bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Docetaxel Monotherapy or DOXIL and Docetaxel in Patients With Advanced Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Docetaxel; DOXIL
Intervention description: Docetaxel monotherapy: docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle. DOXIL in combination with docetaxel: docetaxel 60 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle; DOXIL 30 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
Intervention MeSH terms: Docetaxel; Liposomal doxorubicin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 751.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast Cancer; Advanced breast cancer; Breast Tumors; Cancer of Breast; Human Mammary Carcinoma; Mammary Neoplasms, Human; DOXIL; Docetaxel

Summary:

      The purpose of the study is to evaluate whether the time to progression for the DOXIL and
      docetaxel combination therapy group was superior to that of the group treated with docetaxel
      monotherapy in participants with advanced breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females with locally advanced or metastatic breast cancer who received prior
             anthracycline therapy in the neoadjuvant or adjuvant setting, and had at least a
             12-month disease-free interval since the end of their last cytotoxic therapy, were
             eligible for the study

          -  Participants who received prior hormonal therapy, or no more than 1 cytotoxic
             chemotherapy regimen (anthracyclines, taxanes, or antitubulin agents were not
             permitted), or both for advanced disease

          -  Participants with normal cardiac function, as evidenced by a normal left ventricular
             ejection fraction

        Exclusion Criteria:

          -  More than 1 prior cytotoxic chemotherapy regimen for advanced breast cancer

          -  Treatment of advanced breast cancer with an anthracycline, paclitaxel, docetaxel,
             vinorelbine, or vinblastine (prior treatment of advanced breast cancer with 1 regimen
             that included alkylating agents or antimetabolite agents was acceptable)

          -  Less than 2 months since the last dose of trastuzumab

          -  Less than 3 weeks since last dose of tamoxifen or fulvestrant, or less than 1 week
             since the last dose of other hormonal therapy

          -  Radiation to areas of disease within 30 days before study enrollment

          -  History of New York Heart Association Class II or greater cardiac disease or other
             clinical evidence of congestive heart failure
Home-HF: Evaluation of Patients With Heart Failure Using Home Telemonitoring
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: HomMed Telemonitoring System
Intervention description: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 182.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: telemonitoring; heart failure; randomised; hospitalisation; HomMed

Summary:

      This project, using home monitoring for the signs and symptoms of heart failure, aims to
      empower patients to be actively involved in their care and provide rapid access to healthcare
      services and advice when needed. The telemonitoring system is easy to use and ensures the
      accurate transfer of information from the home to the hospital. The information is then
      screened and if important changes are seen, the patient will be contacted by a heart failure
      nurse who will offer advice and may arrange a clinic visit or suggest alterations to the
      medication. The project uses modern technology to provide disease management, links the
      patient in their home with the hospital and reinforces education and self-care behaviour.
      This innovative programme will be tested to see if it reduces the risk of re-admission to
      hospital, reduces anxiety, improves quality of life following a hospital admission for heart
      failure and whether this represents good value for money in terms of the health benefits it
      provides.

      Hypothesis:

      Patients using home telemonitoring of signs and symptoms of heart failure following discharge
      from hospital with chronic heart failure have a reduced risk of all-cause re-hospitalisation
      when compared with usual care.
    

Eligibility criteria:

        Inclusion Criteria:

          -  NYHA class II - IV (i.e. breathlessness at rest or on mild-moderate exercise) at time
             of randomisation (hospital discharge)

          -  Proven diagnosis of heart failure, in line with the guidelines for management of
             chronic heart failure of the European Society of Cardiology or as determined by the
             cardiologist or physician caring for the patient

          -  Admission to hospital following a new diagnosis of heart failure or episode of acute
             decompensation of chronic heart failure

          -  Home telephone line

          -  Deemed fit for discharge home by the clinical team

        Exclusion Criteria:

          -  Dementia/confusion which is likely to interfere with the use of the HomMed
             telemonitoring equipment.

          -  < 18 years of age

          -  Lack of home telephone line
Effect of Sildenafil on the Microcirculatory Blood Flow and Endothelial Progenitor Cells in Systemic Sclerosis
Condition: Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Limited; Raynaud Phenomenon
MeSH terms: Raynaud Disease; Scleroderma, Systemic; Scleroderma, Diffuse; Scleroderma, Localized; Scleroderma, Limited
Intervention: Sildenafil citrate; Placebo (Sugar pill)
Intervention description: Oral sildenafil citratre, 50mg b.i.d., 8 weeks; Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks
Intervention MeSH terms: Sildenafil Citrate; Citric Acid; Sodium Citrate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 41.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Sildenafil; Endothelial Progenitor Cells; Laser Doppler Imaging

Summary:

      Early phases of systemic sclerosis is characterized by inflammatory and microvasculature
      alterations. Sildenafil citrate has been shown to have vasodilatory effects and to enhance
      vasculogenesis. The purpose of this study is to evaluate the effect of sildenafil citrate on
      hand blood flow of patients with systemic sclerosis, using Laser Doppler Imaging.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Systemic sclerosis according to the classification criteria of the American College of
             Rheumatology (1980) with no more than 4 years since diagnosis

          -  Early systemic sclerosis as defined by LeRoy and Medsger (2001)

          -  6 or more Raynaud's crisis per week

          -  Written informed consent provided by the subjects prior to initiating study procedures

        Exclusion Criteria:

          -  Smoking

          -  Peripheral or central vasculopathy other than Systemic sclerosis

          -  Uncontrolled Diabetes

          -  Liver disease

          -  Pregnant or lactating woman

          -  Current use of cyclosporin, prostanoids, bosentan or any PDE-5 inhibitors (including
             current Sildenafil use during randomization)

          -  History of stroke, myocardial infarction or life threatening cardiac condition within
             the last 6 months

          -  History of surgical sympathectomy

          -  Systolic blood pressure < 85mm Hg

          -  History of scleroderma renal crisis

          -  Known hypersensitivity to Sildenafil or any of the excipients

          -  History of Retinitis Pigmentosa

          -  Current use of Nitrates
A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) for Treatment of Chronic Hepatitis C Infection in Treatment-experienced Adults
Condition: Chronic Hepatitis C Infection
MeSH terms: Infections; Communicable Diseases; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: ABT-450/r/ABT-267, ABT-333; Ribavirin; Pegylated Interferon a-2a (PegINF); Telaprevir
Intervention description: Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet; Tablet; Pre-filled syringe; Film-coated tablet
Intervention MeSH terms: Interferons; Ribavirin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 148.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Partial responder; Interferon free; Treatment-experienced; Relapser; Hepatitis C Virus; Null responder; Hepatitis C Genotype 1; paritaprevir; ombitasvir; dasabuvir; ribavirin; Viekira PAK; Chronic hepatitis C

Summary:

      The purpose of this study is to evaluate the safety and antiviral activity of 3 direct-acting
      antiviral agents (DAAs; ABT-450/ritonavir/ABT-267 [ABT-450/r/ABT-267; ABT-267 also known as
      ombitasvir] and ABT-333 [also known as dasabuvir]) plus ribavirin (RBV) compared with
      telaprevir (TPV) with pegylated interferon/ribavirin (pegIFN/RBV) in patients with chronic
      hepatitis C virus genotype 1 (HCV GT1) infection without cirrhosis who were previously
      treated with pegylated interferon/ribavirin (pegIFN/RBV).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Females must be practicing specific forms of birth control on study treatment, or be
             post-menopausal for more than 2 years or surgically sterile

          -  Chronic hepatitis C infection (positive for anti-HCV antibody or HCV RNA at least 6
             months before screening and at the time of screening; or positive for anti-HCV
             antibody or HCV RNA at the time of screening with a liver biopsy consistent with
             chronic HCV infection)

          -  Screening laboratory result indicating HCV genotype 1 infection (HCV GT1)

          -  Participant must have documentation of adherence to a prior pegIFN/RBV combination
             therapy and meet one of the protocol definitions for treatment failure: null
             responder, partial responder, relapser

          -  No evidence of liver cirrhosis

        Exclusion Criteria:

          -  Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody

          -  Positive screen for drugs or alcohol

          -  Significant sensitivity to any drug

          -  Use of contraindicated medications within 2 weeks of dosing

          -  Abnormal laboratory tests
Treatment of Mania Symptoms With Drug Therapy
Condition: Bipolar Disorder; Schizophrenia
MeSH terms: Schizophrenia; Bipolar Disorder
Intervention: Divalproex-extended release (DVP-ER); Lithium; Quetiapine
Intervention description: Divalproex ER will be given in 250 mg or 500 mg tablets. Dosing is once a day, every day, for the duration of study participation, either 12 or 26 weeks.; Extended release lithium will be provided in 300 mg capsules. Participants will be dosed to a therapeutic blood level of lithium from 0.8 to 1.2 mcg/L.; Quetiapine will be dosed to efficacy, provided in 50 mg, 100 mg, 200 mg, or 300 mg pills.
Intervention MeSH terms: Valproic Acid; Quetiapine Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 75.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Mania; Manic-depressive; Psychotic disorder

Summary:

      This study will determine the effectiveness of three different drug therapies in treating the
      symptoms of mania.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of bipolar I disorder or schizophrenia

          -  Experiencing symptoms of mania at study entry

          -  Able to speak and understand English

          -  Willing and able to comply with all study requirements

        Exclusion Criteria:

          -  History of partial response or nonresponse to any of the drugs or drug combinations
             given in this study

          -  History of intolerance to DVP, DVP-ER, lithium, or quetiapine

          -  Disorders that would contraindicate the use of DV, DV-ER, lithium, or quetiapine

          -  Use of antidepressants within 1 month prior to study entry

          -  Use of fluoxetine within 3 months prior to study entry

          -  Impaired cardiac function, as evidenced by abnormal EKG in participants 50 or over

          -  Unstable medical illness within 2 months prior to study entry

          -  At risk for suicide

          -  Substance abuse or dependence within 1 month prior to study entry

          -  Pregnancy, breastfeeding, or plans to become pregnant during the study
Comparative Study of Ceftaroline vs. Ceftriaxone in Adult Subjects With Community-Acquired Pneumonia
Condition: Bacterial Pneumonia
MeSH terms: Pneumonia; Pneumonia, Bacterial
Intervention: Ceftaroline fosamil for Injection; IV Ceftriaxone; Placebo; Clarithromycin
Intervention description: 2 consecutive, 300 mg dose parenteral infused over 30 minutes, every 12 hours, for 5 to 7 days; 1 g dose parenteral infused over 30 minutes, every 24 hours, for 5 to 7 days; Subjects randomized to receive ceftriaxone will receive ceftriaxone at a dose of 1 g infused over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h). Twelve hours after each dose of ceftriaxone and saline placebo (ie, between ceftriaxone doses), subjects in this group will receive two consecutive saline placebo infusions, each infused over 30 minutes q24h. The ceftriaxone and saline placebo infusions will correspond to the q12h infusions of ceftaroline, thereby maintaining the blind; In both treatment groups, two doses of oral clarithromycin (500 mg q12h), defined as adjunctive therapy, were initiated on Study Day 1 with study drug therapy in order to provide an immunomodulatory benefit and initial therapy for possible infection due to an atypical organism.
Intervention MeSH terms: Clarithromycin; Ceftriaxone; Ceftaroline fosamil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 606.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ceftaroline; Community-acquired pneumonia; CAP; IV (intravenous); Streptococcus pneumoniae; Haemophilus influenzae; Mycoplasma pneumoniae; Chlamydophila spp; Legionella spp; Multi-drug resistant Streptococcus pneumoniae (MDRSP); antimicrobial resistance; pneumococci; Ceftriaxone; bacteria; ß-lactam; beta-lactam; antibiotic

Summary:

      The purpose of this study is to determine whether ceftaroline is effective and safe in the
      treatment of Community-Acquired Pneumonia
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects are required to meet the following inclusion criteria:

          -  Community-acquired pneumonia

          -  initial hospitalization, or treatment in an emergency room or urgent care setting

          -  infection would require initial treatment with IV antimicrobials.

        Exclusion Criteria:

        Subjects must NOT meet any of the following exclusion criteria:

          -  CAP suitable for outpatient therapy with an oral antimicrobial agent

          -  respiratory tract infections not due to community-acquired bacterial

          -  Non-infectious causes of pulmonary infiltrates

          -  Pleural empyema

          -  Infection with an atypical organism

          -  History of any hypersensitivity or allergic reaction to any ß-lactam antimicrobial

          -  History of any hypersensitivity or allergic reaction to clarithromycin or any
             macrolide/ ketolide
Evaluation of Upadacitinib in Adolescent and Adult Patients With Moderate to Severe Atopic Dermatitis (Eczema)
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Intervention: Placebo for Upadacitinib; Upadacitinib
Intervention description: Tablets taken orally once a day; Tablets taken orally once a day
Intervention MeSH terms: Upadacitinib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 912.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Atopic Dermatitis; Upadacitinib

Summary:

      The objective of this study is to assess the efficacy and safety of upadacitinib for the
      treatment of adolescent and adult participants with moderate to severe atopic dermatitis (AD)
      who are candidates for systemic therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body weight of ≥ 40 kg at Baseline Visit for participants between ≥ 12 and < 18 years
             of age

          -  Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years before Baseline
             Visit and subject meets Hanifin and Rajka criteria.

          -  Active moderate to severe AD defined by:

               -  Eczema Area and Severity Index (EASI) score ≥ 16 at the Screening and Baseline
                  Visits;

               -  Validated Investigator's Global Assessment (vIGA) score ≥ 3 at the Screening and
                  Baseline Visits;

               -  ≥ 10% Body surface area (BSA) of AD involvement at the Screening and Baseline
                  Visits;

               -  Baseline weekly average of daily Worst Pruritus NRS ≥ 4.

          -  Candidate for systemic therapy or have recently required systemic therapy for AD

          -  Subject has applied a topical emollient (moisturizer) twice daily for at least 7 days
             before the Baseline Visit.

          -  Documented history of inadequate response to topical corticosteroids (TCS) or topical
             calcineurin inhibitor (TCI) or documented systemic treatment for AD within 6 months
             before Baseline Visit

        Exclusion Criteria:

          -  Prior exposure to any Janus kinase (JAK) inhibitor

          -  Unable or unwilling to discontinue current atopic dermatitis treatments prior to the
             study

          -  Requirement of prohibited medications during the study

          -  Other active skin diseases or skin infections requiring systemic treatment or would
             interfere with appropriate assessment of atopic dermatitis lesions

          -  Female subject who is pregnant, breastfeeding, or considering pregnancy during the
             study
A Study Of Galcanezumab In Participants With Episodic Cluster Headache
Condition: Episodic Cluster Headache
MeSH terms: Cluster Headache; Headache
Intervention: Galcanezumab; Placebo
Intervention description: Administered SC; Administered SC
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 109.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to evaluate the efficacy and safety of the study drug known
      as Galcanezumab in participants with episodic cluster headaches.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a diagnosis of cluster headache as defined by International Headache Society
             (IHS) International Classification of Headache Disorders (ICHD)-3 beta guidelines with
             a history of episodic cluster headache with at least two cluster periods lasting from
             7 days to 1 year (when untreated) and separated by pain-free remission periods of >=1
             month.

          -  Participants are able to distinguish cluster headache attacks from other headaches.

        Exclusion Criteria:

          -  Current enrollment in or discontinuation within the last 30 days from, a clinical
             trial involving any investigational drug or device.

          -  Current use or any prior exposure to any calcitonin-gene-related peptide (CGRP)
             antibody, any antibody to the CGRP receptor, or antibody to nerve growth factor (NGF).

          -  Are taking indomethacin and/or are suspected of having another distinct trigeminal
             autonomic cephalalgia.

          -  A history of migraine variants that could implicate or could be confused with
             ischemia.

          -  Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic
             proteins.

          -  A history or presence of other medical illness that indicates a medical problem that
             would preclude study participation.

          -  Evidence of significant active or unstable psychiatric disease, in the opinion of the
             investigator.

          -  Women who are pregnant or nursing.
The Use of Zoledronic Acid to Prevent Cancer-treatment Bone Loss in Post-menopausal Women Receiving Adjuvant Letrozole for Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Zoledronic acid; Letrozole
Intervention description: Zoledronic acid 4 mg Intravenous (IV)15 minute infusion every 6 months.; Letrozole tablets 2.5 mg/day/taken orally for 5 years.
Intervention MeSH terms: Zoledronic Acid; Letrozole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 527.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: breast cancer; letrozole; zoledronic acid; adjuvant; postmenopausal

Summary:

      Post-menopausal breast cancer patients will receive letrozole 2.5 mg daily for the treatment
      of breast cancer and will be randomized to a treatment group to receive either upfront
      zoledronic acid 4 mg IV 15-minute infusion every 6 months or delayed start zoledronic acid 4
      mg IV 15-minute infusion every 6 months. Delayed start zoledronic acid will be initiated when
      either the Bone Mineral Density T-score is below -2 Standard Deviations at either the lumbar
      spine or hip or any clinical fracture unrelated to trauma or an asymptomatic fracture
      discovered at the month 36 scheduled visit. Letrozole 2.5 mg will be given daily for 5 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stage I-IIIa breast cancer

          -  Postmenopausal

          -  Recent surgery for breast cancer

        Exclusion Criteria:

          -  Metastatic disease

          -  Invasive bilateral disease

          -  Clinical or radiological evidence of existing fracture in spine or hip

        Other protocol-defined inclusion / exclusion criteria may apply.