bioihbjkbjnl/mcl2 huggingface dataset:
Anidulafungin Plus Voriconazole Versus Voriconazole For The Treatment Of Invasive Aspergillosis
Condition: Aspergillosis
MeSH terms: Aspergillosis
Intervention: voriconazole; anidulafungin; voriconazole
Intervention description: First week: Voriconazole 6 mg/kg IV bid for the first 24 hours, followed by 4 mg/kg IV BID plus anidulafungin placebo IV qd.
Second week: Voriconazole 4 mg/kg IV bid or 300 mg PO bid plus anidulafungin placebo IV qd.
Third and fourth weeks: Voriconazole 4 mg/kg IV bid OR 300 mg PO bid plus anidulafungin placebo IV qd,
OR
Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.
Fifth and sixth weeks: Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.; First week: Voriconazole 6 mg/kg IV bid for the first 24 hours, followed by 4 mg/kg IV bid plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV qd thereafter.
Second week: Voriconazole 4 mg/kg IV bid or 300 mg PO bid plus anidulafungin 100 mg IV qd.
Third and fourth weeks: Voriconazole 4 mg/kg IV bid OR 300 mg PO bid plus anidulafungin 100 mg IV qd,
OR
Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.
Fifth and sixth weeks: Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.; First week: Voriconazole 6 mg/kg IV bid for the first 24 hours, followed by 4 mg/kg IV bid plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV qd thereafter.
Second week: Voriconazole 4 mg/kg IV bid or 300 mg PO bid plus anidulafungin 100 mg IV qd.
Third and fourth weeks: Voriconazole 4 mg/kg IV bid OR 300 mg PO bid plus anidulafungin 100 mg IV qd,
OR
Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.
Fifth and sixth weeks: Voriconazole 4 mg/kg IV bid or 300 mg PO bid monotherapy.
Intervention MeSH terms: Voriconazole; Anidulafungin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 459.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      This study compares the effectiveness and safety of the combination of anidulafungin and
      voriconazole compared to that of voriconazole alone (which is generally considered the
      standard of care) for the treatment of Invasive Aspergillosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Immunocompromised state due to either 1. receipt of hematopoeitic stem cell
             transplantation or 2. hematologic malignancy;

          -  Diagnosis of possible, probable, or proven invasive aspergillosis.

        Exclusion Criteria:

          -  Patients with aspergilloma or chronic aspergillosis

          -  Receipt of 4 or more days of systemic antifungal treatment for the current episode of
             invasive aspergillosis

          -  Anticipated survival of less than 5 days or Karnofsky score <=20
Perioperative Pregabalin in Ureteroscopy: a Pilot
Condition: Nephrolithiasis; Urolithiasis; Perioperative/Postoperative Complications; Pain, Postoperative; Pain, Acute; Anesthesia; Urologic Diseases; Anesthesia Morbidity
MeSH terms: Urolithiasis; Urinary Calculi; Nephrolithiasis; Kidney Calculi; Urologic Diseases; Pain, Postoperative; Postoperative Complications; Acute Pain
Intervention: Pregabalin 300mg
Intervention description: One 300mg capsule will be administered PO 1 hour before surgery
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: All participants will receive 300mg PO pregabalin one hour before procedure start
Masking: None (Open Label)
Masking description: There will be no blinding for this pilot
Enrollment: 10.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pregabalin; Perioperative medicine; Opioid sparing; Urolithiasis; Ureteroscopy

Summary:

      The investigators propose a pilot clinical trial on the use of perioperative pregabalin in
      order to decrease ureteral stent related symptoms and decrease opioid usage after
      ureteroscopy with stent placement. Patients undergoing ureteroscopy with stent placement will
      receive a single dose of 300 mg pregabalin PO in the preoperative area. This work will assess
      safety and feasibility of studying this regimen at our institution, with the aim of
      performing a randomized, placebo-controlled, double-blinded study in the future.
    

Eligibility criteria:

        Subject Population Undergoing elective ureteroscopy with stent placement by Dr. Murray at
        University of Missouri Hospital and affiliated facilities

        Subject Inclusion

        Age >= 18 years

        Subject Exclusion

          -  Renal insufficiency (eGFR < 30 mL/minute/1.73 m2)

          -  Chronic indwelling ureteral stent

          -  Chronic opioid use

          -  History of opioid abuse

          -  Chronic gabapentinoid use

          -  Plan for inpatient hospitalization

          -  Pregnancy

          -  Inability of the patient to consent for themselves in English

          -  Allergy to gabapentinoid

          -  Liver failure or hepatic dysfunction
Efficacy of Vortioxetine (Lu AA21004) in the Prevention of Relapse of Major Depressive Episodes
Condition: Major Depressive Disorder
MeSH terms: Recurrence; Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Placebo; Vortioxetine (Lu AA21004)
Intervention description: capsules, daily, orally; encapsulated tablets, daily, orally
Intervention MeSH terms: Vortioxetine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 639.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Relapse prevention; Antidepressants; Placebo-controlled; Double-blind; Multicentre study

Summary:

      This study will evaluate the efficacy of Vortioxetine in the prevention of relapse of major
      depressive episodes in patients who responded to open-label treatment with Vortioxetine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Major Depressive Episode (MDE) as the primary diagnosis according to DSM-IV TR
             criteria

          -  At least one other MDE before the current one

          -  Moderate to severe depression

        Exclusion Criteria:

          -  Any current psychiatric disorder other than Major Depressive Disorder (MDD) as defined
             in the DSM-IV TR

          -  Any substance disorder within the previous 6 months

          -  Female patients of childbearing potential who are not using effective contraception

          -  Use of any psychoactive medication 2 weeks prior to screening and during the study

        Randomisation Criteria: Patients in remission (MADRS total score <=10) at both Week 10 and
        Week 12

        Other protocol-defined inclusion and exclusion criteria may apply.
Empagliflozin (BI 10773) Comprehensive add-on Study in Japanese Subjects With Type 2 Diabetes Mellitus
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Metformin; BI 10773; Placebo (low dose); BI 10773; Placebo (high dose)
Intervention description: Metformin tablets 500-2250 mg a day (twice or three times per day); BI 10773 low dose tablet once daily; Placebo tablets once daily; BI 10773 high dose tablet once daily; Placebo tablets once daily
Intervention MeSH terms: Metformin; Empagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 1162.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      The objective of the study is to investigate the long-term safety and efficacy of BI 10773
      given for 52 weeks as add-on therapy to one oral antidiabetic drug in patients with type 2
      diabetes mellitus with insufficient glycaemic control.
    

Eligibility criteria:

        Inclusion criteria:

          -  .Diagnosis of type 2 diabetes mellitus prior to informed consent

          -  Male and female patients, on diet and exercise regimen, who are pre-treated with one
             of the following oral antidiabetic drugs: sulfonylurea, glinide, biguanide,
             Alpha-glucosidase inhibitor (a-GI), dipeptidyl peptidase-IV (DPP-IV) inhibitor or
             thiazolidinedione

          -  glycosylated haemoglobin (HbA1c) at Visit 1: >=7.0 to =<10.0% (national
             glycohemoglobin standardization program)

        Exclusion criteria:

          -  Uncontrolled hyperglycaemia with a glucose level >240 mg/dL (>13.3 mmol/L)

          -  Acute coronary syndrome, stroke or transient ischemic attack (TIA) within 12 weeks
             prior to informed consent

          -  Indication of liver disease, defined by serum levels of either alanine transaminase
             (ALT), aspartate transaminase (AST), or alkaline phosphatase (ALP) above 3 x upper
             limit of normal (ULN)
Safety and Tolerability and Efficacy of LCZ696 in Japanese Severe Hypertensive Patients
Condition: Severe Hypertension
MeSH terms: Hypertension
Intervention: LCZ696; LCZ696; LCZ696
Intervention description: LCZ696 200 mg tablet once daily; 2 tablets of LCZ696 200 mg once daily titrated up from 1 tablet of 200 mg once daily; 2 tablets of LCZ696 200 mg once daily titrated up from 1 tablet of 200 mg once daily plus other HTN medications
Intervention MeSH terms: Sacubitril and valsartan sodium hydrate drug combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 35.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Hypertension, Severe, LCZ696

Summary:

      This study assessed the safety, tolerability, and efficacy of LCZ696 in severe hypertensive
      Japanese patients
    

Eligibility criteria:

        Inclusion Criteria:

          -  Satisfy office msSBP ≥180 mmHg or office msDBP ≥110 mmHg at baseline

        Exclusion Criteria:

          -  Patients show msSBP ≥220 mmHg and/or msDBP ≥120 mmHg

          -  History of angioedema, drug-related or otherwise, as reported by the patient

          -  Patients unwilling or not able to discontinue safely the use of current
             antihypertensive medications during the study, as required by the protocol.

          -  Patients have significant cardiovascular co-morbidities

          -  Patients who previously entered a LCZ696 study and had been randomized or enrolled
             into the active drug treatment epoch.

        Other protocol defined inclusion/exclusion criteria may apply.
Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Iron Dextran in Treating Iron Deficiency Anemia
Condition: Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Intervention: Ferric Carboxymaltose; Iron Dextran
Intervention description: 15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.; As determined by the investigator to a maximum cumulative dose of 2,250 mg.
Intervention MeSH terms: Dextrans; Iron-Dextran Complex
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 161.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of this study is to evaluate the safety of FCM in patients with anemia who are
      not dialysis dependent.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects ≥18 years of age and able to give informed consent

          -  Iron deficiency is the primary etiology of anemia

          -  History of intolerance or an unsatisfactory response to oral iron

          -  Screening Visit central laboratory Hgb ≤11 g/dL

          -  Screening Visit ferritin ≤100 ng/mL or ≤300 when TSAT was ≤30%

        Exclusion Criteria:

          -  Previous participation in a FCM trial

          -  Known hypersensitivity reaction to FCM or iron dextran

          -  Requires dialysis for treatment of chronic kidney disease

          -  Current anemia not attributed to iron deficiency

          -  Received IV iron, RBC transfusion(s), or antibiotics 10 days prior and during the
             screening phase

          -  Anticipated need for surgery during the 30 day period prior to screening or during the
             study period

          -  AST or ALT greater than 1.5 times the upper limit of normal

          -  Received an investigational drug within 30 days of screening

          -  Women who are breastfeeding

          -  Pregnant or sexually-active females who are not willing to use an effective form of
             birth control
GWPCARE2 A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet Syndrome
Condition: Epilepsy; Dravet Syndrome
MeSH terms: Epilepsies, Myoclonic; Syndrome
Intervention: GWP42003-P; Placebo Control
Intervention MeSH terms: Cannabidiol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 199.0
Sex: All
Minimum age: 2 Years
Maximum age: 18 Years
Healthy volunteers: No
Keywords: Cannabidiol; CBD; GWP42003-P; Epidiolex

Summary:

      To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children
      and young adults with Dravet syndrome.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Participant must have been male or female, aged between 2 and 18 years (inclusive).

          -  Participant must have had a documented history of Dravet syndrome that was not
             completely controlled by current antiepileptic drugs.

          -  Participant must have been taking 1 or more antiepileptic drugs at a dose that had
             been stable for at least 4 weeks.

          -  All medications or interventions for epilepsy (including ketogenic diet and vagus
             nerve stimulation) must have been stable for 4 weeks prior to screening and
             participant was willing to maintain a stable regimen throughout the study.

        Key Exclusion Criteria:

          -  Participant had clinically significant unstable medical conditions other than
             epilepsy.

          -  Participant had clinically relevant symptoms or a clinically significant illness in
             the 4 weeks prior to screening or randomization, other than epilepsy.

          -  Participant was currently using or had in the past used recreational cannabis,
             medicinal cannabis, or synthetic cannabinoid-based medications (including Sativex®)
             within the 3 months prior to study entry and was unwilling to abstain for the duration
             for the study.

          -  Participant had any known or suspected hypersensitivity to cannabinoids or any of the
             excipients of the investigational medicinal products.

          -  There were plans for the participant to travel outside their country of residence
             during the study.

          -  Any history of suicidal behavior or any suicidal ideation of type four or five on the
             Columbia-Suicide Severity Rating Scale (Children's) at screening.
Concomitant Use and Staggered Use of Vaccine and Oral Poliovirus (OPV) in Healthy Infants (V260-014)(COMPLETED)
Condition: Rotavirus Infections; Gastroenteritis
MeSH terms: Rotavirus Infections; Gastroenteritis
Intervention: Rotavirus Vaccine, Live, Oral, Pentavalent; Comparator: Oral Poliovirus Vaccine (OPV); Comparator: Oral Poliovirus Vaccine (OPV) (staggered)
Intervention description: Three doses of rotavirus vaccine, live, oral, pentavalent. Dose 1 was given on Day 1, Dose 2 was given 56 to 84 days post Dose 1, and Dose 3 was given 56 to 84 days post Dose 2.; Three doses OPV. Dose 1 was given on Day 1, Dose 2 was given 56 to 84 days post Dose 1, and Dose 3 was given 56 to 84 days post Dose 2.; Three doses OPV. Dose 1 was given 14 to 28 days post Dose 1 of RotaTeq, Dose 2 was given 14 to 28 days post Dose 2 of RotaTeq, and Dose 3 was given 14 to 28 days post Dose 3 of RotaTeq.
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 735.0
Sex: All
Minimum age: 6 Weeks
Maximum age: 12 Weeks
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The study is being conducted to demonstrate that vaccine to prevent gastroenteritis due to
      rotavirus may be administered concomitantly with oral polio vaccine (OPV) without impairing
      the safety or immunogenicity of either vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Infants in good health

        Exclusion Criteria:

          -  Previous administration of any oral poliovirus vaccine (OPV) and rotavirus vaccine

          -  Receipt of inactivated poliovirus vaccine (IPV) prior to the first dose of either
             study vaccine, or at any time during the course of the study

          -  Any condition resulting in depressed immunity

          -  Any allergy to any vaccine component as stated in the package circulars

          -  Allergies to polymyxin B, neomycin or any other antibiotics

          -  Receipt of intramuscular, oral, or intravenous corticosteroid treatment

          -  History of congenital abdominal disorders, intussusception, or abdominal surgery;
             clinical evidence of active gastrointestinal illness

          -  History of known prior rotavirus gastroenteritis, chronic diarrhea, or failure to
             thrive

          -  Prior receipt of a blood transfusion or blood products, including immunoglobulin

          -  Fever, with a rectal temperature of ≥38.1°C (≥ 100.5°F) at the time of immunization

          -  Infants residing in a household with an immunocompromised person
Age-Related Eye Disease Study 2 (AREDS2)
Condition: Age-related Macular Degeneration; Cataract
MeSH terms: Cataract; Macular Degeneration; Eye Diseases
Intervention: Lutein/zeaxanthin; DHA/EPA; Lutein/zeaxanthin and DHA/EPA
Intervention description: 10 mg lutein and 2 mg zeaxanthin (1 tablet) Placebo-DHA/EPA (2 soft-gel capsules); Placebo-lutein/zeaxanthin (1 tablet) 350 mg DHA and 650 mg EPA (2 soft-gel capsules); 10 mg lutein and 2 mg zeaxanthin (1 tablet) 350 mg DHA and 650 mg EPA (2 soft-gel capsules)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 4203.0
Sex: All
Minimum age: 50 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: age-related macular degeneration; AMD; lutein; zeaxanthin; docosahexaenoic acid; eicosapentaenoic acid

Summary:

      Oral supplementation with the Age-Related Eye Disease Study (AREDS) formulation (antioxidant
      vitamins C and E, beta carotene, and zinc) has been shown to reduce the risk of progression
      to advanced age-related macular degeneration (AMD). Observational data suggest that increased
      dietary intake of lutein + zeaxanthin (carotenoids), omega-3 long-chain polyunsaturated fatty
      acids (docosahexaenoic acid [DHA] + eicosapentaenoic acid [EPA]), or both might further
      reduce this risk. AREDS2 was designed to test whether adding lutein + zeaxanthin, DHA + EPA,
      or lutein + zeaxanthin and DHA + EPA to the AREDS formulation might further reduce the risk
      of progression to advanced AMD. A secondary goal was to test the effects of eliminating beta
      carotene and reducing zinc dose in the AREDS formulation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women between the ages of 50 and 85 years

          -  Macular status ranges from large drusen in both eyes or large drusen in one eye and
             advanced AMD (neovascular AMD or geographic atrophy) in the fellow eye

        Exclusion Criteria:

          -  Ocular media not clear enough to allow good fundus photography
Evaluation of the Long- Term Effects of Spiriva on Lung Function in COPD Patients
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive
Intervention: tiotropium; placebo
Intervention MeSH terms: Tiotropium Bromide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Parallel Assignment
Enrollment: 5993.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The primary objective of this trial is to determine whether daily treatment with tiotropium
      (Spiriva®, Bromuro de Tiotropio®) inhalation capsule via HandiHaler® reduces the rate of
      decline in lung function over time in patients with COPD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written informed consent.

          -  Male or female patients 40 years of age or older.

          -  Smoking history of at least 10 pack years.

          -  Diagnosis of COPD with post bronchodilator FEV1 less than or equal to 70% of predicted
             normal and FEV1<70% of FVC and on stable respiratory medication.

        Exclusion Criteria:

          -  Significant diseases other than COPD which in the opinion of the investigator may put
             the patient at risk or influence the patients ability to participate.

          -  Myocardial infarction in past 6 months.

          -  Unstable or life threatening arrhythmia in past year.

          -  Hospitalization for NYHA heart failure class III or IV in past year.

          -  Active tuberculosis.

          -  Asthma.

          -  Pulmonary resection.

          -  Malignancy treated with radiation or chemotherapy in past 5 years.

          -  Respiratory infection in 4 weeks prior to screening.

          -  Known hypersensitivity to anticholinergic drugs or components.

          -  Known moderate to severe renal impairment.

          -  Known narrow angle glaucoma.

          -  Significant symptomatic BPH or bladder neck obstruction.

          -  Need for oxygen therapy >12 hr/day.

          -  Use of oral corticosteroids at unstable doses or >10 mg/day.