bioihbjkbjnl/mcl2 huggingface dataset:
Indoor Air and Children Health Study
Condition: Cardiopulmonary Disease
MeSH terms: Pulmonary Heart Disease
Study type: Interventional

Summary: 
      The objective of this study is to investigate the cardiopulmonary health effects of indoor
      air purification and different indoor environmental factors among school students in Beijing.
    

Detailed description: 
      This randomized, double-blind crossover study was conducted to explore the cardiopulmonary
      effects of ionization air purification among 48 children in Beijing. Real or sham
      purification was performed in classrooms for 5 weekdays in a random order with a 2-month
      wash-out period. During the study periods, different indoor environmental factors were
      monitored including size-fractionated particulate matter (PM), black carbon (BC), ozone,
      carbon dioxide (CO2), negative air ions (NAI), noise, temperature and relative humidity,
      which were controlled as confounders in the analysis of the effects of indoor air
      purification. In addition, we analyzed the cardiopulmonary effects of those environmental
      factors on the children.
    

Intervention name(s): Air purifier
Intervention type(s): Other
Intervention description(s): active- or sham-mode air purifier used in 6 classrooms in a school with a crossover design
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Females, Aging, Metabolism, and Exercise
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This study is designed to determine whether a reduction in hormones (such as occurs during
      menopause) causes a decrease in calories burned during physical activity. This study will
      also determine whether a reduction in hormones decreases calories burned while sleeping,
      resting, and eating and whether an exercise intervention can prevent this.
    

Detailed description: 
      Participants will be women who are nearing menopause based on age (42-52 y) but have normal
      menstrual cycles. Participants will be randomized to receive monthly injections of placebo or
      a study drug that reduces sex hormones (GnRH agonist) for 24 weeks. Women who receive GnRH
      agonist will be further randomized to no exercise or a supervised exercise program. Thus, the
      3 treatment groups are: placebo, GnRH agonist, GnRH agonist+exercise. The investigators will
      measure changes in calories burned during physical activity, sleep, rest, and after a meal
      after 3 and 6 months of hormone suppression using doubly-labeled water and room calorimetry.
      Other measures include food intake estimated from food records; body composition measured by
      dual-energy x-ray absorptiometry (DXA); glucose and insulin responses to an oral glucose
      tolerance test; and markers of inflammation in the blood.
    

Intervention name(s): GnRH agonist; Supervised cardiovascular exercise; Placebo
Intervention type(s): Drug; Behavioral; Drug
Intervention description(s): Drug: leuprolide acetate
Other Names:
Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 6 months; Supervised exercise, 4 days per week for 45 to 60 minutes per session for 6 months; Placebo
Other intervention name(s): Leuprolide Acetate 3.75mg
Intervention MeSH terms: Leuprolide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: hormone therapy; obesity; menopause; disease /disorder proneness /risk; insulin sensitivity /resistance; metabolic syndrome; women's health
Dose-ranging Trial of OPC-249 Powder Inhalation in Patients With Pain Due to Osteoporosis
Condition: Pain Due to Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine the efficacy and safety of OPC-249 by once daily
      inhalation at 0 (placebo), 30, 60 or 120 IU for 4 weeks in patients with pain due to
      osteoporosis.
    


Intervention name(s): OPC-249
Intervention type(s): Drug
Intervention description(s): 1 pugh/day for 4 weeks (30 IU, 60IU, or 90IU)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of T3 for the Treatment of Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      Determine if T3 - the active form of thyroid hormone - is beneficial in fibromyalgia.
      Determine the feasibility and promise of an appropriately powered future prospective
      randomized controlled study of using T3 (the active form of thyroid hormone) for the
      treatment of fibromyalgia. We specifically aim to assess the feasibility, cost, obstacles and
      promise of conducting a prospective controlled study in the future.
    


Intervention name(s): T3
Intervention type(s): Drug
Intervention description(s): Patients receive T3 in a dose of 25mcg and 50mcg
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Yogurt With Spirulina on Cardiometabolic Risk Markers
Condition: Overweight and Obesity; PreDiabetes; Hypertension; Dyslipidemias
MeSH terms: Overweight; Dyslipidemias
Study type: Interventional

Summary: 
      The effects of yogurt with spirulina consumption compared to conventional yogurt (without
      spirulina) on several cardiometabolic and anthropometric parameters in individuals at risk of
      cardiovascular disease
    

Detailed description: 
      This randomized, single-blind, controlled clinical trial aims to evaluate the effects of the
      consumption of yogurt with spirulina compared to conventional yogurt in 64 high
      cardiometabolic risk volunteers. Volunteers must be overweight/obese either with prediabetes,
      and/or hypertension, and/or hyperlipidemia. The participants will be divided and randomly
      assigned into 2 groups of 32 individuals each. Participants will consume 2 cups of either
      yogurt with spirulina (2 g of spirulina in each cup) or conventional yogurt (without
      spirulina) daily for 8 weeks as an addition to their usual dietary intake. Participants will
      be asked to maintain their usual physical activity during the intervention period. At the
      beginning of the study, at 8 weeks, and 12 weeks after the beginning of the intervention
      (follow-up), blood samples will be collected after 12 hours of fasting. Two-hour oral glucose
      tolerance test (OGTT) will be performed using a continuous glucose monitoring system at the
      beginning and at 8 weeks. Anthropometric measurements will be performed at the beginning and
      every two weeks for 12 weeks. Basal metabolic rate (BMR) and central aortic blood pressure
      will be measured at the beginning, 4 weeks, 8 weeks, and 12 weeks of the intervention. Fecal
      samples will be collected and analyzed to study the gut microbiome composition at the
      intervention's beginning and at 8 weeks.
    

Intervention name(s): Spirulina yogurt; Conventional yogurt
Intervention type(s): Other; Other
Intervention description(s): 32 high cardiometabolic risk volunteers will be asked to consume 2 cups of yogurt with spirulina, each containing 2 g spirulina, daily for 8 weeks, without any other change in their dietary habits and physical activity.; 32 high cardiometabolic risk volunteers will be asked to consume 2 cups of conventional yogurt (without spirulina), daily for 8 weeks, without any other change in their dietary habits and physical activity.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: spirulina; yogurt; cardiometabolic risk factors
Evaluation of Factors Affecting the Tear-film Lipid Layer Thickness
Condition: Dry Eye Syndrome
MeSH terms: Dry Eye Syndromes
Study type: Observational

Summary: 
      In this study, the investigators aim to determine the effects of age, sex, history of ocular
      surgery and contact lens use, and ocular surface and meibomian gland parameters on the lipid
      layer thickness (LLT) in normal subjects and patients with dry eye syndrome. Patients with
      dry eye syndrome and subjects with a healthy ocular surface will be enrolled. All participant
      will underwent LLT measurement with a LipiView interferometer, tear meniscus height
      measurement using optical coherence tomography, tear film break-up time (TBUT) determination,
      corneal and conjunctival staining, Schirmer's test, examination of the lid margins and
      meibomian glands, and assessment using the Ocular Surface Disease Index(OSDI) questionnaire.
    


Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        age over 19 years old, Patients with dry eye syndrome and normal subjects
      
Keywords: Dry eye; Lipiview; Tear Lipid Layer; meibomian gland dysfunction
Effect of Single Doses of 10 mg NRL001 Applied as a Suppository to the Anal Canal or Rectum
Condition: Fecal Incontinence
MeSH terms: Fecal Incontinence
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to assess the effects of 10mg NRL001 on mean anal resting pressure (MARP) when
      administered as a slow release suppository applied to the anal canal or rectum. In addition,
      the pharmacokinetics of NRL001 in plasma, adverse events, and any changes in heart rate or
      blood pressure were to be assessed.
    


Intervention name(s): NRL001
Intervention type(s): Drug
Intervention description(s): 10mg NRL001 was administered as a slow release suppository
Other intervention name(s): Methoxamine Hydochloride
Intervention MeSH terms: Methoxamine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Extension Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Duodenitis
Condition: Eosinophilic Gastritis; Eosinophilic Gastroenteritis; Eosinophilic Duodenitis
MeSH terms: Gastroenteritis; Gastritis; Eosinophilic Esophagitis; Enteritis; Duodenitis; Eosinophilia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, open-label, extension study to assess the safety and tolerability of
      AK002, given monthly for up to 26 doses.
    


Intervention name(s): AK002
Intervention type(s): Drug
Intervention description(s): AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Eosinophilic Gastritis; Eosinophilic Gastroenteritis; Eosinophil; EG; EGE; EGID; Eosinophilic gastrointestinal disorders; Eosinophilic Duodenitis; EoD
Staccato Prochlorperazine in Migraine (Out Patient)
Condition: Migraine Headache; Aura
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 2

Summary: 
      Staccato Prochlorperazine is being developed to treat patients suffering from acute migraine
      headaches. In October 2005, we completed a 75 patient, multi-center, double-blind
      placebo-controlled Phase 2A clinical trial in patients suffering from moderate to severe
      acute migraine headaches. This Phase 2B clinical trial of Staccato Prochlorperazine has been
      initiated to assess the efficacy and safety in outpatients with migraine headache with or
      without aura.
    


Intervention name(s): Inhaled Placebo; Inhaled PCZ 5 mg; Inhaled PCZ 7.5 mg; Inhaled PCZ 10 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Inhaled Staccato Placebo; Inhaled Staccato Prochlorperazine 5 mg; Inhaled Staccato Prochlorperazine 7.5 mg; Inhaled Staccato Prochlorperazine 10 mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Migraine, Staccato Prochlorperazine; Migraine headache with or without aura.
Post Occlusive Reactive Hyperemia on Gingiva Assessed by Laser Speckle Contrast Imaging
Condition: Ischemia
MeSH terms: Ischemia
Study type: Interventional

Summary: 
      Apply the LASCA for follow-up the postocclusive microcirculation after strangulation of the
      gingiva in order to characterize the kinetics of the blood flow changes in human subjects.
    

Detailed description: 
      During surgical endodontics the cortical bone is exposed by elevating a full- thickness
      tissue flap. Cutting across mucosal blood vessels disturbs perfusion and causes ischemia. On
      the other hand, preserving sufficient blood flow of the soft tissue segment is important for
      the postoperative wound healing. In order to minimize the damage of the microvasculature of
      the operated area, the incision should be properly designed.

      The investigators will model surgical incisions by strangulation of the gingiva of healthy
      human subjects based on the commonly applied endodontic incision such as horizontal, vertical
      and papilla base. The primary aim is to determine the effect of a short term disruption of
      the blood flow at the respective region on the surrounding area in order to assess the
      functionally active collateral circulation. Using Laser Speckle Contrast Analysis (LASCA),
      which provides blood perfusion data, the investigators will have the possibility to detect
      functional alterations in gingival microcirculation during and after a short term of
      strangulation. The secondary aim is to assess the time course of the restoration of the
      circulation on the affected area.
    

Intervention name(s): strangulation
Intervention type(s): Procedure
Intervention description(s): The strangulation is applied on the attached gingiva with an angulated manual instrument. The force of the occlusion is standardized by a calibrated spring connecting the head with the handle of the tool. The head is overlaid onto the gingiva covering 10mm long and 1mm width surface. The amount of the applied pressure is 100 gram.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Effects of Therapeutic Exercise With Elastic Bands on Strength and Pain in Women With Non-specific Neck Pain.
Condition: Neck Pain; Exercise Therapy; Women
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The study consists of an intervention of 16 therapeutic exercise sessions during 8 weeks with
      a frequency of two sessions per week. All sessions had a practical focus (strength and
      stretching exercises) with the help of elastic bands. In addition, they had an initial
      session and another at the end of the intervention in which measurements of the different
      variables (cervical pain, cervical flexor strength, cervical extensor strength and strength
      of the scapular stabilising musculature) were taken on two occasions, at the beginning of the
      study and at the end of the intervention, an average of 2 months.

      Nonspecific neck pain has a higher incidence in women than in men. Female sex is a risk
      factor for this pathology. Clinical practice guidelines highlight the importance of
      preventing neck pain through exercise. There are previous studies on the effects of strength
      programmes on patients with non-specific neck pain, but none have used elastic bands as an
      implement, despite the fact that it is one of the most commonly used implements in
      physiotherapy clinics. Therefore, the aim of this study is to investigate the effects of an
      elastic band therapeutic exercise intervention in women with non-specific neck pain. It was
      previously hypothesised that this intervention would have positive effects on pain and
      strength in the cervical and scapular region.
    


Intervention name(s): Therapeutic exercise
Intervention type(s): Behavioral
Intervention description(s): The therapeutic exercise intervention with the help of elastic bands was carried out for 8 weeks with a frequency of two sessions per week, for a total of 16 sessions of 45 minutes duration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Pilot Study to Assess the Efficacy of Short Exposure to Defocus to Slow the Progression of Myopia in Children
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The objective of this pilot study is to establish whether brief periods of high levels of
      acutely imposed myopic defocus can be used to slow the progression of myopia in children, as
      measured by changes in spherical equivalent refraction and axial length.
    

Detailed description: 
      Recent results on animal models of myopia suggest that the eye has the ability to detect the
      overall sign of defocus of images falling on the retina, with myopic defocus imposed by the
      fitting of plus-lenses halting or slowing axial elongation of the eye. In the animal models,
      these STOP growth signals have been shown to be particularly strong - with brief periods of
      high myopic defocus able to outweigh the effects of prolonged periods of imposed hyperopic
      defocus in promoting eye growth. These results therefore suggest a novel strategy for
      preventing the progression of myopia in children - the imposition of high levels of myopia
      for brief periods of time. This approach is conceptually distinct from under-correction,
      which imposes chronic mild myopic defocus.
    

Intervention name(s): Hyperopic lens
Intervention type(s): Device
Intervention description(s): +3 D glasses
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Myopia, defocus
Clinical Trial of the Efficacy and Safety of Beclomethasone Dipropionate Plus Formoterol vs Fluticasone Propionate Plus Salmeterol in the 6 Months Step Down Treatment of Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      Asthma is a serious global health problem. People of all ages in countries throughout the
      world are affected by this chronic airway disorder that can be severe and sometimes fatal.
      The prevalence of asthma is increasing everywhere, especially among children.According to
      international guidelines, once control of asthma is achieved and maintained for at least 3
      months, a gradual reduction of the maintenance therapy should be tried in order to identify
      the minimum therapy required to maintain control. This will help reduce the risk of side
      effects and enhance patient adherence to the treatment plan.

      Reduction of therapy in patients on combination therapy should begin with a reduction in the
      dose of inhaled glucocorticosteroid.1 The present study is designed to evaluate if patients
      with controlled asthma treated with FP 1000 mcg + salmeterol 100 mcg daily can be stepped
      down. Stepping-down will be attempted with two medications: a new combination of extrafine
      beclomethasone dipropionate 400 mcg + formoterol 24 mcg daily (test medication, Foster™) and,
      alternatively, fluticasone propionate 500 mcg + salmeterol 100 mcg daily(reference
      medication) without losing asthma control.If this hypothesis will be confirmed, the present
      study will demonstrate that asthma control can be maintained with less than half the dose of
      inhaled corticosteroid and with less medical costs.

      Given the aims of this study, the population to be monitored includes adult patients with
      moderate persistent asthma, which can be defined controlled according to the current
      guidelines under standard stabilised treatment. The intended treatment duration is therefore
      designed to ensure that good control of asthma is firmly achieved before stepping down the
      treatment (8 weeks run-in period), but also that the condition of the patients are followed
      long enough (24 weeks comparative treatment period) to ensure that a new stable condition is
      also obtained and properly monitored.
    


Intervention name(s): Beclomethasone plus formoterol fixed combination; Fluticasone plus salmeterol fixed combination
Intervention type(s): Drug; Drug
Intervention description(s): 100+6 pMDI; diskus 250/50
Intervention MeSH terms: Fluticasone; Beclomethasone; Formoterol Fumarate; Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma; Stepdown; Beclomethasone; Formoterol; Corticosteroids
Effect of Bupropion on Smoking Behavior in Smokers With Schizophrenia
Condition: Schizophrenia; Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder; Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      Many individuals with schizophrenia smoke cigarettes but little is known about the factors
      that control smoking in people with schizophrenia. The purpose of this trial is to evaluate
      how bupropion, an antidepressant medication, affects smoking behaviors in individuals with
      schizophrenia who smoke.
    

Detailed description: 
      There is a high prevalence of cigarette smoking among people with schizophrenia and few
      smoking cessation interventions have been developed for these individuals. Bupropion is an
      antidepressant medication commonly used to treat smoking in smokers without psychiatric
      disorder. This study compares how smokers with schizophrenia and smokers without psychiatric
      illness respond to bupropion (0, 300 mg/day).

      Participants will be randomly assigned to receive either bupropion or placebo. Study visits
      will occur after one-week treatment with placebo or bupropion. During study sessions,
      participants will come to the laboratory at 9 am and will remain abstinent in the laboratory
      for 5 hrs. Participants will then be assessed for craving and withdrawal symptoms after
      viewing and handling neutral cues and smoking cues. After that, participants will have a
      90-min period to smoke, and smoking topography will be measured.
    

Intervention name(s): 300 mg/day bupropion-sr; 0 mg/day bupropion-sr
Intervention type(s): Drug; Drug
Intervention description(s): 300 mg/day for 1 week; 0 mg/day bupropion-sr
Other intervention name(s): zyban, wellbutrin; placebo
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia; tobacco dependence; nicotine