bioihbjkbjnl/mcl2 huggingface dataset:
A 5-Period, Single Dose, Phase 1 Study in Healthy Elderly Subjects to Assess Relative Bioavailability and Food Effect of Two Oral Formulations of GSK1325756 (Free Base vs HBr Salt) and Food Effect on the HBr Formulation When Given With Omeprazole
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      The current study will help to increase our understanding of the pharmacokinetics (PK) of
      danirixin. The primary objective of the study is to estimate the relative bioavailability of
      danirixin Hydrobromide (HBr) tablet, when compared to danirixin free base (FB). Safety and
      tolerability information for oral administration of danrixin HBr tablets in elderly subjects
      will also be obtained. Secondarily, this study will evaluate effect of food on PK of
      danirixin HBr, effect of gastric acid suppression, and within-subject PK variability of
      danirixin HBr. The outcome of this study will contribute to the selection of the most
      appropriate formulation/dosing regimen for future studies.

      This is an open-label, 5-period crossover study. Study will be conducted in 18 healthy
      elderly subjects. Screening will occur within 42 days prior to Day 1 of period 1. The
      Treatment Periods will be separated by a washout period of a minimum 5 days. Follow-up will
      be done within 3 to 10 days post last dose.
    


Intervention name(s): Danirixin HBr 50 mg IR Tablet; Danirixin FB 50 mg IR Tablet; Prilosec (omeprazole) 40mg Delayed-Release capsule
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Danirixin HBr 50 mg IR Tablet is white, film-coated, oval-shaped tablet for oral administration.; Danirixin FB 50 mg IR Tablet is white, film-coated, capsule-shaped tablet for oral administration.; Prilosec (omeprazole) 40 mg delayed-release capsule is opaque, hard gelatin, apricot, and amethyst colored capsules, coded 743 on cap and PRILOSEC 40 on the body for oral administration.
Intervention MeSH terms: Omeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioavailability; Omeprazole; Danirixin; Food Effect; Pharmacokinetics
The IBEP Study: an Intervention for Lifestyle Modification in Women With Gestational Diabetes
Condition: Gestational Diabetes; Weight Gain During Pregnancy; Weight Loss After Pregnancy
MeSH terms: Diabetes, Gestational; Diabetes Mellitus; Body Weight; Weight Loss; Weight Gain
Study type: Interventional

Summary: 
      The IBEP study is a randomized control trial of a healthy lifestyle intervention program for
      women with gestational diabetes. The primary aim of the study is to evaluate whether women
      with gestational diabetes enrolled in an intensive behavioral educational program (IBEP)
      demonstrate lower mean fasting glucose levels measured by 2 hour 75 gram oral glucose
      tolerance test (OGTT) at 6 weeks postpartum compared to women with gestational diabetes who
      undergo routine gestational diabetes education and counseling.
    


Intervention name(s): Intensive Behavioral Modification
Intervention type(s): Behavioral
Intervention description(s): Intensive dietary counseling, increased physical activity, lactation counseling
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Gestational diabetes
Diagnostic Device for the Assessment of Pulpal Blood Flow
Condition: Dental Pulp Test
Study type: Observational

Summary: 
      The purpose of this study is to assess tooth health by using a pulse oximeter which measures
      the blood flow within the tooth. This method is not currently being used in dentistry. We
      hypothesize that if we can measure both sensation and blood flow in a tooth, we will be able
      to better determine if the tooth is "alive or dead". In the future, this method may help
      determine which teeth are diseased and require dental treatments.
    

Detailed description: 
      The vitality of the pulp is determined according to the health of the vascular supply not the
      sensory fibers. Conventional subjective tooth assessments (percussion, palpation, cold, and
      electrical pulp testing) and objective pulpal blood flow measurements will be used for teeth
      that are planned for extraction and also up to 2-5 additional teeth in each participant. The
      correlation between a single combined score from collective conventional subjective tooth
      assessments and the objective pulse oximetry reading for selected teeth will be used to
      evaluate if pulse oximeter measurements are a reliable marker for patient's reported
      symptoms.
    

Intervention name(s): Pulse Oximetry
Intervention type(s): Device
Intervention description(s): Pulse Oximeter is being applied with a special holding tool to test the oximeter for its ability to measure pulpal blood flow, but no effect of the oximeter is being measured. Thus, to that degree the use is observational rather than interventional.
Observational model: Case-Only
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        30 healthy individuals with 2-5 non-endodonticaly treated teeth in addition to the tooth
        planned for the extraction with intact non-metallic crown
      
Keywords: Dental Pulp Test; Vitality Testing; Pulpal Blood Flow Measure
The Impact of Postoperative Catheterization Time After Stress Incontinence Surgery to Success of Surgery
Condition: Stress Urinary Incontinence; Surgery
MeSH terms: Urinary Incontinence; Urinary Incontinence, Stress
Study type: Observational

Summary: 
      After incontinence surgery, the patients randomly will be divided two groups. In group A
      postoperative urinary catheterization time will be applied one day, In group B
      catheterization will be applied two days. After removal of urinary catheter, residual volume
      will be measured and voiding function will be controlled. In postoperative period; third,
      sixth month and one year after surgery stress test will be applied to control success of
      surgery
    


Intervention name(s): to measure the residual volume after catheterization
Intervention type(s): Diagnostic Test
Intervention description(s): after first micturition to measure the residual volume in bladder
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        the women who have stress incontinence at physical examination and urodynamics tests
A Study to Assess EDP-938 for the Treatment of Acute Upper Respiratory Tract Infection With Respiratory Syncytial Virus in Adult Subjects
Condition: Respiratory Syncytial Virus
MeSH terms: Respiratory Tract Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This was a randomized, double-blind, placebo-controlled, multicentre, phase 2 study to
      evaluate the efficacy, safety and tolerability of orally administered EDP-938 in adults with
      RSV infection.
    

Detailed description: 
      Subjects (aged 18 to 75 years, inclusive) with up to 48 hours of upper respiratory tract
      infection (URTI) symptoms who tested positive for respiratory syncytial virus (RSV) and
      negative for influenza virus by rapid testing (ie, Rapid Viral Screen). Subjects with stable
      asthma or chronic obstructive pulmonary disease (COPD) were allowed in the study.

      Eighty-two (82) subjects were enrolled in this Phase 2b, randomized, double-blind,
      placebo-controlled, multicentre study of EDP-938 administered orally for the treatment of
      acute URTI with confirmed RSV infection in ambulatory adult subjects.

      For each subject, the duration of study participation was approximately 2 weeks and consisted
      of 3 periods: Screening (occurs on Day1), Treatment (5 days), and Follow-up (9 days after
      last dose).
    

Intervention name(s): EDP-938; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Four tablets daily for 5 days; Four tablets daily for 5 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: RSV
Intravenous Haloperidol Versus Ondansetron for Treatment of Established Post-operative Nausea and Vomiting
Condition: Postoperative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to prove that at a dose of 1 mg Haloperidol possesses a high success rate in
      controlling established postoperative nausea and vomiting (PONV) in the first 24 hours
      following administration similar to the standard of care ondansetron 4 mg.
    

Detailed description: 
      Patients undergoing surgery under general anesthesia may experience several complications in
      their postoperative period. Nausea and vomiting are some of the more common of these
      complications. Several medications can be used for prevention of these specific
      complications, but treatment remains more cost-efficient.

      Haloperidol is anti-psychotic which, at low doses, can prevent the occurrence of nausea and
      vomiting. Its usefulness for prophylaxis has been demonstrated in several studies. However,
      its use for treating established postoperative nausea and vomiting (PONV) has not been
      properly studied.

      In a prospective randomized clinical trial involving adult patients undergoing elective
      surgery under general anesthesia, investigators will enroll 120 patients, and compare the
      effect of a dose of 1 mg Haloperidol versus Ondansetron 4 mg and document the varying degrees
      of success in treating nausea and vomiting as well as possible side effects.

      Investigators expect to observe that Haloperidol is as effective as treatment with
      Ondansetron.
    

Intervention name(s): 4 mg of Ondansetron IV; 1mg of Haloperidol IV
Intervention type(s): Drug; Drug
Intervention MeSH terms: Haloperidol; Ondansetron; Haloperidol decanoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Varenicline as a Treatment for Methamphetamine Dependence
Condition: Methamphetamine Dependence; Methamphetamine Abuse; Substance Abuse
MeSH terms: Substance-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of the study is to determine the effects of treatment with varenicline (1
      and 2 mg daily), compared to treatment with placebo, on methamphetamine-induced craving and
      subjective effects in methamphetamine-dependent human volunteers.
    

Detailed description: 
      This study is part of an effort to develop treatments for methamphetamine abuse. Varenicline
      is a drug that changes levels of certain brain chemicals that may also be useful in helping
      people to stop using methamphetamine. Our goal is to determine the safety and effects of
      varenicline (1 and 2 mg, daily, vs. a placebo) when it is used before experimental
      administration of methamphetamine, on a number of physical and psychological measures;
      specifically blood pressure, heart rate, and how you feel after taking methamphetamine. The
      secondary purpose is to determine the effects of treatment with varenicline (1 and 2 mg
      daily), compared to treatment with placebo, on the reinforcing effects of methamphetamine by
      measuring methamphetamine self-administration in methamphetamine-dependent human volunteers.
    

