bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Trial for the Investigational Drug (PB-201) in Subjects With Type 2 Diabetes Mellitus
Condition: Type2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This crossover study investigates the safety, tolerability, pharmacokinetics (PK)
      ,pharmacodynamics (PD) effect of three dose levels of PB-201,and characterizes the PK profile
      of a prominent des-methyl metabolite of PB-201(WI-0800), following dosing of three dose
      levels of PB-201 in drug-naive Chinese adult subjects with Type 2 diabetes mellitus (T2DM) as
      monotherapy.

      There were 7 days separating 4 treatment periods and at least 7-day washout (but not
      exceeding 14 days) between dosing in 4 periods with 3 dose levels of PB-201 and placebo.
      Three dose levels of PB-201 are: split dose regimen of 50 mg 30 minutes before morning meal
      plus 50 mg 30 minutes before lunch at approximately 3.5 hours after morning dose, and split
      dose regimen of 100 mg 30 minutes before morning meal plus 100 mg 30 minutes before lunch at
      approximately 3.5 hours after morning dose, and split dose regimen of 150 mg 30 minutes
      before morning meal plus 100 mg 30 minutes before lunch at approximately 3.5 hours after
      morning dose.
    


Intervention name(s): glucokinase activator; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): PB-201 is a kind of dual and partial GKA; Placebo oral tablet
Other intervention name(s): PB-201; PB-201 Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Glucokinase activator(GKA); hypoglycemia
Text Message Stop Smoking Among Young Population
Condition: Young Adult Behavioral Change
Study type: Interventional

Summary: 
      Smoking cessation is a priority for preventing smoking-attributable disease and reducing its
      burden. Quitting smoking at any age confers substantial and immediate health benefits,
      including reduced risks of stroke, cardiovascular disease and smoking-related cancers, and
      quitting smoking by the age of 30 reduces the risk of dying from tobacco-related diseases by
      almost 90%. The World Bank suggests that if adult cigarette consumption were to decrease by
      half in the year 2020, approximately 180 million tobacco-attributable deaths could be
      avoided. Therefore, promotion of smoking cessation has been proposed as a primary focus of
      tobacco control efforts, especially in developing countries where smoking prevalence and
      cigarette consumption are both still relatively high
    

Detailed description: 
      most risk factors are associated with more than one disease, and targeting those factors can
      reduce multiple causes of disease. Since smoking has 9% contributions on the leading global
      risk towards mortality in the world and this risk factor has resulted in multiple causes of
      disease for example, lung cancer, heart disease, stroke, chronic respiratory disease and
      other conditions therefore by quantifying the impact of this risk factors on diseases, may
      help to decrease the number of burden disease that is caused by smoking. University students
      age of 18 -24 are among the group of age that has the highest prevalence on smoking, thus it
      is necessary to targeting the high-risk people, who are most likely to benefit from the
      intervention. Population-based strategies seek to change the social norm by encouraging an
      increase in healthy behavior and a reduction in health risk. University students are in
      transition between the adolescence and early adulthood and developed unhealthy behaviors like
      cigarette smoking
    

Intervention name(s): Lets Quit; pamphlets material
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Five tracks were created including "Not Ready", "Beginner", "Advance", "Relapse", and "Distraction". The "Distraction" track was combined with all of the other remaining 4 tracks. It was aimed as a distraction (as the name indicated) method to lighten the participants mood. It consisted of general information such as sports, fashion, dining, movies, and travelling.; Given pamphlets material on smoking and complication
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Neurotrack Test Validation Protocol
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Observational

Summary: 
      This protocol describes a study to validate Neurotrack's visual paired comparison task, aimed
      at early detection and monitoring of memory impairment. The investigators will determine
      whether the novel task developed by Neurotrack is associated with markers of brain pathology
      associated with very early Alzheimer's disease. The elderly subjects studied will be
      cognitively normal (CN) or have amnestic mild cognitive impairment (aMCI). For the current
      study, the primary brain pathology parameters will be derived from MRI scans. Data from this
      study will be correlated with data from a parallel study designed to validate a larger group
      of new cognitive tasks by correlating test performance with a broader array of biomarkers of
      Alzheimer's disease.
    

Detailed description: 
      The Neurotrack test has the potential to dramatically alter the current methods used for
      detecting cognitive deficits. Patients and research subjects could be screened for medial
      temporal lobe (MTL) impairment using inexpensive, widely available, safe, and non-invasive
      technology.

      Subjects will be elderly individuals who are participating in ongoing research at the NYU
      Alzheimer's Disease Center (ADC) and who have received the standard ADC clinical evaluation
      within the past year, including a medical-neurological evaluation, neuro-psychological
      assessment and structural neuroimaging (MRI). As part of the current study, all subjects will
      receive both the Neurotrack Visual Paired-Comparison (VPC) Task and MRI scans. The current
      protocol strictly for a research study and there will be no "standard care" provided.
      Participants will be asked to come in for two separate sessions. The first session will
      involve screening to confirm eligibility and administration of the cognitive testing
      procedures, while the second session will involve the MRI protocol.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Individuals will be recruited from among participants at the NYU Alzheimer's Disease Center
        ADC, at the affiliated Center for Brain Health (CBH), and from other ongoing NYU research
        studies of the Center for Cognitive Neurology (CCN) that are affiliated with the ADC and
        for which participants receive the standard ADC research diagnostic assessment (the ADC
        Clinical Evaluation).
      
Keywords: Alzheimer's Disease; MRI
Oral CF101 Tablets Treatment in Patients With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial will test the hypothesis that the administration of CF101, a novel
      anti-inflammatory agent, to patients with rheumatoid arthritis and high A3AR expression at
      baseline will relieve signs and symptoms of the disease.
    

Detailed description: 
      This will be a multi-center, randomized, double-blind, parallel-group, placebo-controlled,
      study in which patients with active RA and high A3AR expression at baseline will be
      randomized to the addition of either CF101 1.0 mg or placebo given orally q12h for 12 weeks.
      Screening examinations will occur within 1 month prior to dosing. Washout of other
      disease-modifying antirheumatic drugs (DMARDs), including biological agents, will occur prior
      to dosing; if washout is necessary, patients must re-qualify for inclusion following the
      washout. Doses of nonsteroidal anti-inflammatory drugs (NSAIDS) and corticosteroids must be
      stable for >=1 month prior to dosing and remain so during protocol participation. Disease
      activity will be assessed using swollen and tender joint counts, physician and patient global
      assessments (by visual analog scale, VAS), patient reported pain (by VAS), a Health
      Assessment Questionnaire (HAQ) Disability Index (DI), Westergren erythrocyte sedimentation
      rate (ESR, Screening, Weeks 0 and12), and C-reactive protein (CRP) levels. Assessments will
      take place at Screening, Baseline (Week 0), and at Weeks 2, 4, 8, and 12.
    

Intervention name(s): CF101; Placebo control
Intervention type(s): Drug; Drug
Intervention description(s): orally q12h; orally q12 hours
Other intervention name(s): IB-MECA; Inactive pill
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Monocular Action Video Game Treatment of Amblyopia
Condition: Amblyopia; Amblyopia Occlusion; Unilateral Amblyopia; Anisometropic Amblyopia; Strabismic Amblyopia
MeSH terms: Amblyopia
Study type: Interventional

Summary: 
      This study evaluates the effectiveness of the monocular treatment with action video-games in
      comparison with the occlusion therapy alone in amblyopic patients, and the satisfaction with
      the different evaluated treatments.
    

Detailed description: 
      Amblyopia is the condition in which there is a decrease in monocular visual acuity or, less
      frequently, binocular, in absence of structural anomalies or ocular pathology. It is a
      reversible condition that affects up to 5% of the population, and that is the result of an
      abnormal visual experience during the most sensitive period of visual development.

      The aim of this study is reviewing, analyzing and, if applicable, updating the current
      treatment model for amblyopia.

      A randomized clinical trial will be performed to evaluate the effectiveness of the monocular
      treatment with action video-games in comparison with the occlusion therapy alone in amblyopic
      patients, and the satisfaction with the different evaluated treatments. The participants will
      be distributed in two groups. The first group will include those participants who will follow
      a daily occlusive treatment and the second group will include patients who will be treated
      with monocular therapy with video-games.The sample will include subjects between 4 to 10
      years old with a diagnosis of refractive and / or strabismic amblyopia.
    

Intervention name(s): Monocular Active Occlusion; Monocular Passive Occlusion
Intervention type(s): Other; Other
Intervention description(s): Occlusion treatment of one hour daily with action video game.; Occlusion treatment of two hour daily.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized clinical trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Action Video Games; Amblyopia treatment
Pharmacokinetics of Single Doses of BILR 355 BS Given With Ritonavir in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Assessment of the effect of two times oral 100 mg ritonavir capsules on pharmacokinetics of a
      single dose of BILR 355 BS dissolved in PEG 400
    


Intervention name(s): BILR 355 BS, D1; BILR 355 BS, D2; BILR 355 BS, D3; BILR 355 BS, D4; BILR 355 BS, D5; BILR 355 BS, D6; BILR 355 BS, D7; BILR 355 BS, D8; BILR 355 BS, D10; Placebo; high-fat breakfast; Ritonavir
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Other; Drug
Intervention MeSH terms: Ritonavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Prediction of Risk Factors for Adverse Events After Head and Neck Vascular Recanalization Surgery Based on Machine Learning Models
Condition: Machine Learning
Study type: Observational

Summary: 
      Prediction of risk factors for adverse events after head and neck vascular recanalization
      surgery based on machine learning models
    


Intervention name(s): observe
Intervention type(s): Other
Intervention description(s): observational study
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing vascular recanalization surgery due to stroke
Effect and Safety of Smart Bra (PUMCH)
Condition: Effects of the Elements
Study type: Interventional

Summary: 
      This is a multicenter, prospective clinical study was conducted to evaluate the safety and
      effectiveness of Xiehe smart bra for breast disease screening in outpatients with breast
      surgery. According to the patients' wishes and written informed consent, they were randomly
      assigned to the study group. A total of 2000 patients were expected to be enrolled. The
      training group: validation group = 1:1.
    

Detailed description: 
      This study is a randomized, open, multicenter clinical study. It will be conducted in Peking
      Union Medical College Hospital, Shanxi Provincial People's Hospital, Beijing Third Hospital,
      Zhalantun ZhongMeng hospital, Chongqing Medical University affiliated university town
      hospital, Shenzhen People's Hospital and other national hospitals. A total of 2000 subjects
      are expected to participate. The patients in the group wore the device for about 3 minutes,
      and took photos of 5 breast sites. After that, the artificial intelligence learning was
      carried out on the photos of the training group. For the photos of the verification group,
      the algorithm obtained by the training group was compared with the existing artificial
      intelligence algorithms of ultrasound and molybdenum target. During the follow-up, the safety
      of the product was evaluated. According to the basic principles of safety and performance of
      who international general GHTF (sg1-n020r5) medical devices.
    

Intervention name(s): smart bra
Intervention type(s): Device
Intervention description(s): This is a patented infrared breast examination bra
Intervention model: Single Group Assignment
Intervention model description: The patients who were going to receive double breast ultrasound and molybdenum target in the breast surgery clinic and ward were enrolled into the group (disease-free: benign: malignant = 1:1:1). The patients were put on the device for about 3 minutes, and the breast was photographed at 5 sites. After that, the artificial intelligence learning was carried out on the photos of the training group. For the photos of the verification group, the algorithm obtained by the training group was compared with the existing artificial intelligence algorithms of ultrasound and molybdenum target.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: effectiveness; safety; smart bra
Efficacy and Safety of Diamel in Patients With Nonalcoholic Steatohepatitis
Condition: Nonalcoholic Steatohepatitis; Insulin Resistance
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease; Insulin Resistance
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to evaluate whether the addition of Diamel, a nutritional
      supplement, to hypocaloric diet and exercise could improve the histological results
      (steatosis, necro-inflammatory activity and fibrosis), insulin resistance, aminotransferase
      levels and anthropometric measures in comparison with a placebo-controlled group with
      hypocaloric diet and exercise during 52 weeks of treatment in patients with nonalcoholic
      steatohepatitis.
    


Intervention name(s): Diamel; Placebo and lifestyle counseling
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Diamel, a nutritional supplement, 2 oral pills (660 mg), every 8 hours, daily, during 52 weeks; Hypocaloric diet of 1620 kcal daily (The dietary pattern will be distributed in carbohydrates 64%, fat 22% with <10% of saturated fatty acids and protein 14%, and exercise)
Other intervention name(s): Dietary supplement; Placebo; Lifestyle modification
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Nonalcoholic steatohepatitis; Insulinresistance; Diet and exercise; Nutritional supplement; Nonalcoholic fatty liver disease; Lifestyle modifications
Irbesartan-Hydrochlorothiazide Phase IV Study: Treatment of Hypertension in Chinese Population
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      To analyse the control rate of irbesartan/hydrochlorothiazide(HCTZ) (COAPROVEL) in the
      treatment of patients with mild to moderate primary hypertension.
    


Intervention name(s): Irbesartan 150mg / Hydrochlorothiazide 12.5mg; Irbesartan 150mg
Intervention type(s): Drug; Drug
Intervention description(s): Once a day; Once a day
Intervention MeSH terms: Hydrochlorothiazide; Irbesartan
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Neurophysiology and Pharmacology of Cough Reflex Hypersensitivity
Condition: Chronic Cough
MeSH terms: Cough; Hypersensitivity
Study type: Interventional

Summary: 
      A cough lasting more than 2 months is known as a chronic cough, affecting 12-23% of the adult
      non-smoking population. Chronic cough has many associated complications including
      incontinence, muscular chest pains, blackouts and depression. Current treatment is often
      ineffective in these patients. To develop new medications the investigators need to
      understand more about the mechanisms that can lead to excessive coughing.

      This study plans to compare a group of 12 healthy volunteers and 12 patients with a chronic
      cough. The investigators hypothesise that that chronic cough patients have a more sensitive
      cough reflex as a result central nervous system hyper-excitability (central sensitisation).
      The investigators will measure cough reflex sensitivity before and after administration of
      ketamine, a medication that blocks an important receptor in the central nervous system.
    


Intervention name(s): ketamine
Intervention type(s): Drug
Intervention description(s): Administration of low dose intravenous ketamine. Dose: 0.075mg/kg over 10 minutes followed by 0.005mg/kg/min over 20 minutes. Given as single infusion.
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: Cough; Cough reflex; NMDA receptor; central sensitisation
Investigating the Efficacy of a Dentifrice in Providing Long Term Relief From Dentinal Hypersensitivity
Condition: Dentine Hypersensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional
Phase: Phase 3

Summary: 
      Clinical studies have demonstrated long term relief from dentine hypersensitivity with twice
      daily brushing of a toothpaste containing stannous fluoride in comparison to marketed
      (negative) controls. The aim of this study is to evaluate the effectiveness of a stannous
      fluoride dentifrice in the treatment of dentinal hypersensitivity compared to a marketed
      (negative) control, over a period of 56 days (8 weeks) with twice daily brushing.
    


Intervention name(s): Stannous fluoride; Sodium monofluorophosphate
Intervention type(s): Drug; Drug
Intervention description(s): Test dentifrice containing 0.454% SnF; Control dentifrice containing 0.76% w/w Sodium Monofluorophosphate [1000 parts per million (ppm) fluoride]
Intervention MeSH terms: Fluorides; Tin Fluorides; Fluorophosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Accuracy of BabySat V3 With Profound Hypoxia and Motion
Condition: Hypoxia
MeSH terms: Hypoxia
Study type: Observational

Summary: 
      Performance testing of pulse oximeters. The protocol involves brief stable arterial oxygen
      desaturation in healthy volunteers and sampling arterial blood when a stable level of hypoxia
      has been attained and during different motion scenarios. The blood sample is analyzed for
      oxygen saturation with a gold standard bench CO-oximeter. This protocol is aligned with the
      latest ISO and FDA guidance documents for pulse oximeter testing.
    


Intervention name(s): BabySat V3
Intervention type(s): Device
Intervention description(s): Evaluation of Accuracy of BabySat V3
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants in this study should be healthy, between 18 and 50 years of age and willing to
        participate in breathing studies with blood samples.
An Open-label Drug-Drug Interaction Study to Evaluate the Effect of BCX7353 on Cytochrome P450 Enzyme Activity Using Probe Substrates
Condition: Hereditary Angioedema
MeSH terms: Angioedema; Angioedemas, Hereditary
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single sequence study to evaluate the effect of BCX7353 on hepatic and
      intestinal cytochrome P450 enzymes using probe substrate drugs in healthy subjects.
      Pharmacokinetics of the probe substrate drugs will be measured prior to and following
      administration of multiple doses of BCX7353.
    

Detailed description: 
      This is a single centre, single sequence, open-label, study to evaluate the effect of BCX7353
      on hepatic and intestinal cytochrome P450 (CYP) 3A4 (midazolam IV and PO, respectively),
      CYP2C9 (tolbutamide), CYP2C19 (omeprazole) and CYP2D6 (dextromethorphan) enzyme activity
      using probe substrate drugs in healthy subjects. Pharmacokinetics of the probe substrate
      drugs will be measured prior to and following administration of multiple doses of BCX7353.

      Twenty healthy male and female subjects are planned for dosing.

      Each subject will receive the following treatments:

      Day 1: 1 mg midazolam will be administered as an IV bolus simultaneously to administration of
      500 mg tolbutamide, 40 mg omeprazole, and 30 mg dextromethorphan orally.

      Day 2: a single oral dose of 2 mg midazolam. Days 3 to 9: 350 mg BCX7353 once a day. Day 10:
      1 mg midazolam will be administered as an IV bolus simultaneously to administration of 500 mg
      tolbutamide, 40 mg omeprazole, 30 mg dextromethorphan and 350 mg BCX7353, orally.

      Day 11: a single oral dose of 2 mg of midazolam along with 350 mg BCX7353.
    

Intervention name(s): BCX7353 and probes
Intervention type(s): Drug
Intervention MeSH terms: Berotralstat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety Study of Flufirvitide-3 Nasal Spray in Healthy Subjects
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and pharmacokinetic profile of
      flufirvitide-3 nasal spray in healthy subjects.
    


Intervention name(s): Flufirvitide-3 0.05 mg single dose; Flufirvitide-3, 0.1 mg single dose; Flufirvitide-3, 0.2 mg single dose; Flufirvitide-3, 0.4 mg single dose; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention description(s): Nasal Spray; Nasal spray; nasal spray; Nasal spray; Nasal spray
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: antiviral; intranasal; influenza