bioihbjkbjnl/mcl2 huggingface dataset:
Patient-driven Compression in Urography
Condition: Urologic Diseases
MeSH terms: Urologic Diseases
Study type: Interventional

Summary: 
      Compression of the abdomen during urography with either a patient-regulated compression
      device or conventional compression.

      Evaluation of radiation dose, image quality and patients' experiences
    

Detailed description: 
      Patients are subjected to radiation from radiographical studies. The nurse can reduce the
      radiation dose for the individual by using dose-reducing measures. One of these is
      compression. It is known that compression in urography reduces the radiation dose because the
      radiation has less tissue to transverse when it is compressed. By reducing patient radiation
      doses, the risk of harmful radiation effects is reduced. This study aims to study if a
      patient-regulated compression device can reduce the radiation dose as effectively as the
      conventional compression, regulated by the nurse.

      Two compression devices are investigated in each patient, in randomized order.

      Aims of the study:

        1. Evaluate if the radiation doses are comparable with a patient-regulated compression
           device and conventional compression.

        2. Evaluate image quality with the two devices.

        3. Describe patients' experiences from using the two devices.
    

Intervention name(s): Patient-regulated compression device; Standard compression device
Intervention type(s): Device; Device
Intervention description(s): Compression of the abdomen with a patient-regulated compression device; Compression of the abdomen with the standard compression device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Urography; Radiation dosage; image enhancement
Compassionate Use of Omegaven to Reverse Parenteral Nutrition Induced Cholestasis
Condition: Cholestasis
MeSH terms: Cholestasis
Study type: Interventional

Summary: 
      The purpose of this research study is to see if giving Omegaven (an intravenous fat emulsion
      containing fish oil) instead of the current lipid emulsion, which contains fat derived from
      soybeans, as part of your child's intravenous (IV) nutrition therapy may be tolerated better.
      It may reduce the harmful effects to the liver, may stop any further liver damage and may
      reverse damage already done to the liver because of the prolonged use of nutrition through
      your child's IV.
    

Detailed description: 
      Enrollment of subjects into this study will occur for up to 4 years. Subjects will receive
      Omegaven at a dose of up to 1 g/kg body weight/day until they no longer require total
      parenteral nutrition or until their conjugated/direct bilirubin has normalized and their
      enteral lipid intake is sufficient to discontinue intravenous lipids.
    

Intervention name(s): Omegaven
Intervention type(s): Drug
Intervention description(s): For the first two days of treatment, subjects will receive Omegaven® at 0.5 g/kg per day to assess tolerance and will progress to a maintenance dosage of up to 1g/kg per day over 12 hours at an infusion rate of 1 g/kg/12 hours (10 ml/kg/12 hours). Dosing is based on previously described dosing of fish-oil emulsions as monotherapy noted within the literature. Omegaven® will be infused intravenously through either a central or peripheral catheter in conjunction with other parenteral nutrition containing dextrose and amino acids. Omegaven® is isotonic. It is compatible with parenteral nutrition solutions and may be co-infused via y-site.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parenteral Nutrition; Cholestasis
Study on the Effect of Capacity Shock Intervention Under Goal-directed Hemodynamic Management on P-V Loop
Condition: Hemodynamics
Study type: Interventional

Summary: 
      By observing the changes of P-V loop in capacity shock intervention Under Goal-directed
      Hemodynamic Management in patients undergoing total knee replacement, we investigate the
      effect of capacity shock on cardiac contractility and work in order to seek a more effective
      target plan of capacity shock for intraoperative patients.
    

Detailed description: 
      Objective:By observing the changes of P-V loop in capacity shock intervention Under
      Goal-directed Hemodynamic Management in patients undergoing total knee replacement, we
      investigate the effect of capacity shock on cardiac contractility and work in order to seek a
      more effective target plan of capacity shock for intraoperative patients.

      Methods:20 patients with total knee replacement were enrolled in this study. Capacity shock
      therapy was used in Group A(n=10) and conventional strategy was used in Group B (n=10). V(t)
      was measured and calculated using TEE and P(t) was acquired by the analysis of
      patients'radial artery pressure waveform. We set five time points of parameter acquisition:
      after grouping (T1), the first shock completion(T2), the second shock completion (T3), 1h
      after shock treatment (T4), and operation completion(T5). We make up the P-V loop fitting
      P(t) and V(t) at each time point after the calibration of cardiac cycle.
    

Intervention name(s): Fluid challenge strategy; conventional strategy
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients received 2ml/kg of succinylateol gelatin within 10 min for fluid shock therapy after grouping, taking SVV as the management target. If SVV< 13% after shock therapy, the shock therapy was stopped and the infusion was maintained with 4ml/kg/h of crystal solution. If SVV ≥ 13% and ΔSV <10%, the individual would be excluded from the experiment. If SVV ≥ 13% but ΔSV≥10%, 2ml/kg of succinylateol gelatin was given again within 10 min for liquid shock therapy until SVV<13%, and 4ml/kg/h of crystal solution was maintained after reaching the target. If SVV≥ 13% after two shock treatments, they were excluded from the experiment. We excluded patients whose intraoperative bleeding ≥400ml and operative time ≥5 hours from the group.; 4ml/kg/h of crystal solution was maintained. We excluded patients whose intraoperative bleeding ≥400ml and operative time ≥5 hours from the group.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Single and Multiple Dose Pharmacokinetics of Sufentanil NanoTab
Condition: Plasma Concentrations
Study type: Interventional
Phase: Phase 1

Summary: 
      Determine the plasma concentration profile after single and multiple dosing of Sufentanil
      NanoTabs
    


Intervention name(s): Single dose of SUF NT 15 mcg; 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes
Intervention type(s): Drug; Drug
Other intervention name(s): Zalviso™
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Stage 3 Liver Fibrosis
Condition: Liver Fibrosis; Nonalcoholic Fatty Liver Disease (NAFLD); Nonalcoholic Steatohepatitis
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Liver Cirrhosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a study of experimental medication BMS-986036 given to adults with Nonalcoholic
      Steatohepatitis (NASH; the buildup of fat and inflammation in the liver that is not caused by
      alcohol) and stage 3 liver fibrosis (severe fibrosis).
    


Intervention name(s): BMS-986036; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Specified dose on specified days.; Specified dose on specified days.
Other intervention name(s): Pegbelfermin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Assessing Fever Rates in Children Ages 24 to 59 Months After Live Attenuated Influenza Vaccine (LAIV) or Inactivated Influenza Vaccines (IIV) Using Text Messaging for U.S. Influenza Vaccines in 2012-2013 & 2013-2014
Condition: Fever
MeSH terms: Influenza, Human; Fever
Study type: Interventional

Summary: 
      In this study, the investigators will prospectively assess fever rates in 24-59 month old
      patients during days 0-10 after administration of inactivated influenza vaccine (IIV) or live
      attenuated influenza vaccine (LAIV). Children in one of three study sites who receive these
      vaccines as part of their routine care can enroll in this study if their parent has the
      ability to receive and send text messages. Children enrolled in this study will be observed
      for an eleven day period starting on the day of vaccine administration via a series text
      messages to their parents.
    


Intervention name(s): text message surveillance for fever
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Comparative Clinical Trial of Lornoxicam to Diclofenac in Patients of Osteoarthritis of Knee Joint.
Condition: Osteoarthritis of Knee Joint
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      The purpose of this study was to compare the pain relieving action of the lornoxicam and
      diclofenac in patients of OA knee.
    


Intervention name(s): Diclofenac; Lornoxicam
Intervention type(s): Drug; Drug
Intervention description(s): Tab. Diclofenac 50 mg 12 hrly, orally, in morning and in evening after taking food for 3 months.; Tab. Lornoxicam 4 mg , orally, 8 hourly after taking food in morning , in noon and evening for 3 months.
Intervention MeSH terms: Diclofenac; Lornoxicam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intravenous Zotatifin in Adults With Mild or Moderate COVID-19
Condition: Corona Virus Infection
MeSH terms: COVID-19; Coronavirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and tolerability, the antiviral activity, and plasma pharmacokinetics
      (PK) of zotatifin administered intravenously (IV) to adults with mild or moderate COVID-19.
    

Detailed description: 
      This randomized, double-blind, placebo-controlled, dose-escalating study will evaluate the
      safety and efficacy of zotatifin administered IV to adults with mild or moderate COVID 19.

      Patients will be randomized to receive zotatifin or placebo in 3 cohorts of 12 patients each.
      Cohorts will be sequentially enrolled at progressively higher zotatifin dose levels. Study
      drug will not be administered to patients who are hospitalized. The second dose of study drug
      will not be administered should a patient progress from mild or moderate COVID-19 to severe
      COVID-19 prior to or on Day 8. Patients will assess and record their symptoms daily through
      Day 22 and at follow up (30 days after last infusion) (or at the early termination visit [if
      conducted]) in a paper patient diary using the WHO 9-point ordinal scale for clinical
      improvement. Other safety and efficacy measures will be assessed according to the Schedule of
      Procedures on Days 1, 4, 8, 10, 15 (end of treatment visit), and 22, and at follow up (30
      days after last infusion). On non-dosing days, study visits will be conducted as home health
      visits, except for the follow-up visit, which will be conducted as a telephone visit.
    

Intervention name(s): Zotatifin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Zotatifin is a potent and sequence-selective inhibitor of eukaryotic translation initiation factor (eIF) 4A1-mediated translation that imparts its regulation through a reversible enhancement of eIF4A1 binding to RNAs (ribonucleic acids) with specific polypurine motifs within the 5'-untranslated region (UTR).; 5% dextrose injection, USP
Other intervention name(s): Zota; PBO
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Patients will be randomized 3:1 to receive zotatifin or placebo in 3 cohorts of 12 patients each. Cohorts will be sequentially enrolled at progressively higher zotatifin dose levels: 0.01, 0.02, or 0.035 mg/kg.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COVID-19
A Study to Evaluate Pharmacokinetic, Safety, Tolerability and Relative Bioavailability of Gepotidacin in Healthy Adult Male and Female Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a randomized, open-label, two periods, cross-over pharmacokinetic, safety,
      tolerability and relative bioavailability of gepotidacin in healthy adult male and female
      participants of aged 18 to 50 years.
    


Intervention name(s): Gepotidacin
Intervention type(s): Drug
Intervention description(s): Gepotidacin will be administered
Intervention MeSH terms: Gepotidacin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a two periods, crossover study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gepotidacin; Relative Bioavailability; Healthy participants
A Single Center Study to Evaluate the Safety of the NovaCross Microcatheter in Crossing Chronic Total Occlusions
Condition: Chronic Total Occlusion
Study type: Interventional

Summary: 
      This is an open label, single-center, prospective, pivotal study in which the investigational
      device, NovaCross™ micro-catheter, will be tested in up to 15 patients scheduled to undergo
      CTO-PCI using an anterograde approach.
    


Intervention name(s): NovaCross
Intervention type(s): Device
Intervention description(s): A device that is intended to asisst interventional cardiologists during catheterization to cross and open coronary chronic total occlusions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of Tenoten in the Treatment of Children With Anxiety Disorders
Condition: Anxiety Disorder of Childhood
MeSH terms: Anxiety Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Purpose of the study:

      • evaluate the efficacy and safety of Tenoten for children in children with anxiety
      disorders.
    

Detailed description: 
      Design: a multicenter, double-blind, placebo-controlled, parallel-group randomized clinical
      trial.

      The study includs children of both sexes aged 5 to 15 years who were diagnosed by a
      neurologist with an anxiety disorder (according to the ICD-10, one of the variants of an
      emotional disorder with an onset specific to childhood - F 93).

      After a parent/legal representative signed an informed consent form for participation in the
      clinical trial at the screening visit (Visit 1, Day 0), patients underwent an initial
      examination, including medical history, assessment of vital signs, and physical examination;
      concomitant therapy was recorded. The initial severity of anxiety disorders (from mild to
      severe) was assessed using a scale for assessing the severity of anxiety in children (G.P.
      Lavrentieva, T.M. Titarenko), using an anxiety test (R. Temple, V. Amen, M. Dorki) and Spence
      Children's Anxiety Scale (SCAS). If the inclusion criteria were met and no exclusion criteria
      were met, the patient was included in the study and randomized to one of the groups: Tenoten
      for children or Placebo (day 0, visit 1). In the course of treatment, patients made 3 visits
      to the doctor within 12 weeks (at 4, 8 and 12 weeks), during which the dynamics of the
      severity of anxiety disorders were recorded using an anxiety test (R. Temple, V. Amen, M.
      Dorki) and SCAS; vital signs and physical examination were performed, prescribed and
      concomitant therapy were controlled. At visit 4 (week 12), doctor assessed the therapeutic
      dynamics and treatment side effects by the end of the treatment period in scores on the
      Clinical Global Impression (CGI) scale.
    

Intervention name(s): Tenoten for children; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration; Oral administration
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double-blind placebo-controlled randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pain in Carpal Tunnel Release Wide-awake Local Anesthesia With no Tourniquet vs Local Anesthesia With Tourniquet
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome
Study type: Interventional

Summary: 
      The aim of this study is to compare pain, satisfaction, and experience between patients who
      underwent Carpal Tunnel Release with wide-awake local anesthesia no tourniquet technique and
      local anesthesia with a tourniquet.
    

Detailed description: 
      The surgical pathology of the hand has grown exponentially. In most cases, the resolution is
      performed in outpatients with short surgical times. Given the increased demand for this type
      of surgery, surgeons have sought different variables to reduce the costs and human resources.
      Thus, the wide-awake local anesthesia no tourniquet procedure (WALANT). It deals with the
      non-need for anesthetic monitoring and with the regional use of anesthesia with epinephrine.

      Its use avoids placing a pneumatic cuff on the arm owing to the vasoconstrictive action of
      epinephrine. However, the drug takes 25-30 minutes to achieve the maximum hemostatic effect,
      and adverse effects, such as distal necrosis, have been reported.

      Therefore, the technique of local anesthesia without epinephrine with a tourniquet (LA-T) is
      also used daily by hand surgeons.

      The use of a tourniquet, a pneumatic cuff, for less than 20 minutes has been associated with
      the same or lower pain profiles than the wide-awake local anesthesia no tourniquet without
      running the risk of adverse effects of epinephrine.

      The objective of this study is to compare and assess pain and patient experience after
      short-duration hand surgery using the WALANT and LA-T techniques. The investigators
      hypothesized that both types of procedures had a similar level of satisfaction.
    

Intervention name(s): Carpal tunnel release, WALANT technique; Carpal tunnel release using a tourniquet
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients will receive 20 ml of 1% lidocaine with 1:100,000 epinephrine (buffered 10:1 with 8.4% sodium bicarbonate). Thirty minutes before carpal tunnel release surgery, 10 mL will be injected subcutaneously, and 10 mL will be injected into the carpal tunnel. Patients will go under open carpal tunnel release without a tourniquet.; Patients will receive 20 ml of 1% lidocaine with 1:100,000 epinephrine (buffered 10:1 with 8.4% sodium bicarbonate). Thirty minutes before carpal tunnel release surgery, 10 mL will be injected subcutaneously, and 10 mL will be injected into the carpal tunnel. Patients will go under open carpal tunnel release using a hemostatic cuff. The hemostatic cuff will be insufflated at the level of the arm at a pressure of 100 mmHg higher than the patient's systolic pressure. The cuff will be removed once wound closure is complete.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Trial of a Botulinum A Toxin (Botox) Injection in the Gastrocnemius Muscle in Children With Idiopathic Toe Walking
Condition: Idiopathic Toe Walking
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the effect of Botox and casting to placebo and
      casting for reducing toe walking problems in children who are idiopathic toe walkers.
    

Detailed description: 
      Patients who have been seen by one of the 5 paediatric orthopaedic surgeons at British
      Columbia's Children's Hospital and have been referred to the Shriner's gait lab for
      assessment of idiopathic toe walking will be eligible for the study.
    

Intervention name(s): Botox injections
Intervention type(s): Drug
Intervention description(s): Data not known.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Randomized control trial; placebo-control study
Prognostic Value of Arterial Spin Labeling Brain Perfusion MRI in Term Neonates With Hypoxic-ischemic Encephalopathy
Condition: Neonatal Hypoxic Ischemic Encephalopathy
MeSH terms: Brain Diseases; Brain Ischemia; Hypoxia-Ischemia, Brain; Ischemia; Hypoxia
Study type: Interventional

Summary: 
      The main purpose of this study will be to evaluate the prognostic value at 3 months of life
      of brain perfusion MRI determined by Arterial Spin Labeling technique in the first week of
      life of term newborns with hypoxic-ischemic encephalopathy requiring management in neonatal
      intensive care unit.
    

Detailed description: 
      Hypoxic-ischemic encephalopathy is the result of birth asphyxia due to transitory cerebral
      blood flow drop during perinatal period. It is the leading cause of neonatal encephalopathy,
      and thus a major cause of perinatal mortality, morbidity and adverse neurodevelopmental
      outcome. Usual care brain MRI is critically important in the diagnosis and prognosis. Lasting
      about 30 to 40 minutes, MRI exam includes successive sequences providing complementary
      information but none relatively to brain perfusion. Perfusion MRI without contrast media
      injection is possible using Arterial Spin Labeling (ASL) sequence. ASL is highly suitable for
      neonates, noninvasiveness, and lasts only 5 minutes. However, only one study assessed ASL as
      a prognostic factor. The purpose of the study is therefore to perform ASL sequence within
      usual care brain MRI.
    

Intervention name(s): Arterial Spin Labeling sequence
Intervention type(s): Device
Intervention description(s): ASL sequence added to the usual care brain MRI
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Hypoxic-ischemic encephalopathy; Neonate; Perfusion; MRI; Arterial Spin Labeling