bioihbjkbjnl/mcl2 huggingface dataset:
To Compare the PK and Safety of Omalizumab (CT-P39, EU-approved Xolair, and US-licensed Xolair) in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A Phase 1, Randomized, Double-blind, Three-arm, Parallel Group, Single-dose Study to Compare
      the Pharmacokinetics and Safety of Three Formulations of Omalizumab (CT-P39, EU-approved
      Xolair, and US-licensed Xolair) in Healthy Subjects
    


Intervention name(s): CT-P39; EU-approved Xolair; CT-P39; EU-approved Xolair; US-licensed Xolair
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): 150 mg/mL, Solution for injection in PFS; 150 mg/mL, Solution for injection in PFS; 150 mg/mL, Solution for injection in PFS; 150 mg/mL, Solution for injection in PFS; 150 mg/mL, Solution for injection in PFS
Intervention MeSH terms: Omalizumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Comparison of Non-nutritive Suck (NNS) Measures to Clinical Estimates of Suck and Feeding Readiness in Preterm Infants
Condition: Preterm Birth
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      This is a research study to quantitatively assess the development of non-nutritive suck (NNS)
      and feeding readiness in preterm infants using a novel device, the NTrainer©, and to compare
      this with two clinical assessment tools, NOMAS and EFS.
    

Detailed description: 
      Fifteen minutes before feeding, the mobile NTrainer recording station will be positioned
      cribside. Following a brief exam of physiologic state, using the Oral Feeding Readiness
      Assessment portion of the EFS, the infant will be cradled in a supportive inclined posture,
      swaddled, with limbs positioned at midline, and background/overhead lighting dimmed in the
      area to promote eye contact with the tester. Sampling of NNS behavior will not be initiated
      until the infant is in an optimal behavioral state, i.e., drowsy to active alert (state 3 or
      4 or 5 as described by the Naturalistic Observation of Newborn Behavior, Newborn
      Individualized Developmental Care and Assessment Program; NIDCAP). The infant will be
      presented with the NTrainer pacifier, and several contiguous 30-second blocks of NNS nipple
      compression data will be sampled using the NeoSuck RT software. The infant will remain
      connected to the usual NICU monitors at all times for observation of respiration, heartbeat
      and oxygen saturation.

      After the NTrainer data collection is completed, the baby will be fed by his or her nurse or
      parents as directed in the care plan. If the baby is able to feed by mouth, one of the
      investigators will observe the feeding, and perform 1) a NOMAS evaluation during the first 2
      minutes of the feeding, and 2) an EFS assessment after the feeding is completed.

      Infants will be studied in 2 sessions each day beginning at Day 4 to 7 of life, then twice
      weekly (2 sessions per day, 2 days per week) until hospital discharge.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infants born prematurely may suffer multiple adverse events in the NICU, and these
        experiences may negatively impact normal developmental processes of immature
        cardiorespiratory, gastrointestinal and central nervous systems. As a result, many infants
        have at least transient difficulties learning to successfully manage oral feedings. Oral
        feeding difficulties in the NICU may prolong the time to discharge, cause significant
        parental anxiety, and persist throughout infancy.
Pazopanib Hydrochloride in Treating Young Patients With Solid Tumors That Have Relapsed or Not Responded to Treatment
Condition: Childhood Central Nervous System Choriocarcinoma; Childhood Central Nervous System Embryonal Tumor; Childhood Central Nervous System Germ Cell Tumor; Childhood Central Nervous System Germinoma; Childhood Central Nervous System Mixed Germ Cell Tumor; Childhood Central Nervous System Teratoma; Childhood Central Nervous System Yolk Sac Tumor; Metastatic Childhood Soft Tissue Sarcoma; Recurrent Childhood Brain Stem Glioma; Recurrent Childhood Central Nervous System Embryonal Tumor; Recurrent Childhood Soft Tissue Sarcoma; Recurrent Childhood Visual Pathway Glioma; Unspecified Childhood Solid Tumor, Protocol Specific
MeSH terms: Neoplasms; Sarcoma; Glioma; Neoplasms, Germ Cell and Embryonal; Teratoma; Endodermal Sinus Tumor; Choriocarcinoma; Germinoma; Recurrence
Study type: Interventional
Phase: Phase 1

Summary: 
      This phase I trial is studying the side effects and best dose of pazopanib hydrochloride in
      treating young patients with solid tumors that have relapsed or not responded to treatment.
      Pazopanib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth and by blocking blood flow to the tumor.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. Estimate the maximum-tolerated dose and/or recommended phase II dose of pazopanib
      hydrochloride in pediatric patients with relapsed or refractory solid tumors.

      II. Define and describe the toxicities of this regimen in these patients. III. Characterize
      the pharmacokinetics of pazopanib hydrochloride in these patients.

      SECONDARY OBJECTIVES:

      I. Preliminarily define the antitumor activity of pazopanib hydrochloride within the confines
      of a phase I study.

      II. Evaluate changes in tumor vascular permeability following initiation of pazopanib
      hydrochloride and correlate these changes with clinical outcome by dynamic contrast-enhanced
      MRI.

      OUTLINE: This is a multicenter study dose-escalation study.

      Patients receive oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every
      28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
      Patients accrued after the maximum-tolerated dose (MTD) of pazopanib hydrochloride has been
      determined receive pazopanib hydrochloride as an oral suspension.

      Some patients undergo dynamic contrast-enhanced MRI at baseline and periodically during
      study. Blood samples are collected at baseline and periodically during study for
      pharmacokinetic studies.
    

Intervention name(s): pazopanib hydrochloride; pharmacological study
Intervention type(s): Drug; Other
Intervention description(s): Given orally; Correlative studies
Other intervention name(s): GW786034B; Votrient; pharmacological studies
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pediatric Autologous Bone Marrow Mononuclear Cells for Severe Traumatic Brain Injury
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      Pediatric severe traumatic brain injury (TBI) is the leading cause of death and disability in
      children ages 1-14 years old. There are no effective therapies to treat secondary brain
      injury and the post-injury response of CNS apoptosis and neuroinflammation. This study is a
      follow-up trial from a previously performed Phase I trial that demonstrated the safety and
      potential CNS structural preservation effect of intravenous autologous bone marrow
      mononuclear cells (BMMNC) after severe TBI in children. (Cox, 2011) The study is designed as
      a prospective, randomized, placebo controlled, blinded Phase 2 safety/biological activity
      study. The investigators hope to determine the effect of intravenous infusion of autologous
      BMMNCs on brain structure and neurocognitive/functional outcomes after severe TBI in
      children.
    

Detailed description: 
      Study Design: Multicenter, randomized, blinded, placebo controlled, Bayesian adaptive dose
      escalation design.

      Study Intervention: Single dose administered within 48 hours from time of injury. Controls
      will undergo a sham harvest and receive similarly labeled/external appearance and volume of
      0.9% NaCl. BMMNC's will be harvested and undergo processing under cGMP conditions to obtain
      6x10^6 cells/kg or 10x10^6 cells/kg weight. The cellular product/placebo will be infused
      within 48 hours of injury.

      Safety Monitoring & Follow-Up: Subjects will be monitored for infusion related toxicity
      post-infusion through hospital discharge and follow-up return study visits. Laboratory and
      imaging studies will be repeated at the 1, 6, and 12-month follow-up visits. A medical safety
      monitor (MSM) will review blinded SAE reports following post-infusion Day 14 for each subject
      in real time to ensure good clinical practice and to quickly identify safety concerns. The
      MSM will remain blinded to the treatment assignment, unless the NINDS appointed DSMB approves
      unblinding.
    

Intervention name(s): autologous bone marrow mononuclear cells; Placebo Infusion
Intervention type(s): Biological; Other
Intervention description(s): BMMNC infusion of either 6x10^6 cells/kg or 10x10^6 cells/kg weight.; Placebo infusion of 0.9% Sodium Chloride
Other intervention name(s): BMMNCs; Saline Infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Traumatic Brain Injury; TBI; pediatric; acute; stem cells
Clinical and Biochemical Presentation of Polycystic Ovary Syndrome in Different Age Group
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Observational

Summary: 
      To study the clinical and biochemical characteristics women with polycystic ovary syndrome
      (PCOS) in different aged groups.
    

Detailed description: 
      Polycystic ovarian syndrome (PCOS) is the most frequent endocrine disorder of reproductive
      age women, affecting an estimated 9-18% of all women in this age group. To diagnose of PCOS
      in early life is especially important because it is now thought to increase metabolic and
      cardiovascular risks. Investigating PCOS is crucial as it is now considered to increase
      metabolic and cardiovascular risk, thereby impacting the health of women to a much greater
      extent than previously thought. We are plan using retrospective analysis to evaluate the
      clinical and biochemical presentation of PCOS in different aged groups.
    

Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Reproductive age women
      
Keywords: Polycystic ovarian syndrome (PCOS)
Bioequivalence Study of Levomerc 500 mg Tablets
Condition: Healthy; Pharmacokintetics
Study type: Interventional
Phase: Phase 1

Summary: 
      An open Label, Randomized, Two Way Cross over, Two Period, Two Treatment, two Sequence
      Bioequivalence Study of Levomerc tablets (Levofloxacin) 500 mg compared with Tavanic
      (Levofloxacin) 500 mg Tablet as reference drug in healthy Pakistani subjects under fasting
      condition.
    

Detailed description: 
      The study will be conducted on 24 healthy subjects. The study will comprise of two Periods, I
      and II, each consisting of 36 hours, 12 hours before and 24 hour after the drug
      administration. All 24 subjects divided in group of 12 each. One group treated with the test
      (T) and other one with reference (R) drug in Period I and after the wash out period, the same
      received the alternate treatment in Period II.

      blood samples will be collected for up to 24 hours post dose in each period for plasma
      analysis of Levofloxacin.
    

Intervention name(s): Levofloxacin 500mg
Intervention type(s): Drug
Intervention description(s): A single dose consisting of one tablet of either test drug (Levomerc 500 mg) or reference drug (Tavanic 500mg) administered to each of the subjects in both Period.
Other intervention name(s): Levomerc (Levofloxacin) tablets 500 mg; Tavanic (Levofloxacin) tablets 500 mg
Intervention MeSH terms: Levofloxacin; Ofloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A single center, open Label, Randomized, Two Way Cross over, Two Period, Two Treatment, two Sequence Bioequivalence Study
Masking: None (Open Label)
Primary purpose: Other
Keywords: Bioequivalence Study; Pakistani Population; healthy volunteers
In Hepatitis C Patients Treated With Interferon and Ribavirin, Does Hepcidin Contribute to Treatment Induced Anaemia
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Observational

Summary: 
      The standard treatment of chronic hepatitis C infection is pegylated interferon alpha
      combined with ribavirin. Anaemia is a common complication occurring in up to 30% of subjects.
      Unfortunately, side effects of interferon and ribavirin therapy can require dose reductions,
      reducing the likelihood of sustained viral response. Recent data shows that interferon alpha
      may increase hepcidin (a key iron regulator) production, resulting in impaired iron
      availability for production of red blood cells. In this study, we will evaluate hepcidin
      levels in 30 patients with Hepatitis C who are treated with interferon containing regimes. If
      hepcidin plays a role in interferon-induced anaemia, cheap and readily available oral
      hepcidin inhibitors could be trialled to potentially reduce the impact of interferon alpha
      induced anaemia.
    


Intervention name(s): Pegylated interferon alpha; Ribavirin
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous weekly pegylated interferon alpha and daily oral ribavirin treatment as per standard treatment. The dosages for interferon and ribavirin are as per therapeutic guidelines and are based on weight, genotype and previous treatments.; Subcutaneous weekly pegylated interferon alpha and daily oral ribavirin treatment as per standard treatment. The dosages for interferon and ribavirin are as per therapeutic guidelines and are based on weight, genotype and previous treatments.
Other intervention name(s): pegasys; pegatron; Copegus; Rebetol; Ribasphere; Vilona; Virazole
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Hepatitis C patients undergoing standard of care treatment with interferon alpha.
      
Biospecimen description: 
      Whole blood is collect for genomic DNA extraction. Serum samples will be stored for hepcidin
      analysis.
    
Keywords: Hepatitis C; Interferon; Ribavirin; Hepcidin; Iron metabolism
The Safety and Efficacy of Methylene Blue MMX® Modified Release Tablets Administered to Subjects Undergoing Screening or Surveillance Colonoscopy
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluation of the histologically proven adenoma and carcinoma detection rate in patients
      undergoing a full colonoscopy with and without mucosal contrast enhancement, obtained with
      200 mg of Methylene Blue MMX® tablets.
    


Intervention name(s): Methylene Blue MMX®; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sugar pill manufactured to mimic Methylene Blue MMX® tablet.
Other intervention name(s): Investigational Product: Methylene Blue MMX® modified release tablets; Active Ingredient: Methylene Blue
Intervention MeSH terms: Methylene Blue
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Screening
Efficacy and Safety of Eriobotyra Japonica Lindley Extract on Improvement of Cognitive Function
Condition: Cognitive Function
Study type: Interventional

Summary: 
      The investigators performed a 12-week, randomized, double-blind, placebo-controlled human
      trial to evaluate the efficacy and safety of Eriobotyra Japonica Lindley Extract on
      improvement of Cognitive Function. The investigators measured improvement of Cognitive
      Function parameters , including K-MMSE, Ability to perform working memory tasks, CNT and
      BCRS, and monitored their blood pressure.
    


Intervention name(s): Eriobotyra Japonica Lindley Extract; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Eriobotyra Japonica Lindley Extract (1.5g/day); Placebo (1.5g/day)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
QUality of Control and slEep in Children With diabeteS, Using New Technology
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The study is an open label single centre randomised cross over study to evaluate the impact
      of a sensor augmented pump (SAP) with a predictive algorithm to suspend temporarily insulin
      administration (640G® with the Smart Guard feature) versus the use of the same pump for
      insulin administration with 'only' continuous glucose measurements (not interacting with the
      pump, Freestyle Libre ® ) on the time in glucose target , in hypo- and hyperglycemia.
      Exploratory endpoints are the effect on sleep and quality of life in children with type 1
      diabetes and their caregivers.
    

Detailed description: 
      Optimising metabolic control in children with Type 1Diabetes Mellitus (T1DM) is essential to
      prevent late complications. Fear of nocturnal hypoglycemia is pervasive amongst parents of
      children with T1DM, leading to a heightened vigilance by parents to control regularly their
      children's blood sugar values or to check the sensor information during the night. This leads
      to chronic sleep interruption and to lack of sleep as well in the parents as in their
      children with diabetes.

      In this study, the impact of new technologies on glucose time in target , hypo fear and
      quality of life will be evaluated, using continuous interstitial glucose measurements either
      with a direct impact on insulin administration (640G medtronic pump (R)) and with alerts , or
      without impact on insulin administration and without alerts.
    

Intervention name(s): CGM augmented pump with PLGS ,; Insulin pump with CGM
Intervention type(s): Device; Device
Intervention description(s): 5 weeks treatment CGM augmented pump with PLGS compared with 5 weeks treatment with insulin pump with CGM , without integration; 5 weeks treatment continuous subcutaneous insulin infusion pump with CGM without data integration,
Other intervention name(s): 640G, Enlite Sensors , Freestyle Libre; 640G , freestyle libre
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Tolerability of MRZ-99030 Eye Drops in Healthy Volunteers and Glaucoma Patients
Condition: Healthy Volunteers and Glaucoma Patients
MeSH terms: Glaucoma
Study type: Interventional
Phase: Phase 1

Summary: 
      -  To assess the safety and tolerability of repeat dose topical administration of MRZ-99030
           Ophthalmic Solution with ascending doses in healthy subjects (stage 1) and glaucoma
           subjects (stage 2).

        -  To assess plasma pharmacokinetics and urine concentration of MRZ- 99030 and its
           metabolite MRZ-9499 after single and repeat dose topical administration of MRZ-99030
           Ophthalmic Solution.
    


Intervention name(s): MRZ-99030 eye drops 5mg/mL; MRZ-99030 eye drops 20mg/mL; Placebo to MRZ-99030 eye drops
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Effect of AG-881 on the Pharmacokinetics of a Single Dose of Lamotrigine in Healthy Adults
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to examine the effect of multiple doses of AG-881 on the
      pharmacokinetics (PK) of a single dose of lamotrigine in healthy adults.
    


Intervention name(s): AG-881; Lamotrigine
Intervention type(s): Drug; Drug
Intervention description(s): Supplied as uncoated tablets.; Supplied as tablets of LAMICTAL® or generic equivalent.
Other intervention name(s): LAMICTAL®
Intervention MeSH terms: Lamotrigine
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetic study
Groin Wound Infection Rate Using Prevena Compared to Standard Dressing in Vascular Surgery Patients With High Risk
Condition: Endovascular Procedures
MeSH terms: Wound Infection
Study type: Interventional

Summary: 
      Evaluate wound healing using Prevena compared to standard dressings in high risk patients
      after vascular surgery.
    

Detailed description: 
      Patients submitted to bilateral femoral endarterectomy will have one groin dressed with
      PrevenaTM and the contralateral one dressed with conventional bandage immediately after
      suture. Both PrevenaTM and the conventional bandage at the contralateral side will be removed
      before the patient discharge. Groin wound complications such as deep space infection,
      cutaneous cellulitis, dehiscence or re-interventions for wound-related complications will be
      observed in a 30-day evaluation window. This observation will be performed during the patient
      admission and in the post-operative standard of care visits among the first 30 days.
    

Intervention name(s): Prevena Dressing; Conventional Dressing
Intervention type(s): Other; Other
Intervention description(s): Prevena dressing is applied on one groin; Conventional dressing is applied on the contralateral groin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Patient will be randomized sequentially to Prevena alternating with standard of care dressing
Masking: None (Open Label)
Primary purpose: Treatment