bioihbjkbjnl/mcl2 huggingface dataset:
MMP-9 Monitoring Particulate Cerebral Embolisation
Condition: Cerebral Embolic Damage
Study type: Observational [Patient Registry]

Summary: 
      1. In carotid endarterectomy(CEA) surgery, the dynamic changes of plasma MMP9 concentration
           cross CEA will be identified.

        2. And the part of patients suffered particulate cerebral embolic injury, their MMP9 level
           will increase in the early stage after CEA.
    


Intervention name(s): vein blood collection
Intervention type(s): Procedure
Intervention description(s): 5 ml peripheral vein blood samples were collected from each patient admitted to our study at the following time-points：Pre-operative（morning of surgery），just before declamping，30mins after declamping and post-operative（12h）.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients under CEA in the PUMCH
      
Biospecimen description: 
      serum,Freeze-saving -80℃
Repeat Dose Study in Male Healthy Volunteer Smokers
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 4 to 6 week study to look at the safety and PK profile of SB656933 in healthy male
      smokers
    


Intervention name(s): SB-656933; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SB-656933 will be available as white film coated, round tablet and will be available in strengths of 50 milligrams, administered orally once daily.; A placebo tablet to visually match the SB-656933 tablet will also be supplied, administered orally once daily.
Allocation: Randomized
Intervention model: Single Group Assignment
Primary purpose: Treatment
Keywords: Smoker,; Male,; Chronic Obstructive Lung Disease; Cystic Fibrosis,; Healthy Volunteer,
Early Versus Delayed Surgery for Infantile Esotropia
Condition: Esotropia
MeSH terms: Esotropia
Study type: Observational

Summary: 
      The goal of this study is to determine whether corrective surgery done earlier than the
      current standard can better improve the visual and eye movement deficits in children with
      infantile esotropia (crossed eyes in infancy).
    

Detailed description: 
      While there is a uniform agreement among pediatric ophthalmologists that most infantile
      esotropia requires surgical correction, the proper timing of surgery is controversial. In
      North America, the typical age at surgery ranges from 11-18 months. Unfortunately, despite
      successful surgical realignment of the eyes, the sensory and eye movement deficits often
      persist. Recently, some pediatric ophthalmologists have advocated earlier surgery. The
      rationale for early surgery stems from animal and human research showing that early
      realignment of the eyes within an early critical period allows normal development of the
      sensory and eye movement systems.
    

Intervention name(s): mVEP Testing; Stereoacuity Testing; Optokinetic nystagmus testing; Motion detection testing; Motion discrimination testing
Intervention type(s): Procedure; Procedure; Procedure; Procedure; Procedure
Intervention description(s): Five small sensors are placed on the head which record the brain's response to moving stripes that are displayed on a computer screen. Each eye is tested while the other eye is patched. Each recording trial lasts about 10 seconds, and several trials are done for each eye.; Subjects will have their 3D perception measured using standard clinical stereo tests (Randot, Lang, Titmus).; Subjects will be asked to view a screen with vertical stripes moving in both leftward and rightward directions while their eye movements are recorded using a remote video-based eye tracker.; Subjects will view a computer screen that has two panels of dots on them. The subject will be required to pick which panel has a section of dots that are moving in a specific direction (ie. nasalward/temporalward).; Subjects will view a computer screen that has two panels of randomly moving dots on them. The subject will be required to pick which panel has a section of dots that are moving in a specific direction (ie. nasalward/temporalward).
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with infantile esotropia will be enrolled from The Hospital for Sick Children in
        Toronto. Infants with characteristics that indicate low likelihood of spontaneous
        resolution will be studied.
      
Keywords: pediatrics; Esotropia; Surgery
Preservative-Free Tafluprost (MK-2452) for the Treatment of Open-Angle Glaucoma or Ocular Hypertension (MK-2452-002)
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will test the hypothesis that preservative-free tafluprost (MK-2452) is
      non-inferior to preservative-free timolol maleate with respect to the diurnal intraocular
      pressure (IOP) change from baseline after 4 weeks of therapy in participants with open-angle
      glaucoma or ocular hypertension.
    


Intervention name(s): Preservative-Free Tafluprost or vehicle; Preservative-Free Timolol maleate
Intervention type(s): Drug; Drug
Intervention description(s): Preservative-free tafluprost (0.0015%) ophthalmic solution; Preservative-free vehicle ophthalmic solution (contains no active drug); Preservative-free timolol maleate (0.5%) ophthalmic solution
Other intervention name(s): MK-2452; Preservative-Free Timoptic
Intervention MeSH terms: Timolol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Tafluprost; Glaucoma; Ocular Hypertension; Timolol; Eye Disorder; Preservative-Free; Prostaglandin Analogue
Buccal Infiltration Anesthesia Versus Inferior Alveolar Nerve Block Anesthesia
Condition: Anesthesia
Study type: Interventional

Summary: 
      This study aims to evaluate the effectiveness of single buccal local infiltration when
      compared to buccal local infiltration with intrapapillary infiltration and inferior alveolar
      nerve block anesthesia in primary mandibular molar extractions.
    

Detailed description: 
      Effective pain control is essential in providing children with successful dental treatment.
      Without it, negative experiences may result in anxiety and fear-related behaviors towards
      subsequent dental treatment. Local anesthesia is the cornerstone of pain control in
      dentistry. Choosing the right local anesthetic technique is of special significance .

      The inferior alveolar nerve block (IANB) is a common practice for anesthetizing mandibular
      molars and/or premolars on one side of the jaw. It is achieved by depositing local anesthetic
      solution at the entrance to the mandibular canal, which inhibits the transmission of action
      potentials along the inferior alveolar nerve.

      Administering an IANB can be technique sensitive and failure rates are reported to be up to
      20%, due to anatomical variations in the position of the mandibular foramen and accessory
      innervations. This effect may be compounded for those who are not used to anesthetizing
      children .

      However, Supraperiosteal infiltration has the advantages of easier administration when
      compared to block anesthesia, shorter anesthetic duration, and generally does not anesthetize
      the lips .

      An ideal local anesthetic should provide maximum efficacy, through a minimal number of
      injections, using techniques that provide the least discomfort, causing negligible adverse
      effects .
    

Intervention name(s): Single buccal infiltration; Inferior alveolar nerve block
Intervention type(s): Procedure; Procedure
Intervention description(s): injecting local anaesthetic solution into the soft tissues of the buccal sulcus adjacent to the target tooth.; Injection of local anesthetic solution into the pterygomandibular space to access the inferior alveolar nerve before it enters the mandible.
Other intervention name(s): Articaine buccal infiltration; Lidocaine nerve block
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Spine MRI in Patients With Deep Brain Stimulation (DBS)
Condition: Parkinson Disease; Dystonia; Depression; Spinal Stenosis; Spinal Diseases
MeSH terms: Spinal Stenosis; Spinal Diseases; Parkinson Disease; Dystonia
Study type: Interventional

Summary: 
      Magnetic resonance imaging (MRI) of patients implanted with deep brain stimulation (DBS) is
      under strict safety guidelines. Depending on the body part being imaged, the safety may vary.

      Many DBS patients will need a spine MRI based on their clinical symptoms. However, the vendor
      safety guidelines are limiting in terms of possible MR pulse sequences. Based on phantom
      safety data, we designed a set of MR pulse sequences deemed as safe as possible and the
      protocol allows acquisition of diagnostic quality MRI images.
    

Detailed description: 
      The patients who clinically require a spine MRI will undergo a spine MRI with our designed
      protocols to obtain diagnostic quality images. Furthermore, a limited brain MRI will be done
      before and after to ensure no peri-electrode tissue changes.
    

Intervention name(s): MRI of the spine
Intervention type(s): Diagnostic Test
Intervention description(s): Perform a clinically indicated MRI of the spine in DBS patients
Intervention model: Single Group Assignment
Intervention model description: This is a prospective cohort study that will enroll patients who have already undergone DBS electrode placement for a variety of disorders including, but not limited to Parkinson's disease, essential tremor, dystonia, depression, epilepsy, neuropathic pain and Alzheimer's disease. This eligible patient population is broad but unified by the fact that they have undergone DBS to treat specific circuit dysfunctions. Patients with internalized leads and IPG may be included. Patients will undergo routine clinical MRI sequences used for the spine (structural in axial and sagittal planes). The choice of imaging the cervical, thoracic or lumbar will depend on the requisition from the treating physician.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: deep brain stimulation
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of UB-612 COVID-19 Vaccine
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, open-label, dose-escalation clinical study to evaluate the safety,
      tolerability and immunogenicity of 3 ascending doses of UB-612 COVID-19 vaccine in healthy
      adults, aged from 20 to 55 years old.
    

Detailed description: 
      This is a phase I, open-label, dose-escalation clinical study to evaluate the safety,
      tolerability and immunogenicity of 3 ascending doses of UB-612 COVID-19 vaccine in healthy
      adults. Up to 60 subjects (20 subjects per group) will be enrolled into this study. Subjects
      in each group will be enrolled to receive two doses of UB-612 vaccine at 28-day interval (Day
      0 and Day 28).
    

Intervention name(s): UB-612
Intervention type(s): Biological
Intervention description(s): UB-612 is a proprietary high-precision designer S1-RBD-protein based vaccine incorporating a Th/CTL epitope peptide pool which could bind to human MHC-I and MHC-II to activate T cells.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Testing the Elevation as Sleep Apnea Treatment
Condition: Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Sleep
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      The purpose of this study is to determine if the elevation of the head of the bed in patients
      with obstructive sleep apnea can decrease the apnea-hypopnea index. First the investigators
      will do a standard polysomnography and see if the patients are included analysing the
      criteria like apnea-hypopnea index equal or more than 5. Within 2 weeks the patient will do
      the second polysomnography but this will be with a elevation of the head of the bed (15 cm of
      elevation of the bed doing a inclination). Then the investigators will compare the data of
      apnea-hypopnea index in the standard polysomnography versus the index with the elevation of
      the head of the bed.
    

Detailed description: 
      There are many researches that demonstrate that the position of the patient modified the
      apnea-hypopnea index(IAH). In supine position the IAH will increase comparing with lateral
      position during th sleep. However few studies were done with the elevation of the head of the
      bed.

      First the investigators will do a standard polysomnography and see if the patients are
      included analysing the criteria like apnea-hypopnea index equal or more than 5. Within 2
      weeks the patient will do the second polysomnography but this will be with a elevation of the
      head of the bed (15 cm of elevation of the bed doing a inclination). Then the investigators
      will compare the data of apnea-hypopnea index in the standard polysomnography versus the
      index with the elevation of the head of the bed.The main outcome will be to analyze the apnea
      hypopnea index comparing standard polysomnography (sPSG) with elevated polysomnography
      (ePSG).
    

Intervention name(s): Head of bed elevation
Intervention type(s): Behavioral
Intervention description(s): head of bed elevation elevation the head of the bed with 15 cm (head of bed elevation) and compare the apnea-hypopnea index with the standard polysomnography
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Polysomnography; Sleep; Patient Positioning
Dexamethasone for the Prevention of Postoperative Cognitive Dysfunction
Condition: Postoperative Cognitive Dysfunction
MeSH terms: Postoperative Cognitive Complications; Cognitive Dysfunction
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to evaluate the possible effect of dexamethasone on prevention of cognitive
      dysfunction in the postoperative period of elderly patients undergoing to surgery under
      general anesthesia.
    

Detailed description: 
      Postoperative cognitive dysfunction is related with the use of opioids in the postoperative
      period, lack of physical activity, fatigue, postoperative pain and quality of life. The use
      of corticosteroids preoperatively reduces postoperative pain, fatigue, nausea and vomiting in
      the postoperative period and is frequently used as an adjuvant in anesthesia. This study aims
      to evaluate the possible effect of dexamethasone on prevention of cognitive dysfunction in
      the postoperative period of elderly patients undergoing to surgery under general anesthesia.
    

Intervention name(s): Dexamethasone; control group
Intervention type(s): Drug; Other
Intervention description(s): a dose of 8 mg of dexamethasone will be administered intravenously before induction of general anesthesia; General anesthesia, without additional interventions
Other intervention name(s): The Dexamethasone and Index Bispectral; Index Bispectral and not received the Desamethasone
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dexamethasone; Postoperative cognitive dysfunction; General Anesthesia; neuropsychological tests
Neoadjuvant Durvalumab Alone or in Combination With Novel Agents in Resectable Non-Small Cell Lung Cancer
Condition: Resectable; Early-stage; NSCLC
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      Study D9108C00002 (NeoCOAST) is a platform study assessing the effectiveness and safety of
      neoadjuvant durvalumab alone or in combination with novel agents in participants with
      resectable, early-stage (Stage I [>2cm] to IIIA) non-small cell lung cancer (NSCLC).
    


Intervention name(s): Durvalumab; Oleclumab; Monalizumab; Danvatirsen
Intervention type(s): Drug; Combination Product; Combination Product; Combination Product
Intervention description(s): Durvalumab 1500 mg IV will be administered Q4W (on Week 1 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period.; Oleclumab 3000 mg IV will be administered Q2W (on Week 1 Day 1 and Week 3 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period.; Monalizumab 750 mg IV will be administered Q2W (on Week 1 Day 1 and Week 3 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period.; Danvatirsen 200 mg IV will be administered on Days 1, 3, and 5 of Week 0 (7-day danvatirsen lead-in period) and later every week (on Week 1 Day 1, Week 2 Day 1, Week 3 Day 1, and Week 4 Day 1) until disease progression, unacceptable toxicity, or other reason of treatment discontinuation over a 28-day treatment period.
Other intervention name(s): MEDI4736; MEDI9447; IPH2201; AZD9150
Intervention MeSH terms: Durvalumab
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be enrolled and randomized into a durvalumab monotherapy arm or into a durvalumab plus other novel therapy arms. Up to approximately 25 sites globally will participate in this study. New treatment arms may be added in the future. Participants will be treated with a single durvalumab dose alone or in combination with other agents. After the single cycle treatment period participants will have the standard surgical resection planned. All participants will have a post-resection monitoring visit. Study treatment will be discontinued upon disease progression, unacceptable toxicity, or other investigators' reasons.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neoadjuvant; Non-small Cell Lung Cancer; Cancer; Lung; Resectable; Early-stage; Stage I; Stage II; Stage IIIA; Durvalumab
Effects of Aprepitant on Satiation, Gastric Volume, Gastric Accommodation and Gastric Emptying
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This research study is being done to compare the effects of Aprepitant and placebo on fasting
      gastric volume, accommodation volume, satiation (fullness) and gastric emptying.
    


Intervention name(s): Aprepitant; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will receive one tablet daily for 5 consecutive days. On Day 1 subjects will take a 125mg tablet, on Days 2-5, subjects will take an 80 mg tablet.; Subjects will receive one placebo tablet daily for 5 consecutive days.
Other intervention name(s): Emend
Intervention MeSH terms: Aprepitant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
18475 - Sun Protection Factor Assay
Condition: Sunscreening Agents
Study type: Interventional

Summary: 
      To evaluate the Sun Protection Factor efficacy on human skin.
    


Intervention name(s): BAY987521
Intervention type(s): Drug
Intervention description(s): Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation number - Y49-103)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of Emotion and Cognition Abilities of Children With PWS and Proposition of an Innovative Remediation
Condition: Prader-Willi Syndrome
MeSH terms: Prader-Willi Syndrome; Syndrome
Study type: Interventional

Summary: 
      The present project project is divided in two parts. The primary aim of the part 1 of this
      study is to evaluate emotional control abilities of children with Prader-Willi syndrome (PWS)
      aged from 9 to 15 years and to study repercussions of this supposed lack of abilities on
      cognitive capacities and behavioral troubles. The study also evaluate influence of the
      emotional symptomatology of patients on quality of parents' life and on the care of parents
      and scholar/institutional caregivers. In the second part of this study, the study evaluate
      the feasibility and the tolerance to a non-invasive device supposed to reduce emotional
      symptoms in this disease.
    

Detailed description: 
      Prader-Willi Syndrome (PWS) is a rare genetic disorder involving a variety of clinical,
      behavioral and cognitive symptoms. 83 to 97% of patients have episodes of temper tantrum,
      associated with an important emotional lability. These different cognitive and behavioral
      limitations are barriers to the social integration of patients. The PWS also has
      repercussions on well-being and quality of life of the family. Thus, the present project
      focuses on the characteristics of emotional control related to the anger of children with PWS
      and its behavioral, cognitive and social implications. In addition, at a therapeutic level,
      our project assumes that transcutaneous electrical nerve stimulation (t-VNS), a non-invasive,
      safe and inexpensive method, could be effective in reducing the severity of behavioral
      disorders such as temper tantrums while improving cognitive performance and social
      communication in the PWS.
    

Intervention name(s): Questionnaires; t-VNS
Intervention type(s): Behavioral; Device
Intervention description(s): Evaluation of behavioral disorders of children with PWS by questionnaires; Evaluation of the influence of 6 month-stimulation by t-VNS on emotional, cognitive, and behavioral/clinical characteristics of 12 children with PWS on 30 PWS patients included.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: The study consists of 2 parts. The first part compares 30 children with PWS compared to 30 control children without PWS. The second part will be based on 12 children with PWS who have undergone part 1.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Emotion; Cognition
Evaluation of a Test Mouthwash and Dentifrice Regimen in an In-situ Model of Dental Erosion
Condition: Tooth Erosion
MeSH terms: Tooth Erosion
Study type: Interventional
Phase: Phase 2

Summary: 
      An in situ model will be used to evaluate and compare enamel remineralization of bovine
      enamel specimens.
    


Intervention name(s): Sodium fluoride; Sodium monoflurophosphate; Sterile water
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Test fluoride toothpaste and test fluoride mouth rinse; United Kingdom marketed fluoride toothpaste; Sterile water rinse
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: enamel erosion; tooth remineralization; tooth erosion