bioihbjkbjnl/mcl2 huggingface dataset:
The Improvement of Intraoperative Neuromonitoring of Recurrent Laryngeal Nerve
Condition: Thyroid Intra-Operative Injury
MeSH terms: Thyroid Diseases
Study type: Interventional

Summary: 
      Objectives: The use of neuromuscular blocking agent may interfere with the function of
      intraoperative neuromonitoring (IONM) in thyroid surgery.
    

Detailed description: 
      An enhanced neuromuscular-blockade (NMB) recovery protocol was investigated in a clinically
      applied during thyroid neural monitoring surgery. In as subsequent clinical application
      study, 60 patients who underwent thyroidectomy with IONM followed an enhanced NMB recovery
      protocol- rocuronium 0.6 mg/kg at anesthesia induction and sugammadex 2 mg/kg at operation
      start. Train-of-four (TOF) ratio was used for continuous quantitative monitoring of
      neuromuscular transmission.
    

Intervention name(s): sugammadex
Intervention type(s): Drug
Intervention description(s): standard general anesthesia protocol with sugammadex
Other intervention name(s): Bridion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: intraoperative neural monitoring
Viapaed Study In Children And Adolescents With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      Asthmatic children who remain symptomatic on inhaled corticosteroids (ICS) require an
      adjustment of their asthma therapy. Current guidelines suggest that the treatment options are
      either an increased dose of inhaled corticosteroid or the addition of other therapy such as a
      long-acting beta-agonist (LABA). In the pediatric age range, major concerns with respect to
      high dose ICS therapy are growth retardation and the suppression of the
      hypothalamic-pituitary-adrenocortical (HPA) axis. Previous studies in adults have shown that
      a combination product that included a LABA as well as the ICS allowed to reduce the steroid
      dose and was still at least as effective in achieving asthma control as treatment with a
      higher dose of ICS. These treatment options shall be compared in the present study. Children
      who remain symptomatic while inhaling 100 µg fluticasone (FP) twice daily shall be randomized
      to receive the salmeterol/ fluticasone combination product, Viani (SERETIDE) 50/100 µg, or
      fluticasone 200 µg as a comparator drug, inhaled twice daily via the DISKUS for a period of
      eight weeks.
    


Intervention name(s): Salmeterol/fluticasone; Fluticasone propionate; Salbutamol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Salmeterol/ fluticasone are a type of long acting beta-agonist (LABA). Salmeterol 50 microgram/ fluticasone 100 microgram combination will be administered to eligible subjects via inhalation route.; Fluticasone propionate is a type of LABA. Fluticasone 100 microgram dose will be administered to eligible subjects via inhalation route.; Salbutamol metered dose inhaler will be provided to all subjects as a rescue medication.
Other intervention name(s): Salmeterol; SERETIDE
Intervention MeSH terms: Fluticasone; Xhance; Albuterol; Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: moderate asthma; fluticasone; children; salmeterol; steroid-sparing; Asthma
Safinamide as Add-On Therapy in Patients With Early Idiopathic Parkinson's Disease Treated With a Stable Dose of a Single Dopamine Agonist
Condition: Idiopathic Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the safety and efficacy of two dose ranges of safinamide (High Dose: 150 to 200
      mg/day and Low Dose: 50 to 100 mg/day) orally, as compared to Placebo, as add-on therapy in
      patients with early idiopathic Parkinson's disease who are currently receiving a stable dose
      of a single dopamine agonist. It is hypothesized that, over a 24-week period, add-on
      treatment with safinamide will result in greater improvement of motor symptoms in these
      patients, compared to treatment with a dopamine agonist alone.
    


Intervention name(s): Safinamide; Safinamide; Placebo
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson Disease
Analgesic Efficacy and Safety of V116517 in Subjects With Moderate to Severe Chronic Pain Due to Osteoarthritis (OA) of the Knee
Condition: Osteoarthritis, Knee; Pain
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Chronic Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the analgesic efficacy of 2 dose levels of
      V116517 versus placebo.
    


