bioihbjkbjnl/mcl2 huggingface dataset:
Study of Adsorption Tetanus-diphtheria-acellular Pertussis (DTaP) Vaccine in Healthy 3 to 5 Months Infants
Condition: Pertussis
MeSH terms: Whooping Cough; Diphtheria
Study type: Interventional
Phase: Phase 3

Summary: 
      Pertussis, diphtheria and tetanus are seriously infectious diseases in children. Since using
      of the adsorption diphtheria-tetanus-whole-cell pertussis (DTwP), it greatly reduced
      incidence of the three kinds of diseases. But the thallus of pertussis in the vaccine may
      cause more side reactions after vaccination. Since 2000, the basic immunization DTwP vaccine
      has been replaced by adsorption tetanus-diphtheria-acellular pertussis vaccine in American.
      In 1995, DTaP was successfully developed in China, and have been used in EPI at present.
      Because of effective immunity and little side reaction, DTaP has been widely recognized and
      accepted by the parents.
    

Detailed description: 
      Pertussis, diphtheria and tetanus are seriously infectious diseases for children. The world
      health organization (WHO) included the adsorption diphtheria-tetanus-whole-cell pertussis
      (DTwP) into the expanded program on immunization (EPI), as a basic immunization. Since using
      the DTwP, it greatly reduced incidence of the three kinds of diseases. Thousands of children
      have been saved since its application. Although the DTwP was productively in against
      pertussis, diphtheria and tetanus, thallus of pertussis in the vaccine could cause more side
      reactions after vaccination. Many individuals did not want to be vaccinated. However, there
      was two large epidemics of pertussis during the period of 1977-1979 and 1981-1983. Since
      2000, the basic immunization DTwP vaccine has been replaced by adsorption
      tetanus-diphtheria-acellular pertussis vaccine (DTaP) vaccine in American. In 1995, DTaP was
      successful developed in the investigators' country, and is used in EPI at present. Because of
      effective immunity and causing little side reaction, DTaP has been widely recognized and
      accepted by the parents. This clinical trial is planning to evaluate the immunogenicity and
      safety of DTaP in 3-5 months infants .
    

Intervention name(s): DTaP Vaccine A; DTaP Vaccine B
Intervention type(s): Biological; Biological
Intervention description(s): Adsorption tetanus-diphtheria-acellular pertussis (DTaP) Vaccine A(Bejing minhai Biological Co., LTD) of 0.5ml, three doses, 28 days interval; Adsorption tetanus-diphtheria-acellular pertussis (DTaP) Vaccine B(Changchun changsheng Biological Co., LTD ) of 0.5ml in 600 infants aged 3-5months on day 0, 28, 56.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Immunogenicity; Safety; DTaP Vaccine
Enbrel-Juvenile Idiopathic Arthritis (JIA) Use Results Survey [All-Case Surveillance]
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Observational

Summary: 
      This surveillance is conducted to survey the followings under the post marketed drug
      utilization on the patients who are administrated ENBREL as a treatment for active
      polyarticular JIA.

        1. Primary Occurrence status of Adverse Events; incidence of all adverse events, serious
           adverse events

        2. Secondary Factors affecting safety and to confirm the efficacy such as DAS28.
    

Detailed description: 
      All patients who administrated ENBREL for active polyarticular juvenile idiopathic arthritis
      during registered period (2.5 year).
    

Intervention name(s): Etanercept (genetical recombination)
Intervention type(s): Drug
Intervention description(s): All patients who administrated ENBREL for active polyarticular juvenile idiopathic arthritis (restricted to the case of lack of effect by other treatment) during registered period (2.5 year).
Other intervention name(s): Enbrel
Intervention MeSH terms: Etanercept
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        All patients who administrated ENBREL for active polyarticular juvenile idiopathic
        arthritis (restricted to the case of lack of effect by other treatment) during registered
        period (2.5 year).
      
Keywords: Enbrel-JIA
Evaluation of Comfort for Two Marketed Daily Disposable Contact Lenses
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This study is a 2-phase adaptive approach utilizing a 2×2 crossover design. The study lenses
      will be worn in a bilateral fashion for a period of approximately 1-week each.
    


Intervention name(s): ACUVUE Oasys 1-Day; Precision 1
Intervention type(s): Device; Device
Intervention description(s): TEST; CONTROL
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of Ketoflo
Condition: Epilepsy Intractable; Glucose Transporter Type 1 Deficiency Syndrome; Ketogenic Dieting
MeSH terms: Epilepsy; Drug Resistant Epilepsy
Study type: Interventional

Summary: 
      For 28 days, 30 participants aged 3 to 18 years of age (inclusive) with a condition requiring
      a ketogenic diet will incorporate Ketoflo into their usual dietary regime. Ketoflo is a
      nutritionally complete Food For Special Medical Purposes and is suitable for administration
      by both tube feeding and use as a sip feed. Data on gastrointestinal tolerance, participants
      adherence to recommended intakes and their thoughts on the product's palatability will be
      self-reported in Daily Study Diaries.
    

Detailed description: 
      This is a 28-day prospective study to evaluate the acceptability of Ketoflo, in terms of GI
      tolerance, adherence to recommended intakes and palatability. The product's nutritional
      suitability for use in a ketogenic diet will also be evaluated by recording ketone levels and
      seizure frequency measured as part of usual clinical care.

      Ketoflo is nutritionally complete liquid feed for use in the dietary management of epilepsy
      or other neurometabolic conditions requiring a ketogenic diet. It is designed to be
      nutritionally complete from 3-18 years and can be used as a supplementary feed thereafter.

      Ketoflo has been designed in liaison with Key Opinion Leaders and will offer an additional
      choice of prescribe-able feeds for use in the ketogenic diet.

      The study will involve 30 participants, aged between three and eighteen years of age
      (inclusive), who are already established on a ketogenic diet for at least three months before
      the study begins.

      Participants will self-report data in Daily Study Diaries over the course of the study. Data
      will also be collected by the Investigators in Baseline CRFs and End of Study CRFs for all
      participants. Any data collected for the study will be anonymised before being relayed to the
      sponsor.

      The data generated by the trial will be used to support a submission by Vitaflo
      (International) Ltd. to the Advisory Committee on Borderline Substances (ACBS) for Ketoflo to
      become reimbursable on prescription in the UK. The data will also be used in a submission to
      the General Medical Services in the Republic of Ireland.
    

Intervention name(s): Ketoflo
Intervention type(s): Dietary Supplement
Intervention description(s): Ketoflo is a ready to use liquid feed for the dietary management of epilepsy and other conditions that may require a ketogenic diet. It has a 4:1 ratio of fat to carbohydrate and protein and can be administered enterally via a tube feeding or oral consumption.
Intervention model: Single Group Assignment
Intervention model description: Single group - all patients to receive Ketoflo.
Masking: None (Open Label)
Primary purpose: Supportive Care
Bioequivalence Study of Vigabatrin ORPHELIA Pharma 500mg Soluble Tablets and SabrilTM 500mg Granules for Oral Administration
Condition: Therapeutic Equivalency
Study type: Interventional
Phase: Phase 1

Summary: 
      Methodology:

      The study was an open label, randomized, crossover, 2 periods study in 20 healthy male/female
      volunteers. Subjects received 500 mg of the new formulation of soluble tablets vigabatrin or
      Sabril, as single oral administration in 2 different study periods depending on the
      randomization, with a 7-days wash out period between administrations
    

Detailed description: 
      Objectives:

      Primary objective:

      Evaluate bioequivalence between a new paediatric formulation of vigabatrin (VGB-ST) and
      Sabril granules for oral administration.

      Secondary objective:

        -  Define pharmacokinetic parameters of the new paediatric formulation soluble tablets of
           vigabatrin (VGB-ST)

        -  Assess the safety of the new formulation of soluble tablets VGB-ST versus Sabril
    

Intervention name(s): VGB-ST
Intervention type(s): Drug
Intervention description(s): Single oral administration of 500 mg VGB-ST
Other intervention name(s): vigabatrin soluble tablets; Kigabeq
Intervention MeSH terms: Vigabatrin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study was an open label, randomized, crossover, 2 periods study in 20 healthy male/female volunteers. Subjects received 500 mg of the new formulation of soluble tablets vigabatrin or Sabril TM, as single oral administration in 2 different study periods depending on the randomization, with a 7-days wash out period between administrations.
Masking: None (Open Label)
Primary purpose: Treatment
Rapid Diagnostic Tests for Assessment of Initial Clearance and Detection of Recurrent Malaria Infections
Condition: Plasmodium Falciparum Malaria
MeSH terms: Malaria; Malaria, Falciparum
Study type: Observational

Summary: 
      The aim of the study was to follow clearance of malaria infections and detection of new
      malaria episodes after initiation of antimalarial treatment in Tanzanian children. For this
      purpose the investigators used five diagnostic tools, 2 Rapid Diagnostic tests based on
      Histidine Rich Protein 2(HRP2) and Lactate dehydrogenase(LDH), 2 microscopical methods and
      one polymerase chain reaction (PCR). The investigators followed the 53 enrolled children
      during 42 days.
    


Intervention name(s): HRP2 and LDH based rapid diagnostic tests for P.falciparum
Intervention type(s): Device
Other intervention name(s): ParaHit (HRP2); CareStart (pLDH)
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children with fever visiting primary health care units in malaria endemic area
      
Biospecimen description: 
      Whole capillary blood collected for Rapid Diagnostic tests, microscopy and PCR
    
Keywords: RDT; malaria; treatment follow up; diagnosis
Safety and Pilot Efficacy of AKB-9778 in Subjects With Diabetic Macular Edema
Condition: Diabetic Macular Edema (DME)
MeSH terms: Macular Edema; Edema
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and
      pilot efficacy of multiple ascending dose levels of AKB-9778 given as subcutaneous injections
      daily for 28 days in patients with diabetic macular edema (DME).
    


Intervention name(s): Subcutaneous AKB-9778
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Music Distraction Strategy in Children Dental Care
Condition: Children Behavior
Study type: Interventional
Phase: Phase 4

Summary: 
      Music plays an important role reassuring helping reduce anxiety. Anxiety can be an
      interference factor in promoting oral health for children with high levels of anxiety tend to
      have negative behavior at the dentist. High oxygen levels and heart and respiratory
      frequencies are associated with high levels of anxiety. The objective of this study was to
      test the use of music in decreased cardiac and respiratory frequency of treated patients
      listening to music and being treated without hearing music.
    

Detailed description: 
      Feelings like anxiety can alter the levels of blood oxygenation from individuals in different
      situations, like during dental treatment. This cross over trial aimed to analyze the use of
      music as a distraction resource during children dental treatment, evaluating their cardiac
      and respiratory frequency. Thirty-four children took part in this study, 16 boys and 18
      girls, from 4 to 6 years old, with no previous dental experience, who had two carious lesions
      on occlusal surfaces of molars, from the 2 municipalities of southeast Brasil. Children were
      selected through oral clinical exams, conducted in public schools. After parents signed a
      written consent; children were allocated in two groups: treatment with music (G1) and
      treatment without music (G2). Children acted as controls of themselves: the cross between
      groups allowed all children to be treated with and without music. Three dental visits were,
      scheduled in a weekly basis, the first for anamnesis and clinical examination; the second and
      third for the modified atraumatic restorative treatment (ARTm). The Mozart Symphony No 40 in
      G minor K550 was played in headphones. Cardiac and respiratory frequencies were obtained
      using a pulse oximeter, with the measures being taken in three moments: in the beginning of
      the treatment, during the intervention (use of a rotating device) and at the end of the
      treatment. Data were compiled and analyzed through the statistic software Statistical
      Analyse. The Wilcoxon test was used for inter and intra groups comparison (p<0,050).

      Music worked as a reassuring instrument during children dental treatment.
    

Intervention name(s): Music
Intervention type(s): Behavioral
Intervention description(s): This cross over trial aimed to analyze the use of music as a distraction resource during children dental treatment, evaluating their cardiac and respiratory frequency. Thirty-four children took part in this study, 16 boys and 18 girls, from 4 to 6 years old, with no previous dental experience, who had two carious lesions on occlusal surfaces of molars,
Other intervention name(s): The Mozart Symphony No 40 in G minor K550
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: children; behavior; anxiety; dentistry
A Trial of Brexpiprazole in the Treatment of Borderline Personality Disorder
Condition: Borderline Personality Disorder
MeSH terms: Personality Disorders; Borderline Personality Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      There are currently no pharmacological treatments approved to treat borderline personality
      disorder (BPD). This trial will be conducted to evaluate the efficacy and safety of
      brexpiprazole for the treatment of participants diagnosed with BPD to provide a
      pharmacological treatment for BPD.
    


Intervention name(s): Brexpiprazole; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Tablet; Tablet
Other intervention name(s): Rexulti®
Intervention MeSH terms: Brexpiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
New Technologies for Endoscopic Treatment of Bleeding Gastroduodenal Ulcers
Condition: Ulcer Hemorrhage
MeSH terms: Peptic Ulcer; Ulcer; Hemorrhage
Study type: Interventional

Summary: 
      The purpose of the study was to improve treatment results of patients with bleeding
      gastroduodenal ulcers by endoscopic applications of autoplasma, enriched with platelets and
      granular sorbent aseptisorb-A.
    

Detailed description: 
      The clinical study was conducted on the basis of the Voronezh city specialized Center for the
      treatment of patients with gastrointestinal bleeding. The study included 112 patients with
      ulcerative gastroduodenal bleeding. All patients were divided into two groups by random
      sampling: the main group (n=57 people) and the comparison group (n=55 people). In the
      treatment of patients of the main group (57 people), an individual approach was used with the
      use of granular sorbent aseptisorb-A and autoplasm enriched with platelets, in the complex
      endoscopic treatment of bleeding-complicated gastroduodenal ulcers (Patent Russian Federation
      (RF) № 2632771). In the comparison group (55 people), traditional methods of endoscopic
      hemostasis were used.
    

Intervention name(s): Complex endoscopic treatment with the use of granular sorbent aseptisorb-A and autoplasm enriched with platelets; Traditional methods of endoscopic hemostasis
Intervention type(s): Combination Product; Procedure
Intervention description(s): Complex endoscopic bleeding ulcers treatment with the use of granular sorbent aseptisorb-A and autoplasm enriched with platelets; Traditional methods of endoscopic hemostasis were used without the use of platelet-enriched plasma and granular sorbents
Intervention MeSH terms: Hemostatics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: ulcer; bleeding; treatment; aseptisorb-A
A Randomized Trial of 24-Week Versus 48-Week Courses of Peginterferon Plus Ribavirin for HCV Genotype-6 Patients
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients with HCV genotype 6 infection who have a rapid virological response to treatment are
      randomised to either 24 or 48 weeks HCV treatment. Our hypothesis is that there is no
      important difference in effect between the two treatment effect.
    

Detailed description: 
      High rate of infection of Hepatitis C Virus(HCV) Genotype 6 was recently confirmed in
      Southern China. Recent study implied chronic hepatitis C genotype 6 responds better to the
      48-week treatment with pegylated interferon and ribavirin than genotype 1. Approximately
      75.7% obtain sustained virological response (HCV RNA undetectable 24 weeks after treatment)
      to this approach. However, the treatment is associated with many and sometimes serious side
      effects. In addition, the treatment is costly also in economical terms. Shorter treatment for
      chronic hepatitis C genotype 6 is necessary to be assessed.

      In this randomised,open label,multicenter phase 3 trial with active controls patients are
      treated with pegylated interferon alfa 2a (180ug/week)and ribavirin(800-1200mg based on
      weight)for 4 weeks. Those who are HCV RNA negative at week 4 (<50 IU; Cobas Amplicor Monitor
      Test, Roche Diagnostic) are defined as rapid virological responders and randomised to either
      an additional 20 or 44 weeks combination treatment. Patients who are HCV RNA positive are all
      treated for 44 more weeks. The endpoint is sustained virological response defined as
      undetectable HCV RNA 24 weeks after end of treatment.

      Our hypothesis is that there is no important difference in the effect in the two groups.

      This is a non-inferiority trial. The smallest difference considered to be clinically
      important is 15%. Thus to state "non-inferiority" the 95% confidence interval of the observed
      difference between the groups shall not overlap 10%. Both intention to treat and and per
      protocol analyses will be published. Conclusion will be conservative and based on the
      analysis who detect the biggest difference.
    

Intervention name(s): Peginterferon alfa2a; Ribavirin; Peginterferon alfa2a; Ribavirin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): patients receive a dose of 180 µg of PEGASYS once a week for 24 weeks; patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 24 weeks; patients receive a dose of 180 µg of PEGASYS once a week for 48 weeks; patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 48 weeks
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a; Interferon-alpha
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A 6-Month Study Of CP-690,550 Versus Tacrolimus In Kidney Transplant Patients
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2 study was designed to evaluate the safety and efficacy of 2 dose levels of
      CP-690,550 (15 mg twice daily and 30 mg twice) against tacrolimus, in combination with
      basiliximab induction, mycophenolate mofetil and corticosteroids, in kidney transplant
      patients. Stage 1 was to randomize approximately 54 subjects. After all Stage 1 subjects had
      completed 6 months of treatment, Stage 2 was to randomize an additional 195 subjects to the
      same treatment groups.
    


Intervention name(s): CP-690,550; CP-690,550; tacrolimus
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 15 mg twice daily; 30 mg twice daily; dose adjusted according to level
Intervention MeSH terms: Tacrolimus; Tofacitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: tofacitinib; CP-690550; kidney transplant
The Effect of Intracameral Cefuroxime on Post-op Fibrin in Pediatric Cataract Surgery
Condition: Cataract; Endophthalmitis
MeSH terms: Endophthalmitis; Cataract
Study type: Interventional

Summary: 
      The study investigates whether placing an antibiotic inside the eye at the end of cataract
      surgery in children will reduce the amount of fibrin formation (fibrin formation can block
      the pupil and reduce vision). We hypothesize that the fibrin is caused by a low-level
      infection and could be prevented by the antibiotic.
    

Detailed description: 
      The study investigates whether using an antibiotic (cefuroxime) in the anterior chamber of
      the eye at the end of surgery for cataract in children will reduce the amount of fibrin
      formation.
    

Intervention name(s): cefuroxime; Saline placebo
Intervention type(s): Drug; Drug
Intervention description(s): intracameral cefuroxime 0.1 ml; 0.1 ml of Ringers lactate
Other intervention name(s): Zinacef; Saline
Intervention MeSH terms: Cefuroxime; Cefuroxime axetil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: fibrin; endophthalmitis; cataract extraction; Lens; implantation,; intraocular