bioihbjkbjnl/mcl2 huggingface dataset:
Darbepoetin Alfa MDS Companion Protocol
Condition: Myelodysplastic Syndrome (MDS)
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Intervention: Darbepoetin Alfa
Intervention description: The first dose of darbepoetin alfa was the same as that administered at the last dosing visit of the active treatment period in Study 20090160. Doses could be increased up to a maximum of 500 μg every two weeks (Q2W).
Intervention MeSH terms: Darbepoetin alfa
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Myelodysplastic Syndrome (MDS); Darbepoetin alfa; low risk MDS; intermediate-1 risk MDS; International Prognostic Scoring System (IPSS)

Summary:

      The primary objective of the study was to provide required access of investigational product
      (darbepoetin alfa) beyond the end of the active treatment period (EOATP) of the darbepoetin
      alfa MDS 20090160 (NCT01362140) study for patients who had continued demonstration of benefit
      from darbepoetin alfa treatment and to describe the safety of longer-term use in this patient
      population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject or subject's legally acceptable representative has provided informed consent
             prior to any study-specific activities/ procedures being initiated;

          -  Subject must continue long term follow up within parent study (20090160);

          -  Subject must have an ongoing clinically relevant erythroid response as assessed by the
             Investigator using current response criteria (ie, International Working Group (IWG)
             response criteria);

        Exclusion Criteria:

          -  Transfusion dependence defined as receiving a total of ≥ 4 units of red blood cell
             (RBC) transfusion in the previous 8-week period prior to enrolment;

          -  Known diagnosis of acute myelogenous leukemia (AML) or marrow collagen fibrosis;

          -  Known refractory anaemia with excess blast-2 (RAEB-2);

          -  Known diagnosis of intermediate-2 or high risk MDS per International Prognostic
             Scoring System (IPSS);

          -  Subjects received thrombopoiesis-stimulating factors (eg, eltrombopag, romiplostim) in
             the MDS 20090160 study or planning to receive such agents during the study;

          -  Other protocol defined inclusion and exclusion criteria may apply.
Loteprednol Ophthalmic Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
Condition: Inflammation; Pain; Cataract
MeSH terms: Cataract; Inflammation
Intervention: Loteprednol Etabonate Gel (BID); Loteprednol Etabonate Gel (TID); Vehicle (BID); Vehicle (TID)
Intervention description: One drop of LE gel instilled into the study eye two times per day (BID) for 14 days; One drop of LE gel instilled into the study eye three times per day (TID) for 14 days.; One drop of vehicle instilled into the study eye two times per day (BID) for 14 days; One drop of vehicle instilled into the study eye three times per day (TID) for 14 days
Intervention MeSH terms: Loteprednol Etabonate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 514.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the safety and efficacy of loteprednol etabonate
      ophthalmic gel
    

Eligibility criteria:

        Inclusion Criteria:

        Visit 1 (Screening Visit)

          -  Be willing and able to comply with all treatment and follow-up/study procedures.

          -  Be a candidate for routine, uncomplicated cataract surgery

        Visit 3 (Postoperative Day 1)

          -  Have undergone routine, uncomplicated cataract surgery (phaco- emulsification with
             posterior chamber IOL implantation, not combined with any other surgery) in the study
             eye.

          -  Have ≥ Grade 2 anterior chamber (AC) cells (6-15 cells) in the study eye.

        Exclusion Criteria:

          -  Have a severe/serious ocular condition or history/presence of chronic generalized
             systemic disease that the Investigator feels might increase the risk to the subject or
             confound the result(s) of the study.

          -  Have known hypersensitivity or contraindication to the study drug(s) or their
             components.
Efficacy and Safety Study of QVA149 in COPD Patients
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: QVA149; Umeclidinium/vilanterol; Placebo (umeclidinium/vilanterol); Placebo (QVA149)
Intervention description: QVA149 capsules for inhalation, delivered via QVA149 single dose dry powder inhaler (SDDPI); Umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler; Matching Placebo to umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler; Matching Placebo to QVA149 capsules for inhalation, delivered via QVA149 SDDPI
Intervention MeSH terms: Glycopyrrolate; Bromides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 357.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: Chronic Obstructive Pulmonary Disease (COPD)

Summary:

      The purpose of this study is to demonstrate that the efficacy of the combination product
      QVA149 is similar to the efficacy of the combination product umeclidinium/vilanterol on a
      pre-specified endpoint of FEV1 AUC0-24h while maintaining an acceptable safety profile.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female adults aged ≥40 yrs

          -  Smoking history of at least 10 pack years

          -  Diagnosis of stable Chronic Obstructive Pulmonary Disease (COPD) as classified by the
             Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2015)

          -  Post-bronchodilator Forced Expiratory Volume in 1 Second (FEV1)< 80% and ≥ 30% of the
             predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) <70%

          -  Modified Medical Research Council questionnaire grade of 2 or higher

        Exclusion Criteria:

          -  Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1

          -  Patients with concomitant pulmonary disease

          -  Patients with a history of asthma

          -  Any patient with lung cancer or a history of lung cancer

          -  Patients with a history of certain cardiovascular co-morbid conditions

          -  Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency

          -  Patients in the active phase of a supervised pulmonary rehabilitation program

          -  Patients contraindicated for inhaled anticholinergic agents and β2 agonists

          -  Other protocol-defined inclusion/exclusion criteria may apply
Study HZA106827: Efficacy/Safety Study of Fluticasone Furoate/Vilanterol (GW642444) in Adult and Adolescent Asthmatics
Condition: Asthma
MeSH terms: Asthma
Intervention: Fluticasone furoate/Vilanterol Inhalation Powder; Fluticasone Furoate Inhalation Powder; Placebo Inhaltion Powder
Intervention description: Fluticasone furoate/Vilanterol Inhalation Powder inhaled orally once daily for 12 weeks; Fluticasone Furoate Inhalation Powder inhaled orally once daily for 12 weeks; Placebo Inhaltion Powder inhaled orally once daily for 12 weeks
Intervention MeSH terms: Fluticasone; Xhance
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 612.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: GW642444; Vilanterol; Asthma; Fluticasone Furoate

Summary:

      The purpose of the study is to compare the efficacy and safety of fluticasone
      furoate/vilanterol (GW642444) inhalation powder and fluticasone furoate inhalation powder
      both administered once daily in adolescent and adult subjects 12 years of age and older with
      persistent bronchial asthma over a 12 week treatment period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Outpatients at least 12 years of age

          -  Male and female; female subjects of childbearing potential must be willing to use
             birth control

          -  Pre-bronchodilator FEV1 of 40-90% predicted normal

          -  Reversibility FEV1 of at least 12% and 200mL

          -  Current asthma therapy includes inhaled corticosteroid use for at least 12 weeks prior
             to first visit

        Exclusion Criteria:

          -  History of life-threatening asthma during last 10 years

          -  Respiratory infection or oral candidiasis

          -  Asthma exacerbation requiring oral corticosteroids or that required overnight
             hospitalisation requiring additional asthma treatment

          -  Uncontrolled disease or clinical abnormality

          -  Allergies to study drugs or the excipients

          -  Taking another investigational medication or prohibited medication

          -  Night shift workers

          -  Current smokers or subjects with a smoking history of at least 10 pack years
Study of Adjunctive or Monotherapy Rapastinel Treatment in Patients With Major Depressive Disorder (MDD)
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Rapastinel
Intervention description: Rapastinel 450 mg (prefilled syringe, weekly or biweekly or up to 4 weeks at the investigator's discretion intravenous IV administration)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 230.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Depression

Summary:

      Multicenter, open-label, long-term extended access treatment protocol in adult patients with
      a primary diagnosis of MDD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completion of lead-in study

          -  Adequate therapeutic benefit in the lead-in study to justify continuation of treatment
             with rapastinel in the judgement of the investigator

        Exclusion Criteria:

          -  Suicide risk, as determined by meeting any of the following criteria:

               1. A suicide attempt within the past year

               2. Significant risk, as judged by the investigator, based on the psychiatric
                  interview or information collected in the Columbia- Suicide Severity Rating Scale
                  (C-SSRS) at any visit in the lead-in study

               3. Montgomery-Asberg Depression Rating Scale (MADRS) Item 10 score ≥ 5 at any visit
                  during participation in the lead-in study where MADRS was conducted.

          -  At imminent risk of injuring self or others or causing significant damage to property,
             as judged by the investigator

          -  Females who are pregnant, breastfeeding, or planning to become pregnant or breastfeed
             during participation

          -  Females of childbearing potential and male partners of females of childbearing
             potential, not using a reliable means of contraception
Comparison of Smoflipid to Soy-based Lipid Reduction for Cholestasis Prevention in Surgical Neonates
Condition: Cholestasis of Parenteral Nutrition
MeSH terms: Cholestasis
Intervention: Smoflipid 20% Lipid Emulsion for Injection; Intralipid, 20% Intravenous Emulsion; Intralipid, 20% Intravenous Emulsion
Intervention description: Intravenous lipid containing soy, MCT, olive, and fish oils at goal doses of 3 g/kg/day; Intravenous lipid emulsion of 20% soy oil at goal doses of 1 g/kg/day; Intravenous lipid emulsion of 20% soy oil at goal doses of 2-3 g/kg/day
Intervention MeSH terms: Soybean oil, phospholipid emulsion; SMOFlipid
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective patients will be randomized to one of the two treatment arms, either composite lipid containing fish oil (Smoflipid) or soy-based lipid reduction. A third arm will include retrospective patients who will act as controls and received soy-based lipid at standard dosing.
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Healthy volunteers: No

Summary:

      Intestinal failure associated liver disease is a cholestatic liver disease associated with
      prolonged need for parenteral nutrition that can lead to such significant complications as
      liver failure. In the neonatal population, infants with history of intestinal resection and
      short bowel syndrome are at increased risk for this disease. The investigators plan to
      compare two possible lipid dosing preventative strategies including a composite, fish oil
      lipid and soy-based lipid reduction.
    

Eligibility criteria:

        Inclusion Criteria: Neonates with anticipated need for parenteral nutrition (based on
        primary physicians opinion) for greater than or equal to four weeks and one of the
        following diagnoses:

          -  Anatomic: Neonate with intestinal atresia, omphalocele, gastroschisis, or volvulus
             with or without intestinal resection.

          -  Ischemic/perforation: Neonates with spontaneous intestinal perforation or necrotizing
             enterocolitis requiring surgical intervention.

        Exclusion Criteria:

          -  Current weight less than 750 grams

          -  AST or ALT greater than 5 times the upper limit of normal within 2 weeks of enrollment

          -  Direct bilirubin greater than 2 mg/dL on any consecutive measurements 5 - 7 days apart
             within 2 weeks of enrollment

          -  Severe coagulopathy with INR greater than 95th percentile for age (>1.7 at less than 5
             days of age, > 1.5 older than five days of age)

          -  Culture confirmed sepsis with positive blood, urine, or CSF culture within 2 weeks of
             enrollment

          -  Renal failure requiring dialysis

          -  Cyanotic heart disease requiring prostaglandin therapy

          -  Hypertriglyceridemia (greater than 250mg/dL) at time of enrollment
Minocycline and Aspirin in the Treatment of Bipolar Depression
Condition: Bipolar Disorder Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Intervention: Minocycline; Aspirin; placebo
Intervention description: 100 mg po bid for 6 weeks; 81 mg po bid for 6 weeks; placebo for minocycline and/or aspirin
Intervention MeSH terms: Aspirin; Minocycline
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 99.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Bipolar Disorder; Minocycline

Summary:

      The purpose of this study is to determine whether minocycline and aspirin are effective in
      the treatment of depression in individuals with bipolar disorder.
    

Eligibility criteria:

        Inclusion Criteria:

        One hundred and twenty male or female outpatients between 18 and 65 years of age, who meet
        DSM-IV-TR criteria for BD (type I or II or NOS) and for a current major depressive episode
        will be recruited. The depressive syndrome must have been present for at least 4 weeks and
        the minimum threshold for depression severity will be set at a Quick Inventory of
        Depressive Symptomatology (QID-C16) score >10. Subjects will provide written informed
        consent as approved by the Western Institutional Review Board.

        Exclusion Criteria:

        (a) Illness onset after 40 years of age; (b) serious risk of suicide; (c) current delusions
        or hallucinations sufficient to interfere with the capacity to provide informed consent;
        (d) current manic symptoms of sufficient severity to pose a substantial risk of the
        development of a manic episode; (e) current treatment with more than four psychotropic
        medications; (f) medical illness including hepatic impairment, renal dysfunction, bleeding
        diatheses, cerebrovascular disease, hypertension or diabetes mellitus that is inadequately
        controlled by diet and/or medication, or known active peptic ulcer disease; (g) abuse of
        drugs or alcohol within the preceding 6 months, or substance dependence within the last
        year; (h) daily alcoholic beverage consumption equivalent to >3 oz. of alcohol; (i) known
        allergies or hypersensitivities to tetracycline antibiotics, aspirin or other NSAIDs; (j)
        current use of drugs that could increase the risks associated with aspirin or minocycline
        administration, (k) chronic infection, (l) use of antibiotics, (m) pregnant or nursing
        women, (n) asthma which in the opinion of the investigator would increase the likelihood of
        an asthmatic attack, and (o) regular use of steroidal or non-steroidal anti-inflammatory
        medications (occasional use of NSAIDS was allowed).
A Comparative Study Of PF-06439535 Plus Paclitaxel-Carboplatin And Bevacizumab Plus Paclitaxel-Carboplatin Patients With Advanced Non-Squamous NSCLC
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Bevacizumab-Pfizer; Bevacizumab-EU; Paclitaxel; Carboplatin
Intervention description: Bevacizumab-Pfizer: 15 mg/kg IV on Day 1 of a 21-day cycle for each of at least 4 and no more than six (6) 21-day cycles, followed by the assigned blinded bevacizumab monotherapy.; bevacizumab-EU: 15 mg/kg IV on Day 1 of a 21-day cycle for each of at least 4 and no more than six (6) 21-day cycles followed by the assigned blinded bevacizumab monotherapy.; Paclitaxel 200 mg/m2 via IV infusions on Day 1 of a 21-day cycle for each of at least 4 and no more than six (6) 21-day cycles.; carboplatin AUC =6.0 via IV infusions on Day 1 of a 21-day cyclefor each of at least 4 and no more than six (6) 21-day cycles.
Intervention MeSH terms: Paclitaxel; Bevacizumab; Carboplatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 719.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a multinational, double-blind, randomized, parallel-group Phase 3 clinical trial
      evaluating the efficacy and safety of bevacizumab-Pfizer plus paclitaxel and carboplatin
      versus bevacizumab-EU plus paclitaxel and carboplatin in first-line treatment for patients
      with advanced (unresectable, locally advanced, recurrent or metastatic) non-squamous NSCLC.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients age at least 18 years of age, or age of consent in the
             region.

          -  Newly diagnosed Stage IIIB or IV non-small cell lung cancer (according to Revised
             International System for Staging Lung Cancer criteria of 2010) or recurrent non-small
             cell lung cancer (NSCLC).

          -  Histologically or cytologically confirmed diagnosis of predominately non-squamous
             NSCLC.

          -  Be eligible to receive study treatment of bevacizumab, paclitaxel, and carboplatin
             based on local standard of care, for the treatment of advanced or metastatic
             non-squamous NSCLC.

        Exclusion Criteria:

          -  Small cell lung cancer (SCLC) or combination SCLC and NSCLC. Squamous-cell tumors and
             mixed adenosquamous carcinomas of predominantly squamous nature.

          -  Evidence of a tumor that compresses or invades major blood vessels or tumor cavitation
             that is likely to bleed.

          -  Known sensitizing EGFR mutations (for example, deletion 19 or L858R) or EML4-ALK
             translocation positive mutations.

          -  Prior systemic therapy for NSCLC; prior neoadjuvant or adjuvant therapy is allowed if
             surgical resection for primary disease was performed.
Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity
Condition: Metabolism and Nutrition Disorder; Obesity
MeSH terms: Obesity; Overweight; Nutrition Disorders
Intervention: Semaglutide; Placebo
Intervention description: Subcutaneous (under the skin) injection of semaglutide once-weekly.; Subcutaneous (under the skin) injection of semaglutide placebo once-weekly.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Sponsor staff involved in the clinical trial is masked according to company standard procedures.
Enrollment: 902.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will look at the change in participant's body weight from the start to the end of
      the study. This is to compare the effect on body weight in people taking semaglutide (a new
      medicine) and people taking "dummy" medicine. In addition to taking the medicine, the
      participant will have talks with study staff about healthy food choices, how to be more
      physically active and what a participant can do to lose weight.

      The participant will get semaglutide for the first 20 weeks. Then the participant will get
      either semaglutide or "dummy" medicine - which treatment the participant gets after the 20
      weeks is decided by chance. The participants will need to take 1 injection once a week. The
      study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper
      arm. The study will last for about 1.5 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female, age greater than or equal to 18 years at the time of signing informed
             consent

          -  Body mass index greater than or equal to 30 kg/sqm or greater than or equal to 27
             kg/sqm with the presence of at least one of the following weight related comorbidities
             (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or
             cardiovascular disease

          -  History of at least one self-reported unsuccessful dietary effort to lose body weight

        Exclusion Criteria:

          -  Haemoglobin A1c greater than or equal to 48 mmol/mol (6.5%) as measured by central
             laboratory at screening

          -  A self-reported change in body weight more than 5 kg (11 lbs) within 90 days before
             screening irrespective of medical records