bioihbjkbjnl/mcl2 huggingface dataset:
Safety Study of BLZ-100 in Adult Subjects With Glioma Undergoing Surgery
Condition: Glioma
MeSH terms: Glioma
Study type: Interventional
Phase: Phase 1

Summary: 
      Many types of cancer are primarily treated with surgery and patient survival is directly
      related to the extent to which the tumor is able to be removed. It is often difficult for
      surgeons to distinguish tumor tissue from normal tissue or to detect tumor cells that have
      spread from the original tumor site, resulting in incomplete removal of the tumor and reduced
      patient survival. In some sites, such as the brain, it is critical to avoid damage to normal
      tissue around the tumor to prevent adverse effects of surgery on function. We hypothesize
      that BLZ-100 will improve surgical outcomes by allowing surgeons to visualize the edges of
      the tumor and small groups of cancer cells that have spread to other sites in real-time as
      operate. This is a safety study to assess the safety of BLZ-100 in patients with gliomas
      undergoing surgery.
    

Detailed description: 
      Subjects who provide voluntary written informed consent will be screened for eligibility.
      Subjects meeting all of the inclusion and none of the exclusion criteria will be eligible to
      participate.

      Subjects will be required to arrive at the hospital (or phase 1 unit if applicable) for
      dosing at least 2 hours before the planned surgical excision. Following dosing, subjects will
      be monitored for safety and surgical excision will occur at least 2 hours after study product
      administration.
    

Intervention name(s): BLZ-100
Intervention type(s): Drug
Other intervention name(s): Tumor Paint
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Glioma; Tumor Paint; BLZ100
Behavioral Activation Intervention, Reward Processing, and Youth Smoking Cessation
Condition: Smoking
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of this study is to develop a specialized behavioral activation treatment
      for smoking in youths ages 18-21 with elevated depressive symptoms. In the first phase we
      utilize focus groups and pilot testing with 15 youths to develop the behavioral activation
      smoking treatment for youth. In Phase II, we will conduct an open-label trial of the new
      treatment that will include 8 weeks of transdermal nicotine patch, which will begin at the
      time of quitting smoking. Participants will be followed over 26 weeks post-quit date. A
      subset of participants will also undergo an fMRI session to examine reward sensitivity.
    

Detailed description: 
      1. 18-21 years of age,

        2. a regular smoker for at least 6 months

        3. currently smoking an average of at least 5 cigarettes per day

        4. want to quit smoking

        5. report current elevated depressive symptoms
    

Intervention name(s): Transdermal Nicotine Patch
Intervention type(s): Drug
Intervention description(s): Transdermal Nicotine: Participants will use 8 weeks of the nicotine patch at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to participant's initial nicotine level.
Other intervention name(s): Nicoderm CQ
Intervention MeSH terms: Nicotine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Behavioral Activation
Coping Kids: Early Intervention for Anxiety and Depression
Condition: Anxiety; Depression
MeSH terms: Depression; Depressive Disorder; Anxiety Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to provide knowledge regarding the effect of early intervention
      and prevention on the development of anxiety and depression in children. The focus of the
      intervention is to reduce symptoms of anxiety and depression and help children develop skills
      to enhance self-esteem in order to improve life quality. Gender and ethnicity will be studied
      as moderating factors. Primary care givers will be trained in the use of evidence based
      methods for children with internalizing difficulties. Children in need will be identified and
      receive improved services, based on international standards. Active collaboration will be
      established nationally between three Centers for child and adolescent mental health
      (RKBU/RBUP) and internationally with Philip C. Kendall at the Temple University in
      Philadelphia and Kevin Stark at University of Texas at Austin.

      Primary aims are to examine if an indicated group and school based program, Coping Kids, is
      more effective than treatment as usual (TAU) in reducing high levels of symptoms of both
      anxiety and depression among 8-12 year old schoolchildren, and if the the effects are stable
      over 12 months.
    


Intervention name(s): Coping Kids; TAU
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The first half (10 sessions) of Coping Kids focuses on building skills that are common to both anxiety and depression. The children practice strategies to regulate their mood, learn problem-solving, and behavioral activation is used to break the cycle of withdrawal. The second half of Coping Kids (10 sessions) is focused on the youth's specific problem; for depressive symptoms, building a positive self-schema and behavioral activation; for anxiety problems, gradual exposure to fear-inducing situations. Cognitive restructuring directed at different maladaptive thoughts is also emphasized.; Treatment as usual
Other intervention name(s): TIM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Immune Globulin for Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      OBJECTIVES: I. Determine whether high-dose intravenous immune globulin (IVIG) is more
      effective than placebo in restoring neurologic function (muscle strength) in patients with
      multiple sclerosis.

      II. Determine the time to recovery following IVIG.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are treated with
      intravenous immune globulin or placebo. In the absence of a hypersensitivity reaction to a
      test dose, a total of 11 doses is administered: daily for 5 days, then every 2 weeks for 12
      weeks.

      Patients are followed at 3 months.
    

Intervention name(s): immune globulin
Intervention type(s): Drug
Intervention MeSH terms: Immunoglobulins; Antibodies; gamma-Globulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: multiple sclerosis; neurologic and psychiatric disorders; rare disease
Replication of the TRITON-TIMI Antiplatelet Trial in Healthcare Claims Data
Condition: Antiplatelet
Study type: Observational

Summary: 
      Investigators are building an empirical evidence base for real world data through large-scale
      replication of randomized controlled trials. The investigators' goal is to understand for
      what types of clinical questions real world data analyses can be conducted with confidence
      and how to implement such studies.
    

Detailed description: 
      This is a non-randomized, non-interventional study that is part of the RCT DUPLICATE
      initiative (www.rctduplicate.org) of the Brigham and Women's Hospital, Harvard Medical
      School. It is intended to replicate, as closely as is possible in healthcare insurance claims
      data, the trial listed below/above. Although many features of the trial cannot be directly
      replicated in healthcare claims, key design features, including outcomes, exposures, and
      inclusion/exclusion criteria, were selected to proxy those features from the trial.
      Randomization is also not replicable in healthcare claims data but was proxied through a
      statistical balancing of measured covariates according to standard practice. Investigators
      assume that the RCT provides the reference standard treatment effect estimate and that
      failure to replicate RCT findings is indicative of the inadequacy of the healthcare claims
      data for replication for a range of possible reasons and does not provide information on the
      validity of the original RCT finding.
    

Intervention name(s): Prasugrel 10mg; Clopidogrel 75mg
Intervention type(s): Drug; Drug
Intervention description(s): Prasugrel 10mg dispensing claim is used as the exposure group; Clopidogrel 75 mg dispensing claim is used as the reference group
Intervention MeSH terms: Clopidogrel; Prasugrel Hydrochloride
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This study will involve a new user, parallel group, cohort study design comparing prasugrel
        90mg to clopidogrel 75mg. The patients will be required to have continuous enrollment
        during the baseline period of 180 days before initiation of prasugrel 90mg or a comparator
        drug (cohort entry date). Follow-up for the outcome (3P-MACE), begins the day after drug
        initiation.
Tissue Repair Device (VergenixTM STR) in Patients With Epicondylitis (Tennis Elbow)
Condition: Non Ruptured Tendon Injuries; Tendinopathy
MeSH terms: Tendinopathy; Tennis Elbow; Tendon Injuries
Study type: Interventional

Summary: 
      The VergenixTM STR device is intended for the repair of non ruptured tendon injuries
      (Tendinopathy).
    

Detailed description: 
      The VergenixTM STR device is an advanced Soft tissue repair device, made of lyophilized Type
      I rhCollagen and Calcium Chloride that will be mixed with autologous PRP prior to injection
      for the repair of non ruptured tendon injuries (Tendinopathy). Three (3) ml of the mixed
      solution will be injected into the common extensor tendon.
    

Intervention name(s): Tissue Repair Device (VergenixTM STR)
Intervention type(s): Device
Intervention description(s): Administration of Soft Tissue Repair Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: safety and performance
Reperfusion With Cooling in Cerebral Acute Ischemia
Condition: Stroke, Acute
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether reducing a patients body temperature (mild
      hypothermia of 33 degrees Centigrade) will significantly reduce the risk of brain injury
      (notably reperfusion injury and hemorrhagic conversion) in patients that have suffered a
      significant interruption of blood flow to an area of brain (occlusion of large proximal
      cerebral artery) and have undergone successful removal of that interruption
      (revascularization).
    


Intervention name(s): Zoll- Coolgaurd 3000
Intervention type(s): Device
Intervention description(s): Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ischemic Stoke; Endovascular Reperfusion; Reperfusion Injury; Mild hypothermia
Imaging Study of Neurovascular Coupling in Cerebral Autosomal Dominant Arteriopathy With Subcortical Infarcts and Leukoencephalopathy (CADASIL)
Condition: CADASIL
MeSH terms: CADASIL; Dementia, Multi-Infarct
Study type: Observational

Summary: 
      The aim of this study is to investigate using fMRI methods, EEG and dedicated mathematical
      models, the potential alterations of neurovascular coupling in CADASIL.
    

Detailed description: 
      Comparison study of parameters derived from mathematical models of neurovascular coupling and
      obtained using fMRI (Bold signal, ASL and EEG).
    

Observational model: Case-Control
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        CADASIL patients compared to age-matched controls (two groups)
To Compare the Efficacy and Safety of LAYLA in Osteoarthritis Patients of the Knee
Condition: Osteoarthritis of the Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a randomized, double-blind study to compare the efficacy and safety of LAYLA tablet
      and CENATONE tablet in the treatment of osteoarthritis of the knee.
    


Intervention name(s): LAYLA tablet; CENATONE tablet
Intervention type(s): Drug; Drug
Intervention description(s): 1 Tablet twice a day; 2 Tablets once a day
Other intervention name(s): LAYLA 405.4mg; Nabumetone 500mg
Intervention MeSH terms: Nabumetone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: LAYLA; Non-inferiority; 100mm pain VAS
Inflammatory Profiles of Children at High Risk for Atherosclerosis
Condition: Cardiovascular Disease; Metabolic Syndrome X; Hypercholesterolemia; Inflammation
MeSH terms: Cardiovascular Diseases; Atherosclerosis; Metabolic Syndrome; Hypercholesterolemia; Inflammation
Study type: Observational

Summary: 
      The purpose of this study is to evaluate levels of inflammatory mediators in children at risk
      for cardiovascular disease due to family history. We are measuring inflammatory markers in
      two groups of children and their parents: children with a family history of early
      atherosclerotic heart disease (cases), and healthy children without such a family history
      (controls). The design is a cross-sectional study, gathering a fasting blood sample and
      clinical and behavioral data on children and a parent.
    

Detailed description: 
      Family history is a well known risk factor for early atherosclerosis. Whether inflammation
      plays a role in the increased risk of family history is not known. In this prospective
      single-center study, we are recruiting children with and without a family history of
      premature atherosclerotic disease, defined as occurring < 55 years in males and <65 years in
      females. Children are recruited primarily from a pediatric preventive cardiology clinic at
      Children's Hospital Boston. We measure anthropomorphic characteristics, fasting lipid
      profiles and inflammatory marker levels, including high sensitivity C-reactive protein
      (hsCRP), intracellular adhesion molecule 1 (ICAM-1), P-selectin, and tumor necrosis factor
      alpha receptor 2 (TNFαR2).

      In this sample of high-risk overweight children, Lp(a) and inflammatory markers could reflect
      cardiovascular risk outside lipid profiles.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primarily children referred to preventive cardiology clinic.
      
Biospecimen description: 
      Fasting serum samples, frozen.
    
Keywords: cardiovascular disease; metabolic syndrome; hypercholesterolemia; child; family history; inflammation
Dutch National ITB Study in Children With Cerebral Palsy
Condition: Cerebral Palsy; Spasticity
MeSH terms: Muscle Spasticity; Paralysis; Cerebral Palsy
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to determine the efficacy and safety of treatment with
      intrathecal baclofen for severe spasticity in children with cerebral palsy.
    

Detailed description: 
      Spasticity in cerebral palsy (CP) is a serious problem leading to pain, sleep disturbance,
      increased expenditure of energy and/or interference with positioning, transfers, dressing and
      body hygiene. In later stages, secondary phenomena, such as contractures, decubitus and
      heterotopic calcifications of joints or tendons may create large treatment problems. A
      substantial group of children with severe CP does not respond to regular treatments, such as
      physical therapy, orthopaedic surgery or oral medication. An effective treatment option for
      intractable spasticity is the continuous delivery of intrathecal baclofen (CITB). In 2000,
      the American Academy for Cerebral Palsy and Developmental Medicine (AACPDM) published a
      systematic review on the body of evidence about intrathecal baclofen (ITB) for spasticity in
      individuals with CP. It appeared that only a small and uncertain number of children had been
      studied. Except for two case-reports, none of the studies solely concerned children. The
      research methodology employed in three quarters of the available studies was not capable of
      confirming treatment effect. The AACPDM underlined the need for further high-level research
      in the form of prospective, randomized trials that use valid and reliable outcome measures in
      well described and homogeneous groups.

      In 1998 the Dutch Study Group on Child Spasticity designed the Dutch national study on the
      effectiveness and safety of ITB for refractory spasticity in children with cerebral palsy.
      The Dutch national ITB study included four phases: 1] the selection phase, 2] the
      double-blind, placebo-controlled dose-escalation test treatment phase, 3] the prospective,
      randomized, open-label implantation phase and 4] the follow-up phase.
    

Intervention name(s): baclofen, intrathecal; infusion pump for intrathecal baclofen, Synchromed, Medtronic
Intervention type(s): Drug; Device
Intervention MeSH terms: Baclofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cerebral palsy; Spasticity; Child; Baclofen; Intrathecal injection
A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of RO7079901 and the Combination of RO7079901 With Meropenem in Adult Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled, multiple-ascending dose (MAD) study
      that will evaluate the safety, tolerability and pharmacokinetics (PK) of RO7079901 and the
      combination of RO7079901 with meropenem in healthy volunteers. The study will consist of
      three parts (Part I, II, and III). At each dose level/cohort, a total of 8 healthy volunteers
      will be randomized to receive active study drug or placebo in a 3:1 ratio.
    


Intervention name(s): RO7079901; Meropenem; RO7049389 Placebo; Meropenem Placebo
Intervention type(s): Drug; Drug; Other; Other
Intervention description(s): RO7079901 will be administered as per schedule described in individual arm.; Meropenem will be administered as per schedule described in individual arm.; Placebo matching to RO7049389 will be administered as per schedule described in individual arm.; Placebo matching to meropenem will be administered as per schedule described in individual arm.
Intervention MeSH terms: Meropenem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Evaluation of Maximum Tolerated Dose, Safety and Efficiency of MSC11FCD Therapy to Recurrent Glioblastoma Patients
Condition: Glioblastoma; Adult Gliosarcoma; Neoplasms, Brain; Neoplasms, Germ Cell and Embryonal; Recurrent Glioblastoma
MeSH terms: Neoplasms; Glioblastoma; Gliosarcoma; Neoplasms, Germ Cell and Embryonal; Brain Neoplasms; Recurrence
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a phase I trial evaluating the maximum tolerated dose, safety and efficiency of
      Mesenchymal stem cells into which the suicide gene, cytosine deaminase (CD), injected into
      the resection cavity of patients with recurrent glioblastoma.
    

Detailed description: 
      Not Provided
    

Intervention name(s): MSC11FCD
Intervention type(s): Drug
Intervention description(s): Administration period: Single dose Route of administration: Intratumoral administration Dose: 1x10^7, 3x10^7cells/dose Summary: Administer the investigational drug in the amount of 1x107, 3x107cells per dose into the tumor or the tumor removal site using a syringe during surgery.
Concomitant drug: 5-Flucytosine (prodrug) Dose: 150mg/kg/day
Directions:
Administration period and directions: Administer 150m of 5-Flucytosine per kilogram of body weight every 6 hours for a total of 4 times a day (QID) for a duration of 7 days after surgery.
Route of administration: Oral administration
Other intervention name(s): Mesenchymal stem cells into which the suicide gene, cytosine deaminase (CD)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Glioblastoma, Mesenchymal stem cells; Brain Tumor; Neoplasms, Germ Cell; Flucytosine; Central Nervous System Neoplasms
Study Of PF-06410293 And Adalimumab In Healthy Subjects (REFLECTIONS B538-01)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This healthy volunteers study will evaluate 210 subjects who will receive a single
      sub-cutaneous dose of PF-06410293 or adalimumab (United States) or adalimumab (European
      Union). This study will involve sampling and pharmacokinetics evaluation of drug levels
      following administration of PF-06410293 and the licensed adalimumab products.
    


Intervention name(s): PF-06410293; Humira (adalimumab-EU); Humira (adalimumab-US)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.; 40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.; 40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.
Other intervention name(s): adalimumab-Pfizer; adalimumab (European Union); adalimumab (United States)
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: Healthy Volunteers; Phase 1; PK; adalimumab; Single-dose; Immunology; Bioequivalence; Biosimilarity; Similarity.
Analysis of the Peripheral Blood Mononuclear Cells of Patients With Ankylosing Spondylitis During Infliximab Treatment (Study P04465)(COMPLETED)
Condition: Spondylitis, Ankylosing
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an open-label, controlled sub-study to the parent protocol (P04041, NCT00779935) to
      examine the expression profile of genes in patients in the active stage of ankylosing
      spondylitis (AS) compared to the healthy population as control, moreover to examine the
      changes in expression profile during anti-tumor necrosis factor (TNF)-alpha treatment
      (Remicade).
    


Intervention name(s): Remicade
Intervention type(s): Biological
Intervention description(s): Remicade will be given at Weeks 0, 2, and 6 and then every 8 weeks up to Week 54.
Other intervention name(s): Infliximab; SCH 215596
Intervention MeSH terms: Infliximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment