bioihbjkbjnl/mcl2 huggingface dataset:
A Study of the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia.
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      A clinical study to evaluate the long-term safety and tolerability of an investigational drug
      in people with schizophrenia.

      This study is accepting male and female participants between 18 years old -65 years old who
      have been diagnosed with schizophrenia. This study will be conducted in approximately 50
      study centers worldwide. The study will last approximately 57 weeks.
    

Detailed description: 
      This is a 52-week, multicenter, randomized, double-blind, parallel-group, flexible-dose study
      designed to evaluate the long-term safety and tolerability of SEP-363856 (50 to 100 mg/day)
      compared with quetiapine XR (400 to 800 mg/day) in clinically stable adult subjects with
      schizophrenia. This study is projected to randomize a least 300 subjects to two treatment
      groups (SEP-363856 50 to 100 mg/day or quetiapine XR 400 to 800 mg/day) in a 2:1 ratio. Study
      drug will be taken once a day and may be taken without food or with a light meal.
    

Intervention name(s): SEP363856; quetiapine XR
Intervention type(s): Drug; Drug
Intervention description(s): SEP-363856, 50mg, 75mg, 100mg, flexibly dosed once daily capsule; quetiapine XR, 400, 600, 800 mg, flexibly dosed once daily capsule
Other intervention name(s): Seroquel XR
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A Randomized, Double-blind, Active Comparator-Controlled Study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia
A Study to Evaluate ASP8232 as Add-On Therapy to Angiotensin Converting Enzyme Inhibitor (ACEi) or Angiotensin Receptor Blocker (ARB) in Reducing Albuminuria in Patients With Type 2 Diabetes and Chronic Kidney Disease
Condition: Chronic Kidney Disease; Type 2 Diabetes
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Albuminuria; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy of ASP8232 in reducing Urinary Albumin
      to Creatinine Ratio (UACR) in subjects with Type 2 Diabetes Mellitus (T2DM) and Chronic
      Kidney Disease (CKD) at 12 weeks compared to placebo.
    


Intervention name(s): ASP8232; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): oral capsule; oral capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Kidney Disease; Type 2 Diabetes; ASP8232
Periodontal Osseous Wall Piezosplitting and EDTA Root Surface Etching
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional

Summary: 
      This study was designed to investigate the use of minimally invasive Piezo knife to harvest
      vascularized interceptal bone pedicle in treating intrabony defects.
    

Detailed description: 
      Sixteen non-smoking patients with severe chronic periodontitis participated in this
      prospective, randomized clinical study. Patients were randomly assigned into one of a 2
      groups (8 patients each): bone substitute grafting of the intrabony defect, control group
      (Gr1), intrabony defect osseous wall swaging (OWS) combined xenograft (Gr2). In both groups
      root surfaces where treated with a neutral 24% EDTA gel and saline irrigation. Clinical and
      radiographic measurements were reassessed at 6 months after surgery.
    

Intervention name(s): bone swaging
Intervention type(s): Procedure
Intervention description(s): osseous wall pedicle was placed to treat the infrabony defect by autogrnous bone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Examination of Implant´s Safety in an Electronic and Magnetic Field Environment
Condition: Disorder of Cardiac Pacemaker System; Disorder of Implantable Defibrillator; Cardiac Arrhythmia
MeSH terms: Arrhythmias, Cardiac
Study type: Observational

Summary: 
      The number of active electrical cardiac implants such as internal cardioverter defibrillators
      (ICDs), pacemakers or cardiac contractility modules (CCM) has significantly risen over the
      last two decades. This has been paralleled by an increase in the number of sources of
      electromagnetic fields in daily life and occupational circumstances.

      To date it remains unclear whether patients are at risk of device failure when being
      subjected to these fields. There are currently no general guidelines available to help
      clinicians informing their patients about safety levels and behavior around these
      electromagnetic fields.

      This study aims to identify the thresholds of safe use of these devices and potential
      failures under worst-case conditions in 50/60 Hz fields (i.e.

      power line frequency). Device implanted patients will be exposed to electric, magnetic and
      combined fields of different intensity at various device programming (e.g. nominal and
      maximum sensitivity). The results will show whether patients are safe in public or
      occupational environments, which medical relevant disturbances can occur and if a correlation
      exists between disturbances and device type or patients physique.
    


Intervention name(s): Magnetic and electric field´s impact on the implant
Intervention type(s): Device
Intervention description(s): Examination of magnetic and electric field's impact on the implant regarding: stability detection threshold using different strength of magnetic and electric field
Other intervention name(s): Examination
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        age between 18 and 80
      
Biospecimen description: 
      blood (serum and plasma) urine
Effect of Vortioxetine, Paroxetine, and Placebo on Sexual Functioning in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effect of vortioxetine (10 and 20 mg, once
      daily) versus paroxetine (20 mg, once daily) on sexual functioning in healthy participants
      after 5 weeks of double-blind treatment.
    

Detailed description: 
      The drug being tested in this study is called vortioxetine. This study will look at the
      effect of treatment on sexual functioning in healthy participants.

      The study will enroll approximately 352 participants. Participants will be randomly assigned
      (by chance, like flipping a coin) to one of the four treatment groups-which will remain
      undisclosed to the patient and study doctor during the study (unless there is an urgent
      medical need):

        -  Vortioxetine 10 mg

        -  Vortioxetine 20 mg

        -  Paroxetine 20 mg

        -  Placebo (dummy inactive pill) - this is a capsule that looks like the study drug but has
           no active ingredient

      All participants will be asked to take one tablet/capsule, daily, orally for up to 5 weeks.

      This multicenter trial will be conducted in United States. The overall time to participate in
      this study is approximately 7 weeks. Participants will be contacted by telephone 2 weeks
      after last dose of study drug for a follow-up assessment.
    

Intervention name(s): Vortioxetine; Paroxetine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Vortioxetine Overencapsulated Tablet; Paroxetine Overencapsulated Tablets.; Vortioxetine Placebo-matching Capsules.
Intervention MeSH terms: Vortioxetine; Paroxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Drug therapy
Effectiveness of a Novel Warm-up in Decreasing Risk Factors for ACL Injury in Female Youth Soccer Players
Condition: ACL Injury
MeSH terms: Wounds and Injuries; Anterior Cruciate Ligament Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      There is a large number of young women who sustain serious knee injuries from playing soccer.
      Female athletes are at high risk of knee injuries from soccer than males. We will conduct a
      research project to assess the effect of a warm-up on changing some of the movement patterns
      thought to contribute to these serious knee injuries.

      It is hypothesized that a core position and control movement strategy (Core-PAC) group reduce
      biomechanical risk factors at the knee compared to a control after the training program.
    

Detailed description: 
      There is a large number of young women who sustain serious knee injuries from playing soccer.
      Female athletes are at high risk of knee injuries from soccer than males. We will conduct a
      research project to assess the effect of a warm-up on changing some of the movement patterns
      thought to contribute to these serious knee injuries.

      A core position and control movement strategy (Core-PAC) may be one method of modifying
      high-risk movements such as side-cutting. The Core-PAC is a simple method of getting the
      centre of mass (COM) closer to the plant foot or base of support (BOS). Moving the COM closer
      to the BOS may bias joint loading to the sagittal rather than the frontal and transverse
      planes, which often occurs in female athletes and poses a risk for ACL injury.

      In this study, we will conduct a randomized controlled trial to compare a Core-PAC trained
      group to a control group for peak flexion angles and peak abduction moments at the knee
      during a side-cut and an unanticipated side-cut prior to kicking a soccer ball and a side-hop
      task after a six-week training program.

      It is hypothesized that a Core-PAC group would have greater peak flexion angles and lower
      peak abduction moments at the knee compared to a control after the training program.
    

Intervention name(s): Core-PAC
Intervention type(s): Other
Intervention description(s): Core position and control movement strategy (Core-PAC):
Do warm-up prior to 6 weeks of regular soccer training for peak flexion angles and peak abduction moments at the knee during a side-cut (SC) and an unanticipated side-cut (USC) prior to kicking a soccer ball and a side-hop (SH) task.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: ACL, Knee , Injury,
Implementation and Dissemination of an Evidence-Based Tobacco Product Use Prevention Videogame Intervention With Adolescents
Condition: Smoking Cessation; Smoking
Study type: Interventional

Summary: 
      To examine the effects on participants who play the smokeSCREEN game in that the game will
      have positive changes in their attitudes, beliefs, knowledge, intentions, behaviors and other
      outcomes related to smoking and tobacco products.
    

Detailed description: 
      For this project, the CVS Pharmacy Health Foundation has identified after-school, school, and
      youth programs nationwide with whom to partner. For this project, the play2PREVENT Lab will
      provide these programs access to the tobacco use reduction/prevention game that the lab has
      created (smokeSCREEN). Program and school staff will enroll participants between the ages of
      10-16 to play smokeSCREEN during their after school, school, and youth program. Before and
      after gameplay, participants will answer assessment questions related to their attitudes,
      beliefs, knowledge, intentions, and behaviors around smoking and tobacco product use. The
      data will be transmitted electronically via the LimeSurvey data collection platform to the
      Lab, for further analysis. None of the Lab staff will have contact with participants or
      after-school/school/youth program coordinators or staff.
    

