bioihbjkbjnl/mcl2 huggingface dataset:
Phase 3 Study to Evaluate the Acid-Inhibitory Effect of Multiple Oral Doses of Vonoprazan (TAK-438)
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the acid-inhibitory effect of multiple oral doses
      of Vonoprazan (TAK-438) and the relative effect of vonoprazan versus two controls
      (esomeprazole and rabeprazole sodium) in healthy Japanese adult male participants with the
      CYP2C19 extensive metabolizer (EM) genotype.
    

Detailed description: 
      This is a Phase 3 open-label crossover study to evaluate the acid-inhibitory effect following
      7 days multiple doses of vonoprazan (20 mg per dose) and esomeprazole (20 mg per dose)
      (Cohort 1) or vonoprazan (20 mg per dose) and rabeprazole sodium (10 mg per dose) (Cohort 2)
      in healthy Japanese adult male participants (CYP2C19 genotype: EM). There will be a total of
      20 participants, 5 per group for both Cohorts 1 and 2. At least 2 participants each with the
      homo EM (*1/*1) or hetero EM (*1/*2, *1/*3) CYP2C19 genotype will be enrolled among the 5
      participants per group.

      The drug being tested in this study is called vonoprazan. This study will look at the acid
      inhibitory effect following 7 days multiple doses of vonoprazan and esomeprazole (Cohort 1)
      or vonoprazan and rabeprazole sodium (Cohort 2) in healthy Japanese adult male participants
      with the CYP2C19 EM genotype.

      The study will enroll a total of 20 participants, 5 per group for both Cohorts. At least 2
      participants each with the homo EM (*1/*1) or hetero EM (*1/*2, *1/*3) CYP2C19 genotype will
      be enrolled among the 5 participants per group.

        -  Group A, Cohort 1: vonoprazan (20 mg per dose for 7 days) followed by esomeprazole (20
           mg per dose for 7 days)

        -  Group B, Cohort 1: esomeprazole (20 mg per dose for 7 days) followed by TAK-438 (20 mg
           per dose for 7 days)

        -  Group C, Cohort 2: vonoprazan (20 mg per dose for 7 days) followed by rabeprazole sodium
           (10 mg per dose for 7 days)

        -  Group D, Cohort 2: rabeprazole sodium (10 mg per dose for 7 days) followed by vonoprazan
           (20 mg per dose for 7 days).

      All participants will be asked to take Study Medication at the same time each day throughout
      the study. This single center trial will be conducted in Japan. The overall time to
      participate in this study is 31 days.
    

Intervention name(s): Vonoprazan; Esomeprazole; Rabeprazole sodium
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Vonoprazan tablets; Esomeprazole capsules; Rabeprazole sodium tablets
Other intervention name(s): TAK-438; Takecab®; Nexium (esomeprazole); Pariet (rabeprazole)
Intervention MeSH terms: Esomeprazole; Rabeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Lycopene in Healthy Male Participants
Condition: Healthy, no Evidence of Disease; Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized phase I trial is studying the side effects and best dose of lycopene in
      healthy male participants. Chemoprevention is the use of certain drugs to keep cancer from
      forming. The use of lycopene, a substance found in tomatoes, may prevent prostate cancer.
    

Detailed description: 
      OBJECTIVES:

      I. Compare the toxicity and safety of 2 different doses of oral lycopene in healthy male
      participants.

      II. Compare the pharmacokinetics of 2 different doses of this drug in these participants.

      III. Determine the toxicity and pharmacokinetics needed to proceed to a large phase II/III
      study in men at high risk for prostate cancer.

      OUTLINE: This is a randomized, crossover study. Participants are randomized to 1 of 2
      treatment arms.

      Arm I: Participants receive high-dose oral lycopene once or twice a day for 14 days. After 2
      weeks of a lycopene-free period, participants crossover and receive high-dose lycopene at the
      alternative daily schedule (once or twice a day) for 14 days.

      Arm II: Participants receive low-dose oral lycopene once or twice a day for 14 days. After 2
      weeks of a lycopene-free period, participants crossover and receive low-dose lycopene at the
      alternative daily schedule (once or twice a day) for 14 days.

      Treatment continues in the absence of unacceptable toxicity. Participants adhere to dietary
      restrictions for 2 weeks at baseline, 2 weeks during study treatment, and 2 weeks during
      pharmacokinetic sampling.

      Blood samples are collected periodically at baseline and during study treatment for
      pharmacokinetic studies.

      PROJECTED ACCRUAL: A total of 20 participants will be accrued for this study.
    

