bioihbjkbjnl/mcl2 huggingface dataset:
Combining Lesinurad With Allopurinol in Inadequate Responders
Condition: Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will compare the serum uric acid lowering effects, clinical benefits, and safety
      of lesinurad in combination with allopurinol to allopurinol alone in subjects with gout who
      have had an inadequate response to allopurinol.
    

Detailed description: 
      Allopurinol is the standard of care for the treatment of gout. Nevertheless, most patients
      treated with allopurinol do not achieve the recommended sUA target of < 6.0 mg/dL and need
      additional therapy to achieve the target. Probenecid and benzbromarone are URAT1 inhibitors,
      generally recommended as second-line agents for patients who are either resistant to or
      intolerant of allopurinol. However, benzbromarone is not available in the US and probenecid
      is rarely used. Consequently, there is a clear unmet medical need for a new safe and
      effective therapy for gout, such as lesinurad, a potent URAT1 inhibitor, that can be used in
      combination with allopurinol in patients not responding adequately to allopurinol monotherapy
      so that very high rates of response can be achieved by nearly all gout patients, rather than
      a minority.The subjects selected for this study will have moderate to severe gout with an
      inadequate response to allopurinol
    

Intervention name(s): Lesinurad; Lesinurad; Placebo; Allopurinol
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablets, 200 mg QD; Tablets, 400 mg QD; Tablets, Placebo QD; Tablets
Intervention MeSH terms: Allopurinol; Lesinurad
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Gout
Effects of Virtual Reality on Dual Task Performance
Condition: Stroke
MeSH terms: Stroke
Study type: Interventional

Summary: 
      This study evaluates the effects of virtual reality treatment in addition to robotic gait
      therapy on dual task performance, balance and gait in chronic stroke patients. Half of
      participants will attend virtual reality treatment in addition to robotic gait therapy for 12
      sessions, while the other half will attend only robotic gait therapy for 12 sessions.
    

Detailed description: 
      Following stroke, motor disorders, balance disorders, falls, gait disturbances and cognitive
      disorders are frequently seen. In stroke rehabilitation, with the use of robots and virtual
      reality systems with conventional methods, it is aimed to increase patient's motivation, to
      check if exercise is effective, to provide objective evaluation data and to support the motor
      learning process and the use of these methods in the field of neurological rehabilitation is
      increasing.

      Multi-task evaluations can be made with the virtual environments created by virtual reality
      applications and complex tasks.

      The traditional approach to stroke rehabilitation is mainly focused on balance and gait
      training under single task conditions. In everyday life, people should not only have balance
      and mobility skills, but also have the ability to perform other cognitive and motor tasks
      with these skills. Therefore, traditional approaches are not sufficient for the individual to
      return to society after a stroke.

      In this respect, this study was planned in order to examine the effects of frequently used
      virtual reality treatment in addition to robotic gait therapy on the dual task, balance and
      gait performance.
    

Intervention name(s): virtual reality; robotic gait
Intervention type(s): Other; Other
Intervention description(s): Virtual reality with a game; robotic gait therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: virtual reality; stroke; dual task
Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis in Pediatric Subjects
Condition: Mydriasis; Dilation
MeSH terms: Mydriasis; Dilatation, Pathologic
Study type: Interventional
Phase: Phase 3

Summary: 
      The objectives of this study are:

        -  To evaluate the safety of Nyxol in pediatric subjects

        -  To evaluate the efficacy of Nyxol to expedite the reversal of pharmacologically induced
           mydriasis in pediatric subjects The Sponsor intends to use this study to evaluate Nyxol
           in pediatric subjects aged 3 to 11 for the indication "the treatment of
           pharmacologically induced mydriasis produced by adrenergic (phenylephrine) or
           parasympatholytic (tropicamide) agents, or a combination thereof."
    

Detailed description: 
      This is a randomized, parallel-arm, double-masked, placebo-controlled study in approximately
      20 randomized pediatric subjects evaluating the safety and efficacy of Nyxol in pediatric
      subjects with pharmacologically induced mydriasis with three dilating agents (e.g.,
      phenylephrine, tropicamide, and Paremyd). Pediatric subjects will be recruited for the study
      into 2 age groups as follows:1) 3 to 5 years of age: 10 subjects 2) 6 to 11 years of age: 10
      subjects.
    

Intervention name(s): Phentolamine Ophthalmic Solution 0.75%; Phentolamine Ophthalmic Solution Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): 0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist; Phentolamine Ophthalmic Solution Vehicle
Other intervention name(s): Nyxol®; Nyxol
Intervention MeSH terms: Phentolamine; Pharmaceutical Solutions; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nyxol; Pharmacologically Induced Mydriasis; Dilation; Pediatrics; Phentolamine; Mydriasis; Phenylephrine; Tropicamide; Paremyd
Pharmacokinetics of Ceftaroline in Normal and Obese Subjects
Condition: Drug Safety
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize plasma and urinary concentrations of ceftaroline
      following intravenous administration of a single dose of ceftaroline 600 mg in healthy
      subjects who are normal weight, overweight, and obese.
    

Detailed description: 
      This study is planned to be a Phase I, open-label, single period, single-dose pharmacokinetic
      study conducted in 32 healthy adult male and female subjects. Adult subjects will be
      recruited and assigned to one of four groups based on their body mass index and total body
      weight. Subject will receive a single dose of ceftaroline fosamil 600 mg as a 1-hour
      continuous intravenous infusion. Serial blood and urine samples will be collected over the
      next 12 hours to determine serum and urinary pharmacokinetics of ceftaroline. Safety
      evaluations will be assessed throughout the study and will include physical examination,
      vital sign monitoring, clinical laboratory tests (serum chemistry and hematology), pregnancy
      testing (female subjects only), monitoring of adverse events, and recording of concomitant
      medications.
    

Intervention name(s): Ceftaroline
Intervention type(s): Drug
Intervention description(s): A single dose of ceftaroline fosamil 600 mg as a 1-hour continuous intravenous infusion
Other intervention name(s): Teflaro
Intervention MeSH terms: Ceftaroline fosamil
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Ceftaroline; Pharmacokinetics; Obesity
A Phase I Dose Escalation Study of Plerixafor in Healthy Subjects of Japanese Descent
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective is to assess the pharmacokinetics of 3 dose levels of plerixafor
      injection (160 μg/kg, 240 μg/kg, and 400 μg/kg) in healthy adult subjects of Japanese
      descent. Three cohorts of subjects will be enrolled. Approximately 8 subjects will be
      enrolled in each cohort, 6 subjects who will receive a single subcutaneous (SC) dose of
      plerixafor (160 μg/kg, 240 μg/kg, or 400 μg/kg), and 2 subjects who will receive a single SC
      dose of placebo. The lowest dose-level cohort (plerixafor 160 μg/kg) will be fully enrolled
      first, followed by the next highest dose-level cohort (plerixafor 240 μg/kg), and finally the
      highest dose-level cohort (plerixafor 400 μg/kg), provided safety criteria for dose
      escalation are met.
    

Detailed description: 
      Screening will occur within 28 days prior to dosing. Dosing will occur on Day 1 of each
      cohort. Subjects will remain at the study center from Day -1 until discharge approximately 24
      hours after dosing (Day 2) for pharmacokinetic, safety, and pharmacodynamic assessments;
      however, all subjects who receive any investigational product, including any subjects who
      prematurely withdraw from the study, will remain at the study center for a minimum of 4 hours
      after dosing. A 15-day follow-up visit will be conducted 15 to 20 days postdose. The study
      will be considered completed for a subject at the time he/she completes the 15-day follow-up
      visit.
    

Intervention name(s): plerixafor; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single subcutaneous (SC) dose of plerixafor (160 μg/kg, 240 μg/kg, or 400 μg/kg),; Single subcutaneous (SC) dose of placebo
Intervention MeSH terms: Plerixafor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
The Pharmacokinetics and Safety of Olaparib Alone and With Paclitaxel in Chinese Patients With Advanced Solid Tumour.
Condition: Advanced Solid Tumours
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a 2 parts phase I, open label trial of olaparib monotherapy and olaparib in
      combination with paclitaxel in patients with solid tumours. Part A will assess the single and
      multiple dose pharmacokinetics of olaparib monotherapy and multiple dose pharmacokinetics of
      olaparib in combination with paclitaxel. Part B will assess the safety of multiple doses of
      olaparib in Cohort 1 and of olaparib when co-administered with paclitaxel in Cohort 2
    

Detailed description: 
      Part A will access the pharmacokinetics of olaparib: Cohort 1 will investigate the single and
      multiple dose pharmacokinetics of olaparib following 300mg bd monotherapy dose(s); Cohort 2
      will investigate the single and multiple dose pharmacokinetics of olaparib following 100mg bd
      monotherapy dose(s) and the multiple dose pharmacokinetics in the presence of co-administered
      paclitaxel (80mg/m2 weekly on days 1, 8 and 15 of a single 28-day cycle).

      In Part B: Safety profile of olaparib 300mg bd as monotherapy and olaparib 100mg bd in
      combination with weekly paclitaxel will also be investigated in Chinese patients.
    

Intervention name(s): Olaparib; Paclitaxel; Olaparib
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablet-150mg, Oral; Injection; Tablet-100mg, Oral
Intervention MeSH terms: Paclitaxel; Olaparib
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chinese Patients
Weekly Versus 3-Weekly Docetaxel Plus Cisplatin for Advanced NSCLC
Condition: Advanced Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the toxicity and efficacy of docetaxel and cisplatin combination on two schedules
      in patients with previously untreated, advanced NSCLC.
    

Detailed description: 
      The combination of docetaxel 75 mg/m2 and cisplatin 60-80 mg/m2 administered every 3 weeks is
      one of the most commonly used chemotherapy regimen in Korea for the first-line treatment of
      advanced NSCLC. Although the 3-weekly regimen is active and tolerated, it is associated with
      a significant incidence of severe neutropenia, often complicated by fever. Therefore, there
      has been increasing interest in the use of a weekly administration of docetaxel as a way of
      reducing its hematologic toxicity. We designed this randomized phase II trial to evaluate the
      safety profile and antitumor activity of two different schedules of docetaxel plus cisplatin
      given as first-line therapy in patients with advanced NSCLC.
    

Intervention name(s): Docetaxel
Intervention type(s): Drug
Intervention MeSH terms: Docetaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison Between GLP 1 Analogues and DPP 4 Inhibitors in Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      To study the effects of GLP 1 analogues and DPP 4 inhibitors on newly detected type 1
      diabetes patients.
    

Detailed description: 
      Inclusion criteria T1DM <3 months GAD Antibody+ Stimulated C peptide<0.5ng/ml Ketosis at
      onset Age < 30 yr Exclusion criteria Age > 30 yr Pancreatic disease significant systemic
      complication
    

Intervention name(s): Insulin; Sitagliptin; Exenatide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Exenatide Sitagliptin; Sitagliptin 100 mg per day oral; Exenatide 10 micrograms daily twice
Other intervention name(s): Premixed Insulin; DPP 4 inhibitors; GLP 1 analogues
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Sitagliptin Phosphate; Exenatide; Dipeptidyl-Peptidase IV Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: type 1 diabetes; exenatide; sitagliptin
Maternal Iodine Supplementation and Effects on Thyroid Function and Child Development
Condition: Iodine Deficiency; Infant Development
Study type: Interventional

Summary: 
      Rationale: In regions of severe endemic goiter, the adverse effects of in utero iodine
      deficiency on neuromotor development are well established: randomized controlled trials of
      iodine supplements given to iodine deficient mothers before pregnancy or during early
      pregnancy improve motor and cognitive performance of their offspring. However, the potential
      adverse effects of mild-to-moderate iodine deficiency during pregnancy are unclear.
      Inadequate thyroid function in the fetus and newborn are the likely cause of brain damage in
      iodine deficiency.

      Objective: To determine whether the daily oral administration of 200 µg iodine to pregnant
      women in areas of mild-to-moderate iodine deficiency improves maternal and newborn thyroid
      function, pregnancy outcome, birth weight, infant growth and cognitive performance.

      Study design: Double-blind randomized controlled multicentre trial. Study population:
      Pregnant women (18-40 years) presenting at the clinic for their first prenatal visit will be
      recruited at two research sites, namely St. Martha's hospital in Bangalore, India and
      Ramathibodi Hospital, Mahidol University, Bangkok, Thailand. At each site, 400 women will be
      recruited.

      Intervention: Half of the women will be randomized to iodine treatment (200 µg per day) and
      the other half to placebo throughout pregnancy.

      Main study parameters/endpoints: Differences between group means in indicators of thyroid
      function, birth outcome, urinary iodine, breast milk iodine, infant growth, and psychomotor
      development.
    


Intervention name(s): Placebo; Iodine
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Daily placebo supplementation from enrolment <14 wk of gestation until delivery; Daily supplementation with 200 µg iodine from enrolment <14 wk of gestation until delivery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Iodine deficiency; Pregnancy; Thyroid function; Infant development; Growth
An Expanded Safety Study of Dapivirine Gel 4759 in Africa
Condition: HIV Infections; Acquired Immunodeficiency Syndrome
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine whether dapivirine gel 4759 is safe for daily use
      by healthy women in Kenya, Malawi, Rwanda, South Africa and Tanzania.
    

Detailed description: 
      To reduce the influence of adherence as a factor in the interpretation of efficacy results,
      IPM is considering using a DOT (Directly Observed Therapy) based method for vaginal
      microbicide gel delivery in a future Phase III study. IPM has denoted this DOT based method
      as Daily Monitored Adherence (DMA). IPM014A is a Phase I/II study designed: (1) to assess and
      compare the safety of a once daily application of Dapivirine Gel 4759, 0.05% 2.5g and a
      matching vehicle placebo gel; (2) to assess the acceptability of a once daily application of
      Dapivirine gel 4759, 0.05% 2.5g and a matching vehicle placebo gel; and (3) to assess the
      feasibility of utilizing the DMA method for a large-scale phase III efficacy study.
    

Intervention name(s): dapivirine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): dosage form: vaginal gel
dosage: 1.25mg dapivirine/day
frequency: once daily
duration: 6 weeks; dosage form: vaginal gel
frequency: once daily
duration: 6 weeks
Intervention MeSH terms: Dapivirine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: HIV Infections; Acquired Immunodeficiency Syndrome; Healthy; HIV seronegativity
Comparison of Extraperitoneal and Intraperitoneal Cesarean Technique
Condition: Postpartum Fever; Ileus; Hemorrhage; Pain
MeSH terms: Hemorrhage
Study type: Interventional

Summary: 
      Cesarean section will performed via intraperitoneally and extraperitoneally. During
      postoperative period pain, need for analgesia, respiratory function tests, ileus, bowel
      movement, discharged time will be compared.
    

Detailed description: 
      Investigators will compared results intra and extraperitoneal cesarean section. Two groups
      will determine according to random numbers table. After operations, blood count, C reactive
      proteins, postoperative temperature, need for analgesia, ileus, bowel movement, mobilization
      time will compare by blind physician. Abdominal, shoulder and incisional pain at
      postoperative 0, 6, 12, 18, 24, 30 hours will compared by use visual analog score. Neonatal
      results and complications also will compare. Investigators and participants will be blind
      regarding technique.
    

Intervention name(s): Extraperitoneal cesarean section; Intraperitoneal cesarean section
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Forced Expiratory Volume in 1 second; Forced expiratory vital capacity; Peak expiratory flow
Comparative Bioavailability Study of Morphine Sulfate Immediate Release and Controlled Release
Condition: Pain
Study type: Interventional

Summary: 
      Characterize the steady-state pharmacokinetics of morphine after oral administration of
      Roxane Laboratories' morphine sulfate immediate release tablets and oral solution and to
      compare their pharmacokinetics to that of AVINZA.
    


Intervention name(s): morphine sulfate
Intervention type(s): Drug
Intervention description(s): morphine sulfate 30 mg tablet, morphine sulfate 15 mg tablet, morphine sulfate controlled release 120 mg
Other intervention name(s): AVINZA
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Atrial and Ventricular Wall Stress During Breathing
Condition: Healthy
Study type: Interventional

Summary: 
      Healthy reclining adult volunteers, with Valsalva manoeuver, Muller manoeuver, light
      continuous positive airway pressure by mask, passive leg raising, and maximal hand-grip.
      Ultrasound heart images captured before and during.
    

Detailed description: 
      With focus on atrial wall strain and strain-rate, In healthy volunteer adult subjects, heart
      ultrasound is recorded during resting, Valsalva manoeuver, Muller manoeuver, passive leg
      raising, and handgrip. Echocardiographic recordings are made before and during each
      intervention. Participants are otherwise resting in a reclined position.
    

Intervention name(s): Simple breathing manuevers during brief echocardiographic imaging
Intervention type(s): Other
Intervention description(s): Valsalva, Muller, light mask CPAP, leg raising, hand grip.
Intervention model: Single Group Assignment
Intervention model description: Healthy reclining adult volunteers, with Valsalva manoeuver, Muller manoeuver, light continuous positive airway pressure by mask, passive leg raising, and maximal hand-grip. Ultrasound heart images captured before and during.
Masking: None (Open Label)
Primary purpose: Diagnostic
A COHORT STUDY TO EVALUATE IMMUNOGENICITY FOR CHINESE CHILDREN AT THE TIME OF CLINICAL PNEUMONIA DIAGNOSIS
Condition: Immunogenicity, Vaccine
MeSH terms: Pneumonia
Study type: Interventional

Summary: 
      This is a PAC study after PCV13 launch in China. Based on recommendation from China Agency,
      Pfizer was required to conduct a descriptive immunogenicity study to measure the antibody
      levels at the time of disease onset.
    


Intervention name(s): PCV13 PAC study
Intervention type(s): Biological
Intervention description(s): To test the serotype-specific IgG geometric mean concentration (GMC) and MOPA geometric mean titers (GMT) for each of the pneumococcal serotypes measured at the time of diagnosis of clinical pneumonia.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Serum concentrations of anticapsular immunoglobulin G (IgG) and serum levels of opsonophagocytic activity (OPA) for the PCV13 pneumococcal serotypes
A Relative Bioavailability Study of Setrobuvir Tablet Formulation Versus Reference Setrobuvir Capsule Formulation in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label, randomized, single dose, 4-sequence, 4-period crossover study will assess
      the relative bioavailability of setrobuvir as tablet formulation versus the reference capsule
      formulation in healthy volunteers. Subjects will be randomized to one of four treatment
      sequences receiving 4 single oral doses of 200 mg setrobuvir, either as tablet or capsule
      formulation with or without a high fat meal, with a washout period of at least 14 days
      between treatments.
    


Intervention name(s): setrobuvir; setrobuvir
Intervention type(s): Drug; Drug
Intervention description(s): 200 mg capsule formulation, single oral dose; 200 mg tablet formulation, single oral dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)