Kornimate/medical-research-clean huggingface dataset:
continued ventilation during cardiopulmonary bypass

Conditions: Coronary Artery Disease

Summary: cardiopulmonary bypass (cpb) is well known to induce a strong anti-inflammatory response. the investigators examined whether continued mechanical ventilation during cpb alters systemic immune activation.

cardiopulmonary bypass is well known to induce a strong anti-inflammatory response. studies had been shown that the contact of blood components with artificial surfaces, the surgical trauma, endotoxemia and a reperfusion injury are in part responsible for the seen immunological affect after surgery. the purpose of this study is to test the effect of continued mechanical ventilation during surgery on a blood marker called soluble st2 in patients sera. soluble st2 acts as a decoy receptor of il-33 and has anti-inflammatory effects. elevated soluble st2 concentrations are reported in patients with acute myocardial infarction, sepsis, congestive heart failure and elevates soluble st2 levels are associated with adverse outcome.

Eligibility criteria:
inclusion criteria: * written informed consent * age \> 40 and \< 80 exclusion criteria: * treatment with steroids or immunomodulatory interventions during the past four weeks * signs of an acute infection

Keywords: thoracic surgery endotoxins respiration, artificial immune system
effect of rimonabant and metformin combination on glycemic control in patients with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the primary objective of the study is to determine the effect of rimonabant 20 mg daily when added to ongoing metformin therapy on glycemic control (hba1c) over a 36 week period in patients with type 2 diabetes. secondary objectives include evaluation of other markers of glycemic control, lipid profile, body weight, and abdominal obesity. also, the trial will study the safety of rimonabant when added to metformin over a period of 47 weeks.

the total duration per patient will be approximately 49 weeks including a 36-week double-blind treatment period.

Eligibility criteria:
inclusion criteria: * history of type 2 diabetes * hba1c between 7% to 10% at screening visit * treatment with metformin only with a fixed and stable dose of 1500 mg/day or more for at least the past 3 months prior to screening visit exclusion criteria: * within 3 months prior to screening visit: change in lipid modifying agent, administration of systemic corticosteroids for more than 10 days, use of any anti-obesity agent or drugs for weight loss * weight loss of more than 5 kg within 3 months prior to screening * administration of other investigational drugs within 30 days prior to screening visit * prior exposure to type 1 cannabinoid receptor (cb1) antagonists including rimonabant * presence or history of cancer within the past five years * pregnant or breast-feeding women * presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation including uncontrolled serious psychiatric illness such a major depression within the last 2 years, and history of other severe psychiatric disorders. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: randomized controlled trial metformin
neuromuscular complications of mek inhibitors: a french case series and a systematic review of the literature

Conditions: Myositis; Myasthaenia Gravis; Neuropathy; Guillain Barré Syndrome; Parsonage Turner Syndrome

Summary: mek inhibitors (trametinib, cobimetinib, selumetinib or binimetinib) have been used since 2016 to treat metastatic melanoma, by targeting the mapk pathway neuromuscular complications (neuropathy, myasthenia or myositis) have been reported in patients treated with mek inhibitors. with the growing use of these new oncology therapies, neurologists, oncologists and other clinicians are likely to be increasingly confronted with mek inhibitor-induced neuropathy, myasthenia or myositis. yet, so far, these complications have only been documented in a few single case reports. our aim was to characterize the neuromuscular complications associated with mek inhibitors used either alone or in combination.


Eligibility criteria:
inclusion criteria: * patients with neuromuscular complications of mek inhibitors used alone or in combination * age \> 18 years exclusion criteria: * refusal of data collection
effect of continue riss block in thoracotomy

Conditions: Postoperative Pain; Thoracotomy

Summary: thoracotomy is one of the most painful surgery. acute postoperative pain increases postoperative morbidity and prolongs hospital stay and also may lead to developing a chronic pain syndrome. this study aimed to assess the efficacy of continuous rhomboid intercostal and subserratus plane (riss) block by inserting a catheter under direct vision for controlling acute thoracotomy pain.

before the closure of the thoracotomy, the surgeon will place two catheters through a tuohy needle into fascial planes for continue riss block. first catheter tip will be place towards the interfascial planes between the rhomboid major and intercostal muscles and the second catheter tip will be place in subserratus fascial plane. continue local anesthetics will be injected through the catheters for 48 hours.

Eligibility criteria:
inclusion criteria: * patients over 18 years of age undergoing elective thoracic surgery * american society of anesthesiologists (asa) physical status i-iii grade exclusion criteria: * patient refusal * history of psychiatric and cognitive disorders. * patients allergic to the drugs used in the study * emergent surgery
comparison between ct and mri in preoperative evaluation of neurogenic myositis ossificans or neurogenic para-osteo-arthritis

Conditions: Neurogenic Myositis Ossificans; Neurogenic Para-osteo-arthritis

Summary: the principal objective of the study is to compare between ct and mri diagnostic performance (sensibility and specificity) in the preoperative assessment of neurogenic para-osteo-arthritis. the second objectives of the study are: * besides the diagnostic performance (sensibility and specificity), to evaluate the imaging par mri in visual and descriptive manner heterotopic ossification and connection with vascular and nervous structures. * to study the concordance (two by two) of results of preoperative obtained by mri and by ct and operative reports. * to study the characteristics of patients with discordant findings (two by two) by mri, ct scan and operative report.

this is a study on diagnostic performance, non randomized, versus gold standard (a prospective multicentric cohort). all eligible patients will be proposed consecutively to participate to the study, to undergo preoperative ct scan and mri examination as usual procedure. the only additional action in this study will be a neurography sequence of type fluorescence subtraction imaging (fsi) during mri, permitting to obtain more details in visualization of nerve structure and their relations of the ossifications. the enrollment visit will performed by neuro-orthopaedic surgeon during preoperative consultation. the follow-up visit will be an usual post-operative visit, non-specific for the study. the duration for each participant will compound 1 month (the duration between preoperative imaging and surgical resection) added by up to two months of post-operative follow-up.

Eligibility criteria:
inclusion criteria: * adult patient with neurogenic para-osteo-arthropathy resulted by prior central nervous system, cerebral or medullar damage * deformation with limitation of articular amplitude which could result limitation in rehabilitation care * an indication of partial or total surgical excision of heterotopic ossification * indication of pre-operative assessment by ct scan and mri, with contrast product injection * signed consent of patient obtained after clear and relevant informations given by physician * patient covered by social security exclusion criteria: * contraindications to an mri examination: cardiac stimulator, metallic intraocular foreign bodies... * contraindications to ct scan * contraindications to contrast injection product, such as iodinated or gadolinium-based contrast media * impractical venous access * severe deformation resulting impossibility to positioning for mri examination or ct scan * patient can not give consent * participation to another interventional study * patient under guardianship

Keywords: neurogenic myositis ossificans para-osteo-arthropathy preoperative evaluation ct scan mri
early detection of lung cancer

Conditions: Lung Cancer

Summary: this research trial studies the long term follow-up for early detection of lung cancer in current or former smokers. following up on smokers by collecting and analyzing specimens in the laboratory, performing chest computed tomography (ct) scans, as well as reviewing medical records may help doctors detect lung cancer at an earlier stage.

primary objectives: i. to provide screening for lung cancer in an underserved and high risk population for lung cancer. ii. to collect clinical and demographic information and research bio specimens prospectively on high risk individuals. iii. to analyze the association between suspected lung cancer risk factors and outcomes such as pre-malignant lesions and diagnosis of lung cancer. iv. to identify and validate biomarkers that are associated with lung cancer risk factors and premalignant lesions. v. to assess the association between patient characteristics and test results to the genetic and histological characteristics of lung preinvasive lesions and cancers. vi. to describe this high-risk cohort and to identify the patients eligible for future clinical trials (e.g. chemoprevention). outline: patients are followed up at 1, 2, 3, 4, and 5 years and undergo collection of sputum, nasal epithelium, buccal epithelium, blood, and urine samples. patients also undergo pulmonary function tests, chest ct, and review of medical records.

Eligibility criteria:
inclusion criteria: * current smoker or former smoker, if former smoker participants must have quit smoking within the past 15 years * \>= 30 pack year of smoking history * participant is uninsured exclusion criteria: * history of diagnosis/treatment of lung cancer in the past 2 years * history of head/neck or esophageal cancer in the last 1 year * inability to provide informed consent
a dose-finding study to evaluate mrna-3210 in participants with phenylketonuria

Conditions: Phenylketonuria

Summary: the main goal of this study is to assess the safety, and tolerability of multiple doses of mrna-3210 in participants with phenylketonuria (pku).


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of pku due to phenylalanine hydroxylase (pah) deficiency by molecular genetic testing from a central lab. * at least 3 blood phenylalanine levels ≥600 micromole(μmol)/litre (l) regardless of diet: 2 obtained during the screening period (at least 72 hours apart) and at least one historical value 6 to 24 months prior to start of screening. * have received documented approval from a study dietitian confirming that participant is willing and able to maintain dietary protein intake consistent with baseline intake during study participation. * if applicable, maintained stable dose of neuropsychiatric medication (that is, for attention deficit hyperactivity disorder (adhd), depression, anxiety, or other psychiatric disorders) prior to enrollment and willing to maintain stable dose throughout study participation unless, per investigator assessment, a change is clinically indicated. exclusion criteria: * receipt of sapropterin or large-neutral amino acids within 14 days or 5 half-lives (whichever is longer) of the start of screening. * receipt of pegvaliase within 2 months of start of screening. * for participants previously on pegvaliase: use or planned use of any injectable drugs containing polyethylene glycol (peg), including medroxyprogesterone injection, within 3 months prior to the start of screening and during study participation with the exception of covid-19 vaccinations. * receipt of any investigational drug within 30 days or 5-half-lives (whichever is longer) of screening. * history of hypersensitivity to any component/excipient used in this study. * any other clinically significant medical condition that, in the investigator's opinion, could interfere with the interpretation of study results or limit the participant's participation in the study note: other protocol-defined inclusion/exclusion criteria apply.

Keywords: mrna-3210 autosomal recessive genetic disorder central nervous system diseases nervous system diseases brain diseases metabolic diseases phenylketonuria in-born errors of metabolism phenylalanine rare metabolic disease
a multicenter, open-label trial to evaluate the safety and efficacy of the sufentanil sublingual tablet 30 mcg in patients with post-operative pain

Conditions: Acute Moderate-to-severe Pain

Summary: this is a multicenter, open-label study in patients 40 years and older who are undergoing a surgical procedure. patients may receive one dose of st 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours.

this is a multicenter, open-label study in patients 40 years and older who are undergoing a surgical procedure. upon meeting all entrance criteria, patients will be administered the first dose of st 30 mcg and will remain in the study for up to 12 hours for safety and efficacy measurements. patients may receive additional doses of st 30 mcg as needed for pain management, but no more frequently than every 60 minutes.

Eligibility criteria:
inclusion criteria: 1. male or female patients who are 40 years of age or older. 2. patients who have undergone a surgical procedure with general anesthesia or spinal anesthesia that does not include intrathecal opioids during the operation. 3. patients classified as american society of anesthesiologists (asa) class iiii (appendix i). exclusion criteria: 1. patients who have taken an opioid for more than 30 consecutive days, at a daily dose of more than 15 mg of morphine (or equivalent), within the past 3 months prior to surgery (e.g. more than 3 doses per day of vicodin®, norco®, lortab® with 5 mg hydrocodone per tablet). 2. patients with a positive drug of abuse screen unless the positive test result is consistent with a prescribed medication. 3. patients with a history of opioid dependence within 2 years before the start of the study, defined as meeting the dsm-iv-tr™ criteria for substance dependence specified in appendix ii. 4. patients who have used any illicit drugs of abuse within five years before the start of the study. 5. patients who have abused any prescription medication or alcohol within one year before the start of the study. 6. patients with an allergy or hypersensitivity to opioids. 7. patients who are currently taking monoamine oxidase inhibitors (maois) or have taken maois within 14 days of the first dose of study drug. 8. patients with current sleep apnea that has been documented by a sleep laboratory study or are on home continuous positive airway pressure (cpap).
nanovectors to prevent placental passage of tocolytic agents

Conditions: Preterm Labor

Summary: the purpose of the study is to find out whether indomethacin encapsulated within a nanovector can stop contractions in pregnant human uterine tissue. preterm delivery is a major contributor to newborn deaths. the treatment of preterm labor includes medications that stop contractions within the uterus, or womb. indomethacin is effective in stopping uterine contractions, but crosses the placenta to the unborn baby causing problems for the baby. nanovectors are used to direct the delivery of medications. if indomethacin can be delivered directly to the uterus using a nanovector, it may be an ideal medication to treat preterm labor. we hypothesize that nanovectors loaded with indomethacin will reduce uterine contractions.

this is a prospective observational study. subjects will undergo a biopsy from the middle of the upper margin of the uterine incision measuring 4 x 2 x 2 cm. this will be performed by the managing doctor at the time of cesarean section after delivery of the baby. once the tissue is obtained, the site will be closed using sutures similar to the usual closure of the uterus at cesarean section. this biopsy will be taken to the laboratory to test whether the nanovector will increase or decrease contractions in the uterus. once this test is finished, the tissue will be frozen and test for the absence or presence of the nanovector within the tissue.

Eligibility criteria:
inclusion criteria: * pregnant women undergoing elective cesarean section who are greater than 37 weeks exclusion criteria: * known infection

Keywords: uterine contractions indomethacin nanovectors
use of pulsed electromagnetic fields for postoperative knee pain

Conditions: Osteoarthritis

Summary: the purpose of this study is to determine whether the torino ii device, which emits a pulsed electromagnetic field), will help to decrease pain and swelling after knee replacement surgery, and thereby decrease the use of narcotic medications after surgery.

the investigators are conducting a research study to determine if the torino ii, a pulsed electromagnetic fields (pemf) device is helpful in reducing postoperative pain and swelling after total knee replacement surgery. postoperative pain and swelling may cause discomfort that may directly influence functional recovery after surgery. by reducing pain and swelling immediately following surgery,the use of high doses of narcotic, nsaid, and tyelenol pain killers can be reduced, and possibly avoided. recovery can be maximized, as well. the pemf device that is being used (the torino ii) is distributed by ivivi health sciences, and has been approved by the fda for the treatment of pain and swelling following surgery. the device is non-invasive, and is fixed onto the outside of the dressing with velcro straps. the device will give off electromagnetic pulses to target pain relief in the knee. pemf devices have been in clinical use for decades, and to date, no reported side effects have occurred. it is important to note that treatment will still follow the standard meritus medical center protocol for knee replacement surgery. this includes pain medication, icing, and physical therapy. this standard protocol will be followed no matter what study group patients are assigned to. participation in this study or lack thereof will not change the treatment protocol.

Eligibility criteria:
inclusion criteria: * age: greater than 18 years * weight: less than 300 lbs. * diagnosis: osteoarthritis * type of surgery: unilateral knee replacement exclusion criteria: * no pacemaker or defibrillator. * no infection of the affected knee. * no previous open surgery of the affected knee. * no history of rheumatoid arthritis. * no more than 2 narcotic pills per month in the last 6 months for pain.

Keywords: pulsed electromagnetic fields device torino ii postoperative knee pain knee replacement
respiratory protection effect of ear-loop-type kf94 mask

Conditions: Infection

Summary: ear-loop-type korean filter 94 masks (kf94 masks, equivalent to the n95 and ffp2) are broadly used in health care settings in korea for the covid-19 pandemic. however, no studies have assessed the adequacy of respiratory protection. in this prospective randomized open-label study, the investigators aimed to evaluate the fitting performance of ear-loop-type kf94 masks by the quantitative fit test according to the occupational safety and health administration (osha) protocol. in addition, by quantitatively comparing the "tight-fitting" method using a clip and the "general-fitting" method, the investigators tried to evaluate whether the tight-wearing method improves the fitting performance of kf94 masks.

sample size: the sample size was calculated based on a pilot study of 10 participants, which examined the ff of general-fitting. the mean ff was 20.3, and the log-transformed ffs were assessed due to skewed data, which was 1.98 (standard deviation 1.34). we assumed that the ff for tight-fitting would increase by 50%, with an α value of .05, and a β error of .10 (power = 90%) for two-sided hypothesis testing. the estimated sample size calculation revealed a required sample of 24 participants. therefore, 30 participants were enrolled to account for a 20% dropout rate. data analyses: repeated-measures analysis of variance or generalized estimating equations were used to compare the ffs or passing rate of the qnfts for the three mask types according to the wearing method. paired t-tests or wilcoxon signed-rank tests were used to compare the ffs according to the wearing method for each mask type. mcnemar's test was used to compare the passing rate of the qnft according to the wearing method. bonferroni's correction was performed for all results of each subgroup analysis. sas ver. 9.4 software (sas institute, cary, nc) was used to perform all statistical analyses.

Eligibility criteria:
inclusion criteria: * healthcare workers with experience in wearing filtering facepiece respirator working in the hospital exclusion criteria: * individuals with expected difficulties in wearing masks or undergoing osha fit tests because of factors such as a facial anomaly, lung disease, or lower back disorder

Keywords: respiratory protective devices quantitative fit test n95 filtering facepiece respirators infection control kf94 mask
impact of nutritional supplementation on aerobic performance and fatigue

Conditions: Performance; Fatigue

Summary: compare an over-the-counter dietary supplement (nutrastem active®) and placebo over a 30-day intervention on aerobic exercise performance and fatigue. the hypothesis is that supplementation with nutrastem active® improve aerobic performance and reduce subjective measures of fatigue.

compare an over-the-counter dietary supplement (nutrastem active®) and placebo over a 30-day intervention on aerobic exercise performance and fatigue. the hypothesis is that supplementation with nutrastem active® improve aerobic performance and reduce subjective measures of fatigue. the basic protocol includes baseline assessment of fitness and participation in a vigorous session of exercise immediately before and 30 days after consumption of the experimental supplement or placebo. the exercise task is intended to be fatiguing and demanding but is not expected to create failure. the supplement makes claims related to boosting exercise performance and reducing fatigue. the study design will determine if these outcomes are in fact present in a group of healthy, young, and active adults. the primary dependent measures are perceived exertion during exercise and levels of fatigue measured on multiple non-exercise days.

Eligibility criteria:
inclusion criteria: * healthy * physically active * non-smoker exclusion criteria: * known cardiovascular, pulmonary, or metabolic disease * body mass index greater than 35

Keywords: supplement impact performance fatigue