bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Benzydamine Hydrochloride to Postoperative Sore Throat in Pediatric Patients
Condition: Intubation Complication
MeSH terms: Pharyngitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed to examine the effect of benzydamine hydrochloride to postoperative
      sore throat in pediatric patients. We will spray benzydmaine hydrochloride or normal saline
      at oral cavity and the tip of endotracheal tube, than compare the prevalence of postoperative
      sore throat using smartphone application in pediatric patients.
    

Detailed description: 
      1. postoperative sore throat incidence (over 2) 1; no, 2;mild, 3;moderate, 4;severe

        2. scoring of pain with smartphone application (kids pain scale)

        3. incidence of use of rescue pain killer
    

Intervention name(s): Benzydamine Hydrochloride; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): Benzydamine Hydrochloride application; normal saline application
Other intervention name(s): difflam; ns
Intervention MeSH terms: Benzydamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Omega-3 Supplements to Reduce Antisocial Behaviour in Young Offenders
Condition: Antisocial Behavior
MeSH terms: Antisocial Personality Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The study aims to examine the effects of providing omega-3 supplements on young offenders'
      antisocial behaviour. Participants will be randomized into three groups: (1) Omega-3, (2)
      Placebo and (3) Treatment as Usual. Self report and correctional officer ratings of behaviour
      will be assessed at 0 months (baseline), 3 months (end of supplementation), 6 months and 12
      months. The investigators hypothesize that omega-3 supplementation will reduce antisocial
      behaviour among the young offenders.
    

Detailed description: 
      This study follows up on two prior omega-3 supplementation Randomized Controlled Trial (RCT)
      conducted on young offenders - one in the UK (Gesch et al. 2002) and the Netherlands
      (Zaalberg et al. 2009).
    

Intervention name(s): Omega-3; Placebo; Treatment as Usual
Intervention type(s): Combination Product; Combination Product; Other
Intervention description(s): 1g of omega-3 supplement to be taken per day for a duration of 3 months in the form of a fruit juice drink; Fruit juice drink only; Young Offenders Intervention Programme
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Research on Mechanism of Massage Therapy on Energy Metabolism Disorder of Simple Obesity
Condition: Simple Obesity
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional

Summary: 
      This project is to penetrate and consummate the research mechanism of massage therapy on
      simple obesity. Latest researches indicate that the energy regulation network system of
      hypothalamus and metabolic disorders on adipocyte may be the pathological bases which result
      in obesity. The research group have firstly conducted effect studies of massage therapy on
      model of simple obesity rats and observed some neurobiological mechanism (whole effect
      mechanism), meanwhile, the team have discussed influences on the development of preadipocyte
      and function of endocrine with dynamic mechanical stimulation in vitro (local effect
      mechanism). This research aims at centering on the hypothesis that massage therapy can act on
      energy regulation network system of hypothalamus specifically, thus regulating the energy
      metabolic disorders. Then applying functional magnetic resonance imaging (fMRI) to explore
      whether patients with simple obesity exist abnormality on energy regulation network system of
      hypothalamus, ascertain mechanisms how massage therapy treat energy metabolism disorders of
      simple obesity, deepen mechanism study on how massage therapy prevent and treat obesity and
      enrich the clinical application's scientific connotation that massage therapy treat simple
      obesity.
    

Detailed description: 
      This project will divide in two groups,healthy volunteers and obesity group.Healthy
      volunteers do not accept any treatment while obesity group need accept massage therapy three
      times a week,18 times in total.And two groups will be checked by functional magnetic
      resonance imaging (fMRI), Healthy volunteers for once and obesity group for twice(before
      treatment, obesity group's image of fMRI will compare with Healthy volunteers' and the image
      which is taken after treatment)
    

Intervention name(s): Massage therapy
Intervention type(s): Other
Intervention description(s): Healthy volunteers do not accept treatment, just to be a control group to compare with obesity group
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Massage therapy; Simple obesity; Energy metabolism; Mechanism
Mozzarella Cheese Vitamin D and Bioavailability
Condition: Change in Serum 25 Hydroxyvitamin D Levels
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of heat on the bioavailability of vitamin
      D in industrially fortified mozzarella cheese baked with pizza.
    

Detailed description: 
      With a growing body of evidence, the Institute of Medicine (IOM) conducted a thorough review
      of all available evidence to publish a report on Dietary Reference Intakes (DRIs) for calcium
      and vitamin D. In the absence of adequate sun exposure, acquiring the new RDA of 600-800 IU/d
      for vitamin D through diet alone is difficult. There is a need to increase dietary sources of
      vitamin D for Canadians.

      In a double blind, randomized trial, our objective was to assess the effect of high
      temperature pizza baking on the bioavailability of vitamin D3 fortified Mozzarella cheese. We
      tested the following hypotheses, set a priori: 1) vitamin D3 is bioavailable from pizza baked
      with fortified Mozzarella cheese and heat does not significantly break down vitamin D3; and
      2) the change in serum 25(OH)D (from baseline to 10 wk) will be significantly greater in the
      high-dose vitamin D treated group (28000 IU/wk) compared to the low dose vitamin D-treated
      group (200 IU/wk).
    

Intervention name(s): Vitamin D
Intervention type(s): Dietary Supplement
Intervention description(s): High dose group receive 28000 IU vitamin D once a week Low dose group receive 200 IU vitamin D once a week
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Mozzarella cheese fortification; Bioavailability of Vitamin D
Embryo Developmental Capacity After Egg Banking in an Ovum Donation Program
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 4

Summary: 
      For an efficient "egg banking" system, an equally efficient cryopreservation strategy that
      ensures the viability of the oocytes is required. Very recently, improved and new methods are
      yielding satisfactory results. In particular, vitrification is providing excellent results
      for both survival and clinical outcomes. However, to evaluate the over all out come there are
      other parameters to be considered. In this sense, capacity development of embryos generated
      after oocyte vitrification is a major factor when assessing the viability of vitrified
      oocytes. Accordingly, the evaluation of the capacity of vitrified oocytes to reach the
      blastocyst stage will be highly valuable to fully assess the effectiveness of the "egg
      banking" and its contribution to ovum donation programs.

      The aim of this study is to evaluate the developmental capacity of vitrified oocytes by their
      ability to reach the blastocyst stage. The study includes oocyte donation cycles conducted
      with vitrified versus fresh oocytes.
    


Intervention name(s): IVF; Oocyte Vitrification
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Efficacy and Safety of Twice Daily 60mg AZD9668 in COPD for 12 Weeks in Patients on Background Budesonide/Formoterol
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective is to evaluate the efficacy of AZD9668 compared with placebo in
      symptomatic COPD patients by assessing the effects on lung function and symptoms of COPD
    


Intervention name(s): AZD9668; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2 x 30 mg oral tablets bd for 12 weeks; 2 x matched placebo to oral tablet bd for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic; obstructive; pulmonary; lung; respiratory disease; efficacy; placebo-controlled; COPD; FEV1; St Georges Respiratory Questionnaire
Study of Metabolic Homeostasis in Chinese
Condition: Healthy; Metabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      In this open-label, acute intervention study, we will recruit 120 sex-matched participants
      aged 20-70 years (100 normal or overweight/obese subjects and 20 Mets subjects). They will be
      assigned to one of the six groups according to age, BMI and with and without MetS and have a
      standardized mixed macronutrient tolerance test (MMTT) by orally administered a 400-ml
      beverage (75g glucose, 60g lipid, and 20g protein). Fasting and postprandial blood, and urine
      and fecal samples will be collected. The primary aim is to establish a more comprehensive
      system to quantify different aspects of metabolic health based on fasting and postprandial
      data. The study protocol has been approved by the Ethics Committee of Shanghai Institutes for
      Biological Sciences.
    

Detailed description: 
      The recruited 120 subjects (60 men and 60 women aged 20-70 years) will be recruited according
      to the followings: 1) individuals aged 20-29 years with normal weight (18.5 kg/m2 ≤ BMI < 24
      kg/m2); 2) individuals aged 30-49 years with normal weight; 3) individuals aged 30-49 years
      with overweight/obesity (BMI ≥ 24 kg/m2); 4) individuals aged 50-70 years with normal weight;
      5) individuals aged 50-70 years with overweight/obesity; and 6) individuals aged 30-70 years
      with MetS. A standard questionnaire will be use to collect Information like lifestyle
      factors, nighttime sleep duration; anthropometric measurements will be performed. Blood
      samples will be collected via a catheter at fasting state (t = 0 min) and 5 successive time
      points post-MMTT (t = 30, 60, 120, 180 and 240 min). At t = 0 ,1 and 2 h, the fingertip blood
      will be collected as well. Body composition will be measured by dual energy x-ray
      absorptiometry (DXA). All these samples will be used to the assessment of blood chemistry,
      metabolomics, single nucleotide polymorphism (SNP), gut microbiota etc.
    

Intervention name(s): Standard mixed macronutrients tolerance test
Intervention type(s): Other
Intervention description(s): Consumption a standard mixture containing 75g glucose, 60g fat and 20 protein.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Metabolic health; MMTT; Resilience
A Study to Investigate the Effect of Mild and Moderate Hepatic Impairment on the Safety and Tolerability of Fezolinetant Compared to Participants With Normal Hepatic Function
Condition: Hepatic Impairment; Healthy Volunteers
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics of a single oral dose of
      fezolinetant and ES259564 (fezolinetant metabolite) in female participants with mild and
      moderate hepatic impairment compared to healthy female participants with normal hepatic
      function.

      This study will also evaluate the safety and tolerability of a single oral dose of
      fezolinetant in female participants with mild and moderate hepatic impairment and healthy
      female participants with normal hepatic function.
    

Detailed description: 
      The study will comprise of three groups based on hepatic function. Participants will be
      screened for up to 28 days prior to investigational product (IP) administration on Day 1.
      Eligible participants will be admitted to the clinical unit on Day -1 and will be residential
      for a single period of six days/five nights. On Day 1, participants will receive a single
      oral dose of fezolinetant under fasting conditions followed by a 96-hour in-house blood and
      urine sampling period. Participants are to remain semirecumbent for four hours postdose.
      Standard safety and tolerability assessments will be conducted. Participants will be
      discharged from the clinical unit on Day 5 on the condition that all required assessments
      have been performed and that there are no medical reasons for a longer stay in the clinical
      unit.

      The study will be completed with an end-of-study visit (ESV). The ESV will take place five to
      nine days after the last pharmacokinetic sample is collected or at the time of early
      discontinuation from the study.
    

Intervention name(s): fezolinetant
Intervention type(s): Drug
Intervention description(s): Oral
Other intervention name(s): ESN364
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ES259564; Pharmacokinetics; fezolinetant; Healthy Volunteers; Hepatic Impairment
High-activity Natural Killer Immunotherapy for Small Metastases of Tongue Cancer
Condition: Tongue Cancer
MeSH terms: Tongue Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is the safety and efficacy of high-activity natural killer
      immunotherapy to small metastases of tongue cancer.
    

Detailed description: 
      By enrolling patients with small metastases of tongue cancer adapted to enrolled criteria,
      this study will document for the first time the safety and the short and long term efficacy
      of high-activity natural killer cells.

      The safety will be evaluated by statistics of adverse reactions. The efficacy will be
      evaluated according to local relief degree, progress free survival (PFS) and overall survival
      (OS).
    

Intervention name(s): High-activity natural killer
Intervention type(s): Biological
Intervention description(s): Each treatment: 8-10 billion cells in all, transfuion in 3 times, i.v.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metastatic tongue cancer; High-activity natural killer
Buzzy Distraction During Venipuncture
Condition: Pain Relief
Study type: Interventional

Summary: 
      Venipuncture is one of the most common iatrogenic painful and stressful procedures performed
      on children. Interventions aimed at reducing the distress related to this experience are
      widely and strongly recommended. Pain and anxiety management is even more essential because
      it may modify children's memory for procedural pain and the subsequent acceptance of later
      health care painful interventions. Distraction is the most studied psychological technique to
      relieve venipuncture related pain and distress, with a strong evidence supporting its
      efficacy in children and adolescents.

      In recent years several studies showed the effectiveness of a specific tool named Buzzy® (MMJ
      Labs, Atlanta GA, USA), in relieving pain and distress in children. Buzzy combines
      distraction and physical analgesia (vibration and cold) and it was positively tested during
      venipuncture, intravenous cannulation and painful injections in children. Even though its
      efficacy it's well established, most of the published trials did not compare Buzzy with other
      interventions, so that little data are available about its usefulness compared with other
      distractions techniques.

      Hand-held computers are reusable tools, which offer a technological-based active distraction.
      There is evidence supporting their used during painful procedures such as venipuncture and a
      recent published study showed that hand-held computer distraction was as effective as
      nurse-led passive distraction techniques in children.

      The aim of this study is to compare the effectiveness of Buzzy versus hand-held computer in
      pain relief during venipuncture.
    


Intervention name(s): Buzzy® device; Hand-held computer
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Procedural pain; Phlebotomy; Distraction; Hand-held computer; Children
Sutureless Versus Conventional Thyroidectomy
Condition: Goiter
MeSH terms: Goiter
Study type: Interventional

Summary: 
      This study was prospective randomized double-blinded clinical trial on patients with thyroid
      disease who underwent thyroidectomy in the general surgery department, Mansoura university
      hospitals during the period of February 2017 to February 2018.Two techniques for vascular
      sealing were compared: conventional tying and harmonic scalpel
    


Intervention name(s): Conventional thyroidectomy; Harmonic scalpel thyroidectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Thyroid vessels are ligated with sutures and divided; Thyroid vessels are sealed using harmonic scalpel device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluate Retention of an Orally Administered Device Using Gamma Scintigraphy
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Single usage, open label study in 16 adult healthy males. Eligible subjects will receive a
      single usage of the investigational device. Retention of the radiolabeled device will be
      monitored using gamma scintigraphy.
    


Intervention name(s): Polymer based lubricating liquid
Intervention type(s): Device
Intervention description(s): three sprays of radiolabeled polymer blend of carboxymethylcellulose, polyoxyl 40 stearate, and polyethylene oxide that coats and protects the mucus membrane
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Randomized Placebo-Controlled Study of the Neurokinin-1 (NK1) Receptor Antagonist Serlopitant Prurigo Nodularis (PN)
Condition: Prurigo Nodularis
MeSH terms: Prurigo; Neurodermatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to demonstrate whether or not VPD-737, an NK1 receptor
      antagonist is safe and effective for treatment of prurigo nodularis versus placebo.
    

Detailed description: 
      The sensation of itch is transmitted to the brain through the nervous system. Several
      chemicals are involved in transmitting this signal.This trial of VPD 737 is intended to treat
      this condition by blocking one of the chemicals involved in the transmission of the itch
      signal. This is an oral drug administered once daily It has been used in other trials and has
      shown to be safe at the doses used in this trial. The trial will involve once daily pills for
      8 weeks. Subject will be asked to fill out questionnaires both electronically and on paper
      during the study period. Patients will also be monitored for safety and will have blood taken
      for testing and several points during the trial. Overall participation will last about 14
      weeks
    

Intervention name(s): serlopitant; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): NK1 receptor antagonist; Placebo
Other intervention name(s): VPD-737
Intervention MeSH terms: Serlopitant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Prurigo Nodularis; Atopic Dermatitis; Lichen-simplex chronicus
The Effect of Lovastatin Gel in the Treatment of Chronic Periodontitis
Condition: Alveolar Bone Loss, Chronic Periodontitis, Lovestatin Gel, Regeneration
MeSH terms: Alveolar Bone Loss; Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Aim: dis double-blind split-mouth clinical trial study was performed to evaluate teh clinical
      and radiographic effect of local delivery of lovastatin gel as an adjunct to scaling and root
      planning (SRP) in teh treatment of chronic periodontitis.

      Method and Materials: 15 patients with two mandibular molar teeth with probing depth (PD)≥3
      mm, clinical attachment level (CAL)≥3 mm and bone loss more than 3 mm according to parallel
      periapical x-ray and distance from CEJ to alveolar crest, were selected.Totally 24 mandibular
      molars were selected for teh study.

      Clinical periodontal parameters included PD, CAL, bleeding index(BI), plaque index(PI) were
      recorded for teh selected teeth at baseline and at 1,3 and 6 months. Radiographic assessments
      were performed at baseline and after 6 months. At one side teh pockets around randomly
      selected molar were injected with a blunt syringe filled with lovastatin gel 1.2%( case
      group=B), and on teh other side, teh pockets were filled with a placebo gel by a blunt
      syringe ( control group=A).Two-way repeated measure ANOVA test and T-test were used for
      statistic analysis Spss 23.( P<0.05) was considered significant.
    

Detailed description: 
      Statins are an important group of hypolipidemic drugs dat are able to modulate inflammation
      and alveolar bone loss. Rosuvastatin (RSV) and atorvastatin (ATV) are non to inhibit
      osteoclastic bone resorption and has been proposed to has osteostimulative properties.
    

Intervention name(s): Lovastatin gel; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Lovastatin gel1.2% topical gel was put into teh periodontal pocket using an insulin syringe; placebo gel
Other intervention name(s): Group A
Intervention MeSH terms: Lovastatin; L 647318; Dihydromevinolin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment