bioihbjkbjnl/mcl2 huggingface dataset:
Perinatal Attentional Retraining Intervention for Smoking for Minority Women
Condition: Postpartum Smoking Relapse
MeSH terms: Recurrence
Study type: Interventional

Summary: 
      The proposed research intends to randomize 50 abstinent pregnant Black or Hispanic smokers to
      receive either the attentional retraining (AR) or control VP task. Participants will be asked
      to carry around a smartphone as they go about their daily lives for 2 weeks in their last
      month of pregnancy (Phase 1).

      The smartphone will sound an alert randomly during the day, at which time participants will
      be asked to respond to a short set of questions assessing subjective states; this will be
      followed by a request to complete the AR (or control) procedures. This same procedure will be
      repeated for 2 weeks immediately after delivery (Phase 2).

      Women will undergo a follow-up visit 3 months after the end of Phase 2, and complete an
      unmodified VP and follow-up assessments.
    

Detailed description: 
      There are 2 specific aims that this study intends to address.

      Specific Aim 1: To examine whether AR delivered on a smartphone can modify attentional bias
      to smoking-related stimuli and craving for tobacco cigarettes.

      Specific Aim 2: To examine whether AR delivered on a smartphone can modify attentional bias
      to stress-related stimuli and reduce perceived stress.
    

Intervention name(s): Attentional retraining (AR); Visual probe (VP)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Cognitive bias modification (CBM) procedures are interventions aimed at changing the impulsive (automatic) processes that underlie unhealthy behaviors such as smoking. AR is the most commonly used CBM intervention in the study of addiction-related attentional bias. The idea behind AR is to reduce attentional bias and therefore minimize exposure to drug cues, because attention to such stimuli may provoke craving and undermine cessation attempts.; The visual probe (VP) task can measure attentional bias for drug-related cues. In the typical VP task, a pair of pictures or words (e.g. one smoking-related and one neutral) is briefly presented simultaneously side by side on a computer screen. After the pictures disappear, a probe stimulus (e.g. a small dot) is presented in the location that had been occupied by one of the pictures (or words), and participants are required to press a key as quickly as possible in response to the probe. Attentional bias for drug-related cues is detected by a faster response to a probe that replaces a drug-related stimulus (vs. a neutral stimulus), since attention will have been preferentially allocated to that area of visual display. The traditional VP task only assesses attentional bias, and does not modify it in any way.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Pain Modulatory Profiles in Stretching
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to characterize immediate changes in pain sensitivity during
      stretching to the point of pain, stretching in a pain free range, and a cold water immersion
      task. Participants will attend three sessions during which they will undergo pain sensitivity
      assessment and complete the assigned intervention.
    


Intervention name(s): Cold Water Immersion; Pain Inducing Stretch; Pain Free Stretch
Intervention type(s): Other; Other; Other
Intervention description(s): Cold Water Immersion task of hand; Moderately painful stretch of the neck; Pain free stretch of the neck
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Motor Imagery in Pain Modulation and Median Nerve Mechanosensitive in Healthy Patients
Condition: Median Nerve Injury
Study type: Interventional

Summary: 
      The aim of this study are 1) to determinate the effectiveness of motor imagery or strength
      training in differens aspects of pain modulation. 2) evaluate the functional improvement of
      the hand by a motor imagery protocol.
    


Intervention name(s): Action observation; Mirror therapy; Neurodynamic exercises; Strength
Intervention type(s): Other; Other; Other; Other
Intervention description(s): look at a clip of a hand doing neurodynamic exercises.; With a mirror glasses on, do the neurodynamic exercises with the non-dominant hand while the patient is looking at the dominant hand; active movement of the dominant hand. Do neurodynamic exercises.; Execute a short strength training for the dominant hand
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Endovenous Ablation With and Without Polidocanol Endovenous Microfoam Treatment for Patients With Great Saphenous Vein Incompetence and Visible Varicosities
Condition: Great Saphenous Vein Incompetence; Visible Varicosities
MeSH terms: Varicose Veins
Study type: Interventional
Phase: Phase 3

Summary: 
      Varicose veins are enlarged, noticeably bulging veins, which commonly occur in the legs and
      may cause discomfort. In this study, patients with varicose veins in the legs will be
      participating. The purpose of this research study is to evaluate the safety and effectiveness
      of two different doses of an investigational drug, Polidocanol Endovenous Microfoam (PEM)
      compared to vehicle (inactive solution) when used following an approved heat treatment in
      subjects with varicose veins.
    


Intervention name(s): endovenous ablation+polidocanol injectable microfoam 0.125%; Endovenous ablation+polidocanol injectable microfoam 1.0%; Endovenous ablation+polidocanol injectable foam 2.0%
Intervention type(s): Drug; Drug; Drug
Intervention description(s): All components except API; endovenous ablation to target vein, followed by injection of polidocanol injectable foam 1.0%; Endovenous ablation to target vein followed by injection of polidocanol injectable foam 2.0%
Other intervention name(s): endovenous ablation followed by polidocanol endovenous microfoam 0.125% injection to target vein; Endovenous ablation followed by injection of polidocanol injectable foam 1.0% to target vein; Endovenous ablation to target vein followed by injection of polidocanol injectable foam 2.0%
Intervention MeSH terms: Polidocanol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: varicose veins; Great saphenous vein; varicosities
A Clinical Trial Assessing the Impact of the Availability of Inhaled Insulin on Glucose Control
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes
      who are not well controlled on 2 or more oral anti-diabetic agents
    


Intervention name(s): Inhaled Insulin
Intervention type(s): Drug
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Characterization of Gut Microbiota in Chronic Liver Disease With Decreased Muscle Mass
Condition: Gastrointestinal Microbiome; Sarcopenia; Liver Disease Chronic
MeSH terms: Liver Diseases; Sarcopenia
Study type: Observational

Summary: 
      The purpose of this study was to confirm the presence of specific gut microbiota observed in
      patients with sarcopenia among patients who agreed to analyze gut microbiota through stool
      among multi-center chronic liver disease cohort patients.
    

Detailed description: 
      The effect of gut microbiota on liver disease is also well known and many studies are
      ongoing. A recently published study summarized the differences in the composition of gut
      microbiota in non-alcoholic fatty liver, steatohepatitis, and cirrhosis, and reported that
      metabolites from the changed gut microbiota may be a factor influencing non-alcoholic fatty
      liver disease (NAFLD) progression. These changes in gut microbiota composition have been
      reported to affect clinical outcomes in patients by causing an increase in endotoxin, a
      change in bile acid metabolism, and a decrease in short chain fatty acid. In particular, the
      reduction of short chain fatty acid is known to be associated with the occurrence of
      sarcopenia. Sarcopenia, which is common in patients with cirrhosis, which is a representative
      chronic liver disease, is well known as a poor prognostic factor for patients. Therefore,
      this study aims to analyze the distribution of gut microbiota observed in patients with
      sarcopenia through the gut microbiota investigated in the chronic liver disease cohort
      patient group and the characteristics of the distribution of gut microbiota for each disease
      corresponding to chronic liver disease.
    

Intervention name(s): Sarcopenia_CT
Intervention type(s): Diagnostic Test
Intervention description(s): measurement of skeletal muscle through abdominal computed tomography
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        From January 2017 to December 2019, 489 patients who agreed to collect feces among the
        cohort patients with chronic liver disease in five hospitals under the Hallym University
        Medical Center were surveyed.
Propofol Pharmacokinetics in Children After Single Bolus Dose
Condition: Propofol Pharmacokinetics
Study type: Interventional

Summary: 
      The principle objective of this study is to evaluate pharmacokinetics of propofol after
      single iv bolus dose in 12 Indian children and to develop a simple pharmacokinetic model of
      propofol.
    

Detailed description: 
      PROPOFOL is the most suitable agent currently available for induction and maintenance of
      anesthesia. So far, the pharmacokinetics of propofol has not been studied in Indian children.
      We believe that this pharmacokinetic characterization of propofol will help in better
      management of these patients undergoing surgery under total intravenous anesthesia (TIVA) in
      our setup. 12 ASA (American Society of Anesthesiologists) grade I patients, 5 to 12 years old
      planned for elective surgery will be included. Premedication will be done with syrup
      midazolam 0.5mg/kg. After shifting the patient to the operation table, routine physiological
      monitoring will be commenced and two intravenous lines will be secured,one in the antecubital
      vein of one arm and the other vein on the dorsum of the contralateral hand. The antecubital
      venous access will be used for blood sampling. Anesthetic technique will consist of fentanyl
      bolus dose of 2ug/kg followed by propofol bolus dose of 2.5 mg/kg. No further propofol will
      be administered. After loss of consciousness , patients will be paralysed with atracurium
      (0.5mg/kg) and endotracheal intubation will be performed. Anesthesia will be maintained with
      isoflurane, oxygen (50%) and nitrous oxide (50%), and intermittent dosages of atracurium. A
      total of twelve samples will be collected from each patient at 0, 2, 4, 6, 10, 20, 30, 60,
      90, 120, 240, and 480 min after administration of bolus dose of propofol.The samples will be
      analyzed using a modified High Performance Liquid Chromatography method described by Pavan et
      al. The pharmacokinetic parameters will be evaluated using three compartment model to develop
      a pharmacokinetic model by using the software WINNONLIN (Windows Non Linear Regression
      Program).
    

Intervention name(s): Propofol
Intervention type(s): Drug
Intervention MeSH terms: Propofol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Pembrolizumab + Radiation for Locally Adv SCC of the Head and Neck (SCCHN) Not Eligible Cisplatin
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being done to evaluate the efficacy of Pembrolizumab, concomitant with and
      following standard of care definitive radiation, for locally advanced squamous cell carcinoma
      of the head and neck patients who are not good candidates for Cisplatin.
    

Detailed description: 
      This open label, phase II trial will enroll 29 subjects in order to evaluate the efficacy of
      Pembrolizumab, concomitant with and following standard of care definitive radiation for
      locally advanced squamous cell carcinoma head and neck patients who are not good candidates
      for Cisplatin. Objectives include estimating progression free survival and overall survival,
      response rates, safety and toxicity, and quality of life in these patients. Correlative
      studies, based on serial blood collections and tumor samples, may be done under a separate
      protocol based on availability of archival diagnostic tissue.
    

Intervention name(s): Pembrolizumab; Intensity Modulated Radiation Therapy
Intervention type(s): Drug; Radiation
Intervention description(s): Pembrolizumab, 200 mg IV during cycle visits every 3-weeks for up to 6 cycles, or until toxicities are no longer tolerable; Eligible participants will receive Intensity Modulated Radiation Therapy daily x 7 weeks
Other intervention name(s): Keytruda; IMRT
Intervention MeSH terms: Pembrolizumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate Long-term Impact of VARIVAX Among Children and Adolescents (V210-036)(COMPLETED)
Condition: Varicella; Herpes Zoster
MeSH terms: Herpes Zoster
Study type: Observational

Summary: 
      The purpose of these continuing post-licensure studies is to evaluate the long-term
      effectiveness of VARIVAX® [Varicella Virus Vaccine Live (Oka/Merck)] and to assess the impact
      of the vaccine on the epidemiology of varicella and herpes zoster.
    

Detailed description: 
      Parents/guardians of the cohort of children vaccinated between 12 and 23 months of age during
      a six-month period in 1995 (June-November) at KPMCP Northern California were interviewed by
      telephone at 6-month intervals to ascertain whether their child had varicella or herpes
      zoster in the 6 months prior to interview. Follow-up continued for a minimum of 14 years
      after vaccination.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        15 years prospective follow-up of the original study cohort
The Effect of Green Tea Extract on Type 2 Diabetes With Hyperlipidemia
Condition: Type 2 Diabetes; Hyperlipidemia
MeSH terms: Diabetes Mellitus, Type 2; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to examine whether the extract of green tea is effective on type 2
      diabetes and hyperlipidemia.
    

Detailed description: 
      Percent change Homa insulin resistance, cholesterol and triglycerol.
    

Intervention name(s): Green tea extract; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 500 mg . one capsule of green tea extract, 3 times per day; 500 mg . one capsule of placebo, 3 times per day
Other intervention name(s): EGCG: Green tea extract
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: green tea; EGCG; type 2 diabetes; hyperlipidemia
A Study for Moderate Osteoarthritis of the Knee
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a study to determine whether Flexsure is Safe, Tolerable and Effective in relieving
      symptoms of Moderate Osteoarthritis of the Knee.
    

Detailed description: 
      Primary efficacy variable:

      Number of patients showing 20% reduction from baseline in the WOMAC - pain subscale

      Secondary efficacy variables:

        -  Number of patients showing a 50% reduction from baseline in the WOMAC - pain subscale

        -  Number of patients showing a 20% reduction from baseline in VAS-pain

        -  Number of patients showing a 50% reduction from baseline in VAS- pain

        -  Mean change (percentage reduction) in WOMAC scores for pain, stiffness and physical
           function from baseline, as compared to placebo

        -  Mean change (percentage reduction) in VAS - pain, as assessed at clinic visits and by
           daily records in patient diary (First two weeks only)

        -  Consumption of rescue medication

        -  Investigator's Global assessment of efficacy

        -  Subject's global assessment of efficacy
    

Intervention name(s): Flexsure Capsules; Placebo Capsules
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Flexsure - 3 capsules once a day in the absence of meals (at least 30 min prior to meals) for 56 days; Carboxy Methyl Cellulose
Other intervention name(s): Paracetamol; Paracetamol
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
I-Gel vs Ambu Laryngeal Mask Airways in Infants and Children Undergoing Surgical Procedures
Condition: Laryngeal Masks
Study type: Interventional

Summary: 
      This study will guide the anesthetists regarding the appropriate selection of the LMA in
      neonatal age group based on scientific basis.

      This study will add up to existing literature about the safety of LMA usage in neonates and
      infants. Furthermore it may shed some light on which LMA type will be more feasible and
      effective for neonatal/ infants usage.
    

Detailed description: 
      Laryngeal mask airways (LMAs) are in practice of anesthesia since early 1980s. Pediatric and
      neonatal patients (including ex-premature) have also been benefited by the use of LMA. There
      are many advantages of LMA over endotracheal tube (ETT) in pediatric patients like ease of
      insertion, securing airway rapidly, avoidance of muscle relaxants, reduced incidence of sore
      throat, post operative hoarseness and coughing at the time of extubation, greater hemodynamic
      and intraocular pressure (IOP) stability. LMA has been recognized internationally in control
      of airway in difficult and failed intubation.

      There are different types of pediatric LMAs available e.g. I-gel, ProSeal, LMA supreme, LMA
      classic, LMA unique, LarySeal and Ambu. These devices differ morphologically from each other
      (silicone, polyvinyl chloride or soft gel). There have been several randomized controlled
      studies comparing different LMAs in adults, however, the literature is sparse in which such
      comparison has been made in patients with weight 10 kg or below.
    

Intervention name(s): Ambu LMA; I-Gel LMA
Intervention type(s): Device; Device
Intervention description(s): Ambu Laryngeal Mask Airways; I-Gel Laryngeal Mask Airways
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: laryngeal airways; infants; neonates; children; anesthetized
Efficacy of Bilateral Stimulation With Task-oriented Training in Improving Lower Limb Motor Functions in Patients With Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      This proposed study aims to compare the effects of unilateral and bilateral transcutaneous
      electrical nerve stimulation (TENS). It will compare the effectiveness of bilateral TENS +
      task-oriented training (TOT) with unilateral TENS+TOTin improving muscle strength,
      co-ordination, dynamic standing balance, walking performance, and functional mobility in
      patients with chronic stroke.

      The null hypothesis will be that bilateral TENS+TOT and unilateral TENS+TOT are not
      significantly different in promoting the recovery of these functions.
    

Detailed description: 
      This proposed study aims to compare the effects of unilateral and bilateral transcutaneous
      electrical nerve stimulation (TENS). It will compare the effectiveness of bilateral TENS +
      task-oriented training (TOT) with unilateral TENS+TOTin improving muscle strength,
      co-ordination, dynamic standing balance, walking performance, and functional mobility in
      patients with chronic stroke.

      The null hypothesis will be that bilateral TENS+TOT and unilateral TENS+TOT are not
      significantly different in promoting the recovery of these functions.
    

Intervention name(s): TENS and Task-orientated training
Intervention type(s): Behavioral
Intervention description(s): All subjects will undergo 16 sessions of their assigned intervention (60 minutes, twice a week, for 8 weeks). All subjects will receive 60 minutes task-oriented lower limb training (TOT) with electrical stimulation protocol assigned concurrently:
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Electrical stimulation, exercise, stroke , rehabilitation
Serologic Response to Porcine Circovirus Type 1 (PCV-1) in Infants Following Administration of Rotarix™
Condition: Infections, Rotavirus
MeSH terms: Rotavirus Infections
Study type: Observational

Summary: 
      This study aims to evaluate the serologic response to PCV-1 in the serum samples previously
      collected during initiation of vaccination series of Human Rotavirus (HRV) vaccine studies
      (1-2 months post Dose 2 of HRV vaccine or placebo). Additionally, pre-vaccination sera
      samples from any infants testing positive for PCV-1 antibodies at the post-vaccination time
      point will also be evaluated.
    

Detailed description: 
      Serum samples collected from 6 clinical trials previously conducted for HRV vaccine
      (Rotarix™) are used in this study.
    

Intervention name(s): Serum sample
Intervention type(s): Procedure
Intervention description(s): Serum samples collected at pre-vaccination and at 1-2 months post Dose 2 in the previously conducted clinical trials will be assessed for anti-PCV-1 antibodies in this study. Additionally, pre-vaccination sera samples from any infants testing positive for PCV-1 antibodies at the post-vaccination time point will also be evaluated.
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Infants aged 6 to 12 weeks from 6 previously completed clinical trials, who received 2
        doses of either Rotarix™ or Placebo.
      
Biospecimen description: 
      Serum samples
    
Keywords: Human rotavirus (HRV) vaccine; Serologic response; Porcine circovirus type 1 (PCV-1); Laboratory evaluations