bioihbjkbjnl/mcl2 huggingface dataset:
Zoledronic Acid in the Prevention of Cancer Treatment Related Bone Loss in Postmenopausal Women Receiving Letrozole for Breast Cancer.
Condition: Bone Loss; Breast Cancer
MeSH terms: Breast Neoplasms; Bone Diseases, Metabolic
Intervention: Zoledronic acid; Letrozole
Intervention description: Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months.; Letrozole tablets 2.5 mg/day taken orally for 5 years.
Intervention MeSH terms: Zoledronic Acid; Letrozole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1065.0
Sex: Female
Healthy volunteers: No
Keywords: Bone Loss; Osteopenia; Breast cancer; letrozole; zoledronic acid; postmenopausal

Summary:

      Post-menopausal breast cancer patients will receive letrozole 2.5 mg daily for the treatment
      of breast cancer and will be randomized to a treatment group to receive either upfront
      zoledronic acid 4 mg IV 15-minute infusion every 6 months or delayed start zoledronic acid 4
      mg IV 15-minute infusion every 6 months. Delayed start zoledronic acid will be initiated when
      either the Bone Mineral Density T-score is below -2 Standard Deviations at either the lumbar
      spine or hip or any clinical fracture unrelated to trauma or an asymptomatic fracture
      discovered at the month 36 scheduled visit. Letrozole 2.5 mg will be given daily for 5 years.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stage I-IIIa breast cancer

          -  Postmenopausal or recently postmenopausal

          -  Recent surgery for breast cancer

          -  Estrogen Receptor positive and/or progesterone receptor positive hormone receptor
             status

          -  No prior treatment with letrozole

        Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Metastatic disease

          -  Invasive bilateral disease

          -  Clinical or radiological evidence of existing fracture in spine or hip

          -  Prior treatment with IV bisphosphonates in the past 12 months

          -  Current treatment with oral bisphosphonates ( must be discontinued within 3 weeks of
             baseline evaluation)

          -  Use of Tibolone within 6 months

          -  Prior use of parathyroid hormone for more than 1 week

          -  Previous or concomitant malignancy

          -  Abnormal renal function

          -  History of disease effecting bone metabolism

        Other protocol-defined exclusion criteria may apply.
A Study on Impact of Canagliflozin on Health Status, Quality of Life, and Functional Status in Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Intervention: Canagliflozin 100 mg; Placebo
Intervention description: Participants will receive 100 mg immediate-release, over-encapsulated tablets (as a capsule) orally once daily.; Participants will receive matching placebo capsules orally once daily.
Intervention MeSH terms: Canagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 476.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the superiority of the effectiveness of
      canagliflozin 100 milligram (mg) daily versus placebo in participants with symptomatic heart
      failure (HF) in improving the overall Kansas City Cardiomyopathy Questionnaire (KCCQ) Total
      Symptom Score (TSS).
    

Eligibility criteria:

        Inclusion Criteria:

        - Have clinically stable symptomatic heart failure (HF) (heart failure with reduced
        ejection fraction [HFrEF] and heart failure with preserved ejection fraction [HFpEF]): (A)
        For HFrEF: (a) ejection fraction (EF) less than or equal to (<=) 40 percent (%) and (b) a
        primary diagnosis of HF OR 2 medical visits (including virtual) with a HF diagnosis code in
        any position in the past 18 months (B) For HFpEF: (a) EF greater than (>) 40%; (b) a
        primary diagnosis of HF OR 2 medical visits (including virtual) with a HF diagnosis code in
        any position in the past 18 months, AND; (C) on a loop diuretic or spironolactone or
        eplerenone (mineralocorticoid receptor antagonists), in the past 18 months

          -  Have a baseline Kansas City Cardiomyopathy Questionnaire (KCCQ) score of less than or
             equal to (<=) 80 prior to randomization

          -  Be able to read and understand English

          -  Possess and have sole use (example: not shared with other users) of smartphone
             compatible with the Fitbit device

          -  Willing/able to wear the Fitbit device on a regular basis for the 9-month study period

        Exclusion Criteria:

          -  Currently taking a sodium-glucose co-transporter 2 inhibitor (SGLT2i) or within the
             last 3 months

          -  History of diabetic ketoacidosis or have type 1 diabetes mellitus (T1DM)

          -  Have acute decompensated HF (exacerbation of symptomatic HF) requiring intravenous
             diuretics, inotropes, or vasodilators within the last 4 weeks

          -  Have stage 4 or 5 Chronic Kidney Disease (that is, estimated glomerular filtration
             rate [eGFR] <30 milliliter per minute [ml/min] on dialysis) from the most recent
             assessment

          -  Have a diagnosis of hypotension within 30 days
Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: Alirocumab; Placebo (for Alirocumab); Non-statin LMT; Diet Alone
Intervention description: Solution for injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using auto-injector (also known as pre-filled pen).; Solution for injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using auto-injector (also known as pre-filled pen).; Ezetimibe or Fenofibrate at stable dose as background therapy.; Stable cholesterol-lowering diet as background therapy.
Intervention MeSH terms: Alirocumab; Antibodies, Monoclonal
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A double-blind treatment period of 24 weeks (3 parallel arms) followed by an open-label extension period (single arm)
Masking: Triple (Participant, Care Provider, Investigator)
Masking description: Masking during the double-blind treatment period
Enrollment: 233.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Primary Objective:

      To demonstrate the reduction of low-density lipoprotein cholesterol (LDL-C) by a regimen of
      Alirocumab including a starting dose of 150 mg every 4 weeks (Q4W) as add-on to non-statin
      lipid modifying background therapy or as monotherapy in comparison with placebo in
      participants with primary hypercholesterolemia not treated with a statin.

      Secondary Objective:

        -  To evaluate the effects on other lipid parameters of Alirocumab 150 mg Q4W versus
           placebo.

        -  To evaluate the safety and tolerability of Alirocumab 150 mg Q4W.

      Alirocumab 75 mg Q2W was added as a calibrator arm.
    

Eligibility criteria:

        Inclusion criteria:

        Participants with primary hypercholesterolemia (heterozygous familial hypercholesterolemia
        [heFH] or non-FH) not adequately controlled with their non-statin LMT (either ezetimibe or
        fenofibrate) or diet alone.

        Exclusion criteria:

          -  LDL-C <70 mg/dL (1.81 mmol/L) at screening for statin intolerant participants at very
             high cardiovascular (CV) risk;

          -  LDL-C <100 mg/dL (<2.59 mmol/L) at screening for statin intolerant participants at
             high or moderate CV risk or, participants not fulfilling the statin intolerant
             definition at moderate CV risk;

          -  LDL-C ≥160 mg/dL (≥4.1 mmol/L) at screening for participants receiving diet only or,
             participants not fulfilling the statin intolerant definition at moderate CV risk and
             receiving a non-statin LMT.

        The above information is not intended to contain all considerations relevant to a
        participant's potential participation in a clinical trial.
Comparison of Psychotherapy Programs to Treat Panic Disorder
Condition: Anxiety Disorders; Panic Disorder; Agoraphobia
MeSH terms: Anxiety Disorders; Panic Disorder; Agoraphobia
Intervention: Cognitive behavioral therapy; Applied relaxation training (ART); Panic focused psychodynamic psychotherapy (PFPP)
Intervention description: CBT for panic disorder will include 19 to 24 sessions over 12 weeks.; ART with exposure protocol will include 19 to 24 sessions over 12 weeks.; PFPP will include 19 to 24 sessions over 12 weeks.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 201.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: PD; CBT; PFPP

Summary:

      This study will determine the relative effectiveness of three psychotherapies in treating
      people with a panic disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets DSM-IV diagnosis criteria for primary PD with or without agoraphobia

          -  History of at least one spontaneous panic attack per week within the month prior to
             study entry

        Exclusion Criteria:

          -  Active substance dependence within 6 months prior to study entry

          -  Lifetime history of any psychotic disorder, including bipolar disorder

          -  Acutely suicidal
Self-injection of Adalimumab in Adult Japanese Subjects With Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Adalimumab
Intervention description: 40 mg or 80 mg every other week (eow), subcutaneous (sc), self-injection
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 88.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: No
Keywords: Rheumatoid arthritis

Summary:

      The purpose of this study is to evaluate the long-term safety of subcutaneous (SC)
      self-injections (by the subject or subject's family member) of adalimumab in adult Japanese
      subjects with Rheumatoid Arthritis in an open-label study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed Week 36 of Study M03-651 [NCT 00235872]

          -  Wish to participate in self-injection study

          -  Give written informed consent

          -  Comply with protocol requirements

        Exclusion Criteria:

          -  Subject develops serious adverse events at time of eligibility confirmation

          -  Subject develops severe infections requiring hospitalization or IV injection of
             antibiotics within 28 days before eligibility confirmation

          -  Subject develops infections requiring oral administration of antibiotics within 14
             days before eligibility confirmation

          -  The investigator considers the subject inappropriate for participation
Study Of A Controlled Release Formulation Of Pregabalin In Fibromyalgia Patients
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Intervention: pregabalin; placebo
Intervention description: controlled release tablet; 165-495 mg/day; given once daily; matching placebo tablet; given once daily
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 441.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: fibromyalgia; pain; pregabalin; Lyrica

Summary:

      The purpose of this study is to evaluate the efficacy and safety of a controlled release
      formulation of pregabalin administered once daily as compared to placebo in the treatment of
      fibromyalgia. All patients will receive pregabalin; half of the patients will receive placebo
      at some point in the study.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have fibromyalgia.

        Exclusion Criteria:

          -  Patients with other painful conditions cannot participate.
Treatment of Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplasia
Condition: Leukemia, Myelocytic, Acute
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Myelodysplastic Syndromes
Intervention: Cladribine, Cyclophosphamide, Cytarabine, Daunorubicin, Dexamethasone; Etoposide, Cytarabine, Gemtuzumab, L-asparaginase, Mercaptopurine, methotrexate, Mitoxantrone, Prednisone, Vincristine
Intervention description: Since limited characters are allowed in this passage, please see detailed Description to know the dosage, dosage form, frequency of administration for the above mentioned drugs; Since limited characters are allowed in this passage, please see detailed Description to know the dosage, dosage form, frequency of administration for the above mentioned drugs
Intervention MeSH terms: Cytarabine; Dexamethasone; Prednisone; Cyclophosphamide; Methotrexate; Etoposide; Vincristine; Daunorubicin; Asparaginase; Mitoxantrone; Mercaptopurine; Cladribine; Gemtuzumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 238.0
Sex: All
Maximum age: 21 Years
Healthy volunteers: No
Keywords: Leukemia,Erythroblastic, Acute; Erythroblastic Leukemia, Acute; Leukemia, Myeloid, Acute; Myeloid Leukemia, Acute

Summary:

      The purpose of this study is to compare the effectiveness of two multi-agent chemotherapy
      regimens using different dosages of cytarabine to eliminate all detectable leukemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of acute myeloid leukemia by immunophenotyping, morphology, and cytochemical
             staining; myelodysplasia; or biphenotypic leukemia.

          -  Age less than or equal to 21 years at time of study entry.

          -  No prior therapy for this malignancy (patients with secondary AML following treatment
             of primary malignancy are eligible) except for one dose of intrathecal therapy.

          -  Negative pregnancy test

          -  Patient does not have Down syndrome, acute promyelocytic leukemia (APL), or juvenile
             myelomonocytic leukemia (JMML)

        Exclusion Criteria:

          -  Positive pregnancy test

          -  Down syndrome, acute promyelocytic leukemia (APL), or juvenile myelomonocytic leukemia
             (JMML)
Randomized Evaluation of the 24-Hour Coverage: Efficacy of Rotigotine
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Rotigotine; Placebo
Intervention description: Rotigotine transdermal patches:
10cm2 (2mg/24h); 20cm2 (4mg/24h); 30cm2 (6mg/24h); 40cm2 (8mg/24h)
Optimal dosing: The maximum Rotigotine dose allowed is 16mg/24h; Placebo transdermal patches
Intervention MeSH terms: Rotigotine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 287.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: rotigotine; Neupro®; Parkinson's Disease

Summary:

      The objective of this trial is to assess the effects of transdermal rotigotine on the control
      of early morning motor function and sleep disorders compared to placebo in subjects with
      idiopathic Parkinsons´s disease. In addition, effects of rotigotine on specific nocturnal and
      non-motor symptoms of Parkinson´s disease will be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Early and advanced Idiopathic Parkinson Disease with early morning motor impairment

        Exclusion Criteria:

          -  Atypical Parkinsonian syndromes
A Trial to Describe the Immunogenicity and Safety of 2 Doses of Bivalent rLP2086 (Trumenba) and a Pentavalent Meningococcal Vaccine in Healthy Subjects >=10 to <26 Years of Age.
Condition: Meningococcal Vaccine
Intervention: MenABCWY; Saline; rLP2086; MenACWY-CRM
Intervention description: N meningitidis group A, B, C, W, and Y vaccine; Placebo; Bivalent recombinant lipoprotein 2086 vaccine; meningococcal group A, C, W-135, and Y conjugate vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1610.0
Sex: All
Minimum age: 10 Years
Maximum age: 25 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is examining safety and immunogenicity of 2 doses of Trumenba administered on a
      0-,6- month schedule. This trial is also studying safety and immunogenicity of a
      meningococcal pentavalent vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subject aged >=10 and <26 years at the time of enrollment.

          -  Healthy subject as determined by medical history, physical examination, and judgment
             of the investigator.

          -  Negative urine pregnancy test for all female subjects.

          -  Subjects who have not received, or who have received no more than 1 prior dose within
             the past 4 years, of a vaccine containing 1 or more ACWY serogroup

        Exclusion Criteria:

          -  Previous vaccination with any meningococcal serogroup B or purely polysaccharide
             (nonconjugate) meningococcal vaccine.

          -  Subjects receiving any allergen immunotherapy with a nonlicensed product or receiving
             allergen immunotherapy with a licensed product and are not on stable maintenance
             doses.

          -  A known or suspected defect of the immune system that would prevent an immune response
             to the vaccine, such as subjects with congenital or acquired defects in B cell
             function, those receiving chronic systemic (oral, intravenous, or intramuscular)
             corticosteroid therapy, or those receiving immunosuppressive therapy. Subjects in the
             United States with terminal complement deficiency are excluded from participation in
             this study.

          -  Significant neurological disorder or history of seizure (excluding simple febrile
             seizure).

          -  Current chronic use of systemic antibiotics.

          -  Received any investigational vaccines, drugs, or devices within 28 days before
             administration of the first study vaccination.

          -  Any neuroinflammatory or autoimmune condition, including, but not limited to,
             transverse myelitis, uveitis, optic neuritis, and multiple sclerosis.
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