bioihbjkbjnl/mcl2 huggingface dataset:
Study to Assess the Pharmacokinetics, Pharmacodynamics, and Safety of Canagliflozin (JNJ-28431754) in Otherwise Healthy Obese Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetics (ie, how the body affects the
      drug) and pharmacodynamics (ie, how the drug affects the body) of increasing doses of
      canagliflozin (JNJ-28431754) in healthy obese volunteers.
    

Detailed description: 
      This study will be a single-center, randomized (the treatment is assigned by chance),
      double-blind (neither investigator nor volunteer knows the identity of the assigned
      treatment), placebo-controlled (one of the study medications is inactive), ascending multiple
      dose study (increasing doses of study medication) to assess the pharmacokinetics and
      pharmacodynamics of canagliflozin (a drug currently being investigated for the treatment of
      type 2 diabetes mellitus) in otherwise healthy obese volunteers. The study will consist of 3
      phases: a screening phase, a double-blind treatment phase, and an end of study (or follow-up)
      phase. Volunteers will be assigned to 5 cohorts (groups) made up of 16 otherwise healthy
      obese men and women. Within each group, 12 volunteers will be given canagliflozin once or
      twice daily and 4 volunteers will be given placebo (inactive medication) once or twice daily
      for 14 days. The dose of canagliflozin will be different for each of the 5 groups and the
      second group will not begin treatment until at least 21 days after the first group start
      treatment. This 21-day gap will be applied to all subsequent groups. Each volunteer will
      participate in the study for approximately 58 days.
    

Intervention name(s): Canagliflozin (JNJ-28431754); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A 30mg/day, 100 mg/day, 300 mg/day, or 600 mg/day liquid dose administered once daily; a 300mg/day liquid dose administered in 2 divided doses (2x150 mg); or a 600 mg/day liquid dose administered in 2 divided doses (2x300 mg) using an oral (by mouth) liquid dispenser on Days 1 through 14.; Matching placebo (inactive medication) liquid dose(s) administered using an oral liquid dispenser once or twice daily on Days 1 through 14.
Other intervention name(s): JNJ-28431754
Intervention MeSH terms: Canagliflozin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy; Canagliflozin (JNJ-28431754); Pharmacokinetics; Pharmacodynamics; Obesity
Relative Bioavailability Study of Emodepside IR-tablets and Solution
Condition: Filariasis
MeSH terms: Filariasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study evaluates 2 new immediate release (IR)-tablet formulations of emodepside and they
      will be compared to the oral liquid service formulation (LSF) used in the FIH Single
      Ascending Dose study (DNDi-EMO-001 study) (CT.gov identifier: NCT02661178)
    

Detailed description: 
      There is an urgent need for a macrofilaricidal drug, killing or sterilizing permanently O.
      volvulus adult worms, which could be used in individual case management and, after
      appropriate testing, as an alternative drug to ivermectin in MDA programs. Emodepside is a
      promising candidate to kill the adult and sexually mature O. volvulus. Emodepside was shown
      to be macrofilaricidal against a variety of filarial nematodes and is a registered drug for
      animal health, commercialized by Bayer AG under the name of Profender® (in combination with
      praziquantel) or Procox® (in combination with toltrazuril).

      A first-in-human (FIH) double-blind, placebo-controlled study of single ascending doses of
      emodepside in healthy Caucasian men has been conducted and the preliminary results are
      favourable, and support continuing the Phase I development program. For this reason, new
      tablet formulations have been developped and the present study will evaluate bioavailability,
      PK safety and tolerability, and as well food effect of single doses of 2 new immediate
      release (IR)-tablet formulations of emodepside compared to the oral liquid service
      formulation (LSF) used in the FIH study.
    

Intervention name(s): Emodepside (BAY 44-4400)
Intervention type(s): Drug
Intervention description(s): 2 tablets compared to the liquid formulation
Other intervention name(s): Profender® (in combination with praziquantel) FOR VETERINARY USE; Procox® (in combination with toltrazuril) FOR VETERINARY USE
Intervention MeSH terms: Praziquantel; Emodepside; Toltrazuril
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a single-centre, open-label, randomized, parallel-group relative bioavailability study in healthy men. The study will be done in 2 parts, as follows:
Part 1 - single oral doses of 5 mg emodepside will be tested:
Part 1a - the LSF (reference formulation) and 2 new IR-tablet formulations (test formulations) will be administered in the fasted state.
Part 1b - the 2 new IR-tablet formulations will be administered in the fed state (high-fat, high-calorie meal).
Part 2 - single oral doses of 10 mg emodepside will be tested: depending on the results from Part 1, one or both IR-tablet formulations will be administered in the fasted state.
Masking: None (Open Label)
Primary purpose: Treatment
A Phase I Open Label Study to Assess PK and Safety of Plant Cannabis Extract
Condition: Healthy
MeSH terms: Marijuana Abuse
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an open-label, single-dose, healthy volunteer phase 1 study after overnight
      fasting designed to study the safety and PK of medicated drops and tablet formulation for
      sublingual administration.
    


Intervention name(s): A1; A2; A3; A4; A5; B1; B2; B3; B4
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Medical Cannabis oil diluted in Olive oil. CBD 36.6 mg, THC 1.8 mg (6 drops); Medical Cannabis oil diluted in Olive oil. CBD 0.6 mg, THC 3.1 mg (1 drop); Medical Cannabis oil diluted in Olive oil. CBD 3.1 mg. THC 3.1 mg (1 drop); Medical Cannabis (oil diluted in MCT oil). CBD 34.8 mg, THC 1.7 mg (6 drops); Medical Cannabis oil (diluted in MCT oil). CBD 0.6 mg, THC 3.1 mg (1 drop); Sublingual tablets. CBD 40 mg, THC 2 mg (1 tablet); Sublingual tablets. CBD 30 mg, THC 5 mg (1 tablet); Sublingual tablets. CBD 40 mg (1 tablet); Sublingual tablets. CBD 40 mg (1 tablet)
Other intervention name(s): Celixir 20 T1/C20- CBD 20%, THC 1%; Telixir 10 T2/C10 - CBD 2%, THC 10%; Equatir 10 T10/C10 - CBD 10%, THC 10%; C18T0.9 in MCT oil - CBD 18%, THC 0.9%; T10/C2 - CBD 2%, THC 10%; Tablet: CBD 40 mg, THC 2 mg; Tablet: CBD 30 mg, THC 5 mg; Tablet: CBD 40 mg; Tablet: CBD 40 mg
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Positron Emission Tomography (PET) Study With (11C) Flumazenil to Determine Central GABAA Receptor Occupancy of AZD6280
Condition: Anxiety
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is carried out in order to determine the relationship between the dose of AZD6280
      and the blood concentration of AZD6280, and to investigate to which extent AZD6280 binds to
      GABAA receptors
    


Intervention name(s): AZD6280; (11C) flumazenil
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of oral solution or capsule(s). 3 times for the 2 subjects in Panel 1. Once for the 6 remaining subjects.; Single dose of intravenous solution. 4 times for 2 subjects in Panel 1. 2 times for the remaining 6 subjects. (once together with AZD6280)
Intervention MeSH terms: Flumazenil
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Anxiety; GABA receptors; Positron Emission Tomography; PET; phase I
Effectiveness of Video System in Improving Learning of Tracheal Intubation Using Standard Laryngoscopy Among Novices
Condition: Intubation Intraesophageal
Study type: Interventional

Summary: 
      The use of the video laryngoscope to teach laryngoscopy will improve the performance of
      tracheal intubation done by novices because it will allow a shared view of the airway leading
      to a better feedback from the trainer to the trainee.
    

Detailed description: 
      A group of 30 fourth year medical students and interns rotating through the department of
      anesthesiology will be studied. Firstly, a standard lecture will be provided in which the
      description and importance of laryngoscopy and tracheal intubation will be explained. This
      will include descriptions of anatomy, relevant equipment and technique of tracheal
      intubation. Following the lecture , the students will be randomly allocated using sealed
      envelopes into two groups : a control group ( taught with a standard Macintosh Laryngoscope )
      and a study group ( taught with the Airtraq video laryngoscope).Each group will receive a
      demonstration and verbal instruction on how to perform laryngoscopy and tracheal intubation
      by their instructor.
    

Intervention name(s): Airtraq; Control group, taught with a standard Macintosh laryngoscope
Intervention type(s): Device; Other
Intervention description(s): Subjects were taught with the Airtraq video laryngoscope; Subjects were taught how to use the Mackintosh blade first
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Teaching; Video Scope; Intubation
Comparative Study of Efficacy and Safety of Oral Ibuprofen and Intravenous Ibuprofen in Closure of Patent Ductus Arteriosus in Very Low Birth Weight Infants
Condition: Patent Ductus Arteriosus
MeSH terms: Ductus Arteriosus, Patent; Birth Weight
Study type: Interventional
Phase: Phase 4

Summary: 
      it is a prospective randomized simple-blinded pilot trial with the principal aim to compare
      efficacy and tolerance between oral ibuprofen and intravenous ibuprofen in early curative
      closure of PDA in very low birth weight infants. The likelihood of ductal closure with only
      one or two doses of treatment is a secondary objective.
    

Detailed description: 
      We calculated that a study group of 62 patients would be necessary for the study to be able
      to detect a difference of at least 25 percentage points in the closure rate between the oral
      ibuprofen and intravenous ibuprofen groups, assuming a closure rate of 65 percent with
      intravenous ibuprofen, with a p value of 0, 05 and a power of 80 percent.Patients
      (gestational age, 25 to 32 weeks) with echocardiographically confirmed patent ductus
      arteriosus and respiratory distress will randomly be assigned to receive one (10 mg / kg),
      two (10 mg / kg followed 24 hours after by 5 mg /kg) or three (10 mg / kg followed at 24-hour
      intervals by two doses of 5 mg /kg each) doses of either intravenous ibuprofen (group I, n =
      32) or oral ibuprofen (group O, n = 32), starting on the third day of life. The rate of
      ductal closure, side effects, complications, and the patients' clinical course will be
      recorded.
    

Intervention name(s): oral ibuprofen; intravenous ibuprofen
Intervention type(s): Drug; Drug
Intervention description(s): one (10 mg / kg), two (10 mg / kg followed 24 hours after by 5 mg /kg) or three (10 mg / kg followed at 24-hour intervals by two doses of 5 mg /kg each) doses of oral ibuprofen starting on the third day of life.the number of doses is depending on echocardiographic findings concerning ductal closure.; one (10 mg / kg), two (10 mg / kg followed 24 hours after by 5 mg /kg) or three (10 mg / kg followed at 24-hour intervals by two doses of 5 mg /kg each) doses of oral ibuprofen starting on the third day of life.the number of doses is depending on echocardiographic findings concerning ductal closure.
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: patent; ductus; arteriosus; ibuprofen; premature; infant
Galvanic Vestibular Stimulation as a Novel Treatment for Seasickness
Condition: Motion Sickness; Seasickness; Habituation; Vestibular Time Constant
MeSH terms: Motion Sickness
Study type: Interventional

Summary: 
      subjects with severe seasickness, who failed to habituate to sea conditions after at least
      six month of active sailing, were enrolled to the single-blind randomized control study. The
      intervention group was treated with rotatory chair stimulation at sinusoidal harmonic
      acceleration protocol coupled with galvanic vestibular stimulation to the mastoid processes.
      This unique procedure was hypothesized to promote habituation to seasickness. The control
      group underwent a sham procedure. All study participants filled out seasickness
      questionnaires at set time points following the intervention and underwent repeated step
      testing to determine their vestibular time constant. The number of anti-motion sickness
      clinic visits and scopolamine prescriptions was also recorded in the three months period
      following the intervention.
    


