bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy Trial of Two Pneumococcal Conjugate Vaccines (PncCRM and PncOMPC) for Prevention of Acute Otitis Media Due to Vaccine Serotypes
Condition: Otitis Media; Pneumococcal Infections
MeSH terms: Pneumococcal Infections; Otitis; Otitis Media
Study type: Interventional
Phase: Phase 3

Summary: 
      This was a randomized, double-blinded multicenter cohort study of Finnish children aged 2 to
      24 months. The study was designed to evaluate the efficacy of two 7-valent pneumococcal
      conjugate vaccines (PncCRM and PncOMPC) parallelly, both vaccines compared with the same
      control vaccine (hepatitis B vaccine).

      The primary endpoint was culture-confirmed pneumococcal acute otitis media (AOM) episodes due
      to all serotypes included in the pneumococcal conjugate vaccine and the primary hypothesis
      was that, compared to the control vaccine group, the pneumococcal conjugate vaccine would
      protect infants from culture confirmed AOM caused by pneumococcal serotypes in the vaccine.
      The efficacy of the two vaccines against any pneumococcal AOM and any AOM was also evaluated.

      The children were vaccinated with the pneumococcal conjugate vaccine or the control vaccine
      at the age of 2, 4, 6 and 12 months and followed at study clinics established specifically
      for the purpose from 2 to 24 months of age. Whenever AOM was diagnosed during the follow-up,
      middle ear fluid was aspirated for bacterial culture.
    


Intervention name(s): 7-valent pneumococcal-CRM197 conjugate vaccine; 7-valent pneumococcal-OMPC conjugate vaccine
Intervention type(s): Biological; Biological
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Otitis Media; Pneumococcal Infections; Pneumococcal Vaccines; Proportional Hazards Models; Prospective Studies; Streptococcus pneumoniae; Vaccines, Conjugate
Ibrutinib in Relapsed Nodular Lymphocyte-predominant Hodgkin Lymphoma (NLPHL)
Condition: Nodular Lymphocyte-Predominant Hodgkin's Lymphoma
MeSH terms: Lymphoma; Hodgkin Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to determine

        1. Disease stabilization/response rate after six 21-day cycles of ibrutinib

        2. Remission status after six, twelve and 20 21-day cycles of ibrutinib
    


Intervention name(s): Ibrutinib
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy Study of Romiplostim to Treat Immune Thrombocytopenia (ITP) in Pediatric Patients
Condition: Idiopathic Thrombocytopenic Purpura; Thrombocytopenia; Thrombocytopenia in Pediatric Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP); Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP); Thrombocytopenic Purpura; Immune Thrombocytopenia
MeSH terms: Thrombocytopenia; Purpura; Purpura, Thrombocytopenic, Idiopathic; Purpura, Thrombocytopenic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy of romiplostim in the treatment of
      thrombocytopenia in pediatric patients with Immune thrombocytopenia purpura (ITP) as measured
      by durable platelet response.
    


Intervention name(s): Romiplostim; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): The starting dose of romiplostim is 1 µg/kg administered weekly by subcutaneous injection. Participants will return to the clinic weekly to provide platelet counts and undergo dose titrations under the supervision of the treating physician. Weekly dose increases will continue in increments of 1 µg/kg up to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L. Dose adjustment will be allowed during the treatment period to maintain a platelet count between ≥ 50 x 10^9/L and ≤ 200 x 10^9/L.; Matching placebo administered by subcutaneous injection
Other intervention name(s): AMG 531; Nplate®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Immune (Idiopathic) Thrombocytopenic Purpura; Pediatric Immune (Idiopathic) Thrombocytopenic Purpura; Immune Thrombocytopenia
Prenatal Testing: Amniocentesis Versus Transabdominal Chorionic Villus Sampling (TA CVS)
Condition: Pregnancy
Study type: Interventional

Summary: 
      Prenatal diagnosis can provide information to parents about specific fetal disorders.
      However, invasive prenatal diagnostic procedures are associated with risks to the fetus. This
      study will compare the safety and effectiveness of two methods of invasive prenatal
      diagnosis: amniocentesis and transabdominal chorionic villus sampling (TA CVS).
    

Detailed description: 
      Amniocentesis is generally performed at 105 to 125 days post last menstrual period (LMP) and
      TA CVS at 63 to 76 days post LMP. This study will compare the safety and accuracy of
      transabdominal amniocentesis and TA CVS, each performed during the same modified gestational
      age window of 77 to 104 days post LMP.

      Healthy, pregnant women at 77 to 104 days gestation, whose only indication for prenatal
      diagnosis is advanced maternal age of at least 34 years at enrollment, will be randomized to
      receive either TA CVS or amniocentesis following a baseline ultrasound. Eligible women who
      refuse randomization or for whom a procedure cannot be scheduled by 104 days will also be
      followed. Primary outcomes include fetal loss or preterm delivery before 196 days gestation
      as well as total fetal loss, amniotic fluid loss, gestational age at delivery, perinatal
      morbidity, neonatal morbidity, and congenital abnormalities, including limb reduction
      defects. Success in obtaining a diagnosis from the two procedures will be compared. One
      ancillary study will evaluate the feasibility and accuracy of fluorescence in situ
      hybridization (FISH) as a rapid diagnostic method for certain cytogenetic abnormalities;
      another will collect data on amniotic fluid alphafetoprotein and acetylcholinesterase for the
      diagnosis of neural tube defects.
    

Intervention name(s): Amniocentesis; Transabdominal chorionic villus sampling (TA CVS)
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Amniocentesis; Transabdominal chorionic villus sampling; Fluorescence in situ hybridization; Alpha fetoprotein; Acetylcholinesterase; Prenatal testing; Prenatal diagnosis
Myo-inositol Versus D-chiro-inositol in the Treatment of Polycystic Ovary Syndrome and Insulin Resistance: Evaluation of Clinical, Metabolic, Endocrine and Ultrasound Parameters
Condition: PCOS
MeSH terms: Insulin Resistance
Study type: Interventional
Phase: Phase 4

Summary: 
      Insulin resistance has important implications in the pathogenesis of the polycystic ovary
      syndrome (PCOS) and insulin-sensitizing drugs are considered a useful therapeutic approach.

      Reduction of insulin levels with administration of insulin sensitizing agents has been found
      to be beneficial in lowering both hyperinsulinemia, hyperandrogenemia, and restoring
      ovulation. Metformin alone or in combination with oral contraceptives (OCs) has been widely
      used in the long term treatment of women with PCOS in whom it modifies the ovarian
      morphology, improves intraovarian androgen levels, and enhances systemic and local insulin
      resistance. Despite to these beneficial effects, several side effects have been reported due
      to the long term administration of this drug.

      In the recent years, inositol has found more and more space in the reproductive clinical
      practice. Indeed, inositol have been classified as "insulin sensitizing agent" and it is
      mainly used as a chronic treatment for PCOS. Inositol exists in 9 different isomers and in
      particular several studies on Myo-inositol and D-chiro-inositol were reported.

      In this study myo-inositol versus D-chiro-inositol treatments were compared to placebo in
      women with PCOS and with or without insulin resistance.
    


Intervention name(s): Myo-inositol + Folic acid; Myo-inositol + Folic acid; D-chiro-inositol, manganese, folic acid, vit B12; D-chiro-inositol, manganese, folic acid, vit B12; Folic acid, vit B12; Folic acid, vit B12
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Drug; Drug
Intervention description(s): Myo-inositol (2g) Folic acid (200mcg) (2 per day); Myo-inositol (2g) Folic acid (200mcg) (2 per day); D-Chiro-inositol (500 mg), manganese (1 mg), folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day); D-chiro-inositol (500 mg), manganese (1 mg), folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day); Folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day); Folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day)
Intervention MeSH terms: Folic Acid; Vitamin B Complex; Hydroxocobalamin; Vitamin B 12; Inositol; Manganese
Keywords: PCOS; Insulin resistance; Myo-inositol; D-chiro-inositol
Strengthening Instrumental Extinction to Prevent Smoking Relapse (VLNCCue)
Condition: Cigarette Smoking
MeSH terms: Recurrence
Study type: Interventional

Summary: 
      The central objective of the project is to evaluate the effect of incorporating smoking
      related contexts into very low nicotine content (VLNC) cigarette extinction trials on
      clinically relevant, smoking-related outcomes. Adult smokers interested in quitting smoking
      (N=80) will be interviewed and trained to take pictures where they smoke cigarettes.
      Following taking these pictures, participants will then be switched to smoke VLNCs while
      wearing a 21 mg/d nicotine patch (EXT) for three weeks. During this 3-week treatment period,
      half of the sample (n=40) will be randomly assigned to undergo six, 60-minute sessions of
      multiple context extinction (MCE+) during which they will view smoking-related environments
      and smoke their assigned cigarettes. The remaining 40 participants will undergo control MCE
      (exposure to nature environments; MCE-) and smoke their assigned cigarettes. At the end of
      the three weeks, participants will quit smoking and continue to wear the nicotine patch while
      being followed during a 10-week abstinence period. Participants will also complete a
      follow-up phone call 6 months after their quit day.
    


Intervention name(s): Nicotine Patch; SPECTRUM Nicotine Research Cigarettes (0.07 mg); MCE+; MCE-
Intervention type(s): Drug; Drug; Behavioral; Behavioral
Intervention description(s): Both groups will receive nicotine patches (21 mg/d if smoking ≥10 cigs/d or 14 mg/d if smoking <10 cigs/d) to wear for 3 weeks prior to the quit date. After the quit date, both groups will wear the nicotine patch for 10 weeks. Participants that smoked ≥10 cigs/d will wear a 21 mg/d patch for 6 weeks, a 14 mg/d patch for 2 weeks, and a 7 mg/d patch for 2 weeks. Participants that smoked <10 cigs/d will wear a 14 mg/d patch for 6 weeks, then step down to a 7 mg/d patch for 4 weeks.; For 3 weeks prior to their quit day, participants will switch to smoking SPECTRUM Nicotine Research Cigarettes instead of their usual brand.; During the 3-week, pre-quit period, participants will undergo six, 60 minute sessions during which they will view smoking-related environments and smoke their assigned cigarettes.; During the 3-week, pre-quit period, participants will undergo six, 60 minute sessions during which they will view nature environments and smoke their assigned cigarettes.
Other intervention name(s): Nicoderm CQ; Very Low Nicotine Content Cigarettes
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
PRPP Model for Evaluation the Effect of Non-pharmaceutical Therapies
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      To assess the application of partially randomized patient preference (PRPP) trial model which
      concerns the patients' preference on evaluation the therapeutic effect of non-pharmaceutical
      therapy, and to observe the therapeutic effect of two kinds of non-pharmaceutical therapies
      (acupuncture and cupping therapy) for fibromyalgia.
    


Intervention name(s): Cupping therapy; Acupuncture
Intervention type(s): Other; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: cupping therapy; acupuncture; partially randomized; patient preference; fibromyalgia; criteria formulated by American College Rheumatology 2002
Effect of Adaptive Sports After Acquired Physical Disability
Condition: Spinal Cord Injuries; Sports Physical Therapy
MeSH terms: Spinal Cord Injuries
Study type: Interventional

Summary: 
      This study is a cross-sectional trial which aims to evaluate the effect of practicing a
      physical activity on different domains of the ICF among individuals with an acquired physical
      disability. Two different groups of individuals with a spinal cord injury will be enrolled:
      one composed of subjects who manage to reach the WHO's recommendations regarding physical
      activity, and the other of subjects who do not.
    

Detailed description: 
      The present study will recruit participants based on a set of defined eligibility criteria,
      in adaptive sports clubs teams and in groups or associations of individuals with an acquired,
      and permanent, physical disability. Based on the presence or absence of a regular physical
      activity practice undertaken by the subjects who give their consent to participate in the
      study, they will be divided into two groups: one where individuals regularly practice a
      physical activity, and one where they do not.

      A set of defined outcome measures (detailed in the "Outcome Measures"section) will be
      assessed in both groups.

      The outcomes measures will be analysed statistically, using SPSS software. Depending on the
      nature of the variables (qualitative or quantitative), different tests will be performed.
      Normality will also be verified and will determine which statistical analysis will be carried
      out.
    

Intervention name(s): Adaptive sports
Intervention type(s): Other
Intervention description(s): This will be the number of hours per week the subjects actively partake in adaptive sports teams.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Patient Narcotic Requirements After Outpatient Otolaryngology Procedures
Condition: Outpatient Surgery; Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      Patient's pain level and narcotic requirements will be evaluated after routine outpatient
      Otolaryngology procedures. This will be done by having study participants record their pain
      level and medication usage from home.
    

Detailed description: 
      It is routine practice to give narcotic medication after surgery for pain control however the
      abuse of prescription medications has become the fastest growing drug problem in the United
      States. Research has shown that post operative pain for some common Ear, Nose, and Throat
      (ENT) procedures are not severe but there is limited data looking at patient narcotic needs
      and their usage pattern to help inform physicians on how much to prescribe.

      The objective of this study is to evaluate patient pain level in the immediate post-operative
      period and quantify pain medication usage in patients who undergo outpatient ENT surgeries.

      Patients who undergo the following procedures will be invited to participate: thyroidectomy,
      parathyroidectomy, parotidectomy, tympanoplasty, mastoidectomy, endoscopic sinus surgery, and
      septoplasty. All patients will receive Hydrocodone/acetaminophen and Ibuprofen in standard
      dosage and assigned to one of two groups before surgery. Group 1 will use the narcotic
      medication for pain control and ibuprofen for breakthrough pain. Group 2 will use ibuprofen
      for pain control and the narcotic medication for breakthrough. Patients will fill out a data
      sheet for 7 days recording their pain level three times per day as well as pain medication
      usage for each day. This will be collected on their first clinic visit after surgery at which
      point the patient's involvement is completed.
    

Intervention name(s): Norco; Ibuprofen
Intervention type(s): Drug; Drug
Intervention description(s): Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control; Ibuprofen as first line therapy every 6 hours as needed for pain control
Other intervention name(s): Hydrocodone/Acetaminophen; Narcotic; NSAID; Motrin; Advil
Intervention MeSH terms: Acetaminophen; Ibuprofen; Acetaminophen, hydrocodone drug combination; Hydrocodone; Narcotics
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomized to one of two groups prior to surgery. All patients will be prescribed both Hydrocodone/acetaminophen and Ibuprofen. Group 1 will take the narcotic medication for initial pain control followed by Ibuprofen if pain is not adequately controlled. Group 2 will take Ibuprofen for initial pain control followed by the narcotic medication if pain is not adequately controlled.
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Thyroidectomy; Parotidectomy; Tympanoplasty; Mastoidectomy; Septoplasty; Sinus Surgery; Postoperative pain; Outpatient surgery
Association of CYP3A4 rs2242480 With Sufentanil Plasma Concentration and PCA Consumption
Condition: Surgery; Individuality
Study type: Observational

Summary: 
      This study was designed for exploring the association of cytochrome P450 3A4 rs2242480
      polymorphism with metabolism of sufentanil in Chinese patients receiving upper abdominal
      surgery，to provide evidence for genetic prediction of personalized medication.Methods:60
      patients who prepared for elective upper abdominal surgery under general anesthesia were
      recruited into study. Liver enzyme inhibitor should be excluded in anesthesia. rs2242480
      genotyping was carried out by direct sequencing. The blood samples were drawn before
      anesthesia，30 min and 45min after anesthesia respectively，used for plasma sufentanil
      concentration detection with high performance liquid chromatography-mass spectrometry
      (HPLC-MS). After surgery，the patients received patient-controlled intravenous sufentanil
      immediately. And postoperative pain at rest，sufentanil consumption，side effects and rescue
      analgesic requirements were recorded at the 6th，12th，24th hour. The plasma sufentanil
      concentration and PCA sufentanil consumption were analyzed to investigate the differences
      among rs2242480 three genotypes.
    

Detailed description: 
      The study consisted of healthy men and women between 18 to 65 years of age.

      Participants were screened and stratified according to cytochrome P450 3A4 rs2242480
      genotype:

        -  1/*1 Grouped by rs2242480 polymorphism, wild-type homozygote

        -  1/*1G Grouped by rs2242480 polymorphism,*1/*1G: mutant heterozygote

        -  1G/*1G Grouped by rs2242480 polymorphism,*1G/*1G: mutant homozygote
    

Observational model: Cohort
Sampling method: Probability Sample
Study population: 
        60 Chinese male and female patients receiving elective upper abdominal surgery (liver,
        pancreatic, gallbladder) under general anesthesia
      
Biospecimen description: 
      The blood samples were drawn before anesthesia，30 min and 45min after anesthesia
      respectively，used for genotyping and plasma sufentanil concentration detection with high
      performance liquid chromatography-mass spectrometry (HPLC-MS).
    
Keywords: sufentanil; metabolism; cytochrome P450 3A4; gene polymorphism
Efficacy and Safety of Vildagliptin Compared to Metformin in Drug Naive Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety and effectiveness of vildagliptin, an
      unapproved drug, compared to metformin in lowering overall blood glucose levels in people
      with type 2 diabetes who have not been previously treated with drug therapy to lower their
      blood sugar.
    


Intervention name(s): vildagliptin; Metformin Comparator
Intervention type(s): Drug; Drug
Other intervention name(s): LAF237A
Intervention MeSH terms: Metformin; Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: type 2 diabetes; vildagliptin
Cardiac Magnetic Resonance for Asymptomatic Type 2 Diabetics With Cardiovascular High Risk (CATCH) - Pilot Study
Condition: Diabetes Mellitus, Type 2; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The aim of this study is to determine the prevalence of myocardial ischaemia in asymptomatic
      high risk type 2 diabetic patients using stress cardiac MR and how many stress cardiac MR
      examinations are false positive.
    

Detailed description: 
      Asymptomatic coronary artery disease (CAD) is highly prevalent (ie. 17-59%) in type 2
      diabetic patients. In addition, cardiovascular disease remains the most common cause of death
      in type 2 diabetics. Previous trials using coronary computed tomography angiograms (CCTA) or
      nuclear myocardial perfusion imaging (MPI) to screen for asymptomatic coronary artery disease
      requiring intervention have been unsuccessful at reducing cardiovascular and all cause
      mortality when compared to optimised medical therapy where cardiovascular risk factors are
      treated in order to reduce cardiovascular complications. Possible reasons for this include,
      the choice of imaging modality, the intervention chosen (eg. bare metal stents vs drug
      eluting stents), patient cohort (eg. all diabetics vs high risk diabetics). Stress cardiac
      magnetic resonance (CMR) is ideally suited to assess this group of high risk patients as
      there is no radiation exposure and it allows a more complete analysis of the heart including
      the assessment of myocardial viability, cardiac systolic and diastolic function. The
      significance of this envisioned randomised controlled trial is firstly to investigate if
      stress CMR screening will reduce major adverse cardiovascular events including death.
      Secondly, a study using stress CMR has never been performed.
    

Intervention name(s): Cardiac Magnetic Resonance
Intervention type(s): Diagnostic Test
Intervention description(s): Screening of asymptomatic of high risk type 2 diabetic mellitus patients with stress cardiac magnetic resonance
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Stress Cardiac Magnetic Resonance