bioihbjkbjnl/mcl2 huggingface dataset:
Effectiveness of DiscontinuinG bisphosphonatEs Study: R21 Pilot Study
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a pilot study evaluating the recruitment strategies for sites and patients, data
      collection instruments, follow-up procedures, administrative processes, and the proposed
      management strategy for the future large scale national trial.
    


Intervention name(s): Alendronate
Intervention type(s): Drug
Intervention MeSH terms: Alendronate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Increasing Uptake of Evidence-Based Screening Services Through CHW-led Multi-modality Intervention
Condition: Human Papillomavirus; Human Immunodeficiency Virus; Hepatitis C; ColoRectal Cancer
MeSH terms: Hepatitis C; Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

Summary: 
      The purpose of this research study is to determine the best way to increase screening for
      cervical cancer, colorectal cancer, HIV, and Hepatitis C among under screened Hispanic,
      Haitian and African-American individuals in Hialeah, South Dade, and Little Haiti. The
      investigator will compare home testing led by a community health worker (CHW) versus clinic
      testing guided by a CHW. Community Health Workers are people who have undergone several weeks
      of community outreach and health education training. During the study period the participant
      will continue to receive all of their regular medical care from their regular health care
      providers. If the participant does not have a health care provider, the Community Health
      Workers would be able to help in referring the participant for care at a local health care
      clinic located in their community.
    


Intervention name(s): OraQuick Swab; Fecal Immunochemical Test; OraQuick Fingerstick; Standard Screening Tests; HPV Self-Sampling Test; Home Based Screening Tests
Intervention type(s): Device; Device; Device; Other; Device; Other
Intervention description(s): OraQuick for oral fluid HIV antibody testing; Fecal Immunochemical stool test specific for human hemoglobin; Patients will be tested for Hepatitis C infection using a fingerstick; Patients will be navigated to a local health center for standard screening tests; Patients will be using swab to check for HPV infection; Patients will provided screening tests and instructed by Community Health Worker on how to perform home screening tests
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Screening
Keywords: Increased Screening Uptake; Community Health Worker; Medically Underserved
Study to Investigate the Seropersistence of TBE Virus Antibodies Approx. 3 Years After a Booster Vaccination With FSME-IMMUN 0.25 mL JUNIOR in Children
Condition: Encephalitis, Tick-borne
MeSH terms: Encephalitis, Tick-Borne; Encephalitis
Study type: Observational

Summary: 
      The objective of this study is to assess the TBE antibody persistence approximately three
      years after administration of a TBE booster vaccination with FSME-IMMUN 0.25 ml Junior in
      children who received either 0.25 mL or 0.5 mL TicoVac for their primary vaccination series
      in Study 146A.
    


Intervention name(s): Formaldehyde inactivated, sucrose gradient purified TBE virus antigen, strain Neudörfl
Intervention type(s): Biological
Intervention MeSH terms: Formaldehyde
Keywords: tick-borne encephalitis
Clearance and Pharmacokinetics of Antibiotics in Renal Replacement Therapy
Condition: Kidney Failure
MeSH terms: Renal Insufficiency
Study type: Observational

Summary: 
      This is an observational study that evaluates the dialysis clearance and pharmacokinetics of
      antibiotics with different protein-bound levels in patients receiving renal replacement
      therapy. Meropenem, vancomycin and ceftriaxone are selected to represent three typical
      protein-bound levels, and the primary dialysis methods being studied are intermittent
      hemodialysis(IHD) and hemodiafiltration(HDF). During and after the dialysis, the drug levels
      in both plasma and spent dialysate are monitored, but no changes are made to therapy. The
      study will provide detailed information on the characteristics of the removal kinetics of the
      three antibiotics during dialysis, and evaluate whether the dosing regimens are the most
      appropriate to achieve therapeutic targets while minimizing the risk of toxicity.
    

Detailed description: 
      This prospective, single-center observational study is taken to evaluate the dialysis
      clearance and pharmacokinetics of antibiotics with three different protein-bound levels in
      patients receiving renal replacement therapy. As is known that the plasma protein binding
      rate affects the distribution, metabolism and elimination of the drug in the body, and is
      also an important factor affecting the removal during dialysis, the study selects meropenem,
      vancomycin and ceftriaxone, of which the protein-bound levels are respectively 2%, 55% and
      85%, to represent three typical protein-bound levels. The primary dialysis methods being
      studied are intermittent hemodialysis(IHD) and hemodiafiltration(HDF). The dialysis pattern,
      the antibiotic choice and its dosage for each subject are made on clinical grounds. A total
      of 16 milliliters of blood and 60 milliliters of spent dialysate are collected from each
      subject for each dialysis pattern. The study will provide detailed information on the
      characteristics of the removal kinetics of the three antibiotics during dialysis, and
      evaluate whether the dosing regimens are the most appropriate to achieve therapeutic targets
      while minimizing the risk of toxicity.
    

Intervention name(s): Blood and spent dialysate collection
Intervention type(s): Other
Intervention description(s): A certain amount of blood and spent dialysate are collected during and after dialysis for quantification of drug concentration.
Intervention MeSH terms: Dialysis Solutions
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients aged from 18 to 85 years, requiring dialysis including intermittent
        hemodialysis(IHD) or hemodiafiltration(HDF), and receiving meropenem, vancomycin or
        ceftriaxone based on clinical grounds from a university-affiliated hospital in Shanghai,
        China.
      
Keywords: Kidney Failure; Pharmacokinetics; Antibiotics
A Phase 2a Study to Evaluate EDP-938 in the Virus Challenge Model
Condition: RSV Infection
MeSH terms: Infections; Respiratory Syncytial Virus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      A randomised, Phase 2a, double-blind, placebo-controlled study to evaluate the safety,
      pharmacokinetics and antiviral activity of multiple doses of orally administered EDP-938 in
      healthy subjects infected with RSV-A Memphis 37b. This study is designed to compare the
      antiviral effect of EDP-938 compared to a placebo control in the respiratory syncytial virus
      challenge model.
    


Intervention name(s): EDP-938 Dose 1; EDP-938 Dose 2; Placebo; EDP-938 Dose 3; EDP-938 Dose 4; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral suspension for 5 days; Oral suspension for 5 days; Oral suspension for 5 days; Oral suspension for 5 days; Oral suspension for 5 days; Oral suspension for 5 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: challenge study; RSV; antiviral; RSV-A Memphis 37b
The Effect of Remote Ischemic Postconditioning on Liver Graft and Renal Function in Patients Undergoing Living-related Liver Transplantation
Condition: Ischemia/Reperfusion Injury of Liver Graft; Ischemia/Reperfusion Injury of Kidney; Remote Ischemic Postconditioning
MeSH terms: Reperfusion Injury; Ischemia; Wounds and Injuries
Study type: Interventional

Summary: 
      The investigators are trying to evaluate the clinical effect of remote ischemic
      postconditioning on liver graft function and postoperative renal function in subjects
      undergoing living-donor liver transplantation.
    

Detailed description: 
      Ischemic reperfusion injury of liver graft and postoperative renal dysfunction is a common
      problem which influence poor outcome in subjects undergoing liver transplantation. The
      incidence of postoperative renal dysfunction was reported as high as 12 ~ 64% and is thought
      to be caused by ischemia/reperfusion injury. Ischemic pre- or postconditioning was reported
      to be effective for preventing ischemia/reperfusion injury during liver transplantation.
      Remote ischemic pre- or postconditioning was also reported to be protective for
      ischemia/reperfusion injury in major organs in previous animal studies. Therefore, we are
      trying to evaluate the clinical effect of remote ischemic postconditioning on liver graft
      function and postoperative renal function in subjects undergoing living-donor liver
      transplantation.
    

Intervention name(s): RIPC
Intervention type(s): Other
Intervention description(s): Those undergoing remote ischemic postconditioning. Remote ischemic postconditioning consists of three 5-min cycles of upper limb ischemia, which was induced by an automated cuff-inflator placed on the unilateral upper limb and inflated to 250 mm Hg, with an intervening 5 min of reperfusion during which the cuff was deflated.
Other intervention name(s): remote ischemic postconditioning
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: ischemia/reperfusion injury; remote ischemic postconditioning
"Safety, Tolerability and Pharmacokinetics of MP-376 Administered for 14 Days to Stable Pediatric (CF) Patients"
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory
      tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which
      has been particularly problematic to eradicate and been implicated as the major cause of
      morbidity and mortality in CF patients. Aerosol delivery of antibiotics directly to the lung
      increases the local concentrations of antibiotic at the site of infection resulting in
      improved antimicrobial effects compared to systemic administration. Bacterial resistance to
      current aerosol antibiotic treatments indicate a need for improved therapies to treat CF
      patients with pulmonary infections caused by multi-drug resistant Pseudomonas aeruginosa and
      other bacteria. High concentrations of MP-376 delivered directly to the lung are projected to
      have antimicrobial effects on even the most resistant organisms. MP-376 is a novel
      formulation of the fluoroquinolone levofloxacin that has been optimized for aerosol delivery
      using the PARI electronic eFlow® nebulizer. Preclinical and early clinical studies in adults
      show that aerosol doses of MP-376 appear to be safe and well tolerated, and exert an
      antimicrobial effect when administered once or twice daily. High concentrations of
      levofloxacin in the lung delivered using MP-376 are expected to be active against CF
      pathogens such as P. aeruginosa and S. aureus, including those resistant to aminoglycosides
      (such as TOBI®) and other inhaled antimicrobial agents. Inhaled MP-376 can be delivered
      rapidly and efficiently using the PARI eFlow® nebulizer system. This Phase 1 study is being
      performed to obtain safety, tolerability and PK data in children ages 6-16 in order to
      determine if MP-376 is safe, prior to enrolling children of these ages in the planned pivotal
      Phase 3 studies.
    

Detailed description: 
      A Phase 1B, Multi-Center, Open Label Study to Evaluate the Safety, Tolerability and
      Pharmacokinetics of MP-376 Inhalation Solution given Daily for 14 Days to Stable Pediatric
      Cystic Fibrosis Patients.
    

Intervention name(s): MP-376 (Levofloxacin solution for Inhalation)
Intervention type(s): Drug
Intervention description(s): DOSE BASED ON PATIENTS WEIGHT
Intervention MeSH terms: Levofloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Oral LAT8881 in Neuropathic Pain
Condition: Neuropathic Pain; Diabetic Peripheral Neuropathy (DPN); Post Herpetic Neuralgia (PHN)
MeSH terms: Neuralgia; Peripheral Nervous System Diseases; Neuralgia, Postherpetic
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomised, placebo-controlled, double-blind, crossover, phase IIa study to
      investigate the efficacy and safety of oral LAT8881 in neuropathic pain.
    

Detailed description: 
      This is a randomised, placebo-controlled, double-blind, crossover, phase IIa study to
      investigate the efficacy and safety of oral LAT8881 in neuropathic pain. After a one week
      baseline period, subjects entered into the study will be randomised to receive
      Investigational Medicinal Product (IMP) (LAT8881 or placebo) twice daily for four weeks.

      The first treatment period will be followed by a washout period of two weeks and then a
      second baseline period of one week. Subjects will not take any IMP over these three weeks.

      After the second baseline period, subjects will cross over to receive the second treatment
      (either LAT8881 or placebo, whichever treatment was not received in the first treatment
      period) twice daily for four weeks.

      The pharmacokinetics (PK) of LAT8881 will be investigated in 15 subjects (PK subjects) at
      selected Australian sites.
    

Intervention name(s): LAT8881; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): LAT8881 oral capsule; Placebo oral capsule
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: This is the first study with LAT8881 in subjects with neuropathic pain. As such, it has been designed to evaluate, in a well-defined patient group, the concept that LAT8881 is safe and effective in this indication.
Subjects enrolled into this study have been diagnosed with Post Herpetic Neuralgia (PHN) or Diabetic Peripheral Neuropathy (DPN), both conditions being well accepted examples of neuropathic pain. Because the pain is chronic, without a period effect, and treatment is symptomatic rather than curative, a crossover study is considered appropriate. Studies with other agents have successfully demonstrated analgesic effects in PHN and DPN with a crossover study design
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Clinical Study to Evaluate the Safety and Tolerability of BioPB-01 in Healthy Adults
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome
Study type: Interventional

Summary: 
      The present study is a randomized, placebo-controlled, parallel-group, double-blind clinical
      study. Seventy-eight individuals will be screened, and considering a screening failure rate
      of 20%, approximately 64 participants will be randomized in a ratio of 1:1 to receive either
      BioPB-01 or Placebo
    


Intervention name(s): BioPB-01; Placebo
Intervention type(s): Other; Other
Intervention description(s): 2 sachets/day, one to be taken orally with (4±1 mins prior) at breakfast and one (4±1 mins prior) at dinner; 2 sachets/day, one to be taken orally with (4±1 mins prior) at breakfast and one (4±1 mins prior) at dinner
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, double-blind, placebo-controlled, parallel-group
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Assessment of Grazax® Treatment Compliance
Condition: Allergy
MeSH terms: Hypersensitivity
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is performed to assess whether the Grazax® treatment compliance can be improved by
      use of a compliance device (Memozax®).
    


Intervention name(s): ALK Grass tablet - use of compliance device
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Allergy
Association Between Mortality and Diabetes in Elderly Koreans: the South-West Seoul (SWS) Study
Condition: Apparently Healthy Elderly People; (Between 60-92 Years of Age)
Study type: Observational [Patient Registry]

Summary: 
      Diabetes mellitus is known to increase the risk of premature death in the general population.
      In this study, the investigators examine the impact of body mass index (BMI) levels, waist
      circumference, and presence/absence of diabetes on all-cause and cardiovascular mortality in
      elderly Koreans.
    

Detailed description: 
      The investigators analyze follow-up data from the South-West Seoul (SWS) Study, a prospective
      observational cohort study of an elderly Korean population residing in Seoul, the
      metropolitan capital city of Korea.

      Briefly, the study population was selected from four urban districts (Guro, Yangcheon, Gwanak
      and Gangseo) located in the south-west area of Seoul. A total of 1737 apparently healthy
      individuals (between 60 and 92 years of age) eventually participated in this survey starting
      in 1999. A follow-up examination was performed in 2002, and an additional 873 subjects who
      had not participated in the first examination were newly recruited.

      After a median follow-up of 10 years, each subject's vital status or cause of death as of 31
      December 2011 was determined after linking these cohort data with death certificate data from
      the Korean National Statistical Office. Terminology and codes from the International
      Classification of Disease, Tenth Revision (ICD-10), were used to classify the underlying
      cause of death due to cardiovascular disease (ICD-10 codes I00-I79), cancer (ICD-10 codes
      C00-C97) and others.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Study subjects in South-West Seoul (SWS) study, a prospective observational cohort study of
        an elderly Korean population residing in Seoul, the metropolitan capital city of Korea.
First in Human Study of RVP-001, a New Manganese Based MRI Contrast Agent
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this trial are:

        1. To evaluate the safety and tolerability of single ascending doses of RVP-001 in healthy
           adult volunteers

        2. To determine the pharmacokinetics and elimination of RVP-001 in healthy adult
           volunteers.
    

Detailed description: 
      The first in human study is intended to evaluate the safety and tolerability of single
      ascending doses of RVP-001 in healthy adult volunteers, and to determine the pharmacokinetics
      and elimination of RVP-001 in healthy adult volunteers.
    

Intervention name(s): RVP-001; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous administration of RVP-001; Intravenous administration of saline placebo
Other intervention name(s): MnPyC3A; saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Comparison of Thoracic Epidural Analgesia and Intercostal Blockade in Patients Undergoing Thoracotomy
Condition: Analgesia, Postoperative
MeSH terms: Agnosia
Study type: Observational

Summary: 
      Postoperative pain is an important issue after thoracotomy operations. Thoracic epidural
      analgesia is most popular analgesic method, but sometimes it is not sufficient for pain. This
      study is designed to compare intercostal block with thoracic epidural analgesia in patients
      undergoing thoracotomy
    


Intervention name(s): epidural
Intervention type(s): Other
Intervention description(s): thoracic epidural analgesia
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients undergoing thoracotomy
Pulmonary Rehabilitation Before Lung Cancer Resection
Condition: Lung Cancer; COPD; Chronic Obstructive Lung Disease; Emphysema
MeSH terms: Lung Neoplasms; Lung Diseases; Pulmonary Emphysema; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Emphysema
Study type: Interventional

Summary: 
      This study seeks to study the effectiveness of a short mindfulness based pulmonary
      rehabilitation program prior to a surgical resection in patients with lung cancer and severe
      Chronic Obstructive Lung Disease (COPD).
    


Intervention name(s): Mindfulness Based Pulmonary Rehabilitation; Usual Care
Intervention type(s): Behavioral; Other
Intervention description(s): Participants in this group will under go 10 sessions of mindfulness based pulmonary rehabilitation prior to surgery. Each session is about 2 hours long and consists of upper /lower extremity training, breathing exercises, and education.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: COPD; Chronic Obstructive Lung Disease; lung cancer; emphysema; Pulmonary Rehabilitation