bioihbjkbjnl/mcl2 huggingface dataset:
Early Diagnosis of Oral Cancer by Detecting p16 Methylation
Condition: Moderate Epithelial Dysplasia; Mild Epithelial Dysplasia
MeSH terms: Carcinoma in Situ; Hyperplasia
Study type: Observational

Summary: 
      The purpose of this study is to verify the function of p16 methylation diagnostic reagents in
      early diagnosis of oral cancer.
    

Detailed description: 
      Background:Oral epithelial dysplasia (OED) is one of the common precancerous lesions among
      Chinese adults. To investigate the clinical predictive value of p16 methylation diagnostic
      reagents in the early diagnosis of oral cancer, the investigators carried out the prospective
      multi-center double-blind cohort study.

      Methods:180 patients with histologically confirmed mild or moderate OED were included in the
      present study. The investigators using p16 methylation diagnostic reagents to analysis of the
      p16 methylation status in these patients. Building two follow-up queue by p16-methylated and
      p16-unmethylated. The Statistical analysis used SAS6.12 software. All P-values were
      two-sided. P<0.05 was considered to test for statistical significance difference.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        180 patients with mild or moderate oral epithelial dysplasia were selected. 81 of them were
        from Peking University of Stomatology and 68 were from Capital Medical University School of
        Stomatology and other 31 were from Fourth Military Medical University School of
        Stomatology.All of the patients with OED had been diagnosed pathologically by at least two
        senior pathologists using the criteria from '2005 WHO Classification System' and The oral
        tissue pathology diagnostic criteria (oral histopathology Edition Sixth).All cases involved
        primary lesions without any LASER, radiation therapy or chemotherapy.
      
Biospecimen description: 
      Oral mucosal biopsy tissues were formalin fixed , paraffin embedded , sliced and
      hematoxylin-eosin (HE) staining.
    
Keywords: oral epithelial dysplasia; p16 methylation; diagnostic reagents; early diagnosis
Genomic Imprinting and Assisted Reproductive Technologies
Condition: Natural Pregnancy; Pregnancy, Ovarian
MeSH terms: Pregnancy, Ovarian
Study type: Observational

Summary: 
      Genomic imprinting, referring to an epigenetic marking resulting in monoallelic gene
      expression, plays a critical role in development. Recently, various imprinting diseases were
      reported in animals (Large Offspring syndrome (LOS)) and humans (Beckwith-Wiedemann syndrome
      (BWS) and Angelman syndrome (AS)) born after ART. In all cases, an imprinting defect was
      involved (loss of methylation at ICR2 in BWS, at SNRPN in AS and at IGF2R DMR2 in LOS). These
      data suggest that ART procedures may impair the establishment or the maintenance (following
      fertilization) of methylation marks at maternally imprinted loci. In view of these data, the
      aim of this study is to determine if children born following ART exhibit an increased risk of
      imprinting defects. If the answer is yes, the second objective is to identify the problematic
      step in the ART procedure and thus to suppress or modify this step.
    

Detailed description: 
      Methodology: assessment of the methylation status at 9 different imprinted loci (using
      Southern blot and methyl-specific quantitative PCR) in 3 groups of patients: 150 children
      naturally conceived, 150 children conceived after ovarian stimulation but with in vivo
      fertilization, and 150 children conceived after ovarian stimulation and in VITRO
      fertilization. These analyses will be performed on cord blood. Fragments of placental tissue
      will also be collected for further analyses. Patients will be selected in maternity hospitals
      associated with ART departments ( ANTOINE BECLERE HOSPITAL, Cochin HOSPITAL, Saint-Vincent de
      Paul HOSPITAL, Jean VERDIER HOSPITAL, Tenon HOSPITAL and Dijon Hospital).

      This work is also a unique opportunity to establish a DNA, RNA and tissue collection allowing
      further investigation regarding other epigenetic modifications than DNA methylation, not only
      at imprinted loci, but also in other genomic regions regulated by epigenetic modifications.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women followed in a participating ART departments
      
Biospecimen description: 
      whole blood (serum, ADN) and placenta samples
    
Keywords: Genomic imprinting; Reproductive techniques, assisted; Beckwith-Wiedemann syndrome; Angelman syndrome
Functional Effects of Botox on the Brain Using MRS and fMRI
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      The injection of BOTOX into peripheral muscles has been shown to have therapeutic effects in
      a growing number of indications including disorders involving skeletal muscle (e.g.,
      strabismus, blepharospasm, cervical dystonia, spasticity, cosmetic), smooth muscle (e.g.,
      bladder), glands (axillary hyperhidrosis) and nociceptive pain (e.g. migraine) (Brin. 2014).
      Recently, several studies have suggested that peripheral BOTOX injections in the region of
      the glabellar lines (muscles around the eyes) may be effective in treating major depression
      and chronic migraine. However, the mechanism underlying the effect of peripheral BOTOX
      injections on the brain is not well understood. Therefore, the Investigators propose to
      further explore the functional effects of BOTOX injections on brain in healthy controls. The
      approach will involve the measurement of brain metabolites in the brainstem using MRS as well
      as an investigation of the functioning and connectivity between regions of the brain using
      resting state MRI and high resolution fMRI.
    

Detailed description: 
      Participants will receive one MRI scan session prior to a standardized, clinical dose of
      BOTOX injected into the forehead per FDA-approved procedures. Participants will then undergo
      a second MRI scan session 2-3 weeks later, after the BOTOX has taken maximal effect.
      Examining fMRI of the brainstem and the functional connectivity of the brainstem and
      connections to cortex, may provide additional insight into the effects of BOTOX on neurologic
      and psychiatric disorders.
    

Intervention name(s): onabotulinumtoxinA
Intervention type(s): Drug
Intervention description(s): This study is a pre- and post-design. One scan will be collected prior to BOTOX injection and the second will be collected 14-21 days post-injection. BOTOX injections will be limited to 20 units in the glabellar area, as approved by the FDA .
Other intervention name(s): Botox
Intervention MeSH terms: Botulinum Toxins, Type A; abobotulinumtoxinA
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Clinical Study to Investigate and Compare the Impact of High Protein Pasta, Lower Protein Pasta and White Rice on Blood Sugar Control in People With Type 1 Diabetes Mellitus (T1DM)
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The aim of this clinical study is to investigate and compare the postprandial glycemic
      response to three different meal types rich in carbohydrates, that is, white pasta, high
      protein pasta and white rice consumed by individuals with T1DM.
    

Detailed description: 
      The aim of this clinical study is to investigate and compare the postprandial glycemic
      response to three different meal types rich in carbohydrates, that is, white pasta, high
      protein pasta and white rice consumed by individuals with T1DM and to demonstrate that:

        1. The choice of carbohydrates consumed significantly affects the postprandial glycemic
           profile in people with type 1 diabetes and

        2. The consumption of high protein pasta will present a tighter postprandial glycemic
           response.

      Previous studies have evaluated the effect of white pasta and rice on postprandial glycemic
      response in people with type 1 diabetes. With this study, we aim to expand upon these
      findings by ensuring that the results can still be applied to more recent commercial food
      products (pasta, rice), but especially to evaluate the effect of high-protein pasta when
      compared to regularly consumed carbohydrates (white pasta, white rice).

      After consuming the study meal, subjects will participate in an education session (a 2 hour
      class per each meal challenge session). Classes will be taught by a registered dietician and
      diabetes & exercise expert and, as appropriate, a culinary instructor.
    

Intervention name(s): Regular pasta; High protein pasta; White rice
Intervention type(s): Other; Other; Other
Intervention description(s): Regular pasta (Approximately 42 grams carbohydrate per meal); High protein pasta (Approximately 38 grams carbohydrate per meal); White rice (Approximately 43 grams carbohydrate per meal)
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects will consume pre-determined meals on 6 difference occasions. There will be three categories of "study meals" consisting of:
Regular pasta (42 grams carbohydrate per meal)
High protein pasta (38 grams carbohydrate per meal)
White rice (43 grams carbohydrate per meal)
Each subject will consume each meal on two separate occasions in random order.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: type 1 diabetes; pasta; rice; protein; carbohydrate
Study of Immunological Memory Induced in Children by a Full 4 Dose Vaccination Schedule of 11 Valent Pneumococcal Conjugate Vaccine by Giving 1 Dose of Aventis Pasteur's 23-valent Pneumococcal Polysaccharide Vaccine (Pneumo 23)
Condition: Prophylaxis Pneumococcal Vaccine
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluate the immunological memory induced by 4 doses of GSK Biologicals' 11valent
      pneumococcal vaccine; study antibody persistence 30 months after the 4 dose vaccination with
      GSK Biologicals' 11-valent pneumococcal vaccine in Undeca-Pn-010 study.
    

Detailed description: 
      Primed group: 50 subjects who previously received 4 doses of GSK Biologicals' 11Pn-PD vaccine
      will receive 1 dose of Pneumo 23 Unprimed group (Control): 50 subjects who received GSK
      Biologicals' Havrix™ vaccine will receive 1 dose of Pneumo 23
    

Intervention name(s): Pneumococcal (vaccine)
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Physiological Flow of Liquids in Head and Neck Cancer Patients: A Pilot Study
Condition: Deglutition Disorders; Oropharynx Cancer
MeSH terms: Head and Neck Neoplasms; Oropharyngeal Neoplasms; Deglutition Disorders
Study type: Observational

Summary: 
      This study is part of a larger grant, for which the overall goal is to collect measurements
      of liquid flow through the oropharynx (i.e., mouth and throat) during swallowing. The focus
      of this study is to evaluate the flow of liquids of varying consistency in the head and neck
      cancer population.
    

Detailed description: 
      Thickened liquids are commonly used as an intervention for dysphagia (swallowing impairment).
      However, the field lacks a clear understanding of how liquids of different consistencies
      behave during swallowing. In order to improve understanding of the effectiveness of altered
      liquid consistency for improving dysphagia, the investigators are studying liquid flow
      through the oropharynx.

      This study explores this question in individuals who have undergone radiation treatment for
      head and neck cancer, specifically located in the oropharynx.

      Participants will swallow 20% w/v barium thickened to different consistencies (thin, slightly
      thick, and mildly thick) using commercially available food thickeners. Swallowing will be
      observed under videofluoroscopy.
    

Intervention name(s): Starch-based Thickened Liquids; Xanthan-gum Thickened Liquids
Intervention type(s): Other; Other
Intervention description(s): Barium will be thickened to slightly, mildly, moderately and extremely thick consistences as defined by the International Dysphagia Diet Standardisation Initiative flow test.; Barium will be thickened to slightly, mildly, moderately and extremely thick consistences as defined by the International Dysphagia Diet Standardisation Initiative flow test.
Other intervention name(s): Nestle Resource ThickenUp; Nestle Resource ThickenUp Clear
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adults who have recently completed radiation treatment for oropharynx cancer at the
        University Health Network, Toronto.
      
Keywords: Swallowing
Clinical Trial of the Inactivated Influenza Vaccine (0.25ml Formulation for Pediatric Use)
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The clinical trial was designed to evaluate the immunogenicity and safety against pediatric
      Inactivated influenza vaccine (Split Virion) (0.25ml formulation) of Hualan administered on
      infants age 6 months to 36 months.
    

Detailed description: 
      The clinical trial was designed randomized and double-blind. Participants included up to 810
      persons (540 persons in test group and 270 persons in control group).

      Healthy 6-36 months infants were selected, whose guardians were volunteers and had signed the
      informed consent. Subjects were selected according to the inclusion and exclusion criteria.
      Every subject accepted 30min's observation in the hospital after vaccination and received
      periodic follow-up till the fourth week after the boost vaccination.

      Blood of subjects was collected at the third week after the boost vaccination for the
      analysis of the immunogenicity. During the test, the adverse reactions and detailed
      information were reported to the SFDA under the status of blinding every month. Unblinding
      was conducted after the completion of the follow-up of subjects.
    

Intervention name(s): Influenza Split Vaccine; Inactivated Influenza Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): 0.25ml, two doses (540 subjects were randomly assigned to receive the first dose, among them, 515 subjects received a boost dose); two doses were assigned to be vaccinated 4 weeks apart; 0.25ml, two doses (270 subjects were randomly assigned to receive the first dose; among them, 263 subjects received a boost dose); two doses was administrated at 4 weeks apart
Other intervention name(s): Hualan Biologicals; Vaxigrip, Shenzhen Aventis Pasteur Biological
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Pediatric influenza vaccine
Tow Techniques of Adductor Canal Block for Analgesia After Total Knee Replacement
Condition: Total Knee Arthroplasty; Analgesia; Nerve Block
MeSH terms: Agnosia
Study type: Interventional

Summary: 
      This study compares the tow technique of continues adductor canal block for total knee
      replacement surgery. Half participants will receive catheterization at the entrance of the
      adductor canal, while the other half will receive catheterization at the middle point of the
      adductor canal.
    


Intervention name(s): ultrasound-guided short-axis placement of catheter at the entrance of the adductor canal; ultrasound-guided long-axis placement of catheter at the middle of the adductor canal
Intervention type(s): Procedure; Procedure
Intervention description(s): Ultrasound probe is placed at the entrance of the adductor canal in short axis ，insertion of a PAJUNK Contiplex S catheter with the tip of the catheter located at the entrance of the canal; Ultrasound probe is placed at the middle of the adductor canal in long axis with the caphelad end of the probe aligned with the entrance of the canal. insertion of a PAJUNK Contiplex S catheter with the tip of the catheter located at the middle of the canal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: adductor canal block
Safety Study of GRNOPC1 in Spinal Cord Injury
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the safety of GRNOPC1 administered at a single
      time-point between 7 and 14 days post injury, inclusive, to patients with neurologically
      complete spinal cord injuries (SCI).
    


Intervention name(s): GRNOPC1
Intervention type(s): Biological
Intervention description(s): One injection of 2 million GRNOPC1 cells.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Spinal Cord Injury; GRNOPC1
Single Leg Squat Performance in Physically and Non-physically Active Individuals
Condition: Single Leg Squat Performance; Athletic Injuries
MeSH terms: Athletic Injuries
Study type: Observational

Summary: 
      Single-leg squat (SLS) is a functional test visually rated by clinicians for assessing lower
      limb function as a preventive injury strategy. SLS clinical rating is a qualitative
      evaluation and it does not count objective outcomes as kinematics data and surface
      electromyography (sEMG) assessment. Based on the SLS rating, the aims of this study were (i)
      to determine the clinical rating agreement among six raters and (ii) to assess kinematic and
      sEMG predictors of good SLS performance in physically and non-physically active individuals.
    


Intervention name(s): performance of the single leg squat task
Intervention type(s): Other
Intervention description(s): The single-leg squat (SLS) is a clinical functional test commonly used to evaluate clinical abnormal movement patterns of the lower limbs in terms of kinetic chain or co-ordinating muscle activity. This scale accounts for the assessment of five dimensions: overall impression, trunk posture, pelvis in space, hip joint motion and knee join motion. The SLS is potentially promising as a functional test since it involves both daily activity and athletic task.
Other intervention name(s): clinical assessment
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        A cohort of healthy young subjects was recruited.
      
Keywords: Reproducibility of Results; Clinical Assessment
Long Term Extension Study Evaluating Safety, Tolerability and Immunogenicity Of ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the long term safety, tolerability, and immunogenicity
      of ACC-001, an investigational active immunization product+, in subjects with mild to
      moderate Alzheimer's disease.
    


Intervention name(s): ACC-001(3µg) + QS21; ACC-001(10µg) + QS21; ACC-001(30µg) + QS21
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Vanutide Cridificar (ACC-001) 3µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18; Vanutide Cridificar (ACC-001) 10µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18; Vanutide Cridificar (ACC-001) 30 µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18
Intervention MeSH terms: Saponin QA-21V1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Drug Interaction Study of Levoketoconazole and Metformin
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, open-label, fixed-sequence drug-drug interaction study to evaluate the
      effect of levoketoconazole on the single-dose PK of metformin in health subjects.
    

Detailed description: 
      This study will enroll healthy male and female subjects to evaluate the effect of
      levoketoconazole on the PK of a single 500 mg dose of metformin. There will be 3 sequential
      treatment periods, and all subjects will receive metformin only in Period 1, escalating doses
      of levoketoconazole in Period 2, and concurrent administration of metformin and
      levoketoconazole in Period 3.
    

Intervention name(s): Metformin 500 mg Oral Tablet; Levoketoconazole 150 - 600 mg (BID)
Intervention type(s): Drug; Drug
Intervention description(s): single dose; escalating dose from 150 mg to 600 mg (BID)
Other intervention name(s): COR-003
Intervention MeSH terms: Metformin
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
An Open-Label Trial of Oxytocin in Adolescents With Autism Spectrum Disorders
Condition: Autism Spectrum Disorders; Pervasive Developmental Disorders; ASD; PDD
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive; Developmental Disabilities
Study type: Interventional

Summary: 
      This study is an 8-week open-label trial testing oxytocin nasal spray (Syntocinon) as a
      treatment for social impairment in adolescents with autism spectrum disorders (ASD). We
      hypothesize that oxytocin nasal spray will be safe, tolerable, and effective in improving the
      core symptoms of autism spectrum disorders in adolescents ages 11-17.
    


Intervention name(s): Intranasal Oxytocin
Intervention type(s): Drug
Other intervention name(s): Syntocinon
Intervention MeSH terms: Oxytocin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autism Spectrum Disorders; Pervasive Developmental Disorders; ASD; PDD; Oxytocin; Syntocinon; treatment