bioihbjkbjnl/mcl2 huggingface dataset:
Early Clinical Evaluation of the Pharmacokinetics and Mechanism Based Pharmacodynamics of Haloperidol Using Positron Emission Tomography in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      In the present study, the investigators will establish the clinical trial technology for
      early evaluation of drug characteristics in terms of pharmacokinetics and pharmacodynamics
      for haloperidol as a model drug, using positron emission tomography.
    

Detailed description: 
      1. Study Design

           This study will consist of two parts. One is "biodistribution study of haloperidol" in
           12 subjects, and the other is "receptor occupancy study of haloperidol" in 12 subjects.
           In the biodistribution study, 18F-haloperidol (10 mCi) will be injected intravenously
           two times into each of the 12 subjects (cross-over design). Whole body PET will be
           conducted after the first haloperidol injection and local brain PET after the 2nd
           haloperidol injection after the 7 day washout period.

           1.1 D2-receptor occupancy study Group Doses No. of subjects 1 0.5 mg 4 2 1 mg 4 3 3 mg 4

        2. Measurement 2.1 The D2 receptor Occupancy of haloperidol.

        3. Test schedule 3.1 Biodistribution study

             -  Whole body PET (day 1)

             -  Brain local PET (day 8) 3.2 Receptor occupancy study

             -  Baseline PET before drug administration (day 1 0h), 6h (day 1 6h), 24h (day 2 0h),
                after the first haloperidol administration (day 1 0h), and 24 h (day 8), 72 h (day
                10), and 168 h (day 14) after the last dosing of haloperidol (day 7 0h).

             -  Drug administration from day 1 through day 7 every 24 hours PK blood sampling (6
                ml, each) prior to the first haloperidol administration (day 1 0h) and 6h (1 day
                6h), 24h (2 day 0h), 48 h (3 day 0h), 96 h (5 day 0h), 144 h (7 day 0h) and, 0.5,
                1, 2, 4, 6, 8, 12, 24 h (8day 0h), 48h (9day 0h), 72h (10 day 0h) after taking the
                last oral dose of haloperidol

        4. Analytic Methods 4.1 Pharmacokinetics: Noncompartmental Analysis Using Winnonlin
           Compartment model using NONMEM VII 4.2 Pharmacodynamics in the brain: Emax or linear
           model using NONMEM VII
    

Intervention name(s): haloperidol, PET
Intervention type(s): Drug
Intervention description(s): Biodistribution study Intravenous 18F haloperidol(10 mCi) Dose injection two times before whole body PET scan
D2-receptor occupancy study Group Doses No. of subjects 1 0.5 mg 4 2 1 mg 4 3 3 mg 4
above doses will be administrated orally every 24 hours for 7 days.
Intervention MeSH terms: Haloperidol; Haloperidol decanoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: early evaluation; pharmacokinetics; pharmacodynamics; Biodistribution; D2-receptor occupancy
Laparoscopic Sleeve Gastrectomy With and Without Omentectomy
Condition: Morbid Obesity
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional
Phase: Phase 3

Summary: 
      -  The investigators aim to determine the clinical and metabolic effects of sleeve
           gastrectomy with or without omentectomy in the treatment of morbid obesity.

        -  The investigators hypothesize that the endocrine suppression of ghrelin (appetite
           hormone)and resistin (insulin antagonist) provided by sleeve gastrectomy and omentectomy
           (omentum or intra-abdominal fat removal) will provide clinical and metabolic benefits
           for morbidly obese patients.
    

Detailed description: 
      This is a phase 3 prospective randomized trial.
    

Intervention name(s): Laparoscopic restrictive procedure; Sleeve gastrectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients will receive laparoscopic sleeve gastrectomy with or without omentectomy; Sleeve gastrectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Morbid obesity; Bariatric Surgery; Obesity Surgery; Omentectomy; Sleeve gastrectomy
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ABBV-157 in Healthy Volunteers and in Participants With Chronic Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to evaluate pharmacokinetics (PK), safety and tolerability of ABBV-157 in
      healthy volunteers and in participants with chronic plaque psoriasis, and to evaluate the
      efficacy of ABBV-157 in the participants with psoriasis. This study consists of two
      substudies. Substudy 1 is a randomized, double-blind, placebo-controlled evaluation of
      multiple ascending oral doses of ABBV-157 in healthy adult volunteers. Substudy 2 is a
      randomized, double-blind, placebo-controlled study in which participants with moderate to
      severe chronic plaque psoriasis will be administered multiple oral doses of ABBV-157.
    


Intervention name(s): ABBV-157; Placebo for ABBV-157
Intervention type(s): Drug; Drug
Intervention description(s): ABBV-157 will be administered orally as capsule; Placebo for ABBV-157 will be administered orally as capsule
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Psoriasis; Chronic Plaque Psoriasis; ABBV-157; Healthy Volunteers
Effects of NSK-SD (Nattokinase) on Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomized double-blinded placebo-controlled study to evaluate the effects of
      NSK-SD consumption in subjects with Stage I hypertension.

      The study population will be randomized into two groups, where both groups will receive
      dietary and lifestyle recommendations to help reduce hypertension. One group will receive
      placebo and the other group NSK-SD for 8 weeks.

      The endpoint will be the change in systolic and diastolic blood pressure after 8 weeks of
      treatment in the two subject groups.
    

Detailed description: 
      Previous randomized double blinded placebo-controlled studies on the consumption of the
      fibrinolytic enzyme Nattokinase and NSK-SD is transported across the gut, and has shown
      multiple effects on vascular health, including fibrinolytic effects and regulation of blood
      pressure.

      A previous study on effects on blood pressure was conducted in an Asian population involving
      86 people, where 73 people completed the study requirements (39 in the NSK-SD group, 34 in
      the placebo group). The data showed statistically significant reduction in both systolic and
      diastolic blood pressure after consumption of Nattokinase, whereas the changes after
      consuming placebo were not significantly different from baseline.

      The objective of this study is to evaluate the effects of consumption of nattokinase on
      hypertension in a North American hypertensive population with associated genetic, dietary,
      and lifestyle factors. This is in extension of, and contrast to, previous studies in Asian
      populations.
    

Intervention name(s): NSK-SD (nattokinase); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Nattokinase is a fibrinolytic enzyme from the fermented soy product natto. Encapsulated 100mg/capsule, excipient include microcrystalline cellulose.; The placebo capsules contain microcrystalline cellulose.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Combination of Two Currently Approved Drugs to Enhance the Treatment of Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Study of a medication for the treatment of Schizophrenia in patients who are already taking
      Abilify, Risperdal, Seroquel, Zyprexa
    


Intervention name(s): olanzapine; atomoxetine; placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Olanzapine; Atomoxetine Hydrochloride
Primary purpose: Treatment
USDA Behavior, Motivation & Nutrition Study
Condition: Body Weight
MeSH terms: Body Weight
Study type: Observational

Summary: 
      This study will be a cross-sectional study. The primary aim of this study is to compare the
      relationship between neurological function, metabolic measures and health-related behaviors
      between normal weight and overweight/obese perimenopausal women.
    

Detailed description: 
      To examine physiological and behavioral factors that may help determine health in
      perimenopausal middle age women. Neuroendocrine function will be measured by broad assessment
      of hypothalamic-pituitary-adrenal (HPA) activity. We will also assess metabolic profiles and
      behavioral and emotional function. We plan to determine correlations between these measures
      and nutritional state. Other measures may include insulin, glucose, leptin, IGF-1,
      triglycerides, free fatty acids, and ghrelin and eating attitudes and physical reactivity.
    

Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Community sample
      
Biospecimen description: 
      Blood and saliva samples will be kept for future research purposes.
Evaluate the Effect of Growth Hormone (GH) Treatment on Fibroblast Growth Factor 23, a Known Phosphaturic Agent
Condition: Growth Disorders
MeSH terms: Growth Disorders
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the effect of growth hormone treatment on phosphorus
      levels in the body. Phosphorus is an important mineral for bone growth. It is well known that
      growth hormone treatment improves bone density and bone mineral content. The amount of
      phosphorus is maintained by the kidneys. Fibroblast Growth Factor 23 has recently been
      recognized to help kidneys control phosphate levels.
    

Detailed description: 
      This study will compare Fibroblast Growth Factor 23 levels in children with and without
      growth hormone deficiency. Children with growth hormone deficiency will have levels taken
      before starting growth hormone replacement and after it has been initiated.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children attending Endocrinology clinics of Children's Hospital of Alabama. Ages are 3-14
        years of age.
      
Keywords: Fibroblast Growth Factors; Bone development
Differential Acute Tolerance Development to Effects of Nitrous Oxide - 7
Condition: Opioid-Related Disorders; Substance-Related Disorders
MeSH terms: Substance-Related Disorders; Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to conduct experiments to examine subjective and reinforcing
      effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug
      abusers and preference procedures will be used to assess reinforcing effects. To examine
      differential acute tolerance development to effects of nitrous oxide in humans.
    


Intervention name(s): Nitrous oxide
Intervention type(s): Drug
Intervention MeSH terms: Nitrous Oxide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: nitrous oxide; acute tolerance; subjective effects; analgesia; psychomotor; healthy volunteer
Promoting Asthma Wellness in Rural Communities
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      This is a research study that compares the effectiveness of a web-based program (known as
      Puff City) and another web-based program (of internet sites such as the American Lung
      Association, American Academy of Asthma, Allergy, and Immunology, etc) that targets five key
      asthma management issues among rural youth:

        1. Improving adherence to asthma controller medication use;

        2. Improving compliance of carrying a rescue inhaler at all times for use at the first sign
           of asthma symptoms;

        3. Improving inhaler technique;

        4. Smoking reduction or cessation in those who are smokers; and

        5. Avoidance of second-hand smoke exposure.
    

Detailed description: 
      A randomized control trial across three southeastern rural high schools comparing a web-based
      tailored intervention (known as Puff City) to web-based traditional control education sites.
    

Intervention name(s): Puff City GA; General Asthma Education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Puff City GA focuses on three areas of health behavior: 1) adherence to controller medications; 2) immediate availability of rescue medication; 3)smoking cessation/reduction.; Students will be directed to generic public websites on asthma and smoking that contain helpful information on general asthma management.
Other intervention name(s): Behavioral Puff City Ga.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: asthma; smoking; teens
Motivational Interviewing to Address Freshman Weight Gain
Condition: Motivational Interviewing
MeSH terms: Weight Gain
Study type: Interventional

Summary: 
      The purpose of the study is to determine the effect of Motivational Interviewing and e-health
      education on body composition and psychological outcomes. After baseline testing,
      participants will be randomly assigned to a motivational interviewing or e-health education
      group for a 10-week intervention. Variables of interest include: body composition, physical
      activity, food consumption and self-determination theory constructs.
    


Intervention name(s): Motivational Interviewing; e-education
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants receiving MI; Participants receiving e-education
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Assigned to either motivational interviewing or e-education.
Masking: None (Open Label)
Primary purpose: Treatment
Study Of Single And Multiple Ascending Doses Of PF-07054894 In Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety, tolerability, and PK of single escalating
      doses and multiple escalating doses of PF-07054894.
    


Intervention name(s): PF-07054894; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive oral ascending doses; Participants will receive matching placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Single-ascending Oral Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ACT-281959 / ACT-246475 in Healthy Male Subjects
Condition: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics
Study type: Interventional
Phase: Phase 1

Summary: 
      Study Part I is a single-ascending dose study. Healthy male subjects to be included in the
      study and randomized in 6 dose groups, Groups A-F (8 subjects per group). Of the 8 subjects
      per group, 6 subjects receive the investigational drug and 2 subjects receive matching
      placebo. Study Part II is a 3-period, crossover, single dose study. Nine healthy male
      subjects to be enrolled in one group (Group G). Each subject to receive 2 different
      formulations of the prodrug and one formulation of the active drug in a randomized sequence.
    

Detailed description: 
      Study Part I is a prospective, single-center, double-blind, randomized, placebo-controlled,
      single-ascending dose, Phase 1 study. Approximately 48 healthy male subjects to be included
      in the study and randomized in 6 dose groups, Groups A-F (8 subjects per group). Of the 8
      subjects per group, 6 subjects are to receive the investigational drug and 2 subjects to
      receive matching placebo. Study Part II is a prospective, single-center, open-label,
      randomized, 3-period, crossover, single dose, Phase 1 study. Nine healthy male subjects to be
      enrolled in one group, Group G. Each subject to receive 2 different formulations of the
      prodrug and one formulation of the active drug in a randomized sequence.
    

Intervention name(s): 5 mg ACT-281959 prodrug formulation I (Group A); 20 mg ACT-281959 prodrug formulation I (Group B); ACT-281959 prodrug formulation I (Groups C to G doses to be defined); ACT-281959 prodrug formulation II (Group G dose to be defined); ACT-246475 (Group G dose to be defined); Placebo (Groups A to F)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ACT-281959; ACT-246475
Effects of Environmental Factors on Opiate Drug Choice in Opioid Dependent Individuals.
Condition: Heroin Dependence; Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders; Heroin Dependence
Study type: Observational

Summary: 
      The purpose is to study how certain factors, including money, the amount of drug available
      and the amount of work effort, affect opiate drug choice.
    

Detailed description: 
      A drug dependent person chooses to take drug more often (and suffer its long-term bad
      consequences) than choosing to engage in healthy activities (which have better long-term
      consequences). The present research will be conducted in a controlled laboratory setting with
      heroin abusers who are not seeking treatment to understand what factors guide their choices.

      This research focuses on environmental (i.e. non-medication) factors that affect choosing a
      drug versus money. Findings from this research are likely to be important in developing a
      theoretical and practical basis for behavioral interventions as part of drug abuse treatment.
      HYD is a drug that is currently used as a cough suppressant and to relieve pain.

      Participants in this observational study will take part in multiple trials in which they have
      the opportunity to choose HYD or money. On the first two experimental days, prior to choice
      sessions, participants will receive a sample of the drug doses that can be chosen. During
      test sessions, participants will have 12 opportunities to choose either drug or money.
      Participants will use a computer to earn choices. Respiration rate, oxygen saturation, heart
      rate, and blood pressure will be monitored throughout choice trials. Self-report
      questionnaires will be completed at different times during the study.

      Participants will be maintained on buprenorphine throughout the study, with a minimum 2-week
      lead before the experiment, and a fixed 3-week detoxification after study completion.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Heroin dependent research volunteers
      
Biospecimen description: 
      Whole blood
    
Keywords: Behavioral Economics; Drug self administration; Opioid
Safety and Immunogenicity of Different Meningitis Vaccine Formulations in Adolescents and Young Adults
Condition: Invasive Meningococcal Disease
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety and immunogenicity of combination vaccines as compared to
      the reference vaccines
    


Intervention name(s): Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + OMV.; Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus OMV.; Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.; Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + qOMV.
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Two injections of a combined vaccine formulation, Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus OMV.; Two injections of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus OMV.; One injection of saline solution placebo and one of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.; Two injections of a combined vaccine formulation, Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus a quarter dose of OMV.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Safety; Immunogenicity; Vaccine; Meningococcal; Seroresponse