bioihbjkbjnl/mcl2 huggingface dataset:
Cetirizine Placebo Controlled Study For Perennial Allergic Rhinitis
Condition: Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 3

Summary: 
      Study objective is to verify the superiority of CTZ DS to the placebo groups in the change of
      total nasal symptom score (TNSS) over the total treatment period from the score of the
      baseline assessment period.
    


Intervention name(s): Cetirizine
Intervention type(s): Drug
Intervention MeSH terms: Cetirizine
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: Perennial Allergic Rhinitis; Placebo control; anti-histamine; Cetirizine
Evaluation of the Interaction Between Acetaminophen and Zidovudine
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional

Summary: 
      To determine if zidovudine (AZT) and acetaminophen (APAP) interact when given to the same
      patient, and if so, the manner of interaction. Patients with AIDS often require therapy with
      painkillers for the management of mild pain and discomfort associated with their disease, and
      APAP is often prescribed. AZT is being used to treat AIDS patients. It is important for
      doctors to understand how AZT and APAP may interact when given to the same patient, because
      other studies have suggested that the dosage of AZT may have to be adjusted when given with
      APAP in order to avoid or minimize adverse effects.
    

Detailed description: 
      Patients with AIDS often require therapy with painkillers for the management of mild pain and
      discomfort associated with their disease, and APAP is often prescribed. AZT is being used to
      treat AIDS patients. It is important for doctors to understand how AZT and APAP may interact
      when given to the same patient, because other studies have suggested that the dosage of AZT
      may have to be adjusted when given with APAP in order to avoid or minimize adverse effects.

      Persons who are infected with HIV and have symptoms (fever, fatigue, weight loss) of AIDS are
      eligible for the study. They will be given AZT orally every 4 hours or APAP orally every 8
      hours alone or in combination for 4 days while at home. On the 4th day, participants will be
      admitted to a clinical research center for studies to determine how they are tolerating the
      medicine. On the 5th day, any scheduled 8 am doses of AZT will be given intravenously, while
      the scheduled doses of APAP will still be given orally. Repeated blood samples will be taken
      over the next 12 hours and urine will be collected for 24 hours. The process will be repeated
      at weekly intervals for 3 weeks, so that each patient receives AZT alone, APAP alone, and the
      combination of AZT and APAP.
    

Intervention name(s): Zidovudine; Acetaminophen
Intervention type(s): Drug; Drug
Intervention MeSH terms: Acetaminophen; Zidovudine
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acetaminophen; Drug Interactions; Drug Therapy, Combination; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Zidovudine
A Phase Ⅲ Randomized Study of Mitomycin/Vindesine/Cisplatin Versus Irinotecan/Carboplatin Versus Paclitaxel/Carboplatin With Concurrent Thoracic Radiotherapy for Unresectable Stage Ⅲ Non-Small-Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate whether two weekly concurrent chemoradiotherapy regimens offer any advantage over
      concurrent chemoradiotherapy regimens with Cisplatin, Vindesine, Mitomycin for unresectable
      stage III NSCLC.
    


Intervention name(s): Cisplatin+Vindesine+MMC/ concurrent radiation; Irinotecan+Carboplatin/concurrent radiation; Paclitaxel+Carboplatin/concurrent radiation
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Paclitaxel; Vindesine; Carboplatin; Irinotecan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase 1/2a, Randomized, Double-Blind, Placebo-Controlled, Study to Assess Safety, Tolerability, PK and PD Response of PB1023 Injection Following Single and Multiple SQ Doses in Adults With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Primary objective:

      To evaluate the safety and tolerability of single and multiple ascending doses of PB1023
      administered as a subcutaneous (SC) injection in adult subjects with T2DM.

      Secondary objectives:

        1. To characterize the pharmacokinetic profile of PB1023 after single and multiple
           ascending doses of PB1023.

        2. To assess the pharmacodynamic response of various single and multiple doses of PB1023
           (daily fasting plasma glucose, and serial glucose, c-peptide and insulin levels in
           response to a liquid Mixed Meal Tolerance Test (MMTT).
    


Intervention name(s): Single Subcutaneous Dose (Part A) of PB1023 or Placebo (0.9% NaCl); Multiple (Four Weekly) Subcutaneous Injections (Part B) of PB1023 or Placebo (0.9% NaCl)
Intervention type(s): Drug; Drug
Intervention description(s): Once weekly injections for up to four weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Efficacy of AST-120 Compared to Lactulose in Patients With Hepatic Encephalopathy
Condition: Hepatic Encephalopathy
MeSH terms: Hepatic Encephalopathy; Brain Diseases
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and effectiveness of the experimental
      drug AST-120 compared to lactulose in patients with mild hepatic encephalopathy.
    

Detailed description: 
      This is a multi-center, open-label, four week trial comparing AST-120 to lactulose in
      patients with mild (Stage 1-2) hepatic encephalopathy.

      Patients will be randomized into two groups:

        -  Lactulose

        -  AST-120

      Patients meeting the inclusion criteria will take either AST-120 or lactulose for 4 weeks (28
      days). AST-120 will be distributed in 2 gram sachets to be taken four times daily. Lactulose
      will be taken in the same formulation, at the same dose and frequency as previously
      prescribed for the individual patient.

      Lactulose naïve patients who are randomized to lactulose will receive an initial dose of 30cc
      twice a day. The dose should be titrated at the discretion of the investigator until the
      patient is experiencing 2-3 soft stools per day.

      Patients randomized to AST-120 will receive 2 grams four times a day for the duration of the
      study. Titration of AST-120 will NOT be allowed.

      Patients will be evaluated throughout the study for efficacy and safety. A follow-up visit
      will be scheduled 1 week after the end of the 4 week treatment period.
    

Intervention name(s): AST-120; lactulose
Intervention type(s): Drug; Drug
Intervention description(s): AST-120; lactulose
Other intervention name(s): Chronulac, Constilac, Constulose, Duphalac, Evalose
Intervention MeSH terms: Lactulose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatic; Encephalopathy; Liver; Liver Disease; Liver Failure; Lactulose; AST-120
Affect Regulation Based on Brain-computer Interface Towards Treatment for Depression
Condition: Emotion Regulation
MeSH terms: Depression
Study type: Interventional

Summary: 
      The primary objective is to examine the feasibility and efficacy of a locally developed
      brain-computer interface (BCI) based system training for regulating mood in healthy elderly.
      The investigators hypothesize that elderly who complete the training program will be better
      at regulating emotions as compared to controls, based on their ratings of the primary outcome
      measures.
    

Detailed description: 
      In this project, we will leverage on a locally developed electroencephalograph (EEG)-based
      BCI technology for decoding affective states of the brain, and thereby develop a closed-loop
      sensing and stimulation mechanism. The technology uses advanced neural signal computing on
      the EEG in real-time and audio feedback using a machine learning model that associates
      individual user's EEG characteristics in relation to music-emotion features. The system is
      portable and will allow emotion regulation training to be done outside of hospital setting
      with ease thus potentially addressing the treatment gap for MDD in the elderly.

      This is a two group randomized study. One group will undergo the intervention which is 24
      sessions of BCI emotion regulation training (i.e. listening to music with audio feedback to
      regulate emotions towards positive affect) over an 8-week period. The control group will
      undergo 8 weeks of music sessions, without any emotion regulation training. Both groups will
      undergo pre- and post- psychometric assessments looking at cognition, quality of life,
      functioning and emotional states. This study will also carry out functional MRI of the brain
      before and after 8 weeks of either training (intervention) or music music session (control)
      to examine changes associated with the affective BCI training. Study findings derived from
      psychometric assessments, EEG analysis and neuroimaging will provide evidences on efficacy
      and usability of this technology.
    

Intervention name(s): BCI
Intervention type(s): Device
Intervention description(s): As participants listen to the music, the EEG waves of their affective states and their variations detected in real-time is converted into an auditory signal providing direct feedback to participants about their affective states and assisting participants to learn and practice emotion regulation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Validity of Bispectral Index Monitoring During Deep Sedation
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Observational

Summary: 
      During Intramuscular botulinum toxin injections for children with cerebral palsy, immobility
      is essential to inject botulinum toxin to the right muscle. Because children with cerebral
      palsy are generally unable to control their movement, deep sedation is required during this
      painful procedure.

      Short-acting drugs such as propofol and remifentanil are widely used for pediatric anesthesia
      and sedation but still have possibility of over-sedation and associated complications due to
      their rather narrow therapeutic window. Therefore, objective scoring system to assess the
      level of sedation to provide an effective and safe sedation in children. Bispectral index
      (BIS) monitoring,an objective guidance of sedation might be helpful.

      The present study is to investigate the validity of the BIS monitoring during deep sedation
      of children with cerebral palsy for injection of botulinum toxin.
    

Detailed description: 
      Intramuscular botulinum toxin injections for children with cerebral palsy have been
      extensively performed to relive spasticity and improve rehabilitation. During procedure
      immobility is essential to inject botulinum toxin to the right muscle for optimal effect.
      Because children with cerebral palsy are generally unable to control their movement, deep
      sedation is required during this painful procedure.

      Short-acting drugs with rapid, predictable onset and offset of action, such as propofol and
      remifentanil, facilitate infusion rate adjustments and rapid recovery. However, there is
      always the possibility of over-sedation, hypotension and respiratory depression due to their
      rather narrow therapeutic window.

      Several clinical sedation scales have been used to provide an effective and safe sedation in
      children. Because clinical scoring depends on patient response to verbal or physical
      stimulation, it is difficult to assess the level of sedatin in patients with deep sedation
      during delicate phase of the procedure. Bispectral index (BIS) monitoring,an objective
      guidance of sedation might be helpful. Although BIS scores in children with conscious and
      deep sedation were reported to correlate with clinical sedation scales, the validity during
      painful procedure in children with cerebral palsy was not investigated yet.

      The present study is to investigate the validity of the BIS monitoring and its correlation to
      University of Michigan sedation scale during deep sedation of children with cerebral palsy
      for injection of botulinum toxin.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        primary care clinic (rehabilitation)
      
Keywords: cerebral palsy; Botulinum toxin; Propofol; Deep sedation; Bispectral index monitor
Efficacy Analysis of Cetuximab Plus Irinotecan in Patients With Wild-type KRAS Without Regard to Epidermal Growth Factor Receptor (EGFR) Expressions
Condition: Advanced Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the response rate of cetuximab plus irinotecan
      every 2 weeks in patients harboring wild-type KRAS with and without detectable
      EGFR-expressing metastatic CRC after failure to irinotecan in an exploratory manner.
    

Detailed description: 
      Twenty patients with positive-EGFR results and 20 patients with negative-EGFR results will be
      accrued in this study. All patients should have wild-type KRAS.
    

Intervention name(s): Cetuximab, irinotecan
Intervention type(s): Drug
Intervention description(s): cetuximab, irinotecan
Other intervention name(s): PharmDx kit for EGFR staining.
Intervention MeSH terms: Irinotecan; Cetuximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Double-blind Study of Safety and Immunogenicity of Two Candidate Malaria Vaccines in Gabonese Children
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 2

Summary: 
      GSK Biologicals is developing a number of candidate malaria vaccines for the routine
      immunization of infants and children living in malaria-endemic areas. The candidate vaccines
      are designed to offer protection against malaria disease due to the parasite Plasmodium
      falciparum. Candidate vaccines containing the RTS,S antigen would also provide protection
      against infection with hepatitis B virus (HBV). This study will evaluate two candidate
      vaccines. The Protocol Posting has been updated in order to comply with the FDA Amendment
      Act, Sep 2007.
    


Intervention name(s): GSK Biologicals' candidate Plasmodium falciparum malaria vaccine 257049
Intervention type(s): Biological
Intervention description(s): 3-dose intramuscular injection, 2 different formulations
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Parasitic Diseases; Malaria, Falciparum; Malaria; Coccidiosis
Axillary Reverse Mapping for Breast Carcinomas
Condition: Axillary Dissection
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Distinct arm from breast axillary dissection (AD), or axillary reverse mapping (ARM),
      involves retrieving all breast related nodes while leaving intact the main lymphatic drainage
      chain of the upper limb. This represents a new surgical technique that is the focus of recent
      surgical interest.
    

Detailed description: 
      Distinct arm from breast axillary dissection (AD), or axillary reverse mapping (ARM),
      involves retrieving all breast related nodes while leaving intact the main lymphatic drainage
      chain of the upper limb. This represents a new surgical technique that is the focus of recent
      surgical interest. The assumption is that the sentinel node (SN) of the upper limb is
      different from the SN of the breast and that it is uninvolved after metastatic involvement of
      the axillary nodes in relation to the breast. During the ARM procedure, it is necessary to
      use an injection of a lymphatic tracer into the upper limb in order to visualize the
      lymphatic arm drainage.The ultimate goal for ARM procedure is to reduce the rate of
      lymphedema in N+ patients requiring an AD.
    

Intervention name(s): Axillary dissection for breast carcinomas
Intervention type(s): Procedure
Intervention description(s): surgery Axillary dissection
Other intervention name(s): surgery Axillary dissection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Axillary dissection
The Pharmacokinetic Interaction Between Celecoxib and Rebamipide
Condition: Healthy Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This clinical trial aims to assess the pharmacokinetic interaction between celecoxib and
      rebamipide in healthy male subjects.
    


Intervention name(s): Celecoxib; Rebamipide; Celecoxib plus Rebamipide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Celecoxib 200mg will be administered orally twice a day for 3 days; Rebamipide 100mg will be administered orally three times a day for 3 days; Celecoxib plus Rebamipide same way as "arm: celecoxib" and "arm: rebamipide"
Intervention MeSH terms: Celecoxib; Rebamipide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Eon® Flanks Safety Clinical Study Protocol
Condition: Adipose Tissue
Study type: Interventional

Summary: 
      This study is designed to provide objective evidence regarding the safety of eon® treatment
      of the flanks.
    

Detailed description: 
      This study is designed to provide objective evidence regarding the safety of eon® treatment
      of the flanks.
    

Intervention name(s): eon® FR 1064 nm device
Intervention type(s): Device
Intervention description(s): The subject will be treatment area - flanks, will be treated with the eon device.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of QGE031versus Placebo and Omalizumab in Patients Aged 18-75 Years With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study assessed the effect on asthma control of different dose levels and regimens of
      QGE031 in asthma patients that are inadequately controlled with inhaled steroid and beta-2
      agonist medication. Safety was assessed also. Comparison was to placebo and omalizumab.
      Information from this study was planned to support the design of future studies.
    


Intervention name(s): QGE031; Omalizumab; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): QGE031 was supplied as 120 mg liquid in vial per 1 mL; Omalizumab was supplied as 150 mg lyophilisate in vial; Placebo to QGE031 and Omalizumab was supplied as QGE031 0 mg in vial per 1 mL
Other intervention name(s): Xolair
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: asthma; asthma control; allergy; atopic; IgE; double-blind; placebo; omalizumab
Safety and Effect of SANGUINATE™ Infusion in Patients at Risk of Delayed Cerebral Ischemia (DCI) Following Subarachnoid Hemorrhage (SAH)
Condition: Cerebral Ischemia
MeSH terms: Subarachnoid Hemorrhage; Brain Ischemia; Cerebral Infarction; Hemorrhage; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      Safety and effect of SANGUINATE on patients DCI following SAH.
    

Detailed description: 
      The purpose of this study is to study the safety and effect of SANGUINATE on patients
      suffering from delayed cerebral ischemia after acute aneurysmal subarachnoid hemorrhage.
    

Intervention name(s): SANGUINATE™
Intervention type(s): Biological
Intervention description(s): Single infusion of SANGUINATE (pegylated carboxyhemogloblin)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: DCI; Delayed Cerebral Ischemia; SAH; Subarachnoid Hemorrhage; Aneurysmal Subarachnoid Hemorrhage; Cerebral Ischemia; Brain Ischemia
An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.
Condition: Candidiasis, Oral; HIV Infections
MeSH terms: Candidiasis; Candidiasis, Oral
Study type: Interventional

Summary: 
      To assess the efficacy and safety of itraconazole oral solution in HIV-seropositive patients
      with oropharyngeal candidiasis that is refractory to fluconazole.
    

Detailed description: 
      Patients receive itraconazole oral solution twice daily. Per 08/15/94 amendment, patients
      with complete resolution of oropharyngeal candidiasis lesions upon completion of treatment
      are eligible for maintenance treatment on protocol FDA 236C. Patients who decline maintenance
      are followed for 6 weeks. Patients who relapse during follow-up are re-treated for 14-28
      days; if lesions clear, patients may enter the maintenance protocol.
    

Intervention name(s): Itraconazole
Intervention type(s): Drug
Intervention MeSH terms: Itraconazole
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Itraconazole; Acquired Immunodeficiency Syndrome; AIDS-Related Complex; Candidiasis, Oral