bioihbjkbjnl/mcl2 huggingface dataset:
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effect of the administration of multiple doses
      of GLPG4716 on the amount of midazolam (MDZ) that gets into the blood when the two drugs are
      administered together compared to when midazolam is administered alone. Other objectives of
      this study are to evaluate the safety and tolerability of GLPG4716 when administered with
      midazolam and assess the amount of GLPG4716 that gets into the blood when administered with
      midazolam. This study will also assess the effect of food on the amount of GLPG4716 that gets
      into the blood.
    


Intervention name(s): GLPG4716; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): From Day 3 to Day 14, participants will receive GLPG4716 tablets once daily in fasted state. On Day 8 GLPG4716 will be administered in fed state.; On Days 1, 3 and 13, participants will receive a single oral dose of MDZ as an oral solution in fasted state.
Intervention MeSH terms: Midazolam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Evaluation of Vaccinal and Natural Immunity Against Meningococcus C
Condition: Prevention of Meningococcus C Infections
Study type: Interventional

Summary: 
      Meningococcus C vaccine was first used in France to prevent epidemics. It was a success in
      Puy-de-Dôme, Landes, Pyrénées Atlantiques and Hautes Pyrénées. Following many European
      countries, France introduced meningococcus C conjugate vaccine in 2009 but this
      recommendation was not suffiicently applied (6,6% of the 20-25 years-old were vaccinated in
      2015).

      The situation in France is very different from UK and there is no data on the subject. The
      vaccination campaign in 2002 in Puy-de-Dôme offers much more detachment, possible comparison
      between vaccinated and unvaccinated people, among which meningococcus circulation could
      maintain immunity. This is the reason why we have decided to assess in 2016 the vaccinal and
      natural immunity among Puy-de-Dôme population.
    

Detailed description: 
      People were recruited during hospitalisation or consultation of Pediatric, Occupational
      Medecine, Infectiology departments of Clermont Ferrand Hospital or Health Service of
      Auvergne's University, from March to September 2016.

      Doctors gave informations about the study and collected consents before blood tests were done
      (two tubes of 4,5mL each).

      Blood tests were daily collected and freezed. Then they were analysed at Meningococcus
      National Reference Center, in Paris.
    

Intervention name(s): Meningococcus C conjugate vaccine
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: meningococcus C
Effect of Linezolid on Ex Vivo Neutrophil and Monocyte Function in Healthy Males
Condition: Gram Positive Infection
Study type: Interventional
Phase: Phase 1

Summary: 
      Results from previous studies have been inconclusive and the effect of linezolid on cytokines
      remains unclear. This study is designed to evaluate the effect of linezolid on the
      functionality of white blood cells (neutrophils and monocytes) in healthy subjects.
    


Intervention name(s): linezolid; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 600 mg oral tablet twice daily for 4.5 days; 500 mg oral placebo twice daily for 4.5 days
Other intervention name(s): Zyvox
Intervention MeSH terms: Linezolid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Study to Investigate the Potential Pharmacokinetic Interaction of Perampanel With Oral Contraceptives in Healthy Female Subjects
Condition: Partial Onset Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the effects of perampanel on the pharmacokinetics
      (PK) of a single-dose oral contraceptive (OC)containing ethinylestradiol (EE) and
      levonorgestrel (LN) (Microgynon-30) and to investigate the effects of repeated dosing of OC
      containing EE and LN (Microgynon-30) on the PK of a single dose of perampanel.
    

Detailed description: 
      This will be an open-label, non-randomized, fixed sequence study in healthy female subjects.
      The study has 2 parts: Part A investigating the effects of steady state perampanel on the
      pharmacokinetics (PK) of a single-dose oral contraceptive (OC) containing ethinylestradiol
      (EE) and levonorgestrel (LN) (Microgynon-30) and Part B investigating the effects of repeated
      dosing of an OC containing EE and LN (Microgynon-30) on the PK of a single dose of
      perampanel.
    

Intervention name(s): Perampanel and Microgynon-30; Perampanel and Microgynon-30
Intervention type(s): Drug; Drug
Intervention description(s): Part A: Microgynon-30 single oral dose on Day 1 Period 1 and Day 35 Period 2; perampanel oral daily dose starting at 4 mg per day Period 2 from Days 1 through 35 and titrated weekly.; Part B: Perampanel single oral dose of 6 mg on Day 1 Period 1 and Day 21 Period 2; Microgynon-30 orally from Day 1 through Day 21 of Period 2.
Intervention MeSH terms: Ethinyl estradiol, levonorgestrel drug combination; Ethinyl Estradiol-Norgestrel Combination
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: epilepsy
Efficacy and Safety Study of Satralizumab (SA237) as Add-on Therapy to Treat Participants With Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)
Condition: Neuromyelitis Optica (NMO); NMO Spectrum Disorder (NMOSD)
MeSH terms: Neuromyelitis Optica
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to evaluate the efficacy, safety, pharmacodynamic,
      pharmacokinetic, and immunogenic profiles of satralizumab, compared with placebo, in addition
      to baseline immunosuppressive treatment in participants with NMO and NMOSD.
    


Intervention name(s): Satralizumab; Placebo; Baseline Treatment
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Satralizumab will be administered subcutaneously (SC) at Weeks 0, 2, and 4, and thereafter once every 4 weeks (Q4W).; Placebo will be administered subcutaneously (SC) at Weeks 0, 2, and 4, and thereafter once every 4 weeks (Q4W).; As specified in the protocol, one of the following drugs at a stable dose is required as monotherapy for baseline treatment during the double-blind period: azathioprine (AZA); mycophenolate mofetil (MMF); or oral corticosteroids (CS). For participants aged 12 to 17 years at the time of informed consent, baseline treatment with AZA or MMF in combination with oral CS is also permitted. Change or termination of baseline treatment is only permitted during the open-label extension period.
Other intervention name(s): SA237; RG6168; RO5333787
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Reliability and Validity of Strength Measurements of the Lower Limbs in Children With Bilateral Spastic Cerebral Palsy.
Condition: Children; Cerebral Palsy; Muscle Weakness
MeSH terms: Muscle Weakness; Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      Specific musculo-tendinous adaptations in children with cerebral palsy (CP) have an influence
      on muscle strength and consequently on functional behavior and participation. Evidence of
      strength training programs has been shown on level of body function but transfer to levels of
      activity and participation is still limited. Lack of transfer is related to lack of
      specificity of the training and poor overall quality of the interventions (intensity,
      duration, frequency and/or type).

      The use of functional strength exercises to assess and train strength of the lower limbs in
      children with CP is well implemented in the most functional children with CP (GMFCS-level I).
      To assess isometric strength the hand held dynamometer (HHD) can be used in clinical settings
      but reliability of this tool is questionable.

      The aim of this study is to adapt existing functional strength tests for less functional
      children with CP (focussing on GMFCS level II and III) and to investigate the correlation
      with isometric strength measurements and other functional parameters.
    

Detailed description: 
      Specific musculo-tendinous adaptations in children with cerebral palsy (CP) have an influence
      on muscle strength and consequently on functional behavior and participation. Evidence of
      strength training programs has been shown on level of body function but transfer to levels of
      activity and participation is still limited. Lack of transfer is related to lack of
      specificity of the training and poor overall quality of the interventions (intensity,
      duration, frequency and/or type).

      The use of functional strength exercises to assess and train strength of the lower limbs in
      children with CP is well implemented in the most functional children with CP (GMFCS-level I).

      The aim of this study is to adapt existing functional strength tests for less functional
      children with CP (focussing on GMFCS-level II and III) and to investigate the correlation
      with isometric strength measurements and other functional parameters.
    

Intervention name(s): Functional strength assessment
Intervention type(s): Other
Intervention description(s): Functional strength exercises to assess strength in lower limbs.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cerebral palsy; Children; Functional strength measurement; Lower limbs; Reproducability
Trial of Caldolor for Treatment of Pain in Post-Operative Adult Patients
Condition: Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study of Caldolor (IV ibuprofen) administered to post-operative
      hospitalized adult patients every 6 hours for 48 hours is to determine the efficacy of
      Caldolor compared to placebo for the treatment of post-operative pain as measured by
      reduction in the requirement for the narcotic analgesic, morphine, post surgery
    


Intervention name(s): Normal saline as placebo comparator; Intravenous ibuprofen
Intervention type(s): Other; Drug
Intervention description(s): 250 ml normal saline as a placebo comparator was administered every 6 hours for a total of eight doses over the first 48 hours. Those patients who received the initial eight doses could continue to receive additional doses as needed through the end of the treatment period (day 5); 800 mg intravenous ibuprofen diluted in 250 milliliters of normal saline was administered every 6 hours for a total of eight doses over the first 48 hours.
Those patients who received the initial eight doses could continue to receive additional doses as needed through the end of the treatment period (day 5)
Other intervention name(s): NS; Caldolor
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Coronary Drug Project Mortality Surveillance
Condition: Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Infarction; Myocardial Ischemia
MeSH terms: Cardiovascular Diseases; Heart Diseases; Myocardial Infarction; Coronary Disease; Myocardial Ischemia; Infarction; Ischemia
Study type: Interventional

Summary: 
      To determine whether there were any long term sequelae of the drugs used in the Coronary Drug
      Project (estrogens, dextrothyroxine, nicotinic acid, clofibrate).
    

Detailed description: 
      BACKGROUND:

      Three of the CDP treatments (two doses of estrogen and dextrothyroxine) were stopped
      prematurely because of toxicity. At the time the treatments were stopped, it was thought that
      future assessment of the status of patients on those treatments would be important to
      evaluate long-term sequellae. Another clinical trial evaluating clofibrate for primary
      prevention found that more patients on that treatment than on placebo had died. This effect
      persisted even after the treatment was stopped. Therefore, it was considered necessary to
      follow the CDP patients on clofibrate.

      Of the original 834l patients, about 6000 were still alive in March l975. Cause-specific
      mortality in those patients was assessed through March l980.

      DESIGN NARRATIVE:

      The vital status of the subjects known to be alive at the end of the CDP in March l975 was
      assessed as of March l980. This was accomplished through questioning the local investigators,
      letters to the subjects, and by use of Social Security Administration and National Death
      Index records.

      The study completion date listed in this record was obtained from the Query/View/Report (QVR)
      System.
    

Intervention name(s): estrogen; clofibrate; dextrothyroxine sodium; niacin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Niacin; Clofibrate; Estrogens
Allocation: Randomized
Primary purpose: Prevention
Tamsulosin Phase III Clinical Trial -Double-Blind, Placebo Controlled Study in Male Patients With Lower Urinary Tract Syndrome
Condition: Urinary Tract Diseases
MeSH terms: Urologic Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether Tamusulosin is effective in the treatment
      of lower urinary tract syndrome with male patients.
    


Intervention name(s): Tamusulosin
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: tamsulosin; urinary tract diseases; male
Biopsychosocial Impact on Caregivers in Patients Undergoing Joint and Spine Surgery
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Observational

Summary: 
      The purpose of this study is to describe the biopsychosocial impact of caregivers in patients
      undergoing total knee arthroplasty, total hip arthroplasty, and cervical/thoracic/lumbar
      spine surgery.Defining such impacts may offer opportunities to enhance caregiver capability
      to provide care following surgery on a loved one.
    

Detailed description: 
      This is a pilot feasibility study with the goal of enrolling 50 caregivers in each surgical
      subgroup, with a total of 150 subjects. Caregivers for patients undergoing the above
      surgeries will be administered Patient Reported Outcome Measurement Information System
      (PROMIS) measures preoperatively, 7 days postoperatively, 14 days postoperatively, and 1
      month postoperatively. PROMIS item banks will include Global Health, Anxiety, Fatigue,
      Depression, Self Efficacy, Social Satisfaction, and Sleep Disturbance. If the caregiver
      reports the presence of persistent pain, Pain Interference and Physical Function will be
      administered.
    

Intervention name(s): No specific treatment based intervention-health measurement instrument
Intervention type(s): Other
Intervention description(s): Caregivers will receive a series of standard health measurement tools/survey from NIH's Patient Reported Outcome Measurement Information System (PROMIS)
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Caregivers of male and female military health care beneficiaries age 18 years and older
        presenting for total knee arthroplasty, total hip arthroplasty, and
        Cervical/Thoracic/Lumbar spine surgery. Caregivers are defined as individuals who will be
        the primary source of assistance (medical, rehabilitative, daily living, etc) within the
        first 30 days after surgery.
Atomoxetine Versus Placebo in Children With Attention Deficit/Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Atomoxetine versus placebo in Children with Attention-Deficit/Hyperactivity Disorder (ADHD)
    


Intervention name(s): Atomoxetine; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Determinants Of Oral Corticosteroid Responsiveness in Wheezing Asthmatic Youth
Condition: Asthma
MeSH terms: Respiratory Sounds
Study type: Observational

Summary: 
      The aim of the prospective cohort study is to: (1) document the magnitude of response to oral
      corticosteroids administered to children presenting to the emergency department with moderate
      or severe asthma and (2) quantify clinically available potential determinants of the response
      to corticosteroids, such as age, gender, triggers of the index exacerbation, environmental
      tobacco smoke (ETS), gene polymorphisms, and their interactions.
    

Detailed description: 
      The objective of the large multicentre cohort study is to quantify the response to oral
      corticosteroids in children aged 1 to 17 years presenting to the ED with a moderate or severe
      asthma exacerbation.

      The main outcome is hospital admission within 72 hours of the oral corticosteroid
      administration.

      Secondary outcomes include the change in Pediatric Respiratory Assessment Measure (PRAM),
      length of active treatment and other markers of response to therapy in the ED as well as
      markers of recovery over the next 10 days.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children aged 1 to 17 years with moderate to severe asthma with Pediatric Respiratory
        Assessment Measure (PRAM) ≥4.
      
Biospecimen description: 
      Saliva for cotinine and for DNA and nasopharyngeal samples for viral analysis.
    
Keywords: Asthma; Children; Cohort study; Corticosteroids
Evaluate the PK of Multiple Oral Doses of Tegoprazan, Metronidazole, Tetracycline and Bismuth in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to evaluate the pharmacokinetic interaction between tegoprazan and
      combination of metronidazole, tetracycline and bismuth in healthy adult volunteers.
    

Detailed description: 
      A open-label, randomized, multiple dose, two arm, two period, crossover study
    

Intervention name(s): Tegoprazan; Metronidazole; Tetracycline; Bismuth
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tegoprazan 50 mg tablet; Metronidazole 250 mg tablet; Tetracycline hydrochloride 250 mg capsule; Tripotassium bismuth dicitrate 300 mg tablet
Other intervention name(s): K-CAB; Flasinyl; Teracyclin; Denol
Intervention MeSH terms: Metronidazole; Tetracycline; Bismuth
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug-Drug interaction; pharmacokinetic
Ketogenic Diet Health and Longevity
Condition: Ketogenic Dieting; Ketoses, Metabolic; Ketosis
MeSH terms: Ketosis
Study type: Interventional

Summary: 
      The goal of this pilot intervention is to learn about how a well-formulated ketogenic diet
      (WFKD) impacts various health factors in generally healthy adults. The main questions it aims
      to answer are:

        -  Establish whether an 8-week isocaloric, WFKD improves body composition and metabolic
           biomarkers in adults without chronic disease.

        -  Examine changes in transcriptomic sequencing pathways pre- and post-WFKD intervention.

        -  Explore gut microbial changes in adults without chronic disease that consume a WFKD.

      Participants will follow a well-formulated ketogenic diet for 8-weeks. Study procedures
      include:

        -  Weekly body weight tracking

        -  Daily urinary ketone assessment

        -  Pre/post stool samples for gut microbiota analyses

        -  Pre/post DXA scans

        -  Diet quality tracking through 3-day food records
    


Intervention name(s): Well-formulated Ketogenic Diet
Intervention type(s): Behavioral
Intervention description(s): 1:1 ketogenic diet that is focused on intake of high-quality fats (nuts/seeds, fatty fish, avocado) and reduction in processed food.
Intervention model: Single Group Assignment
Intervention model description: Single-arm, pilot clinical trial
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: ketogenic; well-formulated ketogenic diet; keto
Dose-escalation Study of GSK2330672 in Japanese Healthy Male Volunteers
Condition: Cholestasis
MeSH terms: Cholestasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be the first to evaluate the safety, tolerability, pharmacokinetics and
      pharmacodynamics following single dose of 10 milligrams (mg) to 180 mg of GSK2330672 in
      Japanese healthy subjects. This is a double-blind, randomized, placebo-controlled,
      dose-escalating and incomplete block crossover study to be conducted in 16 Japanese healthy
      subjects. Study will be conducted in four periods; subjects will receive either placebo or
      GSK2330672 (10 mg, 30 mg, 90 mg or 180 mg based on randomization) in each treatment period.
      Each period will be separated by washout period (at least 6 days from dosing). Total duration
      of study for each subject will be approximately 5 weeks from the first dosing to follow up
      visit.
    


Intervention name(s): GSK2230672; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): It will be supplied as white to slightly colored, round, film coated tablet for oral administration containing 10 mg or 45 mg of GSK2330672.; It will be supplied as placebo tablets (with no GSK2230672) visually matching to GSK2230672
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: tolerability; healthy volunteers; Cholestasis; safety
Evaluate Long-term Safety and Efficacy of ORADUR®-Methylphenidate in Children and Adolescents With ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the long-term safety and efficacy of
      ORADUR®-Methylphenidate in children and adolescents with ADHD.
    

Detailed description: 
      In order to evaluate the long-term safety and efficacy of ORADUR®-Methylphenidate in children
      and adolescents with ADHD, subjects who participated in the previous OP-2PN012-301 study will
      be invited to join this extension study for 24-month follow-up. Subjects will continue to
      receive ORADUR®-Methylphenidate at the previously determined optimal dose.
    

Intervention name(s): ORADUR®-Methylphenidate
Intervention type(s): Drug
Intervention description(s): ORADUR®-Methylphenidate is available in three dosage forms, 22 mg, 33 mg or 44 mg. Subjects will continue to receive ORADUR®-Methylphenidate at the previously determined optimal dose for 24 months.
Intervention MeSH terms: Methylphenidate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ORADUR®-Methylphenidate