bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetics Study of Zolpidem Hemitartarate Orodispersible Tablet 1.75 mg Formulation
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics of the new formulation of
      zolpidem hemitartarate orodispersible tablet 1.75 mg in male and female healthy volunteers.
    

Detailed description: 
      This is a phase I study of zolpidem hemitartarate orodispersible tablet 1.75 mg in fasting
      and postprandial administration. Sample size is 28 healthy volunteers, male and female, aged
      from 18 to 50 years old.

      This is an open-label, randomized, crossover study. Each volunteer will be randomized to one
      of the following sequencies:

      Sequency 1: zolpidem hemitartarate 1.75 mg in fasting (period 1) and zolpidem hemitartarate
      1.75 mg postprandial (period 2) Sequency 2: zolpidem hemitartarate 1.75 mg postprandial
      (period 1) and zolpidem hemitartarate 1.75 mg in fasting (period 2) Formulation will be
      administered in a single dose, orally in each period. Trial volunteers will be admitted in
      two different periods of 36 hours each, when investigational product will be administered and
      blood samples will be collected at pre-determined periods of time up to 24 hours for
      pharmacokinetics evaluation.

      Primary objective is to evaluate the pharmacokinetics of the new formulation of zolpidem
      hemitartarate orodispersible tablet 1.75 mg in healthy volunteers. As a secondary objective,
      it will be evaluated if there is any pharmacokinetics difference between genders.
    

Intervention name(s): zolpidem hemitartarate 1.75 mg - Sequency 1; zolpidem hemitartarate 1.75 mg - Sequency 2
Intervention type(s): Drug; Drug
Intervention description(s): zolpidem hemitartarate 1.75 mg in fasting (period 1) and zolpidem hemitartarate 1.75 mg postprandial (period 2); zolpidem hemitartarate 1.75 mg postprandial (period 1) and zolpidem hemitartarate 1.75 mg in fasting (period 2)
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: pharmacokinetics; Healthy Volunteers
Base-in Prism Spectacles for Intermittent Exotropia
Condition: Exotropia Intermittent
MeSH terms: Exotropia
Study type: Interventional

Summary: 
      The objective of this short-term, pilot randomized trial comparing spectacles with relieving
      prism to spectacles without prism is to determine whether to proceed to a full-scale,
      longer-term randomized trial. This decision will be based primarily on assessing the initial
      (8-week) response to prism by comparing treatment groups on the following outcomes:

        -  Mean distance intermittent exotropia (IXT) control score (the mean of 3 control scores)
           (primary outcome)

        -  The proportion of participants demonstrating a "treatment response," defined as ≥1 point
           improvement in the mean distance IXT control score without spontaneous exotropia during
           control testing (secondary outcome)

        -  The proportion of participants reporting adverse effects and good/excellent spectacle
           wear compliance
    


Intervention name(s): Prism Glasses; Non-Prism Glasses
Intervention type(s): Device; Device
Intervention description(s): Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by PACT at distance or near) equally divided between the 2 lenses; Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism
Intervention MeSH terms: Methamphetamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Prism
BPM Cuff： 15-24cm, 20-34cm, 30-44cm, 40-48cm, 22-42cm
Condition: Blood Pressure
Study type: Observational

Summary: 
      The purpose of this study is to verify the accuracy of the 5 blood pressure cuffs, with blood
      pressure monitor device.

      The cuff range is as follows:

      15cm-24cm, 20cm-34cm, 30cm-44cm, 40cm-48cm, and 22cm-42cm
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        resident of a community
A Pilot Study of the Feasibility and Accuracy of the TrueVie CGM System - A Non-Significant Risk Study
Condition: Continuous Glucose Monitoring
Study type: Observational

Summary: 
      The purpose of the investigation is to obtain sufficient preliminary information about the
      performance of the TrueVie Continuous Glucose Monitoring (CGM) device to identify any need
      for any design modifications.
    

Detailed description: 
      After being informed about the study and potential risks, all participants giving written
      informed consent will be screened for participation. Qualifying participants will insert CGM
      sensors and come to 3 clinic visits at the beginning, middle and end of the 15 days intended
      sensor life. At the clinic visits participants are served two meals and perform a brief
      period of exercise of moderate intensity while blood samples are drawn according to a planned
      schedule timed to coincide with the TrueVie measurements.
    

Intervention name(s): Continuous glucose monitoring device; Laboratory plasma glucose concentration determination
Intervention type(s): Device; Other
Intervention description(s): Continuous glucose monitoring device; Laboratory plasma glucose concentration determination
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with type 1 diabetes
Relative Bioavailability Study of Four Experimental Formulations for Alzheimer's Disease
Condition: Alzheimer's Disease; Healthy
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the bioavailability of four experimental formulations
      relative to the current reference formulation used in the Phase 2 study.
    


Intervention name(s): BMS-708163; BMS-708163; BMS-708163; BMS-708163; BMS-708163
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral, 25 mg Hard Gelatin Capsule, Size #2, 150 mg, Once per period of 3, 7 days between dosings. Will be compared with any 2 comparators.; Oral, 75 mg Tablet Formulation 1, 150 mg, Once per period of 3, 7 days between dosings; Oral, 50 mg Hard Gelatin Capsule, Size #0, 150 mg, Once per period of 3, 7 days between dosings; Oral, 75 mg Soft Gelatin Capsule, 150 mg, Once per period of 3, 7 days between dosings; Oral, 75 mg Tablet Formulation 2, 150 mg, Once per period of 3, 7 days between dosings
Intervention MeSH terms: BMS 708163
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Mechanized Instrumentation for Endodontic Treatment of Primary Teeth
Condition: Endodontic Treatment of Primary Teeth
Study type: Interventional

Summary: 
      Mechanized instrumentation systems stand out amongst various devices used in modern
      Endodontics. Its use in Pediatric Dentistry, its action in primary teeth, has been in the
      center of many discussions and laboratory studies. Nevertheless, up to now, a lack of
      clinical studies on this issue can be found. Our objective is to conduct a double blinded, 2
      years follow up clinical trial to compare the success of endodontic treatment in primary
      teeth using mechanized reciprocating instrumentation to the use of manual instrumentation.
    

Detailed description: 
      With the approval of the Ethics Committee of University of São Paulo, after clinical and
      radiographic examination, patients in search for endodontic treatment in primary teeth will
      be invited to take part in the study. The participants of the study will be randomized to one
      of two groups (manual or reciprocating instrumentation). Endodontic treatment will be held by
      a specialist according to the randomized group. A blinded examiner will proceed one week, 3
      months, 6 months, 12 months and 24 months follow ups. Clinical and radiographic conditions of
      endodontic treatments will be analyzed to classify them as Success or Failure. The unit of
      analysis will be the teeth; hence, each participant may have more than one tooth included in
      the study. The randomization will be performed considering the tooth. Data analysis will
      consider the cluster nature of the sample.

      The primary outcome of the study will be the success rates according to the groups. The
      longevity of treatments will be evaluated by estimating survival rates by Kaplan-Meier and
      Cox regression. The differences between survival rates of both groups will be through Cox
      regression adjusted for the cluster nature of the sample (more than one tooth per
      participant), considering a level of significance of 5%.
    

Intervention name(s): Manual instrumentation; Reciprocating Instrumentation
Intervention type(s): Procedure; Procedure
Intervention description(s): Manual conventional files will be used in endodontic treatment of primary teeth; Reciprocating files system will be used in endodontic treatment of primary teeth.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, single-blind, controlled clinical trial with two parallel arms.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Endodontics; Primary Teeth; Reciprocating instrumentation; Mechanized instrumentation
PHARMACOKINETIC CHARACTERIZATION OF PF-06651600 IN CHINESE ADULT PARTICIPANTS
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label, single arm study in healthy Chinese male and/or female adult
      participants. Approximately 9 participants total are planned to participate in this study to
      ensure that a total of 8 evaluable participants (with all primary PK parameters) can complete
      the study.
    


Intervention name(s): PF-06651600
Intervention type(s): Drug
Intervention description(s): oral PF-06651600 tablet 200 mg once daily
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Low-grade Inflammation and Gut Symptoms From A2 and Hydrolyses A1 Milk
Condition: Milk Intolerance
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The aim of this study is to reveal how different forms of milk casein, lactose and moderate
      breakdown of proteins affect the symptoms that may arise from milk and markers of
      inflammation in volunteers receiving symptoms from milk. Research hypotheses are: 1) Protein
      hydrolyzed milk is as tolerated or better tolerated than A2 milk, and 2) Lactose is the main
      causative agent of stomach symptoms in milk-sensitive individuals.
    


Intervention name(s): Dietary intervention
Intervention type(s): Other
Intervention description(s): The arising gastrointestinal symptoms and inflammation markers from consumption of milk + lactase capsule / placebo.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Theophylline as a Treatment for Children With Pseudohypoparathyroidism Type 1a (Albright Hereditary Osteodystrophy)
Condition: Pseudohypoparathyroidism Type 1a; Albright Hereditary Osteodystrophy
MeSH terms: Pseudohypoparathyroidism; Pseudopseudohypoparathyroidism
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will test an investigational drug, theophylline, in children with
      pseudohypoparathyroidism type 1a (PHP1a). This study involves a 3 day visit to the Vanderbilt
      Clinical Research Center.
    

Detailed description: 
      Study measures will be done at baseline and during a 24h infusion of IV theophylline.
      Theophylline levels will be drawn to ensure therapeutic dosing and to monitor for toxicity.
      Measures include laboratory values, response to PTH infusion and resting energy expenditure.
    

Intervention name(s): Theophylline
Intervention type(s): Drug
Intervention description(s): 24 hour infusion of IV theophylline
Other intervention name(s): Theo
Intervention MeSH terms: Theophylline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Electronic Cigarette (ECIG) Liquid Vehicles on ECIG Acute Effects
Condition: Nicotine Exposure; Nicotine Withdrawal Suppression
Study type: Interventional
Phase: Phase 1

Summary: 
      This study examines the acute effects in ECIG users of the two primary vehicles in ECIG
      liquids, propylene glycol and vegetable glycerin. Thirty experienced ECIG users will use an
      ECIG in five conditions that will differ only by the propylene glycol:vegetable glycerin
      ratio: 100:0, 70:30, 50:50, 30:70, and 0:100 (device voltage, heater resistance, liquid
      nicotine concentration, puff number, and interpuff interval all will be held constant).
      Plasma nicotine concentration, subjective effects, and puffing behaviors will be recorded in
      each condition.
    

Detailed description: 
      Electronic cigarettes (ECIGs) are among the most important issues in public health today due
      to their dramatic increase in popularity. However, very little is known about ECIGs,
      including what factors may make them more likely to be used and abused. Examining factors
      that influence nicotine yield, delivery, and subjective effects from ECIGs is essential to
      understanding their abuse liability. Limited pre-clinical research has revealed that nicotine
      yield may be influenced by the ratio of the two liquid vehicles, propylene glycol (PG) and
      vegetable glycerin (VG), most commonly found in ECIG solutions. Specifically, higher
      proportions of PG result in greater nicotine yields. However, the influence of PG:VG ratio on
      nicotine delivery and subjective effects associated with ECIG use has not been examined
      previously. The primary hypotheses are that higher proportions of PG will result in greater
      nicotine delivery and subjective effect profiles suggestive of higher abuse liability in ECIG
      users. Results from this project will result in further understanding of the factors that
      influence the abuse liability of ECIGs and could inform regulation of these products.
    

Intervention name(s): ECIG liquid vehicles
Intervention type(s): Other
Intervention description(s): The ratio of propylene glycol and vegetable glycerin will be changed while all other factors of the electronic cigarette provided to participants will be held constant.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science
Effects of Resistance Training in Untrained Older Adults
Condition: Aging; Older Adults
Study type: Interventional

Summary: 
      The latest randomized controlled trials and systematic reviews of resistance training
      performed by older adults reported that the systematic use of exercise in machines improves
      muscle strength and power, functional abilities, body mass and body balance. However, the
      effect of resistance training with elastic tubes exercises have not been studied in all the
      variables described above. The objective of this study is to analyze the effects of elastic
      tubes exercises on muscle mass, muscle strength, functional performance and postural control
      in elderly untrained.
    

Detailed description: 
      This is a randomized clinical trial study (RCT) with 2 parallel arms. The subjects will be
      divided in 2 groups with a randomized block technique: Elastic Training Group (ETG) and
      Machine Training Group (MTG). The subjects will be submitted to a two-week familiarization
      period and then a sixteen-week of strength training program will be performed twice a week.

      This regimen of resistance training in both groups will consist of four exercises for lower
      limbs and four exercises for upper limbs which will be alternately performed with a
      one-minute interval between them during familiarization and training periods. Lower limb
      exercises will consist of: hip extension and abduction, and knee flexion and extension. Upper
      limb exercises will consist of: bench press, rowing, triceps and high pulley exercise.
    

Intervention name(s): Machines exercises; Elastic exercises
Intervention type(s): Other; Other
Intervention description(s): Resistance training in pneumatic machines.; Resistance training with elastic tubes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Aging; Resistance training; Muscle strength; Functional performance; Postural balance
Dialogical Family Guidance for Neurodevelopmental Disorders
Condition: Family Dynamics
MeSH terms: Neurodevelopmental Disorders
Study type: Interventional

Summary: 
      Previous studies have highlighted the need to offer targeted effective interventions to
      strengthen the wellbeing of all family members in families with children with
      neurodevelopmental disorders (NDD). Interventions for this target group requires development
      and research. A new family intervention, Dialogical Family Guidance (DFG) was tested in this
      study. All families received DFG intervention ( 6 meetings ).
    

Detailed description: 
      Previous studies have highlighted the need to offer targeted effective interventions to
      strengthen the wellbeing of all family members in families with children with
      neurodevelopmental disorders (NDD). Interventions for this target group requires development
      and research. A new family intervention, Dialogical Family Guidance (DFG) was tested in this
      study.

      Fifty families of children with NDD were randomized into two intervention groups.
      Intervention group I were delivered DFG immediately, and Intervention group II were delivered
      DFG after three months. Family functionality, health and support (FAFHES), SDQ and the
      5-15-questionnaire and DFG parent questionnaires were used to collect data at baseline, after
      three and six months. Fifty families were invited to the study. Thirty-four families
      completed the study. A comparison were made between Intervention group I and II.
    

Intervention name(s): DFG
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Intervention group I were delivered DFG immediately and Intervention group II were delivered DFG after three months.
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Dialogical family guidance; family health; neurodevelopmental disorders
Improving Physical, Mental, and Spiritual Health in Faith-Based Settings Through Creating a Healthy Culture in Bronx, NY
Condition: Mental Health Issue
Study type: Interventional

Summary: 
      The proposed study "Improving Physical, Mental, and Spiritual Health in Faith- Based Settings
      through Creating a Healthy Culture in Bronx, NY" aims to assess the efficacy of a holistic
      health intervention that seeks to integrate physical, mental, spiritual, and community
      engagement processes into faith-based settings, compared to usual care in Bronx, NY. Briefly,
      the intervention involves a seven-session faith-based small group education program conducted
      by trained lay educators. A health ministry at each partner religious institution will be
      developed and sustained
    

Detailed description: 
      The purpose of this research study is test a holistic health intervention that combines
      physical, mental, spiritual, and community processes into faith-based settings in Bronx, NY.
      The program involves a seven-session faith-based small group education sessions to be
      conducted by lay educators.
    

Intervention name(s): The Seven Pathways to Healing, Health and Wellness curriculum
Intervention type(s): Behavioral
Intervention description(s): The curriculum seeks to increase civic engagement by fostering a sense of community and a sense of social and personal responsibility in community. There will be 7 monthly session that will be approximately 1 hour in duration. Session topics include:
Education and Information (including mental health awareness, and a one-day certificate program in Mental Health First Aid)
Connection with Others
The Body as Temple
Emotional Healing
The Nature of Mind
Life Assessment
The Nature of Spirit
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
The Effect Of Somatosensory Perceptıon And Proprıoceptıon On Upper Extremıty Functıonal Skılls
Condition: Cerebral Palsy; Somatosensory Disorders; Upper Extremity Dysfunction; Proprioceptive Disorders
MeSH terms: Cerebral Palsy; Somatosensory Disorders
Study type: Observational [Patient Registry]

Summary: 
      Cerebral Palsy (CP) is a non-progressive neurodevelopmental disorder characterized by posture
      and movement disorders as a result of damage to the immature brain for any reason before,
      during or after birth.In addition to tone, postural and neuromuscular control in children
      with Cerebral Palsy; Problems are also observed in communication skills, perceptual and
      cognitive systems and sensory systems.
    

Detailed description: 
      In neurodevelopmental theory, sensory and motor systems mutually support the development of
      each other. In addition to the motor problems observed in SP; Sensory-motor impairment, which
      occurs with the effects of systems such as proprioception, tactile (touch), and vestibular
      (balance), emerges as the main problem. With the involvement of the central nervous system
      (CNS) in CP, the sensory systems are also affected along with the motor systems. The
      involvement of the sensory system is seen in 45% of these children and presents with a white
      matter lesion. One of the important factors affecting the activities of daily living (ADL) in
      children with Cerebral Palsy is the deficiencies in their functions as a result of the
      affected upper extremity. Deficiencies in sensory input can cause delays in learning new
      motor movements. This can result in disuse of the extremities and sensitivity. The
      somatosensory cortex, which is important for sensory integration; It is the area of the brain
      that is sensitive to tactile sensations from the body. It is known that the somatosensory
      system, which carries these tactile stimuli to the somatosensory cortex, is active from the
      early stage of life. Sensory and motor interactions experienced in the early stages of life
      are important for motor development even in the early stages. The improvement in measurable
      cortical responses of the tactile system; It starts from the 8th week of intrauterine and
      continues until the postpartum period. In the newborn period, the infant's responses to
      tactile and proprioceptive stimuli play an important role in the development of motor,
      cognitive, social and communication skills during infancy and early childhood. The aim of
      this study is to investigate the effects of somatosensory perception and proprioception on
      upper extremity functional skills in children with hemiparetic and diparetic CP.
    

Intervention name(s): assessment
Intervention type(s): Other
Intervention description(s): assessment of upper extremity functions, somatosensorial functions and proprioseption of upper extremity
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        children with cerebral palsy and healty peer aged children