bioihbjkbjnl/mcl2 huggingface dataset:
Risk Factors and Machine Learning Model for Aminoglycines Related Acute Kidney Injury
Condition: Aminoglycoside Toxicity; Acute Kidney Injury
MeSH terms: Acute Kidney Injury; Wounds and Injuries
Study type: Observational

Summary: 
      Drug-induced acute kidney injury (D-AKI) can occur after treatment with aminoglycosides.
      Predicting the risk of D-AKI is important for a tailored prevention and palliation strategy.
      There are currently no studies to construct a model for predicting the risk of D-AKI
      associated with aminoglycosides. Therefore, the study aimed to develop a model to predict the
      risk of D-AKI that could be used in clinical practice. Clinical data of inpatients treated
      with aminoglycosides at the First Affiliated Hospital of Shandong First Medical University
      from January 2018 to December 2020, were collected. The primary endpoint was D-AKI, defined
      according to the 2012 Global Outcomes for Kidney Disease Improvement (KDIGO). Patient
      clinical information, including demographic information, admission and discharge information,
      disease history, medication information, and laboratory tests, was obtained through an
      in-hospital electronic medical record system. Independent risk factors associated with D-AKI
      will be screened by univariate and multifactorial analyses. Covariates with significant
      differences (P < 0.05) were included in logistic regression models. The models were evaluated
      by the area under the curve (AUC) of the receiver operating characteristic curve (ROC)
      obtained by ten-fold cross-validation. Future studies are needed to test the application of
      this model in clinical practice to determine whether D-AKI in this setting can be predicted
      and mitigated.
    


Intervention name(s): Aminoglycoside
Intervention type(s): Drug
Intervention description(s): Inpatients using aminoglycoside
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The patients were included if received treatment with aminoglycosides and discharged from
        the hospital between January 1, 2018 and December 31, 2020.
      
Keywords: Aminoglycosides; Acute kidney injury; Pharmacoepidemiology; Miss diagnosis; Risk factors; Logic regression
Drug-Drug Interaction Study Assessing Effect of Itraconazole on PF-07321332/Ritonavir in Healthy Participants
Condition: Healthy Participant
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to estimate the effect of a strong inhibitor of CYP3A4
      (itraconazole) on the pharmacokinetics (PK) of PF-07321332/ritonavir in healthy participants.
    


Intervention name(s): PF-07321332/ritonavir; Itraconazole; PF-07321332/ritonavir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally every 12 hours for days for a total of 5 doses from Day 1 through Day 3; Administered orally once daily for 8 days from Days 1 through 8; Administered orally BID for 3 day for a total on 5 doses starting on Day 4 through Day 6
Intervention MeSH terms: Ritonavir; Itraconazole; Nirmatrelvir
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a Phase I, fixed sequence, 2-period study to evaluate the effect of the strong CYP3A4 inhibitor, itraconazole, on the PK of PF-07321332 and ritonavir in healthy participants. A total of 12 healthy participants will be enrolled into this study.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Drug-drug interaction; Itraconazole; CYP3A4 inhibitor
Applicaion of Mouth Opener Combined With Electronic Video Laryngoscope in Double-lumen Intubation of Patients With Difficult Airway
Condition: Difficult Airway Intubation; Double-lumen Tube
Study type: Interventional

Summary: 
      How to quickly expose glottis and accurately insert double luminal tracheal tube in patients
      with difficult airway in thoracoscopic surgery has become an urgent problem in anesthesia
      induction.This study through the double cavity bronchial tube visual laryngoscope intubation
      with open mouth and electronic video laryngoscope used in combination, to explore whether can
      shorten the glottis exposure, improve the success rate of the double lumen tube intubation
      will reduce pharyngeal damage, reduce intubation hemodynamic fluctuations, in order to
      improve the glottis appeared difficult patients with bronchial intubation success rate to
      provide the reference.
    

Detailed description: 
      A total of 60 patients who needed double-lumen endobronchial catheterization in thoracic
      department and whose Arne o 'risk index score was at least 7 points were randomly divided
      into three groups.Group B was intubated with video laryngoscopy.Group C was intubated with a
      mouth opener for video laryngoscope combined with a double-lumen bronchial tube for video
      laryngoscope intubation (hereinafter referred to as the mouth opener).The glottis exposure
      time, bronchial intubation time, intubation times, success rate of one intubation, and NRS
      score of pharyngeal pain 8 hours after surgery were observed and recorded in the three
      groups, and the hemodynamic changes after intubation were observed and recorded.
    

Intervention name(s): laryngoscope with mouth opener; video laryngoscope with mouth opener
Intervention type(s): Device; Device
Intervention description(s): Double-lumen tube combined with mouth gag for laryngoscope intubation; Double-lumen tube combined with mouth gag for video laryngoscope intubation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: video laryngoscop; double-lumen tube; mouth gag
Study Assessing AR-1105 in Subjects With Macular Edema Due to Retinal Vein Occlusion (RVO)
Condition: Macular Edema
MeSH terms: Macular Edema; Retinal Vein Occlusion; Edema
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety, tolerability and efficacy of AR-1105 (dexamethasone
      implant) for the treatment of macular edema (ME) due to retinal vein occlusion (RVO). A more
      durable intravitreal implant containing a low dose of dexamethasone may result in less
      frequent retreatments, and potentially lower the incidence of steroid-related side effects
      without compromising efficacy.
    

Detailed description: 
      AR-1105 is a dexamethasone containing implant drug delivery system that is injected into the
      back of the eye. It is designed to dissolve slowly over time, continuously releasing a
      consistent low dose of steroid to treat the symptoms of RVO and associated inflammation with
      a goal of halting further visual disturbance and damage, and also possibly restoring some
      vision as symptoms are controlled. In this study, 2 different formulations are being tested
      to find the optimum combination of efficacy, safety and durability that will offer patients a
      potential treatment option that is as safe and effective as the treatments currently
      available, but which requires less frequent injections and potentially has a lower risk for
      certain side-effects.
    

Intervention name(s): AR-1105-CF1; AR-1105-CF2
Intervention type(s): Drug; Drug
Intervention description(s): AR-1105 clinical formulation 1 (AR-1105-CF1); AR-1105 clinical formulation 2 (AR-1105-CF2)
Other intervention name(s): AR-1105-CF1 (dexamethasone intravitreal implant); AR-1105-CF2 (dexamethasone intravitreal implant)
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single injection of either of 2 formulations of AR-1105 dexamethasone intravitreal implant (CF1 or CF2) administered in a single eye. An initial safety cohort of up-to 5 subjects may be enrolled onto CF1 prior to the randomized phase. During the randomized phase of the study, subjects will be assigned in a 1:1 ratio to either CF1 or CF2. Each subject will complete a 6-month primary evaluation period. Residual implant assessment will be performed by 3-field fundus photography at Day 7 and at Months 3, 4, 5, and 6, and if necessary at monthly visits thereafter until the subject requires retreatment, or until 1 month after the implant is no longer visible, or to Month 9, whichever comes first.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Macular Edema; Retinal Vein Occlusion; Dexamethasone Intravitreal Implant
Routine or On-demand Fentanyl in Colonoscopy
Condition: Pain
Study type: Interventional

Summary: 
      Colonoscopy may be an unpleasant procedure. Sedation and/or analgesics is therefore routinely
      administered in most countries. In Norway, however, routine sedation is rare, and medication
      is normally given on demand, that is, if necessary during the procedure. The investigators
      want to evaluate whether the effect of fentanyl, a synthetic opioid with fast onset of
      action, is better given before the procedure than during the procedure.
    


Intervention name(s): Routine medication arm; Fentanyl on-demand arm
Intervention type(s): Drug; Drug
Intervention description(s): 50 micrograms of fentanyl given before the procedure; Fentanyl 50 microgram is provided on-demand, that is, if the patient has pain during the procedure.
Other intervention name(s): fentanyl; Fentanyl
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: colonoscopy; pain
A Study of PF-06410293 Following Subcutaneous Administration Using A Prefilled Syringe Or A Prefilled Pen In Healthy Adult Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study comparing adalimumab Pfizer (PF-06410293) administered as a subcutaneous(SC)
      injection using a pre-filled syringe (PFS) or pre-filled pen in healthy adult subjects
    


Intervention name(s): PF-06410293 PFS; PF-06410293 PFP
Intervention type(s): Device; Device
Intervention description(s): PF-06410293 40 mg administered subcutaneously by Prefilled syringe; PF-06410293 40 mg administered subcutaneously by prefilled pen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy Subjects; Device; PK; Phase 1; Bioequivalence; Adalimumab; Single Dose
Safety, Tolerability, and Pharmacokinetics of EQU-001 in Healthy Volunteers
Condition: Safety Issues
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, placebo-controlled, double-blinded single and multiple ascending dose
      (SAD and MAD) study of the safety, tolerability, and pharmacokinetics of EQU-001 in healthy
      volunteers.
    

Detailed description: 
      EQU-001 is a Phase 1 randomized, placebo-controlled, double-blind SAD/MAD study to evaluate
      safety, tolerability, PK, and high-fat food effects on EQU-001. Eight healthy adult
      participants will be enrolled in each of up to 5 cohorts in both the SAD and MAD portions of
      the study (10 mg, 20 mg, 40 mg, 80 mg, and 120 mg). The participants will be randomized 3:1,
      drug to placebo. The MAD dosing is for 14 days, to include a period of time where the study
      drug will be at steady-state. Eight participants from the SAD study (the 40 mg dose cohort or
      the MTD dose cohort, whichever dose is lower) will also complete a fed portion of the study.

      This study of EQU-001 will provide baseline safety, tolerability, PK, and food effect data in
      healthy individuals and aims to identify drug-specific DLTs and an MTD. The PK component will
      characterize the PK of EQU-001 to inform dosing and may help to correlate exposures with any
      DLTs or other treatment-related AEs. The food effect component will characterize the effect
      of a high-fat meal on EQU-001 kinetics and exposure.
    

Intervention name(s): EQU-001; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): EQU-001 in 10 and 20 mg capsules; Matched placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: 3:1 treatment to placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy; Adult; Volunteer
AZD0585 Phase III Long-term Study in Japan
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a randomised, double-blind phase III long-term study to evaluate efficacy and
      safety of 12 weeks and 52 weeks of AZD0585 administration compared to placebo in patients
      with hyperlipidemia accompanied by hypertriglyceridemia .
    


Intervention name(s): AZD0585; AZD0585 placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1g soft capsule; 1g soft capsule
Other intervention name(s): Epanova; Corn oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Endotracheal Tube Placement in Neonatal Intubation
Condition: Neonatal Respiratory Failure
MeSH terms: Respiratory Insufficiency
Study type: Interventional

Summary: 
      Endotracheal intubation is a frequent procedure performed in neonates with respiratory
      distress. Clinicians use different methods to estimate the intubation insertion depth.

      In this study, the investigators aimed to compare the two different methods (kilogram + 6 cm
      and nasal septum-tragus length (NTL) + 1 cm) used to determine the endotracheal intubation
      insertion depth.
    

Detailed description: 
      Endotracheal intubation is a frequent procedure performed in neonates with respiratory
      distress. The ideal location of the tube is between the top of the 1st thoracic vertebra and
      the bottom of the 2nd thoracic vertebra in the X-ray. Clinicians use different methods to
      estimate the intubation insertion depth.

      In this study, investigators aimed to compare the two different methods (kilogram+6 cm and
      nasal septum-tragus length (NTL)+ 1 cm) used to determine the endotracheal intubation
      insertion depth.

      In this multicentre randomized prospective study, infants who had intubation indications in
      neonatal intensive care unit will be enrolled. The intubation tube will be fixed at the lip
      level using the Tochen formula (Group 1) or the NTL+1 cm formula (Group 2). The same brand
      endotracheal tubes will be used and after intubation the chest radiograph will be performed
      in the neutral position. Chest X-ray will be evaluated blindly by a single radiologist in the
      digital environment (above T1, in place and below T2).
    

Intervention name(s): Weight+6; NTL+1
Intervention type(s): Other; Other
Intervention description(s): For the Tochen formula in Group 1, ETT depth will be calculated by taking the infant's actual weight within the last 24 h and adding 6 cm.; The infants in Group 2 will be intubated by measuring the NTL, the distance from the basement of the nasal septum to the the tragus of the ear. Measurements will be recorded as centimeters.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Nasal septum-tragus length; newborn
The Effect of Liraglutide Treatment on Postprandial Chylomicron and VLDL Kinetics, Liver Fat and de Novo Lipogenesis
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to evaluate the mechanisms underlying the effect of incretin therapy on
      lipoprotein metabolism in subjects with type 2 diabetes and to study the effect of
      liraglutide on hepatic de novo lipogenesis.
    

Detailed description: 
      The well recognized dyslipidemia in people with type 2 diabetes consists of high fasting and
      non-fasting plasma triglycerides (TG), low high-density lipoprotein (HDL) -cholesterol and
      preponderance of small dense low-density lipoprotein (LDL) particles nominated as the
      atherogenic lipid triad. Humans are mostly in a postprandial rather than fasting state and
      therefore non-fasting TG values reflect more accurately the continuous exposure of arterial
      wall to triglyceride rich lipoproteins (TRLs) and more importantly, to substantial
      cholesterol load that these particles deliver.

      Postprandial lipemia is highly prevalent even in type 2 diabetes patients with normal fasting
      TG concentrations. Intestinal overproduction of chylomicrons (CMs) and the structural protein
      apolipoprotein (apo)-B48 has been identified as an integral feature of postprandial lipemia
      in type 2 diabetes and insulin resistance. It is clinically important to elucidate the
      mechanism for delayed postprandial lipemia and the interactions between dysglycemia and
      dyslipidemia in type 2 diabetes patients.
    

Intervention name(s): Liraglutide; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Victoza
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effect of RAS on Balance and Gait After Stroke
Condition: Stroke; Gait, Hemiplegic; Gait Disorders, Neurologic
MeSH terms: Stroke; Nervous System Diseases; Gait Disorders, Neurologic
Study type: Interventional

Summary: 
      A rhythmic auditory stimulation intervention may be beneficial in order to improve movement
      parameters after stroke. Reviews argue that more randomized controlled trials with a control
      group are needed. Main objective: Evaluate the effect of a rhythmic auditory stimulation on
      the quality of balance and gait parameters in people with stroke. Methodology:
      quasi-experimental study. The study has been approved by the hospital ethics committee.
    

Detailed description: 
      A rhythmic auditory stimulation (RAS) intervention may be beneficial in order to improve the
      parameters of the post-stroke movement: increase of the speed of the walk, improvement in the
      width of the step with the affected side, improvement of the walking index dynamics (Dynamic
      Gait Index), improvement in cadence and improvement in the static balance.

      Current systematic reviews argue that more randomized controlled trials with a control group
      are needed.

      Main objective: To evaluate the effect of a rhythmic auditory stimulation on the quality of
      progress and balance in people with stroke.

      Methodology: experimental group will be done between 2019 and 2020 and historical control
      group of the years 2017 and 2018. Experimental group will do 3 sessions in a week of RAS, and
      daily 2 hours of physiotherapy except of Sundays. Control group received 2 hours daily of
      physiotherapy, except Sundays.

      The study has been approved by the hospital ethics committee.
    

Intervention name(s): Rhythmic auditory stimulation
Intervention type(s): Other
Intervention description(s): Rhythmic auditory stimulation 3 times in a week, and 2 hours of physiotherapy 6 days in a week.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rhythm; musicotherapy; balance; gait; stroke; physiotherapy
Recombinant Leptin Therapy for Treatment of Nonalcoholic Steatohepatitis (NASH)
Condition: Fatty Liver Disease, Nonalcoholic
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Nonalcoholic steatohepatitis (or NASH) is known to be caused by deposition of fat in the
      liver and development of scarring. This condition occurs more frequently in overweight and
      obese persons. It is often associated with resistance to the actions of insulin hormone. Fat
      cells secrete a hormone called leptin. Recently, we have learned that obese or overweight
      persons make too much leptin, which may contribute to insulin resistance. Paradoxically,
      patients who do not have any fat cells, also have insulin resistance. In these patients,
      insulin resistance is caused by the absence of leptin and leptin replacement significantly
      improves insulin resistance and fat deposition in the liver. In an earlier study, we
      determined the leptin levels in patients with NASH and how these levels are related to body
      fat levels as well as responsiveness to insulin. We saw that a subgroup of patients with NASH
      have relatively low levels of leptin in contrast to the amount of body fat they had. We now
      would like to see if restoring leptin levels to normal will improve the disease process in
      these patients. Our study patients will be male patients, aged between 18 and 65 (inclusive),
      who do not have any other cause for their liver disease. We have put some restrictions in
      body size such that a spectrum of patients from normal weight to obese range would be
      included. They will also demonstrate low leptin levels (levels similar to only 25% of normal
      population). We will use a genetically engineered form of leptin manufactured by Amylin Inc.
      given via injections under the skin. We plan to continue therapy for a period of one year and
      evaluate the change in liver disease by a liver biopsy. We will also follow the metabolic
      parameters and body composition characteristics that we examined in our earlier study. We
      expect that patients with low blood leptin levels will show improvement in their liver
      disease and insulin resistance when their blood leptin levels are restored to normal.
    


Intervention name(s): metreleptin
Intervention type(s): Drug
Intervention description(s): 0.1 mg/kg/day once a day via subcutaneous injections
Other intervention name(s): (originally A100, recombinant-human-Methionyl-leptin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nonalcoholic fatty liver disease; Insulin resistance; Obesity; Leptin therapy; NASH