bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety Study of BMS-986142 in Patients With Moderate to Severe Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: BMS-986142; Placebo; Methotrexate
Intervention description: BMS986142 specific dose on specific days; Placebo of BMS-986142 specific dose on specific days; Methotrexate specific dose on specific days
Intervention MeSH terms: Methotrexate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 508.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether the study drug, BMS-986142, is safe and
      effective in treating moderate to severe rheumatoid arthritis in subjects with an inadequate
      response to methotrexate or methotrexate and up to 2 tumour necrosis factor (TNF) Inhibitors.
      Patients who qualify will be randomized to either one of 3 doses of BMS-986142 or placebo in
      1:1:1 randomization for 12 weeks. Disease activity and safety will be assessed over the
      course of the study.
    

Eligibility criteria:

        For more information regarding BMS clinical trial participation, please visit
        www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Male and female age 18 and above

          -  Diagnosed with active rheumatoid arthritis (RA) by standard criteria at least 16 weeks
             before screening, have functional ACR class I-III

          -  Have an inadequate response to methotrexate

          -  In addition to an inadequate response to methotrexate have an inadequate response or
             intolerance to 1 but not more than 2 TNF inhibitors

          -  Have a minimum of 6 swollen and 6 tender joints (from 66/68 joint count)

          -  Have hsCRP of ≥ 0.8 mg/dL (8mg/L) [by central laboratory values] or an ESR ≥ 28 mm/hr

          -  Willing to use effective birth control for the entire length of the study

        Exclusion Criteria:

          -  Diagnosed with juvenile Rheumatoid Arthritis

          -  Have been treated with other biologic treatment than a TNF inhibitor

          -  Active systemic bacterial, viral or fungal infection or evidence of prior or current
             Hepatitis B or C infection or HIV infection, latent bacterial, viral or fungal
             infections

          -  Have been treated with Intramuscular or Intra-articular glucocorticosteroids within 4
             weeks of randomization

          -  Taking Oral steroids at dose above 10 mg/day of prednisone (or prednisone equivalents)

          -  Have other autoimmune disease other than RA like lupus, multiple sclerosis

          -  Have significant concurrent medical condition at the time of screening or baseline
             visit
Effect of Propolis or Metformin Administration on Glycemic Control in Patients With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Propolis; Metformin; Placebo
Intervention description: Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.; Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.; Calcined magnesium, two times per day before break-fast and dinner during 12 weeks.
Intervention MeSH terms: Metformin; Propolis
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 36.0
Sex: All
Minimum age: 30 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus type 2; Glycemic control; Propolis; Metformin; Pharmacological treatment-naïve patients

Summary:

      The aim of this study was to evaluate the effect of propolis or metformin on glycemic control
      in patients with type 2 diabetes mellitus without pharmacological treatment.

      All patients received for 12 weeks propolis, metformin or placebo. Fasting serum glucose, 2-h
      serum glucose after oral glucose tolerance test, glycated hemoglobin A1c, a metabolic
      profile, areas under the curve of glucose and insulin, insulinogenic index, Stumvoll index,
      and Matsuda index were measured.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients both sexes

          -  Age between 30 and 60 years

          -  Mild to moderate physical activity

          -  Stable body weight for at least 12 weeks prior to the study

          -  BMI 25.0 - 34.9 kg/m2

          -  Diabetes mellitus type 2 of recent diagnosis without pharmacological treatment, with
             one of the following criteria (fasting blood glucose levels >126 mg/dl; or
             postprandial blood glucose levels after an oral glucose tolerance test with 75 of oral
             glucose >200 mg/dl

          -  Informed consent signed

        Exclusion Criteria:

          -  Women with confirmed or suspected pregnancy

          -  Women under lactation and/or puerperium

          -  Previous treatment for glucose

          -  Fasting glucose ≥250 mg/dL

          -  Known uncontrolled renal, hepatic, heart or thyroid diseased

          -  Hypersensibility to ingredients of intervention

          -  Known allergies to bee stings or their derived products

          -  Triglycerides ≥500 mg/dL

          -  Total cholesterol ≥240 mg/dL
Empagliflozin and ACEi- Effects on Hyperfiltration: BETWEEN Study
Condition: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Obesity
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
Intervention: Empagliflozin; Placebo (matching empagliflozin); ramipril
Intervention description: Empagliflozin will be taken once daily; Placebo will be taken once daily; Ramipril will be taken once or twice daily
Intervention MeSH terms: Empagliflozin; Ramipril
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized, double-blind, double-dummy, placebo-controlled, cross over design trial
      with empagliflozin compared to placebo that is added to open-label ramipril.
    

Eligibility criteria:

        Inclusion criteria:

          -  Signed and dated written informed consent.

          -  Male or female patients diagnosed with type 1 diabetes (T1D) at least 6 months prior
             to informed consent or type 2 diabetes (T2D) or non-diabetic obese patients.

          -  T1D patients must use and be willing of and be willing to continue throughout the
             duration of the trial either:

          -  multiple daily injections of insulin OR

          -  continuous sub-cutaneous insulin infusion of any insulin type, with at least 3 months
             experience

          -  For patients with T1D or T2D,HbA1c of 6.5 - 11%

          -  Age at least 18 years of age

          -  Body mass index of >=18.5 kg/m^2

          -  Estimated glomerular filtration rate greater than or equal to 60 ml/min/1.73m2

          -  Blood pressure greater than 90 /60 mmHg and less than or equal to 140 / 90 mmHg

          -  Use of a highly effective method of contraception.

          -  Further inclusion criteria apply

        Exclusion criteria:

          -  For patients with T1D, treatment with an antihyperglycaemic agent within 3 months
             prior to visit 1

          -  occurrence of severe hypoglycaemia within 3 months prior to visit 1

          -  hypoglycaemic unawareness within 3 months prior to visit 1

          -  occurrence of diabetic ketoacidosis within 3 months of visit 1 and until visit 3
             Further exclusion criteria apply
ADA Gene Transfer Into Hematopoietic Stem/Progenitor Cells for the Treatment of ADA-SCID
Condition: Immunologic Deficiency Syndromes
MeSH terms: Immunologic Deficiency Syndromes
Intervention: Gene Therapy; Busulfan
Intervention description: Infusion of autologous CD34+ cells transduced with retroviral vector encoding ADA after non-myeloablative conditioning with busulfan; Busulfan is used for non-myeloablative conditioning
Intervention MeSH terms: Busulfan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Maximum age: 17 Years
Healthy volunteers: No
Keywords: SCID; gene therapy; Adenosine deaminase; retroviral vector

Summary:

      This is a phase I/II protocol to evaluate the safety and efficacy of ADA gene transfer into
      hematopoietic stem/progenitor cells for the treatment of adenosine deaminase
      (ADA)-deficiency. This condition is an autosomal recessive form of Severe Combined
      Immunodeficiency (SCID) characterized by impaired immune responses, recurrent infections,
      failure to thrive and systemic toxicity due to accumulation of purine metabolites.
      Transplants from an human leukocyte-antigen (HLA)-identical sibling donor is the treatment of
      choice, but available for a minority of patients. The use of alternative bone marrow donors
      or enzyme replacement therapy is associated with important drawbacks. The drug product
      studied in this protocol consists of autologous cluster of differentiation (CD)34+
      hematopoietic stem/progenitor cells engineered ex vivo with a retroviral vector encoding the
      therapeutic gene ADA. The engineered CD34+ cells are infused following a nonmyeloablative
      conditioning with busulfan to make space in the bone marrow. The study objectives are: a) to
      evaluate the safety and the clinical efficacy of gene therapy, in the absence of enzyme
      replacement therapy; b) to evaluate the biological activity (engraftment, ADA expression) of
      ADA transduced CD34+ cells and their hematopoietic progeny. c) to evaluate the immunological
      reconstitution and purine metabolism after gene therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ADA-SCID with no HLA-identical sibling donor available

          -  pediatric age and at least one of the following criteria:

          -  inadequate immune response after PEG-ADA for > 6 months

          -  patients who discontinued PEG-ADA due to intolerance, allergy or auto-immunity

          -  patients for whom enzyme replacement therapy is not a life long therapeutic option

        Exclusion Criteria:

          -  HIV infection

          -  history or current malignancy

          -  Patients who received a previous gene therapy treatment in the 12 months prior to
             receiving Strimvelis

          -  any other conditions dangerous for the patients according to the investigator
Deferasirox, Cholecalciferol, and Azacitidine in the Treatment of Newly Diagnosed AML Patients Over 65
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia
Intervention: Deferasirox; Cholecalciferol; Azacitidine
Intervention description: Deferasirox (20mg/kg/day)on days 1-7 of protocol every 4 wks for 8 cycles PO; Cholecalciferol(4,000 units/day) on days 1-7 of protocol every 4 wks for 8 cycles PO; Azacitidine (75mg/m2 subcutaneous or IV administration) on days 1-7 of protocol 28 days for 32 wks
Intervention MeSH terms: Vitamin D; Cholecalciferol; Azacitidine; Deferasirox
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 65 Years
Maximum age: 89 Years
Healthy volunteers: No
Keywords: Azacitidine; Vidaza; Deferasirox; Exjade; Cholecalciferol; Vitamin D

Summary:

      The purpose of this study is to find out if by giving a combination of 3 drugs the leukemia
      will go into complete remission (meaning the leukemia is completely gone), and to find out
      how long it stays away. The drugs used in this project are FDA approved and commercially
      available.
    

Eligibility criteria:

        Inclusion Criteria:

          -  65 or older (must have reached 65th birthday)

          -  Morphologically confirmed diagnosis of AML, excluding AML-M3

          -  Must have a Zubrod performance status of 0-3

        Exclusion Criteria:

          -  Patients with known HIV infection are excluded. If HIV infection is suspected based on
             clinical condition, testing may be performed at the discretion of treatment team, but
             is not mandated prior to enrollment.

          -  Patients with central nervous system involvement by AML are excluded

          -  Patients with history of an active cancer (except basal cell and squamous cell cancers
             of the skin) within the previous 2 years are excluded
Losartan to Reduce Inflammation and Fibrosis Endpoints in HIV Trial
Condition: Inflammation; Fibrosis
MeSH terms: Fibrosis; Inflammation
Intervention: Losartan 100mg daily; Matching placebo
Intervention MeSH terms: Losartan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 108.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the potential effectiveness of losartan (100mg
      daily) for reducing inflammation and improving immune recovery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HIV infection (verified by previous positive antibody or detectable HIV RNA level)

          -  Age > 50 years

          -  Receiving continuous ART for >= 2 years (regimen changes > 6 months prior to
             enrollment are allowed)

          -  HIV RNA level < 200 copies/mL for >= 1 year (1 measure >= 200 allowed if also < 1000
             and preceded and followed by values < 200 copies/mL)

          -  Blood CD4+ T-cell count < 600 cells/mm cubed

          -  Systolic blood pressure > 120 mmHg (mean value if >= 2 measures obtained)

          -  Estimated glomerular filtration rate (GFR )> 30 mL/min/1.73 m squared

          -  Do not anticipate starting or stopping statin or aspirin therapy during the study

        Exclusion Criteria:

          -  Pregnancy or breastfeeding

          -  A contra-indication to taking an angiotensin receptor blocker (ARB) (e.g., cirrhosis,
             prior angioedema with angiotensin-converting enzyme inhibitor (ACE-I), or use of drug
             with potential drug-interaction [e.g., rifaximin])

          -  A clinical indication for ARB or ACE-I therapy (e.g., cardiovascular disease (CVD),
             stroke, or diabetes mellitus (DM))

          -  Current treatment with ARB or medication with overlapping mechanism (e.g., ACE-I or
             aldosterone antagonist)

          -  Current treatment with immunomodulatory drugs within the past 6 months

          -  Current hepatitis treatments (e.g., interferon, ribavirin) within the past 6 months

          -  Serum potassium > 5.0 millimoles per liter (mmol/L) within 3 months of entry

          -  Invasive cancer in the prior year or receiving cancer treatment (not including
             carcinoma-in-situ or basal cell cancer of the skin)

          -  Cirrhosis or end-stage liver disease

          -  Rheumatologic or chronic inflammatory disease (e.g., systematic lupus erythematous,
             psoriasis, rheumatoid arthritis, vasculitis, sarcoidosis, Crohn's disease)
Study To Evaluate Safety And Efficacy Of PF-06700841 In Subjects With Moderate To Severe Plaque Psoriasis
Condition: Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Intervention: PF-06700841; Placebo
Intervention MeSH terms: PF-06700841
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 212.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: plaque psoriasis

Summary:

      The purpose of this study is to determine whether PF-06700841 is safe and effective in the
      treatment of chronic plaque psoriasis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have had a diagnosis of plaque psoriasis (psoriasis vulgaris) for at least 6 months
             prior to Baseline/Day 1 (prior to first dose of study drug)

          -  Have a PASI score of 12 or greater AND a PGA score of 3 ("moderate") or 4 ("severe")
             at Baseline/Day 1 (prior to first dose of study drug)

          -  Have plaque-type psoriasis covering at least 10% of total body surface area (BSA) at
             Baseline/Day 1 (prior to first dose of study drug)

          -  Considered by dermatologist investigator to be a candidate for systemic therapy or
             phototherapy of psoriasis (either naïve or history of previous treatment)

        Exclusion Criteria:

          -  Currently have non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular
             psoriasis, with the exception of nail psoriasis which is allowed

          -  Have evidence of skin conditions (eg, eczema) at the time of screening or baseline
             visit that would interfere with the evaluation of psoriasis

          -  Cannot discontinue systemic therapies and/or topical therapies for the treatment of
             psoriasis and cannot discontinue phototherapy (UVB or PUVA)

          -  Have previously been treated with Secukinumab (Cosentyx), and Ixekizumab (Taltz).

          -  Have taken Apremilast (Otezla) within 3 months of first dose of study drug.

          -  Have undergone treatment with tofacitinib within 3 months of first dose.
Study of Intravitreal REGN2176-3 in Participants With Neovascular ("Wet") Age-Related Macular Degeneration (AMD)
Condition: Neovascular Age-Related Macular Degeneration
MeSH terms: Macular Degeneration; Wet Macular Degeneration
Intervention: REGN2176-3; Intravitreal Aflibercept Injection (IAI)
Intervention MeSH terms: Aflibercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 505.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      The primary objective of the study was to explore the effect of REGN2176-3 on the Early
      Treatment Diabetic Retinopathy Scale (ETDRS) best-corrected visual acuity (BCVA) in
      participants with neovascular age-related macular degeneration (AMD), compared to
      intravitreal aflibercept injection (IAI) monotherapy.

      The secondary objectives of the study were the following:

        -  To explore the effect of 2 dose levels of IVT REGN2176-3 on anatomical changes of CNV in
           participants with nAMD compared to IAI monotherapy (at week 12)

        -  To evaluate if short-term treatment with REGN2176-3 followed by IAI monotherapy offered
           the same or additional benefit compared to continuous treatment with REGN2176-3. Also to
           determine if there was benefit in initiating IAI treatment prior to REGN2176-3 compared
           to continuous treatment with IAI.

        -  To assess the safety and tolerability of IVT REGN2176-3 in participants with nAMD
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Men or women ≥50 years of age

          2. Active subfoveal CNV secondary to AMD as evidenced by FA in the study eye, as
             determined by the reading center, including juxtafoveal lesions that affect the fovea

          3. BCVA ETDRS letter score of 73 to 24 (20/40 to 20/320) in the study eye at the
             screening visit

          4. Provide signed informed consent

        Key Exclusion Criteria:

          1. Any prior treatment with anti-VEGF treatment in the study eye

          2. Any prior treatment (ie, systemic or ocular treatment) with PDGF or PDGFR inhibitors

          3. Dense fibrotic scar or atrophy in the study eye involving the center of the fovea

          4. Presence of retinal pigment epithelial tears or rips involving the macula in the study
             eye

          5. Prior vitrectomy in the study eye

          6. Any history of macular hole of stage 2 and above in the study eye

          7. Any intraocular or periocular surgery within 3 months of day 1 in the study eye,
             except lid surgery

          8. History of corneal transplant in the study eye

          9. Evidence of diabetic retinopathy or diabetic macular edema in either eye

         10. Positive serum human chorionic gonadotropin/urine pregnancy test at the screening or
             baseline visit
A Phase II Study to Evaluate Axumin PET/CT for Risk Stratification for Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Axumin PET/CT
Intervention description: Synthetic amino acid uptake agent injection followed by imaging
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Intervention model description: Cohort
Masking: None (Open Label)
Masking description: No masking
Enrollment: 20.0
Sex: Male
Minimum age: 45 Years
Healthy volunteers: No

Summary:

      To investigate the utility of fluciclovine F 18 for evaluation for metastatic disease in men
      undergoing laser focal therapy of prostate cancer and the impact on inclusion for a focal
      therapy cohort.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male, 45 years of age or older.

          2. Diagnosis of prostate adenocarcinoma.

          3. Clinical stage T1a, T1b, T1c, T2a, T2b orT2c.

          4. Gleason score of 7 (3+4 or 4+3).

          5. PSA density less than 0.375.

          6. One, two, or three tumor suspicious regions identified on multiparametric MRI.

          7. Negative radiographic indication of extra-capsular extent.

          8. Karnofsky performance status of at least 70.

          9. Estimated survival of 5 years or greater, as determined by treating physician.

         10. Tolerance for anesthesia/sedation.

         11. Ability to give informed consent.

        Exclusion Criteria:

          1. Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.

          2. Severe lower urinary tract symptoms as measured by an International Prostate Symptom
             Score (IPSS) of 20 or greater. ( (http://www.urospec.com/uro/Forms/ipss.pdf)

          3. History of other Primary non-skin malignancy within previous three years.

          4. Diabetes.

          5. Smoker.