Kornimate/medical-research-clean huggingface dataset:
the impact of covid-19 on maternal and neonatal outcomes

Conditions: COVID-19; Pregnancy; Infection

Summary: the novel coronavirus (sars-cov-2) infection (covid-19) has caused a worldwide pandemic. there is still much that is unknown regarding the virus, especially its effects on pregnancy, the fetus, and the neonate. this study seeks to evaluate adverse pregnancy and neonatal outcomes related to covid-19 infection. the fda has authorized emergency use authorization for the sars-cov-2 messenger ribonucleic acid (mrna) vaccines from pfizer and moderna. pregnant women were excluded from the phase iii clinical trials of the mrna vaccines. there are no studies that have evaluated functional antibody responses, antibody reactivity to variant viruses, t cell frequencies or activity, or protection against infection or development of covid-19. having a more detailed understanding of how pregnancy and lactation alters the longevity, specificity, and activity of antiviral antibody and t cell-mediated immune responses to covid-19 mrna vaccines is essential for the fda to inform future recommendations and regulation of these vaccines.


Eligibility criteria:
inclusion criteria for vaccine arm: * all pregnant women receiving their prenatal care from the johns hopkins hospital or johns hopkins bayview medical center, who are planning to receive an mrna covid vaccine and/or a third dose booster during their pregnancy. exclusion criteria: * prior covid-19 infection. inclusion criteria for sample collection arm: * all pregnant women admitted to the johns hopkins hospital or johns hopkins bayview medical center for delivery and their newborn (at birth), will be considered for enrollment. * pregnant patients with a positive covid-19 test during their pregnancy or at the time of admission to labor \& delivery. exclusion criteria: * none
sestrin-2 levels and insulin resistance

Conditions: Obese Adolescents

Summary: the aim of this study is to evaluate sestrin-2 levels in children with obesity


Eligibility criteria:
inclusion criteria: obese adolescents body mass index above the 95th percentile bmi z-score above 2 exclusion criteria: primary hyperlipidemia primary liver disease hypothyroidism diabetes

Keywords: antioxidant childhood obesity insulin resistance sestrin-2 oxidative stress
naloxone nasal spray compared with naloxone injection for opioid overdoses outside the hospital

Conditions: Overdose; Drug Abuse

Summary: this trial will compare the clinical response to intramuscular and intranasal naloxone in pre-hospital opioid overdoses. objective of the study is to measure and evaluate clinical response (return of spontaneous respiration within 10 minutes of naloxone administration) to a new nasal naloxone formulation in real opioid overdoses in the pre-hospital environment. the aim is to demonstrate that intranasal administration of naloxone is not clinically inferior to intramuscular administration, which is now standard treatment of care.


Eligibility criteria:
inclusion criteria: * suspected opioid overdose clinically diagnosed by emergency medical service (ems) based on the following criteria 1. reduced (below and equal to 8 breaths per minute) or absent spontaneous respiration 2. miosis 3. glasgow coma scale (gcs) below 12 * palpable carotid or radial arterial pulse exclusion criteria: * cardiac arrest * failure to assist ventilation using mask-bag technique * facial trauma or epistaxis or visible nasal blockage * iatrogenic opioid overdose when opioid is administered in- hospital, or by ems or other health care workers in the pre- hospital setting * suspected or visibly pregnant participant * has received naloxone by any route in the current overdose * in prison or custody by police * ems staff without training as study workers * no study drug available * study drug frozen as indicated by freeze watch in kit or past its expiry date * deemed unfit for inclusion due to any other cause by study personnel at the scene; such as unsafe work environment for ems

Keywords: naloxone administration, intranasal injections, intramuscular narcotic antagonists
a study of orforglipron (ly3502970) compared with semaglutide in participants with type 2 diabetes inadequately controlled with metformin

Conditions: Type 2 Diabetes

Summary: the main purpose of this study is to assess efficacy and safety of orforglipron compared with oral semaglutide in participants with type 2 diabetes and inadequate glycemic control with metformin.the study will last around 61 weeks.


Eligibility criteria:
inclusion criteria: * have type 2 diabetes * have hba1c ≥7.0% (53 mmol/mol) to ≤10.5% (91 mmol/mol), as determined by the central laboratory at screening. * have been on stable diabetes treatment with metformin ≥1500 milligram (mg)/day during the 90 days prior to screening and maintained through randomization. * are of stable body weight (±5%) for at least 90 days prior to screening and agree to not initiate an intensive diet or exercise program during the study with the intent of reducing body weight, other than the lifestyle and/or dietary measures for diabetes treatment exclusion criteria: * have type 1 diabetes * are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema, for example, laser photocoagulation or intravitreal injections of anti-vascular endothelial growth factor inhibitors. * have a history of ketoacidosis or hyperosmolar state or coma within the last 6 months prior to screening, or between screening and randomization. * have a new york heart association functional classification iv congestive heart failure. * have an estimated glomerular filtration rate (egfr) \<45 milliliter/minute (ml/min)/1.73 square meter (m²) or lower than the country-specific threshold for discontinuing metformin therapy per local label as determined by the central laboratory at screening. * have a serum calcitonin level of ≥35 nanogram/liter (ng/l), as determined by the central laboratory at screening. * have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy for less than 5 years.
a study of a comprehensive prevention program to reduce lymphedema after axillary lymph node dissection in people with breast cancer

Conditions: Lymphedema; Lymphedema Arm; Lymphedema of Upper Arm; Breast Cancer; Breast Carcinoma; Female Breast Cancer

Summary: the purpose of this study to test whether a comprehensive program may help the lymph fluid to drain out of the arm and prevent lymphedema in participants with breast cancer.


Eligibility criteria:
inclusion criteria: * female sex * diagnosis of breast cancer * ages 18 to 75 years * consented for unilateral alnd or for unilateral slnb with possible alnd exclusion criteria: * male sex * does not speak english * does not fit into study garment * axillary recurrence * history of alnd * requirement of bilateral alnd for the treatment of breast cancer * treatment with slnb only * known anaphylactic allergy to icg dye used in ilr * impaired decision-making capacity

Keywords: immediate lymphatic reconstruction axillary lymph node dissection lymphedema lymphedema arm lymphedema of upper arm breast cancer breast carcinoma female breast cancer memorial sloan kettering cancer center 23-303
comparing tai chi training to a low-stress physical activity to enhance sleep in older adults

Conditions: Sleep Deprivation; Sleep Initiation and Maintenance Disorders

Summary: the purpose of this study is to examine the effects of tai chi, in comparison to conventional exercise, on the quality of sleep among sedentary older adults.

elderly individuals often suffer from sleep disturbances. chronic sleep problems can cause significant medical, psychological, and social disruptions. although many sleep-related studies exist, few studies have focused on improving quality of sleep. tai chi, an exercise that incorporates meditation and breathing with whole body movements, may improve the quality of sleep and health status of elderly individuals. participants will be randomly assigned to either a tai chi group or a conventional exercise control group. participants in each group will exercise for 60 minutes, 3 times per week, for 6 months. assessment of sleep quality and health status will be done at study start, 3 months, 6 months, at the end of the study, and at a 3-month follow-up visit.

Eligibility criteria:
inclusion criteria: * sedentary, as defined by a lack of regular exercise during the previous 6 months * healthy to the degree that participation in exercise testing and an exercise program would not exacerbate any existing disease condition * physician's clearance for participation * willingness to adhere to the conditions of the study exclusion criteria: * sleep medication or other psychotropic medication during the study * current sleep disorder treatment * significant cognitive impairment as indicated by a score of 3 on the pfeiffer mental status questionnaire * more than 7 alcoholic beverages per week or use of alcohol close to bedtime * smoking more than 10 cigarettes per day * score of 5 or higher in the pittsburgh sleep quality index questionnaire * score of 3 or higher on 2 out of 3 sleep items drawn from the sleep questionnaire and assessment of wakefulness

Keywords: tai ji
infusion of apomorphine: long-term safety study

Conditions: Idiopathic Parkinson's Disease

Summary: this is a phase 3, multicenter, open-label, safety and tolerability study of continuous apomorphine infusion in subjects with advanced parkinson's disease (pd) whose motor fluctuations remain unsatisfactory with levodopa (or levodopa/carbidopa) and at least one other class of drugs or mode of therapy for pd.

this phase 3, multicenter, open-label study will assess the long-term safety and tolerability of continuous subcutaneous infusion of apomorphine in advanced parkinson's disease (pd) patients whose motor fluctuations remain unsatisfactory with levodopa (or levodopa/carbidopa) and at least one other class of drugs or mode of therapy for pd. further, this study will assess the clinical effectiveness of continuous apomorphine subcutaneous infusion in reducing "off" time in advanced pd patients and to assess the clinical effectiveness of continuous subcutaneous infusion of apomorphine in improving "on" time without resulting in an increase in troublesome dyskinesias.

Eligibility criteria:
inclusion criteria: * advanced idiopathic pd consistent with uk parkinson's disease society brain bank clinical diagnostic criteria * overall motor control is unsatisfactory in the opinion of the investigator and subject despite optimized treatment with available therapies, which must include a stable regimen of daily maintenance levodopa (or levodopa/carbidopa), and at least one of the following other classes of therapies: * dopamine agonists (note: apokyn intermittent injection is not to be considered here) * monoamine oxidase b \[mao b\] inhibitors * catechol-o-methyltransferase (comt) inhibitors * deep brain stimulation (dbs) * levodopa/carbidopa intestinal gel surgery (duopa, duodopa) * other - amantadine at doses of up to 400 mg per day) * experiences "off" periods averaging ≥3.0 hours per waking day * other criteria will be discussed in detail with potential subjects by site investigator exclusion criteria: * planned surgical intervention for the treatment of parkinson's disease during participation in the study * history of hypersensitivity to apomorphine hydrochloride or any of the ingredients of apokyn pfs, including sodium metabisulfite * known, suspected, or planned pregnancy or lactation. * recent history (within the previous 12 months) of alcohol or substance abuse * history of impulsive/compulsive behaviors primarily associated with the use of dopamine agonists * history of previously treated or current diagnosis of malignant melanoma * exhibits certain signs and symptoms of cardiovascular disease * other criteria will be discussed in detail with potential subjects by site investigator

Keywords: parkinson's disease, apomorphine apokyn dopamine agonist levodopa advanced pd carbidopa pramipexole ropinirole rotigotine mao-b inhibitors comt inhibitors off dyskinesia
myocardial damage in covid-19

Conditions: COVID-19; Cardiovascular Diseases

Summary: this study aims to investigate the clinical characteristics, the incidence of myocardial injury, and the influence of myocardial injury on the prognosis in covid-19 patients. there is no additional examination and treatment for this project.

the epidemic of the covid-19 has expanded from wuhan through out china, and is being exported to a growing number of countries. recently, investigators have revealed that acute myocardial injury is existed in 7.2% patients with covid-19, and this proportion in patients admitted to the icu (22.2%) is higher than patients not treated in the icu (2.0%). thus, cardiac troponin i (ctni), the biomarker of cardiac injury, might be a clinical predictor of covid-19 patient outcomes. this study aims to investigate the clinical characteristics, the incidence of myocardial injury, and the influence of myocardial injury on the prognosis in covid-19 patients.

Eligibility criteria:
inclusion criteria: * (1) age ≥18 years. (2) laboratory (rt-pcr) confirmed infection with sars-cov-2. (3) lung involvement confirmed with chest imaging. exclusion criteria: * no ctni test on admission

Keywords: covid-19 myocardial injury
lung and gut microbiome in chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: increasing evidence have implied that microbiota from airway and gut might be involved in the pathogenesis of chronic obstructive pulmonary disease (copd). however, the cross-talk between respiratory and gastrointestinal microbiome in copd is still undetermined. the study is aimed to investigate the interaction between lung and gut flora, and their role in the process of copd.

despite the high prevalence of chronic obstructive pulmonary disease (copd), there continues to be a large gap in our understanding of disease pathogenesis and mechanisms accounting for large variability in disease phenotype. cigarette smoking is the principal cause of copd, but only approximately 15% of adults with substantial tobacco exposure develop clinical copd. besides, bacterial colonization or infection is also considered as an important factor in copd. there are very limited data from microbiome studies that suggest that respiratory and gastrointestinal microbiota may be involved in the pathogenesis of copd. however, the cross-talk between between lung and gut microbiome, and their relationship with various clinical phenotypes of copd. here, we conducted 16s rrna-based pyrosequencing to evaluate the link between the lung-gut axis and the clinical phenotypes of copd, such as lung function, emphysema, symptoms, exacerbations, inflammation levels and metabolic features.

Eligibility criteria:
inclusion criteria: 1. males aged 40-80; 2. diagnosed with copd according to the gold guidelines; 3. clinically stable patients without medication changes or exacerbation in two months; 4. smoking history of more than 10 pack years exclusion criteria: 1. diagnosed with unstable cardiovascular diseases, significant renal or hepatic dysfunction or mental incompetence; 2. diagnosed with asthma, active pulmonary tuberculosis, diffuse panbronchiolitis, cystic fibrosis, clinically significant bronchiectasis, exacerbation of copd or pneumonia in two months; 3. prescribed immunosuppressive medications.
assessment of the impact of the return home of premature newborns less than 2 kilos morbidity/mortality

Conditions: Premature Birth

Summary: the aim of this study is to evaluate the impact of discharge from hospital with a weight of less than 2 kilos. to do this, the investigator will look at the short-term and long-term outcome of newborns weighing less than 2 kilos who were discharged from the neonatology department at the novo hospital between 2012 and 2024.

prematurity in itself, whether simple or associated with intrauterine growth retardation, continues to be a real public health problem. in addition to gestational age at birth, the presence of co-morbidities can affect the morbidity and mortality of premature babies, as well as the length of hospital stay. advances in neonatal care and the involvement and skills of parents in the care of premature infants have led to a considerable reduction in mortality among these patients. according to the latest recommendations published in november 2022 by the who, and thanks to changes in the criteria for discharging these patients in recent years, the same applies to low-birthweight infants. the early and well-planned discharge of premature babies is currently the subject of a great deal of study and research. according to these studies, it has been shown that the essential criteria for this discharge are the physiological capacities and skills of these vulnerable patients (thermoregulation, autonomous feeding and breathing, etc.). essential care, parental support and home visits by qualified health workers (pmi, had, etc.) are also essential. premature birth has a real impact on the economic consequences in several countries. infants small for gestational age had longer hospital stays, were more likely to be admitted to an intensive care unit and were more likely to be hospitalised in the first year of life, resulting in higher costs. it is against this backdrop that the novo hospital is proposing to evaluate the impact of discharging babies weighing less than 2 kilos. to do this, the investigator will base his study on the short-term and long-term outcome of newborns weighing less than 2 kilos who were discharged from the novo hospital's neonatology department between 2012 and 2024.

Eligibility criteria:
inclusion criteria: * premature newborn baby (born at less than 37 days' gestation) * newborn baby with iugr (intra-uterine growth retardation) * newborn baby hospitalised in the neonatology department of the novo hospital - pontoise site * patient born between 01/01/2012 and 31/12/2024. * newborn who has left the neonatology department or the kangaroo unit to return home weighing less than 2 kg. * newborn beneficiary of a social security scheme or entitled person. exclusion criteria: * newborn transferred to another hospital before discharge. * refusal by one of the parents. * parent does not speak or understand french.

Keywords: prematurity weight at discharge morbi-mortality neonatology
application software in dosage adjustment for advanced cancer patients with pain

Conditions: Pain; Physicians; Oxycodone

Summary: the purpose of this trial is to determine whether application (app) would help clinical doctors to adjust the dose of oxycodone hydrochloride prolonged-release tablets in advanced patients with cancer pain.


Eligibility criteria:
inclusion criteria: * a histologically confirmed diagnosis of cancer or sarcoma * advanced patients with severe cancer pain(score \>3) * having used or expected to use the oxycodone hydrochloride prolonged-release tablets exclusion criteria: * allergic to oxycodone hydrochloride prolonged-release tablets, or other reasons (determined by clinical doctors) unable to use the opioids
efficacy of fixed combination of beclometasone + formoterol + glycopyrrolate in chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the purpose of this study is to determine the triple combination of beclometasone dipropionate+formoterol fumarate+glycopyrrolate bromide is effective for the treatment of severe copd patients (chronic obstructive pulmonary disease)

a 52-week, double blind, double dummy, randomized, 3-arm parallel group, active controlled clinical trial of fixed combination of beclometasone dipropionate plus formoterol fumarate plus glycopyrrolate bromide administered via pmdi (chf 5993) versus tiotropium bromide and versus fixed combination of beclometasone dipropionate plus formoterol fumarate administered via pmdi and tiotropium bromide in patients with chronic obstructive pulmonary disease a total of 8 clinic visits (v0 to v7) will be performed during the study, as follows: * a pre-screening visit (v0) to obtain the written informed consent from the patient * a screening visit (v1) to establish the eligibility of patients, followed by a 2-week open-label run-in under tiotropium * after the randomisation (v2), patients will be assessed after 4, 12, 26, 40 and 52 weeks of treatment (v3 to v7) the assessments performed at visits include routine haematology and blood chemistry, medical history, physical examination, a 12-lead ecg, spirometric parameters, vital signs). during the run-in and the randomised treatment periods, patients use an e-diary to record symptoms, rescue medication use and compliance to the study medications daily. aes/saes and copd exacerbations will be monitored.

Eligibility criteria:
inclusion criteria: * male and female copd patients aged ≥ 40 years * current smokers or ex-smokers * fev1\<50% predicted (fev1/fvc \<0,7) * at least 1 documented exacerbations in the last 12 mo exclusion criteria: * pregnant or lactating women and all women physiologically capable of becoming pregnant * diagnosis of asthma, history of allergic rhinitis or atopy * patients treated for exacerbations 1 mo prior to screening * patients treated with non-cardioselective β-blockers * patients treated with long-acting antihistamines * known respiratory disorders other than copd * patients who have clinically significant cardiovascular condition

Keywords: frequent exacerbators
evaluation of the effectiveness of intraoperative frozen section on the treatment of suspected gallbladder cancer

Conditions: Gallbladder Cancer

Summary: evaluate the effectiveness of intra-operative frozen section in the treatment of gallbladder cancer. the study will be looking in to identify if intraoperative frozen section is a viable method to intraoperatively evaluate the presence of adenocarcinoma and the depth of its invasion and if the information given by frozen section is enough to modify the operative strategy.


Eligibility criteria:
inclusion criteria: - patients with suspected gb cancer exclusion criteria: -
communication skills intervention to promote transition into survivorship

Conditions: Hodgkin's Lymphoma; Diffuse Large B-cell Lymphoma

Summary: the purpose of this study is to improve the communication skills of physicians who transition lymphoma cancer patients from the end of treatment to survivorship.


Eligibility criteria:
inclusion criteria: physicians: * who treat patients with dlbcl and hd as per self report patients of physicians: * have a new diagnosis of hodgkin's or diffuse large b-cell lymphoma as per pathology report or physician assessment in medical record and/or clinical judgment of the treating physician treated with curative intent. for part 1 - have scans indicating remission and completing planned chemotherapy and/or radiation therapy. the treating physician will determine that clinical remission has been achieved based on their best judgment. for part 2 (longitudinal phase): - have new scans indicating remission and completing planned chemotherapy and/or radiation therapy. the treating physician will determine that clinical remission has been achieved based on their best judgment. * be at least 18 years old * speak english well enough, in the judgment of the consenting professional, to be able to understand all aspects of the study, provide informed consent, and be able to complete all study measures. exclusion criteria: physicians: * who do not have adequate patients in their clinical practice to meet the 8 patient enrollment requirement for patients with either dlbcl or hd as per self report patients of physicians: * show evidence of cognitive impairment severe enough to preclude giving permission to the study staff, or completing the survey instruments of the study. * as per physician judgment, patient's prognosis and/or co-morbidities make them inappropriate for participation in a survivorship study. for part 2 only (longitudinal phase): * those who consented to part 1, consult recording, of the study.

Keywords: patient outcomes survivorship communication skills communication strategies physicians communication 11-180