bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate Tezepelumab in Adults With Chronic Spontaneous Urticaria
Condition: Chronic Spontaneous Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the effect of tezepelumab on improvement
      in the Urticaria Activity Score over 7 days (UAS7).
    


Intervention name(s): Tezepelumab Dose 1; Tezepelumab Dose 2; Omalizumab; Placebo
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Subcutaneous injection.; Subcutaneous injection.; Subcutaneous injection.; Subcutaneous injection.
Other intervention name(s): AMG 157; AMG 157; Xolair
Intervention MeSH terms: Omalizumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: CSU
Nitrate Supplementation During Final Examination Stress
Condition: Airway Disease
Study type: Interventional

Summary: 
      The purpose of the present study is to explore the effects of a dietary nitrate supplement on
      immunity, mood, cardiovascular activity, and lung function during and following final exam
      stress in both healthy and asthmatic individuals.
    

Detailed description: 
      Past research has demonstrated significant changes in immune response and airway inflammation
      during times of stress. Specifically, significant decreases in the fraction of exhaled nitric
      oxide (FeNO) in both healthy and asthmatic undergraduate students have been found during
      times of final exam stress. Additionally, research suggests that dietary supplementation of
      nitric oxide may have beneficial cardiovascular effects which may offset the physiological
      consequences of stress.

      This research study explores the effects of a dietary supplement on immunity, mood,
      cardiovascular and respiratory function during and following final exam stress. In this
      study, investigators monitor changes in respiratory infection incidence, airway nitric oxide,
      mood, blood pressure, and lung function in students with and without asthma during the time
      of final exams and a comparable time of low stress during the term. There are three
      assessments in the laboratory, as well as two additional brief questionnaires on separate
      days. During the final exam period, half of the participants are randomly assigned to the
      experimental group which is provided with a dietary supplement (beetroot juice drink) of
      which they are asked to take one dose every day in the morning for seven days. The three
      assessments periods include two during the week of final exams and one during a period of low
      stress scheduled up to two weeks to two months before that time. For the final exam period,
      the first of the two sessions takes place on the day before the second of these exams, and
      the second assessment takes place on a subsequent day after second exam. A follow-up
      assessment of cold symptoms takes place online 7 days after the final exam period.
    

Intervention name(s): Beetroot Juice Group
Intervention type(s): Dietary Supplement
Intervention description(s): Beetroot juice drink- 7 daily doses (70 ml, containing 0.4-0.5 mg nitrate) taken over a week
Other intervention name(s): Beet-It Sport Beet Juice Shot
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Dietary nitrate supplementation; Cold symptoms; Stress; Immunity; Exhaled nitric oxide; Lung function; Cardiovascular activity
Study to Explore the Pharmacokinetics and Pharmacodynamics of Epinephrine in Healthy Male and Female Subjects With Different Skin to Muscle Depth (STMD)
Condition: Anaphylaxis
MeSH terms: Anaphylaxis
Study type: Interventional
Phase: Phase 1

Summary: 
      A single dose, open label, randomized cross-over study to explore the pharmacokinetics and
      pharmacodynamics of epinephrine in healthy male and female subjects
    

Detailed description: 
      A single dose, open label, randomized cross-over study to explore the pharmacokinetics and
      pharmacodynamics of epinephrine in healthy male and female subjects with different
      skin-to-muscle depth (STMD) of the thigh after injections with four different marketed
      auto-injectors
    

Intervention name(s): Part 1; Part 2 Group 1; Part 2 group 2; Part 2 group 3; Part 2 Group 4
Intervention type(s): Device; Device; Drug; Device; Device
Intervention description(s): A single dose of 500 μg epinephrine (0.5 mL Suprarenin®) will be administered i.m. and s.c. by using a needle and a syringe in randomized order; 300 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length); 500 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length); 300 μg epinephrine auto-injector (Fastjekt, MEDA Pharma, 16 mm needle length); 300 μg epinephrine auto-injector (Jext, Alk-Abelló, 15 mm needle length)
Other intervention name(s): Group 1; Group 1; Group 2; Group 3; Group 4
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Pharmacokinetics and pharmacodynamics of epinephrine in healthy male and female subjects with different skin-to-muscle depth (STMD) of the thigh after injections with four different marketed auto-injectors
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Dietary Ingredients on Vascular Function
Condition: Vascular Diseases; Impaired Glucose Tolerance
MeSH terms: Vascular Diseases; Glucose Intolerance
Study type: Interventional

Summary: 
      The main aim of the study is to investigate the effects of dietary ingredients (polyphenols
      and carotenoids) on vascular function during acute glucose load. Each subject will receive 4
      weeks of intervention with test product or placebo product after a dietary restriction run-in
      period of 14 days. Subjects will be challenged with an oral glucose tolerance test (OGTT)
      immediately after the run-in phase and at the end of the intervention phase. During the OGTT,
      blood samples will be taken at regular intervals.

      The study will be conducted in subjects with impaired glucose tolerance.
    


Intervention name(s): A capsule containing both polyphenols and carotenoids; Placebo intervention
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Placebo intervention
Intervention MeSH terms: Carotenoids
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Vascular function; Dietary ingredients; Acute glucose load; Oxidative stress
Carisbamate as a Potential Treatment for Alcohol Dependence
Condition: Alcohol Dependence; Alcohol Abuse; Substance Abuse
MeSH terms: Substance-Related Disorders; Alcoholism
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine the effects of treatment with carisbamate compared
      to treatment with placebo, on alcohol-induced stimulant and subjective effects in
      non-treatment seeking alcohol-dependent human volunteers.
    

Detailed description: 
      This within-subjects placebo-controlled experimental protocol will assess the effects of
      carisbamate (600mg qd) on the positive subjective effects of alcohol in non-treatment-seeking
      alcohol-dependent volunteers. Participants will receive study drug (carisbamate or placebo)
      from days 2- 4. On day 4, study drug will be followed by alcohol (0.8g/kg; 16% by volume) and
      a placebo beverage (1% by volume as a mask), both separated by 2 hours. Physiologic,
      subjective effects and BAL will be obtained after the alcohol challenges. Participants will
      be discharged on day 4 and asked to return a week later to repeat the study under the
      alternate study drug condition (active carisbamate vs. placebo).
    

Intervention name(s): Carisbamate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 600mg Orally on days 2-4; Placebo treatment only
Other intervention name(s): YKP 509; Sugar Pill
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
The Effect of Regular Naltrexone Dosing on Disordered Gamblers
Condition: Gambling
MeSH terms: Gambling
Study type: Interventional
Phase: Phase 1

Summary: 
      This study examines the effect of regular naltrexone dosing on disordered gamblers. Gamblers
      will also be scanned pre- and post-treatment where we will investigate the functional changes
      to tasks designed to engage brain region associated with gambling and addiction. These
      changes will be correlated with treatment outcomes and urge scores.
    

Detailed description: 
      This study will investigate the effects of regular dosing of naltrexone for the treatment of
      disordered gambling. It will also examine the changes of neurological functioning to tasks
      associated with addiction. Converging evidence suggests that disordered gambling shares
      similarities with substance dependence and disordered alcohol use. Naltrexone is a medication
      that is used to reduce the cravings and euphoria from opioids and alcohol use and some
      studies have shown that it also has efficacy as a treatment for problematic gambling. Pilot
      data suggest the prefrontal cortex is activated for a healthy subject during a
      delay-discounting task, possibly indicating some consideration of the delayed value of a
      hypothetical money amount. If discounting rates can be correlated with treatment outcomes and
      neurological activation, these tasks may provide a new predictive tool for treatment outcome.
      However, no previous study has examined the neurological changes from pharmacological
      treatments of gambling. This study will provide data on the differences between pre- and
      post-treatment of regular naltrexone dosing for disordered gamblers
    

Intervention name(s): Naltrexone
Intervention type(s): Drug
Intervention description(s): Regular opioid antagonist dosing of disordered gamblers
Other intervention name(s): Revia
Intervention MeSH terms: Naltrexone
Intervention model: Single Group Assignment
Intervention model description: Pre-post design, single treatment group
Masking: None (Open Label)
Primary purpose: Treatment
Stress Response in Emergency Among Physicians in Helicopter and Ambulance Based Emergency Medical Systems
Condition: Hormone Disturbance; Stress Reaction; Stress Related Disorder
MeSH terms: Endocrine System Diseases; Fractures, Stress
Study type: Observational

Summary: 
      Stress reactions in emergency physicians will be measures using cortol-awakening-reaction,
      heart-rate-variability and standardised stress questionnaires
    

