bioihbjkbjnl/mcl2 huggingface dataset:
Phase 3 Trial to Evaluate the Efficacy and Safety of LC15-0444 in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Double-blind, randomized, multicenter, multinational (South Korea and India), parallel group
      study The study was divided into three parts: part 1 was started with an initial 2 weeks of
      exercise/diet program followed by another 2 weeks of single-blind placebo run-in period; part
      2 was a double-blind treatment period during which eligible patients were randomized to
      LC15-0444 50mg or placebo groups and received the assigned treatment for 24 weeks; part 3 was
      for those patients who completed part 1 & 2 and consented to receive another 28 weeks of
      treatment with LC15-0444 50mg. Screening tests were performed on the patients who had given
      the written informed consent. After 2-week exercise/diet program according to the generally
      recognized guideline, patients took placebo for another 2 weeks while continuing
      exercise/diet program. When the 2-week placebo run-in period was completed, eligible patients
      were assigned either to placebo or 50 mg of LC15-0444 with 1:1 ratio. During the total of 24-
      week treatment period of part 2 after randomization, each patient visited the investigational
      site at Week 6, 12, 18, and 24. Completing treatment with placebo or LC15-0444 50mg for 24
      weeks after randomization, each patient was asked to provide consent to participate in the
      part 3 of the study where all the patients were to receive LC15-0444 50mg regardless of the
      treatment received during the part 2 of the study. During 28-week treatment period of the
      part 3, each patient visited the investigational site at Week 30, 38, 46, and 52. Total study
      period from screening was 56 weeks per each patient.
    


Intervention name(s): Placebo group(once daily); LC15-0444 50mg qd
Intervention type(s): Drug; Drug
Intervention description(s): eligible patients were randomized to LC15-0444 50mg or placebo groups and received the assigned treatment for 24 weeks.; eligible patients were randomized to LC15-0444 50mg or placebo groups and received the assigned treatment for 24 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of Novel Fiber on Glucose Metabolism and Insulin Sensitivity
Condition: Insulin Resistance
MeSH terms: Insulin Resistance; Hypersensitivity
Study type: Interventional

Summary: 
      This study will critically evaluate the effects of a novel dietary fiber administered to
      subjects at high risk for developing diabetes to determine if this intervention will improve
      insulin sensitivity compared to control product administration and, thus, decrease risk for
      developing diabetes.

      The hypothesis is that consuming this novel fiber twice a day for 12 weeks will significantly
      decrease fasting plasma glucose, insulin and glycosylated hemoglobin values in pre-diabetic
      subjects (i.e. subjects with fasting plasma glucose levels 95-140 mg/dl at screening)
      compared to consumption of the control product.
    


Intervention name(s): Novel dietary fiber; Novel dietary fiber; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): oral consumption in beverage; Oral consumption in beverage; Oral consumption in beverage
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: dietary fiber; fiber; insulin sensitivity; insulin resistance; glucose metabolism
ABSORB II Randomized Controlled Trial
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      Prospective, randomized (2:1), active control, single blinded, parallel two-arm, multi-center
      clinical investigation using Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular
      Scaffold System (ABSORB BVS); compared to Abbott Vascular XIENCE Everolimus Eluting Coronary
      Stent System (XIENCE)
    

Detailed description: 
      In the USA, ABSORB BVS is currently in development at Abbott Vascular. Not available for sale
      in the US.
    

Intervention name(s): Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System; Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System
Intervention type(s): Device; Device
Intervention description(s): XIENCE implantation in the treatment of coronary artery disease.; ABSORB BVS implantation in the treatment of coronary artery disease.
Intervention MeSH terms: Everolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Bioabsorbable; Coronary scaffold; Coronary Stent; Everolimus; Drug eluting stents; Angioplasty; Coronary artery disease; Total coronary occlusion; Coronary artery restenosis; Stent thrombosis; Myocardial ischemia; Coronary artery stenosis
Could Bulk Fill Glass Hybrid Restorative Materials Replace Composite Resins in Treating Permanent Teeth?
Condition: Dental Restoration Failure of Marginal Integrity
Study type: Interventional

Summary: 
      The aim of this study is to compare the clinical and radiographic efficacy of Equia system
      bulk fill glass hybrid material with composite resins in the permanent restoration of
      pediatric patients' permanent teeth.
    

Detailed description: 
      The study included 44 pediatric patients aged 8 to 16 years who applied to the Pedodontics
      Department of the Necmettin Erbakan University Faculty of Dentistry. The groups were formed
      as symmetrical teeth in the same patient using the split-mouth design. The study included
      class I caries lesions of 144 permanent teeth, 72 of which were restored with the Equia
      system bulk fill glass hybrid material [Equia Forte HT+Equia Forte Coat (GC, Co, Tokyo,
      Japan)] and 72 with the Charisma Smart universal composite resin (Kulzer, Gmbh, Hanau,
      Germany) + Clearfil SE Bond (Kuraray, Noritake, Sakazu, Okayama). Evaluations were performed
      clinically and radiographically by 2 physicians in the 2nd week, 3rd month, 6th month, and
      12th month and the results were recorded. Clinical evaluation was carried out using modified
      USPHS criteria. Obtained data were statistically analyzed using Kendall's W test and
      Cochran's Q test for the comparison within the group, and the Chi-Square test for the
      comparison between the groups.
    

Intervention name(s): Restoration
Intervention type(s): Other
Intervention description(s): Restorations completed with these materials.
Other intervention name(s): Restorative Interventions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Composite Resins; Clinical Trial; Glass Ionomer Cements; Permanent Dental Restoration
Correlation of Molecular Biomarkers With Biopsy Findings and Outcomes in Renal Transplant Recipients
Condition: Delayed Graft Function
MeSH terms: Delayed Graft Function
Study type: Observational [Patient Registry]

Summary: 
      This is a single-center, prospective, non-randomized, observational study to evaluate
      specific proteogenomic biomarker panels for acute rejection (AR) and chronic allograft
      nephropathy/interstitial fibrosis and tubular atrophy (CAN/IFTA) in blood, urine and kidney
      tissue (biopsy) in kidney transplant recipients. Proteogenomic profiles will be routinely
      monitored over one year after enrollment.
    

Detailed description: 
      OBJECTIVE: The objective of this phase of the study is to allow the clinical site to gain
      familiarity with patient recruitment, sample and data collection, and interpretation of the
      proteogenomic biomarker report provided, through retrospective analysis. This phase of the
      study will provide a platform for the transplant physicians to gain confidence with the
      format, logistics, and potential use of the biomarker tests on blood and tissue.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        post-transplant and are undergoing kidney transplant biopsies at the UC Davis transplant
        center. Ten subjects will be enrolled who are receiving surveillance "protocol biopsies"
        and 10 subjects who will be receiving "for cause" biopsies in the setting of an elevated
        serum creatinine or proteinuria. Samples of blood, and formalin-fixed, paraffin-embedded
        biopsy tissue will be sent to Transplant Genomics INC. (TGI) for study purposes. In
        addition, clinical data will be collected on each subject.. Blood and tissue will be
        analyzed by TGI using Affymetrix microarrays, and reports will be sent to UC Davis
        retrospectively. Samples may be batch-shipped and results will not be reported in real
        time. These results will be compared to both the histological diagnosis, and to the
        clinical course.
      
Biospecimen description: 
      Laboratory evaluations: The UC Davis laboratory will be used for clinical chemistry, and
      hematology, as well as other outside laboratories that the participants may go to

        1. Hematology: Routine hematological parameters will be analyzed as indicated by standard
           clinical care

        2. Clinical chemistry: Routine clinical chemistry parameters will be analyzed including
           basic and comprehensive metabolic profiles as indicated by standard clinical care
           Immunologic Profiles: As per standard routine monitoring with both indicated and
           surveillance biopsies, donor specific antibodies will be monitored
    
Keywords: Renal Biopsy; elevated serum creatinine; proteinuria
Moxonidine for Prevention of Post-ablation AFib Recurrences
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation; Recurrence
Study type: Interventional
Phase: Phase 4

Summary: 
      Hypothesis: Modulation of central nervous sympathetic activation by administration of
      moxonidine, a centrally acting medication which decreases the sympathetic nervous system
      activity, can lead to a decrease in atrial fibrillation recurrence after ablation treatment
      with pulmonary vein isolation.
    


Intervention name(s): Moxonidine; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Moxonidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: atrial fibrillation; paroxysmal; persistent; ablation; pulmonary vein isolation; recurrence
Safety Study of a Dual Anti-HIV Gene Transfer Construct to Treat HIV-1 Infection
Condition: Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is an early phase research study looking at whether an experimental gene transfer,
      LVsh5/C46 (also known as Cal-1), is safe and if it can protect the immune system from the
      effects of HIV without the use of antiretroviral drugs.

      Cal-1 is an experimental gene transfer agent designed to inhibit HIV infection through 2
      active parts:

        1. Removing a protein named CCR5 from bone marrow and white blood cells

        2. Producing a protein named C46 on bone marrow and white blood cells
    

Detailed description: 
      It is estimated that 33 million individuals are currently infected with HIV. HIV/AIDS is a
      disease that impairs immune function, primarily by decreasing CD4+ T lymphocytes. The
      progression can be contained by daily dosing with antiretroviral therapy (ART) but there are
      side effects that can be treatment limiting, and the development of HIV drug resistance can
      force the physician to modify the ART regimen. There are no effective vaccines currently
      available for HIV.

      LVsh5/C46 (also known as Cal-1) is a dual therapeutic, self-inactivating lentiviral vector
      that encodes for both a short hairpin RNA against the HIV-1 co-receptor CCR5 (sh5) and a
      HIV-1 fusion inhibitor, C46 and inhibits two processes required for HIV-1 infection:

        1. Binding of the virus to the cellular CCR5 co-receptor and

        2. Fusion of the virus with the host cell

      The rationale is that Cal-1 introduced into hematopoietic progenitor/stem cells (HSPC) and
      mature CD4+ T lymphocytes will protect these cells and their progeny cells from HIV-1
      infection and its pathogenic sequelae. This may provide a continuous means of controlling
      HIV-1 after a single or infrequent dose(s), thereby decreasing or delaying (partially or
      completely) the need for antiretroviral drug therapy.
    

Intervention name(s): Busulfan; Cal-1 modified HSPC; Cal-1 modified CD4+ T lymphocytes
Intervention type(s): Drug; Biological; Biological
Intervention description(s): Intravenous busulfan; Hematopoietic progenitor/stem cells (HSPC) modified with LVsh5/C46 (Cal-1); CD4+ T lymphocytes modified with LVsh5/C46 (Cal-1)
Other intervention name(s): Busulfex; LVsh5/C46 modified HSPC; LVsh5/C46 modified CD4+ T lymphocytes
Intervention MeSH terms: Busulfan
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV-1
Central and Peripheral Arterial Pressure Decoupling In Cardio-Pulmonary Bypass
Condition: Cardiopulmonary Bypass; Cardiac Surgery; Extracorporeal Circulation
Study type: Interventional

Summary: 
      Central and peripheral arterial pressure decoupling occurs in some clinical conditions like
      sepsis or cardiopulmonary bypass. This decoupling may leed to unsuitable decisions such as
      the use of catecholamines.

      The aim of this study is to evaluate the pulse wave's speed as a marker of central and
      peripheral arterial pressure decoupling in a scheduled condition which is the cardiopulmonary
      bypass during cardiac surgery.
    


Intervention name(s): Non-invasive blood pressure oscillometer (NIBP) implementation
Intervention type(s): Procedure
Intervention description(s): Implementation of two additional NIBP on humeral and femoral sites.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Transection of Sternothyroid Muscle Increases the Rate of Exposure of the External Laryngeal Nerve During Thyroidectomy
Condition: Thyroid; Surgery; Thyroid Disease
MeSH terms: Thyroid Diseases
Study type: Interventional

Summary: 
      The sternothyroid (ST) muscle is closely adherent to the thyroid gland with oblique insertion
      into the thyroid cartilage. EBSLN passes through the sternothyroid laryngeal triangle with a
      parallel course deep to the ST muscle.

      This study evaluates the transection of the sternothyroid muscle as a key step during
      thyroidectomy to increase the rate of exposure and visual identification of EBSLN compared to
      ST muscle retraction as a traditional technique.
    

Detailed description: 
      The study was conducted on patients eligible for total thyroidectomy, which meets the
      standard of the ATA Thyroid Guidelines. Preoperative biochemical thyroid function tests and
      neck ultrasound with FNAC of suspicious nodules confirmed the clinical diagnosis. Patients
      who had previously undergone neck surgery or irradiation or were preoperatively diagnosed
      with a vocal cord movement disorder, a vocal cord benign lesion, or speech disorders were
      excluded from the study. A random number was used to determine the patient group allocation.

      Data about patients were gathered via history, examinations, and investigations. The patients
      were randomized (computer-generated) with the use of an opaque-sealed envelope into two
      groups; group A: conventional method of thyroidectomy with ST muscle retraction, group B:
      transection of ST muscle.

      The study's primary endpoint was the identification rate of the EBSLN in both techniques. The
      secondary endpoints included: a comparison of operative time in both techniques as well as
      anatomical variability of the EBSLN according to Cernea classification, rate of injury of
      EBSLN, and changes in postoperative voice performance.
    

Intervention name(s): thyroidectomy
Intervention type(s): Procedure
Intervention description(s): removal of the diseased thyroid gland by conventional method vs transection method of sternothryroid muscle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Two Formulations of Biphasic Insulin Aspart 70
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to compare two formulations of
      biphasic insulin aspart 70 and characterise the pharmacokinetics of biphasic insulin aspart
      50 and biphasic insulin aspart 70 in healthy male subjects.
    

Detailed description: 
      Each subject participated in three treatment periods, and were randomly assigned to each of
      the six treatment sequences in varying order
    

Intervention name(s): biphasic insulin aspart 70; biphasic insulin aspart 70; biphasic insulin aspart 50
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single dose administrated subcutaneously (s.c., under the skin); A single dose administrated subcutaneously (s.c., under the skin); A single dose administrated subcutaneously (s.c., under the skin)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination; Biphasic Insulins
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety And Tolerability Of Multiple Dose Lersivirine For 21 Days In Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Randomized, open-label, parallel group study in a group of 75 healthy subjects, to evaluate
      the safety and toleration of 2 different doses of lersivirine administered either fed or
      fasted (proposed Phase 3 formulation) given over 21 days, compared to lersivirine 500 mg QD
      (Phase 2b formulation). The pharmacokinetics of lersivirine in each group will also be
      evaluated.
    


Intervention name(s): Lersivirine; Lersivirine; Lersivirine; Lersivirine; Lersivirine
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Lersivirine 500 mg QD fasted (wet granulated tablet) for 21 days; Lersivirine 500 mg QD fed (wet granulated tablet) for 21 days; Lersivirine 750 mg QD fasted (wet granulated tablet) for 21 days; Lersivirine 750 mg QD fed (wet granulated tablet) for 21 days; Lersivirine 500 mg QD fasted (dry granulated tablet) for 21 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lersivirine; UK-453; 061; safety; tolerability; pharmacokinetics; HIV; non-nucleoside reverse transcriptase inhibitor; NNRTI
Carbon Monoxide Breath Sensor System Performance, Human Factors, and Usability Assessment Conducted in a Single Visit
Condition: Smoking, Tobacco
Study type: Interventional

Summary: 
      Prospective, open label, single center clinical study enrolling 70 subjects to study
      Performance, Human Factors, and Usability for the Carbon Monoxide Breath Sensor System
      (COBBS)
    

Detailed description: 
      Performance:

        -  Non-invasively measure carbon monoxide (CO) levels in the exhaled breath of study
           subjects using two different types of measurement devices.

        -  Assess the correlation between the measured CO levels (in parts per million, or ppm) of
           the study CO breath sensor (Carrot Sense) and the predicate CO breath sensor (Bedfont).

      Human Factors and Usability:

        -  Ensure that representative intended users are able to operate the COBSS independently.

        -  Validate appropriate mitigations of use related hazards identified in risk management
           documentation.

        -  Uncover previously unforeseen use errors.

      NOTES:

        -  The study design allows for the assessment of a performance endpoint and human factors
           endpoint in a single study.

        -  Each participant will complete the study in a single visit which will include the
           consent process, entry into the study, the study session, and conclusion of the study.
           The study session is completed on a single day requiring up to 90 minutes.
    

Intervention name(s): Carbon Monoxide Breath Sensor System (COBSS); Bedfont - Micro+™ Smokerlyzer®
Intervention type(s): Device; Device
Intervention description(s): Carbon Monoxide Breath Sensor System (COBSS): Device to measure carbon monoxide levels in one's breath and inform the user.; Bedfont - Micro+™ Smokerlyzer® : Predicate Device to measure carbon monoxide levels in one's breath.
Intervention MeSH terms: Carbon Monoxide
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: All subjects experience device use compared to a control device (predicate).
Masking: None (Open Label)
Primary purpose: Other
A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effect of dapagliflozin on renal outcomes and
      cardiovascular mortality in patients with chronic kidney disease.
    

Detailed description: 
      This is an international, multicentre, event-driven, randomized, double-blind, parallel
      group, placebo-controlled study, evaluating the effect of dapagliflozin versus placebo, given
      once daily in addition to standard of care, to prevent the progression of chronic kidney
      disease (CKD) or cardiovascular (CV)/renal death.
    

Intervention name(s): Dapagliflozin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg or 5 mg tablets given once daily, per oral use.; Placebo matching dapagliflozin 10 mg or 5 mg
Other intervention name(s): Forxiga TM; Farxiga TM
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Kidney Disease (CKD); Cardiovascular Events (CV); Phase III outcome trial