Intervention name(s): Placebo; Varenicline; Varenicline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive varenicline or matched placebo from day 1 through day 7, then the same subjects will return within 2-4 weeks and assigned to each of the two remaining study medication conditions, and undergo the identical procedures (3-phase study).; For varenicline 1 mg, dosing will begin at 0.5 mg once daily (with 0 mg placebo to maintain blind of bid dosing) for days 1-3, will be increased to 0.5 mg twice daily for the days 4-6, and then reduced to 0.5 mg once daily on day 7. No medication is given on Day 8.; For varenicline 2 mg, dosing will begin at 0.5 mg once daily for days 1-3 (with 0 mg placebo to maintain blind of bid dosing), will be increased to 0.5 mg twice daily for day 4, and increased to 1 mg twice daily on days 5-6, and then reduced to 1 mg once daily on day 7. No medication is given on Day 8.
Other intervention name(s): Sugar pill; Chantix; Chantix
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Methamphetamine; Chantix; Varenicline
Effect of Kinesio Taping in Muscle Fatigue
Condition: Muscle Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The aim of this study was to determine the effect of Kinesio taping on lactic acid in an
      running anaerobic test.
    


Intervention name(s): Kinesio Tape Method
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Bandage; Treadmill; Lactate Acid
A Multi-Center Randomized Controlled Trial of Mentoring to Prevent Youth Violence
Condition: Violence
Study type: Interventional

Summary: 
      The purpose of this study is to test whether a violence prevention curriculum delivered by
      Big Brothers and Big Sisters staff and mentors can reduce violence involvement for
      assault-injured youth.
    

Detailed description: 
      Violent injury is a major cause of morbidity and mortality among adolescents. The presence of
      a positive adult role model is a well-established protective factor against violence and
      other maladaptive outcomes among youth. Big Brothers Big Sisters (BBBS) is the largest U.S.
      mentoring organization with proven effectiveness in improving youth outcomes. However, these
      programs may be less effective with youth who already are exhibiting involvement in problem
      behavior at the time of program referral. Take Charge!, a mentor- and
      professional-implemented intervention with 10-15 year old assault-injured youth, showed
      promise for improving perceived self efficacy for avoiding violence and for decreasing
      aggression and problem behavior.

      The overall goal of the proposed project is to develop, implement, and evaluate a
      research-informed youth development program that adapts the BBBS model to work for
      assault-injured youth. The aims are:

        -  To expand and refine Take Charge! and integrate it with BBBS practices;

        -  To conduct a randomized, controlled trial in which assault-injured 10-15 year old youth
           recruited from emergency departments in Baltimore and D.C. receive either standard
           emergency department follow-up care or the Take Charge! 2 intervention with assessment
           of violence-related, mental health, and educational outcomes;

        -  To conduct a comprehensive process evaluation of Take Charge! 2;

        -  And to accurately measure the costs of the intervention and assess cost-effectiveness.

      Youth violence is a major cause of morbidity and mortality with marked disparities by
      race/ethnicity and socioeconomic status. This study is a critical next step in translating
      evidence-based research to real-world settings and practice.
    

Intervention name(s): Take Charge 2
Intervention type(s): Behavioral
Intervention description(s): Youth assigned to the intervention receive a Big Brothers, Big Sisters (BBBS) mentor. During the match process, BBBS staff provide 3 session on violence prevention for the youth's parents. Six months into the mentoring relationship, mentors provide 6 sessions on violence prevention for the youth.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Youth; Violence; Assault-injured; Mentoring; Emergency Room; Urban
Association Between TMD and LBP Back Pain
Condition: Conditions
MeSH terms: Back Pain
Study type: Interventional

Summary: 
      Investigate the relationships between temporomandibular disorder and low back pain
    

Detailed description: 
      Some patients with chronic low back pain reveal temporomandibular disorder,and others do not.
      So the aims of my study were to find out the risk factors that contribute to the concurrence
      of temporomandibular disorder.
    

Intervention name(s): balance assessment with Biodex balance system
Intervention type(s): Device
Intervention description(s): All subjects of three groups will be assessed with the evaluation device( balance system).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Emotion Regulation Group Therapy for Bipolar Disorder
Condition: Bipolar I Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      Psychoeducation has been the only group treatment developed for bipolar disorder thus far.
      Deficits in emotion regulation, a core impairment among patients with bipolar disorder, are
      not directly addressed in this treatment. The objective of this study is to develop a group
      treatment for bipolar disorder that focuses on emotion regulation strategies (Enhancing
      Emotion Regulation; EER). This study will examine the efficacy of this treatment using an
      open trial design. It is hypothesized that patients who receive EER will show a reduction in
      mood symptoms and improvement in well-being. Reductions in emotion regulation difficulties
      will predict improvements.
    


Intervention name(s): Enhancing Emotion Regulation
Intervention type(s): Behavioral
Intervention description(s): 12 week of group therapy 3 modules: 1) mindfulness, 2) emotion regulation, 3)distress tolerance
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bipolar disorder; depression; mania; emotion regulation; dialectical behavior therapy; group therapy; mindfulness
A Long Term Follow-up Study of AMG0001 in Subjects With Critical Limb Ischemia
Condition: Critical Limb Ischemia
MeSH terms: Chronic Limb-Threatening Ischemia; Ischemia
Study type: Observational

Summary: 
      Subjects from the AG-CLI-0206 phase 3 study that received AMG0001 will be eligible for the
      AG-CLI-0206-LTFU study
    

Detailed description: 
      The study is designed to assess the long term safety of subjects who have been treated in the
      phase 3 study with AMG0001. A health questionnaire will be used to collect specific
      information from the subject every 6 months. Only those subjects that were randomized in the
      AG-CLI-0206 study and who received AMG0001 are eligible to participate in this long term
      follow-up study. Subjects that received placebo will not be eligible for participation in
      this study.
    

Intervention name(s): Subjects from Study AG-CLI-0206 who received AMG0001
Intervention type(s): Biological
Intervention description(s): Subjects from Study AG-CLI-0206 who received the study product AMG0001
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with critical limb ischemia who have previously been treated with AMG0001 in the
        AG-CLI-0206 study.
Evaluation of a Low-fluoride Anticaries Toothpaste
Condition: Tooth Abnormality
MeSH terms: Tooth Abnormalities
Study type: Observational

Summary: 
      The purpose of this trial is to evaluate the anticaries remineralizing potential of a
      toothpaste containing 500 ppm fluoride plus fTCP technology relative to a commercially
      available toothpaste via a double-blind cross-over in situ (or intra-oral) clinical model,
      whereby approved human participants will wear an orthodontic appliance fitted with an enamel
      specimen for the duration of a leg (28 days). There will be two test legs.
    


Intervention name(s): Fluorides, Topical
Intervention type(s): Drug
Intervention description(s): 500 ppm F and 1100 ppm F topical toothpastes comprise sodium fluoride in each.
Intervention MeSH terms: Fluorides; Fluorides, Topical
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        This in situ study will recruit 30 adult subjects (between 18-50 years of age). No
        potential subject will be excluded from this study, regardless of their gender or
        racial/ethnic origins. However, it is expected that about 18 (60%) of the 30 subjects in
        the trial will be women. This distribution will allow for meaningful comparisons between
        gender groups. We will recruit patients attending the clinics of UTHSCSA dental school
        clinics, which reflect the ethnic mix of the area the clinics serve. However, majority of
        subjects will be Hispanic due to the high Hispanic prevalence (57.8%) in San Antonio. Thus,
        minorities will be included at a similar rate to that in the general population attending
        for dental care,
      
Keywords: Anti-erosion dental benefits
Driving Simulation to Assess Non-Sedative Effects of Tolperisone
Condition: Driving Impaired
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized blinded study to assess the sedative effect of 150 mg TID tolperisone
      and 10 mg TID cyclobenzaprine compared to placebo on simulated driving performance and
      cognitive functioning in healthy adult volunteers.
    

Detailed description: 
      This will be a randomized, placebo-controlled, multiple-dose 3-way cross-over study of the
      safety and cognitive effects of multiple doses of 150 mg tolperisone administered TID in 30
      male and female healthy volunteers. Treatment groups include 450 mg tolperisone (i.e., 150 mg
      administered three times daily), 30 mg cyclobenzaprine (i.e., 10 mg administered three times
      daily), and placebo. Subjects will receive 3 days of each treatment.

      Subject participation will be approximately 3 weeks as outpatients with 3 days each week as
      overnight clinic participants.

      In this crossover study, treatment effects will be assessed following the second initial
      dose, the morning following nighttime dosing (to assess residual next day effects), and at
      steady state (i.e., following AM dosing on Day 3).

      Subjects will be dosed on the morning of Day 1. Approximately one hour after the second dose
      on Day 1, subjects will be administered the cognitive test, followed by the driving simulator
      examination.

      On the morning of Day 2, prior to dosing, subjects will be readministered the cognitive test
      and driving examination to assess residual next day effects.

      Subjects will repeat cognitive testing and the driving examination on the morning of Day 3,
      after administration of the AM study medication, to evaluate the cumulative effects of 3 days
      of dosing.
    

Intervention name(s): Cyclobenzaprine 10 Mg Oral Tablet; Placebo Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): cyclobenzaprine 10 mg tablets; sugar pill
Other intervention name(s): Flexeril; tolperisone matching placebo
Intervention MeSH terms: Cyclobenzaprine; Tolperisone
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: multiple-dose 3-way cross-over study
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cognitive function