Detailed description: 
      In a field study with within-subject design, there will be conducted the hormonal and
      physiological stress strain of emergency physicians working in rescue helicopters or van on
      different days of service on different headquarters. The investigation of the parameter of
      stress will be conducted on two days of rescue service, on two days of clinical service and
      as a control on two days off. The quantification of the hormonal stress strain will be
      carried out with the cortisol awakening response, there will be conducted 3 saliva samples
      with identical interval after getting up within 30 minutes. While the labour time on the
      rescue service and on the clinical service and the whole day off, the heart rate variability
      will show the degree of physiological stress. This will be measured with a pulse-belt on the
      chest, which the participant will carry the whole day. In addition, participants will fill
      out a set of questionnaire on the first day of measurement.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Medical Doctor working in rescue helicopter or van
      
Biospecimen description: 
      Cortisol
A Phase II Clinical Trial for Inactivated Vaccine (Vero Cell) Against EV71 in Chinese Children and Infants
Condition: Immunogenicity; Safety
Study type: Interventional
Phase: Phase 2

Summary: 
      Hand, foot, and mouth disease (HFMD) is a common viral illness in infants and children caused
      by viruses that belong to the enterovirus genus of the picornavirus family. Although most
      HFMD cases do not result in serious complications, outbreaks of HFMD caused by enterovirus 71
      (EV71) can present with a high rate of neurological complications, including
      meningoencephalitis, pulmonary complications, and can even cause infant death. HFMD caused by
      EV71 has become a major emerging infectious disease in Asia and the highly pathogenic
      potential of EV71 clearly requires the attention of world medical community.

      The phase I study of inactivated vaccine (vero cell) against EV71 has completed last month in
      Jiangsu Province in China. The data from the phase I study suggested that the inactivated
      EV71 vaccine had a clinically acceptable safety and good immunogenicity for healthy Chinese
      children and infants. In order to provide more evidence for the immunogenicity of the
      vaccine, to further explore the probable immunizing dose and the safety profile of this
      vaccine, a phase II clinical trial is planed to conduct.
    


Intervention name(s): 160U /0.5ml EV71 Vaccine; 320U /0.5ml EV71 vaccine; 640U /0.5ml EV71 vaccine; (without adjuvant) 640U /0.5ml; 0/0.5ml placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): inactivated vaccine (vero cell) against EV71 of 160U /0.5ml, two doses, 28 days interval; inactivated vaccine(vero cell) against EV71 of 320U /0.5ml, two doses, 28 days interval; inactivated vaccine (vero cell) against EV71 of 640U /0.5ml, two doses, 28 days interval; inactivated vaccine (vero cell) against EV71 of (without adjuvant) 640U /0.5ml, two doses, 28 days interval; 0/0.5ml placebo, two doses, 28 days interval
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: immunogenicity; safety; inactivated EV71 vaccine
The Study on the Relationship Among Meridian, Acupoint and Internal Visceral Organs
Condition: Meridian
Study type: Interventional

Summary: 
      The study on the relationship among meridian, acupoint and internal
    

Detailed description: 
      Meridian system is the pathway of transporting qi and blood, and that distributes all the
      body. Meridian system connects to internal visceral organs interior, and also connects to
      joints (or acupoint) exterior. The relationship among meridian, acupoints and internal
      visceral organs is still unclear. Therefore, the purpose of the present study was to
      investigate the relationship among meridian, acupoints and internal visceral organs. Total 33
      subjects randomly finished three sessional studies as follows: 1) sham electroacupuncture
      (EA) session: the stainless steels acupuncture needles inserted into the subcutaneous layer
      of Zusanli (cathode) and Shangjuxu acupints (anion) , and the needles connected to EA
      stimulator, but no electric discharge for 30 min; 2) Zusanli session: the acupuncture needles
      inserted into Zusanli (cathode) and Shangjuxu acupoints (anion), and twisting obtain qi, and
      the needles then connected to EA stimulator, the frequency was 2 Hz, the duration was 30 min,
      and the intensity was visual slightly muscle contraction; 3) Shaohai session: the methods
      were identical Zusanli group, but Shaohai acupoint (cathode), and 3 cm below Shaohai (anion)
      . The major outcome measure was the changes of the percentage of gastric slow wave and
      dysrhythmia in 30 min electrogastrogram recordings, and the changes of cardiac output and
      stroke volume in 30 min recordings. Secondary outcome measure was the changes of saliva,
      blood and urine metabolites.

      The investigators predict the results of the present study can test and verify meridian
      theory of traditional Chinese Medicine, meridian system connects internal visceral organ
      interior, and connects joint (or acupoint) exterior.
    

Intervention name(s): sham electroacupuncture (EA) session; Zusanli session; Shaohai session
Intervention type(s): Other; Other; Other
Intervention description(s): The stainless steels acupuncture needles inserted into the subcutaneous layer of Zusanli (cathode) and Shangjuxu acupints (anion) , and the needles connected to EA stimulator, but no electric discharge for 30 min.; The acupuncture needles inserted into Zusanli (cathode) and Shangjuxu acupoints (anion), and twisting obtain qi, and the needles then connected to EA stimulator, the frequency was 2 Hz, the duration was 30 min, and the intensity was visual slightly muscle contraction.; The methods were identical Zusanli group, but Shaohai acupoint (cathode), and 3 cm below Shaohai (anion).
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Meridian; Internal visceral organs; Zusanli; Shaohai; Acupoint
Bioequivalence Study Coadministered to Healthy Subjects in the Fasted State
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate bioequivalence of coadministered drugs on healthy
      subjects.
    


Intervention name(s): Saxagliptin; Dapagliflozin
Intervention type(s): Drug; Drug
Other intervention name(s): Onglyza; Farxiga in the United States; Forxiga in other countries
Intervention MeSH terms: Dapagliflozin; Saxagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Study Evaluating the Safety and Tolerability of a New Intravenous Formulation of MOA-728 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to determine the safety and tolerability of the new IV formulation
      versus the current formulation of MOA-728 focusing on the theoretical potential for
      infusion-related and formulation-related complications.
    


Intervention name(s): MOA-728
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: healthy; safety
A Study to Evaluate the Pharmacokinetics of Intranasal Esketamine Administered With and Without a Nasal Guide on the Intranasal Device
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of the study is to evaluate the pharmacokinetics (what the body does to
      the medication) of intranasally (through the nose) administered esketamine using a device
      with and without a nasal guide in healthy participants.
    

Detailed description: 
      This is a randomized (the study medication is assigned by chance), single-center,
      single-dose, 2-way crossover (participants may receive different interventions sequentially
      during the study in 2 sequence groups), open-label (all people know the identity of the
      intervention) study. Approximately, 14 participants will be enrolled in this study. This
      study will consist of a screening phase of up to 21 days, a treatment phase of 3 days, and a
      follow-up phase of 9-13 days. Participants will be randomly allocated to 1 of the 2 treatment
      groups (Sequence 1 and 2). In sequence 1, participants will self-administer esketamine
      intranasally using a device with nasal guide as treatment A on Day 1 of period 1 and
      intranasally esketamine using a device without nasal guide as treatment B on Day 1 of period
      2. In sequence 2, participants will self-administer intranasally esketamine as treatment B on
      Day 1 of period 1 and intranasally esketamine as treatment A on Day 1 of period 2. There will
      be a washout period of 5 to 10 days between each treatment regimen. Safety evaluations will
      include assessment of adverse events, clinical laboratory tests, electrocardiogram, vital
      signs, physical examination, pulse oximetry, targeted nasal examination, nasal device
      questionnaire, and in addition to these evaluations, specific scales will be used to assess
      the safety. The study duration for each participant will be approximately 45 days.
    

Intervention name(s): Esketamine
Intervention type(s): Drug
Intervention description(s): Participants will self administer 1 spray of esketamine solution using a intranasal device with a nasal guide in Treatment A regimen and without nasal guide inTreatment B regimen at time 0 and repeated twice every 5 minutes (total dose: 84 mg).
Intervention MeSH terms: Esketamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Esketamine; Intranasal; Nasal Guide; Pharmacokinetics
Efficacy and Safety Study of Two Propofol Formulations
Condition: General Anaesthesia; Induction of Anaesthesia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study to compare Propofol-MCT/LCT with LCT in terms of their efficacy and
      safety during total intravenous anaesthesia
    

Detailed description: 
      Propofol (chemical substance 2, 6-Diisopropylphenol) is a short-acting intravenous general
      anaesthetic which is used for induction and maintenance of a general anaesthesia, for
      long-term sedation of ventilated intensive care patients or for short-term sedation in
      diagnostic and surgical procedures. As an active substance propofol produces good and readily
      controlled anaesthesia with smooth and problem-free recovery both in adult patients and in
      children over 1 month of age. One potential advantage of this formulation is that the
      MCT/LCT-emulsion reduces pain on injection, a frequently reported adverse reaction with
      LCT-emulsions of propofol.
    

Intervention name(s): Propofol
Intervention type(s): Drug
Intervention description(s): intravenous (total intravenous anaesthesia)
induction and maintenance
Other intervention name(s): Propofol Lipuro 1%; Diprivan 1%
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: anaesthesia