bioihbjkbjnl/mcl2 huggingface dataset:
The Aboriginal Youth Mentorship Program
Condition: Type 2 Diabetes; Obesity
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      Building on the successes of a communal, relationship based approach to Aboriginal youth
      mentoring in an after school physical activity program (AYMP), the investigators are
      evaluating a peer-led approach for diabetes prevention.
    

Detailed description: 
      Building on the successes of a communal, relationship based approach to Aboriginal youth
      mentoring in an after school physical activity program (AYMP), the investigators are
      evaluating a peer-led approach for diabetes prevention. High school students volunteer as
      mentors, and develop an after-school program that they then deliver to children in grade 4.
      The mentors meet twice a week. The first day, they develop an activity plan and decide roles
      and responsibilities to ensure successful delivery of each activity. The second day, they
      deliver the program to the grade 4s, which incorporates a healthy snack, 45-minutes of
      physical activity, and educational games/activities. Our primary goal is to determine the
      health benefits of AYMP; guided by our youth mentors and community advisors, the
      investigators will also develop a number of research questions that will help us to better
      understand the social, emotional, physical and spiritual outcomes of the peer-led mentor
      program. To answer these questions, the investigators will train community members in both
      qualitative and quantitative methods. The quantitative outcomes of this study include
      physical activity, waist circumference, obesity rates, and self-esteem. Qualitative methods
      may include photovoice and focus group interviews. All of these will be used to assess the
      social determinants of health and contextual features of the program.
    

Intervention name(s): Aboriginal Youth Mentorship Program
Intervention type(s): Behavioral
Intervention description(s): High school students volunteer as mentors, and develop an after-school program that they then deliver to children in grade 4. The mentors meet twice a week. The first day, they develop an activity plan and decide roles and responsibilities to ensure successful delivery of each activity. The second day, they deliver the program to the grade 4s, which incorporates a healthy snack, 45-minutes of physical activity, and educational games/activities. Grade 4s are our intervention group
Other intervention name(s): AYMP
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Peer-mentoring; Obesity; Type 2 Diabetes; Physical Activity; After-school program
An Extension Study to Evaluate the Long-Term Safety and Tolerability of Ubrogepant in the Treatment of Migraine
Condition: Migraine, With or Without Aura
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the long-term safety and tolerability of intermittent treatment with
      ubrogepant for the acute treatment of migraine over 1 year.
    

Detailed description: 
      Usual care is the open-label control arm. Dose of ubrogepant (50 mg or 100 mg) will be
      double-blind for active treatment arms.
    

Intervention name(s): Ubrogepant; Placebo-matching Ubrogepant; Usual Care
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.; Ubrogepant placebo-matching tablet orally for the treatment of a qualifying migraine attack.; Treatment for a migraine as prescribed by the physician as standard of care in clinical practice.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Absorption, Metabolism, and Excretion (ADME) of BMS-986435
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the absorption, metabolism, excretion; and to
      evaluate the safety and tolerability of BMS-986435 in healthy male participants

      Participants will be admitted to the study site for 3 weeks.
    


Intervention name(s): MYK-224
Intervention type(s): Drug
Intervention description(s): Specified dose on specified days
Other intervention name(s): BMS-986435
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Absorption, Metabolism, and Excretion (ADME); MYK-224
Microbiome and the Gut-Brain Axis
Condition: Mental Disorder
MeSH terms: Mental Disorders; Psychotic Disorders
Study type: Observational

Summary: 
      This research study will examine the relationship interconnecting medical body health, mental
      health, and microbes of the digestive tract in persons living with serious mental
      illnesses,as compared to persons without such disorders. Existing research suggests that
      interactions between digestive tract microbes and the body may influence brain function
      circuits, mood, anxiety state, cognition, behavior, and medical physiology.
    

Detailed description: 
      People living with serious mental illnesses have far shorter life expectancy due to various
      attending medical disorders. Vast knowledge gaps exist regarding microbial taxa responsible
      for governing various the human states of health or morbidity or interactions with
      medications. Serious mental illnesses collectively comprise the single largest medical
      category of life-long disability worldwide. Mounting evidence in humans and in animal models
      of schizophrenia, post-traumatic stress disorder (PTSD) and related mental illnesses point to
      gut microbiome-host interactions that may influence brain function circuits, mood, anxiety
      state, cognition, behavior, as well as generate medical comorbidities. This research study
      will collect stool samples and blood for in vitro analysis of microbiome and metabolomics.
    

Intervention name(s): Biological Sample; Blood Sample
Intervention type(s): Other; Other
Intervention description(s): A one time sample will be collected.; A one time blood sample will be collected.
Other intervention name(s): Stool Sample
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Group 1 will have a diagnosis of a mental illness. Group 2 will not have a diagnosis of
        mental illness.
      
Keywords: Gut Microbiome; Mental Disorder; Dysbiosis
Comparative Study of Specular Microscopes for Measurements of Cell Density, Coefficient of Variation and Hexagonality
Condition: Corneal Endothelial Cell Loss
MeSH terms: Corneal Endothelial Cell Loss
Study type: Observational

Summary: 
      The primary objective of this clinical study is to collect clinical data to support an FDA
      510(k) submission for the Nidek CEM-530 Center point method and Corner point method. The
      secondary objective is to evaluate any adverse events found during the clinical study.
    

Detailed description: 
      The primary objective of this clinical study is to collect clinical data to support an FDA
      510(k) submission for the Nidek CEM-530 Center point method and Corner point method.
    

Intervention name(s): Specular Microscope Nidek CEM-530; Specular Microscope Konan CELLCHEK XL
Intervention type(s): Device; Device
Intervention description(s): Nidek CEM-530; Konan CELLCHEK XL
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Ophthalmology Practice
Comparing Ciprofloxacin (CPFX) With Cefepime (CFPM) in Febrile Neutropenic Patients With Hematologic Diseases
Condition: Febrile Neutropenia
MeSH terms: Neutropenia; Hematologic Diseases; Febrile Neutropenia; Hyperthermia; Fever
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to investigate whether intravenous ciprofloxacin is as effective as
      cefepime for the initial treatment of febrile neutropenia developed in patients with
      hematologic diseases.
    

Detailed description: 
      Infectious complications during neutropenic periods are major causes of morbidity and
      mortality especially for patients with hematological diseases, and prompt initiation of
      antibiotic therapy is warranted for those who develop febrile neutropenia. As for initial
      therapeutic agents, beta-lactam antibiotics, i.e., third- or fourth-generation cephalosporins
      and carbapenems have been used frequently because of their strong and broad-spectrum of
      action. However, under these conditions, development of resistance mediated by a
      beta-lactamase is concerned, and there is a need for alternative non-beta-lactam antibiotics
      for this indication. Ciprofloxacin is a potent agent covering against wide range of strains
      including Pseudomonas aeruginosa, and expected as a potential candidate. We have therefore
      planned a prospective randomized controlled trial designed to compare intravenous
      ciprofloxacin with cefepime for febrile neutropenic patients.
    

Intervention name(s): ciprofloxacin; cefepime
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ciprofloxacin; Cefepime
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: febrile neutropenia; hematologic disease
Effect of a 4-week Fun Fast Interval Training (FFIT) Activity Programme on Physical Fitness and Quality of Life in Adolescent School Pupils
Condition: High-intensity Interval Training
Study type: Interventional

Summary: 
      Low-volume high-intensity interval exercise training may improve aspects of health and
      fitness in young people, but the effect of this type of exercise on quality of life has yet
      to be assessed. The investigators aim to examine the effect of a 4-week school-based
      low-volume high-intensity interval training programme (called the Fun Fast Interval Training
      [FFIT] activity project) on physical fitness and quality of life in adolescent school pupils.
      Approximately 145 English adolescents aged 11-12 years will be approached and invited to take
      part in the study. Participants will be healthy female volunteers, recruited from one school
      in Northeast England. Using a non-randomised design, one school year group will be assigned
      to take part in the intervention, and a second year group assigned to the control
      condition.Those in the intervention group will complete a 4-week school-based high-intensity
      interval exercise training programme. The intervention will take place twice per week, and
      comprise of 6-8 repetitions of 45 s maximal effort exercise (boxing, running, soccer and
      basketball drills), each interspersed with 90-s rest. Participants will be encouraged to work
      maximally during the 45-s repetitions. Control participants will be instructed not to change
      their lifestyle, dietary or physical activity habits during the intervention period, and
      maintain their normal school physical education routine. Study outcomes will be 20 m shuttle
      run test performance, health-related quality of life, standing broad jump performance, hand
      dynamometer performance, waist circumference and 10 m and 20 m sprint performance.
    


Intervention name(s): High-intensity interval exercise training
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: high-intensity interval training; adolescents; physical fitness; quality of life; school-based intervention
Pharmacokinetics, Safety and Tolerability Study of Abacavir/ Dolutegravir/ Lamivudine Fixed-dose Combination Tablets in Healthy Japanese Subjects
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) 600 milligrams (mg)/50 mg/300 mg
      fixed-dose combination (FDC) tablet is currently approved in the United States (US) and
      Europe. Although the pharmacokinetics (PK), safety and tolerability of ABC/DTG/3TC FDC
      tablets have been extensively studied in subjects not of Japanese heritage, these parameters
      have not been exclusively assessed in Japanese subjects. To support the marketing application
      in Japan, this single-dose, open-label study will characterize the PK, safety and
      tolerability of ABC/DTG/3TC FDC tablet in adult Japanese healthy subjects. A maximum of 12
      subjects will be enrolled such that approximately 10 evaluable subjects complete the study.
      The study will consist of a screening, treatment phase (single oral dose under the fasted
      state) and follow-up visit (within 7-14 days of the last PK sample collected). The total
      duration of the study for each subject will be approximately up to 48 days.
    


Intervention name(s): ABC/DTG/3TC FDC tablet
Intervention type(s): Drug
Intervention description(s): ABC/DTG/3TC FDC will be supplied as purple, biconvex, oval tablets debossed with "572 Trı" on one side and plain on the other side. A single dose, with a unit dose strength of 600 mg/50 mg/300 mg will be administered orally.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pharmacokinetics; Healthy subjects; Abacavir/dolutegravir/lamivudine; Japanese; Fixed-dose combination; safety
Clinical Trial to Compare the Pharmacokinetics and Safety of Eperisone HCl SR Tablet 75mg and Myonal Tablet 50mg
Condition: Low Back Pain
MeSH terms: Low Back Pain
Study type: Observational

Summary: 
      The purpose of this study is to Evaluate and Compare Safety and Pharmacokinetic of the
      Eperisone HCl SR and Myonal in healthy Korean male adults.
    

Detailed description: 
      Myonal: Eperisone Hydrochloride (muscle relaxant)
    

Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        acute low back pain
      
Biospecimen description: 
      plasma
Safety, Tolerability and Immunogenicity Study of Different Vaccine Regimens of Trivalent Ad26.Mos.HIV or Tetravalent Ad26.Mos4.HIV Along With Clade C Glycoprotein (gp)140 in Healthy Human Immunodeficiency Virus (HIV)-Uninfected Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to assess the safety/tolerability of the 2 different vaccine
      regimens of priming with trivalent Ad26.Mos.HIV and boosting with trivalent Ad26.Mos.HIV and
      Clade C gp140 plus adjuvant or priming with tetravalent Ad26.Mos4.HIV and boosting with
      Ad26.Mos4.HIV and Clade C glycoprotein (gp)140 plus adjuvant. Immune responses of the
      different vaccine schedules will be assessed.
    


Intervention name(s): Ad26.Mos.HIV; Ad26.Mos4.HIV; Clade C gp140; Placebo
Intervention type(s): Biological; Biological; Biological; Drug
Intervention description(s): Recombinant replication-deficient Ad26 vectored vaccine and consists of 3 Ad26 vectors, one containing a mosaic insert of envelope (Env) sequence, and 2 vectors containing mosaic inserts of Gag and Pol sequences (Ad26.Mos.1.Env + Ad26.Mos1.Gag-Pol + Ad26.Mos2.Gag-Pol). Total dose is 5*10^10 viral particle per 0.5 milliliter (mL) injection administered intramuscularly.; Recombinant replication-deficient Ad26 vectored vaccine and consists of 4 Ad26 vectors, 2 containing a mosaic insert of envelope (Env) sequence, and 2 vectors containing mosaic inserts of Gag and Pol sequences (Ad26.Mos.1.Env + Ad26.Mos.2S.Env + Ad26.Mos1.Gag-Pol + Ad26.Mos2.Gag-Pol). Total dose is 5*10^10 viral particle per 0.5mL injection administered intramuscularly.; Clade C gp140 vaccine containing 250 mcg of total protein, mixed with aluminum phosphate adjuvant, per 0.5 mL injection administered intramuscularly.; Normal saline 0.9 percent (%), 0.5 mL injection administered intramuscularly.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Malmö Breast Tomosynthesis Screening Trial
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      To compare digital breast tomosynthesis (DBT) with full field digital mammography (FFDM)
      regarding effectiveness as screening modalities.
    

Detailed description: 
      Mammography is the only approved method for breast cancer screening, but not all tumors can
      be detected with mammography. The main reason is overlapping structures that can either mimic
      or hide a tumor on a 2-dimensional image like mammography. Digital breast tomosynthesis,
      (DBT) is a 3-dimensional x-ray technique that has been developed during the last years. A
      tomographic technique like DBT, which reduces or eliminates the detrimental effect of over-
      and underlying tissue, can probably help to find more tumors. This study aims to investigate
      whether more breast cancers can be detected with DBT compared to full field digital
      mammography (FFDM) in population invited to screening. An interim analysis will be performed
      during 2013 including the first 7,500 women of the study cohort.
    

Intervention name(s): DBT and FFDM
Intervention type(s): Radiation
Intervention description(s): Women in the study will once undergo both standard FFDM screening (2-views) and DBT (1 view, MLO). This will result in a doubled radiation dose compared to only 2-view FFDM, which is the standard procedure for women in the screening program.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: breast cancer; screening; sensitivity; tomosynthesis
Comparison of Tramacet Versus Percocet in Post Surgical Patients
Condition: Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Opioid naive patients are randomized to receive either TRAMACET or PERCOCET at the time of
      discharge following mild to moderate pain risk surgery. The following will be assessed: 1)
      Brief pain inventory (BPI) for the month. 2) Post operative pain management satisfaction. 3)
      Whether they sought any repeat opioid prescription. 4) Whether they intend to seek repeat
      opioid prescription. It is expected that both groups will have similar pain outcomes but
      those patients in the Percocet group will be more likely to seek a second prescription.
    

Detailed description: 
      Patient operating lists will be screened on a daily basis at identify potential patient
      candidates. The surgeon of note will be consulted to ensure that each patient, in their
      opinion, may be a candidate. If approved by the surgeon of note, the patient will then be
      approached in the preoperative area by a member of the research team to determine if they
      will consent to enrollment in the study.

      Patients will be double blinded and randomized following low to moderate pain surgery
      (surgery in which patients do not generally require a patient controlled analgesic pump
      post-operatively, or require post operative analgesia beyond 14 days) to receive either
      tramacet 1-2 tablets orally every 4 hours prn or percocet 1-2 tablets orally every 4 prn. At
      time of discharge patients will recieve unidentifiable tablets in an unidentifying container
      of the usual dispense amount that their surgeon would standardly prescribe(range is usually
      between 30 and 60 tabs).

      At 6 weeks patients will receive a phone call to determine a) brief pain inventory score for
      the month. B) if they sought a second opioid prescription. C) if they plan to seek a second
      script. E) satisfaction of post operative pain control on a 1-10 numerical scale f) any
      adverse side effects.
    

Intervention name(s): Tramacet; Percocet
Intervention type(s): Drug; Drug
Intervention description(s): Pain medication commonly used post-operatively; Pain medication commonly used post-operatively
Other intervention name(s): tramadol/acetominophen; oxycodone/acetominophen
Intervention MeSH terms: Acetaminophen; Oxycodone; Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Post Operative Pain; Addiction
Study To Assess The Bioequivalence Under Fed And Fasted Conditions Of The Fesoterodine Beads-In-Capsule SR4 And SR7 Formulations And To Estimate The Bioavailability of SR7 Beads Sprinkled On Apple Sauce Relative To The Beads-In-Capsule SR7 Formulation Administer
Condition: Neurogenic Detrusor Overactivity
MeSH terms: Urinary Bladder, Overactive; Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      Open Label, Single-Dose, Crossover Study To Assess The Bioequivalence Under Fed And Fasted
      Conditions Of The Fesoterodine Beads-In-Capsule (BIC) SR4 And SR7 Formulations And To
      Estimate The Bioavailability of SR7 Beads Sprinkled On Apple Sauce Relative To The
      Beads-In-Capsule SR7 Formulation Administered Intact.
    

Detailed description: 
      After oral administration, fesoterodine is not detected in plasma as it is rapidly and
      extensively hydrolyzed by non-specific esterases to its primary active metabolite
      5-hydroxymethyl tolterodine (5-HMT) . Therefore characterization of the rate and extent of
      absorption of the test and reference fesoterodine formulations will be based on
      pharmacokinetic parameters of 5-HMT derived from the 5-HMT concentration-time profiles.
    

Intervention name(s): Fesoterodine BIC SR4 fasted (Treatment A in Part A, Treatment G in Part B); Fesoterodine BIC SR7 fasted (Treatment B in Part A, Treatment H in Part B); Fesoterodine BIC SR7 fed (Treatment C in Part A, Treatment F in Part B); Fesoterodine BIC SR7 on apple sauce (Treatment D in Part A); Fesoterodine BIC SR4 fed (Treatment E in Part B)
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 4 mg administered under fasted condition.; 4 mg administered under fasted conditions.; 4 mg administered under fed conditions.; 4 mg sprinkled on apple sauce administered under fasting conditions; 4 mg administered under fed conditions
Intervention MeSH terms: Fesoterodine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is a Phase 1 randomized, open-label, single-dose crossover study in healthy participants. A two stage approach outlined below will be followed:
Part A (Cohort 1): This part of the study is a 2 sequence, 4 period, crossover design.
Part B (Cohort 2): This part of the study is a 4 sequence, 4 period, crossover design. Participants will be randomized to 1 of 4 possible treatment sequences. If bioequivalence (BE) criteria for the comparison of the BIC SR7 formulation with the BIC SR4 formulation administered in the fasted state are met in Part A, the formulations will be considered bioequivalent in the fasted state and only the first two periods of Part B will be conducted. Part B (all periods) may not be conducted if the AUCinf or Cmax Percent Geometric Mean Ratio GMR is less than 90% and greater than 111% and/or if variability suggest a highly variable drug (e.g., greater than 30%) because BE demonstration may not be possible with a reasonably sized 4 sequence 4 period study.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Phase I, Fesoterodine beads- in-capsule, Bioequivalence, Pharmacokinetics