Intervention name(s): GVS stimulation coupled with inverse phase rotatory chair stimulation at sinusoidal harmonic acceleration protocol; Sham procedure
Intervention type(s): Procedure; Procedure
Intervention description(s): GVS stimulation coupled with inverse phase rotatory chair stimulation at sinusoidal harmonic acceleration protocol; Participants with severe motion sickness were sited in the the rotatory chair with the videonystagmography recorder masking their eyes, while two galvanic vestibular stimulation electrodes were connected to the mastoid processes. No active stimulus was given.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Motion Sickness; Seasickness; Galvanic vestibular stimulation; Rotatory chair; Vestibular time constant
Acute Fetal Response to Prenatal Yoga
Condition: Pregnancy
Study type: Interventional

Summary: 
      Prenatal yoga has become a popular means of exercise during pregnancy.
    

Detailed description: 
      In 2012, yoga was reported to be practiced by approximately 20 million Americans, out of
      which 82% are women practitioners. The effects of yoga on the fetus have not been
      demonstrated. The purpose of this study is to evaluate the acute fetal response to yoga
      exercises by assessing fetal well-being via ultrasound and non-stress testing among healthy
      women. The investigators hypothesize that yoga during pregnancy does not have any acute
      negative effects on fetal behavior as assessed by umbilical artery Dopplers and fetal heart
      rate or maternal vital signs.
    

Intervention name(s): Yoga intervention
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Prenatal Yoga; Yoga, Pregnancy; Yoga, Fetal Response
A Double-Blinded, Randomized Placebo Controlled Pilot Study Comparing the Efficacy and Safety of IncobotulinumtoxinA Versus Saline Injections to the Cheek Region in Patients With Rosacea
Condition: Rosacea
MeSH terms: Rosacea
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a double-blinded, randomized placebo controlled pilot study comparing the efficacy
      and safety of incobotulinumtoxinA versus saline injections to the cheek region in patients
      with rosacea.

      The pilot study will enroll and treat a total of 10 subjects who present with rosacea of the
      cheek area. Upon study entry, subjects will be randomized to receive treatment with
      incobotulinumtoxinA or bacteriostatic saline to the cheek area. Study treatment will be
      prepared by an unblinded designee and both Physician Investigator (PI) and subject will
      remain blinded for the duration of the study. At the 16 week visit, control subjects will
      enter the rescue arm portion of the study and all study subjects will receive treatment with
      incobotulinumtoxinA to the cheek areas.
    


Intervention name(s): IncobotulinumtoxinA; Bacteriostatic saline
Intervention type(s): Drug; Drug
Intervention description(s): Experimental injection given at baseline and Week 16; Placebo at baseline, incobotulinumtoxinA at 16 weeks
Intervention MeSH terms: incobotulinumtoxinA
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rosacea
Randomized Trial to Reduce Environmental Tobacco Smoke in Children With Asthma
Condition: Asthma; Lung Diseases
MeSH terms: Asthma; Lung Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to test the effects of reducing indoor environmental tobacco
      smoke (ETS) on unscheduled asthma visits, asthma symptoms, airway inflammation, and exposure
      to tobacco smoke measured using air nicotine dosimeters, serum and hair cotinine.
    

Detailed description: 
      BACKGROUND:

      Asthma, a disease characterized by increased airway reactivity and inflammation in response
      to a variety of stimuli, is emerging as the most prevalent and serious environmental health
      problem among children in the United States. Numerous studies, both prospective and
      cross-sectional, suggest that exposure to ETS is one of the predominate risk factors for
      childhood asthma, but this has not been confirmed in a controlled trial.

      DESIGN NARRATIVE:

      The randomized, double-blind prospective trial involving 225 children with doctor-diagnosed
      asthma who are exposed to environmental tobacco smoke tests the efficacy of reducing such
      exposure on unscheduled asthma visits and asthma symptoms. The intervention consists of
      placement of 2 high efficiency air filtration with activated carbon, potassium permanganate
      and zeolite filter insert to reduce exposure to ETS in the experimental homes and inactive
      (placebo) units in the control group homes. The following hypotheses are tested. (1.0)
      Children assigned to the ETS reduction group will have a greater than 20 percent reduction in
      unscheduled asthma visits during one-year follow-up compared with those in the control group.
      (1.1) Children assigned to the ETS reduction group will have significant improvements in
      asthma symptoms compared with children in the control group. (1.2) Children assigned to the
      ETS reduction group will have greater than 10 percent reduction in ETS exposure and exhaled
      nitric oxide, a measure of airway inflammation during one year of follow-up compared with the
      control group.
    

Intervention name(s): HEPA Air Cleaner; Placebo Filtration Unit
Intervention type(s): Device; Device
Intervention description(s): Placement of two active HEPA air cleaners in the homes of children; Placement of inactive filtration unit in the homes
Other intervention name(s): Austin Healthmate HEPA air cleaner
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: asthma; HEPA; ETS
Investigation of the Influence of Careless™, a Mangifera Indica Fruit Powder, on Microcirculation and Endothelial Function
Condition: Microcirculation; Metabolism; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      Investigation of the acute effects of a single dose of Careless™, a Mangifera indica fruit
      powder on cutaneous microcirculation and endothelial function.
    


Intervention name(s): Mango fruit powder
Intervention type(s): Dietary Supplement
Intervention description(s): Dietary supplement; Mango fruit powder
Other intervention name(s): Careless
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Microcirculation; Endothelial function; Metabolism; Cardiovascular Disease; human study; healthy subjects; Mangifera indica; Careless
Airway Inflammation in Swimmers
Condition: Asthma
MeSH terms: Inflammation
Study type: Observational

Summary: 
      Studies have shown that the prevalence of respiratory symptoms, airway hyperresponsiveness
      (AHR) and asthma is high and increasing in elite athletes. The inflammation seen in the
      airways of elite athletes might differ from the inflammation seen in the airways of
      "ordinary" asthmatics and it might represent a different kind of asthma.

      The primary purposes are

        1. To investigate the type of airway inflammation in young swimmers.

        2. To investigate the acute changes in airway inflammation after a short training session.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Elite swimmers
      
Biospecimen description: 
      Blood samples EBC Sputum
    
Keywords: Asthma; Airway inflammation; Sport
Effects of Indomethacin on Retinal and Choroidal Blood Flow in Healthy Volunteers
Condition: Ocular Physiology; Regional Blood Flow
Study type: Interventional

Summary: 
      Prostaglandins (PG) are known to alter regional ocular blood flow and exhibit vasoactive
      properties in isolated ocular blood vessels. A variety of animal experiments indicate that
      endogenous PGs play a role in the regulation of retinal (RBF) and choroidal (ChBF) blood
      flow. There is also evidence that the prostaglandin pathway is involved in the activation of
      NO production in humans, however, the mechanisms for interactions between PG and NO in ocular
      vasculature are still unclear.

      Animal studies suggest that retinal and choroidal blood flow decrease after administration of
      indomethacin (a nonspecific cyclooxygenase inhibitor). More recently, it has been shown that
      indomethacin injected intravenously decreased optic nerve oxygen tension and reduced the CO2
      reactivity. This is probably the result of decreased blood flow through vasoconstriction of
      vessels in the optic nerve. Systemic administration of indomethacin also diminishes cerebral,
      renal and mesenteric blood flow by an unknown mechanism. However, no clinical trials exist so
      far investigating the effects of indomethacin on ocular blood flow. Therefore, the aim of
      this study is to investigate the effect of indomethacin on ocular blood flow in healthy
      humans.
    


Intervention name(s): indometacine (drug) effect on ocular blood flow
Intervention type(s): Drug
Intervention MeSH terms: Indomethacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Keywords: indometacine; retinal blood flow; choroidal blood flow