bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Effectiveness Study of Actinic Keratosis Treatment Following Cryosurgery
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: imiquimod cream; placebo cream
Intervention description: Imiquimod 3.75% cream (250 mg/packet) up to 2 packets applied daily Two 2-week treatment periods (Cycle 1 and Cycle 2) separated by a 2-week no-treatment period; cream applied once daily for two 2-week treatment periods (Cycle 1 and Cycle 2) separated by a 2-week no-treatment period
Intervention MeSH terms: Imiquimod
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 247.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: actinic keratosis; skin disease

Summary:

      The objective of this study is to evaluate the efficacy and safety of imiquimod cream versus
      placebo cream when used after cryosurgery in the treatment of actinic keratoses (AKs).
    

Eligibility criteria:

        Inclusion Criteria:

          -  In good general health

          -  Negative urine pregnancy test (for women of child-bearing potential) and agree to use
             an approved method of birth control while enrolled in the study.

          -  Prior to cryosurgery, have ≥ 10 clinically typical (visible or palpable) AKs in an
             area that exceeds 25 cm2 on the face.

          -  Must have had cryosurgery on 5 to 14 AKs on the face after giving informed consent and
             prior to receiving study medication. Lesions previously treated with cryosurgery must
             be healed sufficiently prior to randomization to study cream.

          -  Following cryosurgery, have ≥ 5 clinically typical (visible or palpable) AKs in an
             area that exceeds 25 cm2 on the face that are suitable for treatment with the study
             cream.

        Exclusion Criteria:

          -  Women who are pregnant, lactating, or planning to become pregnant during the study

          -  Had a medical event within 90 days of the visit (e.g., stroke, heart attack, etc.).

          -  Have any skin condition in the treatment area that may be made worse by treatment with
             imiquimod (e.g., rosacea, psoriasis, atopic dermatitis, eczema).

          -  Have received specific treatments/medications in the treatment area within the
             designated time period prior to study treatment initiation
Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Intervention: pantoprazole; Placebo
Intervention MeSH terms: Pantoprazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 129.0
Sex: All
Minimum age: 28 Days
Maximum age: 11 Months
Healthy volunteers: No
Keywords: GERD; Infants; Gastroesophageal Reflux

Summary:

      To assess the efficacy of pantoprazole for the treatment of infants with symptomatic
      Gastroesophageal Reflux Disease (GERD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  term or post term infants beyond the neonatal period of an age greater than 28 days
             but less than or equal to 11 months

          -  clinical diagnosis of GERD

          -  weight greater than 2.5 kg and less than or equal to 15 kg

        Exclusion Criteria:

          -  known history of upper GI anatomic disorders

          -  history of acute life-threatening medical conditions

          -  clinically significant medical conditions or laboratory abnormalities
COVID-19 3rd Dose Vaccine in Transplant Patients
Condition: Covid19
MeSH terms: COVID-19
Intervention: BNT162b2 vaccine; JNJ-78436735 Vaccine
Intervention description: Single dose of 0.3 mL BNT162b2 vaccine administered intramuscularly in the deltoid muscle; Single dose JNJ-78436735 Vaccine administered intramuscularly in the deltoid muscle
Intervention MeSH terms: Vaccines
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 58.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: transplant patients

Summary:

      The purpose of this study is to investigate the efficient vaccine type as a booster dose for
      Coronavirus Disease of 2019 (COVID-19) in solid organ transplant recipients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients 18 years of age and older

          -  Patients who had received a solid organ (kidney, liver, lung, heart, and pancreas)
             transplant patient from living or deceased donors.

          -  Patients with active graft with at least one immunosuppressive medication

          -  Completed two doses of BNT162b2 vaccination at least 28 days ago

        Exclusion Criteria:

          -  Patient with non-active graft

          -  Any significant side effect with previous COVID-19 vaccination

          -  Within 28 days of BNT162b2 vaccine completion

          -  Already received more than and equal to three doses of COVID-19 vaccination

          -  Previously received COVID-19 vaccine other than BNT162b2 vaccine

          -  Previously received monoclonal Antibody treatment that are specifically directed
             against the spike protein for Severe Acute Respiratory Syndrome (SARS) Coronavirus 2
             (CoV)-2 such as Mab, Bamlanivimab, etesevimab, Casirivimab, imdevimab, Sotrovimab
             and/or any combination.

          -  Thrombocytopenia (if less than 50,000 per microliter 30 days prior vaccination)

          -  History of Capillary Leak Syndrome

          -  Adults unable to consent

          -  Individuals who are not yet adults (younger than 18 year old)

          -  Vulnerable patients (prisoners)

          -  Pregnant women
Comparison of Sternal Wound Infiltration With Liposomal Bupivacaine v. Bupivacaine Hydrochloride
Condition: Coronary Artery Disease; Coronary Artery Stenoses; Valve Regurgitation, Mitral; Valve Regurgitation, Tricuspid
MeSH terms: Coronary Artery Disease; Coronary Stenosis; Tricuspid Valve Insufficiency; Mitral Valve Insufficiency
Intervention: Exparel Injectable Product; Bupivacaine Hydrochloride
Intervention description: Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision); Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
Intervention MeSH terms: Bupivacaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Participants, care provider, investigator, and outcomes assessor are all blinded to the treatment allocation in double-blind fashion
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cardiac surgery; sternotomy; post-operative pain; sternal wound infiltration

Summary:

      The aim of this study is to evaluate the analgesic efficacy and safety of wound infiltration
      with liposomal bupivacaine (LB) in patients undergoing cardiac surgery with sternotomy and
      cardiopulmonary bypass (CPB) and compare it with bupivacaine hydrochloride infiltration
    

Eligibility criteria:

        Inclusion Criteria:

          -  Open cardiac surgery through sternotomy approach (eg. coronary artery bypass graft,
             valvular heart procedures, as well as other open cardiac procedures along with
             coronary artery bypass)

          -  Surgery with the use of cardiopulmonary bypass

        Exclusion Criteria:

          -  Minimally invasive heart surgery through thoracotomy approach

          -  Patient undergoing procedures under deep hypothermic circulatory arrest

          -  Patients with active infections such as infective endocarditis

          -  Emergency surgery

          -  Patients undergoing transplantations and ventricular assist device insertion

          -  Patients on any mechanical circulatory support preoperatively

          -  Patient's refusal

          -  End stage liver or renal disease

          -  Allergy to bupivacaine

          -  Patient who cannot understand the study procedure or refuse to participate

          -  Redo-sternotomy

          -  Participation in another study

          -  Patients with severe right or left ventricular dysfunction (EF< 25%)

          -  Patients requiring chronic opioids for chronic pain condition
Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis
Condition: Postmenopausal Women With Osteoporosis
MeSH terms: Osteoporosis
Intervention: Romosozumab; Alendronate; Placebo to Romosozumab; Placebo to Alendronate
Intervention description: Romosozumab 210 mg administered by subcutaneous injection once a month during the double-blind treatment phase.; Alendronate 70 mg tablet taken once a week; Administered by subcutaneous injection once a month during the double-blind treatment phase.; Matching placebo tablet taken once a week during the double-blind treatment phase.
Intervention MeSH terms: Alendronate; 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: 4093.0
Sex: Female
Minimum age: 55 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: Osteoporosis, Osteoporosis-postmenopausal, Bone Diseases-Metabolic, Bone Diseases, Musculoskeletal Diseases

Summary:

      The purpose of this study is to determine if treatment is effective in preventing fractures
      in women with postmenopausal osteoporosis.
    

Eligibility criteria:

        Inclusion Criteria:

        Postmenopausal women who meet at least one of the following bone mineral density (BMD) and
        fracture criteria:

          -  BMD T-score at the total hip or femoral neck of ≤ -2.50 and EITHER:

               -  at least 1 moderate (semiquantitative grade [SQ]2) or severe (SQ3) vertebral
                  fracture OR

               -  at least 2 mild (SQ1) vertebral fractures OR

          -  BMD T-score at the total hip or femoral neck of ≤ -2.00 and EITHER:

               -  at least 2 moderate (SQ2) or severe (SQ3) vertebral fractures OR

               -  a fracture of the proximal femur that occurred within 3 to 24 months prior to
                  randomization.

        Exclusion Criteria:

          -  History of metabolic or bone disease (except osteoporosis)

          -  Use of agents affecting bone metabolism

          -  Vitamin D insufficiency

          -  History of solid organ or bone marrow transplants

          -  Hyper- or hypocalcemia

          -  Hyper- or hypothyroidism

          -  Hyper- or hypoparathyroidism

          -  Possible signs of intolerance to alendronate
Validation of Multidimensional Assessment of THYmic States (MATHYS): A Study in a Population of Bipolar Patients Treated With Olanzapine
Condition: Bipolar Disorder I or II
MeSH terms: Bipolar Disorder
Intervention: olanzapine
Intervention description: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks.
Intervention MeSH terms: Olanzapine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 141.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A non randomized study to validate the MATHYS Scale in a population of in and outpatients
      greater than or equal to 18 years of age, suffering from Bipolar Disorder I or II, and
      treated with olanzapine.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth
             Edition, Text Revision (DSM-IV-TR) disease diagnostic criteria for Bipolar Disorder

               -  currently or most recently in a Manic Episode (Single Manic Episode or Most
                  Recent Episode Manic) or

               -  currently or most recently in a Hypomanic Episode or

               -  currently or most recently in a Mixed Episode or

               -  currently or most recently in a Major Depressive Episode

               -  and confirmed by the module D of the SCID (Semi-Structured Interview).

          2. Patients must be more than 18 of age at Visit 0.

        Exclusion Criteria:

          1. A valid current or lifetime DSM-IV-TR Axis I or II diagnosis which could interfere, at
             the investigator's opinion, with the evaluation.

          2. Patients on antidepressant or mood stabilizer therapy one week (four weeks with
             fluoxetine) prior to Visit 1, with the exception of mood stabilizer therapy considered
             in the opinion of the investigator as an efficient treatment for at least one year
             prior to the study.
Efficacy and Safety of DaxibotulinumtoxinA for Injection to Treat Moderate to Severe Glabellar Lines
Condition: Glabellar Frown Lines
Intervention: Botulinum Toxins, Type A; Placebos
Intervention description: Intramuscular injection; Intramuscular injection
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 306.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: glabellar lines, frown lines

Summary:

      This is a safety and efficacy study of DaxibotulinumtoxinA for Injection to treat moderate to
      severe frown lines.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provide written informed consent including authorization to release health information

          -  Moderate (2) or severe (3) glabellar lines during maximum frown based on the
             Investigator Global Assessment Frown Wrinkle Severity (IGA-FWS) scale

          -  Moderate (2) or severe (3) glabellar lines during maximum frown based on the Patient
             Frown Wrinkle Severity (PFWS) scale

          -  Willing and able to follow all trial procedures, attend all scheduled visits, and
             successfully complete the trial

        Exclusion Criteria:

          -  Any neurological condition that may place the subject at increased risk with exposure
             to botulinum toxin type A, including peripheral motor neuropathic diseases such as
             amyotrophic lateral sclerosis and motor neuropathy, and neuromuscular junctional
             disorders such as Lambert-Eaton syndrome and myasthenia gravis

          -  Active skin disease, infections or inflammation at the injection sites

          -  Plan to receive botulinum toxin type A anywhere in the face through the duration of
             the study

          -  History of allergy or sensitivity to any botulinum toxin preparations or to any
             component of the test article

          -  Current enrollment in an investigational drug or device trial or participation in such
             a trial within the last 30 days prior to screening through end of trial
Early Use of Cryoprecipitate With Major Hemorrhage Protocol (MHP) Activation
Condition: Trauma Injury
MeSH terms: Hemorrhage
Intervention: Cryoprecipitate; Red Blood Cells; Plasma; Platelets; Whole Blood
Intervention description: Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).; RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.; Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.; Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.; Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1604.0
Sex: All
Minimum age: 16 Years
Healthy volunteers: No

Summary:

      The purpose of this trial is to compare standard of care (SOC) massive transfusion protocol
      to SOC massive transfusion protocol plus early use of cryoprecipitate (within 90 minutes of
      emergency department arrival).
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient is judged to be an adult (according to local practice, e.g. 16 years or
             older in UK) and has sustained severe traumatic injury. In the event the age is
             unknown, estimated body weight ≥50 kg.

          -  The patient is deemed by the attending clinician to have on-going active hemorrhage
             AND REQUIRES Activation of the local major hemorrhage protocol for management of
             severe blood loss AND HAS STARTED or HAS RECEIVED at least one unit of any blood
             component

        Exclusion Criteria:

          -  The patient has been transferred from another hospital

          -  The trauma team leader deems the injuries incompatible with life

          -  More than 3 hours have elapsed from the time of injury

          -  Prisoner (as defined as someone admitted from a correctional facility)

          -  Known "Do Not Resuscitate" orders

          -  Enrolled in a concurrent ongoing interventional, randomized clinical trial

          -  Patients who wear "opt out" bracelet for study

          -  Obvious pregnancy

          -  Severely burned
Study of Monotherapy Rapastinel in the Prevention of Relapse in Patients With Major Depressive Disorder (MDD)
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Rapastinel; Placebo
Intervention description: Rapastinel 450 mg or 225 mg (prefilled syringe, weekly intravenous IV administration) or Rapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks); Placebo (prefilled syringe, weekly IV administration)
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 363.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Depression

Summary:

      The study will evaluate the efficacy, safety, and tolerability of 450 milligrams (mg) or 225
      mg of Rapastinel compared to placebo in the prevention of relapse in participants with major
      depressive disorder (MDD).
    

Eligibility criteria:

        Inclusion Criteria: -

          -  Completion of Study RAP-MD-30, RAP-MD-31, or RAP-MD-32

          -  If female of childbearing potential, have a negative serum β-human chorionic
             gonadotropin (β-hCG) pregnancy test

        Exclusion Criteria: -

          -  DSM-5-based diagnosis of any disorder other than MDD that was the primary focus of
             treatment within 6 months before Visit 1

          -  Lifetime history of meeting DSM-5 criteria for:

          -  1.Schizophrenia spectrum or other psychotic disorder

          -  2.Bipolar or related disorder

          -  3.Major neurocognitive disorder

          -  4.Neurodevelopmental disorder of greater than mild severity or of a severity that
             impacts the participant's ability to consent, follow study directions, or otherwise
             safely participate in the study

          -  5.Dissociative disorder

          -  6.Posttraumatic stress disorder

          -  7.MDD with psychotic features

          -  Significant suicide risk, as judged by the Investigator
Study of Efficacy and Safety of Brodalumab in Subjects With Psoriatic Arthritis
Condition: Psoriatic Arthritis
MeSH terms: Arthritis; Arthritis, Psoriatic
Intervention: 210 mg brodalumab; 140 mg brodalumab; Placebo
Intervention description: 210 mg brodalumab administered via subcutaneous injection.; 140 mg brodalumab administered via subcutaneous injection.; Placebo administered via subcutaneous injection until week 24.
Intervention MeSH terms: Brodalumab; 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: 484.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Psoriatic Arthritis; Brodalumab; AMG 827

Summary:

      The primary objective of this study is to evaluate the efficacy of brodalumab, compared to
      placebo, in subjects with psoriatic arthritis. The key secondary objective is to evaluate the
      efficacy of brodalumab compared to placebo at week 16. The safety objective of this study is
      to evaluate the safety profile of brodalumab in subjects with psoriatic arthritis.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects has a diagnosis of psoriatic arthritis (by the Classification of Psoriatic
        Arthritis criteria (CASPAR), with ≥ 3 tender and ≥ 3 swollen joints (excluding distal
        interphalangeal joints). Subjects must have at least

        1 psoriatic skin lesion. Exclusion Criteria:

        • -Subject has known history of active tuberculosis.

          -  Subject has a planned surgical intervention between baseline and the week 52
             evaluation.

          -  Subject has an active infection or history of infections.

          -  Subject has any systemic disease (eg, renal failure, heart failure, hypertension,
             liver disease, diabetes, anemia) considered by the Investigator to be clinically
             significant and uncontrolled.

          -  Subject has any concurrent medical condition or electrocardiogram (ECG) abnormality
             that, in the opinion of the investigator, could cause this study to be detrimental to
             the subject.

        Subject has severe depression measured by Personal Health Questionnaire Depression Scale
        (PHQ-8) or suicidal ideation/behavior as measured by and Columbia Suicide Severity Rating
        Scale (e-CSSRS)

        • Subject has a history or evidence of psychiatric disorder or substance abuse considered
        by the Investigator to pose a risk to subject safety