bioihbjkbjnl/mcl2 huggingface dataset:
Assessing of Tooth Sensitivity Using Ibuprofen Before in Office-tooth Bleaching
Condition: Inflammation; Pulpitis
MeSH terms: Pulpitis; Dentin Sensitivity; Inflammation
Study type: Interventional

Summary: 
      Ibuprofen has been recognized as anti-inflammatory and analgesic. The purpose of this study
      is to determine the effect of ibuprofen 400 mg on tooth sensitivity (TS) caused by in-office
      bleaching.

      Methods: 30 health adults who received either placebo or ibuprofen. The drugs were
      administered 1 hour prior to the bleaching and will be prescribed 5 doses every 8 hours
      during 48 hours. For bleaching will be used 35% hydrogen peroxide gel. The tooth sensitivity
      will be recorded for up and lower arc on two scales: VAS (visual analogic scale) and 0-4. The
      shade evaluation will be performed before and 30 days after bleaching with visual shade guide
      and spectrophotometer.
    

Detailed description: 
      Background: Ibuprofen has been recognized as anti-inflammatory and analgesic. The purpose of
      this study was to determine the effect of ibuprofen 400 mg on tooth sensitivity (TS) caused
      by in-office bleaching.

      Methods: A triple-blind, parallel design, randomized clinical trial will be conducted on 30
      health adults who received either placebo or ibuprofen. The drugs will be administered 1 hour
      prior to the bleaching and a every eight hours during 48 hours. For bleaching used 35%
      hydrogen peroxide gel. The TS will be recorded for up and lower arc on two scales: VAS and
      0-4. The shade evaluation will be performed before and 30 days after bleaching with visual
      shade guide and spectrophotometer. The % of patients that reported TS at least once during
      treatment and the TS intensity will be evaluated by Fisher's and Mann-Whitney tests,
      respectively. The color changes will be evaluated by repeated measures ANOVA.
    

Intervention name(s): Ibuprofen.
Intervention type(s): Drug
Intervention description(s): Ibuprofen Group will be receive a dose of non-steroidal antiinflammatory drug ibuprofen 400 mg. All the participants will be watched to ensure that they took the drugs 1 hour prior to treatment. A second dose of ibuprofen (400 mg), will be administered a every 8 hours after the first dose during 48 hours.
Other intervention name(s): Uniprofen / National Pharmaceutical Chemistry União S / A.
Intervention MeSH terms: Ibuprofen
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Analgesics; Ibuprofen; Inflammation; Tooth Bleaching
Prospective Clinical Evaluation of Periodontal Response to Different Prosthetic Margin Design
Condition: Gingival Recession; Gingival Disease; Gingival Bleeding
MeSH terms: Gingival Recession; Gingival Diseases; Gingival Hemorrhage
Study type: Interventional

Summary: 
      Background: The actual literature is consistent in considering potential negative effects of
      sub-gingival prosthetic margins on the periodontal health, but no research has focused the
      attention on the type of prosthetic margin designs. Hence, the aim of the present study is to
      evaluate if a horizontal finishing line (deep chamfer preparation) may have a different
      influence on periodontal soft tissue in comparison with a vertical finishing line (feather
      edge preparation).

      Methods: A prospective randomized controlled double blind clinical trial with one single
      operator and three experienced examiners was performed. One hundred and six crowns were
      prepared with horizontal tooth preparation while ninety-four with vertical tooth preparation.
      All the margins were positioned within the periodontal sulcus, at 0.5mm sub-gingivally and
      all the all-ceramic restorations were cemented with resin cement. Periodontal Probing Depth
      (PPD), Plaque Index (PI), Gingival Index (GI) and Gingival Bleeding on Probing (BOP) were
      recorded prior to tooth preparation and twelve month after crown cementation. Also, at 12
      months follow-up, the gingival margin position was related to the crown margin position.
    


Intervention name(s): Horizontal Tooth preparation; Vertical Tooth preparation
Intervention type(s): Procedure; Procedure
Intervention description(s): Round parallel chamfer diamond burs were used for teeth preparation; coarse first (151 micron) and extra-fine after (25 micron); Long flame diamond burs were used for teeth preparation; coarse first (151 micron) and extra-fine after (25 micron)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Mouse Allergen and Asthma Intervention Trial
Condition: Asthma; Mouse Allergy; Mouse Allergen Exposure
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The MAAIT is a randomized, controlled trial of a home intervention to reduce mouse allergen
      exposure in mouse allergic children with asthma and mouse allergen exposure. Participants
      will be randomized to either the Integrated Pest Management (IPM) Group or the Education
      Group. The IPM Group will receive professional mouse abatement, education, two HEPA filters,
      allergen-proof mattress and pillow encasements, and targeted cleaning. The Education Group
      will receive education about IPM at the beginning of the trial and then after completion of
      the trial, will receive the IPM intervention. Participants will be followed for 12 months.
    


Intervention name(s): Integrated Pest Management; Education
Intervention type(s): Other; Other
Intervention description(s): The IPM intervention will include professional mouse abatement, two HEPA filters, targeted cleaning, education about IPM, and allergen-proof mattress and pillow encasements. The intervention will be delivered at baseline to the IPM Group, and then repeated if recurrent or persistent mouse infestation is present.; This group will receive education about mouse IPM.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: asthma; mouse allergen; environmental intervention
A Study to Evaluate the Safety and Pharmacokinetics of HH-120 Nasal Spray in Healthy Volunteers
Condition: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a clinical study evaluating the safety, tolerability, pharmacokinetic (PK)
      characteristics and immunogenicity of HH-120 nasal spray in healthy subjects. This study is
      divided into two parts: Part A is of open-label design and mainly aims to assess the local
      distribution and PK in nasal cavity of HH-120 nasal spray, subjects from 10 cohorts are
      sequentially enrolled to perform either nasal endoscopic examination or nasal/ nasopharyngeal
      samples collection at different time points post administration. Part B mainly aims to assess
      the safety, systematic pharmacokinetic and immunogenicity after multiple dosing of HH-120
      nasal spray, subjects are randomly assigned (3:1) to HH-120 and placebo groups.
    


Intervention name(s): HH-120 nasal spray, PartA cohort 1; HH-120 nasal spray, Part A cohort 2-7; HH-120 nasal spray, Part A cohort 8-9; HH-120 nasal spray, Part B; Placebo nasal spray, Part B
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention description(s): A single dose of HH-120 nasal spray premixed with 1mg/ml methylene blue injection.; A single dose of HH-120 nasal spray.; Two doses of HH-120 nasal spray.; HH-120 nasal spray, 10 times daily for 7 consecutive days.; Placebo nasal spray, 10 times daily for 7 consecutive days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Postoperative Discomfort After Dental General Anesthesia
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The aim of this prospective, randomised, controlled clinical trial was to compare immediate
      postoperative discomfort, emergence delirium and recovery time of the patients intubated
      using either laryngeal mask airway or nasotracheal intubation.
    

Detailed description: 
      A total of 70 children aged 3 to 7 years received full mouth dental rehabilitation under
      general anesthesia. Children were randomly grouped into Laryngeal mask airway (LMA) group
      (n=35) and nasotracheal intubation (NTI) groups (n=35). In LMA group LMA was inserted after
      anesthesia induction using 8% sevoflurane. In NTI group rocuronium and remifentanil were
      given intravenously during %8 sevoflurane induction and the patients were intubated by a
      nasotracheal tube. After completion of the dental treatments patients were transferred to the
      post anesthesia care unit (PACU). Duration of dental operation ,duration of anesthesia,
      recovery time, postoperative discomfort, emergence delirium, pediatric dentist's access were
      recorded.
    

Intervention name(s): Laryngeal mask airway; Nasotracheal intubation
Intervention type(s): Device; Device
Intervention description(s): Laryngeal mask airway; Nasotracheal intubation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: laryngeal mask airway; nasotracheal intubation; dental treatment
Intranasal Dexmedetomidine Premedication
Condition: Benign Neoplasm of Vocal Fold - Glottis
MeSH terms: Neoplasms
Study type: Interventional

Summary: 
      Most patients with preoperative varying degrees of stress, anxiety, which makes the stress
      response in patients and affect the normal conduct of anesthesia and surgery.The sympathetic
      system hyperexcitability prone to cause adverse cardiovascular events and affect
      postoperative recovery. However, phenobarbital, as the traditional premedication, has less
      sedative, weak anxiolytic and other shortcomings. Midazolam accompanied by inhibition of
      respiration,excessive sedation, easily induced delirium,prolonged recovery time and so on.
      Dexmedetomidine is a highly selective α2-adrenergic receptor agonist, it has sedative,
      anxiolytic, no inhibition of respiration, and also colorless, odorless, non-mucosal
      stimulation, nasal drip ease of administration, patient acceptance, comfortable. Therefore,
      dexmedetomidine as premedication has certain advantages. The purpose of this research is to
      study sedative effect, safety and the impact of anesthesia recovery period of intranasal
      dexmedetomidine premedication for suspension laryngoscopy.
    

Detailed description: 
      All patients received intranasal dexmedetomidine (1μg.kg-1) or placebo at approximately 45
      min before induction of anesthesia.The study drug was prepared in a 1-ml syringe.An equal
      volume of dexmedetomidine or placebo was dropped into each nostril by a blinded research
      assistant in the supine position.Automatic sphygmomanometer measure blood pressure.Oxygen
      saturation and heart rate were measured by a pulse oximeter. Respiratory rate, sedation score
      and anxiety levels regularly assessed. Patients with general anesthesia, suspension
      laryngoscopy surgery and postoperative care, standard monitoring are unified.
    

Intervention name(s): Dexmedetomidine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia.; 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia.
Other intervention name(s): intranasal dexmedetomidine; saline
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: intranasal; dexmedetomidine; early recovery; suspension laryngoscopy
Impact of Intensive Exercise Training on Coronary Collateral Circulation in Patients With Stable CAD
Condition: Stable Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      Exercise training in patients with coronary artery disease is able to correct several risk
      factors. Furthermore endothelial function can be improved.

      There are some hinds for improved collateral circulation after exercise training,
      nevertheless there is no study showing significant improvement/ increase in coronary
      collaterals. This might be due to technique of collateral measurement. Therefore we conduct a
      study were coronary blod flow before and after 4 weeks of exercise training were measured.
    


Intervention name(s): exercise training; Intensive exercise training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): exercise training min. 4 times a day for at least 30 min; Intensive exercise training for 4 times / day incl. interval training at 95% individual threshold
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stable coronary artery disease; significant coronary stenosis
Probiotics On Resistant Bacteria Colonization In Preterm Receiving Antibiotics
Condition: Infant, Premature, Diseases
MeSH terms: Infant, Premature, Diseases
Study type: Interventional

Summary: 
      In this study, the investigators investigated the effect of probiotic use on colonization of
      resistant microorganisms in newborn preterm infants receiving antibiotics. This study of the
      use of probiotics in preterm neonates in neonatal intensive care units expect to prevent
      colonization by resistant microorganisms.
    

Detailed description: 
      The gut which is sterile in newborn preterm infants begins to colonize with birth. Factors
      such as developmental immaturity of the immune system, encountering with the flora of
      neonatal intensive care unit, exposure to diagnostic and therapeutic interventional
      procedures, use of antibiotics, delay of enteral feeding may poorly affect the development of
      natural and mucosal immunity of intestine in newborns preterm during postnatal period.
      Exposure to these factors, newborn preterm infants' life threatens especially to change the
      development of the normal intestinal flora and intestinal immunity. Many randomized
      controlled studies reported that probiotics reduce intestinal inflammatory process and
      prevent colonization with pathogenic microorganisms of the intestines . In this study, the
      investigators investigated the effect of probiotic use on colonization of resistant
      microorganisms in newborn preterm infants receiving antibiotics.
    

Intervention name(s): Lactobacillus reuteri (biogai AB, Sweden)
Intervention type(s): Dietary Supplement
Intervention description(s): Lactobacillus reuteri (biogai AB, Sweden) was given to probiotic group, same way to all newborn newborn preterm infants, directly oral feeding and without any along with a mixture, admission following the in nicu, as a daily dose 1x108 cfu / day (1x5 drops / day) during hospitalization
Other intervention name(s): Probiotics were randomly given to newborn preterm infants.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Newborn, preterm, probiotic, resistant microorganisms
Effects of a Synbiotics-containing Starter Formula on Infant Growth
Condition: Infant Nutrition
Study type: Interventional

Summary: 
      In this study the investigators want to evaluate the satiety of two infant formulas, one
      containing prebiotics and the other containing synbiotics. Rate of weight gain, a proxy
      measurement for the healthy development of an infant, will be assessed in both groups and
      compared to the growth observed in the WHO Child Growth Standards in order to demonstrate non
      inferiority.
    

Detailed description: 
      Growth studies continue to be a centrepiece of clinical evaluation of infant formulas. In
      order to standardize growth, the investigator proposes to calculate the weight-for-age
      Z-score related to the WHO Child Growth Standards. Z-scores express the difference between
      the measurement of an individual and the median value of the reference population as a
      proportion of the SD of the reference population taking into account age and gender.

      The hypothesis to be tested is that infants fed with starter formula with prebiotics and
      probiotics blend and those fed only with probiotics will grow as much as infants in the
      reference growth of WHO.

      Other parameters such as digestive tolerance, frequency of morbidity and microbiota pattern
      will also be investigated.
    

Intervention name(s): Standard infant formula with prebiotics; Infant formula with synbiotics
Intervention type(s): Other; Other
Intervention description(s): From 0-6 months of age. As per standard requirement; From 0-6 months of age as per standard requirement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: infants; prebiotics; probiotics; safety
Expiratory Rib Cage Compression in Mechanically Ventilated Patients
Condition: Pulmonary Infection
MeSH terms: Infections
Study type: Interventional

Summary: 
      This is a randomized crossover study, designed to evaluate if the manual expiratory rib cage
      compression technique improves respiratory mechanics and is effective in secretion removal in
      mechanically ventilated patients.
    

Detailed description: 
      Chest physiotherapy is an essential component of the multidisciplinary approach in critical
      care settings. In this context, a number of devices and manual techniques have been used to
      remove pulmonary secretions and re-expand collapsed areas. This study was designed to
      evaluate whether manual rib cage compression improves airway clearance and respiratory
      mechanics in mechanically ventilated patients. In a randomized crossover trial, 20
      mechanically ventilated patients underwent thoracic manual compression and control
      intervention (normal ventilation) at the same day. The main outcomes were sputum production
      and the changes in respiratory mechanics.
    

Intervention name(s): Expiratory Rib Cage Compression
Intervention type(s): Other
Intervention description(s): The therapist hands were positioned on the lower ribs, and the force was applied every two breaths only during the expiration, synchronizing the maneuver rate with the patient's respiratory rate. Then, the patients underwent a suctioning procedure, and a hyperinflation maneuver consisting of a 10 minutes period under pressure support ventilation of 35 cmH2O was done. In control intervention instead of the compressive maneuver the patients were kept on normal ventilation.
Other intervention name(s): Manual thoracic compression
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: mechanical ventilation; chest physiotherapy; critical care; pneumonia; Mechanically ventilated patients with pulmonary infection.
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Adenovirus Serotype 26 Based Respiratory Syncytial Virus Pre-fusion (Ad26.RSV.Pre-F) Vaccine in RSV-Seronegative Toddlers 12 to 24 Months of Age
Condition: Respiratory Syncytial Virus
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to assess the safety and reactogenicity of an intramuscular
      regimen of 3 doses of 2.5*10^10 viral particles (vp) of adenovirus serotype 26 based
      respiratory syncytial virus pre-fusion protein (Ad26.RSV.preF) vaccine in RSV-seronegative
      toddlers aged 12 to 24 months.
    

Detailed description: 
      RSV is considered the most important cause of serious acute respiratory illness in children
      under 5 years of age. Ad26.RSV.preF (JNJ-64400141) investigational vaccine is a
      replication-incompetent serotype 26 adenoviral vector (Ad26) containing a deoxyribonucleic
      acid (DNA) transgene that encodes for the F protein derived from the respiratory syncytial
      virus (RSV) A2 strain stabilized in the pre-fusion conformation (Ad26.RSV.preF). The study
      will evaluate whether Ad26.RSV.preF is safe, well-tolerated, and immunogenic in
      RSV-seronegative toddlers. The study will have 3 phases: a screening phase (up to 6 weeks
      before the first dose), a vaccination phase (34 weeks), and a safety follow-up phase through
      2 RSV seasons after the first dose. RSV infection will be monitored by active and passive
      surveillance. The total duration of the study will be approximately 26 months.
    

Intervention name(s): Ad26.RSV.preF; Placebo; Nimenrix
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Ad26.RSV.preF will be administered as IM injection at a dose of 2.5*10^10 vp.; Placebo will be administered as IM injection of sterile 0.9 percent (%) saline for injection.; Nimenrix will be administered as 0.5 milliliter (mL) solution for IM injection.
Other intervention name(s): JNJ-64400141
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
A Study in Patients With Venous Leg Ulcers and Measuring the Effects of Using Geko™ Device
Condition: Venous Leg Ulcer
MeSH terms: Varicose Ulcer; Leg Ulcer; Ulcer
Study type: Interventional

Summary: 
      This is a single centre open label study measuring lower limb physiology in patients with
      venous leg ulcers at the University Hospital of South Manchester.

      Ambulatory venous pressure, venous transit times, wound bed tissue oxygenation and changes in
      microcirculation will be measured at baseline after the gekoTM device is activated.
      Ambulatory venous pressure and venous transit times will be performed whilst the participant
      is standing, sitting and supine
    


Intervention name(s): geko™ device
Intervention type(s): Device
Intervention description(s): The geko™ (T-2 and R-2) devices are small disposable, internally powered, neuromuscular stimulators that are applied externally to the leg.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Phase 2b Study of Icosabutate in Fatty Liver Disease
Condition: Non Alcoholic Steatohepatitis (NASH)
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2b study to evaluate the efficacy of different doses of NST-4016 on the resolution of
      NASH without worsening of fibrosis
    

Detailed description: 
      This is a 62 week (including screening and follow-up), multicenter, randomized, double blind,
      placebo-controlled, parallel group study in male and female patients with a histological
      diagnosis of NASH. The study includes a screening period, double blind treatment period, and
      post-treatment follow up
    

Intervention name(s): Icosabutate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Icosabutate oral capsule once daily; Matching placebo oral capsule
Other intervention name(s): NST-4016
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment