bioihbjkbjnl/mcl2 huggingface dataset:
Social Interactions: Ocular Explorations and Pupillometry in Autism
Condition: Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Observational

Summary: 
      The primary objective of this work will first to characterize in typical childhood, visual
      exploratory behavior and pupillary response associated with salience of human social stimuli
      (faces and body movements), and then to evaluate these markers in children with autism.

      The second objective of this work will be to achieve in a population of children with autism
      a longitudinal evaluation of these markers during development and therapeutics.
    

Detailed description: 
      Patients with autism have significant social difficulties and communication alterations. It
      has been shown in these patients difficulties to understand some clues indispensable to
      social relations, for example, faces and their emotions and motion of human bodies. The faces
      and human movements are an important source of information helping to interact with others.
      Understanding the intentions of the others through facial expressions and gestures can help
      them to adapt their behavior and their interactions. While in healthy subjects, faces and
      human movements receive special attention, autistic patients seem to pay less attention to
      this kind of social stimuli. It has already been shown that children and healthy adults spend
      more time looking at faces and human movements (relative to objects), whereas the opposite
      behavior is observed in patients with autism. Studying gaze behavior seems to be essential
      for progress in the understanding of autism pathology. Eye-tracking systems allow to measure
      precisely what a subject looks on a picture. Moreover, eye-tracking systems permit the
      measurement of the pupil size which variations are correlated with cognitive processes. The
      objective of this study is to analyze the ocular behavior (ocular scan path and pupil
      diameter) of young patients with autism when viewing faces and human movements and to compare
      these measurements with those of chronologically age-matched healthy children. This work will
      identify attentional problems concerning exploration of human faces and movements that can be
      related to their social difficulties. These disorders should be manifested by an atypical
      ocular scan path and by changes in pupil variation in response to face and human motion. Then
      to follow the evolution of these indices will allow to evaluate the effect of therapies.
      These results will highlight new data essential to understanding disorders of social
      relations and to better adapt rehabilitative strategies.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Autistic children from the University Hospital of Tours Healthy children from the normal
        population
      
Keywords: visual exploration; pupil size; social interactions; faces; human motion
Efficacy of Nitric Oxide Administration in Attenuating Ischemia/Reperfusion Injury During Neonatal Cardiopulmonary Bypass
Condition: Ischemia/Reperfusion Injury After Neonatal Cardiac Surgery; Inflammatory Reaction After Neonatal Cardiac Surgery
MeSH terms: Reperfusion Injury; Ischemia; Inflammation; Wounds and Injuries
Study type: Interventional

Summary: 
      Around 7500 neonates born yearly in the United States have complex congenital heart disease
      that require surgical repair in the first few days of life. The complexity of the surgical
      repair requires long periods of cardiopulmonary bypass (CPB) and the use of intermittent
      periods of low flow or complete circulatory arrest. The immature neonatal vital organs are
      more prone to the complications of the cardiopulmonary bypass circulation, namely
      ischemia/reperfusion (I/R) injury and systemic inflammatory response. Inhaled nitric oxide
      (NO) is used frequently in neonates for the treatment of pulmonary hypertension,
      Additionally, many studies have shown that NO has an anti-inflammatory effect by reducing I/R
      injury and endothelial dysfunction.

      The purpose of this pilot study is to assess the efficacy of NO administration via the CPB
      circuit in attenuating the CPB induced I/R injury and systemic inflammatory reaction in
      neonates undergoing repair of complex congenital heart defects. Specific goals will be to
      demonstrate that NO use via CPB will:

        -  Decrease markers of I/R injury and systemic inflammatory response.

        -  Decrease platelet activation leading to reduced postoperative bleeding and transfusion
           requirements.

        -  Decrease postoperative organ dysfunction, and hence decrease operative mortality and
           postoperative morbidity.

      Twelve neonates undergoing repair of complex congenital heart defects will receive NO via the
      CPB circuit, for the duration of surgery. They will be compared to a control group of 12
      similar patients. Serum levels of different ischemic reperfusion injury and inflammatory
      markers will be measured at different time points after surgery and will be correlated with
      different end organ function tests and clinical course in the postoperative period. The
      results will be compared between the two groups to try to determine the clinical benefit of
      NO administration through CPB circuit.
    


Intervention name(s): Inhaled Nitric Oxide; placebo
Intervention type(s): Drug; Drug
Intervention description(s): delivering inhaled Nitric Oxide into the cardiopulmonary bypass circuit during neonatal cardiac surgery; inhaled Nitric Oxide not delivered to the cardiopulmonary bypass circuit during neonatal cardiac surgery
Other intervention name(s): study group; control group
Intervention MeSH terms: Nitric Oxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Ischemia/reperfusion injury
Prevention of Hepatitis B Virus Mother-to-child Transmission by Serovaccination.
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Observational

Summary: 
      The prevalence of HBsAg carriage in pregnant women varies in France, according to the native
      country, with highest rates in those originating from sub-Saharan Africa and Asia (5 to 8 %
      in Parisian area). The level of HBV-DNA varies according to HBe status and geographical
      origin, and is strongly predictive of the risk of HBV mother-to-child transmission (MTCT). It
      has been shown that the rate of vertical transmission (Chinese study by Yuan J et al) was 0 %
      in newborns to mothers whom HBV-DNA was < 105 copies/mL and up to more than 40 % in newborns
      to mothers with high viral loads > 108 copies/mL, despite HBIg and vaccine at birth. Thus,
      data are needed concerning the current practices about the prevention of HBV MTCT in France,
      and their results.
    

Detailed description: 
      This monocentre, observational study will include pregnant women whom HBV-DNA is > 105 IU/mL.
      HBV MTCT rates will be evaluated, according to the level of HBV-DNA in the women during the
      last three months of pregnancy and at childbirth (between 105 and 108 IU/mL, or > 108 IU/mL),
      and according to the clinical practices of serovaccination in the participating center. The
      evaluation will be based on the rate of HBsAg positivity in infants at 9 months, despite a
      correct immunization at birth. The rate of detectable HBV-DNA will be also evaluated in
      infants at the same date.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This monocentre, observational study will include pregnant women whom HBV-DNA is > 105
        IU/mL and who are not currently treated for HBV hepatitis.
      
Keywords: HBV mother-to-child transmission; women with HBV DNA > 105 I.U./mL; France
Comparing Effectiveness of the Hydrus Microstent (TM) to Two iStents to Lower IOP in Phakic Eyes
Condition: Primary Open Angle Glaucoma; Pseudoexfoliative Glaucoma; Pigmentary Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Study type: Interventional

Summary: 
      This clinical trial compares two implantable devices intended to lower the pressure inside
      the eye of glaucoma patients.
    

Detailed description: 
      This is a prospective, multicenter, single-masked, randomized clinical trial comparing the
      Hydrus Microstent to two iStent implants for the reduction of intraocular pressure in phakic
      patients with a positive diagnosis of primary open angle glaucoma, pseudoexfoliative
      glaucoma, or pigmentary dispersion glaucoma. Post-operative follow-up visits will be
      conducted at regular intervals.
    

Intervention name(s): Hydrus Microstent; iStent Trabecular Micro Bypass
Intervention type(s): Device; Device
Intervention description(s): Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.; Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Primary open angle glaucoma; POAG; Pseudoexfoliative glaucoma; PXG; Pigmentary glaucoma; PG; Hydrus
Evaluation of the Efficacy and Safety of PRX-100 in the Treatment of Early to Moderate Presbyopia
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a one-day, randomized, double-masked, single-center evaluation of the efficacy and
      safety of PRX-100 ophthalmic solution compared to placebo in 20 subjects (randomized 4:1,
      PRX-100:placebo) to evaluate the safety of PRX-100 and the magnitude and duration of effects
      on improving near-vision acuity.
    


Intervention name(s): PRX-100; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ophthalmic solution; saline ophthalmic solution
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ophthalmology; vision; ocular
A Placebo and Active Controlled Study of ONO-6950 Following Allergen Challenge in Patients With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objectives are

        -  to determine the effect of ONO-6950 200 mg QD versus placebo administered for 8 days on
           early asthmatic response (EAR) and late asthmatic response (LAR) induced by inhaled
           allergen

        -  to determine the safety and tolerability of ONO-6950 200 mg QD administered for 8 days
           in patients with asthma

      The secondary objectives are:

        -  to compare the effect of ONO-6950 versus montelukast on the % decrease of FEV1 following
           allergen exposure, and

        -  to determine the effect of ONO-6950 versus placebo and montelukast on allergen-induced
           airway hyperresponsiveness (AHR) as measured by methacholine challenge
    

Detailed description: 
      The study will examine if ONO-6950 could alleviate EAR and LAR caused by an allergen
      challenge in subjects with asthma. Patients will be required to have EAR and LAR after
      standardized allergen challenges during the screening. Eligible patients will complete a
      randomized, double-blind, three-way crossover study. During each of three evaluation periods,
      patients will be administered either 200 mg ONO-6950, 10 mg Montelukast, or placebo for 8
      days. Each evaluation period will occur over 8 days and will include various assessments
      following allergen challenge and methacholine challenge. The study does not require an
      overnight stay at the clinical research center.
    

Intervention name(s): ONO-6950; Placebo; Montelukast
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 200 mg QD for 8 days; Placebo to match ONO-6950 tablets or over-encapsulated Montelukast tablets dosed in a similar manner; 10 mg Montelukast QD for 8 days
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: asthma; ONO-6950; asthma in adult patients
Second Line Therapy in Advanced Biliary Tract Cancer
Condition: Biliary Tract Cancer
MeSH terms: Biliary Tract Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the therapeutic activity of capecitabine alone or in
      combination with mitomycin C as second-line therapy in patients with advanced/metastatic
      biliary adenocarcinoma in progression after gemcitabine and platinum compounds
    

Detailed description: 
      Biliary tract adenocarcinoma is an uncommon tumor with a poor prognosis and a median overall
      survival (OS) rarely exceeding 6 months. Less than 25% of patients are resectable at
      diagnosis and, even in this subset of patients, relapse rate is high. An improvement of OS
      and quality of life for patients receiving chemotherapy versus best supportive care was
      demonstrated in advanced disease. Recently, cisplatin and gemcitabine combination was
      identified as the new standard first-line chemotherapy, yielding a median progression free
      survival (PFS) and median OS of 8.5 and 11.7 months, respectively. Despite the outcome
      improvement, disease progression is a constant and approximately half of patients failing
      upfront treatment has a good performance status and are willing to undergo further treatment.
      No standard salvage chemotherapy regimen has been identified. Clinical trials are difficult
      to perform due to the rarity and heterogeneity of these tumors and to the lack of interest of
      the pharmaceutical industry. Fluoropyrimidines and mitomycin C have been considered the basis
      of palliative chemotherapy for a long time. The investigators decided to explore the
      activity, in terms of PFS, of capecitabine alone or combined with mitomycin C as second-line
      therapy in patients with pathological diagnosis of advanced biliary tract cancer and
      progressive disease after gemcitabine and cisplatin, by means of an open label randomized
      multicentric phase II trial.
    

Intervention name(s): capecitabine and mitomycin; Capecitabine
Intervention type(s): Drug; Drug
Intervention description(s): oral capecitabine 2000 mg/m2 day 1-14 in two divided doses taken with food plus bolus IV infusion mitomycin C 6 mg/m2 day 1.
Cycles will be repeated in both arms every 3 weeks till progression, unacceptable toxicity, medical decision or patient's refusal or for a maximum of 6 months; oral capecitabine 2000 mg/m2 day 1-14 in two divided doses taken with food.
Cycles will be repeated in both arms every 3 weeks till progression, unacceptable toxicity, medical decision or patient's refusal or for a maximum of 6 months
Other intervention name(s): capecitabine; mitomycin
Intervention MeSH terms: Capecitabine; Mitomycins; Mitomycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: biliary tract cancer; advanced disease; chemotherapy
The Effect of a Peat and Apple Extract on Muscle ATP and Exercise Performance
Condition: Caffeine and Endurance Performance
Study type: Interventional

Summary: 
      A study to test the hypothesis that a combined peat and apple extract will increase blood and
      muscle ATP, which will increase cycling performance
    


Intervention name(s): ElevATP supplement; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): ElevATP supplement containing apple and ancient peat extract; Maltodextrin placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Effectiveness Study of the Guardian RT in Type 1 Diabetics
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether Type 1 diabetic patients using the Guardian
      RT glucose sensor can improve glycemic control over a 12-week period, compared to patients
      using self-monitoring blood glucose testing (SMBG) alone.
    

Detailed description: 
      The long-term benefit of tight glycemic control in diabetics is well documented. HbA1c
      generally assesses the average/long term quality of glycemic control. On a daily basis,
      patients assess their glycemic control through finger stick measurements (SMBG), which allows
      them to adjust their therapy. A device which would provide a patient with a real-time glucose
      value, as well as high and low alerts, could aid the patient in knowing when to perform
      confirmatory SMBG tests and intervene so that dangerous glycemic excursions may occur less
      frequently.
    

Intervention name(s): Guardian RT Telemetered Glucose Monitoring System
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Glycemic Control; Continuous Glucose Monitoring
Antidepressant Controlled Trial for Negative Symptoms in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this double-blind, placebo-controlled trial is to establish the clinical and cost
      effectiveness of an SSRI antidepressant, citalopram, in the management of persistent negative
      symptoms of schizophrenia over a year.
    

Detailed description: 
      The negative symptoms of schizophrenia represent an important dimension of psychopathology,
      and reflect the absence or diminution of normal behaviours and functions. They include
      deficiencies in emotional responsiveness, drive, and emotional and social engagement.
      Persistent negative symptoms are held to account for much of the long-term morbidity and poor
      functional outcome in patients with established schizophrenia, but if they prove resistant to
      antipsychotic medication there is a very limited evidence base regarding specific treatments.
      The aim of this double-blind, placebo-controlled trial is to establish the clinical and cost
      effectiveness of an SSRI antidepressant, citalopram, in the management of negative symptoms
      of schizophrenia over a year. The study sample will be adults with a diagnosis of
      schizophrenia, clinically stable for 3 months with a consistent antipsychotic regimen, and
      characterised by persistent negative symptoms to a criterion level of severity.
    

Intervention name(s): Citalopram; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Treatment with citalopram will be initiated at 20mg/day for the first 4 weeks (or one placebo capsule), followed by the option to increase the dose to 40mg per day (or two placebo capsules) for the remainder of the study period.; Treatment with citalopram will be initiated at 20mg/day for the first 4 weeks (or one placebo capsule), followed by the option to increase the dose to 40mg per day (or two placebo capsules) for the remainder of the study period.
Intervention MeSH terms: Citalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SSRI antidepressant; Negative symptoms; Schizophrenia
MRI to Assess the Effects of Dysautonomia and Chronic Nausea on Brain Transmitters
Condition: Dysautonomia
MeSH terms: Primary Dysautonomias; Autonomic Nervous System Diseases
Study type: Observational

Summary: 
      The purpose of this research study is to better understand what causes dysautonomia and how
      this affects blood pressure and pulse. Dysautonomia is a condition of the autonomic nervous
      system. It is associated with fluctuations in blood pressure and pulse and may cause symptoms
      of nausea and belly pain, fatigue, excessive thirst, lightheadedness, dizziness, feelings of
      anxiety or panic, and fainting. A common example of dysautonomia is postural orthostatic
      tachycardia syndrome or POTS. Sometimes symptoms worsen when people move from lying down to
      standing, called orthostatic intolerance. We would like to learn more about the link between
      orthostatic intolerance and nausea. While medications currently used to treat orthostatic
      intolerance and nausea have proven to be effective in some patients, this may not be the best
      treatment for everyone as long term use could pose certain risks including high blood
      pressure. In order to provide a more focused and safer treatment for patients suffering from
      nausea and orthostatic intolerance, we have looked at how the blood pressure, pulse, and
      certain blood tests change during a tilt table test. This test helps to create the same
      circumstances that patients with orthostatic intolerance experience when they stand. To
      better understand if some of these problems are associated with the brain, we will study MRI
      in patients with dysautonomia compared to children without dysautonomia. This information may
      allow us to use alternative and safer treatments in the future.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        A combination of male and female subjects who are healthy or ahve dysautonomia/
      
Keywords: Dysautonomia; Postural orthostatic tachycardic hypotension; Neurocardiogenic vasovagal syncope