bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition on Arterial Wall Inflammation in Patients With Elevated Lipoprotein(a) (Lp(a))
Condition: Subjects With Hyperlipidemia, Dyslipidemia
MeSH terms: Dyslipidemias; Hyperlipidemias; Hyperlipoproteinemias; Inflammation
Study type: Interventional
Phase: Phase 3

Summary: 
      A study to assess the effects of proprotein convertase subtilisin/ kexin type 9 (PCSK9)
      inhibition on the arterial wall inflammation in patients with elevated lipoprotein(a).
    


Intervention name(s): Evolocumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneously once a month using an autoinjector/pen.; Administered subcutaneously once a month using an autoinjector/pen.
Other intervention name(s): Repatha; AMG 145
Intervention MeSH terms: Evolocumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Hyperlipidemia; Dyslipidemia; Proprotein convertase subtilisin/kexin type 9 (PCSK9) Inhibition; Arterial Wall Inflamation; Elevated lipoprotein a
Arm Cycling in Facioscapulohumeral Dystrophy (FSHD) Patients
Condition: Facioscapulohumeral Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Facioscapulohumeral
Study type: Interventional

Summary: 
      The investigators believe that arm cycling has the potential to be effective in maintaining
      or improving shoulder muscle functioning. However, there is no evidence for its safety or
      effectiveness in the upper extremity. The aim of the study is to establish the ability of
      FSHD sufferers to perform arm cycling to underpin the future design of an arm exercise trial.
      The study hypothesis is that the limited range of shoulder movement and muscle weakness
      should not impact the ability of FSHD sufferers to perform arm cycling.
    


Intervention name(s): Arm cycling
Intervention type(s): Other
Intervention description(s): The arm cycle will be placed on table with height adjusted to be the same as the acromion (highest point on shoulder). Participants will start arm cycling at a low intensity and increase as per tolerance. They will exercise for a maximum of two minutes at a time, followed by a rest period for 30 seconds. In this manner 5 cycles of exercise and rest will be performed. The exercise sessions are anticipated to last a maximum of 20 minutes, depending on the patient's abilities.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase II Iressa + Irradiation Followed by Chemo in NSCLC
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to determine wether the ZD1839 associated with a radiotherapy,
      before the beginning of chemotherapy is effective in the treatment of your disease and to
      evaluate the tolerance of these treatments.
    


Intervention name(s): Gefitinib; Radiation therapy; Cisplatin; Vinorelbine
Intervention type(s): Drug; Procedure; Drug; Drug
Intervention MeSH terms: Vinorelbine; Gefitinib
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Atomoxetine and Huntington's Disease
Condition: Huntington Disease; Chorea
MeSH terms: Huntington Disease; Chorea
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to evaluate the effect of atomoxetine (also known as
      Strattera) compared to placebo (inactive substance) on daily activities such as attention and
      focus, thinking ability and muscle movements in subjects with early Huntington Disease (HD)
      and attention deficit disorder (ADD).
    

Detailed description: 
      No medications have been investigated to improve attention and executive functions in
      patients with Huntington's disease, despite the evidence that these cognitive domains can be
      abnormal even before motor symptom onset. Because cognitive symptoms are highly associated
      with functional disability, treatments aimed at improving cognitive functions would be of
      significant benefit to patients in the early stages of the disease. Atomoxetine is the ideal
      choice for such a trial. It has proven efficacy in adults with attention deficit
      hyperactivity disorder (ADHD) and it selectively targets norepinephrine and dopamine in the
      prefrontal cortex rather than in subcortical areas. This selectivity is an advantage for
      patients with HD, because motor side effects are less likely to be facilitated than with a
      psychostimulant. The present study is a feasibility study in which we propose to administer
      either 80 milligram (mg) atomoxetine for 4 weeks or placebo to 20 patients with early HD who
      also complain of mild cognitive symptoms. The groups will then crossover to the other
      condition (atomoxetine or placebo). Participants will be assessed on measures of ADHD
      symptoms and a sensitive battery of neuropsychological tests. Based on the shared neural
      circuitry in ADHD and HD, and the demonstrated effectiveness of atomoxetine on attention in
      adults with ADHD, improved performance on cognitive tests of attention and executive
      functions and on subjects' report of ADHD symptoms are expected in the atomoxetine treatment
      phase. No changes in motor status are predicted during the study.
    

Intervention name(s): atomoxetine; Matching Placebo
Intervention type(s): Drug; Drug
Intervention description(s): This study utilizes a crossover design. Accordingly, half of the participants receive 40 milligram twice a day atomoxetine at arm one while the remaining half receive this intervention at arm two.; This study utilizes a crossover design. Accordingly, half of the participants receive twice a day matching placebo at arm one while the remaining half receive this intervention at arm two.
Other intervention name(s): Strattera; Sugar pill
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Huntington Disease; Chorea; Attention; ADHD; ADD; Strattera; Atomoxetine
Embryo Selection Using Non-invasive Metabolomic Analysis Versus Morphology
Condition: Embryo Viability
Study type: Interventional
Phase: Phase 4

Summary: 
      Metabolomics was recently introduced in human IVF for non-invasive identification of viable
      embryos with the highest developmental competence. The investigators intended to investigate
      if embryo assessment using non-invasive metabolomic profiling leads to increased implantation
      rates compared to routine morphology evaluation alone.
    

Detailed description: 
      Metabolomics was recently introduced in human IVF for non-invasive identification of viable
      embryos with the highest developmental competence. The aim of the present study was to
      determine whether embryo selection using non-invasive metabolomic profiling as an adjunct to
      morphology leads to increased implantation rates compared to routine morphology evaluation
      alone.
    

Intervention name(s): non-invasive metabolomic profiling; morphological evaluation
Intervention type(s): Procedure; Other
Intervention description(s): non-invasive metabolomic profiling of IVF human embryos; Simple microscopic observation of embryos and evaluation of morphological characteristics
Other intervention name(s): ViaMetrics-E, Molecular Biometrics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: non-invasive,; metabolomics,; morphology,; embryo selection,; implantation rates
Meditation and Exercise to Treat Chronic Back Pain
Condition: Chronic Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      This study evaluates the analgesic effect of a combination treatment of exercise and
      mindfulness based meditation in patients with chronic back pain. Half of the participants
      will partake in a 4-week exercise and meditation intervention, while the other half will
      receive a placebo treatment. The investigators hypothesize that a combination treatment
      reduces disability and pain more than the control intervention.
    

Detailed description: 
      Exercise and mindfulness based mediation can both produce analgesic effects in patients with
      chronic pain, but the mechanisms are not clear.

      Combining treatments could produce analgesic effects that are additive, synergistic, or
      counteractive to each other. Here, the investigators examine the effects of a 4-week
      intervention in patients with chronic low back pain. Patients are assigned to a
      meditation/exercise group or a control group. The investigators will measure pain and
      disability using a variety of tools including surveys (disability, anxiety, mindfulness, and
      pain), pain VAS scales, and quantitative sensory testing.
    

Intervention name(s): Exercise and Meditation; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The Exercise and Meditation group will listen to recorded meditations (15 minutes) that are based on mindfulness. They will then walk on a treadmill for 30 minutes at a moderate intensity. The intervention is completed five days per week for four weeks.; The Control group will listen to a recorded audio book for 15 minutes, They will then sit quietly for 30 minutes. The intervention is completed five days per week for four weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Mindfulness; Exercise; Meditation; Back pain
Bioequivalence of Alprazolam Sublingual vs Oral Tablets
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study tests the assumption that the bioavailability of alprazolam from a new sublingual
      formulation is the same as that from a standard orally administered tablet.
    


Intervention name(s): alprazolam sublingual tablet; alprazolam oral tablet
Intervention type(s): Drug; Drug
Intervention description(s): 1 mg alprazolam sublingual tablet, given as a single dose to each subject; 1 mg alprazolam immediate release oral tablet, given as a single dose to each subject
Other intervention name(s): Xanax
Intervention MeSH terms: Alprazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Bioequivalence, Pharmacokinetics, Alprazolam, Sublingual
Treatment of Apogeotropic Horizontal Canal Benign Paroxysmal Positional Vertigo
Condition: Benign Paroxysmal Positional Vertigo
MeSH terms: Vertigo; Benign Paroxysmal Positional Vertigo; Dizziness
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine the short term therapeutic efficacies of Gufoni maneuver and mastoid oscillation
      in apogeotropic type of benign paroxysmal positional vertigo (BPPV) involving the horizontal
      semicircular canal (HC-BPPV), a randomized, prospective, sham-controlled study was conducted.
    

Detailed description: 
      The apogeotropic type of benign paroxysmal positional vertigo involving the horizontal canal
      (HC-BPPV) is likely due to otolithic debris in the anterior arm of the canal (canalithiasis)
      or the debris attached to the cupula (cupulolithiasis). It is important to seek the method to
      convert treatment-resistant apogeotropic form to the more treatment-responsive geotropic form
      in HC-BPPV. Recent randomized trials demonstrated that head shaking maneuver was more
      effective than the modified Semont maneuver and the Gufoni and head shaking maneuvers showed
      similar efficacy in treating apogeotropic HC-BPPV. Moreover, new repositioning maneuver using
      mastoid vibration showed good efficacies in patients with apogeotropic HC-BPPV in recent
      study. So we tried to compare the short term therapeutic efficacies of Gufoni maneuver and
      mastoid oscillation in apogeotropic HC-BPPV with a randomized, prospective, sham-controlled
      study.
    

Intervention name(s): Gufoni; Vibration; Sham
Intervention type(s): Procedure; Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Safety Study to Assess the Feasibility of Use in Humans of the TAXUS Petal Bifurcation Coronary Stent System
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and feasibility of use in humans of the
      TAXUS Petal Paclitaxel-Eluting Bifurcation Coronary Stent System in the treatment of de novo
      lesions in native coronary arteries involving a major side branch. The TAXUS® Petal™ is an
      investigational device with an indication of improving coronary artery luminal diameter while
      maintaining side branch access in subjects with symptomatic ischemic disease due to discrete
      atherosclerotic bifurcation lesions
    

Detailed description: 
      To assess the safety and feasibility of use in humans of the TAXUS Petal Paclitaxel-Eluting
      Bifurcation Coronary Stent System (TAXUS® Petal™) for the treatment of de novo
      atherosclerotic bifurcation lesions (by visual estimate):

        -  Phase 1:

             -  Main branch: 3.0 to 3.5 mm RVD and lesion length ≤20 mm

             -  Side branch: 2.5 to 3.5 mm RVD and lesion length ≤14 mm

        -  Phase 2:

             -  Main branch: 3.0 to 3.5 mm RVD and lesion length ≤28 mm

             -  Side branch: 2.25 to 3.5 mm RVD and lesion length ≤14 mm

      Bifurcation main branch (MB) lesion length will be measured from the proximal shoulder of the
      most proximal lesion to the distal shoulder of the most distal lesion. Bifurcation side
      branch (SB) lesion length will be measured from the proximal shoulder of the side branch (if
      the ostium is disease-free) or the side branch ostium (if the disease continues into the main
      branch) to the distal side branch shoulder of the most distal lesion. At follow-up, the
      entire stented region will be used to determine MLD and %DS.
    

Intervention name(s): Percutaneous Coronary Intervention (PCI) TAXUS Petal
Intervention type(s): Device
Intervention description(s): TAXUS Petal, paclitaxel eluting stent
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: safety; feasibility; bifurcation; lesion; de novo; intervention
Study of Social Cognition Processes With Multimodal MRI on Healthy Adult Patients.
Condition: Social Cognition
Study type: Observational

Summary: 
      The study of higher cognitive functions (learning, memory, language, reasoning, decision
      making) in humans constitutes an interdisciplinary field, which combines neurobiological and
      neurological, neuropsychological, as well as linguistic and artificial intelligence skills.
      Historically, the study of patients with cerebrovascular lesions or brain pathologies
      associated with primary and/or cognitive deficits has produced fundamental knowledge in this
      area. The development of modern non-invasive investigation techniques of the human brain -
      such as Structural Magnetic Resonance Imaging (MRI), Diffusion Tensor Imaging, Functional
      Magnetic Resonance Imaging (fMRI), Positron emission (PET), the study of event-related
      electrophysiological potentials (ERP) or magneto-encephalography (MEG) - has made it possible
      to carry out similar studies on healthy subjects, as well as the in-vivo analysis of adaptive
      and plastic mechanisms of the human brain. Recently, the interest of cognitive neuroscience -
      this is the name taken by this vast interdisciplinary sector which aims to understand the
      neural mechanisms underlying human cognitive processes - has been oriented towards the study
      of decision making in social contexts. Knowledge of the mechanisms underlying these processes
      is fundamental for the most complete description of the biological bases of human behavior
      and above all for the optimal development of treatments for brain pathologies, whether
      surgical, pharmacological or rehabilitation in general.
    


Intervention name(s): study of higher cognitive functions
Intervention type(s): Diagnostic Test
Intervention description(s): General objective: increase knowledge about neural correlates:
of the cognitive processing of stimuli of a social nature; of decision-making processes in the context of individual choice; of the influence of the social context on individual decision-making processes.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Behavioral study with neuro-anatomical functional correlates consisting of cognitive
        activation experiments during functional magnetic resonance imaging, with observation of
        images of a social nature and decision making in an individual or social context.
A Phase IV Safety and Efficacy Study of VI-0521 in Adolescents With Obesity
Condition: Adolescent Obesity; Obesity in Adolescence; Adolescent Overweight
MeSH terms: Obesity; Overweight; Pediatric Obesity
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is being conducted to assess weight loss efficacy, as determined by changes in
      body mass index (BMI), and safety of VI-0521 (Qsymia®) or placebo, taken for 56 weeks
      accompanied by a lifestyle modification program in obese adolescents age 12-16 years.
    


Intervention name(s): VI-0521 oral capsule; Placebo oral capsule; Lifestyle Modification
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): Phentermine/Topiramate; Inactive drug; The lifestyle modification includes physical activity, behavior change, reduced calorie diet advice, and family support. This intervention is applied to all treatment groups.
Other intervention name(s): Qsymia; Phentermine and topiramate
Intervention MeSH terms: Topiramate; Phentermine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: weight loss; obesity; weight control
The Use of Manuka Honey to Improve Healing After Third Molars Surgery
Condition: Surgical Extraction of Impacted Third Molars
MeSH terms: Tooth, Impacted
Study type: Interventional

Summary: 
      Since there is an evidence that Manuka honey is an antibacterial agent, the present study
      aims to confirm this characteristic and assess its effect in improving healing and reducing
      postsurgical symptoms, if topically applied after the surgical removal of impacted mandibular
      third molars
    

Detailed description: 
      Sufficient evidence exists recommending the use of honey in the management of acute wounds
      and burns. Studies revealed that the healing effect of honey could be classified by its
      antibacterial, antiviral, anti-inflammatory and antioxidant properties of its components.
      Manuka honey has been shown to inhibit a wide range of microorganisms, including
      multiresistant strains. This unique honey is derived from flowers of manuka tree
      (Leptospermum scoparium) in New Zealand. Dihydroxyacetone and methylglyoxal are unique and
      naturally occurring constituents of manuka honey that correlate with its antibacterial
      activity.

      Since surgical extraction of impacted molars is one of the most common operations in the oral
      cavity and the postoperative symptoms disturbing the patient may reduce the quality of health
      service, this study aims to assess the healing potential of Manuka honey in reducing these
      symptoms by comparing the outcome of extraction of impacted lower molars with and without
      topical application of Manuka honey into the extraction socket.
    

Intervention name(s): Manuka Honey
Intervention type(s): Biological
Intervention description(s): This material is going to be placed into the sockets of the extracted third molars in the experimental group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Cortical Excitability and Decision Making After Total Sleep Deprivation and Sleep Restriction
Condition: Acute and Partial Sleep Deprivation
MeSH terms: Sleep Deprivation
Study type: Interventional

Summary: 
      The investigators examine changes in decision making, vigilance and cortical excitability in
      healthy male subjects undergoing total acute sleep deprivation (40 hours) on the one hand,
      and chronic partial sleep restriction (7 nights with 5 instead of 8 hours in bed per night)
      on the other hand, in a cross over controlled manner. The investigators hypothesize that
      total sleep deprivation, as well as partial sleep restriction lead to impairments in decision
      making and vigilance, and enhanced cortical excitability.

      Beside these three primary outcomes, the investigators also assess changes in sleep by EEG,
      dim light melatonin onset, skin temperature, subjective mood and sleepiness, working memory,
      and also collect saliva samples.
    


Intervention name(s): Sleep Deprivation
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Effect of Anticholinesterase Drugs on Sleep in Alzheimer's Disease Patients
Condition: Alzheimer Disease; Sleep Apnea, Obstructive
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Alzheimer Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the effects of the anticholinesterase drug
      donepezil on sleep in Alzheimer disease patients. Sleep structure and respiratory parameters
      will be analyzed by polysomnography.
    

Detailed description: 
      Central acting cholinesterase inhibitors are the first primary pharmacological treatment
      approved for Alzheimer disease, of which donepezil is the most frequently used. Multicenter
      studies have found little toxicity, and its side effects (diarrhea, nausea, vomiting,
      nightmares, among others) are mild and transient. According to the literature, cholinergic
      active drugs may be expected to affect REM (rapid eye movement) sleep. Another possible
      effect is related to respiratory parameters in patients with Alzheimer disease and
      obstructive sleep apnea. In fact, cholinergic activity influences the upper airway opening
      via central and peripheral mechanisms.

      Intervention: Patients will be administered donepezil or placebo. The study has a randomized,
      double-blind placebo-controlled design. Complete polysomnography with REM sleep EEG spectral
      analysis and ADAS-cog scoring will be performed at baseline and after 3 and 6 months.
    

Intervention name(s): donepezil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): donepezil 5 mg 1 p / day for 1 month and 2p / day for 5 months on.; Placebo 1p / day for 1 month and 2 / day for 5 months on
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Alzheimer; polysomnography; REM sleep; donepezil; sleep apnea; oxygen saturation