bioihbjkbjnl/mcl2 huggingface dataset:
The Influence of Sampling Site When Assessing Glucose Tolerance or Insulin Sensitivity With Oral Glucose Ingestion
Condition: Hyperglycemia; Insulin Sensitivity
MeSH terms: Insulin Resistance; Hyperglycemia; Hypersensitivity
Study type: Interventional

Summary: 
      For decades, it has been known that post-meal blood glucose concentrations were associated
      with the risk of T2D, which was reflected in early diagnostic guidelines. The oral glucose
      tolerance test (OGTT) has been used since at least 1923 and has remained the most common test
      for assessing glucose tolerance. Arterial blood (or arterialised blood using heated hand
      technique) is most appropriate for determining glucose tolerance and insulin sensitivity
      since this best represents the concentrations of metabolites and hormones that peripheral
      tissues are exposed to. It is essential to investigate whether venous blood (sometimes used
      during an OGTT) is representative of arterialised blood during an OGTT, and under different
      metabolic conditions.

      The investigators want to understand whether OGTT-derived insulin sensitivity indices differ
      from venous and arterialised blood; and 2) investigate whether metabolic status (i.e. rest vs
      lower-limb exercise) influences the difference between forearm venous and arterialised
      concentrations of glucose and insulin during an OGTT.
    


Intervention name(s): Rest; Exercise; Dorsal Hand Vein Cannulation (heated hand technique); Venous Cannulation
Intervention type(s): Behavioral; Behavioral; Other; Other
Intervention description(s): Allowed to watch television or read for one hour prior to oral glucose tolerance test; One hour of cycling at 50% of maximal power output
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Brain Function and Structure in Cocaine Dependence
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine the role of brain MRI findings in predicting
      treatment outcomes among individuals with cocaine dependence.
    

Detailed description: 
      The Specific Aims of this project are:

      Aim 1: To determine whether pretreatment brain activation on fMRI while performing a Go-Nogo
      task predicts response to pharmacotherapy in cocaine dependent subjects.

      Hypothesis related to Aim 1:

      Pretreatment fMRI BOLD activation in cocaine dependent subjects during impulsive responding
      on the Go-Nogo task predicts 8-week outcome from medication known to enhance serotonin
      function (citalopram). The regression coefficient of TES on pretreatment mean BOLD activation
      on the Go-Nogo task will be significantly greater for the citalopram group than the placebo
      group.

      Aim 2: To determine whether pretreatment brain activation on fMRI while performing an
      attentional bias (cocaine Stroop) task predicts response to pharmacotherapy in cocaine
      dependent subjects.

      Hypothesis related to Aim 2:

      Pretreatment fMRI BOLD activation in cocaine dependent subjects during cocaine related words
      on the cocaine Stroop task predicts 8-week outcome from medication known to enhance serotonin
      function (citalopram). The regression coefficient of TES on pretreatment mean BOLD activation
      from the cocaine Stroop task will be significantly greater for the citalopram group than the
      placebo group.
    

Intervention name(s): Citalopram; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg or 40 mg daily for 8 weeks; Placebo daily for 8 weeks
Other intervention name(s): Celexa; Citalopram HBr
Intervention MeSH terms: Dexetimide; Citalopram; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: substance abuse; cocaine; impulsivity; serotonin; MRI
Oral Hygiene Intervention for Adolescents
Condition: Oral Hygiene
Study type: Interventional

Summary: 
      The purpose of this study is to promote oral hygiene behaviors (toothbrushing, flossing) and
      oral health with high-risk adolescents in San Diego, CA, through a Motivational Interviewing
      (MI) Intervention.
    

Detailed description: 
      This randomized controlled trial (RCT) will evaluate the efficacy of a new, brief
      motivational interviewing (MI)- based intervention and assess its impact on several sets of
      outcomes among 14-19 years old Latino adolescents: clinical oral health and hygiene indices,
      counts of biological caries-causing bacteria, and oral hygiene behaviors. Three one-on-one,
      half hour educational and skill-building MI sessions will address: proper oral hygiene
      technique, bacteria and dental caries process, and nutrition. Intervention group adolescents
      will also receive three telephone calls (one/month reinforcing their hygiene behavior goals.
      Outcomes will be assessed at baseline (T1), and at one-month (T2), after the intervention
      group received three MI sessions and three booster calls.

      Aim 1. To develop and assess a new Motivational Interviewing (MI)-based behavioral oral
      health intervention for Latino adolescents in a randomized controlled trial (RCT) design.
      Finalize all intervention educational materials and scripts and assessment tools.

      Aim 2. To assess the efficacy of the brief intervention on reductions in clinically
      determined outcomes among intervention versus control participants.

      Aim 3. To assess the efficacy of the brief intervention on reductions in the presence and
      count of two types of biological bacteria involved in the dental caries disease process.

      Aim 4. To assess the efficacy of the brief intervention in increasing the frequency of daily
      oral hygiene behaviors, including properly brushing, flossing, and rinsing.

      Aim 5. Conduct process evaluation via two focus groups post-intervention to assess the
      acceptability and feasibility of the intervention and assessments (one for intervention
      group; one for control group).

      The investigators hypothesize that the intervention group will see improved clinical
      outcomes, lower bacteria counts, and better oral hygiene behavior than the control group.
    

Intervention name(s): Motivational Interviewing
Intervention type(s): Behavioral
Intervention description(s): Intervention will include 3 one-on-one motivational interviewing sessions and 3 follow-up calls with a trained MI health educator. These sessions aim to promote better oral hygiene and oral health.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Intervention and control groups will be enrolled and followed over one-month.
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Post-operative Sore Throat and Gum Chewing
Condition: Anesthesia; Surgery
MeSH terms: Pharyngitis
Study type: Interventional

Summary: 
      The purpose of this study is to determine if chewing gum immediately prior to transport to
      the operating room reduces the severity of post-operative sore throat in patients who have an
      LMA (laryngeal mask airway) placed for procedures with duration greater than 1 hour.
    

Detailed description: 
      Patients will be randomized into two groups. Group 1 will receive a piece of gum immediately
      prior to transport to the operating room. They will be asked to chew the gum for 2 minutes
      and then spit the gum in the garbage. Group 2 will not receive any gum. They will be asked to
      swallow twice and have no other intervention.
    

Intervention name(s): Gum; Control
Intervention type(s): Other; Other
Intervention description(s): 2 minutes of gum chewing prior to procedure; 2 swallows prior to procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Photodynamic Therapy in Endodontic Treatment
Condition: Endodontic Disease
MeSH terms: Dental Pulp Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      This randomized clinical trial evaluated the effectiveness of supplemental photodynamic
      therapy (PDT) in optimizing the removal of bacteria and endotoxins from primarily infected
      root canals after one-visit and two-visit treatments.Twenty-four primarily infected root
      canals with apical periodontitis were selected and randomly divided into one-visit (n=12) and
      two-visit treatments (n=12). Chemo-mechanical preparation (CMP) was performed by using the
      single-file reciprocating technique + 2.5% NaOCL and a final rinse with 17% Ethylenediamine
      tetraacetic acid (EDTA). The photosensitizer agent (methylene blue 10 mg/mL) was applied to
      root canals for 60 seconds and submitted to laser with a potency of 60 milliwatts (mW) and
      energy density of 129 J/cm2 for 120 seconds after CMP in the one-visit treatment and after
      14-day inter-appointment medication with Ca(OH)2 + saline solution (SSL) in the two-visit
      treatment. Samples were collected before and after root canal procedures. Endotoxins were
      quantified by chromogenic limulus amebocyte lysate assay. Culture techniques were used to
      determine bacterial colony-forming unit counts.
    


Intervention name(s): Laser; Calcium hydroxide
Intervention type(s): Device; Drug
Intervention description(s): 1-visit-treatment (n=12): Chemomechanical preparation (CMP) - CMP was performed by using the single-file reciprocating technique + 2.5% NaOCL and 17% EDTA. Methylene blue was applied to root canals for 60 seconds and submitted to laser with a potency of 60 mW and energy density of 129 J/cm2 for 120 seconds after CMP; 2-visit-treatment (n=12): Chemomechanical preparation (CMP) + Ca(OH)2 + SSL medication for 14-days + PDT. CMP was performed by using the single-file reciprocating technique + 2.5% NaOCL and 17% EDTA. Methylene blue was applied to root canals for 60 seconds and submitted to laser with a potency of 60 mW and energy density of 129 J/cm2 for 120 seconds after 14-days of intracanal medication
Other intervention name(s): PDT
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Hydroxychloroquine in the Prevention of COVID-19 Infection in Healthcare Workers
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      In order to assess the efficacy of hydroxychloroquine treatment weekly for a total of 7 weeks
      in the prevention of COVID-19 infection, three hundred sixty (360) Healthcare workers with
      high risk exposure to patients infected with COVID-19 will be tested for COVID-19 infection
      via nasopharyngeal (NP) swab once weekly for 7 weeks. Of those, one hundred eighty (180) will
      receive weekly doses of hydroxychloroquine for the duration of the study. Subjects who opt
      not to receive the study drug will form the control group.
    


Intervention name(s): Hydroxychloroquine
Intervention type(s): Drug
Intervention description(s): Weekly treatment in individuals at high risk
Other intervention name(s): Plaquenil; HCQ
Intervention MeSH terms: Hydroxychloroquine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: hydroxychloroquine
Comparative Safety and Immunogenicity of 1.0 µg Intramuscular (i.m.) and 2.0 µg Subcutaneous (s.c.) Dosing With VAX102 (M2e-flagellin) Universal Influenza Vaccine in Healthy Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      1. To assess the safety, reactogenicity, tolerability, and adverse events (AEs) of the
           VAX102 vaccine in a two dose regimen (Day 0 and Day 28) at the 1.0 µg dose level
           delivered i.m., or the 2.0 µg dose level delivered s.c. in a healthy adult population.

        2. To assess the immunogenicity (anti-M2e serum antibody concentration) of the VAX102
           vaccine in a two dose regimen (Day 0 and Day 28) at the 1.0 µg dose level delivered
           i.m., or the 2.0 µg dose level delivered s.c. as measured by an enzyme-linked
           immunosorbent assay (ELISA) in a healthy adult population.
    


Intervention name(s): VAX102
Intervention type(s): Biological
Intervention description(s): Universal M2e influenza vaccine
Other intervention name(s): STF2.4xM2e
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: influenza vaccine; M2e; Universal influenza vaccine
Double-Blind Trial of Miglitol in Type 2 Diabetic Patients Treated With Biguanide
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the clinical efficacy and safety of Miglitol in
      patients with Type2 Diabetes Mellitus treated with Biguanide.
    


Intervention name(s): Miglitol
Intervention type(s): Drug
Intervention MeSH terms: Miglitol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: alpa-glucosidase inhibitor,Biguanide
Stepped Preventive Care to Reduce the Impact of Acute Pediatric Injury
Condition: Stress Disorders, Posttraumatic
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the impact of a brief psychosocial intervention delivered to
      children or adolescents who are hospitalized for an unintentional injury. The intervention is
      designed to promote psychological recovery and enhance functional outcomes after injury. The
      study will also provide preliminary data concerning cost-effectiveness of the intervention.

      The core study hypotheses are that children receiving the intervention will (1) have lower
      severity of post-traumatic stress disorder (PTSD) and depression symptoms at follow-up; (2)
      show greater adherence to discharge instructions and better health-related quality of life at
      follow-up, and (3) have higher rates of attendance at scheduled follow-up appointments and
      lower rates of emergency room utilization and re-hospitalization in the 6 months post-injury,
      compared to those receiving usual care.
    

Detailed description: 
      The purpose of this study is to examine the effectiveness of a stepped care model for
      prevention of psychosocial distress (especially posttraumatic stress) after injury. The model
      includes screening for risk, standard follow-up with those at risk, and additional
      evidence-based interventions matched to individual need.

      The study will evaluate the impact of the intervention on psychosocial outcomes (PTSD and
      depression symptoms); as well as health outcomes (adherence to discharge instructions,
      health-related quality of life), and will provide preliminary data to inform
      cost-effectiveness analyses by describing the costs of providing the intervention and
      examining its impact on subsequent health service utilization.

      Study Design: 180 children at risk for persistent psychosocial distress post-injury, based on
      a screening assessment, will be randomized to the Stepped Preventive Care intervention or
      usual care. An additional comparison group of 90 low risk children will also receive usual
      care and be followed for assessment.
    

Intervention name(s): stepped preventive care
Intervention type(s): Behavioral
Intervention description(s): 2 targeted assessments (T1: in hospital within a few days of injury; T2: two weeks post-discharge) are administered by nurse or social worker, and determine need for additional assistance modules. Additional modules include case management, care coordination, assistance with child and family coping with injury/distress, and trauma-focused Cognitive Behavior Therapy (CBT) beginning at 4-6 weeks post-injury if needed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Effects of Heat and Moisture Exchanger in Combination With Air Forced Warming Blankets or Warming Intravenous Solutions on Intraoperative Hypothermia Prevention in Obese and Non Obese Patients During Intravenous Anesthesia
Condition: Hypothermia
MeSH terms: Hypothermia
Study type: Observational

Summary: 
      The aim of the present study was to evaluate if the combination of heat and moisture
      exchanger with air forced warming blankets or warming intravenous fluids prevents
      intraoperative hypothermia in obese and non obese women under target controlled
      infusion-total intravenous anaesthesia (TCI-TIVA) during lower abdominal surgery.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Forty female obese and non obese patients scheduled to gynecologic surgeries were warmed
        with warming blankets and warming intravenous fluids in association with heat and moisture
        exchanger.
      
Keywords: Hypothermia; Obesity; Heat and moisture exchanger; Warming blanket; Warming fluids; Gynecological surgery; Intravenous anesthesia; Obese patients; Non obese patients
Effectiveness of Chlorhexidine Wipe for Prevention of Multidrug-resistant Organisms in Intensive Care Unit Patients
Condition: Antibiotic Resistant Infection
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine 2% chlorhexidine wipes are effective in preventing
      of colonization of multi-drug resistant bacteria in intensive care unit patients.
    

Detailed description: 
      The purpose of this study is to evaluate the usefulness of bathing with chlorhexidine wipe to
      reduce the risks of multidrug resistant bacteria acquisition and hospital-acquired
      bloodstream infection among ICU patients
    

Intervention name(s): 2% chlorhexidine wipe; Soap
Intervention type(s): Drug; Drug
Intervention description(s): The ICU patients will be bathing with 2% chlorhexidine wipe; The ICU patients will be bathing with Soap
Other intervention name(s): chlorhexidine wipe; Control soap
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: colonization
A Family Literacy Program for Latino Families
Condition: Literacy
Study type: Interventional

Summary: 
      A pilot study of a health-focused family literacy program. The program will consist of a
      series of 8 weekly workshops centered around different health topics (e.g. physical activity)
      that introduce basic literacy skills. The workshops are designed for children entering
      kindergarten and their parents
    

Detailed description: 
      This is a pilot study of a health-focused family literacy program. The program consists of 8
      weekly health-themed workshops designed to introduce basic literacy skills to children
      entering Kindergarten and their parents. There will be a pre and post test assessment for
      participating parents and children. During the 8 weeks, parents will receive 2-3 weekly text
      messages to reinforce material presented at the weekly workshop.
    

Intervention name(s): Ready and Healthy for Kindergarten Family Literacy program
Intervention type(s): Behavioral
Intervention description(s): Participants will participate in 8 parent-child health-themed literacy workshops. Participants will receive 2-3 text messages per week for 8 weeks.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: child development; family literacy program; primary care
Cymbopogon Citratus Gel as Local Drug Delivery Agent in Reducing Matrix Metalloproteinase-8 Levels Intra-crevicularly in the Treatment of Stage II Periodontitis
Condition: Periodontitis Chronic Generalized Moderate
MeSH terms: Periodontitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Background: Phytotherapeutics is widely used nowadays as an adjunct to scaling and root
      planing (SRP) to modulate inflammatory host response and eradicate microbes. Matrix
      metalloproteinase-8 (MMP-8) is associated with the onset of inflammation and considered an
      indicative biomarker to the severity of inflammatory response. Since MMP-8 can be used as a
      predictive biomarker for treatment response; our research aimed to investigate clinically the
      effectiveness of intra-pocket application of Cymbopogon citratus (lemongrass oil) gel and
      biochemically on MMP-8 levels in gingival crevicular fluid (GCF) of stage II periodontitis
      patients.

      Methods: A randomized controlled clinical trial was conducted on forty patients with stage II
      periodontitis, divided equally into two groups. Group-I (test) was managed by SRP with
      intra-pocket application of 2% lemongrass oil gel. Group-II (control) was managed by SRP with
      intra-pocket application of a placebo gel. Periodontal pocket depth (PPD) and clinical
      attachment loss (CAL) were measured for both groups, before treatment and twelve weeks after.
      Moreover, GCF was collected from both groups at baseline, one week, and twelve weeks after
      treatment. Then analysed by Enzyme-linked Assay (ELISA) technique.
    


Intervention name(s): Cymbopogon citratus (lemongrass) oil gel
Intervention type(s): Drug
Intervention description(s): Biochemical Efficacy of Cymbopogon Citratus Gel as Local Drug Delivery Agent in Reducing Matrix Metalloproteinase-8 Levels Intra-crevicularly in the Treatment of Stage II Periodontitis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Safety, Tolerability and Pharmacokinetics in AD Subjects and Healthy Subjects of Cutaneous Application of LEO 39652 Cream
Condition: Atopic Dermatitis
MeSH terms: Dermatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The principle aim of this study is to obtain safety, tolerability and pharmacokinetic data
      when LEO 39652 cream is administered cutaneously as single dose to subjects with atopic
      dermatitis and to healthy subjects.
    


Intervention name(s): LEO 39652 cream; cream vehicle
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Pregnancy Outcome and Vitamin D Level Among Vitamin D Supplementation During Pregnancy
Condition: Pregnancy Outcome Among Vitamin D Supplementation During Pregnancy
Study type: Interventional
Phase: Phase 3

Summary: 
      To compared pregnancy outcome (Serum vitamin D level in mother and infant , preeclampsia
      rate, preterm birth rate, Infant birth weight, Infant length , APGAR score) between pregnant
      women who were given vitamin D supplementation and pregnant women who were given placebo
    


Intervention name(s): Vitamin D 2; Placebo drug
Intervention type(s): Drug; Drug
Intervention description(s): Vitamin D2 20000IU 1 tab oral weekly; Placebo drugs 1 tab oral weekly
Intervention MeSH terms: Vitamin D; Ergocalciferols
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vitamin D; 25-hydroxyvitamin D; Pregnancy; Infant