bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation Of Different Rapid Orthodontic Expansion Devices
Condition: Cross Bite
MeSH terms: Malocclusion
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluating and comparing the short term effects of different palatal expanders on the amount
      of palatal expansion and buccal tipping of posterior teeth.

      Hypothesis:

      H0: There is no difference in the short term effects between the different palatal expanders.

      H1: There is a significant difference in the short term effects between the different palatal
      expanders.
    


Intervention name(s): Rapid Expansion of palatal suture
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Toothbrush Bristles in Plaque Reduction
Condition: Plaque, Dental; Gingivitis
MeSH terms: Gingivitis; Dental Plaque
Study type: Interventional

Summary: 
      The purpose of this cross-over clinical research is to evaluate the cleaning efficacy of
      toothbrushes tufted with two types of tapered bristles and end rounded bristles in removal of
      interdental plaque with clinical measurement (Plaque Index) and objective measurement
      (digitally measured plaque area). This study will demonstrate the influence by a type of
      processing bristles on removal of interdental plaque and determine an agreement between the
      different evaluation methods.

      This is a randomized evaluator-masked crossover study with 10 subjects. Subjects will be
      randomly allocated to three test groups. Subjects will use the assigned toothbrush at
      baseline appointment and two times a day for a week. Plaque Index and plaque area will be
      assessed before/after one time use at baseline and Day 7. Subjects will be assigned to
      another toothbrush after one week wash-out period.
    


Intervention name(s): Tapered bristles A; Tapered bristles B; End rounded bristles
Intervention type(s): Device; Device; Device
Intervention description(s): Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week .; Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week.; Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Device Feasibility
Peri-neural Dexmedetomidine Versus Dexamethasone for Supraaclavicular Block Adjuvant to Bupivacaine Supraclavicular Brachial Plexus Block
Condition: Brachial Plexus Block
Study type: Interventional

Summary: 
      to assessthe impact of addition of Dexmedetomidine or Dexamethasone to Bupivacaine, on
      Duration of analgesia (time in hours to the first report of postoperative pain )at the
      surgical site
    

Detailed description: 
      This randomized, controlled double blinded study included 42 adult patients undergoing
      arteriovenous fistula surgery. Ultrasound-guided supraclavicular brachial plexus block was
      initiated after placement of full monitoring . Supraclavicular brachial plexus block was
      achieved with the use of total volume 32 ml of anesthetic drugs in all patients. Bupivacaine
      30 ml 0.25% was combined with 2 ml normal saline (control group A, n=14), Bupivacaine 30 ml
      0.25% was combined with 50 microgram (0.5 ml) peri-neural dexmedetomidine plus 1.5 ml normal
      saline ( dexmedetomidine group B ,n=14), or Bupivacaine 30 ml 0.25% was combined with 4 mg
      peri neural dexamethasone (2 ml) ( dexamethasone group C, n=14).The onset and duration of
      sensory and motor blocks, the time to first request to postoperative rescue analgesic,
      Richmond Agitation-Sedation Score, hemodynamic data, visual analogue pain scores, were
      reported at predetermined time assessment points. Postoperative rescue intravenous fentanyl
      consumption over 24 hours and complications occurred were recorded.
    

Intervention name(s): Dexmedetomidine injection; Dexamethasone; saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): perineural injection of Bupivacaine 30 ml 0.25% combined with 50 microgram (0.5 ml) peri-neural dexmedetomidine plus 1.5 ml normal saline; perineural injection of Bupivacaine 30 ml 0.25% combined with 4 mg peri neural dexamethasone (2 ml); perineural injection of Bupivacaine 30 ml 0.25% combined with 2 ml normal saline
Other intervention name(s): precedex; decadrone; normal saline
Intervention MeSH terms: Dexamethasone; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Other
Keywords: dexmedetomidine; dexamethasone
Post-licensure Safety Surveillance Study of Menactra Vaccine When Administered As a 2-dose Schedule to Children
Condition: Meningitis; Meningococcal Infection
MeSH terms: Meningococcal Infections; Meningitis
Study type: Observational

Summary: 
      This is a passive-surveillance study that will accrue subjects for surveillance. For each
      accrued subject, surveillance for outcomes will continue for six months following the first
      dose. If a second dose is given within that time, then surveillance will be continued for six
      months following the second dose.

      Observational Objective:

        -  To describe and characterize adverse events occurring after vaccination with Menactra
           vaccine.
    

Detailed description: 
      The study will be carried out in collaboration with the Kaiser Permanente Medical Care
      Program (KPMCP) under the direction of the Kaiser Permanente Vaccine Study Center (KPVSC).
      KPMCP is a closed-panel healthcare organization that maintains comprehensive encounter
      databases that capture all medical care received by enrollees.

      Vaccination will be according to routine clinical practice. Vaccination databases will be
      reviewed to identify eligible persons receiving Menactra vaccine within the KPMCP system.
    

Intervention name(s): Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate
Intervention type(s): Biological
Intervention description(s): 0.5 mL, Intramuscular
Other intervention name(s): Menactra®
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants at age 9 to 23 months at the time of receipt of the first dose of Menactra
        vaccine according to routine clinical practice during the study period.
      
Keywords: Meningitis; Meningococcal Infection; Menactra®
Safety and Tolerability of Buprenorphine/Naloxone Film Strips
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the safety and tolerability on the oral mucosa of
      buprenorphine/naloxone film strips administered either sublingually or buccally daily for 12
      weeks in opioid dependent individuals who are already on a stable regimen of
      buprenorphine/naloxone.
    

Detailed description: 
      Buprenorphine and naloxone soluble film was developed as an alternative dosage form to
      Suboxone (buprenorphine and naloxone) sublingual tablets and was evaluated for both
      sublingual and buccal administration. The soluble film dosage is expected to provide the
      following enhancements and potential advantages over the current Suboxone (buprenorphine and
      naloxone) product:

        -  mitigation against unintentional pediatric exposure by providing child-resistant
           packaging in unit dose format.

        -  improvement in subject convenience and compliance by ensuring rapid disintegration.

        -  protection against diversion by providing a dosage form that is very difficult for the
           subject to remove from the sublingual or buccal mucosa after administration. This
           provides assurance to the caregiver that the dose has actually been taken appropriately
           in a supervised setting.

        -  provision of a unit dose product format for hospital and institutional use.

        -  decreased product damage during shipping as compared to Suboxone tablets.
    

Intervention name(s): Buprenorphine/naloxone Film Strip; Buprenorphine/naloxone Film Strip
Intervention type(s): Drug; Drug
Intervention description(s): Buprenorphine/naloxone dosed between 4/1 mg to 32/8 mg once a day for 12 weeks by sublingual route; Buprenorphine/naloxone dosed between 4/1 mg to 32/8 mg once a day for 12 weeks by buccal route
Intervention MeSH terms: Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Opioid dependence
Sodium-Restricted Diet and Diuretic in the Treatment of Severe Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the intervention of the 1) sodium-restricted diet, or 2) diuretic, or 3)
      placebo pill in the treatment of obstructive sleep apnea in adults.
    

Detailed description: 
      Men with apnea-hypopnea index greater than 30/hour will be included and randomly assigned
      into three groups: sodium-restricted diet, or diuretic, or control. The intervention will
      last one week. The diuretic group will receive combined spironolactone 100mg plus furosemide
      20mg daily. The diet group will receive a regimen with a maximum intake of three grams of
      sodium per day. The control group will receive a placebo pill and will maintain all eating
      habits.
    

Intervention name(s): Lasilactone; Sodium-Restricted Diet; Placebo
Intervention type(s): Drug; Other; Drug
Intervention description(s): Active drug (spironolactone 100 mg plus furosemide 20 mg).; The sodium-restricted diet will enforce some rules: do not use salt in cooking; do not use the salt shaker; do not ingest any industrialized food; to eat fresh salads and vegetables; do not add high-sodium seasonings, among others. The complete dietary rules will be delivered to each volunteer in a four page handout.; The placebo group will receive cellulose-based placebo pills with identical pills and flasks to active drug.
Other intervention name(s): Spironolactone 100 mg plus Furosemide 20 mg; Low sodium diet; Placebo pill; Control
Intervention MeSH terms: Furosemide; Spironolactone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sleep apnea; Treatment; Sodium-Restricted Diet; Diuretic; Lasilactone
Sildenafil for Treatment of Priapism in Men With Sickle Cell Anemia
Condition: Sickle Cell Disease; Priapism
MeSH terms: Priapism; Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      This research is being done to evaluate if the phosphodiesterase type 5 (PDE5) inhibitor
      sildenafil has an effect on the frequency of recurrent priapism and the quality of life of
      males with sickle cell disease (SCD).
    

Detailed description: 
      The proposed research is designed to investigate the utility of continuous, long-term PDE 5
      inhibitor therapy as an intervention for recurrent ischemic priapism, a disorder of
      non-willful, excessive penile erection, in patients with SCD. Although precise prevalence
      figures are not available, priapism in SCD is highly prevalent and thought to afflict
      approximately 40% of males, based on available literature. Additionally, the disorder exacts
      devastating consequences, including erectile tissue necrosis, erectile dysfunction, and
      psychological distress. Management of this disorder remains challenging because the
      mechanisms underlying priapism are incompletely understood.
    

Intervention name(s): sildenafil; placebo
Intervention type(s): Drug; Other
Intervention description(s): sildenafil 50 mg tablet daily for first 8 weeks (phase 1), and then sildenafil 50 mg tablet daily for final 8 weeks (phase 2); placebo 50 mg tablets daily for first 8 weeks (phase 1), and then sildenafil 50mg tablet daily for final 8 weeks (phase 2)
Other intervention name(s): Viagra
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: priapism; sickle cell disease; sildenafil; phosphodiesterase type 5 inhibitor
Automatization of Counting Procedures in Children With Dyscalculia
Condition: Dyscalculia
MeSH terms: Dyscalculia
Study type: Interventional

Summary: 
      Researchers in numerical cognition usually think that the greatest and most common difficulty
      in children suffering from dyscalculia is retrieval of arithmetic facts from long-term
      memory. However, we have recently shown that retrieval might not be the optimum strategy in
      mental arithmetic. In fact, expert adults would rather solve simple problems such as 3 + 2 by
      automated and unconscious procedures. Therefore, we hypothesize that children with
      dyscalculia might not present deficit in retrieval but, instead, in counting procedure
      automatization. The aim of the current project is to test this challenging position. Through
      a longitudinal approach, we plan to precisely examine the behavior of children suffering from
      dyscalculia over a 3-year period. Children will be aged between 8 to 11 years at the
      beginning of the study and we will precisely observe the evolution of their solution times
      when they solve simple addition problems involving one-digit numbers. If children with
      dyscalculia still struggle with simple additions three years, their solution times plotted on
      the sum of the problems should still follow an exponential function. Indeed, if counting is
      not automated, difficulties necessarily increase with the progression on the number line or
      the verbal sequence, hence the exponential function. On the contrary, if counting procedures
      tend towards automatization, moves along a number line will progressively become as easy at
      the beginning of the line as at the end, hence the linear function. Importantly, a retrieval
      model would predict exactly the inverse pattern because, according to this model, the linear
      function, which is unanimously considered as the hallmark of counting procedures, should
      progressively be replaced by a non-linear function through practice.
    


Intervention name(s): Arithmetic facts solving
Intervention type(s): Behavioral
Intervention description(s): The experiment will contain several tasks. The main one will be a computerized task on arithmetic facts where participants will have to solve simple additions. There will also be three additional tasks: a processing speed task where the participant will have to tell the orientation of an arrow as fast as possible, a visuo-spatial task where the participant will have to reproduce a tapping block sequence and an arithmetic task where the participant will try to solve a maximum of operations in a limited time.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Dyscalculia
Targin® for Chronic Pain Management in Patients With Spinal Cord Injury
Condition: Chronic Pain
MeSH terms: Spinal Cord Injuries; Chronic Pain; Opioid-Induced Constipation
Study type: Interventional
Phase: Phase 4

Summary: 
      The study will be investigating the effectiveness of oxycodone-naloxone (brand name Targin®)
      at treating chronic pain in individuals with spinal cord injury. The goal of the study is to
      compare the effectiveness of Targin® at treating chronic pain in individuals with sub-acute
      and chronic spinal cord injury compared to opioid medication that is not compounded with
      naloxone.
    

Detailed description: 
      This is a Phase 4, open-label prospective cohort study investigating Targin® for treating
      chronic pain in individuals with sub-acute and chronic spinal cord injuries. Targin® is
      currently approved for use by Health Canada for the treatment of moderate-to-severe chronic
      pain and will be investigated here for the management of moderate-to-severe chronic pain
      following spinal cord injury. The effectiveness and safety of opioid use for individuals with
      spinal cord injury has yet to be thoroughly investigated. Additionally, individuals with
      spinal cord injury using opioids may have the superimposed effect of neurogenic bowel and
      opioid induced constipation, which may cause increased frequency and severity of autonomic
      dysreflexia episodes, reduced quality of life, depressive symptoms, and discontinuation of
      opioid medication. Targin® has the potential to ameliorate these symptoms and improve
      treatment adherence in individuals with spinal cord injury.
    

Intervention name(s): Oxycodone Naloxone Combination
Intervention type(s): Drug
Intervention description(s): A flexible dosing schedule will be used in this study. The dose and schedule will be based on the minimal amount of medication required to manage pain related to spinal cord injury. The dose and/or frequency will be titrated to the individual's pain level at the discretion of their regular attending physician and/or investigator.
Oxycodone-Naloxone is available in the following oral dosages:
5 mg oxycodone hydrocholoride / 2.5 mg naloxone hydrochloride
10 mg oxycodone hydrocholoride / 5 mg naloxone hydrochloride
20 mg oxycodone hydrocholoride / 10 mg naloxone hydrochloride
40 mg oxycodone hydrocholoride / 20 mg naloxone hydrochloride
Other intervention name(s): Targin®
Intervention MeSH terms: Oxycodone; Naloxone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Spinal Cord Injury; Traumatic Spinal Cord Injury; Targin®; Opioids; Naloxone; Opioid Induced Constipation; Oxycodone-Naloxone
The Absorption, Metabolism and Excretion of [14C]APG-2575 in Healthy Subjects
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a single-center, open-label, single-dose clinical pharmacokinetic study. The
      purpose of this study is to investigate the absorption properties, as well as to evaluate the
      mass balance and elucidate the pathways of biotransformation after a single oral dose of
      400mg, 200μCi [14C] APG-2575 to healthy subjects.
    


Intervention name(s): [14C ]APG-2575
Intervention type(s): Drug
Intervention description(s): orally, single dose of 400 mg / 200 μCi [14C] APG-2575
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Artemisinin to Reduce The Symptoms of Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      The investigators intend to explore the hypothesis that symptoms of schizophrenia may be
      reduced by the antimalarial compound artemisinin when used in addition to standard
      antipsychotic medications.
    

Detailed description: 
      The aims of the current study are:

        1. To evaluate the efficacy and side effects of artemisinin as an add-on compound for
           patients with schizophrenia who have residual psychotic symptoms of at least moderate
           severity.

        2. To evaluate the effect of artemisinin on cognitive impairments and associated functional
           skills.

        3. To investigate whether treatment with artemisinin produces a significant effect on the
           levels of antibodies to Toxoplasma.

        4. To examine whether changes in cognitive impairment or psychiatric symptoms are
           correlated with changes in antibodies to Toxoplasma before and during the treatment with
           artemisinin.
    

Intervention name(s): Artemisinin; Identical looking placebo capsule
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 100 mg of artemisinin twice per day for 10 weeks; Identical looking placebo twice per day for 10 weeks
Intervention MeSH terms: Artemisinins; Artemisinin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Concurrent Aerobic Exercise and Virtual Reality Cognitive Training
Condition: Preclinical Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      The study will implement and test a unique Virtual Reality Cognitive Training (VRCT) combined
      with concurrent cycling on a recumbent stationary cycle, also known as exergame that
      seamlessly integrates specific cognitive tasks into a virtual environment and is synchronized
      with cycling to promote cognition.
    

Detailed description: 
      The proposed project will implement and test a unique Virtual Reality Cognitive Training
      (VRCT) combined with concurrent cycling on a recumbent stationary cycle, also known as
      exergame that seamlessly integrates specific cognitive tasks into a virtual environment and
      is synchronized with cycling to promote cognition. Cycling through an interesting virtual
      environment will motivate and engage the older adult to participate in the exercise, and VRCT
      could augment cycling's effects on cognition. The purpose of this project is to demonstrate
      the feasibility and efficacy of the exergame intervention on cognition through two phases. In
      Phase I, a prototype of the VRCT exergame will be developed, followed by a feasibility
      testing using a single-group mixed methods design. In Phase II a more fully-featured version
      of the VRCT exergame will be developed followed by a an RCT which will randomize subjects on
      a 2:1:1 allocation ratio to 3 parallel groups (exergame:cycling only:attention control).
      Mixed methods will be used to assess outcomes in both phases.
    

Intervention name(s): Exergame
Intervention type(s): Behavioral
Intervention description(s): Participants will take part in the exergame, 3 times a week for a month. The session will start for 30-35 minutes of cycling on recumbent stationary cycles in session 1 and progress to moderate intensity for 50 minutes a session. Participants will do warm-up and cool-down activities before and after cycling. While cycling, participants will be playing virtual reality based games. An exercise interventionist will supervise the sessions and monitor participant's conditions and responses to ensure safety.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Subjective memory complaint
Clinical Evaluation of Two Marketed Artificial Tears in Non-contact Lens Wearing Patients
Condition: Visual Acuity
Study type: Interventional
Phase: Phase 4

Summary: 
      This clinical study is a randomized, double-masked, cross-over, bilateral, 2 treatment x 2
      period, dispensing 4-visit study with a 7-9 day washout period in between visits 2 and 3. The
      study will last approximately 3 months.
    


Intervention name(s): Test Eye Drops; Control Eye Drops
Intervention type(s): Device; Device
Intervention description(s): blink® intensive TRIPLE ACTION 3 in 1 eye drops; Systane® BALANCE eye drops
Intervention MeSH terms: Ophthalmic Solutions
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment