bioihbjkbjnl/mcl2 huggingface dataset:
Biomarkers of Antidepressant Treatment in Adolescents With Major Depression (The Adolescents MDD Study)
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will aim to evaluate the use of Electroencephalography (EEG) biomarkers in
      adolescent depression. Two specific hypotheses will be tested:

      H1: Early decreases in prefrontal cordance values will be greater in responders to
      antidepressant therapy than in medication non-responders.

      H2: Subjects with high Antidepressant Treatment Response(ATR) Index values [i.e., predicted
      to show symptomatic improvement with fluoxetine (FLX)] will achieve greater improvement in
      symptoms and in functional status than those with low ATR values.

      Exploratory analyses will be undertaken to compare and contrast the cordance changes and ATR
      values in medication and placebo-treated responders and non-responders.
    

Detailed description: 
      A total of 26 adolescent subjects with Major Depressive Disorder(MDD), ages 12 to 20, will be
      consented and join this project at UCLA. For analytic purposes, we will define an "enrolled"
      subject as one who has completed the single-blind lead-in week and one week of double-blind
      treatment, and the three EEG recordings at these visits, as any subject who leaves the
      project prior to that point cannot contribute useful data to testing our hypotheses.

      Subjects who enroll in this project will receive 1 week of single-blind placebo lead-in,
      followed by 8 weeks of double-blind randomized treatment either with fluoxetine (FLX), a
      Selective Serotonin Reuptake Inhibitor (SSRI) with FDA approval for use in this age group, or
      with placebo. Brain activity will be assessed with Qualitative EEG (QEEG) recording at
      pretreatment baseline, after lead-in, and at 1, 2, 4, and 8 weeks of treatment to expand the
      evidence base on the neurophysiology of treatment response in adolescents. Subjects will be
      assessed for symptom change, adverse events, and suicidality at each visit. Functional
      measures related to treatment will be assessed at baseline and at weeks 4 and 8. Subjects and
      the staff who interact with them will be blinded to QEEG biomarker values during the project.
    

Intervention name(s): Fluoxetine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): one-week single-blind PBO-lead-in phase, FLX 10 mg/d for 4 days then 20 mg/d of FLX thereafter; One pill of PBO for 4 days then two pills of PBO thereafter
Intervention MeSH terms: Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Fluoxetine; QEEG; cordance; ATR
Study of a Candidate Clostridium Difficile Toxoid Vaccine in Healthy Adult Subjects Aged 40 to 75 Years in Japan
Condition: Clostridium Difficile Infection
MeSH terms: Clostridium Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of the study is to evaluate a candidate C. difficile Toxoid Vaccine in the Japanese
      population.

      Primary objectives:

        -  To describe the safety profile of all subjects who receive at least 1 injection

        -  To describe the immunogenicity to toxin A and toxin B in all subjects from serum samples
           obtained on Days 0, 14, 30, and 60.
    

Detailed description: 
      Participants will be randomly assigned to receive the vaccine or placebo on the selected
      schedule. Safety parameters, solicited injection site and systemic reactions will be
      collected for 6 days after each injection; unsolicited adverse events including serious
      adverse events will be collected up to Day 60 post-vaccination.
    

Intervention name(s): Clostridium difficile Toxoid Vaccine; 0.9% normal saline
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, intramuscular; 0.5 mL, intramuscular
Other intervention name(s): NaCl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Clostridium difficile infection; Clostridium difficile Toxoid Vaccine
The Comparison of Hemodynamic Effects Between Remimazolam-remifentanil and Propofol-remifentanil in Patients Undergoing Laparoscopic Cholecystectomy
Condition: Acute Cholecystitis
MeSH terms: Cholecystitis; Cholecystitis, Acute
Study type: Interventional

Summary: 
      This study is conducted to determine whether the occurrence of hypotension is reduced by the
      combined use of remimazolam and remifentanil compared to the conventional combination use of
      propofol and remifentanil. Patients enrolled in the study are infused continuously with
      either propofol or remimazolam from the start of anesthesia to the end of surgery.
    


Intervention name(s): propofol group; remimazolam group
Intervention type(s): Drug; Drug
Intervention description(s): During induction, the propofol group starts the effect site concentration at 4.0 ng/ml with TCI and adjusts it to around 3.0 ~ 4.0 ng/ml after intubation to maintain an appropriate EEG-based depth of anesthesia.; In the remimazolam group, start remimazolam at 6 mg/kg/hr and adjust it to 1 mg/kg/hr after loss of consciousness to maintain an appropriate EEG-based depth of anesthesia.
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Markers of Bone Turnover in Saliva and How This Compares to Urine and Blood
Condition: Bone Turnover Markers; Osteoporosis
MeSH terms: Osteoporosis
Study type: Observational

Summary: 
      Study is being done to determine if it is possible to use saliva to measure bone specific
      proteins and predict bone turnover which could be used in the treatment of osteoporosis.
    

Detailed description: 
      Prevention and treatment of osteoporosis require sensitive and specific assays of bone
      turnover. Presently, serum or urinary assessments are used. However, the development of other
      procedures that are more patient-convenient, non-invasive and cost-efficient would
      significantly facilitate a clinician's ability to determine bone turnover. The objective of
      this application is to determine the feasibility of using saliva for this measurement. We
      will compare serum, urinary and salivary levels in 50 pre- and 50 post-menopausal women.
      Markers to be measured are bone alkaline phosphatase, osteocalcin, procollagen type
      propepties hydroxypyridinium crosslinks of collagen and crosslinked collagen telopeptides.
      Collection of saliva, serum and urine will be done at a single visit. We expect to observe
      reasonable good correlation between serum and saliva levels and poorer correlation between
      urine and saliva levels.
    

Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The subject population will be limited to pre-menopausal and post-menopausal females who
        are in good systemic health in an attempt to determine whether salivary levels of bone
        turnover markers hold valuable promise as a replacement or partner biofluid for serum
        and/or urine. In addition, proper selection of the subject population will minimize the
        effect of confounding variables. The specific inclusion criteria and exclusion criteria are
        listed below.
A Study to Evaluate the Safety and Immunogenicity of Novel Oral Polio Vaccine
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This will be a single center, age de-escalation, partly-blinded, randomized study.

      The trial will be performed with the participation of 100 healthy children age 1-5 years who
      have been vaccinated with inactivated polio vaccine (IPV) and/or oral polio vaccine (OPV) in
      their first year of life and of 648 healthy 6 week-old infants, who will be pre-vaccinated
      with bOPV-IPV before being randomized to study groups. The allocation of 18-22 week-old
      infants to groups will be performed in a randomized manner. Following completion and Data
      Safety Monitoring Board (DSMB) review of follow-up for general safety data (Serioius Adverse
      Events -SAEs-, Important Medical Events -IMEs- and severe adverse events -AEs), a DSMB
      recommendation to proceed will result in randomization of the final cohort of infants.
      Allocation of 1 to 5 year-old children to groups will be performed in a randomized manner.

      The DSMB will establish and continuously assess stopping rules for safety.
    


Intervention name(s): nOPV2 (monovalent oral polio vaccine)
Intervention type(s): Biological
Intervention description(s): Cohort A: 150 IPV and/or OPV vaccinated participants aged 1 to 5 years vaccinated with candidate 1 or 2; two 10‸6 CCID50 (50% cell culture infective dose) doses separated by 28 days.
Cohort B: 972 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 10‸5 CCID50 dose of candidate 1 or 2.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
A Phase I/II Study to Evaluate the Safety and Efficacy of PerioSept® as Adjunct to SRP in Subjects With Periodontitis
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A Pharmacokinetic Pilot followed by a Phase I/II, Blinded, Randomized, Controlled, Parallel
      Arm Trial to Evaluate the Safety, Tolerability and Efficacy of PerioSept® and Scaling and
      Root Planing in Subjects with Periodontitis
    

Detailed description: 
      This trial will follow an adaptive trial design, whereby information regarding PerioSept(r)
      drug levels will be obtained via a PK trial lead in period (PK Pilot) in a limited number of
      subjects (up to N=8). This will be followed by the main safety and efficacy trial of
      PerioSept(r) as an adjunct to scaling and root planing (SRP) in subjects with moderate to
      severe periodontitis (Main Trial, N=87). The PK Pilot will be an open label PK study. Up to 8
      qualifying subjects will receive SRP on Day 1 followed by 3% PerioSept(r) administered in a
      minimum of 4 qualifying periodontal Study Pockets in at least 2 quadrants with a probing
      pocket depth (PPD) ≥ 5mm and bleeding on probing (BOP) and at least 20 other qualifying
      pockets (PPD ≥ 5 mm). The Main Trial will be a multi-center, randomized, blinded, placebo
      controlled, parallel arm trial of PerioSept(r) (0.3%, 1% or 3%) administered up to three
      times (over Days 1 and 2, at Weeks 4 and 12) into a minimum of 4 qualifying periodontal Study
      Pockets in at least 2 quadrants with a PPD ≥ 5mm and BOP following SRP at baseline. All other
      eligible pockets with a PPD ≥ 5mm will also be treated.

      Full mouth SRP will be initiated on Day 1 followed by randomized treatment of that side. If
      necessary, SRP and randomized treatment may be completed on the other side of the mouth on
      Day 2. Treated pockets that still have a PPD ≥ 5mm at the 4 and 12 week visits will be
      retreated with SRP or SRP plus placebo or PS, as randomized. Assessments will be conducted
      over a 24 week (6 month) period including safety assessments and assessments of dental
      parameters (PPD, BOP, Plaque index, Gingival Index, Clinical attachment level).
    

Intervention name(s): PerioSept(r)
Intervention type(s): Drug
Intervention description(s): Taurolidine is derived from the amino acid taurine and has antimicrobial and immune modulating properties
Other intervention name(s): Taurolidine
Intervention MeSH terms: Taurolidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: periodontitis; taurolidine (PerioSept(r)); scaling and root planing
Dexmedetomidine Infusion in Hypospadias Surgery
Condition: Pain
MeSH terms: Hypospadias
Study type: Interventional
Phase: Phase 3

Summary: 
      The investigators hypothesize that giving Dexmedetomidine in combination with Fentanyl for
      pediatric patients undergoing hypospadias surgery, will reduce the fentanyl requirement for
      intraoperative and postoperative analgesia.
    


Intervention name(s): Dexmedetomidine and Fentanyl; Fentanyl
Intervention type(s): Drug; Drug
Intervention description(s): Dexmedetomidine in a dose of 1 ug/kg initial dose then continuous infusion of 0.7 ug/kg/hr . Combined with Fentanyl at a dose of 2 ug/kg initially plus boluses of fentanyl to keep the patient hemodynamically stable.; This group received Fentanyl at a dose of 2 ug/kg initially, followed by boluses to keep the patient hemodynamically stable.
Other intervention name(s): Precedex
Intervention MeSH terms: Fentanyl; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Dexmedetomidine; Fentanyl; Pain; Pediatrics
Stroke and Traumatic Acute Brain Injury Line Indicator System for Emergent Recognition (STABILISER-I)
Condition: Ischemic Stroke; Hemorrhagic Stroke; Traumatic Brain Injury
MeSH terms: Stroke; Brain Injuries; Ischemic Stroke; Brain Injuries, Traumatic; Hemorrhagic Stroke; Wounds and Injuries
Study type: Interventional

Summary: 
      In the search for a novel marker of stroke that could be rapidly assessed in blood, the
      investigators developed a point-of-care (POC) lateral flow device (LFD) that rapidly (< 15
      min) detects levels of a biomarker that is released into blood following neuronal injury
      associated with stroke and traumatic brain injury. The protein's expression in human brain
      should serve as a useful biomarker of neuronal injury in stroke and traumatic brain injury.
    

Detailed description: 
      The use of a lateral flow device (LFD) to indicate the presence of a blood biomarker is
      feasible and may provide an important diagnostic tool for stroke and traumatic brain injury
      (TBI).

      Primary Objectives:

        1. Determine the first-in-humans feasibility using the investigators' biomarker lateral
           flow device on whole blood samples to diagnose patients with acute stroke (both ischemic
           and hemorrhagic) and traumatic brain injury being evaluated in the Emergency Department
           and Inpatient Services at University of Kentucky. Provide initial pilot data for
           estimating sensitivity and specificity of the assay.

        2. Establish a visual ordinal grading scale that is easy to use clinically to judge the
           severity of injury, from the Lateral Flow Device result. Verify that the visual scale
           has inter-rater reliability, and evaluate it against a digital detection assay.

        3. Examine the correlation between clinical and radiographic parameters of injury severity
           and blood levels of the biomarker. The investigators will correlate the results of the
           test with NIH Stroke Scale and with MRI infarct volume for ischemic stroke, with
           hemorrhage volume on CT for hemorrhagic stroke, and with Glasgow Coma Scale for
           Traumatic Brain Injury (TBI).
    

Intervention name(s): Lateral Flow Device
Intervention type(s): Device
Intervention description(s): A drop of whole blood from a finger stick is placed on the lateral flow device at two different time points to indicate the presence of a neuronal specific biomarker. The results will also be correlated to severity of clinical and radiographic injury. Separate drops are evaluated similarly for serum levels. The objective is to determine feasibility of a diagnostic tool for stroke (ischemic and hemorrhagic and traumatic brain injury (TBI). No diagnostic results or resulting treatments will be applied to any subject.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Lateral Flow Device (LFD); Acute Stroke; Traumatic Brain Injury (TBI); Point of Care (POC); Biomarker
Study in Patients With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine which dose of the investigational drug is safest
      and most effective compared to the control drug.
    


Intervention name(s): Formoterol Fumarate
Intervention type(s): Drug
Intervention MeSH terms: Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Asthma; Formoterol; Fumarate; Foradil
A Trial to Compare Prophylaxis Therapy to On-demand Therapy With a New Full Length Recombinant FVIII in Patients With Severe Hemophilia A
Condition: Hemophilia A
MeSH terms: Hemophilia A
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of the trial is to demonstrate that 2-3 times per week prophylaxis therapy with
      BAY81-8973 is superior to on-demand therapy with BAY81-8973 in patients with severe
      Hemophilia A. The hypothesis is that prophylaxis will result in fewer bleeds than on-demand
      treatment.
    


Intervention name(s): rFVIII (BAY81-8973) on demand; rFVIII (BAY81-8973) prophylaxis low-dose; rFVIII (BAY81-8973) prophylaxis high-dose
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization; Participants received low dose prophylaxis treatment at 20, 25 or 30 IU/kg twice per week with rFVIII (BAY81-8973) assayed by CS/EP for 6 months and by CS/ADJ for 6 months, sequence according to randomization.; Participants received high dose prophylaxis treatment at 30, 35 or 40 IU/kg 3 times per week with rFVIII (BAY81-8973) assayed by CS/EP for 6 months and by CS/ADJ for 6 months, sequence according to randomization.
Intervention MeSH terms: Factor VIII
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Haemophilia treatment; rFVIII
Enhancing Juvenile Drug Court Outcomes With Evidence-Based Practices
Condition: Adolescent Substance Use
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Juvenile drug courts were developed in response to a perceived need to intervene more
      effectively with youth with substance abuse problems. Close collaboration between the court
      and substance abuse treatment provider is a defining component of the drug court model and is
      critical to helping youth achieve positive outcomes. Despite the proliferation of juvenile
      drug courts in recent years, however, evaluation of their capacity to reduce offender
      substance use and criminal activity has lagged. Moreover, the Institute of Medicine (IOM,
      1998) and leading experts (McLellan, Carise, & Kleber, 2003) have presented a bleak picture
      of the nation's capacity to meet the treatment needs of substance abusing individuals.
      Although community-based programs provide the backbone of substance abuse treatment in the
      nation, their capabilities have not kept up with major scientific advances in the development
      and validation of evidence-based substance abuse interventions.

      Building on our research findings and experience regarding juvenile drug court outcomes as
      well as the transport of evidence-based practices to community treatment settings, the
      purpose of this study is to develop and test a relatively flexible and low cost strategy for
      enhancing the outcomes of juvenile drug courts by integrating components of evidence-based
      treatments into existing substance abuse services.

      Specifically, this project aims to:

      Aim 1: Adapt existing intervention and training protocols from evidence-based practices
      (i.e., Contingency Management for adolescent substance abuse; family engagement strategies
      from evidence-based treatments of juvenile offenders) for integration into juvenile drug
      court sites.

      Aim 2: Conduct a study to examine youth (e.g., substance use and criminal behavior) and
      system level (e.g., intervention adherence, feasibility, retention and completion rates,
      consumer satisfaction, cost estimates) effects of implementing the intervention protocols in
      juvenile drug courts.

      Aim 3: Revise the intervention and training protocols in preparation for a Stage II study if
      findings are supportive.
    


Intervention name(s): Contingency Management-Family Engagement (CM-FAM); Usual Services (US)
Intervention type(s): Behavioral; Other
Intervention description(s): Evidence-based outpatient intervention for adolescent substance use; Typical community-based substance abuse treatment services
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Substance Use; Delinquency; Juvenile Drug Court; Contingency Management; Family Engagement
Influence of Drug-drug Interactions on the Pharmacokinetics (PK) of Voriconazole
Condition: Invasive Aspergillosis
MeSH terms: Aspergillosis
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the drug-drug interaction between rifampicin and voriconazole according to
      CYP2C19 genotype quantitatively following a single oral administration of 200 mg voriconazole
    


Intervention name(s): Voriconazole
Intervention type(s): Drug
Intervention description(s): Day1: voriconazole 200 mg x 2, oral administration, Day2-7: rifampin 600 mg, once a day oral administration, Day8: voriconazole 200 mg x 2 + rifampin 600 mg, oral co-administration
Intervention MeSH terms: Voriconazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Study of NeisVac-C Vaccine to Evaluate Immunological Interference With Hepatitis B, Inactivated Polio and Acellular Pertussis Vaccines in Healthy Infants
Condition: Meningitis, Meningococcal
MeSH terms: Hepatitis B; Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary aim of the study is to show that NeisVac-C does not influence the seroconversion
      rates induced by hepatitis B (Hep B), inactivated polio (IPV) and acellular pertussis (aP)
      vaccines in infants.
    


Intervention name(s): Group C Meningococcal Polysaccharide-Tetanus Toxoid Conjugate Vaccine (GCMP-TT)
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningococcal Vaccine; Meningococcal Meningitis, Serogroup C; Neisseria Meningitidis