bioihbjkbjnl/mcl2 huggingface dataset:
A Trial To Evaluate A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults 50-85 Years Of Age
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a 2-stage, phase 1/2, randomized, active-controlled, observer-blinded study with a
      2-arm parallel design in each stage.

      In Stage 1 healthy adults 50 to 64 years of age with no history of pneumococcal vaccination
      will be randomized equally to receive either a single intramuscular dose of multivalent
      pneumococcal conjugate vaccine or a licensed tetanus, diphtheria, acellular pertussis
      combination vaccine (Tdap) (control group).

      In Stage 2 healthy adults 65 to 85 years of age previously vaccinated with Prevnar 13 >=2
      months prior to investigational product administration will be randomized equally to receive
      either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or the
      licensed 23-valent pneumococcal polysaccharide vaccine (control group).
    


Intervention name(s): Multivalent; Tdap; polysaccharide
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Pneumococcal conjugate vaccine; Tetanus, diphtheria, acellular pertussis vaccine; 23-valent pneumococcal polysaccharide vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Evaluation of Peripheral Microcirculation Hemodynamics Following Various Changes Based on Noninvasive Thermography
Condition: Microcirculation
Study type: Interventional

Summary: 
      The objective of the current study is to investigate the hemodynamic changes in the
      peripheral microcirculation system as a response to various changes, using noninvasive
      thermography and laser doppler
    

Detailed description: 
      This study includes a single session per subject. Microvascular and systemic variables will
      be monitored in response to a number of non-invasive interventions/device that are approved
      for clinical use and known to elicit microvascular responses. These interventions are applied
      consecutively, include breathing at different rates, low power visible light in the
      red-to-near-infrared range, increase in local temperature, and changes in the arm position.
    

Intervention name(s): Omnilux new-U (Red LED); Omnilux new-U (Near infrared LED); RESPeRATE; Heating bag
Intervention type(s): Device; Device; Device; Device
Intervention description(s): The left wrist (including area of radial artery) will be illuminated with the Omnilux new-U (Red LED) light source, while the right wrist will not be illuminated; The left wrist (including area of radial artery) will be illuminated with the Omnilux new-U (Near infrared LED) light source, while the right wrist will not be illuminated; The subjects will be guided by a digital metronome to breath at 15, 10, and 6 breaths/min for 2 minutes each using the metronome function of the device RESPeRATE (InterCure, Israel) that guides breathing using musical tones played at selectable rhythm; Applying a standard 10X13 [cm] heating bag on the surface of the hand at 43-45 degree Celsius for 10 seconds
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Mindfulness-Based Stress Reduction for Gulf War Syndrome
Condition: Persian Gulf Syndrome
MeSH terms: Syndrome; Persian Gulf Syndrome
Study type: Interventional

Summary: 
      This pilot study is a two arm randomized, controlled clinical trial that evaluated whether a
      standardized Mindfulness-Based Stress Reduction (MBSR) intervention reduces symptoms
      associated with Gulf War Syndrome (GWS) more effectively than treatment as usual. Fifty-five
      veterans meeting diagnostic criteria for Gulf War Syndrome were randomized to treatment as
      usual (TAU) or TAU plus an 8-week course of course of MBSR. Study measures were collected at
      baseline, immediate post-MBSR, and 6 months post intervention. Measures were obtained at
      equivalent time points for veterans randomized to TAU only. Following completion of all study
      activities, veterans randomized to TAU only had the opportunity to enroll in MBSR.
    

Detailed description: 
      A randomized controlled trial with two arms. 55 veterans meeting diagnostic criteria for Gulf
      War Syndrome were randomized to standard care or standard care plus an 8-week course of
      course of Mindfulness-Based Stress Reduction (MBSR). Study measures were collected at
      baseline, immediate post-MBSR (within one week of completion of the MBSR class) and 6 months
      following completion of the MBSR course. Measures were obtained at equivalent time points for
      veterans randomized to usual care only. Following completion, veterans randomized to standard
      care only had the opportunity to enroll in MBSR.

      This pilot study will whether there is sufficient evidence of benefit to warrant further
      study, and gathered data that will allow estimation of the sample size needed in future
      studies. We also obtained measures working memory and attention, in addition to patient
      self-report measures of symptoms, in order to provide additional assessment of whether MBSR
      is effective. This project is prerequisite to a larger study.
    

Intervention name(s): Mindfulness-based stress reduction
Intervention type(s): Behavioral
Intervention description(s): Mindfulness-Based Stress Reduction (MBSR) teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Persian Gulf Syndrome; Pain; Fatigue; Attention; Meditation
Modifications in the Anaerob Threshold in Cyclists by Consuming Docosahexaenoic Acid (DHA)
Condition: Performance
Study type: Interventional

Summary: 
      In a double-blind, parallel randomized clinical trial with 38 cyclists in whom the
      performance improvement was determined after the consumption of docosahexaenoic acid for one
      month.
    


Intervention name(s): docosahexaenoic acid; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 5 dragees every 24 hours; 5 dragees every 24 hours
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: performance; cyclists; docosahexaenoic acid; anaerobic threshold
Comparative Study of Safety and Efficacy of Heavyweight and Partially Absorbable Mesh in Inguinal Hernia Repair
Condition: Hernia, Inguinal
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional
Phase: Phase 4

Summary: 
      Proflex® Mesh (partially absorbable mesh, Korea) and Marlex® Mesh (heavyweight mesh) will be
      used for inguinal hernia repair to compare the safety and efficacy (pain score, quality of
      life)of two devices at 3 months follow-up.
    


Intervention name(s): Proflex® Mesh Mesh implantation; Marlex® Mesh Implant
Intervention type(s): Device; Device
Intervention description(s): Implantation of mesh in the incision of inguinal area
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Montelukast in Mild Asthmatic Children With Allergic Rhinitis (0476-367)
Condition: Asthma; Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess real-world effectiveness of montelukast in children (2
      to 14 years) with asthma and allergic rhinitis.
    


Intervention name(s): montelukast sodium; inhaled corticosteroid
Intervention type(s): Drug; Drug
Intervention description(s): Montelukast 4/5 mg tablet (oral chewable), once daily, 12 weeks to up to 12 months; Inhaled corticosteroid solution, 1-4 puffs daily, 12 weeks to up to 12 months
Other intervention name(s): Singulair, MK0476
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Bioavailability Crossover Study of Two Formulations of Lamotrigine Extended Release Tablets in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to determine bioequivalence between two different formulations
      of lamotrigine extended release tablets (one reference product and one generic product) in a
      healthy adult population, following a single oral dose under fed conditions.
    

Detailed description: 
      This is a single center, randomized, open-label, single dose, two treatment, four-period,
      two-sequence, fully replicated crossover design in the fed state.

      The study will include two treatments:

        -  Treatment-A: One dose of Lamotrigine extended-release tablet (Test) administered in the
           morning after a 10-hour overnight fast and 30 minutes after the start of a high-fat,
           high-calorie breakfast.

        -  Treatment-B: One dose of Lamictal XR extended-release tablet (Reference) administered in
           the morning after a 10 hour overnight fast and 30 minutes after the start of a high-fat,
           high-calorie breakfast.

      A total of 30 healthy subjects will be dosed to ensure that at least 24 subjects will
      complete the 4-period replicate design. For each treatment period, subjects will be confined
      from the day prior to dosing until approximately 48 hours post-dose. Subjects will return to
      the clinical site for the remaining blood samples. There will be a minimum 14-day washout
      between doses.

      Subject participation from the Screening Visit to the Follow-Up Visit will be approximately
      71 days.
    

Intervention name(s): Lamotrigine Extended Release
Intervention type(s): Drug
Intervention description(s): Lamotrigine Extended Release (generic) and Lamictal XR (brand).
Other intervention name(s): Lamictal XR
Intervention MeSH terms: Lamotrigine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioequivalence; Lamotrigine Extended Release; Generic; Pharmacokinetic
Evaluation of Efficacy and Safety of Two New Formulations Compared to Gynomax® XL Ovule
Condition: Trichomonal Vaginitis; Bacterial Vaginosis; Candidal Vulvovaginitis; Mixed Vaginal Infections
MeSH terms: Infections; Vaginosis, Bacterial; Candidiasis, Vulvovaginal; Trichomonas Vaginitis; Vaginal Diseases; Vaginitis; Vulvovaginitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Efficacy and safety of two new formulations compared to Gynomax® XL ovule in the treatment of
      trichomonal vaginitis, bacterial vaginosis, candidal vulvovaginitis and mixed vaginal
      infections was evaluated in this randomized, three-arms, multicentral study.
    

Detailed description: 
      This was a national, randomized, 3-arms, phase III study conducted in 16 centers in Türkiye.

      It was aimed to evaluate the efficacy and safety of different fixed dose vaginal ovule
      formulations of fenticonazole + tinidazole + lidocaine (Formulation A and Formulation B) in
      the treatment of bacterial vaginosis, candidal vulvovaginitis, trichomonal vaginitis and
      mixed infections with comparison to Gynomax® XL vaginal ovule.
    

Intervention name(s): EVEGYN A; EVEGYN B; Gynomax® XL Vaginal Ovule
Intervention type(s): Drug; Drug; Drug
Intervention description(s): EVEGYN A: Fixed-dose combination of 600 mg fenticonazole nitrate + 1000 mg tinidazole + 100 mg lidocaine vaginal ovule Single dose, single administration (1x1); EVEGYN B: Fixed-dose combination of 600 mg fenticonazole nitrate + 2000 mg tinidazole + 100 mg lidocaine vaginal ovule Single dose, single administration (1x1); 200 mg tioconazole + 300 mg tinidazole + 100 mg lidocaine single dose / day, during three consecutive days (1x1 / 3 days)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of AGN-199201 and AGN-190584 in Patients With Presbyopia
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional
Phase: Phase 2

Summary: 
      A study to evaluate the safety and efficacy of AGN-199201 alone, AGN-190584 alone and
      concurrent use of AGN-199201 and AGN-190584 in patients with presbyopia (inability to focus
      for near vision).
    


Intervention name(s): AGN-199201; AGN-190584; AGN-199201 Vehicle
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 to 2 drops of AGN-199201 ophthalmic solution in the eye(s) as per protocol.; 1 to 2 drops of AGN-190584 ophthalmic solution in the eye(s) as per protocol.; 1 to 2 drops of AGN-199201 vehicle in the eye(s) as per protocol.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of Novel Noise Reduction Principles in Hearing Instruments
Condition: Hearing Loss
MeSH terms: Hearing Loss
Study type: Interventional

Summary: 
      In the study, the speech intelligibility in noise (Outcome) between a novel noise reduction
      algorithm (Intervention) versus the standard noise reduction (Comparator) will be tested in
      adults with a N3-N4 hearing loss (Population) using streamed signals via hearing aids.
    


Intervention name(s): Measures of Standard Noise Reduction NR1; Measures of Noise Reduction Principle NR2; Measure of Noise Reduction Principle NR3
Intervention type(s): Device; Device; Device
Intervention description(s): Each participant will be fitted with the Standard Noise Reduction (NR1); Each participant will be fitted with the novel Noise Reduction principle NR2 on the same hearing aid; Each participant will be fitted with the novel Noise Reduction principle NR3 on the same hearing aid
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
A Single-center Retrospective Cohort Study to Explore the Prognostic Significance of CONUT in Elderly CAD Patients With HFpEFand Compare CONUT With Other Objective Nutritional Indices.
Condition: Heart Failure With Preserved Ejection Fraction; Malnutrition; Aged; Prognosis
MeSH terms: Malnutrition
Study type: Observational

Summary: 
      HF is an advanced or terminal stage of various heart diseases, with high rehospitalization
      and mortality rates. In HF patients, undernutrition is not uncommon and represents one of the
      most significant determinants of poor clinical outcomes. Therefore, nutritional management is
      of paramount importance for patients with HF.The basic method of nutritional management is to
      effectively identify the nutritional status of patients with heart failure, especially in
      elderly patients with heart failure who are not easy to find in the early stage. Limited data
      are available regarding the association between CONUT score and prognosis in elder patients
      with HFpEF, despite its easy availability in routine blood chemistry. Therefore, we aimed to
      evaluate the prognostic significance of CONUT score and to compare it with other
      well-established nutritional indices in HFpEF, a common HF phenotype in the elderly
      population with coronary artery disease.

      This was a single-center retrospective cohort study which were approved by the Clinical
      Research Ethics Committee of our hospital (TRECKY2021-185). Written informed consent was
      obtained from all patients.

      Participants were accorded with diagnostic criteria of CAD and HFpEF excluding rheumatic
      heart disease, congenital heart disease, acute myocardial infarction, hemodialysis or
      hemofiltration, tumour activity, urgent surgery, death during hospitalization, HF of unknown
      reasons, New York Heart Association(NYHA) class1and data deficiency. Demographic
      characteristics and medical parameters were collected from the electronic medical record
      system . All enrolled patients were followed-up in an outpatients setting. The primary
      endpoint of this study was readmission due to heart failure and all-cause mortality in the
      first year after hospitalization. To explore the prognostic significance of controlling
      nutritional status score in elderly with ejection fraction preserved heart failure and
      compare controlling nutritional status score with other objective nutritional indices.All
      analyses were performed using Statistical Product Service Solutions(SPSS) version 19.0 .
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        elderly HFpEF Ⅱ-Ⅳ patients with coronary heart disease hospitalized in the Department of
        Geriatrics Medical Department of Beijing Tongren Hospital affiliated to Capital Medical
        University from January 1, 2017 to December 31, 2019 were selected
Health Coaching to Effect Lifestyle Behaviour Change
Condition: Prediabetes; Prehypertension
MeSH terms: Prehypertension
Study type: Interventional

Summary: 
      A health coaching intervention in those with pre-disease (pre-hypertension or pre-diabetes)
      but without pre-existing cardiovascular disease will effectively help participants change
      their lifestyle behaviour and prevent or delay onset of cardiovascular disease.
    


Intervention name(s): Health Coaching
Intervention type(s): Behavioral
Intervention description(s): The intervention will take approximately six months to complete. A combination of group and individual face-to-face meetings will be used. Participants will be divided into groups of 20 for group meetings. Groups will be brought together for a group coaching session at the beginning and the end of the coaching process (i.e., intervention). Each participant will also receive four individual coaching sessions with the health coach and will be able to avail of three one-hour telephone coaching sessions during the six month intervention. Participants will be encouraged to utilize telephone coaching for key support periods.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Study Aimed at Detecting Potential Abuse of Nitrous Oxide in Children During Dental Care
Condition: Periodontal Disease
MeSH terms: Periodontal Diseases
Study type: Observational

Summary: 
      The aim of this study is to evaluate the potential risk of abusive behavior for children in
      care using nitrous oxide for dental care.
    

Detailed description: 
      The expected prospects are therefore maintaining surveillance around the MEOPA following his
      release from hospital reserves, but also to ensure that the MEOPA not an addictive potential
      in the context of its use in dentistry. The results of this study will in any case to secure
      its application for dental care.
    

Intervention name(s): questionnaire
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All patients seen in consultation EMENO and being younger than 15 years will be offered
        this study.

        This is a population of non-cooperative patients to dental care or with a disability
        limiting their cooperation.

        A quick questionnaire will be submitted in the consultations EMENO the SSC, the children
        after their parents' permission.
      
Keywords: dental care; emeno; abuse
Adipose Tissue Inflammation in Individuals Undergoing Bariatric Surgery
Condition: Obesity, Morbid; Bariatric Surgery Candidate
MeSH terms: Obesity, Morbid; Inflammation
Study type: Observational

Summary: 
      A growing body of work done over the past few decades has established that adipose tissue as
      an active endocrine organ which secretes a wide range of metabolic and immunological factors
      collectively called "adipokines (1)." Importantly, these secreted factors enter into the
      circulation and have paracrine and autocrine actions, which profoundly impact systemic
      metabolism (e.g., insulin sensitivity). Additionally, in animals, loss of ovarian hormone
      production via ovariectomy (similar to menopause in humans) leads to increases in both in
      adipose tissue mass and in adipose tissue inflammation (2) making this tissue less healthy
      than that from premenopausal animals. To date, no studies have investigated the effect of
      menopause on abdominal fat in overweight individuals. Knowing if adipose tissue-specific
      changes occur with menopause may potentially lead to recommendations or therapeutics to
      improve women's health post menopause.
    

Detailed description: 
      Subjects will just have to agree to having a small amount of adipose tissue being removed
      during the bariatric surgery. The investigators will also collect a blood sample at that
      time. There will be no other visits for the subject.
    

Intervention name(s): bariatric surgery
Intervention type(s): Procedure
Intervention description(s): We are recruiting only those going through bariatric surgery
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All subject are already scheduled to have bariatric surgery at the University of
        Missouri-Columbia Department of Surgery.
Analysis of Circulating Epithelial Tumor Cells in Peripheral Blood in Patients With Primary Non-metastatic Breast Cancer Under Adjuvant Radiotherapy
Condition: Breast Cancer Female
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The aim of this study was to investigate the systemic effect of radiotherapy on patients with
      primary non-metastatic breast cancer using CETC and to analyze possible changes in CETC
      quantity under adjuvant radiotherapy.
    

Detailed description: 
      In cooperation with the Women's Hospital of the Friedrich Schiller University in Jena, a
      total of 161 patients with clinically proven, primarily non-metastatic breast cancer were
      sampled and examined before and after radiotherapy over a period from 09/2002 to 09/2012. The
      MAINTRAC method was used to quantitatively determine the amount of CETC in the blood and to
      observe its peritherapeutic course.
    

Intervention name(s): radiation
Intervention type(s): Radiation
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Primary non-metastatic breast cancer
      
Keywords: Radiotherapy; CETC; CTC; breast cancer