bioihbjkbjnl/mcl2 huggingface dataset:
Acute Effects of a Heat-not-burn Tobacco Product on Pulmonary Function
Condition: Heated Tobacco; Respiratory Function; Tobacco Toxicity
Study type: Interventional

Summary: 
      Background: IQOS ("I-Quit-Ordinary-Smoking,") is a type of the growing class of
      "heat-not-burn" (HNB) tobacco products. The effect of the acute exposure to IQOS smoke on the
      pulmonary function of healthy smokers has not been studied extensively.

      Objectives: Evaluation of the acute effects of IQOS on pulmonary function.

      Methods: Healthy non symptomatic smokers, underwent exhaled CO measurement, spirometry
      including flows, volumes and diffusion capacity, and measurement of their respiratory
      resistances at 5, 10 and 20 Hz (R5Hz, R10Hz and R20Hz) with the use of an impulse
      oscillometry system (IOS) before and 15 min after the use of an IQOS.
    

Detailed description: 
      All participants underwent pulmonary function tests (PFT) (MasterScreen PFT, Jaeger,
      Wurzburg, Germany) and total respiratory resistances measurement with an impulse oscillometry
      system (IOS)( (Viasys Jaeger MasterScreen IOS system).From the basic pulmonary measurements
      (flows and dynamic lung volumes), Forced Expiratory Volume in 1 second (FEV1), Forced Vital
      Capacity (FVC), Tiffenau index (FEV1/FVC, FEV1%), Peak Expiratory Flow (PEF), Maximal
      Expiratory Flow (MEF) at 25%, 50%, and 75% of vital capacity, Functional Residual Capacity
      (FRC), Total Lung Capacity (TLC), Residual Volume (RV), Diffusion Capacity (DLCO) were
      measured. Each manoeuvre was repeated for at least three technically acceptable forced
      expiratory flow curves in order to attain the best results. Respiratory impedance at 5 Hz
      (Z5Hz) and respiratory resistance at 5, 10, and 20 Hz (R5Hz, R10Hz, and R20Hz, respectively),
      reactance at 5, 10, and 20 Hz and resonant frequency were assessed with IOS.

      After smoking heated tobacco (IQOS): 5 minutes after smoking IQOS , they repeated again PFTs
      and IOS measurements.
    

Intervention name(s): IQOS
Intervention type(s): Device
Intervention description(s): "Smoke" IQOS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: pulmonary function; IQOS; heated tobacco
Cycling, Air Pollution and Health
Condition: Endothelial Dysfunction; Endothelial Function; Cardiovascular Physiological Phenomena
Study type: Interventional

Summary: 
      Introduction: Cycling is currently promoted at the municipal, provincial and national level
      as a form of active transportation that increases physical activity while at the same time
      reducing traffic congestion, traffic-related air pollution and greenhouse gas emissions.
      While at a population level the health benefits of exercise via cycling are estimated to
      substantially exceed any health impacts related to air pollution exposure and injuries from
      traffic accidents , cyclists are known to experience elevated exposures to traffic-related
      air pollutants. Combined with exposure to elevated concentrations of air pollutants, cyclists
      also are subject to substantially increased inhaled doses due to their level of exertion and
      consequently increased inhalation rate. Therefore, given that cyclists experience exposures
      to relatively high concentrations of traffic-related air pollutants and that their inhalation
      of these pollutants is increased, it is important to evaluate the potential health impacts of
      this scenario. Research on the potential health impacts related to exercise (cycling) and
      urban air pollution exposure can help inform public communication strategies related to air
      quality and its health impacts. In addition, as our previous work suggests substantial
      variability in air pollution exposures to cyclists that is related to the route type and the
      levels of traffic along cycling routes, there is potential for transportation planners to
      promote increased cycling by enhancing infrastructure while at the same time developing
      routes that also minimize exposure to air pollution. The cyclist population is also
      interested in information regarding the air pollution exposures and potential health impacts
      related to cycling.

      The objective of this study is to investigate the relationship between traffic-related air
      pollution exposure, and respiratory and cardiovascular health impacts in commuting cyclists.
      Specifically, the investigators propose to:

        1. determine commuting cyclists' exposure to traffic-related air pollutants (PM 2.5, PM10,
           ultrafine particulate, black carbon) while cycling along two different bicycle routes in
           the city of Vancouver;

        2. estimate the pollutant dose received by each cyclist, and relate this to the health
           effects observed; and

        3. determine if there is a change in lung function, endothelial function, and C-reactive
           protein level related to the level of air pollution exposure and dose
    


Intervention name(s): Cycling on a residential route
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Air Pollution; Particulate Matter; Exercise; Respiratory Rate; Inflammation; Oxidative Stress; Plethysmography
The Effect of a Non-hormonal Cox-2 Inhibitor (Celebrex) on Ovulation
Condition: Ovulation; Luteal Development
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effect that Celebrex (a COX-2 inhibitor and
      non-steroidal anti-inflammatory drug) has on ovulation.
    

Detailed description: 
      A prospective randomized double-blind crossover study of healthy reproductive-aged (18-35
      years old) women with regular cycles, not currently using or needing hormonal contraception,
      were recruited. Women will undergo ovarian ultrasound and serum hormone monitoring during
      four menstrual cycles (control cycle, treatment cycle 1, washout cycle, treatment cycle 2).
      Subjects received study drug (oral celecoxib 400 mg or placebo) either 1) once daily starting
      on cycle day 8 and continuing until follicle rupture or the onset of next menses if follicle
      rupture did not occur (pre-LH surge dosing) or 2) once daily beginning with the LH surge and
      continued for 6 days (post-LH surge dosing). Women will be randomly assigned to one of the
      above treatment schemes and received the other in the subsequent treatment cycle.

      This study aims to determine if treatment with a highly selective COX2 inhibitor, celecoxib,
      would be a more effective agent in terms of causing ovulatory dysfunction. This study also
      aims to determine whether treatment with celecoxib would adversely affect luteal function.
    

Intervention name(s): Celebrex; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 400 mg PO daily intermittently based on hormone and ultrasound findings; Placebo identical to celecoxib
Other intervention name(s): Celecoxib
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: Celebrex; prostoglandin inhibitor; ovulation; emergency contraception
Treatment of Infected Pulp in Primary Teeth With a Mixture of Calcium Hydroxide and Gingerols
Condition: Primary Teeth; Pulp Necroses; Infected Pulp; Root Canal Treatment
MeSH terms: Dental Pulp Necrosis; Necrosis
Study type: Interventional

Summary: 
      This study was conducted to evaluate Calcium Hydroxide mixed with Gingerols versus Metapex in
      treatment of primary teeth with infected necrotic pulp
    

Detailed description: 
      Study compare Calcium Hydroxide mixed with Gingerols versus Metapex in treatment of primary
      teeth with infected necrotic pulp clinically and radiographically
    

Intervention name(s): Ginge-Cal; Metapex
Intervention type(s): Procedure; Procedure
Intervention description(s): Fill the infected root canal of of primary teeth with Gingerols extract and Calcium Hydroxide (Ginge-Cal); Fill the infected root canal of of primary teeth with Metapex
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Selected children will be divided randomly into 2 groups:
Group 1: Ginge-Cal group: primary molars were filled with a creamy mixture of pulpectomy paste of Gingerols and Calcium Hydroxide.
Group 2: Metapex group: primary molars were filled with a ready-made injectable creamy mixture pulpectomy paste of Metapex.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric Dentistry; Pulpectomy; Infected Pulp; Necrotic Pulp; Gingerols; Calcium Hydroxide; Metapex; Ginge-Cal
Safety and Efficacy Study of Islets Xenotransplantation
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The neonatal pig islets will be used as donor culturing with our modified culture medium. At
      the same time the autologous T regulatory cells will be used to induce specific immune
      tolerance for porcine islets grafts combined the costimulation of T cell activation channel
      blockers. The treatment for type 1 diabetes will be evaluated the efficacy and safety.
    


Intervention name(s): Porcine islets; Autologous Treg
Intervention type(s): Other; Other
Intervention description(s): Porcine islets: 10000IEQ/Kg;
Tacrolimus: 0.087mg/kg, Bid;
mycophemo-latemofetil (MMF): 1g x 2/d;
NULOJIX(belatacept): Day 1 (prior to transplantation), Day 5, Week 2, Week 4, Week 8, Week 12 10mg/kg; Autologous Treg: 2x10^6/Kg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type1 diabetes; porcine islets; treg cells; immunosuppress; xenotransplantation
Vibration Training and Muscle Strength Development
Condition: Muscle Strength; Disabilities of the Arm, Shoulder and Hand
Study type: Interventional

Summary: 
      Introduction:

      Vibration has been used to enhance muscle strength development during resistance training.

      Aim:

      To assess the effect of adding vibration to a regular resistance training program, using free
      weights, on muscle strength and everyday functioning of upper limbs in untrained adults

      Methods:

      60 healthy untrained adults, 30-65 yrs, will divide into two groups: experiment and control.
      Training program will include 24 sessions, over a course of 8 weeks. The experiment group
      will use a 1 kg vibrating weights and the control group will use a standard 1 kg free
      weights. Every session will include 10-15 min of 3-5 standard resistant exercises for upper
      limbs. Each subject will perform an Isokinetic evaluation of muscular performance, for upper
      limbs, in 3 occasions: before starting the program, immediately after completing the 8-weeks
      training program and 4 weeks afterwards, to check the chronic effect of each training regime.
      Each subject will complete a DASH (Disabilities of the arm, shoulder and hand) questionnaire
      at 4 occasions- as mentioned above and one more time, when completing the first 4 weeks of
      the training program, to reject any development of negative effects of the training program,
      such as pain or inflammation of the joints .
    


Intervention name(s): Vibration resistance training
Intervention type(s): Other
Intervention description(s): adding vibration to a standard resistance training with free-weights and checking the effect on muscle strength development and everyday functioning of upper limbs in untrained adults.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Prevention, Randomized, Double-Blinded, Placebo-Controlled, Parallel Assignment, Safety/Efficacy Study
Condition: Traveler's Diarrhea
MeSH terms: Diarrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of this study is to evaluate the body's immune response to the LT patch at
      different doses.

      The secondary purpose of this study is to evaluate the safety of the LT patches at different
      doses and the safety of the skin preparation system. Another secondary purpose is to compare
      the safety and the body's immune response to LT patches placed on the upper arm versus the
      lower back.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, dose ranging, multicenter study.
      Subjects will be assigned to one of ten treatment groups and vaccinated according to the
      study group designation. Treatments will remain the same for first and second vaccinations
      (alternating left and right sides).
    

Intervention name(s): Biological: heat-labile enterotoxin of E. coli (LT)
Intervention type(s): Biological
Intervention description(s): LT patch applied on either the deltoid or the lower back.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: LT; Healthy Adults; Dose Ranging; Patch; Vaccine
The Norwegian Physical Therapy Study in Preterm Infants
Condition: Movement Disorders
MeSH terms: Movement Disorders
Study type: Interventional

Summary: 
      This is a pragmatic randomized controlled study. The purpose of the study is to evaluate the
      practice and effect of customised physiotherapy on preterm infants'motor development when the
      intervention is performed over a period of three weeks while the infant resides in the
      neonatal intensive care unit. The study will also attempt to analyze the parents' experiences
      in being actively involved in education and practice of the intervention designed to promote
      the child's motor development, and the effects on the parent-child relationship in the short
      and long term.The children are followed up until a corrected age of two years. This study
      consists of a pragmatic randomized controlled trial and a qualitative study.
    

Detailed description: 
      Infants born preterm with an gestational age below 32 weeks have an increased risk of
      developing different grades and types of abnormalities, among them delayed motor development,
      co-ordination difficulties and cerebral palsy. The prevalence of serious developmental
      abnormalities increases the lower the gestational age and birth weight. The reported
      incidence of mild developmental abnormalities is 15-20 % in children with a gestational age
      <28 weeks or with a birth weight under 1000 g, 10-20 % in children with a gestational age of
      28-31 weeks or a birth weight between 1000-1500 g and only 5 % in children born at term. The
      incidence of cerebral palsy is 10-20% amongst children in the first group, 5-10% in the
      second group and only 0,1 % in children born at term.With such a high risk of developing
      motor abnormalities for infants born preterm together with limited evidence-based knowledge
      of early physiotherapy approaches that facilitate motor development, it is essential that
      more research is done in this area to ensure that physiotherapy if used, is in the right
      manner to prevent and reduce such difficulties.
    

Intervention name(s): Individually customized physiotherapy
Intervention type(s): Other
Intervention description(s): Main elements in the intervention are postural support and facilitating techniques. The intervention will be carried out twice a day over a three-week period if the infant's condition allows it. The length of each treatment session will be adjusted dependent on the infant's response and condition. Maximum treatment time is 10 minutes.
Other intervention name(s): Physiotherapy; Physical Therapy; Premature birth; Early Intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Infants born preterm; Early physiotherapy intervention; Motor development; Parental participation; Parental competency
The Effects of SAFE Early Intervention Approach in Premature Infants in Turkey
Condition: Infant, Premature, Diseases
MeSH terms: Premature Birth; Infant, Premature, Diseases
Study type: Interventional

Summary: 
      In this study, it was aimed to develop the SAFE treatment approach, which is a family
      collaborative early intervention approach based on sensory strategies, activity-based motor
      training and environmental enrichment, and to examine the effects of this approach on
      sensory, motor, cognitive and language development in premature infants.
    

Detailed description: 
      Early intervention practices in Turkey is widely based on the principle of
      neuro-developmental therapy (NDT). It has been reported in recent years that the NDT approach
      has minimal effect on the development of risky premature infants. For these reasons, it was
      necessary to develop an early intervention program that does not include passive
      interventions and includes sensory and motor strategies in our country.

      Within the scope of this study, a new early intervention approach that can be applied to
      infants between 0-24 months has been developed based on the shortcomings in the literature.
      Sensory strategies, activity-based motor training, family collaboration and environmental
      enrichment constitute the basic principles of this early intervention program. The name of
      the early intervention program was formed from the English initials of these basic principles
      and was determined as SAFE early intervention approach (S: Sensory Strategies, A: Activity
      Based Motor Training, F: Family Collaboration, E: Environmental Enrichment).

      In this study, it was planned to establish the theoretical and practical foundations of the
      SAFE early intervention approach developed by the Gazi University, Faculty of Health
      Sciences, Department of Physiotherapy and Rehabilitation. Also we aimed to examine the
      effects of this approach on sensory, motor, cognitive and language development in preterm
      infants with corrected ages of 9-10 months.
    

Intervention name(s): SAFE early intervention approach
Intervention type(s): Procedure
Intervention description(s): SAFE approach is a national early intervention approach which is based on sensory strategies, activity based motor training, family collaboration and environmental enrichment.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single blind randomised controlled trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Adolescent Idiopathic Scoliosis and Mental Health
Condition: Scoliosis
MeSH terms: Scoliosis
Study type: Observational

Summary: 
      The purpose of this pilot study is to determine the presence, frequency, and severity of
      mental health disorders amongst adolescents undergoing spinal surgery for scoliosis.
    

Detailed description: 
      This study is a cross-sectional pilot study investigating the prevalence of psychiatric
      illness at various time points in the course of treatment of AIS. Three independent sets of
      questionnaires will be administered during a single scheduled clinical visit. There will be
      no clinical visits for the exclusive purpose of completing questionnaires. The first
      questionnaire will be the SRS outcome instrument. The second questionnaire will be the
      Achenbach YSR, completed by the adolescents, and the parents will be asked to complete the
      CBCL. Finally, a generic outcome measure specific to children and adolescents, the Pediatric
      Outcome Data Collection Instrument, will be administered. The time requirement to complete
      these questionnaires is anticipated to be approximately 45 minutes. The Achenbach
      questionnaires will be scored promptly after each is completed using the provided scoring
      templates. This data will be used to identify those at risk and make appropriate resources
      available. This would provide appropriate care for adolescents at high risk of mental health
      disorder by identifying those at risk via a non-invasive screening tool.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Aadolescents undergoing spinal surgery for scoliosis.
      
Keywords: Observation; Mental health; Scoliosis; Screening; Adolescent idiopathic scoliosis
Verification of Pulse Oximetry in Neonatal Population
Condition: Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
Study type: Observational

Summary: 
      The purpose of this his post-market, observational study titled Verification of Pulse
      Oximetry in the Neonatal Population is to gather data to further support the accuracy of
      Nonin's pulse oximeters when used in the neonate population. Neonates who are currently
      undergoing arterial blood gas (ABG) sampling, as part of their medical care will be recruited
      to participate in this study for collecting opportunity samples. Nonin's PureLight®
      noninvasive sensor will be applied to a foot of the neonate; an adhesive wrap secures the
      sensor to the neonate. The sensor immediately begins obtaining SpO2 and pulse rate
      measurements which are sent to the oximeter module for display on the Electronic Data
      Collection System (EDCS). At the time the prescribed ABG is drawn, the EDCS must have a
      marker captured to identify the end of the ABG for SpO2 comparison. The SpO2 accuracy of
      pulse oximeter will be measured by comparing SpO2 readings of the pulse oximeter to values of
      SaO2 (opportunity samples) determined by a CO-oximeter.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Neonates 25 weeks gestation to full term
      
Keywords: Oximeter; Arterial blood gas; comparison
A Clinical Trial to Evaluate the Efficacy and Safety of HL301 Versus Umkamin Tab in Acute Bronchitis Patients
Condition: Acute Bronchitis
MeSH terms: Bronchitis; Acute Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      A Multicenter, Randomized, Double-blinded, Active-controlled, Parallel, Phase III Clinical
      Trial to Evaluate the Efficacy and Safety of HL301 versus Umkamin tab. in acute bronchitis
      patients

      Endpoint: BSS, The improvement and improvement rate of the tester for the treatment response,
      The satisfaction of the subject
    


Intervention name(s): HL301(Experimental); Umkamin(Active Comparator)
Intervention type(s): Drug; Drug
Intervention description(s): Total 7 days of treatment and The daily dose is as follows [Morning: HL301 1Tab + Placebo of Umkamin 1Tab] [Noon: Placebo of Umkamin 1Tab] [Evening: HL301 1Tab + Placebo of Umkamin 1Tab]; Total 7 days of treatment and The daily dose is as follows [Morning: Placebo of HL301 1Tab + Umkamin 1Tab] [Noon: Umkamin 1Tab] [Evening: Placebo of HL301 1Tab + Umkamin 1Tab]
Other intervention name(s): HL301 and Placebo of Umkamin; Placebo of HL301 and Umkamin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute Bronchitis