bioihbjkbjnl/mcl2 huggingface dataset:
Functional and Anatomical Magnetic Resonance Imaging (MRI) of Chronic Brain Injury and Hyperbaric Oxygen (HBO2) Study Subjects
Condition: Brain Injury; Sequelae; Stroke; Anoxia; Trauma
MeSH terms: Brain Injuries; Hypoxia; Wounds and Injuries
Study type: Observational

Summary: 
      The purpose of this study is to evaluate Brain MRI (Magnetic Resonance Imaging), and Brain CT
      (Computed Tomography) Angiogram data in subjects who participate in the "Hyperbaric Oxygen
      for Chronic Stable Brain Injury" (HYBOBI) study. Including information from MRI and CT
      studies provide information about whether hyperbaric oxygen improves brain function in
      subjects who have had a brain injury. Subjects will complete MR and CT scans twice during the
      study. The first MR and CT will be performed prior to the first hyperbaric session of the
      HYBOBI study, and the second will be performed within two weeks following the last hyperbaric
      session.
    

Detailed description: 
      In an ongoing feasibility study (HYBOBI), brain-injured subjects are exposed to hyperbaric
      oxygen at 1.5 atmospheres for 60 minutes. They receive this exposure five days per week, and
      receive 60 total sessions. Prior to hyperbaric oxygen, these study subjects have neurologic,
      cognitive, and functional measures. The measures are repeated at the conclusion of 60
      hyperbaric oxygen sessions, and again six months later. The goal of the HYBOBI feasibility
      study is to learn about these patients and determine possible hyperbaric oxygen effects, if
      any, to prepare for a blinded randomized controlled clinical trial.

      This study adds an imaging component to the HYBOBI study, further investigating brain changes
      in participants. Participants will undergo Brain MRI (Magnetic Resonance Imaging) using a 3
      tesla magnet, and Brain CT (Computed Tomography) Angiogram. Subjects will undergo imaging
      before receiving hyperbaric oxygen and within 2 weeks of completion of the 60 hyperbaric
      sessions.
    

Intervention name(s): Magnetic Resonance Imaging; Computed Tomography Angiography
Intervention type(s): Procedure; Procedure
Intervention description(s): Imaging of the brain without gadolinium will be performed with a 3 Tesla magnetic resonance (MR) System (Intera Achieva 3T; Philips Medical Systems). The protocol will include anatomical sequences, a diffusion tensor imaging sequence with fiber tracking, and auditory, visual, and motor functional magnetic resonance imaging (MRI).; Computed tomography angiography (CTA) with intravenous (IV) contrast will be performed on a 320 head computed tomography (CT) scanner, assessing brain perfusion.
Other intervention name(s): MRI; fMRI; CT; CTA
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adults with chronic brain injury who are enrolled in the HYBOBI study.
      
Keywords: brain injury; sequelae; stroke; anoxia; trauma
A Study of Effects of Itraconazole and Rifampin on Selpercatinib (LY3527723) in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to assess the effect of itraconazole and rifampin on how
      fast selpercatinib gets into the blood stream and how long it takes the body to remove it
      when administered in healthy participants. Information about safety and tolerability will be
      collected. The study is conducted in two parts and it will last up to 54 days (part 1) and 59
      days (part 2), respectively, inclusive of screening period.
    


Intervention name(s): Selpercatinib; Itraconazole; Rifampin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally.; Administered orally.; Administered orally.
Other intervention name(s): LY3527723; LOXO-292
Intervention MeSH terms: Itraconazole; Rifampin
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
To Determine Blood Concentrations of Ibuprofen and Caffeine in a Tablet Against Ibuprofen Alone From Another Tablet
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the trial is to compare to combination of 400 mg ibuprofen and 100 mg
      caffeine against 400 mg ibuprofen alone under fed conditions
    


Intervention name(s): Ibuprofen; Caffeine; Ibuprofen
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Ibuprofen; Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Safety and Immunogenicity of Three Consistency Lots and a High-Dose Lot of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in Healthy Adults (V920-012)
Condition: Prevention of Ebola Infection
MeSH terms: Hemorrhagic Fever, Ebola
Study type: Interventional
Phase: Phase 3

Summary: 
      The study evaluated the safety and immunogenicity of 3 consistency lots and a high-dose lot
      of rVSV-ZEBOV-GP (V920 Ebola Vaccine) in healthy adults. The primary purpose of this study
      was to demonstrate consistency in the immune responses of participants receiving 3 separate
      lots of V920 through 28 days postvaccination. In addition to the 3 lot groups, a high-dose
      group and a placebo group were studied. A subset of participants representative of all
      treatment groups continued through 24 months postvaccination in the extension study for the
      evaluation of long-term safety. The primary hypothesis states that the geometric mean titer
      of anti-Zaire ebolavirus envelope (ZEBOV) glycoprotein antibody at 28 days postvaccination is
      equivalent across the three consistency lots.
    


Intervention name(s): V920 Consistency Lot A; V920 Consistency Lot B; V920 Consistency Lot C; V920 High-dose Lot; Placebo to V920
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot A, live, attenuated, sterile solution for intramuscular injection; V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot B, live, attenuated, sterile solution for intramuscular injection; V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot C, live, attenuated, sterile solution for intramuscular injection; V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine high-dose lot, live, attenuated, sterile solution for intramuscular injection; Sodium chloride 0.9%, sterile solution for intramuscular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Use of Seamguard to Prevent Leak and Bleeding in Gastrointestinal Surgery
Condition: Leak on Lineal Stapled Anastomoses; Bleeding on Lineal Stapled Anastomoses
MeSH terms: Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determinate the utility of staple-line reinforcement on
      lineal gastrointestinal anastomoses.

      Hypothesis: Seamguard device will decrease the incidence of leak and bleeding in digestive
      lineal stapled anastomoses.
    


Intervention name(s): Seamguard
Intervention type(s): Device
Intervention description(s): GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement is specifically engineered to reduce the incidence of perioperative leaks and bleeding in a variety of open and minimally invasive surgeries. Then, after six months, it is completely absorbed eliminating the risk of a prolonged inflammatory response.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Seamguard; staple-line reinforcement; leak; bleeding
Does Perineural Dexmedetomidine Prolong Duration of a Nerve Block?
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      Brief Summary: The aim of this trial is to investigate if dexmedetomidine prolongs the
      duration of an adductor canal block. By using healthy volunteers the investigators can
      perform a bilateral adductor canal block and thereby control for a systemic effect to clarify
      if the effect is actually peripheral or systemic. The investigators hypothesis is that
      dexmedetomidine as an adjunct to a local anaesthetic prolongs the duration of a peripheral
      nerve block by a peripheral mechanism.
    

Detailed description: 
      Background:

      Efficient pain management promoting mobilization and convalescence is essential in an ideal
      perioperative course. Regional nerve blocks are a central element in postoperative regimes
      for many patients and it is therefore important that these nerve blocks are both long lasting
      and efficient. This trial will investigate whether it is possible to optimize the
      postoperative pain management when adding dexmedetomidine to the local anaesthetic
      ropivacaine in peripheral nerve blocks.

      The prolonging effect of using dexmedetomidine as adjunct in peripheral nerve blocks have
      been investigated in several studies. However, it remains uncertain whether the effect is
      mediated by a systemic-, a peripheral- or a combined systemic/peripheral mechanism. In this
      trial the adjuvating effect of dexmedetomidine will be investigated using the adductor canal
      block. This is a nerve block that besides being efficient as pain treatment after knee
      surgery, is primarily sensory, and therefore augments mobilization after total knee
      arthroplasty.

      Method:

      On the trial day the volunteers will receive bilateral adductor canal blocks. In one thigh
      they will receive the local anaesthetic ropivacaine 20ml 5mg/ml and placebo (saline) and in
      the other thigh ropivacaine 20ml 5mg/ml and dexmedetomidine 100μg. The allocation is blinded
      to volunteer and investigator.

      The duration of the nerve block will be measured by five different tests: Temperature test,
      Pinprick, Pain during tonic heat stimulation, Warmth detection threshold and pain detection
      threshold. All tests are validated within pain research.
    

Intervention name(s): Dexmedetomidine; Ropivacaine; Isotonic Saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 100 ug dexmedetomidine added to the ropivacaine nerveblock; 20 ml Ropivacaine 5mg/ml; Placebo
Other intervention name(s): Dexdor
Intervention MeSH terms: Dexmedetomidine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Volunteers
: Pharmacokinetics of Enoxaparin After Coronary Artery Bypass Graft Surgery
Condition: Venous Thromboembolism; Pulmonary Embolism; Thromboprophylaxis
MeSH terms: Pulmonary Embolism; Embolism; Thromboembolism; Venous Thromboembolism
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the pharmacokinetics of thromboprophylactic doses of LMWH enoxaparin in
      postoperative CABG patients, drug is administered either as a continuous intravenous infusion
      (CIV) or subcutaneous bolus (SCB) once per 72h. Plasma anti-Xa values are measured 12-14
      times during study period and concentration maximums calculated to enable comparison of
      anti-Xa values between administration routes.
    

Detailed description: 
      This is a prospective, randomized, controlled trial. After informed consent, 80 elective on
      pump CABG patients with a clinical indication for post-operative thromboprophylaxis will be
      studied in the Tampere University Heart Hospital. Study has two independent parts with 40
      patients in both. Results are reported separately from these two parts of the study.

      Firts part of the study: After written consent, 20+20 patients are randomized to receive
      enoxaparin either as continuous intravenous infusion (treatment group) or subcutaneous bolus
      injection (control group). Enoxaparin dose is 40mg/24h either CIV of SCB. Anti-Xa values are
      measured 12-14 times from blood samples to evaluate the anticoagulation effect of enoxaparin.

      Second part of the study: After written consent, 20+20 patients are randomized to receive
      enoxaparin either as continuous intravenous infusion (treatment group) or subcutaneous bolus
      injection (control group). Enoxaparin dose is 1mg/kg/24h in CIV group and 0,5mg/kg twice a
      day in SCB group. In this second part of the study with eleveted enoxaparin dosage, 4
      additional blood samples will be taken and analysed by ROTEM to investigate the overall
      coagulation status of the patients before and after the initiation of enoxaparin.

      The study will consist of two independent parts.
    

Intervention name(s): Enoxaparin
Intervention type(s): Drug
Intervention MeSH terms: Enoxaparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Venous thromboembolism; pulmonary embolism; thromboprophylaxis; anticoagulant; anti-FXa; low-molecular weight heparin; enoxaparin
Use of PARniv for Early Diagnosis of LVF in AECOPD
Condition: Acute Heart Failure; COPD Exacerbation
MeSH terms: Heart Failure
Study type: Observational

Summary: 
      Left ventricular failure (LVF) is a common cause of acute exacerbation of chronic obstructive
      pulmonary disease (AECOPD).

      This association is frequently underestimated with regard to the difficulty of clinical
      diagnosis .

      The investigators expect that the application of pressure support under NIV could be useful
      in this issue.
    

Detailed description: 
      Acute heart failure (AHF) is a common cause of COPD exacerbation however its role is very
      often underestimated. Until now, the use of echocardiography and some invasive hemodynamic
      exploration techniques such as the Swan-ganz catheter has been stated as reference. Other
      noninvasive diagnostic methods have been studied, such as systolic time intervals and
      Valsalva maneuver, but their application still difficult in patients with COPD exacerbation,
      especially in emergency department (ED) settings. the study aimed to evaluate the performance
      of a new diagnostic technique based on the measurement of the PAR using non invasive
      ventilation (NIV) for the early identification of left ventricular failure (LVF) in patients
      presenting to the ED with acute COPD exacerbation
    

Intervention name(s): non invasive ventilation
Intervention type(s): Diagnostic Test
Intervention description(s): invasive mechanical ventilation session in the BIPAP Mode with a pressure support (PS) level of 5cmH2O, a positive end expiratory pressure (PEEP) level of 5 cmH2O and an inspiratory fraction of oxygen (FiO2) allowing a pulse saturation (SpO2) of at least 92% for a one minute and followed by an increase of the PS level to 30cmH2O.The plethysmographic PAR (PAR) was calculated based on the following formula: PARpleth= PP30 / PP5
Other intervention name(s): NIV
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        all patients presenting to the ED with an acute COPD exacerbation
      
Keywords: COPD; Left Ventricular Failure; Pressure Support under NIV
Impact of Electronic Devices on Myopia Development and Progression
Condition: Myopia
MeSH terms: Myopia
Study type: Observational

Summary: 
      The aim of the stuy is to investigate the effects of the adoption of a curriculum with
      electronic devices for teaching materials and textbooks in Hong Kong schoolchildren on their
      changes in refractive error and visual function.
    

Detailed description: 
      With the blooming of information technology and electronic engineering in recent years,
      e-books or tablet computers have been introduced at some local primary and secondary schools
      and have been provided for their students during studying at school and at home. Parents and
      teachers' utmost concern are adverse effects on eye-sight of children, especially the higher
      progression rate in myopia and the visual discomfort which may be caused by the e-book
      technology.

      This is a prospective cohort study to determine if implementation of electronic devices for
      teaching promotes myopia development and progression and affects visual function in primary
      schoolchildren.

      The schools will introduce e-books to their students in some classes. Signed informed consent
      letters from parents will be obtained prior to subject recruitment and data collection. Eye
      examination and data collection will be conducted in primary school campus. The children from
      two local primary schools in same grade will be assigned into two groups by their schools.
      One group will use e-books (e-book group) to study course materials assigned by their
      teachers whereas another group will use ordinary textbooks (control group). Their refractive
      errors, axial length (AXL) and binocular functions will be measured and monitored at
      six-month intervals for a maximum of 2 years.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary schoolchildren in Hong Kong
Evaluation of the Safety and Efficacy of a Single Dose of a Dengue Vaccine (TV005) in Healthy Adults
Condition: Dengue
MeSH terms: Dengue
Study type: Interventional
Phase: Phase 1

Summary: 
      Dengue viruses are widespread in most tropical and subtropical regions of the world. This
      study will evaluate the safety and protective efficacy of a dengue vaccine (called TV005)
      against viremia and rash induced by a DENV-2 vaccine virus (called rDEN2∆30-7169) in healthy
      adults.
    

Detailed description: 
      There are four types of dengue viruses (DENV-1, DENV-2, DENV-3, and DENV-4), each of which
      can cause mild to life-threatening illness. This study will evaluate the protective efficacy
      of TV005 (a dengue virus vaccine) administered at Day 0 against viremia and rash induced by
      rDEN2∆30-7169 (a live attenuated candidate DENV-2 vaccine) administered at Day 180. The
      safety and immunogenicity of the TV005 and rDEN2∆30-7169 vaccines will also be evaluated.

      This study will enroll healthy adults with no history of previous infection with a dengue
      virus or a flavivirus. Participants will be randomly assigned to receive a single injection
      of TV005 or placebo at study entry (Day 0). All participants will receive a single injection
      of rDEN2∆30-7169 on Day 180. For at least 30 minutes after each vaccination, participants
      will remain in the study clinic to be monitored for any adverse effects of the vaccines.
      Participants will record their temperature three times a day for 16 days after the first and
      second vaccinations.

      In addition to study visits at Day 0 and 180, participants will attend study visits at Day 4,
      6, 8, 10, 12, 14, 16, 21, 28, 56, 90, 150, 184, 186, 188, 190, 192, 194, 196, 201, 208, 236,
      270, and 360. At select study visits, participants will undergo a physical examination,
      medical history review, blood collection, and a pregnancy test for female participants.
    

Intervention name(s): TV005; Placebo; rDEN2∆30-7169
Intervention type(s): Biological; Biological; Biological
Intervention description(s): TV005 is a live attenuated recombinant tetravalent dengue virus vaccine. It will be administered as a 0.5 mL dose containing 10^3 plaque forming units (PFUs) of each component (10^3.3 PFUs/mL of rDEN1∆30, 10^4.3 PFU/mL of rDEN2/4∆30(ME), 10^3.3 PFU/mL of rDEN3∆30/31-7164 and 10^3.3 PFU/mL of rDEN4∆30). It will be delivered by subcutaneous injection in the deltoid region of the upper arm.; The placebo vaccine will be administered as a 0.5 mL dose delivered by subcutaneous injection in the deltoid region of the upper arm.; rDEN2∆30-7169 is a live recombinant attenuated DENV-2 candidate vaccine virus. It will be administered as a 0.5 mL dose containing 10^3 PFUs of rDEN2∆30-7169. It will be delivered by subcutaneous injection in the deltoid region of the upper arm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Surgery Versus Manual Rupture for Dorsal Carpal Ganglion
Condition: Dorsal Carpal Ganglion
MeSH terms: Ganglion Cysts; Synovial Cyst; Rupture
Study type: Interventional
Phase: Phase 3

Summary: 
      This study objectives are to compare the efficacy and safety between surgical excision and
      manual rupture for dorsal carpal ganglion.The participants with dorsal carpal ganglion will
      be randomized into 2 groups:surgical excision or manual rupture.The patients will be
      follow-up for at least 1 yr.Telephone interview will be used for outcome assessment.
    


Intervention name(s): local excision
Intervention type(s): Procedure
Intervention description(s): surgical excision by orthopaedic surgeon under local anesthesia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: surgery; manual rupture; dorsal carpal ganglion
Study Comparing the Affect of Bifeprunox Vs Olanzapine on Weight During the Treatment of Outpatients With Schizophrenia.
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will compare bifeprunox to a currently marketed medication, Zyprexa (olanzapine),
      with respect to the affect on weight during the treatment of outpatients with schizophrenia.
      The study will compare the effect of these medications on several variables, including body
      weight and triglyceride levels.
    

Detailed description: 
      This is a multicenter, randomized, double-blind, parallel-group study of bifeprunox in the
      treatment of outpatients with schizophrenia, with olanzapine as the active comparator.
      Subjects must be stable for 3 months or more of treatment with olanzapine at baseline. There
      will be 2 treatment arms in this study, approximately 60 subjects per arm. After
      randomization and blinding, each subject will either remain on olanzapine or switch to
      bifeprunox. Assessments, including body weight and waist measurements, will be made at each
      study visit.Subjects will participate in the study for approximately 11 weeks. After a
      screening period of 6 to 14 days, eligible subjects will be treated for 8 weeks. Subjects who
      do not enter the long-term extension will return for a follow-up visit 7 days after
      discontinuing the use of test article. Subjects who do enter the long-term extension will
      have a 7-day taper/titration period after the 8 weeks of double-blind treatment.
    

Intervention name(s): bifeprunox, olanzapine
Intervention type(s): Drug
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: schizophrenia