bioihbjkbjnl/mcl2 huggingface dataset:
Airway and Pulmonary Vascular Endothelial Function in Healthy Smokers: Effect of Inhaled Glucocorticosteroid Treatment
Condition: Smoking
Study type: Interventional

Summary: 
      The purposes of the present proposal are to 1) compare inhaled albuterol-induced changes in
      airway blood flow (Qaw), and in CO and Ppas in healthy current smokers and lifetime
      non-smokers as an index of endothelial function in the airway and pulmonary circulations, 2)
      compare the results between smokers and non-smokers, and 3) determine the effect of a 4-week
      treatment with an ICS on albuterol responsiveness of Qaw and the echocardiographic
      parameters. With this protocol the Investigators will test the hypotheses that a) there is a
      correlation between airway and pulmonary vascular endothelial function within the current
      smoker and non-smoker groups, and b) ICS treatment improves airway and pulmonary vascular
      endothelial function in the current smoker group.
    

Detailed description: 
      With this protocol the Investigators will test the hypotheses that a) there is a correlation
      between airway and pulmonary vascular endothelial function within the current smoker and
      non-smoker groups, and b) ICS treatment improves airway and pulmonary vascular endothelial
      function in the current smoker group.

      Fifteen healthy current smokers with a >10 pack-year history of smoking and 15 healthy
      never-smokers will be enrolled. Males and females between 25 and 75 years of age will be
      recruited There will be 1-4 visits to the laboratory (one for non-smokers, 4 for smokers).
      All subjects will have the first visit. Current smokers will have 3 additional visits.
      Current smokers will be asked not to smoke before coming to the laboratory on the 3 study
      days. All subjects will be instructed to abstain from ingesting alcoholic beverages, coffee
      or caffeinated drinks for at least 12 hours the night before each study day. The subjects
      will also be instructed not to use PDE5 inhibitors for 24 hours before coming to the
      laboratory. On each study day, the protocol will start at the same time (in the morning).
    

Intervention name(s): echocardiogram plus albuterol; airway blood flow plus albuterol; Fluticasone propionate; placebo
Intervention type(s): Procedure; Procedure; Drug; Drug
Intervention description(s): participants will performed echocardiogram before and 15 minutes after inhaled albuterol; participants will performed echocardiogram before and 15 minutes after inhaled albuterol; participant will be received a 4-week course of inhaled fluticasone (220 μg fluticasone twice a day administered as a MDI using a spacer); participant will be received a 4-week course of identically appearing placebo (2 puffs twice a day via spacer).
Other intervention name(s): Qaw
Intervention MeSH terms: Fluticasone; Xhance; Albuterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Keywords: smokers; airway blood flow; fluticasone; echocardiogram
Isometric Exercises in Healthy Elderly Individuals
Condition: Healthy
Study type: Interventional

Summary: 
      A total of 58 participants were selected and divided into two groups equally, namely,
      elderly, and young groups with the age groups of 60-80 years and 20-30 years, respectively.
      The Heart Rate (HR), Respiratory Rate (RR), Blood Pressure (BP), Oxygen Saturation (SaO2),
      and Mean Arterial Pressure (MAP) for each participant were assessed before and after the
      treatment session.
    

Detailed description: 
      The elderly participants in the experimental group and the young participants in the control
      group underwent a single session of 5-minute quadriceps isometric exercise. The participant
      was asked to take rest of 10 minutes before performing the exercise. After that, the exercise
      was performed from a long-sitting position.
    

Intervention name(s): Exercises; Young isometric exercise
Intervention type(s): Other; Other
Intervention description(s): The elderly participants in the experimental group underwent a single session of 5-minute quadriceps isometric exercise. The participant was asked to take a rest of 10 minutes before performing the exercise. After that, the exercise was performed from a long-sitting position.; The young participants in the experimental group underwent a single session of 5-minute quadriceps isometric exercise. The participant was asked to take a rest of 10 minutes before performing the exercise. After that, the exercise was performed from a long-sitting position.
Other intervention name(s): Elderly isometric exercise
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Blood pressure; Isometric exercise
A Study to Evaluate the Effects of Single-dose Seltorexant on Electrocardiogram Intervals in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effects of single dose seltorexant on QT/QTc
      intervals and electrocardiogram (ECG) morphology at therapeutic and supratherapeutic
      exposures in healthy adult participants.
    


