bioihbjkbjnl/mcl2 huggingface dataset:
Predictive Factors of Endoscopic Mucosal Healing in Quiescent Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Observational

Summary: 
      The purpose of this study is to determine whether fecal calprotectin, fecal immunochemical
      test, and Rome III criteria for irritable bowel syndrome (IBS) can predict mucosal healing in
      patients with quiescent ulcerative colitis (UC).
    


Intervention name(s): colonoscopy
Intervention type(s): Other
Other intervention name(s): fecal calprotectin; fecal immunochemical test; Rome III criteria for IBS
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with inactive UC (Mayo score <3) who are scheduled to undergo colonoscopy for
        surveillance or mucosal healing check-up
      
Keywords: Ulcerative colitis; fecal calprotectin; mucosal healing
Comparison of Cervical Pathologies in the Presence of High Risk Hpv Positivity
Condition: Human Papilloma Virus; Cervical Neoplasm
MeSH terms: Papilloma; Uterine Cervical Neoplasms
Study type: Observational

Summary: 
      The only malignancy screening test among gynecological cancers is cervical cancer.

      Cytology examination and Hpv typing with smear are used as screening tests. Hpv positivity is
      detected in more than 90% of cervical cancers. However, only the Hpv 16-18 type positive
      patients undergo colposcopy in the routine screening program.

      Patients with Smear negative, Type 16-18 high-risk Hpv positivity are evaluated by quota
      after 1 year.

      the authors performed colposcopy with this study; authors aimed to compare the results of
      patients with type 16-18 Hpv positivity and type 16-18 high-risk Hpv positivity and to find
      out whether there was any difference between them.

      In this way, other high-risk Hpv types other than type 16-18 (31,33,35,45,51, etc.) may be
      exposed to premalign cervical lesions and possible cancer in a number of earlier and earlier
      periods by performing colposcopic examination instead of expecting to perform quota after 1
      year. we aimed to remove.
    


Intervention name(s): colposcopy and colposcopic biopsy
Intervention type(s): Diagnostic Test
Intervention description(s): high-risk hpv positivity and colposcopy and cervical biopsy results will be evaluated. thus, it will be defined whether colposcopy will be performed routinely at high-risk hpv.
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with high-risk HPV and colposcopy were the study groups.
      
Keywords: colposcopy; High Risk HPV
Safety and Immunogenicity of GlaxoSmithKline (GSK) Biologicals' Meningococcal B Recombinant Vaccine When Administered Concomitantly With Routine Vaccines to Healthy Infants of 2 Months of Age and Older, in Taiwan.
Condition: Meningococcal Disease; Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      Assess the safety and immunogenicity of a 3-dose schedule (at 2, 4, 6 months) of GSK
      Biologicals' Meningococcal B recombinant vaccine followed by a booster at 12 months when
      concomitantly administered with routine vaccines in healthy infants in Taiwan.
    


Intervention name(s): Bexsero®; Routine vaccines
Intervention type(s): Biological; Biological
Intervention description(s): Four doses administered in the anterolateral area of the right or left thigh.; Infanrix-IPV + Hib®, Prevenar-13®, Engerix-B®, Priorix® and Varilrix® administered in the anterolateral area of the right or left thigh.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningitis; Infants; Meningococcal B Recombinant Vaccine
Cosmetic Effects of Topical Acetyl Zingerone
Condition: Wrinkle Appearance; Skin Pigment; Erythema; Side Effect; Microbiome; Lipidome
MeSH terms: Erythema
Study type: Interventional

Summary: 
      Cosmeceuticals are an emerging market within dermatology and the growth of natural products
      and derivatives of natural products has accelerated in use within the field. Here the
      investigators aimed to study the microbial and cosmetic effects of Synoxyl AZ, the trade name
      for topical acetyl zingerone (AZ), a novel compound designed based on Zingerone and curcumin.
    

Detailed description: 
      Cosmeceuticals are an emerging market within dermatology and the growth of natural products
      and derivatives of natural products has accelerated in use within the field. Here the
      investigators aim to study Synoxyl AZ, the trade name for topical acetyl zingerone (AZ), a
      novel compound designed based on Zingerone and curcumin.

      Both curcumin and Zingerone are from the Zingiberacea family of plants (also known as the
      ginger family). Both have been widely studied and noted to have antibacterial effects and
      promote skin health effects. Curcumin has been studied widely in recent years due to various
      microbial effects. AZ is a derivative that is similar to both Zingerone and curcumin and has
      been noted to have many different activities including anti-inflammatory, antimicrobial, and
      antioxidant functions. However, there are no studies looking at how it modulates the skin
      cosmetically or the superficial microbiome.

      The aim of this study was to compare the cosmetic effects of AZ to a vehicle over an 8-week
      period.
    

Intervention name(s): Acetyl Zingerone Topical Cream; Topical cream
Intervention type(s): Other; Other
Intervention description(s): Topical cream with an active acetyl zingerone component.; Topical cream without an active acetyl zingerone component and just the carrier cream.
Other intervention name(s): Synoxyl AZ (Brand Name)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be randomized to two groups:
AZ Group (n= 17) Control Group (n=17)
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ginger; Curcumin; Zingerone
A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to < 9 Years
Condition: Influenza, Human
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a study to assess the safety of a bioCSL split virion, inactivated Trivalent
      Influenza Virus vaccine containing the 2014/2015 Northern Hemisphere strains of vaccine in
      children aged 5 years to less than 9 years. Comparison will be made to a licensed
      Quadrivalent Influenza Virus vaccine that complies with the FDA recommendations for the
      2014/2015 influenza season in the US.
    


Intervention name(s): bioCSL Trivalent Influenza Virus Vaccine (CSL TIV); Comparator Quadrivalent Influenza Virus Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.; Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.
Other intervention name(s): Fluzone Quadrivalent
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Observational Safety Study of Menactra® Administered Under Standard Health Care Practice in the Russian Federation
Condition: Meningitis; Meningococcal Meningitis; Meningococcal Infections
MeSH terms: Meningococcal Infections; Meningitis, Meningococcal; Meningitis
Study type: Observational

Summary: 
      The aim of this study is to generate local data on the safety of Menactra® in individuals 2
      to 55 years of age in the Russian Federation.

      Primary Objective:

        -  To describe the safety profile after 1 dose of Menactra® administered in individuals
           2-55 years of age under standard health care practices.
    

Detailed description: 
      Participants will be enrolled after receipt of one dose of Menactra® during a routine health
      care visit. They will be monitored for safety throughout the study.
    

Intervention name(s): Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine; Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine; Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): No vaccine will be provided as part of this study; No vaccine will be provided as part of this study; No vaccine will be provided as part of this study
Other intervention name(s): Menactra®; Menactra®; Menactra®
Intervention MeSH terms: Vaccines
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants aged 2 to 55 years will be enrolled after receipt of one dose of Menactra®
        during a routine health care visit.
      
Keywords: Meningitis; Meningococcal Meningitis; Meningococcal Infections; Menactra®; Meningococcal Vaccine
Investigation of Bioequivalence of Ethinylestradiol (EE) and Drospirenone (DRSP) in Two Different Tablet Formulations: YAZ and YAZ + Levomefolate Calcium (Metafolin) & L-5-MTHF in Two Different Tablet Formulations: Levomefolate Calcium (Metafolin) and YAZ + Levomefolate Calcium (Metafolin)
Condition: Contraception
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is examine and compare the uptake of YAZ (oral contraceptive
      containing drospirenone and ethinylestradiol) with or without levomefolate calcium
      (Metafolin, a registered vitamin supplement) in the body and to examine and compare the
      uptake of levomefolate calcium with or without YAZ in the body, in healthy volunteers not
      using hormonal contraception
    


Intervention name(s): EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300); EE 0.02 mg/DRSP 3 mg/L-5-MTHF Ca 0.451 mg (EE20/DRSP/L-5-MTHF Ca); L-5-MTHF 0.451mg (Metafolin)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Treatment group A: Single 1 film-coated tablet (Ethinylestradiol [EE] 0.02mg / Drospirenone [DRSP] 3mg) taken orally under fasting condition at intervals of at least one menstrual cycle.; Treatment group B: Single 1 film-coated tablet (Ethinylestradiol [EE] 0.02mg / Drospirenone [DRSP] 3mg / L-5-methyltetrahydrofolate [L-5-MTHF] 0.451mg) taken orally under fasting condition at intervals of at least one menstrual cycle.; Treatment group C: Single 1 coated tablet (L-5-methyltetrahydrofolate [L-5-MTHF] 0.451mg) taken orally under fasting condition at intervals of at least one menstrual cycle.
Intervention MeSH terms: Tetrahydrofolates; Drospirenone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
An Effectiveness and Safety Study of Cyclobenzaprine HCl Alone or in Combination With Ibuprofen for Acute Back or Neck Muscle Pain With Muscle Spasm
Condition: Pain; Spasm
MeSH terms: Muscle Cramp; Myalgia; Spasm; Hyperkinesis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the effectiveness and safety of cyclobenzaprine HCl
      5 mg (muscle spasm medication) taken three times a day, alone or in combination with
      ibuprofen 400 mg or 800 mg (pain relief medication) taken three times a day, for the
      treatment of back or neck muscle pain with muscle spasm.
    

Detailed description: 
      The objective of this multicenter, randomized, open-label, parallel-group, one-week study is
      to evaluate the effectiveness and safety of cyclobenzaprine HCl 5 mg three times a day for
      one week, alone or in combination with ibuprofen 400 mg or 800 mg taken three times a day,
      for acute back or neck muscle pain with muscle spasm. The primary measurement of efficacy is
      the subject-rated global impression of change after seven days of treatment, compared to
      baseline. Safety assessments during the study include the monitoring of adverse events, and a
      physical examination, assessment of vital signs and medical history of any present illnesses
      conducted during the baseline visit. The study hypothesis is that there will not be a
      statistically significant difference in patient ratings of global impression of change,
      muscle spasm, muscle pain, medication helpfulness, and functional ability, between the
      cyclobenzaprine HCl monotherapy group versus the cyclobenzaprine HCl/ibuprofen 400 mg and
      cyclobenzaprine HCl/ibuprofen 800 mg groups, for the treatment for acute back or neck muscle
      pain with spasm. Patients receive cyclobenzaprine HCl 5 mg administered orally three times a
      day for one week, or cyclobenzaprine HCl 5 mg with ibuprofen 400 mg administered orally three
      times a day for one week, or cyclobenzaprine HCl 5 mg with ibuprofen 800 mg administered
      orally three times a day for one week.
    

Intervention name(s): cyclobenzaprine hydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Cyclobenzaprine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: muscle spasm; cyclobenzaprine hydrochloride
A Phase I/II Trial of TS-1 and Oxaliplatin in Patients With Advanced Colorectal Cancer
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Capecitabine and oxaliplatin(XELOX) is active first-line therapy for patients with metastatic
      colorectal cancer. Phase II study of TS-1, a novel oral fluoropyrimidine derivative, showed
      activity in patients with metastatic colorectal carcinoma. Preclinical data of TS-1 with
      oxaliplatin showed synergistic activity in vivo human colorectal cancer xenograft. There is
      no data about the optimal dose of TS-1 with 2 weeks schedule combined with oxaliplatin.
      Therefore in a phase I study, we would like to determine the maximum tolerated dose(MTD) of
      TS-1 and oxaliplatin and define the recommended dose for subsequent phase II study. And then,
      in a phase II study we would like to evaluate the efficacy(response rates) and toxicities of
      the new combination regimen in advanced colorectal cancer.
    

Detailed description: 
      Subjects meeting all of the following criteria will be considered for enrolment into the
      study.

        1. Histologically documented colorectal adenocarcinoma

        2. Previous chemotherapy up to two regimens(including adjuvant chemotherapy and first-line
           chemotherapy without oxaliplatin) is allowed in phase I portion; patients are required
           to have discontinued chemotherapy and/or radiotherapy for at least 4weeks before entry
           into phase I portion. No prior chemotherapy or radiotherapy allowed(adjuvant
           chemotherapy and/or radiotherapy would be allowed) in phase II portion

        3. Age 18 to 75 years old

        4. At least one unidimensional measurable lesion with a diameter >20 mm using conventional
           CT or MRI scans or >10 mm using spiral CT scans (use of spiral CT must be documented in
           medical records and used consistently throughout study).

        5. In phase I study, prior radiotherapy is permitted if it was not administered to target
           lesions selected for this study, unless progression of the selected target lesions
           within the radiation portal is documented, and provided it has been completed at least 4
           weeks before study entry.

        6. Performance status (ECOG scale): 0-2

        7. Patients can take food and drugs orally

        8. Adequate organ functions

        9. Life expectancy ≥ 3 months

       10. Written informed consent
    

Intervention name(s): TS-1, oxaliplatin
Intervention type(s): Drug
Intervention description(s): Oxaliplatin(130 mg/m2) day 1, intravenously TS-1 at a dose of 60, 70, 80, 90, 100, 110, 120 mg/m2 given orally starting day 1 until day 14(2 weeks ON, 1 weeks OFF), every 3 weeks
Intervention MeSH terms: Oxaliplatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: TS-1 and oxaliplatin; Phase I/II study; Colorectal cancer; First line treatment
Effect of mgso4 on Oxygenation and Lung Mechanics in Morbidly Obese Patients During Bariatric Surgery
Condition: Anesthesia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to study the effect of mgso4 infusion on oxygenation and lung
      mechanics in morbidly obese patients undergoing bariatric surgery
    

Detailed description: 
      Background and objectives: morbidly obese patients are characterized by a high prevalence of
      restrictive lung disease. Respiratory mechanics are significantly altered in obesity. These
      changes are exacerbated with general anesthesia .Obesity also results in reduced lung and
      chest wall compliance ,increased lung resistance ,reduced oxygenation.MgSo4 is promising in
      managing several respiratory disorders.it cause smooth muscle relaxation and reduce airflow
      obstruction.

      The objective of this trial is to study the effect of mgso4 infusion on oxygenation and lung
      mechanics in morbidly obese patients undergoing bariatric surgery.

      the following will be recorded :intraoperative oxygenation,lung
      mechanics,MAP,HR,EtCO2,plateau and peak airway pressure,sedation score,serum mgso4
      level,change in P/F ratio and dynamic lung compliance,respiratory rate postoperative
    

Intervention name(s): mg sulphate
Intervention type(s): Drug
Intervention description(s): mgso4 infusion will start 15 minutes after intubation , 30 mg/kg LBW of 10%mgso4 in 100 ml normal saline I.V ,over 30 minutes followed by 10 mg/kg LBW for 90 minutes
Other intervention name(s): mgso4
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: mgso4; oxygenation; lung mechanics
Evaluation of Airtraq in Pediatric
Condition: Intubation
Study type: Interventional

Summary: 
      This study indented to evaluate the use of Optical laryngoscope in pediatric
    

Detailed description: 
      The authors are welling to study how intubation will differ if Airtraq optical laryngoscope
      used in pediatrics
    

Intervention name(s): Airtraq; Macintoch
Intervention type(s): Device; Device
Intervention description(s): intubation with airtraq; use Macintoch laryngoscope for intubation
Other intervention name(s): Optical laryngoscope; Standard laryngoscope
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Airtraq; Pediatric
Study in Healthy Volunteers to Investigate the Effects of Rifampin on the Pharmacokinetics of NKTR-118
Condition: Drug Induced Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 1

Summary: 
      Study in healthy volunteers to investigate the effects of Rifampin on the Pharmacokinetics of
      NKTR-118.
    

Detailed description: 
      An Open-label, fixed-sequence, 3-period, 3-treatment, Crossover Study to Assess the Effects
      of Rifampin on Pharmacokinetics of NKTR-118 in Healthy Subjects.
    

Intervention name(s): NKTR-118; Rifampin
Intervention type(s): Drug; Drug
Intervention description(s): Oral 25 mg; Oral 600 mg
Intervention MeSH terms: Rifampin; Naloxegol
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Phase 1; Healthy male and female volunteers; Drug-drug interaction; Pharmacokinetics; NKTR-118; Bioavailability; Plasma AUC and Cmax; Plasma AUC0-t and t1/2λz and tmax
Resynchronization Surgery Combined Unified Efficacy
Condition: Ischemic Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to compare survivability and efficacy of the patients with severe
      ischemic heart failure after coronary artery bypass grafting alone and coronary artery bypass
      grafting with single-step implantation of CRT system (CABG alone vs CABG + CRT )
    


Intervention name(s): Coronary artery bypass grafting; Epicardial implantation of cardiac resynchronization therapy device
Intervention type(s): Procedure; Device
Intervention description(s): Standard coronary surgry according guidelines; During the cardiac surgery, the CABG+CRT arm patients will be implanted with epicardial leads to the right atrium, right and left ventricles. Left ventricle leads will be fixed to the posterolateral wall provided that there is no scar or fat tissue (behind and 2-3 cm apical than obtuse marginal artery). Right atrial and right ventricular leads will be fixed in a traditional way. Then the leads will be guided into a preformed pocket (left subclavian region) and connected with the CRT device.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Resynchronization Therapy
Electroencephalogram (EEG) and Electroconvulsive Therapy(ECT) Response in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Observational

Summary: 
      This study is designed to find quantitative Electroencephalogram(qEEG) biomarkers to predict
      Electroconvulsive Therapy(ECT) Response in Schizophrenia
    

Detailed description: 
      The purpose of this proposal is to explore quantitative Electroencephalogram(qEEG) biomarkers
      that would predict Electroconvulsive Therapy(ECT) Response in Schizophrenia (SZD). The
      investigators will recruit 30 SZD patients who are preparing for ECT treatment and assesse
      psychotic symptoms using Positive and Negative symptom scale(PANSS) before and after
      8-sessions clinical course of ECT treatment. These patients needed ECT treatment are assessed
      by clinicians according to American Psychiatric Association(APA) guidelines. Meanwhile
      resting EEG will be recorded for 10 minutes before the first episode of ECT treatment.
      Decrease of PANSS scores will be calculated after the last session of ECT treatment to
      distinguish responder/non-responder.
    

Intervention name(s): Electroconvulsive therapy(ECT)
Intervention type(s): Procedure
Intervention description(s): Patients recieve 8-sessions ECT treatments and those kinds of drugs they take since they were recruited remain unchanged during this study.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        schizophrenia patients