bioihbjkbjnl/mcl2 huggingface dataset:
Innovative Interventions for Smoking Cessation
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Intervention: Nicotine Patch; VLNC Cigarette; VLNC Cigarette Plus Nicotine Patch
Intervention description: 21 mg; Cigarette where the tobacco contains <0.1 mg of nicotine yield.; 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield.
Intervention MeSH terms: Nicotine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Enrollment: 235.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Smoking Cessation; Nicotine Free Cigarettes

Summary:

      The purpose of this study is to evaluate the effect of a combination of the 21 mg nicotine
      patch and very low nicotine content (VLNC) cigarettes compared to 21 mg nicotine patch only
      and very low nicotine content cigarette only on abstinence, time to relapse and toxicant
      levels. The study will determine if adding nicotine replacement medication to the very low
      content cigarettes (VLNC) will augment treatment compared to nicotine patch only or to very
      low nicotine content cigarettes only.
    

Eligibility criteria:

        Inclusion Criteria:

          -  a) Smoking at least 10 cigarettes daily for the past year;

          -  b) In good physical health;

          -  c) No contraindications for medicinal nicotine; and

          -  d) Stable, good mental health.

        Exclusion Criteria:

          -  a) Subjects must not be using other tobacco or nicotine products.

          -  b) Female subjects cannot be pregnant or nursing and must be using appropriate birth
             control.
Isosorbide Mononitrate For Anti-Vascular Endothelial Growth Factor (VEGF) Induced Kidney Injury
Condition: Kidney Injury; Proteinuria; Hypertension
MeSH terms: Proteinuria; Hypertension; Wounds and Injuries
Intervention: Isosorbide Mononitrate; Placebo oral tablet
Intervention description: The starting dose will be Isosorbide Mononitrate 60 mg ER daily and after 4 weeks, if tolerated but response is not achieved, the dose will be escalated to Isosorbide Mononitrate 120 mg ER daily (2 tabs of 60 mg ER tablets).; Placebo will be given daily and will be doubled after 4 weeks of start of therapy.
Intervention MeSH terms: Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Double blinded
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Kidney Injury; Proteinuria; Hypertension; Anti-VEGF

Summary:

      The purpose of this study is to test the hypothesis that isosorbide mononitrate prevents
      deterioration of renal function in patients receiving anti-angiogenic therapies that target
      vascular endothelial growth factor (VEGF).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients on or enrolled for anti-VEGF therapy

          -  new-onset proteinuria, defined as a urine protein: creatinine ratio (UPC) of >500mg/g
             or hypertension (Systolic BP ≥ 140 mm Hg and/or diastolic BP ≥ 90 mm Hg) or a decrease
             in eGFR by ≥ 25% from baseline before starting therapy.

        Exclusion Criteria:

          -  Pregnant women

          -  Breast-feeding women.
Efficacy and Safety of Ranibizumab (Intravitreal Injections) Versus Laser Treatment in Patients With Visual Impairment Due to Diabetic Macular Edema
Condition: Diabetic Macular Edema; Visual Impairment
MeSH terms: Vision Disorders; Vision, Low; Macular Edema; Edema
Intervention: RFB002; Laser photocoagulation
Intervention description: 0.5 mg
Intervention MeSH terms: Ranibizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 83.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetic Macular Edema; Ranibizumab; Laser Treatment; Visual impairment

Summary:

      This study will assess the efficacy and safety of ranibizumab (intravitreal injections)
      versus laser treatment in patients with visual impairment due to diabetic macular edema.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diabetes mellitus 1 or 2, HbA1c < 11.0%, With: Clinically significant Diabetic Macular
             Edema in at least one eye.

          2. Previous treatment with macular photocoagulation only should be considered if the
             investigator believes that the study eye may possibly benefit from additional
             photocoagulation.

          3. Best corrected visual acuity score between 78 and 25 letters (Early Treatment Diabetic
             Retinopathy Study- ETDRS Chart - 4 meters).

          4. Central foveal thickness >250µm (Optical Coherence Tomography).

          5. Diabetes medication stable in the 3 months prior.

        Exclusion Criteria:

        In the study eye:

          1. Active intraocular inflammation.

          2. Any active infection.

          3. History of uveitis.

          4. Structural damage within 500 microns of the center of the macula.

          5. Neovascularization of the iris.

          6. Uncontrolled glaucoma in either eye (Intraocular Pressure > 24 mmHg).

        Other protocol-defined inclusion/exclusion criteria may apply.
Optimizing the Effectiveness of Selective Serotonin Reuptake Inhibitors (SSRIs) in Treatment-Resistant Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Treatment-Resistant
Intervention: S-adenosyl methione (SAMe); Placebo
Intervention description: Oral SAMe tosylate, up to 1600 mg per day for 6 weeks; Placebo to be taken daily for 6 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 73.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Selective Serotonin Reuptake Inhibitors; S-adenosyl Methionine; SSRI; SAMe

Summary:

      This study will determine the effectiveness of adding S-adenosyl methionine to antidepressant
      drug treatment in reducing depressive symptoms in depressed people who have not responded to
      antidepressants alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Major depressive disorder

          -  Use of an SSRI for at least 6 weeks prior to study entry with partial or no response

        Exclusion Criteria:

          -  History of psychosis

          -  Allergy to SAMe

          -  Alcohol or drug abuse in the past 3 months prior to study entry
Abiraterone Acetate Combined With Dutasteride for Metastatic Castrate Resistant Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Abiraterone acetate; Dutasteride; Prednisone
Intervention MeSH terms: Prednisone; Abiraterone Acetate; Dutasteride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: prostate; metastatic; castrate resistant

Summary:

      The purpose of this research study is to determine if the addition of dutasteride to a
      regimen with abiraterone acetate and prednisone will improve on therapy in patients with
      castrate-resistant prostate cancer and metastatic disease. This study will also help
      determine the side effects of the study treatment and how often they occur.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of adenocarcinoma of the prostate

          -  Castrate resistant disease

          -  Metastatic disease

          -  Normal organ and marrow function

          -  Subjects with partners of childbearing potential must be willing to use adequate
             methods of birth control

        Exclusion Criteria:

          -  Uncontrolled intercurrent illness

          -  Uncontrolled hypertension

          -  Active or symptomatic viral hepatitis or chronic liver disease

          -  History of pituitary or adrenal dysfunction

          -  Clinically significant heart disease

          -  History of a different malignancy unless disease-free for at least 5 years

          -  Known brain metastasis

          -  History of gastrointestinal disorders

          -  Prior therapy with abiraterone acetate

          -  HIV-positive individuals on antiretroviral therapy

          -  Requirement for steroid use greater than the equivalent of 5 mg of prednisone daily

          -  Atrial fibrillation or other cardiac arrhythmia requiring therapy

          -  Thromboembolism in the last 6 months
A Trial of Preoperative MM-121 With Paclitaxel in HER2-negative Breast Cancer
Condition: ER Positive, Her2 Negative Breast Cancer Patients; Triple Negative Breast Cancer Patients
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Intervention: MM-121; Paclitaxel
Intervention description: MM-121 IV at 40 mg/mg loading dose on Cycle 1, Week 1 followed by 20 mg/mg weekly for all subsequent doses; Standard dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.
Intervention MeSH terms: Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 196.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast Cancer; Neoadjuvant; Her2 negative; Her2 non-overexpressing; Estrogen Receptor Positive; Triple Negative; MM-121; Paclitaxel

Summary:

      To demonstrate whether addition of MM-121 to paclitaxel is more effective than treatment with
      paclitaxel alone, when administered as part of the neoadjuvant treatment in Her2 negative
      locally advanced operable breast cancer patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological confirmation of ER positive, HER2 negative invasive breast cancer (Group
             1) or invasive triple-negative breast cancer (Group 2)

          -  Free of metastatic disease

          -  ≥ 18 years old

          -  Female

          -  Had no prior treatment for any cancer

          -  Eligible for treatment with paclitaxel, doxorubicin and cyclophosphamide

        Exclusion Criteria:

          -  Have a history of severe allergic reactions to paclitaxel or other drugs formulated in
             Cremaphor® EL

          -  Are pregnant or breastfeeding
Comparison Of 4 CP-690,550 Doses Vs. Placebo, Each Combined With Methotrexate, For The Treatment Of Rheumatoid Arthritis in Japan
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Placebo; CP-690,550; CP-690,550; CP-690,550; CP-690,550
Intervention description: 0 mg BID, 3 blinded tablets administered BID for 12 weeks; 10 mg BID, 3 blinded tablets administered BID for 12 weeks; 1 mg BID, 3 blinded tablets administered BID for 12 weeks; 3 mg BID, 3 blinded tablets administered BID for 12 weeks; 5 mg BID, 3 blinded tablets administered BID for 12 weeks
Intervention MeSH terms: Tofacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 140.0
Sex: All
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Phase II MTX add-on study in Japan

Summary:

      The purpose of this study is to determine the effectiveness and safety, over 3 months, of 4
      dose regimens of CP-690,550, combined with methotrexate, for the treatment with active
      rheumatoid arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Active rheumatoid arthritis

          -  Inadequate response to stably dosed methotrexate

        Exclusion Criteria:

          -  Current therapy with any DMARD or biologic other than methotrexate
Phase II Study of MEDI4736 Monotherapy or in Combinations With Tremelimumab in Metastatic Pancreatic Ductal Carcinoma
Condition: Metastatic Pancreatic Ductal Adenocarcinoma
MeSH terms: Adenocarcinoma
Intervention: MEDI4736 monotherapy; tremelimumab+MEDI4736
Intervention description: MEDI4736 via IV infusion.; tremelimumab+MEDI4736 via IV infusion.
Intervention MeSH terms: Durvalumab; Tremelimumab; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pancreatic Ductal Adenocarcinoma, PDAC

Summary:

      A Phase II Open-Label, Multi-Center Study of MEDI4736 Evaluated as Single Agent or in
      Combination with Tremelimumab in Patients with Metastatic Pancreatic Ductal Adenocarcinoma.
    

Eligibility criteria:

        Inclusion Criteria: -

          1. Histologically or cytologically confirmed metastatic PDAC, no more than 1 prior
             chemotherapy regimen

          2. Eastern Cooperative Oncology Group 0 or 1

          3. At least 1 lesion, not previously irradiated, that can be accurately measured at
             baseline as ≥10 mm in the longest diameter (except lymph nodes, which must have short
             axis ≥15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) scan
             and that is suitable for accurate repeated measurements

        Exclusion Criteria:

          1. Any concurrent chemotherapy, investigational product , biologic, or hormonal therapy
             for cancer treatment.

          2. History of leptomeningeal carcinomatosis

          3. Ascites requiring intervention

          4. Brain metastases or spinal cord compression.
Study to Assess Effectiveness of Giving Combination of Standard Chemotherapy Drugs Versus Combination of Standard Chemotherapy and New Drug Ixabepilone When Given Before Surgical Removal of Early Stage Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Ixabepilone; Paclitaxel; Cyclophosphamide; Doxorubicin
Intervention description: Intravenous Solution, intravenous (IV), 40mg/m², Day 1 every 21 days, 12 Weeks; Intravenous Solution, IV, 80mg/m², Weekly, 12 Weeks; Intravenous Solution, IV, 600mg/m², Day 1 every 21 days, 12 Weeks; Intravenous Solution, IV, 60mg/m², Day 1 every 21 days, 12 Weeks
Intervention MeSH terms: Paclitaxel; Epothilones; Cyclophosphamide; Doxorubicin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 384.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Early Breast Cancer

Summary:

      The study will evaluate the effectiveness of ixabepilone when given after doxorubicin plus
      cyclophosphamide (AC) compared to standard treatment of paclitaxel given after doxorubicin
      plus cyclophosphamide in patients with early stage breast cancer. In addition the study will
      verify predefined biomarkers as well as discover new biomarkers that could identify patients
      who are more likely to respond to ixabepilone than standard paclitaxel based therapy.
    

Eligibility criteria:

        Inclusion criteria

          -  Histologically confirmed primary invasive adenocarcinoma of the breast , T2-3, N0-3,
             M0, with tumor size of ≥ 2 cm

          -  All patients with early stage breast adenocarcinoma may enroll irrespective of
             receptor status

          -  No prior treatment for breast cancer excluding therapy for DCIS

          -  Karnofsky performance status of 80 - 100

          -  left ventricular ejection fraction (LVEF) ≥ 50% by echocardiogram or multiple gated
             acquisition (MUGA)

          -  Adequate hematologic, hepatic and renal function

        Exclusion Criteria

          -  women of child-bearing potential (WOCBP) unwilling or unable to use an acceptable
             method to avoid pregnancy during and up to 8 weeks after the last dose of the
             investigational drug

          -  Women who are pregnant or breastfeeding

          -  Inflammatory or metastatic breast cancer

          -  Unfit for breast and/or axillary surgery

          -  Evidence of baseline sensory or motor neuropathy

          -  Significant history of cardiovascular disease, serious intercurrent illness or
             infections including known human immu immunodeficiency virus (HIV) infection

          -  History of prior anthracycline therapy Allergies to any study medication or Cremophor®
             EL
Tocilizumab for Prevention of Respiratory Failure in Patients With Severe COVID-19 Infection
Condition: COVID-19
MeSH terms: Infections; COVID-19; Respiratory Insufficiency
Intervention: Tocilizumab
Intervention description: Participants will receive Tocilizumab 8 mg/kg i.v. at enrollment. Dose will be capped at 800 mg per infusion. If there is no improvement or toxicity, a second dose can be given 24 hrs to 5 days later.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: COVD-19; Tocilizumab; Respiratory infection; 20-185; Memorial Sloan Kettering Cancer Center

Summary:

      The purpose of this study is to find out whether the study drug tocilizumab is an effective
      treatment for COVID-19 infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient or designated proxy willing and able to provide informed consent prior to
             enrollment in the study.

          -  COVID-19 PCR positive on nasopharyngeal swab

          -  Aged >/= 18 years old

          -  Patient hospitalized with newly diagnosed documented severe COVID-19 infection: with
             respiratory rate >/= 30 breaths/min OR peripheral capillary oxygen saturation (SpO2) <
             93% on room air for nonintubated pts.

          -  Fever of 38.5 C or suspected respiratory infection

          -  IL-6 level >/= 80 pcg/ml

          -  Cohort #1 - non intubated Cohort #2 - intubated

          -  Women of childbearing potential must have a negative serum or urine pregnancy test

          -  Patients receiving ongoing steroid therapy are eligible

          -  Patients will be allowed to receive concurrent or sequential treatment with remdesivir

        Exclusion Criteria:

          -  Patients with uncontrolled systemic fungal and bacterial infections

          -  Patients with latent tuberculosis

          -  Patients with known hypersensitivity to tocilizumab or any component of the
             formulation

          -  Concurrent initiation of steroid therapy is not allowed

          -  Patients with uncrontroled malignant disease, with a life expectancy of 3 months or
             less
A Dose Determination Study of Chinese Herbal Medicine for Functional Constipation
Condition: Constipation
MeSH terms: Constipation
Intervention: MaZiRenWan (MZRW) Low dose; MaZiRenWan (MZRW) Median dose; MaZiRenWan (MZRW) High dose
Intervention description: Dissolved MaZiRenWan (MZRW) granule (2.5g/sachet) in 150 ml hot water, take orally twice daily for 8 weeks; Dissolved MaZiRenWan (MZRW) granule (5.0g/sachet) in 150 ml hot water, take orally twice daily for 8 weeks; Dissolved MaZiRenWan (MZRW) granule (7.5g/sachet) in 150 ml hot water, take orally twice daily for 8 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Randomized Controlled Trials; Medicine, Chinese Traditional; Medicine, Herbal; Constipation

Summary:

      Functional constipation (FC) is common with 14.3% estimated prevalence in Hong Kong, but
      treatment for this condition in conventional medicine is suboptimal. Complementary and
      alternative medicines, especially Chinese herbal medicine (CHM) are used frequently by
      patients with FC, but there is little research evidence about these commonly used CHM. The
      purpose of the study is evaluate the efficacy and safety of CHM, as well as determining the
      optimal dosage.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of functional constipation with Rome II criteria

          -  General stool type belongs to Type 1 to 4 according to Bristol Stool Form Scale

          -  Complete spontaneous bowel movement≦2 movements per week

        Exclusion Criteria:

          -  Anti-diarrhoeal therapy

          -  Drug-induced constipation

          -  Medical history of important bowel pathology, such as inflammatory bowel disease,
             congenital or acquired megacolon / megarectum

          -  Medical history of previous abdominal surgery

          -  Taking chronic medications that contain any kind of herbs, mineral, or specific
             vitamin supplements

          -  Medical history of carbohydrate malabsorption, hormonal disorder, cancer, diabetes
             mellitus, hypothyroidism, asthma, renal impairment and/or any other serious diseases

          -  History of laxative abuse

          -  History of allergy to Chinese herbal medicine

          -  Psychiatric or addictive disorders

          -  Pregnancy or breast-feeding

          -  Any other serious diseases