bioihbjkbjnl/mcl2 huggingface dataset:
Examining the Effectiveness of the FaCES Adolescent SBIRT Intervention
Condition: Adolescent Health Services; Adolescent Behavior
Study type: Interventional

Summary: 
      The study will utilize a stepped wedge cluster randomized design to examine the effectiveness
      of the full FaCES (Facilitating Change for Excellence in SBIRT) adolescent SBIRT change
      package. Primary care providers will be randomized as to when they receive training and begin
      delivery of FaCES with their 12 to 17 year old patients, which includes targeted feedback
      based on the patient's endorsed substance use level on the S2BI screening instrument.
    

Detailed description: 
      The study will utilize a stepped wedge cluster randomized design to examine the effectiveness
      of the full FaCES (Facilitating Change for Excellence in SBIRT) adolescent change package for
      12 to 17 year old primary care patients. Primary care providers at two rural federally
      qualified health centers in New Mexico and Tennessee will be randomized as to when they
      receive training and begin delivering FaCES to their adolescent patients. FaCES includes
      targeted feedback based on the patient's endorsed substance use level on the S2BI screening
      instrument. Study participants will complete a baseline and follow-up assessment 3-months
      post study recruitment.
    

Intervention name(s): brief intervention; treatment as usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 1 minute or less of anticipatory guidance will be provided for adolescents reporting no use in the past year, a 3-5 minute abbreviated brief intervention including raising the subject, asking more questions, and correcting misinformation will be provided for adolescents reporting substance use once or twice in the past year, and a 5-10 minute full brief intervention will be provided, including the above steps as well as assessing readiness and negotiating change and scheduling a follow-up to potentially include a referral to treatment will be provided to adolescents reporting monthly to weekly use in the past year.; standard care conducted by primary care providers during clinic visits
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: SBIRT
Immunogenicity and Safety of Two-Dose Series of Menactra® in Japanese Healthy Adult Subjects
Condition: Meningitis; Meningococcal Meningitis; Meningococcal Infections
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study was to collect further information regarding an increase immune
      response of SP284 after an additional dose in Japanese participants.

      Primary Objective:

        -  To evaluate and describe the immune responses to meningococcal antigens (serogroups A,C,
           Y and W-135) at 28 days following each vaccination with SP284 vaccine in participants 20
           through 55 years of age.

      Other Pre-specified objective:

        -  To describe the safety in terms of immediate systemic adverse events (AEs), solicited
           reactions, unsolicited non-serious adverse events, and serious adverse events (SAEs)
           following receipt of each dose of SP284 vaccine in persons 20 through 55 years of age.
    

Detailed description: 
      All participants received a 2-dose series of the study vaccine with 8-week interval and was
      monitored for safety and assessed for immunogenicity at baseline (pre-vaccination) and at 28
      to 35 days following each vaccination.
    

Intervention name(s): Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate
Intervention type(s): Biological
Intervention description(s): 0.5 mL, Intramuscular (2 doses with 8-week interval)
Other intervention name(s): SP284; Menactra®
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningitis; Meningococcal Meningitis; Meningococcal Infections; Menactra®; Meningococcal Vaccine
Posterior Lateral Fusion (PLF) With Dynesys
Condition: Spondylolisthesis
MeSH terms: Spondylolisthesis
Study type: Observational

Summary: 
      The primary purpose of this study is to track and document the clinical outcomes of patients
      with radicular pathology following posterior lateral fusion with the Dynesys Spinal System.
      Secondary purpose of this study is to assess outcomes with historical controls along a
      continuum of motion and anatomy sparing procedures.
    

Detailed description: 
      This study will help the patient to the extent that it will allow the comparison of this
      unique treatment to the corpus of literature on radicular pathology, thus focusing a specific
      treatment for a specific pathology.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Clinical outcomes following postierior lateral fusion with the Dynesys(R) Spinal System
      
Keywords: dynamic stabilization; Dynesys; fusion success; Immobilization of spinal segments as an adjunct to fusion in the treatment of the following:; acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine; degenerative spondylolisthesis with objective evidence of neurologic impairment; failed previous fusion (pseudarthrosis).
To Evaluate the Pharmacokinetics and Safety of Yimitasvir Phosphate Capsules in Subjects With Moderate and Severe Liver Function Impairment and in Healthy Subjects
Condition: Hepatic Impairment
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the pharmacokinetics and safety of Yimitasvir phosphate capsules in subjects with
      moderate and severe liver function impairment and healthy subjects in a single-center,
      non-randomized, open, single-dose administration
    

Detailed description: 
      A phase I, a single-center, non-randomized, open, single-dose administration study to explore
      the safety, pharmacokinetics of Yimitasvir phosphate capsules in subjects with moderate and
      severe liver function impairment and healthy subjects

      This study is divided into four cohorts, cohort A and cohort C in healthy subjects, cohort B
      for moderate liver function impairment participants, cohort D for severe liver function
      impairment, participants in cohort A and cohort B, group C and group D should be matched in
      terms of sex, age, and body mass index (BMI). A total of 32 subjects, 8 in each cohort, both
      male and female, are planned to be enrolled. If a complete PK blood sample is not collected
      due to subjects' early withdrawal from the study, new subjects will be enrolled to meet the
      pharmacokinetic parameters that can be evaluated for each cohort of 8 subjects.
    

Intervention name(s): Yimitasvir Phosphate; Yimitasvir Phosphate; Yimitasvir Phosphate; Yimitasvir Phosphate
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Cohort A: On the first day, 100 mg of Yimitasvir phosphate was given in a single dose on fasted by each subjects; Cohort B: were subjects with moderate liver function impairment. On the first day, 100 mg of Yimitasvir phosphate was given in a single dose on fasted by each subjects.; Cohort C: Cohort C are healthy subjects, cohorts C and D, should be matched in terms of sex, age, and body mass index (BMI). On the first day, 100 mg of Yimitasvir phosphate was given in a single dose on fasted by each subjects.; Cohort D: were subjects with severe liver function impairment. On the first day, 100 mg of Yimitasvir phosphate was given in a single dose on fasted by each subjects.
Intervention MeSH terms: Yimitasvir
Intervention model: Sequential Assignment
Intervention model description: This study is divided into four cohorts: healthy subjects in cohort A and C, moderate liver function impairment subjects in cohort B, and severe liver function impairment subjects in cohort D. Cohorts A and B, C and D should be matched in terms of gender, age, and body mass index (BMI).
Masking: None (Open Label)
Primary purpose: Treatment
ABX Combined With Cisplatin Compared With Gemcitabine Combined With Cisplatin in NSCLC
Condition: Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      Assess the PFS/ORR/OS of ABX Combined With Cisplatin Compared With Gemcitabine Combined With
      Cisplatin in first Treatment of NSCLC
    


Intervention name(s): ABX Combined With Cisplatin; Gemcitabine Combined With Cisplatin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Cisplatin; Gemcitabine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PFS
Evaluation of the Safety and Efficacy of the CardioPulseTM PuLsed fiEld Ablation SystEm in Patients With Paroxysmal Atrial Fibrillation (PLEASE-AF Study)
Condition: Paroxysmal Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The purpose of this clinical trial is to evaluate the safety and efficacy of a pulsed field
      ablation system developed and manufactured by Hangzhou Dinova EP Technology Co., Ltd in the
      treatment of patients with paroxysmal atrial fibrillation
    

Detailed description: 
      This study is a premarket clinical trial of a pulsed field ablation catheter system, this
      study evaluates the safety and effectiveness of the pulsed field ablation catheter system
      developed and produced by Hangzhou Dinova EP Technology Co., Ltd. in the endovascular
      interventional treatment of patients with paroxysmal atrial fibrillation, and provided a
      clinical basis for the formal application of this product in China.
    

Intervention name(s): CardioPulsesTM pulsed field ablation system
Intervention type(s): Device
Intervention description(s): Using pulsed field ablation (PFA) catheter, steerable sheath and pulsed field generator to treat atria fibrillation.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessment of a New "Boosting" Strategy for HIV Pre-exposure Prophylaxis in Healthy Volunteers
Condition: Pre-Exposure Prophylaxis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The study will be a randomized, open-label, cross-over clinical pharmacokinetic trial to
      investigate a strategy for probenecid "boosting" in the setting of tenofovir disoproxil
      fumarate (TDF)/emtricitabine (FTC) for HIV pre-exposure prophylaxis (PrEP). The study will be
      conducted at the Indiana University Clinical Research Center. All samples will be processed
      and the amount of tenofovir/FTC in plasma, blood, and urine, and tenofovir diphosphate and
      emtricitabine in peripheral blood mononuclear cells will be determined using validated
      analytical methods developed by the investigators at the University of Colorado. Probenecid
      plasma and urine concentrations will also be measured using an in-house assay. Following
      completion of the study, the secondary aim will be accomplished via analysis of selected
      samples collected at baseline and following treatment. Those selected samples will be
      assessed for urinary markers of proximal tubulopathy (urine total protein, albumin,
      creatinine, phosphorus, retinol binding protein, and beta-2-microglobulin) and serum alkaline
      phosphatase, osteocalcin, procollagen type 1 N propeptide, cystatin C, and creatinine to
      determine if the probenecid boosting strategy does indeed lead to less potential renal and
      bone toxicity.
    


Intervention name(s): Probenecid Oral Tablet; Tenofovir disoproxil fumarate/Emtricitabine
Intervention type(s): Drug; Drug
Intervention description(s): Included in arm/group descriptions.; Included in arm/group descriptions.
Other intervention name(s): TDF/FTC, Truvada
Intervention MeSH terms: Tenofovir; Emtricitabine; Probenecid
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects will be randomly allocated to enter the study in either the control or treatment arm using a blocked design to ensure equal numbers of subjects in each sequence group (n=8, control to treatment; n=8, treatment to control). Following a washout period of at least 6 weeks, each individual will crossover to the next study phase. The randomization table will be constructed prior to subject enrollment by the Principal Investigator using the Statistical Analysis Software (SAS®) randomization procedure. In the event that an individual is withdrawn from the study, an alternate participant will replace that individual using an identical study sequence to maintain the block design. A total of 16 subjects will be initially enrolled in an effort to ensure that at least 14 subjects complete the entire study. If needed, additional subjects will be screened and enrolled until the target enrollment of n=14 subjects have completed the entire study.
Masking: None (Open Label)
Primary purpose: Basic Science
The Breathe Light Study
Condition: Over-eating; Obesity
MeSH terms: Hyperphagia
Study type: Observational

Summary: 
      The purpose of this study is to develop a novel, non-invasive method that will provide
      personalized feedback during dietary interventions as a marker for compliance.
    


Intervention name(s): 20% fewer calories; 40% fewer calories
Intervention type(s): Other; Other
Observational model: Case-Crossover
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Men & Women age 18 to 65 years with a BMI of 25- 40 kg/m2.
      
Keywords: obesity; carbon13; over-eating; metabolic chamber; room calorimeter
Singe Dose, First in Human Study of PF- 06946860 in Healthy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of
      PF-06946860 in healthy adult subjects following single ascending doses This is the first
      clinical study of PF-06946860.
    


Intervention name(s): PF-06946860; Placebo
Intervention type(s): Biological; Other
Intervention description(s): PF-06946860 administered subcutaneously; Placebo, administered subcutaneously
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single, Oral Escalating Doses of GSK2647544 in Healthy Volunteers
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The current study will examine the safety, tolerability, plasma pharmacokinetics (PK), and
      plasma pharmacodynamics (PD) of single-doses of GSK2647544.The study will be conducted as a
      randomized, single-blind, placebo controlled, 4-way crossover single oral ascending dose
      design in 2 independent cohorts, eight healthy male subjects in each of the cohorts. Each
      potential subject will undergo Screening visit, Treatment Phase and Follow-up visit.
    


Intervention name(s): GSK2647544; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Capsules containing 0.5mg to 50mg of GSK2647544.; Matching placebo capsules.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Lp-PLA2; Alzheimer's disease
Safety Study of LLF580 in Obese Volunteers
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety and tolerability of multiple doses of
      LLF580 administered subcutaneously over 3 months in obese subjects. In addition, the study
      will also determine early efficacy signals in various metabolic diseases associated with
      elevated triglycerides and/or obesity.
    


Intervention name(s): LLF580; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): LLF580 300mg; Placebo to LLF580
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: obesity; hypertriglyceridemia
Effects of Plant Polar Lipids on Glucose Tolerance
Condition: Healthy
Study type: Interventional

Summary: 
      In this randomized controlled trial, two different plant polar lipids are investigated with
      respect to their potential to affect acute and second meal glucose tolerance and appetite
      sensations. The effects are compared with a common non-polar commercial oil. The lipids are
      consumed spread on a white wheat bread. A white wheat bread without added lipids is included
      as a control product. The test products are consumed at breakfast, and test variables are
      investigated in the postprandial period after the test breakfast and also after a second meal
      standard lunch.
    


Intervention name(s): Polar lipid 1; Polar lipid 2; Non-polar lipids; No lipids
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Other
Intervention description(s): 15g plant polar lipids from plant source 1. The lipid supplement is consumed spread on a commercial white wheat flour bread as a source of available carbohydrates (50 g).; 15g plant polar lipids from plant source 2. The lipid supplement is consumed spread on a commercial white wheat flour bread as a source of available carbohydrates (50 g).; 15g non-polar plant lipids from plant source 1. The lipids supplement is consumed spread on a commercial white wheat flour bread as a source of available carbohydrates (50 g).; A commercial white wheat flour bread as a source of available carbohydrates (50 g), without added lipids.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Higher Intensity Interval Training in Cardiac Rehabilitation
Condition: CAD
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effect higher intensity interval exercise (HIIT)
      with standard intensity non-interval exercise on fitness in cardiac rehabilitation patients
      with CAD. Also to assess practical implementation of HIIT in cardiac rehabilitation.
    


Intervention name(s): HIIT; Standard intensity non-interval training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Higher intensity interval training.; Standard intensity non-interval training.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: CAD; cardiac rehabilitation; fitness
ETEC Logistics Trial (TREK)
Condition: Diarrhea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multicenter, double-blind, randomized, placebo-controlled field trial to evaluate
      the epidemiology of natural infection with ETEC occurring after transcutaneous immunization
      in a field setting.
    

Detailed description: 
      The primary objectives of the study are to evaluate the incidence of ETEC illness in a field
      setting and to compare the safety of LT delivered by TCI with placebo. The secondary
      objectives include, but are not limited to:

      evaluate the stool frequency per episode of ETEC illness in placebo recipients, to evaluate
      the immunogenicity of LT delivered by TCI, to evaluate the incidence of IBS following travel
      to areas of ETEC endemnicity, and to evaluate the incidence of VPO in placebo and LT patch
      recipients.
    

Intervention name(s): Heat-Labile Enterotoxin of Escherichia coli (LT); Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Subjects in Group 1 will receive two vaccinations of a patch containing 37.5µg LT 2 to 3 weeks apart.; The placebo patch contains all of the components of the active patch, but with no LT included in the formulation.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Keywords: ETEC; Traveler's diarrhea; TCI; patch vaccine; diarrhea prevention; epidemiology ETEC; Escherichia coli
SANGUINATE™ in Sickle Cell Disease Associated Leg Ulcer
Condition: Leg Ulcer
MeSH terms: Anemia, Sickle Cell; Leg Ulcer; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      SANGUINATE™ Sickle Cell Disease associated Leg Ulcers.
    

Detailed description: 
      This is an escalating, repeated-dose, open-label Phase 2 study to test SANGUINATE (pegylated
      carboxyhemoglobin bovine) in patients suffering from leg ulceration associated with Sickle
      Cell Disease (SCD leg ulcer).

      Patients will undergo consent and screening procedures at the time of presentation for leg
      ulcer treatment. Eligible patients will begin a 3-week Run-In Period. A total of
      approximately fifteen (15) patients are expected to be screened in order to achieve an
      enrollment target of ten (10) evaluable patients for participation in the study. Evaluable is
      defined as a patient receiving a minimum of three doses of investigational product. Five (5)
      patients (Cohort 1) will receive four (4) once-weekly 2-hour IV infusions of SANGUINATE at a
      dose of 320 mg/kg (8 mL). An additional five (5) patients (Cohort 2) will receive six (6)
      once-weekly 2-hour IV infusions of SANGUINATE also at a dose of 320 mg/kg. Each patient will
      be contacted by telephone approximately 24 hours after dosing to verify the safety status of
      the patient. One week following the Treatment Phase, patients will return to the study center
      for a Final Visit where safety assessments will be performed. During the Final Visit,
      patients will receive standard of care treatment of ulcer. All patients will receive
      once-weekly Standard of Care (SOC) therapy for SCD leg ulcer for the duration of the study.
      SOC includes dressing the wound with multi-layer, short stretch, compression bandaging.
      Non-adherent, medical-grade foam will be used as the wound contact layer and primary
      dressing.
    

Intervention name(s): SANGUINATE
Intervention type(s): Biological
Intervention description(s): A two-hour infusion provided once a week over a 4-week or 6-week period.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Leg Ulcer; LU; SANGUINATE; QOL; SCD; Sickle Cell Disease; Sickle Cell; Anemia; Leg Wound; Leg; Skin Lesion
Hydroxytriptolide in Active Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to investigate the efficacy and safety of Hydroxytriptolide(LTS)
      in active rheumatoid arthritis patients with an inadequate response to methotrexate.
    

Detailed description: 
      1. Investigate the efficacy of Hydroxytriptolide in active RA patients

        2. Investigate the safety of Hydroxytriptolide in active RA patients. Especially in female
           reproductive system.

        3. Population PK study.
    

Intervention name(s): LTS 0.25mg; LTS 0.5mg; LTS 1.0mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): use LTS 0.25mg/d; use LTS 0.5mg/d; use LTS 1.0mg/d; use placebo once daily
Other intervention name(s): Hydroxytriptolide; Hydroxytriptolide; Hydroxytriptolide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hydroxytriptolide; Rheumatoid Arthritis; Methotrexate; T8; LTS