bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Air Polishing With Ultrasonic Debridement in the Treatment of Initial Periodontal Pockets
Condition: Gingivitis
MeSH terms: Gingivitis; Periodontal Pocket
Study type: Interventional

Summary: 
      Clinical evaluation of using erythritol powder as air polishing with ultrasonic scaling and
      root planing in the treatment of initial periodontal pockets. This trial will be split-mouth
      design, in which each patient will receive traditional treatment (ultrasonic mechanical
      therapy and polishing) in one side, while the contralateral two quadrants of the jaws will be
      treated with erythritol powder by means of air polishing and ultrasonic scaling and root
      planing.
    

Detailed description: 
      The aim of the study is to evaluate the usage of erythritol powder by means of air polishing
      in hand of undergraduate dental students as a single way to remove biofilm and the adjunctive
      application of ultrasonic piezo afterward for calculus removal and root planing only in the
      treatment of initial periodontal pockets.

      The sample size will be 15 patients. Initially, oral hygiene instructions with scaling and
      root planing will consist of the treatment phase. Each subject will be informed
      comprehensively about oral hygiene instructions using disclosing solution (such as
      erythrosine) and hand mirror. The participant will be shown modified bass technique and the
      proper usage of dental floss and appropriate interdental brushes.

      The control side will be treated with supra- and subgingival ultrasonic piezo scalers then
      supragingival polishing with rubber cup and a special fluoride containing paste as a
      traditional way of removal of plaque and calculus, while the test side, will be confined to
      erythritol powder by means of air polishing as the only way to remove ultrasonic piezo
      scalers.

      At the end of treatment, hand instruments may be used to ensure the smoothness 0f the teeth
      surfaces.

      Clinical measurements will be performed at baseline and at 2 weeks, 4 and 6 weeks for the
      plaque index and gingival indices, whereas probing will be performed only after 6 weeks.
    

Intervention name(s): Electro Medical Systems AIRFLOW®; Electro Medical Systems Piezo
Intervention type(s): Device; Device
Intervention description(s): An erythritol powder will be used by Electro Medical Systems AIRFLOW® and then Electro Medical Systems Piezo will be used for supra- and subgingival ultrasonic instrumentation; Electro Medical Systems Piezo will be used for supra- and subgingival ultrasonic instrumentation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Antibody Persistence to REVAXIS or DT Polio and Immune Response to TETRAVAC-ACELLULAIRE
Condition: Diphtheria; Tetanus; Poliomyelitis
MeSH terms: Diphtheria; Poliomyelitis
Study type: Interventional
Phase: Phase 4

Summary: 
      PRIMARY OBJECTIVES

        -  To describe in 11 to 13-year-old children previously vaccinated with either REVAXIS or
           DT Polio at 6 years of age the antibody persistence against diphtheria, tetanus, and
           poliovirus types 1, 2 and 3

        -  To describe one month after a booster dose of TETRAVAC-ACELLULAIRE the immune responses
           against diphtheria, tetanus, and poliovirus types 1, 2 and 3

      SECONDARY OBJECTIVES

        -  To describe other parameters of the antibody persistence against diphtheria, tetanus and
           poliomyelitis antigens

        -  To describe other parameters of the immune responses to diphtheria, tetanus and
           poliomyelitis antigens one month after a booster dose of TETRAVAC-ACELLULAIRE

        -  To describe the safety profile of a booster dose of TETRAVAC-ACELLULAIRE
    


Intervention name(s): Diphtheria, tetanus, polio and pertussis vaccination
Intervention type(s): Biological
Intervention description(s): 1 dose of TETRAVAC-ACELLULAIRE (0.5 mL) at Day 0
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Formalizing a Conceptual Framework of Work Domain Knowledge
Condition: Knowledge Representation; Knowledge Modeling
Study type: Observational

Summary: 
      The purpose of this study is to learn the daily activities of nutrition management software
      users through an improved informed consent process and develop a conceptual model to describe
      these activities. The investigators will gather information from nutrition management
      software users, and design and test a new prototype of nutrition management software.
    


Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Inclusion Criteria:

          1. Subjects must be over 21 years old

          2. Subjects must be a student or employee in University of Texas

          3. Subjects must be able to read and write in English

          4. Subjects must be able to give signed informed consent
Vitamin D Plasma Level and Its Role in Headache
Condition: Headache
MeSH terms: Headache
Study type: Interventional

Summary: 
      To date there are conflicting data concerning a correlation between plasma vitamin D levels
      and headache.

      The aim of this study was to evaluate plasma vitamin D levels in patients with headache
      admitted to the Center of Headache of Pugliese Ciaccio Hospital.
    

Detailed description: 
      Several papers suggest that inflammation is able to induces both headache and low levels of
      vitamin D. However, to date a correlation between plasma vitamin D levels and headache has
      not been demonstrated. Recently we documented that low levels of Vitamin D are related to a
      low statin efficacy. In this study we will evaluate the plasma levels of vitamin D in
      patients with headache admitted to the Center of Headache of Pugliese Ciaccio Hospital.

      Moreover it will be also evaluated:

        -  the correlation between efficacy and safety of drugs used in headache treatment and
           plasma vitamin D levels.

        -  the role of vitamin D supplementation on both headache symptoms and drug effects.

      Plasma vitamin D levels in patients with headache will be evaluated respect to patients
      without headache.
    

Intervention name(s): vitamin D supplementation
Intervention type(s): Dietary Supplement
Intervention description(s): In patients with headache and with low vitamin D plasma levels, will be administered a vitamin D supplementation.
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Effect of Early Enteral Tube Feeding Nutrition With an Immune Enhancing Diet in Severe Burn Patients
Condition: Infections on; Severe Burn Patients
MeSH terms: Burns
Study type: Interventional
Phase: Phase 4

Summary: 
      Compare clinical and biological effects of two enteral tube feeding nutrition formula (immune
      enhancing diet versus polymeric diet)in severe burn hospitalized patients .
    


Intervention name(s): Crucial; Sondalis HP
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Treatment between minimum 14 days and maximum 6 months. Apports depend on method of CURRERI.; Treatment between minimum 14 days and maximum 6 months. Apports depend on method of CURRERI.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: infections
Evaluation of Preclinical Toxicity andTherapeutic Efficacy of Kandhaga Rasayanam in Padarthamarai
Condition: Tinea Infections Such as Tinea Corporis, Tinea Cruris, Tinea Pedis, Tinea Mannum, Tinea Barbae, Tinea Capitis Are Studied
MeSH terms: Tinea; Tinea Pedis; Tinea cruris; Tinea Capitis
Study type: Interventional
Phase: Phase 2

Summary: 
      this study is intended to find out the therapeutic efficacy of the siddha drug Kandhaga
      Rasayanam in Padarthamarai ( Ring worm infection )
    


Intervention name(s): kandhaga rasayanam
Intervention type(s): Drug
Intervention description(s): KANDHAGA RASAYANAM is a siddha herbo mineral drug with sulphur as a sole mineral ingredient. It is chosen from the classic Siddha text Siddha Vaidhya Thirattu.
Other intervention name(s): Siddha herbo mineral drug KR.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tinea
Study of M5049 in Healthy Japanese and Caucasian Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate and determine the safety, tolerability and
      pharmacokinetics of single-doses of M5049 up to 3 dose levels administered as film-coated
      tablet under fasted conditions in healthy Japanese and Caucasian participants.
    


Intervention name(s): M5049; M5049; M5049
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive single oral dose of film-coated tablet M5049 at low dose on Day 1 under fasted condition.; Participants will receive single oral dose of film-coated tablet M5049 at medium dose on Day 1 under fasted condition.; Participants will receive single oral dose of film-coated tablet M5049 at high dose on Day 1 under fasted condition.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Healthy; M5049; Japanese; Caucasian
One-year Mortality After Surgery and Low Bispectral Index
Condition: General Anesthesia
Study type: Interventional

Summary: 
      A correlation between deep anesthesia (defined as time with Bispectral Index (BIS) lower than
      45) and death within 1 yr after surgery has previously been reported. In order to confirm or
      refute these findings, the investigators have designed a study which compares two methods of
      administration for total intravenous anesthesia (propofol and remifentanil):

        -  manual administration: the anesthesiologists are instructed to maintain the BIS value
           between 40 and 60.

        -  closed loop administration: an algorithm is used to maintain the BIS value between 40
           and 60.

      Based on previous studies, the amount of time that BIS is maintained above 40 is greater when
      anesthetics agents are administered using closed loop compared with manual administration.
    


Intervention name(s): manual administration of iv anesthetics (propofol and remifentanil) using the Toolbox platform; closed-loop administration of iv anesthetics (propofol and remifentanil) using the Toolbox platform
Intervention type(s): Device; Device
Intervention description(s): the anesthesiologists are instructed to maintain the BIS values between 40 and 60 throughout anesthesia using target controlled infusion method; an algorithm is used to maintain automatically the BIS values between 40 and 60
Intervention MeSH terms: Remifentanil; Propofol; Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Safety and Tolerability of Glyceryl Tribenzoate (GTB) Capsules in Healthy Subjects
Condition: Neurological Disorder
MeSH terms: Nervous System Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to assess the safety and PK/PD of GTB and Benzoic Acid (Benzoate)
      using a single ascending dose (SAD) study (under fasting conditions).
    

Detailed description: 
      This study is designed to assess the safety and PK/PD of GTB and Benzoic Acid (Benzoate)
      using a single ascending dose (SAD) study (under fasting conditions). After a wash out
      period, a cohort under fed conditions (ingestion of a high-fat morning meal) will be
      evaluated. Following the SAD, the multiple ascending dose phase will take place with two
      different cohorts. A battery of labs, hematology, physical examinations including vital
      signs, and ECGs will be monitored throughout the study for assessment of the study drug (GTB)
      compared with placebo. The clinical and laboratory data (excluding PK/PD data) of each cohort
      will be evaluated by a Data Monitoring Committee (DMC) to allow escalation to the next dose
      level during the SAD and MAD portions of the study.
    

Intervention name(s): Glyceryl Tribenzoate
Intervention type(s): Drug
Intervention description(s): Oral Solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Assess the Safety, Efficacy and Immunogenicity of Leishmania Vaccine ChAd63-KH in PKDL
Condition: Leishmaniasis, Cutaneous
MeSH terms: Leishmaniasis; Leishmaniasis, Cutaneous
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is designed to assess the therapeutic efficacy and safety of CHAd63-KH, a new
      candidate Leishmania vaccine, in patients with persistent PKDL. 100 participants will be
      randomly assigned (50 participants in each arm) to receive placebo or ChAd63-KH 7.5
      x10(10)vp. Doses will be administered at a single time point.
    

Detailed description: 
      This study is a randomised, double blinded, placebo controlled trial designed to assess the
      therapeutic efficacy and safety of CHAd63-KH, a new candidate Leishmania vaccine, in patients
      with persistent PKDL. 100 participants will be randomly assigned (50 participants in each
      arm) to receive placebo or ChAd63-KH 7.5 x10(10)vp intramuscular injection into the deltoid
      region. Doses will be administered at a single time point. Volunteers aged between 12-50
      years with persistent PKDL will be recruited at Professor El-Hassan's Centre for Tropical
      Medicine, Dooka, Gedarif State, Sudan, and will be followed up for 120 days after the dosing
      visit. The trial is planned to run for 24 months.

      Secondary objectives are as follows:

        1. To compare the humoral and cellular immune responses generated by the candidate vaccine
           in patients with persistent PKDL.

        2. To observe any clinical changes in the cutaneous PKDL disease over a 120 day period
           following vaccination
    

Intervention name(s): ChAd63-KH; Placebo
Intervention type(s): Biological; Other
Intervention description(s): The vaccine will be injected intramuscularly into the arm.; The placebo will be injected intramuscularly into the arm.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised, double blinded, placebo controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Determine the Effect of Efavirenz on the ECG QTcF Interval in Healthy Subjects
Condition: HIV/AIDS
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether multiple doses of Efavirenz has an effect
      on the QTc interval (corrected by Fridericia) in CYP2B6 *1/*6 and *6/*6 healthy subjects.
    

Detailed description: 
      CYP = Cytochrome p-450

      Primary Purpose: Other: This is a Phase 1 clinical pharmacology thorough QT study being
      conducted as a post marketing requirement
    

Intervention name(s): Moxifloxacin; Placebo; Efavirenz
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Avelox®; Sustiva®; BMS-561525
Intervention MeSH terms: Moxifloxacin; Efavirenz
Intervention model: Single Group Assignment
Masking: None (Open Label)
A Phase III Study of SM-13496 in Patients With Bipolar I Depression.
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The study evaluates the efficacy and safety of SM-13496 compared with placebo in patients
      with Bipolar I Depression.
    

Detailed description: 
      The primary objective is to compare the efficacy of SM-13496 (20-60 or 80-120 mg/day)
      monotherapy with that of placebo in patients with depressive symptoms associated with bipolar
      I disorder by assessing the change from baseline in the MADRS total score at Week 6.
    

Intervention name(s): Placebo; SM-13496; SM-13496
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo comparator; SM-13496 20mg for Days 1-7 and beginning Day 8 flexibly dosed 20-60 mg/day for Weeks 2-6; SM-13496 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6, 80 mg/day on Day 7 and beginning Day 8 flexibly dosed 80-120 mg/day for Weeks 2-6
Other intervention name(s): Lurasidone HCl; Lurasidone HCl
Intervention MeSH terms: Lurasidone Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluating the Infectivity, Safety, and Immunogenicity of Recombinant Live-Attenuated RSV Vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 in RSV-Seronegative Infants 6 to 24 Months of Age
Condition: Respiratory Syncytial Virus Infections
MeSH terms: Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to evaluate the infectivity, safety, and immunogenicity of the
      recombinant live-attenuated respiratory syncytial virus (RSV) vaccines RSV ΔNS2/Δ1313/I1314L
      or RSV 276 when delivered as nose drops to RSV-seronegative infants 6 to 24 months of age.

      This study was a companion study to Center for Immunization Research (CIR) 321.
    

Detailed description: 
      Human respiratory syncytial virus (RSV) is the most common viral cause of serious acute lower
      respiratory illness (LRI) in infants and children under 5 years of age worldwide. This study
      evaluated the infectivity, safety, and immunogenicity of two recombinant live-attenuated RSV
      vaccines: RSV ΔNS2/Δ1313/I1314L and RSV 276. The vaccines were delivered as nose drops to
      RSV-seronegative infants 6 to 24 months of age.

      Participants were randomly assigned to receive a single dose of the RSV ΔNS2/Δ1313/I1314L
      vaccine, the RSV 276 vaccine, or placebo at study entry (Day 0).

      Participants could be enrolled in the study outside of RSV season, i.e., between April 1 and
      October 14 for most sites or-for sites with local RSV seasons that start earlier-as specified
      on a site-by-site basis in the manual of procedures. Participants remained on study until
      they completed the post-RSV season visit between April 1 and April 30 in the calendar year
      following enrollment. Participants' total study duration was between 6 and 13 months,
      depending on when they enrolled in the study. Participants attended several study visits
      throughout the study, which included physical examinations, blood collection, nasal washes,
      and/or nasal adsorption (nasosorption) specimen collection. Participants' parents or
      guardians were contacted by study staff at various times during the study to monitor
      participants' health.
    

Intervention name(s): RSV ΔNS2/Δ1313/I1314L; RSV 276; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 10^6 plaque-forming units (PFU); administered as nose drops; 10^5 PFU; administered as nose drops; Isotonic diluent, administered as nose drops
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Study of Pregnenolone in the Treatment of Individuals With Autism
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the tolerability and effectiveness of pregnenolone in the treatment of
      behavioral deficits in adults with autism. Pregnenolone is a naturally occurring hormone
      found in the body which has been shown to help with the function of nerve cells. It is also
      shown to modulate the activity of certain brain receptors implicated in autism. We hope to
      examine the tolerability of pregnenolone in adults with autism.
    

Detailed description: 
      This study will assess the tolerability and effectiveness of pregnenolone in the treatment of
      behavioral deficits in adults with autism. Pregnenolone is a naturally occurring hormone
      found in the body which has been shown to help with the function of nerve cells. It is also
      shown to modulate the activity of certain brain receptors implicated in autism.

      Pregnenolone has been used safely in research studies involving individuals with
      schizophrenia. In the proposed trial, we hope to examine the tolerability of pregnenolone in
      adults with autism. We hope to see improvement in behavioral outcomes as measured by
      standardized behavioral measures. Further, we will measure concentrations of pregnenolone and
      related neuroactive compounds in the blood. The use of pregnenolone has been studied in a
      number of mental disorders but not autism. Thus, we hope the study will identify new avenues
      of research for the treatment of autism.
    

Intervention name(s): Pregnenolone
Intervention type(s): Drug
Intervention description(s): With Baseline serving as approximately day 1, twice daily intake of orally administered pregnenolone will occur on a schedule consisting of an up-titration followed by a down-titration as described below.
Week 1 and 2: 100 mg
Week 3 and 4: 200 mg
Week 5 and 6: 300 mg
Week 7 and 8: 400 mg
Week 9 -12: 500 mg
At the end of Week 12, pregnenolone was decreased by 50 mg twice a day every 3 days until it was discontinued.
If the participant is unable to tolerate a specific dose then he/she will be maintained at the highest tolerated dose until down titration occurs.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: autism