bioihbjkbjnl/mcl2 huggingface dataset:
Antimicrobial Photodynamic Therapy Associated With the Conventional Endodontic Treatment: A Clinical and Microbiological Study
Condition: Photochemotherapy Reaction; Dental Pulp Necrosis; Polymerase Chain Reaction; Infection; Enterococcal Infections; Candida
MeSH terms: Infections; Communicable Diseases; Dental Pulp Necrosis; Necrosis
Study type: Interventional

Summary: 
      Microorganisms play a critical role in the etiology and pathogenesis of apical periodontitis.
      Enterococcus faecalis and Candida sp. are frequently associated with persistent infections.
      The aim of this study was evaluated the antimicrobial photodynamic therapy (aPDT) as an
      adjunct of the endodontic treatment. Ten uniradicular teeth [control group (CG)=4 and test
      group (TG)=6] with primary endodontic infections were analyzed. Microbiological samples were
      collected before and after the chemical-mechanical instrumentation (CMI), after the aPDT (for
      the TG) and after the temporary restorations removal (second session).
    


Intervention name(s): ANTIMICROBIAL PHOTODYNAMIC THERAPY; Conventional endodontic treatment
Intervention type(s): Radiation; Procedure
Intervention description(s): The aPDT was performed with 0.01% methylene blue and irradiated with low-level laser therapy (InGaAIP, 660 nm; 100 mW; 40 sec) with an optical fiber-coupled. Another irradiation (3 J; 30 sec; spot size of 3 mm2) was performed in the gingiva close to the apical foramen.; After local anesthesia the supragingival calculus, biofilm and the carious tissues were removed. The access cavity preparation was completed. The crown-down technique was performed using Gates Glidden and Kerr files with an anatomic diameter compatible to the radicular canal, and the irrigation was performed with 5 mL of 2.5% NaOCl solution between each endodontic file. The working length was established 1 mm short of the radiographic apex. Smear layer was removed by rinsing the canal with 17% ethylene diamine tetra-acetic acid solution, which was left in the canal for 5 min, followed by a final irrigation with 15 mL of 2.5% NaOCl solution. Calcium hydroxide paste with paramonoclorophenol, was inserted into the canal, filling the root canal as temporary medication between the sessions. The coronal sealing was performed using Coltosol, followed by glass ionomer Maxxion R. Seven days later the root canal was filled by the hybrid Tagger technique, with a Mc Spadden condenser.
Intervention MeSH terms: Anti-Infective Agents; Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
BAY14-2222 Prophylaxis and Joint Function Improvement (Adults)
Condition: Hematologic Disease; Hemophilia A
MeSH terms: Hemophilia A; Hematologic Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to evaluate the effect of prophylactic treatment on the number of
      joint bleeds and quality of life in severe hemophilia A subjects compared to on-demand
      treatment in a one-group two-treatment schedule design.

      In addition, the effect of prophylactic treatment on the joint function, the number of all
      bleeds, and on the quality of life compared to on-demand treatment and health-economic data
      will be assessed.
    


Intervention name(s): Kogenate (BAY14-2222)
Intervention type(s): Drug
Intervention description(s): One group two treatment schedules, first on-demand then switch to prophylaxis
Intervention MeSH terms: Factor VIII
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Coagulation Disorders
The Optimal Strategy of Switching From Clopidogrel to Ticagrelor in Patients With Complexity of Coronary Artery Disease
Condition: Coronary Artery Disease; Ticagrelor
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      The study is to further exploring the optimal switching strategy by evaluating the
      pharmacodynamic responses as well as adverse events in patients with complexity of coronary
      artery disease managed by percutaneous coronary intervention (PCI). All participants will be
      divided into three groups and recieving ticagrelor 90mg plus aspirin 100mg at 12 hours after
      the last dose of clopidogrel; recieving ticagrelor 90mg plus aspirin 100mg at 24 hours after
      the last dose of clopidogrel; recieving ticagrelor 180mg plus aspirin 100mg at 24 hours after
      the last dose of clopidogrel.
    


Intervention name(s): Ticagrelor
Intervention type(s): Drug
Intervention description(s): Ticagrelor, 90mg, 90mg twice daily
Intervention MeSH terms: Ticagrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ticagrelor; Clopidogrel; Switching strategy
Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ Electromechanical Device for Growth Hormone Treatment
Condition: Growth Disorders
MeSH terms: Growth Disorders
Study type: Observational

Summary: 
      This is a Chinese, Multicentre, Observational Study to study Adherence and Long Term Outcomes
      of Therapy in paediatric subjects using easypod™ electromechanical device for growth hormone
      treatment to assess the level of adherence of subject receiving SAIZEN® via easypod™.
    

Detailed description: 
      Subjects will be enrolled in a multicenter longitudinal observational study. Parents/subjects
      will provide their Informed Consent/assent to upload their data for population-based analyses
      and, ultimately, clinical outcomes. Adherence data will be primarily derived from the
      easypod™ device combined with physician data entry of outcome measures. Data will be
      collected retrospectively and prospectively. This will allow the establishment of adherence
      profiles and subsequent clinical outcomes. Collected data will be also analyzed in a
      multinational pooled analysis of comparable national studies.

      Primary Objective:

        -  To assess the level of adherence of subjects receiving SAIZEN® via easypod™ Secondary
           Objectives:

        -  To describe the impact of adherence on clinical outcomes for subject receiving SAIZEN®
           via easypod™

        -  To identify adherence subject profiling

        -  To asses the impact of adherence on Insulin-like Growth Factor 1 (IGF1) (i.e. above,
           below or within normal ranges)
    

Intervention name(s): easypod ™
Intervention type(s): Device
Intervention description(s): Saizen (Somatotropin) as per Summary of Product Characteristics administered by easypod™
Other intervention name(s): Somatotropin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Paediatric subjects (aged 2-18) who are taking SAIZEN® for registered indications using the
        easypod™ electromechanical device.
      
Keywords: Growth disorders; Saizen; Easypod; Growth hormone; Pediatric subject
A Study to Evaluate Albumin and Immunoglobulin in Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to evaluate the changes in the cognitive, functional, behavioral
      and global domains based on the different applicable psychometric batteries and scales.
    

Detailed description: 
      A clinical trial comprised of 350 subjects with probable mild to moderate Alzheimer's Disease
      (AD) will be conducted primarily to determine whether plasmapheresis with infusion of human
      albumin combined with intravenous immunoglobulin (IVIG) is able to modify patient's
      cognitive, functional, behavioral and global domains. There will be 3 treatment groups and 1
      control group. The subjects will be randomized in a 1:1:1:1 proportion.
    

Intervention name(s): Albumin 5%; Albumin 20%; Immunoglobulin
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Therapeutic plasma exchange with human albumin 5%; Low volume plasma exchange with human albumin 5%; Intravenous human immunoglobulin 5%
Other intervention name(s): Albutein® 5%; Human Albumin Grifols 5%; Albutein® 20%; Human Albumin Grifols 20%; Flebogamma® 5% DIF
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer's disease; Amyloid Beta (AB) peptide; Albumin; Intravenous immunoglobulin; IVIG
A Study of Administration of Trastuzumab (Herceptin) by a Single-use Injection Device Versus a Handheld Syringe
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, open-label, parallel, 2-arm, multicenter study will compare the
      administration of Herceptin (trastuzumab) with a single-use injection device versus a
      handheld syringe in healthy male volunteers. The volunteers will receive a single dose of 600
      mg Herceptin. The anticipated time of the study is 21 weeks.
    


Intervention name(s): trastuzumab [Herceptin]; trastuzumab [Herceptin]
Intervention type(s): Drug; Drug
Intervention description(s): 600 mg subcutaneously using a single-use injection device on Day 1; 600 mg subcutaneously using a handheld syringe on Day 1
Intervention MeSH terms: Trastuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Bioavailability and Pharmacokinetic Study of GDC-0032 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This 2-arm, open-label, non-randomized study will investigate the absolute bioavailability,
      pharmacokinetics, mass balance, and routes of elimination of GDC-0032 as well as its safety
      in healthy volunteers. Patients will receive either a single oral dose of GDC-0032 followed
      by a 14C-labeled IV dose of GDC-0032 or a single oral dose of 14C-labelled GDC-0032.
    


Intervention name(s): GDC-0032; GDC-0032
Intervention type(s): Drug; Drug
Intervention description(s): Single oral dose; Single IV dose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Cow's Milk Allergy and Functional Gastrointestinal Disorders
Condition: Cow's Milk Allergy; Functional Gastrointestinal Disorders
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases; Hypersensitivity; Milk Hypersensitivity
Study type: Observational

Summary: 
      Cow's milk allergy (CMA) is the most common food allergy in early childhood, with an
      estimated incidence ranging between 2% and 3% in infants and marginally lower in older
      children. It has been demonstrated that it could be a risk factor for the development of the
      functional gastrointestinal disorders in children. Intestinal microflora has been indicated
      as potential target for the management of CMA and FGDIs through the use of probiotics.
      Lactobacillus rhamnosus GG (LGG) is the most studied probiotic. Recently, it has been
      demonstrated that an extensively hydrolyzed casein formula remains hypoallergenic following
      the addition of LGG, satisfying both the American Academy of Pediatrics guidelines.
      Lactobacillus GG exerts several benefits when added to an extensively hydrolyzed casein
      formula (Nutramigen LGG), including decreased severity of atopic dermatitis, improved
      recovery of intestinal symptoms in infants with CMA-induced allergic colitis, and faster
      induction of tolerance in infants with CMA. The mechanisms of these effects are multiple and
      exerted at different levels: epithelium, immune system and enteric nervous system. Studies
      and meta-analyses showed that LGG increases treatment success in children with functional
      gastrointestinal disorders.
    


Intervention name(s): Extensively hydrolyzed casein formula + LGG
Intervention type(s): Dietary Supplement
Intervention MeSH terms: Caseins
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population will be enrolled from a cohort of about 300 children (aged from 4 to 6
        yrs) with a history of sure diagnosis of CMA obtained in the first year of life treated
        with hypoallergenic formula for at least 6 months and who are already in follow-up at the
        Department of Pediatrics of University of Naples "Federico II".
A Study to Assess the Safety, Tolerability and Pharmacokinetics of NXL104 Alone and in Combination With Ceftazidime Administered as Single and Repeated Intravenous Doses in Healthy Japanese Subjects
Condition: Healthy Male and Female Japanese Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single and multiple dose study in healthy male and female (of non-childbearing
      potential) Japanese volunteers, to assess the safety, tolerability, and blood and urine drug
      levels of intravenous (IV) NXL104 alone and when given in combination with ceftazidime.
    


Intervention name(s): NXL104; CAZ104; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): IV Solution; IV Solution; IV saline
Intervention MeSH terms: Avibactam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: NXL104; ceftazidime; CAZ104; Healthy Japanese volunteers; Phase 1; Single and Multiple Dose Study
Difference in Efficacy of Natalizumab Versus Fingolimod for the Treatment of Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      Under the escalation treatment strategy when a patient displays breakthrough disease
      parameters under first line therapy, MS physicians are allowed by the EMEA to switch for
      Natalizumab (NTZ) or fingolimod (FGL). NTZ and FGL efficacy have been demonstrated by
      randomized therapeutic trial. As both treatments have been tested versus placebo a common way
      to compare them is to look at their respective annualized relapse risk ratio decrease.
      Roughly NTZ decrease by 70% and FGL by 50%. Nevertheless it is a terrible comparison since
      the placebo group had different behaviour in the 2 trials and the patients demographic
      features at baseline are also different. Therefore, it is right now totally impossible to
      compare these 2 drugs with a decent methodology. Only a head-to-head comparison could do it.
      Unfortunately this head-to-head comparison is not available and will not probably be done
      under the drug companies initiative. During the time of this study, we will perform a phase
      IV, observational, prospective head-to-head comparison of NTZ versus FGL efficacy in 600
      patients. Our primary end point will be disease free patients after 1 year of treatment.
      Further, this trial will allow us to collect new biological samples, useful for a validation
      our project main aim. Further these new samples will be obtained from 3 European countries,
      which is a must if we want to generalize our conclusion obtained from a French cohort.
      Cooperation at the European level is thus essential for the implementation of this project .
    


Intervention name(s): biological samples and clinical data
Intervention type(s): Procedure
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Multiple sclerosis
      
Biospecimen description: 
      urine and blood
    
Keywords: progressive multifocal leucoencephalopathy; JC virus; Zoster infection
Multicenter Trial of Immunotherapy With House Dust Mite Allergoid
Condition: Rhinoconjunctivitis
MeSH terms: Conjunctivitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Multicenter Immunotherapy House Dust Mite Allergoid
    

Detailed description: 
      A multicentre randomized placebo-controlled double-blind clinical trial for evaluation of
      safety and efficacy of a specific immunotherapy with an aluminium hydroxide-adsorbed
      allergoid preparation of house dust mite (Dermatophagoides pteronyssinus) in patients with
      rhinitis/rhinoconjunctivitis and/or allergic asthma bronchiale
    

Intervention name(s): specific immunotherapy with Acaroid, subcutaneously, Up-titration till strength B 0.6 mL (6000 TU)
Intervention type(s): Biological
Intervention description(s): Injection Number Date Proposed Dose Individual Dose Strength A=1000 TU/ml B=10000TU/ml ml Dose per Injection
to be det. A 0.1 100 TU
7 (+7) days later A 0.2 200 TU
7 (+7) days later A 0.4 400 TU
7 (+7) days later A 0.6 600 TU
7 (+7) days later B 0.1 1000 TU
7 (+7) days later B 0.2 2000 TU
7 (+7) days later B 0.4 4000 TU
7 (+7) days later B 0.6 6000 TU
Maintenance (Init 2,4) 4-6 weekly B 0.6 6000 TU To be continued Injection Number Date Proposed Dose Individual Dose Strength A=1000 TU/ml B=10000TU/ml ml Dose per Injection
to be det. A 0.1 100 TU
7 (+7) days later A 0.2 200 TU
7 (+7) days later A 0.4 400 TU
7 (+7) days later A 0.6 600 TU
7 (+7) days later B 0.1 1000 TU
7 (+7) days later B 0.2 2000 TU
7 (+7) days later B 0.4 4000 TU
7 (+7) days later B 0.6 6000 TU
Maintenance (Init 2,4) 4-6 weekly B 0.6 6000 TU To be continued
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: House Dust Mite Allergen; Aluminium hydroxide-adsorbed
Safety and Efficacy Study of SYN115 in Parkinson's Patients Using Levodopa to Treat End of Dose Wearing Off
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this research study is to test the effect of SYN115 compared to placebo (a
      "sugar pill" that looks like SYN115 but does not include active drug) on movement during the
      "on" and "off" states as well as other symptoms that some patients with Parkinson's disease
      experience. This study will also look at whether or not patients with Parkinson's disease
      experience "side-effects" with SYN115.
    


Intervention name(s): Tozadenant (SYN115) 60 mg BID; Placebo; Levodopa (L-dopa); Tozadenant (SYN115) 120 mg BID; Tozadenant (SYN115) 180 mg BID; Tozadenant (SYN115) 240 mg BID
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
Total daily doses include 60 mg BID.; White-coated, modified-oval placebo tablets.; One intravenous infusion of L-dopa to reach approximately 600 ng/ ml plasma concentration.; Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
Total daily doses include 120 mg BID.; Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
Total daily doses include 180 mg BID.; Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
Total daily doses include 240 mg BID.
Other intervention name(s): L-dopa
Intervention MeSH terms: Levodopa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Switching to Low Oxidant Content Cigarettes in Adult Smokers
Condition: Nicotine; Oxidative Stress
Study type: Interventional

Summary: 
      The overall objective of this clinical study is to determine if smokers who switch from their
      usual high reactive oxygen and nitrous oxide species (ROS/NOS) products to a low ROS/NOS
      product exhibit increased or decreased levels of oxidative stress/damage, respectively.
    

Detailed description: 
      Researchers at Penn State Hershey are seeking healthy adult cigarette smokers between the
      ages of 21-65 who smoke at least 10 cigarettes a day for at least one year.

      The aim of this study is to evaluate the effect of reduced oxidative/ nitrogen species
      (ROS/RNS) cigarettes compared to high ROS/RNS cigarettes.

      Study participation lasts 8 weeks, with 5 study visits at the Hershey Medical Center. All
      eligible participants will be given Spectrum research cigarettes, provided free of charge,
      and will be asked to only smoke those cigarettes for the first four weeks of the study.
      Following that four-week period of time all participants will be given low ROS content
      cigarettes (American Spirit Dark Green or Pall Mall Red). Participants will be asked to smoke
      only these cigarettes for the final four weeks of the study, these cigarettes will also be
      provided to you free of charge.
    

Intervention name(s): Reduced ROS/RNS content products; Typical to high (ROS/NOS) products
Intervention type(s): Other; Other
Intervention description(s): Participants will be given and asked to spoke only the cigarettes provided for them. Biosamples and surveys will be collected every 2 weeks throughout the study.; Participants will be given and asked to spoke only the cigarettes provided for them. Biosamples and surveys will be collected every 2 weeks throughout the study.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Long-term Follow-up of Participants From Studies Evaluating GSK HIV Vaccine
Condition: AIDS
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this long-term follow-up study is to assess the long-term health status of
      HIV-infected subjects who previously participated in GSK-sponsored trials evaluating the
      investigational HIV vaccine 732462. This study will provide additional data concerning the
      long-term benefits/risks associated with vaccination.

      No vaccine will be administered during the study period. Vaccines were administered during
      the primary studies.
    

Detailed description: 
      General information on the health of the subject and persistence of the cellular and humoral
      immune responses to study vaccination will be evaluated.
    

Intervention name(s): Blood collection; GSK HIV vaccine 732462
Intervention type(s): Procedure; Biological
Intervention description(s): Once a year after Visit 1 (during a maximum of 4 years). The samples will only be taken in conjunction with, and at the same time as, planned routine blood testing using the same needle-stick.; No vaccine will be administered during this long-term follow-up study. Vaccines were administered during the primary studies.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: long-term follow-up study; HIV-infected subjects; HIV therapeutic vaccine