Intervention name(s): Seltorexant; Placebo Matched to Seltorexant; Placebo Matched to Moxifloxacin; Moxifloxacin Dose 1
Intervention type(s): Drug; Other; Other; Drug
Intervention description(s): Participants will be administered oral dose of seltorexant over-encapsulated tablets on Day 1.; Participants will be administered matching placebo to seltorexant tablets on Day 1.; Participants will be administered oral dose of moxifloxacin placebo tablet on Day 1.; Participants will be administered oral dose 1 of moxifloxacin on Day 1.
Other intervention name(s): JNJ-42847922
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Safety and Efficacy of a Low Dose Naloxone Infusion in NICU Patients
Condition: Opioid Tolerance; Pain
Study type: Observational

Summary: 
      When narcotic pain medicine, like fentanyl or morphine, is given to adults and children for
      several days, they often develop a tolerance to the medicine. This means they may need higher
      doses over time to get the same amount of pain control. When it is time to stop the medicine,
      the dose has to be decreased slowly so that the patient does not have withdrawal symptoms.

      Naloxone is a medicine that at high doses can reverse the effects of narcotics. At very small
      doses it may help prevent tolerance and lessen the severity of withdrawal symptoms. This
      could mean less narcotic pain medicine is needed over fewer days.

      The purpose of this research study is to see if giving naloxone to neonates who require
      narcotic infusions is safe and effective. Safety will be measured by the incidence of side
      effects. Efficacy will be measured by monitoring for changes in pain and sedation scores and
      need for more pain medicine.
    

Detailed description: 
      This is a prospective, non-randomized, single center, open label dose escalation study. We
      hypothesize that critically ill patients in the NICU may benefit from a low dose naloxone
      infusion resulting in decreased tolerance, less severe withdrawal symptoms, lower cumulative
      doses of opiates, and fewer total days of opiates, all while maintaining adequate or enhanced
      pain control and sedation. Establishing safety and efficacy data for this potentially
      beneficial therapy is an important first step towards using this therapy to decrease the risk
      of opioid tolerance and withdrawal in this population of infants.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Neonates admitted to the NICU within the first five days of life with an anticipated need
        for opiate infusion for at least four days
      
Keywords: Naloxone; Neonate; Pain
BRP1602: Evaluation of Technical and Logistical Feasibility to Measure Lung Permeability
Condition: Tobacco Use; Smoking; Smoking, Tobacco
Study type: Interventional

Summary: 
      This will be a single-center, single-blind, four-cohort, 22-day ambulatory study during which
      up to 24 healthy adult subjects [6 smokers (SMK), 6 moist snuff consumers (MSC), 6 vapers
      (VAP), and 6 non-tobacco consumers (NTC)] will complete 3 measurements of lung permeability.
      Nasal epithelial cells, sputum, and blood samples will also be collected for current and
      future biomarker research.
    

Detailed description: 
      Test Visit 1 will consist of sampling for nasal epithelial cells, sputum, and blood.
      Additional subjects ("alternates") may be required to complete these procedures to better
      ensure that 24 subjects are available to complete the lung permeability assessments. During
      Test Visits 2, 3, and 4, subjects will provide additional blood samples and will complete the
      lung permeability procedure. A solution containing approximately 40 mCi of a radiolabeled
      tracer molecule (99mTc-DTPA) will be loaded into a radioaerosol administration system and
      subjects will breathe the aerosol over approximately 3 minutes, depositing approximately 1
      mCi into the lungs (effective dose of approximately 0.3 rem). Subjects will lie supine in
      front of a gamma counter and a series of images will be obtained over 60 minutes, from which
      the 99mTc-DTPA clearance rate from the lungs will be calculated.
    

Intervention name(s): Lung Permeability Assessment
Intervention type(s): Procedure
Intervention description(s): A gamma camera will be used to scintigraphically monitor the clearance of an inhaled radiolabeled tracer molecule from the lungs into the blood. Clearance will be monitored for 60 minutes. The rate of clearance of radioactivity will serve as an index of alveolar epithelial permeability.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
A Study to Evaluate the Effect of Repeat Doses of GW870086X in Mild to Moderate Asthmatics
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will measure the effect of repeat inhaled doses of GW870086X on lung function.
    


Intervention name(s): GW870086X; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Investigational product; Placebo control
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: asthma; GW870086X; Efficacy; FEV1; repeat-dose
Effectiveness of Podiatry on Plantar Pain
Condition: Heel Pain; Plantar Fasciitis; Plantar Pain
MeSH terms: Fasciitis; Fasciitis, Plantar
Study type: Interventional
Phase: Phase 4

Summary: 
      MAIN OBJECTIVE: To value the effectiveness of the different quiropody interventions in the
      heel pain.

      SECONDARY OBJECTIVES: To evaluate the effectiveness of lasw different technologies in front
      of each one of the other experimental technologies. To analyze the state of general health
      and of quality of the patients' life in all the treatment groups. To analyze the study
      cost-effectiveness of each one of the experimental interventions. DESIGN: randomized
      controled trial, prospective.

      SUBJECT OF STUDY: Patient that go to the Assistance Educational Unit of Podología of the E.U.
      Sciences of the Health with footpain like consultation reason.

      INTERVENTION: Establishment of four experimental groups with intervention varied podológica.
      He/she will be carried out a complete pursuit with valuations at the 1,2, 6, 12 and 24
      months, by means of pain scales and function of the foot (FHSQ), the index postural of the
      foot (FPI), the study of pressures by means of biofoot/IBV and of the state of general health
      (SF-12) and quality of life (Euroqol).

      VARIABLES: Of intervention; treatment basic orthopodiatry, treatment advanced orthopodiatry,
      of treatment quiropody. Of result: pain and function of the foot (FHSQ), of the state of
      general health (SF12) and quality of life (Euroqol). Variables of characterization of the
      sample.

      ANALYSIS DATA: Descriptive statistic, with measures of central tendency and dispersion of the
      study variables. They will be carried out statistical inferenciales between the main
      variables of intervention and result (square chi, t Student, ANOVA, Mann-Whitney, Wilcoxon,
      according to types and normality of variables). Likewise, measures of the size of the effect
      will settle down in the main variables of result, by means of the relative reduction of the
      risk, absolute risk and odds ratio, with their respective intervals of trust.
    


Intervention name(s): chiropody; basic orthesis; advantage orthesis; chiropody and advantage orthesis
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): basic procedure of chiropody in podiatry; individual basic orthesis of foot; advantage orthesis of foot with special material and design; chiropody and advantage orthesis of foot
Intervention MeSH terms: Imidacloprid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: chiropody; podiatry; insoles; foot orthesis
Effect of Clarithromycin on the Pharmacokinetics of Apixaban in Healthy Participants
Condition: Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to evaluate the effects of multiple-dose clarithromycin on the single-dose
      pharmacokinetics (PK) of apixaban with parameters like Cmax, AUC(INF), and AUC(0-T).
    


Intervention name(s): Apixaban; Clarithromycin
Intervention type(s): Drug; Drug
Intervention description(s): Multiple-dose clarithromycin and single-dose Apixaban; Multiple-dose clarithromycin and single-dose Apixaban
Intervention MeSH terms: Clarithromycin; Apixaban
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Bupropion and Weight Control for Smoking Cessation - 1
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether the addition of bupropion (Zyban) to
      cognitive behavioral therapy (CBT) will enhance longer-term tobacco abstinence in women.
    

Detailed description: 
      Although rates of smoking have declined, the decrease in prevalence has been much less
      pronounced in women than in men, and women are particularly vulnerable to ongoing
      smoking-related morbidity and mortality. One important reason for gender differences in
      smoking cessation is concern about cessation-related weight gain among women, which is
      associated with poorer cessation outcome. We previously documented that cognitive behavior
      therapy to minimize weight concerns (CBT) was effective in promoting cessation and
      controlling weight gain among weight concerned women smokers. The current study is a
      randomized, double-blind, controlled trial to determine whether the addition of bupropion
      (Zyban) to CBT (12 sessions over 14 weeks, with 6 booster sessions) will enhance longer-term
      abstinence. Bupropion was the clear medication of choice for this trial because it is
      efficacious in promoting smoking cessation, attenuates cessation-related weight gain
      (particularly in women), and relieves negative mood, which appears more common in
      weight-concerned women. Four hundred fifty weight concerned women smokers will be randomized
      to either CBT for weight concerns plus standard cessation or standard smoking cessation only
      and six months of either bupropion (Zyban) or placebo (2 x 2 design). Primary outcome will be
      rates of smoking abstinence at 1 year and time to relapse across the four treatment
      conditions. In addition, we will determine the effects of these treatments on tobacco
      withdrawal, mood, and weight. Results of this investigation will provide information on the
      relative efficacy of the CBT intervention and bupropion alone and in combination and the
      utility of drug and counseling strategies that are specifically tailored for a high-risk
      population.
    

Intervention name(s): Bupropion; Placebo; weight concerns intervention; smoking cessation intervention
Intervention type(s): Drug; Drug; Behavioral; Behavioral
Intervention description(s): smoking cessation medication aid; A matched placebo pill; cognitive behavioral treatment to address weight concners; Cognitive behavioral intervention for smoking cessation
Other intervention name(s): zyban
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: smoking cessation; Women; bupropion; weight concerns; weight
Determining the Relationship Between the Atherosclerosis and Periodontopathogenic Microorganisms
Condition: Atherosclerosis; Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis; Atherosclerosis
Study type: Interventional

Summary: 
      Determine the relationship between the systemic indications of atherosclerosis by means of
      the change in the ratio of periodontopathogenic microorganisms following periodontal
      treatment of individuals who have been diagnosed with chronic periodontitis-atherosclerosis
      and for individuals who have been diagnosed with systemically healthy-chronic periodontitis.
    

Detailed description: 
      It has been aimed in this study to compare 1) the change in periodontal status; 2) the change
      of the periodontopathogen microorganisms (A. actinomycetemcomitans, P. gingivalis, T.
      forsythia, T. denticola, P. intermedia, P. micros, F. nucleatum/periodonticum, C. rectus, E.
      nodatum, E. corrodens, and C. gingivalis/ochracea/sputigena) in dental plaque samples, 3) the
      changes of the amounts of HDL, LDL, hs-CRP white blood cell levels (WBC), platelet levels
      (PLT), creatinine, and fibrinogen in serum samples; and 4) the correlation between
      periodontopathogen microorganisms (A. actinomycetemcomitans, P. gingivalis, T. forsythia, T.
      denticola, P. intermedia, P. micros, F. nucleatum/periodonticum, C. rectus, E. nodatum, E.
      corrodens, and C. gingivalis/ochracea/sputigena) and HDL, LDL, hs-CRP WBC, PLT, creatinine,
      and fibrinogen in patients that have been diagnosed with atherosclerosis-chronic
      periodontitis and systemic healthy patients and patients diagnosed with chronic
      periodontitis, following non surgical periodontal treatment.
    

Intervention name(s): Non-surgical periodontal treatment
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Periodontopathogenic microorganisms; Non-surgical periodontal treatment
A Phase 1 Study to Examine the Effect of Renvela on the Pharmacodynamics of AZD1722
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is designed to evaluate safety, tolerability, pharmacodynamics and pharmacokinetics
      of AZD1722 in healthy volunteers taking Renvela.
    


Intervention name(s): AZD1722; Renvela
Intervention type(s): Drug; Drug
Other intervention name(s): RDX5791; Tenapanor; Sevelamer carbonate
Intervention MeSH terms: Sevelamer
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Volunteer
Bone Tissue Engineering Using Autologous Bone Repair Cell (BRC) Therapy for Sinus Floor Bone Augmentation
Condition: Tooth Loss
MeSH terms: Tooth Loss
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this research is to determine if one's own bone marrow tissue can help
      regenerate (grow) bone in the area of the jaw where an implant will be placed. The name of
      the process is called Bone Repair Cell (BRC) Therapy. A sample of bone marrow tissue will be
      collected and sent to a laboratory where it will be processed to form more cells. These new
      cells will then be transplanted in the regenerative site or sinus floor augmentation site.
      The researchers are testing to see if these cells (BRC) will help form bone indicating. The
      research will also determine if the implant will be more stable in the area with new bone
      growth.
    

Detailed description: 
      The overall aim is to promote bone regeneration, using Aastrom's proprietary Adult Stem Cell
      Therapy (AST) developed collaboratively with the University of Michigan, to enable placement
      of dental implants in patients who lack adequate alveolar bone. This project addresses
      specifically the placement of dental implants following bone regenerative sinus floor
      augmentation. This novel therapy mitigates the risks of other therapies, providing additional
      benefits of adequate cell numbers for high quality bone regeneration, and has the potential
      to become the new standard of care. In Aastrom's patented manufacturing technology, iliac
      bone marrow aspirates are expanded ex-vivo to enrich for adult multipotent cells (Bone Repair
      Cells- BRC) capable of regenerating bone and blood vessels. BRC will then be mixed with bone
      matrix graft extender, beta-tricalcium phosphate (β-TCP), before their implantation into the
      regenerative site.
    

Intervention name(s): Sinus lift augmentation and dental implant; Aastrom BRCs
Intervention type(s): Procedure; Biological
Intervention description(s): transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.; sinus augmentation, BRC application, dental implant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sinus lift; tooth extraction; dental implant
Influence of Wrist Taping on Handgrip Strength in Crossfit Athletes
Condition: Sport Injury; Hand Injury Wrist
MeSH terms: Wounds and Injuries; Athletic Injuries; Hand Injuries
Study type: Interventional

Summary: 
      The idea that the use of a wristband can increase the grip strength is old, but without
      systematic scientific evidence. Most Crossfit practitioners wear wrist bands during training
      because it is believed that the wristband increases the grip strength of the hand. The aim of
      this study is to to analyze the influence of the use of the wristband on the maximum force
      value and on the dynamic resistance of hand hold. A simple blind randomized cross-over trial
      will be performed.
    


Intervention name(s): Wrist taping
Intervention type(s): Other
Intervention description(s): Wrist taping as used as standard in CrossFit practice
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sports