Intervention name(s): smokeSCREEN web-based game
Intervention type(s): Device
Intervention description(s): smokeSCREEN tobacco use reduction/prevention web-based game. The game has 1.5-2 hours of unique game play and focuses on combustible cigarettes, e-cigarettes, and flavored tobacco products. Guided by the social cognitive theory and the theory of planned behavior, smokeSCREEN addresses a range of challenges that teens often face involving peer pressure and the use of tobacco products. Participants are provided access to the smokeSCREEN game through a private, password-protected website link and instructed to complete the game.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: smoking; tobacco; e-cigarettes; flavored tobacco
Blood Endothelium Biomarkers to Predict Major Adverse Cardiovascular Events After Percutaneous Coronary Intervention
Condition: Atherosclerosis; Percutaneous Coronary Intervention; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Atherosclerosis
Study type: Interventional

Summary: 
      In stent restenosis and myocardial infarction are have been linked the balance between injury
      and healing of the endothelium These processes can be measured respectively using the number
      of circulating endothelial cells and endothelial progenitor cells. We therefore aimed to
      evaluate the relationship between the balance of injury and healing of the endothelium at the
      time of PCI and major adverse cardiovascular events including death, myocardial infarction
      and target lesion revascularization at 6 and 12 months follow-up.
    

Detailed description: 
      Following percutaneous coronary intervention with bare metal stents, the rate of major
      adverse cardiovascular events including death, myocardial infarction and target lesion
      revascularization is high ranging between 20 and 25%.
    

Intervention name(s): Data private hospitals, angioplasty, sampling of blood
Intervention type(s): Other
Intervention description(s): Data private hospitals : Age, sex, index of body mass, factors of cardiovascular risk, medical surgical histories, treatment before and after the angioplasty, the renal insufficiency
coronary angioplasty
Sampling of blood : Before the angioplasty, 6 hours after the angioplasty and 24 hours after the angioplasty. A numeration of the proparents circulants (hématopoietics, PEC) and a numeration of CEC are made
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Major adverse
Pregabalin on Interleukin-6 Levels in Living Donor Kidney
Condition: Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      Pregabalin, a ligand for alfa2delta subunits of voltage-gated calcium channels, has been
      shown to be an effective adjuvant therapy for acute postoperative pain, by inhibiting central
      sensitization. The IL-6, is detectable 60 minutes after surgical incision, persisting for
      until 10 days, with maximal plasmatic level in 4 and 6 hours. The objective of this study is
      evaluating the analgesic effect of pregabalin and its repercussion on serum levels of IL6.
    

Detailed description: 
      After approved by the Ethical Committee and signed informed consent, 40 patients aged from 18
      until 60 years undergoing nephrectomy will be randomized in two groups. Group 1 patients will
      receive a single dose of 300 mg pregabalin, 1 hour before the surgical incision; group 2
      patients will receive a placebo dose. Pain intensity will be assessed with the numeric rating
      scale. The consumption of tramadol in 24 hours after surgery and the time for the first
      complementation dose will be registered. Blood samples will be collected by 6 hours and 24
      hours after surgical incision, for IL-6 dosage, and maintained at -70 celsus degree. The IL-6
      dosages will be performed by the ELISA (enzyme-linked immunosorbent assay) method. The number
      of patients was calculated by Instat Graph® program. To detect difference in pain intensity
      of 3 between the groups by NRS, with 95% of power (estimated SD= 2.0), when the alpha level
      is set at 0.05, the sample should be of 20. Statistical analyses will be performed with
      parametric and nonparametric tests, considering the variety studied. The statistical program
      that will be utilized is Instat Graph®.
    

Intervention name(s): Pregabalin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Effect of Preoperative Pregabalin on Pain Intensity. 300mg of pregabalin before surgical incision; placebo
Other intervention name(s): acute pain; interleukin-6
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: pregabalin; postoperative pain control; interleukin-6; acute pain
The EarLens Contact Hearing Device (CHD) Spectrum Study
Condition: Hearing Loss, Sensorineural
MeSH terms: Hearing Loss; Hearing Loss, Sensorineural
Study type: Interventional

Summary: 
      The EarLens System is an assistive hearing device that is intended to provide amplification
      for the treatment of patients with sensorineural hearing impairment. The purpose of the
      proposed study (Extended Investigation under the Continued Access Policy) is to continue to
      allow access to the investigational medical device with the collection of device utility and
      clinic process-flow data while the marketing application is under review at the FDA.
    

Detailed description: 
      The study is designed to obtain observational data and as such no primary safety or efficacy
      endpoints or sample sizes are computed. Information gathered about device utility and clinic
      procedures from the physician, audiologist as well as subject questionnaires will be analyzed
      for the purpose of optimizing the process flow in different types of practice settings. A
      subset of relevant safety and efficacy measures from the Definitive Study (DEN150002) will be
      collected and adverse events will be tracked and reported per applicable regulations.
    

Intervention name(s): Sound amplification provided via the EarLens CHD
Intervention type(s): Device
Intervention description(s): Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Migalastat Food Effect Study
Condition: Fabry Disease
MeSH terms: Fabry Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      A 5-period crossover study to evaluate the effect of meal type and timing on migalastat HCl
      pharmacokinetics in healthy male and female subjects. Subjects will be randomly assigned to 1
      of 5 treatment sequences and will receive each treatment over the course of 5 weekly periods.
    

Detailed description: 
      This is a Phase 1, randomized, open-label, 5-period crossover study to evaluate the effect of
      meal type and timing on migalastat HCl pharmacokinetics in healthy male and female subjects
      between the ages of 18 and 65 years. A total of 20 subjects will be enrolled such that
      approximately 14 evaluable subjects complete dosing and critical assessments. Subjects will
      be randomly assigned to 1 of 5 treatment sequences and will receive each treatment over the
      course of 5 successive weekly periods including a single dose of migalastat HCl 150 mg in the
      fasting state as the reference treatment. There will be at least a 7-day washout period
      between each dose of migalastat HCl and a follow-up visit approximately 7 to 10 days after
      the last dose in Period 5.

      All subjects will be screened within 28 days of admission to the clinical unit. In each
      period, subjects will check in to the clinical unit the day prior to drug administration and
      have relevant assessments to ensure continued eligibility for dose administration. On Day 1
      of each period, subjects will receive a single dose of migalastat HCl within 1 of the
      following 5 treatment regimens as follows:

        -  150 mg migalastat HCl in the fasting state (reference arm)

        -  150 mg migalastat HCl with simultaneous consumption of a glucose drink

        -  150 mg migalastat HCl 1 hour before consumption of a high fat meal

        -  150 mg migalastat HCl 1 hour before consumption of a light meal

        -  150 mg migalastat HCl 1 hour after consumption of a light meal

      Subjects will be confined to the clinical unit for 24 hours after dosing with serial blood
      samples collected for PK analysis. Safety will be assessed throughout the study by monitoring
      clinical laboratory tests, ECGs, physical examinations, vital signs, and AEs.
    

Intervention name(s): A (migalastat); B (migalastat); C (migalastat); D (migalastat); E (migalastat)
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 150 mg migalastat HCl in the fasting state (reference arm); 150 mg migalastat HCl with simultaneous consumption of a glucose drink; 150 mg migalastat HCl 1 hour before consumption of a high fat meal; 150 mg migalastat HCl 1 hour before consumption of a light meal; 150 mg migalastat HCl 1 hour after consumption of a light meal
Intervention MeSH terms: 1-Deoxynojirimycin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Food effect; GR181413A; AT1001; migalastat hydrochloride; Lysosomal storage disorders; Pharmacokinetics
Study to Evaluate the Pharmacokinetics of 14C-labeled Isavuconazole Following a Single Oral Dose of 14C-labeled Prodrug Isavuconazonium Sulfate (BAL8557) in Healthy Male Subjects
Condition: Pharmacokinetics of 14C-labeled Isavuconazole; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics of 14C-labeled isavuconazole
      and the routes of excretion and the extent of metabolism of 14C-labeled prodrug BAL8557.
    

Detailed description: 
      Subjects will be admitted to and stay in a clinical research unit for 23 days. On Day 1, they
      will receive a single oral dose of BAL8557 and throughout the study period the excretion and
      metabolism of the study drug will be monitored.
    

Intervention name(s): 14C-labeled prodrug isavuconazonium sulfate
Intervention type(s): Drug
Intervention description(s): oral
Intervention MeSH terms: Isavuconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: BAL8557; 14C-labeled isavuconazole; 14C-labeled prodrug isavuconazonium sulfate (BAL8557)/([cyano-14C]ASP9766 sulfate)