Kornimate/medical-research-clean huggingface dataset:
engaging pacific islander perspectives on mental illness and mental health services

Conditions: Mental Disorder

Summary: this study will enroll 100 samoan and 100 marshallese adults to discuss mental health, mental disorders, and approaches for engaging pacific islander adults with mental illness into mental health services.

despite enduring high mental health burden, pacific islanders have received minimal research or clinical attention in the us. due to our poor understanding of the issues surrounding pacific islander mental health, engaging pacific islanders in mental health services has been very difficult. this study draws from the cultural determinants of help-seeking model to address this research and clinical gap by conducting focus groups and citizens' panels to obtain public input from 50 samoans in lac and 50 marshallese in arkansas on their unique mental health perspectives, needs, barriers and facilitators to services, and strategies to overcome these barriers. the citizens' panels will bring together lay public members, present multiple viewpoints about various mental health issues, and have members deliberate and reach a collective decision on these issues. all group materials will be translated into english, samoan, and marshallese, and interpreters will be present during the sessions. the groups will be audio-recorded, transcribed verbatim, and analyzed by the research team for themes. numerical data will also be collected about levels of public awareness about mental illness, mental health stigma, acculturation, and underutilization of mental health services from 100 samoan and 100 marshallese community members to better understand these possible service barriers. analyzed data will be used to develop a set of intervention components that are likely to increase service engagement among both samoans and marshallese. these components will provide the foundation for a universal service engagement intervention for pacific islanders that will be developed and tested in future research.

Eligibility criteria:
inclusion criteria: * samoan or marshallese heritage; living in los angeles county or northwest arkansas; age 18 years or older; english, samoan, or marshallese oral and reading fluency exclusion criteria: * not of samoan or marshallese heritage; living outside the catchment areas; younger than 18 years; not fluent in english, samoan, or marshallese
breathe ald: a shared decision-making intervention for adults with advanced lung disease

Conditions: Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial

Summary: this study aims to: 1. develop the breathe-ald intervention for adults with advanced lung disease, multiple chronic conditions, and palliative care needs and their caregivers using interviews with 10 advanced lung disease (ald) adults and their caregivers 2. to evaluate the feasibility and acceptability of intervention procedures; and 3. to explore intervention effects on ald outcomes

this study addresses the important problem of adults with symptomatic advanced lung disease (ald) who are at high risk for poor outcomes. palliative care (pcare) improves the quality of life of individuals and their caregivers through the prevention and relief of suffering by identifying, assessing and treating the physical, psychosocial and spiritual problems associated with life-threatening illness. however, pulmonary clinicians rarely refer adults with ald to pcare because of time demands, a lack of confidence in pcare and the perceived threat pcare poses to the relationship they have established with the ald adult. therefore, we are developing breathe-ald (brief intervention to enhance adherence to treatment and health advice in advanced lung disease \[ald\]), a novel shared decision-making (sdm) intervention to improve outcomes for adults with ald. the study includes two phases: (1) a development phase to develop breathe-ald using interviews with 10 ald adults and their caregivers with expert review to adapt breathe, and (2) a pilot validation phase conducting a pilot trial in which 10 adults with ald receive breathe-ald. we will follow adults with ald for 3 months post-intervention to assess the impact of breathe-ald on self-management and patient outcomes.

Eligibility criteria:
pre-trial inclusion criteria: * patient participants with symptomatic advanced lung disease (ald) followed at weill cornell medicine (wcm). * caregiver participants who care for adults with symptomatic ald followed at weill cornell medicine. exclusion criteria: * patients that have serious mental health conditions that preclude completion of study procedures or confound analyses. * caregivers that have serious mental health conditions that preclude completion of study procedures or confound analyses. trial inclusion criteria: * patient participants with symptomatic advanced lung disease (ald) followed at weill cornell medicine (wcm). * nurse practitioner must manage a panel of adult ald patients. exclusion criteria: * patients that have serious mental health conditions that preclude completion of study procedures or confound analyses. * patients anticipated to have less than 3-month survival.

Keywords: lung disease
impact of the depth of neuromuscular blockade on respiratory mechanics in moderate to severe ards patients

Conditions: Acute Respiratory Distress Syndrome; Ventilator-Induced Lung Injury

Summary: neuromuscular blockade (nmb) is proposed in patients with moderate to severe acute respiratory distress syndrome (ards). the supposed benefit of these muscle relaxants could be partly linked to their effects on respiratory mechanics by reducing ventilator induced lung injuries (vili), especially the so called atelectrauma. although its monitoring is recommended in clinical practice, data about the depth of nmb necessary for an effective relaxation of the thoracic and diaphragmatic muscles and, therefore, the reduction of the chest wall elastance, are scarce. the investigators hypothesised that complete versus partial nmb can modify respiratory mechanics and its partitioning.

the investigators conducted a prospective study to compare the respiratory mechanics of patients with moderate to severe ards according to the nmb depth, using an oesophageal pressure catheter (nutrivent®, sidam) for transpulmonary pressure (pl) assessment, and facial train of four (tof) for neuromuscular blockade monitoring. the oesophageal balloon was calibrated according to the method recently described to estimate the individual target volume which is assumed to be more adequate. each patient was analysed at two different times: deep nmb (tof = 0) and intermediate to light nmb (tof \> 0). the mechanical ventilation parameters were identical for these two measurements. the primary endpoint was the proportion of patients with expiratory transpulmonary pressure (plexp) greater than or equal to 0 according to the nmb level, in order to assess the risk of region-dependent atelectasis and alveolar opening/closing injury (atelectrauma). secondary endpoints included: the impact of the depth of nmb on other partition parameters of respiratory mechanics, and the variability of results according to the type of oesophageal balloon calibration.

Eligibility criteria:
inclusion criteria: * moderate to severe ards patients with pao2/fio2 ratio \< 150 mmhg * mechanical ventilation, deep sedation and neuromuscular blockade with continuous infusion of cisatracurium for more than 24 hours * presence of an oesophageal catheter * written informed consent exclusion criteria: * contraindication of oesophageal catheter

Keywords: oesophageal pressure transpulmonary pressure train of four neuromuscular blockade
safety and efficacy study of high dose colistin

Conditions: Infectious Diseases

Summary: colistin is a rapidly acting bactericidal antimicrobial agent that possesses a post antibiotic effect against mdro gram-negative bacteria, such as as pseudomonas aeruginosa, acinetobacterbaumannii, and klebsiella pneumonia.


Eligibility criteria:
* inclusion criteria: 1. patient age more than or equal 18 years old. 2. patient has clinical signs and symptoms of infection with suspected or proven infection due to carbapenem resistant microorganism. 3. patient was started with empirical therapy of colistin and positive mdro within 5 days of empirical therapy. * exclusion criteria: 1. patient age less than 18 years. 2. pregnant patient. 3. if received colistin treatment for less than 72 hours. 4. renal replacement therapy.

Keywords: colistin icu critical care
effects of hict and intermittent fasting on pcos

Conditions: Polycystic Ovary Syndrome; PCO

Summary: the goal of this randomized controlled trial is to compare the effects of high intensity circuit training, intermittent fasting, and their combination on pcos morphology, anthropometrics, clinical hyperandrogenism and body image concerns in females with pcos. participants will be divided into three groups who will receive high intensity circuit training, intermittent fasting and their combination. the outcomes will be pcos morphology, anthropometrics', clinical hyperandrogenism and body image concerns.


Eligibility criteria:
inclusion criteria: * unmarried females * diagnosed with pcos phenotype a based on rotterdam criteria: * pcom on us * ovulatory dysfunction * clinical hyperandrogenism (hirsutism modified ferriman gallway score ≥ 8) * not engaged in any regular lifestyle intervention for \&lt;3 months prior to inclusion exclusion criteria: * use of estrogen, progestin or combination. * taking medications or supplements for insulin resistance \&lt; 3 months prior to the inclusion * type i or ii dm * hypo/hyperthyroidism * bmi ≥27 (obese according to bmi asia)

Keywords: pco polycystic ovary syndrome females body image concerns
synchronous effect of anesthetics on fmri, eeg and clinical responses

Conditions: Sedative Overdose

Summary: background: the mechanisms of action of intravenous anesthetics are unclear and the current monitors have limitations. this signifies difficulties when assessing the correct dosage due to the considerable inter-individual variability of the patients, particularly in the elderly or seriously ill. it is necessary to customize the administration of anesthetics as underdosage can lead to the patient awareness during aggressive procedures, and over-dosage can cause serious complications and even augment mortality. objective: to design a new monitoring system of the levels of consciousness and analgesia in anesthetized subjects which is more accurate than those currently employed. it will be based on the synchronic changes of functional magnetic resonance (fmr) and electroencephalograph (eeg) readings, and clinical responses. methodology: thirty healthy volunteers will be given propofol and remifentanil in different combinations, and painful stimuli will be also applied. the principal variable will be fmr images obtained by echo-planar imaging sequences. real time will be correlated with cortical connectivity maps, eeg parameters (qcon, qnox), clinical responses, and concentrations of anesthetics measured by pharmacokinetic and pharmacodynamic models (tci).

main goal: develop a system for monitoring the effect of anesthetics on consciousness and pain, based on synchronous changes in functional neuroimaging, eeg and clinical responses. secondary objectives: * analyze the changes produced in the cortical connectivity map during the induction of anesthesia to understand the process of "advancement". * know more accurately the neuronal circuits involved in propofol-induced sleep. * study if the application of a known painful stimulus modifies in any way (clinical, eeg or by rmf) the loc that has just been reached. * establish propofol dosing guidelines adjusted to each patient, studying if they reach the loc at "sedative" or "hypnotic" doses. * establish remifentanil dosing guidelines, adjusted to each patient, studying the concentration of remifentanil to which the pain response in neuroimaging is inhibited (activation deactivation neuronal in fmri). * validate existing mathematical models in relation to plasma and brain concentrations of propofol and remifentanil. * validate the value of clinical signs to predict whether a patient feels the painful stimulus received.

Eligibility criteria:
inclusion criteria: * healthy adult volunteers (asa 1 physical state) who agree to participate voluntarily in the study, previous information about it by the principal investigators (ip). exclusion criteria: * psychological, psychiatric or neurological disorders. consumption of drugs. alterations cutaneous or anatomical cranial. idiomatic or communication barrier. allergy to propofol, remifentanil or to some of its excipients. body mass index (bmi) \ 30 kg / m2. pregnancy. airway or ventilation criteria hard. absence of accompanying adult at the end of the study.

Keywords: propofol, remifentanil, hypnosis, eeg, fmri,
irreversible electroporation(ire) for unresectable lymph node metastases(close to nerve)

Conditions: Lymph Node Metastases

Summary: the purpose of this study is to evaluate the safety and efficacy of irreversible electroporation (ire) for unresectable lymph node metastases.

by enrolling patients with unresectable lymph node metastases adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous ire for unresectable lymph node metastases.

Eligibility criteria:
inclusion criteria: * lymph node metastases diagnosed by positive biopsy or non-invasive criteria, * not suitable for surgical resection, * eastern cooperative oncology group (ecog) score of 0-1, * a prothrombin time ratio \> 50%, * platelet count \> 80x10\^9/l, * ability of patient to stop anticoagulant and anti-platelet therapy for seven days prior to and seven days post nanoknife procedure, * able to comprehend and willing to sign the written informed consent form (icf), * have a life expectancy of at least 3 months. exclusion criteria: * cardiac insufficiency, ongoing coronary artery disease or arrhythmia, * any active implanted device (eg pacemaker), * women who are pregnant or women of child-bearing potential who are not using an acceptable method of contraception, * have received treatment with an investigational agent/ procedure within 30 days prior to treatment with the nanoknife™ ledc system, * are in the opinion of the investigator unable to comply with the visit schedule and protocol evaluations.

Keywords: irreversible electroporation unresectable lymph node metastases
pilot study of atorvastatin in children with chronic hyperlipidemia secondary to nephrotic syndrome

Conditions: Nephrotic Syndrome; Hyperlipidemia

Summary: objectives: i. determine the effect of atorvastatin on the plasma levels of lipids, lp(a), and apoproteins for treating hyperlipidemia in children with nephrotic syndrome in whom proteinuria and hyperlipidemia persist after other appropriate measures to treat their primary disease have been exhausted. ii. determine the safety and tolerability of atorvastatin in these patients. iii. provide preliminary data for a future investigation into the potential effect that lowering cholesterol levels may have on the rate of progression of renal insufficiency in such patients.

protocol outline: this is a randomized, double blind, placebo controlled, multicenter study. after 3 months of low cholesterol diet, patients are randomized to receive atorvastatin tablets daily (arm i) or placebo tablets daily (arm ii) for 3 months. arm i patients receive increasing doses of atorvastatin every 4 weeks until individual maximum tolerated doses (mtds) are determined. after 3 months of treatment, all patients are given atorvastatin in a 6-9 month open label extended evaluation. arm i patients receive atorvastatin for an additional 6 months and arm ii patients receive atorvastatin for 9 months with increasing doses of atorvastatin every 4 weeks for the first 3 months until mtds are determined. patients are followed every 6-8 weeks for one year.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- chronic hyperlipidemia with treatment-resistant nephrotic syndrome; must have received at least 2 months of therapy with steroids on a daily or alternate basis primary nephropathy described as minimal change nephrotic syndrome, mesangioproliferative glomerulonephritis, igm neuropathy, and focal segmental glomerulosclerosis glomerular filtration rate at least 30 ml/min ldl cholesterol at least 160 mg/dl --prior/concurrent therapy-- no concurrent medications affecting or interacting with lipids or atorvastatin, with the exception of angiotensin converting enzyme inhibitors at discretion of referring physician, including: lipid-lowering medications, beta blockers, thiazides, fish oils, cyclosporine, cytoxan, azathioprine, chlorambucil, and erythromycin concurrent prednisone and other corticosteroids allowed on a continual basis at a dose of no greater than 1 mg/kg every other day (maximum dose, no greater than 40 mg every other day); concurrent acute courses of steroids no greater than 1 week for other unrelated conditions (e.g., asthma) also allowed --patient characteristics-- hepatic: alt or ast less than 2 times normal renal: see disease characteristics; creatine phosphokinase less than 3 times normal other: no history of familial hypercholesterolemia; no systemic disease such as systemic lupus, schoenlein-henoch purpura, hodgkin's disease, polyarteritis nodosum, sickle cell disease, or hiv; not pregnant; effective contraception required of all adolescent patients

Keywords: cardiovascular and respiratory diseases hyperlipidemia nephrotic syndrome rare disease renal and genitourinary disorders
hyperbaric oxygen therapy improves outcome of hypoxic-ischemic encephalopathy

Conditions: Hypoxic-ischemic Encephalopathy

Summary: the purpose of this study is to to evaluate the safety and efficacy of hyperbaric oxygen in term gestation newborn infants with hypoxic-ischemic encephalopathy..

hypoxic-ischemic encephalopathy (hie) remains a major cause of neonatal death and long term disabilities. data from animal studies have shown protective effects of hyperbaric oxygen therapy to impaired brain. recently research priorities have moved from bench to bedside. several studies have shown a trend for brain protection of hyperbaric oxygen therapy has emerged as a promising treatment for hie. therefore,the investigators organized a multi-centered randomized controlled trial of hyperbaric oxygen therapy in hie newborn infants.

Eligibility criteria:
* inclusion criteria: * newborn infants whose gestational age ≥37 weeks' gestation, weighing over 2500 g ; * acute perinatal event (e.g., late or variable decelerations, cord prolapse, cord rupture, uterine rupture, maternal trauma, hemorrhage, or cardiorespiratory arrest) * with an apgar score ≤ 3 at one minute and ≤5 at five minutes, and/or a potential of hydrogen of 7.0 or less or a base deficit of 16 mmol per liter or more in a sample of umbilical-cord blood or any blood during the first hour after birth. * having moderate-to-severe encephalopathy (indicated by lethargy, stupor, or coma) and either hypotonia, abnormal reflexes (including oculomotor or pupillary abnormalities), an absent or weak suck, or clinical seizures, and/or have abnormal background activity of at least 20 minutes' duration or seizures on amplitude integrated electroencephalography * exclusion criteria: * a congenital and the hereditary disease, a chromosome abnormalities, and a congenital abnormality. * during the acute phases of intracranial and (or) fundus hemorrhage. o * intracranial infection. * pneumothorax. * infants who have been received hypothermia.

Keywords: hypoxic-ischemic encephalopathy hyperbaric oxygen therapy
effectivity and safety of irreversible electroporation for refractory neoplasms in liver and pancreas

Conditions: Refractory Neoplasms

Summary: the pupose of this study is to evaluate the safety and efficacy of irreversible electroporation (ire) for refractory neoplasms in liver and pancreas, the investigators used preoperative and postoperative us/ceus/ct/mri to assess lesions, and laboratory tests including the tumor markers to evaluate the general condition of patients. intraoperative us/ceus/ct would be applied to monitor ablation lesions.


Eligibility criteria:
inclusion criteria: 1. patients with hepatic portal focal lesion adjacent to important structures like bile duct and portal blood vessels, or intolerant surgery. 2. patients with pancreatic cancer adjacent to blood vessels, or intolerant surgery. exclusion criteria: patients with: 1. metal in the body 2. childpugh ≥ 3 3. long-term use of anticoagulant drugs including warfarin, clopidogrel bisulfate 4. poor cardiac or renal function with intolerant surgery or anesthesia.

Keywords: effectivity safety irreversible electroporation liver pancreas
hyperoxia and pulmonary complications after cardiac surgery

Conditions: Hyperoxia

Summary: the main objective is to demonstrate that hyperoxia in cardiac surgery increase the occurrence of post-operative pulmonary complications


Eligibility criteria:
inclusion criteria: * adult patient (≥18 years old) * patient operated heart surgery with extra-corporal life support * hospitalization in cardiology intensive and critical care unit * patient operated in hus between 01/01/2015 and 31/12/2019 * subject consent, after information, to the reuse of its data for the purposes of this study exclusion criteria: * non-consent patient * hypoxemic patient * emergency surgery * patient with post-operative cardiac assist device * patient with guardianship

Keywords: hyperoxia cardiac surgery pulmonary complications lung collapse post-operative
sitagliptin/metformin (janumet) re-examination study (0431a-182)

Conditions: Type 2 Diabetes Mellitus

Summary: this survey is conducted for preparing application materials for re-examination under the pharmaceutical affairs laws and its enforcement regulation, its aim is to reconfirm the clinical usefulness of sitagliptin/metformin (janumet) through collecting the safety and efficacy information according to the re-examination regulation for new drugs.


Eligibility criteria:
inclusion criteria: * has type 2 diabetes mellitus * is treated with sitagliptin/metformin within local label for the first time exclusion criteria: * has a contraindication to sitagliptin/metformin according to the local label * is treated with sitagliptin/metformin before contract and out of enrollment period

Keywords: diabetes mellitus non-insulin-dependent