Intervention name(s): lycopene; pharmacological study
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Given orally; Correlative studies
Other intervention name(s): all-trans-Lycopene; Lyc-O-Mato; LYCO; psi,psi-Carotene; pharmacological studies
Intervention MeSH terms: Lycopene
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Safety of Haemophilus Influenza Type b Vaccine When Administered to Korean Children
Condition: Haemophilus Influenzae Type B Infection
MeSH terms: Influenza, Human; Haemophilus Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multicenter, post marketing surveillance study which aims to evaluate the safety
      profile of haemophilus influenza type b vaccine when administered to Korean children
      according to the product insert.
    


Intervention name(s): Haemophilus influenza type b conjugate vaccine
Intervention type(s): Biological
Intervention description(s): Primary series is 3 doses given to infants beginning at 2 months of age with an interval of 2 months apart (i.e. 2, 4 and 6 months of age). Booster vaccination consists of 1 dose and is given to toddlers 16 to 20 months of age. In this study, subjects will receive vaccination from routine primary care.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Haemophilus influenza type b; children; Korea; vaccine; Prevention of haemophilus influenza type b
First-Time-in-Human (FTIH) Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of VH4004280 in Healthy Participants
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This FTIH study aims to evaluate the safety, tolerability and PK of the novel investigational
      Human immunodeficiency virus (HIV)-1 capsid inhibitor VH4004280 in healthy adults. The study
      will be conducted in 3 parts: Part 1 will investigate single ascending doses (SAD), Part 2
      will investigate multiple ascending doses and drug-drug interaction (MAD/MAD DDI) Part 3 will
      investigate single dose relative bioavailability (RBA) of a new formulation of VH4004280.
    


Intervention name(s): VH4004280; Placebo; Midazolam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): VH4004280 will be administered.; Placebo will be administered.; Midazolam will be administered
Other intervention name(s): GSK4004280
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: First-time-in-human; GSK4004280; VH4004280; HIV-1 capsid inhibitor; Single ascending doses; Multiple ascending doses
Clinical Value of Heart Rate Variability Indexes to Predict Outcomes After Exercise Training in Chronic Heart Failure
Condition: Heart Failure; Systolic Heart Failure
MeSH terms: Heart Failure; Heart Failure, Systolic; Systolic Murmurs
Study type: Interventional
Phase: Phase 4

Summary: 
      Controlled exercise training is a valuable therapeutic addition to pharmacological treatment
      in most patients with chronic heart failure, reducing long-term mortality, preventing cardiac
      remodeling and improving functional capacity. Despite the mechanism underlying its benefits
      might be multifactorial, a sustained improvement in autonomic balance is usually attributed
      as a major effect. Nevertheless, not all eligible subjects show the same response to
      exercise, probably due to several differences in the subpopulations enrolled. The
      investigators hypothesize that some Heart Rate Variability indexes could be valid tools to
      optimize the selection and follow-up of chronic heart failure patients to training
    

Detailed description: 
      Forty subjects followed in a University Heart Failure Management Program were prospectively
      included. All patients were evaluated before the randomization and after 24 weeks from
      enrollment. The investigators performed a detailed anamnesis and complete physical
      examination, Doppler echocardiography, Stress Testing, 6-minute walk test, heart rate
      variability analysis, and quality of life test. Patients were randomized either to a training
      group: performing a supervised training program, or a control group receiving usual care. All
      patients received an optimal pharmacologic treatment including diuretics, angiotensin
      converting enzyme inhibitors or angiotensin receptor blockers and beta-adrenergic blocking
      agents. All patients included in the training group attended a supervised program 3-days/week
      during 24 weeks (68-74 sessions). Physical aerobic training appears to impart beneficial
      changes in autonomic control of patients with chronic heart failure through both
      parasympathetic and sympathetic control of hear rate. These effects produce changes in
      several Heart Rate Variability indices as HF and rMSSD related with parasympathetic tone.
    

Intervention name(s): Cardiac Rehabilitation
Intervention type(s): Behavioral
Intervention description(s): All patients included in this group attended a supervised exercise training program. A cardiologist supervised the hole training sessions. Blood pressure, pulse rate, oxygen saturation, and body weight were measured in each session. The modified Borg scale was used to measure the perceived exercise intensity
Other intervention name(s): Exercise training; Educational approach
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Heart rate variability; Systolic heart failure; Physical exercise; Parasympathetic indexes
Piloting a Novel Intuitive Eating Intervention for College Women With Disordered Eating
Condition: Disordered Eating Behaviors
Study type: Interventional

Summary: 
      The purpose of this research study is to pilot test a new intervention that helps young adult
      women learn adaptive eating and exercise strategies, increase their body acceptance, decrease
      unhealthy weight control behaviors and prevent future eating and problems. This intervention
      is experimental, and the study will test its feasibility, acceptability, and effectiveness.
    

