bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy Study of JTT-851 in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the effect of JTT-851 on diabetes as well as to
      assess the safety, tolerability, and pharmacokinetics of JTT-851 in type 2 diabetic patients
      either treated with metformin or treatment-naïve.
    

Detailed description: 
      This is a randomized, double-blind, double-dummy, placebo and active-controlled
      (glimepiride), multi-center, parallel-group study to investigate the effect of JTT-851 on
      HbA1c and other ancillary efficacy parameters and to assess the safety, tolerability, and
      pharmacokinetics of JTT-851 in inadequately-controlled treatment-naïve or metformin-treated
      type 2 diabetic patients.
    

Intervention name(s): JTT-851; Glimepiride; Placebo for Active; Placebo for comparator
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Encapsulated Glimepiride tablets
Intervention MeSH terms: Glimepiride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes
Ceftazidime-Avibactam Compared With Doripenem Followed by Oral Therapy for Hospitalized Adults With Complicated UTIs (Urinary Tract Infections)
Condition: Complicated Urinary Tract Infection (cUTI) Including Acute Pyelonephritis
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections; Pyelonephritis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effects of Ceftazidime Avibactam compared to
      Doripenem for treating hospitalized patients with complicated urinary tract infections,
      including acute pyelonephritis
    

Detailed description: 
      A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group, Comparative
      Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam (CAZ-AVI,
      formerly CAZ104) Versus Doripenem Followed by Appropriate Oral Therapy in the Treatment of
      Complicated Urinary Tract Infections, Including Acute Pyelonephritis, With a Gram Negative
      Pathogen in Hospitalized Adults
    

Intervention name(s): Ceftazidime - Avibactam ( CAZ-AVI); Doripenem; Either switch to oral therapy: 500 mg of Ciprofloxacin (oral); or switch to oral therapy: 800 mg/160 mg of sulfamethoxazole/trimethoprim (oral)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Ceftazidime 2000 mg and 500 mg of avibactam. Patients randomized to receive CAZ-AVI will receive an infusion of CAZ-AVI (2000 mg ceftazidime and 500 mg avibactam) every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 120 minutes; 500 mg of Doripenem. Patients randomized to receive Doripenem will receive an infusion of Doripenem 500 mg every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 60 minutes; Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement; Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement
Intervention MeSH terms: Ciprofloxacin; Ceftazidime; Avibactam; Doripenem; Trimethoprim, Sulfamethoxazole Drug Combination; Trimethoprim; Sulfamethoxazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ceftazidime, Avibactam, Doripenem, Ciprofloxacin, sulfamethoxazole/trimethoprim, Anti-Infective Agents, Complicated Urinary Tract Infection,Acute Pyelonephritis
Age-related Changes in Posture Control and Cortex Activity Under a Dynamic Perturbation
Condition: Aging
Study type: Observational

Summary: 
      With aging, the elderly decreased ability to control postural balance will be accompanied by
      increased risk of falling (Berg et al, 1992;. Tinetti et al, 1988). According to previous
      studies, it showed that the elderly over 65 years fall each year probability was 30 %, and it
      increased with age (Skelton, & Todd, 2004). In view of this, age-related posture control has
      become important issues of modern preventive medicine and family care.
    

Detailed description: 
      Many clinical studies have been developed assessment tools and measurements for clinical
      staff to provide balanced assessment and intervention. However, the factors of affecting
      postural control are diverse and complex, not all tools or measurement could effectively
      detect a risk of falling. In daily living, the postural control involved integration of
      sensation, biofeedback, movement response, and kinesthetic sense to maintain postural
      stability, and finally integrated into the neuromuscular system and coordination to help
      achieve the perfect postural control. Current clinical tools used to assess the fall or
      research methods to detect the incidence of falls and the lack of effective relevant and
      contradictory, and it's difficult to effectively evaluate the risk of falls (Gates, et al,
      2008).

      With the development of postural balance issues associated with aging process in older
      people, there is no set of standardized equipment, and lack of effective methods for the
      assessment of normal and older people who fall. In response to these problems, if we can
      provide a virtual reality interfaces, and with daily living activities as gait, across
      obstacles activity, sit to stand, will be able to better meet the desire to explore the issue
      of real significance to enhance researchers for aging, motion analysis, and brain cortex
      activity mechanism in postural control mechanism.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The volunteers from the community will be recruited in this study, the inclusion criterion
        contained: able to walk and climb the stairs without assistive devices, could follow the
        instructions, and without well-known balance related diseases or impairments. With the
        disease of cardiac and pulmonary system, neuromusculoskeletal system, vision, vestibular
        apparatus, dizziness experience or cognitive deficit would be excluded the study.
      
Keywords: aging of elderly; falling prevention; electroencephalography; postural control; biomechanics
Safety, Tolerability, and Blood Levels of Ritonavir-Boosted Atazanavir and Rifampin When Taken Together in HIV Uninfected Adults
Condition: HIV Infections; Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional

Summary: 
      Rifampin (RIF) is used for the treatment of tuberculosis (TB), an infectious disease that
      affects many people with HIV. RIF was shown to lower concentrations and decrease the
      effectiveness of some anti-HIV drugs, including the HIV protease inhibitor (PI) atazanavir
      (ATV) boosted with ritonavir (RTV). The purpose of this study is to determine the
      interactions between RTV-boosted ATV and evaluate the safety and tolerability of giving these
      drugs together in HIV uninfected adults.
    

Detailed description: 
      TB is common in resource-limited countries, and people infected with HIV are especially at
      risk for TB infection. The antituberculous drug RIF lowers plasma concentrations of PIs by
      increasing the activity of enzymes responsible for PI breakdown. RIF has been shown to reduce
      PI effectiveness, a particular concern for HIV infected patients who are also being treated
      for TB. RTV has been shown to delay the plasma clearance of ATV and increase the plasma
      half-life of ATV. This study will evaluate the safety, tolerability, and pharmacokinetic (PK)
      interactions of RTV-boosted ATV, taken concurrently with RIF in HIV uninfected people.

      Medical and medication history, a complete physical exam, blood collection, and an
      electrocardiogram (ECG) will occur at screening. Participants will be enrolled in this study
      for 41 to 58 days; there will be 3 dosing periods. From Days 1 to 8, participants will
      receive 600 mg RIF every 24 hours. From Days 9 to 19, participants will receive 300 mg ATV
      and 100 mg RTV every 12 hours and 600 mg RIF every 24 hours. From Days 20 to 27, participants
      will receive 400 mg ATV and 100 mg RTV every 12 hours and 600 mg RIF every 24 hours. Study
      visits will occur at entry; at Days 5, 8, 11, 14, 19, 23, and 27; and at an additional visit
      between Days 41 and 48. Blood and urine collection will occur at all visits. A targeted
      physical exam, an ECG, and blood collection for PK analysis will occur at Days 8, 19, and 27.
    

Intervention name(s): Atazanavir; Rifampin; Ritonavir
Intervention type(s): Drug; Drug; Drug
Intervention description(s): From Days 9 to 19, participants will receive a 300 mg tablet orally daily. From Days 20 to 27, participants will receive a 400 mg tablet orally daily.; From Days 1 to 27, participants will receive a 600 mg tablet orally daily.; From Days 9 to 19, participants will receive a 100 mg tablet orally daily. From Days 20 to 27, participants will receive a 100 mg tablet orally twice daily.
Other intervention name(s): ATV; RIF; RTV
Intervention MeSH terms: Ritonavir; Atazanavir Sulfate; Rifampin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV Seronegativity; Antitubercular agents
The Impact of Texas Senate Bill 42 on Middle School Children's Level of Physical Activity
Condition: Obesity; Body Weight
MeSH terms: Body Weight
Study type: Observational

Summary: 
      The purpose of this study was twofold: 1) to assess awareness of and adherence to Texas SB42
      among a representative sample of public middle schools in Texas; and 2) to assess the impact
      of SB42 on the frequency of school PE class, the quality of school PE, and prevalence of
      child self-reported physical activity behaviors and child overweight along the Texas-Mexico
      border.
    

Detailed description: 
      Childhood overweight is a significant public health issue in Texas. In response to this
      problem, the 79th Texas legislature passed Senate Bill 42 (SB 42), which promotes healthier
      school environments in middle schools, in June, 2005. As a result of SB 42, all Texas public
      middle schools must require students to engage in at least 30 minutes of daily physical
      activity or a total of 135 minutes of physical activity per week, beginning in the 2006-2007
      school year. The purpose of this study was to determine the barriers and facilitators of
      implementation and the ultimate impact of this mandate on school PE, child physical activity,
      and child overweight in Texas public middle schools, and specifically among children living
      in the Lower Rio Grande Valley (LRGV) of South Texas. Questionnaires with key informants
      (school principals, PE teachers, and school district PE and health education directors) were
      conducted in a random sample of middle schools to assess the implementation of SB 42
      (2006-2007). In addition, a more detailed evaluation of SB 42 was accomplished with a
      representative sample of middle schools in the LRGV, a low-income Latino area of the state.
      Measurements in the LRGV schools included observed and measured child physical activity,
      self-reported physical activity behaviors, and child overweight (BMI).
    

Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        There are 1,224 school districts and 1,159 public middle schools in the state of Texas. Of
        all Texas students, 43% are Hispanic, 14% are African American, 40% are White, and 3% are
        other. Additionally, 51.8% are considered economically disadvantaged. PHR 11 covers a large
        area of the LRGV (along the Texas/Mexico border), and including 50 school districts and 485
        public schools. Within PHR 11, 84.5% of children are considered economically disadvantage
        and more than 90% are Latino).
      
Keywords: coordinated school health; school health policy evaluation; physical activity
Safety, Tolerability and Pharmacokinetics of KBP-7072
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the
      safety, tolerability and pharmacokinetics of a single dose of KBP-7072 following oral single
      ascending dose administration and with an open label food effect panel.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the
      safety, tolerability and pharmacokinetics of a single dose of KBP-7072 following oral single
      ascending dose administration and with an open label food effect panel.

      Part 1: A total of 40 subjects will be evaluated with 30 subjects randomized to receive
      active drug and 10 subjects randomized to receive placebo in a double-blind fashion (eight
      subjects in each dose cohort, six subjects randomized to active drug and two subjects
      randomized to placebo). 5 dose levels will be evaluated. Extensive PK samplings will be
      collected after dosing (pre-dose (within 30 min prior to dosing) and at 0.5, 1, 2, 4, 6, 10,
      12, 18, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216 and 240 hr post-dose).

      Part 2: A separate panel of 6 subjects will receive a single dose of KBP-7072 under fed
      conditions. The dose tested in Part 2 will be determined based on the safety, tolerability
      and PK data available from Part 1. Extensive PK samplings will be collected after dosing
      (pre-dose (within 45 min prior to dosing) and at 0.5, 1, 2, 4, 6, 10, 12, 18, 24, 36, 48, 72,
      96, 120, 144, 168, 192, 216 and 240 hr post-dose).

      Safety assessments will include monitoring of adverse events (AEs), vital signs (blood
      pressure, pulse rate, respiratory rate and oral temperature), clinical laboratory findings,
      12-lead electrocardiograms (ECGs), and physical examination findings.
    

Intervention name(s): KBP-7072; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): KBP-7072; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Safety; tolerability; pharmacokinetics; KBP-7072
CKD-391 Pharmacokinetic Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A randomized, open-label, 2-way crossover study to compare the pharmacokinetics and safety
      CKD-391 to coadministration Atorvastatin and Ezetimibe in health volunteers.
    

Detailed description: 
      To compare the CKD-391 (Experimental product) to the dose Atorvastatin calcium and Ezetimibe
      combination in health male subjects is the purpose of this trial.

      Following are evaluated in this trial; Characteristics and safety/Tolerability Of CKD-391.
    

Intervention name(s): CKD-391; Atrovastatin and Ezetimibe combination therapy
Intervention type(s): Drug; Drug
Intervention description(s): Investigational product is prescribed to all of radomized subjects for two times.; Investigational products are prescribed to all of radomized subjects for two times.
Intervention MeSH terms: Ezetimibe
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dyslipidemia; CKD-391; Atorvastatin; Ezetimibe
A Single-Blind, Placebo-Controlled, Dose-Ranging Trial of Oral HDV-Insulin in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Study type: Observational

Summary: 
      A study designed to determine the appropriate doses of Oral HDV Insulin at meal times.
    


Observational model: Cohort
Time perspective: Prospective
Study population: 
        Have a current diagnosis of type 2 DM, which is currently managed with oral hypoglycemic
        agents for at least 3 months
      
Keywords: Diabetes; Type 1 and Type 2 Diabetes
Placebo Effects on Blood Pressure Induced by Expectancy Manipulation
Condition: Blood Pressure
Study type: Interventional

Summary: 
      The objective of the present study was to examine the effects of a single placebo
      intervention on blood pressure and to investigate autonomic and psychological mediating
      mechanisms.
    


Intervention name(s): Placebo globuli; Histaminum hydrochloricum globuli
Intervention type(s): Drug; Drug
Intervention description(s): placebo globuli administered together with verbal suggestions of a hypotensive drug effect
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Omalizumab Use and Asthma-Related Quality of Life in Patients With Severe Persistent Allergic Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      This study investigated asthma-related quality of life in Brazilian patients using
      omalizumab.
    


Intervention name(s): Omalizumab; Inhaled corticosteroids (ICS); Long-acting beta 2-adrenergic agonist (LABA); Short-acting beta 2-adrenergic agonist (SABA)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Omalizumab 150 to 375 mg was administered subcutaneously every 2 or 4 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of IgE.; Any ICS with proprietary drug and device > 500 mcg of fluticasone or equivalent; Fixed dose of LABA as prescribed prior to study entry; Home use of nebulized Β2-agonist such as salbutamol 5 mg or terbutaline 10 mg for symptoms of intercurrent bronchospasm.
Other intervention name(s): Xolair; salbutamol; terbutaline
Intervention MeSH terms: Omalizumab; Terbutaline; Adrenergic Agents; Adrenergic Agonists
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma, anti-immunoglobulin E, omalizumab
Dexmedetomidine and Laparoscopic Surgery
Condition: Anesthesia Complication
Study type: Interventional

Summary: 
      Conventionally General anaesthesia remains the choice for the majority of open abdominal
      surgical procedures, and regional anaesthesia is preferred only for patients who are at high
      risk under general anaesthesia . The main reason for selecting spinal anaesthesia as the
      first choice for laparoscopic cases was its advantages over general anaesthesia which include
      uniform total muscle relaxation, a conscious patient, economical, relatively uneventful
      recovery, pain free early postoperative period and the protection from potential
      complications of general anaesthesia. The main debatable point, however, seems to be the
      status of respiratory parameters among the two modes of anaesthesia during laparoscopic
      surgery. In this context it can be stated that spontaneous physiological respiration during
      spinal anaesthesia would always be better than an assisted respiration as in general
      anaesthesia.

      The pneumo-peritoneum induced rise in intra-abdominal pressure including pressure on the
      diaphragm and carbon dioxide induced peritoneal irritation are the factors to be considered
    


Intervention name(s): Normal saline; Dexmedetomidine
Intervention type(s): Drug; Drug
Intervention description(s): intravenous flluid; anaesthetic adjuvants and pain killer medication.
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Efficacy of LASIK Versus PRK in Asians With Mild and Moderate Myopia
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      Laser in situ keratomileusis (LASIK) and photorefractive keratectomy (PRK) are currently the
      2 main refractive surgeries to correct myopia which are being performed worldwide, with more
      patients preferring LASIK to PRK because of better comfort and faster rehabilitation.
      However, in post-LASIK patients, there is a low risk of flap dislodgement. This risk
      increases with certain occupations which have a higher risk of trauma. Hence, there may be a
      role for PRK for people which such occupations, e.g. soldiers, parachutists, sportsman.

      There are several non-randomised studies which show that PRK is as efficacious, predictable
      and safe as LASIK for low to moderate myopes. But there have been only a few randomized
      controlled studies to compare the efficacy and safety of the 2 treatment modalities and all
      studies comparing LASIK and PRK suffer from a high dropout rate during the follow-up period.
      We compared the efficacy, predictability, stability and safety of LASIK versus PRK over a one
      year duration with almost 100% attendance during all follow-up visits.
    

Detailed description: 
      This study is a prospective, randomized, clinical trial comparing the efficacy,
      predictability, stability and safety of LASIK versus PRK in a volunteer group of myopic
      military servicemen recruited from the Singapore Armed Forces. 132 subjects who were eligible
      for the study were randomized to undergo either LASIK or PRK in both eyes in a 2:1 ratio. 45
      subjects (90 eyes) underwent PRK and 87 subjects (174 eyes) underwent LASIK.

      An additional 59 subject underwent a non-randomised arm of the study and underwent PRK.
    

Intervention name(s): Laser in Situ Keratomileusis (LASIK); Photorefractive Keratectomy (PRK)
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: LASIK; PRK; Myopia
A Phase II Study Looking at Moderate to Severe Osteoarthritis Knee Pain
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to look at the effects of RN624 on moderate to severe knee pain
      due to osteoarthritis. This study will look at the safety and pain relieving effects of RN624
      compared to placebo over a 4 month period.
    


Intervention name(s): RN624 (PF-04383119); RN624 (PF-04383119); RN624 (PF-04383119); RN624 (PF-04383119); RN624 (PF-04383119); placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 10 mcg/kg; 25 mcg/kg; 50 mcg/kg; 100 mcg/kg; 200 mcg/kg
Intervention MeSH terms: Tanezumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: osteoarthritis monoclonal antibody