bioihbjkbjnl/mcl2 huggingface dataset:
Biomarkers in Saliva in Children With Juvenil Idiopathic Arthritis
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Observational

Summary: 
      Purpose and aims This as a pilot study that aims to investigate which inflammatory biomarkers
      can be found in saliva in children with Juvenile Idiopathic Arthritis (JIA).

      The hypothesis is that children with JIA will show a different pattern of inflammatory
      biomarkers in saliva than healthy Children.

      The null hypothesis is that there are no differences.
    

Detailed description: 
      This is a comparison between 100 children with JIA and 100 healthy children. Saliva will be
      collected and analyzed with respect to biomarkers.

      One-hundred consecutive patients with active JIA, as diagnosed by the Department of Pediatric
      Rheumatology, Astrid Lindgrens Barnsjukhus, Karolinska University Hospital will be included.

      Inclusion criteria are:

        -  age between 7 and 14 years

        -  a diagnosis of JIA according to the International League of Associations for
           rheumatology

      Exclusion criteria are:

        -  current malignancies

        -  TMJ surgery or trauma within two years

        -  recent intra-articular glucocorticoid injection in TMJ (within 1 month)

        -  other conditions or diseases than JIA that may cause orofacial pain. The parents of the
           patients and/or the patients will give their verbal and written informed consent to
           participate in the study according to the permission from the regional ethical committee
           2011/2:1.

      The control group of 100 age and sex matched healthy children will be included at
      Folktandvården Stockholms Län AB.

      Inclusion criteria are:

      • age between 7 and 14 years

      Exclusion criteria are:

        -  current malignancies

        -  TMJ surgery or trauma within two years

        -  recent intra-articular glucocorticoid injection in TMJ (within 1 month)

        -  A diagnosis of JIA

        -  other conditions or diseases than JIA that may cause orofacial pain. The parents of the
           patients and/or the patients will give their verbal and written informed consent to
           participate in the study according to the permission from the regional ethical committee
           2011/2:1.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Group 1: 40 consecutive patients with active JIA, as diagnosed by the Department of
        Pediatric Rheumatology, Astrid Lindgrens Barnsjukhus, Karolinska University Hospital will
        be included.

        Group 2: 40 healthy children, age-and sex-matched.
      
Biospecimen description: 
      Saliva sampels
    
Keywords: Juvenile Idiopathic Arthritis; Saliva
Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-Acebilustat (CTX-4430)
Condition: Heathy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-centre, open-label, non-randomised, single oral dose study in healthy male
      subjects. It is planned to enroll and dose 6 subjects. Subjects will be admitted to the
      clinical unit on the evening of Day 1 prior to investigational medicinal product (IMP)
      administration. Subjects will be dosed on the morning of Day 1 and it is planned that they
      will remain resident in the clinic until up to 168 hour after dosing (up to Day 8). It is
      planned that subjects will be released as a group when all subjects have achieved a mass
      balance cumulative recovery of >90% or if <1% of the dose administered has been collected in
      urine and faeces within 2 separate, consecutive 24 hour periods.
    


Intervention name(s): [14C]-acebilustat solution
Intervention type(s): Drug
Intervention description(s): Acebilustat is a novel synthetic small molecule leukotriene A4 hydrolase (LTA4H) inhibitor.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Effect of the Method Pilates in Women With Temporomandibular Disorders
Condition: Pain; Temporomandibular Joint Disorders
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome; Joint Diseases
Study type: Interventional

Summary: 
      Introduction: the influence of temporomandibular disorders (TMD) related to postural changes
      are yet no consensus, but it is believed that the imbalances of a system can influence
      another. Several techniques have been used to treat TMD and its associated problems, however
      there is a paucity of studies evaluating the effects of global treatments, such as Pilates,
      in individuals with TMD literature. Objective: To evaluate changes in the level of pain, the
      severity of TMD, the EMG activity of masticatory muscles and posture of young women
      undergoing training in Pilates, as well as correlating postural changes, pain level, severity
      of TMD and EMG activity of masticatory muscles. A randomized clinical trial with blinded
      assessors will be held. 40 patients divided randomly into two groups will be assessed, the
      control group (CG) who receive conventional treatment with occlusal splint and intervention
      group (IG), which in addition to conventional treatment will undergo Pilates sessions. Both
      groups will be formed for women aged 18 to 35 years with TMD and pain. The IG will receive
      treatment with the Pilates Method for 15 weeks with frequency of twice weekly and use
      occlusal splint as directed by the dentist. The CG will make use of occlusal splint alone. At
      the beginning and end of the 15 weeks the individuals are evaluated to verify the presence of
      TMD, TMD severity, pain, EMG evaluation of masticatory muscles and body posture. Data will be
      analyzed statistically.
    

Detailed description: 
      t-test or Mann-Whitney test will be used to compare data before and after 15 weeks of
      treatment.

      Multiple Two-Way ANOVAs will be used to compare treatment and evaluation period, for each
      depended variable: effects of pain, severity of TMD, EMG activity of masticatory muscles and
      posture.
    

Intervention name(s): Pilates
Intervention type(s): Other
Intervention description(s): The intervention group will perform Pilates exercises for 15 weeks with frequency of twice weekly
Other intervention name(s): Pilates exercises; Pilates method
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Temporomandibular Joint Disorders; posture; pain; clinical trial; Pilates
ImmuneSense™ COVID-19 Study
Condition: Coronavirus Disease (COVID-19); SARS-CoV-2 Infection
MeSH terms: COVID-19; Coronavirus Infections
Study type: Observational

Summary: 
      Coronavirus disease is of an urgent global priority. The purpose of ImmuneSense™ COVID-19
      study is to evaluate the clinical performance and to provide data for clinical validation for
      the T-Detect™ SARS-CoV-2 (previously referred to as immunoSEQ Dx SARS-CoV-2) Assay in support
      of Adaptive's Emergency Use Authorization (EUA) request for T-Detect™ SARS-CoV-2 and
      secondary aims. This assay is intended to detect immune response to the virus that causes
      coronavirus disease (COVID-19), SARS-CoV-2. This is critically important because the immune
      system may be able to tell us important information about how our own bodies detect and
      respond to the disease that current tests cannot.
    

Detailed description: 
      Comprehensive diagnostic testing has an important role to play in the control and containment
      of the current pandemic. Adaptive Biotechnologies Corporation (Adaptive) has developed an
      immunosequencing technology, called immunoSEQ®, which utilizes polymerase chain reaction
      (PCR) and next-generation sequencing (NGS) to identify and quantify rearranged T-cell
      receptor (TCR) gene sequences from peripheral blood, collectively referred to as the T-cell
      repertoire. The T-cell repertoire can be further analyzed using indication-specific
      algorithms that are based on disease-associated TCR sequences.

      Adaptive has developed a clinical test called T-Detect™ SARS-CoV-2, which is intended to
      identify a T-cell response to the SARS-CoV-2 virus, indicating recent or prior infection. In
      this investigational study, Adaptive plans to clinically validate samples acquired from
      patients with COVID-19 and present results for an eventual EUA-submission for the T-Detect™
      SARS-CoV-2 Assay. T-Detect™ SARS-CoV-2 is a single-site assay performed at Adaptive
      Biotechnologies Corporation.
    

Intervention name(s): T-Detect™ SARS-CoV-2 Assay
Intervention type(s): Other
Intervention description(s): T-Detect™ SARS-CoV-2 Assay is an investigational device that is indicated to assess T-cell immune response to SARS-CoV-2 via the testing of blood samples from patients with signs and symptoms of suspected COVID-19. These results will not be shared with the participant.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Eligible participants include male and female participants, of any race and ethnicity, ages
        18-89.
      
Keywords: COVID-19; SARS-CoV-2; Coronavirus
The Experiences of People Who Live With Glanzmanns Thrombasthenia.
Condition: Glanzmann Thrombasthenia
MeSH terms: Thrombasthenia
Study type: Observational

Summary: 
      To understand the lived experiences of people with Glanzmanns Thrombasthenia
    

Detailed description: 
      A qualitative study of people with Glanzmanns Thrombasthenia including an on-line survey,
      qualitative in-depth interviews and bleed diary completion.
    

Intervention name(s): survey and interview
Intervention type(s): Other
Intervention description(s): qualitative assessment
Other intervention name(s): diary completion
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        People with Glanzmanns Thrombasthenia or parents of children with Glanzmanns
        Thrombasthenia.
Effects of Exercise Intervention in Patients With Spondylolisthesis Related LBP
Condition: Low Back Pain; Spondylolisthesis
MeSH terms: Spondylolisthesis; Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The first purpose of this study is to define parameters of the trunk neuromuscular functions
      that are pathologically altered in patients with low back pain due to spondylolytic
      spondylolisthesis. The second and also the main purpose of the study is to examine the
      effects of exercise intervention on patients with low back pain due to spondylolytic
      spondylolisthesis. Our overall hypothesis is that specific exercise intervention will improve
      neuromuscular functions of the trunk in patients with low back pain due to spondylolytic
      spondylolisthesis.
    

Detailed description: 
      Low back pain is known to affect a considerable portion (> 75%) of the society, causing
      enormous financial burden for the healthcare systems.

      Exercise interventions incorporated into low back pain patients rehabilitation protocols are
      known as successful treatment strategies, but ore often focused on strength training and not
      on functional stabilization. Spondylolytic spondylolisthesis is one of the most known types
      of spine instabilities. To date, no studies examined the effects of exercise intervention on
      patients with low back pain due to spondylolytic spondylolisthesis. Research will be carried
      out as a cross-sectional study, where patients with spondylolytic spondylolisthesis will be
      randomly arranged in one controlled and two experimental groups. For the forth group healthy
      asymptomatic participants will be recruited.

      Exercise intervention will last 12 weeks with a frequency of three times a week and duration
      of 60 minutes per training unit. Exercise intervention will include congregated set of trunk
      stabilisation exercises, starting with simple isometric tasks. Dynamic and more complex
      movements will be added progressively to achieve whole body tasks involving fast and sudden
      movements.

      Neuromuscular functions of the trunk will be measured before and after the intervention.
    

Intervention name(s): Exercise intervention; Exercise and e-stim
Intervention type(s): Procedure; Procedure
Intervention description(s): Functional stabilisation exercise for the trunk.; Functional stabilisation exercise for the trunk and electrical stimulation at the same time.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exercise; Electric Stimulation
Single Dose Study With Unlabeled Dose and 14C-labeled Microdose of PF-06700841 in Healthy Male Subjects
Condition: Healthy Male Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label, fixed sequence, 2-period including a single oral dose 60 mg PF-06700841 with
      14C-labeled microtracer in 1st period, and a single oral dose of 60 mg unlabeled PF-06700841
      followed by intravenous administration of 14C-labeled microdose of PF-06700841 1 hour after
      oral dose in period 2 to characterize the absorption, disposition, metabolism and excretion
      of PF-06700841 and evaluate the absolute bioavailability and fraction absorbed in the GI
      tract
    


Intervention name(s): Oral PF-06700841 containing 14C microtracer; Oral unlabeled PF-06700841; IV 14C-labeled PF-06700841
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral dose of 60 mg unlabeled PF-06700841 co-formulated with 30 ug 14C-labeled (300 nCi) PF-06700841 in 1st period; 60 mg unlabeled PF-06700841 oral dose in 2nd period; 30 ug 14C-labeled (300 nCi) PF-06700841 intravenous infusion over 5 min in 2nd period
Intervention MeSH terms: PF-06700841
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PF-06700841; mass balance; metabolites; absolute bioavailability
Interferon ß-1b Treatment by Cyclical Administration
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The therapy with Interferon-ß-1b reduces the inflammatory component of multiple sclerosis
      with positive effects on the disease course. The 8 MUI dose at alternate days is kept
      constant for years. About 1/3 of patients suspend treatment by three years due to side
      effects or suspected or accepted ineffectiveness. The main objective of the study is to
      verify the safety and effectiveness of a cyclical administration (a month of suspension after
      two of treatment) from the beginning of treatment. There is the possibility that a scheme
      envisaging therapy free intervals can reduce the onset of negative feedbacks (antagonising
      the drug therapeutic effect) compared to the standard administration protocol. This might
      also result in an increase of the drug effectiveness and/or in a longer duration of
      effectiveness itself. Finally, cyclical administration allows patients to spend actual
      periods of "therapeutic vacation", with positive psychological effects.
    


Intervention name(s): Interferon-ß-1b; Interferon ß-1b
Intervention type(s): Drug; Drug
Intervention description(s): 250 micrograms (8 MIU) administered subcutaneously (sc) every other day with a discontinuance month every 2 months; 250 micrograms (8 MIU) administered subcutaneously (sc) every other day
Intervention MeSH terms: Interferons
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Interferon-ß-1b; Therapy
Evaluation of the Effects of Eccentric Training on a Cycle Ergometer, Versus Conventional Concentric Training
Condition: Readaptation to Effort; Coronaropathy; Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The aim of this study is to assess the efficacy of a rehabilitation protocol based on
      individualized combined eccentric and concentric cycle ergometer training compared to
      classical concentric cycle training among patients with either coronary artery disease (CAD)
      or chronic obstructive pulmonary disease (COPD). This study will therefore evaluate the
      efficacy of combined eccentric/concentric training on physical capacity and overall autonomy,
      and will analyse the adaptive mechanisms with regard to both adaptation to cardiac and
      muscular effort and tolerance.
    

Detailed description: 
      The research will take place in 3 phases:

      PHASE 1 :

      30 healthy volunteers will be included to test tolerance to personalized exercise on an
      eccentric cycle ergometer.

      PHASE 2 :

      15 patients suffering from coronary artery disease (CAD) and 15 patients suffering from
      chronic obstructive pulmonary disease (COPD) will be included to test the same protocol.

      PHASE 3 :

      A total of 169 patients split into 2 parallel groups will be included: a group receiving
      conventional rehabilitation (group A) and the other group receiving eccentric exercise
      combined to conventional rehabilitation (group B).

      Coronary patients: 93 patients will be included (62 patients in group A and 31 in group B).

      COPD patients: 76 patients will be included (38 patients per group).
    

Intervention name(s): conventional rehabilitation program (including concentric cycle ergometer); cycling included into a conventional rehabilitation program
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Pharmacokinetic Drug Interaction Study in Healthy Male Subjects
Condition: Healthy Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A Randomized, Open Label, Drug-Drug interaction study to investigate effect of ketoconazole
      or rifampicin on the Pharmacokinetic characteristics and safety of LC15-0444 in Healthy Male
      Volunteers.
    

Detailed description: 
      This study is a randomized, open-label, 2-period, 3-treatment, 1-sequence, drug-drug
      interaction study in healthy volunteers to evaluate effect of ketoconazole or rifampicin on
      the PK characteristic and safety of LC15-0444.

      Eligibility for participation of this study will be determined by demographic information,
      medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests
      within 4 weeks(-28 d ~ -2 d) before the first drug administration(1 d). Eligible subjects
      will be randomized to one of study treatment groups.

      According to the characteristics of anti-diabetic drugs, it is expected to be administered
      with other drugs in many patients. Therefore, Drug-Drug Interaction with CYP3A4 inducer and
      inhibitor should be identified in this trial.
    

Intervention name(s): Ketoconazole; rifampicin
Intervention type(s): Drug; Drug
Intervention description(s): Period 1 : LC15-0444 Period 2 : LC15-0444 with ketoconazole; Period 1 : LC15-0444 Period 2 : LC15-0444 with rifampicin
Intervention MeSH terms: Rifampin; Ketoconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Assess Drug-Drug Interaction Between ABBV-903 and Midazolam in Adult Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this study is to assess the drug-drug interaction and pharmacokinetics
      of ABBV-903 and Midazolam in healthy adult participants.
    


Intervention name(s): ABBV-903; Midazolam
Intervention type(s): Drug; Drug
Intervention description(s): Oral Tablet; Oral Liquid
Intervention MeSH terms: Midazolam
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Volunteer; ABBV-903; Midazolam
Effect of Nebivolol on Oxidative Stress and Endothelial Progenitor Cells
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      Hypertension, or high blood pressure, is a common disease that affects many Americans, and
      can lead to devastating consequences such as heart attack, stroke, and death if not treated.
      Nebivolol is a medication that has been recently approved by the FDA for the treatment of
      hypertension. Nebivolol has an unusual profile compared to other medications, in that its
      effects may be related to release of a substance called nitric oxide. Nitric oxide is
      released from the cells lining the blood vessels, and nebivolol may stimulate these cells to
      release more nitric oxide. Our study will investigate whether treatment with nebivolol, as
      compared to another medication called metoprolol, in hypertensive subjects will be more
      effective in protecting blood vessels against the harmful effects of high blood pressure. The
      mechanisms we will investigate include oxidative stress markers and circulating levels of
      endothelial progenitor cells.
    


Intervention name(s): Nebivolol; Metoprolol succinate
Intervention type(s): Drug; Drug
Intervention description(s): Nebivolol 5 mg PO qday for 2 weeks, titrated up to Nebivolol 10 mg PO qday if BP is >125/80 for the 2 more weeks, and then titrated up to Nebivolol 20 mg PO qday if BP is >125/80 for the remaining 8 weeks; Metoprolol 50 mg PO qday for 2 weeks, titrated up to Metoprolol 100 mg PO qday if BP is >125/80 for the 2 more weeks, and then titrated up to Metoprolol 200 mg PO qday if BP is >125/80 for the remaining 8 weeks
Other intervention name(s): Bystolic; Toprol XL
Intervention MeSH terms: Metoprolol; Nebivolol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
A Study to Assess the Absorption of a Single Dose of BMS-986205 in Healthy Volunteers When Administered as a Crushed Tablet Orally or Crushed Tablet Suspension Via Nasogastric Tube, as Compared to a Tablet
Condition: Healthy Volunteers
MeSH terms: Crush Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the absorption of BMS-986205 into the bloodstream of
      healthy volunteers, when administered as an intact tablet taken orally, or as a crushed
      tablet taken orally with soft food, or as a crushed tablet suspension taken via a nasogastric
      (NG) tube. Eligible participants will be randomly assigned to 1 of 4 treatment sequences and
      will receive a single dose of BMS-986205 twice during the course of the study.
    


Intervention name(s): BMS-986205
Intervention type(s): Drug
Intervention description(s): Single 100 mg dose on Day 1 and Day 15
Intervention MeSH terms: Linrodostat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy participants; Healthy subjects