bioihbjkbjnl/mcl2 huggingface dataset:
First-in-Human Study of LHA510 in Elderly Subjects and Patients With Age-Related Macular Degeneration
Condition: Age-Related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this first-in-human study is to assess the local ocular and systemic safety
      and tolerability of LHA510 eye drops when administered at various concentrations and dosing
      frequencies.
    

Detailed description: 
      This first-in-human study was conducted in two parts. Part 1 was a single ascending dose
      (SAD) design to assess the local ocular and systemic safety and tolerability of a single
      topical eye drop of LHA510 administered at various concentrations. Four separate cohorts of
      unique elderly subjects (55 to 80 years) were utilized, with each cohort randomized to
      receive either topical LHA510 or vehicle in a 3:1 ratio as a single dose. A disposition
      evaluation was performed 7 days later. Part 2 was a multiple ascending dose (MAD) design to
      assess the local ocular and systemic safety and tolerability of LHA510 administered at
      various concentrations and dosing frequencies. Six separate cohorts of unique AMD subjects
      were utilized, with each cohort randomized to receive either topical LHA510 or vehicle in a
      3:1 ratio for 7 days. A disposition evaluation was performed 14 days after the first dose of
      study drug. A review of all available safety data was conducted by the Sponsor and the PI(s)
      prior to dose escalation (cohort progression). The same concentrations levels were used in
      Part 1 and Part 2 and are ordered as Lowest, Next Lowest, Next Highest, and Highest.
    

Intervention name(s): LHA510 Ophthalmic Suspension; LHA510 Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): Ophthalmic suspension in 4 concentration levels topically administered in Part 1 and Part 2; Inactive ingredients used for masking purposes
Intervention MeSH terms: Acrizanib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: LHA510; First in human; Safety; Tolerability; Pharmacokinetics; Elderly; Age-Related Macular Degeneration; AMD; Ocular; Eye drop
Pharmacogenomics of Antiplatelet Response
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This clinical trial will examine with effect of 2-week aspirin therapy on platelet gene
      expression in persons at high-risk of developing heart attacks due to family history of
      early-onset coronary artery disease
    

Detailed description: 
      In this clinical trials we will select individuals from GeneSTAR cohort based o their
      platelet function. Equal number of individuals will be selected from each race and gender and
      from low or high platelet aggregation. We will have baseline platelet functions performed and
      baseline platelet gene expression examined. Participants will be given 2-week supply of
      aspirin(81 mg/daily) and will be examined at the end of 2-weeks with platelet aggregation
      studies and a repeat platelet gene-expression (using RNA-seq). The ultimate goal is to
      examine platelet gene expression differences due to aspirin and across different gender,
      race, platelet-aggregation groups.
    

Intervention name(s): Aspirin
Intervention type(s): Drug
Intervention description(s): 2-week aspirin therapy (81mg/day)
Intervention MeSH terms: Aspirin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: aspirin, atherosclerosis
Spectralis OCT Repeatability and Reproducibility Study
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional

Summary: 
      This single-center, prospective, interventional clinical study is conducted to evaluate the
      repeatability and reproducibility of structural parameters of the optic nerve head, the
      peripapillary retinal nerve fiber layer, and the macula using the Heidelberg Spectralis OCT
      (Optical Coherence Tomography) device. Data obtained from healthy volunteers in this study
      are compared to those from a previous, larger healthy volunteer study that was conducted in
      the United States and Europe (S-2012-1), and data from glaucoma patients are compared to
      those from the healthy volunteers.
    

Detailed description: 
      The study will include approximately 15 normal subjects and approximately 15 subjects who
      have glaucoma of varying degree. All subjects will undergo Spectralis OCT imaging and other
      study procedures in one single visit. All examinations performed on the subjects are
      non-significant risk procedures because the medical devices are cleared for marketing in
      Europe and in the U.S. Total study duration is anticipated to not exceed 4 weeks.
    

Intervention name(s): OCT performed to collect data from the back of the eye
Intervention type(s): Device
Intervention description(s): comparative retinal parameters with Spectralis OCT
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
The Effect of HMG-CoA Reductase Inhibition on Postprandial GLP-1 Secretion
Condition: Diabetes Mellitus, Type 2; Hydroxymethylglutaryl-CoA Reductase Inhibitors
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The primary objective of the present study is to evaluate the effect of HMG-CoA reductase
      inhibition during 14 days on the postprandial plasma GLP-1 response in healthy individuals.
      Secondary objectives include the evaluation of HMG-CoA reductase inhibition on postprandial
      glucose tolerance, gallbladder emptying, gastric emptying, plasma responses of lipids, bile
      acids and pancreatic and enteric hormones known to influence glucose metabolism and appetite,
      and faecal content of bile acids and gut microbiota composition.
    


Intervention name(s): Atorvastatin; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Atorvastatin tablet; Placebo tablet
Intervention MeSH terms: Atorvastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Validation of Existing Diabetes Risk Models in a Swedish Population
Condition: Type2diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      The goal of this observational study is to validate existing non-invasive diabetes clinical
      prediction models in a Swedish population. The main question it aims to answer is: how well
      11 existing models will perform in predicting incident type 2 diabetes in participants from
      the Västerbotten Intervention programme (VIP). Participants in VIP are residents of
      Västerbotten that are invited for a comprehensive health screening at 30- (until 1995), 40-,
      50-, and 60-years of age.
    

Detailed description: 
      Several type 2 diabetes risk prediction models have been developed but how it will perform in
      a Swedish population is not known. No diabetes risk prediction model is routinely used in
      Sweden. The aim of this study is therefore, to validate 11 non-invasive models and to
      evaluate the performance to predict incident type 2 diabetes in a Swedish population. A
      population-based cohort from the Västerbotten Intervention programme (VIP) from 1990 to 2020
      will be the validation sample. Incident type 2 diabetes within 10-years of follow-up, will be
      determined by oral glucose tolerance test or through self-reports. A self-administered
      questionnaire is completed, and anthropometric, clinical, and biochemical measures are
      obtained at each of the health screening visits. In the statistical analysis the overall
      performance of the models will be compared using the Brier score. In addition. discrimination
      and calibration of all the models will be evaluated. Recalibration of models will be done.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Inhabitants from the Västerbotten region in Sweden that have been invited to participate in
        the Västerbotten Intervention Program for a comprehensive health screening at 30 (stopped
        in 1995) 40, 50 and 60 years of age.
      
Keywords: Non-invasive prediction model; Incident diabetes; Validation
Treatment Trial for Acute Central Serous Chorioretinopathy
Condition: Acute Central Serous Chorioretinopathy
MeSH terms: Central Serous Chorioretinopathy
Study type: Interventional

Summary: 
      Central serous chorioretinopathy (CSC) is a relatively frequent eye disease in younger
      patients. It is characterized by serous detachment of the neurosensory retina with or without
      serous detachment of the retinal pigment epithelium (RPE), which can cause vision drop, image
      distortion, loss of color and contrast vision. Although nonfoveal focal leakage can be
      treated with traditional laser photocoagulation, but it has the side effects of causing RPE
      atrophy, scotoma, or secondary CNV. Photodynamic therapy (PDT) is another effective treatment
      but it's more than most families can afford to pay because of the high cost, what's more, it
      is accompanied with side-effects, such as choroidal ischemia, retinal pigmental epithelium
      (RPE) atrophy and RPE rip.

      To date there is no international consensus on the optimal treatment of CSC Many
      retrospective studies suggest that micropulse laser (MPL) therapy may also be effective
      without obvious complications in this disease.

      The purpose of this study is to evaluate the effect of micropulse laser (MPL) on acute
      central serous chorioretinopathy compared with the traditional laser coagulation.
    

Detailed description: 
      The study is a prospective randomized controlled trial about 577nm micropulse laser versus
      traditional laser coagulation therapy on acute central serous chorioretinopathy. The primary
      outcome measures is the proportion of eyes with complete absorption of subretinal fluid 3
      months after treatment.
    

Intervention name(s): 577-MPL; 577-TL
Intervention type(s): Device; Device
Intervention description(s): All treatments were provided by a single practitioner with the 577-nm yellow laser system(Supra 577nm affected area in micropulse model.The power titration was started at 700 milliwatt(mW) and then gradually increased until a just visible burn was seen. When this threshold was reached, the power was reduced by 50%, using a 100-μm spot diameter and a 200-ms duration with 5 % duty cycle LaserSystem) in 577-MPL arm. The individual power for the patient was titrated at a normal area of near the; All treatments were provided by a single practitioner with the 577-nm yellow laser system(Supra 577nm LaserSystem) in 577-TL arm.
100 microns light spot size, 0.05 seconds duration, 80 ~ 200 milliwatts of power
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: CSC; Micropulse Laser; Traditional Laser
FOTO: Five Consecutive Days on Treatment With Efavirenz, Tenofovir, and Emtricitabine Followed by Two Days Off Treatment Versus Continuous Treatment
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      For people with HIV who are currently taking specific medications (including Sustiva
      (efavirenz)) and have no detectable viral load, this study tracks how patients do if they
      take their medications for five days of the week compared with seven days of the week.
    

Detailed description: 
      The purpose of this study is to evaluate virologic control of a weekly schedule of 5 days of
      treatment followed by two days off treatment versus continuous treatment with the same
      regimen. This is a larger study based on the results of our successful pilot study using the
      same protocol. The 48 week, phase IV trial addresses the issues of the high cost of HIV
      treatment, adherence problems associated with daily treatment, and cumulative toxicities.
      Virologic and immunologic parameters, drug levels of efavirenz, adherence, and toxicity will
      be measured. Subjects will have to be seen at CRI for 6 visits after randomization. Subjects
      randomized to daily therapy will cross over to 5/2 therapy at 24 weeks if their viral load
      remains undetectable.
    

Intervention name(s): Intermitent Dosing
Intervention type(s): Drug
Intervention description(s): Intermittent dosing treatment is the maintenance of the "5/2" schedule, where the regimen, 300 mg tenofovir td, 600 mg efavirenz, 200 mg emtricitabine is dosed for 5 consecutive days - typically Monday through Friday - followed by two days off of medication, 300 mg tenofovir td, 600 mg efavirenz, 200 mg emtricitabine. .
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This study is designed to compare the control and the experimental arm groups for 24 weeks of treatment. After 24 weeks, subjects on the control arm then cross over to the experimental intervention.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV/AIDS; efavirenz; tenofovir; emtricitabine; FOTO; treatment interruption; Atripla; Truvada; Treatment Experienced
The Influence of Cancer Stem-cells on Risk of Relapse in Patients Harboring Adenocarcinoma and Squamous Cell Carcinoma of the Lung
Condition: Lung Cancer, Nonsmall Cell; Relapse/Recurrence; CSC
MeSH terms: Lung Neoplasms; Carcinoma, Squamous Cell; Adenocarcinoma; Carcinoma, Non-Small-Cell Lung; Recurrence
Study type: Observational

Summary: 
      The present study is a prospective cohort study. The aim is to assess the relationship
      between the presence of cancer stem-cells (CSC) and the risk of relapse in patients with
      early and locally advanced adenocarcinoma and squamous cell carcinoma of the lung
    


Intervention name(s): Exposure to lung cancer stem cells
Intervention type(s): Genetic
Intervention description(s): The exposure to lung cancer stem cells was measure as the percentage of Aldehyde dehydrogenase (ALDH) on all viable cells extracted from surgically resected tumor specimens
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who underwent major lung resection by lateral thoracotomy or videothoracoscopic
        approach for stage I, II, or IIIA adenocarcinoma or squamous cell carcinoma of the lung
        (tumor, node, metastasis (TNM) staging system, eighth edition)
      
Keywords: Non Small Cell Lung Cancer; Cancer Stem Cells
Pregabalin Versus Celecoxib on Sevoflurane and Analgesic Consumption in Spine Fixation Surgery
Condition: Post-Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The anti-epileptic drugs such as gabapentin and other non-steroidal anti-inflammatory drugs
      (NSAID) such as celecoxib were used as a part of multimodal analgesia to control such pain.
      Gabapentin is an anticonvulsant drug that has analgesic effect in post-herpetic neuralgia,
      diabetic neuropathy, and neuropathic pain. Celecoxib is one of the NSAIDs, that its analgesic
      effect is reported in various studies by cyclooxygenase-2 (COX-2) inhibitor.

      The aim of this randomized double-blinded study was to asses and compare the efficacy of
      using gabapentin versus celecoxib as a part of multimodal analgesia in perioperative
      hemodynamic control and pain relief in patients underwent posterior approach lumbar spine
      disc fixation surgery.
    


Intervention name(s): Celecoxib capsules; Pregabalin 150mg
Intervention type(s): Drug; Drug
Intervention description(s): received celecoxib 200 mg 2 hours preoperative and the same dose 6 hours postoperative.; received Pregabalin 150mg 2 hours preoperative and the same dose 6 hours postoperative.
Intervention MeSH terms: Celecoxib; Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Efficacy Trial of a Commercial EV71 Vaccine
Condition: Hand, Foot and Mouth Disease
MeSH terms: Foot-and-Mouth Disease; Hand, Foot and Mouth Disease; Mouth Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this post-marketing study is to evaluate the efficacy, immunogenicity, and
      safety of the EV71 vaccine post marketing, and explore the protective levels of various
      enterovirus neutralizing antibodies
    

Detailed description: 
      This study is a post-marketing aims to evaluate the efficacy, immunogenicity, and safety of
      the EV71 vaccine, and explore the protective levels of various enterovirus neutralizing
      antibodies. This study includes the following three sections: (1) efficacy study of EV71
      vaccine based on enhanced cases monitoring, using prospective cohort study design (2) study
      on correlation between EV71 vaccine protection and EV71 antibody levels, using case-control
      study design (3) pathogenic spectrum and sero-epidemiological investigation of hand, foot and
      mouth disease (HFMD) in children. 15500 volunteers aged 6-71 months are expected to
      participate in this study, among which 5000 volunteers aged 6-35 months will receive two
      doses EV71 vaccine manufactured by Sinovac Biotech Co., Ltd, and constitute the experimental
      cohort. 10000 unvaccinated volunteers aged 6-35 months will constitute the the control
      cohort. The efficacy evaluation will be conducted based on the abovementioned two cohort.
      Enhanced HFMD surveillance system will be established to report the HFMD cases in the
      abovementioned 2 cohorts, as well as another cohort consisting of 500 volunteers aged 36-71
      months. The case surveillance period of this study is one year. Laboratory tests will be
      conducted for case confirmation.
    

Intervention name(s): 5000 volunteers (6-35 months)-EV71 vaccine
Intervention type(s): Biological
Intervention description(s): two doses EV71 vaccines will be administrated on day 0, 30 respectively
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: EV71 vaccine; Efficacy; Seroprotective correlates
Bio-Behavioral Predictors of the Efficacy of Nicotine Replacement Therapy (NRT)
Condition: Smoking
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research study is to:

        1. compare the effectiveness of a nicotine patch and nicotine nasal spray for smoking
           cessation; and

        2. identify predictors of response to these alternate forms of nicotine replacement therapy
           (NRT).
    

Detailed description: 
      The ultimate objective is to obtain information necessary to match NRT to those smokers with
      the greatest need and likelihood of benefit. The investigators hypothesize that the nicotine
      nasal spray (NS) will result in significantly higher abstinence rates than transdermal
      nicotine (TN) for the following subgroups of smokers: those with genotypes associated with
      less transmission of dopamine or serotonin, or greater metabolism of nicotine; and those with
      higher levels of novelty-seeking, depression, and attention deficit symptoms.
    

Intervention name(s): Nicoderm Transdermal Patch; Nicotine Nasal Spray
Intervention type(s): Drug; Drug
Intervention description(s): The dosing schedule is as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours. Treatment lasted 8 weeks.; 8 weeks of self-administered nicotine nasal spray at 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray dosing was 0.5 mg spray per nostril (1 mg) for a maximum of 5 doses per hour and 40 doses per day. This dosing schedule is based on the average nicotine intake per cigarette of 1 mg per cigarette. Treatment lasted 8 weeks.
Other intervention name(s): Nicoderm®; Nicotrol
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nicotine nasal spray + counseling; Transdermal nicotine + counseling
Coping After Pediatric Scoliosis Surgery
Condition: Adolescent Idiopathic Scoliosis
MeSH terms: Scoliosis
Study type: Interventional

Summary: 
      This is a prospective, randomized controlled trial evaluating the efficacy of expanded
      patient education and coping skills on pain management following multilevel pediatric spinal
      surgery. The intervention will include a smartphone- based platform and a comprehensive
      library of peri-operative educational and coping skills videos as a means for better
      addressing the psychosocial elements of a child's individual pain experience. The study
      evaluated whether this novel intervention will reduce pain, improve outcomes and accelerate
      functional recovery up to 6 weeks after surgery.
    


Intervention name(s): Video Intervention; Control
Intervention type(s): Other; Other
Intervention description(s): Peri-operative video series focusing on expanded education and coping skills before and after scoliosis surgery for adolescent idiopathic scoliosis; Routine, Standard-of-Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, Randomized Controlled Clinical Trial
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: Pain; Function; Pediatric; Scoliosis; Scoliosis Surgery; Spinal Fusion; Idiopathic Scoliosis; Coping; Coping Skills; Education; Video Intervention; Randomized; Prospective; Satisfaction; Adolescent; Opioid