bioihbjkbjnl/mcl2 huggingface dataset:
Symbicort Single Inhaler Therapy vs Conventional Best Practice for the Treatment of Persistent Asthma in Adults
Condition: Asthma, Bronchial
MeSH terms: Asthma
Intervention: Symbicort (budesonide/formoterol) Turbuhaler; Conventional treatment
Intervention MeSH terms: Budesonide; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 654.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is intended to extend the knowledge of Symbicort Single Inhaler Therapy into a
      more general setting in order to assess the real-life impact of introducing this new
      treatment concept. The study will compare the Symbicort Single Inhaler Therapy concept with a
      conventional stepwise treatment regimen according to the investigator's judgement in patients
      who present with symptoms on inhaled glucocorticosteroids (GCS) treatment or who require and
      are already on treatment with a combination of inhaled and long-acting B2 agonists (LABA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Minimum of 3 months history of asthma, diagnosed according to the American Thoracic
             Society (ATS) definition (9).

          -  Prescribed inhaled GCS at a dose of 400μg/day of budesonide (or equivalents)and within
             the approved label for the relevant drug during the last 3 months prior to Visit 1.

          -  Either daily maintenance treatment with both inhaled GCS and LABA or daily treatment
             with inhaled GCS alone (i.e. without LABA)

          -  A history of suboptimal asthma control the month prior to enrolment as judged by the
             investigator

          -  Use of ≥3 inhalations of as needed medication for symptom relief during the last 7
             days before enrolment

        Exclusion Criteria:

          -  Previous treatment with Symbicort Single Inhaler;

          -  Use of any b-blocking agent, including eye-drops and oral GCS as maintenance
             treatment.

          -  Known or suspected hypersensitivity to study therapy or excipients.

          -  A history of smoking ≥ 10 pack years.

          -  Asthma exacerbation requiring change in asthma treatment during the last 14 days prior
             to or at Visit 1.
Adapalene Gel 0.3% Versus Tretinoin 0.05% Emollient Cream for Treatment of Photodamage
Condition: Photoaging
Intervention: adapalene gel, 0.3%; tretinoin 0.05% emollient cream
Intervention description: applied topically once daily in the evening; applied topically once daily in the evening
Intervention MeSH terms: Adapalene; Tretinoin; Emollients
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 30.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The primary purpose of this study is to compare the efficacy of adapalene (Differin®) gel
      0.3% and tretinoin 0.05% emollient cream for the treatment of signs of photodamage, with
      tolerability assessment as a secondary objective.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or Female aged 40 years of age and older with Fitzpatrick skin types I through
             III

          -  Clinically moderate to severe photodamage

        Exclusion Criteria:

          -  Subjects with history of laser resurfacing, dermabrasion, medium or deep chemical peel
             of the face

          -  Subjects with diagnosis of skin cancer within 3 months of study entry

          -  Subjects who have had superficial chemical peels, exfoliation or microdermabrasion of
             the face within 3 months of study entry

          -  Subjects who have had botulinum toxin for facial rejuvenation within 6 months of study
             entry and are unwilling to refrain from botulinum toxin treatments during the study
Evaluating the Safety and Efficacy of Proellex® in Premenopausal Women With Symptomatic Uterine Fibroids
Condition: Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma
Intervention: Proellex; placebo
Intervention description: 25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 71.0
Sex: Female
Minimum age: 18 Years
Maximum age: 48 Years
Healthy volunteers: No
Keywords: Uterine Fibroids

Summary:

      Premenopausal women with symptomatic uterine fibroids will be randomized to either Proellex
      25mg or 50mg or placebo for one treatment cycle (four months). Safety and effectiveness
      between 50 mg versus placebo, and between 25mg and placebo will be analyzed.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Speak, read and understand English or Spanish;

          -  Not have undergone hysterectomy, uterine arterial embolization or endometrial ablation
             therapy (previous myomectomy is acceptable) for any cause and no surgical
             interventions for uterine fibroids (e.g. hysterectomy, myomectomy, uterine arterial
             embolization) are planned or anticipated during the study;

          -  One uterine fibroid must be identifiable and measurable by transvaginal ultrasound;

          -  Menstrual cycle lasting from 24 to 36 days;

          -  History of excessive menstrual bleeding;

          -  Negative urine pregnancy test at screening.

        Exclusion Criteria:

          -  Six months or more (immediately prior to Screening Visit) without a menstrual period;

          -  Prior hysterectomy;

          -  Prior bilateral oophorectomy;

          -  Pregnant or lactating females or women who are attempting or expecting to become
             pregnant at any time during the study;

          -  Documented endometriosis, active pelvic inflammatory disease (PID), platelet
             dysfunction, or Von Willebrand's Disease;

          -  Any history or diagnosis of gynecological cancer or cervical dysplasia of any grade
             including atypical squamous cells of undetermined significance (ASCUS) associated with
             Human Papilloma Virus (HPV);

          -  Subject with diagnosed or suspected carcinoma of the breast, reproductive organs or
             any other organ system;

          -  Subject with known active infection with HIV, Hepatitis A, B or C, Gonorrhea, or
             Chlamydia or previous history of auto-immune disease or positive serum antinuclear
             antibodies.
A Study of Subjects Switched to Lurasidone for the Treatment of Schizophrenia or Schizoaffective Disorder
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Intervention: Lurasidone HCl
Intervention description: 40 mg Lurasidone tablets, 40 - 120 mg per day for up to 6 months
Intervention MeSH terms: Lurasidone Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 149.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Schizophrenia; Lurasidone; Latuda

Summary:

      Lurasidone (lurasidone HCl) is a novel psychotropic agent that is being developed as a
      potential new antipsychotic treatment for patients with schizophrenia. Switching between
      antipsychotic medications is common in the treatment of schizophrenia. The purpose of this
      study is to characterize the long-term safety and tolerability of lurasidone in subjects with
      schizophrenia or schizoaffective disorder and to allow for continued treatment for subjects
      completing the core study (D1050289-NCT01143077).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject has completed 6 weeks of treatment and all required assessments on the final
             study visit (Visit 8) of Study D1050289 (NCT01143077).

        Exclusion Criteria:

          -  Subject is considered by the investigator to be at imminent risk of suicide or harm to
             self, others, or damage to property.

          -  Subject has a body mass index (BMI) greater than 40 or less than 18 kg/m2 (see
             Appendix 3 for BMI determination).
Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis
Condition: Postmenopausal Osteoporosis
MeSH terms: Osteoporosis; Osteoporosis, Postmenopausal
Intervention: Romosozumab; Placebo; Denosumab
Intervention description: Administered by subcutaneous injection once a month (QM); Administered by subcutaneous injection once a month (QM); Administered by subcutaneous injection once every 6 months (Q6M)
Intervention MeSH terms: Denosumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 7180.0
Sex: Female
Minimum age: 55 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Osteoporosis, Osteoporosis-Postmenopausal, Bone Diseases-Metabolic, Bone Diseases, Musculoskeletal Diseases

Summary:

      The purpose of this study is to determine if treatment with romosozumab is effective in
      preventing fractures in women with postmenopausal osteoporosis
    

Eligibility criteria:

        Inclusion Criteria:

        - Postmenopausal women with osteoporosis, defined as low bone mineral density (BMD T-score
        at the total hip or femoral neck of ≤ -2.50)

        Exclusion Criteria:

          -  BMD T-score of ≤ -3.50 at the total hip or femoral neck

          -  History of hip fracture

          -  Any severe or more than 2 moderate vertebral fractures, as assessed by the central
             imaging based on lateral spine x-rays

          -  Use of agents affecting bone metabolism

          -  History of metabolic or bone disease (except osteoporosis)

          -  Vitamin D insufficiency (vitamin D repletion and rescreening is permitted)

          -  Current hyper- or hypocalcemia

          -  Current, uncontrolled hyper- or hypothyroidism

          -  Current, uncontrolled hyper- or hypoparathyroidism
Study of Lopinavir/Ritonavir Tablets Comparing Once-Daily Versus Twice-Daily Administration When Coadministered With Nucleoside/Nucleotide Reverse Transcriptase Inhibitors in Antiretroviral-Experienced Human Immunodeficiency Virus Type 1 Infected Subjects
Condition: Human Immunodeficiency Virus Infections
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Intervention: lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs); lopinavir/ritonavir (LPV/r) tablet with nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs)
Intervention description: LPV/r 800/200 mg once-daily (QD) tablet; LPV/r 400/100 mg twice-daily (BID) tablet
Intervention MeSH terms: Ritonavir; Lopinavir; Reverse Transcriptase Inhibitors
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 599.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study was to compare the safety, tolerability, and antiviral activity of
      once-daily (QD) and twice-daily (BID) dosing of the lopinavir/ritonavir (LPV/r) tablet
      formulation in combination with nucleoside/nucleotide reverse transcriptase inhibitors
      (NRTIs) in antiretroviral-experienced human immunodeficiency virus type 1 infected subjects
      with detectable viral load while receiving their current antiretroviral therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects were human immunodeficiency virus type 1 (HIV-1) positive,
             antiretroviral-experienced adults at least 18 years of age currently receiving an
             antiretroviral regimen which had not changed for at least 12 weeks.

          -  Subjects had plasma HIV-1 ribonucleic acid (RNA) levels > 1,000 copies/mL at screening
             and were not acutely ill.

          -  Subject was currently failing his/her antiretroviral regimen with the most recent 2
             consecutive prestudy plasma HIV-1 RNA levels > 400 copies/mL with the most recent
             being > 1000 copies/mL, and in the investigator's opinion, should change therapy

          -  Female subjects were nonpregnant and nonlactating.

        Exclusion Criteria:

          -  Subjects were excluded if screening laboratory analyses showed hemoglobin <= 8.0 grams
             per deciliter.

          -  Subjects were excluded if screening laboratory analyses showed absolute neutrophil
             count <= 750 cells/microliter.

          -  Subjects were excluded if screening laboratory analyses showed platelet count <=
             50,000 per cubic millimeter.

          -  Subjects were excluded if screening laboratory analyses showed alanine
             aminotransferase (ALT) or aspartate aminotransferase (AST) >= 5.0 x upper limit of
             normal (ULN).
The Study Of Azithromycin Switch Therapy For Treatment Of Community Acquired Pneumonia (CAP)
Condition: Community Acquired Pneumonia (CAP)
MeSH terms: Pneumonia
Intervention: Azithromycin
Intervention description: The intravenous formulation 500 mg is administered once daily for 2-5 days; followed by the oral formulation 500 mg will be given once daily to complete a 7 to 10-day course of therapy.
Intervention MeSH terms: Azithromycin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 102.0
Sex: All
Minimum age: 16 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Azithromycin has high rates of clinical response and eradication, wide spectrum of activity,
      so we suppose the development of the azithromycin injectable formulation in Japan would
      deliver benefit to patients of community acquired pneumonia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  16 years of age or older patients with CAP.

          -  Patients who were diagnosed as moderate in severity.

        Exclusion Criteria:

          -  Known or suspected hypersensitivity or intolerance to azithromycin, other macrolides,
             or ketolides.

          -  Hepatic dysfunction (AST, ALT, total bilirubin > 3 times institutional normal).

          -  Severe renal dysfunction (creatinine clearance < 30 ml/min).

          -  Patients who have a history of severe heart diseases (4th -degree of NYHA). Patients
             who have a congenital or sporadic long QT syndrome, or who are received the drugs with
             reported QT prolongation.

          -  Severe underlying disease.
Study of Durvalumab Alone or Chemotherapy for Patients With Advanced Non Small-Cell Lung Cancer (PEARL)
Condition: Non Small Cell Lung Carcinoma NSCLC
MeSH terms: Carcinoma, Non-Small-Cell Lung
Intervention: Durvalumab (MEDI4736); Paclitaxel + carboplatin; Gemcitabine + cisplatin; Gemcitabine + carboplatin; Pemetrexed + cisplatin; Pemetrexed + carboplatin
Intervention description: Anti-PD-L1 monoclonal Antibody monotherapy; Chemotherapy Agents; Chemotherapy Agents; Chemotherapy Agents; Chemotherapy Agent; Chemotherapy Agent
Intervention MeSH terms: Paclitaxel; Cisplatin; Carboplatin; Gemcitabine; Pemetrexed; Durvalumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 669.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: NSCLC; PD-L1; Durvalumab (MEDI4736); OS

Summary:

      This is a randomized, open-label, multi-center Phase III study to determine the efficacy and
      safety of durvalumab versus platinum-based SoC chemotherapy in the first-line treatment of
      advanced NSCLC in patients who are epidermal growth factor receptor (EGFR) and anaplastic
      lymphoma kinase (ALK) wild-type and with PD-L1 high expression (PEARL)
    

Eligibility criteria:

        Inclusion Criteria

          -  Aged at least 18 years

          -  Documented evidence of Stage IV NSCLC

          -  No sensitizing EGFR mutation and ALK rearrangement

          -  PD-L1 high expression

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

        Exclusion Criteria:

          -  Prior chemotherapy or any other systemic therapy for advanced NSCLC

          -  Prior exposure to immune-mediated therapy, including, but not limited to, other
             anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), anti-programmed cell death1
             (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti PD-L2 antibodies,
             excluding therapeutic anticancer vaccines

          -  Brain metastases or spinal cord compression unless the patient is stable and off
             steroids for at least 14 days prior to start of study treatment

          -  Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant

          -  Active or prior documented autoimmune or inflammatory disorders (e.g., colitis or
             Crohn's disease]
A Study of Retreatment With MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (RA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: rituximab [MabThera/Rituxan]; rituximab [MabThera/Rituxan]; rituximab [MabThera/Rituxan]
Intervention description: 500mg iv in days 1 and 15, and 500mg iv on days 168 and 182; 500mg iv on days 1 and 15, and 1000mg iv on days 168 and 182; 1000mg iv on days 1 and 15 and 1000mg iv (or placebo in UK)on days 168 and 182
Intervention MeSH terms: Rituximab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 378.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of various treatment and retreatment
      regimens of MabThera. All patients will receive concomitant methotrexate, 10-25mg once weekly
      either orally or parenterally. The anticipated time on study treatment is 2+ years, and the
      target sample size is 100-500 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients >=18 years of age;

          -  RA for >=6 months;

          -  receiving outpatient treatment;

          -  inadequate response to methotrexate, having received and tolerated it for >=12 weeks,
             with a stable dose for >=4 weeks.

        Exclusion Criteria:

          -  rheumatic autoimmune disease other than RA, or significant systemic involvement
             secondary to RA;

          -  inflammatory joint disease other than RA, or other systemic autoimmune disorder;

          -  diagnosis of juvenile arthritis, or RA before the age of 16;

          -  previous treatment with >1 biologic agent, any cell-depleting therapies, or concurrent
             treatment with any biologic agent or DMARD other than methotrexate.
Dynepo Infrequent Dosing Study
Condition: Anemia; Kidney Failure
MeSH terms: Renal Insufficiency; Anemia
Intervention: Dynepo (Epoetin delta); Dynepo; Dynepo; Dynepo
Intervention description: subcutaneous, BIW for 24 weeks; subcutaneous, QW for 24 weeks; subcutaneous, QW for 24 weeks; subcutaneous, Q2W for 24 weeks
Intervention MeSH terms: Epoetin Alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 407.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Chronic

Summary:

      The purpose of this study is to demonstrate non-inferiority of efficacy between twice weekly
      and once weekly dose schedule of Dynepo in previously erythropoietin (EPO)-naive patients, as
      measured by haemoglobin at week 24 and secondly to demonstrate the non-inferiority of
      efficacy between once weekly and once every two weeks dose schedules of Dynepo in patients
      previously stable on EPO, as measured by Hb over Weeks 16 to 24.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Aged at least 18 years with chronic kidney disease (Kidney Disease Outcomes Quality
             Initiative [KDOQI] stage III-V).

          -  Stable on and taking doses <= 10,000 IU/week of subcutaneous (sc) EPO or requiring
             initiation of EPO.

          -  Transferrin saturation >= 20% and ferritin >= 100 ng/mL.

        Exclusion Criteria:

          -  Uncontrolled hypertension.

          -  Requiring doses of EPO > 10,000 IU/week.

          -  Two or more doses of prescribed EPO treatment missed ot withheld by physician order in
             the 14 days immediately prior tp randomisation in the study.

          -  Active bleeding disorder (diathesis) (for example, Gastrointestinal or Genitourinary
             tract bleeding).

          -  Treatment with immunosuppressive drugs (other than corticosteroids for a chronic
             condition) in the 30 days immediately prior to randomisation in the study.

          -  Androgen therapy in the 30 days immediately prior to randomisation in the study.

          -  Known Human Immunodeficiency Virus(HIV)infection.

          -  History of hypersensitivity to EPO therapy or to any of the excipients of Dynepo.