy treatment. the tumor rda score will be evaluated by performing fine needle aspiration (fna) biopsies under local anesthetic, if the tumor is clinically palpable, after the first, second, and third cycles of chemotherapy. tumor rda score will also be determined if palpable tumor is present after the first cycle of any second chemotherapy agent.

Eligibility criteria:
inclusion criteria: * patients must be female. * patients must be 18 years of age or older. * patients with stage i, ii, or iii breast cancer that is greater or equal to 2 cm on clinical examination. * patients that have biopsy proven invasive breast cancer diagnosed by core needle biopsy * patients who are chemotherapy and radiotherapy naïve for the treatment of the current breast cancer. * patients that accept to undergo neoadjuvant chemotherapy. * patients with bilateral breast cancer are eligible. * patients that understand, accept, and have signed the approved written consent form. * patients will need to consent to be part of the study. exclusion criteria: patients with one or more of the following conditions are ineligible for this study: * patients who have had previous surgery, chemotherapy or radiotherapy for the current breast cancer * patients who are pregnant or breast feeding. * psychiatric or addictive disorders or conditions or social factors that may preclude the patient from meeting study requirements.

Keywords: breast cancer chemotherapy neoadjuvant rna disruption assay biopsies response
feeding tolerance and growth of preterm infants consuming a supplement containing two human milk oligosaccharides (hmos)

Conditions: Premature Infant; Low Birthweight Infant

Summary: the goal of this post-market study is to describe the effect of a liquid supplement containing 2 specific human milk oligosaccharides (hmos), 2'-fucosyllactose \[2'fl\] and lacto-n-neotetraose \[lnnt\], on feeding tolerance, growth, and adverse events of special interest in preterm infants in a real-world setting.


Eligibility criteria:
inclusion criteria: 1. written informed consent has been obtained from at least one parent (or other legally acceptable representative \[lar\], if applicable) 2. infant's parent(s)/lar is of legal age of majority, has parental authority, must understand the consent form and other relevant study documents, and is willing and able to fulfil the requirements of the study protocol 3. infant gestational age is ≤ 34 weeks as determined by the first day of the mother's last menstrual period or by fetal ultrasound 4. infant birth weight ≤ 2500g 5. infant postnatal age ≤ 14 days 6. infant has tolerated trophic feeds (e.g., 10-15 ml/kg/day) for at least 24 hours but has not yet reached full enteral feeding exclusion criteria: 1. infant is clinically unstable, for example: 1. infant has hemodynamic instability as evidenced by clinical signs of sepsis, hypotension (map \< 5th percentile for age for at least three hours), or is receiving vasopressor drugs 2. infant has received an exchange transfusion within the past 48 hours 3. infant has had an episode of severe asphyxia at birth (ph less than 7.0) 4. infant has signs of necrotizing enterocolitis according to modified bell staging criteria (stage iia or higher) 2. major congenital (e.g., heart disease, skeletal dysplasia, chondrodystrophy, gastrointestinal obstruction or atresia) or chromosomal abnormality (e.g., trisomy 21, turner syndrome) 3. infant has other medical condition that, in the judgement of the investigator, would make the child inappropriate for entry into the study 4. participation in another interventional clinical study that may interfere with the results of this study

Keywords: human milk oligosaccharides feeding tolerance growth
reduction of pulmonary artery pressure in patients subjected to cardiac surgery

Conditions: Anesthesia

Summary: the aim of this study is to assess the ability of clonidine to reduce the mean pulmonary artery pressure in patients with pulmonary hypertension subjected to cardiac surgery.

prospective, clinical-interventionist, randomized, and double-blind study. patients with group 2 pulmonary hypertension will be included and subjected to cardiac surgery with extracorporeal circulation. mean pulmonary artery pressure and the doses of dobutamine and sodium nitroprusside will be assessed four times: before (t0) administration of 2 μg/kg of intravenous clonidine or a placebo, 30 minutes after the onset of treatment (t1), immediately after extracorporeal circulation (t2), and 10 minutes after the injection of protamine (t3).

Eligibility criteria:
inclusion criteria: * signing an informed consent form, * aged 18 to 80 years * pulmonary hypertension due to left heart disease, * physical status 2 or 3 according to the classification system of the american society of anesthesiologists, * subjected to cardiac circulation with extracorporeal circulation

Keywords: clonidine hypertension pulmonary cardiac surgical procedures
outcomes of patients not responding to antibiotics in the community

Conditions: Sinusitis; Bronchitis, Chronic; Pneumonia, Bacterial

Summary: a study to report the outcomes of patients who fail to respond to beta-lactam and macrolide antibiotics in the community

to document and describe the clinical, microbiological, and pharmacoeconomic outcomes of two hundred patients who failed to respond to outpatient macrolide or beta-lactam therapy. evaluable patients must have a positive culture obtained after they failed their initial macrolide or beta-lactam. the isolated pathogen must have a known mic to the antibiotic class they failed to respond to (i.e. macrolide or b-lactam). the isolate must be available to be sent to the central laboratory for mic testing

Eligibility criteria:
inclusion criteria: patients who have failed to respond to at least three (abecb and cap) or five (ams/abrs/aecrs) days of macrolide or b-lactam therapy meeting all of the protocol criteria for acute bacterial exacerbations on chronic bronchitis(abecb), community acquired pneumonia(cap) and acute maxillary sinusitis(ams) will be eligible for enrollment. all patients, whether enrolled retrospectively or concurrently, must have a positive culture. the pathogenic bacteria must be identified by a local laboratory and have a known susceptibility to the antibiotic class the patient failed to respond to (i.e. macrolide or b-lactam). the isolate must be sent to the study coordinating center for precise mic determination. exclusion criteria: patients presenting with any of the following will not be included in the study: 1. life expectancy \<3 months from underlying disease 2. underlying lung carcinoma 3. cystic fibrosis

Keywords: beta-lactam macrolide antibiotics
effect of statins on asthma control in smokers with asthma

Conditions: Asthma; COPD; Smoking

Summary: asthma is a chronic inflammatory condition of the lungs. there is evidence that cigarette smoking can make asthma symptoms worse and that smokers with asthma do not respond as well to standard therapies as non-smokers. statins are drugs which are already used to lower cholesterol. they have also been shown to have some anti-inflammatory properties. in this trial the investigators will give a randomised group of smokers atorvastatin and the remaining group a placebo or blank tablet. the investigators will then monitor patients' responses in terms of peak flow data, symptom diaries, questionnaires and breathing tests.

despite several studies, which have shown that smokers with asthma have more severe symptoms, accelerated decline in lung function and diminished response to treatment with inhaled and oral corticosteroids, more than 25% of asthmatics continue to smoke. smoking cessation advice is often ineffective. statins are used as cholesterol lowering agents, however, there is now also evidence that they have additional anti-inflammatory effects which may be useful in treatment of smokers with asthma. this is a randomised placebo controlled double-blind parallel group study. following screening to assess suitability for the study, patients will be randomised to treatment with either atorvastatin 40mg or placebo (blank tablet)for 8 weeks. after 4 weeks of treatment, all patients will be commenced on a low dose inhaled corticosteroid for the remainder of the study to assess whether treatment with statins can overcome steroid resistance in smokers with asthma.

Eligibility criteria:
inclusion criteria: * diagnosis of asthma for more than 1 year * symptomatic asthma * smoker with greater than 5 pack year history * on short acting bronchodilator only- although may have medication weaned if stable exclusion criteria: * ex-smokers or non-smokers * patients already on statin therapy * unstable asthma * previous statin sensitivity or myopathy or myositis * on any medications known to interact with statins note separate entry criteria for pilot study of copd patients

Keywords: asthma smokers statin atorvastatin randomised placebo cigarette blind copd