bioihbjkbjnl/mcl2 huggingface dataset:
The Effect Of Immersive Virtual Reality Application On Anxiety, Pain And Family Satisfaction In The Perioperative Process Of Children
Condition: Anxiety; Pain; Satisfaction
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      An immersive virtual reality (VR) tour of the operating theater before surgery could reduce
      preoperative anxiety. The aims of this study were to analyze whether a preoperative virtual
      reality tour shows a reduction in anxiety in children and an increase in parental
      satisfaction.
    

Detailed description: 
      Children who will undergo surgery for the first time and their families were randomly
      allocated into the control or VR group. The control group received conventional education
      regarding the perioperative process of surgery. The VR group watched a 1.5-minute VR video
      showing the operating theater and explaining the perioperative process. The main finding was
      preoperative anxiety evaluated using the Children's State Anxiety (CSA) before surgery.
      Secondary findings included children's postoperative pain ratings using Wong-Baker Faces Pain
      Rating Scale and parental satisfaction scores using PedsQL Health Care Satisfaction Scale
    

Intervention name(s): Virtual reality
Intervention type(s): Device
Intervention description(s): Immersive virtual reality tour of the operating theatre before surgery and distraction methods both using VR headset
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Anxiety; Pain; Parental Satisfaction; Virtual Reality
A Study of Equivalence of Generic Ingenol Mebutate Gel 0.05% and Picato Gel 0.05% in Subjects With Actinic Keratosis
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study was to evaluate the safety and therapeutic equivalence of generic
      ingenol mebutate gel, 0.05% to Picato gel, 0.05% and to establish the superiority of the
      efficacy of these two products over the vehicle gel in the treatment of Actinic Keratosis
      (AK) on the trunk or extremities.
    

Detailed description: 
      Picato® (ingenol mebutate) gel is the first and only ingenol mebutate product approved by the
      FDA in 2012 for the topical treatment of AK(s) on the face and scalp (0.015% formulation) and
      on the trunk and extremities (0.05% formulation). A generic ingenol mebutate gel, 0.05% has
      been developed for the topical treatment of clinically typical, visible, and discrete
      non-hyperkeratotic, non-hypertrophic AK lesions of the trunk or extremities.
    

Intervention name(s): Ingenol Mebutate (Picato®); Generic Ingenol Mebutate; Vehicle Foam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Brand product; Generic formulated to have the same therapeutic effect of the brand; It does not contain active ingredient. A placebo to test the sensitivity of the active treatments.
Other intervention name(s): Picato; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
To Compare the Efficacy and Safety of Tripterygium Wilfordii (TW) Versus Valsartan in the Membranous Nephropathy (MN)
Condition: Membranous Nephropathy
MeSH terms: Kidney Diseases; Glomerulonephritis, Membranous
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the efficacy of TW compared to Valsartan in treatment
      of heavy proteinuria of membranous nephropathy.
    

Detailed description: 
      Membranous nephropathy with heavy proteinuria have high risks of progressing to CRF.

      Tripterygium (TW) is a Chinese traditional patent drugs, it can reduce proteinuria of chronic
      glomerular nephritis,such as IgA nephropathy. So, we designed this randomized, prospective
      clinical trial to assess the efficacy and safety of TW versus Valsartan in the treatment of
      heavy proteinuria of MN.
    

Intervention name(s): TW
Intervention type(s): Drug
Intervention description(s): TW,120mg/d
Other intervention name(s): TW,Tripterygium wilfordii Hook.f
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TW; Valsartan; treatment; membranous nephropathy; proteinuria
Intralesional PV-10 Chemoablation of Metastatic Melanoma
Condition: Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to investigate the safety of intralesional (IL) PV-10 for the
      treatment of metastatic melanoma. This study will also include a preliminary assessment of
      response of treated and untreated lesions by clinical evaluation at follow-up of 12 to 24
      weeks following IL PV-10 treatment.
    

Detailed description: 
      This is a two center, open label, ascending dose study. Subjects with at least two measurable
      melanoma lesions will receive a single intralesional injection of 10% PV-10 solution into
      each of one to twenty (20) target lesions. Additionally, one to three measurable untreated
      non-target lesions will be followed for assessment of bystander response. Systemic and
      locoregional adverse events will be monitored over the study interval. Dose escalation will
      be made only if no subjects at the first dose level have a Grade 3 non-hematological or Grade
      4 hematological toxicity over a period of two weeks after PV-10 administration. Subject
      accrual and PV-10 administration at the second dose level will be stopped if more than 1
      subject has a treatment related Grade 3 non-hematological or Grade 4 hematological toxicity
      within a period of two weeks after PV-10 administration.
    

Intervention name(s): PV-10 (rose bengal disodium, 10%)
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stage III and IV melanoma
Exercise Training and Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The present study aimed to determine the effects of 16 weeks of aerobic interval training on
      quality of life and a set of clinical biomarkers.
    

Detailed description: 
      Besides the traditional metabolic syndrome risk factors (dyslipidemia, raised blood pressure,
      central obesity and dysglycemia) subclinical disorders related to chronic inflammation and
      cell damage have been reported on metabolic syndrome. Therefore, regarding the systemic
      feature of metabolic syndrome, we investigated an new approach of aerobic interval training
      on several clinical biomarkers widely used. Such training used differs from current aerobic
      protocols in order to attenuate metabolic and musculoskeletal overload on untrained and
      unhealthy subjects.
    

Intervention name(s): Aerobic interval training
Intervention type(s): Behavioral
Intervention description(s): Carried out 3 times per week for 16 weeks
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: aerobic interval training; biomarkers
Functional Study to Investigate the Efficacy of a New Medical Device (Modified Diprobase Formulation)
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional

Summary: 
      This clinical trial is intended to investigate the efficacy and safety of a medical device
      compared to untreated on patients with quiescent atopic dermatitis.
    


Intervention name(s): BAY987534
Intervention type(s): Device
Intervention description(s): Form: cream; Route of Administration: topical; Frequency of Administration: twice daily ; Duration of Treatment: 4 weeks .
Other intervention name(s): modified Diprobase formulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Phenomenology of Anxiety in Preschool Children With ASD
Condition: Anxiety; Autism Spectrum Disorder
MeSH terms: Anxiety Disorders; Autistic Disorder; Autism Spectrum Disorder
Study type: Observational

Summary: 
      This study investigates the prevalence, phenomenology, and correlates of anxiety in preschool
      children with autism spectrum disorder (ASD) across a two-year period. Attention bias to
      threat, a potential objective marker of anxiety, also is examined using eye tracking methods.
    

Detailed description: 
      Anxiety disorders in children with autism spectrum disorders (ASD) are one of the most
      prevalent and impairing co-occurring conditions, affecting approximately 40% of the
      population and causing major disruptions in school and family life. Research in typically
      developing (TD) children suggests that anxiety usually emerges in the preschool years (3-5
      years) and can result in future psychopathology. Early detection and treatment of childhood
      anxiety in children with ASD can lead to improved clinical outcomes.

      This study assesses the prevalence and phenomenology of anxiety in preschool children with
      ASD utilizing an established and comprehensive measure of anxiety in children with ASD across
      three time points (baseline, one year post, two years post).It also investigates the
      association of child (e.g., ASD features) and parent (e.g., mental health, caregiver strain)
      characteristics with anxiety cross-sectionally and longitudinally, to determine if certain
      correlates predict or maintain future anxiety. Attention bias to threat stimuli and its
      physiological correlates are also examined as potential objective markers of anxiety using
      eye tracking and pupillometry methods.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Clinical and community based sample
      
Keywords: Autism; Anxiety; Eye tracking; Preschool
Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia
Condition: Tardive Dyskinesia
MeSH terms: Dyskinesias; Tardive Dyskinesia
Study type: Interventional
Phase: Phase 3

Summary: 
      This Phase 3b, rollover study will provide participants who completed a Phase 3 valbenazine
      (NBI-98854) study open-label access to valbenazine (fixed doses administered once daily) for
      the treatment of adults with TD until valbenazine is anticipated to be available commercially
      or they complete 72 weeks of treatment. This study will allow enrollment of up to 150
      medically stable male and female participants with TD who previously participated in and
      completed the NBI-98854-1304 (Kinect 3) or NBI-98854-1402 (Kinect 4) Phase 3 study.
    

Detailed description: 
      This study was terminated after 60 weeks due to the commercial availability of valbenazine.
    

Intervention name(s): Valbenazine
Intervention type(s): Drug
Other intervention name(s): NBI-98854
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Short Implants - An Alternative to Bone Grafting?
Condition: Jaw, Edentulous, Partially
MeSH terms: Jaw, Edentulous; Jaw, Edentulous, Partially
Study type: Interventional

Summary: 
      The study, with the ASTRA TECH Implant System, is comparing short implants (OsseoSpeed™) to
      standard length implants (OsseoSpeed™) in combination with bone grafting. The hypothesis is
      that the use of short implants in posterior maxilla with inadequate bone is as safe and
      predictable as placing standard length implants in combination with bone augmentation.
    

Detailed description: 
      This study was designed as an open, prospective, randomized, controlled, multicenter, 5-year
      follow-up investigation evaluating the outcome of treatment with the OsseoSpeed™ implant 6 mm
      placed in the posterior maxilla compared to treatment with OsseoSpeed™ implant 11, 13 or 15
      mm placed after bone grafting. The study was during the conduct of the study amended to
      include a 10-year extension cohort.
    

Intervention name(s): ASTRA TECH Implant System, OsseoSpeed™ 4.0 S (length: 6 mm); ASTRA TECH Implant System, OsseoSpeed™ implants (lengths: 11, 13, 15 mm) in combination with bone grafting
Intervention type(s): Device; Device
Intervention description(s): ASTRA TECH Implant System, OsseoSpeed™ 4.0 S (length: 6 mm); ASTRA TECH Implant System, OsseoSpeed™ implants (lengths: 11, 13, 15 mm) in combination with bone grafting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Transforming Nanoparticle Dressing For Management of Chronic Venous Ulcers
Condition: Chronic Venous Hypertension With Ulcer
MeSH terms: Varicose Ulcer; Ulcer
Study type: Interventional
Phase: Phase 4

Summary: 
      The present randomized controlled study aims to evaluate the role of transforming
      nanoparticle dressing n management of chronic venous ulcers.
    

Detailed description: 
      The present randomized controlled study was conducted at Helwan University Hospitals, Cairo,
      Egypt. The study protocol was approved by the local ethical committee and all patients gave
      informed consent before enrollment.

      The study included 60 patients with CVU. Patients were diagnosed on the basis of clinical
      findings and vascular Doppler ultrasonography. Exclusion criteria were associated infection
      and associated ulcers of other etiologies. Patients randomization was achieved using computer
      generated numbers and sealed envelope technique. Randomization and patients' allocation to
      the study interventions was performed by an independent researcher who wasn't aware of the
      study interventions and outcome.

      Upon recruitment, patients were subjected to careful history taking, thorough clinical
      examination, standard laboratory investigations and vascular ultrasound examination. The
      recorded parameters included demographic data (age, sex and body mass index), associated
      morbidities, duration and size of CVU and history of previous interventions.

      After randomization, patients in the treatment group (n=30) had transforming nanoparticle
      dressing while the control group (n=30) received conventional compression dressing. Before
      applications of both dressings, the wound area was thoroughly cleaned. In the treatment
      group, the dressing powder was applied as a thin layer to the ulcer surface. Any excess
      powder surrounding the ulcer area was removed. In both groups, a secondary protective gauze
      dressing was applied. Patients were follow up at weekly intervals until complete healing
      occurs.

      The primary end-point in the present study is the time to complete healing. The secondary
      end-point the rate of healing (percent of reduction in ulcer area).
    

Intervention name(s): Transforming nanoparticle dressing; Conventional compression dressing
Intervention type(s): Combination Product; Combination Product
Intervention description(s): Transforming nanoparticle dressing; Conventional compression dressing
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Cardiac Autonomic Functions During Head-out Immersion and During Head Down Tilt
Condition: Healthy
Study type: Interventional

Summary: 
      Head down tilt (HDT) was widely used to simulate microgravity effects on cardiovascular
      system. HDT could be a suitable model of water immersion (WI) which is also used to simulate
      the cardiovascular effects of microgravity and which is not easy to study in laboratory. To
      define the possibility to simulate immersion by HDT, a comparison between these models is
      required. A comparison between WI and few angles during HDT seems necessary to understand
      which angle is more adapt.

      The immersion induces an increase of the central blood volume. This increase is caused by a
      redistribution of blood from peripheral portions of the body to the intrathoracic
      circulation. It seems to load cardiopulmonary and arterial baroreceptors. These baroreceptors
      bring into play autonomic nervous system (ANS) activation and induce a bradycardia.

      HDT induces an increase in central blood volume as supported by the central venous pressure
      and cardiac volume increase and in return, MSNA and heart rate decrease. These cardiovascular
      effects seem to be the same as the thermoneutral immersion and suggest that the ANS
      activation is the same during HDT and WI.

      Nevertheless, a few previous studies about ANS in HDT indicate some discordant results: a
      sympathetic decrease was reported but several results show an increase of parasympathetic
      activity linked with a trend of increase of arterial baroreflex. The aim of this study is to
      assess ANS activity in HDT on different angles (-6° and -15°) and WI. The investigators
      suppose an increase of parasympathetic activity during WI corresponding to parasympathetic
      activation during HDT especially at -6°.
    


Intervention name(s): Head-down tilt and immersion
Intervention type(s): Other
Intervention description(s): Head-down tilt -6° at inclusion, head-down tilt -15° at week one and Water Immersion at week two
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Autonomic nervous system; Immersion; Heart rate variability; Head-down tilt; Healthy volunteers
The Effect of Omega 3 on 25 Hydroxyvitamin D
Condition: 25-hydroxyvitamin D Levels
Study type: Interventional

Summary: 
      The effect of omega 3 fatty acid on serum 25-hydroxyvitamin D levels.
    

Detailed description: 
      No data are available on the effect of omega 3 on serum 25-hydroxyvitamin D levels in
      Jordanian men and women.

      This study was designed to investigate whether omega 3 supplementation has a potential effect
      on the reducing of serum 25-hydroxyvitamin D levels.

      This randomized, placebo-controlled clinical trial (RCT) was designed to evaluate 300 mg
      omega-3FA daily for 2 months on serum levels of 25-hydroxyvitamin D levels. This RCT will be
      conducted on 80 to 90 Jordanian men and women aged 22 to 66 years. Baseline and follow-up
      levels for 25-hydroxyvitamin D (25OHD), parathyroid hormone (PTH), calcium, phosphate, liver
      and kidney functions will be assayed.
    

Intervention name(s): Dietary Supplement: Omega3-FA
Intervention type(s): Dietary Supplement
Intervention description(s): Dietary Supplement: Omega3-FA 300 mg of omega3-FA once daily for 8 weeks
Other intervention name(s): n-3FA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: omega 3; 25 hydroxyvitamin D; 25OHD; Vitamin D
Administration of Expanded Autologous Adult Bone Marrow Mesenchymal Cells in Established Chronic Spinal Cord Injuries
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to analyze the potential clinical efficacy of intrathecal
      administration, in the subarachnoid space, of in vitro expanded autologous adult bone marrow
      mesenchymal stem cells in the treatment of patients with established chronic spinal cord
      injury (LEM).
    

Detailed description: 
      This is a clinical trial phase II, single-center, non-randomized, uncontrolled, open
      prospective follow-up of a cohort of patients with chronic spinal cord injury.

      Patients are treated with repeated administrations of in vitro expanded autologous adult bone
      marrow mesenchymal stem cells.

      The expanded cells are administered in the subarachnoid space by lumbar puncture. The minimum
      duration of the follow-up period for each patient is 10 months after the first
      administration.

      The study duration is 24 months, that include recruiting, treatment and follow period for all
      patients. For each patient at the first day will be administered the first cellular doses,
      then 3 doses will be administrated every 3 months. At the end of the clinical trial, a
      completed check of all obtained parameters will be performed.

      It is considered Day 1 for each patient the first day of the first cell administration. The
      remaining 2 doses will be administered at intervals of 3 months from the first administration
      (of the treatment period after, months 4 and 7). At the end of the study will be performed a
      full assessment of the variables collected along the study trial.
    

Intervention name(s): Autologous Mesenchymal Bone Marrow Cell
Intervention type(s): Biological
Intervention description(s): Suspension in autologous plasma cell of Adult mesenchymal stem cells expanded autologous bone marrow.
Route of administration: Intrathecal in subarachnoid space by lumbar puncture.Total dose of 300 x 106 CME, divided in 3 injections of 100 x 106 CME, with intervals of three months between each administration
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adult Autologous Bone Marrow Mesenchymal Cells Expanded; chronic spinal cord injury (SCI)
Genetic Variation - The Need for Opioids During Surgery
Condition: Pain
Study type: Interventional

Summary: 
      The purpose of this study is to find out if the tetanic noxious stimuli and the measured skin
      conductance response can be used as a test in patients before surgery to have an indication
      about what amount of analgesics the patient will need during surgery.
    

Detailed description: 
      Skin Conductance (SC) shows the emotional state as reflected in changes in the sympathetic
      nervous system. During sleep or other states of low basic sympathetic activity, activation of
      the sympathetic nervous system results in filling of the palmar and plantar sweat glands, and
      the SC increases transiently before the sweat is removed and the SC decreases again. When a
      short lasting outgoing sympathetic nervous burst occurs, fluctuations of SC will follow. An
      increase in the number of SC fluctuations (NSCF) can therefore be interpreted as increased
      activity in this part of the sympathetic nervous system. When remifentanil, an opioid
      analgetic is given, NSCF is reduced.

      Genetic variation influences the pharmacokinetics and the pharmacodynamics of analgesics like
      morphine derivates and remifentanil. 50 female patients will therefore be blood tested to
      study if they are Val/Val or Met/Met for the COMT gene, or if they are homozygous or
      heterozygous for the 118G allele and the 118A allele.

      This study will show if skin conductance can be used to measure noxious stimulation response
      before surgery (by giving a tetanic stimuli), and then predict what level of analgesic a
      patient will need during surgery.
    

Intervention name(s): Measuring of skin conductance; Tetanic stimuli
Intervention type(s): Device; Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Remifentanil; Skin Conductance; Anesthesia; Analgesics, Opioid