bioihbjkbjnl/mcl2 huggingface dataset:
STA-21 Topical Efficacy on Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The clinical assessment of patients with plaque-type psoriasis is performed by open,
      intrapatient comparison of 0.2% STA-21 with vehicle(Vaseline) alone within a 2 week period.
    

Detailed description: 
      Two discrete psoriatic lesions with a similar size (approximately coin-sized) and clinical
      severity are selected in each patient. Clinical assessment of psoriatic lesion severity is
      performed at the baseline and at 1 and 2 (end of treatment) using the scores of erythema,
      induration, scaling on a scale of 0-4 by two observers. Since STA-21 inhibits Stat3
      activation, which is essential for disease activity of psoriasis, topical application of 0.2%
      STA-21 in Vaseline should improve psoriasis in two weeks.
    

Intervention name(s): Topical application of STA-21 ointment for treatment of psoriasis
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Dose Escalation Study MORAb-066 Targeting TF-expressing Malignancies Including Breast, Pancreatic, Colorectal, NSCLC
Condition: Breast Cancer; Pancreatic Cancer; Colorectal Cancer; Non-small-cell Lung Cancer; NSCLC; Adenocarcinoma
MeSH terms: Adenocarcinoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a Phase I, first in human, dose-escalation study of MORAb-066, an
      investigational humanized immunoglobulin G (IgG) monoclonal antibody (mAb) that targets
      TF-expressing malignancies that include breast, pancreatic, colorectal, and non-small-cell
      lung cancer (NSCLC) (adenocarcinoma). This open-label study will assess the safety,
      tolerability, and pharmacokinetics of MORAb-066 administered weekly. This study will identify
      the MTD when MORAb-066 is administered IV once weekly on a 28-day cycle.
    

Detailed description: 
      Primary Objective

      -To evaluate the safety and tolerability of weekly intravenous (IV) infusions of MORAb-066.

      Secondary Objectives

        -  To identify the dose-limiting toxicities (DLT) and to determine the maximum tolerated
           dose (MTD) of MORAb-066.

        -  To characterize the pharmacokinetic (PK) properties of MORAb-066.

        -  To identify, on the basis of safety, PK, and pharmacodynamics (PDx) data, a recommended
           Phase II dose and schedule for MORAb-066.

        -  To make a preliminary assessment of the antitumor activity of MORAb-066.

        -  T

        -  To detect any antibody response (i.e., human antihuman antibodies [HAHA]) to multiple IV
           infusions to MORAb-066.

      Exploratory Objectives

        -  To evaluate the presence of tissue factor (TF) substrates such as protease activated
           receptor 2 when applicable.

        -  To evaluate the archived tumor tissue for TF overexpression by immunohistochemistry.

        -  To evaluate whether there are potential biomarkers that correlate responses to
           MORAb-066.
    

Intervention name(s): MORAb-066
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Non-Heme Iron Load Quantification in the Brain - MRI of Patients With Stroke
Condition: Stroke
MeSH terms: Stroke
Study type: Observational

Summary: 
      This study will determine if MRI imaging can be used to estimate the amount of iron in areas
      of the brain affected by a stroke. This may help future patients if the scan can be used to
      predict the amount of brain damage and therefore the effects on the patient.

      New research treatments are being used to reduce the amount of iron build-up in the brain.
      The effects of that treatment may also be estimated using new MRI techniques.
    

Detailed description: 
      Hemorrhagic stroke has devastating consequences. The mechanisms resulting in early and
      delayed brain injury following a hemorrhagic stroke is poorly understood. One of the
      mechanisms demonstrated in

      animal studies points towards deposition of iron in the brain tissue following hemorrhage.
      Preliminary data in animal studies also support a favorable effect of iron chelate agents.
      Iron chelate agents are compounds that bind iron to them and may show the extent of neural
      tissue damage.

      Initial results of human trials based on this hypothesis demonstrated the safety of
      increasing amounts of desferroxamine given to human patients. The evaluation of iron chelate
      agents for hemorrhagic stroke is entering into phase II/III trials.

      There is no modality at this date that can quantify the iron in tissue non invasively. Some
      preliminary studies have demonstrated the role of MRI in identifying parenchymal iron
      deposition in traumatic brain injury.

      We propose to validate an MRI based method to not only identify but also quantify the non
      heme iron levels deposited in brain tissue following hemorrhagic stroke. Once validated this
      method will be a robust mechanism to reliably quantify tissue iron in the brain which then
      can be closely followed through iron chelate therapy in a trial setting.
    

Intervention name(s): MRI scans with non heme iron levels
Intervention type(s): Other
Intervention description(s): MRI scans of the head will be performed to determine the amount of Non heme iron in areas of the brain of hemorrhagic stroke patients and hopefully predict the amount of brain damage.
Each MRI will take up to 1 hour to complete and will be done on day 3, day 14 and day 30. Some of the (MRIs) Magnetic Resonance Imaging will be clinically indicated and sequences will be added to the clinical scan with each sequence adding 10 minutes to the scan. Some sequences will be done only for research.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population includes men and women, aged 18-85 who have had a hemorrhagic stroke
        and who can safely have an MRI scan.
Brain Plasticity Underlying Acquisition of New Organizational Skills in Children-R61 Phase
Condition: ADHD; Attention Deficit Hyperactivity Disorder; Neurodevelopmental Disorders
MeSH terms: Attention Deficit Disorder with Hyperactivity; Neurodevelopmental Disorders
Study type: Interventional

Summary: 
      Organizational, time management and planning (OTMP) skills deficits are seriously impairing
      features of developmental disorders, such as Attention Deficit Hyperactive Disorder (ADHD)
      and autism, which compromise school performance and family relations. The manualized
      Organizational Skills Training program (OST) was designed to target children's specific OTMP
      deficits. However, the brain mechanisms of treatment-induced changes remain unknown. The
      current study combines a training intervention with non-invasive MRI imaging in a
      pre-/post-design to address this question.
    


Intervention name(s): OST Intervention for participants with Organizational skill difficulties
Intervention type(s): Behavioral
Intervention description(s): Will undergo two magnetic resonance imaging (MRI) sessions: one within 2 weeks prior to OST treatment and one within 2 weeks of completion of the OST treatment.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Compound Edaravone Injection for Acute Ischemic Stroke
Condition: Acute Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      1. To investigate the efficacy and safety of multi-doses Compound Edaravone Injection
           versus Edaravone Injection for acute ischemic stroke patients;

        2. To provide evidence for the design of Compound Edaravone Injection Phase III trial.
    


Intervention name(s): Compound Edaravone Injection; Edaravone Injection
Intervention type(s): Drug; Drug
Intervention MeSH terms: Edaravone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of Parkinson's Early Stage With Deferiprone
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this study is to evaluate the effects of deferiprone, an iron-chelating drug, in
      patients with Parkinson's disease. Participants will be randomized to receive one of four
      different dosages of deferiprone or placebo, and will take the assigned study product twice a
      day for nine months.
    

Detailed description: 
      This study will enroll 140 patients who have been diagnosed with Parkinson's disease within
      the last 3 years and are currently taking antiparkinsonian medication. There are four dosage
      cohorts, with patients in each cohort receiving either deferiprone tablets or placebo. At the
      baseline visit, participants will be randomized to a dosage cohort and to either active
      product or placebo within that cohort, and will take the assigned study product twice-daily
      for 9 months. They will come back to the study site for assessments at Months 1, 2, 3, 4, 5,
      6, and 9, and will need to have their blood count checked weekly, at either the study site or
      a local laboratory.
    

Intervention name(s): Deferiprone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 600 mg tablets; Tablets that match the deferiprone tablets in appearance
Other intervention name(s): DFP
Intervention MeSH terms: Deferiprone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's disease; Deferiprone
A Study of GK Activator (2) in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy, safety, tolerability, and pharmacokinetics of oral GK
      Activator (2), compared to placebo, in patients with type 2 diabetes mellitus. The
      anticipated time on study treatment is less than 3 months, and the target sample size is
      100-500 individuals.
    


Intervention name(s): GK Activator (2); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Escalating doses po bid; po bid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
An Abuse Potential Study of Orally Administered HORIZANT in Healthy, Non-dependent, Recreational Drug Users
Condition: Abuse Potential
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the abuse potential of gabapentin enacarbil in healthy
      adult, non-dependent, recreational drug users.
    

Detailed description: 
      The primary purpose of this study is to evaluate the abuse potential of gabapentin enacarbil
      immediate-release (GE-IR), the active moiety in Horizant in comparison to placebo and an
      active control with known abuse potential (i.e., alprazolam).

      This study will be a randomized, double-blind, active- and placebo-controlled, 5-way
      crossover study to determine the abuse potential of gabapentin enacarbil immediate release
      (GE-IR) relative to alprazolam (active control) and placebo, in nondependent, recreational
      drug users with sedative drug use experience.

      This study will consist of 3 phases: screening, qualification, and treatment.
    

Intervention name(s): Placebo; Alprazolam 2 mg; Gabapentin Enacarbil Immediate Release (GE-IR) 200 mg; Gabapentin Enacarbil Immediate Release (GE-IR) 450 mg; Gabapentin Enacarbil Immediate Release (GE-IR) 700 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Placebo; Oral dose of alprazolam 2 mg; Oral dose of GE-IR 200 mg; Oral dose of GE-IR 450 mg; Oral dose of GE-IR 700 mg
Other intervention name(s): Xanax; Horizant; Horizant; Horizant
Intervention MeSH terms: Gabapentin; Alprazolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 2 to 18 Years in Taiwan
Condition: Bacterial Meningitis
MeSH terms: Meningitis, Bacterial; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the immunogenicity and safety of a single injection of Novartis
      Meningococcal ACWY conjugate vaccine in healthy subjects from 2 to 18 years in Taiwan.
    


Intervention name(s): Meningococcal ACWY conjugate vaccine
Intervention type(s): Biological
Intervention description(s): All subjects received a single dose of Meningococcal ACWY conjugate vaccine and had blood draw at day 1 and day 29.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningococcal; ACWY; bacterial meningitis; conjugate vaccine; healthy; children; adolescents; Taiwan
Nutritional Status of Adult Slovenes After the Covid-19 Epidemic
Condition: Body Weight; Nutrition, Healthy; COVID-19 Pandemic
MeSH terms: COVID-19; Body Weight
Study type: Observational

Summary: 
      There is objective need to examine nutritional status (i.e., body mass index (BMI), body
      composition and dietary intake) of healthy adult Slovenes after SARS-CoV-2 (Covid-19)
      epidemic period.

      In the Slovenian (pair of European Union) adult population (with only 2 million inhabitants),
      we do not yet have representative data on the body composition of adult Slovenes published in
      the scientific literature.

      In the study after the Covid-19 pandemic period (4th wave) the investigators will use
      medically approved body analyzer (Tanita 780 S MA, Tokyo, Japan) and standardized food
      frequency questionnaire (FFQ). In addition, the investigators will measured body height of
      the participants with a portable altimeter (ADE MZ10042, Germany).

      The research will include randomly recruited adults (participants) who will attend various
      free or/and paid publicly available seminars, congresses and fairs in Slovenia, directly
      unrelated topics to physical activity or healthy eating (i.e., healthy and active lifestyle)
      thus obtaining a more realistic current population status.
    

Detailed description: 
      In the study investigators will randomly but voluntarily enroll 700-1000 healthy adult
      participants within inclusion/exclusion criteria that are willing to participate in the
      study. Investigators anticipate that for this number of adults (aged 18-80 years) will
      require approx. 5000 invited candidates (10-15 events), of both sexes.

      The methods to be used are body composition monitor and FFQ. In addition to the assessment of
      BMI and body composition status, we will compare the proportion of obese subjects according
      to BMI and body fat percentage threshold criteria (by World Health Organization). For the
      dietary intake analysis the investigators will use the national a dietary software program,
      OPEN Platform for Clinical Nutrition, which is a web-based application developed by the Jožef
      Stefan Institute in Slovenia.

      The power of the sample was calculated on the basis of published body composition data on the
      adult population of the scientific monographs of the Slovenian National Institute of Public
      Health and data on the BMI of the scientific research on the dietary intake status of adults
      (SI.Menu).

      The participants included in the study will signed consent form for inclusion in the study
      and will not be remunerated financially for participation in the study.
    

Intervention name(s): No intervention
Intervention type(s): Other
Intervention description(s): No intervention
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Healthy adult Slovenes
Early Connections, Early Detection and Intervention in Infants at Risk for Autism
Condition: Autism Spectrum Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

Summary: 
      Early connections has two broad goals:

        -  to identify risk indices for autism spectrum disorder (ASD) in 6 to 24 month old infants
           who have an older sibling with ASD or infants who have an older neurotypical sibling.

        -  to assess whether it is possible to alter risk processes through early intervention with
           high-risk infants, thereby reducing social-communication delays or the severity of
           autism symptoms.
    

Detailed description: 
      Researchers at the University of Washington want to learn more about the benefits of early
      monitoring and intervention for younger siblings of children with autism spectrum disorders
      (ASD). The information gained in this study may improve methods of early detection and
      intervention for infants who may be at risk for developing autism and lead to better outcome
      for these young children and their families.

      Participants include families with a child who has been diagnosed with an autism spectrum
      disorder or typical development and a younger sibling 12 months old or younger. The study
      protocol includes: (1) comprehensive infant evaluations at the University of Washington
      Autism Center at 6-months, 12-months, 18-months and 24-months of age. (2) Developmental
      screening for the older sibling. (3) Questionnaires and phone interviews for parents. (4)
      Random assignment to an assessment and monitoring intervention group or a University of
      Washington intervention group. All families will receive advice regarding appropriate
      intervention services. Families who are assigned to the UW intervention will take part in a
      parent delivered intervention.
    

Intervention name(s): Assessment, Monitoring & Intervention
Intervention type(s): Behavioral
Intervention description(s): Assessment and monitoring at 6, 12, 18 and 24 months; Parent delivered intervention provided between 6 and 12 months.
Other intervention name(s): Promoting First Relationships
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Infants; Risk markers; ERP; Parent child interaction; Promoting First Relations; Social Communication
Mirabegron as Medical Expulsive Therapy (MET) for Ureteral Stones and Ureteral Stent Pain
Condition: Ureteral Obstruction; Flank Pain
MeSH terms: Ureteral Calculi; Ureterolithiasis; Ureteral Obstruction; Flank Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The study will be a prospective randomized double-blind placebo-controlled trial of
      mirabegron for medical expulsive therapy (MET) in patients with a CT (Computed Tomography)
      scan-proven ureteral stone between 4 to 10 mm undergoing expectant management.
    

Detailed description: 
      The study will be a prospective randomized double-blind placebo-controlled trial of
      mirabegron for medical expulsive therapy (MET) in patients with a CT scan-proven ureteral
      stone between 4 to 10 mm undergoing expectant management. Subjects will be distributed at a
      1:1 ratio between the control and treatment groups. The treatment group will receive
      mirabegron and the control groups will receive a placebo. Both groups will receive analgesics
      and hydration will be recommended. All subjects will then be followed for 30 days to
      determine the proportion of subjects with spontaneous passage. Patients will record narcotic
      usage and pain scores during this time. If there is stone persistence in the ureter based on
      imaging (CT scan of the abdomen and pelvis versus renal ultrasound plus KUB), then the
      patient will undergo ureteroscopy with stent placement. In these patients, treatment will
      continue while the stent is in place and patients will fill out a validated questionnaire
      regarding stent pain.
    

Intervention name(s): Mirabegron; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Randomized 1:1 ratio using a randomized block design, stratified by stone size (≤5 mm versus >5 mm) and location (upper versus lower ureter). The randomization will be implemented through a database with software designed by the Director of Research Informatics at the Baylor College of Medicine's Dan Duncan Institute of Clinical and Translational Research. It will be a HIPPA-compliant secure database accessible via internet.; Randomized 1:1 ratio using a randomized block design, stratified by stone size (≤5 mm versus >5 mm) and location (upper versus lower ureter). The randomization will be implemented through a database with software designed by the Director of Research Informatics at the Baylor College of Medicine's Dan Duncan Institute of Clinical and Translational Research. It will be a HIPPA-compliant secure database accessible via internet.
Other intervention name(s): Myrbetriq
Intervention MeSH terms: Mirabegron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Medical expulsive therapy; ureteral stone; stent pain
A Pharmacokinetic and Pharmacodynamic Study Comparing HLX01 And Rituximab in Patients With CD20-Positive, B-cell Lymphoma
Condition: B-cell Non Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Randomised, double-blind, parallel group study to compare PK and PD profiles between HLX01
      and rituximab (MabThera®) in patients with CD20+ B-cell Lymphoma.
    


Intervention name(s): HLX01; Rituximab
Intervention type(s): Drug; Drug
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment