bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of the Combination of Empagliflozin and Linagliptin Compared to Linagliptin Alone Over 24 Weeks in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Linagliptin; Empagliflozin + Linagliptin; Empagliflozin + Linagliptin; Empagliflozin + Linagliptin; Empaglifozin placebo + Linagliptin placebo; Empagliflozin + Linagliptin
Intervention description: tablet; Fixed dose combination.; Fixed dose combination; Fixed dose combination; Matching Empaglifozin + Linagliptin low dose; Fixed dose combination.
Intervention MeSH terms: Empagliflozin; Linagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 607.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This trial compare the use of two different doses of Empagliflozin to placebo, in T2DM
      patients on 16 wks linagliptin treatment and metformin background therapy.
    

Eligibility criteria:

        Inclusion criteria:

          1. Diagnosis of type 2 diabetes mellitus.

          2. Male and female patients on diet and exercise regimen, pre-treated with immediate
             release metformin for at least 12 weeks, and patients should be on a dose higher or
             equal to 1500 mg/day of metformin, or maximum tolerated dose, or maximum dose as per
             local label.

          3. HbA1c higher or equal to 8.0% and lower or equal to 10.5% at screening visit.

          4. Age 18 years or more at screening.

          5. Body Mass Index lower or equal to 45 kg/m2 at screening visit.

          6. Signed and dated written informed consent.

        Exclusion criteria:

          1. Uncontrolled hyperglycemia with glucose level above 270 mg/dl (above 15 mmol/dl) after
             an overnight fast.

          2. Use of any other antidiabetic drug (except metformin background therapy).

          3. Acute coronary syndrome, stroke or TIA within 3 months prior to informed consent.

          4. Indication of liver disease.

          5. Impaired renal function.

          6. Gastrointestinal surgery.

          7. Treatment with anti-obesity drugs within 3 months prior to screening, or any other
             treatment at the time of screening (i.e. surgery, aggressive diet regimen, etc.)
             leading to unstable body weight.

          8. Current treatment with systemic steroids at time of informed consent or uncontrolled
             endocrine disorder except type 2 diabetes mellitus.
Immunogenicity, Safety of GSKs Tdap Vaccine Boostrix When Coadministered With GSKs Influenza Vaccine Fluarix in Adults
Condition: Acellular Pertussis; Diphtheria; Tetanus
MeSH terms: Diphtheria
Intervention: Fluarix®; Boostrix®
Intervention description: GSK Biologicals' inactivated influenza split virus vaccine.; GSK Biologicals' tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, containing 0.3 mg aluminum.
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1726.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Immunogenicity,; Influenza; Co-administration,; Tdap,

Summary:

      The current study will provide information for the use of Boostrix concomitantly with
      influenza vaccine in adults aged 19-64 years. This study will also provide safety and
      immunogenicity data in a cohort of adults aged greater than or equal to 65 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male or female adults aged between 19 to 64 years, inclusive for the primary
             cohort), or aged 65 years or older (for the exploratory cohort), at the time of
             vaccination.

        Exclusion Criteria:

          -  Administration of an influenza vaccine within six months prior to study entry

          -  Administration of a diphtheria-tetanus (Td) booster within the previous 5 years.

          -  Administration of a Tdap vaccine at any time prior to study entry.

          -  Administration of any investigational or non-registered drug or vaccine other than the
             study vaccines within 30 days preceding vaccination, or planned use during the entire
             study period.

          -  History of diphtheria and/or tetanus and/or pertussis disease.

          -  History of serious allergic reaction (e.g. anaphylaxis) following any other tetanus
             toxoid, diphtheria toxoid or pertussis-containing vaccine or influenza vaccine or any
             component of the study vaccines.
A Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Period in Subjects With Moderate to Very Severe COPD (Sophos)
Condition: Chronic Obstructive Pulmonary Disorder
MeSH terms: Lung Diseases
Intervention: BFF MDI (PT009) 320/9.6 μg; BFF MDI (PT009) 160/9.6 μg; FF MDI (PT005) 9.6 μg
Intervention description: Blinded Treatment; Blinded Treatment; Blinded Treatment
Intervention MeSH terms: Budesonide; Formoterol Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1876.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: COPD

Summary:

      This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD
      exacerbation and lung function study with PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6
      μg, all administered BID.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Give their signed written informed consent to participate

          2. At least 40 years of age and no older than 80 years of age

          3. COPD patients who are symptomatic

          4. Must be receiving one or more inhaled bronchodilators as maintenance therapy

          5. Must have a documented history of COPD exacerbations

        Exclusion Criteria:

          1. Current diagnosis of asthma

          2. COPD due to α1-Antitrypsin Deficiency

          3. Known active tuberculosis, lung cancer, cystic fibrosis, and significant
             bronchiectasis, Pulmonary resection or Lung Volume Reduction Surgery during the past 6
             months.

          4. Long-term-oxygen therapy (≥ 15 hours a day).
A Study of Tarceva (Erlotinib) Following Platinum-Based Chemotherapy in Patients With Advanced, Recurrent, or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Intervention: erlotinib [Tarceva]; Placebo
Intervention description: 150mg po daily; po daily
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 889.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva,
      compared with placebo, following platinum-based chemotherapy in patients with advanced,
      recurrent, or metastatic NSCLC who have not had disease progression or unacceptable toxicity
      during chemotherapy. Following 4 cycles of platinum-based chemotherapy, eligible patients
      will be randomized to receive either Tarceva 150mg po daily, or placebo daily. The
      anticipated time on study treatment is until disease progression; the target sample size is
      500+ individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  adult patients >=18 years of age;

          -  histologically documented, locally advanced , recurrent or metastatic NSCLC;

          -  measurable disease;

          -  no disease progression after 4 cycles of platinum-based chemotherapy.

        Exclusion Criteria:

          -  unstable systemic disease;

          -  any other malignancies in the last 5 years.
Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Twice or Three Times Daily in Patients With Acute Ankle Sprain
Condition: Grade I/II Ankle Sprain
MeSH terms: Sprains and Strains; Ankle Injuries
Intervention: diclofenac diethylamine gel 2.32%; diclofenac diethylamine gel 2.32%; Placebo
Intervention description: diclofenac diethylamine gel 2.32% twice a day; diclofenac diethylamine gel 2.32% three times a day; Placebo
Intervention MeSH terms: Diclofenac
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 242.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ankle sprain; soft tissue injury

Summary:

      The main purpose of this trial is to compare the efficacy and safety of diclofenac
      diethylamine 2.32% gel applied twice (b.i.d) or three times a day (t.i.d.) with placebo in
      the treatment of acute ankle sprains (distortions).
    

Eligibility criteria:

        Inclusion Criteria:

        1. Acute sprain of the lateral ankle, Grade I-II .

        Exclusion Criteria:

          1. Any concurrent injury affecting the lower extremities that is painful at rest or on
             movement, or could affect the mobilization of the patient.

          2. Topical analgesic or anti-inflammatory treatment over the previous month in the area
             to be treated.
Safety and Efficacy of Intravenous OAV101 (AVXS-101) in Pediatric Patients With Spinal Muscular Atrophy (SMA)
Condition: Spinal Muscular Atrophy
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal; Atrophy
Intervention: OAV101
Intervention description: Gene Therapy - 1.1e14 vector genome (vg)/kg as a one-time IV infusion was administered over approximately 60 minutes.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: Participants will receive a single administration of OAV101
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Zolgensma; OAV101; AVXS 101; gene therapy; Muscle atrophy; SBMA; spinal and bulbar muscular atrophy; spinal muscular atrophy; bulbar muscular atrophy; muscle function; myopathy; muscle wasting; atrophied muscle; loss of muscle strength

Summary:

      To evaluate the safety, tolerability and efficacy of intravenous administration of OAV101
      (AVXS-101) in patients with spinal muscular atrophy (SMA) with bi-allelic mutations in the
      survival motor neuron 1 (SMN1) gene weighing ≥ 8.5 kg and ≤ 21 kg, over a 12 month period.
    

Eligibility criteria:

        Inclusion

          -  Symptomatic SMA diagnosis based on gene mutation analysis with bi-allelic survival
             motor neuron 1 (SMN1) mutations (deletion or point mutations) and any copy of the
             survival motor neuron 2 (SMN2) gene.

          -  Weight ≥ 8.5 kg and ≤ 21 kg at the time of Screening Visit 2

          -  Naive to treatment or have discontinued an approved drug/therapy

        Exclusion:

          -  Previous OAV101 use or previous use of any adeno-associated virus serotype 9 (AAV9)
             gene therapy

          -  BMI < 3rd percentile

          -  Participant with history of aspiration pneumonia or signs of aspiration

          -  Elevated anti-AAV9 antibody

          -  History of gene therapy, hematopoietic transplantation, or solid organ transplantation

          -  Inability to take corticosteroids

          -  Concomitant use of immunosuppressive therapy

          -  Requiring invasive ventilation, tracheostomy or awake non-invasive ventilation 9.
             Administration of vaccines 2 weeks prior to infusion of OAV101

          -  Awake hypoxemia or awake oxygen saturation level decrease

          -  Hepatic dysfunction

          -  Presence of a confirmed or suspected infection

          -  If previously treated with disease modifying therapy, specified washout times apply

          -  Documented any parental consanguinity.
SKIPPAIN - Speed of Onset of SecuKinumab-Induced Relief From Pain in Patients With AxIal SpoNdyloarthritis
Condition: Spondyloarthritis
MeSH terms: Spondylitis; Spondylarthritis; Axial Spondyloarthritis
Intervention: AIN457; AIN457 Placebo
Intervention description: anti IL-17a monoclonal antibody; Placebo matching AIN457
Intervention MeSH terms: Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 383.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: axial spondyloarthritis; ankylosing spondylitis; non-radiographic axial spondyloarthritis; inflammatory back pain; spinal pain; secukinumab; AIN457

Summary:

      The purpose of the study was to evaluate the efficacy and safety of secukinumab 150 mg
      compared to placebo in the early management (Baseline to Week 8) of spinal pain, disease
      activity, fatigue, and predictability of disease flares in patients with axial
      spondyloarthritis (axSpA) who had an inadequate response to prior non-steroidal
      anti-inflammatory drugs (NSAIDs). This study also explored the efficacy and safety of
      secukinumab 300 mg compared to secukinumab 150 mg from Week 8 to Week 24 in order to assess
      the potential additional benefits of dose escalation in patients with axSpA.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Diagnosis of axial spondylarthritis (axSpA, either ankylosing spondylitis or non
             radiographic axial spondylarthritis) according to ASAS axSpA classification criteria

          -  patients with back pain for at least 3 months and age of onset less than 45 years

          -  Active axSpA as assessed by total BASDAI score of at least 4 at Baseline.

          -  Spinal pain numeric rating scale score of more than 4 at Baseline.

          -  inadequate response to or failure to respond to at least 2 different NSAIDs at the
             highest recommended dose for at least 4 weeks in total prior to randomization

        Key Exclusion Criteria:

          -  Chest X-ray or MRI with evidence of ongoing infectious or malignant process

          -  Patients previously treated with any biological immunomodulating agents, except those
             targeting tumor necrosis factor alpha.

          -  Patients who have been exposed to more than one anti-tumor necrosis factor alpha
             agent.

          -  Active ongoing inflammatory diseases other than axial spondyloarthritis

          -  Other ongoing mechanical diseases affecting the spine.
Study of Nivolumab (BMS-936558) vs. Everolimus in Pre-Treated Advanced or Metastatic Clear-cell Renal Cell Carcinoma (CheckMate 025)
Condition: Advanced or Metastatic (Medically or Surgically Unresectable) Clear-cell Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Intervention: Nivolumab; Everolimus
Intervention MeSH terms: Nivolumab; Everolimus
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 821.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to compare the clinical benefit, as measured by duration of
      overall survival, of Nivolumab vs. Everolimus in subjects with advanced or metastatic
      clear-cell renal cell carcinoma who have received prior anti-angiogenic therapy
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men & women ≥18 years of age

          -  Histologic confirmation of renal cell carcinoma (RCC) with clear-cell component

          -  Advanced/metastatic RCC

          -  Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
             criteria

          -  Received 1 or 2 prior anti-angiogenic therapy regimens in advanced or metastatic
             setting

          -  No more than 3 total prior systemic treatment regimens in the advanced or metastatic
             setting, and evidence of progression on or after last treatment regimen received and
             within 6 months of enrollment

          -  Karnofsky Performance Score ≥70%

        Exclusion Criteria:

          -  Any Central Nervous System (CNS) metastases or history of CNS metastases

          -  Prior therapy with an Mammalian target of rapamycin (mTOR) inhibitor

          -  Any active known or suspected autoimmune disease

          -  Uncontrolled adrenal insufficiency

          -  Active chronic liver disease

          -  Prior malignancy active within past 3 years, except for locally curable cancers

        Other protocol-defined inclusion/exclusion criteria apply
Role of Sildenafil for Fontan Associated Liver Disease (SiFALD) Study
Condition: Cirrhosis; Congenital Heart Disease
MeSH terms: Liver Diseases; Heart Diseases; Heart Defects, Congenital
Intervention: Sildenafil; Placebo
Intervention description: Sildenafil will be initiated at 5 mg 3 times per day for the first week, and titrated to 10 mg 3 times per day for the second week and 20 mg 3 times per day from the third week to the end of the study period, 12 months.; Placebo capsules matching study drug
Intervention MeSH terms: Sildenafil Citrate
Phase: Phase 3
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Double-blind Placebo-control study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Both the treatment arm (sildenafil) and the placebo arm will receive monthly package of similar pills. Equal number of patients will be randomly assigned to each arm.
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if the medication, sildenafil (also known as
      Revatio), can slow or stop the progression of liver disease in patients who previously had a
      Fontan operation.
    

Eligibility criteria:

        Inclusion criteria:

          -  All adult Fontan patients who have no contraindications for magnetic resonance imaging
             (MRI) will be eligible for the study.

        Exclusion criteria:

          -  Subjects with implantable pacemakers

          -  Residual cardiac lesions (severe ventricular dysfunction, severe atrioventricular
             valve regurgitation, Fontan baffle or conduit obstruction)

          -  Viral hepatitis

          -  Severe renal dysfunction

          -  History of sildenafil use in the six months prior to study enrollment

          -  Ongoing sildenafil therapy

          -  Patients currently taking nitrates

          -  Hypotension at baseline (BP <90/50 mmHg)

          -  Pulmonary veno-occlusive disease

          -  Hearing/vision impairment

          -  Pulmonary hypertension due to sickle cell disease

          -  Women of child-bearing potential with a positive pregnancy test will additionally be
             excluded
The Use of Galantamine HBr (Reminyl) in Electroconvulsive Therapy: Impact on Mood and Cognitive Functioning
Condition: Major Depression; Bipolar Depression; Schizoaffective Disorder
MeSH terms: Depression; Depressive Disorder; Psychotic Disorders; Bipolar Disorder
Intervention: Razadyne; Placebo
Intervention description: The starting dose of study medication is 4 mg twice a day; 4 mg, 2 times a day
Intervention MeSH terms: Galantamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      The purpose of the study is to see if galantamine HBr (Razadyne) is safe and can help treat
      problems with thinking and memory caused by electroconvulsive therapy (ECT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Criteria to enter the study include males and females between the ages of 18-90
             (females must be post menopausal) and a DSM-IV diagnosis of Major Depressive Disorder,
             Major Depressive Disorder with psychotic features, Bipolar Disorder, depressed type,
             or Schizoaffective Disorder, depressed type (19).

        Exclusion Criteria:

          -  DSM-IV diagnoses of dementia and its subtypes

          -  Substance use disorder (active use within the last 6 months)

          -  Organic mental disorders; seizure disorder

          -  Unstable physical disorder or physical disorder judged to significantly affect the
             central nervous system function

          -  A heart rate of <60

          -  A systolic blood pressure < 90

          -  Heart block

          -  Pre-existing sick-sinus

          -  Chronic treatment with beta blockers

          -  Any cardiac arrythmia

          -  Hypotension

          -  Coronary artery disease

          -  Liver and renal function impairment

          -  Urge incontinence, colitis Crohn's disease, GI motility disorders, asthma and COPD

          -  Treatment with anti-cholinergic and cholinomimetic medications; and

          -  Female patients who are pregnant.

          -  Additionally, women subjects must be postmenopausal, surgically sterile, or using
             prescription oral contraceptives (e.g. estrogen-progestin combinations) ,
             contraceptive implants (e.g. NorplantTM, DepoProveraTM ), or transdermally delivered
             contraceptives (Ortho EvraTM) before entry and throughout the study; and have a
             negative serum b-HCG pregnancy test at screening.

        Note: Abstinence and the use of double barrier contraceptive methods are not acceptable in
        this study.