bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Vitamin D on Endothelial Function and Blood Biomarkers Including CD28 Null Cells in CKD
Condition: CKd Patients With Stage 3 and 4
Study type: Interventional
Phase: Phase 3

Summary: 
      Vitamin D deficiency is common in CKD and assciated with CV complications. Endothelial
      dysfucntion is common in CKD and is a harbinger of atherosclerosis. The study investigated
      the impact of Vitamin D on endothelial fucntion and blood biomarkers in CKD.
    


Intervention name(s): Cholecalciferol
Intervention type(s): Drug
Intervention MeSH terms: Cholecalciferol; Vitamin D
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetic, Safety/Tolerability Study of a Single SC Dose of PB1023 Injection in Subjects With Normal and Impaired Renal Function
Condition: Diabetes Mellitus, Type 2
MeSH terms: Renal Insufficiency; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objective:

      To compare the pharmacokinetic profile of Glymera (PB1023) Injection after a single dose
      administered by subcutaneous injection to subjects with normal renal function and impaired
      renal function.

      Secondary objectives:

      To evaluate the safety and tolerability of Glymera (PB1023) Injection administered as a
      subcutaneous injection in adult subjects with normal renal function and impaired renal
      function.
    


Intervention name(s): PB1023 Injection
Intervention type(s): Drug
Intervention description(s): 90 mg Dose
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase II Study of Adenovirus/PSA Vaccine in Men With Hormone - Refractory Prostate Cancer
Condition: Hormone Refractory Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This investigational study involves treatment with an Ad/PSA vaccine for men with prostate
      cancer who present with evidence of hormone refractory metastatic disease.
    

Detailed description: 
      Subjects in this trial will be eligible if they have recent evidence of hormone refractory
      disease (D3) and either (a) have a positive bone scan or a positive CT scan (with obvious
      soft tissue metastasis or lymph nodes >1 cm), with a PSA doubling time of >/= 12 months, a
      total PSA of < 5 mg/ml, and are asymptomatic; or (b) have a negative bone scan with any PSA
      doubling time, are asymptomatic, and are not a candidate for chemotherapy.

      This is a virus vaccine in which the gene for prostate specific antigen (PSA) has been placed
      into a common cold virus termed adenovirus (Ad) to produce this Ad/PSA product. The purpose
      of this study is to determine whether vaccination with the Ad/PSA vaccine will induce an
      anti-PSA immunity that will result in the destruction of the remaining prostate cancer cells.

      Subjects will be vaccinated three times, each injection administered at 30-day intervals.
      Based upon our earlier clinical trial, the vaccine is considered safe and should not induce
      any major side effects. The investigators hope that vaccination with this PSA virus will
      cause the body to produce immunity to the PSA and that immunity will destroy any cell that
      produces PSA. Since the only cells left in the body that produce PSA will be the cancer
      cells, the investigators propose that the vaccination and ensuing anti-PSA immunity will kill
      the prostate cancer cells. Importantly, this treatment should not cause any major side
      effects as would treatment with anti-cancer drugs.
    

Intervention name(s): ADENOVIRUS/PSA VACCINE
Intervention type(s): Biological
Intervention description(s): 1x10E8 pfu in Gelfoam subcutaneously on days 0, 30, 60
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: prostate cancer; vaccine; immunotherapy
Phase 2 Study in Vascular Inflammation on Patients After an Acute Coronary Syndrome Event
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome; Inflammation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the effect of VIA-2291 as compared to placebo on
      vascular inflammation following 24 weeks of dosing.
    

Detailed description: 
      The effect of VIA-2291 on vascular inflammation will be assessed through 18FDG PET vascular
      imaging measurements and various biomarkers after 24 weeks.
    

Intervention name(s): VIA-2291; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg, oral dosing, 1 time daily for 24 weeks; oral dosing, 1 time daily for 24 weeks
Intervention MeSH terms: Atreleuton
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Atherosclerosis
Ropivacaine and Bupivacaine in Sphenopalatine Ganglion Block in Sinus Surgery
Condition: Functional Endoscopic Sinus Surgery (FESS)
MeSH terms: Ganglion Cysts
Study type: Interventional
Phase: Phase 3

Summary: 
      Postoperative analgesia after FESS can be achieved through opioids, NSAIDs, topical or
      infiltration of local anaesthetic and regional techniques like sphenopalatine ganglion (SPG)
      block, infraorbital nerve block and nasociliary block. As the current evidences regarding the
      benefit of SPG block after FESS is controversial, efficacy of sphenopalatine ganglion block
      will be evaluated using bupivacaine or ropivacaine as local anaesthetic in adult patients
      undergoing FESS under general anaesthesia in this study.
    

Detailed description: 
      Functional endoscopic sinus surgery (FESS) is a minimally invasive and safe technique for the
      treatment of sinonasal disease. Although it is a minimally invasive and less traumatic
      procedure, it is usually associated with pain of mild to moderate intensity which reaches its
      maximum level in the first few postoperative hours. However, even low-level postoperative
      pain may be associated with delayed functional recovery and it frequently contributes to
      dissatisfaction with the procedure delay in return to work and readmission after surgery.
      Postoperative analgesia after FESS can be achieved through opioids, NSAIDs, topical or
      infiltration of local anaesthetic and regional techniques like sphenopalatine ganglion (SPG)
      block, infraorbital nerve block and nasociliary block. As the sensory innervations of the SPG
      supplies the nasal turbinates, nasopharynx and palate, SPG block is expected to provide
      perioperative analgesia after FESS. Integration of regional anaesthesia with general
      anaesthesia technique can provide a better hemodynamic control, less perioperative opioid
      use, less bleeding and higher level of patients' satisfaction. Reduction in surgical bleeding
      in FESS can improve surgical field and also surgeons' satisfaction and a reduced opioid use
      may be translated into a less postoperative nausea & vomiting, rapid recovery and early
      hospital discharge. But, the current evidences regarding the benefit of SPG block after FESS
      is controversial. In this randomized controlled trial, efficacy of sphenopalatine ganglion
      block will be evaluated using bupivacaine or ropivacaine as local anaesthetic in adult
      patients undergoing FESS under general anaesthesia.
    

Intervention name(s): Bupivacaine; Ropivacaine; Normal Saline
Intervention type(s): Drug; Drug; Other
Intervention description(s): Post operative pain control; Post operative pain control; Acts as comparator
Other intervention name(s): Anawin; Ropin; Saline
Intervention MeSH terms: Bupivacaine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: ropivacaine, bupivacaine
Full-mouth and Partial-mouth Scaling and Root Planing in Type 2 Diabetic Subjects
Condition: Periodontitis; Diabetes
MeSH terms: Periodontitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study will be to evaluate: 1- the effect of full-mouth (FM) scaling and root
      (SRP) planing in 24 hours associated with or without extensive application of chlorhexidine
      (CLX) on clinical, microbiological, glycemic and immunological parameters in diabetic
      subjects with chronic periodontitis at 3, 6 and 12 months post-therapy. The hypothesis is
      that FMSRP associated with CLX use will provide the best clinical, microbiological, glycemic
      and immunological outcomes for the treatment of diabetic subjects with periodontitis. Sixty
      diabetic subjects with chronic periodontitis will be divided in the following therapeutic
      groups (n=20 subjects per group): FMSRP+CLX group - FMSRP in a maximum of 24 hours,
      application and irrigation of chlorhexidine 2% gel, rinsing chlorhexidine 0.12% solution
      during 60 days; FMSRP + placebo group - FMSRP in a maximum of 24 hours, application and
      irrigation of placebo, rinsing placebo solution during 60 days; Partial-mouth (PM) SRP group:
      SRP in 4-6 sessions in a maximum of 2 weeks. The following clinical parameters will be
      evaluated at 3, 6 and 12 months post-therapy: plaque accumulation, gingival bleeding, probing
      depth, clinical attachment level, bleeding on probing and suppuration. At these same periods,
      glycated hemoglobin levels will be obtained from all subjects. In addition, six subgingival
      biofilm samples per subject will be analyzed by checkerboard DNA-DNA hybridization for 40
      bacterial species at baseline, 3, 6 and 12 post-therapy. Finally, gingival crevicular fluid
      samples from two shallow and two deep sites will be evaluated for the levels of
      cyto/chemokines by ELISA. Data will be submitted to appropriate statistical analysis.
    


Intervention name(s): FMSRP; Chlorhexidine; PMSRP; Placebo
Intervention type(s): Procedure; Drug; Procedure; Other
Intervention description(s): FMSRP in a maximum of 24 hours.; Application and irrigation of chlorhexidine, rinsing chlorhexidine solution during 60 days; Scaling and root planing in 4-6 sessions in a maximum of 2 weeks; Application and irrigation of placebo, rinsing placebo solution during 60 days
Other intervention name(s): (N/A)
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus; Chronic Periodontitis; Root Planing; Cytokines; microbiology; Glycated hemoglobin; diabetic subjects
Immune Response & Safety of GSK Biologicals' Mencevax™ ACWY in Subjects Primed in the DTPW-HBV=HIB-MENAC-TT-011 Study
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will be conducted in three stages. In the DTP booster stage at 15 to 24 months of
      age, all subjects will receive a booster dose of Tritanrix™-HepB/Hiberix™. In the Mencevax™
      ACWY "full dose" stage at 24 to 30 months of age all subjects will receive a dose of
      Mencevax™ ACWY. In the Mencevax™ ACWY "small dose" stage at 30 to 36 months of age, the first
      75 subjects in each of the two centers will be tested for boostability of the MenA and MenC
      immune response by giving a fifth of a dose of a Mencevax™ ACWY vaccine. The Protocol Posting
      has been updated in order to comply with the FDA Amendment Act, Sep 2007.
    

Detailed description: 
      Subjects in the group that was previously primed with Tritanrix™-HepB/Hiberix™ will be the
      control group for the group that was previously primed with Tritanrix™-HepB/Hib-MenAC.

      Blood samples will be drawn from subjects as follows:

        -  prior to and one month after the full dose of the Mencevax™ ACWY vaccine.

        -  prior to and one month after 1/5th of a dose of Mencevax™ ACWY vaccine (only for the
           first 75 subjects in each of the two centers).
    

Intervention name(s): Tritanrix™- HepB; Hiberix™; Mencevax™ ACWY
Intervention type(s): Biological; Biological; Biological
Intervention description(s): One intramuscular dose during the booster vaccination study in subjects aged 15 to 24 months; One intramuscular dose during the booster vaccination study in subjects aged 15 to 24 months; One full subcutaneous dose in subjects aged 24 to 30 months or 1/5th of a dose intramuscular in subjects aged 30 to 36 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: hepatitis B; meningococcal vaccine; pertussis; Prophylaxis diphtheria; meningococcal serogroups A and C diseases; tetanus; Haemophilus influenzae type b
Comparison of the Pharmacodynamics of Imipenem in Patients With Febrile Neutropenia
Condition: Patients With Febrile Neutropenia
MeSH terms: Neutropenia; Febrile Neutropenia; Hyperthermia; Fever
Study type: Interventional
Phase: Phase 4

Summary: 
      This is prospective and randomized study to compare the pharmacodynamics (t>MIC) of 0.5 g
      every 6 h of imipenem in twelve patients with febrile neutropenia following administration by
      a 4 h infusion or bolus injection.

      Concentration of imipenem in plasma will be measured by HPLC method and simulated in Monte
      Carlo technique (Computer model) to get PK/PD index (40%T>MIC) and reported to %PTA
      (Probability Target Attainment) and %CFR (Cumulative Faction Response.
    


Intervention name(s): Imipenem; Imipenem
Intervention type(s): Drug; Drug
Intervention description(s): Each patient will receive 0.5 g of imipenem, 0.5 hr infusion every 6 hr at room temperature; Each patient will receive 0.5 g of imipenem, 4 hr infusion every 6 hr of at room temperature
Other intervention name(s): Tienam; Tienam
Intervention MeSH terms: Imipenem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Imipenem; Febrile neutropenia; Gram-negative infection; Pharmacodynamic; Monte Carlo Simulation
A Study to Assess Mass Balance Recovery, Metabolite Profile and Identification of IV and Oral 14C-BC-3781
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-centre, open-label, non-randomized, single dose study in healthy male
      subjects designed to assess mass balance recovery, metabolite profile and metabolite
      identification of radio-labeled BC-3781 administered via the intravenous or oral routes.
    

Detailed description: 
      This is a single-centre, open-label, non-randomised, single dose study to assess the
      pharmacokinetics, mass balance recovery, and metabolite profiling and identification
      following administration of iv or oral 14C-BC-3781 to healthy male subjects It is planned to
      enrol 2 cohorts of 5 subjects or 10 subjects in total. The active substance being
      investigated in this study is radiolabeled lefamulin ([14C] BC 3781), present in the
      investigational medicinal products (IMPs) as the acetate salt ([14C]-BC-3781.Ac).

      Subjects assigned to Cohort A will receive a single IV administration of 14C-BC-3781
      containing 150 mg BC-3781 and not more than (NMT) 4.3 MBq (117 µCi) 14C, administered as an
      infusion over 60 min after a light breakfast.

      Subjects assigned to Cohort B will receive a single oral administration of 14C-BC-3781
      containing 600 mg BC-3781 and NMT 4.1 MBq (112 µCi) 14C, in the fasted state
    

Intervention name(s): BC-3781
Intervention type(s): Drug
Intervention description(s): Lefamulin (BC-3781) is a potent, semi-synthetic antibacterial belonging to a novel class for systemic human use known as the pleuromutilins
Other intervention name(s): Lefamulin
Intervention MeSH terms: Lefamulin
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Tracking Optical Coherence Tomography
Condition: Macular Degeneration; Glaucoma; Diabetic Retinopathy; Choroidal Disease
MeSH terms: Macular Degeneration; Diabetic Retinopathy; Choroid Diseases
Study type: Observational

Summary: 
      The purpose of this research study is to evaluate an investigational system that may allow
      doctors to show images of the different parts inside the eye that show greater detail than
      current equipment can produce.
    

Detailed description: 
      The purpose of this research study is to evaluate an investigational system that may allow
      doctors to make images of the parts inside the eye that show greater detail than current
      equipment can produce.
    

Sampling method: Non-Probability Sample
Study population: 
        Subject can range between 18 to 85 years old. They can be healthy or diseased. Recruiting
        males and females.
      
Keywords: maculopathy
Wound Additives in Primary Total Joint Athroplasty
Condition: Arthroplasty, Replacement
Study type: Interventional
Phase: Phase 3

Summary: 
      3 cohorts of total joint patient of 30 members each were randomized to receive PRP or
      Activated Collegen or no additive were studied for status of the wound at 6 weeks and
      recorded all complications, infections and reoperations. The three groups were than compared
      for statistical analysis
    

Detailed description: 
      Background: Wound healing remains a concern in primary total joint arthroplasty given the
      risk of deep infections arising from hematomas, wound separations, and superficial
      infections. If wound additives can prevent these early complications, their universal
      application would be cost effective. This study examined whether two wound additives,
      Platelet-Rich Plasma (PRP) and CellerateRX® (activated collagen), would improve postoperative
      wound healing and reduce complications in primary total joint arthroplasty.

      Methods: A prospective, randomized, controlled study using three cohorts with 30 patients
      each (Group 1: PRP, Group 2: activated collagen, Group 3: control) were examined
      postoperatively at two and six weeks, at which time the following data were recorded: six
      wound measurements, total postoperative blood loss, complications of superficial infections,
      and reoperations.
    

Intervention name(s): Platelet Rich Plasma; Cellerate
Intervention type(s): Biological; Biological
Other intervention name(s): PRP; Activated college
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 3 groups with identical surgical closures randomized into 2 groups with wound additives and the third group without wound additives.
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: total joint arthroplasty; platelet-rich plasma; activated collagen
A Study to Assess the Safety, Tolerability and Pharmacokinetics of AVI-7288 in Healthy Adult Volunteers
Condition: Marburg Hemorrhagic Fever
MeSH terms: Hemorrhagic Fevers, Viral; Marburg Virus Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of healthy male and
      female subjects with intravenous (IV) infusions of AVI 7288 compared to matched placebo in
      and to evaluate the pharmacokinetics (PK).
    

Detailed description: 
      The purpose of this study is to evaluate the safety and tolerability of 14 once daily
      intravenous (IV) infusions of ascending doses of AVI 7288 compared to matched placebo in
      healthy male and female subjects.

      To evaluate the pharmacokinetics (PK) of 14 once daily doses of AVI-7288 in healthy male and
      female subjects
    

Intervention name(s): AVI-7288; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Cohort 1: AVI-7288 at 1 mg/kg IV; Cohort 2: AVI-7288 at 4 mg/kg IV;Cohort 3: AVI-7288 at 8 mg/kg IV; Cohort 4: AVI-7288 at 12 mg/kg IV
The amount of AVI-7288 required to administer the required dose will be diluted to a volume of approximately 150 mL with normal saline solution (NSS) and given by IV infusion over 30 minutes once a day for 14 days. Infusions will be administered at approximately the same time each day.; Normal Saline Solution (NSS)
Other intervention name(s): Normal Saline Solution (NSS)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple Ascending Dose (MAD); Marburg Virus; Post Exposure Prophylaxis
Cholecalciferol Supplementation in Hemodialysis Patients
Condition: Anemia; Hemodialysis Complication; Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is prospective single-blind randomized study, in Ain Shams University hospital) in
      Egypt, to assess the impact of Cholecalciferol on Anemia status in regular hemodialysis
      outpatients
    

Detailed description: 
      This Srudy is to assess the Impact of Cholecalciferol on Anemia status in regular
      hemodialysis outpatients in terms of increase of Hgb >11 g/dl, transferrin saturation (TSAT)
      of ≥ 30%, and ferritin levels to achieve a range of (300 to < 800 ng/ml), and effect on
      Epoetin Dose needed. This study is also to adress the factors affecting the correcetion of
      Anemia by Cholecalciferol supplementation, such as oxidative stress and Inflammatory markers.
    

Intervention name(s): Cholecalciferol
Intervention type(s): Drug
Intervention description(s): 50.000IU weekly in Group A , or 200.000IU monthly in Group B
Other intervention name(s): Vitamin D3
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Expression Profiling of microRNA Following Administration of Dexmedetomidine
Condition: Coronary Disease
MeSH terms: Coronary Disease
Study type: Interventional

Summary: 
      The purpose of the study is to find out the differential expression profiling of microRNA
      before and after adiministration of dexmedetomidine in patients undergoing procedures, and
      then investigators will do some in vitro studies to validate the functions of the microRNA.
    

Detailed description: 
      Background and objective: The use of dexmedetomidine may have benefits on the clinical
      outcomes of cardiac surgery. MicroRNAs are non-coding RNA sequences that act as regulators of
      gene expression. Investigators conduct a study to determine the role of microRNAs in
      cardioprotection mediated by dexmedetomidine.

      Methods: In this study 3 patients were selected. The blood sample were taken before
      administration of dexmedetomidine.Investigators infused loading dose of dexmedetomidine for
      10 minutes and maintaining dese of dexmedetomidine for 20 minutes.Thirty minutes after the
      administration, another blood samples were taken and stored in the liquid nitrogen and both
      the samples were marked. Those sample were analyzed for differentially expressed microRNA
      with Exiqon miRNA Array.
    

Intervention name(s): Dexmedetomidine Injection
Intervention type(s): Drug
Intervention description(s): Investigators gave the patients loading dose of dexmedetomidine for 10 minutes and maintaining dose of dexmedetomidine for 20 minutes. Investigators took blood samples before and after the administration of dexmedetomidine.
Other intervention name(s): Dex group
Intervention MeSH terms: Dexmedetomidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science