bioihbjkbjnl/mcl2 huggingface dataset:
ATC Vs PSV for Ventilatory Weaning of Pediatrics Postcardiac Surgery
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional

Summary: 
      The ventilator modality of automatic tube compensation (ATC) can provide variable pressure
      supports during the weaning process to overcome any change in the resistance of the breathing
      circuit, endotracheal tube, and airways. The aim of the study is to evaluate the automatic
      tube compensation (ATC) as a tool for ventilatory weaning in pediatrics after surgeries for
      congenital cardiac anomalies.
    

Detailed description: 
      The ventilator modality of automatic tube compensation (ATC) can provide variable pressure
      supports during the weaning process to overcome any change in the resistance of the breathing
      circuit, endotracheal tube, and airways. ATC is effective in overcoming the work of breathing
      caused by airway resistance to allow successful weaning process and extubation. Pressure
      support ventilation (PSV) has been widely used in the performance of a spontaneous breathing
      trial because it can compensate to some extent for the additional work of breathing imposed
      by the endotracheal tube and the breathing circuit. However, it is difficult to recognise the
      exact pressure support to overcome the tubing resistance during the weaning process till
      extubation. The aim of the study is to evaluate the automatic tube compensation (ATC) as a
      tool for ventilatory weaning in pediatrics after surgeries for congenital cardiac anomalies.
      The primary objective of our study is to compare the efficacy of ATC versus PS as a modality
      for ventilatory weaning of pediatric postcardiac surgery as regards effects on work of
      breathing, lung compliance, and alveolar recruitment. The secondary objective is to determine
      perioperative predictors of extubation failure (requirement for reintubation and mechanical
      ventilation after prior successful weaning from ventilation, within 48 hours after
      extubation) after cardiac surgery. Patients will be included after fulfilling weaning
      criteria and being pain free. a weaning trial for 30 minutes will be commenced according to
      the following and assessed by the attending physician:- Group A: Weaning trial will be done
      for 17 patients using PSV 0 cmH2O with 100% automatic tube compensation (ATC).

      Group P: Weaning trial will be done for 17 patients using PSV 8 cmH2O without ATC.
    

Intervention name(s): Weaning from mechanical ventilation
Intervention type(s): Other
Intervention description(s): Weaning from mechanical ventilation post congenital cardiac surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Safety and Initial Feasibility of Using the Neurolyser for Facet Related Low Back Pain
Condition: Facet Related Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Single arm pilot study to evaluate the safety and initial feasibility of the Neurolyser XR, a
      new portable high intensity focused ultrasound device, for noninvasive thermal ablation of
      medial nerve branches of painful lumbar facet joint/s
    

Detailed description: 
      Study design: Prospective, single arm

      Timeline: six month enrollment period and 12 months follow-up period.

      Sites: The study will be conducted at McGill University.

      Study population: Ten adult patients diagnosed with facet related low back pain.

      Primary study objective: Safety and efficacy of the Neurolyser XR for the treatment of facet
      related low back pain.

      Safety would be evaluated by the incidence and severity of treatment related adverse events
      Efficacy would be evaluated by the changes in average pain score and Rolland Morris
      Disability Questionnaire between baseline and 6 months.
    

Intervention name(s): Focused Ultrasound Thermal ablation
Intervention type(s): Device
Intervention description(s): Focused Ultrasound Thermal ablation of the Medial Nerve Branch
Intervention model: Single Group Assignment
Intervention model description: Single arm, non-randomized
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetics, Safety, and Tolerability Study of the Pen and PFS of SB5 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the pharmacokinetics, safety, and tolerability of the
      pre-filled pen and pre-filled syringe of SB5 in healthy subjects.
    


Intervention name(s): Pen of SB5; PFS of SB5
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
A Pilot Study of Riluzole Versus Placebo in the Treatment of Children and Adolescents With ASD
Condition: Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will examine the potential efficacy and safety of riluzole for core and associated
      symptom domains of autism and will explore biological markers of safety and treatment
      response.
    

Detailed description: 
      There are no pharmacologic treatments available for social function deficits in individuals
      with Autism Spectrum Disorders (ASD). The data for pharmacologic treatment of repetitive
      behaviors in this disorder has also become difficult to interpret given that the last two
      large multisite trials of selective serotonin reuptake inhibitors (SSRIs) in autism are
      reported to be negative for the treatment of repetitive behaviors. Only the associated
      symptom of irritability has 2 drugs with FDA indications whereas no systematic data exists on
      the pharmacologic treatment of anxiety in ASD, and response to rates to stimulants for
      hyperactivity are lower than what is seen in attention deficit hyperactivity disorder (ADHD).
      In addition, there are no biological markers of treatment response identified in this
      population at this point. This study will examine the potential efficacy and safety of
      riluzole for core and associated symptom domains of autism and will explore biological
      markers of safety and treatment response.
    

Intervention name(s): Riluzole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50mg once daily (QD) for 12 weeks for participants 6-11 years old; 50mg twice daily (BID) for 12 weeks for participants 12-17 years old; Placebo comparator once daily (QD) for 12 weeks for participants 6-11 years old; Placebo comparator twice daily (BID) for 12 weeks for participants 12-17 years old
Other intervention name(s): Rilutek
Intervention MeSH terms: Riluzole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism Spectrum Disorders
Non-invasive Diagnosis of Portal Hypertension With Acoustic Radiation Force Impulse (ARFI)
Condition: Portal Hypertension; Chronic Liver Disease
MeSH terms: Liver Diseases; Hypertension, Portal; Hypertension
Study type: Interventional

Summary: 
      The aim of this diagnostic study is to evaluate the efficacy of ARFI imaging (a specific type
      of ultrasound) in assessing the pressure of the portal vein (the major vein passing through
      the liver) and the amount of liver fibrosis in patients with chronic liver disease.
    

Detailed description: 
      DESIGN The study is designed as a prospective, cross-sectional, diagnostic study in which the
      investigators will evaluate the use of ARFI to diagnose clinically significant portal
      hypertension (CSPH defined as hepatic veous pressure gradient (HVPG)greater than 10 mmHg),
      taking HVPG measurements as gold standard.

      METHODOLOGY

        -  The study will be performed at the VA Connecticut Healthcare System-West Haven and Yale.

        -  Study population will be recruited among patients from the VA/Yale Liver Clinics or
           outside hospitals that are referred to VA/Yale for a transjugular liver biopsy and
           hepatic venous pressure gradient measurement as part of their routine care.
    

Intervention name(s): ARFI ultrasound
Intervention type(s): Device
Intervention description(s): ARFI imaging of the liver and spleen will be performed immediately before transjugular liver biopsy and HVPG procedures
Other intervention name(s): acoustic radiation force impulse
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: portal hypertension; cirrhosis; ARFI; diagnostic study
Safety and Efficacy Study of Subjects With Onychomycosis of the Great Toenail
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to determine the safety and efficacy of 5.0% AN2690 Solution in
      the treatment of distal, subungual onychomycosis of the great target toenail.
    

Detailed description: 
      In this cohort, only the targeted great toenail identified at Baseline prior to the
      commencement of treatment from culture results collected at the Screening visit were
      evaluated for primary efficacy whereas all treated toenails were evaluated for safety. At
      each visit, the investigator was asked to make a clinical evaluation of the targeted great
      nail, marking whether or not they considered the nail to be clear of onychomycosis. This
      evaluation was the basis for determining whether or not study medication should be dispensed
      at the visit.

      This record includes information only for Cohort 3 (5% solution) of the study. Cohorts 1 and
      2, are described in NCT00679523 (7.5% solution). No comparison was made between Cohorts 1&2
      and Cohort 3.
    

Intervention name(s): AN2690 Solution, 5.0%
Intervention type(s): Drug
Intervention description(s): Once daily application for 360 days
Intervention MeSH terms: Tavaborole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Onychomycosis; Fungal Nail
Characterization and Functionality of Calcium Channels Cav1.4 of Th17 Lymphocytes in Human With Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional

Summary: 
      It's clearly known that lymphocyte activation in particular Th17 response, plays a major role
      in the development of plaque psoriasis. New therapies targeting this pathway are showing
      great clinical efficacy in patients with moderate to severe plaque psoriasis.

      Pioneering observations have shown that the expression of Cav1.4 channels in Th17 lymphocytes
      and they're functional role is supported by the inhibition of IL-17 production by a
      pharmacological inhibitor of Cav1 channels that is effective in a mouse model of Psoriasis.

      This data strongly suggest that the Cav1.4 channel, via its involvement in the signalling
      responsible for the production of Th17 cytokines represents an interesting therapeutic target
      in Psoriasis.

      The aim of the study is to explore biological functions related to the activation of the
      Cav1.4 pathway in Psoriasis.
    

Detailed description: 
      -  Evaluate the expression of Cav1.4 calcium channels by Th17 lymphocytes from plaque
           psoriasis.

        -  To assess:

             -  The role of Cav1.4 channels on the activation of Th17 lymphocytes

             -  The transcriptomic signature relating to the signalling channel Cav1.4

             -  The epigenetic signature, in particular changes in overall methylation and specific
                promoter methylation
    

Intervention name(s): Skin biopsies; Blood sample
Intervention type(s): Biological; Biological
Intervention description(s): 3 biopsies on lesion skin (and one more for the first fifteen subjects in group 1); One blood sample for the group 1 only.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Monocentric, open-label, comparative, parallel group and intra-individual patho-physiological study :
Group 1 : 20 subjects with plaque psoriasis
Group 2 : 10 subject with atopic dermatitis
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Th17; Cav1.4; Lymphocyte; Channel
Vagus Nerve Stimulation: Treatment for Gulf Veterans With Gulf War Illness
Condition: Pain; Migraine
Study type: Interventional

Summary: 
      The researchers propose studying Gulf veterans with Gulf War Illness (GWI), characterized by
      a problem with widespread pain. Besides their pain, the researchers will also assess the
      effect of vagus nerve stimulation (VNS) in alleviating migraine headache, another complaint
      of Gulf veterans, which is common in the presence of widespread pain. Importantly, the
      researchers are partnering with a company that has made a hand-held device that allows for
      stimulation of the vagus nerve without the need for surgery; it works by the patient putting
      it on the skin overlying the vagus nerve in their neck and then turning it on for 120 second
      periods three times a day. The device is programmed to deliver only 6 bouts of stimulation
      per day - one to each side of the neck three times a day; it is then inactive until the next
      day. The fact that this device can be used without surgery and is non-invasive makes it
      extremely practical for use.

      After collecting pre-treatment measurement of pain severity and headache severity, veterans
      will receive either the actual active VNS device or an inactive device, which does not
      stimulate the nerve. Veterans will use their device for ten weeks - providing similar
      information periodically over this period by responding to questions about the severity of
      their pain and headaches, They will then return to the Center for the final phase of the
      study where all veterans will receive active devices. Ten weeks later, they will return to
      the Center to provide information to allow the investigators to gain further knowledge as to
      the effectiveness of actual VNS in relieving pain - both throughout the body and in the head.
    

Detailed description: 
      The Three Phases of the Study

      Subject Identification Phase of Study face to face visit at the War Related Illness & Injury
      Study Center at the East Orange Veterans Administration Medical Center (EOVAMC).

      Blinded Phase of Study Office Visit [first time at Icahn School of Medicine at Mount Sinai.
      (ISMMS)] Subjects randomized to either VNS device or inactive device.

      Open Label Phase of Study All subjects receive the VNS device
    

Intervention name(s): VNS device; Inactive device
Intervention type(s): Device; Device
Intervention description(s): Hand held device to use for self administration of vagus nerve stimulation.; Hand held device to use for self administration of simulated vagus nerve stimulation.
Other intervention name(s): Non-InvasiveVagus Nerve Stimulation (nVNS) Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Differences in Ovarian Aging Between Caucasian and Indian Women
Condition: Age of the Patients and the Body Mass Index in Both Groups
Study type: Observational [Patient Registry]

Summary: 
      The investigators want to carry out a prospective study of 400 infertile Caucasian and Indian
      women who will undergo a controlled ovarian stimulation for in vitro fertilization (IVF). The
      investigators will collect data about ovarian reserve markers and also the results after
      ovarian stimulation in both ethnic groups.The aim is to identify differences in ovarian
      response after IVF stimulation between both groups.
    

Detailed description: 
      A total of 200 Caucasian patients and 200 Indian patients who will attend the first or second
      IVF cycle will be included.

      The date we will collect in both groups include the age, the body mass index, and the ovarian
      reserve markers like the antral follicle count (AFC), the follicle stimulation hormone (FSH)
      and antimullerian hormone (AMH) serum levels.

      The investigators will also determine the number of oocytes retrieved and the metaphase two
      oocytes in both groups after IVF stimulation.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Caucasian infertile women and Indican infertile women age < 42 years old, with both ovaries
        present, undergoing an IVF treatment due to male factor, tubal disease or previous failed
        IUI.
      
Keywords: AMH, AFC, aging, ethnicity
Effect of Transcranial Direct Current Stimulation (tDCS) on Tobacco Consumption
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      The primary purpose of the protocol is to evaluate the effect of repeated application for 5
      consecutive days of a real tDCS compared to the application of a placebo tDCS (sham
      procedure) on the evolution of tobacco consumption in the short term between Day 1 and Day 5.

      The study hypothesis is that a repeated application for 5 consecutive days of a real tDCS on
      the left dorsolateral prefrontal cortex region will reduce the craving induced causing a
      decreased of daily tobacco consumption between Day 1 and Day 5 which can persist at the final
      visit between Day 15 and Day 20.
    

Detailed description: 
      Smoking is a major public health problem and it is the leading cause of preventable death in
      the world. Care should include education, psychotherapy and treatments, but despite these
      therapeutics, the smoking cessation process is often characterized by relapses. The main risk
      factor for relapse is craving. Neurophysiological studies have provided evidence in the
      understanding of craving. This craving involves surface structures including the dorsolateral
      prefrontal cortex, accessible by neurostimulation. Repetitive neurostimulation applies on
      this structures involved in craving could therefore modulate it. Two non-invasive stimulation
      techniques exist: repetitive transcranial magnetic stimulation (rTMS) and transcranial direct
      current stimulation (tDCS). The choice of tDCS is based on its ease of use, excellent
      tolerance, its better quality of placebo and low cost.
    

Intervention name(s): tDCS procedure; Sham procedure
Intervention type(s): Device; Device
Intervention description(s): The tDCS is a non-invasive neuromodulation method. A stimulator delivers a constant current of low intensity (1-2 mA) applied to the average of two bipolar electrodes placed on the scalp for 20 minutes. This constant current generates a static electric field that selectively modulates the activity of cortical neurones. A tingling sensation under the electrodes appears at the beginning and at the end of stimulation but it is transient and disappears quickly in 30 or 60 seconds.; The tDCS placebo differs from the real tDCS by the interruption of stimulation after 30 to 60 seconds and reactivation of this stimulation 30 to 60 seconds before the end of the session, which lasted 20 minutes. The tingling felt at the beginning and the end of the session will be the same as those experienced with real stimulation. The electrodes establishment does not differ with respect to tDCS.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Direct transcranial electrical stimulation (tDCS); Sham procedure; Tobacco consumption; Craving
Insulin Resistance and Intramyocellular Lipid Content in Glucose Intolerant Subjects Receiving Rosiglitazone
Condition: Insulin Sensitivity
MeSH terms: Insulin Resistance; Hypersensitivity
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will include subjects with an abnormal glucose tolerance test. Using a crossover
      design, we will evaluate the insulin sensitivity and intracellular lipid content of the
      heart, liver and skeletal muscle of subjects before and after therapy with Rosiglitazone and
      placebo. We hypothesize that Rosiglitazone will improve insulin sensitivity in association
      with reduced muscle lipid content that may arise either from increased lipid oxidation or
      enhanced storage of fat in adipose tissue.
    

Detailed description: 
      This protocol is a crossover study that will include subjects with an abnormal glucose
      tolerance test. Participants will be treated in a community-based practice setting and will
      receive detailed instruction on diet and glucose self-monitoring. The patients will be
      randomly assigned to treatment with 4 mg daily of Rosiglitazone or placebo. They will return
      to the clinic after 4 weeks to monitor changes in glucose levels, HbA1c and liver enzymes.
      The drug dose will be increased as indicated to 8 mg daily and the patients will be
      reevaluated every 4 weeks. The participants will all be admitted to the General Clinical
      Research Center at UT-Southwestern Medical Center at the end of 16 weeks to measure changes
      in the following primary endpoints: 1) insulin sensitivity, 2) lipid content of heart, liver,
      and skeletal muscle, 3) lipid oxidation. Additional noninvasive HMRS measurements will be
      made to quantify the muscle lipid content and respiratory gas exchange will be used to assess
      lipid oxidation. Following the GCRC admission, patients will switch to the alternative
      therapy for 16 additional weeks before the studies are repeated. We expect Rosiglitazone to
      improve insulin sensitivity in association with reduced muscle lipid content that may arise
      either from increased lipid oxidation or enhanced storage of fat in adipose tissue.
    

Intervention name(s): Rosiglitazone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Rosiglitazone 8mg PO daily for 16 weeks; Placebo 1 tablet PO daily for 16 weeks
Other intervention name(s): Avandia
Intervention MeSH terms: Rosiglitazone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: insulin sensitivity; magnetic resonance spectroscopy (MRS); lipotoxicity; lipid oxidation; thiazolidinediones; intracellular; triglyceride; content