bioihbjkbjnl/mcl2 huggingface dataset:
A Clinical Trial to Evaluate a Recombinant Staphylococcus Aureus Vaccine (Escherichia Coli) in Healthy Adults
Condition: Staphylococcus Aureus Infection
MeSH terms: Staphylococcal Infections; Escherichia coli Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single center, open-label phase1b clinical trial. The study will evaluate the
      safety and immunogenicity of an experimental recombinant staphylococcus aureus vaccine with
      different immunization schedules in healthy adults aged 18-70 years, including day 0-3-7, day
      0/0-3-7, day 0/0-7 and day 0/0-7-14.
    


Intervention name(s): Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0-3-7; Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-3-7; Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7; Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7-14
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): 36 participants will be given three dose of Staphylococcus aureus vaccine(Escherichia Coli) at day 0-3-7; 36 participants will be given four dose of Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-3-7; 36 participants will be given three dose of Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7; 36 participants will be given four dose of Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7-14
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Copanlisib Pharmacodynamic Study
Condition: Non Hodgkin Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to analyze what the study drug does to the body and its relationship to drug
      levels and safety after patients with advanced cancer have been treated with copanlisib in
      different dose groups.
    


Intervention name(s): Copanlisib (BAY80-6946)
Intervention type(s): Drug
Intervention description(s): 0.8 mg/kg body weight and 0.4 mg/kg (not to exceed 65 mg) for the non-diabetic patients;45 mg and 60 mg for the diabetic patients; Intravenous (IV) infusion over 1 hour. Dosing of copanlisib will be on Days 1, 8, and 15 of each 28 day treatment cycle.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Solid tumors
Safety, Tolerability and Pharmacokinetics of KPG-818 in Healthy Subjects
Condition: Systemic Lupus Erythematosus
MeSH terms: Lupus Erythematosus, Systemic
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 study to investigate the safety, tolerability and pharmacokinetics (PK) of
      KPG-818 in healthy male and female participants and the effect of food on the PK of KPG-818.
      The study will assist in identifying appropriate, well tolerated doses that can be
      administered in subsequent studies in healthy participants and participants with systemic
      lupus erythematosus (SLE).
    

Detailed description: 
      A total of 40 subjects will be evaluated with 30 subjects randomized to receive active drug
      and 10 subjects randomized to receive placebo in a double-blind fashion (8 subjects in each
      dose cohort, 6 subjects randomized to active drug and 2 subjects randomized to placebo). Five
      dose levels (2, 5, 10, 20 and 30 mg) are planned to be evaluated.The study will be double
      blinded with regard to treatment (KPG-818 or placebo) at each dose level. KPG-818 and placebo
      will be matched for formulation, appearance and number of capsules. Safety assessments will
      be performed throughout the study including physical examinations, vital signs, clinical
      laboratory tests, 12 lead electrocardiograms and monitoring of adverse events.
      Pharmacokinetic blood and urine samples will be collected up to 72 hours after dosing. A
      post-treatment follow-up visit will be performed within 10 days of the last dose of study
      treatment.
    

Intervention name(s): KPG-818
Intervention type(s): Drug
Intervention description(s): KPG-818 Capsules (1 mg, 5 mg and 20 mg) for oral administration is the drug substance powder filled in capsule (PIC) dosage form. KPG-818 Capsules and placebo capsules are packaged in HDPE bottle capped with HDPE cap.
Other intervention name(s): Matching placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel and Sequential
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Scorpio Posterior Stabilised (PS) vs Scorpio NRG ("Energize") PS - Total Knee Arthroplasty
Condition: Arthroplasty, Replacement, Knee
Study type: Interventional

Summary: 
      Single-centre, prospective, randomized comparative study to compare the maximum flexion and
      Chair Raise achievement ratios of the Scorpio PS and and the Scorpio NRG PS. Documentation of
      all complications.
    

Detailed description: 
      Surveillance design: Single-centre, prospective, randomized comparative study. Objectives: To
      compare the maximum flexion (active and passive) and Chair Raise achievement ratios. All
      complications will be documented.

      Number of subjects to be enrolled: All consecutive Scorpio patients are included until a
      group size of 88 is reached.

      Clinical evaluations: Chair raise test, Stair climb test, Western Ontario McMaster
      Osteoarthritis Index (WOMAC) patient self evaluation, EuroQuol - 5 dimension (EQ-5D) patient
      questionnaire. Standard clinical, functional and pain parameters (Knee Society Score),
      pre-operatively and post-operatively. All per- and post-op complications.
    

Intervention name(s): Scorpio PS (posterior stable); Scorpio NRG PS
Intervention type(s): Device; Device
Intervention description(s): Implantation of total knee prosthesis; Implantation of total knee prosthesis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Intraprostatic Botulinum Toxin Type "A" Injection in Patients With Benign Prostatic Hyperplasia and Unsatisfactory Response to Medical Therapy
Condition: Benign Prostatic Hyperplasia (BPH); Benign Prostatic Enlargement (BPE)
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The injection of botulinum neurotoxin A into the prostate represents an alternative, minimal
      invasive treatment in patient with lower urinary tract symptoms (LUTS) associated to benign
      prostatic hyperplasia (BPH).

      Objective: To evaluate the effectiveness of BTA in treating patients with symptomatic BPH and
      unsatisfactory response to combined medical therapy.
    


Intervention name(s): BOTOX
Intervention type(s): Drug
Intervention description(s): Botulinum Toxin type A, 200-300 UI dilued in 6 ml of saline solution
Other intervention name(s): Botulinum toxin type A
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Silicone Hydrogel Soft Contact Lens 7-Day Extended Wear Basis
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The objective of this study is to evaluate the safety and effectiveness of the Bausch + Lomb
      samfilcon A soft (hydrophilic) contact lens, a new silicone hydrogel contact lens, compared
      to the Bausch + Lomb PureVision® soft contact lens when worn for 7-day extended wear by
      adapted soft contact lens wearers.
    

Detailed description: 
      Approximately 816 participants (1,632 eyes) will be enrolled in this 12-month randomized,
      parallel, Investigator/Sponsor masked study at approximately 35 investigative sites in the
      US.

      At the Screening/Dispensing Visit, approximately one-half of the participants will be
      randomized to receive Bausch + Lomb investigational samfilcon A soft contact lenses (Test)
      and approximately one-half of the subjects will be randomized to receive Bausch + Lomb
      PureVision soft contact lenses (Control). Both groups will wear the assigned lenses
      bilaterally on a 7-day extended wear basis throughout the 12 month study. The lenses are to
      be worn overnight for up to six consecutive nights per week. The lenses are to be removed,
      cleaned and disinfected on the seventh night and re-inserted the following morning. The
      lenses will be replaced with new lenses at the beginning of each month. Lenses will be
      provided at the Screening/Dispensing, 3-Month, 6-Month and 9-Month Follow-Up visits to
      maintain a monthly replacement schedule. Participants will also be required to complete a
      paper diary.
    

Intervention name(s): Bausch + Lomb Samfilcon A Soft Contact Lens; Bausch + Lomb Pure Vision Soft Contact Lens
Intervention type(s): Device; Device
Intervention description(s): soft contact lenses; soft contact lenses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Effectiveness of the FearNot!v.2.0 Software in Reducing Bullying Victimisation Among Primary School Children
Condition: Bullying Victimisation
MeSH terms: Bullying
Study type: Interventional

Summary: 
      This study will evaluate the effectiveness of a virtual learning treatment in reducing
      bullying among primary school children in the UK and Germany.
    

Detailed description: 
      In this study, a virtual learning environment application called FearNot!v.2.0 will be
      evaluated as a way to improve the quality of life in schools by altering children's attitudes
      and behavior towards bullying.

      Participants will be assigned to either the intervention or the control group. The intention
      was to assign randomly, however, only a minority of primary schools have the computer
      facilities to run the software with all pupils participating. Thus, assignment is based on
      the school computer compatibility with the FearNot!v.2.0 software for intervention versus
      control group controlling for social variables. Participants in the intervention group will
      interact with the software during 30-minute sessions once a week for a total of 3 weeks while
      participants in the control group will follow the normal curriculum.

      The FearNot! narrative comprises a number of emergent episodes, which play out like an
      improvisational drama. During each of these emergent episodes, the characters will act out
      their roles resulting in a dramatic movie-like display on the computer's monitor. In between
      each of these episodes, the child can interact with the victim character. He/she can learn
      how the character feels, and offer them coping strategy advice as to how to behave in the
      following episode.

      Outcomes will be assessed through student questionnaires at baseline, one week, and four
      weeks after treatment. In addition, classroom teachers will be asked to complete the Teacher
      Incidence of Bullying Scale at baseline and 4 weeks after the treatment.
    

Intervention name(s): FearNot
Intervention type(s): Behavioral
Intervention description(s): Behavioral: Three sessions of FearNot!v.2.0 software interaction over a three-week period (each session lasting approximately 30 minutes)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bullying; victimisation; aggressive behavior
The Association Between Central Aortic Blood Pressure Indices and Severity of Coronary Artery Disease
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Observational

Summary: 
      Abstract

      Objectives:

      Primary: To study the association between central aortic blood pressure indices and coronary
      artery disease in patients undergoing elective angiography. Secondary: (a) To study whether
      any association exists between central aortic pressure indices and the incidence of major
      adverse cardiovascular events (MACE) in the same patients during a 6 month follow up period.
      (b) To study whether any association exists between the central aortic pressures and
      peripheral pressures.

      Methods: The investigators conducted a prospective observational study in consecutive
      patients undergoing coronary angiography. Central and peripheral pressures were invasively
      recorded and coronary artery disease (CAD) classified into obstructive and non-obstructive
      group. CAD severity was graded using the Gensini score and subjects were divided into
      tertiles. Patients were followed up and the role of central aortic pressure indices in the
      prediction of cardiovascular events were analysed.
    


Intervention name(s): CORONARY ANGIOGRAM AND CENTRAL AORTIC WAVEFORM ANALYSIS
Intervention type(s): Procedure
Intervention description(s): coronary angiogram
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        ALL CONSECUTIVE SUBJECTS UNDERGOING CORONARY ANGIOGRAM FOR THE DIAGNOSIS OF CAD DURING A 6
        MONTH PERIOD
      
Keywords: central pressure; Gensini score; pulsatility; coronary artery disease
Acute Application of Antibiotic Powder in Open Fracture Wounds
Condition: Fractures, Open; Wounds and Injuries--Infections; Anti-Bacterial Agents; Fractures, Bone; Extremity Fracture Lower; Extremity Fractures Upper
MeSH terms: Fractures, Bone; Wounds and Injuries; Fractures, Open
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to help determine the best treatment for severe injures like
      open fracture wounds.

      Some broken bone injuries can be more likely to get an infection. It is mostly due to the way
      they were injured. Surgical site infection in the orthopedic surgery population is a big
      public health issue. Wound infections result in both longer length of hospital stay and total
      cost of care. This study will be using an antibiotic called Vancomycin or Tobramycin in a
      powder form.
    

Detailed description: 
      The investigators aim to investigate the effectiveness of preoperative intrawound antibiotic
      powder in preventing infection and reducing bacterial burden after open fracture.

      The investigators hypothesize that the participants who receive preoperative intrawound
      antibiotic powder will have fewer superficial and deep surgical site infections compared to
      participants who do not receive the antibiotic powder. The investigators also anticipate that
      the application of the antibiotic powder to open fracture wounds preoperatively will decrease
      the bacterial burden.

      Sample swabs will be analyzed using the 16S metagenomics sequencing on the Illumina platform.
      Both RNA and DNA extracts will be utilized to identify and quantify the bacterial load in the
      wound bed at the time immediately prior to surgical debridement.
    

Intervention name(s): Vancomycin; Tobramycin
Intervention type(s): Drug; Drug
Intervention description(s): 1 vial of Vancomycin 1g powder applied topically to the open fracture wound injury.; 1 vial of Tobramycin 1.2g powder applied topically to the open fracture wound injury.
Intervention MeSH terms: Vancomycin; Tobramycin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The management of open fractures involves an expedited administration of systemic antibiotics and while effective in reducing the rate of infection, complications from infections are still common following open fractures. This trial aims to evaluate the incidence of surgical site infections using topical vancomycin antibiotic powder or topical tobramycin antibiotic powder in combination with standard of care treatment and to evaluate the effectiveness of both topical antibiotic powders in reducing surgical site infection.
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Open fractures; Antibiotic powder; Vancomycin; Tobramycin; Infection; Gustilo; 16S
Postoperative Analgesic Effect of Hydromorphone on Partial Pulmonary Resection Under Video-assisted Thoracoscopy
Condition: Pain, Postoperative; Thoracic Surgery, Video-Assisted
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Postoperative pain remains relatively high within 48h for Chinese patients who receive
      video-assisted thoracoscopic surgery. Multimodal analgesia combines several agents and/or
      techniques to function on diverse nociceptive mechanisms to enhance pain relief and lessen
      side effect. Hydromorphone is a hydrogenated ketone of morphine and approximately 5-10 times
      more potent. There lacks about efficacy and efficiency of hydromorphone in electrical pump
      for patient controlled intravenous analgesic (PCIA).
    


Intervention name(s): Hydromorphone; Morphine
Intervention type(s): Drug; Drug
Intervention description(s): 0.002 mg*kg-1 bolus with 0.002 mg*kg-1 background infusion for group BH 0.002 mg*kg-1 bolus without background infusion for group NBH Drug is administered through PCIA pump.; 0.015 mg*kg-1 bolus without background infusion for group M Drug is administered through PCIA pump.
Intervention MeSH terms: Morphine; Hydromorphone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Objective Brain Function Assessment of mTBI/Concussion in High School Athletes
Condition: Brain Injuries, Traumatic; Concussion, Brain; Concussion, Mild; Concussion, Intermediate; Concussion, Severe
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
Study type: Observational

Summary: 
      This study (Part 2) is designed to build a database including EEG, neurocognitive
      performance, clinical symptoms, history and other relevant data, which will be used to derive
      a multimodal EEG based algorithm for the identification of concussion and tracking of
      recovery. In addition, neuroimaging will be conducted at time of injury and following Return
      to Play (RTP).
    

Detailed description: 
      Injured/concussed subjects will be studied at time of injury, and at 3 follow-up time points
      following injury. Matched controls will be tested following the same schedule as the injured
      athletes. In addition, the study will include an additional pool of contact and non-contact
      athletes who are not head injured and will be assessed prior to the season and then after the
      season has ended. This data will be used to populate a database for the purpose of deriving a
      multimodal concussion index.
    

Intervention name(s): BrainScope Ahead 200iD; Advanced MRI Neuroimaging
Intervention type(s): Device; Device
Intervention description(s): The BrainScope Battery evaluation will consist of 4 tests to aid in the assessment of concussion: History, Physical, signs and symptoms (SAC, SCAT3), Electrophysiological Function; Neurocognitive Performance Assessment and a balance/sway measurement. BrainScope Ahead 200iD device will be used to perform EEG.; Diffusion tensor imaging (DTI) is a magnetic resonance imaging technique that enables the measurement of the restricted diffusion of water in tissue in order to produce neural tract images instead of using this data solely for the purpose of assigning contrast or colors to pixels in a cross sectional image.
Other intervention name(s): Magnetic Resonance Imaging; Diffusion Tension Imaging
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Approximately 150 male and female student-athletes from participating high schools will be
        invited to participate.
      
Keywords: Concussion; Mild Traumatic Brain Injury; Sport Related Concussion
Alzheimer's Disease and Aging: Therapeutic Potential of Estrogen
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate the potential beneficial effects of estrogen on cognitive
      function of women with Alzheimer's Disease.
    


Intervention name(s): estrogen
Intervention type(s): Drug
Intervention MeSH terms: Estrogens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Feeding Malnourished Children Different Types of Fatty Acids to Promote Neurocognitive Development
Condition: Severe Acute Malnutrition
MeSH terms: Malnutrition; Severe Acute Malnutrition
Study type: Interventional

Summary: 
      An appropriate balance of omega-6 and omega-3 fatty acids is important for support of
      neurocognitive development in healthy infants and toddlers. In young children recovering from
      severe acute malnutrition (SAM), excess omega-6 intake depletes omega-3 fatty acid status.
      This research will evaluate how novel ready-to-use therapeutic foods (RUTF) with balanced
      fatty acids improve the metabolic and neurocognitive effects in young children in Malawi
      recovering from SAM, yielding new knowledge that also has implications for development of
      well-nourished children.
    


Intervention name(s): Amoxicillin; HO-RUTF; D-HO-RUTF; S-RUTF
Intervention type(s): Drug; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): All patients with severe acute malnutrition will receive a course of amoxicillin.; HO-RUTF: Milk, perilla oil, palm oil, white sugar, high oleic peanuts; D-HO-RUTF: DHA, milk, perilla oil, palm oil, white sugar, high oleic peanuts; S-RUTF: Milk, canola oil, palm oil, white sugar, standard peanuts
Other intervention name(s): Amoxil
Intervention MeSH terms: Amoxicillin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Malnutrition; Micronutrients; Polyunsaturated fatty acids; Ready-to-use therapeutic foods; Omega-3 fatty acids; Peanuts