bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Aclidinium Bromide 400 µg BID (Twice a Day)Compared to Placebo in Patients With Stable Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Aclidinium Bromide; Placebo
Intervention description: 1 puff of 400 micro grams in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h); 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h)
Intervention MeSH terms: Bromides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 112.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD; Antimuscarinic

Summary:

      The aim of the present study is to evaluate the effect of aclidinium bromide 400 μg twice a
      day (BID) administered twice a day versus placebo on exercise endurance and on hyperinflation
      and dyspnoea at rest and during exercise after 3 weeks of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult male and female patients aged ≥ 40 with stable moderate to severe COPD (Global
             Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines).

          -  Post-salbutamol Forced Expiratory Volume in one second(FEV1) < 80% and ≥ 30% of
             predicted normal value and Post-salbutamol FEV1/Forced Vital Capacity (FVC) < 70%.

          -  Current or ex-smokers of ≥ 10 pack-years

          -  Functional residual capacity (FRC) measured by body plethysmography at Screening Visit
             ≥ 120% of predicted value

        Exclusion Criteria:

          -  History or current diagnosis of asthma

          -  Signs of an exacerbation within 6 weeks ( or 3 months if results in hospitalisation)
             prior to the screening visit or during the run-in period.

          -  Clinically significant respiratory and/or cardiovascular conditions or laboratory
             abnormalities.

          -  Conditions where the use of anticholinergic drugs is contraindicated, such as known
             symptomatic prostatic hypertrophy, bladder neck obstruction or narrow-angle glaucoma.

          -  Patients with an oxygen saturation < 85% during cycle exercise on room air at
             Screening Visit, Run- in Visit and Visit 1.

          -  Contra-indications of cardiopulmonary exercise testing.

          -  Patient who in the investigator's opinion will need to start a pulmonary
             rehabilitation program during the study and/or patients who have just started/finished
             pulmonary rehabilitation at least 3 months prior to the Screening Visit.
A Phase III Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Dapagliflozin; Placebo; Metformin
Intervention description: Tablets administered orally as a 2.5-, 5-, or 10-mg dose once daily for up to 102 weeks; Dapagliflozin-matching placebo administered as tablets orally once daily for up to 102 weeks; Open-label metformin administered as ≥1500 mg per day for up to 102 weeks
Intervention MeSH terms: Metformin; Dapagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 915.0
Sex: All
Minimum age: 18 Years
Maximum age: 77 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus, Type 2; Diabetes Mellitus; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Metformin; Hypoglycemic Agents; Pharmacologic Actions; Physiological Effects of Drugs

Summary:

      The purpose of this clinical research study is to learn whether dapagliflozin can help reduce
      blood sugar levels in participants with Type 2 diabetes that is not well controlled on
      metformin alone. The safety of this treatment will also be studied.
    

Eligibility criteria:

        Key Inclusion Criteria

          -  Males and females, 18 to 77 years old, with type 2 diabetes and inadequate glycemic
             control

          -  Participants who have been receiving metformin at a total daily dose ≥1500 mg per day
             for at least 8 weeks

          -  C-peptide ≥1.0 ng/mL

          -  Body mass index ≤45.0 kg/m^2

          -  Serum creatinine level <1.50 mg/dL for men or <1.40 mg/dL for women.

        Key Exclusion Criteria

          -  Aspartate aminotransferase and/or alanine aminotransferase level >3.0 times the upper
             limit of normal

          -  Serum total bilirubin level >2 mg/dL

          -  Creatinine kinase level >3 times upper limit of normal

          -  Symptoms of severely uncontrolled diabetes

          -  Serum creatinine level ≥1.50 mg/dL for men or ≥1.40 mg/dL for women

          -  Currently unstable or serious cardiovascular, renal, hepatic, hematologic, oncologic,
             endocrine, psychiatric, or rheumatic diseases
A Study to Evaluate the Effect of Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients With Chronic Kidney Disease
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Intervention: Dapagliflozin; Placebo
Intervention description: 10 mg or 5 mg tablets given once daily, per oral use.; Placebo matching dapagliflozin 10 mg or 5 mg
Intervention MeSH terms: Dapagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 4304.0
Sex: All
Minimum age: 18 Years
Maximum age: 130 Years
Healthy volunteers: No
Keywords: Chronic Kidney Disease (CKD); Cardiovascular Events (CV); Phase III outcome trial

Summary:

      The purpose of this study is to evaluate the effect of dapagliflozin on renal outcomes and
      cardiovascular mortality in patients with chronic kidney disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of signed informed consent prior to any study specific procedures

          -  Female or male aged ≥18 years at the time of consent

          -  eGFR ≥25 and ≤75 mL/min/1.73m2 (CKD-EPI Formula) at visit 1

          -  Evidence of increased albuminuria 3 months or more before visit 1 and UACR ≥200 and
             ≤5000 mg/g at visit 1

          -  Stable, and for the patient maximum tolerated labelled daily dose, treatment with
             ACE-I or ARB for at least 4 weeks before visit 1, if not medically contraindicated,

        Exclusion Criteria:

          -  Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis
             or ANCA-associated vasculitis

          -  Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for
             primary or secondary renal disease within 6 months prior to enrolment

          -  History of organ transplantation

          -  Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or
             previous intolerance of an SGLT2 inhibitor

          -  Type 1 diabetes mellitus

          -  New York Heart Association (NYHA) class IV Congestive Heart Failure at the time of
             enrolment

          -  MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to
             enrolment
Study Of Irinotecan Hydrochloride (Campto(R)) And Cisplatin Versus Etoposide And Cisplatin In Small Cell Lung Cancer
Condition: Small Cell Lung Carcinoma
MeSH terms: Small Cell Lung Carcinoma
Intervention: Etoposide + cisplatin; Irinotecan + cisplatin
Intervention description: etoposide 100 mg/m2 days 1, 2 and 3 cisplatin 80 mg/m2 day 1 3 week cycle; irinotecan 65 mg/m2 day 1 and 8 cisplatin 80mg/m2 day 1 3 week cycle
Intervention MeSH terms: Cisplatin; Irinotecan; Etoposide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 485.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      To compare the effects of irinotecan hydrochloride with cisplatin to the "standard" regimen
      etoposide plus cisplatin on overall survival, in chemotherapy-naive patients with newly
      diagnosed Extensive Disease-Small Cell Lung Cancer (ED-SCLC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically proven Small Cell Lung Cancer (SCLC)

          -  WHO performance status : 0, 1

        Exclusion Criteria:

          -  No previous radiotherapy is allowed except on bone metastases when newly diagnosed.
             Radiotherapy is not allowed for vena cava syndrome, a stent is recommended ;

          -  No prior surgery on the primary tumor except for palliative purpose (stent for vena
             cava syndrome).
Clinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Macitentan
Intervention description: Tablet, oral administration, 10 mg dose once daily
Intervention MeSH terms: Macitentan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 550.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: SERAPHIN; Pulmonary Arterial Hypertension; ACT-064992

Summary:

      The main objective of the AC 055 303/SERAPHIN OL study, which will follow the AC 055
      302/SERAPHIN study, will be to assess the long-term safety and tolerability of ACT 064992 in
      patients with symptomatic PAH.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent prior to initiation of any study-mandated procedure.

          -  Patients with pulmonary arterial hypertension and having completed the event-driven
             study, AC 055 302/SERAPHIN, or Patients who have experienced a clinical worsening of
             PAH in AC 055 302/SERAPHIN and for whom a written approval to roll over into this
             study has been obtained from the Sponsor.

          -  Women of childbearing potential must have a negative pre-treatment serum pregnancy
             test and must use a reliable method of contraception during study treatment and for at
             least 28 days after study treatment termination.

        Exclusion Criteria:

          -  Any major violation of protocol AC 055 302/SERAPHIN.

          -  Pregnancy or breast-feeding.

          -  AST and/or ALT > 3 times the upper limit of the normal range.

          -  Any known factor or disease that might interfere with treatment compliance, study
             conduct or interpretation of the results, such as drug or alcohol dependence or
             psychiatric disease.

          -  Known hypersensitivity to ACT 064992 or any of the excipients.
Safety and Effectiveness Study of Imiquimod Creams for the Treatment of Actinic Keratoses (AKs)
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: Imiquimod cream; Placebo cream; Imiquimod cream
Intervention description: 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.; 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.; 250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
Intervention MeSH terms: Imiquimod
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 490.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Actinic keratosis; Dermatologic disease

Summary:

      The purpose of this study is to determine whether imiquimod creams are effective in treating
      Actinic Keratoses when applied to the face or balding scalp.

      Actinic keratosis (AK) is a skin condition that shows up on skin routinely exposed to the
      sun, such as the face, scalp, shoulders, chest, back, arms, and hands. The active ingredient
      contained in the study cream for this study is the same as that of the approved product
      Aldara, which has shown to be safe and effective for the treatment of AKs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  In good general health.

          -  Have 5 to 20 AKs on the face or balding scalp.

          -  Negative pregnancy test (for women who are able to become pregnant).

          -  Willing to make frequent visits to the study center during the treatment and follow-up
             periods.

        Exclusion Criteria:

          -  Women who are pregnant, lactating or planning to become pregnant during the study.

          -  Have had a medical event within 90 days of the first visit (such as: stroke, heart
             attack).

          -  Have any skin condition in the treatment area that may be made worse by treatment with
             imiquimod (such as: rosacea, psoriasis, atopic dermatitis, eczema).

          -  Have received specific treatments/medications in the treatment area(s) within the
             designated time period prior to study treatment initiation.
Study Of FOLFIRI Chemotherapy With Or Without Sunitinib In Patients With Metastatic Colorectal Cancer
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: 5 fluorouracil; irinotecan; levo- leucovorin; sunitinib; 5 fluorouracil; irinotecan; levo- leucovorin; placebo
Intervention description: 400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days; 180mg/m2 iv day 1 every 14 days; 200mg/m2 iv; day 1 every 14 days; 37.5mg of blinded therapy every day for 28 days followed by 14 days of blinded therapy free period; 400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days; 180mg/m2 iv day 1 every 14 days; 200mg/m2 iv; day 1 every 14 days; 37.5mg of blinded placebo therapy every day for 28 days followed by 14 days of blinded therapy free period
Intervention MeSH terms: Leucovorin; Fluorouracil; Irinotecan; Sunitinib; Levoleucovorin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 768.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: colorectal neoplasms

Summary:

      The purpose of the study is to evaluate the safety and efficacy of FOLFIRI (Irinotecan,
      Leucovorin and 5 Fluorouracil) chemotherapy when combined with sunitinib or FOLFIRI
      chemotherapy without adding sunitinib as the first line treatment of patients with metastatic
      colorectal cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed (histologically or cytologically) colorectal adenocarcinoma with metastatic
             disease.

          -  Not received previous therapy for metastatic colorectal disease but for whom FOLFIRI
             treatment is clinically indicated.

          -  Adequate organ function defined by blood test.

        Exclusion Criteria:

          -  History of another primary cancer in the last 3 years.

          -  Previous full field radiotherapy within the last 4 weeks or limited field radiotherapy
             within 2 weeks of enrolling into the study. Or previous radiation treatment of more
             that 30% of the bone marrow.

          -  History of presence of brain metastasis, spinal cord compression carcinomatous
             meningitis or leptomeningeal disease.
Randomized Phase III Study to Evaluate the Efficacy and Safety of Xyzal® (Levocetirizine) vs Zyrtec® (Cetirizine) in Subjects With Dermatitis and Eczema
Condition: Dermatitis; Eczema
MeSH terms: Dermatitis; Eczema
Intervention: Levocetirizine; Cetirizine; Placebo-Levocetirizine; Placebo-Cetirizine; Standard topical steroid (1% hydrocortisone) ointment
Intervention description: 1 Levocetirizine 5mg tablet per day before bedtime for 14 days; 1 Cetirizine 10mg tablet per day before bedtime for 14 days.; 1 Placebo-Levocetirizine tablet per day before bedtime for 14 days; 1 Placebo-Cetirizine tablet per day before bedtime for 14 days; 1% hydrocortisone ointment, applied 2-3 times a day to all affected areas
Intervention MeSH terms: Cetirizine; Hydrocortisone; Levocetirizine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 466.0
Sex: All
Minimum age: 15 Years
Healthy volunteers: No
Keywords: Dermatitis; Eczema; Pruritus; Xyzal; Zyrtec; Levocetirizine; Cetirizine

Summary:

      Korean double-blind non-inferiority study to asses the efficacy (as measured by the responder
      rate of pruritus severity score by the patient at visit 4 or end-of-treatment visit over the
      2 weeks treatment period) and safety of Xyzal® to Zyrtec® in subjects suffering from
      dermatitis and eczema with pruritus symptoms
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects diagnosed as having atopic dermatitis, contact dermatitis, prurigo, pruritus
             in the dermatitis and eczema

          -  Subjects who require and agree to the concomitant use of a topical steroid
             preparation.

          -  Subjects having a minimum level of pruritus and having used topical hydrocortisone
             during the run -in period

          -  Written informed consent signed and dated by subject/legal guardian

          -  Female subjects with childbearing potential are eligible if they use a medically
             accepted contraceptive method and have a negative pregnancy test.

        Exclusion Criteria:

          -  Subjects with a known hypersensitivity to cetirizine or levocetirizine

          -  Any clinically significant condition that might interfere with the treatment
             evaluation, both for efficacy and safety

          -  Have used forbidden concomitant medications or having not respected adequate wash-out
             periods as defined by the protocol
FREEDOM - M: Oral Treprostinil as Monotherapy for the Treatment of Pulmonary Arterial Hypertension (PAH)
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Hypertension
Intervention: Oral treprostinil (UT-15C) Sustained Release Tablets; Placebo
Intervention description: Sustained release oral tablet, twice daily; Placebo oral tablet twice daily
Intervention MeSH terms: Treprostinil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 349.0
Sex: All
Minimum age: 12 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Pulmonary Arterial Hypertension

Summary:

      This study was an international, multicenter, randomized (2:1 active:placebo), double-blind,
      placebo-controlled study in subjects with PAH who were NOT currently receiving approved
      therapy for their PAH. Study visits occurred at 4 week intervals for 12 weeks (with an
      additional visit at Week 11) with the key measure of efficacy being the 6-minute walk test.
      Study procedures included routine blood tests, medical history, physical exams, disease
      evaluation, and exercise tests. Two optional substudies were also a part of FREEDOM-M at
      select centers - a hemodynamic substudy with a right heart catheterization at Baseline and
      Week 12 and a genetics and biomarkers substudy with blood samples collected at Baseline and
      Week 12.

      Patients who completed all assessments for 12 weeks were also eligible to enter an
      open-label, extension phase study (FREEDOM - EXT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Between 12 and 75 years of age, inclusive.

          -  Body weight at least 40 kg with a Body Mass Index < 45

          -  PAH that is either idiopathic/heritable; associated with repaired congenital
             systemic-to-pulmonary shunts (repaired ≥ 5 years); associated with collagen vascular
             disease; associated with HIV.

          -  Previous testing (e.g., right heart catheterization, echocardiography) consistent with
             the diagnosis of PAH.

          -  Baseline 6-minute walk distance between 200 and 425 meters, inclusive.

          -  Reliable and cooperative with protocol requirements.

        Exclusion Criteria:

          -  Nursing or pregnant.

          -  Currently receiving an endothelin receptor antagonist, a phosphodiesterase-5
             inhibitor, or prostacyclin within 30 days of Baseline.

          -  PAH due to conditions other than noted in the above inclusion criteria.

          -  History of uncontrolled sleep apnea, renal insufficiency, anemia, left sided heart
             disease, uncontrolled systemic hypertension, or parenchymal lung disease.

          -  Use of an investigational drug within 30 days of Baseline.
Effect of SPD422 on Platelet Lowering and Safety in Japanese Adults With At Risk Essential Thrombocythaemia
Condition: Essential Thrombocythemia (ET)
MeSH terms: Thrombocytosis; Thrombocythemia, Essential
Intervention: Anagrelide Hydrochloride
Intervention description: Subjects will be started at 1.0 mg per day and titrated as necessary.
Intervention MeSH terms: Anagrelide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 53.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate how effective and safe SPD422 (Anagrelide
      Hydrochloride) is in Japanese subjects, diagnosed with Essential Thrombocythemia, who's
      previously treatment has either not been effective or has caused unacceptable adverse
      reactions. The study will aim to show that platelet counts can be safely reduced in treated
      patients to below 600 x 10^9/L after a minimum of three months treatment. To demonstrate an
      positive effect platelet levels will need to remain below 600 x 10^9/L for at least 4 weeks.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have previously been treated with a cytoreductive therapy and been
             intolerant or refractory to that therapy.

        Exclusion Criteria:

          -  Subjects should not have any other underlying conditions or medications that would
             confound the study analysis or interact with the study medication.