bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Adjunctive Zonisamide in Paediatric Partial Onset Seizures (CATZ Study)
Condition: Epilepsy; Paediatric Partial Onset Seizures
MeSH terms: Epilepsy; Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the safety and efficacy of zonisamide with placebo.
    

Detailed description: 
      This will be a double-blind, randomised, study comparing zonisamide with placebo: each arm
      will consist of 102 subjects. Zonisamide/placebo dosing will commence with a dose of 1 mg/kg.
      Further dose increases will occur at weekly intervals until a dose of 8 mg/kg is reached at
      the end of Week 8. In the event of dose limiting adverse events (AEs), during the eight week
      Titration Period, one down titration to a lower dose is permitted, this can happen at any
      point in the Titration Period. Subjects who require further down titration steps will be
      withdrawn from the study. During the Maintenance Period the dose of study medication must
      remain unchanged.

      Changes in concomitant AEDs are not permitted during the Screening, Titration or Maintenance
      Periods.

      This trial consists of the following periods:

        1. Screening Period (duration four weeks): once the Screening Visit has been performed, a
           seizure diary will be maintained to document the baseline seizure frequency in the eight
           weeks between the Screening Visit and the Randomisation Visit.

        2. Titration Period (duration four weeks): during this period, zonisamide/placebo dosing
           will commence with a dose of 1 mg/kg. Further dose increases will occur at one week
           intervals until a dose of 8 mg/kg is reached at Visit 6 (Week 8). In the event of dose
           limiting AEs during the Titration Period, one down titration step to the previous dose
           will be permitted.

        3. Maintenance Period (duration 12 weeks): during this period, randomised subjects will be
           treated with the dose of zonisamide/placebo which they were receiving at Visit 6 (Week
           8). No changes to the dose are allowed during this phase.

      Following the Maintenance Period subjects will have the opportunity to enter an open label
      extension study. This open label extension study will be the subject of a separate protocol
      and will not be discussed further at this time.
    

Intervention name(s): Zonisamide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 8mg/kg per day for approximately 24 weeks.
Other intervention name(s): Zonegran
Intervention MeSH terms: Zonisamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Epilepsy; paediatric; partial onset seizures
Treatment Patterns With Targeted Therapies In Mrcc In Sweden - A Retrospective Analysis Of Data From National Registries
Condition: Kidney Neoplasms
MeSH terms: Kidney Neoplasms
Study type: Observational

Summary: 
      The objectives of this study is to investigate treatment patterns and outcomes for Sutent and
      Inlyta in mRCC patients in a nationwide population-based setting in Sweden.
    


Intervention name(s): sunitinib; axitinib
Intervention type(s): Drug; Drug
Intervention description(s): As provided in real world; As provided in real world
Other intervention name(s): Sutent; Inlyta
Intervention MeSH terms: Sunitinib; Axitinib
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The data used for the analyses includes all patients aged ≥ 18 years with at least one
        filled prescription of an oral targeted therapy relevant for treating mRCC registered in
        the Swedish Prescribed Drug Register between July 1st 2005 (there is no data available in
        the register before this date) and June 30th 2020. The Anatomical Therapeutic Chemical
        (ATC) codes for the oral drugs relevant for treating mRCC are the following: L01XE04
        (sunitinib), L01XE05 (sorafenib), L01XE11 (pazopanib), L01XE17 (axitinib), L01XE10
        (everolimus), L01XE26 (cabozantinib), L01XE34 (tivozantib), L01XE29 (lenvatinib). The
        patients identified in the PDR that also are identified in the SCR with the International
        Classification of Diseases and Related Health Problems (ICD)-7 diagnosis codes I800 or I809
        and ICD-10 codes C64.0 and C64.9 from January 1st 2000 until December 31st 2019;excluding
        ICD-7 code I801 (cancer of the renal pelvis) will be included in the analysis set.
Intranasal Ketamine Versus Intranasal Fentanyl
Condition: Multiple Trauma; Pain, Acute
MeSH terms: Acute Pain; Multiple Trauma
Study type: Interventional
Phase: Phase 3

Summary: 
      Abstract Background: Given the inadequate control of pain in patients with injury that refer
      to the emergency departments, the rapid onset of action of intranasal administration in pain
      management, and the avoidance of administering opioid medications, the present study aimed at
      evaluating the effect of intranasal ketamine versus intranasal fentanyl on pain management in
      isolated traumatic patients Materials and Methods: The current study was performed on 125
      patients that were divided into the following three groups: control group (n = 41), 1 mg/kg
      intranasal ketamine group (n = 40), and 1μg/kg intranasal fentanyl group (n = 44). Then pain
      scores, HR, RR, BP, and SaO2 were recorded at baseline, 5, 10, 15, 30, and 40 minutes after
      the intervention.
    


Intervention name(s): Placebo; Ketamine; Fentanyl
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Distilled water; 1 mg/kg intranasal ketamine; 1μg/kg intranasal fentanyl
Intervention MeSH terms: Fentanyl; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
To Assess the Pharmacokinetics and Safety and Tolerability of Efanesoctocog Alfa (BIVV001)in Adults With Type 2N and 3 Von Willebrand Disease (VWD)
Condition: Von Willebrand's Disease (VWD)
MeSH terms: Von Willebrand Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      -To characterize the pharmacokinetics (PK) of BIVV001 after a single intravenous (IV)
      administration, as assessed by factor VIII (FVIII) activity determined by the one-stage
      activated partial thromboplastin time (aPPT) clotting assay, as well as, BIVV001 capture
      chromogenic Coatest FVIII activity assay

      Secondary Objective:

      -To assess the safety and tolerability of a single IV dose of BIVV001 in adult patients with
      type 2N and 3 VWD
    

Detailed description: 
      Duration of each part of the study for one participant:

      Total study duration: Up to 57 days.

        -  Screening: up to 28 days.

        -  Up to 29 days of safety observation following the IV BIVV001 dose administration (this
           period includes PK sampling up to the first 10 days following administration).
    

Intervention name(s): efanesoctocog alfa (BIVV001)
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form:solution for injection Route of administration: intravenous injection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
The Clinical and Economic Impact of Pharmacogenomic Testing of Warfarin Therapy in Typical Community Practice Settings
Condition: Embolism and Thrombosis; Embolism; Vascular Diseases; Warfarin; Venous Thromboembolism; Thrombosis; Thromboembolism
MeSH terms: Thrombosis; Embolism; Thromboembolism; Vascular Diseases; Venous Thromboembolism; Embolism and Thrombosis
Study type: Observational

Summary: 
      The purpose of this quasi-experiment study, which could also be classified as a prospective
      observational intervention study, is to assess the impact of cytochrome P450 2C9 (CYP 2C9)
      and vitamin K epoxide reductase complex, subunit 1 (VKORC1) testing within a primary patient
      care setting.
    

Detailed description: 
      Anticoagulation therapy with warfarin is the most common mode of treatment and prophylaxis
      for venous and arterial thromboembolic conditions. Warfarin is metabolized in the liver by
      the cytochrome P450 system, the cytochrome P450 2C9 (CYP 2C9) isoenzyme specifically, and
      polymorphisms in the CYP 2C9 gene have been associated with changes in metabolic function of
      the translated isoenzyme . These polymorphisms result in reduced metabolism of warfarin as
      compared to subjects having the wild type gene, consequently leading to systemic accumulation
      of warfarin; it is theorized that this leads to higher risk of adverse events. Other allelic
      variations have also been linked to changes in vitamin K conservation through their effects
      on vitamin K epoxide reductase complex, subunit 1 (VKORC1) . The combined impact of CYP 2C9
      and VKORC1 polymorphisms on warfarin's pharmacology have recently been reported.

      It is hypothesized that evaluation of genomic allelic type guided warfarin dosing will reduce
      thromboembolic and bleeding risks associated with warfarin therapy, and that adoption of a
      genetic testing strategy in a primary patient care setting would improve warfarin
      effectiveness and patient safety, and reduce costs to health care payers.
    

Intervention name(s): CYP 2C9 and VKORC1 Testing for Warfarin
Intervention type(s): Other
Intervention description(s): Test patients for their warfarin sensitivity and provide this information to their physician authorizing the test.
Other intervention name(s): Genetic testing for drug sensitivity
Intervention MeSH terms: Warfarin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The active study population consists of male and female covered lives with Medco for
        clients have agreed to enroll their members for ages 40-75 for new warfarin starts who
        match the inclusion criteria.
      
Biospecimen description: 
      Blood draw and buccal swab
    
Keywords: CYP2C9; VKORC1; polymorphism; warfarin; Coumadin
Craving, Binge Eating and Obesity
Condition: Binge Eating Disorder; Obesity
MeSH terms: Obesity; Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This research study is designed to look at the effectiveness of bupropion for reducing binge
      eating in overweight persons with binge eating problems. Participants in the study will
      receive either bupropion or placebo ("sugar" pill, inactive medication) as an outpatient for
      eight weeks. In addition, participants will be given the option to receive 8 weeks of free
      behavioral weight loss treatment. This treatment, known to be effective for reducing binge
      eating and helping people lose weight, will be administered following the medication phase
      and at no cost.

      It is expected that compared to placebo, bupropion will produce greater reductions in binge
      eating.
    

Detailed description: 
      The proposed study is an 8-week randomized placebo-controlled trial to test the efficacy of
      bupropion in treating overweight women with binge eating disorder (BED). Bupropion is an
      antidepressant that has demonstrated efficacy in smoking cessation and some efficacy in
      obesity treatment. Since cravings and depressed mood are hypothesized to contribute to binge
      eating episodes, bupropion is a promising psychopharmacological agent in treating binge
      eating and reducing weight. It is hypothesized that compared to placebo, bupropion will
      produce significantly greater reductions in the frequency of binge eating. Secondary goals
      are to explore interrelationships between treatment and changes in cravings, frequency of
      binge episodes, emotional eating, and weight loss. Following the medication phase of the
      trial, all patients will be offered 8 weeks of behavioral weight loss treatment administered
      by doctoral-level psychologists specializing in eating disorders and weight management.
    

Intervention name(s): bupropion; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 300 mg per day for 8 weeks; Placebo
Other intervention name(s): wellbutrin; zyban
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Binge eating; Obesity; Medication; Craving; Emotional eating
Absorption and Metabolism of Olive Leaf Extract and Its Effect on Vascular Reactivity and Cytokine Concentrations
Condition: Absorption and Metabolism; Effect on Vascular Function; Effect on Cytokine Concentrations
Study type: Interventional

Summary: 
      The purpose of this study is to determine how olive leaf is absorbed and metabolised and also
      whether it has any effect on the elasticity of blood vessels and the immune system.
    

Detailed description: 
      The purpose of this study is to determine how olive leaf is absorbed and metabolised and also
      whether it has any effect on vascular function and cytokine concentrations.
    

Intervention name(s): Olive leaf extract capsules
Intervention type(s): Dietary Supplement
Intervention description(s): Four capsules taken at baseline each containing 4mg oleuropein
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Olive leaf extract; Polyphenols; Vascular function; Bioavailability; Cytokines
Multi-site Evaluation of an Evidence-based Positive Youth Development Program
Condition: Unintended Pregnancy; Adolescent Problem Behavior
MeSH terms: Problem Behavior
Study type: Interventional

Summary: 
      Investigators are carrying out a study to assess the immediate and long-term effects of a
      positive youth development program (the Teen Outreach Program) on high school youth in
      Florida. This study will answer the following questions: What is the impact of the Teen
      Outreach Program on sexual activity and positive youth development at the end of the program
      and 10 months after the program?
    

Detailed description: 
      Schools were randomly allocated to either the intervention or the control group. At treatment
      (intervention) schools, youth participated in TOP in addition to their Health, HOPE, Critical
      Thinking, Career Research, or Leadership class. At control (non-intervention) schools, youth
      simply participated in their business-as-usual Health, HOPE, Critical Thinking, Career
      Research, or Leadership class. Two cohorts of students were recruited for this study, the
      first cohort joined the study in August 2012 and the second cohort joined the study in August
      2013. A survey was given to youth at both treatment and control schools. The paper-and-pencil
      survey took approximately 30 minutes and asked questions about youth school, grades, peers,
      health behaviors, and behaviors related to teen pregnancy, including what the participant
      believes and does in regards to sexual health. The survey was completely confidential and
      participant names were not linked to survey responses. All survey materials were pre-approved
      by school administration and the school district office. Participants will be asked to
      complete the a survey at pre-intervention, post-intervention, and 10-months post-intervention
      (Cohort 1 only)
    

Intervention name(s): Teen Outreach Program
Intervention type(s): Behavioral
Intervention description(s): The Teen Outreach Program (TOP) is a positive youth development program that uses weekly educational peer group sessions, Community Service Learning (CSL), and positive adult guidance to help youth in grades 6-12 build healthy behaviors, life skills, and a sense of purpose. For this study, TOP was implemented in traditional public high schools in Florida and delivered by local health department staff, who were trained and certified as TOP facilitators. Youth enrolled in these classes received the TOP intervention in addition to, not as a replacement for, all business-as-usual curriculum content.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Positive Youth Development; Teen Outreach; Teen Pregnancy Prevention
A Phase 1 Trial to Determine Dosimetry, Biodistribution and Safety of LMI 1195-101 in Healthy Subjects and Patients With Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical study is to estimate the safety and radiation dosimetry of a
      single dose of LMI1195 in healthy subjects and heart failure patients undergoing positron
      emission tomography (PET)
    


Intervention name(s): LMI 1195-101
Intervention type(s): Drug
Intervention description(s): Single dose, bolus IV injection of LMI 1195
Other intervention name(s): LMI 1195-101 Clinical Trial
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Heart Failure, PET Imaging, Implantable Cardioverter-Defibrillator, Dosimetry
A Phase 1 Study of EXT608 in Healthy Adults
Condition: Safety Issues
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose safety
      and tolerability study of EXT608 in healthy subjects. There will be up to 6 sequential dose
      escalation cohorts of 4 participants. In each cohort 3 participants will receive EXT608 and 1
      participant will receive placebo.
    

Detailed description: 
      This is a randomized, double-blind, first-in-human, placebo-controlled single ascending dose
      study to study the safety, tolerability, PK, and PD of EXT608 in healthy adult participants.

      Participants will be enrolled into 1 of up to 6 planned single dose cohorts in ascending
      fashion.

      Each cohort will consist of 4 participants randomized to receive either EXT608 or placebo,
      whereby 3 will receive a single injection of EXT608 and 1 will receive matching placebo.

      Up to 6 dosing cohorts are planned with no single dose escalation to exceed a 3-fold dose
      increment. A Data Monitoring Board will review the seven-day safety data in each cohort
      before authorizing the initiation of the next cohort.

      A screening visit will take place within 28 days of dosing. Eligible participants for each
      cohort will be admitted to the Clinical Research Unit (CRU) 1 day prior to dosing and remain
      in the CRU through at least 72 hours after dosing for safety and PK assessments before
      discharge. The total confinement period will be 4 nights, unless extended for management of
      AEs at the discretion of the Investigator
    

Intervention name(s): EXT608; Placebo
Intervention type(s): Drug; Other
Intervention description(s): EXT608 is an investigational drug administered via subcutaneous injection; matching placebo administered via subcutaneous injection
Other intervention name(s): test drug
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Single ascending dose with up to 6 sequential dose escalation cohorts. Participants will be randomized to either study intervention (EXT608) or placebo
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Validation of DNA Methylation Biomarkers for Oral Cancer Detection
Condition: Oral Cancer; Recurrence
MeSH terms: Mouth Neoplasms; Lip Neoplasms; Recurrence
Study type: Observational

Summary: 
      The purpose of this study is to investigate the correlation between DNA methylation and the
      treatment and recurrence of oral cancer.
    

Detailed description: 
      In this study, investigators plan to recruit 40~50 patients who had, or currently has oral
      cancer. The study procedures are as below:

        -  After the Informed Consent Form is signed, swab from the lesion site and normal site to
           obtain oral epithelial cells.

        -  Collect tissue from the tumor site and the non-cancerous matched site from the surgery
           or the tissue bank.

        -  Collect oral swab from the lesion site and the normal site when patients return to the
           clinic for a regular follow-up.

      Specimens will be collected for DNA methylation testing, and the results will be compared
      with patient's clinical diagnosis. It is expected that the relationship between DNA
      methylation, oral cancer, and the recurrence of oral cancer will be found.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Investigators plan to retrieve the tissue from the biobank in Taipei Veterans General
        Hospital or recruit oral cancer patients in this study over six months. The total patient
        number are 40-50. Specimen types include non-cancerous matched tissues, cancer tissues, and
        the oral swab. DNA methylation for several genes will be tested by using standardized
        reagents and instruments.
      
Biospecimen description: 
      oral swab, non-cancerous matched tissue and tumor tissue
    
Keywords: Primary oral cancer; DNA methylation; Recurrence oral cancer
Study to Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of AZD9291, in Patients With EGFR Positive Non-small Cell Lung Cancer. Patients Will be Chosen From Those Who Have Already Been Prescribed an EGFR TKI Medicine (Such as Iressa or Tarceva)
Condition: Advanced Non Small Cell Lung Cancer; Advanced (Inoperable) Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 2 part study in patients with EGFRm+ non small cell lung cancer (NSCLC), whose
      disease has progressed on an EGFRm TKI, who are refractory or resistant to standard therapy.
      Part A will assess the effect of multiple oral doses of itraconazole on the single dose
      pharmacokinetic (PK) parameters of AZD9291. On completion of Part A, patients may continue to
      take AZD9291 tablets (Part B) following the collection of the 216 hour sample on Day 19 if
      they and the Investigator deem it appropriate, until such time as their disease progresses,
      the Investigator believes they are no longer deriving clinical benefit, or they stop taking
      AZD9291 for any other reason
    


Intervention name(s): Pharmacokinetic sampling; AZD9291; Itraconazole
Intervention type(s): Procedure; Drug; Drug
Intervention description(s): Blood samples taken pre and post dosing with AZD9291+/- itraconazole; AZD9291 tablets: Part A 80mg od, days 1 and 10 only. Part B 80mg od for 12 months.; Itraconazole tablets: 2x100mg bd, Part A days 6 to 19 only
Intervention MeSH terms: Itraconazole; Osimertinib
Allocation: Non-Randomized
Masking: None (Open Label)
Primary purpose: Other
Keywords: oncology, cancer, non small cell lung cancer, anticancer drug, pharmacokinetics, AZD9291, intraconazole, EGFR sensitivity mutation