bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel in Patients With Acute Ankle Sprain
Condition: Ankle Sprain
MeSH terms: Sprains and Strains; Ankle Injuries
Intervention: Diclofenac diethylamine 2.32% gel; Placebo; Diclofenac diethylamine 2.32% gel / Placebo
Intervention description: Diclofenac diethylamine 2.32% gel twice daily; Vehicle 2 times daily; Diclofenac diethylamine 2.32% gel once daily / Vehicle once daily
Intervention MeSH terms: Diclofenac
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 271.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Ankle, sprain, diclofenac diethylamine

Summary:

      This study will evaluate the efficacy of diclofenac diethylamine 2.32% gel in the treatment
      of acute ankle sprain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Acute sprain of the ankle

          -  Injury within past 48 hours.

        Exclusion Criteria:

          -  Pain medication taken since the injury

          -  Pain or instability in the same ankle due to previous ankle sprain or any other
             trauma.

          -  Ankle sprain due to a known disease affecting the ligaments

        Other protocol-defined inclusion/exclusion criteria may apply
Efficacy Study of Intranasal Insulin to Treat Tobacco Abstinence Syndrome
Condition: Tobacco Abstinence Syndrome
MeSH terms: Syndrome
Intervention: Intranasal Insulin; Placebo
Intervention MeSH terms: Insulin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will evaluate safety and efficacy of intranasal insulin in abstinent smokers.
      Groups' (placebo vs. insulin) cognitive function and stress response will be compared.
    

Eligibility criteria:

        Inclusion Criteria:

          -  smokers (>10 cig/day) for the past 1 year

          -  normosmic olfactory function

        Exclusion Criteria:

          -  previous/current use of insulin

          -  current Diagnostic and Statistical Manual-IV-Revised (DSM-IV-R) Axis I disorder

          -  current pregnancy (or lactation)

          -  lifetime history of endocrine disease

          -  excessive alcohol use (>25 standard units of alcohol/week)

          -  current use of illicit drugs

          -  current use of a smoking cessation aid (NRT, Chantix or Wellbutrin), or a psychotropic
             agent

          -  local infections, inflammation, structural abnormalities, or other nasal pathology

          -  current use of any medications administered intranasally, including intranasal
             steroids
A Study to Assess the Effect of Ticagrelor in Reducing the Number of Days With Pain in Patients With Sickle Cell Disease
Condition: Sickle Cell Disease
MeSH terms: Anemia, Sickle Cell
Intervention: Ticagrelor; Placebo
Intervention description: Two arms: 1) 10 mg ticagrelor + 45 mg ticagrelor placebo or 2) 45 mg ticagrelor + 10 mg ticagrelor placebo. Drugs taken orally, twice a day (morning and evening, at least 12 hours apart) from randomization until the end of treatment.; 10 mg ticagrelor placebo + 45 mg ticagrelor placebo. Drugs taken orally, twice a day (morning and evening at least 12 hours apart) from randomization until the end of treatment
Intervention MeSH terms: Ticagrelor
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Maximum age: 30 Years
Healthy volunteers: No
Keywords: Sickle cell disease; Young adults; Hestia2; Ticagrelor

Summary:

      The purpose of this study is to determine whether ticagrelor is effective in reducing the
      number of days of pain, intensity of pain, and reducing the use of analgesics due to sickle
      cell disease
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed medical history or diagnosis of homozygous sickle cell (HbSS) or sickle
             beta-zero-thalassaemia (HbS/β0) by HPLC

          -  If treated with hydroxyurea, the dose must have been stable for 3 months

        Exclusion Criteria:

          -  History of transient ischaemic attack or clinically overt cerebrovascular accident

          -  Moderate or severe hepatic impairment

          -  Treatment with chronic red blood cell transfusion therapy

          -  Pre-dominate cause of pain is not sickle cell disease related

          -  Chronic treatment with anticoagulants or antiplatelet drugs.
Study to Determine the Safety and Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) in Patients Who Have Previously Not Received the Standard of Care
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: PSI-7977; Daclatasvir; Ribavirin
Intervention description: Tablets, oral, 400 mg, once daily; Tablets, oral, 60 mg, once daily; Tablets, oral, 200 mg
Intervention MeSH terms: Ribavirin; Sofosbuvir
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 350.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to determine whether therapy with the combination of PSI-7977 and
      daclatasvir (BMS-790052) with or without ribavirin is effective in treating hepatitis C virus
      (HCV) infection when given for 12 or 24 weeks as measured by sustained virologic response
      with undetectable HCV RNA 12 weeks post treatment
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women, ages 18 to 70 years.

          -  Participants infected with hepatitis C virus (HCV) genotype 1, 2, or 3, with no
             previous exposure to an interferon formulation (ie, interferon-alpha, pegylated
             interferon-alpha) ribavirin, or other HCV-specific direct-acting antiviral (including
             daclatasvir and PSI-7977).

          -  Patients should have chronic hepatitis C genotype 1a, 1b, 2, or 3 as documented by:
             positive test results for anti-HCV antibody; HCV RNA; or a HCV genotype at least 6
             months prior to screening, and HCV RNA and anti-HCV antibody at the time of screening.

        Exclusion Criteria:

          -  Evidence of a medical condition associate with chronic liver disease other than HCV.

          -  History of variceal bleeding, hepatic encephalopathy, or ascites requiring management
             with diuretics or paracentesis.

          -  History of hemophilia.

          -  History of torsade de pointes.

          -  Current or known history of cancer (except in situ carcinoma of the cervix or
             adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior
             to enrollment.

          -  History of gastrointestinal disease or surgical procedure (except cholecystectomy).

          -  History of clinically significant cardiac disease.

          -  Blood transfusion within 4 weeks prior to study drug administration.

          -  Poor venous access.

          -  Any other medical, psychiatric, and/or social reason which, in the opinion of the
             Investigator, would make the candidate inappropriate for participation in this study.
A Phase 2a Study to Assess Safety, Daily Symptoms, PK, and Biomarkers of YPL-001 in COPD Patients
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: YPL-001 80 mg; YPL-001 160 mg; Placebo
Intervention description: twice daily [BID]; twice daily [BID]; twice daily [BID]
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 61.0
Sex: All
Minimum age: 30 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: COPD

Summary:

      This is a Phase 2a, proof-of-concept, multicenter, randomized, double-blind, double dummy,
      3-treatment, parallel study, with low and high YPL 001 doses (low dose and high dose twice
      daily [BID]) and a placebo control in moderate to severe Chronic Obstructive Pulmonary
      Disease (COPD) patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult males and/or females, 30 to 85 years of age (inclusive).

          -  History of COPD for at least 12 months prior to screening.

          -  Diagnosed with COPD as defined by the American Thoracic Society (ATS)/European
             Respiratory Society (ERS) guidelines with symptoms compatible with COPD for at least
             12 months prior to screening.

          -  Classified as moderate to severe COPD based on the current severity classification
             GOLD Stage 2-3 disease in terms of post-bronchodilator spirometry at screening

          -  etc.

        Exclusion Criteria:

          -  History of life-threatening COPD including respiratory arrest, intensive care unit
             admission and/or requiring intubation.

          -  History of more than 2 hospitalizations for COPD within 12 months prior to screening.

          -  Presentation of an acute exacerbation of COPD that will be associated with increase
             sputum volume or change in sputum color within 4 weeks before Day 1 of the Run-in
             Period.

          -  Evidence of pulmonary heart disease, or clinically significant pulmonary hypertension.

          -  etc.
A Phase 2 Study of LY3209590 in Participants With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: LY3209590; Insulin Degludec
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Insulin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 278.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The reason for this study is to see if the study drug LY3209590 is safe and effective in
      participants with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have type 2 diabetes mellitus according to the World Health
             Organization (WHO) criteria treated with a stable dose of metformin in combination
             with a stable dose of Dipeptidyl Peptidase IV (DPPIV) inhibitor and/or a
             Sodium-glucose co-transporter-2 (SGLT2) inhibitor for at least 3 months prior to
             screening

          -  Participants must have a HbA1c value of 7.0% to 9.5%, inclusive

          -  Participants must have a body mass index (BMI) between 20 and 45 kilograms per meter
             squared (kg/m²), inclusive

        Exclusion Criteria:

          -  Have type 1 diabetes mellitus or latent autoimmune diabetes

          -  Have any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6
             months prior to screening

          -  Have any of the following cardiovascular (CV) conditions: acute myocardial infarction,
             New York Heart Association Class III or IV heart failure, or cerebrovascular accident
             (stroke)

          -  Have acute or chronic hepatitis, or obvious clinical signs or symptoms of any other
             liver disease

