Kornimate/medical-research-clean huggingface dataset:
pressure support ventilation versus neurally adjusted ventilatory assist in difficult to wean pediatric patients

Conditions: Distress Respiratory Syndrome; Weaning Failure

Summary: this study assessed the effects of nava versus pressure support ventilation (psv) on patient-ventilator interaction in pediatric patients with difficult weaning from mechanical ventilation after moderate pediatric acute respiratory distress syndrome (pards).

12 pediatric patients, admitted in pediatric intensive care unit (picu) with moderate pards and who failed up to 3 sbts in less than 7 days, were enrolled in this study. these patients underwent three studies conditions, lasting 1 hour each: pressure support ventilation 1, neurally adjusted ventilatory assist and pressure support ventilation 2. during each trial were recorded the patient tracings of flow, airway pressure and electrical activity of diaphragm for the patient-ventilator interaction analysis.

Eligibility criteria:
inclusion criteria: * diagnosis of moderate pards * 3 spontaneous breathing trials failed in less than 7 days exclusion criteria: * hemodynamic instability * severe respiratory instability * contraindication to nasogastric tube exchange * increase in intracranial pressure * palliative care for end-stage oncologic disease * neuromuscular disease * lesions of medulla

Keywords: patient-ventilator interaction pediatric acute respiratory distress syndrome difficult weaning
temps-a and menopause symptoms

Conditions: Menopause; Personality; Temperament

Summary: this study investigates the relationship between temperament traits and menopausal symptoms using the temps-a and mrs scales in women at menopausal transition stages. it is a cross-sectional observational study.

this observational, cross-sectional study aims to investigate the relationship between temperament traits and menopausal symptoms in women in the menopausal transition stage, specifically classified as straw stages -1, +1a, and +1b. participants are recruited from menopause outpatient clinics. data are collected through the administration of the validated temperament evaluation of memphis, pisa, paris and san diego autoquestionnaire (temps-a) and the menopause rating scale (mrs). participants voluntarily complete the questionnaires after providing informed consent. all responses are anonymized and securely stored. quality assurance measures include verification of data entry, use of validated scales, and compliance with ethical standards approved by the istanbul medipol university non-interventional clinical research ethics committee. no interventions are applied; the study strictly follows observational registry procedures.

Eligibility criteria:
inclusion criteria: * women classified as straw stages -1, +1a, and +1b (menopausal transition stages) * ability to complete questionnaires and provide informed consent exclusion criteria: * history of hormone therapy during the past 6 months * history of surgical menopause (bilateral oophorectomy) * presence of severe physical disorders (e.g., malignancy, severe cardiovascular diseases) * presence of severe psychological disorders (e.g., major depressive disorder, psychosis)

Keywords: menopausal transition personality traits personality characteristics
nitrous oxide versus intravenous sedation for anesthesia

Conditions: Pregnancy Termination in Second Trimester

Summary: this study is a multi-site, double-blinded, randomized, non-inferiority clinical trial of inhaled nitrous oxide with oxygen (n2o/o2) versus intravenous (iv) sedation, with fentanyl and midazolam, for pain management in adult women having a pregnancy termination procedure between 12 and 16 weeks gestational age.

this study will evaluate whether nitrous oxide is a feasible and acceptable alternative to iv sedation for pain management during early second trimester d\&e. primary endpoints will include maximum procedural pain using the visual analog scale (vas) as well as satisfaction with anesthesia using the iowa satisfaction with anesthesia scale.

Eligibility criteria:
inclusion criteria: * 18 years old or older * pregnancy termination at gestational age of 12-16 weeks * able to read and understand either english or spanish * able to obtain reliable post-procedure transportation exclusion criteria: * contraindications to outpatient pregnancy termination * contraindications to nitrous oxide use (such as pernicious anemia, current treatment with bleomycin chemotherapy, active upper respiratory illness, or copd) * intrauterine fetal demise * chronic narcotic use * known adverse reaction to nitrous oxide, fentanyl, or versed

Keywords: nitrous pain
bamberg diabetes transitional care pilot study

Conditions: Diabetes

Summary: bamberg county residents who has been diagnosed with or is at high risk for diabetes, may be eligible for a clinical research study to improve diabetes self-management and decrease hospital re-admissions. the purpose of this study is to compare the effectiveness of three hospital discharge follow-up methods: 1. standard of care, 2. a nurse telephone intervention (care coordination and education), and 3. an in-home community health worker intervention (care coordination and education).


Eligibility criteria:
inclusion criteria: * bamberg county resident * between 18 and 75 years of age * a patient discharged from the regional medical center emergency department or regional medical center hospital within 72 hours prior to consent * diagnosed with diabetes or at high risk for diabetes * will be a regional medical center patient for follow-up care * speaks english * has access to a phone stage 2 recruitment: * if recruitment at 3 weeks after the first patient is enrolled is \ 8 or blood pressure \>140/90) is uninsured or who self-reports problems with obtaining medications. exclusion criteria: * end-stage renal disease * terminal illness (e.g., advanced cancer, end-stage chronic obstructive pulmonary disease, advanced dementia) * incarceration * resident in a skilled nursing home.

Keywords: diabetes
sodium bicarbonate supplementation in chronic kidney disease evaluation of dose response, safety and beneficial effects

Conditions: Chronic Kidney Disease

Summary: this study will enroll 25 patients with kidney disease to evaluate the effects of different doses of sodium bicarbonate (baking soda) on levels of bicarbonate in the blood, kidney function and muscle strength. the investigators will also evaluate safety and tolerability of different doses.

this study enrolled 20 patient to evaluate the effects of different doses of sodium bicarbonate. we will test serum bicarbonate levels, potassium levels and muscle function.

Eligibility criteria:
inclusion criteria: * estimated gfr \ 15 ml/min/1.73 m2 determined by abbreviated 4 variable modification mdrd equation * age \>21 exclusion criteria: * previous chronic treatment with alkali (including sodium bicarbonate, calcium carbonate or baking soda) * bicarbonate level \ 25 meq/l * decompensated heart failure * systolic blood pressure \>160 mm/hg * moderate or greater lower extremity edema * initiation of esrd treatment planned within 6 months * kidney transplantation * treatment with immunosuppressives within the last 3 months

Keywords: metabolic acidosis chronic kidney disease estimated gfr 15-45
post dural puncture headache after accidental dural puncture

Conditions: Post Dural Puncture Headache

Summary: epidural anesthesia is associated with potential risks and complications, post dural puncture headache (pdph) one of the most recognized with epidural or spinal anesthesia. accidental dural punctures occur with approximately 1.5% of all epidural attempts. studies have suggested that the use of an intrathecal catheter reduces the incidence of pdph. a systematic review of the existing literature will identify if there is reliable evidence to support this theory. a secondary outcome, headache severity, will also be explored via incidence rates of epidural blood patch, as this intervention is performed as a treatment for the most severe headaches.

post dural puncture headache (pdph) is one of the recognized complications experienced with epidural or spinal anesthesia, resulting from needle puncture of the dura layer of the meninges. this puncture can be deliberate (during spinal anesthesia) or accidental (during epidural anesthesia). dural punctures allow a leak of cerebrospinal fluid, leading to the characteristic syndrome of pdph; also known as a spinal headache or low-pressure headache. accidental dural punctures occur with approximately 1.5% of all epidural attempts. studies have estimated that, within the obstetrical population, headaches resulting from an inadvertent dural puncture are as high as 50% to 75%. as the risk of accidental dural punctures (adp) cannot be eliminated, research has focused on possible interventions that may be taken in order to avoid the onset of a pdph, eliminate its severity, or treat effects. one of the most common and effective treatments being an epidural blood patch (ebp). more recently, threading the epidural catheter directly into the intrathecal space after the dural puncture has been recognized as a viable option.

Eligibility criteria:
inclusion criteria: * any comparative methodology, including case-control studies, cohort studies, randomized clinical trials, and chart reviews. * insertion of the epidural catheter into the intrathecal space at the level of dural puncture, was compared to resiting an epidural catheter at another level exclusion criteria: * any intentional dural punctures (spinal anesthesia) or use of spinal microcatheters were excluded

Keywords: post dural puncture headache accidental dural puncture pdph adp spinal catheter epidural catheter intrathecal catheter dural puncture systemic review
screening for atrial fibrillation with prolonged continuous single-lead ecg devices in high-risk patients

Conditions: Atrial Fibrillation

Summary: atrial fibrillation(af) can be asymptomatic and thus left unidentified in many people, but holds potential risk of lethal complications such as stroke and congestive heart failure. with different screening strategy, the screening result will be different. the longer the monitoring period is, the higher chances af episodes can be identified, but with greater cost and lower compliance. therefore, in this study, the investigators want to find the most cost-effective method for af screening in high risk population with prolonged continuous single-lead ecg device.


Eligibility criteria:
we created a score system as to predict af risk. 1. age ≥ 75: 2points age between 65-74: 1point 2. male: 1point 3. stroke: typical symptoms of acute stroke with multiple foci on imaging examination: 5points typical symptoms of acute stroke with single or uncertain lesion on imaging: 3 points imaging examination shows old cerebral infarction, transient ischemic attack(tia), lacunar infarction with clear symptoms: 2points 4. congestive heart failure: ejection fraction(ef)≥50%, n terminal pro-brain natriuretic peptide(nt pro-bnp)\>1500 pg/ml: 1point ef 40-49%: 2points ef\<40%: 4points 5. echocardiography: mitral stenosis or regurgitation, aortic stenosis or regurgitation: moderate degree and above: 2points left atrial anterior-posterior diameter: 40-49mm: 1point left atrial anterior-posterior diameter: ≥50mm: 2points 6. vascular disease: history of myocardial infarction, percutaneous coronary intervention(pci) or coronary artery bypass graft(cabg): 2points clear history of peripheral arterial obstruction: 3points 7. hypertension: blood pressure controlled: 1point blood pressure uncontrolled(systolic blood pressure\>160mmhg): 2points 8. diabetic mellitus: plasma glucose level controlled:1point plasma glucose level uncontrolled(hba1c\>7):2points i:chronic kidney disease: estimated glomerular filtration rate(egfr) 30-49: 1point egfr \<30: 2points j:sleep apnea syndrome: 1point k:chronic obstructive pulmonary disease: 1point l:thyroid disease: 1point inclusion criteria: * 1.age between 18-85 2.score ≥5points in the above scoring system 3.volunteer to participate in the study exclusion criteria: * 1.clear history of atrial flutter or atrial fibrillation 2.history of pacemaker implacement 3.already on anticoagulation therapy 4.history of severe contact dermatitis 5.ecg recorded by our device unrecognizable 6.patients with end-stage disease or at advanced stage of cancer with life expectancy less than 1 year
investigation of drug-drug interaction of ritonavir and itraconazole on the pharmacokinetics of shr-a1811 in subjects with her2-expressing advanced breast cancer

Conditions: Advanced Breast Cancer

Summary: the study is being conducted to evaluate the pharmacokinetics and safety of shr-a1811 monotherapy and in combination with ritonavir or itraconazole in subjects with her2-expressing advanced breast cancer.


Eligibility criteria:
inclusion criteria: 1. ecog score of 0 or 1; 2. expected survival of not less than 3 months; 3. important organ functions meet the following criteria: * absolute neutrophil count (anc) ≥1.5×109/l (1,500/mm3); * platelet count (plt) ≥100×109/l (100,000/mm3); * hemoglobin (hgb) ≥9.0 g/dl (90g/l); * albumin level ≥3.0 g/dl; * total serum bilirubin ≤1.5× the upper limit of normal (uln); * prothrombin time and activated partial thromboplastin time (aptt) ≤1.5×uln; * alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤2.5×uln (for patients with liver metastasis, alt and ast ≤5×uln); * serum creatinine ≤1.5×uln or creatinine clearance ≥60 ml/min; * qtcf ≤470 msec; * left ventricular ejection fraction (lvef) ≥50%. exclusion criteria: 1. known active central nervous system metastases that have not been treated with surgery or radiation, except those that have been stable for at least 1 month after treatment and have discontinued corticosteroids for \>2 weeks; 2. having cardiac diseases, such as severe/unstable angina, symptomatic congestive heart failure (nyha ii-iv), clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention, myocardial infarction within 6 months before the first administration, etc. 3. known severe allergic history to any component of the shr-a1811 product (adc, total antibody, unconjugated toxin shr169265 or its excipients), or hypersensitivity to humanized monoclonal antibody products (such as trastuzumab, pertuzumab, etc.); 4. having contraindications to ritonavir or itraconazole use; 5. having one or more factors that affect oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction, partial or total gastrectomy, etc.), or having active gastrointestinal diseases or other diseases that may significantly affect drug absorption, distribution, metabolism, or excretion.
transparent elastomeric respirator for aerosol-based protection

Conditions: Personal Protective Equipment

Summary: in times of crisis, diminishing supplies of personal protective equipment (ppe) in hospitals has forced both healthcare workers and the general population to reuse and clean ppe using anecdotal strategies which may weaken its effectiveness of preventing acquisition of airborne respiratory illnesses, such as covid-19. there is therefore a great need to develop innovative measures to generate reusable ppe that can be safely cleaned and sterilized. a novel reusable injection molded respirator will be evaluated using qualitative and quantitative fit tests to assess overall fit and comfort.

ppe is the last line of defense in the hierarchy of controls to prevent the spread of airborne transmissible infections. there are many varieties of respirators including quarter-mask, half mask, and full facepiece respirators that filter 95, 99, or 100% of airborne particles. the elastomeric half mask respirators (ehmrs), in particular, have several advantages over commonly used n95 ffrs. firstly, ehmrs may be cleaned, disinfected, and reused unlike ffrs that are normally discarded after a single use. ehmrs may be transparent as a result of material choice and will allow for visualization of the mouth. lastly, they have been shown to properly fit faces after multiple rounds of decontamination. some disadvantages of ehmrs include the requirement to disinfect and reinspect the quality of components on the respirator by a qualified individual for proper function, as well as manual exchange of filter components. notwithstanding, it has been found that fit testing and training to use ehmrs for healthcare personnel is not significantly different than n95 respirators and that ehmr may serve as a suitable alternative to disposable n95 respirators during public health emergencies. furthermore, a 2018 consensus report from the national academies of engineering, science, and medicine recommended that the durability and reusability of elastomeric respirators made them desirable for stockpiling for emergencies. a new transparent elastomeric respirator has been developed that can maintain respirator integrity after decontamination and fits many people with different face sizes and shapes. fit testing of the respirator will be performed using an osha-approved testing method.

Eligibility criteria:
inclusion criteria: * healthcare workers that have undergone successful fit test with n95 ffr within 1 year of the trial exclusion criteria: * facial hair
twinrix pregnancy registry

Conditions: Hepatitis

Summary: the purpose of the twinrix pregnancy registry is to prospectively collect data describing exposure to twinrix before or during pregnancy, potential confounding factors (such as exposure to other medications) and information related to the outcome of the pregnancy. this is a prospective, voluntary, observational, exposure-registration study. twinrix is designated as food and drug administration (fda) pregnancy category c, which means that its safety in human pregnancy has not been determined. the registry is intended to provide an early signal of potential risks in advance of results from formal epidemiologic studies. registry statistics can supplement animal reproductive toxicology studies and assist clinicians in evaluating the potential risks and benefits of vaccination for individual patients.

the twinrix pregnancy registry will be maintained by gsk vaccines clinical safety and pharmacovigilance. enrolment in the registry will begin at the time of commercial launch of twinrix in the united states (us). at the time of initiation of the registry, pre-existing reports of pregnancy from clinical trials will be evaluated and enrolled when the criteria for registration are met. reporting of exposed pregnancies is voluntary. pregnancies will be registered following maternal exposure to twinrix within 28 days prior to conception or during pregnancy. registration of pregnancies is prospective, i.e., reported during pregnancy before the pregnancy outcome is known. retrospective reports, in which the pregnancy outcomes are known at the time of reporting, will also be reviewed to assist in the detection of any unusual patterns that may exist among the reported birth defects. however, because there is no denominator from which risk can be calculated, these reports will be excluded from the analysis.

Eligibility criteria:
inclusion criteria: * documentation that twinrix was administered ≤ 28 days before or during pregnancy; * confirmation that the pregnancy is being prospectively reported; * report made by a patient or a health care professional; * the timing of the prenatal exposure to twinrix (no broader than during which trimester); * a patient identifier that will allow follow-up to be obtained so that the pregnancy outcome can be ascertained; * whether the patient was involved in a clinical trial at the time of the exposure; * full reporter contact information. exclusion criteria: -

Keywords: teratogenicity pregnancy hepatitis b twinrix prenatal exposure hepatitis a
immunogenicity and safety of gsk biologicals' influenza vaccine versus a licensed comparator in children

Conditions: Influenza

Summary: the purpose of this study is to evaluate the immunogenicity and the safety of glaxosmithkline biologicals' seasonal influenza vaccine, fluarix, compared to fluzone (a us-licensed vaccine) in children, 6 to 35 months of age.


Eligibility criteria:
inclusion criteria: * a male or female child aged 6 to 35 months at the time of the first vaccination; children who may or may not have had previous administration of influenza vaccine in a previous season are acceptable. * subjects having a parent/guardian who the investigator believes can and will comply with the requirements of the protocol. * written informed consent obtained from the subject's parent/guardian. exclusion criteria: * use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period. routine, registered childhood vaccinations are not an exclusion criterion. * history of hypersensitivity to any vaccine. * history of allergy or reactions likely to be exacerbated by any component of the vaccine. * acute disease at the time of enrolment. * history of guillain barré syndrome within 6 weeks of receipt of prior inactivated influenza virus vaccine. * receipt of an influenza vaccine outside of this study, during current (2008-09) flu season. * administration of immunoglobulins and/or blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
a safety and efficacy study of two dose levels of taliglucerase alfa in pediatric subjects with gaucher disease

Conditions: Gaucher Disease

Summary: this is a multi-center, double-blind trial to assess the safety and efficacy of taliglucerase alfa in untreated subjects (2 to \<18 years old) with gaucher disease randomly assigned to treatment with one of two doses, 30 or 60 units/kg. subjects will receive an intravenous (iv) infusion of taliglucerase alfa every two weeks. the total duration of treatment will be 12 months. at the end of the 12-month treatment period eligible subjects will be offered enrollment in an open-label extension study if taliglucerase alfa is not commercially available.


Eligibility criteria:
inclusion criteria: * males and females 2 to \<18 years old. * diagnosis of gaucher disease with leukocyte acid β-glucosidase activity ≤30% of the mean of the reference range for healthy subjects. * subjects who have not received enzyme replacement therapy (ert) in the past or who have not received ert in the past 12 months and have a negative anti-glucocerebrosidase antibody assay. * subjects who have not received substrate reduction therapy (srt) in the past 12 months. * subjects whose clinical condition, in the opinion of the investigator, requires treatment with enzyme replacement therapy (ert). exclusion criteria: * currently taking another investigational drug for any condition. * presence of neurological signs and symptoms characteristic of gaucher disease with complex neuronopathic features other than longstanding oculomotor gaze palsy. * presence of unresolved anemia due to iron, folic acid, or vitamin b12 deficiency * previous hypersensitivity reaction to cerezyme® (imiglucerase) or ceredase® (alglucerase). * history of allergy to carrots. * presence of hiv, hbsag or hepatitis c infections. * subject's parent(s) or legal guardian(s) are unable to understand the nature, scope and possible consequences of the study. * presence of any medical, emotional, behavioral or psychological condition that in the judgment of the investigator would interfere with the subject's compliance with the requirements of the study.

Keywords: gaucher disease pediatric