bioihbjkbjnl/mcl2 huggingface dataset:
Modafinil in Treating Fatigue and Behavioral Change in Patients With Primary Brain Cancer
Condition: Brain and Central Nervous System Tumors; Cognitive/Functional Effects; Fatigue
MeSH terms: Nervous System Neoplasms; Central Nervous System Neoplasms; Fatigue
Study type: Interventional

Summary: 
      RATIONALE: Modafinil may be effective in relieving fatigue and improving behavioral changes
      such as memory loss in patients who have undergone treatment for primary brain cancer. The
      effectiveness of modafinil in relieving fatigue and improving behavioral change is not yet
      known.

      PURPOSE: This randomized clinical trial is comparing how well two different doses of
      modafinil work in treating fatigue and behavioral changes in patients who have undergone
      treatment for primary brain cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Compare the effectiveness of low-dose vs high-dose modafinil for treatment of fatigue
           and neurobehavioral dysfunction in patients with primary brain tumors.

        -  Determine the safety of this drug in these patients.

        -  Compare quality of life of patients treated with 2 different doses of this drug.

      OUTLINE: This is a randomized, double-blind, parallel-group study. Patients are randomized to
      1 of 2 arms.

        -  Randomized phase:

             -  Arm I: Patients receive oral high-dose modafinil twice daily.

             -  Arm II: Patients receive oral low-dose modafinil twice daily. In both arms,
                treatment in this phase continues for 3 weeks followed by a 1-week washout period.

        -  Extended treatment phase:After the 1-week washout period, all patients receive oral
           low-dose modafinil once daily on days 1-3. The dose is then titrated to an optimal level
           and administered in divided doses.

      Fatigue, neurobehavioral dysfunction, and quality of life are assessed during the randomized
      phase at baseline and on days 7 and 21 and then during the extended treatment phase at
      baseline and on days 28 and 56.

      PROJECTED ACCRUAL: Approximately 30 patients will be accrued for this study.
    

Intervention name(s): modafinil
Intervention type(s): Drug
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: adult brain tumor; fatigue; cognitive/functional effects
Use of WhatsApp for Communication Between Consulting Physicians and the Emergency Physicians
Condition: Consultation
MeSH terms: Emergencies
Study type: Observational

Summary: 
      The aim of this study is to determinate outcomes of WhatsApp Messenger (a messaging program
      for smart phones) usage for Communication Between Consulting Physicians and the Emergency
      Physicians.
    

Detailed description: 
      Effective communication between consulting physicians and the emergency physicians is
      critical for patients in the emergency department. WhatsApp Messenger (a messaging program
      for smart phones), is the most commonly used for communication in at present. WhatsApp
      Messenger is the most globally popular messaging application. Also, it has been started to be
      used for communication in healthcare. The aim of this study is to determinate outcomes of
      WhatsApp Messenger usage for communication between consulting and the emergency physicians.
    

Intervention name(s): WhatsApp
Intervention type(s): Other
Intervention description(s): Consultations used WhatsApp Messenger
Other intervention name(s): A smart phone application
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who were consulted with whatsApp and who were admitted to Emergency Department.
      
Keywords: Emergency Physicians; Consulting Physicians; WhatsApp
Carotid Endarterectomy Versus Carotid Artery Stenting? A Prospective Comparison of Neuropsychological Outcome in Patients With Carotid Stenosis.
Condition: Carotid Stenosis
MeSH terms: Carotid Stenosis; Constriction, Pathologic
Study type: Interventional

Summary: 
      In this prospective study, patients with carotid stenosis will be randomly assigned to one of
      the two surgical procedures (carotid endarterectomy (CEA) and carotid stenting (CAS)). Pre-
      and postoperative neuropsychological functions, levels of several biomarkers and
      intraoperative embolization load will be examined. In a subgroup of patients, MRI-data will
      also be gathered. The mix of these data will allow us to answer several questions regarding
      the absence or presence of preoperative impairments, postoperative changes in cognitive
      performance and possible differences between CEA and CAS regarding postoperative
      neuropsychological functions. The use of a matched control group and implementation of a long
      term follow-up will contribute to the uniqueness of this study. It will meet several flaws of
      previous studies and will complete the ongoing randomized studies comparing CEA and CAS that
      are lacking neuropsychological data.
    


Intervention name(s): Carotid endarterectomy (CEA); Carotid stenting (CAS); Neurocognitive functions; Levels of biomarkers; Detection of peri-operative embolization; Validation results
Intervention type(s): Procedure; Procedure; Procedure; Procedure; Procedure; Procedure
Intervention description(s): Carotid endarterectomy (CEA) will be performed on the patients; Carotid Stenting (CAS) will be performed on these patients.; Neurocognitive functions will be measured pre-operatively and after 3 weeks, 6 months and 1 year.; Levels of biomarkers (Protein S100B) will be examined pre- , peri- and post-operatively after 2 hours, 6 hours and 24 hours.; A Transcranial Doppler Ultrasonography will be used to detect peri-operative embolization.; On a subgroup of 20 patients a MRI-scan will be done pre- and post-operatively after 48 hours and 3 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Tea Components, Mental Stress and Blood Pressure
Condition: Healthy
MeSH terms: Stress, Psychological
Study type: Interventional

Summary: 
      Assess the effects of adding theanine to a caffeinated beverage on changes in blood pressure
      during acute mental stress.
    

Detailed description: 
      Caffeine and (mental) stress can increase blood pressure. In a typical everyday and/or work
      environment they commonly coincide. Tea has the reputation of being a relaxing drink.
      L-theanine is an amino acid found almost exclusively in tea. In a previous study it was shown
      that caffeine increased blood pressure, while theanine antagonised these effects. In the
      current study the effect of theanine to a placebo on blood pressure are directly compared.
    

Intervention name(s): Combination of caffeine and theanine; Caffeine
Intervention type(s): Other; Other
Intervention description(s): Beverage containing caffeine and theanine; Beverage containing caffeine
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Motor Evoked Potentials With Modified Facilitation Technique
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      Investigating the change in Test- Retest- reliability in healthy individuals when applying a
      modified easy to use facilitation technique compared to standard facilitation technique and
      analyzing sensitivity and specificity in patients with multiple sclerosis regarding detection
      of pathologic results
    


Intervention name(s): MEP using standard facilitation technique; MEP using modified facilitation technique
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): measuring of MEP using standard facilitation technique according to the Guidelines of International Federation of Clinical Neurophysiology; measuring of MEP using modified facilitation technique (application of additional 8-12x magnetic stimuli for arms and legs)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: facilitation technique; multimodal evoked potentials (mmEP) in multiple sclerosis; motor evoked potential (MEP) in multiple sclerosis
The Effects of Epinephrine in Endotoxemia in Normal Volunteers
Condition: Immune System
MeSH terms: Endotoxemia
Study type: Interventional
Phase: Phase 1

Summary: 
      Epinephrine (adrenaline) is a substance produced by the body (in the adrenal gland) in
      response to stress such as infection or injury. Endotoxin is a man- made substance, which
      causes the body to "mimic" sickness (fever, chills, and achiness) for a few hours. This study
      is designed to give epinephrine before and/or after endotoxin to determine if this medication
      can prevent or relieve any of the symptoms caused by endotoxin.
    

Detailed description: 
      The body's immune response to injury otr infection is very complex. immune cell activity, the
      release of specific mediators (such as proteins), genetics (Deoxyribonucleic acid or DNA)
      and/or the body's "instructions" for making proteins (Ribonucleic Acid or RNA) may effect the
      body's clinical response to a stress such as an infection.Epinephrine (adrenaline) is a
      substance produced by the body (in the adrenal gland)in response to stress such as infection
      or injury. Endotoxin is a man- made substance, which causes the body to "mimic" sickness
      (fever, chills, and achiness) for a few hours. This study is designed to give epinephrine
      before and/or after endotoxin to determine if this medication can prevent or relieve any of
      the symptoms caused by endotoxin.In addition, this study may determine whether any of the
      above(proteins,DNA,RNA,etc.) correlate with or affect the body's response to epinephrine
      and/or endotoxin. This will enable the investigator to better understand whether treatment
      with this substance can alter the body's immune response.
    

Intervention name(s): Endotoxin, Lipopolysaccharide, LPS; Endotoxin, Epinephrine
Intervention type(s): Biological; Biological
Intervention description(s): Clinical Center Reference Endotoxin, lot 2, sterile saline, 2 ng/kg, bolus IV administration (~5 minutes); Clinical Center Reference Endotoxin, lot 2, sterile saline, 2 ng/kg, bolus IV administration (~5 minutes/Epinephrine 30mcg/kg/min
Other intervention name(s): Sodium Chloride Solution; Adrenaline Chloride
Intervention MeSH terms: Epinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Physiotherapy for Children With Dysfunctional Breathing
Condition: Dysfunctional Breathing
MeSH terms: Respiratory Aspiration
Study type: Interventional

Summary: 
      Dysfunctional breathing in children primarily affects the ability to participate in sport or
      exercise but can also stop children doing other activities such as playing musical
      instruments. Clinical experience has shown that physiotherapy (through the use of breathing
      retraining and other associated techniques) can stop the symptoms of dysfunctional breathing,
      allowing children to return to normal activities and reduce or stop inhaled medications.

      Whilst there is some evidence in adults with this condition to support the use of
      physiotherapy, there have been no studies carried out in children investigating whether
      physiotherapy is beneficial for children with dysfunctional breathing.

      This study therefore aims to investigate the feasibility of a future large scale multicentre
      clinical trial designed to investigate whether physiotherapy improves outcomes for children
      with dysfunctional breathing. The improved management of this common but under recognised
      condition would lead to significant improvements in the quality of life of children coupled
      with the reduction in potentially harmful medications.
    


Intervention name(s): Physiotherapy
Intervention type(s): Behavioral
Intervention description(s): A course of breathing retraining delivered by a physiotherapist and practiced by the participant at home.
Other intervention name(s): None - Inhalers and scans are not interventions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
A Prospective Controlled Study on Treatment of Giant Cavernous Hemangiomas of the Liver
Condition: Laparoscopic Hepatectomy; Radio-frequency Ablation; Giant Cavernous Hemangiomas; Liver
MeSH terms: Hemangioma; Hemangioma, Cavernous
Study type: Interventional

Summary: 
      In the past, the investigators often treated giant cavernous hemangiomas of the liver by
      hepatectomy.Recently RFA and laparoscopic hepatectomy are also available and could be applied
      to cure this disease.But we can't get a clear answer about their effectiveness and safety.
      Hence the investigators conduct this study to explore the effectiveness and efficiency of the
      these two methods and compare their short to mid-term outcomes.
    


Intervention name(s): RFA; hepatectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): using RFA to treat cavernous hemangiomas; using hepatectomy to treat cavernous hemangiomas
Other intervention name(s): radiofrequence ablation; liver resection
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: laparoscopic hepatectomy; radio-frequency ablation; giant cavernous hemangiomas; liver
Effects of Arousal and Stress in Anxiety
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      This study has several parts. One part will examine the influence of factors such as
      personality and past experience on reactions to unpleasant stimuli. Others will examine the
      effect of personality and emotional and attentional states on learning and memory.

      When confronted with fearful or unpleasant events, people can develop fear of specific cues
      that were associated with these events as well as to the environmental context in which the
      events occurred via a process called classical conditioning. Classical conditioning has been
      used to model anxiety disorders, but the relationship between stress and anxiety and
      conditioned responses remains unclear. This study will examine the relationship between cued
      conditioning and context conditioning . This study will also explore the acquisition and
      retention of different types of motor, emotional, and cognitive associative processes during
      various tasks that range from mildly arousing to stressful.
    

Detailed description: 
      Objective: Fear and anxiety are adaptive responses to different types of threats. Fear is a
      short-duration response evoked by explicit threat cues and anxiety a more sustained state of
      apprehension evoked by unpredictable threat. This protocol studied fear using Pavlovian fear
      conditioning in two studies. Studies 1 and 3. Study 2 focused on anxiety. Studies 1 and 3
      will be discontinued to focus uniquely on the study of anxiety. Specifically, we will examine
      the interactions between anxiety induced experimentally using verbal threat and cognitive
      processes. We will seek to 1) characterize the effect of anxiety on key cognitive processes
      including working memory and attention control and 2) examine the extent to which performance
      of cognitive tasks distract from anxiety.

      Study population: This more-than-minimal-risk protocol will test medically and
      psychiatrically healthy volunteers aged 18-50. Pregnant or nursing women will be excluded.

      Method: Fear and anxiety will be measured using the startle reflex to brief and loud sounds.
      Fear conditioning will be assessed using shock as unconditioned stimulus. Cognitive
      performance will be examined during periods of unpredictable shock anticipation.

      Outcome measures: The study will include cognitive performance and measure of aversive
      states, primarily the startle reflex.
    

Intervention name(s): Shock Device; Auditory Startle Device
Intervention type(s): Device; Device
Intervention description(s): Shock Device; Auditory Startle Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Classical Conditioning; Fear Conditioning; Stress; Learning; Normal Volunteers; Healthy Volunteer; Normal Control
Digital Flow Enhancement in Raynaud's Phenomenon With an sGC (Soluble Guanylate Cyclase) Stimulator
Condition: Raynaud Disease
MeSH terms: Raynaud Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients with Raynaud's phenomenon suffer from painful attacks triggered by stress or cold
      causing acute lowering of blood flow through the digits. In this trial the safety and
      efficacy as well as the effect of one dose of the sGC stimulator Riociguat on digital blood
      flow will be measured during a cold exposure test in patients suffering from Raynaud's
      phenomenon. Measurements of two periods will be compared: in one period the patient will be
      given active drug and in the other period a placebo.
    


Intervention name(s): Riociguat (Adempas, BAY63-2521); Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Riociguat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Digital ischemia; Raynaud's phenomenon
Characterization of CD Responders to Vedolizumab
Condition: Crohn Disease; Ulcerative Colitis
MeSH terms: Crohn Disease
Study type: Observational

Summary: 
      The purpose of this study is to characterize which patients with Crohn's disease are likely
      to respond to standard of care to vedolizumab therapy.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants being seen at the University of Miami IBD clinics with a diagnosis of CD or UC
        and about to initiate standard of care treatment with vedolizumab.
      
Keywords: Inflammatory Bowel Disease (IBD); IBD; CD; UC; Vedolizumab; VDZ; Biomarkers; Response
Vibrotactile Feedback During Vestibular Therapy
Condition: Vestibular Disease
MeSH terms: Vestibular Diseases
Study type: Interventional

Summary: 
      This study evaluates the use of vibrotactile feedback to traditional vestibular treatment
      protocols. Half the patients will have vibrotactile feedback added to their treatment
      protocols while the other half will undergo traditional vestibular treatment without
      vibrotactile feedback.
    

Detailed description: 
      Vestibular and balance rehabilitation is an effective way to improve balance for individuals
      with balance impairments by using the strategies of adaptation, habituation, or substitution.
      Typical vestibular treatment is usually 3 sessions per week for 6 weeks. For people with
      uncompensated unilateral vestibular hypofunction or bilateral vestibular loss,
      recovery/adaptation is often incomplete and chronic balance impairments result.

      Vibrotactile feedback (VTF) is a strategy of substitution, or augmentation, to replace
      disrupted or absent vestibular function. The sensory information replaces disrupted or absent
      vestibular function to give persons additional signals about their body position in space.
      Real-time VTF applied to the trunk has been shown to decrease postural sway but the long-term
      benefits of training with VTF on balance and function have not been examined.
    

Intervention name(s): Vibrotactile Feedback
Intervention type(s): Other
Intervention description(s): Balance training Vibrotactile feedback applied to the trunk
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: vibrotactile feedback; vestibular rehabilitation; balance
Effects of the Interventions Using Multiple Sensory Integrations on Preterm Infants' Stress-Related Outcomes
Condition: Preterm Infants; Pain
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Frequent pain and distress may affect infants' brain and neural development, and highlight
      the need for relieve pain interventions. Peripheral venous puncture procedures are an
      important source of preterm infants' pain and distress. Brain development is mainly created
      by infant sensory experience. It becomes important, therefore, to relieve preterm infants'
      pain and distress using multiple sensory integrations during peripheral venous puncture
      procedures.The proposed 2-year study has specific aim: to compare the effects of different
      combination of sensory integrations on preterm infants' pain and distress before, during, and
      after peripheral venous puncture procedures.
    


Intervention name(s): Multiple Sensory Integrations
Intervention type(s): Other
Intervention description(s): breast milk odor, oral expressed breast milk, heartbeat sounds, nonnutritive sucking.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Effect of a Nasal Bolus Allergen Challenge on Inflammatory Markers
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 1

Summary: 
      The current study will investigate nasal inflammatory markers obtained by filter paper
      collection techniques, in subjects with allergic rhinitis, determining the most appropriate
      time points and handling conditions, prior to running a larger study with subjects with
      allergic rhinitis.
    


Intervention name(s): Intra-nasal allergen challenge with Phleum pratense.; Collection of nasal effluent using filter paper.; Measurement of nasal congestion using acoustic rhinometry.
Intervention type(s): Procedure; Procedure; Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment