bioihbjkbjnl/mcl2 huggingface dataset:
Acalabrutinib (ACP-196) Alone and in Combination With Pembrolizumab in Ovarian Cancer (KEYNOTE191)
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Intervention: Acalabrutinib; acalabrutinib and pembrolizumab combination
Intervention MeSH terms: Pembrolizumab; Acalabrutinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 78.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To characterize the safety and efficacy of acalabrutinib (ACP-196) monotherapy and
      acalabrutinib plus pembrolizumab combination therapy in subjects with recurrent ovarian
      cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women ≥ 18 years of age.

          -  Histologically confirmed ovarian epithelial (including fallopian tube and primary
             peritoneal) carcinoma.

          -  Progression of disease after the most recent anticancer treatment. At least 1 prior
             chemotherapy regimen must have included a taxane.

          -  Platinum-sensitive ovarian cancer defined by recurrence or progression of disease > 6
             AND < 24 months after completion of the most recent platinum-based therapy.

          -  Measurable disease as defined by RECIST 1.1.

          -  ECOG performance status of 0 or 1.

          -  Completion of all therapy for the treatment of cancer 2 weeks before the start of
             study therapy and recovered.

        Exclusion Criteria:

          -  Evidence of platinum-refractory ovarian cancer defined as recurrence or progression
             during the first 6 cycles of or < 6 months after the beginning of first-line platinum
             based chemotherapy.

          -  Evidence of platinum-resistant ovarian cancer defined as recurrence or progression
             within 6 months after completing the most recent platinum-based therapy.

          -  More than 3 prior lines of cytotoxic chemotherapy for ovarian cancer.

          -  Prior malignancy (other than ovarian cancer), except for adequately treated basal cell
             or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the
             subject has been disease free for ≥ 2 years or which will not limit survival to < 2
             years.

          -  Breastfeeding and pregnant.

          -  Known central nervous system metastases and/or carcinomatous meningitis.

          -  Subjects with active cardiovascular disease not medically controlled or those who have
             had myocardial infarction in the past 6 months..

          -  Malabsorption syndrome, disease significantly affecting gastrointestinal function, or
             resection of the stomach or small bowel, symptomatic inflammatory bowel disease,
             partial or complete bowel obstruction.
Study to Assess the Safety and Efficacy of SelK2 to Prevent Blood Clots in Patients Undergoing Total Knee Replacement
Condition: Venous Thromboembolism
MeSH terms: Thromboembolism; Venous Thromboembolism
Intervention: SelK2; Enoxaparin
Intervention description: I.V., single-dose; SC, QD for up to 10 ± 2 days
Intervention MeSH terms: Enoxaparin
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This was an adaptive design study. The first two arms of the study enrolled patients in a 1:1 ratio to receive either SelK2 or an active comparator. The adaptive arm (SelK2 plus active comparator) was initiated at the discretion of the Steering and Safety Committee. The study then enrolled patients in a 2:1 ratio to receive either SelK2 with an active comparator or an active comparator only.
Masking: Single (Outcomes Assessor)
Enrollment: 207.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: venous thromboembolism; adhesion molecule; P-selectin glycoprotein ligand 1; P-selectin; venous thrombosis

Summary:

      The main purpose of this study is to determine if an investigational medication called SelK2
      works in preventing a condition called "venous thromboembolism" (VTE) in patients having a
      total knee replacement. SelK2 has been designed to attach to a protein found on blood cells
      and blood vessels. By attaching to this protein, SelK2 is designed to decrease the
      inflammatory process in the blood vessel wall that leads to the formation of blood clots in
      the vessel (called thrombosis). By decreasing the inflammatory process, SelK2 may reduce the
      risk of VTE following joint replacement surgery. In addition, because SelK2 is not a blood
      thinner, it is expected that the risk for bleeding will also be reduced.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Males or females, 18-80 years of age (inclusive)

          -  Planned to undergo elective, primary total unilateral Total Knee Arthroplasty under
             general anesthesia

        Key Exclusion Criteria:

          -  Previous deep vein thrombosis (DVT) of the leg or pulmonary embolism (PE) within the
             past year

          -  Any underlying condition (e.g., atrial fibrillation, mechanical heart valve, or recent
             pulmonary embolism) that may lead to the required concomitant use of
             anticoagulants/antiplatelet agents (e.g., warfarin, dabigatran, rivaroxaban, apixaban,
             clopidogrel) that may affect study outcome or any other drug influencing coagulation
             (except low dose aspirin (100 mg or less))

          -  Anticipated use of intermittent pneumatic compression devices and/or
             electrical/mechanical muscle stimulators post Total Knee Arthroplasty procedure
Navelbine And Radiotherapy in Locally Advanced Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Navelbine; 66 Gy/33F; 60 Gy/30F
Intervention description: Navelbine oral 150 mg of Vinorelbine administered in 3 weekly doses a week for 6-6½ weeks; irradiation to 66 Gy (2 Gy x 30, 5 F á weeks); irradiation to 60 Gy (2 Gy x 30, 5 F á weeks)
Intervention MeSH terms: Vinorelbine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Masking description: No blinding after randomization
Enrollment: 117.0
Sex: All
Minimum age: 18 Years
Maximum age: 100 Years
Healthy volunteers: No
Keywords: Induction chemotherapy; Non-small cell lung cancer; Randomized phase II study; Navelbine Oral (R); 3D-conformal radiotherapy; Chemo-radiotherapy; Local-regionally advanced non-small cell lung cancer

Summary:

      This study is an open label randomized multi-centre phase II trial in patients with
      inoperable locally advanced stage IIB-IIIB Non Small Cell Lung Cancer who fulfils the general
      criteria for curatively intended irradiation. The treatment plan consists of two courses of
      inductions chemotherapy followed of concomitant therapy chemo-radiotherapy 3 weeks after day
      1 of the last induction chemotherapy has been given. The patients will be included in the
      study after completing the induction chemotherapy. Randomization will take place only if an
      acceptable dose plan can be obtained.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age ≥18 years

          -  Patients with histologically or cytologically documented diagnosis of locally advanced
             NSCLC stage IIB to IIIB without pleural effusion

          -  Performance status 0-1 on the ECOG scale

          -  Weight loss ≤10% during the last 6 months

          -  Adequate lung function measured as FEV1 ≥1.0

          -  Neutrophile count ≥1.5 x 109/L and platelet count ≥100 x 109/L

          -  Serum bilirubin ≤1.5 upper limit of normal (ULN)

          -  ALAT ≤2 x ULN

          -  Able to comply with study and follow-up procedures

          -  Patients with reproductive potential must use effective contraception

          -  Written (signed) informed consent to participate in the study

        Exclusion Criteria:

          -  Any unstable systemic disease (including active infection, unstable angina, congestive
             heart failure, severe hepatic, renal, or metabolic disease)

          -  Any other active malignancies within 5 years (except for adequately treated carcinoma
             in situ of the cervix or basal or squamous cell skin cancer)

          -  Prior chemotherapy for lung cancer, including neo- and adjuvant chemotherapy

          -  Inability to take oral medication, or requirement of intravenous alimentation

          -  Active peptic ulcer disease

          -  Nursing mothers
An Extension Study of NKTR-102 in Cancer Patients Previously Enrolled in NKTR-102 Studies
Condition: Malignant Solid Tumor
Intervention: NKTR-102 145 mg/m2; NKTR-102 120 mg/m2; NKTR-102 95 mg/m2; NKTR-102 50 mg/m2
Intervention description: A 90 minute IV infusion of 145 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.; A 90 minute IV infusion of 120 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.; A 90 minute IV infusion of 95 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.; A 90 minute IV infusion of 50 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.
Intervention MeSH terms: Etirinotecan pegol
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Open Label multicenter extension study advanced solid tumors

Summary:

      The study objective of this open label, multicenter study is to provide access to NKTR-102
      treatment to subjects previously enrolled in a NKTR-102 study who are without signs of
      disease progression since receiving NKTR-102.

      In addition the study will evaluate the safety of continued exposure to NKTR-102, observe
      disease status and survival status in subjects receiving NKTR-102, and evaluate the efficacy
      of NKTR-102 in subjects with advanced or metastatic solid tumors.
    

Eligibility criteria:

        Inclusion:

          1. Received prior treatment with NKTR-102

          2. Free of disease progression since receiving NKTR-102

          3. Adequate bone marrow and organ function

          4. Treatment with NKTR-102 in the extension study to begin within 8 weeks after receipt
             of their of last dose of NKTR-102

          5. Agree to use adequate contraception

        Exclusion:

          1. Treatment with other anti-cancer therapy between the last dose of NKTR-102 in the
             prior study and before first dose of NKTR-102 in the extension study

          2. A toxicity that requires a 3rd dose reduction after taking NKTR-102 or are scheduled
             to receive a dose < 70 mg/m2 upon entry into this study

          3. Pregnancy or lactation
A Dose-finding Study to Evaluate the Change in Weight After Treatment With LIK066 in Japanese Patients With Obesity
Condition: Obesity
MeSH terms: Obesity
Intervention: LIK066; Placebo
Intervention description: LIK066 will be supplied in different doses as tablets to be taken orally daily.; Placebo will be supplied as tablets to be taken daily orally.
Intervention MeSH terms: Licogliflozin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Parallel Assignment
Enrollment: 126.0
Sex: All
Minimum age: 20 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Obesity disease; Over weight; T2DM; interventional study; Weight loss

Summary:

      The purpose of the study is to evaluate the efficacy, tolerability and safety of LIK066 to
      support dose selection for Phase 3 development in Japanese adults with obesity disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with obesity disease and inadequately controlled body weight with diet and/or
             exercise

          -  BMI ≥ 25 kg/m^2 combined with at least two obesity-related comorbidities, or BMI ≥ 35
             kg/m^2 at least one obesity-related comorbidity

          -  Patients with FPG ≥ 110 mg/dL and/or 5.6% ≤ HbA1c ≤ 10.0%, or T2DM with HbA1c ≤ 10.0%

          -  Waist circumference at umbilical level ≥ 85 cm for male, ≥ 90 cm for female

          -  Visceral fat area ≥ 100 cm^2

          -  Agreement to comply with the study-required life-style intervention and treatment
             during the full duration of the study

        Exclusion Criteria:

          -  Pregnancy or lactating women

          -  Use of pharmacologically active weight-loss medications

          -  Bariatric surgery

          -  Ketoacidosis, lactic acidosis, hyperosmolar coma

          -  Symptomatic genital ingection or urinary tract infection in the 4 weeks prior to
             screening

          -  Gastro-intestinal (GI) disorders associated with chronic diarrhea

          -  Congestive heart failure, New York Heart Association (NYHA) class III or IV
Qsymia as an Adjunct to Surgical Therapy in the Superobese
Condition: Obesity; Metabolic Surgery; Weight Loss; Bariatric Surgery Procedures
MeSH terms: Weight Loss
Intervention: Phentermine/topiramate; low calorie diet
Intervention description: Minimum of 3 months on Qsymia (7.5/46 mg) prior to scheduled weight loss surgery and continuance of up to 24 months of Qsymia after scheduled weight loss surgery.; The low-calorie diet will be individually tailored based on initial resting metabolic rate measurement and co-morbid conditions.
Intervention MeSH terms: Topiramate; Phentermine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This study tests the efficacy of the medication, Qsymia, as an adjunct therapy in superobese
      individuals planning to undergo weight loss surgery. Individuals taking the medication before
      and after surgery will be compared to historical controls who had surgery without taking the
      medication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  BMI ≥ 50 kg/m2

          -  Determined to be a good candidate for surgery based on medical and psychological exam.

          -  Willing to participate in a 3-6 month medically supervised weight loss plan prior to
             surgery.

          -  Planning to remain in the reasonable vicinity of the Wake Forest Baptist Health -
             Weight Management Center for the duration of the study.

        Exclusion Criteria:

          -  History of prior weight loss surgery (removal/conversion from band to sleeve will not
             be excluded)

          -  Pregnant (women of childbearing potential will complete a pregnancy test (blood draw)
             to make sure they are not pregnant at the time that they initiate the medication).
             Ongoing monitoring of pregnancy status is the responsibility of the patient and they
             are instructed as such in the consent form.

          -  Ongoing use of weight loss medication

          -  Contraindications to use of Qsymia, including pregnancy, history of glaucoma, unstable
             cardiac disease (unstable angina, recent heart attack or stroke (in the past 6
             months), uncontrolled arrhythmia), hyperthyroidism, taking monoamine oxidase
             inhibitors (MAOIs) or allergy to either topiramate or sympathomimetic amines like
             phentermine.
A Study of the Concurrent Use of AGN-190584 and AGN-199201 in Participants With Presbyopia
Condition: Presbyopia
MeSH terms: Presbyopia
Intervention: AGN-199201 ophthalmic solution; AGN-190584 ophthalmic solution; AGN-190584 vehicle; AGN-199201 + AGN-190584 Combination; AGN-199201 vehicle
Intervention description: 1 drop of AGN-199201 ophthalmic solution Doses A, B, C in the eye.; 1 drop AGN-190584 ophthalmic solution doses A, B and C in the eye.; Vehicle to AGN-190584; 1 drop AGN-199201 and AGN-190584 fixed combination ophthalmic solution in the eye.; Vehicle to AGN-199201
Intervention MeSH terms: Pharmaceutical Solutions; Ophthalmic Solutions
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 163.0
Sex: All
Minimum age: 40 Years
Maximum age: 50 Years
Healthy volunteers: No

Summary:

      This study will identify the optimum concentrations of AGN-199201 and AGN-190584 when dosed
      in combination once a day for the improvement of uncorrected near visual acuity in
      participants with presbyopia (inability to focus on items close-up).
    

Eligibility criteria:

        Inclusion Criteria:

        -Normal vision at distance, either natural or post corneal laser refractive surgery, with
        presbyopia in each eye and complaints of poor near vision that impacts activities of daily
        living.

        Exclusion Criteria:

          -  Use of any topical ophthalmic medications, including artificial tears other than the
             study medications during the study

          -  Corneal abnormalities in either eye that interfere with visual acuity

          -  History of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery or
             any intraocular surgery

          -  Diagnosis of glaucoma or ocular hypertension.
Chemoradiotherapy in Stage III Non-small Cell Lung Cancer (NSCLC)
Condition: Stage III Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Chemotherapy; ERBITUX; Radiotherapy
Intervention description: Pemetrexed 500 mg/m², D1 (D1=D22, 4 cycles) Cisplatin 75 mg/m², D1 (D1=D22, 4 cycles); The initial dose of cetuximab (ERBITUX) is 400 mg/m² intravenously administered over 120 minutes, followed by 11 weekly infusions at 250 mg/m² IV over 60 minutes; 66 Gy (2 Gy by fraction, 5 fractions by week)
Intervention MeSH terms: Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 106.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      Radiochemotherapy is a standard for the treatment of unresectable stage III non-small cell
      lung cancer. The investigators goal is to study the efficacy and the toxicity for a promising
      association of new agents (cetuximab and pemetrexed) with concurrent radiotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  non-squamous stage III non-small cell lung cancer

          -  measurable disease (RECIST 1.1)

          -  ECOG performance status 0-1

          -  normal organ and marrow function

        Exclusion Criteria:

          -  prior chest radiation therapy

          -  history of any cancer other than NSCLC (except non-melanoma skin cancer or carcinoma
             in situ of the cervix) within the last five years.

          -  Prior therapy with known specific inhibitors of the EGFR.

          -  history of severe allergic reaction to prior therapy with monoclonal antibodies
Study of Tarceva and Targretin Oral Capsules in Patients With Advanced Lung Cancer
Condition: Carcinoma, Non-small-cell Lung
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: erlotinib and bexarotene
Intervention description: Daily Erlotinib 150mg and daily bexarotene oral capsules 400mg.
Intervention MeSH terms: Erlotinib Hydrochloride; Bexarotene
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: tarceva; targretin; non-small cell lung cancer; Carcinoma, non-small cell lung cancer; NSCLC

Summary:

      The purpose of this study is to learn about the effects of two new anticancer drugs,
      erlotinib (Tarceva) and bexarotene (Targretin), when treating patients with advanced lung
      cancer.

      Erlotinib is approved by the Food and Drug Administration (FDA) for the treatment of
      non-small-cell lung cancer (NSCLC). Bexarotene is approved by the FDA for the treatment of
      cutaneous T-cell lymphoma. This combination of drugs is experimental.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced NSCLC

          -  Prior chemotherapy or radiotherapy is allowed.

        Exclusion Criteria:

          -  Hepatic or renal dysfunction
Study to Evaluate the Efficacy, Safety and Pharmacokinetics of ASB17061 Capsules in Adult Subjects With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: 5 mg ASB17061; Placebo; 10 mg ASB17061; 20 mg ASB17061
Intervention description: Oral administration of 5 mg ASB17061 taken once daily for 28 consecutive days.; Oral administration of placebo taken once daily for 28 consecutive days.; Oral administration of 10 mg ASB17061 taken once daily for 28 consecutive days.; Oral administration of 20 mg ASB17061 taken once daily for 28 consecutive days.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 370.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Atopic Dermatitis; eczema

Summary:

      The purpose of this research study is to gather scientific information about the
      effectiveness of the study drug, ASB17061 capsules, when compared to placebo in adult
      subjects with atopic dermatitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult subjects ages 18 to 65 years

          -  A diagnosis of atopic dermatitis (AD)

          -  An Investigator's Global Assessment (IGA) score of 2 or higher and AD affecting at
             least 5% of total Body Surface Area (BSA)

          -  Other than active AD, in good health with no medical condition that may jeopardize the
             safety of the subject or impact the validity of the study results

          -  Subjects must be practicing acceptable birth control methods

        Exclusion Criteria:

          -  Taking systemic immunosuppressive therapy within 3 months prior to screening or
             systemic (cortico) steroid therapy within 4 weeks prior to screening

          -  Use of phototherapy or tanning beds within 6 weeks of screening

          -  Presence of a clinically significant disorder involving gastrointestinal, renal,
             hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic,
             psychiatric, or cardiovascular disease or any other condition, which will jeopardize
             the safety of the subject or impact the validity of the study results

          -  Female subjects who are pregnant or breastfeeding