bioihbjkbjnl/mcl2 huggingface dataset:
To Evaluate the Efficacy (Immunogenicity) and Safety of Euvichol in Healthy Adults and Children
Condition: Prevention Harmful Effects
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy (Immunogenicity) and Safety of Euvichol
      in Healthy Adults and Children.
    

Detailed description: 
      A randomized, single blind, multicenter, therapeutic confirmatory study to assess the
      efficacy (immunogenicity) and safety of Euvichol in healthy adults and children
    

Intervention name(s): Euvichol; Shanchol
Intervention type(s): Biological; Biological
Intervention description(s): Number of doses and intervals: two doses/Weeks 0 and 2
Method of administration: oral administration
Dose of drug to be administered: 1.5 mL/dose; Number of doses and intervals: two doses/Weeks 0 and 2
Method of administration: oral administration
Dose of drug to be administered: 1.5 mL/dose
Other intervention name(s): Oral Cholerae Vaccine; Oral cholera vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Open Cholecystectomy Among Patients Undergoing Laparoscopic Cholecystectomy.
Condition: Cholelithiasis; Laparoscopic Cholecystectomy; Cholecystectomy
MeSH terms: Cholelithiasis; Cholecystolithiasis; Gallstones
Study type: Observational

Summary: 
      In the current era, laparoscopic cholecystectomy is the treatment of choice for symptomatic
      gallstone disease. The aim of this study is to find out the prevalence of open
      cholecystectomy among patients undergoing laparoscopic cholecystectomy in a tertiary care
      center.
    

Detailed description: 
      Laparoscopic Cholecystectomy (LC) is the gold standard surgery for symptomatic cholelithiasis
      with low mortality and morbidity.1,2 However, 1% to 15% of conversion rate to Open
      Cholecystectomy (OC) during laparoscopic cholecystectomy has been reported.3 Converted cases
      were associated with increased perioperative time, complication rates, perioperative costs,
      the length of hospital stay, and a higher 30-day readmission rate.3,4 Conversion was also
      associated with complications including bile leak, bile duct injury, or bleeding, requiring
      reoperation or transfusion, and death. A recent detailed critical review found that
      preoperative variables like male gender, older age, high body mass index, previous abdominal
      surgery, the severity of cholecystitis, and gallbladder wall thickness were associated with
      the higher rate of conversion to OC.4 However, data regarding its prevalence lacking in our
      setting.

      The aim of this study is to find out the prevalence of open cholecystectomy among patients
      undergoing laparoscopic cholecystectomy in a tertiary care centre.
    

Intervention name(s): No intervention is done
Intervention type(s): Other
Intervention description(s): It is a descriptive cross-sectional study so no groups like case/controls are present. All the cases are included in the study.
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All the cases of elective LC admitted at the Department of Surgery at CMCTH were included.
Smartphone Application in Reducing Dental Anxiety
Condition: Dental Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      evaluating the effectiveness of smartphone applications (Tell-Play-Do) (TPD) in reduction of
      preoperative anxiety in children undergoing restorative treatment, as measured by heart rate
      and Venham's Picture Test.
    

Detailed description: 
      A total of at least 78 patients aged from 6-8 years will be included. All participants will
      be divided equally into two groups. Study group TPD using smartphone application and Control
      group (Tell-Show-Do) (TSD) using traditional behavior management technique.

      Dental anxiety using Venham's Picture Test and heart rate using pulse oximeter will be
      assessed during dental treatment
    

Intervention name(s): Tell-Play-Do; Tell-Show-Do
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Using smart phone application; Using traditional behavior management technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Bioavailability of Phytonutrients From Novel Preparations of Broccoli
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The primary objective of this study is to determine the effects of different methods of
      broccoli preparation on levels of urinary glucosinolate metabolites. The secondary objective
      is to determine the effects of different methods of broccoli preparation on levels of plasma
      carotenoids.
    

Detailed description: 
      Consumption of Brassica vegetables (which include broccoli, cabbage, and kale) is inversely
      associated with the incidence of several cancers, including cancers of the lung, stomach,
      liver, colon, rectum, breast, endometrium, and ovaries. Brassica vegetables are a good source
      of many nutrients including glucosinolates and carotenoids. Glucosinolates are
      sulfur-containing compounds that are converted to bioactive metabolites by an enzyme called
      myrosinase, which is released when the vesicles containing myrosinase are ruptured by chewing
      or cutting. These bioactive compounds are considered to be active agents for cancer
      prevention. Their ability to reduce risk of cancer may derive in part from their ability to
      modulate foreign-substance metabolizing enzymes, which include enzymes called Phase I
      cytochrome P450s and Phase II enzymes. Carotenoids may also have a role in cancer prevention
      and other health benefits including reducing age-related macular degeneration, and therefore
      merit research to reveal factors that affect their presence in the body.

      The primary aim of this study is to investigate how various preparations of broccoli impact
      levels of these healthful nutrients in humans.
    

Intervention name(s): Common Snack Combination; Cheesy Broccoli Snack; Cheesy Broccoli with Daikon Radish Snack; Uncooked Broccoli Snack
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Combination of Chips, Pretzels, and Popcorn.; Oven-roasted, freeze-dried, cheese flavored broccoli; Oven-roasted, freeze-dried, cheese flavored broccoli with Daikon radish powder; Uncooked, freeze-dried broccoli with ranch-type dip
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Other
A Combination of Abraxane and Cisplatin in Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase II trial on the assumption that abraxane and cisplatin combination therapy is
      efficacy in metastatic breast cancer.
    

Detailed description: 
      The rationales for the combination of Abraxane and cisplatin include that either drug has
      antitumor activity; they have different mechanisms; no cross-resistance are documented
      between them, and there have been some preclinical evidences indicating synergistic effects
      between the two agents. This phase II study will be undertaken to evaluate combination of
      cisplatin and weekly abraxane in terms of efficacy and safety in MBC patients.
    

Intervention name(s): Abraxane and Cisplatin combination
Intervention type(s): Drug
Intervention description(s): Abraxane will be given at 125 mg/m2, venous infusion within 30 minutes, administered on days 1, 8 and 15.
Cisplatin at 75mg/m2, venous infusion for 120 minutes, will be administered on day 1.
Other intervention name(s): Abraxane; Cisplatin
Intervention MeSH terms: Cisplatin; Albumin-Bound Paclitaxel; Paclitaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: metastatic breast cancer; combined chemotherapy
Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Single Doses Of PF-04958242 In Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to assess the safety, tolerability, and pharmacokinetics of PF-04958242 at a
      number of single ascending doses in healthy volunteers
    

Detailed description: 
      This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to
      Biogen.
    

Intervention name(s): PF-04958242; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered as specified in treatment arm; Administered as specified in treatment arm
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Single ascending doses; pharmacokinetics; safety; tolerability; healthy volunteers; cognitive impairment associated with schizophrenia (CIAS)
Safety and Immunogenocity Study of GSK Biologicals' Pandemic Influenza (H1N1) Candidate Vaccine in Japanese Children
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to evaluate the immunogenicity and safety of GSK Biologicals'
      investigational influenza vaccine GSK2340274A following one dose and following a second dose,
      using the same dosage as has been used in the H5N1 development program in Japanese children
      aged 10-17 years and an alternative dose in children aged 6 months to 9 years.
    


Intervention name(s): GSK Biologicals' Pandemic influenza (H1N1) candidate vaccine (GSK2340274A)
Intervention type(s): Biological
Intervention description(s): Two intramuscular injections
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: GSK Bio's influenza vaccine GSK2340274A; influenza infection
The Effects of Different Music Genres on Heart Rate Variability in Extremely and Very Low Birth Weight Newborns
Condition: Infant Behavior; Infant Conditions; Infant Morbidity
MeSH terms: Birth Weight
Study type: Observational

Summary: 
      AIM: to investigate the influence of different music genres on Heart Rate Variability (HRV)
      of preterm infants.

      Neonates undergo a daily randomized music listening program. An electrocardiogram is
      performed to evaluate HRV parameters in each neonate with and without music exposure.
    

Detailed description: 
      AIM: to investigate the influence of different music genres on Heart Rate Variability (HRV)
      of preterm infants.

      HRV has been previously used to evaluate autonomic nervous system fluctuations in heart rate
      related to maturation in healthy neonates and in neonates with pathological conditions. This
      parameter has been used to show how music could improve well-being and the development of the
      autonomic nervous system in infants.

      In this study, neonates (see also inclusion/exclusion criteria), recruited on the basis of
      birth order, undergo a daily randomized music listening program (25 minutes, every day, for 3
      days) based on different music genres listening (soft pop-rap, pop-rock and classical music).
      Music programs is followed by 1 day of no music monitoring (25 minutes). An electrocardiogram
      is performed to evaluate HRV parameters in each neonate with and without music exposure.
    

Intervention name(s): The influence of different music genres on Heart Rate Variability (HRV) in preterm infants
Intervention type(s): Behavioral
Intervention description(s): Neonates undergo a daily randomized music listening program (25 minutes, every day, for 3 days) based on different music genres listening (soft pop-rap, pop-rock and classical music). Music programs is followed by 1 day of no music monitoring (25 minutes). An electrocardiogram is performed to evaluate HRV parameters in each neonate with and without music exposure
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Enrollment performed when sufficient stability of the vital parameters and absence of
        active infections and episodes of apnoea during the 72 hours before the test
      
Keywords: Music; Preterm infants; Heart Rate Variability
Pressure Gradient vs. Flow Relationships in Patients With Symptomatic Valvular Aortic Stenosis
Condition: Aortic Valve Stenosis
MeSH terms: Aortic Valve Stenosis; Constriction, Pathologic
Study type: Observational

Summary: 
      The objective of the present study is to investigate to hemodynamic profile at rest and
      during peak exercise of patients with suspected severe aortic stenosis and to compare flow-
      and pressure changes between high gradient patients and low gradient patients.
    


Intervention name(s): Simultaneous right and left heart catheterization
Intervention type(s): Procedure
Intervention description(s): Pressure recordings across the aortic valve with simultaneous flow measurements by right heart catheterization, during rest and during supine exercise.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with suspected severe AS scheduled for evaluation for aortic valve intervention
Effectiveness of a Home Based Exercise Program on Temporomandibular Dysfunction Syndrome
Condition: Temporomandibular Disorder
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Observational

Summary: 
      patients with chronic refractory temporomandibular dysfunction were prescribed home exercise
      and were followed for 6 months. Pain , mouth opening and Fonseca's were done at day 1 and
      after 6 months of the study.
    

Detailed description: 
      Each patient was seen by the rheumatologist who did the following; Full history taking
      including special habits like chewing gums or biting nails, Pain level measured by visual
      analogue scale 100 (both at rest and during temporomandibular joint movement) Clinical
      Examination of the temporomandibular joint including localized tenderness and amount of mouth
      opening After that the patients were prescribed the rehabilitation program in the form of
      heat modalities and Transcutaneous electric nerve stimulation on the on the temporomandibular
      joint, given an individual demonstration of the home based exercises and were given a
      reminding handout.

      The rehabilitation program consisted of the following exercises: lateral deviation,
      protrusion/retraction and mandibular opening.

      Isometric cervical muscle strengthening exercises were also prescribed for the patients.

      Assessment of the severity of temporomandibular joint affection using the Fonseca's
      questionnaire were done twice; the first at the entry point to the study and once again after
      6 months.
    

Intervention name(s): exercises
Intervention type(s): Other
Intervention description(s): stretching exercises - physiotherapy modalities - self care instructions
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients with chronic Temporomandibular pain refractory to medical treatment
      
Keywords: Temporomandibular dysfunction; Exercise; treatment; pain
The Use of the Hormone Kisspeptin in 'in Vitro Fertilisation' (IVF) Treatment
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 2

Summary: 
      We want to find out if kisspeptin is successful in stimulating oocyte maturation when it is
      used as a 'trigger' injection during IVF therapy for infertility.
    

Detailed description: 
      Participants in the study will have a standard Gonadotrophin Releasing Hormone (GnRH)
      antagonist IVF cycle, but instead of having a trigger injection of hCG (human chorionic
      gonadotrophin) they will be randomised to receive one of 4 doses of kisspeptin injection.

      Oocytes will be retrieved and graded by an embryologist to see whether or not they have
      matured.

      The reproductive hormones Luteinising hormone, follicle stimulating hormone, oestradiol and
      progesterone will also be measured
    

Intervention name(s): Kisspeptin 1.6nmol/kg; Kisspeptin 3.2nmol/kg; Kisspeptin 6.4nmol/kg; Kisspeptin 9.6nmol/kg; Kisspeptin 12.8nmol/kg; Kisspeptin 9.6 nmol/kg double; Kisspeptin 9.6 nmol/kg + saline
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): single kisspeptin dose 1.6 nmol/kg subcutaneously; single kisspeptin dose 3.2 nmol/kg subcutaneously; single kisspeptin dose 6.4 nmol/kg subcutaneously; single kisspeptin dose 9.6 nmol/kg subcutaneously; single kisspeptin dose 12.8 nmol/kg subcutaneously; kisspeptin dose 9.6 nmol/kg given twice 10hrs apart subcutaneously; kisspeptin dose 9.6 nmol/kg subcutaneously and saline subcutaneously, 10hrs apart
Other intervention name(s): kisspeptin-54; kisspeptin-54; kisspeptin-54; kisspeptin-54; kisspeptin-54; kisspeptin-54; kisspeptin-54
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Different dose for each volunteer
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: kisspeptin; infertility; in vitro fertilisation
Mite Asthma Pediatric Immunotherapy Trial
Condition: Allergic Asthma Due to Dermatophagoides Farinae; Allergic Asthma Due to Dermatophagoides Pteronyssinus; Allergic Rhinitis Due to House Dust Mite
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 3

Summary: 
      The trial aims to demonstrate efficacy of the House Dust Mite SLIT-tablet versus placebo as
      add-on treatment in children and adolescents (5-17 years) with House Dust Mite allergic
      asthma based on clinically relevant asthma worsening.
    

Detailed description: 
      The trial aims to demonstrate efficacy of the HDM SLIT-tablet versus placebo as add-on
      treatment in children and adolescents (5-17 years) with HDM allergic asthma based on
      clinically relevant asthma exacerbations.

      Additionally, the trial will investigate if the treatment has an effect on asthma symptoms
      including nightly awakenings due to asthma, asthma medication use, asthma control, lung
      function, allergic rhinitis and allergic rhinoconjunctivitis.

      Finally, quality of life (QoL) for subjects and caregivers will be measured.

      The trial is a randomised, parallel-group, double-blind, placebo-controlled multi-national
      phase III trial conducted in Europe and North America. The treatment period will be
      approximately 2 years. Subjects will receive a written asthma action plan.
    

Intervention name(s): HDM SLIT-tablet; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day); Placebo sublingual tablet, for daily administration (1 tablet per day)
Other intervention name(s): Acarizax; Odactra
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel-group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Allergic asthma, allergic rhinitis, HDM, pediatric
Effects of Korean Red Ginseng Extract on Electrical Brain Activity in Elderly Subjects
Condition: Brain Waves
Study type: Interventional
Phase: Phase 4

Summary: 
      A prospective, randomized, double blind, placebo-controlled study to determine if a
      hydroponically-cultivated red ginseng preparation is superior to conventionally grown ginseng
      and placebo for positively affecting electrical activity of the brain during performance of
      various cognitive tasks.
    


Intervention name(s): HRG80 Hydroponic Red Ginseng; Conventional White Ginseng; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Powdered root preparation of Panax ginseng standardized to 31.7 mg total ginsenosides; Powdered root preparation of Panax ginseng standardized to 9.8 mg total ginsenosides; Visually identical placebo capsule containing rice flour
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Efficiency Study of Clarithromycin and Bismuth-containing Quadruple Therapy to Treat H.Pylori
Condition: Functional Dyspepsia; Peptic Ulcer; Helicobacter Pylori
MeSH terms: Peptic Ulcer; Dyspepsia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to observe the efficacy of ten day triple therapy-based,
      bismuth-containing quadruple therapy for H.pylori treatment.
    

Detailed description: 
      The success rate of currently recommended triple therapy with a proton pump inhibitor (PPI)
      plus amoxicillin and clarithromycin has fallen into the unacceptable range. The purpose of
      this study is to observe the efficacy of ten day triple therapy-based, bismuth-containing
      quadruple therapy for H.pylori treatment, while ten day triple therapy is used as control.
    

Intervention name(s): Esomeprazole; Amoxicillin; Clarithromycin; Bismuth Potassium Citrate; long duration (14 day)
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention description(s): antisecretary drug of the quadruple therapy; antibiotic of the quadruple therapy; antibiotic of the quadruple therapy; one of a component of a quadruple therapy
Other intervention name(s): proton pump inhibitor; antibiotic; antibiotic; Bismuth
Intervention MeSH terms: Anti-Bacterial Agents; Amoxicillin; Clarithromycin; Antibiotics, Antitubercular; Potassium Citrate; Esomeprazole; Bismuth; Proton Pump Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment