bioihbjkbjnl/mcl2 huggingface dataset:
Plegridy Satisfaction Study in Participants
Condition: Relapsing-Remitting Multiple Sclerosis (RRMS)
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to investigate whether Peg-IFN beta-1a improves the
      satisfaction of Relapsing-Remitting Multiple Sclerosis (RRMS) participants unsatisfied with
      injectable subcutaneous Interferons, as measured by the Abbreviated Treatment Satisfaction
      Questionnaire to Medication (TSQM-9), at 12 weeks. The secondary objectives of this study are
      to evaluate in this study population: effects of Peg-IFN beta-1a treatment on participants'
      satisfaction at 24 weeks; effects of Peg-IFN beta-1a treatment on short-term participants'
      adherence; effects of Peg-IFN beta-1a treatment on participants' fatigue; effects of Peg-IFN
      beta-1a on disease activity and physical disability; impact of Peg-IFN beta-1a treatment on
      participant-reported health-related quality of life; impact of Peg-IFN beta-1a treatment on
      participants' injection-system satisfaction; Evaluate the relationship between participants'
      satisfaction and adherence; Evaluate the relationship between participants' satisfaction and
      social-demographic factors (age, sex, employment working, level of education, etc) and
      clinical characteristics (annualized relapse rate [ARR], disability, etc.) and to evaluate
      the treatment safety and tolerability.
    


Intervention name(s): peginterferon beta-1a
Intervention type(s): Drug
Intervention description(s): 125 mcg administered subcutaneously (SC) every 2 weeks.
Other intervention name(s): BIIB017; PEGylated Interferon Beta-1a; Plegridy; PEG IFN β-1a
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Crossover Bioequivalence Study of Oxcarbazepine 600 mg Suspension Under Fasted Conditions
Condition: Seizures
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to prove the bioequivalence of Roxane Laboratories'
      Oxcarbazepine Suspension 600 mg under fasted conditions.
    


Intervention name(s): Oxcarbazepine
Intervention type(s): Drug
Other intervention name(s): Trileptal
Intervention MeSH terms: Oxcarbazepine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparing the PrePex™ Device to Surgical MC for Rapid Scale Up of MC in Resource Limited Setting
Condition: HIV
Study type: Interventional
Phase: Phase 2

Summary: 
      The protocol, approved by the Medical Research Council, was issued to assess the safety and
      efficacy of the non-surgical device for applying it to the national scale up of adult male
      circumcision in Zimbabwe
    

Detailed description: 
      Models show that to have the highest impact on the HIV epidemic, circumcision of up to 80% of
      men in high prevalence countries, where MC rates are low, needs to be achieved (UNAIDS 2009;
      Manicaland HIV/STD Prevention Project, 2008; Bollinger, et al, 2009). Hallett and colleagues
      in 2008 showed that for Zimbabwe specifically, HIV incidence could be reduced between 25% to
      35% if about 50% of men are circumcised. All modelings conducted show that MC programs must
      be part of a comprehensive HIV prevention package as MC alone will not tip the HIV epidemic
      into a terminal decline.

      The PrePex Device offers hope for rapid scale up of adult male circumcision in resource
      limited settings.

      Once the safety and efficacy have been established, it is important to conduct operations
      research to determine how best to implement both device and surgical circumcisions in the
      national program. Thus, the Zimbabwe MOHCW is planning a three phase trial in order to
      determine the safety of the PrePexTM device, its performance and the ease of use in an
      implementation roll out.
    

Intervention name(s): PrePex™ device for adult male circumcision; Surgical circumcision
Intervention type(s): Device; Procedure
Intervention description(s): The PrePex™ device is designed to enable bloodless male circumcision procedure with no anesthesia and no sutures.; The penis will be surgically circumcised according to one of the WHO recommended circumcision methods as described in the Manual for Male Circumcision under Local Anaesthesia Version 2.5C January 2008
Other intervention name(s): The PrePex Device; PrePex; PrePex™
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Male Circumcision; HIV Prevention; Medical Device
Obstructive Sleep Apnea in Obese Children and Teenagers - Occurrence and Importance of Intervention
Condition: Sleep Apnea, Obstructive; Pediatric Obesity
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Pediatric Obesity
Study type: Observational

Summary: 
      The prevalence of childhood obesity has increased at an alarming rate over the last decades,
      both globally and in Denmark. There are a number of serious sequelae related to obesity, such
      as hypertension, hypercholesterolemia, fatty liver and prediabetes. Obesity is found to be a
      risk factor for obstructive sleep apnea (OSA). OSA in childhood is known to be associated
      with cardiovascular complications, neurocognitive problems and reduced quality of life. The
      correlation between obesity and OSA is still poorly understood. Early detection and
      intervention is of great importance as the health consequences related to OSA as well as
      obesity are severe. Adenotonsillectomy is recommended as first-line therapy in children with
      OSA. However, only around 25% of obese children benefit from this treatment compared to
      around 75% of normal-weight children suggesting that there might be other structural factors
      predisposing to OSA in obese children.

      In this study the investigators aim to clarify the impact of obesity in the development of
      OSA. The prevalence of OSA in obese children will be investigated. Furthermore the purpose is
      to assess the effect of weight loss on OSA.
    


Intervention name(s): Weight loss
Intervention type(s): Behavioral
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The cohort consists of children attending the Childrens Obesity Clinic in Holbaek.
      
Keywords: Sleep Apnea, Obstructive; Pediatric Obesity
Comparison Between IMV and SIMV/PS for Ventilatory Support of Children: a Randomized Clinical Trial
Condition: Respiratory Failure
MeSH terms: Respiratory Insufficiency
Study type: Interventional
Phase: Phase 3

Summary: 
      Objectives: to compare intermittent mandatory ventilation (IMV) with synchronous intermittent
      mandatory ventilation associated with pressure support (SIMV/PS) related to duration of
      mechanical ventilation/weaning and length of stay in PICU (LS). Design: randomized clinical
      trial. Setting: Pediatric intensive care unit at a university-affiliated hospital.
    

Detailed description: 
      Objectives: to compare intermittent mandatory ventilation (IMV) with synchronous intermittent
      mandatory ventilation associated with pressure support (SIMV/PS) related to duration of
      mechanical ventilation/weaning and length of stay in PICU (LS). Design: randomized clinical
      trial. Setting: Pediatric intensive care unit at a university-affiliated hospital. Patients:
      children between 28 days and 4 years old, admitted between 10/2002 and 06/2004, and receiving
      mechanical ventilation (MV) for more than 48 hours. Patients were randomly assigned into two
      groups: IMV (IMVG; n=35) and SIMV/PS (SIMVG; n=35). Children with acute respiratory distress
      syndrome and tracheostomy were excluded. Ventilation and oxygenation data were recorded at
      admission and beginning of weaning. Results: Groups were not statistically different for age,
      gender, MV indications, PRISM score, COMFORT scale, sedatives, and ventilation and
      oxygenation parameters. Median of MV duration was 5 days for both groups (p>0.05). Also,
      there were no statistical differences for duration of weaning [IMVG: 1 day (1 - 6) vs. SIMVG:
      1 day (1 - 6); p>0.05] and LS [IMVG: 8 days (2 - 22) vs. SIMVG: 6 days (3 - 20); p>0.05].
      Conclusion: There was no statistically significant difference between IMV and SIMV/PS in
      these children related to MV and weaning duration, and PICU length of stay.
    

Intervention name(s): Intermittent mandatory ventilation (IMV) and synchronous IMV
Intervention type(s): Procedure
Intervention description(s): Patients divided to receive two different modes of mechanical ventilation.
Other intervention name(s): IMV (intermittent mandatory ventilation); SIMV (synchronous intermittent mandatory ventilation)
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: mechanical ventilation; respiratory failure
Follow-up Evaluation of Photo-Dynamic Therapy for Pituitary Tumours
Condition: Pituitary Neoplasms
MeSH terms: Pituitary Neoplasms; Pituitary Diseases
Study type: Observational

Summary: 
      A study to followup patients that have previously been treated for pituitary tumours with
      either photodynamic therapy or placebo in a previous trial. The study aims to determine
      whether photodynamic therapy has any long term effect on tumour size, visual fields or
      endocrinological function.
    

Detailed description: 
      No patients will receive any medical or procedural treatments in this study, since these have
      been administered in a previous trial. The previous trial participants will be contacted and
      asked to attend a clinic or to have a telephone interview, where they will answer a
      questionnaire. They will be assessed clinically for visual fields, as well as undergoing an
      MRI scan of their head to assess tumour size (unless they have had a scan anyway in the
      previous 12 months), these tests would ordinarily form part of the routine outpatient workup
      for patients with pituitary tumours. There is no significant risk to the physical well-being
      of the patients with any of the methods to be used.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Details of previous research participants will be extracted from the study files by the
        researchers, who are all members of the direct care team.
Exploratory Clinical Study to Evaluate the Optimal Dosage of Mosapride and Probiotics in Irritable Bowel Syndrome Without Predominant Diarrhea
Condition: Irritable Bowel Syndrome Without Diarrhea
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to Evaluate the Optimal Dosage of Mosapride (Medirac) and
      Probitics in Irritable Bowel Syndrome Without Predominant Diarrhea.
    


Intervention name(s): Probiotics (Medirac); Probiotics (Medirac); Probiotics (Medirac); Probiotics (Medirac); Probiotics (Medirac) placebo/mosapride placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 10/mosapride 10mg three times a day, P.O. 4week; 15/mosapride 10mg three times a day, P.O. 4week; 15/mosapride 15mg three times a day, P.O. 4week; 30/mosapride 15mg three times a day, P.O. 4week; three times a day, P.O. 4week
Intervention MeSH terms: Mosapride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: irritable bowel syndrome without predominant diarrhea; Probiotics(Medirac) 10/mosapride 10mg; Probiotics(Medirac) 15/mosapride 10mg; Probiotics(Medirac) 15/mosapride 15mg; Probiotics(Medirac) 30/mosapride 15mg; Probiotics(Medirac) placebo/mosapride placebo
Postural Control Among Children With and Without Dyslexia
Condition: Child Development Disorder
MeSH terms: Dyslexia; Developmental Disabilities
Study type: Observational

Summary: 
      As Chinese-speaking children with dyslexia typically have different cerebellar sign behavior
      from non-Chinese-speaking counterparts, this study compared the effect of visual occlusion on
      the static balance between dyslexic and non-dyslexic children using the Chinese language.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The participants will be 80 Chinese-speaking children between 8 and 12 years of age
        recruited from elementary schools in Taiwan. Half of the participants will be formally
        identified as dyslexia by specialists in the field of special education (Table 1), based on
        formal psycho-educational assessments (Chinese Character Recognition Test (Huang, 2001),
        Chinese reading diagnostic evaluation, and Wechsler Intelligence Scale for Children 4th
        Edition-Chinese version.
      
Keywords: child with dyslexia, postural sway; visual perception
An Observational Study of Environmental and SocioEconomic Factors in Opioid Recovery
Condition: Opioid-use Disorder; Opioid-related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Observational

Summary: 
      The RECOVER Study will examine clinical, environmental and socioeconomic factors in recovery
      from opioid use disorder (OUD) over a 24-month period following exit from a Phase III
      clinical program for a buprenorphine extended-release injection (RBP-6000). The study
      population will consist of participants from studies NCT02357901 (RB-US-13-0001) and
      NCT02510014 (RB-US-13-0003).

      The RECOVER study will characterize OUD subjects' recovery process as they transition from
      the controlled clinical trial environment to the real world setting.
    


Intervention name(s): Not applicable - no defined intervention
Intervention type(s): Other
Intervention description(s): Participants who received at least one injection of RBP-6000 or placebo and either withdrew from or completed the Phase III clinical program which included studies NCT02357901 (RB-US-13-0001) and NCT02510014 (RB-US-13-0003) were eligible for the RECOVER Study.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who are currently diagnosed with moderate or severe OUD according to Diagnostic
        and Statistical Manual 5 (DSM-5) criteria and for 3 months immediately prior to signing the
        informed consent form for protocols NCT02357901 (RB-US-13-0001) and/or NCT02510014
        (RB-US-13-0003).
      
Keywords: Opioid recovery; Recovery; Opioid-related disorders; Substance-related disorders; Heroin dependence; Opioid dependence; Addiction; Buprenorphine; Opiate substitution treatment; Analgesics; Opioid; Narcotics; Patient outcome assessment; Patient-centered care; Cost of illness; Employment; Health-related quality-of-life; Family relations; Lifestyle; Citizenship
Effect of Neck Extension on Intraocular Pressure in Patients Undergoing Palatoplasty
Condition: Cleft Palate
MeSH terms: Cleft Palate
Study type: Observational

Summary: 
      The purpose of this study is to investigate the change in intraocular pressure according to
      the neck extension during palatoplasty in pediatric patients.
    


Intervention name(s): Position
Intervention type(s): Other
Intervention description(s): Neck extension
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who have undergone a palatoplasty with cleft palate and who are 6 months or older
        and under 24 months
DiaCon Overnight Closed-Loop Glucose Control Study
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The objective of this in-clinic study is to test our closed-loop glucose control system in
      patients with type 1 diabetes.
    


Intervention name(s): Closed-loop control; Open-loop control
Intervention type(s): Device; Other
Intervention description(s): Blood glucose controlled by algorithm; Blood glucose controlled by patient
Other intervention name(s): Metronic Veo-pump. DexCom 7+ sensor.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 diabetes; Glucose control; Closed-loop; Insulin pump; Glucose sensor
Cognitive Behavioral Therapy in Panic Disorder
Condition: Panic Disorder
MeSH terms: Panic Disorder
Study type: Observational

Summary: 
      The investigators hypothesized that the group of patients receiving the medication
      interventions and CBT would show significant changes in their behavior, such as remission or
      reduction in anxiety, panic attacks, anticipatory anxiety, fear of body sensations, loss of
      control, and agoraphobia avoidance. And also, in the general evaluation of well-being, in the
      beginning and end of the treatment, in comparison to the control group (medication without
      CBT), during the same period.
    

Detailed description: 
      This trial consisted in tracing the profile and evaluating their response to
      cognitive-behavioral techniques in a sample of 50 panic disorder patients with agoraphobia
      treated at the Psychiatric Institute of the Federal University of Rio de Janeiro/Brazil.
      Objective: To test a specific model of cognitive-behavioral therapy through instruments
      applied in the beginning and end of the procedures. Two groups of 25 patients were formed,
      the first one with medication and therapy and the second one with medication and without
      therapy, as the control group. Methods: The cognitive-behavioral therapy sessions were held
      weekly and individually, with one-hour sessions. The work focused on physiological, cognitive
      and behavioral aspects with techniques of cognitive reorganization, exercises of induction of
      symptoms, "in vivo" exposure, breathing and relaxation exercises. The prescribed medication
      consists of tricyclic antidepressants (TCA) or selective serotonin reuptake inhibitors
      (SSRI). Results: There was a significant difference between the initial and final evaluation
      of the group with the specific therapy, such as, reduction in panic attacks, anticipatory
      anxiety, agoraphobia avoidance, and fear of body sensations. In the global assessment
      functioning scale, global well-being increased from 60.8% to 72.5% among patients in the
      first group with therapy, differently from the group without therapy. We observed that 77.6%
      of the sample in both groups presented the respiratory subtype and 22.4% the non-respiratory
      subtype. Conclusion: The association of specific cognitive-behavioral therapy focusing on
      somatic complaints associated with pharmacologic treatment in the first group was effective
      in this sample, in comparison to pharmacological treatment alone in panic disorder patients
      with agoraphobia.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        panic disoder patients over 18 years old
      
Biospecimen description: 
      None retained
    
Keywords: panic; respiration; anxiety; exercise; cognition
Curcumin Gel On Radiation Induced Oral Mucositis
Condition: Radiation-Induced Mucositis; Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms; Mucositis; Stomatitis
Study type: Interventional

Summary: 
      The goal of this clinical study is to investigate the effect of a curcuma longa oral gel
      (curenext) on reducing radiation-induced oral mucositis severity in cancer patients and
      provide a context for understanding if there is a relationship between the curcumin clinical
      effect and production of EGFs and IL8.

      Researchers will compare between curcumin group and standard treatment group.
    


Intervention name(s): Curcumin Gel; Standard Preparation
Intervention type(s): Drug; Drug
Intervention description(s): Curcuma longa oral gel for prevention radiation induced oral mucositis; Standard preparation for prevention radiation induced oral mucositis
Intervention MeSH terms: Curcumin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups A) curcuma longa oral gel group B) standard treatment group
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Radiation induced oral mucositis; Head and neck cancer; Curcuma longa; EGF; IL8
Levels of High-Sensitivity C-Reactive Protein in Heart Transplant Patients
Condition: Heart Transplant Failure; Periodontitis; Crp
MeSH terms: Periodontitis
Study type: Observational [Patient Registry]

Summary: 
      Objectives: The outcomes of heart transplantation are very favorable but inflammation still
      plays a critical role in deterioration of chronic transplants. Periodontal diseases are not
      only limited to supporting structures of the teeth, they also cause systemic inflammation.
      Based on the importance of inflammation in heart transplant recipients and the association
      between periodontal disease and systemic inflammation, this study explored whether
      periodontitis may be a modifier of serum high-sensitivity C-reactive protein (HsCRP) in heart
      transplant patients.
    


Intervention name(s): clinical measurements
Intervention type(s): Other
Intervention description(s): only clinical parameters were recorded
Other intervention name(s): no intervention was made
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        The patients who underwent heart transplant between 2004 and April 2016 at Baskent
        University Hospital,will be asked to participate in the study during routine outpaient
        visits at Baskent University Hospital
      
Keywords: heart transplant; periodontitis; hsCRP