bioihbjkbjnl/mcl2 huggingface dataset:
A Bioequivalence Study Testing Two Formulations of Sotagliflozin in Healthy Male and Female Subjects Under Fasted Conditions
Condition: Type 2 Diabetes Mellitus; Healthy Subjects
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To determine the bioequivalence of a single dose of one tablet of sotagliflozin (test)
      compared to two tablets of sotagliflozin (reference) under fasting conditions in healthy male
      and female subjects

      Secondary Objectives:

        -  To evaluate the single-dose pharmacokinetics of sotagliflozin following administration
           of one tablet sotagliflozin (test) compared to two tablets of sotagliflozin (reference)
           in healthy male and female subjects under fasting conditions

        -  To evaluate safety and tolerability of one tablet sotagliflozin (test) compared to two
           tablets of sotagliflozin (reference) administered under fasted conditions in healthy
           male and female subjects
    

Detailed description: 
      Study duration per participant is approximately 103 days including a screening period up to
      21 days before first dose, 4 periods of dosing and pharmacokinetic (PK) sampling each lasting
      7 days, a washout period of 8-21 days between dosing, and an end of study visit 10-15 days
      after the last dose.
    

Intervention name(s): sotagliflozin (SAR439954)
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form: tablet
Route of administration: oral
Intervention MeSH terms: (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Determine the Fed Bioequivalence of Reformulated OXY Tablets and Original OxyContin® (OXY) Tablets
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the bioequivalence of a new oxycodone formulation (10
      mg) relative to the original OxyContin® (OXY) formulation (10 mg) in the fed state.
    

Detailed description: 
      Oxycodone hydrochloride (oxycodone) is a semi-synthetic opioid analgesic that is effective in
      the relief of moderate to severe malignant and non-malignant pain.
    

Intervention name(s): Reformulated OXY (oxycodone HCl); Original OxyContin® (OXY) (oxycodone HCl)
Intervention type(s): Drug; Drug
Intervention description(s): Reformulated OXY 10-mg tablet x 1 dose taken with food.; Original OxyContin® (OXY) 10-mg tablet x 1 dose taken with food.
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: healthy subjects; opioid
Anfibatide Phase Ib-IIa Clinical Trial
Condition: Non-ST Segment Elevation Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Investigate the safety and efficacy of Anfibatide in non-ST segment myocardial infarction
      patients
    

Detailed description: 
      1. This study is a phase Ib-IIa exploratory study to observe the safety of Antiplatelet
           Thrombolysin for Injection for the treatment of non-ST segment myocardial infarction
           (NSTEMI) patients and preliminarily evaluate the efficacy of different doses, providing
           the theoretical basis of the phase II and III clinical study protocol.

        2. To investigate the pharmacokinetics of different doses.
    

Intervention name(s): Anfibatide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Snake venom; Saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: anti-platelet;; safety;; efficacy
Exploring the Safety And Tolerability of Doses of E2007 up to a Maximum of 12 mg In Patients With Refractory Partial Seizures
Condition: Epilepsy
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled, parallel group study to determine the
      maximum tolerated dose of E2007. Epilepsy patients with refractory partial seizures will be
      divided into two groups of 24 patients each. One group will be patients who take concomitant
      inducing AEDs (anti-epileptic drugs) and the second group will be patients who do not take
      concomitant inducing AEDs. In each group, 18 patients will receive E2007 (dose escalating to
      a maximum of 12 mg per day) and six will receive placebo.
    


Intervention name(s): E2007; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Normal Variation of T1 Values With Cardiac Magnetic Resonance in Healthy Individuals
Condition: Cardiac Magnetic Resonance; T1 Mapping; Healthy Individuals
Study type: Interventional

Summary: 
      The purpose of the study is to determine the normal variation of T1 values with cardiac
      magnetic resonance in healthy individuals with respect to reproducibility, changes over time,
      and dependency on hydration status.
    

Detailed description: 
      T1 mapping with cardiac magnetic resonance (CMR) is a novel non-invasive technique to
      quantitatively characterize the myocardium. T1 mapping is a surrogate marker of myocardial
      edema and fibrosis, and has the potential to be implemented in the diagnosis and follow-up of
      various cardiac diseases. However, there is limited data on the natural variation of T1
      mapping in healthy individuals.

      The study comprises three substudies:

        1. Reproducibility: Two identical CMR examinations with T1 mapping will be performed on the
           same day .

        2. Hydration changes: Participants will receive two liters of isotonic saline intravenously
           between two identical CMR with T1 mapping and echocardiographic examinations. The
           post-fluid order of CMR and echocardiography will be randomized.

        3. Time changes: Participants will undergo CMR with T1 mapping at baseline, at 6-months
           follow-up, and at 1-year follow-up.
    

Intervention name(s): Fluid administration (Fresenius Kabi Sodium Chloride 0.9%)
Intervention type(s): Other
Intervention description(s): All participants in substudy 2 will be administered 2 liters of isotonic saline infusion (Fresenius Kabi Sodium Chloride 0.9%) intravenously. CMR and echocardiography will be performed before and after infusion.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Mediterranean Diet and Mushrooms
Condition: Diet, Healthy
Study type: Interventional

Summary: 
      The investigators propose to assess the effects of including mushrooms as part of a healthy
      eating pattern on indices of perceived mental health/anxiety/depression, along with risk
      factors for cardiovascular disease and type 2 diabetes.
    

Detailed description: 
      The investigators hypothesize that consuming mushrooms as part of a healthy eating pattern
      will lead to greater improvements in fasting insulin concentrations and systolic and
      diastolic blood pressures. The brain health-related outcomes and other cardiometabolic risk
      outcomes (e.g. lipoprotein particle size) are exploratory due to the paucity of human
      research addressing these important topics. Collectively, this short-term (8-week)
      randomized, controlled feeding trial will provide important pilot data to inform the
      plausibility, focus, and design of longer-term intervention trials, consistent with The
      Mushroom Council's research agenda.
    

Intervention name(s): Mediterranean Diet -- Mushrooms; Mediterranean Diet -- Control
Intervention type(s): Other; Other
Intervention description(s): During the 2-week baseline period all participants will consume their usual, unrestricted self-chosen diets. During intervention weeks 1-8, all participants will consume the same Mediterranean-style diet, rich in fruits and seafoods and lower in dairy, designed to meet their estimated energy needs. The mushroom group will consume 0.5 cups/day of cooked mushrooms (white button mushrooms and yellow oyster mushrooms on 4 and 3 days/week, respectively). All foods will be provided to subjects during the intervention to achieve the desired eating pattern.; During the 2-week baseline period all participants will consume their usual, unrestricted self-chosen diets. During intervention weeks 1-8, all participants will consume the same Mediterranean-style diet, rich in fruits and seafoods and lower in dairy, designed to meet their estimated energy needs. The control group will not consume mushrooms at any point. All foods will be provided to subjects during the intervention to achieve the desired eating pattern.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: For this investigator-blinded, randomized, parallel design study, 100 participants (60 to finish; n=30/group) will complete a 10-week study period, which includes a 2-week baseline testing period (no diet control), followed by an 8-week controlled diet period (Figure 1). In order to define the effects of adding mushrooms to a healthy dietary pattern on fasting blood glucose and insulin concentrations and blood pressures, we will provide a Mediterranean-style diet devoid of mushrooms as the control diet for this study. Questionnaires assessing depression/anxiety, perceived quality of life, and mood will be administered and the results will provide a foundation to power future, more robust, studies.
Masking: Single (Investigator)
Primary purpose: Screening
Keywords: Mediterranean; Mushrooms
Effect of Cyclic Loading (Vibration) on Orthodontic Tooth Movement
Condition: Malocclusion
MeSH terms: Malocclusion
Study type: Interventional
Phase: Phase 3

Summary: 
      To gather data indicating whether or not the OrthoAccel device speeds tooth movement in
      people who use orthodontics (braces).
    

Detailed description: 
      This is a randomized, blinded study that will follow 32 patients for up to six months.
      Patients will have a minimum of 3 mm of extraction space that needs to be closed by moving
      the anterior teeth or canine distally. Patients will have standard orthodontic treatment and
      temporary anchorage devices for tooth movement and space closure. Half the patients will
      receive a functioning device and half the patients will receive a sham-device. Patients will
      use the device for 20 minutes daily; the device has a mouthpiece for the patient to lightly
      bite into plus a connected enclosure that stays outside the mouth. The enclosure provides a
      light vibration.
    

Intervention name(s): OrthoAccel Device; Sham Device
Intervention type(s): Device; Device
Intervention description(s): The OA device provides a light vibration at 0.25 Newtons and 30 Hz frequency for 20 minutes daily.; Inactive sham device that is held in the mouth for 20 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Orthodontic; Extraction; Device; Space Closure; Orthodontic malocclusion
Antibiotic Use in a Neonatal Intensive Care Unit Practicing Integrative Medicine
Condition: Neonatal Infection
MeSH terms: Infections
Study type: Observational

Summary: 
      The goal of this study is to describe the antibiotic use in a neonatal intensive care unit
      (NICU) in Germany that is practising integrative medicine. The investigators will review
      hospital records to find out how often and how long antibiotics were given to newborns;
      compare antibiotic use to other NICU in the same area; describe how sick infected newborns
      were (comparing those treated with or without antibiotics); and describe which anthroposophic
      medicines were used, how often and if there were safety problems.
    

Detailed description: 
      A retrospective study, analysing antibiotic use in a level 2 neonatology intensive care unit
      (NICU) in Germany over a 4-year period from 2014 to 2017. The study will analyse frequency of
      antibiotic prescribing; compare antibiotic use to other level 2 NICU; compare clinical and
      laboratory parameters among neonates with infectious disease diagnosis managed with or
      without antibiotics; use and tolerability of anthroposophic medicinal products.
    

Intervention name(s): Antibiotic treatment; No antibiotic treatment
Intervention type(s): Other; Other
Intervention description(s): Antibiotic treatment; No antibiotic treatment
Intervention MeSH terms: Anti-Bacterial Agents; Antibiotics, Antitubercular
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Neonates (aged 0 to 30 days) who are hospitalized for neonatal infection.
      
Keywords: Neonatal infection; Neonatal sepsis; Antibiotic prescribing; Antibiotic stewardship
Staccato Fentanyl Single and Multidose PK
Condition: Breakthrough Pain
MeSH terms: Breakthrough Pain
Study type: Interventional
Phase: Phase 1

Summary: 
      The Phase I clinical trial in approximately 50 healthy volunteers will be conducted at a
      single clinical center in two stages. Stage 1 is an open-label, cross-over comparison of a
      single dose of Staccato Fentanyl and an equivalent dose of intravenous (IV) fentanyl. Stage 2
      is a randomized, doubleblind, placebo-controlled dose escalation of Staccato Fentanyl,
      evaluating multiple doses of fentanyl. The three primary aims of the Phase I clinical trial
      are to evaluate the pharmacokinetics (PK) and absolute bioavailability for Fentanyl, compare
      the Staccato Fentanyl PK profile to the IV fentanyl PK profile, and examine the tolerability
      and safety of Staccato Fentanyl in a non-opioid-tolerant, healthy volunteer population.
    


Intervention name(s): Inhaled Placebo; Inhaled Fentanyl 25 mcg; Intravenous Fentanyl 25 mcg; Inhaled Fentanyl 25 mcg x 2; Inhaled Fentanyl 25 mcg x 4; Inhaled Fentanyl 25 mcg x 6; Inhaled Fentanyl 25 mcg x 12
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Inhaled Staccato Placebo, same number of doses as active comparator in that arm; Inhaled Staccato Fentanyl, 25 mcg x 1 dose; Intravenous Fentanyl 25 mcg, single dose; Inhaled Staccato Fentanyl, 25 mcg x 2 doses; Inhaled Staccato Fentanyl, 25 mcg x 4 doses; Inhaled Staccato Fentanyl, 25 mcg x 6 doses; Inhaled Staccato Fentanyl, 25 mcg x 12 doses
Intervention MeSH terms: Fentanyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Staccato Fentanyl, Pharmacokinetics, Pharmacodynamics, inhaled fentanyl
Effect of Altered Mechanical Loading in ACLR
Condition: Anterior Cruciate Ligament Reconstruction
Study type: Interventional

Summary: 
      Altered loading is a causative factor for the development of knee osteoarthritis following
      anterior cruciate ligament reconstruction (ACLR), and real-time biofeedback may be an
      effective intervention to manipulate altered mechanical loading about the knee. The purpose
      of this study is to 1) determine if ACLR participants are able to acquire and retain various
      loading patterns using real-time biofeedback, 2) determine the effect of altered loading on
      lower extremity biomechanics during walking gait, and 3) determine the effect of altered
      loading on biochemical markers of collagen turnover and inflammation during walking gait.
    

Detailed description: 
      Participants will attend 4 testing sessions. Lower extremity biomechanical outcomes and blood
      samples will be taken before and following the participant walking at a self-selected speed
      for 20 minutes. During the 20 minutes of treadmill walking real-time biofeedback will be
      displayed in an attempt to alter mechanical loading. Participants will complete a control,
      overloading, under-loading, average loading testing session. Order of loading condition will
      be randomized.
    

Intervention name(s): Real-Time Biofeedback
Intervention type(s): Other
Intervention description(s): A custom written MatLab script will sample bilateral peak vertical ground reaction forces and display the magnitude in real time on a screen placed in front of the participant. A target line will be placed in the middle of the screen which corresponds to one of the three loading conditions. Participants will be instructed to alter their movement in an attempt to match each limb's vertical ground reaction force to the target line.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Lot-to-lot Consistency Trial of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine
Condition: Japanese Encephalitis
MeSH terms: Encephalitis, Japanese; Encephalitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The proposed study is a four-arm double-blind randomized controlled single center trial to
      evaluate, by examining post-vaccination seroprotection titers, the lot-to-lot consistency of
      three lots of Japanese Encephalitis live attenuated SA 14-14-2 vaccine (LJEVac) manufactured
      in a new good manufacture practice (GMP) facility, and to establish non-inferiority of the
      new vaccine in comparison to a single lot of the same vaccine manufactured in the existing
      facility. The study aimed to enroll a total of 1,000 Bangladeshi infants aged 10 to 12
      months. In addition to providing immunogenicity data, this study provided local safety data
      of JE live attenuated SA 14-14-2 vaccine among Bangladeshi children. This is the first step
      to secure licensure for this life-saving vaccine in Bangladesh as well as provide data to
      support WHO prequalification of JE live attenuated SA 14-14-2 vaccine.
    


Intervention name(s): Vaccine produced in existing facility; Vaccine produced in new facility
Intervention type(s): Biological; Biological
Intervention description(s): Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the existing facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China; Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Cardiovascular Biomarkers and Quetiapine in Depression and Anxiety Patients
Condition: Depression; Anxiety
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      No suitable treatment has been identified to reverse and ideally prevent, the cardiovascular
      disease risk associated with depression and anxiety. The purpose of this study is to
      determine if quetiapine treatment of depression can reverse the signs of arterial stiffening
      that often occurs in depression and anxiety, and which are believed to be risk factors for
      future heart disease.
    

Detailed description: 
      The evidence that depressive and anxiety disorders confer a high relative risk (RR) for
      cardiovascular disease (CVD) development is clear and compelling. A cadre of inflammation,
      platelet activation and other biomarkers of endothelial dysfunction strongly suggest multiple
      and possibly interrelated mechanisms underlying this co-morbidity. Early detection of the
      vulnerability to develop CVD has become an urgent health issue. However, detection alone of
      vulnerability without proper therapeutic intervention aimed at reversing it, is merely of
      scientific interest. The evidence to date that antidepressant drugs, while highly efficacious
      in restoring euthymia, may not normalize the biomarkers of CVD vulnerability. Hence, there is
      a need to identify other pharmacologic interventions for depression. Quetiapine, due to its
      unique molecular structure and unique pharmacological profile, belongs to none of the known
      classes of antidepressants. However, quetiapine clearly has antidepressant and anti-anxiety
      efficacies. Now, we propose to explore whether quetiapine can reverse those
      pathophysiological changes occurring in mixed depression/anxiety that have been linked
      causally to the development of CVD. Accordingly, the primary purpose of this study is to
      compare C-Reactive Protein between the treatment and healthy control groups at 12 weeks post
      treatment.
    

Intervention name(s): Quetiapine-XR
Intervention type(s): Drug
Intervention description(s): Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks.
Other intervention name(s): Seroquel
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cardiovascular Biomarkers; Depression; Quetiapine
Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of SUN13837 Injection in Adult Subjects With Acute Spinal Cord Injury (ASCI)
Condition: Acute Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to gather scientific information about the
      effectiveness of the study drug, SUN13837 Injection, when compared with the placebo (inactive
      substance) in participants with acute spinal cord injury.
    


Intervention name(s): SUN13837 injection; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SUN13837 injection, injection 1 x daily for 28 doses; Matching placebo, volume equivalent to injection 1 x daily for 28 doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ASCI; SUN13837; Acute traumatic cervical spinal cord injury
A 12-week Human Trial to Compare the Efficacy and Safety of Polycan on Bone Metabolism
Condition: Bone Health in Perimenopausal Women
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Beta-glucans are polysaccharides consisting of glucose residue jointed by beta linkage. They
      are found at a high level in the cell wall of fungi, yeast, oat, barley, bacteria, as well as
      various mushroom. Studies have reported that extract of mushroom (Pleurotus eryngii) can
      prevent the bone loss caused by estrogen deficiency. Furthermore, polycan (a purified
      β-glucan from Aureobasidium pullulans) has been reported to exhibit osteoporosis preventing
      effects. However, no investigation has been conducted on the effect of polycan on bone health
      in perimenopausal women.

      Therefore, in this study, we investigated the effect of polycan on biochemical markers of
      bone metabolism in Korean perimenopausal women.
    


Intervention name(s): Polycan; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): polycan 150 mg/d for 12 weeks; Placebo 150mg/d for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Polycan; Bone metabolism; Osteocalcin; Deoxypyridinoline