          -  Have an estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 m²

          -  Have active or untreated cancer

          -  Are receiving chronic (>14 days) systemic glucocorticoid therapy
Post-transplant Cyclophosphamide and Sirolimus Following Reduced Intensity Conditioning (RIC) Transplant
Condition: Hematologic Neoplasms
MeSH terms: Hematologic Neoplasms
Intervention: Allogeneic Hematopoietic Stem Cell Transplantation
Intervention description: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Chronic Myelogenous Leukemia; Acute Myelogenous Leukemia; Myelodysplastic Syndrome; Myelofibrosis; Acute Lymphocytic Leukemia; Acute Lymphoblastic Lymphoma; Chronic Lymphocytic Leukemia; Prolymphocytic Leukemia; Low-grade non-Hodgkin's Lymphoma; Mantle Cell Lymphoma; Hodgkin Lymphoma; Myeloma

Summary:

      This trial will evaluate the safety and efficacy of post-transplant Cy and sirolimus
      following reduced intensity allogeneic SCT. It is hoped that the combination of a reduced
      intensity preparative regimen with a calcineurin-free GVHD prophylaxis regimen will decrease
      the risk of acute and chronic GVHD, by both limiting mucosal toxicity and augmenting immune
      reconstitution, thereby improving the safety of the procedure. The past experience with
      post-transplant Cy suggests that SCT recipients will attain rapid donor T cell chimerism,
      which the investigators hope will translate into improved disease control through the well
      documented graft-versus-malignancy effects of donor T cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Availability of a 7/8 or 8/8 (HLA-A, B, C, DR) related or unrelated donor

          -  Age 18-75

          -  One of the following high-risk malignancies

          -  Chronic Myelogenous Leukemia

          -  Acute Myelogenous Leukemia

          -  Myelodysplastic Syndrome

          -  Myelofibrosis

          -  Acute Lymphocytic Leukemia

          -  Acute Lymphoblastic Lymphoma

          -  Chronic Lymphocytic Leukemia

          -  Prolymphocytic Leukemia

          -  Low-grade non-Hodgkin's Lymphoma

          -  Mantle Cell Lymphoma

          -  Hodgkin Lymphoma

          -  Myeloma

        Exclusion Criteria:

          -  Poor cardiac function (EF <40%)

          -  Poor pulmonary function (FEV1 and FVC <50% predicted)

          -  Poor liver function (bilirubin >/= 2 mg/dl not due to hemolysis, Gilbert's or primary
             malignancy)

          -  Poor renal function (creatinine >/= 2 mg/dl or creatinine clearance <40mL/min)

          -  Karnofsky status <70%

          -  HIV positive
Bone Biopsy Study For Dialysis Patients With Secondary Hyperparathyroidism of End Stage Renal Disease
Condition: Secondary Hyperparathyroidism
MeSH terms: Neoplasm Metastasis; Kidney Failure, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: Sensipar (Cinacalcet HCl)
Intervention description: All enrolled subjects receive study medication at a starting dose of 30 mg cinacalcet once daily beginning on day 1. Possible sequential doses are 30 mg, 60mg, 90mg, 120mg, 180 mg taken once daily. During the study, dose adjustment (dose increase/decrease/withholding) is based upon iPTH, serum calcium, and subject safety information. Subjects swallowed tablets whole without biting or chewing. Subjects were dispensed investigational product every 4 weeks starting from Day 1 through to Week 48.
Intervention MeSH terms: Cinacalcet
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 110.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cinacalcet HCl, Cinacalcet, Amgen (AMG) 073, Sensipar, Mimpara, Calcimimetic

Summary:

      The purpose of this study is to evaluate the effects of cinacalcet on markers of bone
      turnover in patients with kidney disease who are receiving dialysis.
    

Eligibility criteria:

        Inclusion Criteria: Subjects will be eligible for the study if they meet all of the
        following criteria:

          -  One Intact Parathyroid Hormone (iPTH) determination obtained from the central
             laboratory must be >/= 300 pg/mL.

          -  One serum calcium determination obtained from the central laboratory must be >/= 8.4
             mg/dL (2.1 mmol/L).

          -  One Bone Alkaline Phosphatase (BALP) determination obtained from the central
             laboratory must be >/= 20.9 ng/mL.

          -  Positive histologic confirmation of high bone turnover disease as assessed by the
             central bone histology center.

          -  Treated with dialysis >/= 1 month before the date of informed consent.

        Exclusion Criteria: Subjects will be ineligible for the study if they:

          -  Have an unstable medical condition in the judgment of the investigator.

          -  Are pregnant or nursing women.

          -  Had a parathyroidectomy in the 3 months before the date of informed consent.

          -  For subjects prescribed vitamin D, have received vitamin D therapy for less than 30
             days before day 1 or required a change in vitamin D brand or dose level within 30 days
             before day 1.

          -  Ever received therapy with Sensipar®/Mimpara®
Study of the BiTE® Blinatumomab (MT103) in Adult Patients With Relapsed/Refractory B-Precursor Acute Lymphoblastic Leukemia (ALL)
Condition: B-ALL
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Intervention: Blinatumomab
Intervention description: Continuous intravenous infusion over four weeks per treatment cycle
Intervention MeSH terms: Blinatumomab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Blinatumomab; B-ALL; adult ALL; relapsed ALL; refractory ALL; Leukemia; ALL; Lymphatic diseases; Lymphoproliferative disorders; bispecific antibody; anti-CD19; Immunotherapeutic treatment

Summary:

      The purpose of this study is to determine whether the bispecific T-cell engager blinatumomab
      is effective, safe and tolerable in the treatment of patients with relapsed/refractory
      B-precursor ALL.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with B-precursor ALL relapsed after at least induction and consolidation or
             having refractory disease

          -  More than 5% blasts in bone marrow

          -  Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2

          -  Life expectancy of ≥ 12 weeks

        Exclusion Criteria:

          -  History or presence of clinically relevant central nervous system (CNS) pathology

          -  Infiltration of cerebrospinal fluid (CSF) by ALL

          -  Autologous/allogeneic hematopoietic stem cell transplantation (HSCT) within six
             weeks/three months prior to start of blinatumomab treatment

          -  Active Graft-versus-Host Disease (GvHD)

          -  Patients with Philadelphia chromosome (Ph)+ ALL eligible for treatment with dasatinib
             or imatinib

          -  Cancer chemotherapy within two weeks prior to start of blinatumomab treatment

          -  Immunotherapy (e.g. rituximab) within four weeks prior to start of blinatumomab
             treatment

          -  Infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or
             hepatitis C virus (anti-HCV positive)

          -  Pregnant or nursing women

          -  Previous treatment with blinatumomab
Empagliflozin (BI 10773) in Type Two Diabetes (T2D) Patients, Open Label Extension
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: BI 10773; Metformin; BI 10773; Sitagliptin
Intervention description: BI 10773 high dose once daily; open label comparator; BI 10773 low dose once daily; open label comparator
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Empagliflozin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 660.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of the current study is to investigate the safety and efficacy of BI 10773 in 2
      different doses compared to Metformin or to Sitagliptin given for 78 weeks in different
      modalities of treatment in patients with type 2 diabetes mellitus.
    

Eligibility criteria:

        Inclusion criteria:

          -  patients completing one of double blind phase II trials 1245.9 or 1245.10

          -  informed consent

        Exclusion criteria:

          -  patients meeting withdrawal criteria of preceding trial

          -  significant hepatic impairment

          -  significant renal impairment with creatinine clearance < 50 ml/min

          -  contraindication to Metformin for all patients treated with Metformin

          -  premenopausal women that are nursing or pregnant or not practicing acceptable methods
             of birth control

          -  drug or alcohol abuse
Confirming The Sitaxsentan Dose In Patients Undergoing Heart Surgery
Condition: Cardiac Surgery Subjects; Subjects Undergoing CABG and/or Cardiac Valve Replacement
Intervention: sitaxsentan (Thelin); sitaxsentan (Thelin); Placebo
Intervention description: sitaxsentan (1.0 mg/kg) will begin immediately following cross-clamp release and 12 hours post-CPB.; Sitaxsentan (2.0 mg/kg) will begin immediately following cross-clamp release and 12 hours post-CPB.; Placebo will begin immediately following cross-clamp release and 12 hours post-CPB.
Intervention MeSH terms: Sitaxsentan
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 48 Years
Maximum age: 82 Years
Healthy volunteers: No
Keywords: multi-center; placebo-controlled; randomized study of sitaxsentan administered to subjects post-cross-clamp release and 12 hours post-CPB

Summary:

      This is a multi-center, randomized study of sitaxsentan administered intravenously to
      subjects who are undergoing elective CABG, cardiac valve replacement, or combined CABG and
      cardiac valve replacement procedures that require CPB.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has been identified for coronary artery bypass grafting (CABG), aortic and/or mitral
             valve replacement, or combined CABG and cardiac valve replacement procedures that
             require cardiopulmonary bypass (CPB).

        Exclusion Criteria:

          -  Requires an emergent or "emergency" CABG and/or cardiac valve replacement.