bioihbjkbjnl/mcl2 huggingface dataset:
Immunogenicity, Safety of Measles-mumps-rubella-varicella Vaccine (MeMuRu-OKA) Compared to Priorix™ Given With Varilrix™
Condition: Varicella; Rubella; Measles; Mumps
MeSH terms: Measles; Chickenpox; Herpes Zoster; Rubella; Mumps
Study type: Interventional
Phase: Phase 2

Summary: 
      As measles-mumps-rubella (MMR) vaccination is established as routine childhood practice in
      most industrialised countries and varicella vaccination is now being introduced in many
      countries during the second year of life, a combined measles-mumps-rubella-varicella vaccine
      was developed for administration convenience and improved compliance to vaccination. To
      account for situations where children have received a first dose of MMR vaccine without
      varicella, this study will evaluate the effect of the combined
      measles-mumps-rubella-varicella vaccine given in place of the second dose of MMR vaccine. A
      second dose of the monovalent varicella vaccine will be given to all children participating
      to this trial since there is a current debate on the need of a second dose to induce a full
      protection against varicella.
    


Intervention name(s): MeMuRu-OKA (study vacc); MMR, Varicella vacc (control)
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Evaluation of Ciclo 21® Effect (Levonorgestrel + Ethinyl Estradiol) Compared to Nordette®.
Condition: Irregular Periods
Study type: Interventional
Phase: Phase 3

Summary: 
      Assessment of the pharmacodynamic profile of the drug Ciclo 21 ®, marketed by União Química
      Farmacêutica Nacional S / A, compared to the drug Nordette ® Laboratory Wyeth Pharmaceutical
      Ltda. Through the modulation of hormonal response (inhibition of the pituitary) evidenced by
      measurement serum LH and FSH for 28 days, as well as by the absence of follicle formation
      demonstrated by transvaginal ultrasound examinations
    

Detailed description: 
      secondary objective

        -  Evaluation of the safety aspects of medicines such as type, frequency and intensity of
           adverse events between groups during the 28 day trial.

      exploratory objective

        -  Evaluation of the pharmacokinetics of the drug administered through the dosage of serum
           hormone levonorgestrel and ethinyl estradiol for 28 days.
    

Intervention name(s): LNG+EE2; Nordette
Intervention type(s): Drug; Drug
Intervention description(s): Administration of one pill contained 0.15 mg of levonosgestrel and 0.03 mg of ethynil estradiol per day over 21 days.; Administration of one pill contained 0.15 mg of levonosgestrel and 0.03 mg of ethynil estradiol per day over 21 days.
Other intervention name(s): Ciclo 21; LNG+EE2
Intervention MeSH terms: Ethinyl Estradiol-Norgestrel Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: hormonal response, levonorgestrel, ethinyl estradiol
Treatment With Iovera° for Total Knee Arthroplasty (TKA) Post-Operative Pain
Condition: Total Knee Arthroplasty
Study type: Interventional

Summary: 
      This study is designed to investigate whether iovera° treatment prior to TKA decreases
      cumulative participant opioid use over the course of 6 weeks following TKA while maintaining
      similar levels of pain relief. The study will also investigate whether there is a
      relationship between participants treated with iovera° and participant reported pain and
      function as measured by knee injury and osteoarthritis outcomes score (KOOS JR), numeric
      rating scale (NRS) for pain; use of hospital services post-TKA and improved physical
      rehabilitation as measured by range of motion.
    


Intervention name(s): iovera°
Intervention type(s): Device
Intervention description(s): The iovera° device applies cold to a target nerve to cause a temporary peripheral nerve block based on a process called Wallerian degeneration (2nd degree axonotmesis) without disrupting connective nerve tissue.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The active group will receive the iovera° treatment prior to a TKA. The control group will receive a TKA and no iovera° treatment.
Masking: None (Open Label)
Primary purpose: Treatment
Dry Needling for Shoulder Pain in Stroke Patients
Condition: Stroke
MeSH terms: Shoulder Pain; Stroke
Study type: Interventional

Summary: 
      Spasticity and pain, particularly int he shoulder region, are the most common impairments
      experienced by subjects who had experienced a stroke. There is preliminary evidence
      supporting the role of dry needling for spasticity in patients who had suffered from a
      stroke. Few data exists on the effects on shoulder pain. In addition, it has been shown that
      application of dry needling induces post-needling soreness in individuals with
      musculoskeletal pain. No previous study has investigated the presence and the duration of
      post-needling soreness in individuals who had experienced a stroke.
    


Intervention name(s): Dry Needling; Physical Therapy
Intervention type(s): Other; Other
Intervention description(s): A single session of modulatory interventions combined with a single session of dry needling into the shoulder muscles which active trigger points will reproduce the shoulder pain symptoms.; A single session of modulatory interventions targeting modulation of central nervous system.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of PF-06412562 on Value-based Decision-making in Healthy Individuals
Condition: Decision Making
Study type: Interventional
Phase: Phase 1

Summary: 
      Numerous psychiatric and neurodegenerative diseases like schizophrenia, dependency on drugs
      of abuse, depression and Parkinson's disease are related to motivational and cognitive
      deficits in value-based decision making, which frequently persist even after a successful
      pharmacological treatment. According to current neurobiologic models, cortical dopamine D1
      receptors play a crucial role in taking value-based decisions. In this study, it will be
      investigated whether value-based decisions in healthy volunteers can be improved by
      stimulation of D1-receptors. For this purpose, a newly developed dopamine D1-agonist will be
      used, which selectively increases the activities of frontal D1- and D5-receptors. In this
      double-blind, randomized, placebo-controlled study, the effects of different single doses of
      PF-06412562, a not yet licensed D1-agonist, on value-based decision making will be compared
      with placebo. The use of different dosage strengths will allow to investigate a potential
      relationship between the extent of activity of the D1-receptor and its influence on
      behavioral indices.

      Therefore, four parallel groups will be investigated. Each participant takes in a single dose
      of either PF-06412562 in different doses or placebo. A screening exam will be carried out 1-3
      weeks before the drug intake, and a follow-up examination will be carried out approx. 1 week
      after the drug intake. At all 3 visits in the study centre, several tests for the
      investigation of value-based decision making will be carried out.
    


Intervention name(s): PF-06412562; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): double-blind oral intake of single doses of the aforementioned drug or placebo; double-blind oral intake of single doses of the aforementioned drug or placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Effect of Oat Compounds on Postprandial Glucose Response
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      In this project we will investigate synergistic effects of oat polar lipids and beta glucans
      on postprandial glucose tolerance
    


Intervention name(s): High beta glucans; Low beta glucans; Low beta glucans + low polar lipids; Polar lipids; Control
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): higher dose betaglucans; lower dose beta glucans; low dose betaglucans in a combination with low dose of polar lipids; low dose polar lipids; No beta glucans or polar lipids
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomised food study in healthy subjects
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Prevention; food; diabetes type 2; postprandial glucose regulation; appetite; oat; polar lipids; obesity; glucose tolerance
Metformin Therapy in HCV Infection
Condition: Chronic Hepatitis C Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      Hepatitis C virus infection (HCV) is a major cause of cirrhosis and death from liver disease
      worldwide. Current therapy for HCV with interferon based therapies results in cure rates of
      around 5055% which leaves a significant number of patients without effective therapy. HCV
      induces (can bring on) insulin resistance and insulin resistance is a factor known to reduce
      the response to antiHCV therapy. This finding stimulated initial studies looking at agents
      that may reduce insulin resistance as additional therapy in HCV infection.

      A study using metformin in addition to interferon and ribavirin showed a nonsignificant
      increase in cure rates (53% vs. 42%), but this was limited to patients with type 1 infection
      AND demonstrable insulin resistance. The assumption was made that the potential effect of
      metformin was likely to be on insulin resistance and thus by modulating this enhances
      response. The investigators (Prof M Harris, University of Leeds) have data (currently
      unpublished)suggesting that metformin may have an antiviral effect independent of its effect
      on insulin resistance, thus raising the possibility that metformin may have a direct
      antiviral effect in vivo. Given that the development of specific antiHCV agents which target
      viral proteins such as its polymerase and protease are in trial development but have so far
      proved either highly toxic or are likely to have a huge cost there is considerable rationale
      for looking at alternative potential antiHCV agents and in this context metformin is cheap,
      readily available and has an excellent safety profile. This pilot study therefore addresses
      the question "Does metformin therapy result in a significant drop in HCV viral load in
      chronically infected patients?"
    


Intervention name(s): Metformin
Intervention type(s): Drug
Intervention description(s): Oral Metformin 1g bd. (total = 2g per day) for 14 days
Other intervention name(s): Glucophage
Intervention MeSH terms: Metformin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Metformin Therapy in HCV
Safety of Two Doses of Avaxim® 80U Pediatric (Inactivated Hepatitis A Vaccine) in Toddlers, Children and Adolescents
Condition: Hepatitis A; Hepatitis A Virus
MeSH terms: Hepatitis A; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to describe the safety profile of Avaxim 80U Pediatric, in order to
      confirm the good safety profile of the vaccine.

      Primary objective:

        -  To describe the safety of Avaxim 80U Pediatric after each dose of vaccine administered 6
           months apart, in subjects aged 12 months to 15 years.
    

Detailed description: 
      Eligible participants aged 12 months to 15 years and 5 months (185 months) at enrollment will
      receive two doses of vaccine for the prevention of hepatitis A (6 months apart), and will be
      followed up for safety until 30 days after the second vaccination.
    

Intervention name(s): Avaxim 80U Pediatric: Inactivated Hepatitis A Virus
Intervention type(s): Biological
Intervention description(s): 0.5 mL, Intramuscular (2 injection 6 months apart)
Other intervention name(s): Avaxim 80U Pediatric
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hepatitis A; hepatitis A virus; Avaxim® 80U Pediatric
Diffusion-Tensor Magnetic Resonance Imaging (MRI) and the Evaluation of Perinatal Brain Injury
Condition: Brain Injury, Fetus and Neonate
MeSH terms: Brain Injuries; Wounds and Injuries
Study type: Observational

Summary: 
      The researchers' objective is to use diffusion-tensor imaging (DTI) to evaluate infants
      diagnosed with cerebral white matter injury during the neonatal period and identify antenatal
      risk factors, electronic fetal heart rate monitoring abnormalities, and umbilical arterial
      gas results that are associated with cerebral white matter injury. The researchers'
      hypothesis is that this new imaging technique will help us better understand how these
      devastating injuries occur.
    

Detailed description: 
      Maternal and neonatal data will be collected as well as the umbilical arterial gas results
      and the electronic fetal heart rate tracing of the labor. Infants will have a head ultrasound
      at 24-72 hours, 10-14 days, and at 4-6 weeks to look for cerebral white matter injury, as
      standard of care. All infants with a birth weight < 1500 grams will be offered DTI, and
      infants > 1500 grams with white matter injury diagnosed by ultrasound will be imaged as well
      as the subsequent delivery born within 7 days of that gestational age without brain injury.
      All infants will have the DTI brain scan at 12-18 months of age corrected for the degree of
      prematurity, and will also have a formal neurological assessment at that time.
    

Intervention name(s): Diffusion-tensor imaging
Intervention type(s): Procedure
Intervention description(s): Obtain a Diffusion tensor MRI of brain.
Other intervention name(s): No other names applicable.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Neonates < 1500 grams, with suspected brain injury, and with severe metabolic acidosis
      
Keywords: Perinatal brain injury; Diffusion-tensor imaging
Motivated Behavior in Adults With and Without ADHD
Condition: ADHD
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate the effects of methylphenidate on motivated behavior in adults with and
      without ADHD
    

Detailed description: 
      This study has a mixed between- and within-subject design. Participants are young adults
      (aged 18-45) with ADHD and non-ADHD matched controls. They will be recruited from locations
      around the community, consented, screened for eligibility, then scheduled for 2 study days.
      Study days will be at least 48 hours apart. Thus, there will be a total of 3 lab visits
      across a 3 week period. Participants will be administered study drug on one study day and
      placebo on the other study day. They will complete a battery of cognitive/behavioral tasks
      and answer questionnaires on both study days.
    

Intervention name(s): ADHD methylphenidate first, placebo second; ADHD placebo first, methylphenidate second; Non-ADHD methylphenidate first, placebo second; Non-ADHD placebo first, methylphenidate second
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): double-blind, counter-balanced administration; double-blind, counter-balanced administration; double-blind, counter-balanced administration
Intervention MeSH terms: Methylphenidate
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: There are two parallel arms of this study (ADHD or non-ADHD subjects).
Within each arm, each subject will be exposed to placebo and a drug (each at a different timepoint in the study). Although all subjects will receive both placebo and the drug, the order of presentation of the placebo and drug is counterbalanced across subjects (i.e., approximately half will receive the drug first and approximately half will receive the placebo first).
For both study arms, regardless of whether the placebo is received first or second, the outcome measure will be calculated as the number of high effort selections.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Study of Neoadjuvant Myocet®, Paclitaxel, Pertuzumab, and Trastuzumab in HER2-positive Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a prospective, multicenter, single-arm, phase II study to evaluate the safety of
      neoadjuvant liposomal doxorubicin plus paclitaxel, trastuzumab, and pertuzumab in patients
      with HER2-positive breast cancer
    


Intervention name(s): Liposomal Doxorubicin
Intervention type(s): Drug
Intervention description(s): Six cycles of:
Trastuzumab 4 mg/kg loading dose on Day 1 of the first cycle, then 2 mg/kg on Days 8 and 15 of the first cycle and on Days 1, 8, and 15 of the subsequent cycles, every 3 weeks
Pertuzumab 840 mg loading dose on Day 1 of the first cycle, then 420 mg on Day 1, every 3 weeks
Liposomal doxorubicin 50 mg/m2 on Day 1, every 3 weeks
Paclitaxel 80 mg/m2 on Days 1, 8, and 15, every 3 weeks
Other intervention name(s): Myocet® (liposome-encapsulated doxorubicin)
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast Cancer; HER2 positive; Neoadjuvant; Liposomal doxorubicin; Paclitaxel; Trastuzumab; Pertuzumab; Safety
Neuroscience Pain Education in Patients With Chronic Low Back Pain
Condition: Chronic Low Back Pain; Manual Therapy; Neuroscience Pain Education
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The cognitive educational strategies such as neuroscience pain education, has been a popular
      and promising technique for treatment patients with chronic pain. However, there are not
      sufficient randomized controlled and blinded studies to explore clinical effectiveness of
      these techniques. Therefore, the aim of this study was determining the short- and mid-term
      effects of neuroscience pain education combined with manual therapy and home exercise on pain
      level, disability, and kinesiophobia in patients with chronic low back pain.
    


Intervention name(s): neuroscience pain education; manual therapy; home exercises
Intervention type(s): Other; Other; Other
Intervention description(s): A total of 4 NPE (Neuroscience paine education) sessions were held, once each week, before an MT session. The NPE sessions were conducted by an experienced physiotherapist certified in NPE in face-to-face, one-on-one sessions lasting 40-45 minutes. In NPE, the patient is taught about the physiology of pain, central sensitization, representation of the different body regions in the brain, pain-related changes in body perception, and the psychosocial dimensions of pain.; In our study, Manual therapy (MT) was individualized according to each patient's response to treatment. In this method, the physiotherapist identifies and performs techniques suitable for the patient's symptoms. If the selected techniques do not have a direct positive effect on the patient's symptoms, they are replaced with other techniques.MT were performed in a total of 8 sessions, held twice a week for 4 weeks. Treatment sessions lasted an average of 40-45 minute.The entire treatment program was carried out by the same physiotherapist who is trained and experienced in this area.; All participants in all groups were assigned the home exercise program. The program aims to increase strength and flexibility of the abdominal, erector spinae, gluteal, quadriceps, and hamstring muscles. The participants were then asked to perform all of the exercises with 10 repetitions of each exercise 3 times a day for 4 weeks.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Correlation of Right-left Shunt Detection in Cardioembolism Etiology in Stroke Patient.
Condition: Foramen Ovale Patent
MeSH terms: Foramen Ovale, Patent
Study type: Observational

Summary: 
      The aim of the study is to compare correlation for right to left shunts (mainly patent
      foramen ovale) detection for three methods-transesophageal echo as a gold standard,
      transcranial doppler with contrast agent (microbubbles) and new method- Flow detection system
      ( Cardiox TM) in young stoke patients ( age under 55 years).
    

Detailed description: 
      The aim of the study is to compare correlation for right to left shunts (mainly patent
      foramen ovale) detection for three methods-transesophageal echo as a gold standard,
      transcranial doppler with contrast agent (microbubbles) and new method- Flow detection system
      ( Cardiox TM) in young stoke patients ( age under 55 years). Flow detection systém is a new
      method for right to left shunt detection comfortable for patients, not dependent on
      experienced examinator and only one method with exact valsalve maneuver measurement. Right to
      left shunt could be important etiology of cardioembolization in young stroke patient
      population, therefore screening for this condition is recommended in all young patient after
      ischemic stroke especially with unclear etiology. Flow detection systes seams to be ideal
      screening method for this patients.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patient after ischemic stroke including TIA, age 18-55 year
Nebulized Corticosteroid for Post Extubation Stridor in Children
Condition: Stridor
MeSH terms: Respiratory Sounds
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and adverse effect of nebulized
      corticosteroid to prevent post-extubation stridor in children.
    

Detailed description: 
      The guideline for prevention and treatment of post-extubation stridor in children is
      inconclusive include Nebulized epinephrine and intravenous corticosteroid. Nebulized
      corticosteroid is alternative treatment for viral croup. the rationale of this study to
      evaluate the efficacy of nebulized fluticasone propionate to prevent pediatric
      post-extubation stridor
    

Intervention name(s): fluticasone propionate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Flixotide 1 mg + NSS upto 4 ml nebulized after extubation. Record vital signs and modified Westley score at 0, 15, 30, 60 min and 2,4,6 hours; NSS 4 ml nebulized after extubation. Record vital signs and modified Westley score at 0, 15, 30, 60 min and 2,4,6 hours
Other intervention name(s): Flixotide; normal saline
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention