bioihbjkbjnl/mcl2 huggingface dataset:
SEEG Investigation of Mood Dysregulation in Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Observational

Summary: 
      Using the novel analysis of stereo-electroencephalography (SEEG) recordings, this proposal
      will investigate the activity and connectivity of mood regulation circuits in subjects with
      suspected epileptic focus who have undergone SEEG electrode implantation for monitoring of
      seizure activity.
    

Detailed description: 
      It is well known that epilepsy is associated with mood dysregulation including symptoms of
      labile mood, impulse control problems, anxiety, depression and increase in incidence of
      suicide. However, until present the neurobiological basis of mood dysregulation in epilepsy
      has not been clear and has been mostly attributed to a psychological reaction to the illness.
      This has severely limited our understanding of the impairments in mood regulation that people
      with epilepsy often experience and has also limited the development of effective treatment
      for ameliorating psychosocial dysfunction in people with epilepsy. The identification of
      these circuits will not only increase our understanding of mood-regulation in epilepsy but
      also possibly provide biomarkers with which the effectiveness of new treatments can be
      investigated. Developing better diagnostic measures and treatments for mood dysregulation
      will be highly beneficial to the quality of life of subjects suffering from epilepsy.
    

Intervention name(s): SEEG Recordings
Intervention type(s): Other
Intervention description(s): To directly record brain activity from the frontal-limbic circuitry of subjects in the resting state and while they engage in behavioral tasks designed to assess emotional response to negative stimuli and different aspects of impulse control and emotional processing
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects from the Epilepsy Center at the Cleveland Clinic for surgical treatment of
        medically refractory epilepsy who would have already had SEEG electrodes placed in cortical
        and limbic areas for clinical diagnostic purposes
Differences in Nerve Fiber Layer Between Patients With Normal- and High-Pressure-Glaucoma
Condition: Normal Tension Glaucoma; High Tension Glaucoma
MeSH terms: Glaucoma; Low Tension Glaucoma
Study type: Observational

Summary: 
      The purpose of the study is to prove if there is any difference in the nerve fiber layer
      between patients with normal- and high-tension-glaucoma with similar structural optic nerve
      head parameters.
    

Detailed description: 
      It is till now not definitely clear whether normal- and high-tension glaucoma are different
      forms of the same disease and whether they have similar pathogenetic mechanisms. Spectral
      domain optical coherence tomography (SD-OCT) is supposed to objectively evaluate retinal
      nerve fiber layer (RNFL) thickness. The investigators propose a study to compare the RNFL in
      patients with normal- and high-tension-glaucoma. In order to exclude other possible
      differences,which could influence the results, only patients with similar structural optic
      nerve head damage in both groups will be compared.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        primary care clinic University hospital of Dresden
Macroalgae Consumption - a Pilot Study
Condition: Iodine Toxicity
Study type: Interventional

Summary: 
      In this study, the aim is to investigate the food safety of macroalgae. There will be an
      analysis of macroalgae products for the concentration of cadmium, inorganic arsenic, and
      iodine in macroalgae, as well as measure the status of these elements in consumers. An
      investigation of the thyroid function of macroalgae consumers and the use of metabolomics to
      explore which biological changes occur when consuming seaweed and kelp and when the consumer
      excludes macroalgae from their diet will be performed.
    

Detailed description: 
      A group of consumers of macroalgae will be recruited to investigate their macroalgae intake
      and iodine, cadmium, and inorganic arsenic status and thyroid function. Iodine, cadmium, and
      inorganic arsenic have been selected since these elements have been described as relatively
      high in a previously published report from Norway. The goal is to recruit consumers of brown
      algae - especially kelp, and certain types of red algae, as these were the species with the
      highest content of iodine, cadmium, and arsenic, described in a previous publication. The
      participants will be asked to abstain from macroalgae for 6 weeks and again examine iodine
      status, cadmium and arsenic exposure, and thyroid function after the cessation period. A
      withdrawal period of 6 weeks has been chosen on the basis that it is calculated 6-8 weeks
      after Levaxin treatment for hypothyroidism before a new equilibrium can be expected and the
      effect of treatment on TSH can be assessed.

      This study will provide new insight into the status of iodine, cadmium, and inorganic arsenic
      that macroalgae consumers have in urine and thyroid function after regular macroalgae
      consumption and after cessation of macroalgae intake. In addition, the study will provide
      descriptive data on macroalgae consumption, how it is eaten, how often, and how much. This
      can provide critical knowledge to the national and European authorities for food safety and
      public health advisers to evaluate the food safety of macroalgae.
    

Intervention name(s): Habitual macroalgae consumption; No macroalgae consumption
Intervention type(s): Other; Other
Intervention description(s): The participant have a habitual macroalgae consumption at baseline.; The participants exclude any macroalgae products from their diet
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: macroalgae; iodine; consumption
Nudges on Hospitalist Behavior and Patient Satisfaction
Condition: Patient Satisfaction; Etiquette, Medical
Study type: Interventional

Summary: 
      Physician behavior plays an important role on patient perception of their care team and on
      patient satisfaction. Though studies have attempted to impact how physicians interact with
      their patients through various initiatives, the effect of more subtle nudges on physician
      behavior have not been studies. As such, the investigators propose a randomized controlled
      deception trial to evaluate the impact of nudges on hospitalist behavior and patient
      satisfaction.
    


Intervention name(s): Nudge
Intervention type(s): Behavioral
Intervention description(s): Room intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Health Services Research
The Point of View of Adolescents Who Have Undergone a Suicidal Act: What do They Expect From Their Relationship With Their Doctor?
Condition: Suicidal Act
Study type: Observational

Summary: 
      Evaluate the expectations of adolescents who have performed a suicidal act with regard to
      their relationship with their doctor
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adolescents aged 12 to 18 years with suicidal act
Prono Position and Mechanical Power
Condition: Acute Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
Study type: Observational

Summary: 
      The primary objective of the study is to compare the mechanical power applied to the
      respiratory system in patient with acute respiratory distress syndrome in supine positioning
      and after the implementation of prone positioning while mantaining the same ventilatory
      setting.

      The secondary objetive of the study is to compare the mechanical power applied to the
      respiratory system in patient with acute respiratory distress syndrome in supine positioning
      and after the implementation of prone positioning and adjusting an individualized ventilatory
      setting.
    

Detailed description: 
      Data of mechanical power will be collected prospectively in three different times:

        1. In supine positioning (T0).

        2. After 15 minutes of having implemented prone positioning while maintaining the same
           ventilatory settings that in supine (T1).

        3. In prone positioning after 15 min of having adjusted an individualized ventilatory
           setting (T2).

      Besides, the investigators will take an arterial blood sample in T0 and T2 to calculate
      changes in oxygenation status and ventilatory ratio.

      In case that esophageal manometry is available, the investigators will collect data regarding
      to transpulmonary and esophageal pressure in order to calculate the mechanical power applied
      to the lung parenchyma.
    

Intervention name(s): Prone position
Intervention type(s): Other
Intervention description(s): The patients will be put in prone position while receiving invasive mechanical ventilation and the investigators will monitor changes in mechanical power applied to the respiratory system and compare with supine position
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The patients included will be those who atend to the intensive care unit of medical centers
        located in Buenos Aires province, Argetina.
      
Keywords: ventilation, artificial; respiratory distress syndrome, adult; prone position; monitoring, physiologic
A Study of Different Particle Sizes of Evacetrapib in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if there is any difference in the way the body
      handles 3 types of evacetrapib tablets with different particle sizes. Information about any
      side effects will also be collected. This study will consist of 3 study periods. Participants
      will be dosed 3 times during the entire study. Each study period will consist of an inpatient
      stay for 3 days - the day before dosing (Day -1), dosing day (Day 1) and the day after dosing
      (Day 2). Then participants will be asked to return to the clinical research unit (CRU) daily
      for outpatient appointments up to Day 8. The overall length of this study is about 7 weeks
      from first dose to end of study. Screening will take place within 28 days prior to the first
      dose of evacetrapib and follow-up will take place 21 days after the last dose of evacetrapib.
    


Intervention name(s): Evacetrapib
Intervention type(s): Drug
Intervention description(s): administered orally
Other intervention name(s): LY2484595
Intervention MeSH terms: Evacetrapib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Evaluation of the Efficacy of Ambu® aScope for Intubation in Cancer Tongue
Condition: Difficult Intubation
Study type: Interventional

Summary: 
      This study compares the ascope with standard fiberscope using the nasal route of intubation
      in patient having sever difficult airway (having posterior one third cancer tongue with fixed
      mobility)
    

Detailed description: 
      patient will be allocated into two group according to the type of endoscope used group (F)
      fibro scope group and group (A) the ambu ascope group The timer will be started (T0), when
      touching the fiberscope or a scope. The standard fiberscope or a scope2 will be introduced
      through the nostril and advanced through the vocal cords, once carina identified the time
      will be recorded ( T1) When correct positioning of the trachea confirmed by detection of the
      end-tidal co2 curve on capnography (T2).
    

Intervention name(s): ambu ascope; fibreroptic bronchoscope
Intervention type(s): Device; Device
Intervention description(s): nasal route intubation by the device in fixed cancer tongue patients; nasal route intubation by the device in fixed cancer tongue patients
Other intervention name(s): Ambu® aScope™
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: parallel assignment
Masking: Single (Participant)
Primary purpose: Other
The Safety and Efficacy of SPD465 in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention-Deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase 2, randomized, multi-center, double-blind, 3-period and 3-treatment crossover
      study designed to evaluate the safety and duration of efficacy of SPD465 (50 or 75 mg)
      compared with placebo and an immediate release amphetamine salt formulation (25 mg) in adults
      with ADHD. The controlled environment used in this study is an analog classroom setting
      adapted for a 16-hour adult day.
    


Intervention name(s): SPD465; Immediate Release Amphetamine Salt; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 50 or 75 mg once daily for 7 days; 25 mg once daily for 7 days; Once daily for 7 days
Intervention MeSH terms: Amphetamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Therapeutic Effects of Peroneal Nerve Functional Electrical Stimulation for Lower Extremity in Patients With Sub-acute Post-stroke Hemiplegia
Condition: Stroke
MeSH terms: Stroke; Hemiplegia
Study type: Interventional

Summary: 
      Among the sequelae of stroke, gait disorder is directly linked to the degree of autonomy in
      the daily life of patients. It is considered significant effects on their Quality of
      Life(QOL).

      Further methods of rehabilitation are required for convalescent patients to recover their
      function soon and better, due to a multitudes of recovery patient with troubles such as gait
      problem.

      This trial is studying to investigate the effects of gait training with a functional
      electrical stimulation (FES) 'WalkAide[R](WA)' to improve the lower-limb function and
      ambulation in convalescent stroke patients.
    

Detailed description: 
      This study is targeting convalescent patients within 6 months after the onset of initial
      stroke (cerebral infarction or cerebral hemorrhage) and also observing the foot drop during
      walking.

      Some study for the patients after the onset of stroke (over several months) are reported that
      a case of the efficacy by the treatment using the FES, and another case of using FES
      indicated the equal efficacy and the higher QOL compared to using ankle-foot orthosis(AFO).

      However, these are clinical research results overseas and there are not so many studies
      targeting only for convalescent stroke patients.

      FES which recover the lost function by paralysis using electrical stimulation is recommended
      as convalescent rehabilitation by Japanese Guidelines for the Management of Stroke 2015 etc..

      The purpose of FES treatment is the electrical stimulation to peroneal nerve of patients with
      foot drop and equinus foot due to central nervous system damage and the objective efficacy is
      following:

        -  To improve the walking by dorsiflexing the foot during swing phase

        -  To prevention and suppression of disuse atrophy

        -  To increase local blood flow

        -  To re-educate muscle

        -  To maintain or increase the range of joint motion
    

Intervention name(s): WA group; Control
Intervention type(s): Device; Other
Intervention description(s): Conventional rehabilitation therapy and gait training with WAIntervention with WA is scheduled 40min/day, five times a week, for 8 weeks.; Conventional rehabilitation therapy and gait training without WA.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stroke; Rehabilitation; WalkAide (WA); Functional Electrical Stimulation (FES)
Assessing Folic Acid in High-Risk Pregnancy for Neural Tube Defects
Condition: Neural Tube Defects; Folic Acid
MeSH terms: Neural Tube Defects; Spinal Dysraphism
Study type: Observational [Patient Registry]

Summary: 
      Aim of this study is to investigate and statistically reveal the prevalence and awareness of
      folic acid usage in pregnant women who have at least one of the risk factors for neural tube
      defects, to express the level of knowledge of the determined population on this subject and
      to present ideas to increase awareness in the society.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Singleton pregnant women over the age of 18 and under the age of 45 who have at least one
        of the risk factors for neural tube defects (family history, MTHFR gene mutation, birth
        history with aneuploidy, history of GDM or known DM).
      
Keywords: neural tube defects; folic acid; awareness; perinatology; pregnancy
Dietary Supplement of Curcumin in Subjects With Active Relapsing Multiple Sclerosis Treated With Subcutaneous Interferon Beta 1a
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a prospective, monocentric, double blind, placebo controlled, two arm study.

      Curcumin is derived from the rhizomes of the plant Curcuma longa (common name, turmeric)
      belonging to the Zingiberaceae family found in South Asian countries, especially India which
      is the largest producer. BCM95 (bioCurcumin) is a combination of a Curcumin extract and oil
      to enhance the bio-absorbability in humans. BCM95 may enhance and prolong the antioxidant and
      anti-inflammatory effects of the standard therapy maintaining a good safety profile.
    

Detailed description: 
      The subjects must experience at least one Gadolinium (GD) enhancing Magnetic Resonance
      Imaging (MRI) lesion at the baseline visit or one Multiple Sclerosis (MS) relapse in the last
      6 months before the screening visit.

      Randomization, in a 1:1 ratio, will be done with two arms:

      40 subjects with Interferon (IFN) beta 1 a 44 mcg TIW + Curcumin (BCM 95) and 40 subjects
      with IFN beta-1a 44 mcg TIW + placebo.

      The study will last 42 months: 18 months of enrolment and 24 months of treatment period.

      The study consists of 6 visits per subject: screening visit (Visit 0), baseline (Visit 1), a
      visit 3 months after baseline (Visit 2), 6 months after baseline (Visit 3), 12 months after
      baseline (Visit 4) and 24 months after baseline (Visit 5).
    

Intervention name(s): IFN beta 1a 44 mcg TIW; Curcumin; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects received IFN beta 1a 44 microgram (mcg) subcutaneously TIW for 24 months.; Subjects received 500 milligram (mg) curcumin orally twice a day for 24 months.; Subjects received placebo matched to curcumin orally twice a day for 24 months.
Other intervention name(s): Interferon beta 1a; Rebif; BCM95
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a; Curcumin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Relapsing; Interferon beta 1a; Curcumin
Alleviating Effects Against High Intraocular Pressure by Oral Intake of Cordyceps Cicadae Mycelia
Condition: Supplement
MeSH terms: Ocular Hypertension
Study type: Interventional

Summary: 
      This study will investigate the effects of lowering intraocular pressure by oral intake of
      Cordyceps cicadae mycelia, to provide evidence-based data for high intraocular pressure
      relief.
    

Detailed description: 
      Study purpose This study investigated the effeicacy of oral Cordyceps cicadae mycelia for the
      relief of high intraocular pressure.

      Subjects

        1. The total recruitment of subjects is 60 people, aged between 20 to 75 years.

        2. Subjects with intraocular pressure more than or equal to 21 mmHg are included,
           irrespective of whether on us of Taflotan (saflutan).

      Methods

      1. Informed consents will be obtained from subjects first. The subjects with pre-test
      intraocular pressure over or equal 21 mm Hg are advised to orally take two capsules
      containing a total of 500 mg of Cordyceps cicadae mycelia. After 90 minutes, the subjects are
      evaluated for intraocular pressure.

      The pre-test and and post-intake intraocualr pressure and blood pressure data will be
      compared by paired t test for significant differences if any.
    

Intervention name(s): Cordyceps Cicadae Mycelia
Intervention type(s): Dietary Supplement
Intervention description(s): Cordyceps Cicadae Mycelia will be given to test its potential for alleviation of high intraocular pressure.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups of subjects are subject to pre-test and post-test intraocular pressure measurements.
Masking: None (Open Label)
Primary purpose: Prevention
Midurethral Sling With Autologus Rectus Sheath
Condition: Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional
Phase: Phase 3

Summary: 
      assessment of the safety and efficacy surgeon tailored rectus sheath midurethral sling
    

Detailed description: 
      the rectus sheath is harvested in 5 cm length and 2 cm width , A 2cm width 8 cm length
      polypropolyine mesh is attached to the harvest rectus sheet sling on both side The procedure
      is carried with a similar technique to the outside in TOT.
    

Intervention name(s): rectus sheath midurethral sling
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment