bioihbjkbjnl/mcl2 huggingface dataset:
Prevention of Atrial Fibrillation Following Valvular Replacement With Cardiopulmonary Bypass: a Prospective, Randomized Clinical Study Comparing Oral Caffeine With Placebo
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 3

Summary: 
      Atrial fibrillation remains a major cause of morbidity following cardiac surgery with
      cardiopulmonary bypass. Many mechanisms have been implicated. Among then, adenosine, a strong
      endogenous vasodilating agent has been involved in cardiac surgery-induced atrial
      fibrillation, via A2A receptors modulation.

      The effects of caffeine on the inducibility of atrial fibrillation are actually well-known,
      leading then to a significant reduction of atrial fibrillation. Moreover, a recent clinical
      study has demonstrated that coffee drinking was inversely associated with total and
      cause-specific mortality.

      The investigators therefore examined the preventive effects of oral caffeine on valvular
      surgery with cardiopulmonary bypass-induced atrial fibrillation. The investigators also
      evaluated prospectively the influence of caffeine on adenosine plasma levels and A2A
      adenosine receptors modulation.
    


Intervention name(s): citrate of caffeine; placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pure Single Incision Laparoscopic Distal Gastrectomy (SIDG) Versus Totally Laparoscopic Distal Gastrectomy (TLDG)
Condition: Early Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional

Summary: 
      1. Compare the immune response and postoperative complications between pure SIDG
           (single-incision laparoscopic distal gastrectomy) and TLDG (totally laparoscopic distal
           gastrectomy) for early gastric cancer (EGC)

        2. Validate the safety, usefulness, minimal invasiveness and feasibility of SIDG (EGC)
    

Detailed description: 
      There are some trends of reducing the numbers and lengths of wounds in the fields of
      laparoscopic surgery.

      Recently, Beyond laparoscopy-assisted distal gastrectomy (LADG), which has the
      mini-laparotomy, TLDG, which has no mini-laparotomy in epigastrium but in umbilicus, has been
      popular procedure in the treatment of gastric cancer. Furthermore, the report on early
      experience of SIDG, which has no incision except umbilicus port, is going to be published.

      However, there've been no objective reports and data on real minimal invasiveness and
      benefits between 2 procedures. In this study, I would like to find out the benefits of the
      reducing port and wound size by comparing the above 2 procedures' immune response and
      postoperative complications.

      This study is planned as a phase II study.

      There are no references on this subject, so the investigators set the numbers of each groups
      into 30, which is minimal requirement for the parametric comparisons.
    

Intervention name(s): Approach Method
Intervention type(s): Procedure
Intervention description(s): SIDG : 1 incision (umbilicus 2.5cm) TLDG : 5 incisions (12mm ports X 3, 5mm ports X 2, umbilicus extension up to 3cm for specimen delivery)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Stomach neoplasm; TLDG; SIDG; single-port; inflammatory response
Pharmacokinetics, Safety and Tolerability of BIIL 284 BS in Patients With Hepatic Impairment in Comparison to Healthy Volunteers
Condition: Hepatic Insufficiency
MeSH terms: Hepatic Insufficiency; Liver Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the pharmacokinetics of a single dose of BIIL 284 BS in patients with hepatic
      impairment in comparison to healthy subjects
    


Intervention name(s): BIIL 284 BS
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Nebulized MgSO4 in Persistent Pulmonary Hypertension of Newborn
Condition: Persistent Fetal Circulation; Persistent Pulmonary Hypertension of the Newborn; PPHN
MeSH terms: Hypertension, Pulmonary; Persistent Fetal Circulation Syndrome; Hypertension
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this pilot randomized controlled blinded study is to evaluate the feasibility of
      using nebulized magnesium sulfate in the treatment of PPHN.
    

Detailed description: 
      The effectiveness and safety of nebulized magnesium sulfate (using isotonic solution in a
      dose of 1024 mg/hour) is compared with intravenous magnesium sulfate (200 mg/kg over 30
      minutes, followed by 50 mg/kg/hour) in treating mechanically ventilated neonates with severe
      persistent pulmonary hypertension of the newborn.
    

Intervention name(s): Nebulized Magnesium Sulfate; Intravenous Magnesium Sulfate
Intervention type(s): Drug; Drug
Intervention description(s): Nebulized magnesium sulfate (isotonic solution) 256 mg every 15 minutes; Intravenous magnesium sulfate 200 mg/kg over 30 minutes, followed by a continuous infusion at a rate of 50 mg/kg/hour
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups of neonates with PPHN
NebMag group: receive nebulized magnesium sulfate and intravenous placebo.
IVMag group: receive intravenous magnesium sulfate and nebulized placebo.
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: neonate; persistent fetal circulation; persistent pulmonary hypertension of the newborn; PPHN; Magnesium Sulfate; Nebulizer; hypoxia
Anakinra in Infants and Children With Coronary Artery Abnormalities in Acute Kawasaki Disease
Condition: Kawasaki Disease
MeSH terms: Mucocutaneous Lymph Node Syndrome
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Kawasaki disease (KD) is the leading cause of acquired heart disease in children in the
      developed world. Despite available treatment, 25% of children in San Diego County
      appropriately treated for KD develop coronary artery abnormalities that may lead to
      complications later in life, including heart attack. Although the investigators can identify
      children with KD that have these coronary artery abnormalities, there is no approved
      additional treatment to decrease coronary artery inflammation and arrest or prevent damage to
      the coronary arteries. Anakinra, a therapy that blocks the high levels of interleukin 1 (IL1)
      that lead to inflammation during acute KD, has been shown in the KD mouse model to prevent
      the development of coronary artery damage. Therefore, the investigators propose to study the
      safety and activity of anakinra in infants and children < 2 years old with coronary artery
      abnormalities from KD.
    


Intervention name(s): Anakinra
Intervention type(s): Drug
Intervention description(s): First two doses IV followed by SQ dosing
Other intervention name(s): Kineret
Intervention MeSH terms: Interleukin 1 Receptor Antagonist Protein
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Kawasaki disease; Anakinra; IL-1
Influence of SLCO2B1 Polymorphism on the PK of Voriconazole in CYP2C19 PM
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A clinical trail to investigate the influence of SLCO2B1 polymorphism on the pharmacokinetic
      characteristics of voriconazole in CYP2C19 poor metabolizers
    


Intervention name(s): Vfend (voriconazole) intravenous infusion; Vfend (voriconazole) tablet
Intervention type(s): Drug; Drug
Intervention description(s): Vfend (voriconazole) 200 mg intravenous infusion during 1.5 h; Vfend (voriconazole) 200 mg tablet once
Other intervention name(s): IV; Oral
Intervention MeSH terms: Voriconazole
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Trial to Evaluate the Safety and Immunogenicity of Multivalent Pneumococcal Vaccines in Japanese Adults 18 to 49 Years of Age
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1b will describe the safety and immunogenicity of 2 multivalent pneumococcal
      conjugate vaccine formulations in healthy Japanese adults in the United States.
    


Intervention name(s): Prevnar 13; multivalent pneumococcal conjugate formulation 1; multivalent pneumococcal conjugate formulation 2
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 13 valent Pneumococcal Conjugate; multivalent pneumococcal conjugate formulation 1; multivalent pneumococcal conjugate formulation 2
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Tax Preparation Pilot
Condition: Financial Stress; Maternal Distress
MeSH terms: Financial Stress
Study type: Interventional

Summary: 
      The goal of this study to understand what percentage of families in the pediatric clinic at
      Boston Medical Center (BMC) currently file taxes and use free tax preparation and would
      accept and use referral to a free tax preparation service. The investigators specifically
      want to understand which of two methods of connecting to free tax preparation (referral
      versus navigated connection) is more effective. Also studied will be the feasibility of using
      surveys on financial wellness and other health indicators to track participants' health.

      These pilot findings will be used to design a larger study that aims to assess whether
      integrating free tax preparation services into a pediatric clinic can increase tax filing
      rates and, as a result, the amount of money families receive in tax refunds. Additionally,
      the investigators hope to understand whether receiving this service impacts parental stress
      as well as how parents and babies are using the healthcare system.
    


Intervention name(s): Referral for tax preparation services; Navigator assisted tax preparation services at BMC
Intervention type(s): Other; Other
Intervention description(s): Printed materials will be provided with contact information for tax preparation services at BMC and other sites in the city.; A study navigator will assist the participant in accessing the BMC located tax preparation services.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Tax preparation service; Tax filing; Earned Income Tax Credit (EITC); Child tax credit
The Influence of Desensitizing Agent on Postoperative Sensitivity in Posterior Composite Restoration
Condition: Dentin Hypersensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional

Summary: 
      This study aims to investigate the influence of desensitizing agents on reducing
      post-operative sensitivity in posterior composite.
    


Intervention name(s): Hurriseal desensitizer; Gluma desensitizer
Intervention type(s): Other; Other
Intervention description(s): Patients will receive Hurriseal desensitizing agent and universal bond and composite.
Cavities will be restored with light-cured composite resin following the application of bonding agent.; Patients will receive Gluma desensitizing agent and universal bond and composite.
Cavities will be restored with light-cured composite resin following the application of bonding agent.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Safety and Immunogenicity Study of Rift Valley Fever Vaccine, Inactivated
Condition: Rift Valley Fever
MeSH terms: Coccidioidomycosis; Coccidiosis; Rift Valley Fever; Fever
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to determine the safety and immunogenicity of an inactivated Rift
      Valley Fever (RVF) Vaccine in adults
    

Detailed description: 
      The primary objectives are to assess safety of Rift Valley Fever (RVF) Vaccine, Inactivated
      (TSI-GSD 200) and to assess immunogenicity of Rift Valley Fever (RVF) Vaccine, Inactivated
      (TSI-GSD 200). The secondary objective is to assess incidence of RVF infection in vaccinated
      personnel
    

Intervention name(s): Inactivated, Dried (TSI-GSD 200), RVF Vaccine
Intervention type(s): Biological
Intervention description(s): All subjects: 1.0-mL (SQ)doses on day 0, once between days 7 & 14, & once between days 28-42. Initial responders: A 6-month mandatory vaccine booster dose (1.0 mL, SQ) will be given if the PRNT80 is ≥1:40 after the primary series. Subsequent booster doses will be given for PRNT80 titer <1:40. Initial non-responders: Individual who has a PRNT80 titer <1:40 following the primary series may be administered a booster dose before 6 months. The individual will not receive the mandatory 6-month booster dose. Once an initial non-responder achieves PRNT80 ≥1:40, additional booster doses will be given for subsequent PRNT80 <1:40). All subjects: RVF booster dose will be administered within 90 days after a PRNT80 result of <1:40.
Intervention model: Single Group Assignment
Intervention model description: Open-label, Phase 2, uncontrolled, vaccine study to assess the safety, immunogenicity of RVF (inactivated) vaccine (1.0 mL subcutaneous, SQ).
Three primary series doses; for responders to the vaccine (PRNT80 ≥ 1:40), 6 month mandatory vaccine booster dose;
Three primary series doses; for non-responders to the vaccine (PRNT80 < 1:40) may be boosted before 6 months.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hemorrhagic Fever; Viral Infections; Neurologic diseases; Arbovirus Infections; RVF
Observational Study of Safety of NovoMix® 30 Treatment for Type 2 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Observational

Summary: 
      This trial is conducted in Europe. The aim of this trial is to evaluate the incidence of
      serious adverse drug reactions when initiating insulin therapy with NovoMix® 30 in subjects
      with type 2 diabetes mellitus under normal clinical practice conditions in Sweden.
    


Intervention name(s): biphasic insulin aspart 30
Intervention type(s): Drug
Intervention description(s): Dose individually adjusted, and administered subcutaneously (under the skin) once or twice daily
Intervention MeSH terms: Insulin Aspart; Biphasic Insulins; Insulin aspart, insulin aspart protamine drug combination 30:70
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        After the physician has decided to initiate biphasic insulin aspart 30 therapy, any
        insulin-naïve patient with type 2 diabetes mellitus in need of improved metabolic control,
        as judged by the treating physician, will be able to participate
A Pilot Study to Evaluate the PK Profile of PrimeC-ER Tablets in Healthy Adult Subjects
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, randomized, single-dose, three treatment, three-period crossover study
      comparing the test and reference products under fasted or fed conditions (as applicable). In
      one period of the study, PrimeC-ER tablets will be administered to subjects following an
      overnight fast of at least 10 hours. In a second period of the study, PrimeC-ER tablets will
      be administered to subjects at 30 minutes following the start of a standardized high-fat,
      high-calorie breakfast that was preceded by an overnight fast of at least 10 hours. In a
      third period of the study, a single 750 mg dose of ciprofloxacin and a single 200 mg dose of
      celecoxib will be co-administered to subjects following an overnight fast of at least 10
      hours. The order of administration will follow a six-sequence randomization schedule. Blood
      samples will be collected at pre-dose and at intervals over 48 hours after dosing in each
      study period. Subjects will be confined at the clinical facility from at least 10.5 hours
      before dosing until 48 hours after dosing in each study period. The interval between doses
      will be at least 7 days. Subjects will return to the clinical facility 7 days (± 1 day) after
      the last study drug administration for an end-of study follow-up visit.
    


Intervention name(s): PrimeC-ER 748 mg; Ciprofloxacin 750 MG; Celecoxib 200mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): PrimeC-ER is an extended release formulation of a fixed dose combination of ciprofloxacin and celecoxib; Ciprofloxacin; Celecoxib
Intervention MeSH terms: Ciprofloxacin; Celecoxib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dopamine and Norepinephrine Infusion With Restricted Hydration
Condition: Renal Function Test, Urine Output, Lactate Level
Study type: Interventional

Summary: 
      This study was designed to assess the effect of adding dopamine infusion in addition to
      restrictive hydration combined with noradrenaline infusion on intraoperative serum lactate
      levels as an indicator for tissue hypo perfusion and renal function in comparison to
      restrictive hydration combined with noradrenaline infusion only and standard hydration during
      open abdominal surgeries.
    

Detailed description: 
      One hundred and twenty patients were randomly assigned into three groups (dopamine
      norepinephrine group, restrictive hydration group and liberal hydration group) undergoing
      open abdominal procedures (radical cystectomy and hemi colectomy). In Restrictive group
      (n=40): Ringer's solution was infused at a rate of 1 ml.kg.h-1 until the basic part of the
      surgery (tumor resection) is completed to be followed by 3 ml.kg.h-1 of Ringer's solution
      until the end of surgery. Noradrenaline infusion (0.07mcg.kg.min-1) was combined with fluids
      until the end of surgery. In Liberal group (n=40): the conventional fluid replacement was
      introduced according to maintenance, deficit for the first 3 hours (hours fasting x body
      weight) and 3rd space loss (estimated between 8-10 ml.kg.h-1).

      The outcome to be assessed was serial measurements of serum lactate intraoperatively and
      immediate postoperatively as an index of tissue perfusion, in addition to blood pressure,
      heart rate and oxygen saturation.
    

Intervention name(s): Norepinephrine, dopamine
Intervention type(s): Drug
Intervention description(s): drugs to decrease bleeding
Intervention MeSH terms: Dopamine; Norepinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Diagnostic
Keywords: Restrictive hydration,; Dopamine,; Norepinephrine,; Serum lactate,; Standard hydration
A Prospective Study of Risperdal (Risperidone) for the Treatment of Behavioral Disorder Following Psychological Therapy for Challenging Behavior in Learning Disabled Children
Condition: Learning Disorders; Child Behavior Disorders
MeSH terms: Learning Disabilities; Mental Disorders; Child Behavior Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess whether risperidone (an antipsychotic medication) is
      safe and effective in treating behaviour disorder in learning disabled children, which does
      not improve with psychological therapy.
    

Detailed description: 
      There is a high incidence of behaviour disorder in people who are learning disabled. The
      purpose of this study is to assess whether risperidone is safe and effective in the treatment
      of learning disabled children diagnosed with behaviour disorder, which does not improve with
      psychological therapy. If the learning disability is very severe, or the behaviour disorder
      is very severe, such therapy is not appropriate and thus is not attempted; these patients are
      nevertheless eligible to participate in the study. At the beginning of treatment, the dose of
      risperidone is titrated, by gradual increase from 0.25 mg/day up to a maximum of 4 mg/day,
      based on therapeutic response, with decreases allowed in case of adverse reactions. Patients
      will be assessed over six months. The primary measure of effectiveness is the change compared
      to baseline in the total score on the Aberrant Behaviour Checklist (ABC). The EPSS is used to
      monitor the appearance of extrapyramidal symptoms. Based on results from other studies and
      the differences observed as a result of treatment, the investigator and his team expect to be
      able to detect a statistically and clinically significant result if data are available for 15
      evaluable patients. Twenty patients will be recruited, taking account of possible drop outs.
      0.25 mg of risperidone per day, taken orally, up to a maximum daily dose of 4 mg/day, for a
      treatment period of 6 months.
    

Intervention name(s): risperidone
Intervention type(s): Drug
Intervention MeSH terms: Risperidone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: learning disorder; children; behaviour disorder; risperidone
Satisfaction and Compliance of Risedronate in PMO
Condition: Osteoporosis, Postmenopausal
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Study type: Interventional
Phase: Phase 4

Summary: 
      Compare subject satisfaction of once a week dosing of 35 mg Risedronate to once daily dosing
      of 5 mg Risedronate in postmenopausal osteoporotic women. Secondary objectives are to measure
      compliance (50 % drug taken), and persistence.
    


Intervention name(s): Risedronate Sodium
Intervention type(s): Drug
Intervention MeSH terms: Risedronic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment