bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Pharmacokinetics of BPI-9016M in Patients With Advanced Solid Tumors
Condition: Solid Tumors
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      BPI-9016M is a novel, highly potent and selective small-molecule inhibitor of c-Met/Axl
      kinase. In preclinical studies, it demonstrated strong activity in vitro and in vivo against
      c-Met/Axl kinase and its downstream signaling targets, and inhibited tumor cell growth. This
      first-in-human study is conducted to assess the maximum tolerated dose (MTD) and
      dose-limiting toxicity (DLT), to evaluate the pharmacokinetics, safety and preliminary
      anti-tumor activity of BPI-9016M with single doses and multiple doses.
    

Detailed description: 
      This is a phase Ia study, first-in-human, open-label, dose-escalation study of BPI-9016M
      administered orally once daily (QD) to patients with locally advanced or metastatic solid
      tumors.The study is designed to evaluate the safety, tolerability, and pharmacokinetics of
      single dose and multiple doses of BPI-9016M.

      All patients will be followed up for adverse events during the study treatment and 28 days
      after the last dose of study drug. Subjects of this study will be permitted to continue
      therapy only when BPI-9016M is well tolerated, and tumor response or stable disease is seen.
    

Intervention name(s): BPI-9016M
Intervention type(s): Drug
Intervention description(s): Seven dose cohorts will be evaluated, including 100mg, 200mg, 300mg, 450mg，600mg, 800mg, 1000mg. BPI-9016M will be administered orally to patients once daily for each dose cohort.
Other intervention name(s): No other name currently
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Superiority of Glimepiride Over Sitagliptin in Naive Type 2 Diabetes Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective:

      To determine the superiority of glimepiride over sitagliptin in the reduction of HbA1c after
      6 months of treatment in patients with monotherapy until the end of the trial.

      Secondary Objective:

      To evaluate the effect of glimepiride compared to sitagliptin in:

      Glucose in fasting conditions; Postprandial glucose; Percentage of patients with HbA1c < 7%
      and < 6.5%; Symptomatic Hypoglycemia; Body weight; Percentage of withdrawal and percentage of
      patients with rescue therapy; Safety (adverse events and serious adverse events,
      hypoglycemia, vital signs and laboratory results).
    


Intervention name(s): GLIMEPIRIDE (HOE490); SITAGLIPTIN
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: 2 mg and 4 mg tablets Route of administration: oral; Pharmaceutical form: 100 mg tablets Route of administration: oral
Intervention MeSH terms: Sitagliptin Phosphate; Glimepiride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prevalence of Primary Aldosteronism in Young Adults With Acute Stroke
Condition: Primary Aldosteronism
MeSH terms: Stroke; Hyperaldosteronism
Study type: Observational

Summary: 
      The guideline requires clinical works to screen for primary aldosteronism(PA) in young adults
      with family history of stroke at early onset. But the prevalence of PA in young adults with
      stroke onset before 45 years old had never been investigated. The study aimed to discover the
      prevalence as well as the clinical characteristics between patients with PA and those without
      PA during stroke attack. In order to fulfill this objective, investigators intended to
      conduct a cross-sectional study by taking screening and confirmatory tests among young adults
      who once admitted due to early onset of acute stroke.
    


Intervention name(s): screening and confirmatory tests
Intervention type(s): Other
Intervention description(s): screening test is a blood test of the ratio of plasma aldosterone concentration(PAC) and direct renin concentration(DRC), confirmatory test is Captopril Challenge test
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        patients who were once admitted in the First affiliated hospital of CQMU during Jan.2006 to
        Feb.2019 with stroke onset less than two weeks. Age between 18 to 45y.
ALLOGRAFT, A Study to Evaluate the Renal Protective Effects of Losartan (0954-222)(COMPLETED)
Condition: High Blood Pressure
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      To demonstrate that losartan (+ conventional therapy) compared to placebo (+ conventional
      therapy) will reduce the number of RT patients who experience histological lesions of chronic
      allograft nephropathy
    


Intervention name(s): losartan potassium; Comparator: Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg of oral losartan once daily, with an up-titration to 50 mg of losartan once daily in later visits if serum creatinine did not increase more than 25%. Patients take medication in the morning.; 25 mg of oral placebo once daily, with an up-titration to 50 mg placebo once daily in later visits if serum creatinine did not increase more than 25%. Patients take medication in the morning.
Intervention MeSH terms: Losartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
AZD 2066 Single Dose Formulation and Food Effect Study in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A open label two way crossover formulation and food effect study in healthy volunteers to
      assess the pharmacokinetics of a single dose of AZD2066 new oral solid formulation and an
      oral solution
    


Intervention name(s): AZD2066
Intervention type(s): Drug
Intervention description(s): single oral dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: formulation; pharmacokinetic; crossover formulation; food effect; oral solution; healthy volunteers
Healing of Burns and the Effect of Shockwave Therapy on the Recovery of Skin Grafts
Condition: Burn Wound and Skin Graft Healing
MeSH terms: Burns
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The study is to review whether musculoskeletal shockwave therapy (ESWT) can speed up the
      healing of second-degree burns as well as skin-graft donor sites.

      In both cases, the primary hypothesis is the shortened period leading up to the complete
      healing of the wound (reepithelization).

      The secondary hypothesis in the course of the study assesses:

      the rare manifestation of undesirable local events (e.g. reddening, swelling, hematoma).
    

Detailed description: 
      ESWT is administered as a one-off treatment on the wound surfaces within 24 hours of a 2nd
      degree burn trauma and immediately after an intraoperative skin graft excision procedure. A
      defocused sound head is orthogradely applied to the burn wound or the donor site. 100
      impulses/cm² is administered at 20 seconds per cm². The defocused sound head is placed on the
      wound along with a sterile gel (Lavaseptgel®, Octenidingel®) and a sterile protection foil.
      The shockwaves deployed are not at an energy density that is painful. This single application
      of ESWT is followed by routine dressing using Mepitel® in combination with
      Polyhexanid/Octenidin®.
    

Intervention name(s): extracorporeal shockwave therapy
Intervention type(s): Device
Intervention description(s): ESWT is administered as a one-off treatment on the wound surfaces within 24 hours of a 2nd degree burn trauma and immediately after an intraoperative skin graft excision procedure. A defocused sound head is orthogradely applied to the burn wound or the donor site. 100 impulses/cm² is administered at 20 seconds per cm². The defocused sound head is placed on the wound along with a sterile gel (Lavaseptgel®, Octenidingel®) and a sterile protection foil. The shockwaves deployed are not at an energy density that is painful. This single application of ESWT is followed by routine dressing using Mepitel® in combination with Polyhexanid/Octenidin®.
Other intervention name(s): ESWT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: musculoskeletal shockwave therapy
Metabolic Viral Host Properties
Condition: HCV Infection
MeSH terms: Hepatitis C
Study type: Observational

Summary: 
      Patients' metabolic properties may affect their immune response. This study aims to assess
      the effect of hosts' metabolic properties to viral infection.
    

Detailed description: 
      Blood samples were drawn from patients with Gaucher disease and healthy individuals, with and
      without HCV. Blood samples were tested for protein specific T cell proliferation, IFNg and
      IL-10 using ELISPOT assays, serum IFNg, IL-2, IL-6, IL-10 and IL-4 levels. FACS analysis was
      used for evaluation of lymphocytes subsets.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Both male and female volunteers were recruited. with and without HCV infection, with and
        without Gaucher disease.
Safety and Efficacy of Vilazodone in Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to evaluate the efficacy, safety, and tolerability of 2 fixed
      dose levels of vilazodone compared to placebo in patients with major depressive disorder.
    


Intervention name(s): Vilazodone; Placebo to citalopram; Placebo to vilazodone; Citalopram
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Vilazodone was supplied as film-coated tablets.; Placebo to citalopram was supplied as a capsule.; Placebo to vilazodone was supplied as film-coated tablets.; Citalopram was supplied as encapsulated tablets.
Other intervention name(s): Viibryd; Celexa; Celexa
Intervention MeSH terms: Dexetimide; Citalopram; Vilazodone Hydrochloride; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; Depression
A Study to Evaluate the Safety of Long Term Treatment With Teriflunomide 14 mg Once Daily in Patients With a First Clinical Episode Suggestive of Multiple Sclerosis in a Long-term Extension Period
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      National, multicenter study:

      The study consists of 3 periods:

        1. A baseline visit to confirm that patient is still in CIS status. All patients will be
           clinically evaluated for CDMS and an MRI (less than 2 months) will be analyzed to
           exclude MS patients according to 2010 Mc Donald's criteria.

        2. Treatment period with timed evaluations

        3. Post-treatment period: 4 weeks, with 2 visits following study drug discontinuation and
           accelerated elimination procedure. All patients who discontinue the study drug and
           according to investgator's decision, will perform the accelerated elimination procedure
           and the post- accelerated elimination visits (at 2 and 4 weeks after the end of
           treatment (EOT).
    


Intervention name(s): Teriflunomide
Intervention type(s): Drug
Intervention MeSH terms: Teriflunomide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Sclerosis
Safety and Tolerability Study for the Pneumococcal Conjugate Vaccine V114 Versus Prevnar™ (V114-001)
Condition: Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to evaluate the safety, tolerability, and immunogenicity of
      15-valent pneumococcal conjugate vaccine (V114) compared to Prevnar™ in healthy adults and
      toddlers.
    

Detailed description: 
      The study was extended to obtain additional sera from adult participants to support further
      development, validation, and performance of anti-pneumococcal antibody assays.
    

Intervention name(s): Prevnar™; V114, Aluminum Adjuvanted; V114, Aluminum Nonadjuvanted
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each), serotype 6B (4.4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.; 15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2.0 mcg each), serotype 6B (4.0 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.; 15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2.0 mcg each), serotype 6B (4.0 mcg) in each 0.5 mL dose.
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Pneumococcal vaccines
Effect Of Methylphenidate On Balance In Children With Attention Deficit Hyperactivity Disorder
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      Attention Deficit Hyperactivity Disorder is a neurodevelopmental disorder that may have poor
      motor coordination and balance control. The effect of Methylphenidate treatment on balance
      and fall risk is still unclear. This study aimed to evaluate the effect of methylphenidate
      (MPH) treatment on balance, fall risk, and sensorimotor integration in children with
      Attention Deficit Hyperactivity Disorder (ADHD).
    

Detailed description: 
      Children who were diagnosed with ADHD for the first time were classified in the ADHD group
      (n=33), children with ADHD who were treated with MPH for a minimum of 3 months were
      classified in the treatment group (n=32), and typically developing children were classified
      in the third-the control group (n=20) in this observational cross-sectional study. Fall risk,
      static postural balance and sensorimotor integration were assessed using the Biodex Balance
      System.Postural stability tests, including overall stability index (OSI), anterior-posterior
      stability index (APSI), and medial-lateral stability index (MLSI), were used to evaluate
      postural control. The Modified Clinical Test of Sensory Interaction in Balance (m-CTSIB)
      testing protocol was used to evaluate sensory integration capabilities and balance. Fall risk
      was evaluated by biodex balance system.
    

Intervention name(s): Fall risk
Intervention type(s): Device
Intervention description(s): Fall risk, static postural balance and sensorimotor integration were assessed using the Biodex Balance System.
Other intervention name(s): static postural balance; sensorimotor integration (m-CTSIB) test
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        All children who were diagnosed with ADHD for the first time according to the Diagnostic
        and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V, American Psychiatric
        Association, 2013) were classified in the ADHD group (n=33), children with ADHD who were
        treated with MPH for a minimum of 3 months and were followed-up at our clinic were
        classified in the treatment group (n=32), and typically developing children were classified
        in the third-the control group (n=20) in this observational cross-sectional study.
      
Keywords: Attention Deficit Hyperactivity Disorder; Methylphenidate; Postural Balance
Efficacy and Safety Study of Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Adults With Influenza
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      This Phase 2 protocol is designed to compare two dose levels of laninamivir octanoate versus
      placebo. The objectives are to obtain safety and efficacy in adults aged 18 to 64 years who
      present to clinic with symptomatic presumptive influenza A or B infection.
    

Detailed description: 
      Approximately 636 subjects will be randomized into the Study.

      Following confirmation of circulating influenza in the local area, eligible subjects with
      recent onset of symptomatic presumptive influenza A or B infection will be enrolled in the
      study. Subjects must be randomized within 40 hours of the first symptom onset. Subjects will
      be randomized to placebo, 40 or 80 mg of laninamivir octanoate.

      The study will be conducted on an outpatient basis. The first dose of study drug will be
      administered via inhalation within 4 hours of randomization in the clinic, followed by a
      second dose at home. Participants will be followed for 14 days to assess efficacy, virology
      and safety. Outpatient visits to the investigational site are scheduled on Days 2 (optional
      PK Sub-study Visit) 3, 5, 8, 15. An End of study visit will be performed on Day 29.
    

Intervention name(s): 40 mg Laninamivir Octanoate; 80 mg Laninamivir Octanoate; Placebo
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): CS-8958; CS-8958; Lactose
Intervention MeSH terms: Laninamivir; Zanamivir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Influenza Laninamivir Octanoate
Study of Prasugrel in Korean Healthy Male Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate how the body processes prasugrel and how
      prasugrel affects blood clotting in healthy Korean men. Three different dosing regimens of
      prasugrel will be given. Information on side effects will also be collected.
    


Intervention name(s): Prasugrel
Intervention type(s): Drug
Intervention description(s): Tablets orally
Other intervention name(s): LY640315; Effient; Efient; Prasita
Intervention MeSH terms: Prasugrel Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Multi-media Health Education on Nurses' Workload and Patient's Satisfaction
Condition: Health Education
Study type: Interventional

Summary: 
      Assessing whether multi-media health education reduce nurse workload and does not decrease
      the satisfaction of patients in surgical ward when admission.
    

Detailed description: 
      Operation usually causes severe physical and mental stress to the patients, mainly because of
      fear and anxiety caused by patients worrying about the uncertainty about surgery, and finally
      affecting the patient's surgical efficacy and recovery. This is the main reason in terms of
      surgical nurse workload is much more than those internal medicine nurse.

      As a major part of nursing work, health education has especially important to patients. The
      quality and efficiency of health education directly affects the rehabilitation of patients.
      It can help patients correctly understand the relevant knowledge of disease and master the
      skills of recovery.

      At present, the health education in surgery department is mainly carried out by oral
      face-to-face communication and guidance from admission nurses. This kind of education method
      showed time-consuming and laborious.In addition, oral guidance is more reliable on nurse
      ability of expression and acknowledgement. Multimedia-based health education is an update
      mode combined with audio-visual stimulation and patients' own participation. Mobile terminal
      makes patient more acceptable, flexible, standardized in receiving the health education
      during hospitalization. This prospective study is aimed to assess whether multimedia-video
      education could reduce nurse workload and do not decrease the satisfaction of surgical
      patients.
    

Intervention name(s): Multimedia video health education
Intervention type(s): Other
Intervention description(s): The experimental group conducted multimedia video education while admission.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Nurse; Workload; Multimedia; Patients Satisfaction; Surgery; Health Education
Effect of Soymilk Replacement on Anthropometric and Blood Pressure Value
Condition: Weight; Waist; Systolic Blood Pressure; Diastolic Blood Pressure
MeSH terms: Systolic Murmurs
Study type: Interventional
Phase: Phase 4

Summary: 
      Soymilk components such as isoflavones, essential fatty acids, phytoesterols, good fats,
      inositols might have beneficial effects on weight control and blood pressure management. Most
      studies in this regard have been conducted on postmenopausal or premenopausal women and there
      are few studies on female youths. Therefore, we are going to determine the effects of soy
      consumption on the weight, waist circumference and blood pressure in overweight and obese
      female youths. This was a cross-over randomized clinical trial which was conducted in 2010 in
      Isfahan on overweight or obese young female youths. After three weeks run-in, females were
      randomly assigned to consume a diet containing caw's milk or a diet in which only one glass
      of soy milk was substituted; each one for six weeks. Random sequencing generated in SPSS was
      used for allocating females in different group randomly. Patients were not blinded because
      they had to use soy milk in one period of trial and use caw's milk in another period.
    


Intervention name(s): soy milk, Caw's milk
Intervention type(s): Dietary Supplement