bioihbjkbjnl/mcl2 huggingface dataset:
US Prediction of Actual Tube Size and Performance Characteristics of Pediatric Cuffed Vs Un-Cuffed ETT.
Condition: Airway Complication of Anesthesia
Study type: Observational

Summary: 
      The aim of this study will be to test the accuracy of Sonography in determining the
      endotracheal tube size in pediatric patients whether cuffed or un-cuffed.
    

Detailed description: 
      -  Children's tracheas have traditionally been intubated with un-cuffed tracheal tubes (TT)
           due to differences between adult and pediatric sub-glottic anatomy and fears that cuffs
           may lead to mucosal damage and subglottic stenosis. Despite this, cuffed TTs are
           increasingly used in pediatric anesthesia. Over the last 20 years, evidence suggests
           that cuffed TT may have advantages over un-cuffed, and are associated with at least
           similar, if not superior, airway outcomes when compared with un-cuffed TT in children.

        -  Formulas based on age and height often fail to reliably predict the proper endotracheal
           tube (ETT) size in pediatric patients. Visualization of the pediatric subglottic airway
           diameter by ultrasonography (USG) can enable a practitioner to better predict ETT size,
           preventing unnecessary tube changes and airway trauma. Also, Visualization of the
           transvers diameter of epiphyseal end of distal radius by ultrasonography (USG) has been
           recently investigated and can enable a practitioner to better predict ETT size. Recent
           reports suggest that the diameter of the subglottic upper airway can be determined by
           ultrasonography in healthy young adults and pediatric patients . However, the extent to
           which ultrasonography by these two measurements can predict optimal ETT size in
           pediatric patients remains under investigation.
    

Intervention name(s): cuffed endotracheal tube; Uncuffed endotracheal tube
Intervention type(s): Device; Device
Intervention description(s): Patients will be anesthetized using high-volume low-pressure cuffed endotracheal tube; Patients will be anesthetized using uncuffed endotracheal tube
Other intervention name(s): C ETT; ETT
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children aged 1-6 years of both sexes undergoing surgical procedures in which an
        endotracheal tube is needed.
A Multicentre, Open Label Phase IIIb/IV Study of Subcutaneously Administered Raptiva in the Treatment of Adult Subjects With Moderate to Severe Plaque Psoriasis
Condition: Candidates for Systemic Therapy for Psoriasis; Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 4

Summary: 
      An open-label, multi-center study to establish psoriasis control of moderate to severe plaque
      psoriasis with Raptiva therapy administered subcutaneously for 24 weeks.
    


Intervention name(s): Efalizumab
Intervention type(s): Drug
Intervention description(s): Subjects will receive a conditioning dose of 0.7 milligram per kilogram (mg/kg) efalizumab subcutaneously on study Day 0 followed by 1.0 mg/kg efalizumab subcutaneously once a week for 23 weeks.
Other intervention name(s): Raptiva
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Hepatitis B Virus Reactivation: a Cautionary Event After Liver Transplantation for Patients With Hepatocellular Carcinoma
Condition: Liver Transplant; Complications
MeSH terms: Hepatitis B; Carcinoma, Hepatocellular
Study type: Observational

Summary: 
      Highly active hepatitis B virus (HBV) is known to be associated with poor outcomes in
      patients with hepatocellular carcinoma (HCC). This study aims to investigate the relationship
      between HBV status and HCC recurrence after liver transplantation. The study retrospectively
      analyzed HCC patients undergoing liver transplantation in 2 centers between January 2015 and
      December 2020. We reviewed post-transplant HBV status and its association with outcomes.
    


Intervention name(s): Diagnosis of postoperative recurrence of liver cancer
Intervention type(s): Diagnostic Test
Intervention description(s): HBV serological markers, such as hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg) and HBV DNA were monitored regularly. The alpha-fetoprotein (AFP) level was determined every 1-2 months. The ultrasound or computed tomography or magnetic resonance imaging was performed every 3-6 months in HCC patients who underwent liver transplantation.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        From January 2015 to December 2020, the electronic medical records of liver cancer patients
        who underwent liver transplantation at the First Affiliated Hospital, Zhejiang University
        School of Medicine and Shulan (Hangzhou) Hospital were retrospectively reviewed.Recipients
        were followed up after liver transplantation until Dec 31, 2022. During the follow-up
        period, the recipients were managed according to a standard protocol. All recipients
        received a nucleoside analog after liver transplantation. HBV serological markers, such as
        hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg) and HBV DNA were
        monitored regularly. The alpha-fetoprotein (AFP) level was determined every 1-2 months. The
        ultrasound or computed tomography or magnetic resonance imaging was performed every 3-6
        months in HCC patients who underwent liver transplantation.
A Study of the Effects of Hepatic Impairment on the Pharmacokinetics and Tolerability of Eliglustat Tartrate
Condition: Gaucher Disease
MeSH terms: Gaucher Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To study the effect of mild and moderate hepatic impairment on the pharmacokinetics (PK) of
      eliglustat.

      Secondary Objective:

      To assess the tolerability of eliglustat tartrate given as a single dose in subjects with
      mild and moderate hepatic impairment in comparison with matched subjects with normal hepatic
      function.
    

Detailed description: 
      The total study duration from screening period is approximately 31 days.
    

Intervention name(s): eliglustat
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form: capsule
Route of administration: oral
Other intervention name(s): GZ385660
Intervention MeSH terms: Eliglustat
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Concurrent Chemoradiotherapy With Docetaxel and Cisplatin in Esophageal Cancer
Condition: Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Study type: Observational

Summary: 
      This study is designed to determined the feasibility and safety in advanced esophageal cancer
      treated with docetaxel and cisplatin cocurrent chemoradiotherapy. The primary end points were
      clinical best response and response rate and secondary endpoints were progression free
      survival and overall survival.
    

Detailed description: 
      Chemotherapy can provide significant palliation of symptoms for patients with unresectable,
      locally advanced or metastatic esophageal cancer. Cisplatin and continuous infusion 5 FU,
      alone or combined with radiotherapy, is the most frequently used regimen. The response rate
      reported with cisplatin and 5 FU ranged from 35 to 40% ,whereas the 2-year survival rates of
      patients with locally advanced esophageal cancer ranged from 8 to 55%, with a mean 27%.
      Therefore, there is a need to test new combination, specifically in unresectable locally
      advanced esophageal patients, with the aim of increasing the pCR rate and survival. Cisplatin
      had been widely used as radiosensitizer and Docetaxel is different from that of cisplatin
      -5FU and and has proved to have an additive effect with cisplatin and supra-additive
      antitumor activity with fluorouracil in vitro and in murine models. To investigate the
      feasibility of combining concomitant radiation with docetaxel and cisplatin and assess the
      regimen's toxicity, locoregional control rate, and survival in patients with locally advanced
      or metastatic esophageal cancer.In this study, docetaxel 25mg/m2 is given with 500ml normal
      saline , as a 1hr infusion, on days 1,8 of every 3 weeks. Cisplatin75mg/m2 is given by
      intravenous infusion in 500 mL of 5% dextrose solution over 60 minutes on day 1 of every
      3weeks.. Therapy will be repeated every 21 days. Radiation therapy (200cGy/day upto 5400 cGy)
      begin on the first day of week 1 over 6 weeks (concomitant chemoradiation therapy). When the
      investigators assume that standard treatment's response rate is 50% and the response of
      experimental treatment is 75% and use Simon's two-stage optimal design under the significance
      level of 5% and the power of 80%, the total sample size of 25 is at least required. For a
      total of 25 subjects, 11 will be accrued during stage 1 and 14 during stage 2. If 6 or fewer
      responses are observed during the first stage then the trial is stopped early. If 16 or fewer
      responses are observed by the end of the trial then no further investigation of the drug is
      warranted. If the investigators assumed that the drop out rate was 10%, number of subjects
      per treatment arm will be 28.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        advanced esophageal cancer diagosed at Chonnam National University Hospital
      
Keywords: docetaxel; cisplatin; combined modality therapy
Comparison Between Low-dose Ketamine Infusion and Intravenous Morphine
Condition: Ketamine
Study type: Interventional
Phase: Phase 4

Summary: 
      Ketamine is an antagonist of N-methyl-d-aspartate (NMDA) receptor that not only abolishes
      peripheral afferent noxious stimulation, but it may also prevent central sensitization of
      nociceptors as shown in animal studies with excellent analgesic property even in
      subanesthetic doses. It is readily available and is being used currently, even by
      non-Anesthesiologists, to provide "sedation" for minor procedures.(.. Low-dose ketamine
      infusion in the perioperative period has shown to produce analgesia and decrease the
      requirements of opioid analgesics.. In obstetrics, it is being used as an adjunct to an
      inadequately functioning spinal anesthesia for caesarean section, as an induction agent for
      cesarean section and also to provide analgesia during labor in intermittent boluses.
    

Detailed description: 
      Ketamine is an antagonist of N-methyl-d-aspartate (NMDA) receptor that not only abolishes
      peripheral afferent noxious stimulation, but it may also prevent central sensitization of
      nociceptors as shown in animal studies with excellent analgesic property even in
      subanesthetic doses. It is readily available and is being used currently, even by
      non-Anesthesiologists, to provide "sedation" for minor procedures.(.. Low-dose ketamine
      infusion in the perioperative period has shown to produce analgesia and decrease the
      requirements of opioid analgesics.. In obstetrics, it is being used as an adjunct to an
      inadequately functioning spinal anesthesia for caesarean section, as an induction agent for
      cesarean section and also to provide analgesia during labor in intermittent boluses.
    

Intervention name(s): Ketamine group:; Control group
Intervention type(s): Drug; Drug
Intervention description(s): Ketamine group: will be administered ketamine in a loading dose of 0.2 mg/kg over 5 min pre incision followed-by an infusion at 0.2 mg/kg/h until the end of surgery.; where normal saline was administered as a loading dose then infused with same rate of another group, throughout the whole surgery.
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Diagnostic
Keywords: Ketamine; Morphine; Laparotomy Myomectomy
Effect of High Levels of Oxygen and Smoking on the Lungs in Human Volunteers
Condition: Healthy Volunteers
Study type: Observational

Summary: 
      Patients with lung disease experiencing difficulty breathing can be treated with oxygen
      therapy. This involves the delivery of "extra" oxygen by a face-mask or through small tubes
      placed in the nose called nasal prongs. This extra oxygen can have concentrations as high as
      100% pure oxygen. The concentration of oxygen in normal air is only 21%. The high
      concentration of oxygen can help to provide enough oxygen for all of the organs in the body.
      Unfortunately, breathing 100% oxygen for long periods of time can cause changes in the lungs,
      which are potentially harmful. Researchers believe that by lowering the concentration of
      oxygen therapy to 40% patients can receive it for longer periods of time without the risk of
      side effects.

      This study is designed to evaluate the effects of oxygen therapy at 100% and 40% for 12 18
      hours on the lungs of normal volunteers. Results of this study will help to determine if
      levels of oxygen therapy currently accepted as being "safe" may actually be damaging to the
      lungs.
    

Detailed description: 
      Stress such as high oxygen or inflammation can result in damage to proteins by processes such
      as oxidation or alternative regulation of signaling pathways by post-translational
      modification of proteins (e.g., phosphorylation). Delivery of oxygen in high concentrations
      to the lungs can result in damage, which is mediated in large part by reactive oxygen
      species. Inflammation can result in activation of intracellular signaling pathways. This
      study will evaluate modification of proteins and nucleic acids in bronchoalveolar lavage
      fluid, bronchial epithelial cells, and peripheral blood of individuals exposed to oxygen or
      who are smokers. In doing so, it will determine the effects of hyperoxia or inflammation on
      the lung.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals exposed to oxygen or who are smokers.@@@
      
Keywords: Oxygen; Bronchoalveolar Lavage; DNA Repair; Carbonyl Groups; Serum; Human Volunteers
Influence of Genetic Polymorphism of Donor on Tacrolimus Concentration in Liver Transplant
Condition: Liver Transplantation
Study type: Observational

Summary: 
      To study the influence of donor's ABCB1、CYP3A4、CYP3A5、POR genetic polymorphism on tacrolimus
      blood concentration in liver transplant recipients.
    

Detailed description: 
      This study will start with a retrospective data analysis. The investigators will use the
      electronic databases of National Taiwan University Hospital to identify patients who
      underwent liver transplantation, received tacrolimus and were still followed up at the
      outpatient clinic. Inclusion and exclusion criteria will be applied to screen appropriate
      participants, and find their donors. And analyze the effect of genetic polymorphism
      (ABCB1、CYP3A4、CYP3A5、POR) of donors, including other factors of recipients, on the dose
      normalized trough concentration of tacrolimus.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        liver transplant patients' donors
      
Biospecimen description: 
      whole blood , paraffin-embedded liver biopsy, or saliva
    
Keywords: Tacrolimus; Pharmacokinetics; Genetic polymorphisms
Medical Treatment of "High-Risk" Neurofibromas
Condition: Neurofibromatosis 1
MeSH terms: Neurofibromatoses; Neurofibromatosis 1; Neurofibroma
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients with neurofibromatosis type 1 (NF1) commonly develop non-cancerous tumors called
      plexiform neurofibromas. These tumors can be defined as "high-risk" when they result in
      severe pain, physical disability, organ dysfunction and/or become life-threatening.
      Presently, there is no effective medical therapy to offer patients with "high-risk" plexiform
      neurofibromas, and surgery does not provide lasting help. This study will evaluate the
      effectiveness of two treatment combinations in patients with "high-risk" plexiform
      neurofibromas.
    

Detailed description: 
      The study's design involves treating eligible patients with a combination of celecoxib and
      pegylated interferon alpha-2b. If the patients have at least a partial response after six
      months, they may continue on the same treatment for up to two years. If the patient
      experiences less than a partial response, or has progressive disease after six months of
      therapy, then vincristine and temozolomide will be added to the celecoxib and interferon
      alpha-2b backbone. Response to treatment will be assessed after a minimum of six months,
      presuming the patient has not experienced progressive disease. Total duration of therapy on
      study is two years for any individual treatment plan.
    

Intervention name(s): Peg-Interferon alpha-2b; Celecoxib (Celebrex); Temozolomide (temodar); Vincristine Sulfate (Oncovin)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): age and weight dependant; age and weight dependant; age and weight dependant; age and weight dependant
Intervention MeSH terms: Interferons; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b; Celecoxib; Vincristine; Temozolomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neurofibromas; Neurofibromatosis 1; Celecoxib; Celebrex; Peg-Interferon alpha-2b; PEG-Intron; Temozolomide; Temodar; Vincristine Sulfate; Oncovin
Pharmacokinetics of Anti-epileptic Drugs in Obese Children
Condition: Epilepsy; Obese
MeSH terms: Epilepsy
Study type: Observational

Summary: 
      The study is a prospective, multi-center, open-label clinical trial. Study's purpose is to
      characterize the pharmacokinetics and safety of four oral anti-epileptics drugs
      (levetiracetam, valproic acid [divalproex sodium ER or immediate release formulation if
      inadequate enrollment}, topiramate, and oxcarbazepine) in a non-randomized sample of obese
      children and adolescents. The study's duration will be up to eleven days (up to seven days of
      screening and four days of pharmacokinetic sampling). Eligible participants ages 2 to 18
      years will be identified through outpatient clinic schedules and inpatient admissions at each
      clinic site. Participants receiving at least one of the study drugs per local standard of
      care will have pharmacokinetic concentrations in plasma drawn according to the specific
      dosing schedule for each drug. Other study measures include demographics, BMI, waist/hip
      ratio, medical history, concomitant medication history, documentation of study drug oral
      intake, adverse effects, and physical examination. The sample size will include 24
      participants for each anti-epileptic drug (total 96).
    


Intervention name(s): Anti-epileptics
Intervention type(s): Other
Intervention MeSH terms: Anticonvulsants
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children with epilepsy who are inpatients in local hospital or managed in outpatient
        settings - community sample.
      
Keywords: Epilepsy; Obese
Platelet Rich Plasma Study in Lower Extremity Bypass Surgery
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Observational

Summary: 
      The use of platelet rich plasma will decrease wound infection postop.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Vascular surgical patients scheduled for elective lower extremity bypass surgery,aortoiliac
        revascularizations and endovascular AAA repair requiring a groin incision
Effects of a Workplace Prevention Program for Problematic Gambling
Condition: Gambling
MeSH terms: Gambling
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effects of a workplace prevention program
      targeting problematic gambling.
    

Detailed description: 
      There is a considerable knowledge-gap regarding the efficacy of problem gambling prevention
      in workplace settings. At the same time, this knowledge is widely requested upon both by
      researchers and government agencies. The evaluation of prevention programs is important both
      in a public health perspective and for the organizations investing in preventive
      interventions for problem gambling at the workspaces and the current study aims to contribute
      with knowledge regarding the potential effects of such an intervention.

      The purpose of this study is to determine the effects of a workplace prevention program
      regarding problematic gambling, on a variety of outcomes. The authors hypothesize that the
      program will lead to differences in:

        -  A change in gambling habits among coworkers and managers

        -  That fewer workers and managers will report problem gambling

        -  That the managers who participate in the intervention will report being more confident
           in handling gambling and problem gambling at the workplace

        -  That the managers who participate in the intervention will report a higher inclination
           to engage in a conversation with an employee when suspicion or worry about problem
           gambling arises

        -  That the number of actions to help employees with problem gambling or other types of
           harmful use will raise among organizations who participate in the intervention.

        -  An increase in the employees' knowledge about what kind of support regarding gambling or
           addiction is available from the workplace and where to find it.
    

Intervention name(s): Prevention program for gambling in the workplace
Intervention type(s): Other
Intervention description(s): The intervention group will receive a gambling prevention program which includes generating and implementing policies and education on addiction and gambling. The full length of the program will be about 14 hours.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: gambling prevention; workplace policy
Pharmaco-Scintigraphic Study to Evaluate the Release Profile of Metronidazole Benzoate Capsules
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, open label, single-site trial to evaluate the in vivo release
      characteristics in the gastrointestinal tract of metronidazole benzoate capsules designed to
      disintegrate in the large intestine. This will be examined by means of metronidazole plasma
      levels and scintigraphic images in healthy subjects. Overall, nine subjects will be evaluated
      for each formulation prototype. Two formulation prototypes will be investigated. Each subject
      will receive one radio-labelled capsule only.
    


Intervention name(s): Metronidazole Benzoate gastro-resistant capsule with radio-labelled mucoadhesive formulation; Metronidazole Benzoate gastro-resistant capsule with radio-labelled non-mucoadhesive formulation
Intervention type(s): Drug; Drug
Intervention MeSH terms: Metronidazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science