bioihbjkbjnl/mcl2 huggingface dataset:
Study Of An NK-1 Anti-Emetic Medication For The Prevention Of Post-Operative Nausea And Vomiting In Female Patients
Condition: Postoperative Nausea and Vomiting; Nausea and Vomiting, Postoperative
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the effectiveness of this medication in preventing
      nausea and vomiting in female patients at risk for post-operative nausea and vomiting (PONV).
    

Detailed description: 
      A Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Group,
      Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Oral (25 mg) and
      Intravenous (3 mg and 18 mg) Formulations of the Neurokinin-1 Receptor Antagonist, GW597599,
      When Administered with Intravenous Ondansetron Hydrochloride for the Prevention of
      Post-operative Nausea and Vomiting and Post-discharge Nausea and Vomiting in Female Subjects
      with Known Risk Factors for PONV Who are Undergoing Surgical Procedures Associated with an
      Increased Emetogenic Risk
    

Intervention name(s): GW597599
Intervention type(s): Drug
Intervention MeSH terms: Vestipitant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: post-operative nausea and vomiting; PONV
Monoclonal Antibody Therapy Plus Sargramostin in Treating Patients With Advanced Neuroblastoma
Condition: Neuroblastoma
MeSH terms: Neuroblastoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver
      tumor-killing substances to them without harming normal cells. Combining colony-stimulating
      factors, such as sargramostim, with monoclonal antibodies may be an effective treatment for
      advanced neuroblastoma.

      PURPOSE: Phase II trial to study the effectiveness of monoclonal antibody 3F8 plus
      sargramostim in treating patients who have advanced neuroblastoma.
    

Detailed description: 
      OBJECTIVES:

        -  Define the antitumor effects of monoclonal antibody 3F8/sargramostim (3F8/GM-CSF) in
           patients with advanced neuroblastoma.

        -  Assess the biological effects of 3F8/GM-CSF in these patients.

      OUTLINE: Patients receive monoclonal antibody 3F8 IV over 1.5 hours on days 0-4 and 7-11 and
      sargramostim (GM-CSF) IV over 2 hours on days -5 to 11. Treatment is repeated every 4 weeks
      for up to 4 courses in the absence of progressive disease, HAMA response, or unacceptable
      toxicity.

      PROJECTED ACCRUAL: A total of 11-40 patients will be accrued for this study over 4 years.
    

Intervention name(s): monoclonal antibody 3F8; sargramostim
Intervention type(s): Biological; Biological
Intervention MeSH terms: Antibodies; Antibodies, Monoclonal; Sargramostim
Primary purpose: Treatment
Keywords: recurrent neuroblastoma
Transducer Selection in the Speed and Quality of Image Acquisition in FAST Exams
Condition: Diagnostic Abdominal Ultrasonography; Trauma Injury
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The Focused Assessment of Sonography for Trauma (FAST) is a rapid point-of-care ultrasound
      exam performed on blunt and penetrating trauma patients who are too critically injured to be
      transported to a CT scanner. Low-frequency ultrasound is used to image the abdomen and
      pericardium in these patients, using either a curvilinear transducer or a phased-array
      transducer. Whether the use of one transducer or the other is better for this application is
      not well studied. In this study, physician ultrasound operators will perform the FAST exam on
      healthy non-injured volunteers to determine if the speed or quality of images between the two
      transducer types is different.
    

Detailed description: 
      The Focused Assessment of Sonography for Trauma (FAST) is a rapid point-of-care ultrasound
      exam performed on blunt and penetrating trauma patients who are too critically injured to be
      transported to a CT scanner. In performing this exam, time to acquisition of adequate images
      is crucial to clinical decision-making as patients undergoing this exam have a high
      probability of deteriorating if not intervened on appropriately.

      Low-frequency ultrasound is used to image the abdominal cavity and pericardium in these
      patients, using either a curvilinear transducer or a phased-array transducer. Both of these
      transducers are capable of acquiring the images necessary to interpret a FAST exam, but it
      has not been well studied whether using one transducer instead of the other improves time to
      image acquisition or image quality.

      In this study, physician ultrasound operators are asked to perform FAST exams on healthy
      non-injured volunteers for the purpose of determining if there is a difference in the time to
      acquisition or quality of images between phased-array and curvilinear transducers.
    

Intervention name(s): Focused Assessment of Sonography for Trauma Exam
Intervention type(s): Diagnostic Test
Intervention description(s): Speed and image quality of ultrasound exams performed with either transducer specified in the arms.
Other intervention name(s): FAST exam; Abdominal sonography; Abdominal ultrasonography
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: ultrasonography; FAST exam; Focused assessment of sonography for trauma; Transducer selection
Phase 2b Booster Vaccination (TURKOVAC) Against COVID-19
Condition: COVID-19; Sars-CoV-2 Infection
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is open-label, two arms, multi-centered, phase 2b clinical trial to determine the
      efficacy, safety, and immunogenicity of booster vaccination (TURKOVAC) against Covid-19.

      The primary aim of the study is to evaluate the efficacy of a booster dose of TURKOVAC
      vaccine administered to subjects who have passed at least 90 days and at most 240 days after
      the second dose of the first course of Comirnaty (Code name: BNT162b2) vaccine.
    

Detailed description: 
      This phase 2b study aims to determine the efficacy, safety, and immunogenicity of a booster
      dose of TURKOVAC vaccine administered to subjects who have passed at least 90 days and at
      most 240 days after the second dose of the first course of Comirnaty (Code name: BNT162b2)
      vaccine.

      Efficacy will be evaluated by spike-specific antibody response and neutralizing antibody
      levels on days 0, 28 (all subjects), 48, 84 and 168 days (50% of subjects).

      For the booster dose, subjects will be assigned open-label according to randomization (1:1)
      for 2 different arms. Comparing the efficacy, safety, and immunogenicity results of different
      series of TURKOVAC vaccines (TURKOVAC-Koçak and TURKOVAC-Dollvet) produced in different
      production facilities are the secondary objectives of the study.

      The booster dose vaccine arms are as follows:

        -  TURKOVAC-Koçak

        -  TURKOVAC-Dollvet
    

Intervention name(s): TURKOVAC-Dollvet; TURKOVAC-Koçak
Intervention type(s): Biological; Biological
Intervention description(s): TURKOVAC-Dollvet vaccines produced by Dollvet Veterinary Vaccine Pharmaceutical Biological Substance Production Industry Co., Ltd.; TURKOVAC-Koçak vaccines produced by Koçak Farma Pharmaceutical and Chemical Industry Co., Ltd.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: National, Open-Label, Two Arms, Multi-Centered, Phase 2b Clinical Trial to Determine the Safety, Efficacy, and Immunogenicity of Booster Vaccination (TURKOVAC) Against SARS-CoV-2
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: COVID-19; SARS-CoV-2 Vaccine; Booster; Efficacy; Immunogenicity; Safety
Catabolic Marker Levels After Platelet Poor Plasma (PPP) Lavage
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to understand how the components of osteoarthritic knee joint
      fluid (synovial fluid) change after lavage treatment with platelet poor plasma. Additionally,
      the study participants will complete outcome questionnaire surveys before and after the
      treatment in conjunction with when synovial fluid is removed from the knee (2, 4, and 6 weeks
      after lavage). This data will help determine if the treatment of an osteoarthritic knee joint
      with platelet poor plasma lavage is a suitable stand-alone therapy or to improve outcome by
      preparing a patient's knee for further regenerative therapies.
    

Detailed description: 
      The objective of this study is to quantify the levels of catabolic markers in osteoarthritic
      (OA) knee synovial fluid microenvironment (ME) before lavage treatment with platelet poor
      plasma (PPP) and to determine whether the anti-catabolic capabilities of the PPP are
      sustainable or if the diseased synovial fluid returns to pre-lavage catabolic marker levels
      within the 6 week period of the study.

      This data will be used to determine if treatment of a diseased (OA) knee with PPP lavage
      would be a suitable therapy for knee OA patients either as a stand-alone treatment or to
      improve outcome by preparing a patient's knee microenvironment for further treatment with
      cellular therapies. Incidence of post-operative complications, adverse events, re-injections,
      and surgical intervention; change in pain score will be considered while determining these
      direct and indirect associations upon completion of the PPP lavage treatment. Correlation of
      subject reported clinical outcomes for the PPP lavage treatment will be evaluated to
      determine whether the treatment provides beneficial clinical outcomes.
    

Intervention name(s): Lavage with Platelet Poor Plasma (PPP)
Intervention type(s): Biological
Intervention description(s): Lavage of 50cc PPP
Intervention model: Single Group Assignment
Intervention model description: Lavage with platelet poor plasma
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Knee OA; lavage; Platelet Poor Plasma (PPP)
Effects of Testosterone and Fat Utilization
Condition: Healthy; Volunteers
Study type: Interventional

Summary: 
      Evidence is accumulating that there are sex differences in energy and substrate metabolism.
      The positive or negative consequences of such metabolic differences between men and women
      need to be evaluated with respect to health outcomes. The importance of aberrant lipid
      metabolism in metabolic diseases such as obesity, diabetes and cardiovascular disease, makes
      understanding the distinction between "normal" vs aberrant critical to future treatment and
      prevention strategies. Sex differences in the effects of catecholamines on lipid metabolism
      and substrate oxidation in non-obese, healthy individuals, have been consistently observed.
      In addition, distinct differences in men and women exist in the distribution of body fat,
      with men typically having greater central adiposity than women. Accumulation of fat in the
      abdomen is associated with an increased risk for metabolic abnormalities such as
      hyperlipidemia and insulin resistance. In the current study, therefore, the role of
      testosterone in determining the sex differences in catecholamine mediated substrate
      metabolism and deposition of dietary fat into upper versus lower body adipose tissue depots
      will be addressed.
    


Intervention name(s): GnRH antagonist; Aromatase Inhibitors; Testosterone gel
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Testosterone; Aromatase Inhibitors
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis
Condition: Hyperparathyroidism, Secondary; Kidney Failure, Chronic
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients with chronic kidney disease and end stage renal disease have greater cardiovascular
      risk than the general population. Vitamin D analogues have been shown in observational
      studies to have mortality benefit for these patients. This study is designed to investigate
      doxercalciferol's effect on the vasculature (i.e. endothelial cell function) as a possible
      mechanism to explain the mortality benefit.
    


Intervention name(s): doxercalciferol
Intervention type(s): Drug
Intervention MeSH terms: 1 alpha-hydroxyergocalciferol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Response to SLT vs. ALT in Patients Under 60 Years of Age
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional

Summary: 
      Laser trabeculoplasty is a routine treatment for glaucoma and can be performed with either
      argon (ALT) or selective Yag (SLT) lasers. The effectiveness of each has not been studied in
      patients under 60 years, which is younger than average for the procedure. The study
      hypothesis is that there will be no difference between the two laser types.
    

Detailed description: 
      Forty-two young patients (age 29 to 60) had one eye randomized to ALT (n = 22) or SLT (n =
      20). Intraocular pressure was measured prior to laser and 1 hour, 1 day, 6 weeks, 3 months,
      every 3 months until 2 years, and then yearly post-laser. χ2 analysis and student's t-test
      were used to determine statistical significance.
    

Intervention name(s): Argon laser trabeculoplasty; Selective laser trabeculoplasty
Intervention type(s): Procedure; Procedure
Intervention description(s): Argon laser 600-800 mW, 0.1seconds, 50 micron spot size, 45 - 55 burns over 180 degrees of trabecular meshwork; Selective laser trabeculoplasty 0.7 - 0.8 mJ, 400 micron spot size, 3 nanosecond, 45 - 55 burns over 180 degrees of trabecular meshwork.
Other intervention name(s): ALT; SLT
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Glaucoma; laser trabeculoplasty; intraocular pressure
A Phase I Safety and Immunogenicity Trial of UBI Microparticulate Monovalent HIV-1 MN Peptide Immunogen in HIV-1 Seronegative Human Subjects
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and immunogenicity of a new microparticulate formulation of an HIV-1
      MN PND peptide for oral administration in healthy, HIV-1 seronegative adult volunteers at low
      risk for infection.

      Vaccine formulations of synthetic peptides adsorbed to alum may not provide other requisite
      characteristics of an effective HIV vaccine, such as induction of mucosal immunity,
      production of cytotoxic T cells, and ease of administration. An oral microparticulate vaccine
      containing a prototype synthetic peptide has been developed. The microparticles can be
      degraded over time, inducing both secretory and systemic immune responses.
    

Detailed description: 
      Vaccine formulations of synthetic peptides adsorbed to alum may not provide other requisite
      characteristics of an effective HIV vaccine, such as induction of mucosal immunity,
      production of cytotoxic T cells, and ease of administration. An oral microparticulate vaccine
      containing a prototype synthetic peptide has been developed. The microparticles can be
      degraded over time, inducing both secretory and systemic immune responses.

      Twelve volunteers per dose regimen will receive oral microparticulate multivalent HIV-1
      peptide vaccine at months 0, 1, and 6, either daily as a low dose for 3 days or a single
      higher dose. Additionally, four volunteers per regimen will receive placebo. Volunteers are
      followed for 1 year. They will be contacted once or twice yearly for 5 years to check on
      health status.
    

Intervention name(s): HIV-1 Peptide Vaccine, Microparticulate Monovalent
Intervention type(s): Biological
Masking: Double
Primary purpose: Prevention
Keywords: Vaccines, Synthetic; HIV-1; Administration, Oral; AIDS Vaccines; HIV Seronegativity; HIV Preventive Vaccine
Comparison of Vibrating Mesh Nebulizer Versus Jet Nebulizer in the Pediatric Asthma Patient
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The purpose of this study is to compare clinical outcomes related to the current practice of
      using a jet nebulizer (JN) with aerosol mask (AM) or mouthpiece (MP) versus a vibrating mesh
      nebulizer (VMN) with a valved-mask (VM) or MP in the treatment of acute moderate to severe
      asthma in Children's Medical Center Dallas Emergency Department (CMCED).
    

Detailed description: 
      The purpose of this study is to compare clinical outcomes related to the current practice of
      using a jet nebulizer (JN) with aerosol mask (AM) or mouthpiece (MP) versus a vibrating mesh
      nebulizer (VMN) with a valved-mask (VM) or MP in the treatment of acute moderate to severe
      asthma in Children's Medical Center Dallas Emergency Department (CMCED). The investigators
      hypothesize that using the combination of a VMN and VM or MP will result in fewer hospital
      admissions and decrease length of stay in CMCED when compared to the current practice of
      using a JN and AM or MP.
    

Intervention name(s): Jet Nebulizer; Vibrating Mesh Nebulizer
Intervention type(s): Device; Device
Intervention description(s): Standard single patient-use small volume JN (AirLife™ Sidestream® High-Efficiency Nebulizer, CareFusion, Yorba Linda, CA); Vibrating Mesh Nebulizer (Aerogen® Solo with Ultra adapter, Aerogen Ltd, Galway, Ireland)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Patient Experience of Consent for Cancer Surgery in Light of Recent Changes to UK Law- a Questionnaire Study
Condition: Patient Satisfaction
Study type: Observational

Summary: 
      Since the 2015 Montgomery vs Lanarkshire Health Board ruling, the consent process in the UK
      has had to change. In practice, this means that doctors must ask themselves whether the
      patient knows about the material risks of the treatment being proposed, alternatives to the
      treatment, and whether reasonable care has been taken to ensure the patient actually knows
      this. This study aims to determine patients' perspectives of consent for major cancer surgery
      in light of the Lanarkshire ruling.
    

Detailed description: 
      A patient satisfaction survey was administered to patients who had undergone urological,
      gynaecological, colorectal, and plastic surgical procedures at a specialised cancer centre
      where changes to consent processes in light of the Lanarkshire ruling had been implemented.
    

Intervention name(s): Survey
Intervention type(s): Other
Intervention description(s): Patients were given a questionnaire/survey to complete in respect of their satisfaction of the consent process for their surgical procedure
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patients undergoing surgery during a 6 week period at The Christie NHS Foundation Trust
Meperidine as the Single Sedative Agent During Esophagogastroduodenoscopy
Condition: Esophagogastroduodenoscopy
Study type: Interventional

Summary: 
      Upper endoscopy is uncomfortable for most patients. Meperidine has both sedative and
      analgesic effects, so its use may be helpful for patients receiving upper endoscopy.
    

Detailed description: 
      Unsedated esophagogastroduodenoscopy (EGD) is a useful tool for upper gastrointestinal tract
      examination and therapy, but it is uncomfortable for many patients. Meperidine has been
      widely used in colonoscopic examination for many years; however, its use in EGD has not been
      completely evaluated.
    

Intervention name(s): Meperidine; normal saline
Intervention type(s): Drug; Drug
Intervention description(s): intramuscular, 25 mg, 5 to 10 minutes before EGD; 25 ml of normal saline, intramuscular, 5 to 10 minutes before EGD
Intervention MeSH terms: Meperidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: meperidine; esophagogastroduodenoscopy; unsedated; minimal sedation
Bioavailability Study of Fixed Dose Combination (FDC) Formulations of Dapagliflozin and Metformin XR Versus Individual Component Coadministered to Healthy Subjects in a Fasted State
Condition: Type 2 Diabetes Mellitus (T2DM)
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the relative bioavailability of dapagliflozin and metformin from the two FDC
      formulations, comprised of 10 mg dapagliflozin and 1000 mg metformin XR, relative to
      coadministration of a dapagliflozin 10 mg tablet and 2 x 500 mg Glucophage® XR tablets, in
      healthy subjects in a fasted state.
    


Intervention name(s): Dapagliflozin; Metformin XR; Glucophage
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablets, Oral, 10 mg, Single Dose; Tablets, Oral, 1000 mg, Single Dose; Tablets, Oral, 1000 mg, Single Dose
Other intervention name(s): Glucophage™
Intervention MeSH terms: Metformin; Dapagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Assessment of Three Basic Progressive Lens Designs
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional

Summary: 
      This clinical trial investigates the differences between three different progressive addition
      lens designs. It is a non-invasive double-masked randomized clinical investigation. For this
      study, 80 participants will be recruited.
    

Detailed description: 
      The purpose of the study is to evaluate the preference, adaptability, and visual performance
      of three progressive lens designs. The difference in these lens designs is a variation of
      zone sizes for intermediate and near vision. The clinical trial helps manufacturers and eye
      care practitioners to give detailed suggestions to patients. Study participants will be
      experienced progressive addition lens wearers, which will be recruited by advertisements, by
      email, and with direct person-to-person solicitation. The study will be conducted at the Eye
      Care Institute at the Patient Care Center Western University of Health Sciences, Pomona, CA,
      91766. For each participant, the study is completed in around two months and requires three
      separate visits.
    

Intervention name(s): Progressive Additional Lenses (PAL), pre calibrated and made of polymeric material with anti-reflection coating
Intervention type(s): Device
Intervention description(s): Subjects will be wearing three different PAL designs with different geometries of the optical progression.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment