bioihbjkbjnl/mcl2 huggingface dataset:
Ultrasound Prediction For Vocal Cord Dysfunction In Patients Scheduled For Anterior Cervical Spine Surgeries
Condition: Vocal Cord Dysfunction
MeSH terms: Vocal Cord Dysfunction
Study type: Observational [Patient Registry]

Summary: 
      • Anterior cervical discectomy and fusion (ACDF) is a highly effective and safe method for
      spinal cord and cervical root decompression. Vocal cord paralysis secondary to recurrent
      laryngeal nerve injury is a common complication after ACDF. The incidence reported as high as
      22%. The standard technique for vocal cord evaluation and the most commonly used tool is
      direct laryngoscopy. Laryngoscopy causes patients annoyance and could potentially contribute
      to poor patient compliance. Ultrasonography is a non-invasive technique that is used as an
      alternative tool.
    

Detailed description: 
      1. Design: A prospective cohort study.

        2. Sample size: Assuming that the target population is 240 and positive predictive value of
           transcutaneous laryngeal ultrasonography is 89.4%. So, the sample size is 91 cases using
           OPEN Source Epidemiologic Statistics for Public Health (OPENEPI) with confidence
           interval 95% and power of test is 80%.

      All patients underwent transcutaneous laryngeal ultrasonography examination by both anterior
      and lateral approach of the Vocal Cords (VCs) before the surgery, immediately after
      extubation, 2 h, 12h, 24 and 48hour postoperatively by an anesthesiologist with an experience
      of at least three years in ultrasonography scan.
    

Intervention name(s): vocal cord ultrasonography
Intervention type(s): Device
Intervention description(s): assess vocal cord motion and recurrent nerve function by Transcutaneous laryngeal Ultrasonography in patients scheduled for anterior cervical spine surgeries
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Egyptian population scheduled for anterior cervical surgeries
Nano-hydroxyapatite and Ozone - Effect on Approximal Initial Caries
Condition: Caries,Dental
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Objectives: to assess the efficiency of three methods of enamel remineralization on initial
      approximal caries: 1. a nano-hydroxyapatite gel, 2. gaseous ozone therapy 3. combination of a
      nano-hydroxyapatite gel and ozone.

      Materials and Methods: Patients (n=92, age 20-30y) with initial approximal enamel lesions on
      premolar and molar teeth (n=546) randomly allocated to three groups subjected to a 6-months
      treatment: Group I: domestic nano-hydroxyapatite remineralizing gel, group II: in-office
      ozone therapy, group III: both remineralizing gel and ozone therapy. Caries lesions assessed
      on bitewing radiographs at baseline, after 1 year and after 2 years.
    


Intervention name(s): ApaCare & Repair
Intervention type(s): Other
Intervention description(s): Initial cariuos lesions were treated.
Other intervention name(s): OzonyTron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prophylactic Tranexamic Acid Use After Vaginal Delivery
Condition: Postpartum Hemorrhage; Vaginal Delivery; Prophylactic Tranexamic Acid Use
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional

Summary: 
      In this study, our aim was to evaluate the effectiveness of prophylactic tranexamic acid use
      after vaginal delivery in pregnant women aged 18-45 years and 34-42 weeks according to the
      risk of postpartum hemorrhage.
    

Detailed description: 
      It was carried out as a double-blind prospective randomized controlled Phase 4 drug study
      with 480 singleton pregnant women in Bursa Yüksek İhtisas Training and Research Hospital
      between September 1, 2021 and February 28, 2022. The patients were divided into two groups as
      low risk (240 patients) and high risk (240 patients) according to their postpartum hemorrhage
      risks, and the patients in each group were randomly divided into two groups. Group 1: were
      given intravenous tranexamic acid and group 2: were given placebo. The blood loss at the 3rd
      and 4th stages of labor was calculated by weighing the blood collected with the help of a
      collecting pochette and using the estimated blood loss formula.
    

Intervention name(s): Tranexamic acid; 5% Dextrose
Intervention type(s): Drug; Other
Intervention description(s): given intravenous tranexamic acid; given placebo.
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: tranexamic acid; vaginal delivery; postpartum hemorrhage; active management of vaginal delivery
The Effect of Nicorandil on Left Ventricular Myocardial Strain in Patients With Coronary Chronic Total Occlusion
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      Background Nicorandil is recommended as a second-line treatment for stable angina, but
      randomized-controlled trials (RCTs) to evaluate the benefit of nicorandil for patients with
      chronic total occlusion (CTO) are still lack.

      Objective To determine whether nicorandil can improve left ventricular myocardial strain in
      patients with CTO.

      Methods Patients with CTO were included and were randomized to the nicorandil group and the
      control group. Nicorandil was given orally 15 mg/day for 3 months in the nicorandil group.
      3-dimentional-speckle tracking echocardiography (3D-STE) and the Seattle angina questionnaire
      (SAQ) survey were performed at baseline and at 3 months. Participants were randomized
      according to an IBM SPSS23.0-generated randomization schedule, with a 1:1 allocation to the
      nicorandil group or the control group.
    


Intervention name(s): nicorandil
Intervention type(s): Drug
Intervention description(s): Patients in the nicorandil group were also given nicorandil (Tohoku Nipro Pharmaceutical Corporation, Japan) orally 5 mg three times per day for 3 months
Intervention MeSH terms: Nicorandil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Leuven Growing Into Deficit Follow-up Study
Condition: Heart Defects, Congenital; Critical Illness; Mental Processes; Child
MeSH terms: Heart Defects, Congenital; Congenital Abnormalities; Critical Illness
Study type: Observational

Summary: 
      The key objective of the Leuven growing-into-deficit (GID) follow-up-study is to test the
      hypothesis that children with a congenital heart disease (CHD) show more neurocognitive
      impairment at the second follow-up at 7 years old than at the first follow-up at the age of
      4, compared to healthy controls.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Seven-year-old children with CHD and healthy seven-year-old control children
      
Keywords: neurocognitive testing; critical illness; executive function; intelligence
Reproducibility and Comparison of Platelet Function Assays With Aspirin and Clopidogrel (MK-0000-167)
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate whether the antiplatelet effects of Aspirin 300 mg daily and
      Clopidogrel 75 mg daily can be reproducibly measured using several point of care platelet
      function assays
    


Intervention name(s): Placebo (to match Aspirin); Aspirin; Clopidogrel; Comparator: Placebo (to match Clopidogrel)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Placebo grossly matched Aspirin 300 mg daily; Aspirin 300 mg daily; Clopidogrel 75 mg daily; Placebo (grossly matched Clopidogrel 75 mg) daily
Intervention MeSH terms: Aspirin; Clopidogrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
The Safety and Efficacy of Nexalin Trans-cranial Electrical Stimulation Stimulation for the Treatment of Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The purpose of this research study is to determine whether Nexalin Trans-Cranial Electrical
      Stimulation (TES) is an effective treatment for depression among patients who are candidates
      for ECT. A secondary aim to assess whether Nexalin can be used as an alternative to ECT.
      Although Nexalin has been approved for use in the US, using Nexalin to treat depression in
      this way is investigational and experimental. If Nexalin is found to be an alternative to
      ECT, it could offer a safer treatment for depression with less side-effects and a lower cost.

      !!! NOTE !!! Post Script / Post Study. The ECT arm (profiling subjects as ECT accepters vs.
      rejecters) was dropped owing to site objections by referring clinicians. Accordingly, the
      study was framed as a simple comparison between TES and SHAM TES.
    

Detailed description: 
      A 2x2 factor Randomized Controlled Trial with block randomization. Inpatient subjects at the
      Carrier Clinic who are referred for ECT will be recruited, typed regarding their acceptance
      of ECT, and randomized to either treatment with TES or to a Sham condition. Treatment
      non-responders in either condition will continue as in patients at the Carrier Clinic until
      they reach acceptable levels of functioning to be discharged.
    

Intervention name(s): Nexalin Based Trans-Cranial Electrical Stimulation
Intervention type(s): Device
Intervention description(s): The Nexalin device, FDA clearance (501K=K024377, Classification: Stimulator, Cranial Electrotherapy: CFR 882. 5800: U.S. Patent #6904322B2), produces a square waveform that provides trans-cranial electrical stimulation to the brain delivered at a frequency of 77.5 Hz at 0 to 4 mA peak current.
Other intervention name(s): TES
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A 2x2 factor Randomized Controlled Trial with block randomization
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of Efficacy, Safety of Fulranumab Monotherapy for OA of Hip or Knee, PAI3003
Condition: Osteoarthritis; Pain
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate the efficacy, safety, and tolerability of
      fulranumab as Monotherapy compared with placebo in participants with signs and symptoms of
      osteoarthritis of the hip or knee that are not adequately controlled by current pain therapy.
    

Detailed description: 
      This is a randomized (the study drug is assigned by chance), double-blind (neither physician
      nor participant knows the name of the assigned drug), placebo-controlled (an inactive
      substance is given to one group of participants while active drug is given to another group
      of participants to see if there is a difference in response), parallel-group (study drugs
      given to participants in all treatment groups during the same time period) to evaluate the
      efficacy (capacity of the investigational drug to produce an effect), safety, and
      tolerability of fulranumab administered as monotherapy (alone; not in combination with other
      drug therapy) to participants with chronic moderate to severe pain and functional impairment
      from knee or hip osteoarthritis (OA) that is not adequately controlled by current pain
      therapy. The duration of participation in the study for an individual participant will be up
      to 67 weeks (includes a screening period of 3 weeks, a double-blind treatment period of 16
      weeks, and a post-treatment follow-up period of up to 48 weeks).). All participants will be
      randomly assigned in a 1:1:1 ratio to 1 of 3 treatments (placebo, fulranumab 1mg, fulranumab
      3mg) and given a single injection subcutaneously (under the skin) once every 4 weeks for up
      to 16 weeks. Blood samples will be collected from each participant at time points during the
      study. Safety evaluations will include assessment of adverse events, physical examinations,
      laboratory tests and vital signs which will be monitored throughout the study.
    

Intervention name(s): Placebo; Fulranumab 1 mg; Fulranumab 3 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo will be administered once every 4 weeks for 16 weeks by subcutaneous (SC) injection (injection under the skin) into the thigh or abdomen.; Fulranumab will be administered once every 4 weeks for up to 16 weeks by SC injection into the thigh or abdomen.; Fulranumab will be administered once every 4 weeks for up to 16 weeks by SC injection into the thigh or abdomen.
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoarthritis; Pain; Fulranumab; JNJ-42160443; Monotherapy; Hip; Knee; Joint replacement surgery
Effect of Nesiritide Infusion on Insulin Sensitivity in Healthy Obese Insulin Resistant Subjects
Condition: Diabetes
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to compare the effects of nesiritide to placebo administered by a
      continuous IV infusion over 48 hours for the treatment of insulin resistance in healthy,
      obese, insulin resistant individuals.
    


Intervention name(s): Continous IV infusion of Nesiritide; Hyperinsulinemic euglycemic clamp; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Nesiritide (fhBNP) administered by continuous IV infusion during 48 hours.; 48 hours IV infusion of nesiritide on insulin sensitivity (IS) measured by two-step hyperinsulinemic euglycemic clamp in obese nondiabetic insulin resistant subjects.; 48 hours of placebo.
Intervention MeSH terms: Natriuretic Peptide, Brain
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This study is prospective randomized, double masked, 2-period cross over design, proof of concept study of the effects of intravenously administered rhBNP (nesiritide) on insulin sensitivity in otherwise healthy obese nondiabetic insulin resistant subjects.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: human B-type natriuretic peptide
The Relationship Among Electroencephalography,Skin Conductance Response,Heart Rate Variability and Mental Health Among Smartphone Users After Receiving Texting or Calling
Condition: Smartphone Users, Smartphone Addiction, Anxiety, and Skin Conductance
MeSH terms: Behavior, Addictive; Internet Addiction Disorder
Study type: Interventional

Summary: 
      The number of smartphone users in Taiwan continues to increase exponentially. Smartphone
      addiction tends to not only disrupt the ability of social communication but cause physical
      and psychological problems as well. This study examined the relationship among skin
      conductance, electroencephalography, heart rate variability (HRV), social interaction anxiety
      and smartphone addiction among Line apps users, and we also tried to identify associated
      factors for further interventions.
    


Intervention name(s): social media stimuli (Line app)
Intervention type(s): Device
Intervention description(s): social media stimuli (Line app) with texting messages or calls
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: skin conductance; anxiety; smartphone users; smartphone addiction
Efficacy and Safety of SEROQUEL Extended Release (XR) in Acute Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to determine whether treatment with quetiapine XR (Seroquel XR)
      tablets for 3 weeks will improve their agitation when they have acute psychosis.
    


Intervention name(s): Quetiapine XR (Seroquel XR)
Intervention type(s): Drug
Intervention description(s): Tablet, oral, once daily
Other intervention name(s): Seroquel XR
Intervention MeSH terms: Quetiapine Fumarate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acute schizophrenia
Multicenter Trial to Evaluate the Effect of Dapagliflozin on the Incidence of Cardiovascular Events
Condition: Diabetes Mellitus, Non-Insulin-Dependent; High Risk for Cardiovascular Event
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is being carried out to determine the effect of dapagliflozin on cardiovacular
      outcomes when added to current background therapy in patients with type 2 diabetes with
      either established cardiovacular disease or cardiovascular risk factors.
    


Intervention name(s): Dapagliflozin 10 mg; Placebo tablet
Intervention type(s): Drug; Drug
Intervention description(s): Oral dose (od); Oral dose (od)
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Phase IIIb; T2DM; cardiovascular events
Office Based Intervention to Reduce Bottle Use in Toddlers: TARGet Kids! Pragmatic Randomized Trial
Condition: Educational Intervention and Toddler Bottle Use
Study type: Interventional

Summary: 
      Observational studies support an association between bottle feeding beyond 15 to 18 months of
      age and lower socioeconomic status, excessive milk intake, dental caries, iron deficiency,
      behavioral issues and obesity. Yet many parents, particularly those from low socioeconomic
      households, choose to feed their children by bottle much beyond this age. Recognizing the
      need for further educational interventions for bottle feeding, the TARGet Kids! Research
      Collaboration recently developed a 5-minute bottle weaning educational intervention for the 9
      month well-child visit. We undertook a pragmatic randomized controlled trial to evaluate its
      effectiveness involving 251 children recruited through TARGet Kids! (PMID: 20624802) The goal
      was to determine whether an office-based, educational intervention for parents of 9-month-old
      children could reduce bottle use and iron depletion at 2 years of age.
    


Intervention name(s): Educational Intervention
Intervention type(s): Behavioral
Intervention description(s): Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Toddler Bottle Use; Educational Intervention; Pediatrics; Iron Deficiency
Effect of Addition of Single Dose of Oral Montelukast to Standard Treatment in Acute Asthma in Preschool Children.
Condition: Asthma; Acute Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if adding single dose of oral montelukast to the
      standard treatment of systemic glucocorticoids plus short acting beta-2 agonist for treatment
      of acute wheezing provide additional clinical benefit in the emergency room.
    

Detailed description: 
      Systemic corticosteroids and short acting beta-2 agonists are the mainstay treatment of acute
      asthma, however, little data exists regarding use of leukotriene antagonists in acute asthma.
      A few studies in adults have shown that oral montelukast also improved pulmonary function
      when being added to the standard treatment. But in school-age children this clinical benefit
      could not be demonstrated by adding montelukast to the standard treatment of acute asthma in
      emergency room. Moreover in preschool children there are no studies on this topic.

      The investigators hypothesized that addition of single dose of oral montelukast to standard
      therapy in acute moderate to severe wheezing may provide additional benefit in the meaning of
      improvement of pulmonary score and/or proportion of discharge from emergency department in
      preschool-age children.
    

Intervention name(s): montelukast 4 mg granule; Montelukast placebo granüle
Intervention type(s): Drug; Drug
Intervention description(s): Children had received single dose of 4 mg oral montelukast after first dose of nebulized salbutamol and systemic glucocorticoids.; Children had received single dose of oral placebo montelukast granule after first dose of nebulized salbutamol and systemic glucocorticoids.
Other intervention name(s): Montelukast placebo granule
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acute asthma; Children; Montelukast; Emergency room
Energy Availability in Male and Female Elite Wheelchair Athletes Over Seven Consecutive Training Days
Condition: Energy Supply; Deficiency
Study type: Observational

Summary: 
      Low energy availability (LEA) is a major problem in sports as athletes ingest often a lower
      amount of energy compared to their actual needs. The availability of energy is calculated
      based on their daily energy intake and the energy cost of the daily training sessions in
      relation to their fat-free mass. Based on this calculation, it is known how much energy will
      available for the body (beside the fuel for training) to keep it in optimal physiological
      functioning. It has been shown, that LEA occurs very often in female athletes, in endurance
      athletes as well as athletes in weight-sensitive sports (i.e. jockeys, combat sports,
      gymnastics, ballet). The purpose of this study was to investigate, whether LEA is a problem
      in wheelchair athletes as well.
    

Detailed description: 
      Energy availability will be assessed over 7 consecutive training days using a dietary and
      training record as well as the Leisure Time PHysical Activity Questionnaire for spinal cord
      injury. Resting Energy expenditure will be measured as well as body composition (by a DXA)
      before the start of data collection.
    

Intervention name(s): evaluating energy availability
Intervention type(s): Other
Intervention description(s): energy availability will be determined by measuring energy intake, exercise energy expenditure and fat-free mass and using the following formula: energy availability = (energy intake - exercise energy expenditure) / fat-free mass
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Elite wheelchair athletes from national team in different wheelchair sports