bioihbjkbjnl/mcl2 huggingface dataset:
Speech Hero Home Therapy for Aphasia
Condition: Broca Aphasia
MeSH terms: Aphasia; Aphasia, Broca
Study type: Interventional

Summary: 
      The investigators will run an at-home usability study of a newly developed speech therapy app
      called Speech Hero with 10 individuals with Broca's aphasia in the chronic stage of stroke.
      The Speech Hero app allows users to perform rhythm-based speech exercises at home. For this
      study participants will be instructed to use Speech Hero for at least 10 hours over a 4-week
      period.
    


Intervention name(s): At home Speech Hero therapy app
Intervention type(s): Device
Intervention description(s): Participants will be instructed to use the Speech Hero therapy app for three hours per week over a 4-week period.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Systemic Normothermia in Intracerebral Hemorrhage (ICH)
Condition: Intracerebral Hemorrhage
MeSH terms: Cerebral Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Patients with a supratentorial intracerebral hemorrhage will be randomly assigned to either
      the experimental group which will keep them at a normal body temperature or the standard of
      care group. The investigators propose to test the hypothesis that prophylactic forced
      normothermia in patients with ICH leads to less systemic inflammation and decreased
      perihematomal edema.
    

Detailed description: 
      This is a randomized device efficacy trial. Patients with a supratentorial intracerebral
      hemorrhage (ICH) admitted to the Cleveland Clinic Neurointensive Care Unit within 1 day of
      symptom onset and who have not experienced episodes of temperature elevation will be enrolled
      after consent. Patients randomized to the experimental arm, will have Artic Sun cooling pads
      applied to the torso and thighs for five days. The Arctic Sun device will keep the body
      temperature at the normal range of 35.5 - 37.5 degrees Celsius. Patients randomized to the
      active comparator arm will receive a standard of care treatment at the discretion of the
      treating physician. Patients will have hourly measurement of blood pressure, heart rate,
      respiratory rate, urine output, temperature (from the urinary catheter) shivering scale, and
      nursing neurological assessment. Glasgow coma scale, NIH Stroke Scale Score (NIHSS),
      telemetry monitoring and labs will also be performed daily. The investigators will also
      collect demographic information about the patients (i.e. age, gender, medical risk factors)
      and information regarding their current disease process.
    

Intervention name(s): Arctic Sun cooling device; Standard of Care
Intervention type(s): Device; Other
Intervention description(s): The Arctic Sun® 5000 Temperature management systems (Bard Medical), a non- invasive, surface cooling technology that allows rapid and precise manipulation of core body temperature will be employed to maintain normothermia (normal temperature) in patients with ICH randomized to the treatment group.; Patient will be given standard fever management (acetaminophen + cooling blanket at the discretion of the treating physician)
Other intervention name(s): The Arctic Sun® 5000 Temperature management systems
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Intracerebral hemorrhage; Perihematomal edema; hemorrhage; normothermia
3D Printing for Pre-Surgical Planning
Condition: Surgical Patients
Study type: Interventional

Summary: 
      3D printing is emerging as a new diagnostic tool for pre-surgical planning. 3D printed models
      are extremely advantageous to surgeons in their preoperative planning. Handling these
      physical replicas engages active spatial perception skills, enabling a more comprehensive
      understanding of the presented information in an inherently intuitive manner that cannot be
      achieved with conventional methods of imaging review that use screen based 2D and volume
      rendered representations. The investigators are developing a novel technique to create 3D
      models derived directly from extremely high-resolution medical images that are superior in
      spatial and contrast resolution to current 3D modelling methods. This produces patient
      specific models that contain previously unachievable special fidelity and soft tissue
      differentiation.

      Investigators hypothesize that the preoperative use of these new diagnostic quality models
      will reduce surgical time and improve post-surgical outcomes in the near future. This
      prospective project will optimize the quality of these 3D models to create highly useful
      pre-surgical models. Investigators will target those subspecialist areas of the
      multidisciplinary surgical and imaging team where it is believed these models will have the
      most impact. The proposed prospective study has two major goals: 1) Investigate the use of
      uncompressed, ultrahigh resolution CT/MR datasets to produce diagnostic 3D models with
      identical spatial/contrast resolution to the acquired datasets in the target areas of
      congenital cardiothoracic surgery, neurosurgical tumor resection and nephrectomy. 2) Compare
      the accuracy of this innovative method for 3D printing to radiological images and
      pathological data when available.
    

Detailed description: 
      The tangible outcome of this research will be measured in a comparative study. The
      investigators will compare the 3D printed models, resulting from the development of this
      iterative process of generating models from ultra-high resolution medical images and review
      by all parties, to radiological images and pathological data. The study team will employ
      non-biased methods to quantify the results of this comparative study. There will be no
      randomization and all subjects will receive the same treatments and all outcomes are data
      focused. Models will not be used for patient treatment and will be used only as to aid
      preparation and will not be used as a therapeutic device. For this reason, the study team
      will not prospectively consent subjects.
    

Intervention name(s): 3D Mapping
Intervention type(s): Diagnostic Test
Intervention description(s): 3D model will be made from diagnostic imaging for pre-surgical planning
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Modified Process Hepatitis B Vaccine in Healthy Neonates (V232-056)
Condition: Hepatitis B; Hepatocellular Carcinoma
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      Hepatitis B Vaccine [Recombinant] is a well-established vaccine which has been used
      extensively, worldwide since its initial licensure in 1986. Hepatitis B vaccines: [1] induce
      protection against the morbidity and mortality of acute hepatitis B virus infection, [2]
      reduce the incidence of chronic infection in vaccinated populations, and [3] thereby, reduce
      the incidence of hepatocellular carcinoma. The purpose of the trial is to assess if the new
      manufacturing process of the Hepatitis B Vaccine [Recombinant] vaccine shows the same level
      of hepatitis B antibody response or better as the currently licensed Hepatitis B Vaccine
      [Recombinant] vaccine. This study will also confirm that the new process vaccine is as well
      tolerated as the current vaccine.
    


Intervention name(s): Comparator: RECOMBIVAX HB™; Comparator: Modified process Hepatitis B Vaccine
Intervention type(s): Biological; Biological
Intervention description(s): RECOMBIVAX HB™ 3 x 5-mcg regimen administered via intramuscular injection.; Modified Process Hepatitis B 3 x 5-mcg regimen administered via intramuscular injection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
NOAC Plasma Concentration and Blood Coagulation in Healthy Volunteers
Condition: Blood Coagulation Disorder
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      Relationship of edoxaban plasma concentration and blood coagulation in healthy volunteers
      using standard laboratory tests and viscoelastic analysis
    


Intervention name(s): Edoxaban 60 MG
Intervention type(s): Drug
Intervention description(s): Viscoelastic analysis and standard laboratory tests after edoxaban ingestion
Intervention MeSH terms: Edoxaban
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Role of Theophylline Plus Low-dose Formoterol-budesonide in Treatment of Bronchiectasis
Condition: Bronchiectasis
MeSH terms: Bronchiectasis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to examine the efficacy and safety of 24 weeks treatment with
      theophylline plus low-dose formoterol-budesonide in subjects with bronchiectasis.
    

Detailed description: 
      Non-cystic fibrosis bronchiectasis is an orphan disease caused by the pathogenic vicious
      circle including infection, inflammation and airway repair. Today's principle of treatment is
      to break the cycle of inflammation and infection. Nowadays, most clinical trials are
      anti-infective treatment by antibiotics trying to break this cycle by reducing the bacterial
      load, which may cause bacterial resistance. There were still some anti-inflammation trials by
      using inhaled corticosteroids(ICS). Tsang and Martínez-García showed that inhaled
      corticosteroids reduced IL-1,IL-8 levels and sputum inflammation cells, and improved sputum
      volume as well as quality of life, though the corticosteroid must be high dose or medium dose
      combined with long-acting ß2 adrenergic agonists. As described in asthma and chronic
      obstructive pulmonary disease(COPD), theophylline can improve the activity of histone
      deacetylase (HDAC) and then enhanced the anti-inflammatory effect of steroids. We hypothesis
      that theophylline may have the same effect in subjects with bronchiectasis. Theophylline plus
      inhaled low-dose formoterol-budesonide may improve quality of life and reduce airway
      inflammation.
    

Intervention name(s): Formoterol-budesonide; Theophylline; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Formoterol-budesonide combined treatment (4.5µg/160µg Q12H); Theophylline 0.1 Q12H; Placebo for theophylline 0.1 Q12H
Other intervention name(s): Symbicort tu rbuhaler; Theophylline Sustained-Release Tablet
Intervention MeSH terms: Budesonide; Theophylline; Formoterol Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bronchiectasis; Theophylline; Therapeutic Uses; HDAC; HAT; Random placebo study; ICS(inhaled corticosteroid); corticosteroid; Inhaled corticosteroid
Efficacy of Lu 31-130 in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose with the study is to explore the efficacy and safety of Lu 31-130 in
      patients suffering from schizophrenia compared to a standard antipsychotic drug.
    

Detailed description: 
      Schizophrenia is a serious and disabling mental disorder that affects approximately 1% of the
      world's population. Antipsychotic drugs remain the cornerstone in the pharmacotherapy of
      schizophrenia. However, none of the available drugs is ideal, in particular because of their
      complex safety profile and the limited effectiveness against certain symptom domains. Whereas
      positive symptoms respond to treatment the effects on negative symptoms and cognitive
      impairment are only very modest.

      Thus present treatment options leave room for improvement and call for new, more effective
      pharmacotherapies for the treatment of schizophrenia. In the current study, patients
      suffering from schizophrenia and experiencing clinically significant symptoms of the disease
      will be included. Eligible patients will be randomised to blinded treatment with either
      flexible doses of Lu 31-130 or flexible doses of a standard antipsychotic treatment
      (olanzapine) for 12 weeks. The efficacy (including potential effects on cognitive symptoms)
      and the safety of Lu 31-130 will be explored in comparison to olanzapine.
    

Intervention name(s): Zicronapine; Olanzapine
Intervention type(s): Drug; Drug
Intervention description(s): 5-7mg/day; orally, encapsulated tablets, once daily; 10-15mg/day; orally, encapsulated tablets, once daily
Other intervention name(s): Lu 31-130; Zyprexa
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Schizophrenia; Antipsychotic; Olanzapine; Lu 31-130
Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of
      the pneumococcal conjugate vaccine, co-admin with a 1st dose or a 2nd dose of MMRV vaccine at
      12-14 or respectively 14-16 months of age in children primed with the pneumococcal conjugate
      vaccine in study 105553. Antibody persistence will be evaluated at 8-10 months after
      completion of the 3-dose immunization course in study 105553. The immunogenicity, safety and
      reactogenicity of the 1st and 2nd dose of MMRV vaccine will also be evaluated when co-admin
      with the pneumococcal conjugate vaccine between 12-16 months of age.

      The study has 3 groups.

        -  The 1st group will receive the booster dose of pneumococcal conjugate vaccine + 1st dose
           of MMRV vaccine at 12-14 mo of age and the booster dose of Infanrix hexa™+ 2nd dose of
           MMRV vaccine at 14-16 mo of age.

        -  The 2nd group will receive the booster dose of Infanrix hexa™ + 1st dose of MMRV vaccine
           at 12-14 mo of age and the booster dose of pneumococcal conjugate vaccine + 2nd dose of
           MMRV vaccine at 14-16 mo of age.

        -  The 3rd group will receive the booster dose of pneumococcal conjugate vaccine + the
           booster dose of Infanrix hexa™ at 12-14 mo. Subjects will be offered one dose of
           Priorix™ and Varilrix™ at 14-16 mo of age, outside the study.
    


Intervention name(s): 10 valent pneumococcal conjugate (vaccine)
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Streptococcus pneumonia, pneumococcal conjugate vaccine
The Different Running Speeds of Strike Patterns
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this research is to investigate the differences of landing patterns while
      running in different speed with barefoot and wearing shoe.
    

Detailed description: 
      Running speed will be adjusted with physical strength and circumstance. When speed changes,
      whether the landing patterns change or not may be one factor of sports injuries. Therefore,
      the purpose of this research is to investigate the differences of landing patterns while
      running in different speed with barefoot and wearing shoe.
    

Intervention name(s): Barefoot; In shoes
Intervention type(s): Other; Other
Intervention description(s): barefoot running test was 20 minutes.; In shoes test was 20 minutes.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: running speeds, strike patterns
A Study To Assess Effects Of PF-04958242 On Bold Functional Magnetic Resonance Imaging During Working Memory Activation And Arterial Spin Labeling At Rest In Healthy Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study aims to determine whether the drug affects brain activity
      in healthy volunteers, either when the participants are performing a memory task, or when
      lying at rest. Subjects will undergo a brain scan under both of these conditions after a dose
      of either the study drug or a placebo is administered.The secondary objective is to evaluate
      the safety and tolerability of the four doses of PF-04958242 administered orally to healthy
      adult participants.
    

Detailed description: 
      This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to
      Biogen.
    

Intervention name(s): Placebo; PF-04958242
Intervention type(s): Drug; Drug
Intervention description(s): Administered as specified in the treatment arm; Administered as specified in the treatment arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Adult Safety Study of 2009/2010 Seasonal Influenza Vaccine
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to verify the safety and immunogenicity of a trivalent seasonal
      influenza vaccine with strain composition according to World Health Organization
      (WHO)/European Union (EU) recommendation for the 2009/2010 season.
    


Intervention name(s): Seasonal influenza vaccine (split virion, inactivated, prepared in Vero Cell cultures)
Intervention type(s): Biological
Intervention description(s): Single 0.5 mL intramuscular injection
Other intervention name(s): PreFluCel 2009/2010
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Prophylaxis of seasonal influenza in adults
NAC to Prevent Cisplatin-induced Hearing Loss
Condition: Neuroectodermal Tumors, Primitive; Liver Neoplasms; Osteosarcoma; Other Childhood Cancers Using Cisplatin-based Regimens
MeSH terms: Osteosarcoma; Neuroectodermal Tumors; Neuroectodermal Tumors, Primitive; Liver Neoplasms; Hearing Loss; Deafness
Study type: Interventional
Phase: Phase 1

Summary: 
      Cisplatin is a key chemotherapy agent for the treatment of multiple childhood cancers but
      causes permanent hearing loss. This study investigates the drug N-acetylcysteine (NAC) to
      determine the dose necessary to protect hearing and also how well tolerated NAC is when
      combined with chemotherapy.
    

Detailed description: 
      The study is a dose-finding study of N-acetylcysteine (NAC) to protect hearing in children
      receiving cisplatin for the treatment of their cancer. NAC also has potential to protect the
      kidneys from cisplatin toxicity.

      The study uses a 3+3 dose-escalation scheme to determine the dose of NAC necessary to achieve
      serum levels consistent with hearing protection in pre-clinical animal models. Three dose
      levels are predefined. Once the maximum tolerated dose is determined, an expansion cohort
      will then be enrolled to further evaluate tolerability as well as intra-patient and
      inter-patient variability in achieved serum levels. An option to enroll in a separate arm for
      study assessments only is available for those who do not wish to receive NAC. Hearing loss in
      the cohort will be assessed in the entire cohort in comparison to historical and non-treated
      children to evaluate for trends toward efficacy.
    

Intervention name(s): N-Acetylcysteine
Intervention type(s): Drug
Intervention description(s): NAC will be administered intravenously over ~60 minutes starting 4 hours following completion of cisplatin chemotherapy.
Three dose levels have been pre-determined:
Dose Level 1: 225 mg/kg Dose Level 2: 300 mg/kg Dose Level 3: 450 mg/kg
Should Dose Level 3 exceed the MTD, the study will examine blood levels of NAC and if below the target blood level necessary for hearing protection, the study will "de-escalate" from Dose Level 3 to an intermediate Dose Level 2.5 and test a dose of 375 mg/kg.
As of August 2018: Dose escalation completed with MTD not reached. Dose level 3 (450mg/kg) selected for expansion with NAC.
Other intervention name(s): N-acteylcysteine; acteylcysteine injectable; Acetadote
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cisplatin; N-acetylcysteine; Hearing Loss; Otoprotection
Comparison of Sevoflurane, Propofol, and Sevoflurane Plus Propofol for Maintenance of Anaesthesia
Condition: Laparoscopic Surgery; Hysteroscopic Surgery
Study type: Interventional
Phase: Phase 4

Summary: 
      Postoperative pain may be affected by general anaesthetics. The effect of propofol and
      sevoflurane on postoperative pain in chinese female patients has not been demonstrated
      before. This study compared the postoperative pain score in patients under general
      anaesthesia maintained with propofol,sevoflurane, or sevoflurane+propofol.
    

Detailed description: 
      After approval from the Institute's Ethics Committee, this study was conducted at Tongji
      Hospital, a general university teaching hospital with 2500 beds in Wuhan, China.The study
      consisted of female patients, American Society of Anaesthesiologists Physical Status (ASA-PS)
      I or II, suffering from infertilities, and undergoing selective gynaecological laparoscopic
      and hysteroscopic surgery. All the patients were randomly assigned to receive
      propofol,sevoflurane,or sevoflurane+propofol for anaesthesia maintenance. The primary outcome
      measure was the level of postoperative pain assessed by Numerical Analogue Scale (NAS) at
      rest 0.5 hour after the operation. The secondary outcomes were postoperative pain assessed by
      Numerical Analogue Scale (NAS) at rest 1 and 24 hour after the operation, the incidence of
      postoperative nausea and vomiting, the incidence of shiver, and quality of recovery
      determined by QOR40 in the first 24 h after surgery.
    

Intervention name(s): Propofol for maintenance; Sevoflurane; Sevoflurane+Propofol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Propofol 6-8mg/kg/h + Remifentail 0.1-0.2ug/kg/min for anesthesia maintenance; Sevoflurane 0.7-1.3MAC + Remifentail 0.1-0.2ug/kg/min for anesthesia maintenance; Sevoflurane 0.7-1.3MAC + Remifentanil 0.1-0.2ug/kg/min + Propofol 2mg/kg/h for anesthesia maintenance
Other intervention name(s): Propofol; Sevoflurane and Propofol
Intervention MeSH terms: Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postoperative pain; Sevoflurane; Propofol; Female; Elective gynaecological surgery; Laparoscopic and hysteroscopic surgery; Female patients; Undergoing elective laparoscopic and hysteroscopic surgery