Kornimate/medical-research-clean huggingface dataset:
natural history of duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy

Summary: baseline study on duchenne muscular dystrophy (dmd) in view to collect data on the natural disease course in a cohort in young male subjects aged from 5 to 9 years over a period of 6 to 36 months using disease appropriate evaluations.

study duration from fpfv: q1 2019 to lplv: q3 2023 primary ojectives: * to assess the natural disease course using standardized and disease appropriate evaluations over a period of 6 to 36 months in a cohort of young male subjects aged from 5 to 9 years at inclusion and diagnosed for duchenne muscular dystrophy (dmd). * to record a baseline period prior to the setup of an aav gene therapy dose escalation phase i/ii first in man clinical study. secondary objectives: * to identify clinical, imaging and/or laboratory parameters that could be predictive indicators of the disease course in dmd, within the selected range of age. * to identify the best outcome measure(s) for further clinical trial assessments.

Eligibility criteria:
inclusion criteria: 1. male 2. 5 to 9 years old inclusive 3. body-weight \< or = 75th percentile of bmi body-mass index scale (according to validated scale in force in the country site) 4. diagnosis of dmd based upon gene testing positive with detailed genotyping 5. able to achieve: * nsaa (north star ambulatory assessment) scale \> or =18 (with a maximum of 2 points difference between inclusion and screening visits) and/or: * gowers test \< or =7 sec * 6 minute walk test (6mwt) \> or = 350 meters at screening visit (m1) and at inclusion visit (m0) with the distance being 20% of each other 6. ongoing corticosteroid therapy or initiation of corticosteroid therapy according to standard of care in the previous 3 months 7. signed informed consent by at least one parent(s) or both parents or legal guardian representative(s), when applicable and according to the country regulation 8. affiliated beneficiary of the national health care scheme exclusion criteria: 9. cardiomyopathy based on physical cardiological examination and echocardiography with left ventricular ejection fraction (lvef) below 55% 10. respiratory assistance: need for either a diurnal and/or a nocturnal ventilation 11. any co-morbidity (ies) and or previous or planned surgical event(s) which may interfere with dmd natural evolution and or evaluation of outcomes designed to assess dmd natural history 12. muscle testing: inability to cooperate with 13. nuclear magnetic resonance imaging (nmri): metal implants in regions of interest for the study 14. unwilling and/or unable to comply with all the study protocol requirements and or procedures 15. previous inclusion to another clinical trial with an investigational medicinal product (imp), within the 3 months (or imp washout period) prior to the screening visit of the study 16. concomitant participation to any other clinical trial
analgesic effects of intrathecal morphine and bilateral erector spina plane block in elective cesarean section

Conditions: Opioid Use; Postoperative Pain

Summary: cesarean section cause severe pain due to surgical incision, abdominal wall retraction and visceral organ movements. cesarean section can be performed with general anesthesia, spinal anesthesia, epidural anesthesia and combined spinal epidural anesthesia methods. because of the possibility of aspiration pneumonia in pregnant women are under general anesthesia, the awareness of anesthesia in the mother during the operation due to insufficient anesthesia, unsuccessful intubation, respiratory complications in the mother and newborn and low apgar scores, regional anesthesia is superior to general anesthesia in elective cesarean section operations. spinal anesthesia, abdominal wall blocks such as erector spinae plane block, parenteral and intrathecal opioids may be used for postoperative analgesia in cesarean section operations. intrathecal morphine can cause postoperative nausea-vomiting, itching, respiratory depression. erector spina plane block can provide effective pain control and reduce opioid consumption. the primary implication of this study is to compare postoperative pain scores and opioid consumption on elective cesarean section patients under spinal anesthesia with intrathecal morphine or erector spina block in addition to spinal anesthesia.


Eligibility criteria:
inclusion criteria: * patients between 18 and 40 years old, asa (american society of anesthesiologists) score i-ii, undergoing elective cesarean section exclusion criteria: * emergency cesarean section * the patients with major hepatic, cardiovascular or renal disease * the patients for whom spinal anesthesia is contraindicated * the patients who is allergic to any drugs that we use for this study * patients who declined to participate in the study

Keywords: postoperative pain opioid consumption erector spinae plane block intrathecal morphine
impulse oscillation to evaluate diagnostic efficacy in patients with chronic airway disease

Conditions: Chronic Airway Disease

Summary: the aim of the research is to explore the diagnostic efficacy of impulse oscillation (ios) before and after bronchial provocation test (bpt) and bronchial dilation test (bdt) in chronic airway disease.

the present study has the following objectives: to explore the diagnostic value of ios before and after bpt/bdt in chronic airway disease, to assess the diagnostic accuracy of ios in chronic airway disease with special regard to its discriminating value between asthma and chronic obstructive pulmonary disease, to evaluate the characteristics of airway resistance after bpt/bdt, to evaluate the airway reversibility and hyperresponsiveness（ahr）in asthma.

Eligibility criteria:
inclusion criteria: 1. 18-75 years old, no gender limit; 2. the subject voluntarily cooperated with the research and signed an informed consent form; 3. meet any of the following three criteria: * patients with asthma, the standard diagnosis of asthma complied with the gina 2019; ② patients with copd, the standard diagnosis of copd complied with gold 2019; ③ the subjects in the healthy control group had normal vital capacity (baseline fev1≥80% of the predicted value, fev1/fvc was greater than the lower limit of normal, and with negative result of bpt or bdt). exclusion criteria: 1. history of other lung diseases, such as cystic fibrosis, bronchiolitis obliterans, tuberculosis, lung cancer, etc.; 2. after taking corticosteroid therapy in the last 4 weeks, respiratory tract infection occurred within 8 weeks; 3. a history of myocardial infarction and stroke in the past 3 months; a history of severe arrhythmia, severe cardiac insufficiency, and unstable angina in the past 4 weeks, etc.; 4. in the past 4 weeks, severe hemoptysis and epileptic seizures require medication; severe hyperthyroidism; 5. pregnant women; 6. other researchers consider it inappropriate.

Keywords: impulse oscillation bronchial provocation test bronchial dilation test asthma chronic obstructive pulmonary disease
health effects of traditional indigenous chokeberry

Conditions: Inflammation; Mental Health Wellness 1; Oxidative Stress

Summary: american indian populations continue to suffer disproportionately from health problems including such nutrition-related chronic diseases as diabetes and heart disease. this research project will therefore investigate how a traditional indigenous food called chokeberry (aronia melanocarpa) impacts epigenetic and metabolic health in relation to resiliency markers in american indian participants. the process of research with american indian communities is significant in that it can inform best practices in community engagement orientations, approaches, and models in future research settings.

this study aims to explore the gene expression and metabolic changes that are mediated by consumption of indigenous chokeberry (aronia melanocarpa) in adult urban american indians and to examine the associations between metabolic endpoints, adverse childhood experiences and mental health. the investigators are doing this research study to answer questions about the impact of adult urban american indians ingesting one of their traditional indigenous foods called chokeberry on epigenetic, metabolic and mental health markers of trauma and resilience. for this study, the investigators will be looking to determine: 1. if there are gene expression changes that are mediated by consumption of traditional indigenous chokeberry in urban adult great plains indians. 2. if there are associations between secondary outcomes such as metabolic endpoints (i.e., 8-ohdg, il-6, lipids, glucose, crp, blood pressure), epigenetic states, adverse childhood experiences, and mental health (historical trauma, resiliency, presence of anxiety and depression) in american indians who have or have not consumed chokeberry as part of a controlled feeding study.

Eligibility criteria:
inclusion criteria: * great plains located american indians * adults between the ages of 18-65 exclusion criteria: * individuals on blood thinning medications, insulin, those pregnant or breastfeeding and those unable to comply with the research schedule, those who have had stomach or upper gastric resection, those on biologic, chemotherapy and immune suppressant medications, those over 65 years of age due to substantially changing metabolic profiles, and those who have started a new hyperglycemic, hypercholesterolemia, anti-depressant, anti-anxiety, or anti-psychotic medication(s) in the last two months. * those who have a current consumption history of chokeberry use (defined by regular use in the last 6 months) or those with a known allergy to chokeberry will also be excluded. * those with an acute infection in the last month, those with a vaccination in the last two months, and those on nsaids within 93.5 hours of testing may be able to still participate if they do not carry these exclusions in the next testing period.

Keywords: american indian epigenetics chokeberry aronia melanocarpa historical trauma
tesetaxel every 3 weeks vs weekly vs capecitabine as 1st-line therapy for locally advanced or metastatic breast cancer

Conditions: Locally Advanced Non-resectable Breast Cancer; Metastatic Breast Cancer

Summary: this study is being conducted to compare the efficacy and safety of tesetaxel administered once every 3 weeks in a 21-day cycle, tesetaxel administered once weekly for 3 consecutive weeks in a 28-day cycle, and capecitabine administered twice daily for 14 consecutive days in a 21-day cycle.


Eligibility criteria:
key inclusion criteria: 1. female 2. at least 18 years of age 3. locally advanced non-resectable or metastatic breast cancer 4. her2 negative disease 5. measurable disease per revised recist, version 1.1 6. eastern cooperative oncology group performance status 0 or 1 7. chemotherapy naïve, or 1 prior chemotherapy regimen in the neoadjuvant or adjuvant setting provided the patient has had a disease-free interval of ≥ 12 months after ending this chemotherapy. if the neoadjuvant or adjuvant chemotherapy included a taxane, ≥ 2 years must have passed since this treatment ended. 8. documented disease recurrence or progression 9. adequate bone marrow, hepatic, and renal function 10. ability to swallow an oral solid-dosage form of medication 11. written informed consent key exclusion criteria: 1. known metastasis to the central nervous system 2. other cancer within the preceding 5 years other than curatively treated basal or squamous cell carcinoma of the skin or carcinoma of the cervix in situ 3. significant medical disease other than breast cancer 4. presence of neuropathy \> grade 1 (nci ctc) 5. history of hypersensitivity to a taxane or capecitabine, other fluoropyrimidine agents, or any of their ingredients 6. history of severe or unexpected reaction to fluoropyrimidine therapy 7. need to continue any regularly-taken medication that is a potent inhibitor or inducer of the cyp3a pathway 8. less than 2 weeks since use of a medication or ingestion of an agent, beverage, or food that is a potent inhibitor or inducer of the cyp3a pathway 9. known dihydropyrimidine dehydrogenase deficiency 10. pregnancy or lactation
the effect of nebulized epinephrine in asthma exacerbation in pediatric age group with the standard treatment compared to standard treatment using improvement pram score as a primary outcome

Conditions: Shortness of Breath; Asthma in Children; Epinephrine Causing Adverse Effects in Therapeutic Use; Salbutamol Adverse Reaction

Summary: our study aiming to look in improvement of pediatric respiratory assessment measure (pram) score as a primary outcome. the secondary outcomes involving the need for second step management, need for admission and possible side effects. it's double blinded randomized control study comparing nebulized epinephrine with standard treatment (salbutamol + ipratropium) versus the standard treatment only in pediatric patient. a pilot study will be conducted before to detect the sample size required and data will be collected at deferent interval post treatment targeting intension to treat for analysis.

because there are no previous studies with the same methodology found, pilot study will be conducted to estimate the sample size. patients who are eligible to be enrolled in the study will be randomized into two group (after receiving the standard of care, 3 back to back nebulization (salbutamol and ipratropium bromide)) , the experimental group will be given epinephrine (1ml of 1:1000) as nebulization and the control group will receive salbutamol nebulization as 4th nebulization. pram score with calculated before and at 60, 80, 100 min after the treatment.

Eligibility criteria:
* inclusion criteria: * pediatric age group 3 - 12 years * known to have asthma * initial pram score showed moderate to severe asthma exacerbation * exclusion criteria: * history of lung or upper airway disease other than asthma: * bronchiolitis, anaphylaxis, pertussis, vocal cord dysfunction, foreign body aspiration, bronchopulmonary dysplasia, cystic fibrosis and lower airway mass effects * history of congenital heart disease or cardiac arrhythmia or heart failure. * known hypertension * impending respiratory failure (decreasing mental status, respiratory fatigue, impending respiratory arrest, hypoxemia (po2 \< 60 mmhg), pco2 could be normal or high) * allergy or hypersensitivity to epinephrine * patient/parents refusal to participate in the study
the effects of low dose naltrexone (ldn) on diseases of aging

Conditions: Aging

Summary: this retrospective, observational study will assess the health status of short- and long-term low-dose naltrexone (ldn) users.

long-term (\>5 years), intermediate-term (1-5 years), and short-term low-dose naltrexone (ldn) users (\<12 months) will be contacted for a retrospective, observational assessment of their health status. participants will be asked to complete a series of questionnaires assessing their quality of life, general physical and mental health, family history, the occurrence of age-related diseases, and immune status. additionally, blood tests for immune and longevity markers will be optional for a subset of participants.

Eligibility criteria:
inclusion criteria: * adults (aged 18-120) * any sex * any ethnicity * taking ldn * willing to complete health questionnaires * technologically competent to complete web forms * subgroup: willing to undergo blood testing exclusion criteria: * ldn doses over 20 mg/day * terminal cancer patients (defined as stage iv and/or with a life expectancy of 12 months or less)

Keywords: low-dose naltrexone longevity health status quality of life
application of needle-free injection of insulin in patients with gestational diabetes mellitus

Conditions: Injection; Blood Glucose, High; Glycemic Control; Gestational Diabetes

Summary: this study is about the application of needle-free injection device in gdm patients in order to observe the variation of blood glucose and patients' experience compared to the traditional insulin pen injection. to provide evidence for the application of needle-free syringe injection in gdm patients.

this study is a prospective, randomized, unblinded,crossover and controlled clinical trail. the first patient was enrolled on november 1, 2019. the follow-up visit of all enrolled patients in our center will be finished on june 30, 2021. there are two arms in our study : test group(ig,n=20) and control group(cg,n=20), 40 patients totally. test group: "needle-free injection device, then traditional insulin pen" patients first received needle-free syringe for insulin injection 3\~4 times per day for 2 weeks. after the period of 2 weeks, they then received conventional insulin pen for insulin injection 3\~4 times per day for 2 weeks. control group: "traditional insulin pen , then needle-free injection device" patients first received conventional insulin pen for insulin injection 3\~4 times per day for 2 weeks. after the period of 2 weeks, they then received needle-free syringe for insulin injection 3\~4 times per day for 2 weeks.

Eligibility criteria:
inclusion criteria: * patients'diagnostic criteria of gestational diabetes mellitus(gdm) is according to the guidelines for the prevention and control of type 2 diabetes in china (2017 edition). * fasting glucose or 2h post prandial glucose was abnormal after 3days' dietary control (fasting glucose ≥ 6.1 mmol/l, or 2h post prandial glucose ≥7.8 mmol/l). * aged≥20 years, han, singleton pregnancy. * patients who gave informed consent voluntarily participated in the study, and had regular perinatal examination at our hospital and intended to deliver at our hospital. exclusion criteria: * patients with multiple pregnancy or undergoing assisted reproductive technology. * patients with polycystic ovary syndrome in preconception. * patients with other endocrine metabolic disorders such as gestational hypertension and hyperthyroidism. * patients with severe anemia and hypoproteinemia, abnormal liver and kidney function, severe heart failure, respiratory failure and other systemic diseases. * patients on long-term medications that affect glucose metabolism.
closed-loop o2 use during invasive mechanical ventilation of pediatric patients

Conditions: Respiratory Failure

Summary: during mechanical ventilation (mv) hypoxemic or hyperoxemic events should be carefully monitored and a quick response should be provided by the caregiver at the bedside. pediatric mechanical ventilation consensus conference (pemvecc) guidelines suggest to measure spo2 in all ventilated children and furthermore to measure partial arterial oxygen pressure (pao2) in moderate-to-severe disease. there were no predefined upper and lower limits for oxygenation in pediatric guidelines, however, pediatric acute lung injury consensus conference palicc guidelines proposed spo2 between 92 - 97% when positive end-expiratory pressure (peep) is smaller than 10 cm h2o and spo2 of 88 - 92% when peep is bigger or equal to 10 cm h2o. for healthy lung, pemvecc proposed the spo2\>95% when breathing a fio2 of 21%. as a rule of thumb, the minimum fraction of inspired o2 (fio2) to reach these targets should be used. a recent meta-analyze showed that automated fio2 adjustment provides a significant improvement of time in target saturations, reduces periods of hyperoxia, and severe hypoxia in preterm infants on positive pressure respiratory support. this study aims to compare the closed-loop fio2 controller with conventional control of fio2 during mechanical ventilation of pediatric patients


Eligibility criteria:
inclusion criteria: * pediatric patients older than 1 month and younger than18 years of age; hospitalized at the picu with the intention of treatment with imv at least for the upcoming 5 hours * requiring fio2 ≥ 25% to keep spo2 in the target ranges defined by the clinician * written informed consent signed and dated by the patient or one relative in case that the patient is unable to consent, after full explanation of the study by the investigator and prior to study participation exclusion criteria: * patient with indication for immediate noninvasive ventilation (nimv), high flow oxygen therapy (hfot) * hemodynamic instability defined as a need of continuous infusion of epinephrine or norepinephrine \> 1 mg/h * low quality on the spo2 measurement using finger and ear sensor (quality index below 60% on the spo2 sensor, which is displayed by a red or orange colour bar) * severe acidosis (ph ≤ 7.25) * pregnant woman * patients deemed at high risk for the need of non-invasive mechanical ventilation within the next 5 hours * patients deemed at high risk for the need of transportation from picu to another ward, diagnostic unit or any other hospital * diseases or conditions which may affect transcutaneous spo2 measurement such as chronic or acute dyshemoglobinemia: methemoglobinemia, carbon monoxide (co) poisoning, sickle cell disease * formalized ethical decision to withhold or withdraw life support * patient included in another interventional research study under consent * patient already enrolled in the present study in a previous episode of acute respiratory failure

Keywords: acute respiratory failure (arf) pediatric acute respiratory distress syndrome (pards) closed-loop oxygen spo2
managerial database ii

Conditions: HIV

Summary: this study will collect information on health status and risk behaviors, as well as basic demographic and biomedical information for a group of hiv positive adolescents receiving care at the atn sites.

the proposed study is a cross sectional study intended to be conducted at each of the 15 adolescent medicine trials units (amtus) participating in the atn and to enroll all participating patients followed at each site. this approach will allow for the examination of the broad spectrum of youth participating in the atn, including those newly entered into care. psychosocial and risk-taking behavioral data will be collected using audio compute-assisted self-interview (acasi); biomedical information will be collected through medical chart abstraction.

Eligibility criteria:
inclusion criteria: * laboratory evidence of hiv-1 infection documented by a positive result on any of the following licensed tests at any time: any hiv-1 antibody test confirmed by western blot, hiv-1 culture, hiv-1 dna pcr, or plasma hiv-1 rna pcr \> 1,000 copies/ml; * knowledge of hiv positive diagnoses; * age 12 years through 24 years, inclusive; * engaged in care at the amtu or its affiliate and/or partnering clinic. individuals will be considered to be engaged in care if: * diagnosed less than or equal to 12 months prior to the date of approval to generate the master list and has attended a minimum of one visit since diagnosis for the management of hiv disease or its sequelae; or * diagnosed more than 12 months prior to the date of approval to generate the master list and has had a minimum of one visit, as described above, within the past 12 months. * ability to understand written and/or verbal english * ability and willingness to provide signed consent/assent; * parental/legal guardian permission (if applicable) exclusion criteria: * presence of serious psychiatric symptoms (e.g., active hallucinations, thought disorder) that would impair the individuals' ability to complete the study measures; * visibly distraught (e.g., suicidal, homicidal, exhibiting violent behavior); or * intoxicated or under the influence of alcohol or other substances at the time of consent/assent.

Keywords: medication adherence substance use sexual risk behaviors