bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Animation Video on the Success Rate of Children Swallowing Capsule Endoscopy
Condition: Capsule Endoscopy
Study type: Interventional

Summary: 
      There are a variety of strategies that can be used for education to improve patients'
      awareness of the electronic capsule endoscopy process at present. The animated images in the
      animation videos are interesting as the explanations are simple and easy to understand. It is
      one of the best choices for children's education. A number of studies have shown that
      animated videos can increase the awareness rate of children's related knowledge, reduce
      anxiety, improve children's compliance with examinations and operations, and achieve good
      clinical results. Effective information transmission to children and their family members can
      increase the children's cognition and may affect the children's compliance with swallowing
      capsules and the success rate of autonomous swallowing, thereby reducing the time for
      swallowing capsule endoscopes and increasing capsule endoscopes Complete small bowel
      examination completion rate. This study aimed to evaluate the impact of animated video
      education on the success rate of children swallowing capsule endoscopy and analyze the
      related factors that affect the time for children to swallow capsules autonomously.
    


Intervention name(s): animation videos; explanation about endoscopy endoscopy
Intervention type(s): Other; Other
Intervention description(s): watch animation videos about capsule endoscopy; Give general explanations about endoscopy endoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Study of a Tetravalent Dengue Vaccine in Healthy Adults in Australia
Condition: Dengue Fever; Dengue Hemorrhagic Fever
MeSH terms: Dengue; Hemorrhagic Fevers, Viral; Severe Dengue; Fever; Hyperthermia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to demonstrate that different CYD dengue vaccine lots
      manufactured using the same method and in the same location but at different times produce an
      equivalent immunological response after 3 doses.

      Primary Objective

        -  To demonstrate that three different Phase III lots of CYD dengue vaccine induce an
           equivalent immune response in terms of post-Dose 3 geometric mean titers (GMTs) against
           the four parental serotypes.

      Secondary Objectives:

        -  To demonstrate that data from one Phase II lot and pooled data from Phase III lots of
           CYD dengue vaccine show an equivalent immune response in terms of post-Dose 3 GMTs
           against the four parental serotypes.

        -  To describe the safety of the CYD dengue vaccine in all participants after each dose.
    

Detailed description: 
      All participants received 3 doses of their assigned vaccine or placebo and provided blood
      samples at defined timepoints for flavivirus status and immunogenicity assessment. Safety
      data were collected in all participants after each dose and throughout the study.
    

Intervention name(s): Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus; Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus; Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus; Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus; Placebo: NaCl 0.9%
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): 0.5 ml, Subcutaneous (SC); 0.5 ml, SC; 0.5 ml, SC; 0.5 ml, Subcutaneous (SC); 0.5 ml, SC
Other intervention name(s): CYD Dengue vaccine; CYD Dengue vaccine; CYD Dengue vaccine; CYD Dengue vaccine; NaCl
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Dengue Fever; Dengue Hemorrhagic Fever; CYD Dengue Vaccine; Lot Consistency
Efficacy of Phosphatidylserine Enriched With n-3 PUFA Supplementation on ADHD in Children With Epilepsy
Condition: Attention Deficit Disorder With Hyperactivity; ADHD Inattention or Mixed Type; Epilepsy; Child
MeSH terms: Epilepsy; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      Our project aims to develop a new therapeutic approach in epilepsy-associated attention
      disorders in children, through evaluation of the clinical impact of dietary n-3 fatty acids,
      containing eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) conjugated to a
      phospholipid vector. The primary objective is to evaluate the efficacy of a PUFA
      supplementation (PS-Omega 3), after 12 weeks of treatment, on attention disorders in children
      with epilepsy. Secondary objectives include:

        -  To evaluate the impact of a supplementation of PS-Omega 3 on quality of life.

        -  To evaluate the impact of a supplementation of PS-Omega 3 on serum and erythrocyte lipid
           profiles.

        -  To assess the tolerance of a supplementation of PS-Omega 3.

        -  To assess the impact of a supplementation of PS-Omega 3 on the frequency of seizures.

        -  To describe the impact of a supplementation of PS-Omega 3, at 24 weeks,

             1. on attention disorders in children with epilepsy,

             2. on quality of life,

             3. and on serum and erythrocyte lipid profiles. This study will recruit 272 subjects
                aged 6- 16 years, suffering from epilepsy (any type) and attention deficit
                hyperactivity disorder (ADHD) (inattentive or combined type) according to DSM V
                criteria in 12 clinical sites in France.
    


Intervention name(s): Vayarin®, supplementation of n-3 PUFA; PLACEBO
Intervention type(s): Drug; Drug
Intervention description(s): Two capsules will be swallowed twice daily, 20 to 30 minutes prior to breakfast and dinner, during 12 weeks, between visit 1 and visit 2.
At the end of this period, active product will be continued, at the same dose, for a 12 week-open label period. All patients will be administered the active product.; Two capsules will be swallowed twice daily, 20 to 30 minutes prior to breakfast and dinner, during 12 weeks, between visit 1 and visit 2.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Epilepsy; Attention Deficit Disorders; VAYARIN; Children; Polyunsaturated n-3 fatty acid supplementation
The Effect of Instrumentation and Obturation on Postoperative Pain in Retreatment
Condition: Endodontically Treated Teeth; Post Operative Pain
MeSH terms: Tooth, Nonvital; Pain, Postoperative
Study type: Interventional

Summary: 
      Objectives: The aim of this study was to assess postoperative pain in prospective randomized
      clinical trial comparing Reciproc or hand instrument and also different obturation techniques
      in one visit of endodontic retreatment.

      Conventional root canal treatment was done to 45 patients who needed retreatment. All
      instruments used in this study are routinely used instrument in endodontic therapy. After
      completed root canal treatment, the patients asked the intense of post operative pain.
    

Detailed description: 
      Materials and metods: The study was included 45 patients (18-65 yrs old) who needed
      endodontic retreatment in mandibular premolar or molar without any symptoms. The teeth had
      been randomly assign into 3 groups according to the instrumentation or obturation techniques;
      hand files with lateral condensation, Reciproc with lateral condensation, or Reciproc with
      continuous condensation technique. Retreatments had performed in a single visit. Coronal
      restorations were removed, the gutta-percha were extracted using either Reciproc or hand
      files. After, biochemical and mechanical praparation, the canals were filled with
      gutta-percha cones and AH Plus sealer using the lateral condensation or continuous wave of
      obturation technique. Participants were been asked to rate the incidence and intensity of the
      postoperative pain on a verbal rating scale 24h, 48h and 72h and 7 days after retreatment.
      All data were analyzed using (Chi-square test, p=0,05)
    

Intervention name(s): Root canal treatment
Intervention type(s): Other
Intervention description(s): The patient usually takes anaesthesia before treatment and access cavity was prepared on the tooth and root canal removed and instrumented and obturated. However, in the present study, previously done root canal was retreated. Usually no anaesthesia was used because all root canals were done before. So just instrumentation and obturation was done.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Conventional root canal treatment was perfomed to 45 patients who had been done unacceptable root canal treatment (such as short root canal filling ) on lower premolar or molar teeth before. The patents were healthy and did not take any antibiotics or any medication .
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: post operative pain, retreatment
Guayusa: The Effect of an Herbal Extract on Alertness and Mental Fatigue
Condition: Attention Difficulties
MeSH terms: Fatigue; Mental Fatigue
Study type: Interventional

Summary: 
      The primary objective of this randomized, double-blind, placebo-controlled, cross-over study
      is to assess the acute effects of a novel ingredient, guayusa on alertness and mental fatigue
      compared to a placebo. This trial will utilize the COMPASS cognitive task and cognitive
      demand battery (CDB) and mood, motivation, and energy measures with assessments taking place
      at baseline, 60- and 120-minutes post treatment on three separate testing days separated by
      ~7 days.
    


Intervention name(s): Gel capsule
Intervention type(s): Other
Intervention description(s): Single capsule per dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: mental fatigue; alertness; cognitive; COMPASS; guayusa; energy; fatigue; mood; memory
A Study of a New Vaccine Against Two Types of Ebola
Condition: Ebola
MeSH terms: Hemorrhagic Fever, Ebola
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label, non-randomised, dose escalation, first-in-human, single centre, phase I
      clinical trial to determine the safety and immunogenicity of a bivalent ChAdOx1 vectored
      vaccine against Zaire and Sudan Ebola virus species in healthy adult volunteers.
    

Detailed description: 
      This is a first-in-human, open-label, dose escalation, phase I clinical trial to assess the
      safety and immunogenicity of the candidate ChAdOx1 biEBOV vaccine in healthy UK volunteers
      aged 18-55. The vaccine will be administered intramuscularly (IM).

      Volunteers will be recruited and vaccinated at the Centre for Clinical Vaccinology and
      Tropical Medicine (CCVTM), Oxford. There will be 3 study groups and it is anticipated that a
      total of 26 volunteers will be enrolled. Dose escalation and sentinel participant procedures
      will be implemented. Volunteers will be first recruited into Group 1 and subsequently into
      Groups 2 and 3 following interim clinical safety reviews. Volunteers will be sequentially
      allocated to a study group by selecting eligible volunteers for enrolment following
      screening. Sequential allocation will occur based on the order in which volunteers are
      enrolled.
    

Intervention name(s): ChAdOx1 biEBOV
Intervention type(s): Biological
Intervention description(s): ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Ebola Virus Disease; Zaire Ebolavirus; EBOV; Sudan Ebolavirus; SUDV; Vaccine
The Effect of Straining Techniques on Women and Newborn
Condition: Prolonged Second Stage of Labor; Other Specified Trauma to Perineum and Vulva During Delivery; Newborn; Vitality
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      Purpose: To examine the effects of straining techniques on the duration of labor, perineal
      trauma status and newborn apgar score.

      Method: This study is a randomized controlled trial. The straining techniques were explained
      to the pregnant women who gave written consent to participate in the study and were randomly
      assigned to groups in the latent phase (natural, spontaneous, Valsalva), and the techniques
      were applied in the second phase of labor.
    

Detailed description: 
      Purpose: The present study was planned to determine the effects of straining techniques on
      the duration of labor, perineal trauma status, and newborn Apgar score.

      Method: The study, which had a randomized-controlled experimental design, was conducted in
      Sivas Numune Hospital Birth Unit. The sampling size was calculated using power analysis. In
      the literature, spontaneous straining is used by pregnant women in the range of 25-81%, and
      Valsalva -type straining has a rate of 32-75%. To represent the population of the study,
      sample volume was determined at =0.05 significance level, 1- =0.95 Confidence Interval, =0.20
      error risk, and 1- =0.80 power, and the total number of individuals was determined as 354.
      The data of the study were collected with the "Pre-Evaluation Form", "Personal Information
      Form", "Labor Evaluation Form", and "Apgar Score" created by the researchers in line with the
      literature data. The straining techniques were explained to the pregnant women who gave
      written consent to participate in the study and were randomly assigned to groups in the
      latent phase (natural, spontaneous, Valsalva), and the techniques were applied in the second
      phase of labor. ANOVA, Kruskal Wallis H-test, Chi-square test, Exact test, Tamhane T2 test,
      and Dunn Test were used to evaluate the data obtained in the study. Statistical significance
      was evaluated at a 0.05 significance level and the SPSS version 23.0 was used.
    

Intervention name(s): Straining types
Intervention type(s): Other
Intervention description(s): Valsalva, spontaneous and natural strainings are supported in 2nd stage of labor. Duration of delivery, perineal trauma status and Apgar Scores were evaluated.
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: Valsalva-type Straining (Group I), Spontaneous Straining (Group II), Natural Straining (Group III))
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Labor; Midwife; Pregnant; Straining techniques; Perineal trauma; Apgar Score
Acute-REMOTION: REMOTION in Acute Psychiatric Care
Condition: Mental Disorder
MeSH terms: Mental Disorders
Study type: Interventional

Summary: 
      This study aims to examine REMOTION, an internet-based intervention aimed at reducing symptom
      severity and improving emotion regulation in an acute psychiatric inpatient care setting.
      REMOTION is currently being studied in an outpatient psychotherapy setting. This study aims
      to investigate feasibility and first effects of this intervention in inpatient psychiatric
      care.
    


Intervention name(s): REMOTION; TAU
Intervention type(s): Behavioral; Behavioral
Intervention description(s): REMOTION is an internet-based program focusing on emotion regulation and aimed at reducing patient symptom severity and improving emotion regulation. It consists of six modules and the structure is based on the extended process model of emotion regulation by Gross (2015). The intervention is currently being studied in an outpatient psychotherapy setting (Bielinski et al., 2020).; Treatment as usual (TAU), refers to standard treatment in an acute inpatient care setting at the Universitäre Psychiatrische Dienste Bern. This treatment includes different standard inpatient psychiatric care components (integrative psychiatric care).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sayana Press UK Self-Injection Study
Condition: Contraception
Study type: Interventional
Phase: Phase 4

Summary: 
      A one-year evaluation of Sayana Press self injection in women of reproductive age in the
      United Kingdom (UK).
    


Intervention name(s): Sayana Press
Intervention type(s): Drug
Intervention description(s): Sayana Press in the Uniject injection system
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Photobiomodulation Therapy Treatment on Facial Paralysis
Condition: Facial Paralysis
MeSH terms: Bell Palsy; Facial Paralysis; Paralysis; Facies
Study type: Interventional

Summary: 
      Objective: Facial paralysis can be caused by a variety of etiological factors, complete palsy
      continues for two months, the chance of full recovery is reduced to zero. The aim of this
      study was to evaluate the effectiveness of photobiomodulation therapy (PBMT) in the in
      patients undergoing facial paralysis over 8 weeks.

      Methods: This study was an open-label, not concurrent control study including 54 patients
      that underwent facial paralysis over 8 weeks. Patients were assigned to the PBMT group and
      control group, with 27 patients in each group. Laser treatments were applied 3 days a week
      after recruited. PBMT was delivered using a class IV Multi-wave Locked System that combines
      with a simultaneous 808 nm continuous emission and 905 nm pulse emission and the maximum peak
      power was 25 W. Clinical outcome measure comprised the House-Brackmann grading system, Facial
      Clinimetric Evaluation Scale (FaCE), Sunnybrook facial grading scale (SBFG), and
      electrophysiological testing, including Electroneuronography (ENoG), Electromyography (EMG)
      and Blink Reflex. All the measurements were collected at the first day and at the end of
      study. All reported P values were two-sided and were declared statistically significant when
      less than 0.05.
    


Intervention name(s): MLS laser
Intervention type(s): Device
Intervention description(s): Treatments were performed with MLS laser (Mphi laser, ASA Srl, Italy). MLS laser is a class IV NIR laser with two synchronized sources (laser diodes). The first one is a pulsed laser diode, emitting at 905 nm, with 25 W peak power. The second laser diode (808 nm) was operated in a continuous mode with power 1 W. Both of the laser beams were synchronized, the locked waves work within the range 1-2000 Hz.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Facial paralysis; photobiomodulation; ENoG; EMG; HB grading
Bioequivalence of Tablet Formulation of Dabigatran Etexilate Compared to Commercial Capsule Formulation Following Oral Administration in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to establish the bioequivalence of tablet formulation
      of dabigatran etexilate compared to commercial capsule formulation following oral
      administration under fasted condition.

      The secondary objective is the evaluation and comparison of several pharmacokinetic
      parameters between the treatments.
    


Intervention name(s): dabigatran etexilate
Intervention type(s): Drug
Intervention description(s): single dose
Other intervention name(s): PRADAXA
Intervention MeSH terms: Dabigatran
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Quality Control of Esophagogastroduodenoscopy Using Real-time EGD Auxiliary System
Condition: Esophagogastroduodenoscopy
Study type: Interventional

Summary: 
      The aim of our study was to develop an automatic quality-control system and assess the
      performance of this system in quality control of esophagogastroduodenoscopy.
    

Detailed description: 
      In this study, the researchers firstly developed an automatic quality-control system, name as
      EAS. Next, the researchers applied the system in a endoscopic center and designed a
      prospective randomised controlled trial to investigate the performance of the system in
      quality control of esophagogastroduodenoscopy.
    

Intervention name(s): automatic quality-control system
Intervention type(s): Other
Intervention description(s): Automatic quality-control system could real-time measuring endoscopic inspection completeness, detecting gastric neoplasms and evaluating gastric mucosal visibility.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Other
Keywords: Esophagogastroduodenoscopy; gastric neoplasm; artificial intelligence; quality control
Dose-finding Study for the Ultralow-dose Levonorgestrel Intrauterine Contraceptive System (LCS)
Condition: Contraception
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate if drug doses lower than the one released from
      Mirena® would be as effective for contraception as Mirena®. Subjects participating in the
      study will be randomly assigned to be inserted with any of the three different intrauterine
      systems (IUSs). The IUSs are nearly alike except that the amount of hormone released from
      them is different.
    

Detailed description: 
      The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been
      renamed to Bayer Schering Pharma AG, Germany.

      Bayer Schering Pharma AG, Germany is the sponsor of the trial.

      Although the title of the study describes "open", it was in fact single-blinded.

      Issues on side effects are addressed in the Adverse Event section.
    

Intervention name(s): Levonorgestrel IUS (BAY86-5028, G04209B); Levonorgestrel IUS (BAY86-5028, G04209C); Levonorgestrel IUS (Mirena, BAY86-5028)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Levonorgestrel intrauterine contraception system (IUS) releasing 12 microg/24 h in vitro, to be used for three years; Levonorgestrel intrauterine contraception system (IUS) releasing 16 microg/24 h in vitro, to be used for three years; Levonorgestrel Intrauterine contraception system (IUS) releasing 20 microg/24 h to be used for three years
Intervention MeSH terms: Levonorgestrel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention