Kornimate/medical-research-clean huggingface dataset:
the might trial - an exploratory clinical trial of ivig in anti-hmgcr immune mediated necrotizing myopathy

Conditions: Anti-3-hydroxy-3-methylglutaryl-CoA Reductase (HMGCR) Immune-Mediated Necrotizing Myopathy

Summary: this is a randomized, placebo-controlled, double blinded phase 2 exploratory clinical trial of intravenously administered pooled human immunoglobulin (ivig) in anti-3-hydroxy-3-methylglutaryl-coa reductase (hmgcr) immune mediated necrotizing myopathy (imnm). planned enrollment is 12 individuals with active anti-hmgcr imnm meeting inclusion and exclusion criteria. assuming 20% drop-out, the investigators anticipate 10 participants will complete all study assessments. enrolled participants will be randomized 1:1 to either ivig 2g/kg or placebo (0.9% sodium chloride at equivalent volume) at weeks 0, 4, and 8. the primary efficacy and co-primary safety and tolerability endpoints will be assessed at week 12. after the randomized phase of the trial, all participants, except those who were randomized to ivig and met the clinical deterioration criteria, will be offered to continue on to an open-label extension phase in which participants will receive ivig at weeks 12, 16, and 20. participants will then return at week 24 for a final non-infusion visit to reassess safety, tolerability, and efficacy outcome.


Eligibility criteria:
inclusion criteria: * 16 years of age or older * anti-3-hydroxy-3-methylglutaryl-coa reductase (hmgcr) antibody positive * serum creatine kinase \> 5x upper limit of normal * anti-hmgcr immune mediated necrotizing myopathy (imnm) disease duration \< 36 months at screening * no moderate or severe respiratory or swallowing dysfunction due to immune mediated necrotizing myopathy at screening * no history of dermatomyositis rash exclusion criteria: * oral glucocorticoid daily dose \> 15mg at screening * change in oral glucocorticoid dose \< 2 weeks prior to screening * prior ivig treatment for anti-hmgcr immune mediated necrotizing myopathy * \> 1 oral conventional synthetic disease-modifying antirheumatic drug (dmard) (e.g., methotrexate, mycophenolate mofetil, azathioprine) use at screening * change in concomitant dmard dose \< 4 weeks prior to screening * rituximab treatment within 6 months prior to screening * plasma exchange, cyclophosphamide, or biologic immunosuppressive medication within 3 months prior to screening * use of statin medication at screening * history of anaphylactic reaction to intravenous immunoglobulin (ivig) * history of angina pectoris, myocardial infarction, transient ischemic attack, or stroke within 12 months prior to screening * females of child-bearing potential who are pregnant, breastfeeding, or are unwilling to practice a highly effective method of contraception during the study * wells' criteria for pulmonary embolism score of 4 or more at screening * wells' criteria for deep vein thrombosis score of 2 or more at screening * any medical condition which, in the investigator's judgment, makes participation in the clinical trial unadvisable or which would interfere with evaluation of the study treatment
monitors to improve indoor carbon dioxide (co2) concentrations in the hospital

Conditions: Healthcare Associated Infection

Summary: ventilation with fresh outdoor air has recently gained considerable attention as a means to reduce the potential risk of indoor aerosol transmission of respiratory pathogens such as severe acute respiratory syndrome coronavirus 2 (sars-cov-2), the virus causing coronavirus disease 2019 (covid-19). commercial carbon dioxide (co2) monitors are increasingly used in schools, long-term care facilities, offices and public buildings to monitor indoor ventilation. however, no formal evidence is available to support the effectiveness of feedback from co2 monitoring devices. moreover, modern hospitals have superior indoor air quality control systems. the aim of this prospective pilot randomized controlled trial (rct) is to evaluate whether co2 monitoring devices would be useful as a means to further maintain lower indoor co2 concentrations in hospitals.

in this pilot, randomized, sham-controlled open-label rct, hospital rooms will be fitted with aranet4 home co2 sensors. each device will continuously measure indoor co2 concentrations at 1-minute intervals during 4 time periods: 1. baseline: staff blinded to co2 levels displayed on sensor 2-3. sham/intervention period: sensors on the same ward will be randomized to placebo (sensor not showing co2 levels to staff) or intervention (sensor displaying co2 levels to staff) in a cross-over design 4. post-intervention phase (3 weeks post-intervention): staff blinded to co2 levels each measurement period will consist of 7 days with no washout period. our primary hypothesis is that co2 sensors will record less time (minutes) with elevated co2 levels during the intervention period, compared to the sham periods. however, carry-over effects will be investigated by comparing the intervention periods to the baseline and post-intervention phases. note \[february 27, 2021\]: due to technical problems with the aranet4 device bluetooth connection, outcome data will be analyzed according to measurement data at 2-5 minute intervals (measurements can be made every minute, but data cannot be downloaded with the current version of the app due to technical problems).

Eligibility criteria:
inclusion criteria: * double-bed hospital rooms exclusion criteria: * unoccupied rooms

Keywords: indoor air quality carbon dioxide ventilation
radiation therapy in preventing central nervous system (cns) metastases in patients with non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: radiation therapy uses high-energy x-rays to damage tumor cells. it is not yet known if giving radiation therapy to the head is effective in preventing cns metastases in patients who have stage iii non-small cell lung cancer. purpose: this randomized phase iii trial is studying how well radiation therapy to the head works in preventing cns metastases in patients who have been previously treated for stage iii non-small cell lung cancer.

objectives: * determine whether prophylactic cranial irradiation improves survival after effective locoregional/systemic therapy in patients with stage iiia or iiib non-small cell lung cancer. * determine the neuropsychologic impact of this therapy in these patients. * assess quality of life of patients receiving this therapy. * determine the impact of this therapy on the incidence of cns metastases in these patients. outline: this is a randomized, multicenter study. patients are stratified according to disease stage (iiia vs iiib), histology (non-squamous cell vs squamous cell), and prior surgery (yes vs no). patients are randomized to 1 of 2 treatment arms. * arm i: patients undergo prophylactic cranial irradiation 5 days a week for 3 weeks. * arm ii: patients undergo observation. patients are followed 3 months during the first year, every 6 months for 2-3 years and then annually thereafter. quality of life is assessed at baseline and at months 6, 12, 24, 36, and 48. projected accrual: a total of 1,058 patients (529 per treatment arm) will be accrued for this study within 36 months.

Eligibility criteria:
disease characteristics: * diagnosis of stage iiia or iiib non-small cell lung cancer * complete response, partial response, or stable disease after definitive locoregional therapy (with surgery and/or radiation therapy, with or without chemotherapy (chemotherapy alone does not constitute definitive therapy)) * no more than 16 weeks since prior therapy * no progressive disease * no extracranial distant metastatic disease * no suspicion of cns metastases by mri or ct scan patient characteristics: age * 18 and over performance status * not specified life expectancy * not specified hematopoietic * not specified hepatic * not specified renal * not specified other * no other malignancy within the past 3 years except nonmelanoma skin cancer * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy * no concurrent anticancer biologic therapy chemotherapy * see disease characteristics * no concurrent anticancer cytotoxic chemotherapy endocrine therapy * not specified radiotherapy * see disease characteristics * no prior cranial irradiation surgery * see disease characteristics other * recovered from all prior therapies * no concurrent enrollment on any other phase iii study that has progression-free, disease-free, or overall survival as an endpoint

Keywords: stage iiia non-small cell lung cancer stage iiib non-small cell lung cancer
effects of resistance training on pain, function and work ability in patients with moderate to severe neck pain

Conditions: Neck Pain

Summary: the purpose of this study is to investigate if high-intensity resistance training can induce additional beneficial effects, for patients with moderate to severe long term pain in the neck, when added to a multidisciplinary treatment program.


Eligibility criteria:
inclusion criteria: * referred to the multidisciplinary clinic for treatment of pain in the neck * long term (≥ 3months) or recurrent (≥ 2 periods of ≥ 4 weeks the past year) non-specific neck pain, * pain intensity ≥ 4 on numerical rating scale (0-10) exclusion criteria: * severe somatic condition (unstable injury, malignity, infectious disease, active rheumatic disease, severe osteoporosis) * psychiatric condition/disease that severely impairs group functioning * insufficient comprehension of norwegian language to participate in group sessions and fill out questionnaires * awaiting surgery of neck * alcohol or drug abuse * ongoing compensation case or applying for disability benefits due to pain in the neck * engaged in high-intensity resistance training on a regular basis the last 6 months * contra-indications for high-intensity resistance training (i.e. shoulder complications)

Keywords: exercise therapy resistance training multidisciplinary treatment
real world observational study of pembrolizumab for chinese advanced nsclc

Conditions: Non-small Cell Lung Cancer

Summary: this observational study is designed to assess the efficacy and safety of pembrolizumab for the treatment of chinese advanced nsclc.

pembrolizumab is a humanized antibody used in cancer immunotherapy.the nmpa(china) approved pembrolizumab for first-line treatment of certain patients with advanced nsclc. this is a multi-center non-interventional study, advanced nsclc patients who treated with pembrolizumab and provide written informed consent will be included. the main objective of this study is to evaluate pembrolizumab efficacy and safety in the clinical practice and explore the prognosis-relevant factors of advanced nsclc.

Eligibility criteria:
inclusion criteria: 1. histologically or cytologically confirmed diagnosis of advanced or metastatic nsclc 2. patients who receive pembrolizumab for advanced nsclc. 3. patients who provided written informed consent. exclusion criteria: 1.patients who would join any interventional clinical studies from first diagnosis to the end of the pembrolizumab treatment

Keywords: non-small cell lung cancer
the icalic accuracy validation in geneva study

Conditions: Critical Illness

Summary: this study aims at validating the accuracy of the new indirect calorimeter (q-nrg, cosmed, italy), developed for the icalic multicenter study. the validation of accuracy will only be conducted in geneva center. the measurements made with the new calorimeter will be compared to the measurements by the mixing chamber method using a mass spectrometer (max300-lg, extrel, usa) for gas composition analysis.

indirect calorimetry is a method to measure energy expenditure of human subjects by analyzing patient breath gas to measure the amount (volume) of oxygen consumption (vo2) and co2 production (vco2). energy expenditure is calculated by the weir's equation using the measured vo2 and vco2 values. the new calorimeter is equipped with a disposable in-line pneumotach flowmeter, which measures the flow of exhaled gas of patients directly within the mechanical ventilator circuit. it also samples small amount of inhaled and exhaled gas to measure the inhaled and exhaled o2 and co2 compositions. the new dynamic micro-mixing chamber technique is used to meaure vo2 and vco2 to derive the energy expenditure. the mass spectrometer measures the inhaled and exhaled gas compositions. the mass spectrometer samples inhaled gas from the mechanical ventilator circuit. a mixing chamber system is used to collect the expired gas from the outlet of the mechanical ventilator. the collected gas is measured for the second time after diluting with a constant flow of ambient air, which is monitored by an independent mass flow meter. the volume of the expired gas is calculated by comparison of the concentrations of exhaled gas before and after the dilution. the measurements will be used to calculate the vo2 and vco2 to derive the energy expenditure.

Eligibility criteria:
inclusion criteria: • mechanically ventilated adult icu patients exclusion criteria: * fraction of inhaled oxygen (fio2) \> 70% * positive end expiratory pressure (peep) \>10cmh2o * peak ventilatory pressure \> 30cmh2o * presence of air leaks from thoracic drain tube * changes in vasoactive agent dose (\>20%, \<1 hr before and/or during ic) * agitation or change in sedative dose (\>20%, \<1 hr before and/or during ic) * change in body temperature (\>0.5°c, \<1 hr before and/or during ic) * expected duration of icu stay \< 24 hours * expected survival of the patient \< 24 hours

Keywords: indirect calorimetry icalic study energy expenditure vo2 vco2 respiratory quotient
inflammatory cytokines associated with perinatal brain injury

Conditions: Infant, Newborn; Infant, Low Birth Weight; Infant, Small for Gestational Age; Infant, Premature; Cerebral Palsy

Summary: this observational study assessed whether measurements of certain pro-inflammatory and anti-inflammatory cytokines in the blood (either singly or in combination) at birth and/or up to day of life 21 can predict cerebral palsy at 18-22 months corrected age.

inflammatory cytokines \[interleukin-1 (il-1β), il-8, il-9, tumor necrosis factor-α (tnf-α), and rantes\] but not anti-inflammatory cytokines released during the perinatal period have been associated with the development of periventricular leukomalacia (pvl) and cerebral palsy (cp) in near term and term infants. however, because blood samples were obtained on any day between day 1 and 18, these data cannot distinguish between prenatal and postnatal effects on neurological outcome. furthermore, very low birth weight infants who are at the highest risk have not been studies. the goal of this study was to measure pro-inflammatory and anti-inflammatory cytokine levels at various times in the perinatal period (at birth up to day of life 21), since they may be elevated at different points in the disease process. blood samples (whole blood spots, dried on filter paper) were obtained on day 1 within 4 hours after birth, and on days 3, 7, 14, and 21. neurodevelopmental assessments were conducted at 18-22 months corrected age.

Eligibility criteria:
inclusion criteria: * infants 401-1,000 grams at birth exclusion criteria: * \>72 hours of age

Keywords: nichd neonatal research network very low birth weight (vlbw) extremely low birth weight (elbw) prematurity pro-inflammatory cytokines anti-inflammatory cytokines interleukin-1 (il-1β) interleukin-2 (il-2) interleukin-3 (il-3) interleukin-8 (il-8) interleukin-9 (il-9) tumor necrosis factor-α (tnf-α) regulated upon activation, normal t-cell expressed and secreted (rantes)
study to assess safety, tolerability and pk of azd1480 in patients with solid tumours

Conditions: Solid Malignancies

Summary: this study is being conducted to assess the safety, tolerability and pk of azd1480 in patients with advanced solid malignancies.


Eligibility criteria:
inclusion criteria: * patients with advanced solid cancer without available therapy in the escalation phase and mutation positive nsclc or non-smokers with other primary tumors lung metastasis in the expansion phase * ecog performance status 0-1 * evidence of post-menopausal status in females or males willing to use barrier contraception exclusion criteria: * prior therapy with any jak2 medications * significant lung disorder or lung disease. previous radiation therapy to chest wall or chest infection requiring antibiotic treatment within 21 days before study screening. evidence of significant pulmonary hypertension or copd * eye disease of the cornea

Keywords: jak2 cancer jak 1 stat 3 phase 1
sham device, pill placebo or treatment for arm pain

Conditions: Cumulative Trauma Disorders; Repetitive Strain Injury; Carpal Tunnel Syndrome; Pain

Summary: this study investigates the role of two active interventions and their placebo effects in randomized control trials. the study conducts two parallel trials of treatments for upper extremity pain secondary to repetitive stress disorder, including carpal tunnel syndrome. the active interventions are amitriptyline and acupuncture. the placebo are sham acupuncture device and placebo pill.

there is evidence that the magnitude of the placebo effect produced by a device is greater than that produced by a pill. if this is the case, it has significant ramifications for all trials involving devices and for our understanding of the role of the placebo effect in randomized controlled trials (rct). this two phase study 1)investigates the role of the placebo effect in rct's and 2)conducts two trials of treatments for persistent upper extremity pain secondary to repetitive strain injury (rsi), including carpel tunnel syndrome. in phase i. 240 patients with rsi are randomly assigned to receive a placebo device (a recently validated sham acupuncture device) or a placebo pill (dummy amitriptyline). our primary hypothesis is that patients will respond better to the sham device than the placebo pill. a finding that sham acupuncture produces a greater placebo response than a placebo pill has important implications for the interpretation of results in trials that compare devices to sham devices, devices to pills, and medical management to surgery. phase ii randomly assigns patients from the sham acupuncture arm of phase i to receive either tca or continue to receive the sham version. patients in the placebo pill arm of phase i will be randomly assigned to receive either ami or continue receiving the placebo pill. from the patients'perspective, the shift in treatment assignment from phase i to ii should not be noticeable. phase ii will allow us to test whether the active treatments outperform their respective placebos. both of these treatments have shown promise in small studies, but neither has been prospectively studied in a large trial with appropriate controls. because phase i also functions as a run-in period for phase ii, analysis combining both phases will allow us to examine whether a run-in has methodological advantages in a device trial. moreover, combined analyses permit testing whether patients level of response to placebo in phase i affects their response to active treatment phase ii. a positive finding here would contribute importantly to our understanding of the role of the placebo in rcts.

Eligibility criteria:
inclusion criteria: * treated for repetitive strain injury for at least 3 months at a clinical site in the greater boston area
ketogenic diet treatment of obesity with co-morbid type 2 diabetes mellitus and/or obstructive sleep apnea

Conditions: Obesity; Diabetes; Obstructive Sleep Apnea

Summary: the purpose of the study is to evaluate the efficacy and safety of ketogenic diet (kd) treatment of (i) obesity, (ii) type 2 diabetes mellitus and (iii) obstructive sleep apnea (osa) in patients with obesity and type 2 dm and in patients with obesity and/or osa. this will be a randomized, open-label three arm controlled study comparing weight loss in obese participants with type 2 diabetes and/or obstructive sleep apnea treated for 9 months with 3:1 \[fat\]:\[protein+carbohydrate\] ratio, 1600 kcal/day diet (group a) with weight loss in participants treated with orlistat 120 mg tid and lifestyle intervention consisting of dietary advice, recommended caloric goal of 1600 kcal/day (group b), and in participants treated with only lifestyle intervention consisting of dietary advice, recommended caloric goal of 1600 kcal/day (group c).

the study sample will be randomized into three treatment arms, kd (group a, n=50), orlistat 120 mg tid (group b, n=50) and dietary and lifestyle counseling (group c, n=50) in a 1:1:1 ratio. each arm will include 100% participants with obesity and co-morbid type 2 dm and 50% participants with co-morbid osa. randomization will be stratified for diabetic status.

Eligibility criteria:
inclusion criteria: * age 18-70 * ability and willingness to signed informed consent form * bmi more than 30kg/m2, with type 2 dm and/or osa * for diabetic participants, stable hypoglycemic medications for at least 2 months * for participants with osa, previously documented polysomnogram with apnea/hypopnea index (ahi)\>15/h. exclusion criteria: * bmi change of +/- 3.0 kg/m2 of baseline bmi within past 12 months. * history of bariatric surgery ≤ 3 years prior to enrollment. * any systemic illness or unstable medical condition that might pose additional risk, including: cardiac, unstable metabolic or endocrine disturbances, renal or liver disease, past history of renal calculi, hyperuricemia, hypercalcemia, mitochondrial disease, known disorder of fatty acid metabolism, porphyria, and active systemic cancer. * history of uncontrolled hyperlipidemia * for participants with dm, change in the dose or type of hypoglycemic treatment within 2 months prior to enrollment. * psychosis within six months of enrollment, evidenced by treatment with anti-psychotic medications with recent medication initiation or dose increase. * active drug or alcohol dependence or any other factors that, in the opinion of the site investigators would interfere with adherence to study requirements; * history of hyperthyroidism * history of glaucoma * history of cerebrovascular disease or unstable heart disease within 6 months of enrollment * pregnancy * use of any investigational drugs within 3 months of enrollment. * inability or unwillingness of subject to give written informed consent.

Keywords: ketogenic diet obesity diabetes obstructive sleep apnea