bioihbjkbjnl/mcl2 huggingface dataset:
A Clinical Trial to Evaluate Long-term Efficacy and Safety of Lozenges Containing Lactobacilli Reuteri (Prodentis™) on Gingivitis
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the long-term efficacy and safety of lozenges
      containing probiotics in reducing gingivitis. The primary purpose of this study is to support
      claims from U.S. instructions for use (IFU) for GUM® PerioBalance®.
    


Intervention name(s): Probiotics
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
8-week Study to Evaluate Safety and Efficacy of Various Combinations of Valsartan, HCTZ, and Amlodipine in Patients With Moderate to Severe Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the safety and efficacy of the various combinations
      of valsartan, HCTZ, and amlodipine in patients with moderate to severe hypertension.
    


Intervention name(s): Valsartan + amlodipine; Valsartan + HCTZ; Amlodipine + HCTZ; Valsartan + amlodipine + HCTZ
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Amlodipine; Valsartan; Hydrochlorothiazide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: hypertension; valsartan; amlodipine; HCTZ
Therapeutic Control of Aspirin-Exacerbated Respiratory Disease (Aspirin)
Condition: Asthma, Aspirin-Induced; Aspirin Exacerbated Asthma
MeSH terms: Asthma; Respiratory Tract Diseases; Respiration Disorders; Asthma, Aspirin-Induced
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators are doing this research study to find out if giving a drug called
      prasugrel, which is used to prevent blood clots, can reduce reactions to aspirin in people
      with aspirin exacerbated respiratory disease (AERD), and to learn why taking aspirin every
      day can work as a treatment for people with AERD. People with AERD have symptoms of asthma,
      severe runny nose, polyps in the nose, and develop allergic reactions if they take
      medications like aspirin.

      People with AERD can be desensitized to aspirin in order to be able to safely use it daily,
      but the investigators do not know if prasugrel may prevent reactions to aspirin and provide a
      safer way for people with AERD to tolerate aspirin.

      The investigators also want to understand what is different about the cells and urine from
      subjects who have AERD, in comparison to subjects who have asthma but do not have AERD and
      subjects who have allergic rhinitis but do not have asthma. Lastly, the investigators want to
      understand how aspirin acts differently in subjects who have AERD, in comparison to subjects
      who have asthma but do not have AERD.
    


Intervention name(s): Placebo Oral Tablet; Prasugrel Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): Participants will take a 60 mg loading dose. After they will take 10 mg by mouth daily if they weigh >60kg or 5 mg by mouth daily if they weigh <60 kg. They will take the drug for 4 weeks prior to the aspirin challenge/desensitization.; Participants will take a 60 mg loading dose. After they will take 10 mg by mouth daily if they weigh >60kg or 5 mg by mouth daily if they weigh <60 kg. They will take the drug for 4 weeks prior to the aspirin challenge/desensitization.
Other intervention name(s): Placebo; Effient
Intervention MeSH terms: Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Supportive Care
Keywords: Aspirin; Prasugrel; Asthma; AERD; Aspirin challenge; Aspirin desensitization; Aspirin induced asthma
FLOW-AF: A Study to Evaluate the Ablacon Electrographic FLOW EGF Technology
Condition: Atrial Fibrillation, Persistent
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      This study is to evaluate the Ablacon Electrographic Flow (EGF) algorithm technology (Ablamap
      Software).
    

Detailed description: 
      The objective of this study is to evaluate the reliability of the Ablacon Electrographic Flow
      (EGF) algorithm technology (Ablamap Software) to identify atrial fibrillation sources and
      guide ablation therapy in patients with persistent atrial fibrillation.
    

Intervention name(s): Ablamap Software
Intervention type(s): Device
Intervention description(s): Subjects will receive cardiac ablation guided by the Ablamap software. The software will identify atrial fibrillation sources to help guide ablation therapy in patients with persistent atrial fibrillation. Subjects will undergo a cardioversion post ablation, as necessary.
Other intervention name(s): Ablamap Electrographic Flow Algorithm Technology
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Physiological, Behavioural and Subjective Measures of Listening Effort
Condition: Hearing Loss
MeSH terms: Hearing Loss
Study type: Interventional

Summary: 
      Participants will perform two different listening tasks: (1) listening to, and repeating
      back, sentence lists presented in noise, and (2) listening to short radio excerpts and
      answering subsequent comprehension questions. At the same time participants are required to
      perform a manual target-tracking task on a touch screen. During this study, continuous,
      non-invasive physiological measurements (heart rate, skin conductance and
      hemoencephalography) will be made from participants. Using this paradigm we will be assessing
      the effect of different hearing aid processing algorithms on listening effort. The study
      takes the form of a three factor (listening task x algorithm x signal-to-noise ratio),
      within-subjects design. Each participant performs each listening task (about 4min long each)
      with each algorithm (reference, noise reduction I, noise reduction II), at two
      signal-to-noise ratios (+4 decibel and 0 decibel) twice (test-retest).
    


Intervention name(s): Hearing Aid without NR enabled; Hearing Aid with NR(1); Hearing Aid with NR(2)
Intervention type(s): Device; Device; Device
Intervention description(s): Each participant will be fitted with noise reduction disabled. Disabled means that no sound processing algorithm that removes noise from the speech signal is active.; Each participant will be fitted with the noise reduction program on the same hearing aid. The principle of the noise reduction algorithm is to remove noise from a speech signal with the aim of improving the speech intelligibility and comfort.; Each participant will be fitted with a second noise reduction program on the same hearing aid. The parameterization of this NR algorithm differs from that in NR(1).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
The Effect of Plant Sterols on Vascular Function
Condition: Vascular Diseases; Hypercholesterolemia
MeSH terms: Vascular Diseases; Hypercholesterolemia
Study type: Interventional

Summary: 
      The main aim of the study is to investigate, in humans, the effect of plant sterols on
      vascular function by measuring flow-mediated dilation (FMD).

      This study also aims to study the effect of plant sterols on pulse wave velocity (PWV),
      aortic augmentation index (Aix), central blood pressure (CBP), office blood pressure (BP),
      blood lipids and plasma plant sterol concentration. At last, the effects of plant sterols on
      z-scores of circulating biomarkers of endothelial dysfunction and low-grade inflammation will
      be assessed.

      For all study outcomes, effect sizes and 95% confidence intervals will be estimated.

      Hypothesis: Based on available evidence, it is hypothesized that plant sterols modestly
      increase FMD.
    

Detailed description: 
      Plant sterols are well known for their LDL-cholesterol lowering benefit. Elevated cholesterol
      and especially LDL-cholesterol concentrations are established risk factors for coronary heart
      disease (CHD) and reducing these concentrations by dietary modification or drug treatment
      have been shown to reduce the risk of CHD. Direct evidence supporting a reduced risk of CHD
      has so far not been generated. Investigating the effects of consuming plant sterols on
      intermediate risk factors beyond cholesterol-lowering is therefore warranted.
    

Intervention name(s): Plant Sterols; Placebo Product
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: vascular function; plant sterols; blood lipids
Study to Find the Percentage of Cases Retaining COVID-19 IgG Antibodies 45-65 After They Have Tested Positive
Condition: Covid19
MeSH terms: COVID-19
Study type: Observational

Summary: 
      As a serosurveillance measure asymptomatic employees of an industrial workforce Jamshedpur
      (India) were tested for COVID-19 IgG antibodies. Of the tested employees who were positive
      for COVID-19 IgG antibodies the study aimed to find the percentage of cases who retained
      their COVID-19 IgG antibodies 45-65 days after initially testing positive.
    

Detailed description: 
      As a serosurveillance measure, 3296 asymptomatic employees of an industrial workforce
      Jamshedpur (India) were tested for COVID-19 IgG antibodies specific for the spike subunit
      antigen by the ErbaLisa COVID-19, Erba Corporate Services (United Kingdom) between 28th June
      and 15th July 2020.

      The cases who tested positive for COVID-19 IgG antibodies were repeat tested for the presence
      of COVID-19 IgG at 45-65 days after initially testing positive. This was done with the aim of
      finding out the percentage of cases retaining their IgG antibodies at 45-65 days of initially
      testing positive.
    

Intervention name(s): Repeat SARS-CoV-2 IgG antibodies at 45-65 days
Intervention type(s): Diagnostic Test
Intervention description(s): All cases who initially tested positive for SARS-CoV-2 IgG antibodies would undergo a repeat test at 45-65 days
Intervention MeSH terms: Antibodies; Immunoglobulin G
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Asymptomatic workforce
Effect of Induction Method in Post Operative Agitation
Condition: Emergence Agitation
MeSH terms: Psychomotor Agitation; Emergence Delirium
Study type: Interventional

Summary: 
      To compare the effect of two different induction method; mask ventilation and intravenous
      cannulation on emergence agitation on pediatric adenotonsillectomy
    

Detailed description: 
      Many things cause emergence agitation after operations on pediatric population. This research
      aims determine which method, mask ventilation or intravenous cannulatin is more effective on
      emergence agitation
    

Intervention name(s): mask ventilation; intravenous cannulation
Intervention type(s): Device; Device
Intervention description(s): before intravenous induction, mask application is made. then intravenous cannulation and induction; induction is applied by using intravenous cannulation
Other intervention name(s): induction method with mask ventilation; induction method with intravenous cannulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Elevated Platelet Count as Prognostic Factor in Colorectal Cancer With Synchronous Liver Metastases
Condition: Colorectal Cancer; Colorectal Carcinoma; Stage IV Colon Cancer
MeSH terms: Colorectal Neoplasms; Thrombocytosis
Study type: Observational

Summary: 
      Colorectal cancer (CRC) is the third most common malignancy worldwide and is often metastatic
      at diagnosis. Despite progresses in surgical techniques and the introduction of novel
      chemotherapy regimens, many patients still suffer from a poor prognosis. It is therefore of
      utmost importance to identify prognostic markers that may improve selection of patients.

      In recent years several studies demonstrated that preoperative blood tests as platelet count
      or neuthophil-to-lymphocyte ratio could be prognostic factors in CRC as well as other
      malignancies. The aim of this study was to evaluate the role of preoperative platelet count
      (PC) in patients with synchronous colorectal liver metastases.
    


Intervention name(s): Measurement of platelet count at diagnosis
Intervention type(s): Diagnostic Test
Intervention description(s): Blood samples were drawn by expert phlebotomists in vacuum blood tubes containing K2-EDTA (Terumo Europe NV, Leuven, Belgium). The complete blood cell count (CBC) was performed using Advia 2120 (Siemens Healthcare Diagnostics, Tarrytown NY, USA). The local reference range for platelets was 150-400 x 109/L. The same analyser was used throughout the study period, and the quality and reproducibility of test results was validated by data of both internal quality control and external quality assessment
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients who underwent surgery for colorectal cancer with synchronous liver metastases in
        the study period, and who fulfilled the inclusion criteria.
      
Keywords: platelets; thrombocytosis; prognosis
Communicating a Cancer Diagnosis-Current Methods and Their Effects
Condition: Behavior; Cancer
MeSH terms: Disease
Study type: Observational

Summary: 
      This study will investigate how patients are informed of their cancer diagnosis or recurrence
      and will explore their experience in learning about the diagnosis. Specifically, it will:

        -  Distinguish methods of telling the diagnosis and identify its relationship to the type
           of cancer.

        -  Determine if the way a patient is informed of their diagnosis is associated with their
           level of satisfaction with the method of being informed.

        -  Identify who informs the patient of their diagnosis..

        -  Determine patient satisfaction with their diagnostic consult.

        -  Identify indicators of satisfaction with the diagnostic consultation.

      Patients 18 years of age or older who are enrolled in or being screened for enrollment in a
      phase I, II or III clinical trial in the National Cancer Institute's Medical Oncology,
      Metabolism, Surgery or Neuro-Oncology branch may be eligible for this study.

      Participants complete a 15-minute questionnaire that includes questions related to the how
      they were informed of their cancer diagnosis.
    

Detailed description: 
      Background:

      - The goals of the study are to identify how a patient with a diagnosis of cancer is informed
      of their condition and to illuminate the way in which this information exchange occurs.

      Objectives:

      To distinguish, identify and determine:

        -  If the method by which a patient is informed of a diagnosis of cancer is associated with
           their level of satisfaction with that method of being informed

        -  Who tells the patient of their condition

        -  The methods used to inform a patient of their condition

        -  Prognostic indicators of high satisfaction within the diagnostic consult

      Eligibility:

        -  Patients currently enrolled or being screened for enrollment for a phase I, II or III
           clinical trial at the National Cancer Institutes clinic center- specifically, within the
           following branch clinics: Medical Oncology, Metabolism, Surgery and Neuro-Oncology.

        -  Patient must be 18 years or older and be willing to participate in the study.

      Design:

        -  Primary methodological practice is a self-administered questionnaire.

        -  Questionnaire to be completed by patient on same day that it is administered at NCI.
    

Time perspective: Other
Keywords: Communicating a Diagnosis; Cancer Diagnosis; Recurrence of Cancer; Initial Cancer Diagnosis
A Pilot Open-Label Crossover Bioavailability Study of Celecoxib in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A pharmacokinetic study in healthy volunteers to determine the relative bioavailability of
      three formulations of celecoxib to the approved formulation.
    

Detailed description: 
      Pharmacokinetics
    

Intervention name(s): celecoxib reference formulation; celecoxib test formulation A1; celecoxib test formulation B2; celecoxib test formulation C1
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 200 mg single oral dose of celecoxib tablets; 150 mg single oral dose of celecoxib A1 formulation tablets; 150 mg single oral dose of celecoxib B2 formulation tablets; 150 mg single oral dose of celecoxib Cl formulation tablets
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Ankylosing spondylitis,Rheumatoid Arthritis,Adenomatous Polyposis Coli,Osteoarthritis,Dysmenorrhoea,pharmacokinetic study
Efficacy of Character Strengths Intervention in Enhancing Character Strengths and Self-esteem Among Adolescents
Condition: Mental Health Issue; Mutism; Orthopedic Disorder
MeSH terms: Musculoskeletal Diseases
Study type: Interventional

Summary: 
      The goal of this study is to better understand the experiences of adolescents with physical
      disabilities and assess the effectiveness of a Character Strengths Intervention (CSI) in
      improving their self-esteem, character strengths, and mental health. We will also compare
      these outcomes between two groups: one receiving the intervention and the other not receiving
      any treatment.

      Main Research Questions:

      How do adolescents with physical disabilities perceive their self-esteem, character
      strengths, and mental health, including psychological adjustment, psychological distress,
      psychological wellbeing, life satisfaction, and resilience? Can the Character Strengths
      Intervention (CSI) enhance the self-esteem, character strengths, and mental health
      (psychological adjustment and distress) of adolescents with physical disabilities?

      Study Tasks:

      Participants, who are adolescents aged 12-18 years, will be asked to provide informed consent
      to participate in the study.

      They will complete questionnaires to assess their self-esteem, character strengths, and
      mental health as a pre-assessment.

      Participants in the intervention group will undergo the Character Strengths Intervention
      (CSI), which includes activities like exploring character strengths, writing gratitude
      letters, and practicing fresh look meditation, among others.

      After the intervention, participants will complete post-assessment questionnaires to measure
      changes in self-esteem, character strengths, and mental health.

      There will be a control group that does not receive any treatment.

      Comparison Group:

      Researchers will compare the outcomes between the intervention group, who received the
      Character Strengths Intervention (CSI), and the control group, who did not receive any
      treatment. This will help us determine if the intervention had a significant impact on
      self-esteem, character strengths, and mental health outcomes for adolescents with physical
      disabilities.
    


Intervention name(s): Character Strengths Intervention
Intervention type(s): Behavioral
Intervention description(s): Session 1. Getting Started: Introducing and Exploring Character Strengths Session 2. Boost a Lower Strength Session 3. Cultivate your inner self + Loving-Kindness Meditation Session 4. Gratitude Letter + Three Good things Session 5. Conclusion Each session will consist of 1-hour, which will be delivered once a week for 5 weeks. Moreover, participants will be given homework which they will practice the rest of the week.
Other intervention name(s): Positive Psychology Interventions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: Adolescents with physical disability
Comparison of Effects of Vestibular Visual Cues and Proprioception To Improve Postural Control in Elderly
Condition: Older Adults
Study type: Interventional

Summary: 
      Background/Objective: The aim of this study was to compare the effects of vestibular visual
      cues and propriception to improve postural control in elderly.
    

Detailed description: 
      RCT study was conducted. Fourty four healthy elderly volunteers aged from 65 years to 75
      years were assigned to a group 1 (n=22) engaging in vestibular visual cues exercises and
      group 2 (n=22) engaging in proprioception exercises. Training sessions (~30 minutes each)
      occurred twice a week for consecutive six weeks. The following parameters were analyzed
      before and after training for both groups: Berg balance scale (BBS) and Clinical test of
      sensory organization and balance (CTSIB).
    

Intervention name(s): vestibular visual cues therapy; propriocetion exercise
Intervention type(s): Other; Other
Intervention description(s): Pelvic rolling to right and left with head movement and stop first on right side for 3 minutes. Do this exercise in front of the mirrorAnterior, posterior, left, and right rectilinear stimulation activities on a therapeutic ball. Anterior, posterior, left and right rectilinear; Alternate knee flexion-extension with extended trunk posture using both hands for support.
Hip and knee flexion-extension with swiss ball between the back and wall.
Hip raises lying with their back on the floor with both legs on the swiss ball. Upper limbs leaning on the floor to help with the exercises. then all exercise are perfomed on gym ball
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postural control; Proprioception; Vestibular; Elderly; BBS; CTSIB