bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Effect of Filgotinib on Semen Parameters in Adult Males With Active Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, or Non-radiographic Axial Spondyloarthritis
Condition: Rheumatoid Arthritis; Psoriatic Arthritis; Ankylosing Spondylitis; Non-Radiographical Axial Spondyloarthritis
MeSH terms: Spondylitis; Arthritis; Arthritis, Rheumatoid; Arthritis, Psoriatic; Spondylarthritis; Spondylitis, Ankylosing; Axial Spondyloarthritis; Non-Radiographic Axial Spondyloarthritis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the effect of filgotinib on semen
      parameters in adult males with active rheumatoid arthritis, psoriatic arthritis, ankylosing
      spondylitis, or non-radiographic axial spondyloarthritis.

      Results of this study may be pooled with the results of a separate study being conducted in
      participants with inflammatory bowel disease (Protocol GS-US-418-4279; NCT03201445) with the
      same objective.
    


Intervention name(s): Filgotinib; Placebo; Standard of Care
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 200-mg tablet administered orally once daily; Placebo to match filgotinib tablet administered orally once daily; Locally approved treatment, accepted by medical experts as a proper treatment for rheumatic conditions, prescribed according to best clinical practice, with no known testicular toxicity.
Other intervention name(s): GS-6034; Jyseleca®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effectiveness of Pharmacist Interventions in Difficult Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      Of the 5.2 million people with asthma in the UK, approximately one in every 40 have severe
      asthma that needs the maximum available treatments advised in national asthma guidelines
      (known as the 'British Thoracic Society / Scottish Intercollegiate Guidelines Network British
      Guideline on the Management of Asthma'). Despite this, asthma is still inadequately
      controlled in about half of these patients and they are classed as having 'difficult asthma'.
      There maybe potential for improvement of the care and health of these patients through better
      use of medicines and greater input from pharmacists, but more research is needed.

      The aim of the study is to measure the effects over six months of coordinated information and
      advice about medicines from hospital and community pharmacists on asthma control in patients
      with difficult asthma. The patients in the study (52 in total) will be recruited from adult
      patients attending a specialist difficult asthma clinic in a hospital.

      Patients will be randomly chosen to have either an appointment with the specialist pharmacist
      (intervention group), or usual medical care (control group). Usual care will involve seeing
      the Consultant or Specialist Registrar (doctor) in the clinic. Patients in the intervention
      group will receive i) assessment and education on asthma, and review of their inhaler
      technique, from a hospital Advanced Clinical Pharmacist and ii) will also be referred for a
      medicines use review from their usual community pharmacist (chemist), to take place 1-2
      months after their hospital clinic appointment. The Advanced Clinical Pharmacist will be
      working closely with the Consultant.

      Results will be measured using methods that have been developed by experts in asthma and
      tested in previous research. Asthma control will be measured using Juniper's Asthma Control
      Questionnaire. Other measurements will cover quality of life, use of medication, use of
      healthcare resources, and inhaler technique.
    


Intervention name(s): Pharmacist intervention and pharmacist support
Intervention type(s): Behavioral
Intervention description(s): Patients randomised to this group will undergo an asthma assessment to assess asthma control, adherence and inhaler technique, by an Advanced Clinical Pharmacist specialising in Respiratory Medicine.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Pharmacy
Plaque and Gingivitis Evaluation of a U-Shaped Toothbrush in a 30-Day Model
Condition: Plaque Induced Gingivitis
MeSH terms: Gingivitis
Study type: Interventional

Summary: 
      The objective of this 30 day, randomized, two group, parallel, examiner-blind clinical trial
      is to assess the safety and efficacy of AutoBrush® 360° U-shaped Sonic Toothbrush on plaque
      and gingivitis, compared to an American Dental Association (ADA) reference manual soft
      toothbrush. The extent of gingival abrasion and recession and oral safety will be evaluated.
    

