bioihbjkbjnl/mcl2 huggingface dataset:
PCV7 in the Prevention of Nasopharyngeal Carriage of Vaccine Serotype (VT) Streptococcus Pneumoniae
Condition: Streptococcal Pneumonia; Nasopharyngeal Diseases; Vaccination Adverse Event
MeSH terms: Pneumonia; Pneumonia, Pneumococcal; Nasopharyngeal Diseases
Study type: Interventional

Summary: 
      A parallel-group, randomized, open-label study will be performed in subjects receiving PCV7
      and subjects receiving controlled vaccine Hib vaccine, to claim the efficacy of PCV7 in the
      prevention of NP carriage of vaccine-serotype S. pneumoniae (serotypes 4, 6B, 9V, 14, 18C,
      19F, and 23F combined) in 2 to 5 years old healthy Chinese children.
    

Detailed description: 
      In 2005, clinical trials with PCV7 (Prevenar) were first conducted in China. In the phase 3
      study involving Chinese infants, Prevenar was shown to be immunogenic, well tolerated, and
      safe when given either separately or concomitantly with a diphtheria, tetanus, and acellular
      pertussis (DTaP) vaccine at 3, 4, and 5 months of age. Controlled clinical trials elsewhere
      in the world showed the correlation between immunogenicity and disease prevention. In
      addition to the direct effect of Prevenar, immunization of children has also reduced the
      incidence of disease in adults. The changes are presumed to be due to reductions in
      nasopharyngeal carriage of vaccine serotype S. pneumoniae in children who have been
      vaccinated.

      The purpose of this study will be to assess the effectiveness of Prevenar vaccination to
      reduce vaccine serotype (VT) NPC rates in Chinese children aged 2 to 5 years old.
    

Intervention name(s): PCV7 (Pneumococcal 7-Valent Conjugate Vaccine); Hib Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): injection 0.5 mL, single dose; Single Dose
Other intervention name(s): Prevenar
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Effectiveness; Prevenar; nasopharyngeal carriage; vaccine serotype
Detection of Subclinical Atherosclerosis in Asymptomatic Individuals
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Atherosclerosis
Study type: Observational

Summary: 
      This study will evaluate the use of cardiac CT in identifying atherosclerosis plaque in
      patients who have not been diagnosed with atherosclerosis and who have no symptoms of the
      disease but who are at risk of developing atherosclerosis based on traditional risk factors
      such as diabetes or a family history of coronary artery disease.
    


Intervention name(s): Cardiac CT
Intervention type(s): Procedure
Intervention description(s): All participants will undergo a coronary artery CT angiogram with contrast.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Coronary Artery Disease
      
Biospecimen description: 
      Whole blood for DNA and RNA analysis for genetics and genomics
    
Keywords: asymptomatic; coronary artery disease
Effect of Psychological Intervention on Drop-out Rates in IVF
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      The most common reason why insured In Vitro Fertilization (IVF) patients drop out of
      treatment is the distress caused by the treatment.

      The objective of this study is to determine the efficacy of a combined Cognitive Coping and
      Relaxation Intervention (CCRI) in reducing drop out behavior in IVF patients.
    

Detailed description: 
      Intervention participants will be given a packet containing the CCRI, which consists of two
      intervention components tailored to the Stimulation Phase and Waiting Phases of IVF. The
      cognitive component of the CCRI is the PRCI intervention (Boivin & Lancastle, 2008) tailored
      to the stimulation/waiting phases of an IVF cycle. The PRCI intervention consists of a series
      of ten statements that facilitate the use of cognitive reappraisal coping, a form of coping
      that helps people think more about the positive aspects of a difficult situation and dwell
      less on problems or uncertainties of the future.

      The relaxation components of the CCRI consists of techniques that have been used for two
      decades in the mind/body infertility program as well as in randomized controlled research
      trials. For the Stimulation phase, participants will receive instructions on how to do "mini
      relaxation" techniques which are specifically designed to reduce anxiety in the moment, for
      example feelings of tension, worry, and nervousness that might occur prior to and during
      Stimulation phase procedures (e.g. injections, blood tests, and ultrasounds). For the Waiting
      Phase the relaxation intervention will include a relaxation CD. The CD contains narrated
      instruction on how to elicit the relaxation response through several techniques

      This is a randomized, controlled prospective study conducted at a private
      academically-affiliated infertility clinic and includes women ages 44 and below scheduled to
      undergo their first IVF cycle. Subjects are randomized to a CCRI or a control group. The
      primary outcome measure is dropout rates.
    

Intervention name(s): CCRI Group; Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Cognitive Coping and Relaxation Intervention (CCRI) Cognitive Coping and Relaxation Intervention (CCRI) group who will receive a packet of relaxation and stress management suggestions; Medical treatment alone
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: IVF; Drop out
Safety and Immunogenicity of a Single Dose of Intranasal Seasonal Trivalent Live-Attenuated Influenza Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      In this Phase II randomized controlled clinical trial, generally healthy male and female
      children from 24 through 59 months of age will be enrolled in Kamalapur (Dhaka), Bangladesh.
      The study is expected to continue for at least 6 months following vaccination. The
      experimental intervention is Serum Institute of India Ltd's Trivalent, Seasonal Live
      Attenuated Influenza Vaccine (SIIL LAIV). The study vaccine has been formulated according to
      WHO recommendations for the 2011-2012 Northern Hemisphere influenza season. The SIIL LAIV is
      administered in a 0.5 ml intranasal dose (one spray of 0.25 ml per nostril) via a reusable
      sprayer device and a single-use nozzle that produces a fine mist that is primarily deposited
      in the nose and nasopharynx. The comparator vaccine will be an inactive placebo identical in
      appearance to the active vaccine.

      The primary study hypothesis is that LAIV is safe and well tolerated by children aged 24
      through 59 months in Bangladesh. A secondary hypothesis is that LAIV is immunogenic among
      children receiving study vaccine as compared to children receiving placebo.
    


Intervention name(s): SIIL LAIV (live, trivalent seasonal influenza vaccine); Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Dose: 0.5 mL, The viral strains in seasonal trivalent influenza vaccine (human, live attenuated) are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season; Inactive placebo will be identical to SII LAIV in appearance, ingredients, and concentrations, except it will be missing attenuated influenza virus.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza vaccines; Influenza, Human; Live Attenuated Influenza Vaccine
Effect of Skipping Breakfast on Metabolic Function
Condition: Skipping Breakfast; Circadian Rhythms
Study type: Interventional

Summary: 
      The purpose of this study is to test the hypothesis that the disruption of the "normal"
      (three meals a day) eating pattern and prolonged overnight fasting caused by skipping
      breakfast: i) alters the expression of specific clock genes and clock gene targets involved
      in regulating adipose tissue lipolysis (breakdown or destruction); ii) increases basal
      adipose tissue lipolytic (breakdown) activity and plasma free fatty acid (FFA)
      concentrations; iii) reduces skeletal muscle insulin sensitivity; and iv) increases daylong
      plasma glucose, FFA, and insulin concentrations. The investigator will do this by studying
      healthy, lean persons either randomized to consume either 3 standard meals per day or omit
      breakfast and consume 2 meals per day without changing daily calorie intake (skipping
      breakfast group).
    


Intervention name(s): 3 standard meals/day; 2 meals/day (omit breakfast)
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Clock genes; Metabolism; Insulin sensitivity
A Phase 2 Exploratory Study of CS-3150 in Japanese Hypertensive Patients With Moderate Renal Impairment
Condition: Hypertension
MeSH terms: Renal Insufficiency; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a multi-center, open label, dose titration, exploratory study to evaluate
      efficacy and safety of CS-3150 in Japanese hypertensive patients with moderate renal
      impairment. Primary endpoint is change from baseline in sitting systolic and diastolic blood
      pressure.
    


Intervention name(s): CS-3150
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension; moderate renal impairment; mineralocorticoid receptor antagonist; CS-3150; Japanese
Value for Cord Blood Procalcitonin to Diagnose Early Neonatal Bacterial Infection
Condition: Neonatal Bacterial Infection
MeSH terms: Infections; Communicable Diseases; Bacterial Infections
Study type: Interventional

Summary: 
      After birth, in the presence of risk factors for early neonatal bacterial infection (IBNP),
      the pediatrician must make a difficult decision quickly or not to prescribe additional
      examinations and / or hospitalize or not the newborn in order to administer parenteral
      antibiotics. This decision takes into account several contextual data, (clinical, biological
      and bacteriological clinical data) to be considered simultaneously. These information lack
      sensitivity and specificity.

      Therefore, the common attitude among newborns in many countries remains the achievement of a
      significant number of additional tests and the establishment, without a prior evidence of
      infection, intravenous empirical antibiotic therapy for 48 -72h at least in hospitalization.
      However, the diagnosis of IBNP posteriori, is often reversed. This attitude is:

        1. one source to higher health care costs (hospitalization, additional examinations)

        2. Selection of the bacterial ecology of the newborn and neonatal services and

        3. stress for the newborn and parents
    


Intervention name(s): dosage of the umbilical cord blood Procalcitonin for diagnosing of IBNP
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: neonatal bacterial infection; procalcitonin
The Practical Evidence of Antidiabetic Combination Therapy in Korea
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluate the efficacy and safety of alogliptin and pioglitazone combination
      therapy in comparison with either alogliptin or pioglitazone on glucose control in the
      metformin-treated type 2 diabetic patients in Korea.
    

Detailed description: 
      Pathophysiology of type 2 diabetes is known as insulin resistance and progressive beta cell
      dysfunction.

      Combination therapy with biguanides, glucagon-like peptide-1(GLP-1) agonists or dipeptidyl
      peptidase-4 inhibitor(DPP4I) and thiazolidinediones(TZD) seems reasonable theoretically, for
      their effects on different pathophysiologic defects.

      Current treatment guidelines recommend a stepwise approach starting with lifestyle
      modification or lifestyle modification + metformin monotherapy, with recent focusing on
      patient individualization.

      In Korea, Korean Diabetes Association also recommends stepwise approach and at the same time,
      emphasizes on the initial aggressive treatment including oral combination or insulin therapy
      according to HbA1c level to achieve target goal <6.5%.

      Guide to the efficacy, timing, options of combination therapy is not clearly defined due to
      lack of sufficient evidences yet.

      There is no clear report to demonstrate the clinical benefit of initial TZD and DPP4I
      combination therapy in the Korean.

      Thus it is reasonable to study the effect of combination therapy in the patients with
      sub-optimal glucose control with metformin therapy only, comparing various combination
      options metformin with DPP4I only, TZD only, or both.

      The hypothesis of this study is that combination therapy of alogliptin and pioglitazone added
      on the metformin has superior effect on HbA1c reduction than metformin and either alogliptin
      or pioglitazone in 6 month treatment.
    

Intervention name(s): alogliptin; Pioglitazone; alogliptin + pioglitazone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): alogliptin 25 mg add-on background medication metformin; pioglitazone 30 mg add-on background medication metformin; alogliptin 25 mg and pioglitazone 30 mg add-on background medication metformin
Other intervention name(s): Nesina; actos; Nesina; Actos
Intervention MeSH terms: Pioglitazone; Alogliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus, Type 2; alogliptin; pioglitazone; DPP4 inhibitor; thiazolidinedione
Three Different Approaches for Ultrasound Guided Femoral Nerve Block for Patients Undergoing Total Knee Arthroplasty
Condition: Knee Arthroplasty
Study type: Interventional

Summary: 
      Patients scheduled to have a surgery for Total Knee Arthroplasty will be assigned to one of
      three groups, each group will use a different approach using the ultrasound to guide the
      femoral nerve block as part of their treatment for controlling pain post-operatively.
    

Detailed description: 
      This will be a prospective, single-blinded, randomized study. The patients will be randomly
      assigned to one of three groups:

      Group I - single shot femoral nerve block Group II - continuous femoral nerve block - non
      stimulating catheter Group III - continuous femoral nerve block - stimulating catheter
    

Intervention name(s): Femoral nerve block; Femoral nerve block non stimulating catheter; Femoral nerve block stimulating catheter
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): A visible or palpable cephalad movement of the patella will confirm needle placement.; A visible or palpable cephalad movement of the patella will confirm needle placement. The catheter will be placed with the nerve stimulator powered off.; A visible or palpable cephalad movement of the patella will confirm needle placement. The catheter will be placed with the nerve stimulator powered on.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Sphenopalatine Ganglion Block for Management of Post- Dural Puncture Headache in Obstetric Patients
Condition: Post-Dural Puncture Headache
MeSH terms: Ganglion Cysts; Post-Dural Puncture Headache; Headache; Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this trial is to study the efficacy and efficiency of sphenopalatine ganglion
      block for management of post dural puncture headache in obstetric patients
    

Detailed description: 
      Background and objectives: Post dural puncture headache(PDPH) is a common complication of
      lumbar puncture, it is likely due to the loss of cerebrospinal fluid into the epidural space
      through the dural tear. The prevalence of PDPH is higher in pregnant women.Sphenopalatine
      ganglion block (SPGB) is a non-invasive intervention with minimal adverse effects, it is
      indicated in acute and chronic facial/head pain like cluster headache, trigeminal neuralgia,
      post herpetic neuralgia and pain due to head and neck cancer.SPGB can be performed by
      different approaches:transnasal,transoral ,sub zygomatic and lateral infratemporal.Transnasal
      is the easiest, least invasive approach which can be done at bedside.

      The objective of this trial is to study the efficacy and efficiency of sphenopalatine
      ganglion block for management of post-dural puncture headache in obstetric patients.The
      following will be recorded: pain score will be assessed using the numeric rating pain
      scale(NRS),heart rate and mean arterial pressure, onset and duration of analgesia, total dose
      of ketorolac, duration of hospital stay and patient satisfaction
    

Intervention name(s): Sphenopalatine ganglion block; paracetamol
Intervention type(s): Procedure; Drug
Intervention description(s): Patients will receive the SPGB via the transnasal approache by a cotton tipped applicator soaked in lignocaine 2% with 4 mg dexamethasone; patients will receive paracetamol 1 g thrice daily intravenously
Other intervention name(s): SPGB; acetaminophen
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sphenopalatine ganglion block; Post-Dural Puncture Headache
Training Induced Reduction of Lower-limb Joint Loads During Locomotion in Obese Children
Condition: Pediatric Obesity; Lower Extremity Biomechanics
MeSH terms: Pediatric Obesity
Study type: Interventional

Summary: 
      Childhood obesity is one of the most critical and accelerating health challenges throughout
      the world. It is a major risk factor for developing varus/valgus misalignments of the knee
      joint. The combination of misalignment at the knee and excess body mass may result in
      increased joint stress and damage to articular cartilage. A training programme, which aims at
      developing a more neutral alignment of the trunk and lower limbs during movement tasks may be
      able to reduce knee loading during locomotion. Despite the large number of guidelines for
      muscle strength training and neuromuscular exercises that exists, most are not specifically
      designed to target the obese children and adolescent demographic.

      The purpose of this study is to evaluate a training programme which combines strength and
      neuromuscular exercises specifically designed to the needs and limitations of obese children
      and adolescents and analyse the effects of the training programme from a biomechanical and
      clinical point of view.
    


Intervention name(s): Strength and neuromuscular exercise programme
Intervention type(s): Other
Intervention description(s): 12 weeks strength and neuromuscular exercise programme for the lower extremity
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gait Analysis; Knee Adduction Moment; Physiotherapy; Obesity
MoviPrep® Versus HalfLytely®, Low-VolUme PEG Solutions for Colon Cleansing: An InvesTigator-blindEd, Randomized, Trial
Condition: Colonoscopy
Study type: Interventional
Phase: Phase 4

Summary: 
      A properly prepared colon is vital to the success of any colonoscopy. The purpose of this
      study is to determine which colon prep, MoviPrep or HalfLytely is the superior prepping
      agent.
    

Detailed description: 
      To demonstrate, by direct visualization, the superior overall colon cleansing efficacy of
      MoviPrep®, to that of HalfLytely® and Bisacodyl Tablets Bowel Prep Kit in adults undergoing
      colonoscopy
    

Intervention name(s): MoviPrep Kit; HalfLytely and Bisacodyl Tablets Bowel Prep Kit
Intervention type(s): Other; Other
Intervention description(s): Diet: At noon the day prior to the procedure, patients will begin a clear liquid diet. Patient will discontinue any ingestion by mouth 4 hours prior to the procedure.
Purgative: Starting at 6pm the evening before the procedure, patient will ingest 250 ml of MoviPrep® at 15 minute intervals until 1 liter is consumed. Following this, an additional 500 ml (approximately 16 oz) of clear liquids will be consumed. The next day, 6 hours before the procedure, the patient will repeat ingestion of one liter MoviPrep® over the course of an hour, again ingesting 250 ml at 15 minute intervals. Patient will then ingest an additional 500 ml (approximately 16 oz) of clear liquid following the MoviPrep® consumption.; Diet: Patients will refrain from solid food and have only clear liquids starting 8 am on the day before colonoscopy. In addition, patients will consume nothing by mouth, except clear liquids, from the time the preparation is completed until midnight. Patients will be instructed not to eat or drink anything from midnight until after the colonoscopy is completed.
Purgative: At noon on the day prior to colonoscopy patients will swallow (not chew or crush) 2 bisacodyl delayed release tablets (10 mg). Once the initial bowel movement has occurred (1 - 6 hours after taking the bisacodyl tablets), or if there has been no bowel movement, not more than 6 hours after ingestion of the bisacodyl tablets patients will then drink the reconstituted HalfLytely® solution over 1 hour and 20 minutes. Patients will drink one 8-oz glass every 10 minutes until the two liters is completed
Intervention MeSH terms: Bisacodyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Diagnostic
Keywords: Colonoscopy,; Prep; MoviPrep; HalfLytely; The effectiveness of colonoscopy preps