bioihbjkbjnl/mcl2 huggingface dataset:
Long-term Persistence Study to Assess a Booster Dose of GSK Biologicals' Hib-MenC
Condition: Haemophilus Influenzae Type b; Neisseria Meningitidis
Study type: Interventional
Phase: Phase 3

Summary: 
      This protocol posting deals with objectives & outcome measures of the extension phase at
      Months 18, 30, 42, 54 and 66 post booster. The objectives & outcome measures of the primary
      phase are presented in a separate protocol posting (NCT number = NCT00352963). The objectives
      & outcome measures of the Booster phase/study are presented in a separate protocol posting
      (NCT number =NCT00323050).

      The purpose of this study is to evaluate the persistence of meningococcal serogroup C and Hib
      antibodies on a yearly basis for a period of 5.5 years after booster vaccination. The
      Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
    

Detailed description: 
      This multicenter study is open. No vaccine will be administered during this persistence phase
      of the study. The subjects were randomized in the primary vaccination study 217744/097
      (DTPa-HBV-IPV-097) and will not be further randomized in this study. The study has 3 groups
      with Meningitec™ primed group as control. The protocol was amended to allow for enrollment of
      subjects of the Meningitec™ primed control group who were boosted with Meningitec™ after the
      end of the booster study as per new local reccommendation in Spain.
    

Intervention name(s): Haemophilus influenzae type b- and meningococcal (vaccine); Infanrix™ penta; Infanrix™ hexa; Engerix-B; NeisVac-C™; Infanrix™ IPV/HIB; Meningitec™
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Biological
Intervention description(s): Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age (group HibMenC) and as booster dose at 14 months of age (groups HibMenC and group NeisPoo).; Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age; Intramuscular injection into the thigh as primary vaccination at 2, 4 and/or 6 months of age (groups NeisPoo and MenCCRM) and/or as booster dose at 14 months of age (group MenCCRM).; Intramuscular injection into the thigh as a birth dose; Intramuscular injection into the thigh as primary vaccination at 2 and 4 months of age.; Intramuscular injection into the thigh as primary vaccination at 4 months of age; Intramuscular injection into the thigh as primary vaccination at 2, 4 and 6 months of age
Intervention MeSH terms: PENTA
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: H.influenzae type b Disease
Effects of Alcoholic Beverages in Pro-inflammatory and Antioxidant Profile After an Oral Fat Diet
Condition: Alcohol Consumption
MeSH terms: Alcohol Drinking
Study type: Interventional

Summary: 
      Hypothesis: Red wine intake but not other alcoholic beverages together with a fat diet will
      decrease inflammatory factors and lipid peroxidation and decrease antioxidant capacity in
      healthy people after a five days period.
    


Intervention name(s): Oral fat diet plus water with sugar; Oral fat diet plus alcoholic beverages
Intervention type(s): Other; Other
Intervention description(s): All participants were assigned to receive and oral fat diet plus sugar water. Oral fat diet contained 1487 kcal/m2 with 654 kcal/m2 (44%) as fat. Sugar water has equivalent caloric intakes as alcoholic beverages.; Oral fat diet contained 1487 kcal/m2 with 654 kcal/m2 (44%) as fat. In all cases, alcohol represented a daily total amount of 16 g/m2. The content of alcohol was 12% in red wine, 37% in rum, and 35% in brandy.Vodka was tri-distilled and contained 40% alcohol.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: alcohol, inflammation, oxidation.
Bioavailability Study of Ciprofloxacin 1000 mg ER Tablets of Dr. Reddy's Under Fasting Conditions
Condition: Fasting
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the relative bioavailability of ciprofloxacin 1000 mg
      ER tablets of Dr.Reddy's with that of CIPRO® XR 1000 mg of Bayer Pharmaceuticals Corporation
      in healthy, adult, non-smoking subjects under fasting conditions.
    

Detailed description: 
      This single dose, randomized, two-period, two-treatment, two sequence crossover study was
      conducted to compare the relative bioavailability of ciprofloxacin 1000 mg ER tablets of Dr.
      Reddy's and CIPRO® XR 1000 mg of Bayer Pharmaceuticals Corporation under fasting conditions.
    

Intervention name(s): CIPRO®XR
Intervention type(s): Drug
Intervention description(s): Ciprofloxacin 1000 mg Tablets Dr. Reddy's Laboratories Limited
Other intervention name(s): CIPRO®XR tablets of Bayer Health Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Silver Diamine Fluoride Effectiveness Versus Atraumatic Restorative Treatment in Arresting ECC
Condition: Early Childhood Caries
Study type: Interventional

Summary: 
      The study was conducted to evaluate the effectiveness of the biannual application of 38%
      silver diamine fluoride in arresting early childhood caries when compared to atraumatic
      restorative treatment.
    

Detailed description: 
      Owing to the virulent nature of early childhood caries (ECC) and its consequences if left
      untreated, immediate intervention is indicated to control the condition.

      Barriers to intervention as young age, uncooperative patient behavior and lack of access to
      dental care are however, very common. The use of silver diamine fluoride as an anticaries
      agent is of growing popularity worldwide due to its promising results, safety of use, ease of
      application and relatively low cost. Further research is still required in order to provide
      evidence-based recommendations regarding the use of SDF in arresting early childhood caries.
      Purpose: To evaluate the effectiveness of biannual application of 38% silver diamine fluoride
      in arresting early childhood caries when compared to atraumatic restorative treatment.
    

Intervention name(s): SDF; ART
Intervention type(s): Drug; Procedure
Intervention description(s): SDF promotes enamel and dentin remineralization, as well as inhibit the growth of cariogenic bacteria. the Food and Drug Administration (FDA) approved SDF as a device for reducing tooth sensitivity in the USA.; The ART technique involves caries excavation by hand instruments only with care to avoid pulp exposure. Such excavation is mainly from the periphery of the lesion to achieve a good seal of the restoration and minimize leakage. The tooth is then restored by glass ionomer cement.
Other intervention name(s): Silver Diamine Fluoride
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Pharmacokinetics of Recombinant Factor XIII in Healthy Volunteers
Condition: Congenital Bleeding Disorder; Congenital FXIII Deficiency; Healthy
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial was conducted in Europe. The aim of this trial was to investigate safety and
      pharmacokinetics of escalating single doses of catridecacog (recombinant factor XIII, rFXIII)
      in healthy volunteers.
    


Intervention name(s): catridecacog; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single doses of rFXIII administered intravenously (IV) to eight subjects in each of the five dose groups (2, 5, 10, 25 and 50 U/kg).; Single doses of placebo administered intravenously (IV) to two subjects in each of the five dose groups (2, 5, 10, 25 and 50 U/kg).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
ARVAC - A New Recombinant Coronavirus Disease 2019 (COVID-19) Vaccine
Condition: COVID-19 Vaccine
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this clinical trial is to test a new vaccine against SARS-CoV-2 (ARVAC-CG)
      in healthy adult volunteers, previously vaccinated against the SARS-CoV-2 virus.

      The main questions it aims to answer are:

        -  What is the safety and tolerability profile of the two-dose schedule of this new
           vaccine?

        -  What is the immune response after each dose of vaccine Participants will receive two
           doses of the study vaccine 28 days apart. They will be required to complete a total of 7
           safety and immunogenicity follow-up visits over a 1-year period.
    


Intervention name(s): ARVAC-CG vaccine (recombinant protein vaccine against SARS-CoV-2)
Intervention type(s): Biological
Intervention description(s): 2 doses of vaccine with an interval between doses of 28 days. Administration route: Intramuscular (IM) injection
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: The volunteers will be divided into 2 arms:
Group 1 will receive a vaccination schedule of 2 doses of 25 µg of antigen Group 2 will receive a vaccination schedule of 2 doses of 50 µg of antigen
Masking: None (Open Label)
Primary purpose: Prevention
A Dose-response Study of Lidocaine and Etomidate
Condition: Etomidate Overdose of Undetermined Intent
MeSH terms: Drug Overdose
Study type: Interventional
Phase: Phase 1

Summary: 
      IV lidocaine administration can reduce the minimal amount of Etomidate and time for induction
      of anesthesia.
    

Detailed description: 
      The study was carried out in West China Hospital of Sichuan University, Chengdu, China. All
      the patients were informed in detail about the procedure and the medications they are going
      to get. Patients are well informed about the beneficial and possible hazards of the medicines
      and procedure. Patients are also informed that they can withdraw from the study at any time
      if they find it uncomfortable or harmful for them. Patients' written informed consent was
      obtained and registered for the permission from the Hospital's Ethics Board.
    

Intervention name(s): Lidocaine 1mg/kg; Lidocaine 1.5mg/kg; Lidocaine 2mg/kg; Lidocaine 2.5mg/kg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): The total dosage of Etomidate needed for induction of anesthesia is recorded at last.; same as other; same as other; same as other
Other intervention name(s): Lidocaine; serial number:1303E11; Etomidate-Lipuro; serial number:11215033; Lidocaine; serial number:1303E11; Etomidate-Lipuro; serial number:11215033; Lidocaine; serial number:1303E11; Etomidate-Lipuro; serial number:11215033; Lidocaine; serial number:1303E11; Etomidate-Lipuro; serial number:11215033
Intervention MeSH terms: Lidocaine; Etomidate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: iv lidocaine; inducing dose; etomidate; dose response
Outcomes of Three Corner Fusion Without Triquetrum Excision Versus Conventional Four Corner Fusion in SNAC Wrist
Condition: Scaphoid Fracture
Study type: Interventional

Summary: 
      The investigator compare two types of limited wrist arthrodesis used for management of cases
      with scaphoid non union advanced collapse (SNAC) as regard the outcome to provide the most
      suitable technique
    

Detailed description: 
      There is a controversy regarding the suitable limited wrist arthrodesis technique for SNAC
      wrist grade II and III . For several decades , scaphoid excision and four corner fusion
      (between lunate , capitate , hamate and triquetrum) was the gold standard with good
      functional outcomes . Later on , a more limited fusion technique was described , three corner
      fusion ( between lunate , capitate and hamate) with scaphoid and triquetrum excision to
      improve ulnar deviation range . On the other hand , biomechanical studies mentioned that the
      triquetrum had a certain proprioceptive function that could be affected when it was included
      in the fusion process .Furthermore , if the triquetrum was excised the radiolunate contact
      pressure would increase with higher risk of development of arthritis. The aim of the study to
      compare the conventional four corner fusion with three corner fusion with triquetrum excision
    

Intervention name(s): Four corner fusion; three corner fusion without triquetrum excision
Intervention type(s): Procedure; Procedure
Intervention description(s): First , we inspected the radiocarpal joint for any arthritis before starting the technique , if there was no arthritis , we go on for the procedure . After scaphoid excision , we denuded the articulating surfaces between lunate , capitate , hamate and triquetrum . Then ,any lunate extension deformity was corrected . Then we use k.wires as a fixation method between the above mentioned carpal bones; First , we inspected the radiocarpal joint for any arthritis before starting the technique , if there was no arthritis , we go on for the procedure . After scaphoid excision , we denude the articulating surfaces between lunate , capitate , hamate and don not include triquetrum. Then ,any lunate extension deformity was corrected . Then we use k.wires as a fixation method between the above mentioned carpal bones.
Other intervention name(s): four corner arthrodesis
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two groups with the first intervention four corner fusion , and the second with three corner fusion without triquetrum excision
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SNAC wrist; Four-corner fusion; Three corner fusion
Inflammatory Response After One-lung Ventilation According to Ventilation Methods
Condition: Lung Cancer
Study type: Interventional

Summary: 
      Unlike conventional thoracic surgery performed under general anesthesia with tracheal
      intubation, non-intubated thoracic surgery with sedation and regional anesthesia has been
      performed recently. Non-intubated thoracic surgery is expected to reduce the postoperative
      inflammatory changes by maintaining more physiologic status during the operation compared to
      intubated thoracic surgery. The aim of this study was to compare perioperative immunological
      changes between intubated and non-intubated thoracic surgery.
    


Intervention name(s): Ventilation method
Intervention type(s): Other
Intervention description(s): Depending on the group assignment, mechanical ventilation or spontaneous breathing was performed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of VMP001 and AS01B (Adjuvant Formulation) in Healthy Malaria-Naïve Adults
Condition: Malaria; Plasmodium Vivax
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a first-in-humans safety, immunogenicity and efficacy study with recombinant protein
      VMP001, a Plasmodium vivax circumsporozoite (CS) protein based vaccine. This open label study
      will be performed in malaria-naïve adults in the United States. Three doses of VMP001
      formulated in AS01B (adjuvant system) will be given intramuscularly at different intervals
      followed by a challenge with P. vivax infected mosquitoes. Safety, immunogenicity and
      efficacy parameters will be studied.
    

Detailed description: 
      This is a Phase 1/2a, non-randomized, open label, dose escalation study in healthy,
      malaria-naïve adults aged 18 to 55 years (inclusive). The vaccine will be administered with
      GlaxoSmithKline Biologicals' adjuvant system AS01B. This is a first-in-human study of VMP001;
      therefore the study design will incorporate a dose-escalation phase evaluating 15 µg, 30 µg,
      and 60 µg doses of VMP001 in 500 µL of AS01B. A total of 30 volunteers, divided into 3 groups
      (10 in each group), will receive 3 doses of the VMP001/AS01B vaccine. Group 1 will receive 15
      µg of VMP001, Group 2 will receive 30 µg of VMP001, and Group 3 will receive 60 µg of VMP001
      at each immunization. The dose of AS01B will be 500 µL for all groups. The first and second
      dose in each group will be separated by 28 days. The third dose in the three groups will be
      given at intervals scheduled to normalize the time to challenge between the last immunization
      and challenge. The second and third dose in Group 1 will be separated by 56 days, Group 2 by
      42 days and Group 3 by 28 days. The challenge will occur 2 weeks following the third
      immunization. A group of 6-12 infectivity controls will begin participation in the study at
      the challenge stage. They will not receive any immunizations or placebos prior to challenge.
      All volunteers will receive a standard treatment regimen consisting of chloroquine and
      primaquine on the day that parasitemia is detected. Volunteers who do not become parasitemic
      will also begin the same treatment regimen on day 28 following the challenge (study day 126).

      >

      > Safety and immunogenicity will be evaluated during the study through the final study visit
      6 months after challenge (study day 280).
    

Intervention name(s): VMP001; P. vivax sporozoite challenge
Intervention type(s): Biological; Other
Intervention description(s): Plasmodium vivax malaria protein 001 (VMP001) with GSK Biologicals' Adjuvant System AS01B; P. vivax sporozoite challenge
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Malaria; Plasmodium Vivax; Vaccine
Bioequivalence Study of Favipiravir 200 mg Film Tablet (ATABAY, Turkey) Under Fasting Conditions
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      A single dose of Reference product containing 200 mg favipiravir and a single dose of Test
      product containing 200 mg favipiravir or vice versa; administered with 240 mL of water at
      room temperature, in each period under fasting conditions with current pandemic precautions.
    

Detailed description: 
      Favipiravir is a drug with a mechanism of action different from that of the existing
      influenza antiviral drugs and effective against all types and sub-types of human influenza A,
      B and C viruses in vitro, showing anti-viral activity against various influenza virus strains
      including avian and swine viruses. Favipiravir also has shown anti-viral activity even
      against amantadine, oseltamivir and zanamivir-resistant influenza viruses in vitro. The
      mechanism of action of favipiravir is the selective inhibition of RNA polymerase by
      favipiravir ribosyl triphosphate formed by cellular enzymes in the influenza virus leading to
      antiviral activity.
    

Intervention name(s): FAVICOVIR 200 mg Film Tablet; AVIGAN 200 mg Film Tablets
Intervention type(s): Drug; Drug
Intervention description(s): FAVICOVIR 200 MG FT is containing 200 mg favipiravir manufactured by Atabay, Turkey.; AVIGAN 200 mg FT is containing 200 mg favipiravir manufactured by Toyama, Japan.
Other intervention name(s): Favipiravir 200 MG FT; Favipiravir 200 mg FT
Intervention MeSH terms: Favipiravir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: COVID-19 drug treatment; Antiviral Agents; Favipiravir; Novagenix; Farmagen
Is the Efficacy of Epidural Steroid Injections Related to the Different Volume Injections?
Condition: Pain
Study type: Interventional

Summary: 
      This study was aimed to investigate the impact of using different epidural volumes.

      Patients with acute discogenic pain were included in the study.
    

Detailed description: 
      Objectives: This study was aimed to investigate the impact of using different epidural
      volumes.

      Methods: Seventy five patients with acute discogenic pain were included in the study.The
      patients were randomly assigned to three groups. All patients received a single epidural dose
      of triamcinolone [80 mg] and 12.5 mg bupivacaine combination. The patients in Group 1, Group
      2 and Group 3 received a volume of 10 mL, 15 mL, and 20 mL by epidural injections,
      respectively. The efficacy of treatment was assessed with VAS (visual analog scale) [O= no
      pain, 10 = unbearable pain], SLET(straight leg elevation test) [0° = worst, 85° = best], and
      Oswestry Disability Index; ODI [0% to 20%:minimal disability , 80% to 100%:bed bound
      patients] before and 2 weeks after the EPSI.
    

Intervention name(s): Triamcinolone; Epidural Volume; Bupivacaine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Triamcinolone; Epidural Volume; Bupivacaine
Other intervention name(s): Kelanocort; Marcaine
Intervention MeSH terms: Triamcinolone; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: Anesthesia; Adverse Effect; Spinal; Epidural
Clinical Research Plan for Human Myopia Models
Condition: Human Myopia Model
MeSH terms: Myopia
Study type: Observational

Summary: 
      Collect optical biological parameters, refractive index data, and other related parameters of
      myopia and refractive errors in children and adolescents, and establish an optical model of
      myopia in children and adolescents.
    

Detailed description: 
      Experimental research purpose:Collect optical biological parameters, refractive index data,
      and other related parameters of myopia and refractive errors in children and adolescents, and
      establish an optical model of myopia in children and adolescents.

      Case selection: This study requires the inclusion of children and adolescents aged between 4
      and 18 years who have been diagnosed with myopia and refractive errors through medical
      examination of dilated pupils.

      Plan: Collect eye parameters such as refractive power, whole eye aberration, corrected visual
      acuity, pupil diameter, axial length, anterior and posterior corneal surface curvature, and
      corneal thickness of all subjects under 9 non dilated stimuli.
    

Intervention name(s): No intervention measures
Intervention type(s): Other
Intervention description(s): No intervention measures
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Recruited volunteers
      
Biospecimen description: 
      Samples Without DNA