bioihbjkbjnl/mcl2 huggingface dataset:
" Acute Brain Changes After Repetitive Headers in Soccer and the Effects of a Protective Device "
Condition: Traumatic Brain Injury; Concussion, Brain
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
Study type: Interventional

Summary: 
      Soccer, the most popular sport in the world, exposes players to repeated head impacts and
      concussions, due to contact with another player or with the ground. Moreover, routine
      game-play in soccer involves intentional and repeated head impacts through ball "heading",
      with frequent high velocities, which might cause a transient brain dysfunction. In this
      pre-post prospective interventional study, 22 soccer players will perform 10 headers from
      machine-projected soccer balls at standardized speeds, modelling routine soccer practice.
      They will perform heading series in 2 different oral conditions, on different days at least 1
      week apart: 1) Without mouthguard and tight jaws ; 2) With mouthguard and tight jaws. The
      strength of the neck muscles will be measured before the heading series. The kinematic of the
      movement will be recorded during each impact during the 2 heading series, as well as the
      activity of the jaw muscles which will be recorded by electromyogram. Before and after each
      heading series, electrophysiological data, multimodal magnetic resonance imaging (MRI), and
      cognitive computerized assessment will be acquired
    


Intervention name(s): Heading series; Magnetic Resonance Imaging (MRI); Cognitive computerized assessment; Electrophysiological records; Dynamometer
Intervention type(s): Procedure; Device; Other; Procedure; Device
Intervention description(s): 10 headers from machine-projected soccer balls at standardized speeds; Brain MRI before and after a series; Cognitive evaluation carried out with two computerized tools; Electrophysiological recording of Motor Evoked Potentials consisting of the application of transcranial magnetic stimulations (TMS) and the collection of muscle activity by electromyogram (EMG); Measure of the strength of the neck muscles using a dynamometer
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Soccer; Traumatic Brain Injury; Heading; Acceleration; Neuroimaging; Cognition
Evaluation of Efficiency of Esophageal Capsule Endoscopy in the Screening of Patients With Gastroesophageal Reflux Disease or Dyspepsia as Compared to Upper Endoscopy
Condition: Gastroesophageal Reflux Disease; Dyspepsia
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic; Dyspepsia
Study type: Interventional

Summary: 
      The exploration of evocative symptoms of esophageal reflux disease or dyspepsia is based on a
      relatively invasive endoscopic examination, often badly tolerated, and which, in France, is
      carried out in 50% of the cases under general anaesthesia. The development of a Capsule
      Endoscopy, of single use, of esophageal exploration (PILLCAM OESO), could allow a painless
      exploration of the oesophagus, without infectious risk.The aim of this study is to validate
      the information provided by the Esophageal Capsule Endoscopy compared to upper endoscopy in
      the screening of patients with gastroesophageal reflux disease or dyspepsia . For that these
      patients, after being informed and to have given their signed assent, will initially have an
      exploration by Esophageal Capsule Endoscopy and then, the very same day or within 3 days
      maximum, a upper endoscopy'. The information provided by the Esophageal Capsule Endoscopy
      then by the upper endoscopy will be analyzed by investigators different. This study should
      make it possible to evaluate the parameters of specificity, sensitivity and predictive values
      of Esophageal Capsule Endoscopy in this indication.
    


Intervention name(s): Esophageal Capsule Endoscopy
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Gastroesophageal reflux; Dyspepsia; Esophageal Capsule Endoscopy
Association of Lutein, Zeaxanthin and Brilliant Blue in Chromovitrectomy
Condition: Epiretinal Membrane; Macular Hole; Proliferative Diabetic Retinopathy
MeSH terms: Diabetic Retinopathy; Retinal Perforations; Epiretinal Membrane
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to test the efficacy of the combination of dye Lutein, Zeaxanthin
      and brilliant blue to stain the internal limiting membrane as well as the epiretinal
      membranes during the Vitrectomy surgery.
    

Detailed description: 
      Twenty five patients with epiretinal membrane, macular hole or proliferative diabetic
      retinopathy and indication of vitrectomy surgery will be selected to participate in this
      study.
    

Intervention name(s): Dye of Lutein, Zeaxanthin and Brilliant Blue
Intervention type(s): Other
Intervention description(s): dye composed of Lutein, Zeaxanthin and Brilliant Blue will be used during the vitrectomy surgery to dye the membranes
Other intervention name(s): lutein, zeaxanthin, brilliant blue
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: chromovitrectomy; epiretinal membrane
Effects of Deep Brain Stimulation on Motor, Mood, and Cognitive Symptoms in Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The purpose of this trial is to study the mood and cognitive effects of deep brain
      stimulation in Parkinson's disease.
    

Detailed description: 
      Deep brain stimulation (DBS) of the subthalamic nucleus (STN) and the globus pallidus interna
      (GPi) has been shown to relieve the motor symptoms of Parkinson's disease (PD) such as
      tremor, rigidity, and bradykinesia. However, there is increasing evidence that DBS may be
      associated with a significant number of mood and cognitive changes.

      The aims of this study are to characterize and compare the mood and cognitive effects
      associated with DBS of the STN and GPi, to delineate regions within or around the STN and GPi
      that are associated with specific mood and cognitive changes when DBS is applied to these
      areas, and to assess the relative effectiveness of right versus left STN or GPi stimulation
      on mood and cognition.

      In the study, researchers will compare motor, mood, and cognitive function in people with PD
      who have had DBS treatment with control subjects (or individuals with PD who have not had
      DBS). The scientists will characterize the types and incidence of mood and cognitive changes
      that occur during DBS in each target (STN and GPi), compare the targets, and examine the role
      of lead location.

      The study will enroll 62 participants-10 control subjects (individuals with PD who have not
      had DBS), and 52 individuals with PD who are scheduled for DBS; the site of the implant (STN
      or GPi) will be randomly assigned. Participants will perform motor, mood, and cognitive tests
      (following 6 months of stimulation) over a 2-day period. Duration of the trial for
      participants is 6 months and includes a 2-night hospital stay.

      Findings from this study may help researchers better understand how DBS affects non-motor
      circuitry.
    

Intervention name(s): DBS of the STN; DBS of the GPI
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients undergo Deep Brain Stimulation (DBS) of the subthalamic nucleus (STN) to treat Parkinson's Disease, using a Medtronic 3387 device.; Patients undergo Deep Brain Stimulation (DBS) of the globus pallidus interna (Gpi) to treat Parkinson's disease, using a Medtronic 3387 device.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's disease; Parkinson disease; PD; deep brain stimulation; DBS; subthalamic nucleus; STN; globus pallidus interna; GPi; mood; motor symptoms; cognition; emotion; memory; attention; tremor; rigidity; bradykinesia
Safety, Tolerability, and Immunogenicity of TETRALITE, a Novel Adjuvanted, Low-dose Influenza Vaccin
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      There is an obvious need for an affordable and more effective seasonal influenza vaccine.
      TETRALITE is a novel, inactivated, adjuvanted influenza vaccine combining a low dose of a
      licensed vaccine with the novel, potent LiteVax Adjuvant.

      A licensed vaccine (Cohort 1) with a normal dose [15 ug per strain] and no adjuvant will be
      compared with two TETRALITE study vaccines with 1/5th of the licensed vaccine added with a
      low (Cohort 2) or high (Cohort 3) dose of LiteVax Adjuvant.
    


Intervention name(s): TETRALITE
Intervention type(s): Biological
Intervention description(s): LiteVax Adjuvanted Seasonal Influenza Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Comparison of licensed influenza vaccine with study vaccines combining 1/5 of the dose of the standard vaccine added with two different doses of LiteVax Adjuvant.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: seasonal influenza vaccine; adjuvant
Social Competence Training for Adolescents With Borderline Intellectual Functioning
Condition: Mental Disorders
MeSH terms: Mental Disorders
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Emotional and behavioural problems as well as a lack of social competence are supposed to be
      common phenomena in adolescents with borderline intellectual functioning, consequently
      impairing their social and vocational integration. Considering the lack of evaluated group
      interventions for this population, a cognitive-behavioural training is developed and its
      effectiveness is examined in a population of students attending special vocational schools.

      77 adolescents with borderline intelligence are enrolled participated in the study. They are
      randomized either to the intervention group, who received 9 group sessions over a period of 3
      months additionally to the standard vocational training (Social Competence Training for
      Adolescents with Borderline Intelligence, SCT-ABI) or to the control group who received only
      the standard vocational training. Outcome measures at the end of the intervention and at a
      6-months follow-up assessment comprise self-reports, caregiver-reports, and behavioural
      observations of cognitive, emotional, and behavioural factors of social competence.
    


Intervention name(s): Social competence training; Special vocational training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 8 group sessions multi-modal social competence training, 2-4 hours each, 2 trainers, 6-10 participants; as provided in German special centres for vocational training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: adolescents; borderline intellectual functioning; social competence training; vocational training; group intervention; cognitive behavioral therapy; Adolescents with borderline intellectual functioning
Comparison of the Effects of Face-to-Face and Internet-Based BBAT in Fibromyalgia Syndrome
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The aim of our study is to compare the effects of face-to-face and internet-based BBAT in
      patients diagnosed with Fibromyalgia Syndrome.

      H0: Face-to-face and internet-based CFT have superiority over each other in patients
      diagnosed with Fibromyalgia Syndrome.

      H1: In patients diagnosed with Fibromyalgia Syndrome, face-to-face and internet-based CFT
      have no superiority over each other.
    

Detailed description: 
      The aim of our study is to compare the effects of face-to-face and internet-based BBAT in
      patients diagnosed with Fibromyalgia Syndrome.

      H0: Face-to-face and internet-based CFT have superiority over each other in patients
      diagnosed with Fibromyalgia Syndrome.

      H1: In patients diagnosed with Fibromyalgia Syndrome, face-to-face and internet-based CFT
      have no superiority over each other.

      Goals:

        1. Investigation of the effects of face-to-face and internet-based BBAT on functional
           disability, pressure pain threshold, body awareness, posture, pain intensity, trunk
           position sense, postural control, balance, sleep quality, quality of life and
           inflammation level in patients diagnosed with Fibromyalgia Syndrome.

        2. Comparison of the effects of face-to-face and internet-based BBAT on functional
           disability, pressure pain threshold, body awareness, posture, pain intensity, trunk
           position sense, postural control, balance, sleep quality, quality of life and
           inflammation level in patients diagnosed with Fibromyalgia Syndrome
    

Intervention name(s): BBAT (Basic Body Awareness Therapy); Online BBAT training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The group I: BBAT Face-to-Face Training (60 min) will be provided.; The group II: Online BBAT training (60 min) will be provided.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Aurograb and Vancomycin in MRSA Infection
Condition: Staphylococcal Infections
MeSH terms: Infections; Communicable Diseases; Staphylococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The study hypothesis is that the addition of Aurograb to standard vancomycin therapy will
      improve outcome in MRSA infection.
    

Detailed description: 
      The Primary Objective will be to determine whether the overall response (clinical and
      bacterial) to Aurograb® (1mg/kg i.v. b.d.) plus vancomycin is greater than the overall
      response to placebo plus vancomycin, in adult hospitalised patients with severe, deep-seated
      staphylococcal infections, particularly MRSA infections, being treated with vancomycin.

      Secondary Objectives will be:

        1. To further determine efficacy, comparing Aurograb versus placebo, regarding:

             -  attributable mortality

             -  overall mortality

             -  clinical response

             -  bacterial response ie eradication or persistence of the infection

             -  rates of clinical resistance to vancomycin.

        2. To compare the safety profile of treatment with Aurograb® (1mg/kg b.d.) plus vancomycin
           versus placebo plus vancomycin in adult hospitalised patients with deep-seated
           staphylococcal infections.

        3. To extend the data base on pharmacokinetics.
    

Intervention name(s): Aurograb
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Educational/Counseling/Training
Keywords: MRSA
A Cohort Study to Compare the Hospitalization Between Naive Sacubitril/Valsartan and Naive ACEi/ARBs Heart Failure Patients With Reduced Ejection Fraction Using Secondary US Electronic Health Records Data
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      A non-interventional retrospective cohort study conducted to compare the naive
      sacubitril/valsartan Heart Failure with reduced Ejection Fraction (HFrEF) patient population
      to a matched naive ACEi/ARB HFrEF patient population.
    

Detailed description: 
      This was a non-interventional retrospective cohort study using the US secondary EHR dataset,
      Optum EHR, to compare the naive sacubitril/valsartan HFrEF patient population (aged ≥ 18
      years) to a matched naive ACEi/ARB HFrEF patient population.

      The study comprised of the following periods:

      Identification period: 01-Jul-2015 to 31-Mar-2019

      Study period

        -  01-Jul-2014 to 31-Mar-2020 for primary objective and secondary objective 2 to 6.

        -  01-Jul-2008 to 30-Sep-2020 for secondary objective 1.

      Follow-up period: Patients were followed up until 31-Mar-2020, death or patient transfer out.

      Baseline period: 365 days prior to index
    

Intervention name(s): Sacubitril/valsartan; ACEi/ARB
Intervention type(s): Drug; Drug
Intervention description(s): Participants who were prescribed with Sacubitril/valsartan; Participants who were prescribed with Angiotensin-converting enzyme inhibitors/Angiotensin II receptor antagonists (ACEi/ARB)
Other intervention name(s): Entresto®
Intervention MeSH terms: Valsartan; Sacubitril and valsartan sodium hydrate drug combination
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        The study included heart failure patients with reduced ejection fraction
      
Keywords: Heart failure hospitalizations,; sacubitril/valsartan,; Angiotensin II receptor antagonist,; United States,; electronic health record
Assessment of the Cytotoxic Immune Status of Pancreatic Cancer Patients and the Severity of the Cancer Using Measurement of Natural Killer Cell Activities
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional

Summary: 
      Pancreatic cancer is the 5th leading cause of cancer death and the worst prognostic cancer in
      the world. This is due to high recurrent rate after surgical resection and poor response to
      chemotherapy and radiotherapy.

      Recent studies revealed that peri-tumoral structure and patients' immune status including
      cytotoxic immunity played significant role in the bad behavior of pancreatic cancer. While
      past studies focused on oncogenes and tumor suppressor genes, recent studies focused on
      patients' own immunity. Patients' immunity modified by cancer cells is found to be correlated
      to cancer progression and metastasis.

      Natural killer cells, playing an important role in cytotoxic immune system, are revealed to
      be decreased in patients with lung cancer, ovarian cancer, prostate cancer, colorectal
      cancer, and breast cancer. And in melanoma mouse model, when NK cell was suppressed, cancer
      progression and metastasis were accelerated.

      This study sought to find the correlation of patients' cytotoxic immune status to cancer
      progression and status by measurement of NK cell activity in pancreatic cancer patients. This
      would be basic support to construct a prognostic model of pancreatic cancer for early
      metastasis and post operational recurrence.
    


Intervention name(s): Blood collection
Intervention type(s): Procedure
Intervention description(s): 1ml of blood specimen collection
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
PK/PD of XM22 in Children With Ewing Family of Tumors or Rhabdomyosarcoma
Condition: Ewing Family of Tumors, Rhabdomyosarcoma
MeSH terms: Rhabdomyosarcoma; Sarcoma, Ewing; Neuroectodermal Tumors, Primitive, Peripheral
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, open label study aimed at assessing the pharmacokinetics,
      pharmacodynamics, the efficacy, safety, and tolerability of a single injection of XM22 in
      children with Ewing family of tumors or rhabdomyosarcoma scheduled to receive chemotherapy
      (CTX)
    


Intervention name(s): Lipegfilgrastim
Intervention type(s): Drug
Intervention description(s): Lipegfilgrastim 100ug/kg
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
The Safety and Efficacy of OPC-64005 in the Treatment of Adult Attention-deficit/Hyperactivity Disorder
Condition: Adult Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      A trial to assess the safety and efficacy of OPC-64005 in the treatment of adult
      attention-deficit/hyperactivity disorder.
    

Detailed description: 
      A multicenter, randomized, double-blind, active- and placebo-controlled, parallel-design
      trial.
    

Intervention name(s): OPC-64005; Atomoxetine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): OPC-64005 film coated tablets; Atomoxetine gelatin capsules; OPC-64005-matching placebo film coated tablets and atomoxetine-matching placebo gelatin capsules
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: ADHD; ADD
Azithromycin Level in Tears and in Conjunctiva in 36 Healthy Volunteers
Condition: Eye Infections, Bacterial
MeSH terms: Bacterial Infections; Eye Infections; Eye Infections, Bacterial
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate azithromycin ocular conjunctiva concentrations 7 and 14 days after treatment
      initiation.

      To assess ocular and systemic tolerance/safety and azithromycin tear concentrations on Day 7
    

Detailed description: 
      The aim of the present study was to compare azithromycin tear and conjunctival ocular
      concentrations after one instillation of T1225 1.5% eye drops, twice a day during one day
      versus one instillation of T1225 1.5% eye drops, twice a day during 3 days versus an oral
      single dose of 1g azithromycin.
    

Intervention name(s): Azithromycin
Intervention type(s): Drug
Intervention MeSH terms: Azithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment