bioihbjkbjnl/mcl2 huggingface dataset:
Validity of an Online Neurocognitive Test Battery, the Brain Performance Test (BPT), in Normal Healthy Adults
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the concurrent validity between the Brain
      Performance Test (BPT) subtests and corresponding conventional in-person neuropsychological
      assessments (NP).
    

Detailed description: 
      This will be a multi-site, randomized, counterbalanced, two-period, two-sequence, validation
      study of the online, unsupervised Brain Performance Test (BPT). Over the course of 14 days,
      participants will complete two in-clinic visits during which they will complete both the BPT
      and in-person neuropsychological assessments (NP).
    

Intervention name(s): BPT; NP
Intervention type(s): Other; Other
Intervention description(s): Brain Performance Test (BPT) computerized cognitive assessment battery developed by Lumos Labs, Inc.; Conventional in-person Neuropsychological Assessments (NP)
Subtests from:
HRB: Halstead-Reitan Battery
MATRICS: Measurement and Treatment Research to Improve Cognition in Schizophrenia
WAIS-IV: Weschler Adult Intelligence Scale - IV
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: cognitive assessment; neuropsychological assessment; Brain Performance Test; computerized assessment
90° Rotation Technique for LMA FlexibleTM Insertion
Condition: Laryngeal Masks
Study type: Interventional

Summary: 
      The 90° rotation technique is known to improve the success rate of conventional LMA but its
      effect in LMA FlexibleTM is not known. We tried to find if 90° rotation technique could
      increase the first attempt success rate of the insertion of LMA FlexibleTM compared to
      standard technique.
    

Detailed description: 
      One hundred and sixteen adult patients undergoing breast surgery were randomized to the two
      insertion techniques. The ease of insertion was assessed by the success rate at the first
      attempt. Heart rate and mean blood pressure were recorded 1 min before and 1 min after
      insertion. Postoperative complications were checked.
    

Intervention name(s): 90° rotational technique
Intervention type(s): Procedure
Intervention description(s): the LMA FlexibleTM was rotated counter-clockwise through 90°
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Other
Keywords: LMA Flexible
Near-infrared Spectroscopy (NIRS) for Intracranial Hematoma Detection
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Hematoma
Study type: Interventional

Summary: 
      Traumatic brain injury is a common neurosurgical emergency managed in all tertiary and
      secondary hospitals. Detecting the underlying pathology is a major challenge especially for
      surgical cases. The outcome differs if the early intervention is performed. Near-infrared
      spectroscopy (NIRS) based device will detect the hematoma at the bedside. It is not the
      replacement of a CT scan but can help in triage. This is a large-scale prospective study to
      establish the role of NIRS device in detecting intracerebral hematoma and correlate the
      finding with CT scan finding.
    

Detailed description: 
      The light used in the near-infrared spectrum, especially between 700 and 1000 nm, is able to
      penetrate the human tissue 'optical window'. Once the light has penetrated into the tissue,
      it is either scattered or absorbed. Light is mostly scattered by bones, skin and cerebral
      white matter. However, red blood cells, which represent roughly have a low scattering effect
      and high absorption. Utilising this principle, the emitter and detector could be used to
      measure the light scattered by the tissues. The 'optical density' of the tissue is calculated
      and by comparing the left and right hemispheres in the eight contralateral locations of the
      brain lobes where lesions with extravascular accumulation of haemoglobin can be detected. A
      NIRS device named Cerebo® was developed by Bioscan Research, Ahmedabad, India. It is a low
      power non risky device that can screen the patient's head multiple times without causing any
      side effect. The built in safety features in Cerebo® make it fail safe system for intentional
      as well as accidental exposure to laser beam. The average power and total power dissipation
      is very low. The system poses no risk to the patients who will be included in the study.

      So far the overall results of detection rate of hematoma using NIRS device are contradictory.
      It is not the replacement of a CT scan but can help in triage. In the present research the
      investigators plan to do a large scale prospective study to establish the role of NIRS device
      in detecting intracerebral hematoma and correlate the finding with CT scan findings.
    

Intervention name(s): near-infrared scanner
Intervention type(s): Other
Intervention description(s): Tests to be administered: Near Infra-Red Scanning of the head at the bedside.
Time taken for testing: Two minutes
Biological samples collected: None
Frequency of testing/collection: Once
Risks for the participants while being tested: None
Other intervention name(s): Cerebo
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: traumatic brain injury; traumatic intracranial hematoma; extradural hematoma; subdural hematoma; cerebral contusion; near-infrared spectroscopy
Different Doses of BI 1467335 Compared to Placebo in Patients With Clinical Evidence of NASH
Condition: Non-alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is the proof of mechanism and support of dose finding,
      together with the safety evaluation in patients with clinical evidence of NASH.

      To gain further insight into clinical effects of AOC3 inhibition on NASH further exploratory
      analyses of biomarkers related to NASH and liver fibrosis will be performed. This will
      include the effect of BI 1467335 on reduction of secondary biomarker endpoints (ALT, AST, AP,
      γ-GT and CK18 fragments). Safety will be assessed throughout the study to provide key
      information regarding the use of BI 1467335 in patients with NASH.
    


Intervention name(s): BI 1467335; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): once daily; once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pharmacogenetics Associated With IV Ketamine
Condition: Treatment Resistant Depression
MeSH terms: Depressive Disorder, Treatment-Resistant
Study type: Observational

Summary: 
      The Canadian Rapid Treatment Center of Excellence (CRTCE) is a healthcare facility
      principally focused on providing best practices of intravenous ketamine treatment to adult
      patients suffering from treatment resistant depression. Patients who have received IV
      ketamine at the clinic are eligible to participate in this study where genetic biomarkers are
      correlated with response to IV ketamine.
    


Intervention name(s): Saliva Genetic Samples
Intervention type(s): Genetic
Intervention description(s): Patients will provide two saliva swabs containing genetic materials.
Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All participants will have received IV ketamine previously for treatment resistant
        depression, as defined by the DSM-5
      
Biospecimen description: 
      Patients will provide two saliva samples containing genetic information.
Evaluating the Effectiveness of Axiostat Hemostatic Dressing Material Versus Conventional Method of Hemostasis and Healing of Extraction Wounds in Patients on Oral Anti-Platelet Drugs - A Comparative Study
Condition: Tooth Extraction
Study type: Interventional

Summary: 
      The rationale of this study was to evaluate the efficacy of Axiostat hemostatic dental
      dressing in achieving hemostasis post-extraction and determining its effect on pain and
      healing of the extraction wound, compared to control, i.e. conventional method of extraction
      in patients on oral anti-platelet therapy.
    


Intervention name(s): Axiostat; Cotton Gauze
Intervention type(s): Device; Device
Intervention description(s): Axiostat® is a sterile, non-absorbable haemostatic dressing intended to control profuse bleeding within minutes of application by providing an active mechanical barrier to the wound site.
Axiostat® stops moderate to severe bleeding due to cuts, abrasions, lacerations, venous/arterial punctures and more. Mechanism of action is such that Axiostat® is an extremely positive dressing that becomes very sticky in the presence of negatively charged blood and thus seals the wound area.; Size: 1 x 1 cm
Other intervention name(s): Chitosan haemostatic dressing
Intervention MeSH terms: Hemostatics; Chitosan
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Burn Outcomes in Young Adult Burn Survivors
Condition: Burns; Trauma
MeSH terms: Burns
Study type: Observational

Summary: 
      As part of Clinical Trials.Gov ID:NCT00253292 a psychometrically sound outcomes instrument
      was developed to study the outcomes of burn survivors in the 19-30 year old age group. This
      workgroup has come together to re-examine the data collected during the previous study and
      determine next steps in understanding the recovery for this population.
    

Detailed description: 
      This study looks to understand previously collected outcomes scores. Identifying young adult
      burned patients at risk for poor outcomes remains an under-published field of study. We
      strive to identify problem areas for this population before they adversely effect their
      quality of life. How are these 19-30 year olds different from their non-burned counterparts
      and what interventions can we provide to equalize the balance?
    

Intervention name(s): Questionnaire self report
Intervention type(s): Other
Intervention description(s): Burn specific outcome measurement and global health measurement
Other intervention name(s): Young Adult Burn Outcomes Questionnaire; Veterans Rand 12 Item Health Survey
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Persons having suffered a burn injury and treated at participating study sites that are
        between the ages of 19-30 years of age and speak English.
      
Keywords: Burns; Trauma; Outcomes; Quality of Life
Study of Midazolam in Healthy Adults
Condition: Status Epilepticus
MeSH terms: Status Epilepticus
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a phase 1, open-label, crossover, comparison study to evaluate the safety and
      pharmacokinetics (PK) of a single IM administration of 10 mg midazolam using Rafa's
      auto-injector compared with seizalam in healthy adults. All subjects will participate in both
      study periods which will span 28 days following a pre study screening visit.
    


Intervention name(s): Midazolam; Seizalam
Intervention type(s): Combination Product; Drug
Intervention description(s): Midazolam Injection, 10mg; Seizalam, 10 mg
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetic Interactions Between Atorvastatin and Metformin in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the pharmacokinetic interactions between atorvastatin
      and metformin single or co-administered in healthy volunteers
    


Intervention name(s): Period I : atorvastatin, Period II : atorvastatin and metformin; Period I : metformin, Period II : atorvastatin and metformin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Metformin; Atorvastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Using High Resolution Function Imaging To Detect Melanoma and Dysplastic Nevi
Condition: Melanoma
MeSH terms: Melanoma; Dysplastic Nevus Syndrome
Study type: Observational

Summary: 
      A novel infrared imaging tool to aid in the clinical detection of atypical pigmented lesions
      and melanoma is developed. Goals include evaluation of the utility of high-resolution
      infrared scanning of cutaneous lesions in the diagnosis of pigmented lesions and the
      identification of high-risk lesions and melanomas.
    

Detailed description: 
      This study uses a specific skin protocol to cool the skin and then measures the cutaneous
      thermal recovery to uniquely identify lesions that may be cancerous. Using computer models,
      the thermal signature is used to determine the size and shape of the lesions in question. In
      particular, this study seeks to add quantification analysis of high resolution thermal images
      of melanoma lesions to provide accurate early diagnostic capability with specific detail
      regarding size, shape and depth of the lesions. This information will be compared to biopsy
      results and surgical resection results.
    

Observational model: Case-Only
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        The subject population will be identified in the Department of Dermatology Pigmented Lesion
        Clinic at the Johns Hopkins Hospital Outpatient Center. Recruited patients will only
        comprise those requesting a cutaneous pigmented lesion removed or patients that are
        examined and found to have a pigmented lesion that is suspicious for malignancy at the time
        of their visit, and thus recommended to have a skin biopsy for diagnosis following the
        standard of care
      
Keywords: Thermography
Exercise Induced Plasma Volume Expansion Lowers Cardiovascular Strain
Condition: Cardiac Output; Stroke Volume
Study type: Interventional

Summary: 
      The goal of this observational study was to better understand the impact of increased plasma
      volume on later exercise in hypoxia. Investigators examined young, healthy, males who
      regularly participated in aerobic exercise.

      Investigators first measured participant's response to exercise in hypoxia (simulated ~7,500
      feet above sea level). The investigators then had participants either 1) undergo 1 bout of
      high intensity interval exercise or 2) undergo 1 bout of moderate, continuous exercise.

      48 hours after the exercise, participants were again examined in hypoxia.
    

Detailed description: 
      A crossover design was utilized to assess the effects of exercise-induced plasma volume
      expansion on cycling performance in hypoxia. All participants completed a high intensity (HI)
      bout and control (CON) intervention in a counterbalanced order. The HI bout consisted of
      8x4min cycling bouts at 85% of VO2peak with 4 min rest between intervals. CON consisted of
      cycling at 50% VO2peak. Two 15 km, self-paced cycling time trials (TT) were performed before
      and after each training intervention. The first TT occurred 5 days before the training
      intervention (HI or CON) and the second TT occurred 48 hours post intervention. Interventions
      were separated by 14 days to ensure sufficient washout of any training effect as data have
      suggested retention of expanded plasma volume may last for 7-14 days. During washout,
      participants were instructed to continue their normal exercise routine.

      The investigators hypothesized that a single HI session would increase plasma volume and
      attenuate cardiovascular strain during exercise in hypoxia, as evidenced by reductions in HR
      and elevations in SV and Q. Furthermore, the investigators hypothesized that these changes
      would contribute to a reduced time-to-completion in a 15 km, self-paced cycling TT.
    

Intervention name(s): High Intensity Intervals; Moderate Exercise
Intervention type(s): Procedure; Procedure
Intervention description(s): 8x4 min cycling bouts at 85% of VO2peak; 81 minutes of cycling at 50% VO2peak
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hypervolemia; high intensity exercise; altitude exposure
Effect of Addition Oral Montelukast to Standard Treatment in Acute Asthma in Hospitalized Preschool Children
Condition: Acute Asthma; Acute Wheezy Bronchitis
MeSH terms: Bronchitis; Bronchiolitis; Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      Leukotriene receptor antagonists (LTRAs) are well established in the management of outpatient
      asthma. Montelukast is a potent, specific, orally active, cysteinyl leukotriene receptor
      antagonist with a rapid onset of action.However, there is very little information as to their
      role in acute asthma exacerbations.

      The purpose of this study is to determine if adding oral montelukast to the maximal standard
      treatment in children hospitalized for acute asthma has any additive benefit.
    

Detailed description: 
      Background: Montelukast is a potent, specific, orally active, cysteinyl leukotriene receptor
      antagonist with a rapid onset of action.

      Objective: To evaluate the effect of the addition of a single dose of oral montelukast to
      standard therapy in acute asthma. Design: Double-blind, randomised, controlled, parallel
      group trial. Setting: Pediatric service of Education and training Hospital Patients: Children
      with the ages of 6-60 months who were hospitalized for acute asthma Intervention: Children
      received montelukast 4 mg or placebo orally in addition to the standard therapy. Clinical
      asthma score was recorded before administering study medication and thereafter, 4 hourly
      until discharge. Main outcome measure: The primary outcome was discharge rates.
    

Intervention name(s): Montelukast 4 Mg Oral Granule; Placebos
Intervention type(s): Drug; Drug
Other intervention name(s): Montelukast sodium
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Acute asthma; Montelukast; Hospitalized children; Preschool children
A Comparison of Two Daily Disposable Contact Lenses.
Condition: Refractive Error; Myopia
MeSH terms: Refractive Errors
Study type: Interventional

Summary: 
      This study seeks to evaluate the clinical fitting performance of a new daily disposable
      contact lens to an existing daily disposable contact lens.
    


Intervention name(s): etafilcon A; narafilcon A
Intervention type(s): Device; Device
Intervention description(s): contact lens; contact lens
Other intervention name(s): 1-Day Acuvue Moist; TruEye
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Clinical Trial to Assess the Pharmacokinetic Characteristics of Lodivikar Tab. 5/40 mg in Healthy Adult Male Subjects
Condition: Healthy Male Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetic characteristics of olmesartan and
      S-amlodipine after single oral administration of Sevikar tab. 10/40mg, a combination
      formulation of olmesartan and amlodipine as reference drug and Lodivikar tab. 5/40mg, a
      combination formulation of olmesartan and S-amlodipine as test drug in healthy male adults.
      Additionally the safety and tolerability of two drugs will be evaluated.
    


Intervention name(s): Sevikar tab. 10/40mg; Lodivikar tab. 5/40mg
Intervention type(s): Drug; Drug
Intervention description(s): Reference drug: Sevikar tab. 10/40mg, 1T, single oral administration in the fasted state; Test drug: Lodivikar tab 5/40mg, 1T, single oral administration in the fasted state
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Monitoring Adherence Using Mobile Technology
Condition: Asthma
Study type: Observational

Summary: 
      This study plans to learn more about how children use their asthma medicines. The
      investigators would like to see if special electronic monitoring devices that connect to
      smartphones and computers can help children to better manage their asthma
    


Intervention name(s): Propeller Health Monitoring Device
Intervention type(s): Device
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Study subjects would be drawn from the list of high risk asthma patients and by pre-clinic
        chart review done by study investigator.
The Desensitizing Treatment Effects of the Laser and Ozone on Dentin Hypersensitivity: In-vivo Comparison
Condition: Dentin Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this split mouth clinical trial is to compare clinical efficacy of diode laser
      and gas ozone in the treatment of dentine hypersensitivity (DHS) of non-carious-cervical
      lesion. The main questions it aims to answer are:

        -  gas ozone affects dentine hypersensitivity?

        -  diode laser affects dentine hypersensitivity? Participants, affected of DHS , were
           treated with gas ozone and diode laser.The pain severity was quantified according to the
           Visual Analogue Scale (VAS) before and after the treatmens.
    


Intervention name(s): Gas ozone; Diode laser and desensitized gel
Intervention type(s): Combination Product; Combination Product
Intervention description(s): The application of ozone was performed with the HealOzone System X4 (HealOzon, Kavo, Germany). The dentist adapted the silicon cup stricken on the cervical surface of the teeth. The pumping system created the vacuum and the machine applied high dosage of ozone, equal to 32 g/m3, for 30 second.; The dentist applied desensitized gel (JW-Desensitizing Gel, Heydent Gmbh, Germany) directly on the cervical zone of the teeth. Subsequently the irradiation was performed with Wiser III (Wiser, Doctor Smile, Italy) in the desensitizing assisted mode (preprogramed protocol). The protocol provides consecutively steps (not in contact) with 20 second of interval, 808 wavelength, and power incrementation, from 0,2 till 0,6 W. radiating the entire desensitize surface second using the "black tip" (400 micron). The procedure continued maintaining the tip of the laser on contact with the dentine surface making movement of lawn mowing (brushing technique) for 30 second. Then the surface was rinsed, and the irradiation applied again without the gel.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Split Mouth: all patients involved received both treatments randomly assigned to either the right or left halves of the dentition.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment