bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Oral UT-15C Tablets to Treat Pulmonary Arterial Hypertension
Condition: Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Hypertension
Intervention: UT-15C SR; Placebo
Intervention description: treprostinil diolamine sustained release tablets
Intervention MeSH terms: Treprostinil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 310.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study is an international, multi-center, randomized, double-blind, placebo-controlled
      study in subjects with PAH who are currently receiving approved therapy for their PAH (i.e.,
      endothelin receptor antagonist and/or phosphodiesterase-5 inhibitor). Study visits will occur
      at 4 week intervals for 16 weeks with the key measure of efficacy being the 6-minute walk
      test. Study procedures include routine blood tests, medical history, physical exams, disease
      evaluation, and exercise tests.

      Patients who complete all assessments for 16-weeks will also be eligible to enter an
      open-label, extension phase study (FREEDOM - EXT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  A subject is eligible for inclusion in this study if all of the following criteria
             apply:

          -  Between 18 and 75 years of age, inclusive.

          -  Body weight at least 40 kg (approximately 90 lbs.)

          -  PAH that is either idiopathic/heritable; associated with appetite suppressant or toxin
             use; associated with collagen vascular disease; associated with repaired congenital
             shunts; associated with HIV.

          -  Currently receiving an approved endothelin receptor antagonist and/or an approved
             phosphodiesterase-5 inhibitor for at least 90 days and on a stable dose for at least
             the last 30 days.

          -  Baseline six-minute walk distance (6MWD) between 150-425 meters

          -  Previous testing (e.g., right heart catheterization, echocardiography) consistent with
             the diagnosis of PAH.

          -  Reliable and cooperative with protocol requirements.
The Effect of QVA149 on Health Related Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: QVA149; Placebo to tiotropium; Placebo to formoterol; Tiotropium; Formoterol; Placebo to QVA149
Intervention description: QVA149 110/50µg, once daily (q.d.) is administered via a single-dose dry powder inhaler; Placebo to tiotropium capsules daily (q.d.) for inhalation, delivered via proprietary inhaler (Handihaler®). Placebo tiotropium inhalation capsules were matched in size and color to tiotropium 18 μg q.d. inhalation capsules; Placebo to formoterol capsules twice daily (b.i.d) delivered via Aerolizer® device. Placebo formoterol inhalation capsules were equally matched in size, shape and color to formoterol 12 μg b.i.d. inhalation capsules.; Tiotropium 18µg, once daily is administered via the manufacturer's proprietary inhalation device.; Formoterol 12µg, twice daily is administered via the manufacturer's proprietary inhalation device.; Placebo to QVA149 is administered via a single-dose dry powder inhaler. Placebo QVA149 inhalation capsules were equally matched in size, shape and color to QVA149 110/50 μg q.d. inhalation capsules
Intervention MeSH terms: Glycopyrrolate; Formoterol Fumarate; Tiotropium Bromide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 934.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: QVA149; Health related quality of life; Formoterol; Tiotropium; COPD

Summary:

      This study will assess the efficacy and safety of QVA149 compared to tiotropium plus
      formoterol in patients with moderate to severe COPD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female adults aged ≥ 40 yrs

          -  Patients with moderate to severe chronic obstructive pulmonary disease (GOLD 2010
             guidelines)

          -  Smoking history of at least 10 pack years

          -  Post-bronchodilator FEV1 < 80% and ≥30% of the predicted normal value and
             post-bronchodilator FEV1/FVC (forced vital capacity) <70%

        Exclusion Criteria:

          -  Pregnant women or nursing mothers or women of child-bearing potential not using
             adequate contraception

          -  Patients with a history of long QT syndrome

          -  Patients with Type I or uncontrolled Type II diabetes

          -  Patients who have had a COPD exacerbation or respiratory tract infection within 6
             weeks prior to screening

          -  Patients with any history of asthma

          -  Patients with pulmonary lobectomy, lung volume reduction surgery, or lung
             transplantation

          -  Patients with concomitant pulmonary disease

          -  Patients requiring long term oxygen therapy (>15 h a day)

        Other protocol-defined inclusion/exclusion criteria may apply.
Erlotinib or Placebo Following Chemoradiotherapy (Chemo/RT) in Stage III Non-Small Cell Lung Cancer (NSCLC)
Condition: Carcinoma, Non-Small-Cell Lung; Non-small Cell Lung Cancer; NSCLC
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: Erlotinib (tarceva); Placebo
Intervention description: Erlotinib 150mg orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events, death or completion of 3 years of therapy.; Matched placebo orally each day. Patients will be treated on a continuous, once daily oral dosing schedule until disease progression, withdrawal of consent, unacceptable adverse events death or completion of 3 years of therapy.
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 245.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Erlotinib; Tarceva; Web based; Stage III NSCLC

Summary:

      This is a national, randomized, web-based, double-blind study to determine whether erlotinib
      (Tarceva) compared to placebo improves progression-free survival (PFS) for patients with
      inoperable, stage III NSCLC following concurrent docetaxel, carboplatin and thoracic
      radiotherapy. We hypothesize that the introduction of this orally active, well-tolerated
      agent following concurrent chemoradiation and prior to the emergence of drug resistance will
      prolong the progression-free survival by 40% (10 months → 14 months).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Unresectable, stage IIIA or IIIB NSCLC (measurable disease is not required)

          -  No evidence of metastatic disease

          -  No prior treatment

          -  Adequate organ function

          -  Adequate pulmonary function (FEV >= 1.0L or predicted FEV >0.8L)

        Exclusion Criteria:

          -  Metastasis

          -  Prior treatment

          -  Malignant pleural or pericardial effusion

          -  Peripheral neuropathy >= grade 2
CONvalescent Plasma for Hospitalized Adults With COVID-19 Respiratory Illness (CONCOR-1)
Condition: COVID-19
MeSH terms: COVID-19
Intervention: Convalescent plasma
Intervention description: Patients will receive 500 mL of convalescent plasma (from one single-donor unit of 500 mL or 2 units of 250 mL from 1-2 donations) collected by apheresis from donors who have recovered from COVID-19 and frozen (1 year expiration date from date of collection). The plasma unit will be thawed as per standard blood bank procedures and infused into the patient slowly over 4 hours. When administering 2 units of 250 mL, the 2nd unit will be administered after the first, and no longer than 12 hours later. The patient will be monitored for adverse events as per each site's policies.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 940.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Convalescent plasma; Transfusion; SARS-CoV-2; Passive immunization

Summary:

      There is currently no treatment available for COVID-19, the acute respiratory illness caused
      by the novel SAR-CoV-2. Convalescent plasma from patients who have recovered from COVID-19
      that contains antibodies to the virus is a potential therapy. On March 25th, 2020, the FDA
      approved the use of convalescent plasma under the emergency investigational new drug (eIND)
      category. Randomized trials are needed to determine the efficacy and safety of COVID-19
      convalescent plasma for acute COVID-19 infection.

      The objective of the CONCOR-1 trial is to determine the efficacy of transfusion of COVID-19
      convalescent plasma to adult patients admitted to hospital with COVID-19 infection at
      decreasing the frequency of in-hospital mortality in patients hospitalized for COVID-19.

      It is hypothesized that treating hospitalized COVID-19 patients with convalescent plasma
      early in their clinical course will reduce the risk of death, and that other outcomes will be
      improved including risk of intubation, and length of ICU and hospital stay.

      This pan-Canadian clinical trial has the potential to improve patient outcomes and reduce the
      burden on health care resources including reducing the need for ICU beds and ventilators.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥16 years old (>18 years of age in the United States)

          -  Admitted to hospital with confirmed COVID-19 respiratory illness

          -  Receiving supplemental oxygen

          -  500 mL of ABO compatible convalescent plasma is available

        Exclusion Criteria:

          -  Onset of respiratory symptoms >12 days prior to randomization

          -  Intubated or plan in place for intubation

          -  Plasma is contraindicated (e.g. history of anaphylaxis from transfusion)

          -  Decision in place for no active treatment
Cross Over Convenience And Preference Study Of New Mark VII Compared To Genotropin Pen In Pediatric And Adult Subjects
Condition: Growth Hormone Deficiency
Intervention: Genotropin Pen; MARK VII pen; Genotropin Pen; MARK VII pen
Intervention description: Pen provided in 5, 5.3 and 12 mg doses, Dose based on body weight, subcutaneous injection daily for 2 months while in study.; Pen provided in 5, 5.3 and 12mg doses, dose based on body weight, subcutaneous injection daily for 2 months while in study.; Pen provided in 5, 5.3 and 12mg doses, dose based on body weight, subcutaneous injection daily for 2 months while in study.; Pen provided in 5, 5.3 and 12mg doses, dose based on body weight, subcutaneous injection daily for 2 months while in study.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 4 Years
Healthy volunteers: No
Keywords: Growth Hormone Deficiency; Somatropin; Injection Pen; Medical Device; Cross Over Study; Preference; Convenience; Children; Dyads; Adults

Summary:

      Convenience and preference for the new Mark VII pen compared to the current Genotropin pen
      will be assessed using a questionaire. it is expected that the new pen will be preferred or
      at least no different to the current pen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age greater than or equal to 8 years.

          -  Subjects who are starting treatment with growth hormone (Genotropin) for the first
             time.

        Exclusion Criteria:

          -  Subjects with Prader-Willi syndrome or chronic renal insufficiency.

          -  Subjects and caregivers who, in the opinion of the investigator are not able to
             adequately participate in the study.

          -  Subjects with chronic systemic disorders, such as diabetes and heart disease.
DHEA Against Vaginal Atrophy - Safety Study of 12 Months
Condition: Vaginal Atrophy
MeSH terms: Atrophy
Intervention: DHEA
Intervention description: Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.
Intervention MeSH terms: Dehydroepiandrosterone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 530.0
Sex: Female
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Vulvar/Vaginal Atrophy; Atrophic Vaginitis; Dehydroepiandrosterone; DHEA; Prasterone; Vaginorm; Menopause; Intrarosa

Summary:

      The purpose of this Phase III trial is to assess the long-term safety of intravaginal
      dehydroepiandrosterone (DHEA) in non-hysterectomized postmenopausal women with vaginal
      atrophy aged 40 to 75 years.
    

Eligibility criteria:

        Main Inclusion Criteria:

          -  Postmenopausal women (non-hysterectomized)

          -  Women between 40 and 75 years of age.

          -  Willing to participate in the study and sign an informed consent.

          -  Women who have self-identified symptom(s) of vaginal atrophy.

          -  Willing to have endometrial biopsy at screening and end of study (Week 52).

        Main Exclusion Criteria:

          -  Undiagnosed abnormal genital bleeding.

          -  Hypertension equal to or above 140/90 mm Hg.

          -  The administration of any investigational drug within 30 days of screening visit.

          -  Endometrial hyperplasia, cancer or endometrial histology showing proliferative,
             secretory or menstrual type characteristics at histologic evaluation of endometrial
             biopsy performed at screening.
Study of Efficacy and Safety in Polycythemia Vera Subjects Who Are Resistant to or Intolerant of Hydroxyurea: JAK Inhibitor INC424 (INCB018424) Tablets Versus Best Available Care: (The RESPONSE Trial)
Condition: Polycythemia Vera
MeSH terms: Polycythemia Vera; Polycythemia
Intervention: ruxolitinib tablets; Best Available Therapy (BAT)
Intervention description: Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy; Best Available Therapy (BAT) will be selected by the Investigator for each participant. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
Intervention MeSH terms: Lenalidomide; Pomalidomide; Hydroxyurea; Pipobroman; Anagrelide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 222.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: INCB018424

Summary:

      This pivotal phase III trial (CINC424B2301) is designed to compare the efficacy and safety of
      ruxolitinib (INC424) to Best Available Therapy (BAT) in participants with polycythemia vera
      (PV) who are resistant to or intolerant of hydroxyurea (HU).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants diagnosed with PV for at least 24 weeks prior to screening according to
             the 2008 World Health Organization criteria

          -  Participants resistant to or intolerant of hydroxyurea

          -  Participants with a phlebotomy requirement

          -  Participants with splenomegaly (palpable or non-palpable) and a spleen volume, as
             measured by MRI (or CT in applicable participants ), of greater than or equal to 450
             cubic centimeters

          -  Participants with an Eastern Cooperative Oncology Group (ECOG) performance status of
             0, 1 or 2

        Exclusion Criteria:

          -  Women who are pregnant or nursing

          -  Participants with inadequate liver or renal function

          -  Participants with significant bacterial, fungal, parasitic, or viral infection
             requiring treatment

          -  Participants with an active malignancy within the past 5 years, excluding specific
             skin cancers

          -  Participants with known active hepatitis or HIV positivity

          -  Participants who have previously received treatment with a JAK inhibitor

          -  Participants being treated with any investigational agent
Effect of Serelaxin Versus Standard of Care in Acute Heart Failure (AHF) Patients
Condition: Acute Heart Failure (AHF)
MeSH terms: Heart Failure
Intervention: Serelaxin; Standard of Care
Intervention description: 30 µg/kg/day IV infusion; This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 2666.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: AHF,; RLX030,; SOC,; WHF,; RELAX-AHF-EU; Renal Impairment

Summary:

      This was a multinational, multicenter, randomized, open-label study to confirm and expand the
      efficacy, safety and tolerability evidence of 48 hours intravenous infusion of serelaxin (30
      micrograms/kg/day) when added to Standard of Care (SoC) in patients admitted to hospital for
      Acute Heart Failure (AHF).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Systolic blood pressure ≥ 125 mmHg

          -  Admitted for Acute Heart Failure (AHF)

          -  Received intravenous furosemide (or equivalent) at any time between presentation and
             the start of screening

          -  eGFR on admission: ≥ 25 and ≤75 mL/min/1.73 m^2

        Exclusion Criteria:

          -  Dyspnea (non-cardiac causes)

          -  T > 38.5°C

          -  Clinical evidence of acute coronary syndrome currently or within 30 days prior to
             enrollment.

          -  Significant left ventricular outflow obstruction, uncorrected, such as obstructive
             hypertrophic cardiomyopathy or severe aortic stenosis (i.e., aortic valve area <1.0
             cm^2 or mean gradient >50 mmHg on prior or current echocardiogram), severe aortic
             regurgitation and severe mitral stenosis.

          -  AHF due to significant arrhythmias

          -  Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive
             cardiomyopathy (does not include restrictive mitral filling patterns seen on Doppler
             echocardiographic assessments of diastolic function).
Safety and Efficacy of Bimatoprost Solution in Increasing Overall Eyelash Prominence
Condition: Eyelashes
Intervention: Bimatoprost 0.03% sterile solution; vehicle sterile solution
Intervention description: Apply one drop of study medication using single-use per eye applicator to upper eyelid margin once daily.; Apply one drop of study medication using single-use per eye applicator to upper eyelid margin once daily
Intervention MeSH terms: Bimatoprost; Pharmaceutical Solutions
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 278.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study evaluates the safety and effectiveness of topical bimatoprost solution for
      enhancing eyelash prominence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Dissatisfaction with eyelash prominence,

          -  Eyelash prominence assessment of minimal or moderate,

          -  Ability to provide written informed consent

        Exclusion Criteria:

          -  Subjects without visible lashes,

          -  Asymmetrical (uneven lashes or longer on one side than the other) eyelashes,

          -  Any eye disease or abnormality,

          -  Eye surgery,

          -  Permanent eyeliner,

          -  Eyelash implants,

          -  Eyelash extension application,

          -  Any use of eyelash growth products within 6 months of study entry,

          -  Treatments that may effect hair growth,

          -  Subjects requiring eye drop medications for glaucoma,

          -  Subjects having a situation or condition, which the study doctor feels might put you
             at risk, may make the study results confusing, or may interfere with the study.
Assessment of the Long-Term Safety and Efficacy of Bempedoic Acid (CLEAR Harmony OLE)
Condition: Hypercholesterolemia; Atherosclerotic Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Atherosclerosis; Hypercholesterolemia
Intervention: bempedoic acid
Intervention description: bempedoic acid 180 mg tablets taken orally, once per day.
Intervention MeSH terms: 8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acid
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1462.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hyperlipidemia; cholesterol; heterozygous familial hypercholesterolemia; atherosclerotic cardiovascular disease; ASCVD; HeFH; LDL

Summary:

      The purpose of this study is to see if bempedoic acid (ETC-1002) is safe and well-tolerated
      in patients with high cardiovascular risk and elevated LDL cholesterol that is not adequately
      controlled by their current therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Successfully completed CLEAR Harmony (1002-040) parent study

        Exclusion Criteria:

          -  Experienced a treatment-related SAE that led to study drug discontinuation in the
             CLEAR Harmony (1002-040) parent study.

          -  Medical condition requires lipid measurement and/or adjustment of background
             lipid-regulating therapy.