bioihbjkbjnl/mcl2 huggingface dataset:
Turmeric Gel as Alternative Non-vital Pulpotomy Medicament in Primary Teeth
Condition: Non-Vital Tooth
MeSH terms: Tooth, Nonvital
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this randomized controlled clinical trial is to use Turmeric gel as non-vital
      Pulpotomy medicament compared to Formocresol in primary teeth by evaluating its antibacterial
      effect against Streptococcus mutans and Lactobacillus acidophilus. It is hypothesized that
      there is no difference in the antibacterial effect of Turmeric gel compared with Formocresol,
      when used as non-vital Pulpotomy medicaments.
    

Detailed description: 
      It is a multi-arm parallel Randomized Controlled Trial in which forty patients aged between 4
      to 8 years, each containing at-least one non-vital primary molar, will be selected and
      randomly divided into Group A (Formocresol) and Group B (Turmeric gel). Non-vital Pulpotomy
      will be performed by removing the coronal necrotic pulp. Sterile paper point will be dipped
      in the root canals and taken to the laboratory. Cotton pellets soaked in the respective
      medicaments will be placed over the root canal orifices and filled temporarily. Patients will
      be recalled after one week. Samples will be again taken, and tooth restored. Comparison
      between bacterial count at baseline and after one week of treatment will be made and
      expressed as Colony-Forming Units/ml (CFU/ml).
    

Intervention name(s): Turmeric Gel; Formocresol
Intervention type(s): Drug; Drug
Intervention description(s): Turmeric gel will be used as non-vital pulpotomy medicament compared with Formocresol (which is gold standard); Formocresol will be used as non-vital pulpotomy medicament (which is gold standard)
Other intervention name(s): Medicaments for non-vital pulpotomy procedure; Medicaments for non-vital pulpotomy procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Turmeric gel= interventional drug Formocresol= Control drug (standard drug)
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Tolerance and Prebiotic Activity of Arabinoxylan-Oligosaccharides in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to evaluate the tolerance of a higher dose of
      arabinoxylan-oligosaccharides (AXOS) and their prebiotic activity in healthy subjects.
    


Intervention name(s): arabinoxylan-oligosaccharides (AXOS)
Intervention type(s): Dietary Supplement
Intervention description(s): intake period: 3 weeks, 10 g/day
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: tolerance; prebiotic; gastrointestinal effects
Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of the study was to provide sera (collected from participants before
      vaccination [Blood Sample 1] and after final vaccination [Blood Sample 2]) to the Center for
      Biologics Evaluation and Research (CBER) for further analysis by the World Health
      Organization (WHO), the Centers for Disease Control and Prevention (CDC), and the Food and
      Drug Administration (FDA) to support formulation recommendations for subsequent influenza
      vaccines.
    

Detailed description: 
      All participants received 1 intramuscular injection of the study vaccine associated with
      their assigned group at Visit 1. For participants 6 months to < 9 years of age for whom 2
      doses of influenza vaccine are recommended per Advisory Committee on Immunization Practices
      (ACIP) guidance, a second intramuscular injection of Fluzone Quadrivalent vaccine was
      administered at Visit 2 (28 days after Visit 1).

      Blood specimens were obtained from all participants prior to the first vaccination:

        -  At Visit 1 (Day 0) and 28 days following the final vaccination (Visit 2, if no study
           vaccine was administered at Visit 2; or Visit 3, if a second dose of study vaccine was
           administered at Visit 2), for participants 6 months to < 9 years of age (Group 1 and
           Group 2)

        -  At Visit 1 and 21 (window, 21-28) days post-vaccination (Visit 2), for participants
           greater than or equal to (>=) 65 years of age (Group 3) Serious Adverse Events (SAEs),
           suspected unexpected serious adverse reactions (SUSARs), or Adverse Event of Special
           Interests (AESIs) were collected from Visit 1 through Visit 2 for participants receiving
           1 dose of study vaccine, and from Visit 1 through Visit 3 for participants receiving 2
           doses of study vaccine.

      Study duration per participant was approximately 28 days for participants 6 months to less
      than (<) 9 years of age, and 21 days for participants >= 65 years of age.
    

Intervention name(s): Fluzone Quadrivalent vaccine, no preservative (0.5-mL), 2019-2020 formulation; Fluzone High-Dose vaccine, 2019-2020 formulation
Intervention type(s): Biological; Biological
Intervention description(s): Pharmaceutical form: Suspension for injection Route of administration: Intramuscular; Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
Other intervention name(s): Fluzone® Quadrivalent, No Preservative
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Substantivity of Oral Rinses: Comparative Study
Condition: Prevention & Control
Study type: Interventional

Summary: 
      A desirable quality of mouthrinses is substantivity an intrinsic feature of some molecules.
      Substantivity requires the adsorption of the agent on the oral surfaces and subsequently
      antimicrobial activity bacteriostatic along following hours. This work aims to quantitatively
      determine the substantivity of (i) a single o-Cymen-5-ol plus CPC oral rinse, (ii) a, CPC
      oral rinse and (iii) a o-Cymen-5-ol mouthwash on the salivary microbiota up to 4 h after
      their application.
    

Detailed description: 
      One of the desirable qualities of mouthrinses is substantivity, which is defined as the
      persistence capacity of its antimicrobial action over time in the mouth. This is an intrinsic
      feature of some molecules.

      Such substantivity seems to require the adsorption of the agent on the buccal surfaces and
      subsequently exert a certain antimicrobial activity that seems to be mostly bacteriostatic.

      Substantivity is the result of multiple factors controlling or altering adhesion, life period
      of antimicrobial capabilities, synergisms, antagonisms, and others. In order to improve
      substantivity and therefore increase antimicrobial effectiveness of CPC, o-Cymen-5-ol has
      recently been proposed to become incorporated to oral rinses. The aim of this work is to
      quantitatively determine the substantivity of (i) a single o-Cymen-5-ol plus CPC oral rinse,
      (ii) a, CPC oral rinse and (iii) a o-Cymen-5-ol mouthwash on the salivary microbiota up to 4
      h after their application.
    

Intervention name(s): Oral rinse; Saliva harvest
Intervention type(s): Other; Other
Intervention description(s): Participants use mouthwasher for a given time.; Non-stimulated saliva harvesting
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: randomized, double-blind, crossover study of the in situ antibacterial efficacy of o-Cymen-5-ol plus CPC, o-Cymen-5-ol and CPC on salivary microbiota.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Mouth rinses; substanticity; oral infections; salivary microbiota
Blood Transfusions and Immune Response
Condition: Infection After Transfusion; Transfusion-related Immunomodulation Reaction; Cytokine Storm; Surgery
MeSH terms: Cytokine Release Syndrome
Study type: Interventional

Summary: 
      -  We have previously reported the results of the primary and secondary outcomes of a
           randomized study aiming to investigate the impact of a restrictive transfusion protocol
           on the magnitude of reduction in blood transfusion in a typically mixed general surgery
           population subjected to major abdominal surgery.

        -  The main finding of that study was a reduction in red blood cell usage with the
           implementation of a restrictive transfusion regimen. This was achieved without adversely
           affecting clinical outcome in the population studied.

        -  The aim of this secondary analysis performed on a subgroup of 20 patients from the
           original study was to determine whether there are any differences in the postoperative
           immunologic response, as expressed by the production of inflammatory mediators, between
           a restrictive approach to red cell transfusion and a more liberal strategy.
    


Intervention name(s): restrictive transfusion strategy; liberal transfusion strategy
Intervention type(s): Procedure; Procedure
Intervention description(s): Patients allocated to the restrictive transfusion strategy were transfused only when their hemoglobin concentration decreased below 7.7 g d dL-1 and were then maintained at hemoglobin concentrations between 7.7 and 9.9 g d dL-1.; Patients assigned to the liberal strategy were transfused when their hemoglobin concentration fell below 9.9 g dL-1, aiming at maintaining hemoglobin at or above 10 g dL-1.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
A Phase 1 Study To Characterize The Safety, Tolerability, PK And PK Of Repeat Doses Of PF-06648671 In Healthy Adults And Healthy Elderly Subjects
Condition: Healthy Adult Subjects and Healthy Elderly Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an investigator-and-subject blind, phase 1 study to characterize the safety,
      tolerability, pharmacokinetics and central and peripheral pharmacodynamics of 14-day repeated
      ascending doses of PF-06648671 once a day in healthy adults (part 1) and repeated doses at
      the maximum tolerated dose (MTD) defined in part 1 in healthy elderly subjects (part 2). The
      study also include an optional cohort (part 3) to evaluate the drug interaction between
      PF-06648671 at MTD and CYP3A probe, midazolam
    


Intervention name(s): PF-06648671; Midazolam; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): experimental Pfizer compound which will be dosed as oral suspension, once a day for 14 days; commercial available oral solution of 2 mg midazolam as CYP3A probe substrate for drug interaction evaluation. Midazolam will be given as single dose with and without co-administration of PF-06648671; Matching placebo which will be given as oral suspension, once a day for 14 days
Intervention MeSH terms: Midazolam
Allocation: Randomized
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Phase 1; Multiple doses of PF-06648671; safety, tolerability, PK; plasma and CSF abeta; drug interaction
Efficacy of Home Blood Pressure Monitoring (MONITOR Study)
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      High blood pressure is the main risk factor for cardiovascular disease worldwide,but its
      control rate is unsatisfactory. Home Blood Pressure Monitoring (HBPM) with automatic
      oscillometric devices and pharmaceutical care have been proposed as interventions to increase
      therapeutic compliance and to guide treatment decisions.

      The purpose of this study is to evaluate the effect of HBPM and of pharmaceutical care in
      blood pressure control measured through 24h ambulatory blood pressure monitoring (ABPM).
    

Detailed description: 
      Home Blood Pressure Monitoring (HBPM) and Pharmaceutical care have been proposed to improve
      therapeutic compliance and to guide treatment decisions, but their effects on BP control are
      still under debate.

      This is a factorial randomized controlled trial including adult hypertensive patients under
      drug treatment but with office BP and 24h ABPM uncontrolled. Participants will be allocated
      to one of four groups: HBPM; HBPM and Pharmaceutical care; Pharmaceutical care; or control.
      All participants will receive usual care for high blood pressure. Participants will be
      followed for 60 days.
    

Intervention name(s): HBPM; HBPM and Pharmaceutical care; Pharmaceutical care; Usual care
Intervention type(s): Device; Device; Behavioral; Other
Intervention description(s): Automatic oscillometric device for home blood pressure measurement and usual care.; Automatic oscillometric device for blood pressure measurement at home and consultations with the pharmacists; consultations with the pharmacists; Consultation with the physician.
Other intervention name(s): HBPM; DADER method; Usual clinical practice.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypertension; Blood pressure; Home Blood Pressure Monitoring; Ambulatory Blood Pressure Monitoring; Pharmaceutical care
Antero-Posterior Knee Stability
Condition: Osteoarthritis; Total Knee Arthroplasty; Stability; Knee Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Observational

Summary: 
      A retrospective one-time evaluation of total knee patients one year or more postoperative, to
      compare antero-posterior (AP) stability with the TELOS Stress device/stress x-rays and
      clinical outcomes. Multiple implant brand/models will be included in the study.
    


Intervention name(s): Stress X-Ray
Intervention type(s): Other
Intervention description(s): Antero-posterior stability of the knee measured with stress x-rays using the TELOS Stress device in 45° and 90° flexion
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        Internal database of prior total knee replacement patients.
Postoperative Controls of Ventilation Tubes in Children - by General Practitioner or Otolaryngologist?
Condition: Otitis
MeSH terms: Otitis
Study type: Interventional

Summary: 
      A large number of children with otitis media undergo surgery with ventilation tubes (VTs)
      placed in the tympanic membrane. This is done to improve hearing and speech development and
      to reduce ear complaints. The long-term results of VTs are unclear. Follow-up care is
      required to assure that the tubes are functional, hearing loss has been corrected, and
      potential complications are properly diagnosed and managed. Guidelines regarding follow-up
      care give different advices concerning when, how and by whom the controls should be made.

      The primary goal of this study is to investigate if follow-up care after surgery with VTs of
      children aged 3-10 years can be done by general practitioners instead of specialists without
      negative consequences for the patient.

      In the study the child's hearing and speech development, middle ear function, subjective
      complaints and complications will be assessed. User satisfaction and other aspects related to
      the quality of control will also be assessed.

      If the study shows that follow-ups after surgery with VTs can be done on the level of primary
      care without loss of care quality, specialist health care services will be spared and
      cost-effectiveness for the overall healthcare system will improve.
    

Detailed description: 
      Remark: the change in age range of included children from 4-10 to 3-10 was approved by REK
      (ethics committee) in November 2018.
    

Intervention name(s): general practice follow-up; ear-nose-throat (ENT) specialist follow-up
Intervention type(s): Procedure; Procedure
Intervention description(s): Post-surgery follow-up by general practitioner; Post-surgery follow-up by ear-nose-throat (ENT) specialist
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Child; Middle ear ventilation; Follow-up studies; General practitioners
Telemedicine in Spina Bifida Transition: A Pilot Study
Condition: Spina Bifida
MeSH terms: Spinal Dysraphism
Study type: Interventional

Summary: 
      The purpose of this study is to explore the feasibility and efficacy of using telemedicine to
      improve transition from pediatric to adult care in patients with spina bifida.
    

Detailed description: 
      After enrollment, patients will be randomly assigned to either the control or intervention
      group. Randomization will be performed using computer software with 1:1 group allocation. We
      anticipate 26 participants in each group.

      The control group will receive the current standard of care transition program which includes
      goal-setting at their annual Multidisciplinary Spina Bifida Clinic visit. Additionally, they
      will receive encouragement e-mail and text messages. These messages will be sent at 2 weeks,
      3 months, 6 months, and 9 months from last in-person appointment.

      The intervention group will participate in face-to-face video telemedicine visits, in
      addition to routine yearly visits to the Spina Bifida Clinic. These 30-minute visits will
      occur at 2 weeks, 3 months, 6 months and 9 months from last in-person clinic appointment. The
      visits will consist of structured counseling using a plan-do-study-act cycle approach to
      incrementally adopt elements of a well-planned transition. Using qualitative notes from each
      session, I hypothesize that I will be able to identify common themes or challenges across
      patients and develop adjunctive education, support, and monitoring tools for patients and
      families in transition. I will collaborate with experts from orthopedic surgery, physical
      medicine and rehabilitation, urology, neurosurgery, nutrition, and psychology to develop
      content for educational tools.
    

Intervention name(s): Intervention group; Standard of care group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): More frequent follow up with face to face interaction.; Transition goal setting during annual follow up.
Other intervention name(s): Telemedicine group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Transition to adult care; Telemedicine; Myelomeningocele
Protocolized Sedative Weaning VS. Usual Care in Pediatric Critically Ill, RCT
Condition: Withdrawal Syndrome
MeSH terms: Substance Withdrawal Syndrome
Study type: Interventional

Summary: 
      Sedative and analgesic agents are widely used in the ICU. These agents can provide hypnotic
      effect, pain alleviation, cooperation, and synchronizing ventilatory support. Prolonged use
      of the agents can lead to withdrawal symptoms when the drugs are weaned.

      Prior study showed the longer duration of sedative drugs, cumulative dose of medications and
      younger age were the risk factors of withdrawal syndrome. Additional, some study showed the
      sedation protocol can reduce the incidence of withdrawal syndrome. However, no worldwide
      standardized sedative weaning protocol including our hospital. The objectives in this study
      are to establish the sedative weaning protocol and to compare the protocol sedative weaning
      with the usual care weaning.
    

Detailed description: 
      Sedative and analgesic agents, particularly benzodiazepines and opioids, are widely used in
      PICU. These agents can provide calmness, hypnotic effect, pain alleviation, cooperation,
      immobilization and synchronizing ventilatory support.

      Prolonged use of the agents can lead to withdrawal symptoms when the drugs are weaned.

      Incidence of withdrawal syndrome is about 50%. Withdrawal syndrome can lead to unnecessary
      and costly diagnostic tests, prolongation of mechanical ventilation and hospital stay, and
      increasing of suffering. Prior study showed the longer duration of sedative drugs, cumulative
      dose of medications and younger age were the risk factors of withdrawal syndrome. Additional,
      some study showed the sedation protocol can reduce the incidence of withdrawal syndrome.
      However, no worldwide standardized sedative weaning protocol including our hospital.
    

Intervention name(s): The sedative weaning protocol group; The usual group
Intervention type(s): Other; Other
Intervention description(s): After physician decide to wean sedative or analgesic drugs. We divided to 2 groups including high risk group and low risk group. The sedative weaning protocol were used in these patients which rely on the high risk or low risk group.; After physician decide to wean sedative or analgesic drugs. The sedative/analgesic drugs were weaned depend on physician
Intervention MeSH terms: Hypnotics and Sedatives
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Drug Interaction Study Between Raltegravir And UK-453,061
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to estimate the effect of steady state raltegravir on the steady
      state pharmacokinetics of UK-453,061 and steady state UK-453,061 on the steady state
      pharmacokinetics of raltegravir.
    


Intervention name(s): UK-453,061; UK-453,061; Raltegravir; Raltegravir
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): UK-453,061 1000 mg once daily for 10 days; UK-453,061 1000 mg once daily for 10 days; Raltegravir 400 mg twice daily for 10 days; Raltegravir 400 mg twice daily for 10 days
Intervention MeSH terms: Raltegravir Potassium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug Interaction, Pharmacokinetics