bioihbjkbjnl/mcl2 huggingface dataset:
Further Psychometric Data for the Reliability and the Diagnostic Validity of CRS-R
Condition: Minimally Conscious State; Vegetative State
MeSH terms: Persistent Vegetative State
Study type: Observational

Summary: 
      This study aims to provide, in a large sample, further psychometric data as regards the
      internal consistency, the test-retest reliability and the diagnostic validity of the Coma
      Recovery Scale-Revised (CRS-R).
    

Detailed description: 
      Recently, a report of the American Congress of Rehabilitation Medicine aiming to provide a
      systematic review of behavioral assessment scales for DOC has indicated that, when compared
      to other scales, the CRS-R meets the highest psychometric standards for the evaluation of
      severely brain-injured patients and may be used to assess DOC with minor reservations.
      However, that report mentions few evidences or studies with small sample sizes for some
      aspects of its reliability and validity such as its internal consistency and its test-retest
      reliability.The report also states that the diagnostic validity of the CRS-R remains
      unproven. In this study, the investigators will therefore aim to provide further psychometric
      data as regards those variables in a large sample of patients with DOC
    

Intervention name(s): Coma Recovery Scale-Revised and Glasgow Coma Scale
Intervention type(s): Diagnostic Test
Intervention description(s): Patients have been assessed with both the Coma Recovery Scale-Revised(CRS-R) and the Glasgow Coma Scale(GCS)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The investigators chosen patients with VS, MCS, EMCS
      
Keywords: disorders of consciousness; Vegetative state; Minimally conscious state; Emergence from MCS; Coma Recovery Scale-Revised
The Efficacy of Adductor-Canal-Blockade on Morphine Consumption, Pain and Mobilisation After Total Knee Arthroplasty
Condition: Total Knee Arthroplasty
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether Adductor-Canal-Blockade is effective at
      reducing morphine consumption and pain, and at the same time improving mobilisation after
      total knee arthroplasty.
    


Intervention name(s): Adductor-Canal-Blockade; Adductor-Canal-blockade with saline
Intervention type(s): Procedure; Procedure
Intervention description(s): US-guided Adductor-Canal-Blockade with ropivacaine 7,5 mg/ml; US-guided Adductor-Canal-blockade with saline
Other intervention name(s): Naropine; Postoperative pain; US-guided nerve block; placebo block
Intervention MeSH terms: Iodine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Adductor-Canal-Blockade; postoperative pain; US-guided nerve block; total knee arthroplasty
Strabismus Recovery With Proparacaine and Oculocardiac Reflex
Condition: Strabismus; Bradycardia; Nausea; Pain
MeSH terms: Strabismus; Bradycardia
Study type: Observational [Patient Registry]

Summary: 
      Observational study to determine if topical anesthetic and intraoperative oculocardiac reflex
      influence post strabismus surgery recovery.
    

Detailed description: 
      In an observational study with de-identified data of oculocardiac reflex (OCR) and strabismus
      surgery under routine anesthesia, a cohort of ongoing patients received topical proparacaine
      immediately post op, or none. Co-variables were intraoperative opioid and OCR, patient age,
      type of surgery. Several post-operative recovery outcome variables were prospectively
      monitored.
    

Intervention name(s): Topical Solution
Intervention type(s): Drug
Intervention description(s): proparacaine 0.5% eye drop
Other intervention name(s): proparacaine
Intervention MeSH terms: Proxymetacaine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        strabismus surgery patients
      
Keywords: post operative recovery; oculocardiac reflex; extra ocular muscle; conjunctiva; numbing drop; heart rate
Comparison of the Effect of Neck Collar, Act-as-Usual, and Active Mobilisation Early After a Whiplash Injury
Condition: Whiplash Injury
MeSH terms: Wounds and Injuries; Whiplash Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      Background: Long-lasting pain and disability, known as chronic whiplash-associated disorder
      (WAD), may develop after forced flexion-extension trauma to the cervical spine. Mechanisms
      behind WAD are virtually unknown, as are the possible effects of early intervention. This
      trial was undertaken to compare the effect of three early intervention strategies for the
      prevention of developing chronic WAD following acute whiplash injury.

      Methods: 458 participants were randomised to one of 1) stiff neck collar, 2) advice to
      act-as-usual, or 3) an active mobilisation regime. Participants were followed for one year
      and treatment effects were compared in terms of lasting neck pain, headache, disability and
      sick-leave.
    


Intervention name(s): neck collar; advice to act-as-usual; active mobilisation
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: whiplash injuries; neck pain; exercise movement techniques; immobilisation
Does Modified Ultrafiltration Affect Thromboelastography Results?
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Observational [Patient Registry]

Summary: 
      The study is to evaluate the effect of modified ultrafiltration on different components of
      Thromboelastography (TEG) in neonates undergoing cardiac surgery using cardiopulmonary
      bypass.
    

Detailed description: 
      The study will be performed at Advocate Children's Hospital, Oak Lawn. All neonates
      undergoing cardiac operations with cardiopulmonary bypass and modified ultrafiltration will
      be enrolled. Parents will be consented before surgery.

      After weaning from cardiopulmonary bypass and before starting modified ultrafiltration, a TEG
      sample will be taken. The components studied are Reaction time (R), Coagulation time (K),
      Angle, Maximum Amplitude (MA) and whole blood clot lysis index at 30 minutes (LY30). Another
      TEG sample will be taken after finishing modified ultrafiltration and before protamine is
      given. The different components will be compared pre and after modified ultrafiltration. The
      Primary end points are the changes of the different TEG components after modified
      ultrafiltration. The secondary end points are the utilization of different blood products
      (packed red cells, fresh frozen plasma and platelets transfusion) during and after surgery.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Neonates with congenital heart disease requiring cardiac surgery during the first month of
        life, with the use of cardiopulmonary bypass and modified ultrafiltration.
      
Keywords: thromboelastography, modified ultrafiltration
Adipose Secretory Function in Patients Before & After Laparoscopic Surgery
Condition: Obesity
Study type: Interventional
Phase: Phase 3

Summary: 
      The central hypothesis of our study is that metabolic and hemodynamic improvements following
      gastric bypass surgery are mediated by downregulation of inflammation-related adipokines
      produced by the intra-abdominal adipose tissue such as Visfatin.
    

Detailed description: 
      Central obesity represents a major risk for the development of type 2 diabetes and
      cardiovascular complications. Obesity is often associated with insulin resistance and
      abnormal production of inflammatory cytokines. Adipose tissue and especially omentum
      (adipocytes and resident macrophages) release several cytokines. Visfatin corresponds to a
      protein identified previously as pre-B cell colony-enhancing factor (PBEF), a 52-kilodalton
      cytokine expressed in lymphocytes. [1] Visfatin exerted insulin-mimetic effects in cultured
      cells and lowered plasma glucose levels in mice. Mice heterozygous for a targeted mutation in
      the visfatin gene had modestly higher levels of plasma glucose relative to wild-type
      littermates. Surprisingly, visfatin binds to and activates the insulin receptor.

      Adipose tissue protein and mRNA expression of Visfatin (PBEF) has not been investigated in a
      single study design with regard to the relationship to fat distribution, insulin resistance
      and other metabolic risk factors, especially in morbidly obese individual undergoing weight
      loss surgery. Therefore, we propose the following specific aims: Investigate the protein and
      mRNA expression of Visfatin (PBEF) in the peripheral (subcutaneous) and visceral (omentum)
      adipose tissues of morbidly obese subjects and their relationships to the changes in body
      composition, fat distribution, insulin sensitivity and time-dependent reversal of
      co-morbidities following gastric bypass surgery.
    

Intervention name(s): Cytokines assessed from fat tissue
Intervention type(s): Procedure
Intervention description(s): Cytokines assessed from fat tissue
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Obese; Adipose Tissue; Visfatin; Gastric Bypass Surgery
Temozolomide and Carmustine in Treating Patients With Anaplastic Glioma
Condition: Brain and Central Nervous System Tumors
MeSH terms: Glioma; Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of temozolomide and carmustine in treating
      patients with anaplastic glioma.
    

Detailed description: 
      OBJECTIVES: I. Evaluate the activity, measured in terms of progression free survival, of
      carmustine plus temozolomide in recurrent glioblastoma. II. Estimate the response rate of
      recurrent glioblastomas to this combination. III. Estimate the response rate of newly
      diagnosed anaplastic astrocytomas and mixed anaplastic glioma to this combination. IV.
      Evaluate the qualitative and quantitative toxicities of this combination in patients with
      anaplastic gliomas.

      OUTLINE: This is a nonrandomized study. Patients are stratified by disease (recurrent
      glioblastoma vs anaplastic astrocytoma or mixed anaplastic glioma). Patients receive
      carmustine intravenously on day 1 two hours prior to temozolomide. Temozolomide is
      administered orally on day 1. Cycles repeat every 42 days. Treatment for patients with
      recurrent glioblastoma may continue for 8 cycles in the absence of disease progression or
      unacceptable toxicity. If there is no disease progression after 8 cycles, treatment may
      continue further at the investigator's discretion. Patients with anaplastic astrocytoma or
      mixed anaplastic glioma continue for 4 cycles of treatment. Patients are followed
      periodically at the investigator's discretion, at least twice in the first 4 months, and then
      until death.

      PROJECTED ACCRUAL: A minimum of 17 patients and a maximum of 37 patients will be accrued in
      the recurrent glioblastoma stratum and 45 patients will be accrued into the anaplastic
      astrocytoma and mixed anaplastic glioma stratum.
    

Intervention name(s): carmustine; temozolomide
Intervention type(s): Drug; Drug
Intervention MeSH terms: Temozolomide; Carmustine
Primary purpose: Treatment
Keywords: recurrent adult brain tumor; adult glioblastoma; adult anaplastic astrocytoma; adult mixed glioma; adult giant cell glioblastoma; adult gliosarcoma
A Clinical Trial to Study the Effect of the Addition of Vitamin D to Conventional Treatment in New Pulmonary Tuberculosis Patients
Condition: Pulmonary Tuberculosis
MeSH terms: Tuberculosis; Tuberculosis, Pulmonary
Study type: Interventional
Phase: Phase 3

Summary: 
      There is some evidence that supplemental Vitamin D may contribute to quicker recovery from TB
      when given in addition to normal TB therapy. This needs to be proven with a controlled
      clinical trial. People receiving Vitamin D with anti TB therapy will be compared against
      people receiving anti TB therapy alone to see if vitamin D contributes to a quicker recovery
      (as shown by a quicker sputum culture conversion).
    

Detailed description: 
      The proposed study is a parallel, randomized, double-blinded, placebo-controlled clinical
      trial to quantify the change, if any, in microbiological outcome in TB patients treated with
      vitamin D in combination with standard DOTS therapy. It will take place in four South Indian
      DOTS centres. The required sample size is 250 patients receiving ATT, to be randomised in a
      1:1 fashion (125 patients to receive vitamin D and 125 patients to receive placebo).
    

Intervention name(s): A. 100,000 IU Cholecalciferol per dose of 3.3ml; B. Migliol Oil without Cholecalciferol
Intervention type(s): Drug; Other
Intervention description(s): 100,000 IU Cholecalciferol in 3.3ml Migliol (Carrier) oil, once every two weeks for 2 Months; 3.3 ml Migliol Oil, every two weeks for two months
Intervention MeSH terms: Cholecalciferol; Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Phase 3 Efficacy and Safety Study in Adults With ADHD Using CTx-1301.
Condition: ADHD; ADHD - Combined Type; Attention Deficit Hyperactivity Disorder Combined; Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The goal of this clinical trial is to evaluate the efficacy and safety of CTx-1301 in adults
      with ADHD in a laboratory classroom setting.
    

Detailed description: 
      A single-center, dose-optimized, double-blind, randomized, placebo-controlled, parallel
      efficacy and safety laboratory classroom study with CTx-1301 in approximately 25 adults aged
      18 to 55 years with ADHD. The study will be comprised of a screening period, a
      dose-optimization phase, a double-blind randomized phase, and a safety follow-up phase.
      Subjects will undergo a screening visit prior to entering a 5-week dose-optimization phase.
      During the dose-optimization phase subjects will have weekly visit and will be titrated to
      doses ranging between 25mg-50mg of CTx-1301. Eligible subjects will be randomized to their
      optimal dose or placebo in a 1:1 ratio after completing a practice Adult Laboratory Classroom
      (ALC) visit with 4 PERMP assessments. Subjects will take their assigned/randomized dose over
      the following 7-day period. On the 7th day subjects will complete a full ALC visit. The
      duration of the full ALC visit will be approximately 17 hours. Subjects will have an
      in-clinic safety follow-up visit within 7 days after the full adult laboratory classroom
      visit.
    

Intervention name(s): CTx-1301 - Dexmethylphenidate 25mg; CTx-1301 - Dexmethylphenidate 37.5mg; CTx-1301 - Dexmethylphenidate 50mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 25mg CTx-1301 (Dexmethylphenidate tablet); 37.5mg CTx-1301 (Dexmethylphenidate tablet); 50mg CTx-1301 (Dexmethylphenidate tablet); Placebo
Other intervention name(s): All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 25mg, 37.5mg, or 50mg of CTx-1301.; All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 25mg, 37.5mg, or 50mg of CTx-1301.; All subjects will be titrated to their optimal dose during the dose-optimization phase. Possible doses are 25mg, 37.5mg, or 50mg of CTx-1301.; Subjects will be randomized (1:1) to their optimal dose or placebo in the 7-day, double-blind, randomized phase.
Intervention MeSH terms: Dexmethylphenidate Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of Betaserc on Vestibular Compensation in Patients Suffering From Disabling Meniere's Disease and Having Undergone Vestibular Neurotomy
Condition: Meniere's Disease
MeSH terms: Meniere Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is to compare the effects of Betaserc 24mg and placebo on compensation of postural
      and locomotor deficits (static and dynamic posturography) after vestibular neurotomy in
      patients suffering from disabling Menière's disease.
    


Intervention name(s): Betahistine 24 mg bid (Betaserc)
Intervention type(s): Drug
Intervention MeSH terms: Betahistine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Meniere's disease; Vestibular neurotomy
Efficacy and Safety of Single Doses of Indacaterol Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) Compared to Placebo in Patients With Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The study is designed to obtain safety and efficacy data on three dose levels of indacaterol
      when delivered via an SDDPI in patients with persistent asthma. All patients will receive 1
      day of treatment with each of the following: indacaterol 150 µg, indacaterol 300 µg,
      indacaterol 600 µg, placebo, and formoterol. Each treatment day will be followed by a
      washout-period of 1 week
    


Intervention name(s): indacaterol maleate
Intervention type(s): Drug
Intervention MeSH terms: Maleic acid
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Asthma, indacaterol, long acting β2-agonist
Efficacy of Single-Shot Dexmedetomidine Versus Placebo in Preventing Pediatric Emergence Delirium in Strabismus Surgery
Condition: Strabismus; Delirium on Emergence; Pediatric Disorders
MeSH terms: Delirium; Strabismus; Emergence Delirium
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is trying to see if using precedex pre-operatively prevents emergence delirium in
      pediatric (ages 1-7) patients undergoing strabismus surgery.
    

Detailed description: 
      Emergence delirium (ED) is a complex behavioral disturbance characterized by psychomotor
      agitation, perceptual disturbances, delusions, and disorientation during recovery from
      general anesthesia. In the population of subjects who undergo strabismus surgery, there are
      multiple factors that may increase the risk of ED. These include age, typically preschool
      children aged 1-7 years, rapid surgical times with rapid awakening, use of sevoflurane as the
      primary anesthetic, and surgically-induced postoperative visual disturbance. The aims of this
      study are: 1) To examine whether post-induction treatment with an α-2 receptor agonist,
      precedex (dexmedetomidine), decreases postoperative emergence agitation after strabismus
      surgery compared to placebo, and 2) to determine whether treatment has any effect on
      postoperative pain, nausea/vomiting, number of pain-related interventions, and time to PACU
      discharge. We hypothesize that precedex will attenuate the ED response greater than placebo
      or a lower dose after strabismus surgery and will reduce PACU pain scores without increasing
      PACU length of stay.

      Inclusion:

      i. Pediatric patients aged 1-7 years of age ii. American Society of Anesthesiologists (ASA)
      physical status I-II iii. No significant laboratory abnormalities

      Exclusion:

      i. Presence of medicated behavioral disorder ii. Subjects for which precedex, opiates,
      benzodiazepines, or inhalational anesthetics are contraindicated iii. Parental refusal
    

Intervention name(s): Dexmedetomidine; Placebo
Intervention type(s): Drug; Other
Intervention description(s): intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes; intraoperative dose of intravenous placebo
Other intervention name(s): Precedex; saline solution
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: strabismus; pediatric; emergence delirium; precedex/dexmedetomidine
FLAT Study: First Line Ablation Therapy for Treatment of Paroxysmal Atrial Fibrillation (RAAFT)
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this multicenter randomized study is to establish the effectiveness of
      treatment for paroxysmal atrial fibrillation (AF), in patients not previously treated with
      anti-arrhythmic drugs, by encircling the pulmonary veins with radiofrequency (RF) ablation,
      using the NaviStar® ThermoCool® catheter and the CARTO™ EP Navigation System. Effectiveness
      will be determined by comparing chronic success of ablation therapy versus anti-arrhythmic
      drug treatment, defined as patients with an absence of atrial tachycardias during 24 months
      of follow-up as determined by 7-days Holter and transtelephonic monitoring, and by 12-lead
      electrocardiogram (ECG) recordings.
    

Detailed description: 
      This study is a prospective, randomized, multicenter clinical study that will enroll in its
      first phase 40 patients. The study will be performed in 3 European hospitals. Patients will
      be randomized to either the RF ablation strategy or to the medication arm.

      Hypothesis:

      As first line therapy, catheter ablation improves the long-term success, health-economic
      outcomes and is equally safe compared to the best anti-arrhythmic medication treatment in a
      selected group of patients with paroxysmal atrial fibrillation.

      Primary endpoint:

        -  long-term success, defined as patients free from any atrial fibrillation during 24
           months after initial study treatment as determined by 7-days Holter and transtelephonic
           monitoring and by 12-lead ECG recordings.

      Secondary endpoints:

        -  AF burden: frequency and duration of episodes

        -  health-economic costs over 24 months

        -  serious adverse events

        -  Quality of Life scores, using SF-36 questionnaire
    

Intervention name(s): RF ablation; anti-arrhythmic drug therapy
Intervention type(s): Device; Drug
Intervention MeSH terms: Anti-Arrhythmia Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: First line ablation therapy