bioihbjkbjnl/mcl2 huggingface dataset:
Group Cognitive Behavioral Therapy and Acupressure for Insomnia
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      This study will examine the use of cognitive behavioural therapy (CBT) and acupressure in
      treating insomnia in Chinese adults. The main components of CBT for insomnia (CBT-I) includes
      psychoeducation, sleep restriction, stimulus control, cognitive restructuring, and
      relaxation. CBT-I is widely used in western countries but it fails to address patient
      preference among Chinese adults with insomnia, as demonstrated in a previous study examining
      the subjective experience of chronic insomnia in Hong Kong Chinese adults. The study revealed
      that Chinese adults showed distrust in hypnotics and preferred traditional Chinese medicine
      (TCM) which was believed to be more natural. In order to maximize the therapeutic effects of
      psychological interventions for insomnia, integrative medicine with a combination of CBT-I
      and TCM could be an alternative to address insomnia in the Chinese population. Acupressure, a
      non-invasive therapy, is commonly used in TCM. It is suggested that acupressure can induce
      relaxation and improve sleep quality. Some studies have demonstrated the separate efficacy of
      CBT-I and acupressure in treating insomnia. However, few studies have examined the effect of
      their combination.
    


Intervention name(s): Cognitive Behavioral Therapy for Insomnia; Acupressure
Intervention type(s): Behavioral; Other
Intervention description(s): Cognitive Behavioral Therapy for Insomnia including psychoeducation, sleep restriction, stimulus control, cognitive restructuring, and relaxation.; Acupressure, a non-invasive therapy, is commonly used in Traditional Chinese Medicine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Insomnia; Cognitive Behavioral Therapy; CBT-I; Acupressure; Traditional Chinese Medicine
Art Therapy Program in the Chronic Phase of Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      INTRODUCTION: After stroke, perceptual impairments, such as negative body perception,
      contribute to social isolation and depression. In the subacute poststroke phase, art therapy
      is effective in improving depression, self-esteem, and community integration. Yet, no study
      has explored the effectiveness of art therapy at the chronic stage of a stroke; where motor
      recovery is slowed, and body image and self-esteem are deeply challenged.

      OBJECTIVES: Primary; to assess the feasibility of an art therapy program (ATP) in the chronic
      phase of stroke. Secondary; to explore the effects of ATP on perceptual impairment (body
      image/self-esteem), mood and community integration.

      METHOD: Nine adults (stroke ≥6 months) will participate in the ATP consisting of a thematic
      group visit to the Montreal Museum of Fine Arts followed by an art workshop, supervised by an
      art therapist (7 visits over 4 months). Feasibility will be evaluated by triangulating data
      from interviews and subject assessment questionnaires and by assessing retention and
      attendance. The effects of the ATP will be assessed by changes in perceptual and mood
      impairment questionnaires (Body Image States, Self-Esteem scales, Beck Depression
      Inventory-Short-Form) and community integration questionnaire (The Community Integration
      Questionnaire).

      EXPECTED RESULTS AND OUTCOMES: The project will confirm the feasibility of ATP to improve
      perceptual impairment and community integration post-stroke.
    


Intervention name(s): art therapy
Intervention type(s): Behavioral
Intervention description(s): guided art tour and workshop
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: art therapy; perceptual impairment; depression
A Study to Assess the Reduction of Daily Maintenance ICS/LABA Treatment Towards Anti-Inflammatory Reliever Treatment in Patients With Severe Eosinophilic Asthma Treated With Benralizumab
Condition: Asthma; Severe Eosinophilic Asthma
MeSH terms: Asthma; Pulmonary Eosinophilia
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multicentre, randomised, open-label, parallel-group, active-controlled, phase IV
      study to assess the reduction of daily Symbicort® maintenance to anti-inflammatory reliever
      treatment only in participants with severe eosinophilic asthma on Fasenra® treatment, while
      maintaining asthma control.
    

Detailed description: 
      This study will be conducted at 24 study sites in 3-5 countries. The study duration for each
      participant will be approximately 52-56 weeks. Approximately 240 participants with severe
      eosinophilic asthma taking high-dose Inhaled corticosteroids/ long-acting β2-agonist
      (ICS/LABA) who have been treated for severe eosinophilic asthma with at least 3 consecutive
      doses of Fasenra® and have clinically responded since the start of Fasenra® treatment
      (defined for the purpose of this study as an Asthma control questionnaire-5 item (ACQ-5
      score) <1.5 at Visit 1 and Visit 2b) will be enrolled into this open-label study. The study
      consists of a Screening Visit (Visit 1) and 4- to 8-week screening and run-in period (to
      align the randomisation study visit with the next Fasenra® injection), a reduction period of
      32 weeks, and a 16-week maintenance period.
    

Intervention name(s): Symbicort®; Fasenra®; Ventolin®
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive Budesonide 400 μg/formoterol fumarate 12 μg per inhalation and Budesonide 200 μg/formoterol fumarate 6 μg per inhalation.; Participants received Benralizumab 30 mg/mL, 1 mL fill volume via Subcutaneous every 4 weeks for first 3 doses.; Participants received Salbutamol sulfate 100 μg per inhalation as needed.
Other intervention name(s): budesonide/formoterol; benralizumab; salbutamol
Intervention MeSH terms: Budesonide; Albuterol; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination; Benralizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anti-Inflammatory; Reduction period; Inhaled corticosteroids; long-acting β2 agonist
P2Y12 Inhibitors Utilization in Bifurcation and Chronic Total Occlusion PCI
Condition: Coronary Arteriosclerosis
MeSH terms: Arteriosclerosis; Coronary Artery Disease; Myocardial Ischemia
Study type: Observational

Summary: 
      Prasugrel and ticagrelor were both associated with a significant reduction in the risk of
      MACE in patients undergoing PCI for an ACS, mostly through a reduced stent thrombosis. The
      1-year relative risk reduction (RRR) of definite of probable stent thrombosis in patients
      receiving a DES were fairly different in TRITON-TIMI 38 and PLATO trials. The incidence of
      "biologically active" stent (DES or BVS) thrombosis is largely variable according to
      different lesion settings. We aim to verify the translation of the postulated different
      reduction in thrombosis rate among various P2Y12 inhibitors (clopidogrel, prasugrel and
      ticagrelor) in a high-risk setting such as the PCI with DES or BVS in CTO and bifurcating
      lesions.
    

Detailed description: 
      All patients aged 18-80 who underwent PCI of a CTO or bifurcating lesion (all Medina types,
      side branch ≥2 mm) with "biologically active stents" (DES or BVS) between January 2012 and
      december 2014 at participating centers will be deemed eligible to enter the registry.

      In-hospital outcomes will be recorded; all patients discharged alive will be followed up with
      a telephone interview (minimum follow-up 6 months).

      The primary end-point will be the occurrence of a cluster of major adverse cardiovascular
      events at 1 year:

        1. Death from any cause.

        2. Myocardial infarction.

        3. Stent thrombosis, defined as definite, probable or possible following the Academic
           Research Consortium.

      Sample size 3150 patients.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All patients aged 18-80 undergoing PCI of a CTO or bifurcating lesion (all Medina types,
        side branch ≥2 mm) with "biologically active stents" (DES or BVS) between January 2012 and
        december 2014 at participating centers will be deemed eligible to enter the registry.
      
Keywords: PCI,; CTO,; bifurcation,; clopidogrel,; prasugrel,; ticagrelor
Dose Finding Study With CYT003-QbG10 in Patients With House Dust Mite Allergy
Condition: Rhinoconjunctivitis; Allergies
MeSH terms: Dust Mite Allergy; Conjunctivitis; Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to test whether vaccinations with CYT003-QbG10 can improve
      allergy symptoms in patients with house dust mite allergy. The active treatment will be
      compared against placebo.
    


Intervention name(s): CYT003-QbG10; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous injection; subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Rhinoconjunctivitis due to house dust mite allergy
Strategic Use of New Generation Antidepressants for Depression
Condition: Unipolar Major Depressive Episode
MeSH terms: Depression
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to establish the optimum treatment strategy for first-line and
      second-line antidepressants in the acute phase treatment of major depression.
    


Intervention name(s): Sertraline; Mirtazapine
Intervention type(s): Drug; Drug
Intervention description(s): Sertraline 50 mg/d or 100 mg/d for 6 more weeks; Augment with or switch to mirtazapine 15-45 mg/d
Intervention MeSH terms: Mirtazapine; Sertraline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
PurTox (Botulinum Toxin Type A) for the Treatment of Adult Onset Spasmodic Torticollis/Cervical Dystonia
Condition: Spasmodic Torticollis
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Study type: Interventional
Phase: Phase 1

Summary: 
      The safety and efficacy of Mentor Purified Toxin, Botulinum Toxin Type A, Purified
      Neurotoxin, injected intramuscularly into the neck, is being evaluated as a treatment for
      painful and non-painful spasmodic torticollis/cervical dystonia. It is hypothesized that
      treatment will decrease symptom severity and will not have any significant side effects.
    


Intervention name(s): Mentor Purified Toxin, Botulinum Toxn Type A, Purified Neurotoxin; Physiologic saline
Intervention type(s): Drug; Other
Intervention description(s): 100U vials, doses ranged from 50U-200U, single injection.; Single injection.
Intervention MeSH terms: Botulinum Toxins
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Torticollis; Cervical Dystonia
Evaluation of the Effects of Duloxetine on Norepinephrine
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate how taking duloxetine 60mg every day affects the
      transfer of two normal body chemicals, 3,4-dihydroxyphenylglycol (DHPG) and norepinephrine
      (NE), across cells in blood and cerebrospinal fluid.
    


Intervention name(s): Duloxetine; Escitalopram; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Duloxetine Hydrochloride; Escitalopram
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Treatment
A Pharmacokinetic Study of MK-1602 in the Treatment of Acute Migraine (MK-1602-007)
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to characterize the pharmacokinetics of MK-1602 in the treatment
      of acute migraine, including the influence of demographic and other variables on MK-1602
      pharmacokinetics, and to evaluate the relationship between MK-1602 concentrations and
      efficacy of the drug.
    


Intervention name(s): MK-1602; Placebo; Rescue medication
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Three administrations of the same dose of MK-1602 on separate days. All 3 doses are either 1, 10, 25, 50 or 100 mg of MK-1602. Dose 1: Taken at onset of migraine of moderate or severe intensity. Dose 2: Taken the evening before Visit 2. Dose 3: Taken at Visit 2, which is Day 4 post migraine treatment (Dose 1).
Dosage form is film coated tablet for oral administration.; Three administrations of placebo for MK-1602 on separate days. Dose 1: Taken at onset of migraine of moderate or severe intensity. Dose 2: Taken the evening before Visit 2. Dose 3: Taken at Visit 2, which is Day 4 post migraine treatment (Dose 1).
Dosage form is film coated tablet for oral administration.; If moderate or severe migraine headache pain continues 2 hours after dose of study medication or if migraine headache comes back within 48 hours,
Participants will be allowed to take their own rescue migraine medication, which may include analgesics (e.g., nonsteroidal anti-inflammatory drugs [NSAIDs]), anti-emetics, triptans, opiates or other medication not explicitly excluded.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Lactobacillus Rhamnosus GG Oral Treatment Efficacy on Vernal Keratoconjunctivitis Treatment
Condition: Vernal Keratoconjunctivitis
MeSH terms: Keratoconjunctivitis; Conjunctivitis, Allergic
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This interventional study aims to evaluate the efficacy of oral administration of
      Lactobacillus Rhamnosus GG in preventing relapses of ocular inflammation in Vernal
      Keratoconjunctivitis (VKC) patients.
    

Detailed description: 
      Vernal keratoconjunctivitis (VKC) is a chronic allergic disease, characterised by ocular
      surface inflammation lasting all year with seasonal relapses. Active phases of VKC are
      characterised by intense ocular symptoms and require treatment with topical steroids to
      control inflammation and corneal damage. To date, safe and effective therapies in preventing
      relapses of VKC are not available. Recently, the use of oral administration of probiotics for
      allergic diseases have been proposed. No data are available on the effects of probiotics on
      ocular allergies. This multicenter, double-masked, randomised, controlled clinical trial will
      allow to obtain more data on the efficacy of oral treatment with Lactobacillus Rhamnosus GG
      in patients affected by VKC. Patients with VKC will be treated with Lactobacillus Rhamnosus
      GG or placebo in addition to ketotifen fumarate 0.025% eye drops (standard treatment). The
      number of relapses per year, signs and symptoms of the disease, total symptom score (TSyS),
      total sign score (TSS), biochemical and molecular parameters will be evaluated at different
      time points.
    

Intervention name(s): Lactobacillus Rhamnosus GG; placebo (sugar)
Intervention type(s): Drug; Drug
Intervention description(s): patients are treated with oral Lactobacillus Rhamnosus GG once daily for six months; Placebo will be administered to patients once daily for six months
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vernal keratoconjunctivitis; probiotic; Lactobacillus Rhamnosus GG; Children; Clinical trial
A Bioequivalence Study Comparing a Single Oral Intake of an Imported PROBUCOL Tablet(Lorelco) With a Marketed PROBUCOL Tablet(Chang Tai) in Chinese Healthy Volunteers
Condition: Chinese Healthy Volunteers
Study type: Interventional

Summary: 
      This study compares the pharmacokinetics characteristics of a single oral intake of an
      imported PROBUCOL tablet(Lorelco)(1*250mg/tablet) with a marketed PROBUCOL tablet (Chang
      Tai)(1*250mg/tablet) in healthy male volunteers to demonstrate they are bioequivalent.
    


Intervention name(s): Group A: imported Probucol ( Lorelco); Group B: Marketed Probucol ( Chang Tai)
Intervention type(s): Drug; Drug
Intervention description(s): Group A: take imported Probucol( Lorelco) (250mg/tablet), Qd, P.O.; Group B: take Marketed Probucol(Chang Tai)(250mg/tablet), Qd, P.O.
Intervention MeSH terms: Probucol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: bioequivalence; imported PROBUCOL table; Lorelco; marketed PROBUCOL tablet; Chang Tai
Naproxen Sodium (2 x 220 mg) Fasted Comparative Bioavailability Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to investigate the rate and extent of naproxen absorption from
      the Test naproxen sodium formulation is bioequivalent to Aleve® naproxen sodium, a Reference
      product currently marketed in The Netherlands in order to support the registration of the
      Reckitt Benckiser (RB) naproxen sodium (220 mg tablets).
    


Intervention name(s): Test; Reference
Intervention type(s): Drug; Drug
Intervention description(s): RB naproxen sodium tablets (2x220mg); Aleve naproxen sodium tablets (2x220mg)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Pharmacodynamics and Pharmacokinetics of Citalopram and Escitalopram
Condition: Depression
MeSH terms: Depression
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is one component of a larger U01 grant that was submitted in August, 2004 to the
      NIGMS as part of the Pharmacogenomic Research Network. This study will enroll 1200 patients
      over 4 years.