Detailed description: 
      The intervention, Intuitive Eating, is an eating approach that addresses important risk
      factors and promotes adaptive eating attitudes and behaviors. It has three central tenets: 1)
      unconditional permission to eat when hungry, 2) eating for physical rather than emotional
      reasons, and 3) eating according to hunger and satiety cues. Intuitive Eating has ten
      principles that focus on rejecting the dieting mentality, honoring hunger cues, decreasing
      restrictive behaviors that lead to deprivation and bingeing, challenging rigid food rules,
      increasing awareness of satiety, discovering the satisfaction of food, coping with emotions
      without food, respecting and accepting one's body, using exercise as self-care, and balancing
      nutrition with satisfaction.
    

Intervention name(s): Group Intervention; Guided Self-Help
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants in the group intervention will attend eight weekly, 90-minute sessions involving group activities and discussions. They will complete homework between sessions to reinforce learning. The intervention focuses on cultivating attunement to bodily sensations and fostering self-compassion to improve physical and mental health.; Participants in the GSH condition will follow the intuitive eating content through self-guided study, with eight weekly scheduled phone calls with an interventionist (~20 minutes each). Interventionists will review homework assignments, answer questions, and reinforce adherence. The intervention materials are the same as the group and also focus on cultivating attunement to bodily sensations and fostering self-compassion to improve physical and mental health.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized to either a group or guided self-help condition, of the same intervention, intuitive eating, of the same duration (8 weeks).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: disordered eating, body image, intuitive eating, undergraduates, college, unhealthy weight control behaviors, eating disorders, weight stigma, weight bias
Factors That Influence Blood Vessel Regulation During Exercise in Humans
Condition: Ischemic Preconditioning; Dietary Exposure
Study type: Interventional

Summary: 
      This study will examine two separate interventions: 1) the effects of ischemic
      preconditioning or 2) a high fat meal on the capacity of the brachial artery to overcome
      sympathetic activation and dilate during exercise (also known as functional sympatholysis).
      Participants will be asked to complete rhythmic handgrip exercise with and without the
      application of -20 mmHg lower body negative pressure to increase sympathetic activation.
      Doppler ultrasound will be used to continuously measure brachial artery blood flow.
      Participants will complete the handgrip exercise and lower body negative pressure before and
      after the applications of each interventions. Participants may elect to only complete one
      intervention rather than complete both protocols. Intervention one is active or control
      ischemic preconditioning. Intervention two is high or low fat meals.
    


Intervention name(s): Ischemic preconditioning; Ischemic preconditioning control; Low fat meal; High fat meal
Intervention type(s): Procedure; Procedure; Dietary Supplement; Dietary Supplement
Intervention description(s): Four 5-minute cycles of 200 mmHg cuff inflation of the brachial artery, each separated by 5-minutes deflated recovery (i.e. 40 minutes total time); Four 5-minute cycles of 20 mmHg cuff inflation of the brachial artery, each separated by 5-minutes deflated recovery (i.e. 40 minutes total time); Meal containing 1006 calories, 1 g fat, 0.2 g saturated fat, 0 g trans fat, 20 mg cholesterol, 191 g carbohydrates, 60 g protein, 1560 mg sodium; Meal containing 1030 calories, 62 g fat, 23 g saturated fat, 0.5 g trans fat, 445 mg cholesterol, 76 g carbohydrates, 41 g protein, 2080 mg sodium.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP4345 in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of multiple ascending
      oral doses of ASP4345 in patients with schizophrenia. In addition, this study will evaluate
      the pharmacokinetics of multiple ascending oral doses of ASP4345 in patients with
      schizophrenia.
    


Intervention name(s): ASP4345; Matching Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Schizophrenia; ASP4345
Evaluate the Efficacy and Safety of Acute Bronchitis Symptoms Improvement for Bronpass Tab. Compared to Erdos Capsule
Condition: Acute Bronchitis
MeSH terms: Bronchitis; Acute Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this clinical trial is to evaluate the acute bronchitis symptom relief effect
      of Bronpass tab. compared to Erdos capsule, and compare and evaluate the safety.
    

Detailed description: 
      The purpose of this clinical trial is to evaluate the following in patients with acute
      bronchitis at the 7th day of administration of the investigational drug.

      primary purpose: Prove the non-inferiority of the acute bronchitis symptom relief effect of
      Bronpass tab. compared to Erdos capsule, and compare and evaluate the safety.

      secondary purpose: Compare and evaluate the effect of improving clinical symptoms, including
      sputum symptoms, of Bronpass tab. compared to Erdos capsule.
    

Intervention name(s): Bronpass Tab.; Placebo of Erdos capsule; Erdos capsule; Placebo of Bronpass Tab.
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Twice a day; Three times a day (It is for the masking.); Three times a day; Twice a day (It is for the masking.)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bioavailability of Carotenoids From Orange Juice in a Cross-over Study in Healthy Subjects.
Condition: Biological Availability; Carotenoids; Lutein; Humans
Study type: Interventional

Summary: 
      Commercially available fruit juices are obtained after applying industrial technologies to
      preserve and extend the shelf-life by inactivation of microorganism and enzymes. These are
      traditional thermal treatment (eg. pasteurization, sterilization) that causes losses of
      nutritional and bioactive compounds, changes physicochemical properties (colour, flavor and
      texture) and can modify their bioavailabilities. Thus, the traditional thermal processing is
      being replaced by less intense thermal technologies (e.g. low-temperature pasteurization /
      refrigerated storage) and non-thermal treatments such as the high-pressure processing (HPP)
      and the pulsed electric fields (PEF) as an alternative to enhace food safety and shelf-life
      without compromising organoleptic qualities (retain the flavour, color healthiness of fresh
      foods) and keeping their health-promoting capacity. The beneficial health effect derived from
      the orange juice intake is partly related to the bioavailability of their bioactive
      compounds.

      The aim of this study was to assess the effect of the intake of freshly squeezed orange juice
      (Citrus sinensis L.) and processed orange juice elaborated with different treatments (low
      pasteurization / refrigerated storage, high-pressure processing, pulsed electric fields) on
      the main serum carotenoid concentrations in a cross-over study in apparently healthy subjects
      using multiple dosis.
    

Detailed description: 
      Methods Twelve healthy subjects (6 men), age 20-32 y, were enrolled in a cross-over study, to
      consume 500 mL of orange juice/day during 14 days periods. All volunteers consumed the LP and
      HPP, six consumed PEF or FS-orange juice. Fasted blood was collected at baseline and on days
      7 and 14. Carotenoid concentrations in serum and orange juice were analyzed by high
      performance liquid chromatogry (HPLC).
    

Intervention name(s): Orange juice
Intervention type(s): Other
Intervention description(s): Subjects were enrolled to consume 500 mL of orange juice/day during three consecutive 14 days periods separated by 1 - 1.5 month washouts. The orange juices assayed were: freshly squeezed (FS), commercially available low pasteurized juice (LP) and juices treated by high-pressure processing (HPP) and by pulsed electric fields (PEF). All participants consumed the LP and the HPP orange juices. Six subjects consumed PEF-orange juice and other six consumed the FS-orange juice.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: Multiple dose cross-over study.
Masking: None (Open Label)
Primary purpose: Basic Science
Effects of H1-Antagonist on Cognition
Condition: Cognition
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether histamine is involved in memory and
      specific processes in human cognition.
    

Detailed description: 
      The neurotransmitter histamine appears to be involved in human cognitive performance.
      However, the exact role is very unclear. The role it plays in memory performance is highly
      disputed, as animal studies show decreased performance when the H1-receptor is blocked in the
      central nervous system while such findings in humans is scarce. To clarify the role of
      histamine in human memory and different processes in cognition, the effects of an
      H1-antagonist (dexchlorpheniramine) on memory, alertness and sensory and motor processes are
      measured. The study will be conducted according to a within subject cross-over design using
      healthy volunteers.
    

Intervention name(s): dexchlorpheniramine, lorazepam
Intervention type(s): Drug
Intervention MeSH terms: Lorazepam; Dexchlorpheniramine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: H1-antagonist; Event Related Potentials; Memory; Information processing; The effects of an H1 antagonist (dexchlorpheniramine) on human cognition
Extract of Ginkgo Biloba and Tardive Dyskinesia
Condition: Tardive Dyskinesia; Schizophrenia
MeSH terms: Dyskinesias; Tardive Dyskinesia; Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether Extract of Ginkgo Biloba is effective in
      the treatment on Tardive dyskinesia
    

Detailed description: 
      Tardive dyskinesia(TD) is a common complication of conventional antipsychotic treatment in
      subjects with schizophrenia. There is no established treatment for TD patients.This disorder
      remains a significant clinical problem for both patients and physicians for the foreseeable
      future.
    

Intervention name(s): Extract of Ginkgo Biloba (EGb-761 capsules); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): EGb-761 240mg/d, 1 capsule(80mg) tid,po,12 weeks; Each capsule contains 19.6mg flavonol glycosides and 4.8mg terpene lactones.; Wheat flour placebo capsule,1 capsule tid, po,12 weeks
Other intervention name(s): YiKangNing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tardive Dyskinesia; Schizophrenia; Extract of Gingko Biloba