bioihbjkbjnl/mcl2 huggingface dataset:
High-dose Bevacizumab in Advanced Renal Carcinoma Patients
Condition: Renal Cancer; Kidney Cancer
MeSH terms: Carcinoma; Kidney Neoplasms; Carcinoma, Renal Cell
Intervention: Bevacizumab
Intervention description: Bevacizumab
Intervention MeSH terms: Bevacizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 119.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Kidney Cancer; Renal Cancer; Clear Cell Carcinoma

Summary:

      This trial will examine the effectiveness and the side effects of 2 higher dosing schedules
      of bevacizumab in patients that have advanced clear cell renal carcinoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically documented metastatic or unresectable locally recurrent clear cell
             renal carcinoma

          -  Previous kidney removal is required except if the primary tumor was smaller than 5 cm
             or there was extensive liver or bone metastasis

          -  Patients may have received a maximum of 1 prior systemic treatment of immunotherapy
             (Interferon, IL-2), chemotherapy, or combination chemo+immunotherapy for metastatic
             disease.

          -  No prior bevacizumab

          -  Measurable disease

          -  Adequate liver and kidney function

          -  Age 18 and older

        Exclusion Criteria:

          -  Acute MI within the past 6 months

          -  Uncontrolled high blood pressure or history of hypertensive crisis

          -  Clinically significant cardiovascular disease

          -  Active brain cancer

          -  Meningeal metastasis

          -  Pregnant or lactating women

          -  Prior treatment for another cancer less than 5 years ago

          -  No diseases of the central nervous system (eg. uncontrolled seizures, strokes or TIAs

          -  No bleeding from the mouth, rectum or coughing up blood or history of other bleeding
             or clotting disorders

          -  No history of deep vein thrombosis less than 12 months ago or are currently requiring
             full dose anticoagulation

          -  No major surgical procedures, open biopsies or traumatic injury in past 28 days

          -  No patients with peg tubes or feeding tubes

          -  No patients with non healing wounds, ulcers or long bone fractures

          -  No history of abdominal fistulas, gastrointestinal perforation or intrabdominal
             abscess within 6 months

          -  No symptomatic peripheral vascular disease

        Please note: there are additional inclusion/exclusion criteria. The study center will
        determine if you meet all of the criteria. If you do not qualify for the trial, study
        personnel will explain the reasons. If you do qualify, study personnel will explain the
        trial in detail and answer any questions you may have. You can then decide if you wish to
        participate.
Efficacy of AIN457 in Adults (18-65 Years) With Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: AIN457; Placebo
Intervention description: The investigational drug, AIN457 50 mg lyophilizate vials was prepared by Novartis. Reconstitution of AIN457 with 1.2 mL SWFI produced a 47 mg/mL concentrate solution for infusion from which at least 1 mL was useable. The AIN457 concentrate was diluted in 5% glucose bags for infusion through a 0.2 micron in-line filter.; Matching placebo to AIN457
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Psoriatic arthritis; IgG1K monoclonal antibody; Interleukin -17A neutralizing

Summary:

      This study is designed as a proof of concept of AIN457 in patients with psoriatic arthritis.
      The study will address the evaluation of the efficacy at 6 and up to 24 weeks after two doses
      of AIN457 10 mg/kg administered three weeks apart.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A diagnosis of psoriatic arthritis

        Exclusion Criteria:

          -  Patients with arthritis or ankylosing spondyitis

          -  Drug-induced psoriasis

          -  Male or female patients who plan to conceive during the time course of the study, or
             for 6 months after the administration of the second dose.

          -  Participation in any clinical trial within 4 weeks prior to initial dosing or longer.

          -  Previous use of immunosuppressive agents eg cyclosporine, without the necessary
             wash-out period

          -  History of severe allergy to food or drugs

          -  Positive TB test. Other protocol-defined inclusion/exclusion criteria may apply
A Neoadjuvant Study of Abemaciclib (LY2835219) in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer
Condition: Breast Cancer; Hormone Receptor Positive Tumor; Early-Stage Breast Carcinoma
MeSH terms: Breast Neoplasms
Intervention: Abemaciclib; Loperamide; Anastrozole
Intervention description: Administered orally; Administered orally; Administered orally
Intervention MeSH terms: Anastrozole; Loperamide; Antidiarrheals
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 224.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cyclin-dependent kinase (CDK) 4/6 inhibitor; CDK 4 and 6 inhibitor

Summary:

      The purpose of this study is to evaluate the biological effects of abemaciclib in combination
      with anastrozole and compare those to the effects of abemaciclib alone and anastrozole alone
      in the tumors of postmenopausal women with hormone receptor positive (HR+), human epidermal
      growth factor receptor 2 (HER2) negative breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have postmenopausal status.

          -  Adenocarcinoma of the breast.

          -  Breast tumor ≥1 centimeter (cm) in diameter, HR+, HER2-.

          -  Neoadjuvant endocrine monotherapy is deemed to be a suitable therapy.

          -  Primary breast cancer that is suitable for baseline core biopsy.

          -  Have adequate organ function.

        Exclusion Criteria:

          -  Bilateral invasive breast cancer.

          -  Metastatic breast cancer (local spread to axillary lymph nodes is permitted).

          -  Inflammatory breast cancer.

          -  Prior systemic therapy or radiotherapy for invasive or non-invasive breast cancer in
             the same breast as currently being treated.

          -  Prior radiotherapy to the ipsilateral chest wall for any malignancy.

          -  Prior anti-estrogen therapy.
OK432 (Picibanil) in the Treatment of Lymphatic Malformations
Condition: Lymphatic Malformations
MeSH terms: Lymphangioma; Lymphatic Abnormalities; Congenital Abnormalities
Intervention: OK432
Intervention description: OK432 will be injected at dosage of 0.01 to 0.05 mg/mL 6-12 weeks apart up to 4 injections total.
Intervention MeSH terms: Picibanil
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: All eligible participants receive the actual drug.
Masking: None (Open Label)
Enrollment: 275.0
Sex: All
Minimum age: 6 Months
Maximum age: 17 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Standard of care for Lymphatic Malformations has been surgical excision. We have been using
      OK432/Picibanil (generously supplied by Chugai Pharmaceuticals in Japan) since 1992 with
      great success for macrocystic disease.

      The objective of the study was to provide OK-432 immunotherapy to subjects with macrocystic
      or mixed (> 50% macrocystic) lymphatic malformations (LMs) and investigate the efficacy and
      safety of OK 432 as a treatment option in subjects with LMs.
    

Eligibility criteria:

        Inclusion Criteria:

        To be eligible to receive OK432 immunotherapy

          -  Patients must be ages 6 months to 17 years

          -  Patients must have a macrocystic Lymphatic Malformation

          -  Patients may have had surgical treatment for their Lymphatic Malformation

          -  Patients must have an imaging study to confirm the diagnosis of a macrocystic or mixed
             Lymphatic Malformation An MRI is preferred over a CT scan (an ultrasound may be used
             between injections if warranted, however an MRI or CT should be done pre and post
             treatment)

        Exclusion Criteria:

          -  Penicillin allergy

          -  Women who are pregnant or nursing

          -  Patients who present with a temperature of 100.5 degrees F or greater

          -  Patients with mixed hemangioma-lymphangioma lesions

          -  Patients with a history OR a family history of rheumatic heart disease or
             post-streptococcal glomerulonephritis

          -  Patients with hemodynamic instability and respiratory failure

          -  Patients with a history OR a family history of obsessive-compulsive, tic disorders, or
             PANDA (pediatric autoimmune neuro-psychiatric disorder associated with streptococcal
             infections)

          -  Patients who demonstrate abnormalities in the history, physical examination or
             laboratory analysis which may indicate significant hepatic, hematologic, or renal
             disease

          -  Patients who are not in "good general health" (including patients with congenital
             disorders, chronic diseases, immunologic dysfunction, transplant recipients)
Study to Evaluate the Efficacy and Safety of Adjunctive Pimavanserin in Major Depressive Disorder (CLARITY)
Condition: Adjunctive Treatment of Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Pimavanserin; Placebo
Intervention description: Pimavanserin 34 mg, tablet, taken as two 17 mg tablets, once daily by mouth All patients continued to receive selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) antidepressants at a stable dose for the duration of the study.; Placebo, taken as two tablets, once daily by mouth All patients continued to receive selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) antidepressants at a stable dose for the duration of the study.
Intervention MeSH terms: Pimavanserin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 207.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To assess the efficacy of pimavanserin compared to placebo when given adjunctively to a
      selective serotonin reuptake inhibitor (SSRI)/serotonin-norepinephrine reuptake inhibitor
      (SNRI) antidepressant as treatment of patients with Major Depressive Disorder (MDD) and an
      inadequate response to antidepressant therapy
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult patients, aged 18 years and above

          2. A clinical diagnosis of major depressive disorder (MDD)

          3. Is being treated with one of the following SSRI or SNRI antidepressants as
             monotherapy:

               -  Citalopram

               -  Escitalopram

               -  Paroxetine

               -  Fluoxetine

               -  Sertraline

               -  Duloxetine

               -  Venlafaxine

               -  Desvenlafaxine

               -  Venlafaxine XR

          4. Has a history of inadequate response to antidepressant treatments

        Exclusion Criteria:

          1. Patient has a psychotic disorder other than MDD

          2. Patient has current evidence of a serious and/or unstable neurologic, cardiovascular,
             respiratory, gastrointestinal, renal, hepatic, hematologic, or other medical disorder,
             including cancer or malignancies, which would affect the patient's ability to
             participate in the program

          3. Patient has a history or symptoms of long QT syndrome

        Patients will be evaluated at screening to ensure that all criteria for study participation
        are met. Patients may be excluded from the study based on these assessments (and
        specifically if it is determined that their baseline health and psychiatric condition do
        not meet all pre-specified entry criteria).
Long-term Safety, Tolerability and Efficacy of BAF312 Given Orally in Patients With Relapsing-remitting Multiple Sclerosis
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: BAF312
Intervention description: BAF312 was supplied in film-coated tablets in strengths of 5, 4 ,2, 1, .5 and .25 mg. The actual doses taken were 10, 2, 1.25, .5 and .25 mg taken orally once a day.
Intervention MeSH terms: Siponimod
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This extension study was originally set up as a 2 year dose-blinded extension study to maintain blinding of ongoing Core study. Study was later amended to include a subsequent Open-Label treatment phase after Core study was unblinded. During the Dose-Blinded phase of the extension study patients received the same dose from the Core study. Patients who received placebo in Period 1 during the Core Study were equally randomized to 1 of the 3 active doses of siponimod used during Period 1 (0.5, 2.0, or 10 mg) and patients who received placebo in Period 2 were equally randomized to 1 of the 2 active doses of siponimod used during Period 2 (0.25 mg or 1.25 mg).
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Masking continued during the double blind period of extension only.
Enrollment: 185.0
Sex: All
Minimum age: 18 Years
Maximum age: 56 Years
Healthy volunteers: No
Keywords: BAF312; siponimod; Multiple Sclerosis; Relapsing remitting Multiple Sclerosis; Demyelinating Autoimmune Diseases; MS; RRMS; inflammatory disease

Summary:

      This study consisted of a two year dose blinded phase during which patients received one of
      five doses of siponimod (10, 2, 1.25, 0.5 or 0.25mg) following which patients were switched
      to open label treatment with siponimod 2mg for approximately a further 3 years. It will
      provide data on long term safety, tolerability and efficacy of siponimod in the RRMS patient
      population
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients completed the core study BAF312A2201

          -  Written informed consent provided before any assessment of the extension study

          -  Female patients at risk of becoming pregnant must have a negative pregnancy test and
             use simultaneously two forms of effective contraception

        Exclusion Criteria:

          -  Newly diagnosed systemic disease other than MS (which may require immunosuppressive
             treatment)

          -  Malignancies, diabetes, significant cardiovascular and pulmonary diseases and
             conditions

          -  Active infections
Axitinib For The Treatment Of Advanced Hepatocellular Carcinoma
Condition: Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Intervention: Axitinib (AG-013736); Best Supportive Care; Placebo; Best Supportive Care
Intervention description: Axitinib [tablet, 1 mg, 5 mg] will be given twice daily [BID] with continuous dosing; duration is approximately 3-6 months; starting dose is 5 mg BID; BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life.; Placebo [tablet, 1 mg, 5 mg] will be given twice daily [BID] with continuous dosing; duration is approximately 3-6 months; starting dose is 5 mg BID; BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life.
Intervention MeSH terms: Axitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 224.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hepatocellular Carcinoma

Summary:

      The study is designed to demonstrate that axitinib plus best supportive care is superior to
      placebo plus best supportive care in prolonging survival in patients with advanced
      hepatocellular carcinoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Locally advanced or metastatic HCC

          -  Failure of one prior antiangiogenic therapy including sorafenib, bevacizumab and
             brivanib.

          -  Child-Pugh Class A or B (score 7 only) disease.

        Exclusion Criteria:

          -  Prior treatment of advanced HCC with more than one prior first-line systemic therapy.

          -  Any prior local therapy within 2 weeks of starting the study treatment.

          -  Presence of hepatic encephalopathy and/or clinically relevant ascites.

          -  Presence of main portal vein invasion by HCC.
Topical Treatment and Prevalence of P. Acnes
Condition: Surgical Site Infection
MeSH terms: Surgical Wound Infection
Intervention: Clindamycin 1% Gel; Benzoyl peroxide 5% gel; BenzaClin 5%-1% Topical Gel
Intervention description: topical clindamycin; topical benzoyl peroxide; Topical clindamycin and benzoyl peroxide together
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Healthy volunteers
Masking: None (Open Label)
Enrollment: 12.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Propionibacterium Acnes; Surgical Site Infection; Shoulder

Summary:

      This study is about preventing surgical site infections of the shoulder. We hope to learn if
      clindamycin alone, benzoyl peroxide alone, or clindamycin and benzoyl peroxide together can
      affect growth of Propionibacterium acnes in the dermal layer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  healthy volunteer

          -  age > 18

        Exclusion Criteria:

          -  history of antibiotic use in the last month

          -  active acne on the back

          -  non-English speakers (the study personnel do not have adequate training to converse
             and consent in other languages)
A Study of LY900014 and Insulin Degludec in Participants With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: LY900014; Insulin Degludec
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Insulin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      In this study, participants with type 1 diabetes (T1D) will take the study drug LY900014 and
      insulin degludec. The reason for this study is to evaluate the amount of time with glucose
      values within target range.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have type 1 diabetes and have been treated with insulin therapy for
             at least 1 year

          -  Participants must be using Continuous Glucose Monitoring (CGM) with total CGM use ≥ 2
             months in the prior 6 months

          -  Participants must have been on the same type of short acting insulin (Humalog U-100,
             Novolog, Admelog, or Apidra) for at least 30 days prior to screening

          -  Participants must have been treated with long-acting insulin degludec U-100 for at
             least 30 days prior to screening

        Exclusion Criteria:

          -  Participants must not have had more than 1 emergency room visit or hospitalization due
             to poor glucose control within 6 months before screening

          -  Participants must not have had more than 1 episode of severe hypoglycemia within the
             last 90 days prior to screening

          -  Participants must not be taking certain diabetes medications that are not allowed for
             study participation