      It is known that functionally significant genetic polymorphisms for the cytochrome P450
      (CYPs) can contribute to individual differences in response to specific selective serotonin
      reuptake inhibitors (SSRIs). However, a better understanding of the pharmacogenomics of both
      PK and PD for SSRI antidepressants will inform clinical practice. Therefore, we propose to
      evaluate the contribution of pharmacogenomics to variation in response to the highly specific
      SSRIs citalopram (a racemic mixture) and escitalopram (a chiral compound containing the
      active S-isomer of citalopram ) by correlating both PK and PD variation for these agents with
      intragene haplotypes in genes encoding proteins involved in citalopram metabolism, as well as
      central nervous system (CNS) pathways for monoamine neurotransmitter biosynthesis,
      metabolism, storage, release, reuptake, and receptors. In the future this "candidate pathway"
      intragene haplotype genotyping strategy will also be complemented by the application of
      genome-wide screens performed with DNA from subjects with extreme phenotypes for response to
      citalopram.

      Phenotypes to be measured before and after the initiation of citalopram or escitalopram
      therapy will include determinations of serum citalopram and metabolite concentrations,
      treatment response as measured by Hamilton Rating Scale for Depression indices, and number
      and severity of side effects as determined by structured questionnaires. The hypothesis to be
      tested is that inherited variation in citalopram metabolism and transport (PK) and/or PD
      variation as a result of inherited variation in monoamine neurotransmitter biosynthesis,
      metabolism, reuptake, storage, receptors or signaling contribute to individual variation in
      citalopram antidepressant efficacy and/or side effects.
    


Intervention name(s): citalopram and escitalopram
Intervention type(s): Drug
Intervention description(s): escitalopram tablets starting at 10 mg, increase to 20 mg at 4 weeks if QIDS-C16 > 5, keep at same dose if QIDS-C16 < 5.
citalopram tablet or solution starting at 2o mg, increase to 40 mg at 4 weeks if QIDS-C16 > 5, keep at same dose if QIDS-C16 < 5.
Intervention MeSH terms: Citalopram; Escitalopram
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Depression; Antidepressants
NASOBOL in Hypogonadal Men in Comparison to Testosterone Levels in Normal Healthy Male Volunteers
Condition: Hypogonadism
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study the serum concentration of testosterone and its main metabolite DHT will be
      measured in hypogonadal men using intranasal testosterone (Nasobol). Different treatment
      regimens (once and twice daily) and administration times will be tested. The serum levels
      obtained will be compared with those of healthy men.

      It is expected that intranasal administration of Nasobol will restore testosterone and DHT
      levels to nearly normal.
    

Detailed description: 
      This pharmacokinetic trial is performed with the aim to determine the pharmacokinetic
      behavior of testosterone after repeated nasal administration of NASOBOL® in patients with
      hypogonadism and to compare the levels of the major analytes to levels seen in normal healthy
      men. For this purpose, four different treatment schedules of administration of NASOBOL® will
      be tested and compared to 24-h levels in normal healthy men.

      This is a Phase I, pharmacokinetic trial with different administration schemes of NASOBOL® in
      patients with moderate hypogonadism (Groups 1, 2 and 3). For reference purposes frequent
      blood samples will be taken in a group of healthy men (Group 4). Subjects will be screened
      for eligibility not more than 4 weeks before the 1st dose of NASOBOL®. Total study duration
      for hypogonadal patients is maximally 38 days (including a 3 days placebo run-in phase).
      Healthy men will be screened for eligibility and will be in the clinic for only 1 day (with
      overnight stay) during the study.

      For hypogonadal patients 7 visits to the clinic are planned, amongst which 2 visits for 24-h
      PK sampling each with an overnight stay. Seven days after the last dose of NASOBOL®
      hypogonadal patients will be asked to come to the clinic for a final follow-up visit.

      Telephone follow-ups will be done on Days 7, 13, 21 and 27 to check whether subjects have
      taken their medication.
    

Intervention name(s): testosterone
Intervention type(s): Drug
Intervention description(s): Intranasal testosterone, 7.6 mg (3.8 mg in each nostril) per application
Other intervention name(s): Nasobol
Intervention MeSH terms: Testosterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pharmacokinetics; testosterone; hypogonadism