bioihbjkbjnl/mcl2 huggingface dataset:
Primary Vaccination With Either Synflorix™ or Prevenar 13™ or Both Vaccines and Booster Vaccination With Synflorix™
Condition: Infections, Streptococcal; Streptococcus Pneumoniae Vaccines
MeSH terms: Pneumonia, Pneumococcal; Streptococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary aim of this study is to assess the reactogenicity of Synflorix vaccine and
      Prevenar 13 vaccine after primary vaccination at 2 and 4 months of age with either Synflorix
      or Prevenar 13 vaccine or Prevenar 13 and Synflorix, respectively. In addition, this study
      aims at assessing the safety, reactogenicity, immunogenicity and antibody persistence
      (approximately 8-11 months following primary vaccination) of the Synflorix vaccine and
      Prevenar 13 vaccine after primary vaccination at 2 and 4 months of age with either Synflorix
      or Prevenar 13 vaccine or Prevenar 13 and Synflorix, respectively. This study also aims at
      assessing the safety, reactogenicity and immunogenicity of the Synflorix vaccine when given
      as a booster dose at 12-15 months of age following primary vaccination at 2 and 4 months of
      age with either Synflorix vaccine or Prevenar 13 vaccine or Prevenar 13 and Synflorix
      respectively.
    

Detailed description: 
      This study is partially blinded as the primary phase will be conducted in an observer-blind
      method and booster phase will be open method.
    

Intervention name(s): Synflorix (3-Dose); Synflorix (2-Dose); Synflorix (Single Dose); Prevenar 13 (Single Dose); Prevenar 13 (2-Dose)
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): 3 doses administered intramuscularly; 2 doses administered intramuscularly; 1 dose administered intramuscularly; 1 dose administered intramuscularly; 2 doses administered intramuscularly
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: pneumococcal conjugate vaccine; Synflorix; Prevnar 13; Pneumococcal diseases
Small Particle Steroids in Refractory Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether an inhaled steroid with a small particle
      size can be an additional treatment option in patients with refractory eosinophilic asthma.
    

Detailed description: 
      We have identified a group of patients with refractory asthma who have ongoing eosinophilic
      airway inflammation despite high dose inhaled corticosteroids.

      Traditional inhaled steroids have a relatively proximal airway distribution which may lead to
      inadequate treatment of the distal airways.

      We aim to demonstrate that a steroid inhaler with a smaller particle size which targets the
      distal airways can be a useful additional treatment option in this group of patients.
    

Intervention name(s): Ciclesonide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Inhaled ciclesonide 320mcg twice daily; Matched placebo inhaler two inhalations twice daily
Other intervention name(s): Alvesco
Intervention MeSH terms: Ciclesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ciclesonide; Asthma; Therapeutic Uses; Pulmonary Eosinophilia; Nitric Oxide; Lung Diseases; Respiratory Tract Diseases
Pronator Quadratus Repair After Volar Plating of Distal Radius Fractures
Condition: Forearm Pronation Strength Recovery
MeSH terms: Radius Fractures; Wrist Fractures
Study type: Interventional

Summary: 
      Investigation of the influence of the pronator quadratus (PQ) muscle repair following volar
      plate fixation of distal radius fractures with regard to the forearm pronation strength.
      During the early recovery period of 3 months an improvement of pronation strength and
      functional scorings was hypothesized for the PQ repair when compared to no repair.

      Randomization of the patients in two groups ( PQ repair and no repair) and follow-up
      examinations after 6 and 12 weeks included bilateral isometric pronation strength
      measurement, range of motion, the QuickDASH and the Mayo-Wrist-Score, and a visual analogue
      scale (VAS)
    

Detailed description: 
      Investigation of the influence of the pronator quadratus (PQ) muscle repair following volar
      plate fixation of distal radius fractures with special regards to the forearm pronation
      strength. During the early recovery period of 3 months an improvement of pronation strength
      and functional scorings was hypothesized for the PQ repair when compared to no repair.

      Therefore the patients are randomized to group A = PQ repair and group B = no repair.
      Follow-up examinations after 6 and 12 weeks are scheduled included bilateral isometric
      pronation strength measurement, range of motion, the QuickDASH and the Mayo-Wrist-Score, and
      a visual analogue scale (VAS)
    

Intervention name(s): Pronator quadratus repair
Intervention type(s): Procedure
Intervention description(s): Suturing of the pronator quadratus muscle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Computer-Based Therapy for Mild Cognitive Impairment
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the neuropsychological and neurophysiological
      impacts of a computer-based training program designed to improve the cognitive performance of
      patients with mild cognitive impairment (MCI).
    

Detailed description: 
      The study is a randomized, double-blind, controlled trial of a computerized, cognitive
      intervention with three main goals: 1) to assess the magnitude of improvements in memory,
      language function, and cognitive function following computer training, 2) to investigate the
      neurophysiological mechanisms underlying such neuropsychological improvements, and 3) to
      demonstrate the feasibility of using this kind of computer-based therapy in older
      populations.
    

Intervention name(s): Computer-based training for Mild Cognitive Impairment (MCI)
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Cognitive remediation; Cognitive impairment; computer; training
Clinical Study of Ningmitai Capsule on Promoting the Passage of Residual Fragments After Ureteroscopic Lithotripsy
Condition: Ureteral Calculi
MeSH terms: Ureteral Calculi; Ureterolithiasis; Calculi
Study type: Interventional
Phase: Phase 4

Summary: 
      Objective: To observe the effect of Ningmitai capsule on ureteral calculi after lithotripsy
      and evaluate the safety of treatment.

      Study Design: A multicenter, prospective, randomized, controlled clinical study design was
      adopted

      Interventions:

      control group: Give antibiotics or diclofenac sodium suppository as needed. Ningmitai group:
      Oral Ningmitai Capsule (produced by Guiyang Xintian Pharmaceutical Co., Ltd.), 0.38
      g/capsule, 4 capsules each time, 3 times a day.

      combination group (Ningmitai plus tamsulosin).: Tamsulosin capsules, 0.2 mg/capsule, one
      capsule each time, once a day, were taken on the basis of Ningmitai group.
    

Detailed description: 
      Sample size: 230
    

Intervention name(s): Control group; Ningmitai capsule; Combined group (Ningmitai plus tamsulosin)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Give antibiotics or diclofenac sodium suppository as needed.; Oral Ningmitai Capsule (produced by Guiyang Xintian Pharmaceutical Co., Ltd.), 0.38 g/capsule, 4 capsules each time, 3 times a day for 12 Weeks.; Tamsulosin capsules, 0.2 mg/capsule, one capsule each time, once a day, were taken on the basis of Ningmitai group for 12 Weeks.
Other intervention name(s): diclofenac sodium; Ningmitai plus tamsulosin
Intervention MeSH terms: Diclofenac; Tamsulosin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ureteral calculi; Lithotripsy of ureteral calculi; Ningmitai capsule; Residual fragments
An Exploratory, Double-Blind, Placebo-Controlled Study of the Medical Food Vayarin in Children With Autism Spectrum Disorder (ASD)
Condition: Autistic Disorder
MeSH terms: Autism Spectrum Disorder; Autistic Disorder
Study type: Interventional

Summary: 
      The primary study objective is to evaluate the efficacy of Vayarin_005 on ASD related
      symptoms in children.
    


Intervention name(s): Medical Food : Vayarin_005; Placebo
Intervention type(s): Other; Other
Other intervention name(s): Cellulose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Behavioral Intervention Study for Better Breast and Cervical Cancer Control for Korean American Women
Condition: Breast Cancer; Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      The long-term goal of this study is to build a sustainable,community-based outreach program
      using Korean American community health workers (CHWs) to promote breast and cervical
      screening among Korean American women, thereby reducing related morbidity and mortality. The
      study is designed to determine the effectiveness of a health literacy-focused tailored breast
      and cervical cancer control intervention delivered by CHWs.

      The investigators hypothesized that, compared to KA women in the delayed intervention group,
      KA women who receive a health literacy-focused CHW intervention will demonstrate: (1) higher
      levels of adherence to screening for breast and cervical cancer, (2) greater levels of health
      literacy, (3) higher levels of breast and cervical cancer knowledge, and (4) improve
      decisional balance.
    

Detailed description: 
      Despite considerable progress in U.S. cancer control over the past 20 years, certain ethnic
      minority groups continue to experience significant health disparities. Recent immigrants
      including Korean Americans (KA), face an unequal cancer burden related to the significant
      language and cultural barriers they face in attempting to navigate the U.S. healthcare
      system. KA women have the second highest incidence of cervical cancer nationally and are
      experiencing rapid increases in breast cancer incidence. Not only are their breast and
      cervical cancers diagnosed at significantly later stages than those of whites, but they are
      also the least likely racial/ethnic group to receive early breast and cervical cancer
      screening.

      This community-based behavioral intervention is designed 1) to evaluate, in a randomized
      controlled trial, the effects of our health literacy-focused cancer control intervention,
      delivered by trained CHWs, on the primary outcomes: mammography and Papanicolaou(Pap)test
      screening adherence, in a sample of 360 KA women, 2)to test the effects of the proposed
      intervention on the secondary outcomes: level of health literacy, breast and cervical
      knowledge, and decisional balance, in the KA sample.
    

Intervention name(s): Health literacy, health message
Intervention type(s): Behavioral
Intervention description(s): The intervention will consist of three main components: (1) 2-hour in-class health literacy-focused education; (2) tailored telephone counseling; and (3) healthcare system navigation assistance tailored to the woman's specific barriers.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Ethnic minority women; Cancer screening; Health literacy; Behavioral intervention; Breast Cancer screening; Cervical Cancer screening
Efficacy and Safety Study of Total Flavonoids of Propolis Dropping Pill to Treat Angina Pectoris
Condition: Stable Angina Pectoris
MeSH terms: Angina Pectoris; Angina, Stable
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to confirm the efficacy and safety of total flavonoids of
      propolis dropping pill to treat angina pectoris, evaluated by total exercise time of
      treadmill exercise test.
    


Intervention name(s): Total Flavonoids of Propolis dropping pill; total Flavonoids of Propolis dropping pill
Intervention type(s): Drug; Drug
Intervention description(s): One pack contains 30 pills, weight 33g. One pack each time, three times a day, 14 days a course.; One pack contains 30 pills, weight 33g. One pack each time, three times a day, 14 days a course.
Intervention MeSH terms: Propolis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Chest stuffiness of TCM; Qi deficiency and blood stasis of TCM
Six Month Plaque and Gingivitis Study Using Colgate Total Toothpaste
Condition: Dental Plaque; Gingivitis
MeSH terms: Gingivitis; Dental Plaque
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this randomized, single center, parallel clinical research study is to
      evaluate the comparative efficacy performance of three dentifrices -Colgate Total Toothpaste,
      Parodontax Toothpaste and Colgate Cavity Protection Toothpaste in controlling gingivitis and
      dental plaque in adults.
    


Intervention name(s): Colgate Cavity Protection toothpaste; Colgate Total toothpaste; Parodontax toothpaste
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 0.76% monofluorophosphate (1000 ppm MFP), Colgate Cavity Protection toothpaste is a control treatment.; 0.32% sodium fluoride (1450 ppm NaF) and 0.3% triclosan. Colgate Total toothpaste is the active comparator toothpaste; 1400 ppm sodium fluoride (NaF), Parodontax toothpaste is the active comparator toothpaste
Intervention MeSH terms: Listerine; Sodium Fluoride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Start-to-Sport - Home-based Exercise for Adolescents and Adults With Congenital Heart Disease
Condition: Congenital Heart Defect
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional

Summary: 
      Almost 1% of all baby's is born with a heart defect (CHD) and most of them survive. Even
      though outcomes are good, they need lifelong follow-up because of a higher risk for
      cardiovascular diseases. Studies have shown that patients with CHD are not active enough and
      that a substantial amount of patients is overweight. Hence preventive strategies and
      education should not only focus on the heart problem, but also on a healthy lifestyle
      including physical activity. Recently a new guideline introduced exercise prescription based
      on the absence/presence of certain key elements. However, a number of important questions
      remain that preclude implementation in clinical practice. Therefore a 'Start-to-Sport'
      program for adults with CHD, based on this new guideline, will be investigated. This study is
      a randomized controlled trial that investigates the effects of the program on daily physical
      activity, exercise capacity, quality of life and exercise self-efficacy both in short (12
      weeks) and long (52 weeks) term, along with possible mechanisms for the training effects by
      using a new exercise-testing protocol that looks simultaneously to all body parts that are
      involved during exercise. Ultimately, our findings will result in the implementation of the
      guideline in clinical practice.
    


Intervention name(s): home-based exercise training
Intervention type(s): Behavioral
Intervention description(s): During a 30 minute face-to-face motivational interview with an exercise specialist, the patient will be advised and coached about his exercise prescription, on how to implement it in his own daily life and on how to prevent relapse. Furthermore, the patients will receive instructions on how to monitor their exercise intensity and on recognizing adverse signals. During the following 12 weeks, patients will be asked to exercise 4.5 hours per week within the prescribed exercise intensity range according to the guidelines.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adult congenital heart disease; exercise capacity; exercise training; physical activity
Modified Uterosacral Ligament Suspension in Vaginal Hysterectomy
Condition: Modified Extraperitoneal Uterosacral Ligament Suspension; Vault Prolapse, Vaginal
MeSH terms: Uterine Prolapse; Prolapse; Pelvic Organ Prolapse
Study type: Observational

Summary: 
      Introduction : The extraperitoneal uterosacral ligament suspension (ULS) can be performed
      during the removal of the uterus in vaginal hysterectomy to prevent cuff prolapse. In this
      study, the modified extraperitoneal ULS technique was evaluated in terms of preventing cuff
      prolapse.

      Methods / Technique : Forty patients with second and third-stage uterine prolapse who were
      operated were included in the study. During routine vaginal hysterectomy procedure performed
      on patients, after sacrouterine ligaments which are the first-bites and uteroovarian and
      round ligaments which are the last-bites have been sutured and knotted, these ligaments were
      marked with 4-distinct clemps to make the right and left, upper and lower separation. After
      vaginal cuff was closed the sutures hanged by the clamps were ligated together, and the cuff
      tissue was stretched to the apical line.
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Stage 2 or 3 uterin prolapse who need surgery
      
Keywords: Vaginal Hysterectomy
Jedi Grip Versus Double Operator Technique For Ultrasound Guided Infraclavicular Block
Condition: Ultrasound; Nerve Block
Study type: Interventional

Summary: 
      The investigators aimed to compare the block characteristics of the single operator "jedi
      grip" technique and the conventional double operator technique.
    

Detailed description: 
      Patients undergoing hand, wrist, elbow and forearm surgery randomly assigned two groups
      (Group I: Jedi grip and Group II: Conventional double operator technique). By a blind
      observer, the block characteristics were evaluated and recorded .
    

Intervention name(s): USG guided infraclavicular block
Intervention type(s): Procedure
Intervention description(s): USG guided infraclavicular block was applied to patients either by conventional two-person technique or by one person Jedi technique according to the allocated group. On Group I single operator controlled the probe with one hand while controlling the needle and the syringe on the other hand with the Jedi technique. The needle was held between the index finger and the middle phalanx of the middle finger, and the syringe was held with fingers 4 and 5, with the plunger part to the thumb in the palm. On Group II, operator used the probe and needle with different hands while an assistant controlling the syringe to aspirate or inject local anesthetic.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: single-center, prospective, randomized into two goups: Jedi grip versus conventional double operator technique
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Jedi Grip; Ultrasound guided infraclavicular block
Once-Daily Asenapine for Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators propose to explore: 1. the acceptance by patients of once versus twice
      daily dosing with asenapine, 2. the acceptance by staff of once versus twice daily dosing
      with asenapine, and 3. the changes in psychopathology associated with these two dosing
      strategies, in 30 patients with schizophrenia or schizoaffective disorder.

      The investigators hypothesize that patient and staff acceptance will be better with once
      daily dosing and that improvements in psychopathology will be similar across once daily and
      twice daily dosing
    

Detailed description: 
      The investigators will randomly assign 30 patients newly admitted to Central Regional
      Hospital (CRH) for a psychotic exacerbation of schizophrenia or schizo-affective disorder to
      14 days of treatment with either asenapine 5 mg BID or asenapine 10 mg QHS.

      The investigators will assess patient and staff acceptance on day 14. The investigators will
      assess staff acceptance on day 14. The investigators will assess changes in psychopathology
      (Brief Psychiatric Rating Scale) from baseline to day 14.

      The investigators propose to achieve the following specific aims:

        1. To compare the patient acceptance of once daily versus twice daily asenapine; The
           investigators hypothesize that patient acceptance will be better for asenapine 10 mg QHS
           than for asenapine 5 mg BID at day 14

        2. To compare the staff (medication nurses) acceptance of once daily versus twice daily
           asenapine; the investigators hypothesize that staff acceptance will be better for
           asenapine 10 mg QHS than for asenapine 5 mg BID at day 14

        3. To compare the changes in psychopathology with once daily versus twice daily asenapine;
           the investigators hypothesize that changes in psychopathology from baseline to day 14
           will be similar for the two dosing strategies
    

Intervention name(s): Asenapine 10 mg daily in the evening; Asenapine 5 mg twice daily
Intervention type(s): Drug; Drug
Intervention description(s): The total daily dose of Asenapine will be given once daily in the evening; Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily
Other intervention name(s): Saphris; Saphris
Intervention MeSH terms: Asenapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: schizophrenia; asenapine; Once daily; twice daily