bioihbjkbjnl/mcl2 huggingface dataset:
Pioglitazone as an Adjunct for Moderate to Severe Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to determine whether Pioglitazone as an adjunct to Citalopram is
      effective in treatment of moderate to severe depression
    

Detailed description: 
      Pioglitazone as a Ppar-gamma agonist is an anti diabetic drug. It was also shown that, it has
      certain anti inflammatory and neuro-protective effects. In recent years it has been proposed
      that Ppar-gamma agonists may have effects on mood and cognition. In animal studies and in one
      human case report as well as a pilot study on human subjects these drugs improved symptoms of
      depression. A randomized controlled and double blind design will provide further evidence for
      the efficacy of these drugs in major depressive disorder.
    

Intervention name(s): Pioglitazone+Citalopram+Chlordiazepoxide; Placebo+ Citalopram+ Chlordiazepoxide
Intervention type(s): Drug; Drug
Intervention description(s): Pioglitazone 15 mg every 12 hours for six weeks Citalopram 20 mg per day for week one, and then 30 mg/day for 5 consecutive weeks.
Chlordiazepoxide 10 mg each night for first three weeks; Placebo 1 Q12h for 6 weeks with the same shape and color as Pioglitazone. Citalopram 20 mg per day for week one, and then 30 mg/day for 5 consecutive weeks.
Chlordiazepoxide 10 mg each night for first three weeks
Intervention MeSH terms: Pioglitazone; Chlordiazepoxide; Dexetimide; Citalopram; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major depressive disorder; pioglitazone; double blind; placebo controlled
Effect of Hypothyroidism on Brown Adipose Tissue
Condition: Hypothyroidism
MeSH terms: Hypothyroidism
Study type: Observational

Summary: 
      The investigators aim to study whether hypothyroidism negatively affects Brown adipose tissue
      (BAT) function in humans and whether BAT function can be restored to normal by thyroid
      hormone supplementation.
    

Detailed description: 
      Hypothyroidism is a frequent endocrine disorder, the prevalence of subclinical disease being
      4.3% and of overt disease being 0.3%. Patients suffering from hypothyroidism frequently
      complain of increased cold sensitivity and involuntary weight gain, indicating changes in
      energy expenditure and response to cold challenge.

      Recently, brown adipose tissue (BAT) has regained attention as an energy expending tissue.
      While it was previously thought to be of no or negligible relevance in human adults, recent
      studies clearly demonstrated the presence and metabolic activity of BAT in human adults. Upon
      activation of BAT by the sympathetic nervous system intracellular lipid stores are rapidly
      depleted. The generated free fatty acids fuel beta-oxidation and the respiratory chain within
      the mitochondria and activate at the same time uncoupling protein 1 (UCP1). This protein acts
      as a protonophore, allowing the flux of protons along the electrochemical gradient into the
      inner mitochondrial matrix instead of transferring their energy to adenosine triphosphate
      (ATP)-synthase. The short circuiting of the oxidative phosphorylation within the mitochondria
      leads to highly active cellular respiration and generation of heat. Basic research highlights
      the importance of thyroid hormone in the development and function of BAT.

      It has recently been shown that hyperthyroidism exerts activating effects on BAT in adult
      humans.

      The investigators aim to study whether hypothyroidism negatively affects BAT function in
      humans and whether BAT function can be restored to normal by thyroid hormone supplementation.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        currently hypothyroid patients which are started on levothyroxin substitution
      
Biospecimen description: 
      Serum
Diurnal Triglyceridemia in Relation to Alcohol Intake
Condition: Healthy Subjects; Hyperlipidemias; Type 2 Diabetes Mellitus; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Diabetes Mellitus, Type 2; Hyperlipidemias; Alcohol Drinking
Study type: Observational

Summary: 
      The purpose of this study is to determine the impact of alcohol consumption in diurnal
      triglyceridemia in a free living situation.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Subjects were healthy volunteers or patients with hyperlipidemia or a known medical history
        of cardiovascular diseases, type 2 diabetes mellitus participating in several clinical
        studies with the same protocol, aimed to investigate factors influencing postprandial
        lipemia
      
Keywords: Ethanol; Lipemia; Postprandial; Triglyceride
Different Types Of Laryngoscopes During Routine Intubation in Adult Patients
Condition: Failed or Difficult Intubation
Study type: Interventional

Summary: 
      C-MAC videolaryngoscope (Karl Storz, Tuttlingen, GERMANY) with its Macintosh like blade is
      used with standard direct laryngoscopy technique. KingsVisionTM videolaryngoscopes
      (KingSystems, IN, USA) have also Macintosh like single use blades that are channeled, wider
      and shorter than conventional Macintosh blades.We aim to compare these two laryngoscopes and
      Macintosh laryngoscope during routine intubation in adult patients.
    


Intervention name(s): laryngoscopy
Intervention type(s): Device
Other intervention name(s): C-MAC videolaryngoscopy (Karl Storz, Tuttlingen, GERMANY); KingsVision videolaryngoscopy (KingSystems, IN, USA); Macintosh Laryngscope (Welch Allyn,USA)
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
A Smart Home-based Exoskeleton Robot System for Stroke Patients
Condition: Rehabilitation, Tenodesis, Stroke, Internet of Things
MeSH terms: Stroke
Study type: Interventional

Summary: 
      In the proposed study, the investigators assumed that high dose of repetitive motor task
      training using an exoskeleton robot-assisted system may provide benefits in motor shaping and
      greater brain priming for hand paresis of the stroke patients. Nevertheless, the amount of
      therapeutic activity with clinicians' guidance is often short of number in therapy
      sessions.Therefore, using Internet of Things (IoT), connected rehabilitation products and the
      data they generate that are a new trend of rehabilitation strategy for providing remote
      home-programs support. The specific aim of this study is to to explore the feasibility of
      introducing the rental services of a Smart Home-based Exoskeleton Robot System through the
      IoT business model. And the second purpose is to investigate the effects of applying the
      exoskeleton robotic device for tenodesisgrip training as a home-based treatment for chronic
      stroke patients.The expected outcomes of this research are to clarify the feasibility of
      using IoT business model for launching smart rehabilitation device rental service and the
      effects of application a high dosage of hand movement training as home program on motor and
      hand function for patients with chronic stroke.
    


Intervention name(s): occupational therapy
Intervention type(s): Other
Intervention description(s): occupational therapy targeted to goals that are relevant to the functional needs of the patient
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Objective Verification of Physiologic Changes During Accommodation Under Binocular, Monocular, and Pinhole Conditions
Condition: Accommodation
Study type: Observational [Patient Registry]

Summary: 
      The investigators believe that this simple, clear, and objective study may be a great help in
      understanding the accommodative response during various accommodative stimulation conditions.
    

Detailed description: 
      The purpose in this study was to investigate physiological changes in accommodative power,
      pupil diameter, astigmatic value, and axis when visual stimuli were applied under binocular,
      monocular (dominant eye, non-dominant eye, ipsilateral, and contralateral), and pinhole
      conditions using the WAM-5500 binocular autorefractor/keratometer (Grand Seiko Co. Ltd.,
      Hiroshima, Japan).
    

Intervention name(s): the WAM-5500 binocular autorefractor/keratometer (Grand Seiko Co. Ltd., Hiroshima, Japan)
Intervention type(s): Device
Intervention description(s): : Subjects underwent a basic ophthalmic examination and the accommodative response to refractive stimuli was measured. Refractive stimuli were given at 0.25 diopters (D) (4 m distance), 2D (50 cm), 3D (33 cm), and 4D (25 cm) and stimulation was applied with the eyes in binocular, monocular (dominant eye, non-dominant eye, ipsilateral, and contralateral), and pinhole conditions. In addition, changes in the astigmatic value and direction of the astigmatism axis under binocular stimulus were evaluated.
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects who visited the department of ophthalmology in Chung-Ang university hospital for
        ocular examination
Development of a Deaf Child With a Cochlear Implant.
Condition: Deafness
MeSH terms: Deafness
Study type: Observational

Summary: 
      Cochlear implantation enables profoundly deaf children to acquire speech and develop their
      understanding of spoken language. However, there are significant interindividual differences
      in the results obtained with the implant. Given the lack of theoretical knowledge on acoustic
      predictors, cognitive and language to obtain optimum speech recognition with cochlear
      implants associated with a good communicative and language development of deaf children, the
      investigators intend to achieve a preliminary longitudinal study aimed to describe the
      cognitive, communicative and perceptive implanted deaf children.

      The main objective of our study is to describe the cognitive and communicative development of
      deaf children implanted from the pre-implant assessment to 18 months post-implantation, by
      addressing the following aspects:

        -  The psychomotor and cognitive development assessed using the Brunet-Lézine test;

        -  The development of preverbal communication, evaluated using the Early Social
           Communication Scale.
    


Intervention name(s): Evaluation of the detection of non-linguistic sounds; Free hearing test categorization; Early Social Communication Scale (ECSP); psychomotor infancy development scale; NEPSY (two domains: "memory and learning" and "attention and executive functions").
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Evaluation of the detection of non-linguistic sounds (sound room); Free hearing test categorization evaluation; Early Social Communication Scale (ECSP) evaluation; NEPSY evaluation
Other intervention name(s): Lézine Brunet-Revised scale
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Young patients consulting in the Unit of Pediatric Cochlear Implantation,
        Hospital-University Centre of Toulouse.

        The normal hearing participants will be recruited by posters, produced in various places
        childcare (crèches, schools) or pediatric services Purpan hospital.
      
Keywords: cochlear implant; Developmental Psychology; cognitive development; communicative development; perceptual development; deaf child
A Study to Evaluate a Single Intravenous (IV) Dose Using a New Manufactured Clone and Single Ascending Doses of Subcutaneous (SC) Injections
Condition: Pharmacokinetics of ASP2408; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability, and pharmacokinetics (PK)
      after intravenous (IV) administration of ASP2408 manufactured from a new production clone and
      also following single ascending doses of subcutaneous (SC) injections of the same clinical
      trial material.
    

Detailed description: 
      The four doses will be studied in sequential cohorts of 8 subjects each, starting with the IV
      dose, followed by the subcutaneous doses in ascending order of dose. Within each cohort,
      subjects will be randomized to either active drug or matching placebo in a 3:1 ratio (6
      active and 2 placebo).

      All subjects in each arm will be confined for 8 days and followed for a minimum of 90 days up
      to 9 months if necessary. Subjects who have study drug terminated should remain in the study,
      if possible and have scheduled procedures and follow-up.

      Subjects who have detectable blood levels of ASP2408 after Day 90 will be unblinded and
      followed monthly until ASP2408 levels are below the limit of quantification. In addition,
      subjects who have persistent anti-ASP2408 antibodies after Day 90 will be unblinded and
      followed every 30 (± 3) days for up to 9 months until the level of these antibodies are
      declining, no longer detectable, and/or have no clinical consequence.
    

Intervention name(s): ASP2408; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous (IV) infusion and subcutaneous (SC) injection; Intravenous (IV) infusion and Subcutaneous (SC) injection
Intervention MeSH terms: ASP2408
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Healthy subjects; ASP2408; Rheumatoid arthritis; Safety and Tolerability; Pharmacokinetics
The Effect of ABPM on Sleep Disturbance
Condition: Blood Pressure Monitoring, Ambulatory
MeSH terms: Dyssomnias; Parasomnias
Study type: Observational

Summary: 
      Ambulatory blood pressure monitoring (ABPM) is an ideal tool for the diagnosis and evaluation
      of hypertension.However, ABPM frequently measures the tightening feeling and buzzing sound of
      the blood pressure cuff during nighttime, which can cause the patient to wake up easily
      during sleep, which will affect the sleep of the patient. Moreover, improper awakening of the
      patient from sleep can significantly increase the patient's blood pressure and affect the
      accuracy of ABPM monitoring. The Effect of ABPM on Sleep Disturbance (EMBED) study is
      designed to examine whether ABPM affects sleep, as well as the relationship and influencing
      factors of sleep and ABPM results, and screening for people who are susceptible to ABPM
      testing.
    

Detailed description: 
      Participants who accept ABPM in the Second Affiliated Hospital of Zhejiang University School
      of Medicine, will be recruited for EMBED enrollment. Participants will be asked to provide
      basic background information and to fill out the STOP-BANG evaluation form. Anxiety,
      depression, insomnia, sleep questionnaire and pain assessment scale for cuff inflation are
      used to assess characteristics of participants and their sleep quality. Before ABPM starts,
      office blood pressure of participants will be measured. Participants will undergo ABPM under
      standardized guidance. At the end of ABPM, participants will be asked to fill in sleep
      questionnaire and pain assessment scale for cuff inflation again. EMBED proposes to study
      whether ABPM affects sleep, as well as the relationship and influencing factors of sleep and
      ABPM results, and screening for people who are susceptible to ABPM testing. A better
      understanding of interaction between ABPM and sleep will help us further evaluate the
      accuracy of ABPM and more precisely control diurnal hypertension in the future.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Participants who undergo ABPM in the Second Affiliated Hospital of Zhejiang University
        School of Medicine
      
Keywords: ambulatory blood pressure monitoring; sleep
Changes in Perception and Cognition During a Meditation Retreat
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      This study aims at assessing neuro-behavioral changes occuring during an intensive ten days
      meditation retreat. The investigator will study changes in tactile, auditory and pain
      perceptions as well as changes in cognitive and affective mental contents and their neural
      markers, as measured by self-reports, EEG event-related potentials, and functional
      connectivity of resting state fMRI. He will recruit healthy participants with a prior
      meditation experience. They will be randomly assigned to two groups, one active group who
      will undergo measurements just before, during and 3 weeks after the retreat. The other group
      will serve of control for task habituation, control participants will undergo the same
      measurements, equally spaced in time, but before the retreat. The main hypothesis is that
      meditation training strengthens meta-awareness, attention capacities resulting in enhanced
      bodily- and self-awareness during sensory perception and emotion regulation during pain.
    


Intervention name(s): 10 days intensive meditation retreat; Waiting for a 10 days intensive meditation retreat
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The intervention consists in a 10 days contemplative retreat, with 6 to 8 hours of sitting and walking meditation per day, and 1 or 2 hours of meditation teachings. The meditation practice will mainly train in mindfulness practice. Mindfulness meditation intends to train attention to detect and regulate afflictive cognitive and emotional patterns. Mindfulness practice requires skills involved in openness to experience, in monitoring the focus of attention and in detecting distraction, disengaging attention from the source of distraction, and flexibly (re)directing and engaging attention to the intended object. A brief introduction to loving-kindness and compassion meditation will also be present throughout the retreat.; At the time of measure, participants in this group are waiting to participate to the same meditation retreat as the active group. They may perform their own daily meditation practices as usual.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Meditation; Emotional Regulation; Metacognitive Awareness; Attention; Mindfulness; Pain; Predictive Coding
Effect of Hypotensive Anesthesia on the Perfusion Index
Condition: Controlled Hypotension for Nasal Surgeries
MeSH terms: Hypotension
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Controlled hypotension has been used as a mean of reducing intraoperative blood loss and
      better visualization of the surgical field in nasal surgeries. Perfusion index has been
      considered a useful tool for monitoring changes in peripheral perfusion using Masimo set and
      serum lactate for central perfusion. Many medications were used to induce hypotension. In
      this study we will compare the effects of tridil and labetalol on the perfusion.
    

Detailed description: 
      The purpose of this study to detect the degree of hypotension that helps the surgeon and
      dosen't impair patient's perfusion and to compare the hypotensive effects of both tridil and
      labetalol infusions on the perfusion.
    

Intervention name(s): Massimo device; Nitroglycerin drug; Labetalol
Intervention type(s): Combination Product; Drug; Drug
Intervention description(s): Massimo is a newly introduced device which can measure the peripheral organ perfusion and expressed it as perfusion index(PI).; Nitroglycerin is a drug used as an hypotensive agent through its vasodilation effect on veins; Labetalol is an antagonist of adrenergic receptors (a1, b1, b2) which is used as an hypotensive inducer. This drug targets the beta receptors 5 to 10 times more specific than alpha receptors so that minor tachycardia happens
Other intervention name(s): tridil; trendate
Intervention MeSH terms: Labetalol; Nitroglycerin
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: controlled hypotension, perfusion
An Open Study for Steroid Resistant, Non-Thymectomized MG Patients
Condition: Myasthenia Gravis
MeSH terms: Myasthenia Gravis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to investigate the efficacy and safety for steroid resistant,
      non-thymectomized MG patients.
    


Intervention name(s): tacrolimus
Intervention type(s): Drug
Intervention description(s): Oral
Other intervention name(s): FK506; Prograf
Intervention MeSH terms: Tacrolimus
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tacrolimus; Myasthenia Gravis
Copper Intrauterine Device (IUD) Insertion at Cesarean Delivery
Condition: Intrauterine Device Expulsion
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the expulsion rates of copper Intrauterine Devices
      (IUDs) placed at time of Cesarean Delivery.
    

Detailed description: 
      This was a prospective clinical study with 90 patients undergoing cesarean section. After
      delivery of the placenta, a ParaGard® copper T380A IUD was inserted through the hysterotomy
      site. IUD placement was confirmed by visualization of the strings at the cervical os or via
      ultrasound at the 6 week postpartum visit. Subjects also received a phone call 6 months after
      IUD placement to ascertain physician follow-up and patient satisfaction. This telephone call
      was to ensure that each subject attended her postpartum visit, had an evaluation of IUD
      placement and then we performed a survey. This survey used a Likert Scale to measure each
      subject's satisfaction. The fields included very satisfied, satisfied, somewhat satisfied,
      neutral, somewhat unsatisfied, unsatisfied and very unsatisfied.
    

Intervention name(s): Copper IUD placement at time Cesarean Delivery (Copper T 380A)
Intervention type(s): Device
Intervention description(s): Placement of Paragard IUD at time of Cesarean Delivery
Other intervention name(s): Copper T 380A
Intervention MeSH terms: Copper
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Postpartum IUD; Cesarean Delivery; 6 months postpartum; satisfaction