bioihbjkbjnl/mcl2 huggingface dataset:
Study of E6007 in Japanese Patients With Moderate Active Ulcerative Colitis
Condition: Moderate Active Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled, multi-center study to evaluate the
      efficacy and safety of E6007 once daily for 8 weeks in Japanese participants with moderate
      active ulcerative colitis. Participants will be stratified by prior therapeutic treatment and
      Mayo score at Baseline, and will be randomized 1:1:1 to receive E6007 30 milligrams (mg),
      E6007 60 mg or placebo.
    


Intervention name(s): E6007; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): once daily administration; once daily administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: moderate active ulcerative colitis; Japanese
A Study of JNJ-67484703 in Participants With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate safety and tolerability of JNJ-67484703
      administrations in participants with active rheumatoid arthritis (RA).
    

Detailed description: 
      JNJ-67484703 is a humanized immunoglobulin G1 kappa (huIgG1κ) antibody that is being
      developed as a treatment for systemic autoimmune disorders. The primary hypothesis of this
      study is that treatment with JNJ-67484703 as compared to placebo will result in a similar
      tolerability and safety profile, as a measure of participants with abnormalities in vital
      signs, physical examinations, and laboratory safety tests. This study will be conducted in 3
      phases: screening phase (up to 6 weeks), treatment phase (up to 10 weeks), and follow-up
      phase (up to 14 weeks). The duration of study participation will be approximately 30 weeks.
      Safety assessment like electrocardiogram (ECG), adverse events will be performed during the
      study. Efficacy assessment like joint assessments, pain assessments, RA joint pain severity
      assessment, patient's and physician's global assessment of disease activity, health
      assessment questionnaires, duration of morning stiffness, functional assessment of chronic
      illness therapy-fatigue will be performed during the study.
    

Intervention name(s): JNJ-67484703; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive JNJ-67484703.; Participants will receive placebo to JNJ-67484703.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Food Effect Study on the Pharmacokinetics of VC004 Capsules in Healthy Adult Subjects
Condition: Locally Advanced or Metastatic Solid Tumor Harboring an NTRK Gene Fusion
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will adopt a randomized, open-label, two-period, 2-way crossover design to
      evaluate pharmacokinetics of a single oral dose of VC004 capsules under fasting and fed
      conditions in healthy subjects.
    


Intervention name(s): VC004 Capsules; VC004 Capsules
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration after fasting/high-fat meal; Oral administration after high-fat/fasting meal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: healthy subjects
Parent-QoL and Sleep Disordered Breathing
Condition: Sleep Apnea Syndromes
MeSH terms: Sleep Apnea Syndromes
Study type: Observational

Summary: 
      In this prospective case-control study the investigators will enrolled parents of 45 children
      younger than five years of age who were planned to undergo adenotonsillectomy due to an
      obstructive airway indication in an academic medical center. A group of parents to healthy
      children will comprise the control group.
    

Detailed description: 
      Parents of children with any chronic illness may experience increased anxiety and reduced
      health-related quality of life (QoL).

      In this study, the investigators will analyze QoL parameters among parents of obstructive
      sleep disordered breathing (OSDB) children before and after surgical treatment.

      In this prospective case-control study the investigators will enrolled parents of 45 children
      younger than five years of age who are planned to undergo adenotonsillectomy due to an
      obstructive airway indication in an academic medical center. A group of parents to healthy
      children will comprisedthe control group.

      The investigators will translate and validate the PAR-ENT-QoL questionnaire through
      forward-backward translation method.

      Main outcome measure: The questionnaire was tested for reliability, consistency,
      reproducibility, responsiveness, and for its clinical use.
    

Intervention name(s): adenotonsillectomy
Intervention type(s): Procedure
Intervention description(s): adenotonsillectomy surgery
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population included parents of children younger than five years old who suffered
        from OSDB and underwent tonsillectomy or tonsillotomy with or without adenoidectomy during
        2018, in the Department of Otolaryngology at Galilee Medical Center, Israel.

        The control group was composed of parents of healthy children of the same age group who did
        not suffer from OSDB or any other acute or chronic disease and were recruited through an
        online survey to complete the questionnaire
Multipurpose Disinfecting Solution Compatibility With a Silicone Hydrogel Contact Lens
Condition: Myopia; Hyperopia
MeSH terms: Hyperopia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to verify the compatibility of a silicone hydrogel lens when
      used with four multipurpose disinfecting solutions (OPTI-FREE® RepleniSH®, ReNu MultiPlus®,
      Solo-Care Aqua™ and MeniCareTM Soft).
    

Detailed description: 
      The purpose of this study is to verify the compatibility of a silicone hydrogel lens when
      used with four multipurpose disinfecting solutions (OPTI-FREE® RepleniSH®, ReNu MultiPlus®,
      Solo-Care Aqua™ and MeniCareTM Soft) by observing changes within the cornea.
    

Intervention name(s): Silicone Hydrogel Contact Lens
Intervention type(s): Device
Intervention description(s): use of lens over 2 days
Other intervention name(s): Premio
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Efficacy & Safety of STG320 Sublingual Tablets of HDM Allergen Extracts in Adults and Adolescents With HDM-associated AR
Condition: Rhinitis, Allergic, Perennial; House Dust Mite Allergy
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Dust Mite Allergy
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study was to assess the efficacy and safety of 12 months of treatment
      with 300 IR of STG320 sublingual tablets compared with placebo in adults and adolescents with
      HDM-associated allergic rhinitis.
    

Detailed description: 
      This study was a randomized, double-blind, placebo-controlled, phase III study with 2
      parallel arms in adults and adolescents with HDM-associated allergic rhinitis (AR) for at
      least one year.

      The primary objective was to assess the efficacy of STG320 sublingual tablets at a daily
      dosage of 300 IR when administered for 12 months to adults and adolescents with
      HDM-associated AR. The primary efficacy variable was the average Total Combined Score.
    

Intervention name(s): 300 IR; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): 300 IR tablet of HDM Allergen Extracts; Placebo tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Long Term Follow up Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children
Condition: Growth Hormone Deficiency (GHD)
Study type: Interventional
Phase: Phase 2

Summary: 
      Protocol CP-4-004-EXT is designed as a long-term, open-label extension using single patient
      use, multi-dose, disposable pre-filled pen.
    


Intervention name(s): MOD-4023
Intervention type(s): Drug
Intervention description(s): Once weekly injection of long acting r-hGH (MOD-4023) provided as a solution for injection containing 20 or 50 mg/mL MOD-4023 in a single patient use, multi-dose, disposable pre-filled pen (PEN).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Growth hormone deficiency (GHD); r-hGH; Long-acting
Exogenous Surfactant in Very Preterm Neonates in Prevention of Bronchopulmonary Dysplasia
Condition: Infant, Premature, Diseases; Respiratory Distress Syndrome, Newborn; Bronchopulmonary Dysplasia
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Bronchopulmonary Dysplasia; Infant, Premature, Diseases; Hyperplasia
Study type: Interventional
Phase: Phase 4

Summary: 
      Advances in perinatal care have made it possible to improve the survival of the most immature
      neonates, but at the cost of an increase in the population at risk of developing
      bronchopulmonary dysplasia (BPD). Measures that have attempted to limit the development of
      BPD are not always effective, or related to major side effects. The physiopathological
      factors that are identified in BPD should, in theory, respond to surfactant. Therefore, the
      use of an exogenous surfactant in neonates presenting with pulmonary disease requiring
      mechanical ventilation, leading to a significant risk of BPD, should allow earlier extubation
      and thus promote pulmonary healing and growth.
    


Intervention name(s): Curosurf; Air
Intervention type(s): Drug; Other
Intervention description(s): 2.5 ml/kg instilled in the trachea; 2.5ml/kg of Air will be instilled in the trachea
Intervention MeSH terms: Poractant alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Very premature infant; Surfactant; Respiratory Distress; Bronchopulmonary Dysplasia
Comparison Of Different Orthodontic Aligner Systems Applied On Single Stage And Three Stage
Condition: Tooth Crowding; Tooth; Lesion, White Spot Lesions
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      Applying to the Orthodontics Department of the Faculty of Dentistry of Erciyes University for
      orthodontic treatment, a periodontally healthy 16-26 year-old periodontally healthy,
      non-congenital or congenital anomaly in the craniofacial region; 25 patients with class 1
      orthodontic malocclusion with moderate permeability will be included in the study. The
      patients will be divided into 2 groups, and the first group of 12 patients will have
      single-stage aligner; The second group of 13 patients is planned to apply 3-stage aligner.
    

Detailed description: 
      It is planned to take lateral cephalometric radiography, panoramic radiography before and
      after the orthodontic treatment, and in addition to orthodontic model and photograph records
      before, during and after the treatment. Patient comfort and satisfaction will be evaluated by
      applying questionnaires to patients before treatment, immediately after starting treatment, 2
      days later, 1 week later, 1 month later, 1 week before and after the treatment, and the
      effects of 2 different treatment methods on the patients will be evaluated according to the
      data obtained. QLF recordings are also taken at the beginning of treatment and at 3-month
      intervals, and the effects of single plaque use and 3 different plaque use on white spot
      lesion formation will be evaluated.

      Hays Nance analysis will be used in the orthodontic models to determine the change in the
      amount of perplexity. In this way, tooth movement speeds can be determined. There are studies
      in the literature with single-stage transparent plates, but there are no studies with
      different-stage plates. In our study, which of the two different types of treatment is more
      comfortable on patients and affects the movement of teeth faster; In addition, the
      investigators plan to investigate which one has a low risk of white spot lesions on the
      teeth.
    

Intervention name(s): EonAligner; Clearfix
Intervention type(s): Device; Device
Intervention description(s): EonAligner system is one stage system.; Clearfix system is three-stage system.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Epidural vs. Wound Catheter Following Liver Resection
Condition: Transplant Surgery
Study type: Interventional

Summary: 
      Good postoperative pain control after any major surgery allows early mobilization, minimises
      postoperative complications and reduces patient distress. Multiple different methods of
      delivering analgesia have been described.

      This study aims to compare postoperative pain control between patients with epidural
      analgesia versus the combination of continuous infiltration of local anaesthetic with wound
      catheters, TAP block and IV PCA with opiate analgesia following open liver resection. The
      investigators expect that pain control will be similar between the two groups but that the
      utilization of wound catheters will confer benefit due to the lack of systemic side effects
      associated with epidural analgesia
    


Intervention name(s): This arm will received perioperative transversus abdominis plane (TAP) block followed by continuous infusion of local anaestheic by wound catheters and an IV morphine PCA.
Intervention type(s): Procedure
Intervention description(s): This arm will received perioperative transversus abdominis plane (TAP) block followed by continuous infusion of local anaestheic by wound catheters and an IV morphine PCA.
Intervention MeSH terms: Morphine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Primary purpose: Other
Abdominal CT to Predict the Risk of Acute Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation
Condition: Myelodysplastic Syndromes; Leukemia, Myeloid, Acute; Leukemia, Myelogenous, Chronic; Multiple Myeloma
MeSH terms: Leukemia; Multiple Myeloma; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Myelodysplastic Syndromes; Graft vs Host Disease
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Contrast-enhanced abdominal CT will be performed 1-2 weeks after allogeneic stem cell
      transplant, and radiographic evidence of mucosal inflammation will be correlated with the
      subsequent development of acute graft versus host disease. The primary endpoint is the
      feasibility and safety of contrast-enhanced abdominal CT in the early post-transplant period,
      as defined by the risk of contrast-related nephropathy or allergic reaction.
    


Intervention name(s): Dynamic contrast-enhanced computed tomography; Ioversol
Intervention type(s): Radiation; Drug
Intervention description(s): CT scan performed between Day +7 and Day +14.; To optimize visualization of bowel mucosal, patient will be given 1350 ml, or as much as can be tolerated, of negative oral contrast to distend the small bowel one hour prior to scanning. A weight-based volume of Optiray-350 will be injected at a rate of 4 cc/sec followed by 50 cc of saline flush also at 4 cc/sec.
Other intervention name(s): CT scan with contrast; Optiray-350
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
The Effect of Nasal Carbon Dioxide (CO2) in the Treatment of Seasonal Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and effect of nasal carbon dioxide in the
      treatment of Seasonal Allergic Rhinitis
    

Detailed description: 
      This multi-center, randomized, double-blind, placebo-controlled, parallel group trial will
      evaluate the efficacy and safety of a nasal, non-inhaled administration of carbon dioxide
      (CO2) in patients with seasonal allergic rhinitis. An estimated 500 patients who meet the
      eligibility criteria will be enrolled into this study at approximately 25 sites to ensure
      that approximately 400 patients are randomized and complete the study.
    

Intervention name(s): Nasal CO2; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Twice daily during the 14 day Treatment Period; Use of the study drug dispenser at the same frequency as the active arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Randomized; Double-Blind; Multi-Center; Placebo-Controlled; Phase II; Nasal Carbon Dioxide; Carbon Dioxide; Efficacy; Safety; Total Nasal Symptom Score; RQLQ
A Trial on the Efficacy, Safety and Immunogenicity of Live-Attenuated Influenza Vaccine (LAIV)
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ⅲ Trial to
      evaluate the efficacy, safety and immunogenicity of a single dose of Live-Attenuated
      influenza Vaccine(LAIV) among healthy children and adolescents aged 3-17 years.
    

Detailed description: 
      This study is a Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase Ⅲ Trial to
      evaluate the efficacy, safety and immunogenicity of a single dose of Live-Attenuated
      influenza Vaccine(LAIV) among healthy children and adolescents aged 3-17 years old. The
      subjects will be randomized in a 1:1 ratio of LAIV to placebo. Each subject will be
      vaccinated with a single dose of LAIV or Placebo. For evaluation of efficacy, subjects
      meeting the protocol-defined clinical case definition the 14th day post-vaccination will have
      a nasal swab collected for testing by RT-PCR or virus culture for evidence of influenza virus
      infection. All adverse events will be collected 30 minutes, 0-30 days after vaccination and
      all serious adverse events during the entire trial period. Blood samples will be collected
      from a part of subjects before vaccination and at the 30th day after immunization. Serum
      samples will be centrifuged for detection of antibodies to H1N1, H3N2, and influenza B.
    

Intervention name(s): Live-Attenuated influenza Vaccine(LAIV); Placebo
Intervention type(s): Biological; Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza Vaccines; LAIV
Merimepodib (MMPD) in Triple Combination for the Treatment of Chronic Hepatitis C
Condition: Hepatitis C; Hepatitis
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is designed to test whether or not the addition of merimepodib (MMPD) to the
      standard therapy of pegylated interferon and ribavirin will result in a positive treatment
      response for people who have not previously responded to this therapy. Approximately 315
      subjects will be enrolled in this research study at approximately 55 clinical sites in the
      United States. There will be three study groups. Everyone in the study will receive Pegasys®
      (pegylated interferon) and Copegus® (ribavirin) at the normally prescribed doses. Two of the
      groups will also receive the study drug merimepodib (MMPD) twice a day, one group at each
      dose level being tested. The third group will take a placebo instead of MMPD, with the
      Pegasys® and Copegus®.

      After the first 24 weeks of treatment, blood tests will be done to see if subjects are
      responding to treatment. If they are responding, they will continue receiving study treatment
      in the study for another 24 weeks. If they are not responding, they will stop study
      treatment. Everyone who is responding will be monitored for 24 weeks after the last dose of
      medication, to see how long the response lasts.

      Evaluations will be performed during the study to look at the safety of the Pegasys®/Copegus®
      and MMPD or placebo combination, and to see how the combination is working by measuring
      Hepatitis C Virus in the blood.

      At some of the clinical sites performing the study, some subjects may also participate in
      additional testing to look at the metabolism of the drugs, or to look at the immune response
      to Hepatitis C virus infection and treatment.
    


Intervention name(s): Merimepodib; PEG-Interferon-alpha 2a (Pegasys®); Ribavirin (Copegus®)
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Hepatitis
Melatonin for Migraine Prevention
Condition: Migraine
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The circadian system with its centre in the hypothalamus is involved in migraine
      pathophysiology. Whether it plays a pivotal role is not clarified. The investigators
      postulate that a destabilized circadian system may increase migraine attack susceptibility,
      and that stabilization by supplying melatonin a migraine preventive effect will be achieved.

      A previous open label study has shown effects that certainly warrant a placebo controlled
      study.
    


Intervention name(s): melatonin
Intervention type(s): Drug
Intervention description(s): Circadin (melatonin) 2 mg ret. TAB vesp. for 8 weeks
Other intervention name(s): Circadin
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Migraine prevention; Crossover; Melatonin
Efficacy and Safety of Deep Sea Water on the Blood Glucose Level
Condition: PreDiabetes
MeSH terms: Prediabetic State
Study type: Interventional

Summary: 
      This study was conducted to investigate the effects of daily supplementation of deep sea
      water on improvement of hyperglycemia
    

Detailed description: 
      This study was a 8 weeks, randomized, double-blind, placebo-controlled, cross-over clinical
      trial.
    

Intervention name(s): Placebo; Deep sea water
Intervention type(s): Other; Other
Intervention description(s): Placeob water 440 ml/day for 8 weeks; Deep sea water 440 ml/day for 8 weeks
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention