bioihbjkbjnl/mcl2 huggingface dataset:
Evaluate the Effectiveness of Brain Network Activation (BNA™) Technology in the Management of Sport Related Concussion
Condition: Minor Traumatic Brain Injury (TBI)
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Observational

Summary: 
      Currently, there is no direct, reliable, bed-side, and non-invasive method for assessing
      changes in brain activity associated with concussion. Event Related Potentials (ERPs), which
      are temporal reflections of the neural mass electrical activity of cells in specific regions
      of the brain that occur in response to stimuli, may offer such a method, as they provide both
      a noninvasive and portable measure of brain function. The ERPs provide excellent temporal
      information, but spatial resolution for ERPs has traditionally been limited. However, by
      using high-density electroencephalograph (EEG) recording spatial resolution for ERPs is
      improved significantly. The paradigm for the current study will combine neurophysiological
      knowledge with mathematical signal processing and pattern recognition methods (BNA™) to
      temporally and spatially map brain function, connectivity and synchronization.

      The proposed study will provide additional evidence for the utility and contribution of the
      BNA™ test (reflecting temporal and spatial changes in brain activity as well as brain
      functional connectivity associated with concussion) in concussion management.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        200-300 athletes from 3-9 college sport teams, from both genders, aged 17-24 years.
      
Keywords: Minor traumatic brain injury (TBI); Concussion
Comparison of the Efficacy of Duloxetine and Pregabalin in Patients With Knee Osteoarthritis With Mix Type Pain
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      Osteoarthritis (OA) is a common degenerative joint disorder associated with chronic pain at
      older age.It is known that patients with osteoarthritis experience nociceptive and
      neuropathic pain to varying degrees. Addition of molecules targeting neuropathic pain to
      conventional therapy has been shown to improve treatment response in the management of
      osteoarthritis.The aim of our study is to evaluate the effect of duloxetine and pregabalin on
      pain, functional capacity, quality of life, depression, anxiety and sleep patterns in knee
      osteoarthritis.
    

Detailed description: 
      A total of 66 patients (aged 40-69) with knee osteoarthritis were randomized into two
      treatment groups to receive either duloxetine 60mg/day or pregabalin 300mg/day. The patients
      were evaluated before and one month after treatment and three months after treatment using
      the visual analog scale (VAS-pain), Neuropathic Pain Diagnostic Questionnaire (DN4), Short
      Form-36 (SF-36) Questionnaire, Western Ontario and McMaster University Osteoarthritis İndeks
      (WOMAC), Beck Depression Scale (BDS), Beck Anxiety Akalası (BAS), Pittsburg Sleep Quality
      Index (PSQI).
    

Intervention name(s): Duloxetine; Pregabalin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Pregabalin; Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized prospective clinical trial
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Knee osteoartrhritis; Duloxetine; Pregabalin; Pain
The Development of Autistic Children Based on Mothers´Response in Autism Behavior Checklist
Condition: Autism; Asperger Syndrome
MeSH terms: Autistic Disorder; Asperger Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the process of development of autistic children, in
      a direct and indirect intervention context from mother´s response in Autism Behavior
      Checklist.
    

Detailed description: 
      Aim: We evaluated the process of development of autistic children, in a direct and indirect
      intervention context from mother´s response in Autism Behavior Checklist.

      Method:

      The sample were composed of 11 mothers of children diagnosed with Autism (6) and Asperger
      Syndrome (5), according to the criteria established by the DSM IVtr (APA, 2002). These
      children were randomly divided into two groups: Six were receiving both direct and indirect
      intervention (Therapy Group -TG), and five were receiving exclusively indirect intervention
      (Orientation Group - OG). We used the Autism Behavior Checklist (Krug et al., 1993), adapted
      to Portuguese on three occasions: at the beginning, six months later and 12 months later.
      This is a list of nonadaptive behaviors (57), in the areas: Sensorial, Body and Object Use,
      Language, Social and Relating.
    

Intervention name(s): Speech Therapy
Intervention type(s): Other
Intervention description(s): Speech Therapy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism; Asperger Syndrome
Effect of UGIR in Adults With Compromised Gut Function and Malabsorption
Condition: Irritable Bowel Syndrome; Crohn Disease; Ulcerative Colitis; Celiac Disease
MeSH terms: Crohn Disease; Irritable Bowel Syndrome; Celiac Disease; Malabsorption Syndromes
Study type: Interventional

Summary: 
      This study assessed the effect of a nutrition support product on quality of life in adults
      with compromised gut function and malabsorption.
    

Detailed description: 
      This prospective, non-randomized, open-label study assessed the effect of a nutrition support
      product on quality of life in adults with compromised gut function and malabsorption. Adults
      with irritable bowel syndrome (IBS), inflammatory bowel disease (IBD) or celiac disease were
      enrolled in the study and asked to take the study product for 6 weeks. The primary measure of
      the study was a validated quality of life questionnaire, the Gastrointestinal Quality of Life
      Index (GIQLI). Secondary measures included the Inflammatory Bowel Disease Questionnaire
      (IBDQ), the Celiac Disease Questionnaire (CDQ), and the Digestive Symptom Frequency
      Questionnaire (DSFQ).
    

Intervention name(s): Nutrition Support Product
Intervention type(s): Other
Intervention description(s): Nutrition support product contains macronutrients, micronutrients, glutamine, and prebiotics. Product is in powder form (41 grams per serving) and is mixed with water or juice before consumption. Taken orally as a nutritional shake twice per day.
Other intervention name(s): UGIR
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
In-home Use Test of the New Modified Diprobase Formulation to Assess the Safety and Tolerability in Infants and Children Under Physician's Control
Condition: Atopic Dermatitis
MeSH terms: Dermatitis
Study type: Interventional

Summary: 
      To investigate the safety and tolerability of the modified Diprobase formulation over 14 days
      in infants and children with a history of Atopic Dermatitis (AD).
    


Intervention name(s): Modified Diprobase formulation (BAY987534)
Intervention type(s): Device
Intervention description(s): The modified Diprobase formulation will be applied topically twice daily over 14 days on the whole body and face.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Active Reference (Fluoxetine) Fixed-dose Study of Vortioxetine in Paediatric Patients Aged 12 to 17 Years With Major Depressive Disorder (MDD)
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluating the efficacy of vortioxetine 10 mg/day and 20 mg/day versus placebo on depressive
      symptoms in adolescents (age ≥12 and ≤17 years) with a DSM-5™ (Diagnostic and Statistical
      Manual of Mental Disorders, 5th edition) diagnosis of Major depressive disorder (MDD).
    


Intervention name(s): Vortioxetine 10 mg/day; Vortioxetine 20 mg/day; Fluoxetine 20 mg/day; Placebo
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): 10 mg/day, encapsulated tablet (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed; 20 mg/day, encapsulated tablet (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed; 20 mg/day, encapsulated tablet (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 10 mg/day. No dose increase will be allowed; Encapsulated tablet
Other intervention name(s): Brintellix ®; Lu AA21004; Brintellix ®; Lu AA21004
Intervention MeSH terms: Vortioxetine; Fluoxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: paediatric patients
Quality of Recovery Following Opioids Free Anaesthesia in Laparoscopic Sleeve Gastrectomy
Condition: Narcotics; Recovery Quality; Analgesia; Bariatric Surgery
Study type: Interventional

Summary: 
      Laparoscopic sleeve gastrectomy is widely employed nowadays. Multimodal analgesia approach is
      implemented within the enhanced recovery protocol in our facility to improve participants'
      recovery. Due to side effects of narcotics, the may adversely affect the quality of recovery,
      the investigators intended to test the efficacy of opioids free anaesthesia on the quality of
      recovery and postoperative narcotic use.
    


Intervention name(s): Fentanyl; Ketamine; Dexmedetomidine Injection [Precedex]; Oblique subcostal transversus abdominis plane block; Lidocaine
Intervention type(s): Drug; Drug; Drug; Procedure; Drug
Intervention description(s): opioids anaesthesia; ketamine induction and analgesia as opioids free anaesthesia versus opioids analgesia; alpha 2 agonist with sedative, analgesic effect; Bupivacaine 0.25% injected under ultrasound usage in the transversus abdominis plane; infusion of lidocaine 2%(1mg/kg/h)
Intervention MeSH terms: Lidocaine; Fentanyl; Dexmedetomidine; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Serotonin-receptor Agonism in Reward Processing
Condition: Anhedonia
MeSH terms: Anhedonia
Study type: Interventional
Phase: Phase 2

Summary: 
      There is growing animal and human evidence for role of 5HT1A receptor agonism in treating
      depression and reward deficits. The next step is to translate this evidence directly into
      humans by characterising the effects of buspirone, as a 5HT1A agonist, on cognitive models of
      reward and emotional processing.

      There is a paucity of behavioural evidence for the effect of 5HT1A receptor agonism, using
      buspirone as a probe, on primary reward processing (e.g. food), effort-based decision making
      or reward learning. Furthermore, the effects of 5HT1A agonism on non-emotive cognition, such
      as working memory, has yet to be investigated at a behavioural level in humans.

      This study will characterise the effects of buspirone, as a probe for 5HT1A receptor agonism,
      on reward processing in human cognitive models. Furthermore it will examine its role in
      emotional processing and working memory. This will add to the evidence base of the
      neurocognitive effects of 5HT1A receptor agonism in humans, which is of relevance to the
      development of this as a target for future treatment development.

      The study will be a double blinded, placebo controlled study involving healthy volunteers.
      Participants will receive a single dose of buspirone and then undergo a battery of
      psychometric testing to examine reward processing, emotional processing and a memory.
      Frequent monitoring of temperature and salivary cortisol shall be taken as surrogate markers
      of pre- and postsynaptic 5HT1A receptor activation.
    


Intervention name(s): Buspirone 20mg; Placebo comparator
Intervention type(s): Drug; Drug
Intervention description(s): Buspirone tablets in opaque capsule. Used as probe for 5HT1A agonism; Lactose-sucrose tablets in opaque capsule
Intervention MeSH terms: Buspirone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: 5HT1A receptor; Reward; Emotion; Memory; Buspirone
Self-operated Endo-vaginal Telemonitoring (SOET), an Economic and Patient-empowered Method for Ovarian Stimulation for In-vitro Fertilization (IVF)
Condition: IVF Treatment
Study type: Interventional

Summary: 
      The SOET project introduces a new strategy for routine follow-up of follicle growth during
      the hormonal treatment phase of an in-vitro fertilization (IVF) treatment cycle. After a
      learning instruction and demo, patients should be able to perform most of their vaginal
      echoes at home. The images can be sent to the medical center over the internet. These images
      are analyzed by the expert.
    


Intervention name(s): Perform Echo at home.
Intervention type(s): Device
Intervention description(s): A group of women that follows an IVF treatment, will perform their echoes at home, instead of always make an appointment in the clinic.
Other intervention name(s): A home echo system will be used to perform an echo.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Influenza Immunity Against Pandemic Respiratory Virus
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      Sixty adults, ages 18-49, will be randomly assigned to receive either FluMist or Fluzone.
      Some of the subjects will have participated in previous studies for these 2 vaccines. The
      study will last 4 months with subject participation being 28 days. The purpose of this study
      is to measure immune response to the vaccinations.
    

Detailed description: 
      This is a Phase 4, single-center, study of the immune responses of adults to one of two
      licensed influenza vaccines (either inactivated vaccine given IM or live, attenuated vaccine
      given intranasally). The study will enroll up to 60 adults, ages 18-49, some of whom were
      immunized in the Years 1 and 2 studies. This study began Year 1 of this grant with a protocol
      testing the two vaccine products in their age-approved populations. FluMist is approved for
      use in healthy children and adolescents, 5-17 years of age, and healthy adults 18-49 years of
      age. Fluzone is approved for all age groups starting at 6 months of age. To match for age and
      to study the youngest children possible, the age cohorts of 5-9 and 18-49 years were chosen
      for initial Year 1 study. In 2003, 70 adults and 16 children were enrolled, randomized 1:1 to
      receive either FluMist or Fluzone and immunized. In 2004, 44 of the original 70 adults were
      re-immunized with the same preparation they received in 2003. In addition, studies were
      conducted in twenty-eight 6mos to 5yo children who all received Fluzone and in thirty-nine
      5-9 yo children who were randomized 1:1 to receive either FluMist or Fluzone. For 2005, we
      propose to study in this protocol, adults from last year who agree to a third immunization
      plus as many new adults to add up to a total of 60. Blood samples will also be taken at Days
      0, 7-9 and 28 to be analyzed for CD4 and CD8 T-cell, B-cell, NK-cell and homing receptor
      responses.
    

Intervention name(s): FluMist; Fluzone
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: influenza, vaccine, respiratory virus, Fluzone, FluMist
Healthy Volunteer Positron Emission Tomography (PET) Brain Occupancy Study of a Phosphodiesterase 4 (PDE4) Inhibitor in Huntington's Disease
Condition: Huntington Disease
MeSH terms: Huntington Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate if a new experimental drug to treat Huntington's Disease gets
      into the brain. If it does get into the brain the study will explore the relationship between
      the amount of drug in the brain and the amount of drug in the blood. The study will involve
      healthy male volunteers.
    

Detailed description: 
      This is an open label, non-randomized, adaptive design PET occupancy study in healthy adult
      males. The primary aim of this study is to describe the relationship between plasma
      concentrations and brain PDE4 occupancy of GSK356278 over time. Up to 24 healthy volunteers
      may be administered single doses of GSK356278 in order to obtain 12 evaluable complete data
      sets of occupancy estimates. This study will help to optimize the dose selection for future
      clinical studies with GSK356278.
    

Intervention name(s): GSK356278; Rolipram
Intervention type(s): Drug; Drug
Intervention description(s): Investigational Medicinal Product; Challenge Agent
Intervention MeSH terms: Rolipram
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
IBD and Women's Health Wellness Program
Condition: Inflammatory Bowel Diseases; Ulcerative Colitis; Crohn Disease
MeSH terms: Crohn Disease; Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      Researchers want to understand if a combination of usual medical care along with a wellness
      program designed for women with Inflammatory Bowel Disease diagnosis will have an effect on
      quality of life, stress, and disease activity.
    

Detailed description: 
      It will take a year to complete the study and involves subjects participating in a Wellness
      program, wellness coaching and completion of surveys. Subjects will be requested to complete
      wellness classes along with one wellness coaching session within the first two months of
      study participation, and continue their year long participation of wellness coaching sessions
      and surveys.
    

Intervention name(s): Wellness Program; Wellness Coaching
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Wellness Program involves participation in classes with topics involving resiliency, stress, physical activity, and nutrition to be completed within a few months of study participation; Wellness coaching sessions throughout 12 months of study participation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Microcirculatory Mapping of the Aging Hand and Foot
Condition: Cutaneous Microcirculation in Vascular Diseases
MeSH terms: Vascular Diseases
Study type: Observational

Summary: 
      Currently, dorsal hand rejuvenation is an upcoming issue as patients seek plastic surgeons to
      address this highly visible area, although no specific statistics concerning the number of
      patients undergoing dorsal hand rejuvenation have been published yet. The solitary use of
      fillers, fat, sclerotherapy, skin excision, resurfacing and combinations of the above
      mentioned therapies have been reported in the literature, but still there is a lack of
      scientific literature about functional microcirculation of the dorsum of the hand.

      Furthermore, there is a lack of scientific data about functional microcirculation of the
      plantar foot in healthy subjects compared to patients suffering from Diabetes mellitus or
      peripheral arterial occlusive disease. Consequently, the aim of this study is the evaluation
      of the functional microcirculation of hands and feet in healthy subjects as well as patients
      suffering from the above mentioned diseases.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Both healthy subjects and patients suffering from diabetes mellitus or manifested
        peripheral arterial occlusive disease
Respiratory Physiotherapy and Neurorehabilitation in Patients With Post-covid19 Sequelae.
Condition: COVID-19 Pandemic
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      The objectives are to reduce dyspnoea, increase exertional capacity, increase vital capacity
      and respiratory muscle strength.

      vital capacity and respiratory muscle strength. In addition to increasing the sensibility of
      smell and taste, observing if there is a relationship between the decrease of these senses
      with the senses with appetite and whether appetite has normalised in post-SARS-CoV-2
      patients. It is a randomised and blinded experimental study with a control group where the
      sample recruited will be 30 patients, with a range of of 30 patients, with an age range of
      19-42 years, where they carried out an assessment of spirometry, modified Borg dyspnoea
      scales and modified Medical Research Council (MMRC), Singapure (MMRC), Singapore Smell and
      Taste Questionnaire (SSTQ) and weekly smell and taste questionnaire.

      taste questionnaire.
    


Intervention name(s): respiratory treatment
Intervention type(s): Other
Intervention description(s): Respiratory treatment based on aerobic exercise and treatment of the musculature to reduce dyspnoea and increase the capacity for exertion, neurorehabilitative treatment focusing on the sense of smell and taste to on the sense of smell and taste to increase sensitivity in post Covid-19 subjects.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: coronavirus; physiotherapies techniques; physiotherapies specialty; agnosia for taste; breathing exercises