bioihbjkbjnl/mcl2 huggingface dataset:
Month 30 & 42 Extension Studies of CRD-004 Primary Study
Condition: Herpes Zoster
MeSH terms: Herpes Zoster
Study type: Interventional
Phase: Phase 2

Summary: 
      The safety and immunogenicity of the GSK324332A vaccine has been evaluated up to Month 12
      post-vaccination in the primary study. In the extension studies presented here, the
      persistence of the cellular and humoral immune responses will be evaluated 30 and 42 months
      after the first vaccination in young and elderly adults who received the GSK324332A vaccine.
      This protocol posting deals only with objectives & outcome measures of the extension phase at
      Months 30 and 42. No new recruitment will be done in these extension phases of the primary
      study. No vaccines are administered in this phase of the study.
    

Detailed description: 
      All subjects in these extension phases of the study were previously vaccinated with the
      investigational herpes zoster vaccine GSK1437173A. The Protocol Posting has been updated in
      order to comply with the FDA Amendment Act, Sep 2007.

      Further details on the primary study can be found on our GSK study register
      (https://www.gsk-studyregister.com/advanced-search) by searching on the GSK study identifier
      101501.
    

Intervention name(s): Blood sampling for assay of persistence of immunogenicity
Intervention type(s): Procedure
Intervention description(s): Two blood samples: 30 and 42 months after first vaccination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: GSK Biologicals; Varicella Zoster Virus (VZV); Intracellular cytokine staining (ICS); Vaccine; Cell mediated immunity (CMI); Herpes Zoster (HZ); Shingles
Study to Investigate Effects of CAL-263 in Subjects With Allergic Rhinitis Exposed to Allergen in an Environmental Chamber
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and effect of CAL-263 in subjects with
      allergic rhinitis.
    

Detailed description: 
      A Phase I, randomized, double-blind crossover study of CAL-263, an oral inhibitor of PI3K
      delta, in patients with allergic rhinitis.
    

Intervention name(s): CAL-263; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): CAL-263 10 mg or placebo once daily for 7 days; CAL-263 10 mg or placebo once daily for 7 days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Allergic Rhinitis; Allergy; Phosphatidylinositol 3-kinase
Real-world Impact of Erenumab on Sick-leaves, Health Care Resource Use and Comorbidities.
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Observational

Summary: 
      This was a retrospective registry-based study utilizing data collected in association with
      clinical care of patients. All data was stored in electronic health records at Terveystalo
      data base, and no patients were contacted for the study.
    

Detailed description: 
      Patients initiating erenumab treatment between 20.9.2018 - 15.10. 2019, and data on sick
      leave days, diagnoses and health care visits as well as medications based on prescriptions
      were assessed.

      Following time frames for analyses of sick leaves and health care utilization in patients on
      erenumab treatment and in controls were reported:

      Follow-up analyses: For cases (erenumab) with occupational healthcare, a minimum of 12 months
      on erenumab treatment was required for the analysis of sick leaves and visits

      Pre erenumab: Follow-up data before index (defined as the first reimbursement
      decision/prescription for erenumab, or initiation of erenumab injections (before
      reimbursement approval)) from the Terveystalo database of those with consent

      Post erenumab: Follow-up data after index, from the Terveystalo database of those with
      consent

      Time frames for comparison (sick leaves and visits): One year before index vs. >12 months
      erenumab after index, One year before index vs. 6-12 months of erenumab after index (patient
      years), sensitivity analysis

      Time frames for comparison (medications): 12 months before index vs. 12 months post follow-up

      Controls (triptan treated migraine patients): Corresponding time frames as in cases.
    

Intervention name(s): Erenumab
Intervention type(s): Other
Intervention description(s): Patients who met the responder definition of two or more erenumab prescriptions with no evidence of switch to other CGRPi were included in the main analyses
Intervention MeSH terms: Erenumab
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients on erenumab treatment
      
Keywords: Erenumab,; CGRP,; real world evidence,; sick leaves,; working impairment,; health care visits,; prescriptions,; migraine
Escitalopram in Depressive Patients With Acute Coronary Artery Syndrome
Condition: Depressive Disorder; Coronary Disease
MeSH terms: Coronary Disease; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aimed to evaluate the efficacy and safety of escitalopram in the treatment of
      depressive patients with acute coronary artery syndrome (CAS).
    

Detailed description: 
      Depression is common in patients with acute CAS and increases cardiac morbidity and
      mortality. However, there are a few limited data available regarding the effects and safety
      of antidepressants for treating depression in patients with acute CAS. This study aims to
      investigate whether escitalopram might be an effective treatment option for these patients.
    

Intervention name(s): Escitalopram; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Study medication will be provided as 1 tablet of escitalopram 5mg/day or 1 or 2 tablets of escitalopram 10mg/day, and matched placebo. The initial dose of escitalopram was 10mg/day generally, but 5mg/day for those aged 65 or over and with hepatic dysfunction. After the 2nd evaluation, the treatment doses are determined by the investigators' clinical decision considering the severity of depression and tolerability of drug. Drugs are taken once daily per orally within 30 min after the supper meal.; Placebo medication will be provided as matched 1 tablet of escitalopram 5mg/day or 1 or 2 tablets of escitalopram 10mg/day.
Other intervention name(s): Lexapro; Cipralex
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depression; Myocardial infarction; Angina, unstable
Efficacy Study of a Facemask Device to Treat Hypotension
Condition: Hypotension
MeSH terms: Hypotension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if the impedance threshold device (ITD) attached to
      a facemask can increase blood pressure in patients who present to the emergency department
      with hypotension secondary to hypovolemia. The cause of hypovolemia could be blood loss,
      sepsis, or dehydration.
    

Detailed description: 
      The study is designed to test the hypothesis that use of the ITD will result in a rapid rise
      in blood pressure secondary to an increase in cardiac output. Either an active or sham ITD
      will be applied to hypotensive patients when initially presented to the emergency department
      with a systolic blood pressure of <95mmHg. The main endpoint of this study will be the rise
      in blood pressure over the first 10 minutes of use. Based upon pre-clinical studies as well
      as clinical studies performed to date, we hypothesize that use of the active ITD will result
      in a more rapid and higher blood pressure than the sham ITD. Multiple additional clinical
      parameters will also be compared between the two groups of patients.
    

Intervention name(s): Impedance Threshold Device; sham ITD
Intervention type(s): Device; Device
Intervention description(s): Active impedance threshold device; sham impedance threshold device
Other intervention name(s): ResQGard
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: hypotension; hypovolemia; dehydration; sepsis; blood loss
A Predictive Model for Inadequate Bowel Preparation
Condition: Bowel Preparation
Study type: Interventional

Summary: 
      We aimed to develop a predictive model of inadequate bowel preparation and to further
      validate it by a randomized controlled trial.
    


Intervention name(s): Polyethylene Glycol
Intervention type(s): Drug
Intervention description(s): In the Tailored group, high-risk people are given intensified bowel preparation regimens, low-risk people are given routine regimens.
In the control group, all the patients are given routine regimens.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: adenoma; bowel preparation; colonoscopy; predictive model; randomized controlled trial
A Study to Investigate Efficacy of Two Experimental Oral Rinses in Providing Long Term Relief From Pain Derived From Exposed Dentine in Response to Chemical, Thermal, Tactile, or Osmotic Stimuli.
Condition: Dentin Sensitivity
MeSH terms: Dentin Sensitivity
Study type: Interventional

Summary: 
      This will be a single center, eight week, randomized, double blind, three treatment arm,
      parallel design, stratified (by mean baseline Schiff Sensitivity Score of the two selected
      test teeth) study in healthy participants.
    


Intervention name(s): Experimental Oral Rinse 1 (1.5% w/w KOX, 0ppm F, pH 7.0); Experimental Oral Rinse 2 (2.0% w/w KOX, 45ppm F, pH 4.5); Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )
Intervention type(s): Other; Other; Other
Intervention description(s): 1.5% w/w KOX, 0ppm F, pH 7.0; 2.0% w/w KOX, 45ppm F, pH 4.5; 0% w/w KOX 0ppm F, pH 4.5
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effectiveness of Myopia Control by Breath-O Correct Orthokeratology Lenses
Condition: Myopia; Orthokeratology
MeSH terms: Myopia
Study type: Interventional

Summary: 
      This is a 24-month longitudinal randomized controlled trial aiming to evaluate the
      effectiveness of myopia control by Breath-O correct orthokeratology lenses in different
      myopia progression groups classified according to their initial electro-retinal responses.
    

Detailed description: 
      Myopia is the most common refractive error in the world. In Hong Kong, the number of children
      in myopia is on the rise and approximately 80% of children are myopic by the end of
      childhood. Orthokeratology is one of the most successful myopia control methods adopting the
      strategy of peripheral defocus, in which the natural emmetropization process is harnessed by
      the myopic defocus induced by the orthokeratology lenses.Currently, Breath-O correct lenses
      are new designed ready-made orthokeratology lenses which are made of new material with higher
      elasticity as compared traditional lens material.

      A recent study has shown young children with an initial weakened central electrical signal
      from the inner retina had faster myopia progression as measured by multifocal
      electroretinogram(ERG). We will classify the slow and fast progression group based on the ERG
      results, so as to evaluate the clinical effectiveness of the newly designed lenses in
      controlling myopia in children with different rates of progression.
    

Intervention name(s): Breath-O orthokeratology lenses
Intervention type(s): Device
Intervention description(s): Specially designed rigid gas permeable lenses which
reshapes corneal profile for myopia control
has higher elasticity compared to traditional lens material.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized clinical trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Myopia; Myopia Control; Orthokeratology; Electroretinogram; Multifocal Electroretinogram
Phase Ib Study of Chiauranib in Patients With Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Chiauranib may stop the growth of tumor cells by blocking Aurora kinase B（Aurora
      B）、VEGFR/PDGFR/c-Kit、CSF-1R targets. This clinical trial is studying the efficacy and safety
      of chiauranib(50mg，QD，PO) works in treating patients with relapsed or refractory ovarian
      cancer, in the meantime, exploring the latent biomarkers accompany with chiauranib, as well
      as the relevancy of which and clinical benefit.
    

Detailed description: 
      The purpose of this study is to assess the efficacy and safety include adverse events, vital
      signs, laboratory tests ,etc., of Chiauranib in ovarian cancer patients due to the outcomes
      of the phase I study, and to explore the relevance between the latent biomarkers of
      Chiauranib and clinical benefit.
    

Intervention name(s): Chiauranib
Intervention type(s): Drug
Intervention description(s): Take 50mg orally once daily
Other intervention name(s): CS2164
Intervention MeSH terms: Chiauranib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ovarian cancer, relapsed or refractory,chiauranib
Improving Substance Abuse Counseling Adherence Using Web-based Videoconferencing
Condition: Substance Abuse Disorder
MeSH terms: Substance-Related Disorders
Study type: Interventional

Summary: 
      This research is being done to compare the effectiveness of standard on-site, in-person
      counseling with Internet web-based videoconferencing (e-therapy) in drug-dependent patients
      in opioid-agonist treatment programs. The study is looking to see if there are any
      differences in satisfaction or in treatment outcome if counseling sessions are given by
      e-therapy compared to standard, in-person counseling given in the clinic. The e-therapy
      happens in real time- it works very much like standard therapy in the clinic except that the
      patient is in his or her own home (or other convenient location outside the clinic) and talks
      to and sees the therapist through an Internet connection on the computer (the therapist will
      usually be at the clinic).
    

Detailed description: 
      This study will be the first to evaluate the efficacy of an accredited and currently
      available, Internet web-based videoconferencing platform to deliver routine schedules of
      counseling in an opioid agonist treatment program. It has outstanding potential to help
      determine transportability of this technology to other treatment programs by demonstrating
      the benefits of integration of web-based therapy with on-site services to expand the
      continuum of care.
    

Intervention name(s): eGet
Intervention type(s): Behavioral
Intervention description(s): eGet individual counseling sessions from home will be scheduled weekly for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Web based videoconferencing; methadone; substance abuse counseling
Methylation of cfDNA in Diagnosing and Monitoring Pulmonary Nodule
Condition: Pulmonary Nodule, Solitary
MeSH terms: Multiple Pulmonary Nodules; Solitary Pulmonary Nodule
Study type: Observational

Summary: 
      Patients found pulmonary nodules by CT screening by will be enrolled in this study
      prospectively. Plasma cfDNA sequencing of these patients will be used to diagnose and monitor
      benign and malignant pulmonary nodules.
    

Detailed description: 
      This study prospectively included patients with pulmonary nodules (0.5-3 cm) diagnosed by CT.
      Methylation of plasma cfDNA in these patients will be performed. Evaluation of benign and
      malignant diagnostic efficacy of cfDNA methylation in pulmonary nodules with definite
      pathological findings. Pulmonary nodules that temporarily not require invasive examination
      will be performed CT follow-up and dynamically monitored methylation changes of cfDNA. And
      the methylation changes were to establish a model for the diagnosis and monitor of benign and
      malignant pulmonary nodules.
    

Intervention name(s): plasma cfDNA methylation
Intervention type(s): Procedure
Intervention description(s): plasma cfDNA will be performed in patients with pulmonary nodules (0.5-3 cm) found by CT scanning. Evaluation of benign and malignant diagnostic efficacy of cfDNA methylation in pulmonary nodules with clear pathological findings. Pulmonary nodules that could not or temporarily not require invasive examination will be performed CT follow-up and dynamically monitored methylation changes of cfDNA.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The population of this study are those who meet the inclusion and exclusion criteria.
      
Biospecimen description: 
      Total cfDNA was extracted from 10ml plasma.
    
Keywords: cfDNA methylation; CT follow-up; plasma; pulmonary nodule
Phase IIb Trial to Evaluate Longeveron Mesenchymal Stem Cells to Treat Aging Frailty
Condition: Aging Frailty
MeSH terms: Frailty
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, placebo-controlled, double-blind, parallel arm, multi-center Phase 2b
      study.
    

Detailed description: 
      The objectives of this study are to assess safety and efficacy of Longeveron Mesenchymal Stem
      Cells (LMSCs) compared to placebo on 1) functional mobility and exercise tolerance, 2)
      patient-reported physical function, and 3) the inflammatory cytokine biomarker tumor necrosis
      factor (TNF-alpha).
    

Intervention name(s): Longeveron Mesenchymal Stem Cells (LMSCs); Placebo
Intervention type(s): Biological; Other
Intervention description(s): Intravenously delivered; Intravenously delivered
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of the Evoke Radiofrequency Device for Improvement of Skin Appearance
Condition: Skin Laxity
MeSH terms: Cutis Laxa
Study type: Interventional

Summary: 
      Evaluation of the Evoke Radiofrequency Device for Improvement of Skin Appearance
    

Detailed description: 
      The aim of the study is to evaluate the safety, efficacy, patient comfort, and patient
      satisfaction after Evoke treatment
    

Intervention name(s): Evoke Radiofrequency Device
Intervention type(s): Device
Intervention description(s): Enrolled subjects will undergo up to 3 successive bi-weekly (every 2 weeks) treatments.Treatment area will include face and under chin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Study of COVID-19 DNA Vaccine (AG0301-COVID19)
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study will assess the safety and immunogenicity of AG0301-COVID19 in healthy adult
      volunteers.
    

Detailed description: 
      This is a Phase 1/2, single-center, non-randomised, open-label, non-controlled trial.
      Approximately 30 healthy volunteers, male or female, aged 20-65, will be enrolled in the low
      dose group for the first 15 and the high dose group for the remaining 15.

      Low dose group: 1.0 mg AG0301-COVID19 intramuscular (IM) (n = 15) High dose group: 2.0 mg
      AG0301-COVID19 IM (n = 15)
    

Intervention name(s): AG0301-COVID19; AG0301-COVID19
Intervention type(s): Biological; Biological
Intervention description(s): 1.0 mg of AG0301-COVID19 twice at 2-week intervals; 2.0 mg of AG0301-COVID19 twice at 2-week intervals
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: vaccine; COVID-19; SARS-CoV-2
Modeling and Pharmacological Targeting of Genetic Cardiomyopathy in Children Via Cardiomyocytes Derived From Induced Pluripotent Stem Cells (DMDstem)
Condition: Cardiomyopathy, Familial
MeSH terms: Cardiomyopathies
Study type: Interventional

Summary: 
      Interventional, cross-sectional biomedical study of children with genetic cardiomyopathy and
      healthy children. The aim is to generate, via induced human pluripotent stem cells (hiPSC),
      "patient-specific" cardiomyocytes (CMs) (hiPSC-CMs) to study the molecular mechanisms of
      cardiomyopathies of genetic origin.
    

Detailed description: 
      Interventional, cross-sectional biomedical study of children with genetic cardiomyopathy and
      healthy children. The aim is to generate, via induced human pluripotent stem cells (hiPSC),
      "patient-specific" cardiomyocytes (CMs) (hiPSC-CMs) to study the molecular mechanisms of
      cardiomyopathies of genetic origin.

      The study will be proposed to the parents or legal guardians of the children from 0 to 17
      included sent in pediatric cardiology consultation to the University Hospital of Montpellier
      as part of their usual follow-up or a health check (control) .

      The only direct intervention performed on the patient is a venous blood sample. The volume of
      blood collected will be lower than the thresholds defined in the Decree of December 2nd, 2016
      on minimal risks in biomedical research (3 ml).
    

Intervention name(s): Electrocardiogram; physical examination; echocardiography; blood test
Intervention type(s): Other; Other; Other; Biological
Intervention description(s): heart testing; done by the investigator; heart testing; A sample of blood will be taken to each patient or healthy children in order to generate hiPSC-cardiomyocytes
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: All participants receive the same intervention throughout the protocol, no matter if they are "healthy children" or "cardiomyopathic children".
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Cardiomyocytes; Induced pluripotent stem cells; Genetic cardiomyopathy
Immunogenicity and Safety of a Cell-derived Influenza Vaccine in Adults Aged >= 18 and <= 64, Plus Revaccination
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      Immunogenicity and safety of a cell-derived influenza vaccine in adults aged >= 18 and <= 64
      years, plus revaccination
    


Intervention name(s): Cell-Derived Trivalent Subunit Influenza Vaccine; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): surface antigen, inactivated, prepared in cell cultures; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza; Phase II; Placebo-controlled