bioihbjkbjnl/mcl2 huggingface dataset:
Prospective, Randomized, Multi-center Clinical Study of Plasma Disc Decompression
Condition: Radicular Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The goal of this post-marketing surveillance study is to compare two procedures which are
      used to treat patients who require a disc decompression procedure. These procedures are: 1)
      plasma disc decompression procedure using Coblation technology and 2) fluoroscopy guided
      transforaminal epidural steroid injection (TFESI). The study will evaluate treatment efficacy
      and rate of improvement in symptoms through the first six months following the procedure.

      The principal objectives of this study are to determine whether subjects receiving the plasma
      disc decompression procedure demonstrate:

        1. Improved clinical outcomes over subjects receiving TFESI

        2. More rapid reversal of symptoms than subjects receiving TFESI
    

Detailed description: 
      Chronic leg and back pain are two of the most common ailments in our society, and are
      associated with serious financial and social consequences. One surgical treatment modality is
      plasma disc decompression, based on the principle that inducing a small reduction of volume
      in the closed hydraulic space of an intact (contained herniated) disc can relieve pressure,
      and thereby reduce or eliminate pain. Another widely accepted treatment is transforaminal
      epidural steroid injection (TFESI), which delivers a high concentration of corticosteroid to
      the targeted disc nerve interface, and is thought to decrease pain by reducing inflammation.

      This study proposes to compare the efficacy of the plasma disc decompression procedure to the
      standard TFESI series in patients who have failed to improve after an initial TFESI
      injection. The goal is to better understand the differences between these two treatment
      modalities and to monitor the rates of symptom improvement through the first six months
      between patients receiving a series of at least two selective nerve root injections and those
      undergoing the one-time plasma disc decompression procedure after failing one fluoroscopy
      guided TFESI. Patients will continue to be monitored over the 2-year post-procedure period to
      assess stability of treatment effect.
    

Intervention name(s): Perc-DLR/Perc-DLG; Fluoroscopy guided transforaminal epidural steroid injection (TFESI)
Intervention type(s): Device; Drug
Intervention description(s): Device technique will be used per IFU; Injection of steroid solution into the lumbar level
Other intervention name(s): Percutaneous Disc Decompression; TFESI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Plasma disc decompression; Intradiscal Pressure; Steroid Injection; Epidural Steroid Injection; Selective Nerve Root Injection; Leg Pain; Radicular Pain; Coblation; SNRI
Phase I/IIa Study on Chitin Microparticles in Subjects Suffering From Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Chitin microparticles (CMP) has been demonstrated in animal studies that have modelled
      allergic rhinitis to be effective against a wide range of common respiratory allergens. It is
      an immuneenhancer.

      The primary purpose of the study is to demonstrate safety in a first into man study on 24
      human volunteers. The secondary objective is to demonstrate efficacy by chosing subjects that
      demonstrate a response to a nasal allergen challenge using grass pollen.

      The subjects are being given increasing doses of CMP, supplied as a nasal spray, for 7 days
      followed by a nasal allergen challenge with Timothy Grass Pollen extract. Over this period
      nasal symptom scores, eosinophil counts and cytokine measurements will be performed.
    

Detailed description: 
      Chitin microparticles are a special preparation of chitin. This a long chain polysaccaride
      derived from shells of the North Atlantic shrimp. CMP acts a an immunenhancer which improve
      immune function by stimulating macrophages and other cells such as T-helper lymphocytes, (Th
      cells). In allergies there is an imbalance between Th1 and Th2 cells. Imuneenhancers shift
      the balance in favour of Th1 cells. The immunomodulatory properties of CMP have been
      demonstrated in animal models against a wide range of respiratory allergens. There have been
      no indications of toxic side effects in animal models.
    

Intervention name(s): Chitin microparticles by nasal route
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Pooled Analysis of Clinical Data From Six GSK Studies to Investigate the Efficacy of a Dentifrice Containing 67% Weight by Weight (w/w) Sodium Bicarbonate on Gingivitis and Plaque Accumulation
Condition: Gingivitis; Dental Plaque
MeSH terms: Gingivitis; Dental Plaque
Study type: Observational

Summary: 
      The aim of this analysis was to pool data from 6 GSK studies with similar clinical design to
      investigate the overall efficacy of a test dentifrice containing 67% w/w sodium bicarbonate
      in the treatment of gingivitis and plaque accumulation after 6, 12 and 24 weeks of
      twice-daily brushing at home relative to a negative control dentifrice.

      The pooled analysis was planned and conducted after completion of all six independent
      studies.
    

Detailed description: 
      This pooled analysis was performed on data collated from six GSK studies that provide
      efficacy data supporting the twice-daily use of a dentifrice containing 67% w/w sodium
      bicarbonate in the management of pre-existing gingivitis, and plaque accumulation. Six
      studies that were chosen for inclusion in the pooled analysis were single-center,
      examiner-blind, 2 to 3 treatments, parallel group, stratified and randomized clinical study.
      In all studies, participants entered the screening period during which eligibility for the
      study was determined. The participants included male and non-pregnant, non-lactating female
      subjects at least 18 years of age with pre-existing gingivitis as determined by an
      appropriately qualified clinical examiner. Participants meeting the inclusion criteria
      entered an acclimatization period in order to minimize any potential placebo response.
      Participants were randomized into treatments, parallel group, stratified and randomized
      clinical studies twice daily at home for 6, 12 and 24 weeks and participants returned to the
      site. Participants underwent a full OST examination and the recording of any Adverse Events
      (AEs). Participants then underwent Modified Gingival Index (MGI), Bleeding Index (BI),
      Gingival Severity Index (GSI) followed by dental plaque assessments.
    

Intervention name(s): Sodium bicarbonate; Control Dentifrice
Intervention type(s): Other; Other
Intervention description(s): Experimental dentifrice containing 67% w/w sodium bicarbonate in 3 studies and additionally 62% w/w sodium bicarbonate in 3 studies.; Negative control dentifrice containing 0% w/w sodium bicarbonate
Observational model: Other
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Retrospective pooled studies include healthy male and non-pregnant, non-lactating female
        subjects at least 18 years of age, with pre-existing gingivitis as determined by an
        appropriately qualified clinical examiner
      
Keywords: Plaque Accumulation
Quetiapine in Co-Morbid Depressive and Anxiety Disorders
Condition: Major Depressive Disorder; Dysthymic Disorder; Anxiety Disorders; Generalized Anxiety Disorder; Social Anxiety Disorder; Panic Disorder; Post-traumatic Stress Disorder
MeSH terms: Anxiety Disorders; Depressive Disorder; Depression; Depressive Disorder, Major; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Panic Disorder; Phobia, Social; Dysthymic Disorder
Study type: Interventional

Summary: 
      This multi-centred study will be conducted at three centres. The design will be a randomized,
      placebo-controlled, parallel-group one. This investigation will evaluate the efficacy of
      add-on Quetiapine XR (extended release) treatment for patients who meet diagnostic criteria
      for depressive disorders and one or more comorbid anxiety disorder.
    

Detailed description: 
      The primary objective is to examine the beneficial effect of quetiapine augmentation of
      first-line antidepressants in refractory depression with co-morbid anxiety, compared to
      placebo. It is hypothesized that significant improvement on depression and anxiety symptoms
      will be seen as evidenced by reduction in Hamilton Depression Rating Scale (HAMD-17) and
      Hamilton Anxiety Scale (HAMA) scores after the 12 week treatment period for those who
      received Quetiapine XR augmentation compared to those who received placebo.2.2

      Secondary objectives: 1) To establish the tolerability and safety of Quetiapine XR versus
      Placebo in patients with co-morbid depressive and anxiety disorders;2) To assess and compare
      the efficacy of Quetiapine XR versus Placebo improving quality of life in patients with
      co-morbid depressive and anxiety disorders.; 3) To assess and compare the efficacy of
      Quetiapine XR versus Placebo on clinical measures symptoms associated to co-morbid depressive
      and anxiety disorders.
    

Intervention name(s): Quetiapine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Patients will be initiated on 50 mg of Quetiapine XR and will be titrated to a maximum dose of 300 mg based on response and tolerability. Dosing will be flexible up to Week 8, and then will remain fixed for until the end of the 12 week period.; Patients will be initiated on 50 mg of Placebo and will be titrated to a maximum dose of 300 mg based on response and tolerability. Dosing will be flexible up to Week 8, and then will remain fixed for until the end of the 12 week period.
Other intervention name(s): Seroquel
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Co-morbid depressive and anxiety disorders; Quetiapine; Randomized; Placebo-controlled; Double-blind; Major depressive disorder; Dysthymic disorder; Anxiety disorders; Generalized anxiety disorder; Social anxiety disorder; Panic disorder; Post-traumatic stress disorder
Role of Endorphins in the Perception of Dyspnea in Patients With Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Dyspnea
Study type: Interventional

Summary: 
      Endorphins are naturally occurring narcotic substances that are released when individuals
      perform exercise. The hypothesis of the study is that endorphins reduce the severity of
      breathlessness during exercise in patients with chronic obstructive pulmonary disease (COPD).
      The initial five visits include familiarization and validation of a computerized system for
      patients to report dyspnea and leg discomfort continuously during exercise testing.

      At Visits 6 and 7 blood is drawn to measure serum endorphin levels pre-exercise, end
      exercise, and 30 minutes after exercise. Normal saline or naloxone is given intravenously 5
      minutes prior to exercise in a double-blinded design. The primary outcome is the slope of
      oxygen consumption - dyspnea.
    


Intervention name(s): naloxone versus placebo; intravenous injection of normal saline or naloxone
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg of naloxone administered IV or normal saline administered IV in randomized order at different visits; Arm A: 10 mg of naloxone given IV in 25 ml of normal saline Arm B: 25 ml of normal saline
Intervention MeSH terms: Naloxone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: dyspnea; leg discomfort; exercise duration
Isobide Solution and Meniace Tablets Compared to Monotherapy With Meniace Tablets
Condition: Meniere's Disease
MeSH terms: Meniere Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      A multicenter, randomized, open-label clinical study with a concurrent control group to
      assess the effectiveness and safety of combined therapy with Isobide solution and Meniace
      tablets compared to monotherapy with Meniace tablets for patients with Meniere's disease
    


Intervention name(s): Meniace; Isobide
Intervention type(s): Drug; Drug
Intervention description(s): 6 mg of Meniace tablets were administered 3 times per day after meals; an initial dosage of 90 mL of Isobide solution was administered orally 3 times a day after meals
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Follow-up Study to Investigate the Effect of GSK2245035 on Nasal Allergic Reactivity in Subjects Completing Treatment in Study TL7116958
Condition: Asthma and Rhinitis
MeSH terms: Rhinitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the duration of effect of GSK2245035 on allergic reactivity by
      repeating a nasal allergen challenge (NAC) approximately one year after treatment in subjects
      from TL7116958. This is a single centre, single period study in subjects with respiratory
      allergy/allergies who completed the study TL7116958 in 2014 to investigate the long term
      effect of previous treatment with GSK2245035 compared with placebo on total nasal symptoms
      elicited by nasal allergen challenge. Subjects and staff will remain blinded to the treatment
      received in the TL7116958 study (GSK2245035 or placebo). The study will consist of a
      screening visit to assess eligibility criteria, a study period consisting of a single visit
      when the nasal allergen challenge will be performed, and follow up by phone or a clinic visit
      at the discretion of the investigator 4-7 days following the allergen challenge. Eligible
      subjects will participate in this study for approximately70 days total from screening to
      follow up.
    


Intervention name(s): Pollen allergen extract
Intervention type(s): Other
Intervention description(s): Pollen (tree, grass or ragweed) allergen extracts will be provided by the research unit and diluted as required in normal saline. The specific pollen allergen extract that will be used for the nasal allergen challenge will be selected according to each subject's individual allergic sensitivity demonstrated in the previous study, TL7116958. If possible, extracts remaining from this study in 2014 will be used, provided they have not reached their expiry date.
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Allergic Rhinitis; Nasal allergen challenge; Allergic Asthma; Effect on Allergen Reactivity
Reserpine for the Treatment of Cocaine Dependence - 1
Condition: Cocaine-Related Disorders; Substance-Related Disorders
MeSH terms: Cocaine-Related Disorders; Substance-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy and safety of reserpine for the treatment
      of cocaine dependence.
    

Detailed description: 
      To assess the efficacy and safety of reserpine in reducing cocaine use in subjects with
      cocaine dependence. This is a double-blind, placebo-controlled, parallel-group design with a
      2 week baseline period.
    

Intervention name(s): Reserpine
Intervention type(s): Drug
Intervention MeSH terms: Reserpine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cocaine dependence
A Post-Marketing Clinical Study of Aricept in Patients With Dementia With Lewy Bodies (DLB)
Condition: Dementia, Lewy Body; Lewy Body Disease
MeSH terms: Dementia; Lewy Body Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to confirm the efficacy of Aricept in patients with dementia
      with Lewy bodies (DLB).
    


Intervention name(s): E2020; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): E2020 tablets will be orally administered once daily after breakfast; Matching placebo tablets will be orally administered once daily after breakfast
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: DLB; Dementia with Lewy bodies; Lewy Body Disease; Dementia; E2020; Donepezil; Aricept
Effects of Cocoa Intake on Blood Pressure in Elderly Individuals With Mild Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      Regular intake of cocoa-containing foods is linked to a considerably lower cardiovascular and
      all-cause mortality in observational studies. Short-term intervention studies indicate that
      high doses of cocoa improve endothelial function and reduce blood pressure (BP), but the
      clinical impact of long-term intake of small dietary amounts of cocoa on BP and the
      underlying BP lowering mechanisms are unclear. We hypothesized that cocoa consumption lowers
      blood pressure by augmentation of the circulating vasodilative nitric oxide (NO) pool due to
      the action of the cocoa polyphenols at the vascular endothelium.

      To test this hypothesis, we will conduct a randomized single-blind, parallel group study in
      subjects with mild essential hypertension to evaluate the effects of polyphenol-rich dark
      chocolate versus polyphenol-free white chocolate on blood pressure and plasma levels of cocoa
      phenols, circulating bioactive nitric oxide, and plasma markers of oxidative stress. After a
      7 day cocoa-free run-in period, 44 subjects will be 1:1 randomized to receive over 18 weeks
      daily doses of either dark chocolate (6.3 g per day with a total of 30 mg of polyphenols and
      30 kcal) or polyphenol free white chocolate (5.6 g per day with 30 kcal, containing similar
      amounts of macronutrients, electrolytes and vitamins). Subjects will be counseled to maintain
      an isocaloric diet and to abstain from other cocoa products during the study. Blood pressure
      and plasma parameters will be assessed in each subject after the run-in period and after 6,
      12, and 18 weeks of treatment.
    


Intervention name(s): dark chocolate
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Cardiovascular Health And Risk Modification in Family Health Teams
Condition: Cardiovascular Risk Factors; Hypertension; Hyperlipidemia; Diabetes
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 3

Summary: 
      Cardiovascular diseases remain the main cause of mortality in Canada. While effective
      interventions are available for reducing the risk of cardiovascular disease,there continue to
      be gaps between the potential reduction in risk that could be achieved by effectively
      managing these risk factors and levels of risk factor control currently in clinical practice.
      This study will evaluate the ability of a different model of risk factor care using other
      health providers assisting family doctors, along with information aids for patients and
      health professionals,to achieve better levels of cardiovascular risk factor control in
      adults.
    


Intervention name(s): Active risk factor surveillance
Intervention type(s): Behavioral
Intervention description(s): Cardiovascular risk status assessment followed by active surveillance and physician review where risk factor control is suboptimal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: chronic disease management; decision aids; cardiovascular risk factors
Effect of Food on the Pharmacokinetics of Apremilast (CC-10004) in Healthy Adults
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the effects of a high fat meal on the
      pharmacokinetics of a single dose of 30 mg apremilast in healthy adults.
    

Detailed description: 
      Participants will be randomized to receive a single dose of 30 mg apremilast during each of
      the 2 periods; once under fasting conditions and once after a high fat meal. Participants
      will be randomly assigned to receive apremilast either fasted first, then fed, or fed first
      then fasted. Participants will check into the study center on Day -1 of each period, will be
      dosed on Day 1, and discharged from the study center on Day 3 after all scheduled
      pharmacokinetic blood draws and safety evaluations. After a washout of 5 to 10 days,
      participants will return for period 2 during which they will receive apremilast according to
      their assigned sequence.
    

Intervention name(s): Apremilast
Intervention type(s): Drug
Intervention description(s): Tablet for oral administration
Other intervention name(s): CC-10004; Otezla®
Intervention MeSH terms: Apremilast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Apremilast,; pharmacokinetic; safety; Safety and pharmacokinetics in healthy volunteer subjects