bioihbjkbjnl/mcl2 huggingface dataset:
Bioavailability Study of SPARC001(Study 1) in Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study is to determine the relative bioavailability, safety and
      tolerability of SPARC001 and Reference001 in healthy, adult, male and female subjects
    


Intervention name(s): SPARC001 type I; SPARC001 type II; Reference001 type I; Reference001 type II
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Treatment type I; Treatment type II; Hydrocodone-Acetaminophen; Hydrocodone-Acetaminophen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safe Study of Dendritic Cell (DC) Based Therapy Targeting Tumor Stem Cells in Glioblastoma
Condition: Glioblastoma; Brain Tumor
MeSH terms: Glioblastoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The study induces an immune response towards the stem-cell like part of glioblastomas in
      combination with standard therapy. The aim is to define and characterize the feasibility,
      potential adverse effects of such therapy and measure time to progression and survival.
    


Intervention name(s): Dendritic cell vaccine with mRNA from tumor stem cells
Intervention type(s): Biological
Intervention description(s): Intradermal injection of transfected dendritic cells
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tumor setm cell
Impact of an Online Positive Affect Journaling Intervention
Condition: Stress
Study type: Interventional

Summary: 
      In this study the investigators plan to recruit 70 patients reporting high levels of stress
      to test the impact of Positive Affect Journaling. Patients randomized to use the online
      intervention will be asked to journal about one of seven topics, several days each week, for
      three months. The topics (e.g., "What went well") are designed to help the individual focus
      on some positive aspect of their life or themselves over the past day. Each topic is based on
      prompts shown to be effective in studies of up to one week in duration. In the summer of
      2012, our research team pilot tested each prompt with 20 patients with high levels of
      anxiety, which led to important changes to the prompts, to increase their potential impact.
      The main aim is to understand the impact of Positive Affect Journaling on psychological
      distress, as measured by the National Health Interview Survey.
    


Intervention name(s): Positive Affect Journaling
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Ceftobiprole in the Treatment of Pediatric Patients With Pneumonia
Condition: Community-acquired Pneumonia (CAP); Hospital-acquired Pneumonia (HAP)
MeSH terms: Pneumonia; Healthcare-Associated Pneumonia
Study type: Interventional
Phase: Phase 3

Summary: 
      This was a study of the safety and efficacy of ceftobiprole medocaril compared with
      intravenous (IV) standard-of-care cephalosporin treatment with or without vancomycin in
      pediatric patients with either hospital-acquired bacterial pneumonia (HAP) or
      community-acquired bacterial pneumonia (CAP) requiring hospitalization, and requiring
      intravenous (IV) antibiotic therapy.
    

Detailed description: 
      This was a randomized, investigator-blind, active-controlled multi-center study to evaluate
      the safety, tolerability, pharmacokinetics and efficacy of ceftobiprole medocaril compared
      with IV standard-of-care cephalosporin treatment with or without vancomycin in pediatric
      patients aged 3 months to less than 18 years with HAP or CAP requiring hospitalization and
      therapy with IV antibiotics. Randomization was stratified by four age groups (3 months to < 2
      years; 2 years to < 6 years; 6 years to < 12 years; 12 years to < 18 years), and by diagnosis
      of HAP or CAP.
    

Intervention name(s): ceftobiprole medocaril; IV standard-of-care cephalosporin
Intervention type(s): Drug; Drug
Intervention description(s): Ceftobiprole medocaril was administered at age-adjusted doses (10, 15 or 20 mg/kg) and infusion durations (2 or 4 hours) every 8 hours. The maximum dose, regardless of body weight, was 500 mg ceftobiprole every 8 hours (maximum total daily dose of 1500 mg ceftobiprole).
After a minimum of 3 days of IV treatment, patients with sufficient improvement in disease signs and symptoms could be switched to an age-appropriate oral antibiotic to complete a total minimum of 7 days and a total maximum of 14 days' antibiotic treatment.; Ceftriaxone was administered at 50 to 80 mg/kg IV as a single daily dose, up to a maximum dose of 2 g/day. The actual dose of ceftriaxone within this dose range was determined by the blinded investigator prior to first study drug administration and was not modified during subsequent study days.
After a minimum of 3 days of IV treatment, patients with sufficient improvement in disease signs and symptoms could be switched to an age-appropriate oral antibiotic to complete a total minimum of 7 days and a total maximum of 14 days' antibiotic treatment.
At the discretion of the blinded investigator, patients received vancomycin at a dose of 10 to 15 mg/kg IV every 6 hours, up to a maximum dose of 2 g/day, in addition to the IV standard-of-care cephalosporin when MRSA was suspected or confirmed.
Other intervention name(s): ceftobiprole
Intervention MeSH terms: Cephalosporins; Ceftobiprole; Ceftobiprole medocaril
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Japanese Pediatric H5N1 Vaccine Study
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to obtain immunogenicity and safety data of an H5N1 pandemic
      influenza vaccine in a Japanese pediatric population aged 6 months to 17 years
    


Intervention name(s): H5N1 (Pre-)Pandemic Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated)
Intervention type(s): Biological
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Working Memory Training in Children With Cerebral Palsy, a Pilot Study
Condition: Cerebral Palsy; Working Memory Training
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The purpose of this pilot study is to assist the preparation of a larger multi-center study.
      The main aim is to determine the feasibility of conducting computerized working memory
      training in a group of children with cerebral palsy.
    


Intervention name(s): Cogmed Robomemo working memory training
Intervention type(s): Behavioral
Intervention description(s): The Cogmed Robomemo program is designed as a computer game in which an animated robot gives different tasks to be solved by the child. The tasks have various degrees of difficulty adapted continuously throughout the intervention period to the performance of the individual child. The program is standardized in that each child receives the same set of tasks during the training period. The child will perform the training sessions at home using their own computer for about 35-40 minutes each day.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Live Microbials to Boost Anti-Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Immunity Clinical Trial
Condition: Covid19
Study type: Interventional

Summary: 
      This pilot double-blind randomized controlled trial will test the preliminary efficacy of two
      doses of a combination of live microbials (probiotics) given to boost the immunity of
      unvaccinated persons previously infected with SARS-CoV-2.
    

Detailed description: 
      This pilot double-blind randomized controlled trial will test the preliminary efficacy of two
      doses (a standard dose and a high dose) of a combination of live microbials (probiotics),
      currently marketed in food (including products labeled as dietary supplements), given daily
      for 21 days to boost the immunity of unvaccinated, generally healthy persons ages 18-60 with
      prior confirmed SARS-CoV-2 infection. Data collected will include demographics,
      comorbidities, medications, information about prior SARS-CoV-2 infection, and self-reported
      symptoms and adverse events (AEs). Biospecimens (saliva, nasal wash, blood, and stool) will
      be collected at baseline and days 21 and 42 for analysis.
    

Intervention name(s): OL-1, standard dose; OL-1, high dose; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): The live microbial components have been present in the food supply, have a long history of safe use in foods, and are already marketed in the United States.; The live microbial components have been present in the food supply, have a long history of safe use in foods, and are already marketed in the United States.; Capsule containing inactive ingredients such as a product of potato starch (maltodextrin), but no probiotics.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Probiotics
Lorazepam for the Treatment of Status Epilepticus in Children
Condition: Status Epilepticus
MeSH terms: Status Epilepticus
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to gather the data to: 1) determine the best dose, and 2)
      evaluate its effectiveness and safety in stopping seizures. Part 1 is a pharmacokinetic study
      (study of how much drug is found in the body after it is given through a vein and how fast
      the body gets rid of the drug).
    

Detailed description: 
      Lorazepam is in a class of drugs called benzodiazepines that is used to treat seizures.
      Lorazepam has been widely used to treat children who have repeated or long seizures, a
      condition known as status epilepticus (SE). However, lorazepam is not currently approved by
      the FDA for use in children under 18 years of age. Therefore, the purpose of this study is to
      gather the data needed for FDA approval. Specifically, we will 1) determine the best dose,
      and 2) evaluate its effectiveness and safety in stopping seizures. Part 1 is a
      pharmacokinetic study. These are studies designed to identify and describe one or more of the
      following basic pharmacological concepts in humans: absorption (i.e. how much gets into the
      body); distribution (i.e. where it goes in the body); and metabolism and elimination (i.e.
      how the body gets rid of the medication and how long it takes). The study procedures involve
      taking blood samples from children, taking their vital signs, and conducting physical
      examinations. Informed consent will be obtained from all participants as required by federal
      guidelines. Patients will be divided into two groups. The first group will be patients who
      present to one of the 10 participating Emergency Rooms (ERs) in status epilepticus (repeated
      or continuous seizures). We will either ask for consent in the ER, or if we know they have a
      seizure disorder and have frequent visits to the ER, consent them beforehand for future
      visits to the ER. The second group will include patients who have a known seizure disorder
      and agree to be electively admitted to the hospital for a dose of lorazepam when they are not
      having seizures. We will draw blood samples from patients for up to 48 hours and then follow
      up via telephone for 30 days from the day the medication was given to assess for side
      effects.
    

Intervention name(s): lorazepam
Intervention type(s): Drug
Intervention MeSH terms: Lorazepam
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: children; status epilepticus; lorazepam; safety; pharmacokinetics; status epilepticus in children
Imaging During Subliminal Perception
Condition: Healthy
Study type: Observational

Summary: 
      Subliminal perception of visual stimuli can be studied with functional brain imaging, e.g.
      with functional magnetic resonance imaging (fMRI). However, it is unclear how subliminal
      perception affects connectivity in the brain.

      Further, it is not known if real-time (rt) fMRI neurofeedback of brain areas involved in
      subliminal perception can lead to supra-threshold perception.

      For attention tasks, the investigators hypothesize that functional connectivity strength is
      mediated by the insular cortex during both supra-threshold and subliminal perception.

      Additionally, the investigators hypothesize that rt-fMRI neurofeedback training should alter
      neuronal and behavioral responses.
    

Detailed description: 
      In this project, using healthy adults, the investigators have 2 aims:

        1. Apply electroencephalography (EEG) and fMRI before and after rt-fMRI neurofeedback
           during attention tasks to identify brain regions involved in subliminal and supraliminal
           perception.

        2. Apply functional connectivity analyses during these tasks.
    

Intervention name(s): real-time fMRI
Intervention type(s): Other
Intervention description(s): Brain regions can be trained, i.e. fMRI activity can be actively modulated online by humans, using rt-fMRI (Bruhl, Scherpiet et al. 2014, Bruhl 2015, Emmert, Kopel et al. 2016).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy adults
      
Keywords: functional MRI; subliminal perception; EEG; neurofeedback; attention
Efficacy and Safety of DBS in Patients With Primary Dystonia
Condition: Dystonia
MeSH terms: Dystonia; Dystonic Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of deep brain
      stimulation (DBS) of the subthalamic nucleus (STN) and globus pallidus internus (GPi) for
      primary dystonia.
    

Detailed description: 
      Dystonia is an uncommon brain disorder in which there is abnormal muscle tone producing
      twisting, writhing movements and abnormal postures. It is associated with abnormal electrical
      activity in two groups of nerve cells in the brain called the globus pallidus internus (GPi)
      and the subthalamic nucleus (STN). GPi DBS appears to be effective for medication-refractory
      focal and segmental dystonia affecting the cranial and cervical regions in open-label series,
      but recently GPi stimulation has been associated with subtle motor disturbances in previously
      non-dystonic body regions (i.e., arms and legs) in this population of patients. DBS of the
      STN has also been reported to be effective for treating generalized and cervical dystonia in
      small open label trials. STN DBS for cranial and cervical regions may provide similar
      efficacy in the treatment of dystonia as GPi DBS, but without unwanted stimulation-induced
      motor effects. Objectives of this study is to evaluate the safety and efficacy of STN-DBS and
      GPi-DBS for dystonia; Participants will be evaluated pre- and postoperatively with standard
      dystonia rating scales including the Burke-Fahn-Marsden Dystonia rating scale (BFMDRS),
      Changes in cognitive function will be assessed with neuropsychological testing. Stimulation
      parameters will be documented, and a patient questionnaire will be administered
      postoperatively to determine if patients are experiencing stimulation-induced motor adverse
      effects. Patient weight will be recorded at study visits. This pilot study will provide
      preliminary open label efficacy outcomes for STN DBS in the treatment of primary dystonia and
      will help determine if this target should be compared to GPi DBS in a larger double-blind
      trial.
    

Intervention name(s): Beijing Pins Medical Co., Ltd. Deep Brain Stimulator
Intervention type(s): Device
Intervention description(s): Deep Brain Stimulation for primary dystonia subjects
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Effect of Electrical Stimulation With Functional Task Training on Balance and Motor Abilities in Children With Diplegia
Condition: Cerebral Palsy Spastic Diplegia
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      The aims of the study are to:

        1. Investigate the combined effect of functional task training with electrical stimulation
           of bilateral hip abductor muscles on balance in children with diplegia.

        2. Investigate the combined effect of functional task training with electrical stimulation
           of bilateral hip abductor muscles on motor abilities in children with diplegia.
    

Detailed description: 
      Cerebral palsy (CP) is a group of permanent disorders of movement and posture. It is
      non-progressive lesion or abnormality of immature brain. The term cerebral refers to the
      brain and palsy refers to the loss or impairment of motor function.

      Functional electrical stimulation (FES) is a subtype of neuromuscular electrical stimulation
      (NMES) in which the stimulation assists functional and purposeful movements. This is achieved
      by applying electrical stimulation to muscles that, when they contract, produce a movement
      that can be used functionally.The FES is used to provide electrical stimulation via the
      peripheral nervous system to activate muscle contractions to assist functional activities
      when nervous or musculo-skeletal systems are damaged.The common applications of FES include
      strengthening muscle, reducing muscle spasticity, increasing range of motion, improving upper
      extremity function and walking speed.
    

Intervention name(s): functional electrical stimulation; functional task training
Intervention type(s): Device; Other
Intervention description(s): electrical stimulation during function; functional exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Evaluation of the Impact of Embryo Biopsy on the Reproductive Potential of Embryos Undergoing In Vitro Fertilization (IVF)
Condition: Each Patient is Both Case and Control; 1 Embryo Will be Biopsied and 1 Embryo is Not
Study type: Observational

Summary: 
      To assess the impact of embryo biopsy on the reproductive potential of human embryos.
    

Detailed description: 
      This study will recruit patients from the NY/NJ/CT/eastern PA area only.

      All patients will undergo an in vitro fertilization (IVF) cycle with hormonal stimulation and
      an egg retrieval procedure as deemed appropriate for their diagnosis. Following biopsy, the
      embryos will be transferred. There will be no delay in the time of transfer as no cells will
      be analyzed prior to transfer.

      On day 3 or day 5 of embryo development, all patients will undergo a two (2) embryo transfer.
      The embryos selected for transfer will be the 2 morphologically best of the embryo cohort.
      Once selected for transfer, the embryos will be randomized so that one will be biopsied and
      the other will be transferred without undergoing biopsy. The embryo randomized to biopsy will
      have a single cell biopsied.

      Following delivery, buccal swabs will be collected from infants.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        200 infertile couples undergoing IVF will be enrolled in the study.
      
Biospecimen description: 
      Blood samples on female and male patients. Buccal swabs on infant(s).
    
Keywords: PGD; IVF
Photo-Plethysmographic Camera to Monitor Heart Rate, Respiration Rate and Oxygen Saturation in Infants
Condition: Child Development
Study type: Observational

Summary: 
      The researchers want to determine if ambient light, plethysmographic , can monitor reliably
      heart rate, respiration rate and oxygen saturation in infant patients in a hospital setting.
    

Detailed description: 
      The plethysmographic signal is typically strong on children. This provides a reliable heart
      rate monitor. However, to measure oxygen saturation, a quantitative value of the strength at
      two wavelength regions (green and red) is required. It is also not known if the normal
      ambient light is spectrally appropriate to analyze the video signals for oxygenation. With
      the current prototype of our system, we can monitor heart rate reliably and estimate oxygen
      saturation in adults, using normal artificial light or daylight, entering through a window.
      Heart rate and oxygen saturation will be extracted from the plethysmographic signal off the
      cheek, forehead or hand while the respiration rate may be retrieved from the plethysmographic
      signal off the chest area.
    

Intervention name(s): Plethysmographic monitoring
Intervention type(s): Device
Intervention description(s): Plethysmographic monitoring
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        infant
      
Keywords: monitoring
Evaluation of the Effect of Fluoride and Laser Application on the Prevention of Sensitivity in Bleached Teeth
Condition: Dentin Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the effects of desensitizing agents on the dental bleaching process, testing
      the hypothesis that they may prevent dental sensitivity.
    

Detailed description: 
      The objective of this double blind, randomized and controlled clinical study, was to evaluate
      the efficacy of 1.1% sodium fluoride associated with LLLT (Low Level Laser Therapy) on teeth
      that were exposed to 35% hydrogen peroxide during 4 weeks of bleaching treatment. Methods: 25
      volunteers were evaluated through the split-mouth model, where the hemiarcates were
      ranzomized and later allocated in one of the experimental groups: G-FLUOR+LASER - constitutes
      the group treated with LLLT + 1.1% sodium fluoride; and G-FLUOR - constitutes the group
      treated with placebo + 1.1% sodium fluoride .
    

Intervention name(s): Low Level Laser Therapy; 1.1% Sodium Fluoride; In-office dental bleaching
Intervention type(s): Device; Drug; Drug
Intervention description(s): Laser therapy: it was used the infrared spectrum with wavelength of 808 nm in its active environment AsGaAl, in two points: cervical and central-medial region of the incisors, canines and premolars.; Fluoride therapy: 1.1% sodium fluoride 5000 ppm was applied for 5 minutes on the vestibular surface of all pre-bleached dental elements.; Both groups received the in-office bleaching treatment. Three 15-minute applications of the 35% hydrogen peroxide gel were performed, totaling 45 minutes in each of the 4 sessions, with a 7-day interval.
Other intervention name(s): LLLT; Fluoride therapy; 35% hydrogen peroxide
Intervention MeSH terms: Listerine; Hydrogen Peroxide; Fluorides; Sodium Fluoride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention