bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Ezetimibe Added On to Rosuvastatin Versus Up Titration of Rosuvastatin in Patients With Hypercholesterolemia (MK0653-139)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      A study to evaluate the low-density lipoprotein cholesterol (LDL-C) lowering efficacy of the
      addition of ezetimibe to rosuvastatin compared with doubling dose of rosuvastatin in
      participants treated with rosuvastatin alone and not at their National Cholesterol Education
      Program Adult Treatment Panel III (NCEP ATP III) LDL-C goal
    


Intervention name(s): Comparator: rosuvastatin 5 mg + ezetimibe 10 mg; Comparator: rosuvastatin 10 mg; Comparator: rosuvastatin 10 mg + ezetimibe 10 mg; Comparator: rosuvastatin 20 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 5 mg rosuvastatin for an additional 6 weeks.; Participants who received open label rosuvastatin 5 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 10 mg once daily for 6 additional weeks.; Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received 10 mg ezetimibe tablets once daily plus 10 mg rosuvastatin for an additional 6 weeks.; Participants who received open label rosuvastatin 10 mg tablets once daily for 4 to 5 weeks then received rosuvastatin 20 mg once daily for 6 additional weeks.
Other intervention name(s): Crestor, Zetia; Crestor; Crestor, Zetia; Crestor
Intervention MeSH terms: Rosuvastatin Calcium; Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study To Compare The Amount Of CP-690,550 That Is Absorbed Into The Blood Of Healthy Subjects Following Oral Administration Of Two Different Strength Tablets Of CP-690,550
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study, a 5 mg dose of CP-690,550 will be given to study subjects on two separate
      occasions using one of two different strength tablets each time. The amount of CP-690,550
      available in the blood following administration of each tablet will be measured and compared.
      The overall aim of the study is to establish that a similar amount of CP-690,550 is absorbed
      into the blood following administration of the same dose of each different strength tablet .
    

Detailed description: 
      This is a bioequivalence study for CP-690,550.
    

Intervention name(s): Treatment A; Treatment B; Treatment B; Treatment A
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Single oral dose of 5 mg CP-690,550 administered as five 1 mg tablets (Phase 2B tablets); Single oral dose of 5 mg CP-690,550 administered as one 5 mg tablet (Phase 2B tablet); Single oral dose of 5 mg CP-690,550 administered as one 5 mg tablet (Phase 2B tablet); Single oral dose of 5 mg CP-690,550 administered as five 1 mg tablets (Phase 2B tablets)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence; healthy volunteer study; Rheumatoid Arthritis
Pulmonary Function Test, Bronchial Hyperresponsiveness and Quality of Life in Patients With Vocal Cord Dysfunction (VCD)
Condition: Dyspnea
MeSH terms: Dyspnea; Bronchial Hyperreactivity; Vocal Cord Dysfunction
Study type: Observational

Summary: 
      Vocal cord dysfunction is a rare clinical picture. It is labeled as a sudden and threatening
      dyspnea. Patients with VCD may also present cough, hoarseness, wheezing, and chest tightness,
      but an inspiratory stridor is the most common symptom. For this reason, such patients are
      often misdiagnosed with refractory asthma, because of poor response to steroids and
      bronchodilators. Diagnosis is suspected on clinical grounds and is confirmed with
      laryngoscopy. The therapy consists of education, speech therapy and if necessary
      psychotherapy. The purpose of the investigators' study is to characterize children,
      adolescents, and young adults with VCD, and the evaluation of predictors as atopy, bronchial
      hyperresponsiveness, and psychiatric features.
    

Detailed description: 
      VCD appears to be significantly more common among females. The episode of dyspnea underlies
      the paradoxical, intermittent adduction of the vocal cords during inspiration. Methacholine
      challenge testing combined with laryngoscopy is useful in differentiating vocal cord
      dysfunction from asthma during the asymptomatic period.

      In one visit patients will be characterized with a questionnaire based on the ISAAC
      questionnaire. Furthermore, FeNO, eCO, skin prick testing and total serum IgE will be
      examined. The psychiatric condition of patients will be determined by CBCL/6-18 and YSR/11-18
      behavior questionnaires. After initial fiberoptic laryngoscopy and pulmonary function
      testing, bronchoprovocation is performed using nebulized methacholine at increasing doses,
      until a 20% decline in the forced expiratory volume in 1 second is achieved (PD20FEV1). Each
      methacholine testing will be followed by a second laryngoscopy and pulmonary function
      testing. The visualization of paradoxical vocal cord motion during inspiration will be
      recorded.
    

Intervention name(s): Methacholine challenge testing; Rhino-laryngoscopy
Intervention type(s): Other; Procedure
Intervention description(s): Nebulized methacholine administered at the following doses: 0,1 mg/0,4 mg/0,8 mg/1,6 mg; Topical anesthesia (Xylocain Pump spray) followed by transnasal fiberoptic laryngoscopy with a flexible fiberoptic laryngoscope.
Other intervention name(s): Aerosol Provocation System (Cardinal Health GmbH); ENF-V2 laryngoscope Olympus
Intervention MeSH terms: Methacholine Chloride
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Outpatients of departement of Pediatric Pulmonology and Allergology.
      
Biospecimen description: 
      Serum, total IgE
    
Keywords: Vocal cord dysfunction; Laryngoscopy; Methacholine challenge; Pulmonary function testing
Music's Effects on Premature Babies.
Condition: Stress; Sleep
Study type: Observational

Summary: 
      This project is being done in order to determine if the music of Mozart will have a soothing
      effect on premature infants while in the neonatal intensive care unit (NICU). The primary
      effect to be anticipated will be a reduction in heart rate from baseline, decreased motor
      activity from baseline, as well as an increase of time in which the babies are in quiet sleep
      states while the music is being played.

      Upon admission, all infants in the NICU are placed on monitors that continuously track their
      heart rate, respiratory rate, and oxygen saturation. During our study, data will be collected
      from the monitors already in use. Total time of observation will be approximately 3 hours. In
      addition, a monitoring device called an Actiwatch will also be used. This device looks
      similar to a traditional wristwatch and will be loosely strapped to the ankle or wrist of
      each infant using a foam and velcro strap. This device continuously monitors the baby's
      movements allowing us to determine if there is a change in the baby's activity level while
      the music is being played. It will record the baby's activity prior to the start of the music
      and will continue until 30 minutes after the music has stopped.

      The music of Mozart will be played using a small speaker in the baby's isolette. The volume
      of the music will be set at 10 decibels over background noise, which on previous measurement
      has been found to be approximately 55 decibels (about the same as a running refrigerator or
      as the sound of rainfall; 60 decibels is the volume of normal conversation). The volume in
      the crib will be continuously monitored throughout the hour. As a final recording device, we
      will also intermittently be using video to capture the reactions of these infants to the
      music. The study will be done once a week per infant on the same day and at the same time
      every week
    


Intervention name(s): Music
Intervention type(s): Behavioral
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Premature infants
Immunogenicity and Safety of FluBlok Trivalent Recombinant Hemagglutinin Influenza Vaccine in Healthy Pediatrics
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study was to evaluate dose-related safety, reactogenicity and
      immunogenicity of FluBlok trivalent recombinant baculovirus-expressed hemagglutinin influenza
      vaccine, administered to healthy children aged 6 to 59 months.
    

Detailed description: 
      Influenza has been identified as a major health problem in young children. Influenza related
      hospitalizations are very high in children less than 24 months of age and children age 24-59
      months have a high rate of medical care utilization due to influenza. Recently, it has been
      noted that there are deaths attributable to influenza even in previously healthy children.
      Recent CDC recommendations reflect this growing awareness of the impact of influenza in
      children and state that virtually all children less than 18 years of age should receive
      annual influenza vaccination.

      Currently available licensed trivalent influenza vaccines (TIVs) are prepared from viruses
      that are grown in embryonated hens' eggs. Alternative substrates for vaccine production are
      desirable in order to reduce the vulnerability of and to expand influenza vaccine supply.
      Recombinant DNA techniques allow for expression of the influenza hemagglutinin (rHA) by
      baculovirus vectors in insect cell cultures. Advantages of this technique include speed of
      production, absence of egg protein, and a highly purified product.
    

Intervention name(s): Influenza Vaccination; Influenza Vaccination
Intervention type(s): Biological; Biological
Intervention description(s): 0.5mL dose for intramuscular injection; 0.25mL dose for intramuscular injection
Other intervention name(s): FluBlok; Fluzone; rHA; rHA0; recombinant hemagglutinin; TIV; FluBlok; Fluzone; rHA; rHA0; recombinant hemagglutinin; TIV
Intervention MeSH terms: Hemagglutinins
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza
Bioequivalence and Food Effect Bioavailability Study of Lumacaftor Film-Coated Tablets
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to assess bioequivalence of lumacaftor from Lumacaftor 200 mg
      Film-Coated Tablet Formulation (Qanatpharma) versus the reference commercial product,
      Lumacaftor 200 mg /Ivacaftor 125 mg Combination Film-Coated Tablet (Orkambi®) in the fed
      state, and food-effect bioavailability of Lumacaftor 200 mg Film-Coated Tablet Formulation
      (Qanatpharma) in the fasted and fed state in healthy, non-smoking, male and non-pregnant
      female volunteers, 18 to 55 years of age, inclusive.
    

Detailed description: 
      This single-dose, randomized, open-label, three-way crossover, three-period, three-sequence,
      three-treatment, single-centre, bioequivalence and food-effect study will compare lumacaftor
      from Lumacaftor 200 mg Film-Coated Tablet test formulation and the commercial product,
      Lumacaftor 200 mg/Ivacaftor 125 mg Combination Film-Coated Tablet (Orkambi®) under fed
      conditions, and food-effect bioavailability study of Lumacaftor 200 mg Film-Coated Tablet
      test formulation from fasted to fed state.

      The products will be studied using a crossover design with 39 healthy, non-smoking male and
      non-pregnant female volunteers being administered an oral dose of 1 x (2 x lumacaftor 200 mg)
      under fasted and fed conditions and 1 x (2 x lumacaftor 200 mg/ ivacaftor 125 mg) under fed
      conditions. There will be at least a 14-day washout period between the study periods to avoid
      carry-over effects of the preceding treatments.

      This study is being conducted to support development of a lumacaftor mono-substance treatment
      for improving cerebral blood flow.
    

Intervention name(s): Lumacaftor 200 mg/Ivacaftor 125 mg Film-Coated Tablet; Lumacaftor 200 mg Film-Coated Tablet Formulation
Intervention type(s): Drug; Drug
Intervention description(s): Film-coated tablet administered orally.; Film-coated tablet administered orally.
Intervention MeSH terms: Ivacaftor
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: lumacaftor; cystic fibrosis transmembrane regulator-corrector; CFTR-corrector; food effect; healthy volunteers; cerebral blood flow; CBF
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of OZ439 in Healthy Male and Female Subjects
Condition: Malaria Falciparum; Malaria Vivax; Healthy Volunteers
MeSH terms: Malaria; Malaria, Falciparum
Study type: Interventional
Phase: Phase 1

Summary: 
      OZ439 is a synthetic trioxolane that has potential value as a peroxide antimalarial agent.

      This was a Phase I, single-centre, multi-component, double-blind, randomised,
      placebo-controlled study in healthy male and female subjects. The study was conducted in 3
      parts:

        -  Part A investigated the safety, tolerability and pharmacokinetics (PK) of single oral
           escalating doses of OZ439. Up to 6 dose levels will be investigated to estimate dose
           proportionality.

        -  Part B, the effect of food on a single oral dose of OZ439 was investigated in a 2-way
           crossover design.

        -  Part C investigated the safety, tolerability and PK profile of multiple oral doses of
           OZ439.

      The starting oral dose was 50 mg and the maximum single dose to be administered did not
      exceed 1600 mg per subject. The maximum duration of dosing proposed was 3 days.
    


Intervention name(s): OZ439 50mg API capsules; OZ439 200mg API capsules; OZ439 400mg aqueous dispersion; OZ439 800mg aqueous dispersion; OZ439 100mg API capsules; OZ439 400mg API capsules; OZ439 1600mg aqueous dispersion; OZ439 800mg API capsules; OZ439 1200mg API capsules; Placebo; OZ439 200mg aqueous dispersion
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): OZ439 100mg (2x50mg API capsules); OZ439 400mg (2x200mg API capsules); OZ439 800mg (4x200 API capsules); OZ439 1200mg (6x200mg API capsules)
Other intervention name(s): OZ439; OZ439; OZ439; OZ439; OZ439; OZ439; OZ439; OZ439; OZ439
Intervention MeSH terms: Artefenomel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Phase I; Safety and tolerability; Pharmacokinetic; synthetic peroxide; trioxolane; treatment of erythrocytic stages of malaria
Vitamin and Asthma Study
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      The study looks at how vitamin D supplement will improve the severity of asthma and lung
      function as well as biomarkers in asthmatic children.
    


Intervention name(s): Vitamin D
Intervention type(s): Drug
Intervention description(s): Vitamin D 2000 IU daily pill Vitamin D 400 IU daily pill
Intervention MeSH terms: Vitamin D
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma; Pulmonary Function Test; Vitamin D
A Study of the Safety and Efficacy of Combination Therapy With Morphine, Phenylephrine and Sorbitol in Human Subjects
Condition: Acute Pain
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Efficacy and Safety of the combined oral adjuvants phenylephrine and sorbitol on oral low
      dose morphine analgesia.
    

Detailed description: 
      The primary objective of this study is to determine the efficacy of the combined oral
      adjuvants phenylephrine and sorbitol on oral low dose morphine analgesia.
    

Intervention name(s): Morphine; Morphine; Sorbitol+Phenylephrine; Sorbitol+Phenylephrine+Morphine; Sorbitol low concentration+Phenylephrine+Morphine
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Morphine; Morphine low dose; Sorbitol+Phenylephrine; Sorbitol+Phenylephrine+Morphine; Sorbitol low concentration+Phenylephrine+Morphine
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Morphine; Sorbitol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of Paliperidone Palmitate 6-Month Formulation
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to demonstrate that injection cycles consisting of a single
      administration of paliperidone palmitate 6-month (PP6M) are not less effective than 2
      sequentially administered injections of paliperidone palmitate 3-month PP3M) (350 or 525 mg
      eq.) for the prevention of relapse in participants with schizophrenia previously stabilized
      on corresponding doses of paliperidone palmitate 1-month (PP1M) (100 or 150 mg eq.) or PP3M
      (350 or 525 mg eq.).
    

Detailed description: 
      The primary hypothesis of this study is that the efficacy of PP6M is non-inferior to PP3M for
      preventing relapse in participants with schizophrenia who were previously stabilized on
      corresponding doses of PP1M or PP3M. The study consists of mainly 3 phases: a screening phase
      (up to 28 days), a maintenance phase (of 1 or 3 months), and a double-blind phase (of 12
      months [neither the researchers nor the participants know what treatment the participant is
      receiving]). Additional/conditional phases include a transition phase (before maintenance
      phase). Study evaluations include efficacy, pharmacokinetics, pharmacodynamics, and safety.
      The study duration will vary from approximately 13 months to 19 months.
    

Intervention name(s): PP6M; PP3M 350 mg eq.; PP3M 525 mg eq.; PP1M; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Other
Intervention description(s): Participants will receive intramuscular injection of PP6M.; Participants will receive intramuscular injection of PP3M 350 mg eq.; Participants will receive intramuscular injection of PP3M 525 mg eq.; Participants will receive intramuscular injection of PP1M 50 to 150 mg eq.; Participants will receive matching placebo.
Other intervention name(s): R092670; R092670; R092670; R092670
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A 6 Week Study to Determine the Effectiveness of R228060 in Adult Subjects With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to determine the effectiveness of 2 target doses of
      R228060 in comparison with placebo during 6 weeks of treatment in moderately to severely
      depressed adult subjects with major depressive disorder.

      Approximately 488 subjects will be involved in the study.
    


Intervention name(s): R228060; Placebo and Paroxetine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Paroxetine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
An Efficacy and Safety Evaluation of Nasacort AQ in Children Ages 2-5 Years With Perennial Allergic Rhinitis
Condition: Rhinitis, Allergic, Perennial
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
Study type: Interventional
Phase: Phase 3

Summary: 
      The purposes of this study are:

        -  To demonstrate the efficacy of once daily administration of Nasacort AQ 110 µg compared
           with placebo in children 2-5 years of age with perennial allergic rhinitis; and

        -  To assess the safety of Nasacort AQ 110 µg in children 2-5 years of age.
    


Intervention name(s): Triamcinolone
Intervention type(s): Drug
Intervention MeSH terms: Triamcinolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: allergic rhinitis
Combination of Cryosurgery and NK Immunotherapy for Recurrent Sarcoma
Condition: Recurrent Adult Soft Tissue Sarcoma
MeSH terms: Sarcoma
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to
      recurrent sarcoma.
    

Detailed description: 
      By enrolling patients with recurrent sarcoma adapted to enrolled criteria, this study will
      document for the first time the safety and the short and long term efficacy of the combined
      therapy using cryosurgery and natural killer (NK) cells.

      The safety will be evaluated by statistics of adverse reactions. The efficacy will be
      evaluated according to local relief degree, progress free survival (PFS) and overall survival
      (OS).
    

Intervention name(s): Cryosurgery; NK immunotherapy
Intervention type(s): Device; Biological
Intervention description(s): Percutaneous ablation under CT or ultrasound guidance; Each treatment: 8-10 billion cells in all, transfuion in 3 times, i.v.
Other intervention name(s): Argon-helium cryosurgical system
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sarcoma; Cryosurgery; NK Immunotherapy