bioihbjkbjnl/mcl2 huggingface dataset:
Galvus on Met Phase 4 Study : Study to Evaluate the Efficacy and Safety of Early Combination of Vildagliptin and Metformin 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 4

Summary: 
      The study design of this trial is open-label, randomized, multi-center, parallel-group study.
    

Detailed description: 
      -  The progressive nature of T2DM will require the use of combination therapy in many
           patients over time to achieve and maintain glycemic control. Early combination, compared
           with maximal dose of monotherapy, could be more effective in lowering glycemia with
           better tolerability.

        -  Vildagliptin is a new oral antidiabetic drug acting as a potent and selective inhibitor
           of dipeptidyl peptidase-4(DPP-4), the enzyme responsible for the rapid degradation of
           circulating glucagon-like peptide-1. Vildagliptin improves islet function by a mechanism
           of increasing plasma levels of the active forms of the incretin hormones, GLP-1 and GIP.

        -  Metformin improves hyperglycemia primarily through its suppression of hepatic
           gluconeogenesis as well as enhancement of peripheral glucose update. Metformin is the
           most commonly prescribed first-line antidiabetic drug worldwide, but due to the
           progressive worsening of blood glucose control during the natural history of type 2
           diabetes, combination therapy usually becomes necessary.

        -  Thus their combination therapy with complimentary action mechanism could be as effective
           as up titration of monotherapy.
    

Intervention name(s): vildagliptin 50 mg bid plus metformin 1500mg (Galvus+Diabex); metformin 1500mg plus metformin 500mg or 1000mg (Diabex)
Intervention type(s): Drug; Drug
Intervention description(s): vildagliptin 50 mg bid plus metformin 1500mg; metformin 1500mg plus metformin 500mg or 1000mg
Intervention MeSH terms: Metformin; Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Galvus
ISIS 5132 in Treating Patients With Metastatic or Recurrent Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase II trial to study the effectiveness of ISIS 5132 in treating patients who have
      metastatic or recurrent ovarian cancer that has not responded to previous chemotherapy.
    

Detailed description: 
      OBJECTIVES: I. Determine the efficacy of ISIS 5132 by evaluating objective response and
      duration of response in patients with recurrent ovarian epithelial cancer. II. Determine the
      tolerability and quantitative toxicity of ISIS 5132 in this patient population.

      OUTLINE: This is a multicenter study. Patients receive ISIS 5132 IV continuously for 21 days.
      Courses are repeated every 28 days. Treatment continues for a maximum of 12 courses in the
      absence of disease progression or unacceptable toxicity. Patients with documented complete
      response receive an additional 2 courses. Patients with documented partial response receive
      an additional 4 courses. Patients are followed at 4 weeks, then every 3 months until disease
      relapse or progression.

      PROJECTED ACCRUAL: A total of 15-30 patients will be accrued for this study over 12-15
      months.
    

Intervention name(s): ISIS 5132
Intervention type(s): Drug
Intervention description(s): 4mg/kg/day IV for 21 days every 4 weeks.
Intervention MeSH terms: ISIS 5132
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IV ovarian epithelial cancer; recurrent ovarian epithelial cancer
Lanreotide as Primary Treatment for Acromegalic Patients With Pituitary Gland Macroadenoma
Condition: Acromegaly
MeSH terms: Acromegaly
Study type: Interventional
Phase: Phase 3

Summary: 
      Acromegaly is a chronic disease caused by excessive secretion of growth hormone (GH) and
      mainly due to benign tumour localized in the pituitary gland.

      The disease develops insidiously, causing a gradual progression of symptoms; consequently
      most patients are diagnosed in their fourth decade of life.

      Administration of somatostatin analogues such as lanreotide have been shown to result in
      normalisation or the decrease of GH and insulin growth factor (IGF-1) levels and improvement
      of clinical symptoms in acromegalic patients. The purpose of this study is to evaluate
      whether lanreotide is also effective on tumour volume reduction (tumour shrinkage) and the
      benefits of this potential tumour shrinkage on disease symptoms and patient's quality of
      life.
    


Intervention name(s): Lanreotide autogel 120 mg
Intervention type(s): Drug
Intervention description(s): 12 months
Intervention MeSH terms: Lanreotide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients
Condition: Transplantation Infection
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to allow the continuation of everolimus treatment in patients
      who have completed the core study (NCT00170885) and to collect long-term safety,
      tolerability, and efficacy data in a group of patients treated with the upper everolimus
      target levels plus very low dose cyclosporin in comparison with the standard everolimus
      target levels plus low dose cyclosporin in patients with renal transplantation.
    


Intervention name(s): Everolimus 0.25 and 0.75 mg tablets; Cyclosporine very low dose (150-300 ng/mL) microemulsion; Cyclosporine low dose (350-500 ng/mL) microemulsion
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The dose of everolimus for each patient was adjusted to achieve the target everolimus blood level range. Everolimus blood trough level was measured 5 days after any dose adjustment to verify that the blood level was within the desired target level range.; The dose of cyclosporine for each patient was adjusted to achieve the target cyclosporine blood level. Cyclosporine dose adjustments were based on drug blood level determined from whole blood samples taken 2 hours (± 10 min) after the morning dose.; The dose of cyclosporine for each patient was adjusted to achieve the target cyclosporine blood level. Cyclosporine dose adjustments were based on drug blood level determined from whole blood samples taken 2 hours (± 10 min) after the morning dose.
Other intervention name(s): Neoral; Neoral
Intervention MeSH terms: Cyclosporine; Everolimus; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: immunosuppression; kidney transplantation; everolimus; safety
Evaluating the Safety, Tolerability, and Effect of a Human Monoclonal Antibody (VRC01) on Markers of HIV Persistence in HIV-Infected Adults Receiving Antiretroviral Therapy (ART)
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to evaluate the safety, tolerability, and effect of an
      experimental human monoclonal antibody (mAb), VRC-HIVMAB060-00-AB (VRC01), in adults infected
      with HIV who were receiving antiretroviral therapy (ART).
    

Detailed description: 
      Monoclonal antibodies (mAbs) have been developed as treatment for a variety of conditions
      including cancer, autoimmune disorders, and infections. mAbs may also be a potential
      treatment for people infected with HIV. The purpose of this study was to evaluate the safety
      and tolerability of an experimental human mAb, VRC-HIVMAB060-00-AB (VRC01), in HIV-infected
      adults receiving ART. Study researchers will also evaluate the effect of VRC01 on the number
      of infected cells containing unspliced HIV-1 transcripts in the blood in participants.

      This study enrolled HIV-infected people 18 to 65 years old, who had been receiving ART for at
      least 2 years and who had a CD4+ count of 200 cells/mm^3 or greater. Participants were
      randomly assigned to Arm A or Arm B. Participants in Arm A received an intravenous (IV)
      infusion of VRC01 at Day 0 and Week 3 and an IV infusion of placebo (normal saline) at Weeks
      6 and 9. Participants in Arm B received an IV infusion of placebo (normal saline) at Day 0
      and Week 3 and an IV infusion of VRC01 at Weeks 6 and 9. Participants recorded their
      temperature and symptoms for 3 days after each infusion. Study visits occured at study entry
      (Day 0), and Weeks 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18, and 30. Study visits
      included physical examinations, clinical assessments, and blood collection.

      The primary safety outcome for this study was descriptive and assessed the occurrence of
      Grade ≥ 3 AEs including signs/symptoms, lab toxicities, and/or clinical events that are
      possibly, probably, or definitely related to study treatment (as judged by the core team,
      blinded to treatment arm) at any time from the initial dose of study treatment to the end of
      study follow-up. Since this outcome is descriptive, no statistical significance testing was
      performed.
    

Intervention name(s): VRC01; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): 40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump; Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
Other intervention name(s): VRC-HIVMAB060-00-AB
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HIV; VRC01
Use of 99mTc Tilmanocept for Imaging Arterial Inflammation
Condition: HIV
MeSH terms: Arteritis; Inflammation
Study type: Observational

Summary: 
      The purpose of this study is to measure arterial 99mTc-Tilmanocept uptake using single photon
      emission computed tomography (SPECT/CT) scanning in HIV infected subjects known to have
      subclinical coronary atherosclerosis as assessed by contrast-enhanced coronary computed
      tomography angiography (CCTA).
    

Detailed description: 
      Detailed Description:

      Patients with HIV have been shown to have increased atherosclerotic risk compared to
      age-matched controls, and this risk is thought to be related to increased systemic immune
      activation. Specifically, systemic immune activation may contribute to destabilizing coronary
      atherosclerotic plaque, leading to plaque rupture and myocardial infarction. This study is
      intended to measure arterial uptake of the macrophage specific marker 99mTc-Tilmanocept using
      single photon emission computed tomography, applied initially to a group of HIV-infected
      patients with known subclinical coronary atherosclerosis on CCTA. Moreover, traditional
      markers of CVD risk and inflammatory markers will be assessed in relation to CV imaging
      outcomes. Positive findings in the index HIV group with known subclinical atherosclerosis
      will prompt subsequent study of three comparison groups, as above.
    

Intervention name(s): Arterial Imaging
Intervention type(s): Other
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        HIV-infected subjects and HIV non-infected subjects
      
Biospecimen description: 
      whole blood, plasma and serum
    
Keywords: HIV; Atherosclerosis; Tilmanocept
Clinical Trial to Evaluate Magtein in Older Adults
Condition: Mood; Anxiety
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      A randomized double blind placebo controlled trial to evaluate the effects of a specialized
      magnesium on mood states and sleep quality in older adults.
    

Detailed description: 
      Efficacy Objectives:

      To determine the effects of 12-weeks supplementation with Magtein™ as compared to placebo on:

        1. anxiety and mood as measured by the Hamilton Anxiety Rating Scale (HAM-A) and the
           Positive and Negative Affect Schedule (PANAS). For the HAM-A, total score and sub-scores
           anxious mood, tension, fears, insomnia and intellectual will be utilized.

        2. quality of sleep as measured by the Pittsburgh Sleep Quality Index (PSQI).

        3. cognitive abilities as measured by the Erikson Flanker Task and computerized cognitive
           tests including Short-Term Memory Test (STM), Working Memory Test (WM), cued name recall
           task and face-name association task.

      To determine the acute effects and the effects of 12-weeks supplementation with Magtein™ as
      compared to placebo on magnesium status as measured by the sponsor's protocol for determining
      body magnesium status.

      Safety Objective:

      To determine if supplementation with Magtein™ is safe within the confines of this study as
      denoted by changes from baseline to 12 weeks in blood work (comprehensive metabolic panel,
      uric acid and complete blood count with differential), blood pressure (BP), heart rate (HR),
      adverse events and subjective remarks.
    

Intervention name(s): magnesium threonate
Intervention type(s): Dietary Supplement
Intervention description(s): nutritional product
Other intervention name(s): Magtein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: magnesium status; sleep quality
A Phase 3, Long-Term Safety Study of Subcutaneous Epoetin Hospira in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME -Anemia Management With Epoetin
Condition: Chronic Renal Failure Requiring Hemodialysis
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the long term safety in treatment-emergent adverse events (TEAEs) of SC
      administration of Epoetin Hospira for maintenance of target hemoglobin (Hgb) levels in
      patients treated for anemia associated with chronic renal failure and on hemodialysis.
    


Intervention name(s): Epoetin Hospira
Intervention type(s): Biological
Intervention description(s): Subcutaneous(SC) injection
Other intervention name(s): ESA; Erythropoetin Stimulation Agents
Intervention MeSH terms: Epoetin Alfa
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic renal failure; Hemodialysis
Multiple-loading Dose Regimen Study in Patients With Chronic Plaque-type Psoriasis
Condition: Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      Loading dose, four arm, double-blind, parallel group, placebo-controlled study comparing
      single and multiple doses of AIN457 to placebo in patients with a diagnosis of moderate to
      severe chronic plaque psoriasis.
    


Intervention name(s): AIN457; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): AIN457 was administered intravenously.; Matching placebo to AIN457 was administered intravenously.
Other intervention name(s): Secukinumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Plaque; psoriasis; inflammatory skin disease; skin condition, thickening; flaking; scaly patches; skin disease
Postoperative Pulpal Complications in Posterior Resin Composite Restorations Without Glass-ionomer Cement Lining
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to observe the effects of glass-ionomer cement (GIC) lining on
      risk of pulpal complications in deep occlusal cavities with resin-based restorations.
    

Detailed description: 
      Fifty three patients aged 18-30 years who had one or two deep occlusal carious lesions (≥ 3
      mm in depth) in molars were recruited. Dental caries was removed and the prepared cavity was
      restored with resin composite using one of two restorative procedures: (1) without GIC
      lining; (2) with (resin-modified) GIC lining. Restored teeth were evaluated for any pulpal
      complications (subjective symptoms, objective signs or loss of tooth vitality) at one month
      (baseline), one year and two years after restoration.
    

Intervention name(s): Glass ionomer cement lining
Intervention type(s): Procedure
Intervention description(s): Resin-modified glass ionomer lining
Other intervention name(s): Vitrebond (3M ESPE, St. Paul, MN, USA)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Deep occlusal caries restored with resin composite; on Pit and Fissure Surface Penetrating Into Dentin
Fluarix Immunogenicity and Safety Trial
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to test the immune response caused by investigational Fluarix
      vaccine in healthy people aged between 18-64 years in the U.S.A. Up to 1050 volunteers at 4
      centers will receive Fluarix or Placebo (saline), and their responses will then be compared.
      Subjects will be placed by age into 2 groups (18 to 49 years old and 50 to 64 years old),
      then randomly assigned to receive a dose of Fluarix or Placebo by injection into a muscle.
      There will be 2 phases in this study: (1) the active study phase (2 visits) for all subjects;
      and (2) the cross-over phase, only for subjects enrolled in the placebo group who accept to
      receive Fluarix. Blood samples will be obtained in order to measure immune response to the
      vaccine. On the day of vaccination, volunteers will receive a diary card to record
      information on symptoms experienced during the next 3 days. Subject participation in either
      group will be up to 2 months.
    

Detailed description: 
      This study is a randomized, double-blinded, placebo controlled Phase III study to evaluate
      the immunogenicity and the safety of GSK Bio influenza vaccine (Fluarix) administered
      intramuscularly in healthy adults aged 18 to 64 years. Vaccination is currently the most
      effective means of controlling influenza and preventing its complications and mortality in
      persons at risk. Following vaccination, seroprotective antibody titers are achieved in a high
      proportion of vaccinated subjects. GlaxoSmithKline Biologicals (GSK Bio) has been marketing
      an inactivated influenza split vaccine (Fluarix®) since 1992. More than 126 million doses
      have been distributed and the vaccine is registered in 78 countries. It has been well
      tolerated and has proven to be highly immunogenic when injected by the intramuscular route.
    

Intervention name(s): Fluarix
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Prevention
Keywords: influenza, flu, Fluarix, vaccine, GSK, immunogenicity
Evaluation of the Effect of Fluvastatin 40 mg (b.i.d.) in the Prevention of the Development of Vasculopathy of the Graft in de Novo Renal Transplant Patients Transplant
Condition: Graft Vasculopathy
MeSH terms: Vascular Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Principal objective is to investigate if the treatment with fluvastatin can prevent the
      progression of vascular graft disease in de novo renal transplant patients.
    


Intervention name(s): Fluvastatin
Intervention type(s): Drug
Intervention description(s): Graft vasculopathy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Renal transplantation; fluvastatin
Infective Keratitis in Minia Governate
Condition: Infective Keratitis
MeSH terms: Keratitis
Study type: Interventional

Summary: 
      The purpose of the study is to determine the microbiological aetiology, epidemiological
      factors, and clinical profile and treatment outcomes of infective keratitis in Ophthalmology
      department, Minia University. Egypt
    

Detailed description: 
      Prospective, non-randomized, observational clinical series of cases, including 150 patients
      clinically diagnosed as infective corneal ulcer, attending the Ophthalmology Department -
      Faculty of Medicine. Minia University, Minia, Egypt. From 2018 to 2020.

      Detailed history taking and all clinical findings were collected. Corneal scrapings were
      obtained from patients and subjected to staining and culture for bacterial and fungal
      pathogens; Bacterial and fungal growth were identified by standard laboratory procedures.
    

Intervention name(s): antimicrobial treatment
Intervention type(s): Other
Intervention description(s): Detailed history taking and all clinical findings were collected. Corneal scrapings were obtained from patients and subjected to staining and culture for bacterial and fungal pathogens; Bacterial and fungal growth were identified by standard laboratory procedures.
Intervention MeSH terms: Anti-Infective Agents; Anti-Bacterial Agents
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: infective keratitis; Bacterial keratitis; Fungal keratitis
Effects of Vibration Training on Exercise Capacity in COPD-patients
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional

Summary: 
      The aim of this study is to investigate the exercise capacity in COPD-patients performing a
      vibration training additional to a standard three-week rehabilitation program in comparison
      to patients performing merely a rehabilitation program.
    


Intervention name(s): whole body vibration training
Intervention type(s): Other
Intervention description(s): performing squats for 3x3 minutes while using vibration platform three times a week
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: COPD III/IV; 6-Minutes-Walking-Distance; Vibration training; Galileo; Pulmonary rehabilitation