bioihbjkbjnl/mcl2 huggingface dataset:
Virtual Reality VAlidation Tool for Cognitive Rehabilitation, Oriented Project for People With Psychosocial Disabilieties
Condition: Mood Disorders
MeSH terms: Mood Disorders
Study type: Interventional

Summary: 
      Randomized controlled open-label cross-over clinical feasibility study with waiting list, 60
      people will be recruited from the Consultation and Psychosomatic Psychiatry Center of the
      University Hospital of Cagliari (San Giovanni di Dio Civil Hospital) with a diagnosis of
      mental disorder. The investigators propose a VR intervention of 3 months with 2 weekly
      session of CEREBRUM (cognitive remedy intervention with virtual reality) first to the group A
      and then to the group B.
    

Detailed description: 
      Background: Cognitive remedial interventions have been found to be effective in the treatment
      of various psycho-social disorders. The use of Virtual reality as a rehabilitation tool has
      been showing various scientific evidences in recent years like in cardiovascular,
      neurological and musculoskeletal rehabilitation. In mental health evidence they seem to be
      concentrated in the rehabilitation of social cognition in people with schizophrenia diagnosis
      and psychotherapy. The aim of this study is to evaluate the feasibility and the effectiveness
      of the first Cognitive Remedial toll in Virtual Reality (CEREBRUM) for people that has
      experienced in mental health.

      Methods: Randomized controlled open-label cross-over clinical feasibility study with waiting
      list, 60 people will be recruited from the Consultation and Psychosomatic Psychiatry Center
      of the University Hospital of Cagliari (San Giovanni di Dio Civil Hospital) with a diagnosis
      of mental disorder. The investigators propose a intervention of 3 months with 2 weekly
      session of CEREBRUM first to the group A and then to the group B
    

Intervention name(s): Cognitive remedy intervention with virtual reality (CEREBRUM)
Intervention type(s): Device
Intervention description(s): Cognitive Remedial method Virtual Reality (CEREBRUM)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized controlled open-label cross-over clinical feasibility study with waiting list
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Virtual Reality; Remediation; Mental Health; Recovery
MSCs Source of Sweat Gland Cells of Large Area Skin Injury Patients Transplant of the Wound
Condition: MSCs
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this test is to assess the umbilical cord mesenchymal stem cells (MSCs)
      UC between source sample sweat gland cells wound transplanted effectiveness and safety for
      the treatment of large area skin lesions of the subjects
    


Intervention name(s): MSCs
Intervention type(s): Biological
Intervention description(s): The main purpose of this test is to assess the umbilical cord MSCs between source sample sweat gland cells wound transplanted effectiveness and safety for the treatment of large area skin lesions of the subjects
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults With Oral Corticosteroid Dependent Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Reducing Oral
      Corticosteroid Use in Adults with Oral Corticosteroid Dependent Asthma
    

Detailed description: 
      A Multicentre, Randomized, Double-Blind, Placebo Controlled, Phase 3 Study to Evaluate the
      Efficacy and Safety of Tezepelumab in Reducing Oral Corticosteroid Use in Adults with Oral
      Corticosteroid Dependent Asthma
    

Intervention name(s): Tezepelumab; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Tezepelumab subcutaneous injection; Placebo subcutaneous injection
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized in a 1:1 ratio to either tezepelumab or matching placebo both administered subcutaneously
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Asthma
A Research Study Comparing Blood Levels of Medicines NNC0194-0499 and Semaglutide Administered as a Combination Formulation Versus Two Separate Formulations
Condition: Non-alcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Novo Nordisk is developing a combination of 2 medicines (NNC0194-0499 and semaglutide) for
      the treatment of nonalcoholic steatohepatitis (NASH). NASH is a serious disease where fat,
      inflammation and scar tissue builds up in the liver. NNC0194-0499 is a new medicine which
      works in the liver. Semaglutide is a well-known medicine, which is already used to treat type
      2 diabetes and obesity. The study is being done to see how 2 medicines (NNC0194-0499 and
      semaglutide) are absorbed, transported, and eliminated from the body in a combination
      formulation. Participants will either get NNC0194-0499 and semaglutide in a combination
      formulation or the separate formulations. Which treatment participants get is decided by
      chance. The study will last for either 13 or 33 weeks. The duration is decided by chance.
    


Intervention name(s): NNC0194-0499; Semaglutide; NNC0194-0499/Semaglutide A (40/3.20 mg/mL); NNC0194-0499/Semaglutide A (40/0.33mg/mL)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): NNC0194-0499 will be administered subcutaneously once weekly.; Semaglutide will be administered subcutaneously once weekly.; NNC0194-0499/Semaglutide A (40/3.20 mg/mL) co-formulation product will be administered subcutaneously once weekly.; NNC0194-0499/Semaglutide A (40/0.33mg/mL) will be administered subcutaneously once weekly.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Active School. A School-based Intervention to Increase Childrens Daily Physical Activity Level.
Condition: Physical Activity; Aerobic Fitness; Executive Function
Study type: Interventional

Summary: 
      This study seeks to explore whether increased physical activity in school affects children's
      executive function, aerobic Fitness and childrens self-regulation. The "Active school" study
      was a 10-month randomized controlled trial. The sample included 449 children (10-11 years
      old) in five intervention and four control schools. The weekly interventions were 2×45
      minutes physically active academic lessons, 5×10 minutes physically active breaks, and 5×10
      minutes physically active homework. Aerobic fitness was measured using a 10-minute interval
      running test. Executive function was tested using four cognitive tests (Stroop, verbal
      fluency, digit span, and Trail Making). A composite score for executive function was computed
      and used in analyses.

      Self-regulation was measured by the Child Behavior Rating Scale.
    


Intervention name(s): Physical activity
Intervention type(s): Behavioral
Intervention description(s): The "Active school" study was a 10-month randomized controlled trial.The weekly interventions were 2×45 minutes physically active academic lessons, 5×10 minutes physically active breaks, and 5×10 minutes physically active homework.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Behavioral; Physical activity; Intervention; School children
The Clinical Trial to Evaluate the Efficacy and Safety of Luphere Depot Inj. 3.75mg(Leuprolide Acetate 3.75mg) in Patients With Precocious Puberty
Condition: Central Precocious Puberty
MeSH terms: Puberty, Precocious
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this Clinical Trial was to Evaluate the Efficacy and Safety of Luphere Depot
      Inj. 3.75mg(Leuprolide acetate 3.75mg) in patients with precocious puberty.
    


Intervention name(s): Luphere depot 3.75mg(Leuprolide acetate 3.75mg)
Intervention type(s): Drug
Intervention MeSH terms: Leuprolide
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pain Associated With Endometriosis
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy and safety of an investigational medication compared
      with placebo in the treatment of pain associated with endometriosis.
    


Intervention name(s): Danazol Once Weekly; Danazol Twice Weekly; Placebo Once Weekly; Placebo Twice Weekly
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): semi-solid; semi-solid; semi-solid; semi-solid
Intervention MeSH terms: Danazol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Assess the Mass Balance Recovery and Metabolite Profile & Identification of [14C]-APX001 in Healthy Males
Condition: Fungal Infection
MeSH terms: Mycoses
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, open-label, non-randomized, single dose study in healthy male
      subjects. It was planned to enroll 2 cohorts of 5 subjects (10 subjects in total), with the
      target of achieving data in 4 evaluable subjects per cohort. Five subjects were to receive a
      single oral dose of APX001 and not more than (NMT) 3.1 megabecquerel (MBq) (84.0 microcurie
      [μCi]) 14C in the fed state. Five subjects were to receive a single IV administration
      containing APX001 and NMT 3.4 MBq (93.0 μCi) 14C in the fed state.
    


Intervention name(s): [14C]-APX001 Oral Solution; [14C]-APX001 Solution for Infusion
Intervention type(s): Drug; Drug
Intervention description(s): Total dose containing NMT 3.1 MBq (84.0 µCi) 14C; Total dose containing NMT 3.4 MBq (93.0 µCi) 14C
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Influence of the Sensory Profile of Deaf Children With Autism Spectrum Disorders on the Outcome of Cochlear Implantation
Condition: Deafness
MeSH terms: Deafness; Autism Spectrum Disorder
Study type: Observational

Summary: 
      An unpublished study conducted at Toulouse University Hospital revealed that 30% of implanted
      children with Autism Spectrum Disorders abandon their implant, while 70% of them keep it. The
      aim of this study is to evaluate the causes of this disparity, which is much greater than in
      children with cochlear implants without associated Autism Spectrum Disorders. Our problem is
      as follows: do the sensory hypersensitivity and hyposensitivity of deaf children with Autism
      Spectrum Disorders have an effect on the expected results after a cochlear implantation from
      a language and auditory reaction point of view?
    

Detailed description: 
      The present study will specifically focus on the sensory profile of these children with
      Autism Spectrum Disorders, which could be the cause of these developmental difficulties in
      language and communication development.
    

Intervention name(s): Dunn's sensory profile questionnaire
Intervention type(s): Other
Intervention description(s): all children will complete the Dunn Sensory Profile questionnaire
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study population is deaf children with cochlear implant. In the first group, children must
        have cochlear implant and autism spectrum disorders, and in second group, children must
        have only cochlear implant.
Left Atrial Volume and Function Evaluation in Patients With Obstructive Sleep Apnea
Condition: Sleep Apnea Syndromes
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Observational

Summary: 
      The purpose of this study is to determine whether patients with obstructive sleep apnea have
      any changes in left atrial morphology and function evaluated by echocardiography three
      dimensional
    

Detailed description: 
      Several studies have been suggesting that Obstructive Sleep Apnea contributes to
      deterioration of left ventricular diastolic function . It may lead to atrial myocardium
      stretching and enlargement which may be associated to increased risk of cardiovascular
      events. We hypothesized that morphological and functional LA changes might be found using
      three dimensional echo, and that such alterations are related to obstructive sleep apnea
      presence.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The investigators recruited 56 recently diagnosed OSA patients, confirmed by full
        polysomnography (PSG), referred to Sleep Laboratory of Psychobiology Department of Federal
        University of Sao Paulo, Brazil, according to the following inclusion criteria: both
        genders aging from 29 to 70 years old, with apnea-hypopnea index (AHI) >5 events/hour of
        sleep. Control group comprised 50 healthy community subjects without OSA confirmed by full
        PSG, matched by age, gender, and BMI.
      
Keywords: Sleep Apnea Syndromes diastolic disfunction left atrium
Study of FAECC Scale (Modified FLACC) to Evaluate Ear Pain in Children With Acute Otitis Media
Condition: Pain; Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is to assess the reliability and validity of the FAECC scale to evaluate pain
      associated with acute otitis media in children aged 2 months to 5 years.
    

Detailed description: 
      to assess the reliability and validity of the FAECC pain scale tool in children aged 2 months
      to 5 years with acute otitis media given AR01 or placebo
    

Intervention name(s): benzocaine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): benzocaine 10 mg/mL, five drops in affected ear canal each hour as needed; placebo solution, five drops in affected ear canal each hour as needed
Other intervention name(s): Arbor otic; AR01
Intervention MeSH terms: Benzocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: pain; pain measurement; ear, middle; otitis media
Training in the Workplace
Condition: Healthy Individuals
Study type: Interventional

Summary: 
      We are testing whether various cognitive training procedures can enhance cognition and brain
      function
    


Intervention name(s): Program 1; Program 2
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Carbohydrates and Children
Condition: Carbohydrate Metabolism
Study type: Interventional

Summary: 
      This study will evaluate the impact of test carbohydrate blends on fat and carbohydrate
      oxidation, glucose, insulin and hunger scores in pre-adolescent boys and girls.
    


Intervention name(s): Control; Experimental
Intervention type(s): Other; Other
Intervention description(s): control carbohydrate blend; experimental carbohydrate blend
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Phase 1 Clinical Trial of the Safety and Immunogenicity of an Adenovirus-based TB Vaccine Administered by Aerosol
Condition: Tuberculosis
MeSH terms: Tuberculosis; Adenoviridae Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1 study, in healthy volunteers who have previously been immunized with
      bacilli Calmette Guerin (BCG), to evaluate the safety and immune responses that develop in
      the blood and lungs following the administration by aerosol of a new experimental
      adenovirus-based vaccine for tuberculosis (TB), Ad5Ag85A.
    

Detailed description: 
      This is a phase 1, open label study to evaluate the safety and immunogenicity of a single
      administration of one of two doses of a recombinant replication deficient human adenoviral
      (Ad5) TB vaccine containing the immunodominant antigen Ag85A delivered to the respiratory
      tract by aerosol in healthy volunteers with a history of BCG immunization.

      28 healthy volunteers will be enrolled. The first cohort (n=8) will receive a lower dose of
      vaccine using the AeroNeb Solo Vibrating Mesh Nebulizer. For the second cohort (n=20)
      participants will be randomized to either a higher dose of vaccine by aerosol (n=10) or
      intramuscular administration (n=10). Cellular immune responses in the lung and peripheral
      blood will be evaluated
    

Intervention name(s): Ad5Ag85A
Intervention type(s): Biological
Intervention description(s): Aerosol administration of Ad5Ag85A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Tuberculosis; Vaccine; Aerosol; Adenovirus; Immunogenicity
Effect of Stellate Ganglion Block Combined With Facial Nerve Block on the Treatment of Idiopathic Facial Paralysis
Condition: Peripheral Facial Palsy
MeSH terms: Bell Palsy; Ganglion Cysts; Facial Paralysis; Paralysis; Facies
Study type: Interventional

Summary: 
      Peripheral facial palsy is caused by damage to the facial nerve at any site of the peripheral
      branches after the facial nucleus.Stellate ganglion block is performed to treat peripheral
      facial palsy because it increases blood flow and promotes nerve regeneration.Facial Nerve
      Block worked with elimination of local inflammation of nerve and oppression. Facial nerve
      block is a treatment that inject drugs into the damaged nerve around to eliminate local
      inflammation and compression of the nerve.
    


Intervention name(s): Stellate Ganglion Block; Facial Nerve Block; Mecobalamin Tablets
Intervention type(s): Procedure; Procedure; Drug
Intervention description(s): Patients underwent a stellate-ganglion block at the anterolateral aspect of the C6 vertebra. After local analgesia (lidocaine 2%), a 22-gauge Quincke needle was placed in the anterolateral aspect of the C6 vertebral body. When the needle contacted the bone, it was drawn back 1 mm. 5 mL of 0·5% ropivacaine was subsequently injected next to the stellate ganglion to produce a sympathetic block.The effect of the stellate-ganglion block on the sympathetic nervous system was confirmed by the presence of Horner's syndrome (ie, facial anhydrosis, enophthalmos, ptosis, swelling of the lower eyelid, miosis, and blood-shot conjunctiva), and an increase in the temperature of the right hand of at least 2°F from baseline.; Operator touching the location of the mastoid, in the external auditory canal just below the front of the mastoid vertical needling.When touch the surface of the mastoid,adjust the needle across the front of the mastoid then slow needling about 1cm.The pin located below the stylomastoid foramen, and then injected drugs 5mL ( mecobalamin injection 1mg；lidocaine 60mg； dexamethasone 10mg ); oral Mecobalamin Tablets tid-8
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Peripheral Facial Palsy; Stellate Ganglion Block; Facial Nerve Block
Vaginal Ovule With Flavonoid Tea Extract for the Correction of Imbalance in the Vaginal Environment
Condition: Vaginosis, Bacterial; Vaginal Flora Imbalance
MeSH terms: Vaginosis, Bacterial
Study type: Interventional

Summary: 
      Randomized, blinded vehicle-controlled multicenter clinical trial (MAT072017) to determine
      the effect of vaginal ovules containing 2 mg of the tea extract Matuzalem on the subjective
      symptoms (5-point scale pruritus (itching), dolor (pain), rubor (redness), fluor (discharge),
      and fetor (odor)), and objective symptoms (pH, Nugent score) of bacterial vaginosis. An ovule
      containing only the vehicle (polyethylene glycol 3000 S) was used as a control. The study was
      blinded from the perspective of the subject, investigator, laboratory personnel and data
      analyst.
    

Detailed description: 
      The objective was to determine whether vaginal ovule with tea extract once-daily for 5-7 days
      improves symptoms of intermediate vaginal flora and prevents the development of bacterial
      vaginosis.

      Composite primary endpoint designed as a drop in the Nugent score, vaginal pH, or improvement
      of subjective symptoms was compared between the active and vehicle (polyethylene-glycol) arm
      after 7 days of application and following 7 days after the application.

      Secondary outcome measures were (1) Correction of the vaginal environment (as previously
      defined) 7 days after the completion of the prescribed 7-day regimen (day 14); (2) change in
      each parameter separately; (3) change in individual subjective symptoms, (4) exploratory
      analysis of the microbial environment at each subject visit.

      The study was approved and supervised by the National authority and Ethics committee and
      prospectively registered in the Czech national medical device trial registry RZPRO and the
      European medical device trial registry EUDAMED.
    

Intervention name(s): Matuzalem ovule; Vehicle ovule
Intervention type(s): Device; Device
Intervention description(s): vaginal ovule with 2 mg tea extract; polyethylene glycol vaginal ovule
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: vehicle-controlled two-arm
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Tea; Polyphenols; Nugent score; Antioxidants; Vaginal pH; complementary medicine
Randomized, Controlled Trial of an Intervention for Preschool Children With Autism: TEACCH
Condition: Autism Spectrum Disorder
MeSH terms: Autism Spectrum Disorder
Study type: Interventional

Summary: 
      This study is design to evaluate the efficacy of the Treatment and Education of Autistic and
      Communication Handicapped Children (TEACCH) on the rehabilitation for preschool children with
      autism spectrum disorders (ASD) in China.A case-randomized controlled study was
      conducted.Sixty children diagnosed with ASD between 36 and 90 months of age were randomly
      assigned to the a TEACCH intervention group or a control group.The control group was
      subjected to regular rehabilitation training, the TEACCH group carried out TEACCH training
      besides regular rehabilitation training for 6 months. Chinese Version of Psycho-educational
      Profile-3rd edition (CPEP-3) was used to evaluate the effectiveness of TEACCH rehabilitation
      training.
    

Detailed description: 
      Statistical analysis plan:The results were analyze using descriptive, t-test and ANOVA.
    

Intervention name(s): TEACCH
Intervention type(s): Behavioral
Intervention description(s): The Treatment and Education of Autistic and Communication Handicapped Children
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: TEACCH