Kornimate/medical-research-clean huggingface dataset:
safety and feasibility of a novel in--bed resistance training device in elderly inpatients

Conditions: Old Age; Debility

Summary: the purpose of this study is to decrease deconditioning of elderly inpatients in acute care institutions and to assess the safety and feasibility of a newly developed resistance training device. investigators believe this device will help hospitalized seniors maintain their independence by preventing the loss of functionality from deconditioning and improve value of care through decreased length of stay and utilization of care. current therapy will be complemented with a new in--bed resistance training device to target weak elderly patients and standardize progressive resistance training in facilities.


Eligibility criteria:
inclusion criteria: * patients greater than or equal to 70 years old * admitted to acute inpatient medicine unit at nyu langone health (17e and 17w) from - - - - - emergency department * receiving physical therapy * initial ampac 6 clicks score 11-18 * english speaking exclusion criteria: * icu level care * acute cardiac risk (including recent acute mi and stroke, unstable arrhythmias, or uncontrolled hypertension) * exercise-limiting physical disability (ie rotator cuff injury, neurologic impairment) * severe cognitive impairment (1) no significant dementia or delirium (2) patient able to accept readiness for pt and comprehend education * contact precautions

Keywords: deconditioning of elderly inpatients loss of functionality
monoclonal antibody therapy in treating patients with advanced kidney cancer

Conditions: Kidney Cancer

Summary: rationale: monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. purpose: phase i/ii trial to study the effectiveness of monoclonal antibody therapy in treating patients with advanced kidney cancer.

this is a dose-escalation study. initially patients receive a scout dose of iodine-131 radiolabeled chimeric monoclonal antibody g250 (131i-cg250) administered intravenously (iv) over 10 minutes to determine whole body clearance. one week later, patients receive incremental doses of 131i-cg250 iv over 10 minutes at 2-3 day intervals for 2-6 weeks,. dose escalation begins at least 8 weeks after the last infusion of 131i-cg250. in the absence of dose-limiting toxicity in the first 3 patients treated, subsequent cohorts of 3 patients each receive escalating doses of 131i-cg250 on the same schedule. if dose-limiting toxicity occurs in 2 of 6 patients treated at a given dose level, then dose escalation ceases and the next lower dose is declared the maximum tolerated dose (mtd). treatment continues once recovery from all toxic effects occurs, beginning 8 to 12 weeks following the last dose of 131i-cg250. patients achieving complete remission, partial remission, or stable disease were eligible to receive up to 3 courses of treatment.

Eligibility criteria:
inclusion criteria histologically proven renal cell carcinoma. clinical presentation consistent with metastatic renal cell carcinoma. bidimensionally measurable disease by conventional imaging. patients must have been off chemotherapy or immunotherapy for at least 6 weeks prior to study entry. women of child-bearing age must have had a negative pregnancy test carried out the day of and prior to receiving therapy, and were asked to use effective contraception during the study. patients were required to be ambulatory with a karnofsky performance status at least 70, serum creatinine ≤ 2mg/dl, serum bilirubin ≤ 1mg/d, white blood cells (wbc) ≥ 3,500/mm\^3, platelet count ≥ 100,000/mm\^3, prothrombin time \< 1.3 x control. exclusion criteria significant prior radiation therapy to the entire pelvis and/or lumbosacral spine. clinically significant cardiac disease. serious infection requiring treatment with antibiotics, or other serious illness. women who are pregnant or lactating. central nervous system (cns) tumor involvement. life expectancy less than 6 weeks. hypercalcemia greater than 12.5 mg/dl or symptomatic.

Keywords: stage iv renal cell cancer recurrent renal cell cancer
schizophrenia and genetic counseling

Conditions: Schizophrenia

Summary: this research is designed to investigate the perceptions and opinions of individuals who either have schizophrenia or who have a family member with schizophrenia, in relation to genetic counseling. data will be collected via a 15 minute online questionnaire. there is also an option for respondents to participate in a 45 minute interview if they wish. it is expected that the study will show that adequate information about genetic counseling is not provided to these individuals. it is also hoped that this research will help to make genetic counseling sessions more specific to people with schizophrenia in their family.

for more information please go to the following website: http://schizophreniageneticcounseling.blogspot.com

Eligibility criteria:
inclusion criteria: * anyone diagnosed with schizophrenia or who has family member diagnosed with schizophrenia * over 18 years old

Keywords: genetic counseling genetic counselling genetics schizophrenia
validity of neck extensor muscles endurance test in non-specific chronic neck pain and asymptomatic subjects

Conditions: Neck Pain

Summary: neck pain (np) is one of the most common and costly musculoskeletal complaints in today's societies. cervical muscles endurance has been commonly associated with the development of np. real-time ultrasound imaging is a reliable and valid technique recently used by physical therapists to evaluate muscle structure, function and activation patterns. the aim of this study is if change in muscle thickness can correlate with the results of the endurance testing.


Eligibility criteria:
inclusion criteria: * subjects with neck pain: experiencing pain for at least 3 months in the last year, having pain score of 3 or more on visual analogue scale. * healthy subjects: no history of neck pain exclusion criteria: * history of cervical discopathy * any surgery on neck * traumatic neck injury * any congenital disorders
addressing disparities in neuromodulation for rehabilitation: a mixed methods approach to optimize access for underrepresented racial minorities

Conditions: Neuropathic Pain

Summary: the purpose of this study is to: 1. development of culturally sensitive videos for enhance informed consent with neurostimulation and determination of factors that influence minority interest in participating in neurostimulation research. 2. examination of the influence that video enhanced informed consent has on expectations with transcutaneous auricular vagus nerve stimulation (tavns) and on treatment intended effects.


Eligibility criteria:
inclusion criteria: 1. between the ages of 18-80 years 2. neuropathic pain lasting longer than 3 months (i.e., complaint of sensation of burning, stabbing or pressing pain, shooting or shock like pain, or paresthesias) 3. neuropathic pain symptom inventory score ≥10. 4. self identifies as black or hispanic exclusion criteria: 1. any unstable medical condition or medical contraindication to moderate physical exertion (e.g., unstable angina or cardiac arrythmia) 2. pregnancy 3. currently taking buprenorphine or recently stopped taking (within 1 month) 4. presence of cognitive impairment or language barrier that impairs full autonomy in the consent process or in the ability to participate in detailed interviews 5. implants in the head or neck, cochlear implants, or pacemaker 6. head or neck metastasis or recent ear trauma 7. history of seizures.

Keywords: neurostimulation video enhanced consent neuromodulation transcutaneous auricular vagus nerve stimulation transcranial direct current stimulation transcranial magnetic stimulation
effort to prevent nosocomial pneumonia caused by pseudomonas aeruginosa in mechanically ventilated subjects

Conditions: Pseudomonas Aeruginosa

Summary: clinical trial looking to evaluate the efficacy and safety of medi3902 in mechanically ventilated participants for the prevention of nosocomial pneumonia caused by pseudomonas aeruginosa.


Eligibility criteria:
inclusion criteria: colonized with p aeruginosa, expected to require prolonged intubation and mechanical ventilation, without any evidence of active pneumonia. exclusion criteria: p aeruginosa disease at randomisation; lung injury score consistent with pneumonia; current lung disease; currently receiving protocol-specified anti-p aeruginosa antibiotics, moribund participants.

Keywords: pseudomonas aeruginosa, pneumonia
effect of a modified oxygen mask associated to nasal prongs during a high flow oxygenation method

Conditions: Oxygen Inhalation Therapy

Summary: the aim of this study is to determine the effect (on pao2) of a modified mask associated to nasal cannula used for high flow oxygenation.

study design this is a single-center, randomized, blind investigator, 2-way crossover study design. enrolled participants had severe hypoxia being treated at intensive care unit associated with a hospital in hornu (epicura). the study consisted of two intervention periods of 2 weeks separated by a washout period of 20 minutes. (figure 1) the objective of the study is to determine whether adjunctive mask of our design (double trunk mask - dtm) has an effect on increasing arterial pressure in oxygen (pao2) diagnosed with severe hypoxia. the protocol and informed consent documents were reviewed and approved by a recognized ethics review board at the study facility. the study was performed in accordance with the declaration of helsinki. statistical analysis all participants who received this intervention and completed two phases of study were included in the efficacy analysis. a sample size of 15 participants was needed to provide 90% power to detect a 10 mm hg difference in pao2. anova for repeated measures followed by a post hoc test were used to compare the difference between participants receiving (chfonp + dtm) and chfonp alone. the test was performed with a significance level of 0.05 (two-sided). statistical analyses were carried out using sigmaplot software version 11.0 (systat software inc. uk). adverse event assessment safety was assessed by the number of participants with adverse events (aes). aes were collected by systematic assessment using terms from the medical dictionary for regulatory activities (meddra), version 11.1 in participants who received one or more doses of intervention. adverse events during washout were not collected.

Eligibility criteria:
inclusion criteria: regardless of gender, at least 18 years of age and diagnosed with severe hypoxia (pao2/fio2 \< 300 mm hg), dyspnea with severe rest at stake accessory muscles of respiration, respiratory rate (rr) ≥ 25 cpm, paco2 ≤ 45 mmhg, patient with an arterial catheter and without hemodynamic instability, glasgow coma scale ≥ 12/15, written consent. participants were also required to have a sufficient level of education to understand study procedures and be able to communicate with site personnel. exclusion criteria patients were excluded if they hypercapnia (\> 45 mm hg with respiratory acidosis), cardiogenic pulmonary edema, copd, pulmonary fibrosis, hypoventilation obesity syndrom, arterial pressure \ to 0,1 gamma/kg/minute, deterioration of awareness (glasgow scale \< or = 12), acute confusional state. participants were randomized in a 1:1 ratio to receive either (chfonp) classical high flow oxygenation with nasal prongs (20 minutes) or chfnop with an adjunctive of a dtm. -

Keywords: oxygen mask high-flow oxygen therapy acute respiratory failure
circulatory coherence in covid-19 and non-covid-19 patients with sepsis

Conditions: Viral Pneumonia; Sepsis

Summary: this prospective observational pilot study investigates circulatory coherence in patients with covid and non-covid sepsis by comparison of microcirculation, endothelial glycocalyx, and clinical course

this prospective observational pilot study investigates circulatory coherence in patients with covid and non-covid sepsis by comparison of microcirculation (sublingual area video recordings and biochemical parameters of endothelial cells activation and damage) endothelial glycocalyx (sublingual area video recordings and biochemical parameter of glycocalyx degradation), and clinical course.

Eligibility criteria:
inclusion criteria: * adult * icu admission due to sepsis with organ failure * need for organ support therapy (mechanical ventilation, crrt, ecmo) * clinical and/or laboratory signs of circulatory instability exclusion criteria: * family withdrawal/disagreement * death within three days from icu admission

Keywords: microcirculation endothelial glycocalyx covid-19
sinovac, pandemic influenza a/h1n1 vaccine in 6 to 35 months infants

Conditions: Influenza

Summary: a single center, observer-masked, randomized clinical trial is to be conducted in 6-35 months infants to evaluate the safety and immunogenicity of sinovac's influenza a/h1n1 vaccine (panflu.1).


Eligibility criteria:
inclusion criteria: 1. healthy male or female aged between 6 and 35 months 2. full-term birth, birth weight 2,500 grams or more 3. provided birth certification or vaccination card parent(s) or legal guardian(s) are able to understand and sign the informed consent exclusion criteria: 1. cases, cured cases and close contact of influenza a (h1n1) virus 2. subject that has a medical history of any of the following: allergic history, or allergic to any ingredient of vaccine, such as egg, egg protein, etc 3. serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain 4. symptoms of acute infection within a week 5. autoimmune disease or immunodeficiency 6. congenital malformation, developmental disorders or serious chronic diseases (such as down's syndrome, diabetes, sickle cell anemia or neurological disorders) 7. asthma that is unstable or required emergent care, hospitalization or intubation during the past two years or that required the use of oral or intravenous corticosteroids 8. bleeding disorder diagnosed by a doctor (e.g. factor deficiency, coagulopathy, or platelet disorder requiring special precautions) or significant bruising or bleeding difficulties with im injections or blood draws 9. history or family history of convulsions, epilepsy, brain disease and psychiatric 10. asplenia, functional asplenia or any condition resulting in the absence or removal o the spleen 11. guillain-barre syndrome 12. administration of 2009-2010 seasonal vaccine 13. history of any blood products within 3 months 14. administration of any other investigational research agents within 30 days 15. administration of any live attenuated vaccine within 30 days 16. administration of subunit or inactivated vaccines within 14 days 17. be receiving anti-tb prophylaxis or therapy currently 18. axillary temperature \> 37.0 centigrade at the time of dosing 19. any medical, psychiatric, social condition, occupational reason or other responsibility that, in the judgment of the investigator, is a contraindication to protocol participation or impairs a volunteer's ability to give informed consent
optimize sirolimus-eluting coronary stent systems pharmacokinetics (pk) study

Conditions: Acute Coronary Syndrome

Summary: to evaluate the pharmacokinetic parameters of sirolimus release from the svelte des.

this is a prospective, open, non-randomized, study involving two (2) centers in the united states. a minimum of twelve (12) and a maximum of fifteen (15) subjects will be consented, treated and have blood samples drawn to evaluate the pharmacokinetic parameters of sirolimus release from the svelte des.

Eligibility criteria:
inclusion criteria: * subject is an eligible candidate for pci * subject has symptomatic coronary artery disease with objective evidence of ischemia or silent ischemia * subject is an acceptable candidate for cabg * subject has ≤ 3 de novo target lesions in ≤ 2 native coronary artery vessels, with ≤ 2 lesions in a single vessel, each meeting the angiographic criteria and none of the exclusion criteria * target lesion(s) must be located in a native coronary artery with rvd ≥ 2.25mm and ≤ 4.00mm exclusion criteria: * subject has cardiogenic shock, hemodynamic instability requiring inotropic or mechanical circulatory support, intractable ventricular arrhythmia, or ongoing intractable angina * subject's target lesion(s) is located in the left main coronary artery * subject's target lesion(s) is located within 3mm of the origin of the lad or lcx coronary artery * subject's target lesion(s) is located within a svg or an arterial graft * subject's target lesion(s) will be accessed via svg or arterial graft
a study assessing the safety and efficacy of sarilumab added to non-mtx dmards or as monotherapy in japanese patients with active rheumatoid arthritis (saril-ra-haruka)

Conditions: Rheumatoid Arthritis

Summary: primary objective: to document the long-term safety of sarilumab added to non-methotrexate (non-mtx) disease-modifying antirheumatic drugs (dmards) or as monotherapy. secondary objective: to document the long term efficacy of sarilumab added to non-mtx dmards or as monotherapy.

total study duration was up to 62 weeks: up to 4-week screening period, 52-week treatment period, and 6-week post-treatment follow-up period.

Eligibility criteria:
inclusion criteria: diagnosis of rheumatoid arthritis (ra), according to the american college of rheumatology/the european league against rheumatism (acr/eular) 2010 rheumatoid arthritis classification criteria with \>=3 months disease duration. moderately to severely active ra defined as: * at least 4 of 68 tender joints and 4 of 66 swollen joints at screening visit. * high sensitivity c-reactive protein (hs-crp) \>=4 mg/l or erythrocyte sedimentation rate (esr) \>=28 mm/hr at screening visit. for the combination stratum: participants who had continuous treatment with non-biologic dmards other than mtx for at least 12 weeks prior to the randomization and on a stable dose for a minimum of 6 weeks prior to screening. for the monotherapy stratum: participants who per investigator judgment were any of inappropriate, intolerant or inadequate to mtx treatment. exclusion criteria: participants \<20 years of age. prior treatment with tumor necrosis factor (tnf) antagonists or any other ra-directed biologic agents without the appropriate off-drug period prior to screening. prior treatment with anti-interleukin-6 (anti-il-6) or anti-interleukin-6 receptor (il-6r) antagonist therapies, including but not limited to tocilizumab or sarilumab. the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
esr1 mutations in asian er+ metastatic breast cancer on hormonal therapy-based treatments

Conditions: Metastatic Breast Cancer

Summary: the investigator propose a prospective study using blood samples (liquid biopsy) of estrogen receptor (er)-positive metastatic breast cancer (mbc) patients to understand the prevalence of estrogen receptor 1 (esr1) mutation variants and the correlation with hormonal therapy (ht)-based treatment resistance in asian er-positive/human epidermal growth receptor-2 (her2)-negative mbc population.

the investigator will use next-generation targeted sequencing covering the entire esr1 ligand-binding domain (lbd) region to understand 1. the spectrum and prevalence of specific esr1 mutation variants in asian women, and 2. the preliminary correlation of asian-specific prevalent esr1 lbd mutation variants such as y537c with treatment efficacy. for the second purpose, the investigator will specifically focus on patients with esr1 y537c mutation, while the results from patients with wild type esr1 and patients with d538g or y537s mutant will be severed as control for preliminary comparison.

Eligibility criteria:
inclusion criteria: * (1) female patients who are ≥ 20 years old at the time of informed consent. * (2) have histologically confirmed er positive (defined as ≥1%) and/ or progesterone receptor (pr) positive (defined as ≥1%) breast cancer. * (3) have histologically confirmed her2-negative breast cancer as defined by immuno-histochemistry (ihc) ≤ 2+, and/or fluorescence in situ hybridization (fish) negative. * (4) patients who fits either one of the following two criteria are eligible: i. have radiological or objective evidence of inoperable locally advanced or metastatic breast cancer and are planned to be given ht single agent, ht plus other targeted therapy, ht plus everolimus (reimbursed by national health insurance), ht plus metronomic oral chemotherapy or oral chemotherapy only by the treating physician. ii. locally advanced but operable patients before the resection of the primary tumor. exclusion criteria: * (1) patients not suitable for oral anti-cancer treatment as determined by the investigator. * (2) known hypersensitivity to mammilian target of rapamycin (mtor) inhibitors, e.g. sirolimus (rapamycin). * (3) patients with a known history of hiv seropositivity. screening for hiv infection at baseline is not required. * (4) patients being treated with drugs recognized as being strong inhibitors or inducers of the isoenzyme cyp3a.
montelukast in very low birthweight infants

Conditions: Bronchopulmonary Dysplasia

Summary: the purpose of this study is to determine the pharmacokinetics (pk) of montelukast (singulair) in very low birth weight (vlbw) infants at risk for developing bronchopulmonary dysplasia (the need for supplemental oxygen). the investigators' long-term hypothesis is that inhibition of leukotriene signaling in the vlbw preterm lung will decrease inflammation, remodeling and the incidence of bronchopulmonary dysplasia (bpd).

this study proposal will determine the pharmacokinetics (pk) of montelukast (cysteinyl leukotriene receptor-1 or cyslt1 inhibitor) in very low birth weight (vlbw) infants between 500 - 1500g birth weight at risk for developing bronchopulmonary dysplasia (bpd). montelukast (singulair) is a fda approved specific cyslt1 antagonist widely used clinically in the prophylaxis of asthma in children older than 12 months of age and blocks leukotriene signaling in the lung. bpd shares some pathogenic mechanisms with asthma, however cysteinyl lt receptor blockade has not been studied in preterm infants. montelukast is metabolized by the cytochrome p450 system which is immature in the preterm infant and hence the need for this study. the investigators' long-term hypothesis is that inhibition of leukotriene signaling in the vlbw preterm lung will decrease inflammation, remodeling and the incidence of bpd. the data will be used to design future efficacy trials of montelukast in the prevention of bronchopulmonary dysplasia.

Eligibility criteria:
inclusion criteria: * vlbw infants between 500 - 1500 gm birth-weight born at good samaritan hospital, cincinnati, tolerating oral feeds equal to or more than 75 ml/kg/day and older than 7 days exclusion criteria: * infants diagnosed with congenital malformations. * infants with an acute life threatening illness. * grade iii or iv intra-ventricular hemorrhage. * patent ductus arteriosus being treated with indomethacin. * oral feedings are contra-indicated. * parents refuse consent. * attending physician does not wish the infant to be enrolled in the study. * infants with known hepatitis or hiv. * infants enrolled in any study using an investigational drug.

Keywords: pharmacokinetics montelukast bronchopulmonary dysplasia pharmacokinetics of montelukast