bioihbjkbjnl/mcl2 huggingface dataset:
Study to Investigate the Safety and Immunogenicity of a Tetravalent Chimeric Dengue Vaccine in Healthy Volunteers Between the Ages of 1.5 - 45 Years
Condition: Healthy
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety of Takeda's tetravalent dengue vaccine
      (TDV) (previously DENVax) administered subcutaneously in healthy adults and children. In
      addition the antibody response to the four dengue virus serotypes will be evaluated.
    

Detailed description: 
      The vaccine tested in this study was tetravalent dengue vaccine (TDV). TDV was tested to
      assess safety and immunogenicity in healthy adults and children living in dengue endemic
      countries.

      The study enrolled 360 healthy participants. The study was conducted in 2 parts, Part 1 - age
      descending and and Part 2 - expansion - ages 1.5-11 years. Participants were allocated to one
      of the four age cohorts in Part 1 (21 to 45 years, 12 to 20 years, 6 to 11 years, and 1.5 to
      5 years) and expansion age cohort 1.5-11 years in Part 2. Participants were randomized in 2:1
      ratio and in 3: 1 ratio in Part 1 and 2 respectively to receive:

        -  TDV 0.5 mL SC injection

        -  Placebo (inactive solution) - this is a solution that looks like the study drug but has
           no active ingredient

      This multi-center trial was conducted worldwide. The overall time to participate in this
      study was up to 37 months (including screening period). Participants made multiple visits to
      the clinic including a final visit at Day 1080.
    

Intervention name(s): TDV; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.; TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Normal healthy adults and children; Safety and tolerability; Active vaccine; Placebo; Dengue virus vaccine; Immune response
Effects of Thoracic Kinesio Taping on COPD Patients
Condition: COPD
Study type: Interventional

Summary: 
      The purpose of this study was to investigate the effect of kinseio taping on functional
      capacity, pulmonary functions, respiratory muscle strength, severity of dyspnea, severity of
      fatigue in Chronic Obstructive Pulmonary Disease (COPD). Assessment of patients was done
      baseline and 6th week.

      Eligible patients for the study randomly allocated to Kinesio Taping Group (KTG), or Control
      Group (CG). Both groups received three different deep breathing exercises (diaphragmatic,
      thoracic, and lateral basal), each consisting of three sets of 10 repetitions, with 30
      seconds of rest between each set. KTG also received thoracic kinesio taping application.
    


Intervention name(s): Kinesio Taping; Deep Breathing Exercises
Intervention type(s): Other; Other
Intervention description(s): The material used for thoracic kinesio taping application was Kinesio® Tex Gold™ (Kinesio Holding. Patients were instructed to sit upright on an armless chair with no back support, with knees flexed to 90 degrees, feet on the floor and arms relaxed. Kinesio tape was applied anteriorly and posteriorly to facilitate respiratory muscles (primarily diaphragm) along the subcostal area. Additionally, two more kinesio tapes were applied to upper trapezius and scalene muscles' area which lies between neck and acromion at both sides (left and right).; Three different deep breathing exercises (diaphragmatic, thoracic, and lateral basal), each consisting of three sets of 10 repetitions, with 30 seconds of rest between each set.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: kinesio taping; COPD; functional capacity; pulmonary functions; pulmonary rehabilitation
Effects of Motor Imagery on Autonomic Function
Condition: Motor Imagery Training
Study type: Interventional

Summary: 
      Most studies on motor imagery suggested the effects of motor imagery are related to
      neuroplastic changes in the brain. In addition to that the neuroplastic changes, it is
      thought that motor imagery can alter metabolic responses just like in actual exercise.
      However, the level of evidence about the effect of motor imagery on autonomic functions is
      limited.

      The aims of this study;

        1. The primary aim of this study is to investigate the effects of activating and relaxing
           kinesthetic motor imagery on autonomic function in healthy individuals and to compare
           these two methods.

        2. The secondary aim of this study is to explore the effects of these methods on motor
           imagery skills of individuals will also be investigated.

      The participants will randomly be allocated into three groups: (1) Activating kinesthetic
      motor imagery training, (2) Relaxing kinesthetic motor imagery training, and (3) Control
      group.

      Participants in the activating kinesthetic motor imagery training group will imagine high
      effort exercises (e.g. planking, boxing, jumping, squats, push-ups) in the sessions in home
      using the study audio-video motor imagery script. The relaxing kinesthetic motor imagery
      training group will imagine relaxing (low effort) exercises (e.g. breathing exercises,
      stretching, body awareness exercises) in home using the study audio-video motor imagery
      script. Prior the sessions, the participants will receive an introductory lecture about motor
      imagery. The intervention groups will practise 5 times per week for 17 minutes per day for 2
      weeks. Phone calls will be performed for support and as a reminder for the assessment (after
      one week). The control group will receive no specific training. Data will be collected at
      baseline and after the two-week intervention by masked outcome assessors.
    


Intervention name(s): Activating kinesthetic motor imagery training; Relaxing kinesthetic motor imagery training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants in the activating kinesthetic motor imagery training group will imagine high effort exercises (e.g. planking, boxing, jumping, squats, push-ups) in the sessions in home using the study audio-video motor imagery script for 5 times per week; 17 min per day for 2 weeks. Phone calls will be performed for support and as a reminder for the assessment (after one week).; Participants in the relaxing kinesthetic motor imagery training group will imagine relaxing (low effort) exercises (e.g. breathing exercises, stretching, body awareness exercises) in home using the study audio-video motor imagery script 5 times per week; 17 min per day for 2 weeks. Phone calls will be performed for support and as a reminder for the assessment (after one week).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Enhancing Extinction Learning in Post Traumatic Stress Disorder (PTSD)
Condition: Chronic Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Phase 2

Summary: 
      Posttraumatic stress disorder (PTSD) is a condition that involves intense memories of a
      traumatic event and intense, persistent feelings of anxiety. There are several effective
      therapies for PTSD, but they are often time consuming. The investigators want to see if the
      investigators can shorten treatment time while keeping therapy effective by adding a
      medication called methylene blue, USP, taken orally as a pill, to the therapy. The specific
      aims are: 1) To see whether medication plus psychotherapy improves PTSD symptoms more than
      placebo plus psychotherapy or a waitlist; 2) To examine the long-term outcome of those
      receiving medication plus psychotherapy 1 and 3 months after treatment has ended; 3) To
      examine whether medication plus psychotherapy helps with depression, trauma-related
      cognitions, and functioning.
    

Detailed description: 
      The psychotherapy the investigators are offering in this study is a type of cognitive
      behavioral therapy called imaginal exposure. In imaginal exposure, the investigators
      encourage the client to approach the memory of the trauma by recounting the trauma story to
      the therapist and discussing his or her reactions to the memory.
    

Intervention name(s): Psychotherapy plus Methylene Blue, USP; Psychotherapy plus Placebo; Delayed Psychotherapy
Intervention type(s): Drug; Behavioral; Behavioral
Intervention description(s): This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, 260 mg of methylene blue, USP will be given.; This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, capsules containing the placebo will be given.; Individuals must wait approximately five to six weeks to start treatment. They will come in for two check-in appointments before starting treatment. Treatment will consist of ten twice-weekly psychotherapy sessions (90-120 min each session).
Intervention MeSH terms: Methylene Blue
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Surgical Site Infection Study
Condition: Cava-pulmonary Anastomosis
Study type: Observational

Summary: 
      The purpose of this study is to investigate the pharmacokinetics of cefazolin using both
      plasma and microdialysate sampling methods in children with single ventricle physiology
      undergoing their second palliation procedure. This will provide data to determine if the
      current standard dosing regimen of cefazolin is adequate to achieve and maintain tissue
      concentrations greater than the minimum inhibitory concentrations (MIC) for common
      post-surgical pathogens that cause Surgical Site Infections (SSIs).
    

Detailed description: 
      This study aims to sample interstitial fluid (IF) of infants undergoing superior
      cava-pulmonary anastomosis (either Glenn or Hemi-Fontan) cardiac surgical procedures who
      receive cefazolin as their surgical prophylactic antibiotic. Cefazolin concentrations will
      then be determined in both microdialysate and plasma samples and used to define the
      pharmacokinetics of cefazolin at the tissue level and compare that to plasma
      pharmacokinetics. In addition, the data gathered will be used to assess how cardiopulmonary
      bypass (CPB), deep hypothermic cardiac arrest (DHCA), and modified ultrafiltration (MUF)
      affect tissue penetration of the prophylactically administered cefazolin.

      The study involves the use of microdialysis (MD) and plasma sampling methods to determine the
      pharmacokinetic properties of cefazolin when used as a prophylactic antibiotic during the
      second palliation procedure (superior vena cava-pulmonary anastomosis) for infants with
      single ventricle physiology. This requires the use of microdialysis (MD) catheters inserted
      into the left deltoid muscle in eligible subjects after the induction of general anesthesia
      as well as collection of microdialysate and blood samples throughout the duration of the
      procedure. Cefazolin will be administered as standard of care. Cefazolin concentrations in
      the collected samples will be measured via a validated high-performance liquid chromatography
      (HPLC) and mass spectrometry assay. Pharmacokinetic analyses will be performed.
    

Observational model: Cohort
Sampling method: Non-Probability Sample
Study population: 
        Males or females with single ventricle physiology undergoing their second palliation
        procedure (typically performed between 3-6 months of age)
      
Keywords: pharmacokinetics; cefazolin; microdialysis sampling; interstitial fluid; skeletal muscle; plasma; children
Trial to Evaluate the Safety & Efficacy of the Absolute Pro™ Peripheral Self-Expanding Stent System in Subjects With Atherosclerotic de Novo or Restenotic Lesions in the Native Common Iliac Artery and/or Native External Iliac Artery.
Condition: Peripheral Vascular Disease
MeSH terms: Vascular Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the safety and efficacy of the Absolute Pro™ Peripheral Self-Expanding Stent
      System in subjects with atherosclerotic de novo or restenotic lesions in the native common
      iliac artery and/or native external iliac artery.
    


Intervention name(s): Absolute Pro™ Peripheral Self-Expanding Stent System
Intervention type(s): Device
Intervention description(s): Absolute Pro™ Peripheral Self-Expanding Stent System: Devices include both Absolute Pro™ and Absolute Pro™ LL Peripheral Self-Expanding Stent Systems. It is indicated for the treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atherosclerosis; Peripheral artery disease; Peripheral vascular disease; PAD; Claudication; Peripheral Arterial Occlusive Disease; Stent; PAOD; PVD
Immersive Virtual Reality Intervention for Non-Opioid Pain Management: A Randomized Controlled Trial
Condition: Pain; Pain Management
Study type: Interventional

Summary: 
      The study is a randomized controlled trial (RCT) of VR non-opioid management vs. a control
      "sham" intervention for a broad and representative group of medical and surgical patients
      with pain. Hospitalized patients will receive specialized VR interventions, administered via
      portable VR headsets, to manage breakthrough pain. Control patients will view content on the
      in-room Health and Wellness television channel. Investigators will follow patients throughout
      the course of their hospitalization and monitor outcomes during and after their stays,
      including pain levels, medication requests, and quality of life.
    

Detailed description: 
      The study population will consist of 120 patients - 60 patients who are exposed to VR, and 60
      control patients exposed to an audiovisual "sham" intervention. Investigators will select up
      to 120 hospitalized patients at CSMC admitted during the study period of November 2016 to
      September 2017. The inpatient wards serve patients ranging in age from 18 to over 100,
      allowing us to assess the feasibility of using VR across diverse age groups. Appropriate
      inpatients will be selected at random by Dr. Rosen or other authorized co-investigators or
      study staff, who will obtain relevant clinical variables from the EHR. All patients admitted
      to the hospital will be considered for the study. The location and identity of the inpatient
      will be relayed by their attending physician to a member of the study team, who will deliver
      a randomly selected intervention (either VR or Health and Wellness Channel) to the patient
      the same day (at the patient's discretion). The patient will continue usage as needed for up
      to 20 days of the hospital stay. VR Interventions include both relaxing environment and
      engaging games. The Health and Wellness Channel includes some of the same types of content,
      but it is delivered passively through the in-room television system. Investigators will
      examine changes in pain level, length of stay, medication requests (amount and timing),
      Quality of Life, Functioning, and Patient Satisfaction.
    

Intervention name(s): Virtual Reality; Health and Wellness Channel
Intervention type(s): Device; Device
Intervention description(s): A menu of VR experiences, lasting from 3-30 minutes each. For example, patients may watch a soothing virtual campfire, or fly over a scenic landscape, or play an interactive game.; Relaxing content broadcast passively on the patient in-room television channel.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Virtual Reality; Non-Opioid Pain Management
Eye-Tracking Rapid Attention Computation
Condition: Post Concussive Syndrome, Chronic
MeSH terms: Post-Concussion Syndrome
Study type: Observational

Summary: 
      The purpose of this study is to validate and refine a diagnostic device that can detect
      attention and memory deficits that result from mild traumatic brain injury (mTBI).
    

Detailed description: 
      The main goal of this project is the development of a military-ready, sensitive and rapid eye
      tracking diagnostic device for individuals with mild traumatic brain injury (mTBI). The
      device will also be tested for its efficacy in diagnosing fatigue and identifying aging
      effects. We will use a predictive visual tracking paradigm to dynamically capture the
      attentional state and correlate the subject's performance with the degree of disruption in
      the attention network caused by mTBI, aging and fatigue. The device will be tested for its
      diagnostic capabilities based on its selectivity, reliability, sensitivity and validity for
      individuals of varying ages (with and without mTBI) and in military personnel who have
      undergone 26 hours of sleep deprivation.

      Testing will be conducted at two sites:

        1. Civilians with mTBI; and civilians with adult attention deficit hyperactivity disorder
           will be tested by trained staff of the Brain Trauma Foundation (BTF) at Weill Cornell
           Medical College (WCMC) in New York City. The ages of the enrolled individuals will range
           between 18-55 years in order to examine aging effects.

        2. Enrolled service members will be tested at the United States Army Research Institute of
           Environmental Medicine (USARIEM) in Natick, Massachusetts. These service members will be
           healthy volunteers without a history of mTBI. Some of these subjects will undergo 26
           hours of sleep deprivation during which they will be tested at specific time points.

      Our objectives are:

      1. Prove that the eye-tracking concept can be brought from a successful laboratory device to
      a specific, reliable, selective, and valid diagnostic tool.

      1.1. Test reliability by examining the test-retest reliability measures of EYE-TRAC;

      1.2. Test selectivity by testing the ability to differentiating the effects of fatigue,
      aging, and mTBI on EYE-TRAC measures;

      1.3. Test validity by determining the relationship between measures of attention and working
      memory based on the EYE-TRAC and validated measures of sustained attention and working
      memory;

      1.4. Test specificity by measuring the spectrum of TBI injury using MRI-DTI and correlate
      with EYE-TRAC.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        TBI patients will be recruited from an outpatient TBI clinic Normals will be friends/family
        of TBI patients who have not suffered a TBI, as well as individuals recruited from the
        community
Dose Escalation Study of Simultaneous Boost Intensity-Modulated Radiotherapy for Locally Advanced Cervical Cancer
Condition: Locally Advanced Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This will be the first study to assess the clinical feasibility of dose escalation with
      simultaneous integrated boost intensity-modulated radiotherapy for patients with locally
      advanced cervical cancer. Following screening to confirm eligibility patients will commence a
      six week treatment period. After this, patients will be followed up by visits to clinic every
      3 months for a period of 24 months (2 years). End of study is defined as 24 months after
      treatment. Patients will be followed up for a minimum of 5 years (as per local policy) after
      treatment.
    


Intervention name(s): Cisplatin; Intensity-modulated radiation therapy; Intracavitary brachytherapy
Intervention type(s): Drug; Radiation; Procedure
Intervention description(s): Each patient will also receive chemotherapy with a drug called cisplatin, which is given intravenously through a drip in the arm once a week during their 6 week radiotherapy treatment. Again this is standard treatment for any patient with cervix cancer.; Patients in this trial will receive radiotherapy to the pelvic area with additional chemotherapy (chemoradiotherapy). This is the standard treatment for cervix cancer and will be almost identical to patients not taking part in this study. As patients in the study will be treated with IMRT, the total radiation dose will be slightly higher but without increasing the dose to normal tissue in the pelvis. This will mean the number of radiotherapy treatments that each patient receives in the study is between 27 and 30 compared with the usual 28. Each patient will undergo 6 weeks of radiotherapy treatment and must attend the radiotherapy department hospital once daily (Monday to Friday) over 6 weeks. Each treatment lasts for approximately 10 15 minutes. This is exactly the same as standard practice if patients were not participating in the trial.; Intracavitary brachytherapy Intracavitary brachytherapy will be given towards the end of external beam radiotherapy usually weeks five and six. This is routine treatment and will be given according to local practice As is the convention patients will be reviewed weekly (more frequently if necessary) by their study doctor and will have weekly blood tests to measure full blood count and urea and electrolytes.
Other intervention name(s): IMRT
Intervention MeSH terms: Cisplatin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cervical adenocarcinoma; cervical adenosquamous cell carcinoma; cervical squamous cell carcinoma; stage IB cervical cancer; stage IIA cervical cancer; stage IIB cervical cancer; stage III cervical cancer; stage IVA cervical cancer