bioihbjkbjnl/mcl2 huggingface dataset:
Effect of OC459 on the Response to Rhinovirus Challenge in Asthma
Condition: Asthma; Rhinovirus; Picornaviridae Infections; Common Cold
MeSH terms: Common Cold; Picornaviridae Infections; Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to assess the effectiveness of a CRTH2 receptor antagonist, OC459,
      in preventing or attenuating the worsening of asthma symptoms during rhinovirus infection.
      The study is a double blind, randomised trial in which half the subjects will receive OC459
      and the other half placebo, before being inoculated with rhinovirus, that would normally
      induce a worsening of asthma symptoms i.e. an exacerbation.
    

Detailed description: 
      Asthma is the most common chronic respiratory disease, and in many countries prevalence is
      rising. The major morbidity, mortality and health care costs related to asthma are a result
      of periods of acutely increased symptomatology called 'exacerbations'. Most exacerbations are
      caused by rhinovirus, the virus associated with the common cold. There are few treatments to
      prevent and treat exacerbations, and despite these >50% of adult asthmatics reported having
      an exacerbation in the last year. There is therefore a major unmet need.

      Experimentally inoculating patients with asthma with rhinovirus, a methodology that has been
      safely used for >15 years, induces an infection and worsening symptoms in ~85%. This model
      offers the possibility to investigate treatment effects on asthma exacerbations with a small
      number of subjects, minimising the numbers exposed to a novel drug with limited safety data.
      In contrast, trials of therapies powered to evaluate an effect on naturally occurring
      exacerbations require several hundred subjects, a long study period to capture enough events,
      and are significantly more expensive to carry out.

      Using this model the investigators have shown that several inflammatory molecules, including
      prostaglandin D2 (PGD2), are significantly increased during rhinovirus-induced asthma
      exacerbations, with the levels of PGD2 strongly correlating with the severity of the
      symptoms. Moreover other studies have shown that when PGD2 binds the CRTH2 receptor, it
      stimulates the release of a number of inflammatory molecules also associated with asthma
      exacerbations. Blocking the CRTH2 receptor therefore appears an extremely promising target
      with potential to limit the virus-induced inflammation underpinning many asthma
      exacerbations.
    

Intervention name(s): OC459; Placebo; Rhinovirus
Intervention type(s): Drug; Drug; Other
Intervention description(s): Inoculation with rhinovirus serotype 16
Other intervention name(s): OC000459
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CRTH2 antagonist; Prostaglandin D2 receptor; Anti-Asthmatic Agents; OC459; Allergic asthma; Eosinophilia
A Study to Investigate the Potential Pharmacokinetic Interaction Between TMC435 and Methadone
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of steady-state (constant concentration
      of medication in the blood) TMC435 (150 mg, once a day) on the steady state pharmacokinetics
      (what the body does to the medication) of R- and S-methadone.
    

Detailed description: 
      This is an open label (all people know the identity of the intervention) drug-drug
      interaction (TMC435 versus methadone) study. Approximately 12 hepatitis C virus-negative
      opioid-dependent participants on stable maintenance therapy (for at least 30 days before
      screening) will be enrolled in the study. The study will consist of 3 phases: 1) Run-in
      phase: during this phase, participants will take individualized (dose of methadone will be
      adjusted for each participant between a range of 30 and 150 mg daily) dose of methadone from
      Day -14 (14 days before the first intake of TMC435) till Day -1 (1 day before the first
      intake of TMC435), which will be supervised by the medical staff. 2) 7 days treatment phase:
      during this phase, the participants will take 150 mg dose of TMC435 once daily from Day 1 to
      Day 7 orally (by mouth) plus the individualized dose of methadone which will be supervised by
      the medical staff. 3) Follow-up phase: during this phase, the participants will continue to
      take only the individualized dose of methadone for 30-32 days. Safety evaluations will
      include assessment of adverse events, clinical laboratory tests, cardiovascular safety,
      physical examination and alcohol breath test. The total study duration will be of 22 days
      excluding screening and follow-up phase.
    

Intervention name(s): TMC435; Methadone
Intervention type(s): Drug; Other
Intervention description(s): Participants will receive 150 mg dose of TMC435 orally (by mouth) once daily for 7 days of treatment (from Day 1 to Day 7).; Participants will receive supervised individualized methadone dose (dose of methadone will be adjusted for each participant between a range of 30 and 150 mg daily [extremes included]) from Day -14 untill Day 8. Participants will continue to receive individualized methadone during follow up of 30 to 32 days.
Intervention MeSH terms: Simeprevir; Methadone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C; HCV; Hepatitis C Virus; HCV negative; Protease inhibitor; Methadone; TMC435
Efficacy and Safety Study of Cilostazol to Prevent Reoccurrence of Stroke
Condition: Cerebral Infarction
MeSH terms: Cerebral Infarction; Infarction
Study type: Interventional
Phase: Phase 3

Summary: 
      The study design is subject to relevant SFDA regulations about clinical trials. This
      indication was approved in Japan in 2003.

      From the end of May 2004 to the end of Dec. 2004, 720 patients with previous cerebral
      infarction(see the inclusion criteria) were enrolled in to the study and received one of the
      two treatment regimens, Cilostazol or Aspirin, the ratio of patient number of each group is
      1:1. For each patient, the chance of entering either of these two groups is the same. The
      treatment will continue till the end of 2005. During the treatment period, patients will be
      observed concerning some certain events, mainly reoccurrence of stroke. If the patient
      experiences reoccurrence of stroke, or other event that the doctors think it is not
      appropriate to continue the study medication, this patient would stop the treatment. Patients
      were also required to take MRI head scan before entering the study and on completion of the
      treatment.
    


Intervention name(s): Cilostazol 200mg/day Oral; Aspirin 100mg/day Oral
Intervention type(s): Drug; Drug
Intervention MeSH terms: Aspirin; Cilostazol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Cerebral infarction; Prevention; Cilostazol; Aspirin; Stroke; Clinical trial
A Comparative Evaluation of TEG Versus ROTEM for Coagulopathy Correction
Condition: Liver Cirrhosis
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Observational

Summary: 
      Studies comparing Thromboelastography or Rotational thromboelastometry versus standard
      coagulation tests are abundant. Data comparing the two exclusively in a liver intensive care
      set up is limited.

      Studies show that TEG and ROTEM cannot be used interchangeably in trauma, liver transplant
      patients, but there is limited evidence of the same in critically ill cirrhotic patients.

      In this study, the investigators tried to demonstrate the comparison of blood products used
      to treat coagulopathy based on TEG versus ROTEM algorithms in cirrhotic patients presenting
      with non variceal bleeding
    

Detailed description: 
      Thromboelastography (TEG) and thromboelastometry( ROTEM) are point-of-care, global hemostasis
      assessment tests that measure the viscoelastic changes that occur during the hemostatic
      process.

      Patients with cirrhosis have an imbalance of procoagulants and anticoagulants combined with
      alterations in fibrinolysis ,platelet number and function.

      Point of care viscoelastic tests (TEG ,ROTEM) demonstrate specific functional coagulation
      defects that can direct blood component transfusion therapy in cirrhosis, with clinical
      validation of individual parameters.

      Studies comparing Thromboelastography or Rotational thromboelastometry versus standard
      coagulation tests are abundant. Data comparing the two exclusively in a liver intensive care
      set up is limited.

      Studies show that TEG and ROTEM cannot be used interchangeably in trauma, liver transplant
      patients, but there is limited evidence of the same in critically ill cirrhotic patients.

      In this study, the investigators tried to demonstrate the comparison of blood products used
      to treat coagulopathy based on TEG versus ROTEM algorithms in cirrhotic patients presenting
      with non variceal bleeding
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients of liver cirrhosis who are presenting with non variceal bleed would be included in
        this study
      
Keywords: THROMBOELASTOGRAPHY; THROMBOELASTOMETRY; nonvariceal; bleeding
Evaluation of Proprioception in Patients Treated With Surgical External Ankle Ligament Recontruction for Traumatic Ankle Instability
Condition: Ankle Sprains; Instability, Joint
MeSH terms: Joint Instability; Ankle Injuries
Study type: Interventional

Summary: 
      The objective of the study is to evaluate post-operatively the postural control through the
      Delos system with the Riva method of patients already treated surgically of external
      capsulo-ligament reconstruction due to ankle instability.
    

Detailed description: 
      The patients will then be divided into two control groups: one group will undergo
      reconditioning through the Delos system and one group will undergo standard rehabilitation
      treatment.

      Primary outcome: improvement of joint stability and postoperative proprioception after
      reconditioning with the Delos system.

      Secondary outcomes: improvement of performance indicators and reduction of disability and
      satisfaction and assessment of long-term ankle stability after reconditioning with Delos
      system.
    

Intervention name(s): Delos instrument (computerized balance board)
Intervention type(s): Device
Intervention description(s): Proprioceptive training using Delos instrument (computerized balance board).
Static and dynamic evaluation through Delos with the Riva method; Physiatric visit; Clinical scores (AOFAs); Functional scores (SPPB); SF12 satisfaction.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Ankle instability; Stabilometry
Trial of a Parenting Discussion Group in Panama, Central America
Condition: Child Behavioural and Emotional Difficulties; Parenting Practices
Study type: Interventional

Summary: 
      The present study aims to examine the effectiveness of a parenting intervention, the Triple P
      Positive Parenting Program Level 3 discussion groups "dealing with disobedience". Triple P is
      a system of interventions to support families and was developed at the University of
      Queensland in Australia in the 1980's. As few studies have tested the effectiveness of
      parenting programs in developing countries, the present study took place in a developing
      country, Panama.

      In a recent study carried out in Australia, this same intervention was found effective in
      reducing child behaviour problems and the use of dysfunctional parenting (Morawska, Haslam,
      Milne & Sanders, 2011).
    

Detailed description: 
      This is a randomized controlled trial (RCT) with two groups (waiting list versus Triple P
      discussion groups) and measurements at pre-intervention, post intervention, three and six
      months follow up.

      The intervention trialed was a 2-hour, one-session discussion group on child noncompliance.
      Groups were composed by a maximum of 10 parents and were facilitated by the principal
      researcher, who is an accredited practitioner. The groups were interactive and discussion
      based, and a power point presentation with embedded-video clips were used to aid the
      facilitator. The key points that were covered in the discussion group included reasons for
      disobedience, parenting traps, encouraging good behaviour, and managing disobedience. Parents
      also received a workbook that included the content covered in the discussion group and 2
      follow up telephone calls to check how they were doing after.

      Participants were randomly assigned to a treatment group (Triple P discussion groups) or to a
      waiting list group. A statistician independent from the research team generated a random list
      of numbers. Randomization was stratified based on the level of child behavioural difficulties
      (high or low) measured at baseline. In order to ensure allocation concealment,
      sequentially-numbered, opaque, sealed envelopes (SNOSE) were opened after participants agreed
      to take part in the study and completed a baseline assessment. After randomization, those
      assigned to the waiting list group were assessed at time 1 (baseline) and then 4 weeks, 3
      months and 6 months after the first assessment. Those assigned to the treatment group were
      assessed at time 1 (baseline), 2 weeks, 3 months and 6 months after the intervention.
      Assessments were carried out by a research assistant who was blind to group allocation.
    

Intervention name(s): Triple P Positive Parenting Program Discussion Group "Dealing with Disobedience"
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Smoking Cessation for Depression and Anxiety Treatment
Condition: Smoking; Anxiety Disorders; Depression Disorders
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary aim of this research study is to enhance smoking cessation outcome among smokers
      with elevated anxiety and depression. We are comparing two group treatment approaches: (1) An
      educational-supportive psychotherapy and standard smoking cessation treatment, and (2) An
      integrated smoking cessation, and anxiety and depression management treatment program (SDAT).
      Both treatments also utilize nicotine replacement therapy.
    


Intervention name(s): Nicotine Patch; Depression and Anxiety Smoking Cessation Treatment; Educational-Support Psychotherapy
Intervention type(s): Drug; Behavioral; Behavioral
Intervention description(s): Cognitive-behavioral treatment program that blends smoking cessation, anxiety, and depression management/reduction treatment strategies; Educational-based psychotherapy and standard smoking cessation treatment program
Other intervention name(s): SDAT
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: smoking; cessation; anxiety; anxious; depression; depressed; smoker; stress
Pharmacokinetics of Omeprazole and Midazolam When Co-administered With ACT-1014-6470
Condition: Drug Drug Interaction; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A study on whether ACT-1014-6470 has an effect on how the body takes up, distributes and gets
      rid of omeprazole and midazolam in healthy male subjects
    


Intervention name(s): Treatment period A; Treatment period B
Intervention type(s): Drug; Drug
Intervention description(s): Midazolam solution for oral administration. Omeprazole hard capsule for oral administration.; ACT-1014-6470 soft capsule for oral administration. Midazolam solution for oral administration. Omeprazole hard capsule for oral administration.
Other intervention name(s): Midazolam and Omeprazole; ACT-1014-6470, Midazolam and Omeprazole
Intervention MeSH terms: Midazolam; Omeprazole
Intervention model: Single Group Assignment
Intervention model description: Two-period, fixed-sequence study
Masking: None (Open Label)
Primary purpose: Other
Keywords: ACT-1014-6470; Omeprazole; Midazolam
BION Active Seating for Pressure Ulcer Prevention
Condition: Pressure Ulcer
MeSH terms: Pressure Ulcer; Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      Pressure ulcers (PUs) are a debilitating pathology resulting from pressure and shear in the
      soft tissues of immobilized patients. In studies to date, BION neuromuscular stimulation has
      been demonstrated to activate strong muscle contractions and to produce skeletal motion, with
      associated increases in muscle bulk (hypertrophy), strength, and metabolic capacity, hence
      counteracting the 3 major etiological factors in PU development (immobility, soft-tissue
      atrophy and hypoxia).

      This study intends to use neuromuscular stimulation to both shift paralyzed subjects' weight
      and build up gluteal muscle volume, in order to prevent recurrence of pressure ulcers. We
      will implant BIONs alongside the already exposed inferior gluteal and sciatic nerves in
      patients who are undergoing gluteal rotation flap surgery for PU reconstruction. The gluteal
      rotation flap is a common reconstructive technique for treating PUs by bringing healthy
      muscle and skin in to repair the deficient area, and to provide healthy tissue covering over
      bony prominences. The implanted BIONs will enable us subsequently to stimulate the gluteus
      maximus and hip extensor muscles. Outcome measures will include tissue health variables
      (measured by clinical assessment, X-Rays, MRI and Sesta-MIBI SPECT perfusion scans), pressure
      redistribution (measured by an array of pressure sensors), and recurrence rates over 12
      months.
    


Intervention name(s): BION
Intervention type(s): Device
Intervention description(s): 30 patients operated will be randomized into 2 equal groups, a BION Therapy Group ("Rx group") and a Control Group ("Control group").
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neuromuscular stimulator; Pressure ulcer prevention
The Interaction Between Metformin and Acute Exercise
Condition: Impaired Glucose Tolerance; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2; Glucose Intolerance
Study type: Interventional

Summary: 
      Physical activity is a first line treatment for patients with type 2 diabetes (T2D), however,
      the vast majority of patients with T2D do not achieve satisfying glycemic control with
      physical activity alone, which is why pharmacological treatment with metformin is most often
      initiated.

      It is known that metformin and exercise both activates 5' adenosine monophosphate-activated
      protein kinase (AMPK) in skeletal muscle and liver, and the activation of AMPK results in
      many different metabolic effects, including improvements in glycemic control. Because of this
      similarity in mechanism of action, an interaction between metformin and exercise is
      plausible, but knowledge in the area is sparse. Thus, the aim of this study is to assess the
      effects of acute physical activity with and without concomitant metformin treatment, in order
      to investigate whether an interaction between the two occur.

      Subjects with impaired glucose tolerance will be randomized (1:1) to metformin/placebo
      treatment in a double-blinded way. Following a treatment run-in period of 17 days, two
      experimental days (one with acute exercise and one without acute exercise), separated by one
      week, will be performed in each subject.

      This registration concerns a sub-study of another study which has previously been registrered
      at ClinicalTrials.gov (Unique Protocol ID: H-17012307). The specific outcomes in this
      registration have not previously been registered.
    


Intervention name(s): Metformin treatment; Placebo treatment
Intervention type(s): Drug; Drug
Intervention description(s): Daily treatment with metformin tablets for 24 days according to the following scheme:
Day 1-4: Metformin tablet 500 mg x 2 Day 5-8: Metformin tablet 1000 + 500 mg Day 9-24: Metformin tablet 1000 mg x 2; Daily treatment with placebo tablets for 24 days according to the following scheme:
Day 1-4: Placebo tablet 500 mg x 2 Day 5-8: Placebo tablet 1000 + 500 mg Day 9-24: Placebo tablet 1000 mg x 2
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Timing of Initiation of Continuous Glucose Monitoring in Established Pediatric Diabetes (The CGM TIME Trial)
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The investigators hypothesize that REAL-Time Continuous Glucose Monitoring (RT-CGM) will be
      more effective if introduced in children and adolescents with established diabetes at the
      same time as they are starting pump therapy. This randomized controlled trial will compare
      the effectiveness of simultaneous vs delayed introduction of RT-CGM in children and
      adolescents with type 1 diabetes who are starting insulin pump therapy.
    

Detailed description: 
      REAL-Time Continuous Glucose Monitoring (RT-CGM) improves diabetes control in adults with
      type 1 diabetes. However, studies of RT-CGM in children and adolescents have been mostly
      negative. The lack of effectiveness in the pediatric population appears directly related to
      adherence to RT-CGM, i.e., the willingness of children and teens to wear and use this
      technology. Most previous RT-CGM studies have focused on experienced pump users or children
      with new-onset diabetes. At the time of pump initiation, children and adolescents who have
      been living with diabetes (and their parents) are highly motivated to make changes in their
      diabetes management and to take on additional responsibilities to improve their diabetes
      control and lifestyle, the two primary reasons for initiating pump therapy in the pediatric
      population. The investigators hypothesize that readiness for making changes in diabetes
      management will be greater at the time of pump initiation than at six months after the pump
      start. Further, the investigators hypothesize that readiness for change at the time of RT-CGM
      initiation will predict future adherence to RT-CGM and its effectiveness.
    

Intervention name(s): Simultaneous RT-CGM and Pump Initiation; Delayed Initiation of RT-CGM
Intervention type(s): Device; Device
Intervention description(s): Subjects in this group will start using RT-CGM at the same time as they initiate insulin pump therapy.; Subjects in this group will start using RT-CGM 6 months after initiation of insulin pump therapy.
Other intervention name(s): Sensor-Augmented Pump Therapy at Pump Initiation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Simultaneous or Delayed initiation of continuous glucose monitoring
Masking: None (Open Label)
Primary purpose: Treatment