bioihbjkbjnl/mcl2 huggingface dataset:
Does Hyaluronic Acid Affect Periodontal Treatment?
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional
Phase: Phase 1

Summary: 
      Objective: The aim of this study is to evaluate the effect of HA as an adjunct to scaling and
      root planning (SRP) on clinical parameters, periodontal inflamed surface area (PISA) and
      adenosine deaminase (ADA), catalase (CAT), and glutathione (GSH) levels in gingival
      crevicular fluid (GCF) in patients with periodontitis.
    

Detailed description: 
      Design: A total of 24 Stage II-III periodontitis patients will be included in this
      split-mouth, randomized-controlled study. The study population will be divided into four
      groups: in Group 1 (SRP): SRP+ saline; in Group 2 (SRP+HAgel): SRP + HA gel; in Group 3
      (SRP+HAmo): SRP+ HA mouthrinse; and in Group 4 (SRP+HAmo+HAgel): SRP+HA mouthrinse + HA
      gingival gel were applied. At baseline and Week 4 periodontal clinical parameters and PISA
      will be calculated. Also, GCF amount will be collected to evaluate ADA, CAT, and GSH by
      spectrophotometric analysis.
    

Intervention name(s): Scaling and root planning; Hyaluronic acid gel (HA) and SRP; HA mouthrinse and SRP; HA mouthrinse+gel and SRP
Intervention type(s): Procedure; Drug; Drug; Drug
Intervention description(s): Under local anesthesia, full-mouth SRP will be performed by a single investigator. Immediately after the SRP, HA gel or mouthrinse will perform according to the groups' procedure. In Group 1, the periodontal sulcus will be irrigated with saline solution after SRP.; In Group 2, after SRP will be performed and irrigated with saline the area was dried with a soft air and, then, a gel containing HA will be applied intrasulcular.; In Group 3, HA hydrogel mouthrinse will be used as an irrigator after SRP.; In Group 4, after SRP will be performed, the sulcus was irrigated with HA hydrogel mouthrinse and, then, intrasulculary HA gingival gel will be applied.
Other intervention name(s): HA and SRP; HAmo+SRP; HAmo+HAgel+SRP
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: periodontitis; hyaluronic acid; scaling and root planning; adenosione deaminase; catalase; glutathione
Useability Test to the Wearable Walking-assist Robot (GEMS-H) for Normal Adults Including the Elderly
Condition: Gait Disorders in Old Age
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the userbility and satisfaction of functional
      gait training with the Gait Enhancing and Motivating System-Hip type (GEMS-H) on locomotor
      function in normal adults including the elderly.
    

Detailed description: 
      The GEMS-H is a hip-type assist device developed by the Samsung Advanced Institute of
      Technology. The GEMS-H is worn around the waist and fastened at the waist and thighs by a set
      of belts with velcro to assist motion at the hip joints. The device weighs 2.1kg, and has 2
      brushless direct current motors running on a rechargeable lithium ion battery. The normal
      operation time for the device is 2 hours. The GEMS-H is available in three sizes to fit
      various waist/hip sizes: small, medium, and large. The width of each version can be adjusted
      further to fit individual body size within the circumference range. Also, the thigh frames
      are available in three sizes (large, medium, and small) for different leg lengths. It is
      controlled through a custom built application on a hand held tablet.

      Participants will be normal adults with community-dwelling older adults aged 19-85.

      Participants will be scheduled for 24 training sessions of training plus 3 sessions of
      testing (pre-training, mid-test after the 12 sessions of training, post-training).
    

Intervention name(s): Training with Gait Enhancing and Motivating System (GEMS-H) Robot
Intervention type(s): Device
Intervention description(s): Training consists of 15 minutes task-specific training and 30 minutes functional gait training on varied environments with device.
Other intervention name(s): Training with GEMS-H
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Wearable hip assist robot; Gait; User test; Robot gait training; Elderly
Comparison Between Two Non-surgical Periodontal Treatment Procedures With and Without Interdental Hygiene Devices in Periodontitis Patients: a Longitudinal Prospective Controlled Clinical Trial
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional

Summary: 
      Periodontitis is treated by regularly clearance of the disease-causing biofilm through
      domestic care and dental measures (Petersilka et al., 2002, Herrera et al., 2008). Healthy
      gums have intact papillae occluding the interdental area. Successful brushing cleans these
      areas; the prophylaxis of gingivitis for such patients does therefore not require special
      aids. In contrast, initial attachment loss as a result of inflammation or restorative therapy
      leads to additional cleaning needs, since the normal brush is not able to clean interdental
      areas as successful as vestibular and oral surfaces (Dörfer and Staehle, 2010).

      It can be said that interdental brushes are the most effective tools for cleaning interdental
      spaces (Salzer et al., 2015). Compared with a toothbrush, they are the only tool showing
      better results of plaque removal and reduction of gingivitis (Slot et al., 2008). Therefore
      their use should not be restricted to older people with already reduced interdental papillae.
      A big advantage is that interdental brushes are generally easy to use. If brush sizes are
      chosen correctly, insertion and multiple forward and backward movement is sufficient to
      obtain com- plete cleaning of the interproximal surfaces. Additional cleaning by other means
      such as dental floss is not always necessary because interdental brushes clean approximal and
      subgingival surfaces sufficiently, providing the size was chosen correctly (Dörfer and
      Staehle, 2010).

      Due to the above mentioned coherences and associations, this study includes the hypothesis
      that patients with periodontitis would benefit from the instruction and motivation of
      interdental brushes within the active periodontitis therapy in comparison to a periodontitis
      therapy without the instructed domestic interdental hygiene by a stronger reduction of
      clinical inflammatory characteristics (Salzer et al., 2015). The corresponding
      Zero-Hypothesis says that no difference would be found between both groups.
    


Intervention name(s): Non-surgical periodontal treatment with interdental hygiene devices; Non-surgical periodontal treatment without interdental hygiene devices
Intervention type(s): Procedure; Procedure
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pragmatic Posterior Capsular Stretch
Condition: Shoulder Impingement; Shoulder Pain; Adhesive Capsulitis; Rotator Cuff Tears; Posterior Capsule Tear; Glenohumeral Subluxation; Glenohumeral Dysplasia; Acromioclavicular; Sprain (Strain); Internal Rotation Contracture-shoulder; External Rotation Contracture-Shoulder; Flexion Contracture; Extension Contracture-Shoulder
MeSH terms: Shoulder Pain; Bursitis; Contracture; Shoulder Impingement Syndrome; Shoulder Dislocation; Rotator Cuff Injuries; Sprains and Strains
Study type: Interventional

Summary: 
      Various stretches are used to lengthen the posterior shoulder capsule. No study has reported
      the comparison of the pragmatic posterior capsular stretch and cross body stertch
    

Detailed description: 
      Background: Posterior capsular tightness (PCT) is a problem frequently seen in shoulder
      disorder. PCT leads to variation in scapular and humeral kinematics. Two techniques
      considered in our study for regaining normal range of motion at shoulder joint and improving
      PCT, one is the pragmatic posterior capsular stretch (PPCS) & the other one is cross body
      stretch (CBS) Objective: The aim of our study id to compare the short term effect of PPCS
      versus CBS on range of motion on shoulder joint in healthy individuals. And to evaluate the
      feedback of subjects regarding both the interventions.

      Methodology: Through RCT 30 asymptomatic subjects (15 males, 15 females) . A simple random
      sampling technique was used. Subjects were screen through a functional movement screening
      tool. The change in hand behind neck and hand behind back will be measured through measuring
      tape. Shoulder ROM and functional movements for both the stretches will be campared

      Results:
    

Intervention name(s): pragmatic posterior capsular stretch; cross body stretch
Intervention type(s): Other; Other
Intervention description(s): pragmatic posterior stretch is used to increase the length of the posterior capsule; crossbody stretch performed by an individual
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: RCT
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Genetic Polymorphism and OROS-Methylphenidate Treatment in Attention Deficit Hyperactivity Disorder(ADHD)
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to examine whether genetic polymorphisms in drug transporters
      were associated with the side effects of OROS-methylphenidate medication in attention
      deficit/hyperactivity disorder(ADHD).
    

Detailed description: 
      20 to 30% of children with attention deficit/hyperactivity disorder(ADHD) do not respond or
      could not tolerate methylphenidate treatment. Drug transporters such as multidrug resistant
      proteins(MDR) plays important role in the clearance of psychotropic drugs and their
      metabolites from brain tissue. It suggested that methylphenidate was a P-glycoprotein(encoded
      by MDR1 gene)substrate and showed inhibitory effects on the P-glycoprotein efflux function.
      Single nucleotide polymorphisms(SNP)in the MDR1 gene were analyzed in children and
      adolescents with OROS-methylphenidate treatment. The hypothesis is that MDR1(ABCB1)
      polymorphisms are associated with the side effects of OROS-methylphenidate.
    

Intervention name(s): OROS-methylphenidate (Concerta)
Intervention type(s): Drug
Intervention description(s): dose: 18mg, 27mg, 36mg, 45mg, 54mg/day, po duration: 8 weeks
Other intervention name(s): Concerta
Intervention MeSH terms: Methylphenidate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Methylphenidate; ADHD; Multidrug resistance(MDR)polymorphism; OROS methylphenidate
Nice Morning- Safety and Efficacy Observational Study of Telmisartan in Hypertensive Patients in Multicenters
Condition: Hypertension
MeSH terms: Hypertension
Study type: Observational

Summary: 
      The purpose of this observational study is to survey the safety and effectiveness of the
      product under the real condition of usual practice in Taiwanese hypertensive patients. During
      the 8-week observation, the safety profiles and the clinical evaluation in between doses
      through blood pressure (BP) measurement for overall effectiveness of telmisartan therapy will
      be concluded.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Hypertension patients
Influence of Protein Source on Satiety and Metabolism
Condition: Healthy
Study type: Interventional

Summary: 
      Dietary protein is the more satiating nutrient, however it is not clear whether satiety may
      be influenced by the nature of the protein. This study was designed to assess potential
      differences between protein sources on satiety and their relationship with digestive and
      metabolic kinetics.
    


Intervention name(s): Casein-enriched diet; Milk soluble protein-enriched diet; Casein and milk soluble proteins-enriched diet; Soy proteins-enriched diet
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects consume for 9 days a supplement of 30g/d of casein; Subjects consume for 9 days a supplement of 30g/d of milk soluble protein; Subjects consume for 9 days a supplement of 30g/d of a mix of casein and milk soluble protein; Subjects consume for 9 days a supplement of 30g/d of soy protein
Intervention MeSH terms: Caseins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy subjects
A Study of the Efficacy and Safety of MEDI7352 in Subjects With Painful Osteoarthritis of the Knee
Condition: Painful Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2b randomised, double-blind, placebo-controlled, dose-response study in
      subjects with painful osteoarthritis (OA) of the knee. The study will assess the safety and
      efficacy of multiple doses of MEDI7352 compared to placebo, as well as the pharmacokinetics,
      pharmacodynamics and immunogenicity of MEDI7352 in subjects with moderate to severe chronic
      pain persistent for 3 months or more not adequately controlled by standard of care
      treatments.
    


Intervention name(s): MEDI7352; MEDI7352; MEDI7352; MEDI7352; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Dose A: MEDI7352 Q2W; Dose B: MEDI7352 Q2W; Dose C: MEDI7352 Q2W; Dose D: MEDI7352 Q2W; Placebo to match MEDI7352 Q2W
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a Phase IIb, multinational, multicentre, randomised, double-blind, placebo-controlled, dose-response study of MEDI7352 in participants 18 to 80 years of age (inclusive) with moderate-to-severe chronic pain of the knee. The study consists of a screening period of up to 45 days, a 12-week treatment period, and a 24-week follow-up (FU) period.
Daily pain scores (as measured on an 11-point numerical rating scale [NRS]) recorded at the first screening visit and from Day -7 to Day -1 will be used be used to determine eligibility.
Participants will be randomised to one of 4 doses of MEDI7352 or placebo. Each participant will receive 6 doses of MEDI7352 or placebo during the treatment period.
After the end-of-treatment (EOT) visit at Week 12, participants will enter the FU period, which comprises 3 clinic visits (Weeks 18, 32, and 36) and 4 FU phone calls (Weeks 15, 21, 24, and 28). All participants who receive IP are expected to complete the FU period.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoarthritis
Effects of Elastic Tape in Shoulder Movements in Hemiparetic Subjects
Condition: Stroke
Study type: Interventional

Summary: 
      The stroke is the second cause of death and the first of disabilities in the world. Although
      a motor spontaneous recovery is observed, around 50 to 70% of the hemiparetic upper extremity
      present alterations of upper extremity, limiting the performance of daily activities even
      after 2 to 4 years of strokes. More recently used in neurological rehabilitation, the ability
      to promote sensory-motor facilitation is given to the Elastic Tape (ET). However, its safety
      and efficacy in the treatment of post-stroke individuals still require further investigation.
      Thus, the objective of this project is to evaluate the immediate effects of ET, applied to
      the paretic shoulder on proprioception during movements of abduction and flexion of the
      shoulder and muscle activation and kinematic variables for the reaching in chronic
      hemiparetic. Fifteen subjects with chronic hemiparesis will participate these crossover
      sham-controlled trial. Participants will be randomized into two condition: elastic tape (ET)
      followed by sham tape (ST- strapping) or ST followed by ET. One month of washout period was
      considered. The motor impairment and the dominance before stroke will be evaluated by
      Fugl-Meyer scale and the Inventory Side dominance of Edinburgh, respectively. ET will apply
      deltoid (anterior, middle and posterior). Assessment before and after the application of ET
      will be performed. For proprioception assessment (joint position sense) will be evaluated
      using a dynamometer. Absolute error for shoulder abduction and flexion at the 30° and 60° was
      calculated. For the assessment of motor performance in a functional task (reach a glass of
      water), spatio-temporal parameters (total duration of the motion, peak velocity, time to peak
      velocity) and three-dimensional joint kinematics of the trunk, scapula, shoulder, and elbow
      (total range of motion, joint angle maximum and minimum) will be used. Concomitantly,
      bilateral activation of the deltoid (anterior, middle and posterior), trapezius (upper and
      lower), serratus anterior and pectoral major will be assessed by electromyography during
      reach. The following electromyographic variables will be analyzed: activation amplitude,
      muscle onset and maximum and minimum activation. For statistical analysis, the normality and
      homogeneity tests will be applied. If the variables have a distribution considered normal and
      homogeneous, Two-way ANOVA with repeated measures gift will be applied. Otherwise it will be
      applied to non-parametric statistics Friedman. Will be considered a 0.05 significance level
      for all statistical tests.
    


Intervention name(s): Elastic tape application in shoulder
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Efficacy and Safety of S 47445 Versus Placebo as Adjunctive Treatment in Depressed Patients Not Fully Recovered From Depressive Symptoms With a Current Antidepressant Treatment
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy and safety of S47445 versus placebo as
      adjunctive treatment of Major Depressive Disorder in patients with an inadequate response to
      antidepressant therapy.
    


Intervention name(s): S47445 15mg; S47445 50mg; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One tablet of S47445 15 mg taken orally once a day during breakfast concomitantly to the current selective serotonin reuptake inhibitor treatment, starting the day after inclusion visit and ending the day of the W8 visit.; One tablet of S47445 50 mg taken orally once a day during breakfast concomitantly to the current selective serotonin reuptake inhibitor treatment, starting the day after inclusion visit and ending the day of the W8 visit.; One tablet of placebo taken orally once a day during breakfast concomitantly to the current selective serotonin reuptake inhibitor treatment, starting the day after inclusion visit and ending the day of the W8 visit.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy Study of a Low Volume of Water Intake and Mosapride for Endoscopy in Patients With Subtotal Gastrectomy
Condition: Foreign Body Left During Endoscopic Examination
MeSH terms: Foreign Bodies
Study type: Interventional
Phase: Phase 3

Summary: 
      A low volume of water intake and mosapride will effectively reduce food residue in remnant
      stomach for patients who had undergone subtotal gastrectomy due to gastric cancer.
    

Detailed description: 
      We evaluate that a 500mL of water intake and mosapride will effectively reduce food residue
      in remnant stomach for patients who had undergone subtotal gastrectomy due to gastric cancer.
      We plan to compare this method with routine midnight fasting method for endoscopy in patients
      with subtotal gastrectomy.
    

Intervention name(s): Mosapride
Intervention type(s): Drug
Intervention description(s): Mosapride 10mg, one dosage, once evening of the day before the endoscopy
Other intervention name(s): Gasmotin
Intervention MeSH terms: Mosapride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Diagnostic
Keywords: Endoscopy; Gastrectomy; Stomach neoplasms
Assessment of Antibody Persistence in Children Previously Vaccinated With Pneumococcal Conjugate Vaccine
Condition: Infections, Streptococcal; Streptococcus Pneumoniae Vaccines
MeSH terms: Pneumonia; Pneumonia, Pneumococcal; Streptococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This protocol posting deals with objectives & outcome measures of the extension phase up to
      48-50 months post booster vaccination, to assess long-term antibody persistence in children
      at around 30, 42 and 66 months of age, who received previously 4 doses of pneumococcal
      conjugate vaccine. The objectives & outcome measures of the primary phase are presented in a
      separate protocol posting (NCT number = 00307554). This Protocol posting has been updated in
      order to comply with the FDA AA (Sep 2007).
    

Detailed description: 
      This study consists in a serological follow-up study to evaluate persistence 12, 24 and 48
      months after the booster vaccination study (107046). No study vaccines will be administered
      within this study.
    

Intervention name(s): GSK1024805A; Prevenar; Infanrix hexa; Havrix; Varilrix
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): No vaccination in this trial; No vaccination in this trial; No vaccination in this trial; No vaccination in this trial; No vaccination in this trial
Other intervention name(s): Synflorix
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Streptococcus pneumoniae; Haemophilus influenzae; Pneumococcal conjugate vaccine; Antibody persistence