bioihbjkbjnl/mcl2 huggingface dataset:
Electrogastrogram (EGG) Reproducibility Study: EEG Readings in Normal Subjects and Dyspeptic Patients
Condition: Functional Dyspepsia
MeSH terms: Dyspepsia
Study type: Observational

Summary: 
      The primary objective of this study is to determine whether EGG readings obtained from both
      normal subjects and dyspeptic patients are reproducible from one EGG recording to another on
      a different day.

      The secondary objective of this study is to determine whether the EGG readings are analyzed
      and diagnosed consistently when reviewed and compared by multiple blinded readers when the
      same tracing is reviewed.
    

Detailed description: 
      This is a single-center study. The duration of this trial is estimated to be six months. A
      total of Forty (40) subjects will be recruited into this study. It will be two Groups; ten
      (10) normal healthy subjects will be recruited by poster advertisement and thirty (30)
      patients who either present to the Gastroenterology Department of Temple University Hospital
      with varying signs, symptoms or complaints of gastric discomfort, or who are scheduled to
      undergo an EGG test by their Gastroenterologist.

      Each study subject/patient will have a total of two (2) EGGs with Water load tests performed
      for this study. Each EGG exam will be performed approximately one (1) week of each other, but
      no more than 4 weeks apart, and will be read in a blinded fashion by three (3) separate
      independent readers, in order to see if the readings are consistent with the previous
      readings that were obtained, as well as, by the readers themselves (Inter-reader rater
      reliability). Each reader will be blinded to the subject status (normal/healthy or patient)
      and also to the specific test they are reading (initial exam [Visit 1], or follow-up exam 1
      week after Visit 1 [Visit 2]). All EGG exam results will be coded in order to keep them
      blind.
    

Time perspective: Prospective
Keywords: Functional Dyspepsia; Electrogastrography
Study of ChimeriVax™ Tetravalent Dengue Vaccine in Healthy Peruvian Children Aged 2 to 11 Years
Condition: Dengue Virus; Dengue Fever; Dengue Hemorrhagic Fever; Dengue Diseases
MeSH terms: Dengue; Hemorrhagic Fevers, Viral; Severe Dengue; Fever; Hyperthermia
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the trial was to evaluate the use of a tetravalent vaccine, CYD dengue vaccine,
      against dengue disease.

      Primary Objectives:

        -  To describe the humoral immune response to dengue before and after each vaccination with
           dengue vaccine in two age cohorts of children (6 to 11 years and 2 to 5 years)
           previously vaccinated with yellow fever (YF) vaccine.

        -  To evaluate the safety of each vaccination with dengue vaccine in two age cohorts of
           children (6 to 11 years and 2 to 5 years).

        -  To describe viremia after the first and second vaccinations with dengue vaccine in a
           subgroup of 130 randomized participants (100 participants in Dengue Vaccine Group and 30
           participants in Control Group) in two age cohorts of children (6 to 11 years and 2 to 5
           years).
    

Detailed description: 
      Participants were randomized to receive either three injections of CYD dengue vaccine or two
      injections of placebo, and one injection of a pneumococcal polysaccharide vaccine (Pneumo23®)
      at 0, 6, and 12 months, respectively.
    

Intervention name(s): CYD Dengue Vaccine Serotypes 1, 2, 3, and 4; Pneumococcal polysaccharide vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Subcutaneous (SC); 0.5 mL, SC
Other intervention name(s): ChimeriVax™; Pneumo23®
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dengue virus; Dengue fever; Dengue Hemorrhagic fever; Dengue diseases; Dengue vaccine
Caudal Epidural Block Versus Ultrasound-Guided Pudendal Nerve Block for Pediatric Circumcision
Condition: Circumcision
Study type: Observational

Summary: 
      The regional anesthesia methods of caudal epidural block (CEB) and dorsal penile nerve block
      (DPNB) play an important role in providing postoperative pain control in pediatric
      circumcision surgery. However, the short-term postoperative analgesic effect and the risk of
      block failure limit the use of DPNB, a peripheral nerve block.
    

Detailed description: 
      CEB is a neuraxial block and commonly used to control moderate and severe postoperative pain
      following surgery related to the lumbosacral and midthoracic dermatomes. CEB can have serious
      undesirable complications such as intravascular and subarachnoid injection, urinary retention
      and motor block. Pudendal nerve block can be used as an alternative to both DPNB and CEB for
      penile surgery such as circumcision. The pudendal nerve is a peripheral nerve combining the
      anterior rami of the sacral plexus nerves (S2-S4) and provides motor and sensory innervation
      to the perineal region.
    

Intervention name(s): Caudal epidural block group; Pudendal nerve block group
Intervention type(s): Procedure; Procedure
Intervention description(s): The linear probe of ultrasound was then rotated 90 degrees and placed longitudinally in the midline to evaluate the sacral cornus, sacrococcygeal ligament and sacral bone. A 22 Gauge 50 mm echogenic block needle was advanced; A 22 Gauge 50 mm insulated needle was then introduced in the anterior-posterior direction at the middle of the ultrasound probe's superior edge with an out-of-plane approach and using an inclination of 15° in the sagittal plane. The needle tip's position was identified by direct visualization using the movement of adjacent anatomical structures.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Male patients aged between 4-12 years in the ASA (American Society of Anesthesiologists)
        I-II group and scheduled for circumcision
      
Keywords: Ultrasound; Pudendal nerve block; Caudal epidural block; Pain
Metformin as Add-on to the Standard Therapy in Patients With Chronic Hepatitis B
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional

Summary: 
      This is a randomized, double-blind, placebo-controlled trial to assess the efficacy and
      safety of metformin as add-on to entecavir therapy in patients with chronic hepatitis B.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled trial to assess the efficacy and
      safety of metformin as add-on to entecavir therapy in patients with chronic hepatitis B.
      Patients with chronic hepatitis B who met eligibility criteria were randomly assigned (1:1)
      to receive either metformin (1000 mg, oral, once a day) or placebo (oral, once a day) for 24
      weeks in addition to their ongoing entecavir therapy. Patients and investigators were both
      blinded to group allocation. The primary outcome, serum HBsAg level (log IU/mL) at weeks 24
      and 36, was analysed using a linear mixed-effect model. The intention-to-treat populations
      were included in primary and safety analyses.
    

Intervention name(s): Metformin & Entecavir; Placebo & Entecavir
Intervention type(s): Drug; Drug
Intervention description(s): Adding sustained-release metformin hydrochloride (1000 mg, oral, once a day) for 24 weeks to the ongoing entecavir therapy (0.5 mg, oral, once a day); Adding placebo (oral, once a day) for 24 weeks to the ongoing entecavir therapy (0.5 mg, oral, once a day)
Other intervention name(s): Combination Therapy; Standard Therapy
Intervention MeSH terms: Metformin; Entecavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Metformin; Entecavir; chronic hepatitis B; hepatitis B virus
CSE for Labour Analgesia: A Comparison of Two Intrathecal Regimens
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Analgesia in labour is not readily available in many parts of Sub-Saharan Africa. The overall
      cost of Epidural services in terms of human personnel and financial implication makes this
      inaccessible to many women in labour. Thus, a cheaper, less technically demanding and easier
      option that can produce as much satisfaction for the parturient and would allow her
      participate in the second stage of labour by being able to bare down is being studied.

      The Single Shot Spinal (SSS) would provide pain relief in these women however its draw back
      is its time limitation as the option of a top up is not available.

      Two regimen of drug options would be considered using opioids. These would be compared to see
      how well they are able to provide analgesia in women who hitherto have had vaginal birth.
      Their onset, duration of action and possible side effects would be compared.

      NULL HYPOTHESIS: Single Shot Spinal with Bupivacaine Fentanyl (BF) cannot provide a
      statistically significant difference in labour analgesia in comparison with Bupivacaine
      Fentanyl Morphine (BFM) ALTERNATE HYPOTHESIS: Single Shot Spinal with BF can provide a
      statistically significant difference in labour in comparison with BFM
    

Detailed description: 
      A double blinded randomized study comparing 2 intrathecal mixtures for labour analgesia.

      94 multiparous parturients in active labour who have given informed consent would be
      recruited into the study. They would be randomly allocated into 2 groups using simple random
      sampling. An Assistant would know the code and prepare the intrathecal solutions.

      Baseline vitals would be taken and patient's pain score noted. Due protocol would be followed
      and a combined spinal epidural sited but with the epidural not activated until the effect of
      the spinal wears off.

      Routine monitoring would be done and various parameters and indices noted. Where the effect
      of the spinal lasts the duration of labour thus no need to activate the epidural, this would
      also be noted.

      Data would be analysed using Statistical Package of Social Sciences (SPSS) version 20.
    

Intervention name(s): Bupivacaine-fentanyl; Bupivacaine-fentanyl morphine
Intervention type(s): Drug; Drug
Intervention description(s): Dosages as previously written; Dosage as previously written
Intervention MeSH terms: Fentanyl; Morphine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 2 groups that would remain with the randomly picked intervention throughout the study duration
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Single Shot Spinal; Intrathecal narcotics; Morphine; Fentanyl; Labour Analgesia
A Study of JNJ-80202135 in Healthy Chinese Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetic (PK) of nipocalimab following
      single intravenous (IV) administration in healthy Chinese participants.
    


Intervention name(s): Nipocalimab
Intervention type(s): Drug
Intervention description(s): Nipocalimab will be administered as an IV infusion.
Other intervention name(s): JNJ-80202135
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Pediatric Femur Research Project
Condition: Femur Fracture
MeSH terms: Femoral Fractures
Study type: Observational

Summary: 
      Current treatment protocol for pediatric femoral shaft fractures is immediate spica casting
      for patients 6 years and younger and for patients over 6 years and older is percutaneous or
      open placement of titanium elastic intramedullary nails. The investigators would like to
      evaluate the current treatment protocol by comparing those patients 6 years and younger
      treated with closed reduction and spica casting to those 6 years and younger treated with
      percutaneous pinned with titanium elastic intramedullary nails or submuscular plating. The
      investigators will be comparing their post-operative functional level, pain management,
      impact on family and complications through chart and x-ray reviews. The goal is to improve
      patient care pre and post-operatively for those who have sustained a femoral shaft fracture 6
      years old and younger and increase the knowledge of those residents/physicians who care for
      this patient population.
    


Intervention name(s): femur fracture repair
Intervention type(s): Procedure
Intervention description(s): all participants will have undergone surgical intervention to repair a femur fracture, the investigators will simply be collecting data after the procedure; participants will not be consented until after the procedure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients will have undergone of the following interventions for the treatment of the femur
        fracture: spica casting, nancy nailing, or submuscular plating, by a participating
        physician in the trial. All of these treatments are considered standard of care for this
        pediatric population.
      
Keywords: Orthopedic Procedures; Fracture Fixation, Internal; Fracture Fixation, External; femur fracture; pediatrics
Safety of NNC 0123-0000-0338 in Healthy Subjects
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to investigate the safety,
      tolerability, pharmacokinetics (the exposure of the trial drug in the body), and the
      pharmacodynamics (the effect of the investigated drug on the body) of NNC 0123-0000-0338 as
      tablets in healthy subjects.
    


Intervention name(s): NNC 0123-0000-0338; placebo; insulin glargine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects will be randomised to receive a single dose of NNC 0123-0000-0338 (tablet), at 7 escalating dose levels. Progression to next dose level will be based on a safety evaluation.; Subjects will receive a single dose of placebo (tablet), as a comparator to NNC 0123-0000-0338 at all dose levels. Placebo dose remains the same at all dose levels.; As an open label active comparator, a single dose of insulin glargine will be administered subcutaneously (under the skin), at all dose levels. Insulin glargine dose remains the same at all dose levels.
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study Aimed at Assessing the Pharmacokinetic Properties of RGB-10 and Forsteo
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Pharmacokinetic properties, safety and tolerability of RGB-10 and Forsteo will be compared in
      healthy female volunteers.
    


Intervention name(s): RGB-10; Teriparatide
Intervention type(s): Drug; Drug
Intervention MeSH terms: Teriparatide
Keywords: female; volunteers
To Assess the Efficacy and Safety of INCB054707 in Participants With Hidradenitis Suppurativa
Condition: Hidradenitis Suppurativa; Acne Inversa
MeSH terms: Hidradenitis Suppurativa; Hidradenitis
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the efficacy and safety of INCB054707 in participants with hidradenitis
      suppurativa over a 16-week placebo-controlled treatment period followed by a 36-week
      open-label extension period. All eligible participants will be invited to continue treatment
      for an additional 48-week Long-term extension period (also open label).
    


Intervention name(s): INCB054707; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Tablet; Oral; Tablet
Other intervention name(s): Povorcitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Long Term Albumin 20% Administration in Patients With Cirrhosis and Ascites.
Condition: Cirrhosis; Ascites
MeSH terms: Liver Cirrhosis; Fibrosis; Ascites
Study type: Interventional
Phase: Phase 4

Summary: 
      Effects of long term albumin administration on the cardiocirculatory and renal function and
      hepatic hemodynamics in patients with advanced cirrhosis and ascites.
    

Detailed description: 
      Pharmacodynamic study of pathophysiological nature to assess the effects of prolonged
      administration of human albumin in the cardiocirculatory and renal function and hepatic
      hemodynamics in patients with advanced cirrhosis and ascites.
    

Intervention name(s): Albumin
Intervention type(s): Drug
Intervention description(s): The pattern of administration of 20% human albumin is 1.5g/kg every week to be infused in 6 hours with a minimum of 90g up and a maximum of 150g in patients weighing less than 60 kg and more than 100 kg, respectively. Treatment duration is 12 weeks, which are 13 administrations of albumin.
Other intervention name(s): Albutein 20%
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
(-)- Epicatechin Becker Muscular Dystrophy
Condition: Becker Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 48-week open-label extension of our initial proof-of-concept study (UCD0113) in
      patients with Becker muscular dystrophy who participated in the earlier trial. This single
      center study will enroll up to 10 adults who will receive the purified nutritional extract
      (-)-epicatechin 100mg/day orally for 8 weeks. After screening visits, participants will be
      enrolled in the study if they meet all inclusion criteria. They will be evaluated at
      screening, baseline, and weeks 4, 8, 12, 24, 16 and 48. The main criterion for success of the
      study will be presence of one or more biologic or strength and performance outcome measures
      that yield a response magnitude that allows for sufficient power in a Phase II B study with a
      sample size of 30 individuals.
    


Intervention name(s): (-)-Epicatechin
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: BMD; Becker muscular dystrophy; epicatechin; clinical trial; neuromuscular disease
Web-Based Intervention Designed to Educate and Improve Adherence Through Learning to Use Continuous Glucose Monitoring
Condition: Type 1 Diabetes Mellitus; Continuous Glucose Monitor
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The goal of this pilot study is to produce a high-quality, theory-driven, therapeutic,
      web-based intervention that provides extended training and peer support to adolescents and
      young adults with type 1 diabetes who are newly implementing CGM. Overall, this web-based
      intervention represents an efficient way to bring together professionally-supported CGM
      educational materials and social support to overcome known barriers and address factors
      associated with inconsistent CGM use.
    


Intervention name(s): Web-Based Education; Social Support; Standard of Care
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Completion of a CGM specific web-based educational intervention that includes a series of online learning modules.; Engagement in peer-led CGM specific discussion boards; Standard of Care - serves as the control group for the treatment arm
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, un-blinded intervention/control design
Masking: None (Open Label)
Primary purpose: Treatment
Work Activity Augmented by Cognitive Rehabilitation for Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This research investigates the benefits of productive activity and cognitive rehabilitation
      for patients with schizophrenia. Key questions are:

        1. does cognitive rehabilitation plus work activity produce better outcomes than work
           activity alone?

        2. Is cognitive rehabilitation more helpful for individuals with moderate or greater
           cognitive impairment than for individuals without such impairment?

        3. Does cognitive rehabilitation reduce the dropout rate and increase participation in work
           activity for cognitively impaired subjects?

        4. What features of cognitive rehabilitation are most important for clinical and
           rehabilitation outcomes?
    

Detailed description: 
      This is a randomized, matching study in which subjects are stratified by degree of cognitive
      impairment, then randomly assigned to one of two conditions: Work Services Only vs. Work
      Services plus cognitive rehabilitation. Longitudinal analysis of work activity, work
      performance, symptoms, quality of life, cognitive function and service utilization are made.
    

Intervention name(s): cognitive rehabilitation; work therapy; work therapy
Intervention type(s): Behavioral; Procedure; Behavioral
Intervention description(s): computer training; opportunity to work in carefully supervised hospital job; work therapy
Other intervention name(s): computer training; IWT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: work therapy; cognitive rehabilitation; schizophrenia; schizoaffective disorder; treatment outcome
Immunogenicity and Safety Study of GSK Biologicals' Influenza Vaccine When Administered in Children
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to assess the safety and immunogenicity of GlaxoSmithKline (GSK)
      Biologicals' investigational vaccine GSK2321138A in children aged 3 to 17 years, and to
      describe safety and immunogenicity of the GSK Biologicals' investigational vaccine
      GSK2321138A in children aged 6 to 35 months.
    


Intervention name(s): Influenza vaccine GSK2321138A; FluarixTM; Influenza vaccine GSK2604409A
Intervention type(s): Biological; Biological; Biological
Intervention description(s): intramuscular injections; intramuscular injections; intramuscular injections
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: GSK Biologicals influenza vaccine GSK2321138A; influenza infection