bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Describe the Safety and Immunogenicity of a RSV Vaccine in Healthy Adults
Condition: Respiratory Tract Infections
MeSH terms: Respiratory Tract Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will describe the safety, tolerability, and immunogenicity of up to 6 RSV vaccine
      formulations when administered alone or concomitantly with seasonal inactivated influenza
      vaccine (SIIV).
    

Detailed description: 
      The study will describe the safety, tolerability, and immunogenicity of up to 6 RSV vaccine
      formulations when administered alone or concomitantly with SIIV. Healthy male and female
      subjects divided into 2 age groups (18-49 years of age and 50-85 years of age in the sentinel
      cohort and 18-49 years of age and 65-85 years of age in the expanded cohort) will be
      enrolled. Age groups will run in parallel. Subjects in the sentinel cohort in each age group
      will receive one of two RSV vaccine formulations at one of 3 antigen dose levels or placebo.
      Subjects in the expanded cohort in each age group will receive one of two RSV vaccine
      formulations at one of 3 antigen dose levels with and without SIIV.
    

Intervention name(s): Formulation A; Formulation B; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): RSV vaccine; RSV vaccine; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Respiratory tract infections, RSV, vaccine
Safety and Efficacy of Low Temperature Contrast in UAP Patients During PCI (LOTA-I)
Condition: Unstable Angina Pectoris
MeSH terms: Angina Pectoris; Angina, Unstable
Study type: Interventional

Summary: 
      Percutaneous coronary intervention (PCI) has become one of the main treatments for rapid
      recovery of revascularization in patients with coronary heart disease (CHD). PCI has some
      advantages, such as easy operation, small trauma and rapid recovery. It can significantly
      improve myocardial ischemic symptom and reduce the incidence of cardiovascular adverse events
      in CHD patients. However, many studies have found that the incidence of PCI-related
      myocardial injury is relatively high, and affect the efficacy of PCI and prognosis in
      patients with unstable angina pectoris (UAP). A meta-analysis of a total of 7578 patients
      with UAP from 15 studies who underwent PCI was found to have a 28.7% increase in myocardial
      biomarkers after PCI. The objective of this randomized control trial is to gain a clinical
      insight on the use of low temperature contrast for the treatment of PCI-related myocardial
      injury in UAP patients. The primary objective is assess efficacy and safety of low
      temperature contrast for the treatment of PCI-related myocardial injury in UAP patients.
    

Detailed description: 
      The current study is designed as a multicenter, randomized and prospective study aiming to
      compare the change in levels of myocardial injury biomarkers (such as TNI and CK-MB) between
      low temperature contrast group and room temperature contrast group. Based on previous study,
      the incidence rate of PCI-related myocardial injury is 28.7% in UAP patients undergoing PCI.
      And in our study the expected incidence rate of PCI-related myocardial injury is up to 14.3%
      in UAP patients undergoing PCI after treatment with low temperature contrast. Moreover, the
      investigators estimated 10% loss follow-up of these patients in each arm. As a result, a
      total of 440 UAP patients were required, and with 220 patients per group as a ratio of 1:1
      randomization.
    

Intervention name(s): low temperature contrast
Intervention type(s): Other
Intervention description(s): UAP patients undergoing PCI were performed with low temperature contrast. The investigators used thermal insulation equipment to keep contrast at 5℃. The EKG and blood pressure were monitored during the PCI procedure. After PCI, the investigators monitored levels of myocardial injury biomarkers for 3 days every 8 hours.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: low temperature; contrast; PCI-related myocardial injury
Intrinsic PEEP During Mechanical Ventilation of Patients With Obesity
Condition: General Anesthesia; Laparoscopic Cholecystectomy
MeSH terms: Positive-Pressure Respiration, Intrinsic; Obesity
Study type: Interventional

Summary: 
      It is demonstrated that expiratory flow limitation and as a consequence, intrinsic positive
      end-expiratory pressure (PEEP) is present in grossly obese subjects especially in the supine
      position. The investigators tried to investigate the effect of low respiratory rate and high
      tidal volume on the intrinsic PEEP and gas exchange for obese subjects undergoing general
      anesthesia.
    

Detailed description: 
      Impaired gas exchange is a common anesthetic problem in obese subjects. It is demonstrated
      that expiratory flow limitation and as a consequence, intrinsic positive end-expiratory
      pressure (PEEPi) is present in grossly obese subjects especially in the supine position. It
      is known that there is a significant negative correlation between PEEPi present and PaO2.
      Therefore, the investigators postulated that if the reduce the PEEPi by reducing the
      respiratory rate in obese subjects, the impaired gas exchange might improve.

      The investigators tried to research the effect of low respiratory rate and high tidal volume
      on the intrinsic PEEP and gas exchange for obese subjects undergoing general anesthesia.
    

Intervention name(s): RR 6 + 0; RR 10 + 0; RR 16 + 0; RR 6 + 5; RR 10 + 5; RR 16 + 5
Intervention type(s): Device; Device; Device; Device; Device; Device
Intervention description(s): Respiratory rate 6 Tidal volume 16.7 ml/kg external PEEP = 0; Respiratory rate 10 Tidal volume 10 ml/kg external PEEP = 0; Respiratory rate 16 Tidal volume 6.25 ml/kg external PEEP = 0; Respiratory rate 6 Tidal volume 16.7 ml/kg external PEEP = 5; Respiratory rate 10 Tidal volume 10 ml/kg external PEEP = 5; Respiratory rate 16 Tidal volume 6.25 ml/kg external PEEP = 5
Other intervention name(s): Ventilator setting; Ventilator setting; Ventilator setting; Ventilator setting; Ventilator setting; Ventilator setting
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Care Provider)
Keywords: intrinsic positive end-expiratory pressure; obesity; ventilator setting; respiratory rate
A Randomized Controlled Trial of PCIT-ED for Preschool Depression
Condition: Depressive Disorder, Major
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      Parent Child Interaction Therapy Emotion Development (PCIT-ED) will be conducted with a
      sample of preschoolers who exhibit symptoms of depression compared to a wait list (WL)
      control after which participants will receive the active treatment. PCIT-ED is an expansion
      of PCIT, a well-known, widely used and proven effective treatment for preschool disruptive
      disorders. To address early disturbances of mood and affect, a novel ED module was added
      based on empirical data in emotion development. The ED module targets parent emotion learning
      skills with the goal of training the parent to serve as a more effective emotion teacher and
      coach to the child. The goal of the ED module is to enhance the child's capacity for emotion
      recognition and regulation or "emotional competence." In order to test the efficacy of
      PCIT-ED, to estimate accurate effect sizes and to investigate mediators and moderators of
      treatment response participants will complete comprehensive pre-, interval, and
      post-assessments.

      Preschoolers over 3 will be offered the option of enrolling in an add-on
      electroencephalography and magnetic resonance imagery study, to investigate neural changes
      associated with PCIT-ED.

      Compared to those randomized to the WL, preschoolers who undergo PCIT-ED will show
      significantly increased rates of remission, greater reductions in MDD symptoms, and decreases
      in impairment; and will show significantly greater increases in emotional competence measured
      by the ability to accurately identify emotions in themselves and others and the ability to
      effectively regulate intense emotions. Compared to those on the WL, parents who undergo
      PCIT-ED will show significantly greater increases in emotion skill learning and reductions in
      MDD symptoms and parenting stress.
    


Intervention name(s): PCIT-ED
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Depressive Disorder, Major; Child Psychiatry; Parent-Child Relationship; Therapy
Virtual Reality Distraction During Dental Local Anesthesia Among Children
Condition: Dental Anxiety; Dental Fear
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      To evaluate the effect of virtual reality (VR) distraction on anxiety and pain during buccal
      infiltration anesthesia (BIA) in pediatric patients.
    

Detailed description: 
      Design and Participants: This randomized clinical trial was conducted including healthy, and
      cooperative 6-12-year-old children, with no known allergy and/or sensitivity to local
      anesthesia who are currently in need of nonemergency dental treatment under local anesthetic
      infiltration by one of the postgraduate or interns at the pediatric dentistry students, were
      eligible for the study. Patients with history of epilepsy and anxiety disorder were excluded
      from the study

      Methods and Material: In the test group, subjects received BIA while being distracted using
      VR goggles; in the control group, subjects watched a cartoon video on a regular screen.
      Subjects' heart rate (HR) was measured at baseline and at four different timepoints during
      BIA administration to assess anxiety. The face, legs, activity, cry, consolability (FLACC)
      Behavioral Pain Assessment Scale was scored by two calibrated investigators to assess pain.
      After BIA, subjects rated their pain using the Arabic version of Wong-Baker FACES Pain Rating
      Scale.
    

Intervention name(s): Virtual Reality Distraction; TV Screen Distraction
Intervention type(s): Other; Other
Intervention description(s): Virtual reality goggles are commercially available wearable devices that are used to view view videos and play video games three dimensionally.; A cartoon video was played on a regular TV screen.
Other intervention name(s): LG 360 virtual reality [VR] headset, LG Electronics
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects receiving dental local anesthesia were randomly assigned to wear VR goggles or watch a cartoon video on a regular screen.
Masking: Single (Investigator)
Primary purpose: Supportive Care
Keywords: Dental Anxiety; Dental Fear; Infiltration Dental Local Anesthesia; Virtual Reality; Dental Pain
A Study on BReast Cancer Patient Care Using chAtbot and Video Education for Radiation Therapy (BRAVE)
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This randomized trial explored whether digital media (videos and chatbots) used for patient
      education could more effectively reduce anxiety in breast cancer patients during radiation
      therapy, compared to traditional paper-based methods. Post-surgery breast cancer patients
      scheduled for radiation therapy were assigned to groups receiving treatment information
      through different media combinations. The study aimed to assess whether these modern tools
      more effectively ease anxiety, thus potentially improving patient compliance and treatment
      experience.
    

Detailed description: 
      This study evaluates the impact of patient management and information provision using
      educational videos and chatbots on patient experience, satisfaction, and patient psychology
      in the breast cancer radiation treatment process.

      The experiment is designed as (2 (with or without using chatbot) X 2 (with or without using
      video) to distinguish groups.

      There is no separate treatment intervention in addition to use chatbot and video utilization.
    

Intervention name(s): Video + Chatbot; Video + Paper; Paper + Chatbot; Paper + Paper
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Participants will receive detailed information about the radiation therapy process, potential side effects, frequently asked questions, and aftercare instructions using a combination of educational videos and interactive chatbot sessions.; Participants will receive detailed information about the radiation therapy process, potential side effects, frequently asked questions, and aftercare instructions using a combination of educational videos and paper materials.; Participants will receive detailed information about the radiation therapy process, potential side effects, frequently asked questions, and aftercare instructions using a combination of paper materials and interactive chatbot sessions.; Participants will receive detailed information about the radiation therapy process, potential side effects, frequently asked questions, and aftercare instructions using paper materials.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Study to Evaluate the Effect of Food on the Pharmacokinetics of BMS-626529
Condition: Infection, Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The current food effect study is being performed to support a Phase 3 study with BMS 663068.
      Results from this study will inform whether patients in the upcoming Phase 3 study can be
      given the flexibility to dose BMS-663068 in the fasted state, if so desired.
    

Detailed description: 
      Primary Purpose: Other: To assess the effect of food on the steady-state exposure of
      BMS-626529 when administered as BMS 663068 600 mg twice daily (BID) to healthy subjects

      Acquired Immune Deficiency Syndrome (AIDS)
    

Intervention name(s): BMS-663068
Intervention type(s): Drug
Intervention description(s): BMS-663068
Intervention MeSH terms: Fostemsavir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Marginal Bone Height Changes Around Two Different Surface Treated Dental Implants Supporting Mandibular Complete Overdenture.
Condition: Assess Marginal Bone Height Changes Around Dental Implants
Study type: Interventional

Summary: 
      Patients participating in this study were rehabilitated by mucosa supported maxillary
      complete denture and mandibular overdenture supported by two different surface treated
      implants; resorbable blast media (RBM) on the right and Acid etched on the left; retained by
      ball attachments. The marginal bone height changes around RBM and acid etched surface treated
      dental implants retaining mandibular complete overdenture were assessed by cone beam computed
      tomography.
    


Intervention name(s): Dental Implants
Intervention type(s): Procedure
Intervention description(s): Resorbable blast media surface treated dental implant and Acid etched surface treated dental implant.
Intervention model: Single Group Assignment
Intervention model description: Ten completely edentulous patients aged from 50-60 years
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Implant surface treatment; Marginal bone height; Cone beam computed tomography
Immediate Loading Of Dental Implants: A Pilot Clinical Study
Condition: Dental Implantation
Study type: Interventional

Summary: 
      Objective: To provide 2-year clinical- and patient-oriented data with regard to mandibular
      overdenture assisted by 2 immediately loaded unsplinted implants.
    

Detailed description: 
      In this pre-post design, Phase-I clinical trial, 18 edentate individuals received a new set
      of complete denture. Then, following standard procedures, 3 threaded implants (OsseoSpeed
      TXTM, Dentsply Implants, Mölndal, Sweden) were placed in the mandible in each patient, and
      locator abutments (Zest Anchors LLC, Escondido, U.S.A.) were inserted on the right and left
      side implants. The midline implant served as a control for within-patient comparison. The
      immediate loading was conducted within 24 h of surgery. Data were collected at baseline (T0),
      12 (T1) and 24 (T2) months after immediate loading. The clinical outcomes included implant
      survival rate, crestal bone level changes and implant stability. These criteria were assessed
      through clinical and radiographic examinations as well as resonance frequency analysis.
      Patient-centered outcomes included patient satisfaction and oral health-related quality of
      life measured using validated questionnaires. Brunner-Langer approach was used for
      statistical analysis.
    

Intervention name(s): Immediate loading
Intervention type(s): Procedure
Other intervention name(s): Procedure: Immediate loading of 2 endo-osseous unsplinted implants of a mandibular overdenture
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: immediate-loading; patient-based outcomes
Effect of Vitamin K on Age-Related Bone Loss and Vascular Calcification
Condition: Osteoporosis; Vascular Calcification; Inflammation
MeSH terms: Osteoporosis; Calcinosis; Vascular Calcification; Inflammation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if supplemental vitamin K will reduce age-related
      bone loss in elderly men and women above that achieved by supplementation.
    

Detailed description: 
      This is a three-year, double-blind, placebo-controlled trial to study the effect of vitamin K
      supplementation (500 µg/d) on bone density at the hip, markers of bone turnover, vascular
      calcification, osteoarthritis and tests of concentration in 452 men and women, aged 60-80
      years. All participants will also be receiving calcium and vitamin D supplements, in addition
      to a multivitamin, to prevent any potential bone loss associated with dietary inadequacy of
      these nutrients.

      Measurements of plasma vitamin K concentrations, percent undercarboxylated osteocalcin
      (markers of vitamin K status), serum osteocalcin, collagen Type-I-crosslink N-telopeptides
      (markers of bone turnover) and BMD of the hip, as well as the heel, spine and total body at
      0, 6, 12, 24, and 36 months of vitamin K supplementation. Vascular calcification will be
      measured at baseline and at 36 months of vitamin K supplementation by multi-slice CT scan. An
      additional EKG will be performed at 36 months of vitamin K supplementation to determine
      cardiac changes that may have occurred over the course of the study. Bilateral hand x-rays
      will be measured at 36 months of vitamin K supplementation, as will the administration of the
      Framingham OA questionnaire. Plasma 25-hydroxyvitamin D concentrations and urinary calcium
      and sodium will be measured at the same time points to be used as covariates in this
      assessment. In addition, 1,25-dihydroxyvitamin D will be measured at the beginning and end of
      the study. Other covariates collected throughout the study include age, weight,
      anthropometric data, physical activity, medication used, smoking, plasma lipids, insulin and
      measures of inflammation, B vitamins and dietary intakes. In addition, two tests of attention
      and concentration will be administered at 36 months of vitamin K supplementation. This trial
      will determine if supplemental vitamin K will reduce age-related bone loss, vascular
      calcification, osteoarthritis and concentration in elderly men and women, above that achieved
      by supplemental calcium and vitamin D alone.
    

Intervention name(s): Vitamin K
Intervention type(s): Drug
Intervention MeSH terms: Vitamin K
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: nutritional supplement; dietary supplement; vitamin therapy; Vitamin K deficiency; bone density
Efficacy and Safety Assessment of Intracameral Injection of T2380 in Cataract Surgery
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the efficacy and safety assessment of T2380 for
      mydriasis and anaesthesia in phacoemulsification cataract surgery versus reference group
      (topical mydriatics and anaesthetic) 2X246 patients.
    

Detailed description: 
      In order to perform pupil size measurements and ocular discomfort assessments at specific
      times, the surgical procedure was divided into 5 time periods according to the following time
      points: T1 (just before first incision), T2 (just before viscoelastic injection), T3 (just
      before capsulorhexis), T4 (just before intraocular lens injection), and T5 (just before
      cefuroxime injection).
    

Intervention name(s): T2380; Mydriatics; Tetracaine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 200 microlitres of T2380 will be administrated intracamerally; 3 drops of tropicamide and phenylephrine were instilled 30 minutes before surgery. The second and the third instillation of both phenylephrine and tropicamide will be realised respectively within 20 and 10 minutes before surgery.; Two drops of tetracaine were instilled in the eye to be operated 5 minutes and 1 minute before surgery
Other intervention name(s): Tropicamide, Phenylpehrine; Tetracaine 1%
Intervention MeSH terms: Tetracaine; Tropicamide; Mydriatics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment