bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV); Non-Influenza Comparator (Boostrix)
Intervention description: 1 dose approximately 0.5 mL of aQIV; 1 dose approximately 0.5 mL dose of Non-influenza comparator vaccine (Boostrix)
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 6790.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      A Phase III, Randomized, Observer-Blind, Controlled, Multicenter Clinical Study to Evaluate
      the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine
      Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females ≥ 65 years old who are healthy or have co-morbidities

          2. Individuals who or whose legal guardian have voluntarily given written consent after
             the nature of the study has been explained according to local regulatory requirements,
             prior to study entry.

          3. Ability to attend all scheduled visits and to comply with study procedures

        Exclusion Criteria:

          1. Hypersensitivity, including allergy to any component of vaccines foreseen in this
             study

          2. Abnormal function of the immune system.

          3. Receipt of any influenza vaccine within 6 months prior to enrolment in this study or
             who plan to receive influenza vaccine while participating in the study.

          4. Additional eligibility criteria may be discussed by contacting the site
This Trial, Evaluating the Long-term Safety and Tolerability of Brivaracetam Will Provide Subjects Suffering From Epilepsy, Who May Have Benefited From Brivaracetam as Adjunctive Treatment, the Opportunity to Receive Open Label Brivaracetam Treatment
Condition: Epilepsy
MeSH terms: Epilepsy
Intervention: Brivaracetam
Intervention description: Active Substance: Brivaracetam
Pharmaceutical Form: Tablet
Concentration: 10 mg and 25 mg
Route of Administration: Oral
Intervention MeSH terms: Brivaracetam
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 668.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No
Keywords: Brivaracetam; Epilepsy; Partial Onset Seizures; open label

Summary:

      This trial, evaluating the long-term safety and tolerability of brivaracetam will provide
      subjects suffering from epilepsy, who may have benefited from brivaracetam as adjunctive
      treatment, the opportunity to receive open label brivaracetam treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male/ female subjects from 16 years and on. Subjects under 18 years may only be
             included where legally permitted and ethically accepted

          -  Subjects with epilepsy who have participated in previous brivaracetam trials which
             allow access to the present study

          -  Subjects for whom the investigator believes a reasonable benefit from the long term
             administration of brivaracetam may be expected

          -  Female subjects without childbearing potential. Female subjects with child bearing
             potential are eligible if they use a medically accepted contraceptive method for the
             duration of the study

          -  Subject/ legally acceptable representative considered as reliable and capable of
             adhering to the protocol, visit schedule or medication intake according to the
             judgment of the Investigator

        Exclusion Criteria:

          -  Severe medical, neurological and psychiatric disorders or laboratory values which may
             have an impact on the safety of the subject

          -  Poor compliance with the visit schedule or medication intake in the previous
             brivaracetam study

          -  Pregnant or lactating women

          -  Participation in any clinical study of another investigational drug or device during
             the study
Intravenous Thyroxine for Heart-Eligible Organ Donors
Condition: Brain Death; Heart Failure
MeSH terms: Brain Death
Intervention: Thyroxine; Saline
Intervention description: Infusion prepared by mixing 500 μg of drug in 500-ml of normal saline (i.e. concentration of 1 μg/ml) and enclosing the bag in an opaque sleeve. Infusion started at 30 μg/hour (30 ml/hour) for twelve hours.; The placebo will be a 500-ml bag of normal saline (without active drug) also enclosed in an opaque sleeve. This infusion will also be started at 30 ml/hour for twelve hours.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 838.0
Sex: All
Minimum age: 14 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Organ donor

Summary:

      This randomized controlled trial will evaluate whether intravenous thyroxine infusion given
      to brain-dead organ donors who are eligible to donate hearts for 12 hours will result in more
      hearts transplanted than saline placebo
    

Eligibility criteria:

        Inclusion Criteria:

          -  Declared dead by neurologic criteria (brain dead)

          -  Authorization for organ donation and research

          -  On one or more vasopressors and/or inotropes

        Exclusion Criteria:

          -  Brain death declared more than 24 hours prior

          -  Only vasopressor is vasopressin

          -  Weight < 45 kg (100 lbs)

          -  Known coronary artery disease or history of myocardial infarction

          -  Known valvular heart disease

          -  Prior sternotomy or cardiac surgery

          -  Donor at VA hospital

          -  Received intravenous or oral thyroxine within past month

          -  Known HIV+ status

          -  Other reason donor is unable to receive study drug (determined by on-site personnel)
Comparative Effectiveness of Pregnancy Failure Management Regimens
Condition: Spontaneous Abortion
MeSH terms: Abortion, Spontaneous
Intervention: Misoprostol; Mifepristone
Intervention MeSH terms: Misoprostol; Mifepristone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 300.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Spontaneous abortion; Early Pregnancy Failure; Mifepristone; Misoprostol

Summary:

      The purpose of the study is to compare the effectiveness of combination treatment
      (mifepristone premedication plus single-dose misoprostol) to single-dose misoprostol
      (standard of care) for the management of early pregnancy failure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  between 5 and 12 completed weeks gestation

          -  18 years or older

          -  hemodynamically stable

          -  confirmed diagnosis of intrauterine embryonic/fetal demise or anembryonic gestation
             (ultrasound examination demonstrates a fetal pole without cardiac activity measuring
             between 5.3 and 40 mm or an abnormal growth pattern diagnostic of early pregnancy
             failure)

          -  willing and able to give informed consent

        Exclusion Criteria:

          -  diagnosis of incomplete or inevitable abortion (absent gestational sac and/or active
             bleeding, open cervical os)

          -  contraindication to mifepristone (chronic corticosteroid administration, adrenal
             disease)

          -  contraindication to misoprostol (glaucoma, mitral stenosis, sickle cell anemia, or
             known allergy to prostaglandin)

          -  cardiovascular disease (angina, valvular disease, arrhythmia, or cardiac failure)

          -  most recent hemoglobin <9.5 g/dL

          -  diagnosis of porphyria

          -  known clotting defect or receiving anticoagulants

          -  pregnancy with an intrauterine device (IUD) in place

          -  breastfeeding during the first 7 days of study participation

          -  unwilling to comply with the study protocol and visit schedule

          -  any evidence of viable pregnancy

          -  possibility of ectopic pregnancy

          -  known or suspected pelvic infection

          -  concurrent participation in any other interventional trial
Phase 3 Study of KHK7580 for the Treatment of Hypercalcemia in Patients With Parathyroid Carcinoma or Primary Hyperparathyroidism
Condition: Parathyroid Carcinoma; Primary Hyperparathyroidism
MeSH terms: Carcinoma; Parathyroid Neoplasms; Hypercalcemia; Hyperparathyroidism; Hyperparathyroidism, Primary
Intervention: KHK7580
Intervention description: oral administration
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 18.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No

Summary:

      To evaluate the efficacy of KHK7580 orally administered up to 24 weeks for hypercalcemia in
      patient with parathyroid carcinoma or primary hyperparathyroidism who are unable to undergo
      parathyroidectomy or relapse after parathyroidectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Personally submitted written voluntary informed consent to participate in the study

          -  Patients with a diagnosis of parathyroid carcinoma or primary hyperparathyroidism who
             are unable to undergo parathyroidectomy or relapse after parathyroidectomy.

          -  Corrected serum calcium level is > 11.3 mg/dL at screening.

        Exclusion Criteria:

          -  Patients receiving cinacalcet hydrochloride within 2 weeks before screening

          -  Patients diagnosed with hypercalcemia associated with malignant tumors other than
             parathyroid carcinoma.

          -  Severe heart disease

          -  Severe hepatic dysfunction

          -  Uncontrolled hypertension and/or diabetes

          -  Treatment with an investigational product (drug or medical device) in a clinical study
             or any study equivalent to clinical study within 12 weeks before screening
Safety, Efficacy and Pharmacokinetics of NNC-0156-0000-0009 in Previously Treated Children With Haemophilia B.
Condition: Congenital Bleeding Disorder; Haemophilia B
MeSH terms: Hemostatic Disorders; Hemophilia A; Hemophilia B; Blood Coagulation Disorders
Intervention: nonacog beta pegol
Intervention description: A single dose of 40 U/kg will be administered intravenously, i.v. (into the vein) once weekly.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: Male
Minimum age: 0 Years
Maximum age: 12 Years
Healthy volunteers: No

Summary:

      This trial is conducted in Asia, Europe and North America. The aim of the trial is to
      evaluate safety, efficacy and pharmacokinetics (the exposure of the trial drug in the body)
      of NNC-0156-0000-0009 (nonacog beta pegol, N9-GP) in previously treated children with
      Haemophilia B.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male patients with moderately severe or severe congenital haemophilia B with a Factor
             IX activity level below or equal to 2% according to medical records

          -  Age below or equal to 12 years (until patient turns 13 years, at time of inclusion)

          -  Body weight above or equal to 10 kg

          -  History of at least 50 exposure days (EDs) to other FIX products

          -  The patient and/or parent(s)/caregiver are capable of assessing a bleeding episode,
             keeping an electronic diary (eDiary), capable of conducting home treatment and
             otherwise able to follow trial procedures

        Exclusion Criteria:

          -  Known history of FIX inhibitors

          -  Current FIX inhibitors above or equal to 0.6 Bethesda Units (BU)

          -  Congenital or acquired coagulation disorder other than haemophilia B

          -  Platelet count below 50,000/mcL at screening

          -  Alanine aminotransferase (ALT) above 3 times the upper limit of normal reference
             ranges at screening

          -  Creatinine level above or equal to 1.5 times above the upper normal limit of normal
             reference ranges at screening

          -  Human immunodeficiency virus (HIV) positive, defined by medical records, and with a
             CD4+ lymphocyte count below or equal to 200/mcL

          -  Immune modulating or chemotherapeutic medication (except single pulse treatment,
             inhaled and topical steroids)

          -  Previous arterial thrombotic events (myocardial infarction and intracranial
             thrombosis, as defined by medical records)
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).
Safety and Immunogenicity Study of 20vPnC When Coadministered With a Booster Dose of BNT162b2
Condition: Pneumococcal Disease; COVID-19; SARS-CoV-2 Infection
MeSH terms: COVID-19; Pneumococcal Infections
Intervention: 20-valent pneumococcal conjugate vaccine (20vPnC); BNT162b2; Saline
Intervention description: 20-valent pneumococcal conjugate vaccine (20vPnC); RNA-based SARS-CoV-2 vaccine (BNT162b2); Normal saline for injection
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Triple
Enrollment: 570.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Study of the safety and immunogenicity of 20vPnC and a booster dose of BNT162b2 administered
      at the same visit or each vaccine given alone
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female participants ≥65 years of age at the time of consent

          -  Participating or participated in Study C4591001, received 2 doses of 30 µg BNT162b2
             with the second dose given ≥6 months prior to the first vaccination in this study, and
             have not received a third dose of BNT162b2

          -  Adults determined by clinical assessment, including medical history and clinical
             judgement, to be eligible for the study, including adults with preexisting stable
             disease

          -  Adults who have no history of ever receiving a pneumococcal vaccine, or received a
             licensed pneumococcal vaccination ≥12 months prior to the first vaccination in this
             study

        Exclusion Criteria:

          -  History of severe adverse reaction associated with a vaccine and/or severe allergic
             reaction (eg, anaphylaxis)

          -  Serious chronic disorder that in the investigator's opinion would make the participant
             inappropriate for entry into the study

          -  Previous clinical or microbiological diagnosis of COVID-19

          -  Previous vaccination with any investigational pneumococcal vaccine, or planned receipt
             of any licensed or investigational pneumococcal vaccine through study participation

          -  Previous vaccination with any coronavirus vaccine, other than those received in Study
             C4591001

          -  Other medical or psychiatric condition including recent (within the past year) or
             active suicidal ideation/behavior or laboratory abnormality that may increase the risk
             of study participation or, in the investigator's judgment, make the participant
             inappropriate for the study
Clinical Efficacy Of BioMin F, Colgate Sensitive Pro-Relief And Sensodyne Rapid Action Dentifrices In DH
Condition: Dentin Hypersensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Intervention: Fluoro-Calcium-Phospho-Silicate based dentifrices; 8% Arginine based dentifrices; 8% Strontium Acetate; Sodium Fluoride
Intervention description: Bio-Active glass based formulation; Tubular occluding formulation; Tubular occluding formulation; No claim of relieving Dentin Hypersensitivity
Intervention MeSH terms: Listerine; Calcium; Fluorides; Sodium Fluoride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking description: Statistician will be masked.
Enrollment: 140.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Dentine hypersensitivity; Dentine Sensitivity; Oral dentifrices; Bio-active glasses

Summary:

      This will be multi-centered, triple blinded, randomized, four parallel treatments assigned
      study to compare clinical efficacy of commercially available dentifrices with placebo for
      immediate and sustained relief from Dentin Hypersensitivity after short term use.

      Condition or disease: Dentin hypersensitivity Intervention/Treatment: Product 1;
      Fluoro-Calcium-Phospho-silicate based BioMin F Product 2; Pro-Argin formula based Colgate
      Sensitive Pro-Relief Product 3; Strontium Acetate based Sensodyne Rapid Action Product 4;
      Sodium Fluoride based Colgate Total
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with at least two teeth sensitive to cold, touch and air blow stimulus

          -  Sensitive teeth anterior to molars either due to erosions or abrasions with or without
             associated gingival recession

          -  Teeth with Linear Visual Analogue Scale (VAS) score of ≥ 4 and code 2 of Schiff Cold
             Air Sensitivity Scale on screening.

        Exclusion Criteria:

          -  Subjects with worst pain response at 100mm on VAS.(Visual Analog Scale)

          -  Teeth with orthodontic or prosthetic appliances, Caries, restorations or cracks

          -  Localized or generalized gingivitis or pulpitis with heavy calculus

          -  Periodontal surgery in the preceding three months

          -  Patients using any desensitizing tooth paste or mouth wash up to six weeks before
             study and taking drugs like anti-inflammatory, sedatives, tranquilizers, analgesics in
             routine.

          -  Pregnant or breastfeeding females.
A Study Comparing LY900014 to Insulin Lispro (Humalog) in Adults With Type 1 Diabetes Using Insulin Pump Therapy
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Ultra-Rapid Lispro; Insulin Lispro
Intervention description: Administered SC; Administered SC
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 471.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The reason for this study is to compare the study drug LY900014 to insulin lispro (Humalog)
      when both are used in insulin pump therapy in adults with type 1 diabetes (T1D).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have been diagnosed with T1D and continuously using insulin for at least 1 year

          -  Have been using CSII therapy for a minimum of 6 months

          -  Currently treated with <100 Units of one of following rapid-acting analog insulin via
             CSII for at least the past 30 days: insulin lispro U-100, insulin aspart, fast-acting
             insulin aspart, insulin glulisine

          -  Must be using a MiniMed 530G (US), Paradigm Revel (US), or MiniMed 630G (US and
             Canada), MiniMed 640G or Paradigm Veo (select countries outside the US), insulin pump
             for at least the past 90 days

        Exclusion Criteria:

          -  Have hypoglycemia unawareness

          -  Have had more than 1 episode of severe hypoglycemia within 6 months prior to screening

          -  Have had more than 1 emergency room visit or hospitalization due to poor glucose
             control (hyperglycemia or diabetic ketoacidosis) within 6 months prior to screening