bioihbjkbjnl/mcl2 huggingface dataset:
DDAVP in the Reduction of Post-operative Ecchymosis in Rhinoplasty
Condition: Postoperative Ecchymosis
MeSH terms: Ecchymosis
Intervention: DDAVP
Intervention description: Patients Receiving DDAVP prior to operation
Intervention MeSH terms: Deamino Arginine Vasopressin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Rhinoplasty; Ecchymosis; Edema

Summary:

      This is study looking at the use of a medication, Desmopressin acetate (DDAVP), to reduce
      bleeding, swelling, and bruising in patients undergoing cosmetic nose surgery. DDAVP is a
      drug used in patients with bleeding disorders. It works by activating molecules in the blood
      stream called platelets that promote clotting. In the study, participants who are have
      cosmetic nose surgery (rhinoplasty) will be randomly assigned to receive or not receive
      medication. Photographs taken before and shortly after surgery will be evaluated for the
      amount of bruising and swelling. Patients with heart, lung, kidney, or liver problems are not
      eligible to participate.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Undergoing Rhinoplasty where nasal bone osteotomy is necessary

        Exclusion Criteria:

          -  Heart Disease

          -  Renal Disease with decreased GFR

          -  Liver Disease
Neoadjuvant Sequential Administration of Two Gemcitabine Combinations in Operable Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: gemcitabine; doxorubicin; cisplatin; surgery
Intervention description: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8); 60 mg/m^2, IV, every 21 days x 4 cycles (1-4); 70 mg/m^2, IV, every 21 days x 4 cycles (5-8); Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision.
Intervention MeSH terms: Gemcitabine; Doxorubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Gemcitabine and anthracycline combination has shown encouraging activity as neoadjuvant
      chemotherapy in locally advanced breast cancer. An addition of sequential gemcitabine and
      cisplatin, also a highly active combination in this indication, may result in improvement in
      pathological response and overall survival. Patients with operable breast cancer will be
      treated in neoadjuvant setting with gemcitabine plus doxorubicin, followed by gemcitabine
      plus cisplatin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of breast carcinoma

          -  No previous chemotherapy, with bidimensionally measurable locally advanced disease

          -  Adequate performance status (Karnofsky Performance Status [KPS] greater than or equal
             to 70), bone marrow reserves, hepatic, cardiac and renal functions.

        Exclusion Criteria:

          -  Inflammatory breast cancer

          -  Pregnancy and Breast-feeding

          -  Serious concomitant disorder or infection

          -  Previous cancer within the last 5 years or a second primary malignancy.
A Study of Nivolumab in Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory Primary Testicular Lymphoma (PTL)
Condition: Lymphoma
MeSH terms: Lymphoma
Intervention: Nivolumab
Intervention MeSH terms: Nivolumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether Nivolumab is effective in the treatment of
      Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL) and Relapsed/Refractory
      Primary Testicular Lymphoma (PTL)
    

Eligibility criteria:

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Pathologically confirmed PCNSL or PTL who failed or did not respond to at least 1 line
             of systemic therapy

          -  Measurable disease requirements on scans:

        PCNSL subjects should have at least one measurable extranodal brain lesion; PTL subjects
        should have at least 1 measurable extranodal lesion or nodal lesion

          -  Have tumor tissue for PD-L1 expression testing

          -  Must have a Karnofsky performance status of 70-100

        Exclusion Criteria:

          -  a) Intraocular PCNSL without evidence of brain disease b) PCNSL patients who cannot
             undergo MRI assessments c) PCNSL patients with systemic disease

          -  Patients with certain diseases such as active autoimmune disease, type I diabetes,
             hypothyroidism that needs hormone replacement, active infection, psychiatric disorder

          -  Prior malignancy active within the previous 3 years except for locally curable cancers
             that have been apparently cured, such as basal or squamous cell skin cancer,
             superficial bladder cancer, or carcinoma in situ of the prostate, cervix, or breast

          -  Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4
             antibody, or any other antibody or drug specifically targeting T-cell co-stimulation
             or checkpoint pathways

        PCNSL, and PTL subjects with brain or spinal cord lesion who have received doses of more
        than 2 mg/day of dexamethasone or equivalent within the 14 days period prior to the first
        dose of nivolumab are excluded

        Other protocol defined inclusion/exclusion criteria could apply
An Exploratory Study of the Effects of Nivolumab Combined With Ipilimumab in Patients With Treatment-Naive Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC)
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Nivolumab; Ipilimumab
Intervention description: Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Nivolumab; Ipilimumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 232.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to explore the possible links between participant
      characteristics and their cancer, with how effective the combination of nivolumab with
      ipilimumab is, in participants with Stage IV or recurrent Non-Small Cell Lung Cancer (NSCLC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed, stage IV or recurrent non-small cell lung cancer with no
             prior systemic anticancer therapy given as primary therapy for advanced or metastatic
             disease

          -  Measurable disease by CT or MRI

          -  Must have full activity or, if limited, must be able to walk and carry out light
             activities such as light house work or office work

        Exclusion Criteria:

          -  Participants with untreated central nervous system metastases

          -  Participants with active, known or suspected autoimmune disease

          -  Prior treatment with any drug that targets T cell co-stimulations pathways (such as
             checkpoint inhibitors)

        Other protocol defined inclusion/exclusion criteria apply
Weight-Based Enoxaparin Dosing and Real-Time Dose Adjustment in Orthopaedic Trauma
Condition: Venous Thromboembolism; Deep Vein Thrombosis; Pulmonary Embolus
MeSH terms: Pulmonary Embolism; Thrombosis; Thromboembolism; Venous Thromboembolism; Venous Thrombosis
Intervention: Enoxaparin
Intervention description: Enrolled patients will receive real-time monitoring of peak and trough steady state anti-Xa levels. Out-of-range patients will receive real time dose adjustment of Enoxaparin using a clinical protocol developed with our inpatient pharmacists.
Intervention MeSH terms: Enoxaparin
Phase: Phase 2
Study type: Interventional
Primary purpose: Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 80.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The rates of Venous thromboembolism (VTE) after orthopedic surgery are as high as 40-60%
      without prophylactic measures. Enoxaparin, a low-molecular-weight heparin, produces an
      anticoagulant effect by binding antithrombin, thereby accelerating antithrombin's
      inactivation of coagulation factor Xa (FXa), thus decreasing the likelihood of clot
      formation. Despite standard dosing enoxaparin prophylaxis, VTE rates in post-operative
      orthopedic trauma patients remain as high as 12.2%.The investigators will examine enoxaparin
      pharmacokinetics and test whether a clinical protocol for real-time enoxaparin dose
      adjustment can favorably alter the proportion of patients with in-range anti-Factor Xa (aFXa)
      levels. Outcomes will include peak and trough steady-state aFXa levels in response to
      standard and escalated doses of enoxaparin and the incidence of venous thromboembolism and
      bleeding events post-surgery. In the trauma and orthopaedic populations, patients with low
      initial aFXa levels are significantly more likely to develop deep venous thrombosis. Thus,
      this study has important implications for appropriate enoxaparin dose magnitude and
      frequency, and may ultimately help to decrease the substantial morbidity and mortality
      associated with post-operative VTE.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Receiving orthopedic trauma surgery

          -  Able to have enoxaparin initiated within 36 hours after procedure

        Exclusion Criteria:

          -  Intracranial bleeding/stroke

          -  bleeding disorder

          -  heparin-induced thrombocytopenia

          -  creatinine clearance < 30 mL/minute

          -  epidural catheter

          -  serum creatinine > 1.6 mg/dL
Study of Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of VAY736 in Patients With Idiopathic Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Intervention: VAY736; Placebo; Standard of Care (SoC)
Intervention description: 300 mg VAY736 administered subcutaneously every 4 weeks for 48 weeks; Placebo administered subcutaneously every 4 weeks for 48 weeks; Background standard-of-care treatment for IPF: nintedanib, pirfenidone, or no background therapy
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: idiopathic pulmonary fibrosis; VAY736

Summary:

      The purpose of this study was to investigate the safety, tolerability and efficacy of VAY736
      as potential therapy for the treatment of idiopathic pulmonary fibrosis (IPF).
    

Eligibility criteria:

        Inclusion Criteria:

          -  A diagnosis of definite or probable IPF within 5 years of the screening visit

          -  Forced Vital Capacity (FVC) 40-90% predicted (inclusive)

          -  Diffusing Capacity of the Lungs (DLCO), corrected for hemoglobin, 25-79% predicted
             (inclusive)

          -  Forced Expiratory Volume in first second (FEV1)/FVC >70%

          -  Unlikely to die from cause other than IPF within the next 3 years, in the opinion of
             the investigator

          -  Unlikely to undergo lung transplantation during this trial

        Exclusion Criteria:

          -  Emphysema > fibrosis on screening high-resolution computed tomography (must be
             confirmed by central reader)

          -  History of major organ, hematopoietic stem cell or bone marrow transplant

          -  Clinically diagnosed acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) or
             other significant clinical worsening within 3 months of randomization

          -  New York Heart Association (NYHA) class III/IV Congestive Heart Failure (CHF),
             Ejection Fraction (EF) <25%

          -  Current smoker

          -  Prior use of any B-cell depleting therapy (e.g., rituximab, ofatumumab, or other
             anti-CD20 mAb, anti-CD40, anti-CD19,anti-CD22 mAb, anti-CD52 mAb, or anti-BAFF mAb)
Interleukin 11, Thrombocytopenia, Imatinib in Chronic Myelogenous Leukemia (CML) Patients
Condition: Leukemia; Chronic Myelogenous Leukemia; Chronic Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Thrombocytopenia
Intervention: Interleukin-11 (IL-11 or Neumega)
Intervention description: 10 mcg/kg under the skin (usually of the arms, legs or abdomen) three times weekly. If the treatment is well tolerated but there is not enough of a platelet improvement, the dose and frequency of injections may be increased.
Intervention MeSH terms: Oprelvekin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Healthy volunteers: No
Keywords: oprelvekin; tyrosine kinase inhibitor; Chronic Myelogenous Leukemia; Leukemia; CML; Thrombocytopenia; Imatinib; IL-11; Interleukin 11; Neumega

Summary:

      The goal of this clinical research study is to find out if IL-11 (NeumegaTM) may increase the
      platelet count in patients with Chronic myeloid leukemia (CML) who develop low platelet
      counts while receiving therapy with imatinib mesylate (Gleevec, STI571), or other tyrosine
      kinase inhibitors such as AMN107, dasatinib, or SK1606.

      Primary Objective:

      1. To determine efficacy of low-dose interleukin-11, (IL-11, oprelvekin, NeumegaTM) in
      improving the thrombocytopenia associate with imatinib or other tyrosine kinase inhibitor
      therapy in patients with CML.

      Secondary Objective:

      1. To determine the safety of low-dose IL-11 in patients with CML and thrombocytopenia
      associated with imatinib or other tyrosine kinase inhibitors
    

Eligibility criteria:

        Inclusion Criteria:

          -  CML patients in chronic or accelerated phase receiving treatment with imatinib
             mesylate (Gleevec), or other tyrosine kinase inhibitors such as AMN107, dasatinib, or
             SK1606.

          -  Grade >/= 3 thrombocytopenia (platelets <50 * 10(9)/L) after the first 4 weeks of
             therapy with the tyrosine kinase inhibitor. Thrombocytopenia must be either recurrent
             (i.e., second or greater episode of grade >/= 3 thrombocytopenia) or having required
             dose reductions of the tyrosine kinase inhibitor.

          -  Signed informed consent.

          -  Expected to have therapy with imatinib continued for > 3 months.

        Exclusion Criteria:

          -  Known allergies to E. coli.

          -  New York Heart Association (NYHA) class III or IV.

          -  Patient has known hypersensitivity to Neumega or any component of Neumega.

          -  Thrombocytopenia that is considered to be unrelated to treatment with imatinib.

          -  Stem cell transplantation within 60 days.

          -  History of atrial arrhythmias

          -  Pregnancy

          -  Papilledema
Finasteride in Treating Patients With Stage II Prostate Cancer Who Are Undergoing Surgery
Condition: Adenocarcinoma of the Prostate; Stage II Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Finasteride; Placebo; Prostatectomy; Laboratory biomarker analysis
Intervention description: Given PO; Given PO; Undergo prostatectomy; Correlative studies
Intervention MeSH terms: Finasteride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 204.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial studies how well finasteride works in treating patients with
      stage II prostate cancer who are undergoing surgery. Testosterone can cause the growth of
      prostate cancer cells. Hormone therapy using finasteride may fight prostate cancer by
      lowering the amount of testosterone the body makes. Giving finasteride before surgery may
      make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
    

Eligibility criteria:

        Criteria:

          -  Histologically confirmed adenocarcinoma of the prostate

          -  Clinical stage T1c or T2 (stage II)

          -  Gleason score of 6 or 7 on initial biopsy

          -  Prostate-specific antigen (PSA) level less than 10 ng/mL within the past 3 months

          -  Candidate for and scheduled to undergo prostatectomy

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2 OR Karnofsky PS
             70-100%

          -  Fertile patients must use effective contraception

          -  No active malignancy at any other site

          -  No history of allergic reactions attributed to compounds of similar chemical or
             biological composition to finasteride

          -  No uncontrolled intercurrent illness including, but not limited to, any of the
             following: Ongoing or active infection; Symptomatic congestive heart failure; Unstable
             angina pectoris; Cardiac arrhythmia

          -  No psychiatric illness or social situation that would preclude study compliance

          -  More than 6 months since prior hormonal agents, including dutasteride or finasteride

          -  More than 6 months since prior chemotherapy

          -  More than 1 month since prior participation in another investigational study

          -  No prior radiotherapy for the primary tumor

          -  No concurrent dehydroepiandrosterone, phytoestrogen supplements, antiandrogen therapy,
             dutasteride, or other finasteride

          -  No concurrent anticoagulation, except for the use of daily acetylsalicylic acid (81 mg
             to 325 mg)
Efficacy and Safety of Bromfenac Ophthalmic Solution
Condition: Cataract Surgery
MeSH terms: Cataract
Intervention: bromfenac ophthalmic solution
Intervention description: sterile opthalmic solution
Intervention MeSH terms: Bromfenac; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 568.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a safety and efficacy study of bromfenac ophthalmic solution
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female greater than or equal to 18 years of age, and scheduled for cataract
             surgery

        Exclusion Criteria:

          -  Active corneal pathology in either eye
Randomized Phase 2 Study With Gemcitabine Alone and Combination Therapy for Patients With Advanced Biliary Tract Cancer
Condition: Biliary Tract Cancer
MeSH terms: Biliary Tract Neoplasms
Intervention: gemcitabine; cisplatin
Intervention description: 1000 milligrams per square meter (mg/m2), intravenous (IV); 25 milligrams per square meter (mg/m2), intravenous (IV)
Intervention MeSH terms: Gemcitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 84.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      To investigate efficacy and safety of gemcitabine combined with cisplatin and of gemcitabine
      alone by comparison in patients with advanced biliary tract cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological or cytological diagnosis of biliary tract cancer

          -  Measurable disease must be at least one lesion

          -  Chemotherapy-naïve

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          -  Estimated life expectancy no less than 3 months

        Exclusion Criteria:

          -  radiological or clinical evidence of pulmonary fibrosis or interstitial pneumonia
A Multicenter Study to Evaluate the Efficacy of a 91-Day Extended Cycle Oral Contraceptive for Menstrually-Related Migraine Headaches
Condition: Migraine
MeSH terms: Migraine Disorders; Headache
Intervention: 91-day Levonorgestrel Oral Contraceptive; Placebo
Intervention description: 91-day treatment consisting of 84 blue combination tablets containing 150 µg LNG/30 µg EE and 7 yellow tablets containing 10 µg EE.; 1 tablet daily to match experimental arm
Intervention MeSH terms: Contraceptive Agents; Levonorgestrel; Contraceptives, Oral
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 109.0
Sex: Female
Minimum age: 18 Years
Maximum age: 34 Years
Healthy volunteers: No
Keywords: Migraine headache; menstrual; oral contraceptive; Menstrually-Related Migraine Headache

Summary:

      This study is being conducted to evaluate the efficacy of a 91-day extended cycle oral
      contraceptive compared to placebo for decreasing the frequency and severity of
      menstrually-related migraine headaches.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Premenopausal, non-pregnant, non-lactating

          -  History of migraine headaches without aura for at least 6 months

          -  History of migraine headaches associated with menstruation

          -  Others as directed by FDA-approved protocol

        Exclusion Criteria:

          -  History of migraine headaches with aura or focal neurological symptoms

          -  Any contraindication to the use of oral contraceptives

          -  Others as dictated by FDA-approved protocol
Late Phase II Confirmatory Study of DE-089 Ophthalmic Solution in Patients With Dry Eye
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca
Intervention: DE-089 ophthalmic solution; DE-089 ophthalmic solution; Placebo ophthalmic solution
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Enrollment: 320.0
Sex: All
Minimum age: 20 Years

Summary:

      Dose response related to efficacy and safety of DE-089 ophthalmic solution are examined in
      patients with dry eye, using a multicenter, randomized, double-blind, parallel group
      comparison study, and the optimal concentration is determined.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Those who show:

               -  Keratoconjunctival disorder confirmed with vital dye staining

               -  Abnormal Schirmer score results

        Exclusion Criteria:

          -  Eye disease that needs therapy other than that for dry eye

          -  Those who need to wear contact lenses during the clinical study