bioihbjkbjnl/mcl2 huggingface dataset:
A Study of RoActemra/Actemra (Tocilizumab) in Patients With Active Systemic Juvenile Idiopathic Arthritis (JIA)
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the efficacy and safety of RoActemra/Actemra (tocilizumab) in
      patients with active systemic juvenile idiopathic arthritis (sJIA) who have an inadequate
      clinical response to NSAIDs and corticosteroids. In Part I of the study patients will be
      randomized 2:1 to receive iv infusions of RoActemra/Actemra (8mg/kg iv for patients >=30kg,
      or 12mg/kg for patients <30kg) or placebo, every 2 weeks. Stable NSAIDs and methotrexate will
      be continued throughout. After 12 weeks of double-blind treatment, all patients will have the
      option to enter Part II of the study to receive open-label treatment with RoActemra/Actemra
      for a further 92 weeks, followed by a 3-year continuation of the study in Part III in which,
      for patients who meet specific criteria, an optional alternative dosing schedule decreasing
      the study drug administration frequency will be introduced. Anticipated time on study
      treatment is up to 5 years.
    


Intervention name(s): tocilizumab [RoActemra/Actemra]; Placebo; Non-steroidal anti-inflammatory drugs (NSAIDs); methotrexate; corticosteroids
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 8mg/kg (patients>=30kg) or 12mg/kg (patients <30kg) iv every 2 weeks. In Part III, administration frequency may be reduced to every 3 and every 4 weeks, respectively, according to an optional alternative dosing schedule.; iv every 2 weeks for 12 weeks; as prescribed; as prescribed; orally, as prescribed
Intervention MeSH terms: Anti-Inflammatory Agents; Anti-Inflammatory Agents, Non-Steroidal; Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of Dexmedetomidine in Spine Surgery
Condition: Collapse of Thoracic Vertebra; Collapse of Lumbar Vertebrae
MeSH terms: Shock
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators will conduct a prospective randomized double blind study comparing
      methadone plus methadone and intraoperative dexmedetomidine in multi-level spine surgery in
      two randomized groups. The investigators plan to document the intraoperative opioid
      requirements, time to first dose of opioids postoperatively and total opioid consumption in
      the first 24, 48 and 72 hours. The incidence of intra and postoperative complications will be
      assessed.
    

Detailed description: 
      Patients presenting for thoracic and/or lumbar spine surgery with neuromonitoring
      (MEP/SSEP/EMG)will be recruited. Standard anesthesia monitoring will be performed. Randomized
      to a placebo or dexmedetomidine arm. Both groups will receive methadone 0.2 mg/kg ideal
      weight after induction of anesthesia.

      The placebo/dexmedetomidine will be loaded at 1 mcg/kg over 20 minutes and then a continuous
      infusion of 0.5 mcg/kg/h for the duration of the procedure.

      Intraoperative analgesia will be provided with fentanyl and dilaudid per the anesthesia team.

      Upon closure the study drug will be terminated. Patients will be followed up for 72 hours
      after surgery. Total opiate consumption and visual analogue scale ratings will be documented.

      Intra and postoperative inotrope/pressor requirements will be recorded.
    

Intervention name(s): Dexmedetomidine
Intervention type(s): Drug
Intervention description(s): In the intervention arm dexmedetomidine at a dose of 1 mcg/kg over 20 mins followed by an infusion of 0.5 mcg/kg/h for the duration of the surgery.
Other intervention name(s): Precedex
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Opiate consumption; Visual Analogue Scale
DU-176b Phase 2 Dose Finding Study in Subjects With Non-valvular Atrial Fibrillation
Condition: Atrial Fibrillation; Stroke
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will be conducted in male and female subjects aged 18 to 80 years, inclusive, with
      non-valvular AF and a CHADS2 Score of at least 1. Subjects will be treated on an outpatient
      basis. The subjects will be allocated randomly to the open-label warfarin or any double-blind
      DU-176b dosages. DU-176b will be administered orally for 12 weeks at two fixed doses.
      Warfarin will be used as active control. Warfarin dosing will be managed and monitored by the
      Investigator with the dose adjusted to achieve an INR of 2.0 to 3.0, inclusive. The primary
      endpoints are incidence of major, clinically relevant non-major and minor bleeding events
      (all bleeding).
    


Intervention name(s): DU-176b tablets; DU-176b tablets; Warfarin tablets
Intervention type(s): Drug; Drug; Drug
Intervention description(s): DU-176b tablets taken once daily for up to 3 months; DU-176b tablets taken once daily for up to 3 months; Warfarin tablets taken once daily for up to 3 months
Intervention MeSH terms: Warfarin; Edoxaban
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Protein Requirements in Children With Phenylketonuria (PKU)
Condition: Phenylketonuria
MeSH terms: Phenylketonurias
Study type: Interventional

Summary: 
      Phenylketonuria (PKU) is an inherited inborn error of an amino acid phenylalanine (PHE)
      metabolism affecting 1:15,000 births. It is caused by a decreased activity of an enzyme in
      the liver called phenylalanine hydroxylase (PAH) which is important to convert PHE into
      tyrosine, another amino acid. Consequently, PHE accumulates in the blood leading to mental
      and developmental delays. Nutritional management is the primary choice of treatment that
      includes providing sufficient protein in the diet and at the same time restricting PHE.
      However the amount of protein to be given is unknown. A new technique called Indicator Amino
      Acid Oxidation (IAAO) will be used to determine the protein requirements in children with PKU
      (5-18y). The study will help treat and manage these children with sufficient protein to
      ensure proper growth and development. Current dietary recommendations range from 35-65 g/day
      and is based on factorial calculations.

      The investigators hypothesize that the protein requirement in children with PKU will be
      higher than the current mathematically calculated recommended intake of 35-65 g/day for the
      5-18y children.
    


Intervention name(s): Protein intake
Intervention type(s): Dietary Supplement
Intervention description(s): Oral consumption of eight hourly experimental meals-
4 tracer free experimental meals containing a mixture of free amino acids and calories from protein free flavored liquid, protein free cookies and corn oil
4 isotopically labeled experimental meals.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Phenylketonuria; PKU; Phenylalanine metabolism; Protein requirements; Indicator Amino acid Oxidation; Stable isotopes
Metformin Therapy for Overweight Adolescents With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Overweight
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the proposed research is to evaluate the efficacy and safety of the use of
      metformin in addition to standard insulin therapy in overweight and obese children and
      adolescents, age 12-<20 years, with type 1 diabetes for at least 1 year. Secondary objectives
      are to assess the effect of metformin on C-peptide levels, a measure of how much insulin is
      still being produced by the beta cells of the pancreas, and on vascular dysfunction. In
      addition, an ancillary study is planned to assess if metformin will improve tissue-specific
      insulin resistance in type 1 diabetes using a hyperinsulinemic euglycemic clamp.
    


Intervention name(s): Metformin (glucophage); oral placebo
Intervention type(s): Drug; Other
Intervention description(s): The strength of each tablet will be 500 mg. Participants will build up to a daily dose over four weeks by taking one tablet per day for 7 days, one tablet twice daily for 7 days, one tablet in morning and 2 tablets at night for 7 days, and then 2 tablets in the morning and 2 tablets at night, daily throughout the remainder of the study treatment period.
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study Evaluating a 13-Valent Pneumococcal Conjugate Vaccine in Healthy Infants
Condition: Vaccines, Pneumococcal
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety, tolerability and immunogenicity of a
      13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given
      concomitantly with routine paediatric vaccinations in Spain.
    


Intervention name(s): 13-valent pneumococcal conjugate vaccine; 7-valent pneumococcal conjugate vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 1 dose at 2,4,6 and 15 months of age; 1 dose at 2,4,6 and 15 months of age
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: Vaccine
A Pharmacokinetic and Tolerability Study of Fexinidazole in a Single Oral Dose in Adult Participants With Mild and Moderate Hepatic Impairment
Condition: Hepatic Function Abnormal
Study type: Interventional
Phase: Phase 1

Summary: 
      In human, metabolic hepatic clearance represents a significant part of the total clearance of
      fexinidazole and could be decreased in patients with liver impairment, leading to some
      overexposure, and conversely, the formation of the 2 active metabolites could be decreased,
      leading to decreased exposure in hepatic impairment (HI).

      As there is no experience of use in patients with hepatic impairment, in fexinidazole summary
      of product characteristics (SmPC) approved by the European Medicines Agency (EMA),
      fexinidazole is contra-indicated in patients with clinical signs of cirrhosis or jaundice,
      and in the proposed USA product information, fexinidazole is contra-indicated in patients
      with liver impairment.

      Therefore, FDA requested a study with the objective to evaluate the effect of mild and
      moderate hepatic impairment (HI) on the pharmacokinetics (PK) of fexinidazole and its 2
      metabolites, as a post-marketing requirement.
    

Detailed description: 
      The duration of the study for 1 participant will be of 38 days maximum, including:

        -  A screening period from Day (D)-28 to D-2

        -  Baseline assessments on D-1

        -  Single dose administration on D1 and institutionalization for 6 days

        -  End of study (EOS): D10, or to be organized as soon as possible in case of early
           withdrawal
    

Intervention name(s): Fexinidazole (HOE239)
Intervention type(s): Drug
Intervention description(s): Route of administration: oral; pharmaceutical form: tablet
Other intervention name(s): Fexinidazole Winthrop®
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Restorative Treatment in First Molars Affected by Molar-Incisor Hypomineralization
Condition: Molar Incisor Hypomineralization
MeSH terms: Molar Hypomineralization; Dental Enamel Hypoplasia
Study type: Interventional

Summary: 
      The restorative management of molars with Molar-Incisor Hypomineralization (MIH) represents a
      challenge in the clinical practice with high failure rate. Thus, this clinical trial aimed to
      evaluate the clinical survival of direct composite resin restorations in first permanent
      molars (FPMs) that are affected by MIH, comparing two adhesive systems.
    

Detailed description: 
      For the research, it was selected first permanent molars (FPMs) with MIH from children aged
      6-8 years. FPM fully erupted and with restorative treatment needed was the inclusion
      criteria. We excluded FPMs with destroyed crowns. The FPMs were randomly assigned to two
      groups: G1 (self-etching adhesive) and G2 (total-etching adhesive). Clinical evaluation was
      performed during 18 months according to the USPHS-Modified by a blinded examiner. The
      actuarial method was used to evaluate survival of the restorations and Fisher's exact test
      was used to compare differences between the groups (α=5%).
    

Intervention name(s): restorative
Intervention type(s): Procedure
Intervention description(s): It was performed direct restoration using two kinds of adhesive system (total-etching adhesive and self-etching adhesive)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
GW823296 Repeat Dose Study In Healthy Male And Female Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to evaluate the safety, tolerability and pharmacokinetics of GW823296
      following 28 days, once-daily repeat oral doses.
    


Intervention name(s): GW823296
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: safety,; healthy volunteers,; GW823296,; pharmacokinetics
Topical Diclofenac Gel in Patients With Superficial Inflammation of the Veins
Condition: Superficial Thrombophlebitis of the Upper Limb
MeSH terms: Thrombophlebitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will assess the efficacy, safety and tolerability of topically administered
      diclofenac gel versus placebo with respect to the symptom score (pain, temperature and size
      of erythema along the superficial vein)
    


Intervention name(s): Diclofenac gel
Intervention type(s): Drug
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Superficial thrombophlebitis, diclofenac gel, non steroidal antiinflammatory drugs
A Study of TAK-536 in Children From 2 to Less Than 6 Years Old With High Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The main aim of this study is to check the safety of TAK-536. This study will take place in
      Japan. At the first visit, the study doctor will check if each child can take part. For those
      who can take part, each participant will have a check-up by the study doctor. This might take
      2 weeks or longer.

      After this, parents or the caregivers of each participant will be given sachets that contain
      granules of TAK-536 to give to that participant. The participants will take the TAK-536
      granules once a day for 52 weeks.

      After treatment has finished, participants will visit the study clinic for a final check-up.
    

Detailed description: 
      The drug being tested in this study is called TAK-536. TAK-536 is being tested in pediatric
      participants with hypertension aged 2 to less than 6 years. This study will look at the
      safety, efficacy, and pharmacokinetics of long-term administration of TAK-536.

      The study will enroll 10 participants. Participants will receive the study drug (TAK-536)
      orally once daily before or after breakfast.

      The initial dose of TAK-536 will be 0.1 mg/kg (not exceeding 2.5 mg/day). After the initial
      dose, TAK-536 will be titrated to 0.2 mg/kg (not exceeding 5 mg/day), 0.4 mg/kg (not
      exceeding 10 mg/day), and 0.8 mg/kg (not exceeding 20 mg/day) if the participants do not
      achieve the target blood pressure and no concerns are found in safety and tolerability.

      This multi-center trial will be conducted in Japan. The overall time to participate in this
      study is approximately 56 weeks. Participants will make multiple visits to the clinic.
    

Intervention name(s): TAK-536
Intervention type(s): Drug
Intervention description(s): TAK-536 granule formulation
Intervention MeSH terms: Azilsartan medoxomil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Antimicrobial Efficacy and Postoperative Pain After Using Silver Nanoparticles and Chitosan Nanoparticles Against Enterococcus Faecalis and Candida Albicans Biofilm
Condition: Endodontic Disease
MeSH terms: Dental Pulp Diseases; Pain, Postoperative
Study type: Interventional

Summary: 
      Silver nanoparticles possess unique physicochemical and biological properties in addition to
      their antibacterial capabilities. Similarly, zinc oxide nanoparticles have demonstrated
      antibacterial effects against a wide range of bacteria, including heat and pressure resistant
      spores. Given these characteristics, it would be valuable to evaluate and compare a new
      irrigation solution containing nanosilver and nanozinc-oxide particles with sodium
      hypochlorite. Furthermore, Chitosan Nanoparticles are expected to exhibit enhanced
      antibacterial activity compared to regular-sized Chitosan due to their ability to penetrate
      and disrupt microbial cell membranes. Consequently, the current study aims to assess and
      compare the antibacterial activity of Silver Nanoparticles and Chitosan Nanoparticles, as
      well as their impact on post-operative pain.
    


Intervention name(s): Silver Nanoparticles Irrigant; Chitosan Nanoparticles Irrigant
Intervention type(s): Drug; Drug
Intervention description(s): Nanosilver irrigant solution; Chitosan nanoparticles irrigant solution
Intervention MeSH terms: Chitosan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Impact Emotional Intelligence Program on Opioid Relapse
Condition: Emotional Intelligence; Opioid Use Disorder
MeSH terms: Opioid-Related Disorders
Study type: Interventional

Summary: 
      Addiction is the repeated and increased use of a substance, the deprivation of which gives
      rise to symptoms of distress and an irresistible urge to use the agent again and which leads
      also to physical and mental deterioration. The concept of emotional intelligent (EI) "the
      ability to perceive accurately, appraise and express emotion; the ability to access and
      generate feelings when they facilitate thought; the ability to understand emotion and
      emotional knowledge; and the ability to regulate emotions to promote emotional and
      intellectual growth". Most drug addicts possess hidden defects in their social skills, and do
      not have good relations with their peers.
    

Detailed description: 
      Addiction is the repeated and increased use of a substance, the deprivation of which gives
      rise to symptoms of distress and an irresistible urge to use the agent again and which leads
      also to physical and mental deterioration. Continued opioid misuse can result in syndromes of
      abuse and dependence and cause disturbances in mood, behavior, and cognition that can mimic
      other psychiatric disorders. Opioid addiction affects the young and the old, the wealthy and
      the poor, and the professional and the unemployed.

      The concept of emotional intelligent (EI) "the ability to perceive accurately, appraise and
      express emotion; the ability to access and generate feelings when they facilitate thought;
      the ability to understand emotion and emotional knowledge; and the ability to regulate
      emotions to promote emotional and intellectual growth", the ability to manage and regulate
      emotions in an effective manner and ability to be sufficiently optimistic, positive and self-
      motivated in order to set and achieve goals.

      Most drug addicts possess hidden defects in their social skills, and do not have good
      relations with their peers. The other possible causes of orienting toward drugs are defects
      in problem solving, stress-management, and prevention from dangerous and impulsive behaviors.
    

Intervention name(s): emotion intelligence program
Intervention type(s): Behavioral
Intervention description(s): The programme was established using research that described emotional intelligence components and their applicability to patients suffering from substance abuse. it considers as awareness program.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants with opioid use disorder were divided into two groups: group with emotion intelligence program (n=20) and group without intelligence program (n=20). A healthy group (n=20) served as a control group.
Masking: Single (Participant)
Primary purpose: Prevention
Accelerated Aging in Middle-Aged Men With Sleep-disordered Breathing.
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Obstructive Sleep Apnea Syndrome (OSAS) regardless of any other associated risk factor can
      lead to accelerated aging. The study of aging-related Obstructive Sleep Apnea (OSA) is
      difficult because of associated risk factors (diabetes, hypertension, dyslipidemia, obesity),
      promoting themselves aging. The investigators propose to compare a group of OSAS patients
      free of any associated pathology, to subjects matched for age, sex, smoking and body mass
      index (BMI)
    


Intervention name(s): Polysomnography , blood collection, bone densitometry and Functional respiratory explorations
Intervention type(s): Other
Intervention description(s): Blood collection, Bone densitometry and Functional respiratory explorations are a specific interventions of protocol for the 3 arms. Polysomnography is a specific intervention for the arms " healthy volunteers "
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Obstructive sleep apnea; Aging; Telomere length
Dose Escalation With SIB to Intraprostatic/Lymphatic GTV in High Risk Prostate Cancer
Condition: Prostatic Neoplasms; Lymphatic Metastasis
MeSH terms: Prostatic Neoplasms; Lymphatic Metastasis
Study type: Interventional

Summary: 
      A single arm phase 2 study to study the outcome of dose-escalation with simultaneous
      integrated boost to intraprostatic lesion and positive lymph nodes. Prostate cancer patients
      with high risk of lymph node metastasis or oligo positive nodes in true pelvic area can be
      included. The boost volumes will be outlined by usin PET-CT and MRI data. Our hypothesis is
      that we will have fewer relapses in this very high risk patient group compared to matched
      historical controls with acceptable side effects.
    


Intervention name(s): SIB Dose-Escalation Radiotherapy
Intervention type(s): Radiation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Quality of Life; Radiotherapy; Radiotherapy, dose-escalation