bioihbjkbjnl/mcl2 huggingface dataset:
Exenatide Versus Glimepiride 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: 
      This study assesses the effects of twice-daily subcutaneous injection exenatide versus
      treatment with sulfonylurea (glimepiride) on long-term glycemic control and beta-cell
      function.
    


Intervention name(s): exenatide; glimepiride
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous injection (5mcg or 10mcg), twice a day; oral tablet (titrated to maximally tolerated dose), once daily
Other intervention name(s): Byetta; Amaryl
Intervention MeSH terms: Exenatide; Glimepiride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: exenatide; diabetes; Amylin; Lilly; glimepiride
Hydration Factor Study for the Stayhealthy BC3
Condition: Body Composition
Study type: Interventional

Summary: 
      This was a pilot study to validate the BC3 hydration factor which will be important for
      determining how well this value represents hydration status compared to assessment of total
      body water by D20.
    

Detailed description: 
      The BC3 body composition analyzer is manufactured by Stayhealthy. It is a handheld,
      noninvasive bioelectrical impedance device. When held, the BC3 sends an electrical impulse
      through the body to determine body fat, lean mass, and total body hydration. Bio-impedance
      devices measure the change in electrical resistance in body tissues by using a detectable
      electrical signal that passes through the body. The method is based on the principle that
      lean body mass contains virtually all the water and conducting electrolytes in the body and
      provides a good electrical pathway. In contrast, fat or fat-containing tissues produce a poor
      electrical pathway. By inducing a low-energy, high-frequency signal, a measurement of the
      baseline resistance to flow of electrical current can be assessed. The resistance measurement
      relates directly to the volume of the conductor. Through repeated measurements and
      identifying other parameters (i.e. gender, weight, age and height) proprietary equations were
      developed that determine total body water, lean mass, and % body fat.

      The purpose of this study is to validate the calculated hydration factor produced by the BC3
      bioelectrical impedance device. If this value is valid and comparable to the gold standard
      (D20) then this hydration factor will offer a very quick and inexpensive method to determine
      total body hydration status using a hand-held bioelectrical impedance device.
    

Intervention name(s): D2O
Intervention type(s): Device
Intervention description(s): All participants received deuterium oxide (D2O) and testing with the BC3 for the measurement of total body water.
Other intervention name(s): Stayhealthy BC3 Body Composition Analyzer
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Body Fat; Total body water
Evaluate Cardiac Function Using Cardiac MRI and Dosimetric Correlation
Condition: Node Positive Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The association between radiation exposure and cardiac disease is well recognized, it is not
      fully understood if there exists an optimal or "safe" radiation dose-volume relationship.
    

Detailed description: 
      Identification of "safe" dose volume constraints (DVC) for the heart from breast cancer
      radiotherapy would permit maximal oncologic benefit from radiation, identifying which
      patients require more complicated and resource consumptive radiation methods such as
      respiratory-gating or intensity modulated radiotherapy (IMRT) and establish patients who need
      targeted follow-up for their long term cardiac risk. Two recent technical developments now
      make it conceivable to identify the dose-volume relationship between heart dose and
      subsequent cardiac event risk: 1. CT based three dimensional conformal radiation delivery
      methods (3DCRT) where the precise radiation dose to any given heart volume is known, and 2.
      Cardiac MRI (CMR) that is more sensitive to prior methods of cardiac evaluation (e.g. SPECT)
      for detecting and measuring cardiac injury.

      An MRI, subject health questionnaire, clinical and dosimetric data will be included in the
      analysis.
    

Intervention name(s): Radiation therapy groups
Intervention type(s): Radiation
Intervention description(s): Radiation Therapy treatment between 2000 and 2007.
Other intervention name(s): Regional nodal irradiation following lumpectomy/mastectomy.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women Treated for Node Positive Breast Cancer with Three-Dimensional Conformal Radiation
        Therapy (3DCRT)
      
Keywords: Breast Cancer
A Study to Evaluate Next Day Effects of MK-4305 on Driving Performance (MK-4305-035 AM1)
Condition: Insomnia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to evaluate next-day residual effects of MK-4305 on highway driving
      performance in healthy, non-elderly participants.
    


Intervention name(s): MK-4305 40 mg; MK-4305 20 mg; Zopiclone; Grossly Matching Placebo for Zopiclone; Matching Placebo for MK-4305
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): 4 x 10 mg MK-4305 tablets; 2 x 10 mg MK-4305 tablets; 1 x 7.5 mg Zopiclone tablet; Grossly Matching Placebo for Zopiclone; Matching Placebo for MK-4305
Other intervention name(s): Zimovane
Intervention MeSH terms: Zopiclone; Suvorexant
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Single Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics (PK) of SP-333 Tablets in Healthy Adult Subjects
Condition: Exposure
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, phase 1, single-blind, placebo-controlled, randomized, sequential,
      escalating, single-dose, study designed to evaluate the safety, tolerability,
      pharmacodynamics (PD) and pharmacokinetics (PK) properties of orally administered SP-333
      tablets.
    

Detailed description: 
      This is a randomized, phase 1, single-blind, placebo controlled, single-dose, study designed
      to evaluate the safety, tolerability, and pharmacokinetic properties of orally administered
      SP-333 tablets. The study will include 7 groups of 8 subjects each (6 active, 2 placebo)
      given a single oral dose of of SP-333 tablets or placebo. Following outpatient screening from
      approximately 5 to 42 days before dosing, each subject will enter the Clinical Pharmacology
      Unit (CPU) and will be housed from at least 48 hours, before dosing until 48 hours after
      dosing. Subjects will be given single dose of the study drug on the day of dosing and remain
      in the CPU for at least 48 hours. Subjects will return to the CPU on Days 8±1 and 15±1 for
      safety follow up. Safety Committee Meetings will be conducted to review safety, tolerability,
      and available Pharmacokinetic data from the current and previous treatment group(s), prior to
      dosing subsequent treatment groups. Subjects in a given treatment group are considered
      completers once they have completed the Day 15±1 day Follow up Visit.
    

Intervention name(s): SP-333
Intervention type(s): Drug
Intervention MeSH terms: Dolcanatide
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Other
Personalized Cellular Vaccine for Brain Metastases (PERCELLVAC3)
Condition: Brain Cancer; Neoplasm Metastases
MeSH terms: Neoplasm Metastasis; Brain Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Cancer patients with brain metastases (BM) have poor prognosis. Current treatments produce
      limited efficacy. Recent advance in cancer immunotherapy has provided important new means to
      treat cancer patients at advanced stages. This study is designed to perform a clinical trial
      to treat advanced caner patients with brain metastases with personalized dendritic cell-based
      cellular vaccines. The patients will receive vaccines consisting of mRNA tumor antigen pulsed
      DCs. Immune response to the immunized tumor antigens will be monitored. Safety and efficacy
      will be observed in this study.
    

Detailed description: 
      This is an open label, single-arm, single-institution, Phase I study designed to investigate
      the safety and efficacy of personalized cellular tumor vaccines for cancer patients with
      brain metastases (BM). BM patients will undergo tumor resection or biopsy and the tumor
      tissues will be analyzed for the expression of tumor antigens and immune-related genes. The
      patients will be immunized with DCs pulsed with mRNA encoded tumor antigens. Patients will be
      immunized with DC vaccines on a biweekly basis. Safety and efficacy will be monitored. The
      objective of this study is to assess the safety of the personalized cellular vaccines and to
      deterimine the antitumor specific T cell responses. The efficacy of the vaccines will be
      determined using RANO-BM criteria, progression-free survival and overall survival.
    

Intervention name(s): Personalized cellular vaccine
Intervention type(s): Biological
Intervention description(s): Cancer patients with brain metastases will undergo tumor resection or biopsy, and receive tumor antigen mRNA pulsed cellular vaccines.
Other Names:
• Tumor antigen pulsed DC and PBMC, autologous tumor vaccine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Solid tumors; Brain metastases; DC vaccine; Personalized vaccine; Tumor antigens
A Study of Meningococcal Vaccine, Menactra® in Healthy Subjects in India
Condition: Meningococcal Infection; Meningitis
MeSH terms: Meningococcal Infections; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety and immunogenicity of a single dose of
      Menactra® vaccine to support registration.

      Primary Objectives:

        -  To describe the antibody titers measured by serum bactericidal activity using baby
           rabbit complement (SBA-BR) before and after Menactra® vaccination.

        -  To describe the safety profile of participants after one dose of Menactra®.
    

Detailed description: 
      Participants will be enrolled in three age cohorts: Children: 2 - 11 years of age;
      Adolescents: 12 - 17 years of age, and Adults: 18 - 55 years of age to receive a single dose
      of Menactra®. They will be followed for a duration of 30 days after vaccination.
    

Intervention name(s): Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Menactra®)
Intervention type(s): Biological
Intervention description(s): 0.5 mL, Intramuscular
Other intervention name(s): Menactra®
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningococcal Infection; Meningitis, Bacterial; Menactra®
Cilostazol Verse Asprin for Vascular Dementia in Poststroke Patients With White Matter Lesions
Condition: Vascular Dementia; Stroke
MeSH terms: Dementia; Dementia, Vascular
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the efficacy of PDE-3 inhibitor, cilostazol, in
      prevention and treatment of vascular dementia, in those with brain white matter lesions and
      vascular risk factors.
    


Intervention name(s): Cilostazol; Aspirin
Intervention type(s): Drug; Drug
Intervention description(s): Cilostazol 100 mg bid for 12 months; Aspirin 100 mg qd for 12 months
Intervention MeSH terms: Aspirin; Cilostazol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cognition
Comparative Wockhardt's Glucose Clamp Study-Human Isophane Susp 30IU/ml/70IU/ml With Novolin70/30, in Healthy Subjects
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this trial is to demonstrate bioequivalence of Wosulin 70/30 to Novolin® 70/30
      with regard to its total and to its maximum serum insulin concentrations.
    

Detailed description: 
      The purpose of this study is is to test for bioequivalence based on AUC0-24h and Cmax between
      Wosulin 70N/30R and Novolin 70/30.The study also compares the pharmacokinetic and
      pharmacodynamic profiles as well as assessing safety and local tolerability of the two
      insulin preparations in healthy subjects.
    

Intervention name(s): 30% Regular Insulin Human Neutral and 70%Isophane Insulin; Novolin 70/30
Intervention type(s): Biological; Biological
Intervention description(s): Total Dose per subject is 0.4 IU/Kg given subcutaneously.; Total Dose per subject is 0.4IU/Kg given Subcutaneously.
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin, Isophane; Isophane Insulin, Human; Isophane insulin, beef
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Characterization of the Iatrogenic Drug Risk in Elderly Patients With Chronic Pain Who Consult the Pain Assessment and Treatment Centre at the Nimes University Hospital
Condition: Iatrogenic Drug Risk; Chronic Pain
MeSH terms: Chronic Pain
Study type: Observational

Summary: 
      Chronic pain may be an additional risk factor for drug iatrogeny due to its management and
      also drug non-compliance in the geriatric population.

      it seems interesting to carry out an inventory of the iatrogenic risk before and after the
      consultation at the pain centre to enable us to identify the patients most at risk. This
      study would make it possible to characterize elderly patients with chronic pain, in order to
      consider, in a future study, setting up a pharmaceutical consultation.
    


Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients aged at least 65 years consulting at the pain centre of the Nîmes University
        Hospital for chronic pain
a Clinical Trial to Evaluate the Efficacy and Safety of Agnucaston Tablets in the Treatment of Premenstrual Syndrome (PMS)
Condition: Premenstrual Syndrome
MeSH terms: Syndrome; Premenstrual Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare the efficacy and safety of Agnucaston tablets with placebo for the treatment of
      Premenstrual Syndrome (PMS) and assess if Agnucaston tablets are superior to placebo on
      efficacy or not.
    

Detailed description: 
      Premenstrual syndrome (PMS) is a common disorder in women and consists of somatic and/or
      behavioral/mood symptoms, which can impair a woman's social and work-related functioning.
      Some clinical studies with preparations containing Vitex agnus castus have demonstrated a
      positive effect on PMS with good tolerability. The aim of this clinical trial is to
      investigate the efficacy and safety of Agnucaston tablets for the therapy of PMS.
    

Intervention name(s): extracts of Vitex agnus castus tablets; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): orally, one tablet daily. Apply for a period of 3 months. Do not interrupt during menses period.; Placebo
Other intervention name(s): Agnucaston tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: premenstual syndrome, PMS, clinical trial
Clinical Outcome of Birmingham Hip Resurfacing (BHR) Using VISIONAIRE Femoral Alignment Guide
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Observational

Summary: 
      The primary objective of this study is to investigate the accuracy of the femoral implant
      placement utilizing the VISIONAIRE Femoral Alignment Guide in Birmingham Hip Resurfacing
      (BHR) surgery postoperatively after total hip resurfacing using the BHR System.
    

Detailed description: 
      This is a prospective, multi- site, clinical study of clinical outcomes following hip
      resurfacing using VISIONAIRE Femoral Alignment Guide. The objective of this study is to
      evaluate the safety and efficacy of the blocks and to assess alignment of the BHR system when
      using VISIONAIRE Femoral Alignment Guide. This study will also document any device-related
      surgical complications or adverse radiographic observations.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The patient population considered for this study is patients requiring total hip
        resurfacing. The following inclusion and exclusion criteria will be used to identify study
        candidates.
Safety Study of ISIS 325568 in Healthy Volunteers
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this trial is to assess the safety of ISIS 325568 when given at
      increasing single doses and to assess the safety of the same doses when given multiple times.
    

Detailed description: 
      To evaluate the safety of a single subcutaneous injection of ISIS 325568 administered at four
      increasing dose levels (50, 100, 200, 400 mg/week) and to evaluate the safety and
      tolerability of multiple doses of ISIS 325568 (three intravenous doses during Study Week 1,
      followed by once weekly subcutaneous administration for 5 weeks) at each of the four dose
      levels
    

Intervention name(s): ISIS 325568
Intervention type(s): Drug
Intervention description(s): 4 arms of single dose s.c. injections: A 50 mg B 100 mg C 200 mg D 400 mg 4 arms of multi-dose: 3 i.v. infusions over 1 week followed by 5 weekly s.c. injections AA 50 mg BB 100 mg CC 200 mg DD 400 mg or EE 50 mg
Placebo: 0.9% Sodium Chloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diabetes
Amniotic Fluid Sludge in Cerclage Patients as an Indicator for Increased Risk of Preterm Delivery and Neonatal Outcome.
Condition: High Risk Pregnancy; Incompetent Cervix; Cerclage; Amniotic Fluid Sludge; Gestation Age at Delivery.
MeSH terms: Premature Birth; Uterine Cervical Incompetence
Study type: Observational

Summary: 
      Amniotic Fluid "Sludge" Does Not Increase Risk of Preterm Delivery in Cerclage Patients.
    

Detailed description: 
      177 patients were selected from a data base of 1890. 60 patients had sludge, 117 did not have
      sludge. Conclusion AF sludge on ultrasound had no association with increased risk of preterm
      delivery in patients with cerclage.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Patients at CMFM
      
Keywords: Amniotic Fluid Sludge; Cerclage; Ultrasound; Preterm Delivery; Neonatal
A Phase 2, Multicenter, Open-label Study of MEDI-551 in Adults With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)
Condition: Chronic Lymphocytic Leukemia (CLL)
MeSH terms: Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The overall purpose of the study was to determine if MEDI-551, when used in combination with
      salvage chemotherapy (bendamustine) in participants with relapsed or refractory CLL who are
      not eligible for Autologous Stem Cell Transplant (ASCT), had superior efficacy compared to
      rituximab in the same population.
    


Intervention name(s): Rituximab; Bendamustine; MEDI-551
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Rituximab was administered by IV infusion as a dose of 375 mg/m^2 on Day 2 of Cycle 1 and then at 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycles; Bendamustine was administered by IV infusion as a dose of 70 mg/m^2 on Day 1 and Day 2 of each 5 subsequent 28-day cycle.; MEDI-551 was administered at 2 mg/kg or 4 mg/kg by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycles.
Other intervention name(s): Rituxan; MabThera
Intervention MeSH terms: Rituximab; Bendamustine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic lymphocytic leukemia; leukemia; B-Cell malignancy; anti-CD19; monoclonal antibody; CLL; Refractory; Relapse; Non-Hodgkin's Lymphoma
A Clinical Trial to Evaluate the Pharmacokinetics and Safety/Tolerability of Fimasartan and Linagliptin in Healthy Volunteers
Condition: Hypertension; Diabetes
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics and safety/tolerability when
      administrated fixed dose combination of Fimasartan/Linagliptin and when co-administrated
      Fimasartan and Linagliptin.
    

Detailed description: 
      This is an open-label, randomized, 3x3 partial replicated crossover study to evaluate the
      pharmacokinetics and safety/tolerability. Within each period, randomized subjects will be 2
      dosing regimens with a fixed dose combination of Fimasartan/Linagliptin and co-administration
      of Fimasartan and Linagliptin.
    

Intervention name(s): Treatment A (Fimasartan, Linagliptin); Treatment B (Fimasartan/Linagliptin)
Intervention type(s): Drug; Drug
Intervention description(s): Co-administration of Fimasartan and Linagliptin; Fixed Dose Combination of Fimasartan 120 mg/Linagliptin 5 mg
Intervention MeSH terms: Linagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Fimasartan; Linagliptin