Detailed description: 
      This single-center, randomized, controlled, examiner-blind, 30-day parallel study will
      consist of Screening and Baseline visits with approximately 80 subjects (age 5-65 years) who
      will read and sign an informed consent form and assent form, assessed for evidence of
      gingivitis and plaque according to the Modified Gingival Index (MGI) and the Lobene-Soparkar
      Modification of Turesky Modified Quigley-Hein Plaque Index (LSPI) at Baseline, Day 15 and Day
      30. Gingival recession and gingival abrasion will be measured at all visits. Subjects will be
      randomly assigned to one of two groups twice daily brushing with ADA accepted fluoride
      toothpaste and 1) two-minute brushing with ADA reference standard manual toothbrush, or 2)
      30-second brushing with AutoBrush® 360° U-shaped Sonic Toothbrush.
    

Intervention name(s): U-shaped Power Toothbrush; Soft Manual Toothbrush
Intervention type(s): Device; Device
Intervention description(s): Twice daily brushing for 30 seconds with fluoride toothpaste; Twice daily brushing for two minutes with fluoride toothpaste
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: gingivitis; dental plaque; Power toothbrush; manual toothbrush
Does a Caffeine Gum Improve 5 km Run Performance in a Competition/Field Setting?
Condition: Running Performance
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether caffeine gum improves the performance of
      runners completing free timed mass participation 5 km runs in the United Kingdom (UK)
    

Detailed description: 
      The study will investigate the ability of an acute intake of caffeine gum to improve
      performance in recreationally trained runners completing park runs. Park runs are free, timed
      5 km mass participation running events that are held in a number of parks around the UK every
      Saturday morning.

      A total of 60 recreationally trained runners will be recruited to the study. Of these, 30
      will be assigned to a randomised placebo-controlled double-blind cross-over trial. The
      remaining 30 will be assigned to a non-intervention comparison group. The non-intervention
      group will be used to account for the effect of changing environmental conditions on running
      performance.

      All participants will complete two 5 km park runs separated by no more than 2 weeks.
      Participants on the intervention study arms will consume either caffeine or placebo gum 30
      minutes before they run. The order of consumption will be randomised. The caffeine gum will
      contain 300 mg (with an approximate 85% bioavailability). Participants will be asked to
      abstain from any caffeine containing beverages or food for 18 hours before each run. They
      will also be asked to record their dietary intake for the day before and the morning of the
      run and to repeat this for their second trial. Physical activity on the days leading up to
      each 5 km run will also be recorded and participants will be asked to closely replicate their
      activity in the week leading up to each trial. They will also be asked to keep training
      intensity and duration light during the 48 hours leading up to each trial.

      The primary outcome measure will be change in overall time for the 5 km runs. Other outcome
      measures will be ratings of perceived exertion, 1 km split times and average heart rate.

      The study size was calculated using an online software package
      (http://www.sportsci.org/resource/stats/), adopting a power of 80% and an alpha of 0.05.
      Using within-person standard deviation from runners completing a local parkrun and an
      expected effect size of 1.2% (Bridge and Jones (2006) J Sports Sciences. 24(4):433-9) a
      sample size of 25 runners was calculated for the intervention study.
    

Intervention name(s): caffeine gum; placebo gum
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Gum is consumed 30 minutes before commencement of run; Gum is consumed 30 minutes before commencement of run
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Caffeine, running, performance
Wavelet Analysis of Electromyography (EMG) in Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Observational

Summary: 
      Several methods exist to evaluate motor function in the child with cerebral palsy and are
      used to assess the outcome of a clinical intervention. However, these scales are not directed
      towards measuring the changes in muscle activity patterns that can result from the
      intervention. For example, there are classification scales aimed at measuring motor function
      and functional abilities, and indices of gait function. These scores, while providing a way
      to quantify function and mechanics, do not directly measure muscle activation
      characteristics. Therefore, these tests may be insensitive to how the intervention has
      directly affected muscle function, which is usually the focus of the intervention (i.e.
      botulinum toxin, functional electrical stimulation, dorsal rhizotomy). Muscle biopsies and
      motor evoked potentials can provide information about the muscle activation characteristics,
      however, they are invasive and there are concerns about using these techniques on the
      pediatric population and/or the practicality of clinical implementation, especially since
      they do not provide insight into how the muscle behaves during a functional task. One method
      that can be used to provide insight into muscle activity in a non-invasive and clinically
      meaningful manner is the use of surface electromyography (sEMG). Surface EMG is typically a
      routine part of clinical assessment and the evaluation of motor impairment in CP. However,
      the analysis of the data has been limited in most cases to examination of signal amplitude or
      differences in muscle onset and offset timing.

      The long-term goal of this research is to develop an analysis method for sEMG that can be
      used during functional tasks for treatment planning, diagnostic, assessment purposes in CP.
      This is to be accomplished through the use of the continuous wavelet transform (CWT). By
      developing an assessment method based on muscle activity, it is believed that a clinically
      viable measurement tool can be devised that will provide a level of insight into the effects
      of an intervention on muscle pathophysiology that is not currently available. The first step
      in progressing towards this long-term goal is to determine the variability and range of
      expected time-frequency patterns that can be expressed in a given population (i.e., cerebral
      palsy) during the execution of a meaningful task (gait), and relate the time-frequency
      information back to more standard assessments
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Children with spastic, diplegic cerebral palsy
      
Keywords: Cerebral Palsy; Electromyography; Wavelet Analysis
Dexmedetomidine Addition to Morphine in Patients With Metastatic Cancer
Condition: Refractory Pain; Metastatic Cancer
MeSH terms: Neoplasm Metastasis; Neoplasms; Neoplasms, Second Primary; Pain, Intractable
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Pain is a common symptom in patients nearing the end of life. Its prevalence varies between
      30 and 75%. Nowadays, morphine is the most used molecule as first line treatment of moderate
      to severe pain. However, this molecule, considering its side effects, may contribute in part
      to the discomfort of these patients and may increase the pre-existing agitation or delirium.
      There is therefore a need to find new agents, other than morphine, for pain control at the
      end of life, without the limitations that the morphine molecule has. The author reviewed the
      literature on the role of dexmedetomidine in the treatment of refractory symptoms in
      palliative care, including pain. It is an agonist of the adrenergic alpha 2 receptor having a
      sedative, analgesic action and a morphine sparing effect demonstrated postoperatively.

      This study aims primarily at demonstrating that dexmedetomidine has a beneficial role in the
      treatment of pain in patients with metastatic cancer.
    


Intervention name(s): Dexmedetomidine
Intervention type(s): Drug
Intervention description(s): Patients allocated to this group receive a combination of Morphine and Dexmedetomidine
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
The Acute Effect of Protein or Carbohydrate Intake on Testosterone Levels and Food Intake in Children and Adolescent Boys
Condition: Appetitive Behavior; Pediatric Obesity
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      The purpose of this study was to determine the effect of acute protein and glucose intake on
      testosterone levels measured in adolescent boys and determine whether changes in testosterone
      levels are associated with alterations in short-term food intake. It was hypothesized that 1)
      ingestion of a protein beverage would result in no change of testosterone levels whereas
      glucose would result in a significant decrease of testosterone levels 60 minutes after
      ingestion and 2) decreases of testosterone levels as a result of the glucose preload would
      predict food intake for boys of similar body size. The first objective was to investigate the
      effect of an acute protein or glucose drink on testosterone levels and the second objective
      was to determine whether changes of testosterone levels associate with food intake.
    


Intervention name(s): Control; Glucose; Protein
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Participants were given 5 minutes to ingest the non-caloric beverage which contained 1.5ml of chocolate extract (Vanilla Food Company, Markham, Ontario, Canada) to account for the flavor differences and mixed with 500ml of water and sweetened with 0.2g sucralose (Tate & Lyle, Stoney Creek, Ontario, Canada) in order to match sweetness with the glucose beverage.; Participants were given 5 minutes to ingest the beverage which contained either 1g of protein (plain whey-protein isolate; BiPro USA., Eden Prairie, Minnesota, U.S.A) per kg of bodyweight and was flavoured with 1.5ml of chocolate extract (Vanilla Food Company, Markham, Ontario, Canada) to account for the flavor differences and mixed with 500ml of water.; Participants were given 5 minutes to ingest the beverage which contained 1g of glucose monohydrate (BioShop Canada Inc., Burlington, Ontario, Canada) per kg of bodyweight and flavoured with 1.5ml of chocolate extract (Vanilla Food Company, Markham, Ontario, Canada) to account for the flavor differences and mixed with 500ml of water.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: In a randomized, crossover study, sixteen 9-18 y old males were given beverages containing either: 1) whey protein (1g/kg bodyweight), 2) glucose (1g/kg bodyweight) or a calorie-free control (C). Serum testosterone, appetite biomarkers and subjective appetite were measured prior (0) and at 20, 35 and 65 minutes after the consumption of the beverage. Food intake at an ad libitum pizza meal was assessed 20 min later (65-85min).
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Testosterone; Food Intake; Appetite
A Study to Assess the Safety, Tolerability, PK and PD of AM1030-CREAM in Patients With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a study of safety, tolerability, pharmacokinetics and pharmacodynamics of
      AM1030-CREAM in patients with Atopic Dermatitis.
    


Intervention name(s): AM1030-CREAM or placebo
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of Ramucirumab (LY3009806) in Children With Refractory Solid Tumors
Condition: Pediatric Solid Tumor; Refractory Tumor; Recurrent Tumor; CNS Malignancies
MeSH terms: Neoplasms; Recurrence
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the safety of the study drug known as
      ramucirumab in children with recurrent or refractory solid tumors including central nervous
      system (CNS) tumors.
    


Intervention name(s): Ramucirumab
Intervention type(s): Drug
Intervention description(s): Administered IV
Other intervention name(s): LY3009806; IMC-1121B; Cyramza
Intervention MeSH terms: Ramucirumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: relapsed pediatric solid tumors; unspecified childhood solid tumor; brain and central nervous system tumors
Emotion Regulation in Binge Eating and Purging Among Adolescents
Condition: Binge Eating; Purging (Eating Disorders)
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Observational

Summary: 
      The study will examine the neural and behavioral correlates of emotion regulation in
      adolescents engaging in binge eating and/or purging and healthy adolescents. Furthermore, it
      will look at the influence of executive function on emotion regulation in this population.
      This study will allow us to gain further understanding of the neural basis of emotion
      regulation in this age group. Moreover, this study supports the need to develop new treatment
      approaches based on a better understanding of the brain processes associated with eating
      disorders.
    


Intervention name(s): Magnetic resonance imaging
Intervention type(s): Other
Intervention description(s): We will conduct MRI and fMRI brain scans to compare brain function between groups.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Female adolescents between ages 14-18.
Improving Measurement Of Parents' Understanding Of Research Permission
Condition: Improve Parent Understanding of Research Permission
Study type: Interventional

Summary: 
      Well-informed potential subjects are presumably better able to make autonomous decisions
      about the risks and benefits of participating in a research study than those in possession of
      less information. In actuality, prior research into consent understanding suggests that
      longer forms offering exhaustive information may inhibit rather than promote understanding.
      Moreover, technical wording in tools used to measure parent understanding of research
      permission may also lead to inhibition of understanding. This study will test the hypothesis
      that, among parents of potential subjects for greater-than-minimal-risk research, two
      modified and simplified subset of questions from the Deaconess Informed Consent Comprehension
      Test (DICCT), one oral and open-ended and one written and multiple choice, will increase
      subject understanding of the nature and risks of the research. The study will enroll the
      parents of 40 potential neonatal research subjects with an interim analysis of data at 20
      subjects. Subjects will review a sham research permission form and will be randomized 1:1 to
      complete one of the two modified comprehension tests in addition to the DICCT (gold-standard)
      test. Parents will be given an open-ended survey after the tests in order to qualitatively
      describe their opinions of each test. A subset of parents who have received the written form
      will also undergo a cognitive interview about the form. A similar subset will also be given
      an open-ended survey about a proposed permission form cover sheet. The primary outcome will
      be the correlation of scores between the DICCT and modified comprehension tests, following
      the sham informed consent process.
    


Intervention name(s): Coversheet to Informed Consent
Intervention type(s): Other
Intervention description(s): The intervention is a one page cover sheet to be affixed to the front of the standard permission form for the trial for which permission is being sought (attached to application). The form will identify the study as research and contain sections that include investigator contact information, the purpose of the study, a brief description of the study procedures, the alternatives, the voluntary nature, the risks, the potential benefits, a discussion of privacy and confidentiality, the costs and the payments. Each topic will also contain a reference to the page in the consent containing the full description of the topic. The form is designed to have a reading level no higher than 6th to 8th grade. Parents will also receive the full permission form, and all required signatures will still be collected on the permission form.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research