bioihbjkbjnl/mcl2 huggingface dataset:
Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine Versus a Licensed Comparator in Children
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the immunogenicity and the safety of GlaxoSmithKline
      Biologicals' seasonal influenza vaccine, Fluarix, compared to Fluzone (a US-licensed vaccine)
      in children, 6 to 35 months of age.
    


Intervention name(s): Fluarix; Fluzone
Intervention type(s): Biological; Biological
Intervention description(s): One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection. Two different doses are tested.; One (Day 0) or two (Day 0 and Day 28) doses by intramuscular injection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Effectiveness of Distraction Techniques on Pain Intensity During Immunization Among Infants
Condition: Pain
MeSH terms: Pain
Study type: Interventional

Summary: 
      A study to assess and compare the effectiveness of Distraction techniques on Pain intensity
      during Immunization among Infants in selected hospital of Ambala, Haryana.
    

Detailed description: 
      Immunization is an important part of public health intervention and cost effective strategy
      to control the infectious diseases especially in children and it is one of the most common
      painful procedure in infants. Pain during immunization leads to distressing experience for
      the infant, parents and health care worker. Distraction is non pharmacological method which
      is used for diverting attention from noxious stimulus by passively redirecting the attention
      or by actively performed by the subject in the performance of diversion technique. Aim and
      objectives:The aim of present study was to compare the effectiveness of distraction
      techniques on pain intensity during immunization among infants. The objectives of the study
      were to assess and compare the mean pain scores among infants receiving immunization in
      electronic toy group, key toy group, simple toy group and control group and to find out the
      association of pain scores among infants receiving immunization with their selected
      variables. Material and methods: A true experimental multiple intervention post test control
      design was used. There were 100 infants selected using simple random sampling technique and
      were randomly allocated in various groups such as electronic toy group, key toy group, simple
      toy group and control group using lottery method. During immunization, distraction techniques
      were shown to experimental groups and routine care was given to control group. Research tool
      was submitted to 7 experts from various specialists for validity. Reliability was calculated
      by Kappa method and it was 0.83 of FLACC pain scale to assess pain intensity during
      immunization among infants. Data collection was done in January 2017. The obtained data was
      analyzed and interpreted in terms of objectives and research hypotheses. Analysis was done by
      using descriptive and inferential statistics.
    

Intervention name(s): Distraction technique
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluate the Efficacy and Safety of Boroda Supramolecular Active Zinc in the Treatment of Scalp Psoriasis
Condition: Scalp Psoriasis
MeSH terms: Psoriasis
Study type: Interventional

Summary: 
      A multicenter, randomized, single-blind, parallel-controlled clinical study to evaluate the
      efficacy and safety of boroda supramolecular active zinc in the treatment of scalp psoriasis.

      Main objective:：Compare the efficacy of boroda supramolecular active zinc and capotetriol
      liniment in the treatment of scalp psoriasis Secondary objective: To observe the safety of
      boroda supramolecular active zinc in the treatment of subjects with scalp psoriasis
    


Intervention name(s): Boleda Supramolecular Active Zinc Conditioner; Capotetriol scalp solution; Supramolecular Hydrogel
Intervention type(s): Other; Drug; Other
Intervention description(s): Boleda Supramolecular Active Zinc Conditioner (Shanghai Ruizhi Pharmaceutical Technology Co., Ltd.): 30ml/bottle. Once a day for 4 weeks, apply topically to the scalp psoriasis area, gently massage for 15 minutes then rinse off with warm water.; Capotetriol scalp solution: 30ml/bottle. Two times a day for 4 weeks, topically applied to scalp psoriasis.; Supramolecular Hydrogel (Shanghai Ruizhi Pharmaceutical Technology Co., Ltd.): 30ml/bottle. Once a day for 4 weeks, apply topically to the scalp psoriasis area, gently massage for 15 minutes then rinse off with warm water.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
CytoSorb Reduction of Free Hemoglobin During Cardiac Surgery
Condition: Elective Cardiac Surgery
Study type: Interventional

Summary: 
      Prospective, multi-center, randomized, feasibility clinical study. Subjects will be
      randomized in a 1:1 ratio to either standard of care (SOC) alone or standard of care and
      treatment with the CytoSorb® device.
    


Intervention name(s): CytoSorb
Intervention type(s): Device
Intervention description(s): Cytosorb device use during cardiopulmonary bypass
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CytoSorb device; Plasma free hemoglobin; inflammation; extracorporeal bypass
Non-invasive Rapid Assessment of NAFLD Using Magnetic Resonance Imaging With LiverMultiScan
Condition: NASH - Nonalcoholic Steatohepatitis; NAFLD; Metabolic Syndrome
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease; Metabolic Syndrome
Study type: Interventional

Summary: 
      A multi-centre randomised controlled trial to determine the implementation and health care
      cost of LiverMultiScan vs. routine methodical assessment (standard care) of Non-alcoholic
      fatty liver disease (NAFLD) across several European countries.
    

Detailed description: 
      Non-alcoholic fatty liver disease (NAFLD) is a condition associated with obesity, insulin
      resistance and heart disease. Research has shown that fatty liver (steatosis) can lead to a
      spectrum of diseases including low grade inflammation (steatohepatitis or non-alcoholic
      steatohepatitis (NASH)), cirrhosis or liver failure.

      The current method used to diagnose liver dysfunction and failure is with percutaneous liver
      biopsy. This is painful and is not without risk, as the liver is a highly vascular organ.
      Even with ultrasound guidance, it carries a 1:1000 risk of serious adverse events (e.g.
      bleeding, infection, bowel perforation). As a result of these factors, liver biopsy is not
      used in all patients with suspected NAFLD/ NASH unless moderate to severe liver disease is
      presented or other liver disease need to be excluded. Various diagnostic pathways have
      arisen, but in the absence of a clearly non-invasive discriminatory test that can stratify
      normal liver, simple steatosis, steatohepatitis and cirrhosis, there is no standardised
      pathway.

      LiverMultiScan has been tested against liver biopsy and has been shown to be the first
      imaging test that can identify early liver disease and predict clinical outcomes accurately.
      LiverMultiScan has recently been CE-Marked and FDA-cleared, so is available for clinical use,
      but as a new test, it is not yet widely established in clinical practice. This study will
      utilise LiverMultiScan and see if it can be the basis of a viable diagnostic pathway in EU
      healthcare systems by adopting it in different EU countries, and determining the economic
      costs and benefits.
    

Intervention name(s): LiverMultiScan
Intervention type(s): Diagnostic Test
Intervention description(s): LiverMultiScan is an imaging technique which is able to identify early liver disease.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Examining the Impact of School-based Dental Screening
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      This study examines the effectiveness of school dental screening in promoting dental
      attendance and reducing untreated caries among primary schoolchildren in Riyadh, Saudi
      Arabia.
    

Detailed description: 
      Background: Dental caries is one of the most common diseases affecting children in Saudi
      Arabia despite the availability of free dental services. School-based dental screening could
      be a potential intervention that might impact uptake of service and subsequently dental
      caries.

      Aim: To examine the effectiveness of school dental screening in promoting dental attendance
      and reducing untreated caries among primary schoolchildren in Riyadh, Saudi Arabia.

      Methods: This is a cluster randomized controlled trial comparing referral of
      screened-positive children to a specific treatment facility (King Saud University Dental
      College Hospital) against the current practice (information letter advising parents to take
      their child to a dentist). A total of 1000 children in 12 schools will be recruited. Schools
      (clusters) will be randomly selected and allocated to either group using computer software.
      Clinical assessment for dental caries will be conducted at baseline and after 12 months by
      dentists using the World Health Organisation (WHO) criteria. Different clinical teams will be
      used for each trial group to ensure blinded outcome assessment. Data on socio-demographic,
      behavioural and dental visits will be collected at baseline and follow-up. Outcome measures
      will be the change in number of decayed teeth and the number of dental visits over 12 months.

      Discussion: This project will use a robust design to provide high level of evidence on the
      clinical benefits of school dental screening. The findings will potentially inform policies
      related to the continuation/ implementation of school-based dental screening in Saudi Arabia.
    

Intervention name(s): Referred to a specific hospital for treatment
Intervention type(s): Other
Intervention description(s): To King Saud University Dental College, treatment will be provided free of charge to the referred participants.
Other intervention name(s): Interventional group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Screening
Keywords: Dental visits; School-based program; Dental screening; Dental Caries
Role of Melatonin Supplementation in Follicular Fluid of in Vitro Fertilization (IVF) Patients With Polycystic Ovarian Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the effects of melatonin supplementation on the main in vitro fertilization (IVF)
      outcomes during ovarian stimulation in patients with Polycystic ovarian syndrome (PCOS).
    

Detailed description: 
      Polycystic ovarian syndrome (PCOS) is a common endocrine disorder that causes infertility due
      to anovulation in women of reproductive age. Anovulation and also decreased oocyte and embryo
      quality may be cause of infertility in women with PCOS. Furthermore, the reactive oxygen
      species (ROS) induce oxidative stress which may be responsible for poor oocyte quality. The
      ROS generation from mononuclear cells is elevated in women with PCOS and a significant
      increment of lipid peroxidation products in women with PCOS has been reported.

      Melatonin is a documented powerful free radical scavenger and a broad spectrum antioxidant.
      It has been observed that a non-PCOS group co-treated with inositol, folic acid, and
      melatonin (Inofolic Plus by LO.LI.Pharma) results in a significantly greater mean number of
      mature oocytes, and a lower mean number of immature oocytes in patients with low oocyte
      quality history when compared to treatment only with inositol and folic acid (Inofolic by
      LO.LI.Pharma).

      The aim of the study is to evaluate the possible effects of melatonin supplementation on the
      main IVF outcomes during ovarian stimulation of patients with PCOS.

      From July 2009 to December 2011, 358 patients with PCOS (Rotterdam criteria) were enrolled in
      this prospective randomized controlled trial.
    

Intervention name(s): Myo-inositol + folic acid + melatonin; Myo-inositol + folic acid
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Myo-inositol (2000mg)+ folic acid (200 mcg)+ melatonin(3 mg); Myo-inositol (2000mg) + folic acid (200 mcg)
Intervention MeSH terms: Folic Acid; Vitamin B Complex; Inositol; Melatonin
Keywords: intrafollicular melatonin; PCOS; embryos quality; oocytes quality
Safety, Tolerability, and Efficacy of Cariprazine in Participants With Bipolar Depression
Condition: Depression, Bipolar
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study was to evaluate the efficacy, safety, and tolerability of
      cariprazine relative to placebo for the treatment of participants with bipolar depression.
    


Intervention name(s): Placebo; Cariprazine
Intervention type(s): Drug; Drug
Intervention description(s): Placebo was supplied in capsules.; Cariprazine was supplied in capsules.
Intervention MeSH terms: Cariprazine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bipolar I disorder; Bipolar depression; Depression; Bipolar disorder
Effect of Fenofibrate on Endothelial Function and High-density Lipoproteins (HDL)in Patients With Coronary Heart Disease
Condition: Coronary Heart Disease; Hyperlipidemia
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 4

Summary: 
      Fenofibrate is a drug that acts on the PPAR alpha receptors, increasing HDL-cholesterol and
      decreasing triglyceride levels. The interaction with these receptors has antiatherogenic
      actions by regulating the expression con key proteins that participate in vascular
      inflammation, plaque stability and thrombosis.

      Fenofibrate reduces triglycerides and increases HDL-C in plasma. It also decreases small,
      dense LDL particles. The use of this drug has resulted in improvement of vascular function
      measured by endothelial function. Our hypotheses state that fenofibrate will improve:
      endothelial function, improve HDL antioxidant capacity and size distribution towards a
      predominance of small HDL particles.
    

Detailed description: 
      Patients with stable coronary heart disease, with LDL-C levels at goal will be invited to
      participate in this randomized, double blind study to receive either placebo or fenofibrate
      in addition to their statin therapy.
    

Intervention name(s): fenofibrate; placebo
Intervention type(s): Drug; Drug
Intervention description(s): fenofibrate 160 mg capsules qd; capsules placebo
Intervention MeSH terms: Fenofibrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: fenofibrate; coronary heart disease; mixed hyperlipidemia
Vecuronium Requirements According to the Operation Phase During Liver Transplantation Under Desflurane Anesthesia
Condition: Liver Transplantation
Study type: Observational

Summary: 
      The vecuronium requirements may be reduced for recipients of living donor liver
      transplantation, as the vecuronium is eliminated principally by the liver. Furthermore, the
      requirements may be different according to the phase of surgery. The requirements may also be
      different according to the preoperative hepatic function as measured by MELD score during
      prehepatic phase, or graft to recipient body weight ratio (GRWR) during neohepatic phase.
      Therefore, the investigators are trying to investigate the difference of vecuronium
      requirements according to the phase of surgery or MELD score, GRWR.
    

Detailed description: 
      The vecuronium requirements may be reduced for recipients of living donor liver
      transplantation, as the vecuronium is eliminated principally by the liver. Furthermore, the
      requirements may be different according to the phase of surgery. The requirements may by
      further reduced during anhepatic phase of liver transplantation. And the requirements may be
      increased as the graft functions during neohepatic phase.

      We also postulated that the requirements may be different according to the preoperative
      hepatic function during preanhepatic phase, and according to the graft to recipient body
      weight ratio (GRWR) during neohepatic phase.

      Therefore, we are trying to investigate the difference of vecuronium requirements according
      to the phase of surgery, MELD score, GRWR.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing elective living donor liver transplantation
      
Keywords: liver transplantation; vecuronium
Antibiotic Prophylaxis in Mesh Repair of Inguinal Hernias
Condition: Inguinal Hernia
MeSH terms: Hernia; Hernia, Inguinal
Study type: Interventional
Phase: Phase 4

Summary: 
      Inguinal hernia repairs is clean surgical procedures. However infection may be a concern when
      prosthetic materials are used. This prospective randomized study has been set to observe if
      antibiotic prohylaxis is of benefit in mesh repair of inguinal hernias.
    

Detailed description: 
      There are two group in the study. Control group received no antibiotic prohylaxis, whereas a
      single dose 1 gr. intravenous cefazoline is given to the patient in prophylaxis arm of the
      study. 30-days surgical site infection rates and 1 year prosthetic intervention late
      infection rates are observed and recorded. Side effects of antibiotic used are also recorded.
    

Intervention name(s): sefazolin
Intervention type(s): Drug
Intervention description(s): In prophylaxis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: inguinal hernia, antibiotic, prophylaxis
EmbryoGen/ Blastgen for Couples With Implantation Problems or Previous Miscarriage
Condition: Recurrent Miscarriage; Infertility
MeSH terms: Infertility; Abortion, Spontaneous; Abortion, Habitual
Study type: Interventional
Phase: Phase 4

Summary: 
      EmbryoGen and BlastGen contain the cytokine growth factor Granulocyte-Macrophage
      Colony-Stimulating Factor (GM-CSF), which has been documented to give significant benefit to
      this difficult group of patients.

      Results showed a highly significant effect of 44% relative improvement in ongoing
      implantation rate (p=0.001) in women who have previously miscarried (Ziebe et al 2013).

      We wish to undertake a randomised Controlled trial to determine if EmbryoGen/BlastGen media
      improves pregnancy outcomes in women with recurrent implantation failure, recurrent
      miscarriage and poor embryo development when compared to standard media.
    

Detailed description: 
      A randomised control pilot study will be undertaken for 100 women who have implantation
      failure (≥ 2 embryo transfers without a pregnancy) or at least 1 previous miscarriage and are
      having a further IVF cycle.

      At oocyte retrieval each couple will be randomised using numbered envelopes containing pre
      randomised group allocations by a person uninvolved in the trial to:

        1. BlastGen Group (n=50): culturing their embryos in ORIGIO standard, sequential culture
           mediums for 3 days (EmbryoGen included) then BlastGen media (GM-CSF containing media)
           for remaining 2 days or

        2. Standard Media Group (n=50): culturing their embryos in Cook standard sequential medium
           for 5 days.

      The best single embryo will be transferred on day 5.

      The clinical staff and participating couple will be blinded as to whether BlastGen or
      standard media was used in culture to day 5. Fertility SA embryologists will not be blind as
      to which study group a couple is in and which media is being used. The embryos will be
      cultured using the usual methods and lab facilities by Fertility SA's current embryology
      staff members who will not be blind to the media being used.

      Records on the outcome of the oocyte fertilisation, blastocyst development, implantation rate
      and pregnancy rates will be recorded, as is standard practice. Pregnancy scans will be
      carried out at 7 and 12 weeks. Live birth outcomes and any congenital anomalies will be
      recorded.
    

Intervention name(s): EmbryoGen/ BlastGen media; Standard Cook sequential media
Intervention type(s): Device; Device
Intervention description(s): Embryos will be cultured in media containing Gm-CSF (EmbryoGen/ BlastGen media); Standard Cook IVF media will be used in the control arm
Other intervention name(s): GM-CSF containing media
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomised control trial comparing EmbryoGen/ BlastGen media use with standard media in IVF
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Myocardial Dysfunction at Early Phase of Traumatic Brain Injury : Evaluation by Two Dimensional and Speckle Tracking Transthoracic Echocardiography
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional

Summary: 
      Traumatic brain injury (TBI) is a frequent pathology leading to major morbidity and mortality
      in young people. Cerebral flood flow maintenance is a major goal directed therapy to improve
      the prognosis of the patient. Due to cerebral-myocardial interaction, a myocardial
      dysfunction might occur at the early phase of the traumatic brain injury. This myocardial
      dysfunction could be partly responsible for a decrease in cerebral blood flow. In such case,
      improving myocardial dysfunction may help to increase cerebral blood flow and improve patient
      prognosis. In clinical practice the easiest and non invasive way to explore myocardial
      dysfunction is with transthoracic echocardiography. The objective of this trial is to
      investigate myocardial dysfunction at the early phase of traumatic brain injury, compared
      with a controlled group without TBI.
    


Intervention name(s): Transthoracic echocardiography on TBI patients; Transthoracic echocardiography on control patients
Intervention type(s): Other; Other
Intervention description(s): Two Dimensional and speckle trackingTransthoracic echocardiography on TBI patients within 24 hours of trauma; Two Dimensional and speckle trackingTransthoracic echocardiography on control patients while intubated-ventilated
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Traumatic brain injury; Myocardial dysfunction; Transthoracic echocardiography; Speckle tracking