bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Efficacy of the EPIC™ Self-Expanding Nitinol Vascular Stent
Condition: Peripheral Arterial Diseases; Superficial Femoral Artery Stenosis
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases
Study type: Interventional

Summary: 
      The intent of this clinical registry is to demonstrate the efficacy of the EPIC™ stent in
      patients with superficial femoral/ popliteal artery disease.

      100 patients with symptomatic femoropopliteal artery lesion will be enrolled in the study and
      shall undergo 4 visits during the trial -a pre-procedure visit, procedure visit at which time
      the stent will be placed, and follow-up visits at 6 and 12 months.

      Study hypothesis: The EPIC™ Self-Expanding Nitinol Vascular Stent with Delivery System will
      be efficacious in patients with Superficial Femoro/Popliteal Artery disease.
    

Detailed description: 
      The SUMMIT Registry addresses the treatment of peripheral arterial disease (PAD).

      PAD represents a major challenge to physicians in treating the Superficial Femoral (SFA) and
      Popliteal arteries. These vessels are exposed to enormous mechanical stress what represents a
      harsh environment for any endovascular device. During flexing of the knee, the SFA/Popliteal
      arteries can bend, rotate, elongate and compress dramatically. An ideal stent designed for
      use in the SFA/Popliteal arteries would offer great ranges of movement while adequately
      supporting the arteries.

      Subject of study is the EPIC™ Femoropopliteal Self-Expanding Stent System which provides a
      great range of motions for a highly flexible femoral artery while adequately supporting the
      vessel.

      Primary objective is to evaluate the efficacy of the device in treating lesions of the
      SFA/Popliteal artery.

      The project is a multi-centre open label study. Primary efficacy parameter will be assessed
      by measuring the in-stent binary stenosis using duplex ultrasound at 6 and 12 months after
      the stent placement. Binary restenosis is defined as a peak systolic velocity ratio (PSVR)
      ≥2.5:1.

      Anticipated study duration is 18 months: 6 months recruiting and 12 months follow-up.
    

Intervention name(s): EPIC™ Self-Expanding Nitinol Vascular Stent
Intervention type(s): Device
Intervention description(s): SFA/Popliteal Artery stenting
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PAD; SFA
Study to Evaluate the Impact of Obesity on Airway Inflammation and Mechanics in Asthmatics
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      In the United States there has been a dramatic increase in the number of people who are obese
      and in the number of people who have asthma. Both are considered serious public health
      concerns. Several studies have shown that becoming obese or overweight can increase the risk
      of developing asthma or can make asthma symptoms more severe and difficult to control. How
      obesity affects asthma is not fully understood. This research study will examine whether
      obesity affects the amount of inflammation that is present in the lungs of people with
      asthma, and will also examine whether obesity leads to narrow and stiff airways.

      Participation in this study involves 2 visits in order to complete questionnaires, various
      pulmonary function tests, as well as the collection of blood, urine, and exhaled breath
      condensate specimens.

      This research study includes optional genetic and bronchoscopy substudies.
    


Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): no intervention
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Asthmatics and healthy volunteers
      
Biospecimen description: 
      Serum, urine, DNA, exhaled breath condensate. For substudy participants, bronchoalveolar
      lavage samples.
    
Keywords: asthma, inhaled corticosteroids
Phase 1 Study to Evaluate Safety of GR-MD-02 in Subjects With Non-Alcoholic Steatohepatitis (NASH) and Advanced Fibrosis
Condition: Non-Alcoholic Steatohepatitis (NASH)
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to characterize the safety, tolerability and
      dose-limiting toxicities (DLTs) for GR-MD-02 when administered intravenously to subjects with
      biopsy-proven NASH with advanced liver fibrosis.
    

Detailed description: 
      This study is a dose ranging study to assess in sequential fashion, the safety, tolerability,
      and dose limiting toxicities (DLTs) of GR-MD-02, in subjects with biopsy-proven NASH with
      advanced fibrosis. This is a dose escalation design comprised of 3 sequential cohorts to
      evaluate the safety of GR MD 02 when administered as a single IV infusion followed by 3
      additional weekly infusions starting 28 days after the first dose. Each cohort will consist
      of 8 subjects, 6 randomized to receive active drug and 2 randomized to receive placebo.Based
      on data safety monitoring board (DSMB) and FDA review, 2 additional cohorts may be
      implemented, consisting of 8 subjects.
    

Intervention name(s): GR-MD-02; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GR-MD-02; galactoarabino-rhamnogalaturonate; GR-MD-02 Placebo
Other intervention name(s): galactoarabino-rhamnogalaturonate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Non-Alcoholic Steatohepatitis (NASH)
Mechanism of Action of tACS for the Treatment of MDD
Condition: Major Depressive Disorder; MDD
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The purpose of this research study is to use a specific type of non-invasive brain
      stimulation known as transcranial alternating current stimulation (tACS) to determine its
      effects on brain activity (measured with EEG) and mood in patients with Major Depressive
      Disorder (MDD).
    

Detailed description: 
      The device used for non-invasive brain stimulation is investigational and has not been
      approved by the FDA, though it has been designated as a nonsignificant risk (NSR) device
      study by the FDA. Half of the participants will receive tACS and half will receive sham
      stimulation, an inactive control procedure for comparison use only. Participation in this
      study includes up to eight appointments, each one lasting from 30 minutes to four hours over
      the course of 3 weeks. The first two appointments will be remote interviews to determine
      eligibility. If the subjects qualify, the next five appointments will be scheduled as
      consecutive stimulation sessions in the Carolina Center for Neurostimulation at the Vilcom
      office. The follow-up appointment will be in our center two weeks after the completion of the
      stimulation sessions. We estimate the total time needed to complete study participation to be
      about 17 hours.
    

Intervention name(s): tACS; Sham tACS
Intervention type(s): Device; Device
Intervention description(s): XCSITE100; XCSITE100
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: tACS; Major Depressive Disorder; MDD; mood symptoms; sham
Increasing Use of Mental Health Services
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The purpose of this study is to test the effectiveness of Open Door (previously known as the
      Treatment Initiation Program [TIP]), a brief psychosocial intervention to address the
      psychological barriers to care and improve the use of mental health services by depressed
      community elderly. The intervention is designed to help the older adult identify the
      barriers, problem-solve to find solutions and mobilize the motivation to seek help. Open Door
      was developed to work collaboratively with an older adult who is depressed to improve access
      and adherence to mental health treatment.
    

Detailed description: 
      The primary aim of this research study did not change from the original application; it is to
      conduct a randomized controlled trial of the effectiveness of a brief, psychosocial
      intervention on engagement in mental health care among homebound depressed older adults.
      Engagement is defined as accepting a referral and attending a visit with a provider who could
      provide traditional mental health care (medication or psychotherapy). The intervention, now
      called Open Door, was developed to work collaboratively with an older adult who has
      depressive symptoms to address the barriers to care with the aim of helping them consider a
      referral and engage in mental health care. In prior research, this intervention has been
      found to improve treatment participation, reduce depressive symptoms and increase adherence
      to antidepressant therapy among depressed older adults in primary care and outpatient
      psychiatric settings. We propose that Open Door will improve the access to mental health care
      by reducing psychological barriers, providing education about care, and managing the
      resignation associated with the symptoms of depression among community dwelling depressed
      elders. Additionally, we believe that despite the heterogeneity of mental health care that
      may be received, Open Door will be associated with reduced depressive symptoms by empowering
      the older adult to initiate care for him/herself.
    

Intervention name(s): Open Door intervention
Intervention type(s): Behavioral
Intervention description(s): Open Door intervention subjects will:
receive an evaluation
receive a referral to a local mental health provider
identify barriers, set goals and problem-solve to achieve a mental health evaluation using available resources.
Other intervention name(s): West group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: geriatric depression
A Study to Assess the Safety and Efficacy of Etrasimod in Subjects With Moderate-to-Severe Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether etrasimod is a safe and effective treatment
      for moderate-to-severe atopic dermatitis (AD).
    


Intervention name(s): Etrasimod 1 mg; Etrasimod 2 mg; Etrasimod matching placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Etrasimod 1 mg tablet taken by mouth, once daily; Etrasimod 2 mg tablet taken by mouth, once daily.; Etrasimod matching placebo tablet by mouth, once daily.
Other intervention name(s): APD334; APD334
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Moderate-to-severe atopic dermatitis; Etrasimod; APD334
Better Weight-Better Sleep (BWBS) Trial
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The hypothesis of this study is that overweight and obese patients exposed to sleep focused
      counseling and standard dietary and exercise counseling will have better outcomes than
      similar patients exposed to standard dietary and exercise counseling only.
    

Detailed description: 
      Objective: To explore the feasibility of integrating sleep management interventions with
      dietary and exercise interventions for obesity in a 12-week randomized trial. Methods: We
      randomized 49 overweight or obese adult patients either to a better weight (BW) cognitive
      behavioral intervention, or to a combination of the BW intervention and a better sleep
      intervention, better weight-better sleep (BWBS). Results: The BWBS group lost weight faster
      (P=.04), and coping self-efficacy accelerated (P=.01). Conclusions: These preliminary results
      merit replication in a larger primary care-based trial with a longer continuous intervention
      and followup period. Key words: obesity, sleep, weight loss, primary care, health behavior E
      Logue et al. Am J Health Behav. 2012;36(3):319-334 DOI: http://dx.doi.org/10.5993/AJHB.36.3.4
    

Intervention name(s): Better Weight; Better Weight & Better Sleep
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Standard cognitive behavioral treatment focused on dietary & exercise behavior; Standard CBT to support dietary and exercise change plus sleep hygiene and sleep focused CBT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: obesity; primary care
Cardiopulmonary Bypass and Inflammatory Response
Condition: Thoracic Surgery; Cardiopulmonary Bypass
Study type: Observational

Summary: 
      The purpose of this study is to determine if a difference exists in the inflammatory response
      which occurs related to coronary artery bypass graft (CABG)surgery performed on
      cardiopulmonary bypass as compared to CABG surgery performed off bypass at the University of
      Pittsburgh Medical Center.
    

Detailed description: 
      Acute inflammatory response occurring in cardiopulmonary bypass (CPB) patients has been
      clearly associated with deleterious clinical outcomes. Increasing understanding of the
      pathophysiology of systemic inflammatory response syndrome (SIRS) following CPB has
      facilitated the development of strategies to attenuate the damaging effects of
      cytokine-induced inflammation. For any strategy to be tested, one needs to clearly define and
      understand the inflammatory response occurring with CPB. Although this has been extensively
      studied, there is wide variation in the reported time course and magnitude of this response.
      This variation is, in part, due to the heterogeneous nature of the patient population studied
      (variable severity of illnesses, ejection fractions, co-morbidities, etc.). Hence, in our
      study, we propose to study the inflammatory response occurring in patients undergoing
      coronary artery bypass graft (CABG) with and without the use of CPB in our institution, and
      to determine whether the severity of inflammatory response seen in CABG patients is
      associated with impairment of any specific clinical parameter in the immediate post-operative
      period (i.e., ventricular dysfunction, lung injury, bleeding, renal failure, etc).
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        CABG patients
      
Biospecimen description: 
      plasma and serum
    
Keywords: cardiac surgery; cardiopulmonary bypass; cytokines
Pediatric Traumatic Brain Injury: Methylphenidate Effects on Early Recovery
Condition: Brain Injuries
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      Traumatic Brain Injury (TBI) is the leading cause of acquired long term disability among
      children and young adults. Deficits in attention and memory are common and persist for years
      after moderate or severe TBI. The similarity between these symptoms and those of children
      with AD/HD, the efficacy of methylphenidate in the treatment of AD/HD, and the efficacy of
      methylphenidate in improving recovery of animals with brain injuries, support the need to
      study methylphenidate effects in children with TBI. This investigation of methylphenidate in
      children with moderate to severe TBI aims to: (1) Assess the acute effects of 2 different
      dosages of methylphenidate on attention and reaction time when the medication is administered
      to children early in recovery; (2) Assess the ability of 8 weeks of methylphenidate to
      improve the rate of recovery of cognitive, memory, and attentional skills in children with
      TBI; (3) Identify the frequency of common methylphenidate side effects in children with TBI.
    

Detailed description: 
      During the first phase of the study which is of 8-days duration subjects will receive placebo
      on some days and methylphenidate on others. During this phase of the study the effects of the
      medication on children's performance on a computerized test of attention will be assessed.
      Individuals who do not have significant methylphenidate side effects during the first phase
      of the study will then participate in the second phase of the study. During the second phase
      subjects will receive either methylphenidate or placebo for 8 weeks. Neuropsychological
      measures of attention, memory, behavioral inhibition, cognitive flexibility, and motor
      performance will be obtained at baseline and after the 8 week medication trial in order to
      assess methylphenidate effects on the rate of recovery. Recovery will also be assessed using
      an interview measure of adaptive behavior and cognitive functioning. A stimulant medication
      side effect rating scale will be used to monitor for common methylphenidate adverse effects
      throughout both phases of the study
    

Intervention name(s): methylphenidate
Intervention type(s): Drug
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Treatment
Keywords: pediatric traumatic brain injury
Self-regulatory Control and Eating: A Neuroimaging Study of Bulimia Nervosa
Condition: Bulimia Nervosa
MeSH terms: Bulimia; Bulimia Nervosa
Study type: Observational

Summary: 
      The purpose of this study will be to replicate previous findings of deficits in prefrontal
      activation during response inhibition tasks in bulimia nervosa and extend these findings by
      demonstrating similar deficiencies in activity during a functional behavioral task that
      requires the inhibition of eating. Findings from this study will potentially help to
      elucidate the underlying neural mechanisms of bulimia nervosa, and thus inform treatment and
      prevention efforts.
    

Detailed description: 
      Bulimia nervosa (BN), is a serious psychiatric disorder that has high rates of comorbidity
      and often results in role impairment for the suffer. Thus far, although psychosocial and
      behavioral risk factors and correlates of BN have been extensively researched, relatively few
      studies have focused on brain-based determinants of BN. Identification of neural mechanisms
      associated with self-regulatory control that may be integral in the development, maintenance,
      and prevention of this debilitating condition would better inform treatment development and
      eating disorder prevention efforts.

      Participation in this study consists of a 3-3.5 hours study visit as well a a one year follow
      up visit. The first portion of initial study visit is part of the screening process, in which
      individuals will complete several questionnaires and be interviewed by the study researcher
      in order to confirm eligibility. If a participant is eligible after the screening portion,
      they move onto the rest of the initial visit. During the initial visit, participants will
      complete a button pressing go/no-go task as well as a sipping go/no-go task, all while
      wearing a functional near-infrared spectroscopy (fNIR) device.

      At a one year follow up appointment, individuals will again complete a variety of self-report
      questionnaires and be interviewed by the study researcher, thus completing the same measures
      used as screening tools in the initial visit.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women (ages 18-45 years) with bulimia nervosa and age, BMI, and IQ-matched controls.
      
Keywords: Bulimia Nervosa; Bulimia; Response Inhibition; fNIR; Neuroimaging
Comparison of Hemodynamic Changes With Morphine Versus Esmolol During Induction of Anaesthesia
Condition: Intubation Complication
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Comparing hemodynamic changes with morphine versus esmolol as an adjuvant agent during
      induction of Anaesthesia
    

Detailed description: 
      Comparing hemodynamic profile of patients during induction of General Anesthesia with
      intravenous morphine as an adjuvant drug versus Intravenous esmolol as an adjuvant agent,My
      aim is to study which drug has superior hemodynamic profile in terms of hemodynamic stability
      of patient requiring General Anesthesia.
    

Intervention name(s): Intravenous morphine
Intervention type(s): Drug
Intervention description(s): Morphine group(an opioid), participants were given intravenous morphine(an opioid) at induction of General Anaesthesia before laryngoscopy and intubation.
The other group,Esmolol group(cardioselective beta blocker), participants were given intravenous esmolol(cardioselective beta blocker) during induction of General Anesthesia before laryngoscopy and intubation.
Other intervention name(s): Intravenous esmolol
Intervention MeSH terms: Morphine; Esmolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care