bioihbjkbjnl/mcl2 huggingface dataset:
To Evaluate the Immunogenicity and Safety of Inactivated Hepatitis A Vaccine
Condition: Hepatitis A Vaccine
MeSH terms: Hepatitis A; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the immunogenicity and safety after one primary dose
      and one additional dose of inactivated hepatitis A vaccine are administered in Korean healthy
      children aged 12-23 months.
    

Detailed description: 
      The objective of this study is to evaluate the immunogenicity and safety after one primary
      dose and one additional dose (administered twice in total at an interval of 6 months) of
      inactivated hepatitis A vaccine are administered in Korean healthy children aged 12-23
      months.

      For this, a two-group comparison study will be conducted using a previously approved
      inactivated hepatitis A vaccine (Havrix Inj., manufactured by GSK) as the control vaccine to
      prove that the immunogenicity of the test vaccine treatment group is not inferior to the
      control vaccine treatment group and to statistically confirm that there is no difference in
      safety.
    

Intervention name(s): Inactivated hepatitis A vaccine; Havrix Inj
Intervention type(s): Biological; Biological
Intervention description(s): Inactivated hepatitis A virus antigen 250 U (Name of viral strain: TZ84); 720 ELISA/0.5 mL Junior (Inactivated hepatitis A virus antigen 160 U (Name of viral strain: HM175 Inj)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Hepatitis A vaccine
Immediate Response With Adalimumab and Its Impact on Quality of Life and Other Comorbidity Factors in Patients With Moderate to Severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 4

Summary: 
      W11-050 is a Mexican open label multicenter study that has been designed to further assess
      the safety and efficacy of adalimumab in the treatment of patients with active plaque
      psoriasis who have failed prior conventional systemic psoriasis treatment or who are
      candidates for systemic therapy.
    

Detailed description: 
      Up to 150 subjects having a diagnosis of active plaque psoriasis and fulfilling the study
      eligibility criteria were enrolled in Mexico. Adalimumab was administered as follows: 80 mg
      at baseline, followed by 40 mg every other week (eow; starting at week 1 until week 15). The
      study drug was self administered via subcutaneous (sc) injection. Safety and efficacy
      measures were performed throughout the study.
    

Intervention name(s): Adalimumab
Intervention type(s): Biological
Intervention description(s): Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
Other intervention name(s): ABT-D2E7; Humira
Intervention MeSH terms: Adalimumab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Humira; Adalimumab; Plaque Psoriasis
Treatment of Advanced Periodontitis Using an Oscillating Chitosan Device Versus Regular Curettes Alone
Condition: Periodontal Diseases
MeSH terms: Periodontitis; Periodontal Diseases
Study type: Interventional

Summary: 
      40 patients diagnosed with localised periodontitis will be included at each center, 20
      patients will be treated with the control treatment, 20 patients will be treated by test
      treatment.
    

Detailed description: 
      2.3 This will be a prospective multicentre parallel arm randomized clinical trial of 6
      months' duration. Clinical parameters of periodontal disease will be recorded at baseline and
      at 6 months. Radiographs will be taken at baseline and at 6 months.Treatment will be
      performed at baseline and thereafter every three months.

      2.5 Study setting Patient screening, inclusions and all clinical examinations will be
      performed by a board-certified specialist in periodontology at the test centres. Treatment
      will be performed by a registered separate therapist, either dentist or dental hygienist.

      2.7 Treatment allocation Patients will be allocated to one of the following treatments:
      control (curettes+ ultrasound scaler (USS) supra and subgingivally), test (curettes + USS
      supra and chitosan brush in oscillating handpiece subgingivally) by computer-generated block
      randomization to ensure equal sample sizes.
    

Intervention name(s): Labrida Bioclean; Gracey Periodontal curettes
Intervention type(s): Device; Device
Intervention description(s): The brush bristles of the test device (Labrida BioClean®, LABRIDA, Oslo, Norway) are made of the biopolymer chitosan; Regular commercially available area specific and medical grade steel Gracey periodontal curettes
Other intervention name(s): Gracey Periodontal curettes
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Absorption, Metabolism and Excretion (AME) of Single Dose Radiolabeled Prucalopride Succinate in Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase I study to evaluate the excretion of radioactivity, the metabolic profile,
      pharmacokinetics, safety and tolerability following a single oral administration of [14C]
      Prucalopride Succinate in healthy male volunteers aged 18 to 50 years (inclusive).The purpose
      of this study is to investigate how and how quickly Prucalopride Succinate or its break down
      products are excreted by analysing blood, faeces and urine samples collected during the
      study.
    


Intervention name(s): Radiolabeled Prucalopride Succinate
Intervention type(s): Drug
Intervention description(s): A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
Intervention MeSH terms: Prucalopride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
A Study of Single Dose Inclacumab in Japanese Healthy Volunteers Compared to Caucasian Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label, parallel group study will evaluate the safety, tolerability,
      pharmacokinetics and pharmacodynamics of single doses of inclacumab in Japanese healthy
      volunteers compared to Caucasian healthy volunteers. Subjects will receive a single
      intravenous dose of inclacumab. Follow-up will be for up to 197 days.
    


Intervention name(s): inclacumab
Intervention type(s): Drug
Intervention description(s): single intravenous doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Evaluation of the Accuracy and Reliability of the Percentage of Glottic Opening Score
Condition: Intubation
Study type: Interventional

Summary: 
      Current classifications of the laryngeal view during laryngoscopy are criticized for being
      subjective.

      The modified CL classification is criticized as it does not predict difficult intubation and
      especially grade 2 is operator dependent and partial view is not well defined. The numerical
      expression of the percentage of the glottic aperture (POGO = percentile of glottic opening)
      is another score. In this score, A POGO score of 100% accounts for full visualization of the
      larynx starting from anterior commissure to the posterior cartilage, while 0% indicated a
      complete absence of glottic opening. Previous validation studies reported on the reliability
      of POGO; however, accuracy was not evaluated.

      The use of a standard and effective classification method will facilitate and accelerate
      communication between anesthetists in difficult life-threatening situations such as difficult
      airway / difficult intubation / difficult ventilation and contribute to patient safety. The
      use of common terminology can also facilitate the evaluation of the performance of intubation
      tools. The aim of this study was to evaluate the accuracy and intra and inter rater
      reliability of the POGO score
    

Detailed description: 
      Reviewer anesthesiologist will be asked to score still images of laryngeal views, which will
      be obtained from patients requiring intubation for general anesthesia, after obtaining
      written informed consent. The images of the larynx will be captured first with the Macintosh
      blade and thereafter with the D blade. An expert panel will score these images with the
      Cormack Lehane and POGO scores. The set of images will be prepared from patients with both
      difficult and normal airway anatomy. Some images in the series will be repeated to assess
      intra rater variability. The anesthesiologist will be asked to rate 20 images both with the
      CL and POGO scores. The experience of the raters in airway management, their experience with
      videolaryngoscopy and scoring systems used currently when documenting videolaryngoscopy and
      demographic data will be also obtained. The POGO scores of the participants and investigators
      will be compared. The primary outcome measure was the reviewer's agreement with the correct
      POGO scores (accuracy).
    

Intervention name(s): Videolaryngoscopy
Intervention type(s): Other
Intervention description(s): Patient will be intubated by using videolaryngoscope
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Intubation; Laryngeal view; Scoring systems; Larynx
Pictorial Representation of Illness and Self Measure
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      PRISM (Pictorial Representation of Illness and Self Measure) has been developed since the
      mid-1990s; the task was first developed as a simple measure of how a person was coping with
      his or her experience of illness. This is an international, multicentre study to evaluate the
      PRISM tool for the assessment of suffering in rheumatoid arthritis at different stages of the
      illness and the effect of treatment intervention. There are 5 sites: Berlin, Oxford, Limoges,
      Montreal and Queensland. The study will recruit 200 patients in total.

      In addition to the procedures for the patient's routine clinical visit, the patients will be
      invited to answer a series of questionnaires and donate 20ml blood sample. Patients will be
      asked to attend 3 times over 24 weeks
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with rheumatoid arthritis from hospital clinics
Assessment of Relation Between Recurrence of Enterocutaneous Fistula and Preoperative C-reactive Protein Level After Complete Surgical Repair
Condition: Enterocutaneous Fistula
MeSH terms: Intestinal Fistula; Recurrence; Fistula
Study type: Interventional

Summary: 
      A prospective study of 40 patients admitted with the diagnosis of enterocutaneous fistula and
      prepared for definite surgical repair in the form of resection anastomosis of ECF. The
      investigators used preoperative serum C-reactive protein as predicting factor to recurrence
      and independent variable for timing of surgery.
    

Detailed description: 
      There is a controversy in timing of operation. The timing depends on clinical assessment,
      laboratory tests and radiological investigations. The cornerstone of this decision is to
      control sepsis and inflammatory condition before surgery. This issue made surgeons favor
      longer interval between incidence of ECF and definite surgical treatment. In some cases there
      may be a hidden place for infection or continuation of the inflammatory situation without
      clear signs, which necessitated the presence of a possible indicator helps in making the
      surgical decision. Serum C-reactive protein is the common inflammatory marker used to exclude
      inflammatory condition. Although its level is within normal range but some cases showed high
      recurrence rate when the level exceeded certain as the investigators believed in their study.
      Now the investigators can say that the perioperative serum C-reactive protein level can be
      used as an objective parameter for helping to make surgical decision and reduce recurrence of
      ECF.
    

Intervention name(s): serum C-reactive protein
Intervention type(s): Diagnostic Test
Intervention model: Single Group Assignment
Intervention model description: A prospective study of 40 patients admitted with the diagnosis of enterocutaneous fistula and prepared for definite surgical repair in the form of resection anastomosis of ECF. the investigators used preoperative serum C-reactive protein as predicting factor to recurrence and independent variable for timing of surgery.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: enterocutaneous fistula - C-reactive protein- surgical repair
Preoperative Chemoradiation for Glioblastoma
Condition: Glioblastoma
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 1

Summary: 
      Trial to determine the safety of neoadjuvant treatment with concurrent temozolomide and
      radiation therapy, followed by surgery and then further temozolomide.
    

Detailed description: 
      Prior to any definitive treatment and after enrollment, the patient will undergo stereotactic
      biopsy of the lesion to confirm the histology of the lesion and to determine methylated
      methylguanine methyltransferase (MGMT) status. Standard image-guided stereotactic technique
      will be used. Patients will be treated with conformal radiation therapy. Temozolomide will be
      given from the day prior to radiation therapy through the last day of radiation therapy. 4-6
      weeks after radiation therapy the patient will undergo craniotomy and maximal safe resection.
      Temozolomide will continue beginning 4 weeks after surgery.

      Imaging:

      MRI within 2 weeks prior to the start of the protocol. MRI at 4 weeks after chemoradiation
      therapy and prior to surgery. MRI within 48 hours after surgery.

      MRI after every 2 cycles of chemotherapy and then every 2 months until progression, up to 2
      years.
    

Intervention name(s): Temozolomide; partial brain irradiation; stereotactic biopsy of brain tumor; craniotomy and tumor resection
Intervention type(s): Drug; Radiation; Procedure; Procedure
Intervention description(s): Neoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further temozolomide.; Neoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further temozolomide.; will be assessed for tumor type and tumor markers; maximal safe resection
Other intervention name(s): Temodar
Intervention MeSH terms: Temozolomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: glioblastoma; temozolomide; radiation therapy; radiotherapy; surgery; pre-operative; neoadjuvant
Predictive Factors for Hypotensive Bradycardic Events During Arthroscopic Shoulder Surgery
Condition: Syncope, Vasovagal
MeSH terms: Syncope; Syncope, Vasovagal
Study type: Observational

Summary: 
      Patients's demographics and perioperative factors affect the occurrence of hypotensive
      bradycardic events in the patients undergoing arthroscopic shoulder surgery in the sitting
      position under interscalene block.
    

Detailed description: 
      Patients' age, Side of the block,Horner's syndrome, the degree of blockade, preoperative
      fasting time and fluid administration volume, waiting time for sitting position after the
      block, intraoperative use of opioids and antihypertensives, and change of heart rate
      variability before the block and after sitting position affect the occurrence of hypotensive
      bradycardic events in the patients undergoing arthroscopic shoulder surgery in the sitting
      position under interscalene block.
    

Intervention name(s): Interscalene brachial plexus block
Intervention type(s): Other
Intervention description(s): After sterile draping around interscalene groove with povidone, a nerve stimulating needle connected to a nerve stimulator is inserted through the interscalene groove. Following involuntary contraction of shoulder, arm, forearm, or hand muscles with 0.5 milliamperes at 1 Hz using the nerve stimulator, 30 to 40 ml of mixture of 1% mepivacaine 20 ml and 0.75% ropivacaine 20 ml are injected.
Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients who are scheduled to receive elective shoulder arthroscopic surgery in the sitting
        position under interscalene brachial plexus block
      
Keywords: Hypotensive bradycardic event; Interscalene brachial plexus block; Sitting position; Shoulder arthroscopic surgery
Physical Therapy Using Virtual Reality/Augmented Reality
Condition: Mobility Limitation; Spinal Fusion; Acute Pain
MeSH terms: Acute Pain; Mobility Limitation
Study type: Interventional

Summary: 
      The purpose of this study is to determine if non-invasive distracting devices (Virtual
      Reality (VR) headset, Augmented Reality (AR) Headset) are more effective than the standard of
      care (i.e., no technology-based distraction) for improving clinical outcomes in patients
      requiring acute rehabilitation due to deconditioning and surgery. Measures will include
      include range of motion, gait progression, strength progression, time to first out of bed,
      time to first step.
    


Intervention name(s): Virtual Reality/Augmented Reality Headset
Intervention type(s): Other
Intervention description(s): A virtual reality (VR) headset is a device the participant will wear over his/her head and eyes like a pair of goggles. It blocks out all external light and shows him/her an image on high-definition screens in front of his/hers eyes. It implies a complete immersion experience that shuts out the physical world.
Augmented reality (AR) headset is a device that the participant will wear over his/hers head and eyes and it adds digital elements to a live view.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: virtual reality; augmented reality; physical therapy; deconditioning
The Influence of Sweet Substrates on Hunger, Gastrointestinal Hormones and the Migrating Motor Complex
Condition: Healthy
Study type: Interventional

Summary: 
      In this study, the investigators aimed at evaluating the role of sweet taste receptors in the
      gastrointestinal tract (GIT). Intragastric administration of glucose, fructose or
      acesulfame-K were compared with placebo administration for their effects on gastrointestinal
      motility, gut hormone release (motilin, ghrelin, glucagon-like peptide-1 (GLP-1) and insulin)
      and hunger feelings.
    


Intervention name(s): 50g glucose; 25g fructose; 220mg acesulfame-K; 250mL tap water
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Short-term Effects of Aromatase Inhibition in Obese Men
Condition: Hypogonadotrophic Hypogonadism; Obesity
MeSH terms: Hypogonadism
Study type: Interventional
Phase: Phase 3

Summary: 
      In this study, 50 obese men with a hormonal imbalance will be treated with letrozole or
      placebo for six months in order to examine the effects on the hormonal balance, and on weight
      loss. The study will also address the side effects and psychological effects of letrozole as
      compared to placebo.
    

Detailed description: 
      The aim of the study is to establish the short-term efficacy and safety of aromatase
      inhibition in restoring and maintaining eugonadism in hypogonadotrophic hypogonadal men.
      Secondary aim is to detect the short-term somatic and psychological effects.

      Study design: Double blind randomized placebo-controlled trial.

      Treatment: 26 weeks of either letrozole or placebo. All patients will start on 1 tablet per
      week, dose adjustments will be performed if serum testosterone or estradiol are outside the
      target range. All men will be prescribed a mildly hypocaloric diet.

      Endpoints: BMI, body weight, waist circumference, body composition, exercise capacity, serum
      levels of several hormone markers, glucose tolerance, psychological characteristics.

      All patients will be measured 6 times during the study.
    

Intervention name(s): Letrozole (Femara)
Intervention type(s): Drug
Intervention MeSH terms: Letrozole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: obesity; Hypogonadotrophic hypogonadism; aromatase inhibition
Influence of the Noradrenergic System on the Formation of Intrusive Memories
Condition: Intrusive Memories
Study type: Interventional

Summary: 
      Intrusive memories of traumatic events are core features of posttraumatic stress disorder
      (PTSD) but little is known about the neurobiological formation of intrusions. The aim of this
      study was to determine whether the activity of the noradrenergic system during an
      intrusion-inducing stressor influences subsequent intrusive memories.
    

Detailed description: 
      The investigators conducted an experimental, double-blind, placebo-controlled study in 118
      healthy women. Prior to watching an established trauma film paradigm that induces short
      lasting intrusions, participants received a single dose of either 10 mg yohimbine,
      stimulating noradrenergic activity, or 0.15 mg clonidine, inhibiting noradrenergic activity,
      or placebo. The number of consecutive intrusions of the trauma film, the mean vividness of
      the intrusions and the mean degree of distress evoked by the intrusions were assessed during
      the following four days. Salivary cortisol and alpha-amylase were collected at seven time
      points prior to, and after the trauma film.
    

Intervention name(s): Stress Film; Yohimbine; Clonidine; placebo
Intervention type(s): Behavioral; Drug; Drug; Drug
Intervention MeSH terms: Clonidine; Yohimbine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
NPC Study : TAX + CIS Neoadjuvant in Patients With Loco Regionally Advanced Undifferentiated Carcinoma of Nasopharyngeal Type (UCNT)
Condition: Head and Neck Neoplasms
MeSH terms: Carcinoma; Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Primary Objective:

      To estimate the overall response rate after neo-adjuvant chemotherapy of Docetaxel 75 mg/m2
      in combination with Cisplatin 75 mg/m2 given for 3 cycles, and followed by conventional
      radiotherapy in UCNT.

      Secondary Objectives:

      To evaluate:

        -  The radiological response after chemotherapy and radiotherapy

        -  The pathological response after chemotherapy by cavum biopsy

      To estimate:

        -  The duration of overall response

        -  The time to progression (T.T.P)

      To analyze:

        -  The overall survival

        -  The safety profile
    


Intervention name(s): DOCETAXEL(XRP6976)
Intervention type(s): Drug
Intervention description(s): docetaxel 75mg/m2 by intravenous infusion over 60 minutes on Day 1 of a 3-week cycle
Intervention MeSH terms: Docetaxel
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment