bioihbjkbjnl/mcl2 huggingface dataset:
Feedback in Augmented Reality to Control of Gait Parameters in Children With Cerebral Palsy
Condition: Cerebral Palsy; Gait Disorders, Neurologic; Feedback, Psychological
MeSH terms: Cerebral Palsy; Nervous System Diseases; Gait Disorders, Neurologic
Study type: Interventional

Summary: 
      Cerebral palsy (CP) describes a group of permanent disorders of the development of movement
      and posture, causing activity limitation, that are attributed to non progressive disturbances
      that occurred in the developing fetal or infant brain. The motor disorder of CP are often
      accompanied by disturbances of sensation, perception, cognition, communication, and
      behaviour; by epilepsy, and by secondary musculoskeletal problems.

      Motor activities, especially walking, can be affected by many factors including sensory
      deficits, biomechanical and postural limitations, muscle weakness and spasticity.To provide
      feedback, during gait rehabilitation is a complementary approach to improve motor learning
      during the rehabilitation protocol. However, the feedback modalities are multiple and no
      study has compared these modalities. This study aims to test which feedback modalities could
      control the gait parameters (speed, cadence, step length) of the child with CP in real-time,
      through an augmented reality environment.
    


Intervention name(s): Feedback modalities given through an augmented reality headset
Intervention type(s): Device
Intervention description(s): All children wear the augmented reality headset. After a habituation period to the holograms, they start the protocol. It consists of a warm-up session, training session (which three feedback modalities are presented), calibration session (to get the maximal speed and spontaneous speed of the child), and test session. During test session, all the children walk on the 30m corridor. They have 6 feedback modalities + the control, given randomly. On the way out, they have to walk fast as possible ; on the return they have to walk at intermediate speed.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Serious Game; Rehabilitation
The Clinical Trial of CL2020 Cells for Neonatal Hypoxic Ischemic Encephalopathy
Condition: Hypoxia-Ischemia, Brain
MeSH terms: Brain Diseases; Brain Ischemia; Hypoxia-Ischemia, Brain; Ischemia; Hypoxia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and the tolerability of CL2020 cells in
      hypoxic ischemic encephalopathy neonates with hypothermia therapy. In addition, we will
      evaluate the efficacy of CL2020 cells for infant development.
    


Intervention name(s): CL2020 cells
Intervention type(s): Biological
Intervention description(s): 1.5 million or 15 million cells, IV on day 5 to 14 of birth
Intervention model: Single Group Assignment
Intervention model description: 3 + 3 dose escalation study design
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypoxia-Ischemia, Brain; Infant, Newborn; Mesenchymal Stem Cells
A Comparison of Exenatide and Insulin Glargine
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a 16-week, Single-center, Randomized, Open Label, Parallel Controlled Group
      Comparison of the Comprehensive Glycemic Control of Exenatide and Insulin Glargine on Type 2
      Diabetes Patients Inadequately Controlled With Metformin Monotherapy.
    

Detailed description: 
      Screening will be made to select eligible patients, then 44 patients receiving a stable dose
      of metformin (≥1500 mg daily) will be randomized (1:1) to receive exenatide or insulin
      glargine for 16 weeks. Exenatide will be administered twice daily by subcutaneous injection
      30- 60 minutes before breakfast and dinner; the dose was 5 μg twice-daily for the first 4
      weeks of treatment and 10 μg thereafter. Insulin glargine will be administered once daily at
      bedtime by subcutaneous injection. The dose of insulin glargine will initiate at ≥8 IU
      once-daily, and titrate based on a dosing algorithm targeting fasting blood glucose (FPG)<6.1
      mmol/L. Titration is only allowed in first 4 weeks. At the end of the study, data will be
      collected and analyzed.
    

Intervention name(s): exenatide; Insulin glargine
Intervention type(s): Drug; Drug
Intervention description(s): 5 μg BID for the first 4 weeks of treatment and 10 μg thereafter.; ≥8 IU QD, and titrate based on a dosing algorithm targeting FPG <6.1 mmol/L. Titration is only allowed in first 4 weeks.
Other intervention name(s): Byetta.Lilly; Lantus,Sanofi Aventis
Intervention MeSH terms: Insulin Glargine; Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: exenatide; insulin glargine
A Phase I Study to Evaluate Safety and Immunogenicity of AERAS 404 Administered in Adults
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase I study will be conducted as a randomized, double-blind, dose-escalation study in
      five groups of healthy adult male and female subjects who are BCG-vaccinated, HIV-negative,
      and have no evidence of tuberculosis infection. Since BCG-vaccinated individuals are the
      target population for which AERAS 404 might be indicated, AERAS 404 will be administered to
      individuals already vaccinated with BCG
    

Detailed description: 
      Sixty subjects will be sequentially enrolled into one of five study groups (i.e., Group 1,
      Group 2, Group 3, Group 4, or Group 5) with 10 subjects per group in Groups 1-4 and 20
      subjects in Group 5. Within each study group, subjects will be randomized to a treatment
      assignment of either AERAS-404 or placebo control at a ratio of 4:1 (Groups 1-4) or two
      different dose amounts of AERAS-404 or placebo control at a ratio of 9:9:2 (Group 5)
      administered by intramuscular injection on Study Day 0 and Study Day 56. The principal
      investigator will determine an appropriate interval between the vaccinations such that the
      entire group is not dosed at the same time. All subjects will receive the same treatment on
      Study Day 0 as they receive on Study Day 56. All subjects will be followed for safety and
      immunogenicity evaluations for 182 days. A total of eleven clinic visits are planned
      (excluding screening) for all subjects
    

Intervention name(s): AERAS-404; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): AERAS-404 is comprised of the H4 antigen, a fusion protein of Mycobacterium tuberculosis antigens 85B and TB10.4; and IC31 adjuvant, a combination of a leucine-rich peptide and a synthetic oligonucleotide.; Sterile buffer containing 10 mmol Tris and 169 mmol of NaCl in 0.8 mL of aqueous solution. This is the identical buffer solution in which H4 and IC31 are formulated.
Other intervention name(s): H4; Sterile Buffer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: BCG Vaccinated; HIV Negative
A Study in Healthy Men to Test How BI 456906 is Processed in the Body
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is intended to examine the basic pharmacokinetics of BI 456906 and total
      [14C]-radioactivity, including mass balance, excretion pathways and metabolism following a
      single subcutaneous (SC) dose of BI 456906 (C-14) in (otherwise) healthy male volunteers with
      normal body weight, overweight or obesity.
    


Intervention name(s): BI 456906 (C-14)
Intervention type(s): Drug
Intervention description(s): BI 456906 (C-14)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pilot Evaluation of CVT-E002 in Pediatric Upper Respiratory Tract Infection.
Condition: Upper Respiratory Infection
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized double-blind three-arm trial to evaluate two dosages of CVT-E002 against
      placebo in pediatric upper respiratory tract infections (URTI). It is hypothesized that
      CVT-E002 use at standard doses reduces the duration of URTI in children aged 3-12 years.
    

Detailed description: 
      The eligible children, for whom parental consent has been obtained, will be randomized to one
      of three groups (standard dose, low dose, or placebo). The standard dose group will receive
      an oral aqueous solution using the standard dose of CVT-E002, adjusted according to the
      child's weight. The second group will receive an oral aqueous solution with half of the
      standard dose of CVT-E002, adjusted according to the child's weight, and the third group will
      receive a placebo as an aqueous solution of starch that does not contain any CVT-E002 or
      active medication, volume adjusted for the child's weight. Parents will be provided with a
      3-day supply of study medication according to the randomization schedule. CVT-E002 will be
      administered by the parent to the child three times daily for three consecutive days
      following the onset of a URTI. Severity and duration of URTI will be measured using the
      reliable and valid Canadian Acute Respiratory Infection Flu Score (CARIFS).
    

Intervention name(s): CVT-E002 ginseng extract
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: cold; flu; respiratory tract infection
Effects of Planned Training and Music Listened to Before a Cesarean Section on Surgical Fear, Anxiety and Depression
Condition: Cesarean Section
MeSH terms: Depression
Study type: Interventional

Summary: 
      This research was conducted to determine the effect of training and listening to music before
      a cesarean section on the surgical fear, anxiety and depression
    

Detailed description: 
      The sample of the experimental study consisted of 120 pregnant women (music: 40, training:
      40, control: 40). The data were collected using the Personal Information Form, Surgical Fear
      Questionnaire, and the Hospital Anxiety and Depression Scale. After the training and
      listening to music applications, statistically significant differences were found between the
      music, training, and the control groups in terms of the short-term, long-term sub-scale
      scores and the overall score of the Surgical Fear Questionnaire, and the anxiety sub-scale
      scores of the Hospital Anxiety and Depression Scale (p < .05). Listening to music before the
      cesarean section was effective in reducing women's short-term and general surgical fears, and
      the training was also effective in reducing their short-term, long-term, and general surgical
      fears and anxiety levels.
    

Intervention name(s): Control group
Intervention type(s): Other
Intervention description(s): No intervention was applied to the women in the control group, only the questionnaires (pre-test, post-test) were filled out. Filling the questionnaires lasted 10-15 minutes on average in all groups
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Anxiety and depression; fear of surgery; listening to music; planned training; cesarean section
Safety and Efficacy of Body-mapping Tank Top Equipped With Biofeedback System for Adolescent With Early Scoliosis
Condition: Adolescent Idiopathic Scoliosis
MeSH terms: Scoliosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Adolescent idiopathic scoliosis (AIS) is a prevalent disease that caused a lateral curvature
      on spine. Spine curvature increases in youths as puberty progresses. The recommended
      treatment for AIS is different depends on the spine deformity condition. For mild scoliosis
      (Cobb's angle ≤ 20°), only periodic observation is suggested. For scoliosis cases that the
      Cobb's angle ≤ 40°, a rigid brace treatment is recommended. A rigid brace that made by rigid
      plastic material restrict nearly all movements of the wearers, which caused irritation.
      Flexible brace is an alternative option, however, the efficiency of such treatment is
      questionable in terms of controlling the spine curvature progression.

      Biofeedback has proven to be effective for a number of physical, psychological and
      psychophysical problems. The basic aim of biofeedback therapy is to support a patient in
      realizing his/her self-ability to control specific psychophysiological processes.

      In this study, a biofeedback embedded tank-top with a specialized design for adolescents as a
      treatment option for AIS patients by monitoring the daily posture of the wearers.
    

Detailed description: 
      This project aims to combine the clinical experience with textiles and biofeedback mechanism
      to research and develop a biofeedback embedded tank-top for AIS. As a result, this will
      reduce the future likelihood of brace wear or surgery.

      In this study, the eligible subjects will be given tailor-made biofeedback tank-top to wear
      it 8 hours daily. Monitor, observation and additional posture training sessions will be
      provided during the 6 months wearing period. The effectiveness of the biofeedback tank-top
      will be evaluated by pre-and post- treatment ultrasonic imaging device (for measuring the
      angle of the spine), electromyography muscle signal assessment and clinical photographs
      assessment.
    

Intervention name(s): Body-mapping Tank-top Embedded with Biofeedback System
Intervention type(s): Device
Intervention description(s): In this study, the eligible subjects will be given tailor-made tank-top embedded with biofeedback system to wear it 8 hours daily. Monitor, observation and additional posture training sessions will be provided during the 6 months wearing period. The effectiveness of the biofeedback tank-top will be evaluated by pre-and post- treatment ultrasonic imaging device (measuring the angle of the spine) and electromyography muscle signal
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
MARLINA - T2D : Efficacy, Safety & Modification of Albuminuria in Type 2 Diabetes Subjects With Renal Disease With LINAgliptin
Condition: Diabetes Mellitus, Type 2
MeSH terms: Albuminuria; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluate linagliptin in terms of glycemic control as defined by HbA1c after 24 weeks of
      treatment and in terms of renal efficacy as defined by changes in albuminuria (UACR) after 24
      weeks of treatment.
    


Intervention name(s): Placebo; Linagliptin 5mg
Intervention type(s): Drug; Drug
Intervention MeSH terms: Linagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Comparison of the Pharmacokinetic and Pharmacodynamic Properties of Biocon's Insulin R U-500 With Humulin® R U-500 (US Reference Product) in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Single-centre, randomised, double-blind, three-period, six-sequence, partially replicated
      design, crossover trial in healthy subjects
    

Detailed description: 
      The present study is designed to demonstrate pharmacokinetic and pharmacodynamic equivalence
      of Biocon's Human Insulin R U-500 with Humulin® R U-500 in healthy subjects.

      The treatment consists of one single dose of the test or reference product, administered
      during each of the three study periods, separated by 5-7 days between each dosing. The
      planned trial duration for each subject is about 18 to 44 days. Eligible subjects will
      undergo three euglycaemic clamp examinations (each of 24 hours duration).

      Depending on the sequence in which a particular subject is randomized, each subject will
      either undergo two clamps with administration of test product plus one clamp with
      administration of reference product, or, two clamps with administration of reference product
      plus one clamp with administration of test product, in random order.
    

Intervention name(s): Biocon's Human Insulin R U-500; Humulin® R U-500 (US Reference Product)
Intervention type(s): Biological; Biological
Intervention description(s): Biocon's Human Insulin R U-500 (Insulin Human Injection 500 units/mL), 3 mL cartridges (containing 1,500 units of insulin).; Humulin® R U-500 (US Reference Product), 3 mL single-patient-use KwikPen® (containing 1,500 units of insulin)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Partially replicated design, crossover trial
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Recombinant Human INsulin Equivalence-4; RHINE-4; Pharmacokinetic; Pharmacodynamic; Biocon's Insulin R U-500; Humulin® R U-500
The Effect of Regional Anesthesia Techniques on Brain Tissue Oxygenation in Thoracic Surgery
Condition: Thoracic Surgery; Epidural Anesthesia; Cerebral Oxygen Saturation
MeSH terms: Aortic Dissection
Study type: Interventional

Summary: 
      Today, it is preferred that the lung with pathology for thorax surgery is not under
      ventilation during operation in terms of reliability and ease of operation.

      For this reason, the anesthesia approach is characteristic and it is ensured that the single
      lung is not ventilated during the operation by means of specially manufactured intubation
      tubes. This application can disrupt tissue oxygenation due to both Operation position and
      single lung ventilation.

      Thoracic epidural analgesia, which is applied as the gold standard of Thoracic Surgery, is
      applied prior to the operation and is provided to assist in postoperative analgesia.
    

Detailed description: 
      The aim of this study was to investigate the effect of thoracic epidural analgesia method on
      brain tissue oxygenation in patients with single lung ventilation.
    

Intervention name(s): Regional oximetry probe; Thoracic Epidural block
Intervention type(s): Device; Procedure
Intervention description(s): Regional oximetry probe will be placed in the frontal area of the head; Thoracic epidural block will be applied to the patients before the operation begins
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: prospective,randomized
Masking: Single (Participant)
Primary purpose: Prevention
Tweens to Teens Project at Penn State
Condition: Congenital Adrenal Hyperplasia
MeSH terms: Adrenal Hyperplasia, Congenital; Adrenogenital Syndrome; Hyperplasia
Study type: Observational

Summary: 
      The goal of this study is to help investigators to understand more about the development of
      characteristics related to being male or female (what is called gender development). The
      investigators will study girls with congenital adrenal hyperplasia (CAH) aged 10 to 13 to
      learn more about the girls' interests and activities, thoughts and feeling about being
      female, and family relationships. This will help investigators to understand the ways in
      which gender development is shaped by hormones and family relationships.
    

Detailed description: 
      Interviewers will visit girls in their home when it is convenient for the family. Girls will
      answer questions about the things they do and are interested in, how they think and feel, and
      complete some cognitive tasks. Girls will also provide saliva so we can examine their
      hormones and determine the CAH gene mutation they have. Parents will also be asked to
      complete questionnaires about their own activities and interests and about their daughter's
      behavior.

      Shortly after the home visit, interviewers will telephone girls and their parents on several
      days and ask what the girls did during the day.
    

Intervention name(s): Questionnaires/Interviews; Questionnaires/Interviews
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Girls answer questions about activities and interests, school, feelings about being a girl, stage of physical development, and family relationships during a home interview , provide saliva samples, and participate in phone interviews to answer questions about daily activities .; Parents complete questionnaires about their daughter's activities, interests, and behaviors, educational goals, family demographics and relationships, grades, diagnosis and treatment of her CAH, their own activities, interests, and thoughts and feelings about being male or female. Parents answer questions during phone interviews about their daughters daily activities.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        We will study girls with the 21-hydroxylase deficiency (21-OHD) form of congenital adrenal
        hyperplasia (CAH) aged 10 to 13. Parents of participants are also included.
      
Biospecimen description: 
      Samples of saliva will be collected from participants with CAH for genetic testing (specific
      mutations of CYP21 gene) and to obtain hormone levels.
    
Keywords: Congenital Adrenal Hyperplasia; CAH; sex differences; adolescence; androgen; behavior; gender development
Safety and Efficacy of Grass Pollen Allergoid in the Treatment of Allergic Rhinoconjunctivitis
Condition: Grass Pollen Allergy
MeSH terms: Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      The trial is performed to assess efficacy and safety of the Grass Pollen Allergoid in
      Allergic Rhinoconjunctivitis
    

Detailed description: 
      Pollen allergoids are prepared by chemical modification of partially purified native allergen
      aqueous extracts that have been depleted of components with a molecular mass of less than
      5000 Daltons by diafiltration. Clinical studies have shown a good tolerance of aqueous grass,
      ragweed and tree pollen allergoids in comparison with allergen preparations. Adsorption of
      pollen allergoids onto aluminium hydroxide suspensions results in depot preparations which
      have been investigated in a series of clinical studies and shown to be well tolerated with
      good clinical efficacy. Depot pollen-allergoids were introduced into the German market in
      1987 under the trade name Allergovit® and are now firmly established and recommended
      primarily for shortcourse preseasonal immunotherapy in pollinosis. Allergovit® is currently
      available in many European and non-European countries. A placebo-controlled study design was
      chosen as improvements in the symptoms of pollen allergies can not be shown over time, as
      pollen seasons of different years are not comparable. Due to the different mechanisms of
      action, specific immunotherapy can not be compared with anti-allergic drugs. Thus the only
      chance to prove efficacy for specific immunotherapy (SIT) is to test versus a parallel
      placebo group.
    

Intervention name(s): Allergovit 6-grasses; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Subcutaneous injections; Subcutaneous injections
Other intervention name(s): Specific immunotherapy with an allergoid preparation.; Comparator
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Allergovit; Grass pollen allergy