Intervention name(s): V116517 50-mg tablets; V116517 30-mg tablets; Naproxen 500-mg capsules; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Taken orally twice daily; Taken orally twice daily; Taken orally twice daily; Tablets to match V116517 and/or placebo capsules to match naproxen taken orally twice daily
Intervention MeSH terms: Naproxen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pain; Osteoarthritis; Knee
The Effects of Omalizumab (Anti-IgE) on the Late-phase Response to Nasal Allergen Challenge
Condition: Cat Allergy
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      This research is being done to study the effects of the drug omalizumab (Xolair) in people
      with cat allergies. The investigators will use omalizumab to study changes in the cells in
      the nose, cells in the blood and cells in the skin that cause allergies. The investigators
      will compare the changes in the nose to changes in the skin and blood cells.

      Objective: To test the hypothesis that treatment with omalizumab will decrease the nasal
      allergen challenge late-phase eosinophil count in nasal brushings at the time when blood
      basophils have become hypo-responsive to in vitro allergen exposure.
    

Detailed description: 
      This is a randomized, placebo-controlled, double-blind, parallel group design study that
      includes 3.5 months of treatment with omalizumab or placebo and a 3 month follow-up. All
      subjects will be cat allergic.

      Twenty four subjects (1:1 randomization) will undergo a cat allergen nasal challenge prior to
      treatment and another challenge after 2 months of treatment or when their blood basophils
      become hyporesponsive to cat allergen in vitro. A second group of 10 subjects (1:1
      active:placebo), will not undergo nasal challenges. This group will participate in an
      ancillary study in which the effects of omalizumab on gene expression profiles in peripheral
      blood cells will be studied.
    

Intervention name(s): Omalizumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks.; Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks.
Other intervention name(s): Xolair; Anti-IgE
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: cat allergy
The Effect of Wearing the 'Nike Free'Shoe on Isokinetic Muscle Strength of Foot and Ankle and on Proprioception.
Condition: Healthy
Study type: Interventional

Summary: 
      To evaluate the effect of wearing the 'Nike Free'Shoe on isokinetic muscle strength of foot
      and ankle and on proprioception the following protocol will be used.

      The test population consists out of students of the physical education department. They will
      at random be divided in three groups. One group will wear the shoe only for daily activities,
      the second group will wear the shoes for the warming up part of the sport classes and the
      control group will not wear the shoe at all. There will be two moments for evaluation: one at
      the beginning of the study and one after four months, during which the shoe will be used. The
      isokinetic strength will be measured with an isokinetic device (Biodex) and the
      proprioception will be evaluated with a force platform (Neurocom Balance Master).
    


Intervention name(s): Wearing the "Nike Free" shoe
Intervention type(s): Device
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Barriers to Substance Use Disorder Recovery
Condition: Substance Use Disorders
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      The study purpose is to investigate how an inpatient recovery coaching intervention can
      overcome or mitigate specific risk factors and barriers to initiating and maintaining
      Substance Use Disorder recovery. This study will offer insight into how and why an inpatient
      link to recovery coaching is effective for promoting long-term Substance Use Disorder
      recovery.
    

Detailed description: 
      Substance Use Disorder (SUD) is a prevalent disease that impacts an estimated 24 million
      Americans each year. The life-altering consequences of SUD are both diverse and severe,
      influencing mortality, the workplace, and economics. The goal of this study is to determine
      how specific risk factors of relapse and barriers to recovery, including neurocognitive,
      health, personal, social, financial, and situational barriers, can be overcome or changed
      through a recovery coaching intervention. This work seeks to provide a mechanism to
      demonstrate exactly how and why this potential new model of care (recovery coaching) is
      effective, rather than simply assessing if it can work. To accomplish this aim, the change
      between baseline and 6-month assessments will be assessed. Then, the difference in the change
      between individuals assigned to the current standard of care and patients assigned to
      inpatient recovery will be compared.
    

Intervention name(s): Recovery Coach Intervention
Intervention type(s): Behavioral
Intervention description(s): Participants randomized to the intervention arm are linked to a recovery peer coach while they are in the hospital. Recovery peer coaches are provided to the participant by Faces and Voices of Recovery (FAVOR) - Greenville. Recovery coaches are Certified Peer Support Specialists (CPSS), individuals who have firsthand experience in successful recovery and are trained in using recovery-oriented tools to help peers overcome addiction. FAVOR offers immediate access to a personal coach, a local center, and assistance to off-site intervention and recovery resources in the community. They provide twice weekly contact with participants.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The investigator/study personnel inform the participant regarding which arm they have been assigned and inform a recovery coach if the participant is randomized to the intervention arm.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: recovery coaching; risk factors; substance abuse; EEG
Transobturator Approach for Paravaginal Repair
Condition: Cystocele
MeSH terms: Cystocele
Study type: Interventional

Summary: 
      A new technique for Applying sutures to the white line in paravaginal repair.
    

Detailed description: 
      A new trial for transobturator repair of the paravaginal defect.
    

Intervention name(s): transobturator approach for paravaginal repair
Intervention type(s): Procedure
Intervention description(s): using TOT needle to apply suturs to white line
Intervention model: Single Group Assignment
Intervention model description: All Patients included in the study will undergo repair of paravaginal defect using tge new technique described in this study
Masking: None (Open Label)
Primary purpose: Treatment
A Study on the Effects of LY2409021 on the Electrical Impulses of the Heart
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Part A: The purpose of Part A of the study is to look at the electrocardiogram (ECG) effects
      due to blood sugar changes after a meal compared to when LY2409021 is also given with a meal.

      Part B: The purpose of Part B is to evaluate the effect of LY2409021, when given at a dose
      level much higher than what would normally be given, on the electrical activity of the heart
      as measured by ECG in relation to placebo and moxifloxacin.
    

Detailed description: 
      This is a 2 part study. Part A is a single-dose study to compare the effects of a meal on
      glucose, insulin and QT in healthy participants with and without LY2409021. Part B of this
      study is a randomized, 3-period, crossover design, in which participants and investigators
      are blinded to placebo and LY2409021, and will assess the electrophysiological effects of a
      single supratherapeutic dose of LY2409021 compared to a positive control (moxifloxacin) and
      placebo.
    

Intervention name(s): LY2409021; Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Prehabilitation Physical Activity in Persons With Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 4

Summary: 
      Knee joint osteoarthritis (OA) reduces functional mobility and performance of daily tasks
      such as rising from a chair. Therefore interventions aimed at improving muscle strength and
      sit-to-stand task performance are very important for these patients. The effect of exercise
      programs, including home exercise programs (HEP), on muscle strength, joint pain and function
      is well known and widely researched, yet not many studies have investigated the effect of an
      HEP on electromyographic activity (EMG) of muscles when performing everyday tasks, such as
      rising from and sitting on a chair. The aim of this study was to investigate effect of
      prehabilitation in women with severe knee joint OA scheduled for knee joint arthroplasty
      (TKA).
    


Intervention name(s): therapeutical exercises
Intervention type(s): Other
Intervention description(s): Participants of experimental group performs daily an 8-week home therapeutical exercise program. Exercises are periodized by weeks (1-8 weeks). The aim of program is the leg muscle strengthening using an elastic band (Thera-Band, System of Progressive Exercise, USA), body balance training, and leg muscle stretching.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
MMR Vaccination Among HIV-infected Adults
Condition: HIV
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prevalence study of protective antibodies to measles, mumps, and rubella (MMR) in
      HIV-infected adults and HIV-uninfected controls. MMR vaccination were provided to both groups
      who had no protective antibodies to at least one of the three viruses.
    

Detailed description: 
      From July to August 2011, 500 HIV-infected and 132 HIV-uninfected participants those met the
      eligibility criteria were enrolled and tested for protective antibodies to measles, mumps,
      and rubella.

      All participants who had no protective antibody to at least one of the three viruses were
      recruited to vaccinate for MMR vaccine. Between June to September 2012, 249 HIV-infected and
      46 HIV-uninfected adults were vaccinated. Antibodies to MMR were measured at week 8-12, and
      week 48 after vaccination, which were completed in August 2013. The results were ready for
      analysis in March 2014.
    

Intervention name(s): 0.5 ml of MMR vaccine
Intervention type(s): Biological
Intervention description(s): Participants in each arm received the same vaccine, a 0.5 ml of MMR vaccine at deltoid region
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: MMR; vaccination; HIV; Serologic response
Transitional Care Study 3
Condition: Surgery--Complications
Study type: Interventional

Summary: 
      In this study patients with elective surgery will wear two devices (HealthDot and Elan) after
      surgery in hospital and after discharge at home for up to 2 weeks (HealthDot) or 3 weeks
      (Elan). The HealthDot will measure heart rate, posture, activity and respiratory rate which
      are stored on the device as well as sent to Philips. The Elan device will measure PPG and
      accelerometer data which is transferred to Philips. The data collected will be used for
      algorithm development. Data will be analysed retrospectively and compared to readmission and
      adverse events to see if the events could have been predicted due to the collected data by
      the devices. No clinical decisions will be based on the measurements done during the study.
    


Intervention name(s): Elan and HealthDot
Intervention type(s): Other
Intervention description(s): Patients with elective surgery will wear two devices (HealthDot and Elan) after surgery in hospital and after discharge at home for up to 2 weeks (HealthDot) or 3 weeks (Elan).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Comparative Study to Evaluate the Effect of HSP-130, US-approved Neulasta and EU-approved Neulasta in Healthy Participants
Condition: Neutropenia
MeSH terms: Neutropenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is for healthy participants. This study tests single dose of the research drug
      HSP-130 against two existing approved drugs United States - approved Neulasta and European
      Union-approved Neulasta.
    

Detailed description: 
      There will be 25 healthy participants in each of the six sequence groups. A total of 150
      participants will be studied in one site in Australia. In addition to the 150 participants
      included, alternate subjects will be asked to come to the site on the day prior to when
      dosing is scheduled to begin. There will be 3 treatment options with 3 study dosing periods
      (1, 2 and 3) and at least 56 days between each treatment. The subject once asked to take part
      in the study will be assigned by chance (randomized) to one of the sequence groups as
      mentioned above (1, 2, 3, 4, 5, or 6).
    

Intervention name(s): HSP-130; US-approved Neulasta; EU-approved Neulasta
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): Pegylated filgrastim; Pegfilgrastim, Amgen; Pegfilgrastim, Amgen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: HSP-130; Pharmacodynamic and Pharmacokinetic equivalence; Pegfilgrastim
Lactobacillus Reuteri in Management of Helicobacter Pylori Infection in Dyspeptic Patients
Condition: Helicobacter Pylori Infection
MeSH terms: Infections; Communicable Diseases; Helicobacter Infections
Study type: Interventional

Summary: 
      Addition of L. reuteri to the standard triple therapy improves H. Pylori treatment outcomes.
    

Detailed description: 
      Helicobacter pylori (H. Pylori) infection is a wide spread disease and is endemic in many
      countries including Egypt with a wide range of morbidity; that requires appropriate
      antimicrobial therapy . However, worldwide the eradication rate following the standard triple
      therapy is declining and this may necessitates introduction of new antimicrobial agents . On
      the sight of bearing in vivo and in vitro activity against H. Pylori, the use of different
      strains of probiotics in treatment of H. Pylori may be thus justifiable, Lactobacillus
      reuteri (L. reuteri) which through different mechanisms including production of reuterin have
      anti H.pylori activity have been tried in improving the eradication rates of H.pylori with
      contradictory results . This study is conducted to test the assumption that addition of L.
      reuteri to the standard triple therapy in treatment of H. Pylori improves the eradication
      rates and clinical aspects in H. Pylori infection.
    

Intervention name(s): Lactobacillus reuteri; Placebo; Omeprazole; Amoxicillin; Clarithromycin
Intervention type(s): Dietary Supplement; Dietary Supplement; Drug; Drug; Drug
Intervention description(s): Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks.; Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks.; All patients will receive omeprazole 20 mg b.i.d for 2 week; amoxicillin 1000 mg b.i.d for 2 weeks; clarithromycin 500mg b.i.d for 2 weeks
Intervention MeSH terms: Amoxicillin; Clarithromycin; Omeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Helicobacter pylori; Lactobacillus reuteri; dyspeptic patients; eradication
Interactive Digital Game for Improving Visual Perceptual Defects in Children With Developmental Disability
Condition: Developmental Disability
MeSH terms: Developmental Disabilities
Study type: Interventional

Summary: 
      Visual perceptual defects in children can negatively affect their activities of daily
      living.The aims of this study were to develop and evaluate an interactive digital game system
      for correcting visual perceptual defects and to evaluate the effectiveness of the proposed
      system.
    


Intervention name(s): Visual-perceptual interactive game system; standard rehabilitation
Intervention type(s): Device; Behavioral
Intervention description(s): Subjects received 30-min interactive digital game training session per week. The game system contain 7 skills training, each of which was named according to the corresponding TVPS-3.; Subjects received the standard 4-week course of rehabilitation delivered in one 30-min session per week. The course of rehabilitation included: sensory integration therapy, cognitive function training and visual perception/auditory attention training.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment