Kornimate/medical-research-clean huggingface dataset:
bolus versus continuous infusion of meropenem

Conditions: Antibiotic Resistant Infection; Critical Illness

Summary: this study arises from the need to optimize antibacterial drug usage to face increasing drug resistance among gram-negative pathogens in intensive care units. gram-negative organisms are responsible for 70% of drug-resistant infections acquired in the intensive care unit. meropenem is a β-lactam, carbapenem, antibacterial agent usually administered by intermittent infusion. as β-lactam efficacy is determined by the time in which the drug concentration exceeds the minimum inhibiting concentration of the target pathogen, intermittent infusion of this short half-lived drug can lead to precipitous drops in serum drug levels, an occurrence linked to emergence of resistant pathogens. the investigators hypothesize a beneficial effect of a continuous meropenem infusion on mortality and emergence of drug resistant pathogens. all patients enrolled will receive 1 g of meropenem bolus. after that, subjects will be randomized to receive a continuous infusion of study drug 3g/day or a bolus administration of the same amount of drugs. the investigators expect a reduction of mortality and emergence of extensive or pan drug resistant pathogens from 52 to 40% in the continuous infusion group.


Eligibility criteria:
inclusion criteria: will be enrolled patients who: * are able to express informed consent or the latter can be given by his/her next of kin or as requested by ethical committee. * need a new antibiotic treatment, by clinical judgment, with meropenem * are admitted to icu * have sepsis or septic shock. sepsis defined as having all the following 1. sirs (systemic inflammatory response syndrome); 2. suspected or documented infection; 3. a sofa score ≥ 2. septic shock defined as having all the following 1.sepsis; 2. persisting hypotension requiring vasopressors to maintain map ≥65mmhg and having a serum lactate level \>2 mmol/l (18mg/dl) despite adequate volume resuscitation. exclusion criteria: will be excluded patients who: * are able to express informed consent and deny it * are already receiving study drug or other carbapenem both as a bolus or continuous infusion * have a known allergy or intolerance to study drug, to other carbapenem antibacterial agents or severe allergic reaction to β-lactam antibacterial agents or to anhydrous sodium carbonate (study drug excipient) * have a little chance of survival, as defined by a saps ii score greater than 65 * have concomitant acquired immunodeficiency syndrome (stage 3 according to cdc) * received immunosuppressant or long-term corticosteroid therapy (more than 0.5 mg/kg/day for over 30 days)

Keywords: meropenem antibiotic resistance critical illness β-lactams continuous antibacterial drug infusion mortality
real-life effectiveness and safety in participants with advanced/metastatic renal cell carcinoma starting 1st line nivolumab and ipilimumab combination therapy or nivolumab monotherapy after prior therapy

Conditions: Renal Cell Carcinoma

Summary: the purpose of this study is to estimate overall survival over a 5-year follow-up period among adult participants with advanced/metastatic kidney cancer, starting 1st line nivolumab and ipilimumab combination therapy or nivolumab monotherapy after prior therapy, in real-life conditions in germany


Eligibility criteria:
inclusion criteria: adult participants, at least 18 years of age at time of treatment decision * diagnosis of advanced/metastatic renal cell carcinoma (rcc) (confirmed by histology or cytology) * treatment decision to initiate a treatment with nivolumab and ipilimumab or nivolumab for the first time for the treatment of advanced/metastatic rcc (according to the label approved in germany) has already been taken * signed informed consent exclusion criteria: * participants with a diagnosis of a cancer other than advanced/metastatic advanced rcc within the past five years, ie, a cancer other than advanced/metastatic rcc that requires systemic or other treatment. participants that have been treated curatively more than five years ago with no evidence of recurrence and prostate cancer patients in active surveillance can be included. * participants previously treated with nivolumab and/or ipilimumab * participants currently included in an interventional clinical trial for their locally advanced or metastatic rcc. participants who have completed their participation in an interventional trial; or who are not receiving study drug anymore and who are only followed-up for os can be enrolled.
the ability of nirs to predict brain injury in hypoxic ischemic encephalopathy

Conditions: HIE - Perinatal Hypoxic - Ischemic Encephalopathy

Summary: a longitudinal study evaluating the predictive ability of near infrared spectroscopy to predict brain injury in infants with hypoxic ischemic encephalopathy. data will be analyzed at two different time periods, at discharge and again at 2 years of age.


Eligibility criteria:
inclusion criteria: * infants with diagnosis at birth of hie exclusion criteria: * none
evaluation using clearview in determining association to the cardiac risk factors

Conditions: Cardiovascular Diseases; Coronary Artery Disease

Summary: the objective of this study is to explore the relationship between the clearview scan results and a variety of cardiovascular risk indicators such as the coronary calcium score, framingham risk factors, reynolds risk score, and biomarkers of inflammation. the clearview device is a bio-electrographic tool that may assist medical professionals in rapid assessment of the systemic origin of the patient's presenting symptom(s). the clearview is a potentially valuable resource that may benefit a physician's office by offering expedited differentiation capabilities. the subsequent results have the potential to include more data that would allow rapid patient diagnosis, triage, and treatment; optimized precious resource expenditure (nursing, physician, etc.); lower costs to facility, patient and insurance company; and decreased office wait time.


Eligibility criteria:
inclusion criteria: * sex: male or female * age range: 18 to 85 * patients who are recommended for and who have had a cardiac ct study that produces a coronary calcium score within 30 days prior to the clearview scan or plan to have the ct within 14 days after the clearview scan. * patients who have had a blood test resulting in hs-crp, fasting lipid panel and mpo results within 6 months prior to the clearview scan or plan to have the tests done within 14 days after the clearview scan. * the patient or legal representative is able to understand and provide signed consent for the procedure. exclusion criteria: * patients with pacemakers or another implanted electrical device, such as an automatic internal cardiac defibrillator. * patients connected to an electrical device that cannot be removed or temporarily powered off (i.e. monitor) during subject testing with the clearview device * vulnerable populations * patients actively being treated for cancer or with a previous diagnosis of cancer that required chemotherapy, radiation therapy or hormonal therapy. * patients missing all or any part of a fingertip (excluding fingernail). * patients with involuntary hand tremors /shaking of the hands that may prevent clear imaging.

Keywords: health risk appraisal hcardiac risk factors
early tips for ascites study

Conditions: Liver Cirrhosis; Portal Hypertension; Ascites

Summary: the purpose of this study is to demonstrate that tips with the gore® viatorr® tips endoprosthesis improves transplant-free survival compared to lvp alone in patients who have cirrhosis of the liver with portal hypertension and difficult to treat ascites.


Eligibility criteria:
inclusion criteria: \> patient has cirrhosis of the liver with portal hypertension \> patient has difficult to treat ascites \> patient is 18 years or older and \<70 years old at randomization \> patient is willing and able to comply with all study protocol requirements, including specified follow-up and testing. \> patient, or legal authorized representative, is willing to provide written informed consent prior to enrollment in the study. exclusion criteria: \> patient has more than 6 large volume paracenteses within 90 days prior to randomization \> patient is contraindicated for tips placement \> patient has had previous tips placement
ph1 marinol interaction study - part 1 - 1

Conditions: Marijuana Dependence

Summary: the purpose of this study is to examine the effects of oral dronabinol tetrahydrocannabinol (thc) on withdrawal symptoms in marijuana dependent volunteers, and evaluate the safety, pharmacokinetics (pk), and cardiovascular effects of the combination of oral dronabinol and smoked marijuana to determine if there are potential significant interactions before conducting outpatient studies.


Eligibility criteria:
inclusion criteria: * must be between the ages of 18 to 45 years of age * must be in good general health * must meet dsm-iv criteria for marijuana dependence and are non- treatment seekers at the time of study * must be able to provide written informed consent * must be able to provide 1 marijuana positive urine specimen (\> 50 ng/ml) within the 28-day screening period * if female and of child bearing potential, must agree to use birth control. exclusion criteria: * please contact site for more information.

Keywords: marijuana dependence
reward system responses to food aromas

Conditions: Adiposity

Summary: food aromas are a part of foods' flavor, and can promote overeating. alcohol consumption also stimulates appetite, and contributes to overeating while under alcohol's acute effects. knowing the brain regions that respond to food aromas and alcohol, and how they are modified by the amount of body fat and alcohol exposure, will provide critical information about the neural systems that underlie loss of control of eating. therefore, the main hypotheses of this study are that: a) lean and obese subjects have different brain responses to food aromas that enhance desire to eat, and b) acute alcohol intoxication i) enhances the brain's response to food odors, and ii) affects brain systems that inhibit or terminate eating. to test these hypotheses, we have modified functional magnetic resonance imaging (fmri) paradigms successfully used to study alcoholic drink aromas in subjects at risk for alcoholism.

food aromas are powerful appetitive cues that are intrinsic to foods' flavor and hedonic qualities, and such cues can facilitate overeating. alcohol consumption similarly "primes" appetite, and contributes to overeating while under alcohol's acute effects. knowing the brain loci that respond to such naturalistic appetitive stimuli, and how they are modified by body fat and alcohol exposure, will provide critical insights about the neural systems that underlie loss of control of eating. therefore, the main hypotheses of this study are that: a) lean and obese subjects have different limbic responses to the olfactory cues that enhance motivation to eat, and b) acute alcohol intoxication i) potentiates the brain's reward system response to food odors, and ii) affects brain systems involved in behavioral inhibition and eating restraint. to test these hypotheses, we have modified functional magnetic resonance imaging (fmri) paradigms successfully used to study alcoholic drink aromas in subjects at risk for alcoholism.

Eligibility criteria:
inclusion criteria: * non smoking, right handed women 18-40 years * good health without self reported neurological or psychiatric disorder * no indication of eating disorders * normal sense of smell exclusion criteria: * pregnant,/breast feeding women * history of drug abuse/dependence, positive drug screen for amphetamines/methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates or pcp * dsm-iv axis i psychiatric disorders or head injury with loss of consciousness * contraindications to mri (ferrous material, claustrophobia)
comparison of pain relief after upper and lower lumbar erector spinae plane block

Conditions: Pain, Chronic

Summary: the primary endpoint of this study was to identify if eretor spinae plane block (espb) has any effect in relieving low back pain or leg pain in lumbar radiculopathy. the secondary endpoint was to compare the number of spread level when upper or lower lumbar espb was performed.

the erector spinae plane block (espb) is a less invasive, safer, and technically easy alternative procedure to conventional neuraxial anesthetic techniques. in contrast to common neuraxial techniques such as paravertebral and epidural injections, the espb targets an interfascial plane which is far from the spinal cord, root, and pleura. first applied to thoracic neuropathic pain, currently espb is being applied to postoperative pain control and includes variable clinical situations. in the abdomen and thoracic wall, thoracic espb can be applied for pain control after cardiac surgery, video-assisted thoracic surgery, laparoscopic cholecystectomy, and thoracotomy. recently, favorable postoperative pain control after lumbar spinal or lower limb surgeries has been reported with lumbar espb. in addition, espb has also been used for chronic pain conditions in the upper and lower extremities. to investigate the possible mechanism of action of the espb, many previous studies have focused on examining the physical spread of the injected agent. commonly, contrast dye injections in human cadavers have been utilized to assess the spread level. physical spread level was determined using various methods including direct dissection or sectioning, computed tomography (ct), thoracoscopic inspection, or magnetic resonance imaging (mri) with radiocontrast injection. apart from human cadaver studies, physical spread level has been evaluated in alive patients using a variable volume of local anesthetics mixed with radiocontrast. however, these studies are limited by the small number of included patients. therefore, the exact spread level of injected local anesthetics remains unclear and a study on a large number of patients is still required

Eligibility criteria:
inclusion criteria: * lumbar disc herniation * lumbar foraminal stenosis * lumbar central stenosis * lumbar spondylolisthesis * severe level of spine at l3-4 * numerical rating scale \> 4 * back pain functional scale \< 45 * duration of pain \> 1 month * patients who can fully understand all items described in bpfs exclusion criteria: * allergy to local anesthetics or contrast medium * pregnancy * spine deformity * prior history of lumbar spine surgery * no previous lumbar mri or ct * patients with coagulation abnormality * incorrect level of espb

Keywords: pain, lumbar, spread
dexmedetomidine in patients after intracranial surgery

Conditions: Central Nervous System Diseases

Summary: dexmedetomidine is a highly selective a2-adrenoreceptor agonist that produces dose-dependent sedation and analgesia without respiratory depression. dexmedetomidine has been used in critically ill medical, surgical, and pediatric patients. no study has been designed specifically to evaluate dexmedetomidine uses in the neurocritical care population. the primary objective is to evaluate the safety and efficacy of dexmedetomidine for prophylactic analgesia and sedation in patients after intracranial surgery.

the pastrial is a non-commercial, multi-center, randomized, placebo-controlled, double blinded clinical trial. the study compares dexmedetomidine versus normal saline (placebo) in patients after intracranial surgery with delayed extubation. in dexmedetomidine group, infusion (0.4μg/kg/h) is started when patients are admitted to neuro-intensive care unit for postoperative recovery. in control group, patients receive normal saline infusion at the same rate and volume in dexmedetomidine group. the patient's level of sedation is assessed by sedation-agitation scale (sas) per hour. midazolam is administered in 0.3-0.5 mg bolus or continuous infusion as sas above 4. the study is designed primarily to compare the percentage of patients with agitation and requiring midazolam infusion in the 2 study arms.

Eligibility criteria:
inclusion criteria: * adult patients after intracranial surgery with delayed extubation exclusion criteria: * emergency operation * brain stem operation * preoperative consciousness disorders or epilepsy * bradycardia, hypotension, acute myocardial infarction, second- or third degree heart block, or need continuous infusions of vasopressor before the start of study drug infusion * patients enrolled in another trial

Keywords: dexmedetomidine sedation neurosurgery postoperative care
high-dose cytarabine and survival in aml

Conditions: Acute Myeloid Leukemia

Summary: in adults with acute myeloid leukemia, especially those \< 60 years of age, high-dose cytarabine consolidation therapy has been shown to influence survival, but the appropriate dose has not been defined.

background in adults with acute myeloid leukemia, especially those \< 60 years of age, high-dose cytarabine consolidation therapy has been shown to influence survival. however, the appropriate dose has not been defined. we evaluated survival after cytarabine consolidation therapy at three different doses. design and methods we conducted a single-center, retrospective study involving 499 acute myeloid leukemia patients, aged 18-92 years, all evaluated between 1978 and 2007. of those 499 patients, 400 received curative treatment and 203 received cytarabine consolidation. the latter were divided into three groups: low-dose (receiving \< 1.5 g/m2 of i.v. cytarabine, every 12 h, on 3 alternate days, for up to 4 cycles); medium-high-dose (\< 45.45 g-the median dose-by the end of the cycles); and very-high-dose (≥ 45.45 g by the end of the cycles). results among the 400 patients receiving curative treatment, five-year survival was 22.8% (91 patients). cytarabine consolidation dose was an independent determinant of survival (significant differences were found among the groups), whereas age, karyotype, induction protocol, french-american-british classification and etiology were not. in comparison with the very-high-dose group, the risk of death was 3.871 times (95% ci, 1.043 to 14.370 times) higher in the high-dose group (p=0.043) and 9.775 times (95% ci, 2.493 to 38.320 times) higher in the low-dose group (p=0.001), assuming, in both cases, that age, karyotype, french-american-british classification and etiology of acute myeloid leukemia were constant. conclusions consolidation therapy with high-dose cytarabine appears to improve survival in patients with acute myeloid leukemia.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of acute myeloid leukemia * age 18 years or above * must have been treated with potentially curative therapy exclusion criteria: * children or age less than 18 years * palliative therapy

Keywords: acute myeloid leukemia prognosis cytarabine
prevalence of anterior open bite in a group of egyptian children aged eight years and above

Conditions: Anterior Open Bite

Summary: this study aims to determine the prevalence of anterior open bite and its etiological factors in a group of egyptian children aged 8 years and above. patients who met the eligibility criteria will be given a questionnaire to fill followed by obtaining casts stabilized into occlusion to obtain the vertical and horizontal relationships.


Eligibility criteria:
inclusion criteria: * medically free children aged 8 years and above, both genders and cooperative parents and children exclusion criteria: * presence of orthodontic appliance and parents refuse to participate
masupirdine for the treatment of agitation in dementia of the alzheimer's type

Conditions: Agitation; Alzheimer's Type Dementia

Summary: this study will be conducted to evaluate the efficacy, safety, tolerability, and pharmacokinetics of masupirdine compared to placebo for the treatment of agitation in participants with dementia of the alzheimer's type.

this is a multicenter, randomized, double-blind, placebo-controlled study, consisting of 12 weeks of treatment. approximately 375 participants will be enrolled at approximately 50 centers worldwide. study medication will be administered orally once-daily from day 1 through day 85. screening will occur within approximately 4 weeks prior to randomization. following screening procedures for assessment of inclusion and exclusion criteria, eligible participants will be randomized into the study.

Eligibility criteria:
inclusion criteria: * has a diagnosis of dementia of the alzheimer's type according to the national institute on aging-alzheimer's association (nia-aa) criteria. * has confirmed agitation using the ipa consensus provisional definition of agitation in cognitive disorders. * has a score between 8 and 24 (both inclusive) on mini-mental state examination (mmse). exclusion criteria: * participants with dementia predominantly of the non-alzheimer's type (e.g., vascular dementia, parkinson's disease, lewy body disease, frontotemporal dementia) * has symptoms of agitation that are not secondary to alzheimer's disease (eg, pain, other psychiatric disorder, or delirium due to a metabolic disorder, systemic infection, or substance-induced). * participant (or caregiver) is deemed otherwise ineligible for participation in this study in the investigator's judgement.

Keywords: masupirdine suvn-502 phase 3 agitation
an 8 week depression study in adults diagnosed with major depressive disorder

Conditions: Major Depressive Disorder (MDD)

Summary: a placebo controlled study evaluating efficacy, safety and tolerability of radafaxine in patients with major depressive disorder (mdd)


Eligibility criteria:
inclusion criteria: * diagnosis of major depressive disorder (mdd) * duration of current depressive episode 12 weeks - 24 months * patients can read and write at a level sufficient to provide a signed consent * if female, patients must be practicing an acceptable method of birth control exclusion criteria: * patients have other psychiatric disorders that would affect patient's response to treatment * patients have not responded to two or more adequate courses of antidepressant therapy * patients cannot be currently abusing illicit drugs or alcohol * patients are not currently receiving psychotherapy * patients have received electroconvulsive therapy within 6 months prior to screening * patients are pregnant or lactating

Keywords: gw353162 major depressive disorder mdd
efficacy and safety of camrelizumab in real-world prospective study

Conditions: Non-small Cell Lung Cancer

Summary: this observational real-world study is designed to evaluate the efficacy and safety of camrelizumab for the treatment of chinese nsclc patients.

camrelizumab is a humanized antibody for cancer immunotherapy. the national medical products administration (nmpa, china) approved camrelizumab as a first-line treatment of certain patients with nsclc. this is a multicenter non-interventional study, nsclc patients who have been treated with camrelizumab will be included. the main objective of this study is to evaluate the efficacy and safety of camrelizumab in the clinical practice.

Eligibility criteria:
inclusion criteria: 1. sign the informed consent and volunteer to participate in the study; 2. non-small cell lung cancer confirmed by histological/cytopathological tests; 3. age ≥18; 4. the investigators determined that patients should receive camrelizumab alone or in combination. exclusion criteria: 1. patients who are also receiving other immunomedications or therapies; 2. patients participating in other interventional studies; 3. patients complicated with other malignant tumors; 4. women who have been confirmed to be pregnant or lactating; 5. the investigator considers the patient unsuitable for participation in any other condition of the study.