bioihbjkbjnl/mcl2 huggingface dataset:
Artificial Root-End Barriers
Condition: Dental Cements; Tooth Abnormalities
MeSH terms: Tooth Abnormalities
Study type: Observational

Summary: 
      This study retrospectively looks to determine the clinical success of ProRoot MTA used as an
      artificial apical barrier in teeth with immature apices.
    

Detailed description: 
      The normal development and maturation of a root depends on a vital, healthy pulp. If the pulp
      becomes necrotic in a tooth with an immature apex, endodontic treatment can be performed
      using an artificial barrier technique. Mineral trioxide aggregate (MTA) has become the
      material of choice to accomplish this procedure, however, few studies have evaluated its
      clinical success. The purpose of this retrospective study was to determine the clinical
      success of ProRoot MTA used as an artificial apical barrier. Twenty patients were included in
      this study. After approximately one week of Ca(OH)2 treatment, each patient had MTA placed as
      an apical barrier in a tooth with a single canal and open apex followed by placement of a
      final restoration. Patients were recalled and evaluated for clinical signs and symptoms and
      osseous healing. Immediate post-treatment and recall radiographs were evaluated by two
      endodontists calibrated for use of the Periapical Index (PAI).
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients between 5-40 years old who have been treated with MTA
      
Keywords: Mineral trioxide aggregate
Effect of Cilostazol on the Pharmacokinetics of Simvastatin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the effect of cilostazol on the pharmacokinetics of simvastatin in healthy adult
      subjects.
    

Detailed description: 
      Eligibility for participation of this study was determined from demographic information,
      medical history, physical examination, electrocardiogram (ECG) and clinical laboratory tests
      within 4 weeks before study drug administration. Subjects suitable for this study were
      admitted to the Clinical Trials Center, Samsung Medical Center on the day before dosing, and
      they were overnight-fasted from 10 p.m. of Day -1. Subjects were dosed simvastatin 40 mg
      orally around at 9 a.m. of Day 1. Subjects performed scheduled procedures including clinical
      laboratory tests and pharmacokinetic samplings for simvastatin. Subjects were dosed
      cilostazol 100 mg in the morning on Day 2 and discharged, and visited Clinical Trials Center
      on Day 3, Day 4 and Day 5 for the oral administration of cilostazol 100 mg. Subjects was
      admitted in the evening on day 5 and dosed simvastatin 40 mg plus cilostazol 100 mg
      concomitantly and scheduled pharmacokinetic sampling for simvastatin was performed. Next
      morning (Day 7), subjects were discharged
    

Intervention name(s): simvastatin/cilostazol
Intervention type(s): Drug
Intervention MeSH terms: Cilostazol; Simvastatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Trial of CMNa Combined With Definitive Concurrent Chemoradiotherapy for Locally Advanced ESCC
Condition: Esophageal Neoplasms
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a perspective, multicenter,randomized controlled trial to evaluate the efficacy and
      safety of treatment with CMNa combined with concurrent chemoradiotherapy in patients with
      locally advanced squamous cell esophageal carcinoma . Analyses of primary objective (ORR)
      will be done as defined in the protocol.
    

Detailed description: 
      The primary end point of this study is objective response rate.The secondary end point is OS,
      PFS and the safty of drug. The primary hypothesis is the CMNa will improve ORR and thus
      improve OS, PFS. Assuming bilateral a=0.05, statistical power of 80%.The total sample size is
      104 cases.
    

Intervention name(s): Sodium Glycididazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sodium Glycididazole 700mg/m2.Three times a week (once every other one day),before radiation therapy, total 6 weeks.; Placebo:three times a week (once every other one day),before radiation therapy, total 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Effects of Web-Based Training on HbA1c, Quality of Life and Depression Levels in Adolescents With Type 1 Diabetes
Condition: Mental Disorder in Adolescence; Behavioral Symptoms; Problem Behavior
MeSH terms: Mental Disorders; Behavioral Symptoms; Problem Behavior
Study type: Interventional

Summary: 
      Objective: This study was conducted to determine the effect of diabetes training on HbA1c,
      levels of depression and quality of life of Type 1 Diabetes Mellitus adolescents by using the
      Web-Based Watson Human Care Model.

      Methods: The study was conducted with 30 adolescents between 11-18 years old who was followed
      by Child Endocrinology Department and who accepted to participate in the research. A web page
      was developed by considering Training Guide for Adolescents with Type 1 Diabetes and
      processes of Watson Human Care Theory. Live video interviews were done with adolescents in
      the experiment group on 14 sessions and these interviews were recorded.
    


Intervention name(s): The web-based Watson's Human Care Theory oriented training
Intervention type(s): Other
Intervention description(s): Video calls were held every 15 days via the skype program with complete adherence to the schedule. In these interviews, the clinical picture of diabetes and the psychosocial status of adolescents were discussed. A total of 14 interviews with 15-day intervals were made with each adolescent. All video interviews were carried out by the first researcher and they were all recorded.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The research had an experimental design with pre-test and post-test control groups. The participants were randomly assigned to the experimental and control groups.
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Depression; Quality of life; Type 1 diabetes; Web-based training
Does Sildenafil Increase Exercise Performance in Air Pollution?
Condition: Pulmonary Hypertension; Pulmonary Artery Pressure; Exercise Performance; Air Pollution
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional

Summary: 
      The purpose of this study is to examine if the ingestion of a standard dose of sildenafil
      enhances the athletic performance of competitive athletes when exercising in a high pollutant
      environment verses a low air pollutant environment.
    

Detailed description: 
      This study will evaluate effects of sildenafil on exercise performance while breathing high
      levels of emission exhaust ultrafine and fine particulate matter. Exercise performance will
      be measured by work accumulation (total kJ) during a 6-min maximal effort cycle ergometer
      ride (CER) done immediately after 30 min cycling at 75% of 6 min mean watts determined from
      familiarization trial. Peak oxygen consumption, cardiac output, pulmonary artery pressure,
      diffusion capacity(DLco), and SaO2 will be determined for each trial. Blood and urine will be
      analyzed for sildenafil using LC/MS.
    

Intervention name(s): sildenafil; placebo
Intervention type(s): Drug; Other
Intervention description(s): sildenafil 50 mg ingested orally 1 hour prior to exercise testing; matching placebo for sildenafil 50 mg to be ingested orally 1 hour prior to exercise testing.
Other intervention name(s): Viagra; sugar pill
Intervention MeSH terms: Sildenafil Citrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: phosphodiesterase; sildenafil; pulmonary hypertension; exercise performance; air pollution
Perceptual Distortions in Acute Neck Pain
Condition: Neck Pain, Posterior; Pain, Acute
MeSH terms: Neck Pain; Acute Pain
Study type: Interventional

Summary: 
      Research has shown that chronic pain is related to variety of perceptual distortions. Little
      is known on how acute pain experience influences perception, especially precision of touch.
      This project is aiming to test the hypothesis of pain as a process of biological value
      leading to improvement in tactile acuity.
    

Detailed description: 
      This project has following goals:

        1. To test the hypothesis of pain as a process of biological value leading to improvement
           in tactile acuity

        2. To investigate intra-rater reliability of tests measuring perceptual distortions in pain

        3. To investigate validity of novel tests measuring perceptual distortions in pain

        4. To explore the influence of acute neck pain on left/right recognition task

        5. To explore the effect of acute neck pain on body perception
    

Intervention name(s): Saline injection; Sham injection
Intervention type(s): Other; Other
Intervention description(s): In the saline injection condition, acute neck pain will be induced via 0.5 ml hypertonic (5% NaCl) saline bolus injection which is a commonly used model of acute pain. Saline will be injected into the right (or left) trapezius muscle at the level of C7 cervical level. Injections will be performed by a physician under ultrasound imaging guidance to ensure that each single injection will be equally placed at the same depth. The side for the pain induction will be randomised across subjects. The place of needle insertion and corresponding point on the opposite side of the body will be covered by placing a small piece of adhesive plaster to ensure blinding.; In the sham-injection condition (nocebo comparator), a real needle will be shown to the participants to imitate and produce the anticipation of a pain experience. A pinprick sensation will be produced by a weighted stimulus applied perpendicularly to the skin without piercing the skin. A stimulus of 512 millinewtons (mN) will be used to produce a pinprick sensation and activation of cutaneous nociceptors. Adhesive tapes covering stimulation points will also be provided. The stimuli will be applied in exactly the same spot as the real injection in previous experimental condition.
Other intervention name(s): Pain induced by saline injection; Pain induced by sham injection
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Within-group designed study. All participants will be assessed in three different experimental conditions (control, saline injection, sham injection). The order of conditions will be counterbalanced across participants and randomly chosen.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Tactile acuity; Tactile dysfunction; Sensory dissociation; Two-point discrimination; Perception
MenB Vaccine: Implementation Via Information, Empowerment and Accessibility
Condition: Meningococcal Vaccine
Study type: Interventional

Summary: 
      As part of an effort to increase MenB vaccine uptake among adolescents and young adults,
      study teams will conduct qualitative research to maximize the effectiveness of nationally
      recommended MenB educational materials. In this study, Study Teams will assess local barriers
      to MenB vaccination by conducting focus groups with parents, students, and health care
      professionals.
    

Detailed description: 
      Participants (parents of 16-23 year old teens and young adults, high school and college
      students 16-23 years old, and health care professionals for 16-23 year olds) will be asked to
      share their thoughts on the completeness of nationally recommended and publicly available
      MenB vaccine educational materials in addressing hesitations to receipt of the MenB vaccine.
      There is no risk in discussing reactions to educational materials. The biggest risk is
      disclosure of information provided in the study which will be reactions to health-promotion
      material.
    

Intervention name(s): Awareness; Education; Empowerment; Accessibility
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Awareness: Conduct an awareness campaign throughout Alachua County to alert the community in general to the significance of Serogroup B meningococcal disease in the United States. To inform the material included in the awareness campaign and the education materials, semi-structured interviews with members for each of the key stakeholder groups: students, parents, and medical practitioners will be conducted.; Education: This component will be both web-based and in-person to meet the individual needs of the learners. There will be parent and a student (18-23 years old) version of the educational curriculum. National resources of patient -focused materials and guidelines will be adapted. There will be pre- and post-education surveys to assess knowledge and vaccine decision-making.; Empowerment: A guided program for adolescents and young adults on "Decision-Making for your Health" will be offered on the vaccination days to assist youth in assessing and utilizing health information to guide their personal decision-making for vaccines.; Accessibility: MenB vaccine will be offer on the high school and university campuses through a collaborative program between the local schools, university and department of health. We will offer students booster shots of Men ACWY and HPV at the same time. All vaccines will be offered free of charge. Each vaccine administered will be recorded in Florida SHOTS.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: educational intervention
The Effect of Hibiscus Sabdariffa L. Tea on Blood Pressure
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The goal of this study is to find out whether the plant compounds present in Hibiscus
      sabdariffa, a plant commonly used in herbal tea blends and other beverages, will have a
      beneficial effect on blood pressure in people with mildly elevated blood pressure.
    


Intervention name(s): herbal therapy/botanical therapy (Hibiscus sabdariffa)
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: pre-hypertension; mild hypertension
Prostate Cancer Detection Screening MRI Protocol
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      Whether a quantitative detection specfic magnetic resonance imaging (MRI) protocol improves
      prostate cancer (PCa) detection in biopsy naïve men is not adequately studied.
    

Detailed description: 
      This will be a 2 arm prospective clinical trial. Men with clinical suspicion for PCa but no
      prior prostate biopsy will be enrolled from the University of Illinois (UI) Health Urology
      clinics. All eligible men will be screened and enrolled by the clinical research coordinator.
      Enrolled men will undergo detection protocol MRI at the UIC Advanced Imaging Center (AIC)
      prior to diagnostic biopsy. The MRI will be processed by the study team and evaluated for
      areas suspicious for high grade PCa by a board certified clinical radiologist. Subjects with
      MRI with no suspicious areas for high grade PCa will undergo standard of care (SOC) core
      transrectal ultrasound (TRUS) biopsy. Subject with MRI suspicious for high grade PCa will
      have 2-4 biopsies guided toward each suspicious lesion using MRI/TRUS fusion biopsies
      (maximum of 12 cores). All biopsies will undergo SOC histologic processing and interpretation
      in pathology. Biopsy results will be communicated to the patients by the Urologist performing
      the biopsy and all additional management will be SOC. This visit will signify the end of the
      study
    

Intervention name(s): Ultrasound and MRI; Ultrasound
Intervention type(s): Device; Device
Intervention description(s): A single subsequent ultrasound guided prostate biopsy with MRI fusion; A single subsequent ultrasound guided prostate biopsy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: 50 men with clinical suspicion of PCa (elevated Prostate specific antigen (PSA) and/or abnormal DRE) will be enrolled into a prospective protocol and will undergo detection protocol MRI
Masking: None (Open Label)
Primary purpose: Screening
Safety, Tolerability, Pharmacokinetics and Antiviral Activity of IONIS-HBVRx in Treatment-Naïve Patients With Chronic HBV Infection
Condition: Hepatitis B; Chronic Hepatitis B Atypical
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      To examine the safety and tolerability of IONIS-HBVRx administration to treatment-naive
      patients with chronic hepatitis B virus infection
    

Detailed description: 
      This study examines the effects of IONIS-HBVRx or placebo (3:1 randomization) administered
      subcutaneously to treatment-naïve patients who are chronically infected with HBV and the
      effects of subsequent nucleos(t)ide analogue treatment on these patients.
    

Intervention name(s): IONIS-HBVRx; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ascending multiple doses of IONIS-HBVRx by subcutaneous (SC) injection; Placebo
Other intervention name(s): ISIS 505358
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hepatitis; Chronic; HBV
Westlake Personalized Nutrition and Health Cohort for Drug Addicts
Condition: Drug Addiction; Undernutrition; Drug Abuse
MeSH terms: Malnutrition; Substance-Related Disorders
Study type: Observational

Summary: 
      This is a prospective cohort study of drug addicts confined in Zhejiang rehabilitation
      centers. The primary aim of this study is to investigate the association between diet and
      health status among drug addicts. The second aim is to characterize the continuous blood
      glucose response to dietary intakes over 2 weeks. The third aim is to describe the dynamic
      changes of gut microbiota at three time points in drug addicts during compulsory
      detoxification and to evaluate the association between gut microbiota, diet and addiction
      severity.
    

Detailed description: 
      Over recent decades, there is a growing trend of drug addiction in China that poses great
      public health challenges. Drug abuse can lead to many health related problems such as
      malnutrition and mental disorders along with reduced quality of life. Dietary intervention
      plays a pivotal role in disease prevention and drug rehabilitation for drug addicts, but the
      associations between dietary intake and health related outcomes among drug addicts remain
      unclear.

      In addition, the relationship between the human gut microbiota and its response to addictive
      drugs as a newly arisen subject is given wide attention in recent years. However, the
      underlying mechanism requires further investigation. The dynamic changes of gut microbiota
      among drug addicts during compulsory drug rehabilitation period are in vague.

      Under the same diet exposure, different drug addicts may have different blood glucose
      responses as well as gut microbiota profiles. Therefore, in order to examine the association
      between diet, gut microbiota and drug addiction, our study design will include three
      components: (1) the measurement of dietary intake using FFQ while the menu offered by drug
      rehabilitation center and food diary; (2) the measurements of blood glucose over 2 weeks
      using continuous glucose monitors; and (3) the measurements of gut microbiota at three time
      points using 16s rRNA sequencing techniques.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Drug addicts confined in Zhejiang drug rehabilitation centers will be recruited.
      
Biospecimen description: 
      Fasting venous blood, urine, saliva and stool.
    
Keywords: Personalized nutrition; Drug addicts; Gut microbiota
A Study to Assess Ebola Vaccines ChAd3-EBO-Z and Ad26.ZEBOV
Condition: Ebola Virus Disease
MeSH terms: Virus Diseases; Hemorrhagic Fever, Ebola
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a clinical trial in which healthy volunteers will be administered two experimental
      Ebola vaccines: ChAd3-EBO-Z and Ad26.ZEBOV. Four groups of volunteers will be vaccinated with
      both vaccines one after the other in a prime/boost regimen.

      All ChAd3-EBO-Z doses are 1x10^11 vp and all Ad26.ZEBOV doses are 5x10^10 vp.

      Group 1 will receive a ChAd3-EBO-Z priming vaccine and an Ad26.ZEBOV boosting vaccine 28 days
      later.

      Group 2 will receive an Ad26.ZEBOV priming vaccine and a ChAd3-EBO-Z boosting vaccine 28 days
      later.

      Group 3 will receive a ChAd3-EBO-Z priming vaccine and an Ad26.ZEBOV boosting vaccine 56 days
      later.

      Group 4 will receive an Ad26.ZEBOV priming vaccine and a ChAd3-EBO-Z boosting vaccine 56 days
      later.

      The study will assess the safety of the vaccinations, and the immune responses to
      vaccination. Immune responses are measured by tests on blood samples.

      The ChAd3-EBO-Z and Ad26.ZEBOV vaccines are called viral vectored vaccines. They are made
      from viruses which are modified so that they cannot multiply. The viruses have extra DNA in
      them so that after injection, the body makes Ebola proteins (but Ebola does not develop), so
      that the immune system builds a response to Ebola without having been infected by it.

      Healthy volunteers will be recruited in Oxford and London, England. The study will be
      co-funded by GSK Biologicals and Crucell Holland BV.
    


Intervention name(s): ChAd3-EBO-Z; Ad26.ZEBOV
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Phase 1, Study to Evaluate HTI-2088 Tablet
Condition: Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      Single Center, Randomized, Double Blind, Placebo Controlled, Single ascending dose trial at 3
      levels. Ten subjects will be enrolled at each dose.
    

Detailed description: 
      This is a single-center, randomized, double-blind, placebo-controlled, single ascending dose
      trial with single oral doses of HTI-2088 tablets to subjects at 3 levels (2.5, 3.75, 5 mg).
      Ten subjects will be enrolled at each dose level, randomized within groups at an active:
      placebo ratio of 4:1.
    

Intervention name(s): HTI-2088; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 3 dose levels; placebo oral tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy Subjects