bioihbjkbjnl/mcl2 huggingface dataset:
Blood Pressure After Endovascular Stroke Therapy-II
Condition: Acute Stroke; Endovascular Thrombectomy
MeSH terms: Stroke
Intervention: Nicardipine; Labetalol; Hydralazine
Intervention description: In the event where SBP values are above the randomly assigned target, intravenous nicardipine will be initiated at 2.5 mg/hr to lower the SBP. If SBP is still not reduced to below assigned target after 15 minutes, nicardipine dose will be increased by 2.5 mg/hr every 15 minutes until the target SBP or a maximum dose of 15 mg/hr is reached.; If SBP is above target despite maximum nicardipine infusion for 30 minutes, 10-20 mg of intravenous labetalol will be added every 15 minutes.; If SBP remains unresponsive for 1 hr despite the use of maximum doses of nicardipine and labetalol, a Hydralazine will be added at the treating physician's discretion. Incidence of the latter scenario is anticipated to be exceedingly rare.
Intervention MeSH terms: Labetalol; Hydralazine; Nicardipine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Blood Pressure Control

Summary:

      The purpose of this study is to assess the safety of lowering blood pressure in acute stroke
      patients that are successfully treated with a mechanical thrombectomy procedure. The
      investogators will evaluate the hypothesis that lower blood pressure management strategies do
      not result in larger volume of stroke or worse 3-month clinical outcome in these patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients (≥18 years)

          -  Undergoing successful EVT (defined as modified Thrombolysis in Cerebral Ischemia
             Score, mTICI, ≥2b) for an occlusion in the anterior cerebral circulation large vessel
             (internal carotid artery and M1 or M2 segments of the middle cerebral artery).

          -  Intervention will be initiated only for those with a successful recanalization
             (modified Thrombolysis in Cerebral Ischemia Score ≥ 2b).

          -  Undergoing a baseline CT or MR perfusion study

          -  Those with unsuccessful recanalization (mTICI 0-2a) will be not intervened upon.

        Exclusion Criteria:

          -  Known heart failure with ejection fraction <30%

          -  Presence of a left ventricular assist device

          -  Patients undergoing extracorporeal membrane oxygenation

          -  Pregnancy

          -  Enrollment in any other clinical trial
Single-dose Crossover Study to Investigate Pharmacodynamics of AZD3199
Condition: Asthma; Airway Obstruction
MeSH terms: Airway Obstruction
Intervention: AZD3199; Formoterol; Placebo
Intervention description: Dry powder for inhalation, single dose; Dry powder for inhalation, single dose; Dry powder for inhalation, single dose
Intervention MeSH terms: Formoterol Fumarate; AZD-3199
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 37.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Asthma; airway obstruction; beta2-agonist; efficacy; inhalation

Summary:

      The purpose of this study is to investigate the pharmacodynamics of single doses of AZD3199
      in asthmatic patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Asthmatic patients with pre-bronchodilatory FEV1 above 60% of predicted normal and
             above 1.5 liters.

          -  Men and post-menopausal women above 18 years of age.

          -  Reversible airway obstruction in response to classical beta2-agonist (salbutamol)

          -  Non/ex-smokers

        Exclusion Criteria:

          -  Any clinically significant disease or disorder other than asthma

          -  Any clinically relevant abnormal findings at screening examinations

          -  Treatment with systemic glucocorticosteroids within the past 30 days

          -  Inhaled corticosteroid use if dosing is not kept constant
Efficacy, Safety and Tolerability of Denosumab in the Treatment of Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: placebo; denosumab
Intervention description: placebo subcutaneous injection; For subcutaneous injection
Intervention MeSH terms: Denosumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 227.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: arthritis; joint pain; Methotrexate

Summary:

      This study will determine the efficacy, safety, and tolerability of denosumab (AMG 162) in
      the treatment of Rheumatoid Arthritis (RA).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of RA.

          -  All subjects will be required to have been taking a stable dose of methotrexate.

          -  Active RA at screening defined as greater than or equal to 6 swollen joints.

          -  The presence of erosive disease

        Exclusion Criteria:

          -  Received any biologic agent (e.g., Enbrel®, Remicade®, Humira®, Kineret®) or Arava®
             within 8 weeks before randomization; past use of these agents is allowed.

          -  Steroid use greater than 15 mg/day.

          -  Scheduled for surgery or joint replacement in the hands, wrists or feet.
Dose-finding Study for the Ultralow-dose Levonorgestrel Intrauterine Contraceptive System (LCS)
Condition: Contraception
Intervention: Levonorgestrel IUS (BAY86-5028, G04209B); Levonorgestrel IUS (BAY86-5028, G04209C); Levonorgestrel IUS (Mirena, BAY86-5028)
Intervention description: Levonorgestrel intrauterine contraception system (IUS) releasing 12 microg/24 h in vitro, to be used for three years; Levonorgestrel intrauterine contraception system (IUS) releasing 16 microg/24 h in vitro, to be used for three years; Levonorgestrel Intrauterine contraception system (IUS) releasing 20 microg/24 h to be used for three years
Intervention MeSH terms: Levonorgestrel
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 742.0
Sex: Female
Minimum age: 21 Years
Maximum age: 40 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate if drug doses lower than the one released from
      Mirena® would be as effective for contraception as Mirena®. Subjects participating in the
      study will be randomly assigned to be inserted with any of the three different intrauterine
      systems (IUSs). The IUSs are nearly alike except that the amount of hormone released from
      them is different.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women with or without children and good general health and in need of contraception.

          -  Regular menstrual cycle without hormonal contraceptives.

        Exclusion Criteria:

          -  Pregnant or lactating.

          -  Last delivery or abortion less than 12 weeks ago.

          -  Previous pregnancies outside the womb.

          -  Previous pelvic infections.

          -  Abnormal bleeding.

          -  Abnormal uterine cavity.

          -  Climacteric signs.

          -  Genital cancer.

          -  Liver diseases.

          -  Alcoholism or drug abuse.
Safety & Effectiveness on Vascular Structure and Function of ACZ885 in Atherosclerosis and Either T2DM or IGT Patients
Condition: Diabetes Mellitus, Type 2; Atherosclerosis; Prediabetic State
MeSH terms: Atherosclerosis; Diabetes Mellitus; Diabetes Mellitus, Type 2; Prediabetic State
Intervention: ACZ885; Placebo
Intervention description: ACZ885 150 mg was administered subcutaneously once a month for 12 months.; Matching placebo to ACZ885 was administered subcutaneously once a month for 12 months.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 189.0
Sex: All
Minimum age: 18 Years
Maximum age: 74 Years
Healthy volunteers: No
Keywords: Atherosclerosis,; Type 2 Diabetes Mellitus, T2DM,; Cardiovascular Diseases, ACZ885, impaired glucose tolerance, IGT, Canakinumab

Summary:

      This study will evaluate the effect of ACZ885 on vascular function in patients with
      documented atherosclerotic disease and T2DM or IGT.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with known atherosclerotic disease and documented diagnosis of T2DM for ≤ 14
             years OR IGT

          -  HbA1c between 6.0% and 10.0%

          -  On stable statin therapy or statin intolerant

          -  Patients who are eligible and able to participate in the study

        Exclusion Criteria:

          -  Contraindications to MRI

          -  NYHA class IV Heart Failure

          -  NYHA class I - III heart failure with acute exacerbation in 3 months prior to
             screening

          -  Patients with type 1 diabetes

          -  Acute infections

          -  HsCRP > 30 mg/dL

          -  Aortic aneurysm ≥5cm

        Other protocol-defined inclusion/exclusion criteria may apply
A Study of Laquinimod in Participants With Systemic Lupus Erythematosus (SLE) Active Lupus Nephritis
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis; Lupus Erythematosus, Systemic
Intervention: Laquinimod; Mycophenolate Mofetil; Prednisolone/Prednisone; Placebo; Methylprednisolone
Intervention description: Laquinimod will be administered per dose and schedule specified in the arm description.; Mycophenolate Mofetil (MMF) will be administered per dose and schedule specified in the arm description.; Prednisolone/Prednisone will be administered per dose and schedule specified in the arm description.; Placebo matching to laquinimod will be administered per schedule specified in the arm description.; Methylprednisolone (MP) will be administered per dose and schedule specified in the arm description.
Intervention MeSH terms: Mycophenolic Acid; Prednisone; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 46.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Systemic Lupus Erythematosus (SLE); Lupus Nephritis; Laquinimod

Summary:

      The study aims to evaluate the safety and clinical effect of daily oral treatment with
      laquinimod capsules in active lupus nephritis participants. This study will assess Laquinimod
      doses of 0.5 milligrams (mg)/day and 1 mg/day in combination with standard of care treatment
      (mycophenolate mofetil [MMF] and corticosteroids). Laquinimod is a novel immunomodulating
      drug which is currently in advanced stages of development by Teva Pharmaceuticals Ltd. for
      Multiple Sclerosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants diagnosed with SLE

          -  Kidney biopsy within 12 months prior to baseline with a histological diagnosis of
             proliferative or membranous Lupus Nephritis (LN)

          -  Clinically active Lupus Nephritis as evident by urine protein-to-creatinine ratio
             (UPCR) of 1 or higher, for LN classes III, IV, or class V in combination with classes
             III or IV, or a UPCR of 2 or higher for LN class V, at screening or any time between
             screening and baseline.

        Exclusion Criteria:

          -  Participants with severe renal impairment or dialysis

          -  Participants with a clinically significant or unstable medical or surgical condition

          -  Women who are pregnant or nursing or who intend to be during the study period

          -  Women of child-bearing potential who do not practice an acceptable method of birth
             control NOTE: Other inclusion and exclusion criteria may apply.
Trial of Growth Hormone Therapy in Pediatric Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: growth hormone; cortecosteroid
Intervention description: Nutropin AQ 0.075mg/kg/day subcutaneously daily; As prescribed by the referring gastroenterologist
Intervention MeSH terms: Prednisone; Hormones
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 22.0
Sex: All
Minimum age: 5 Years
Healthy volunteers: No
Keywords: Pediatric Crohn's disease; Pediatric; Crohn's Disease

Summary:

      The purpose of this study is to determine whether taking a growth hormone (GH) drug called
      somatropin causes the intestine of a person with Crohn's Disease (CD) to heal faster when
      compared to a person with Crohn's Disease that does not receive growth hormone drug.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability to provide written informed consent

          -  Age ≥ 5 years.

          -  Diagnosis of Crohn's disease (CD) with ileo-colonic involvement as determined by
             standard clinical, radiological, and pathological criteria.

          -  Moderate to severely active CD as defined by a PCDAI (Pediatric Crohn's Disease
             Activity Index) ≥ 30.

          -  Currently taking Prednisone or Budesonide at starting dose (not tapering)

          -  May continue stable doses of AZA/6-MP, methotrexate, and/or mesalamine at entry.

          -  For the 52 week extension, baseline bone age ≤ 12 years for girls and ≤ 13 years for
             boys.

          -  For the 52 week extension phase, remission or mild Crohn's disease as determined by a
             PCDAI < 30.

        Exclusion Criteria:

          -  Acute critical illness

          -  Active neoplasia

          -  Diabetes mellitus

          -  History of intracranial lesion and/or neoplasia

          -  Severe disease requiring hospitalization for treatment

          -  Current therapy with infliximab as this may independently rapidly reduce clinical
             disease activity and promote mucosal healing

          -  Use of prednisone or budesonide and in tapering phase

          -  Family history of colorectal cancer before age 50

          -  Personal or familial history of familial polyposis syndrome

          -  Pregnancy (positive pregnancy test) prior to randomization

          -  Any other condition that the investigator believes would pose a significant hazard to
             the subject if the investigational therapy were initiated

          -  Participation in another simultaneous medical investigation or trial other than the
             Pediatric IBD (Inflammatory Bowel Disease) registry
Evaluation of BOL-303242-X Versus Vehicle for the Treatment of Inflammation Following Cataract Surgery
Condition: Cataract; Inflammation
MeSH terms: Cataract; Inflammation
Intervention: BOL-303242-X; Vehicle for BOL-303242-X
Intervention description: Medication instilled into the study eye, subjects randomized to various drug concentrations and dose schedules.; Medication instilled into the study eye, subjects randomized to various drug dose schedules.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 415.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Surgery

Summary:

      This clinical study is being conducted to identify the most effective drug concentration and
      dose frequency of BOL-303242-X (Mapracorat) ophthalmic suspension, for the treatment of
      inflammation following cataract surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must be at least 18 years of age on the date the Informed Consent Form (ICF)
             is signed and with the capacity to voluntarily provide consent.

          -  Subjects must be able to understand and provide written consent on the Institutional
             Review Board (IRB)/Ethics Committee (EC) approved ICF and provide authorization as
             appropriate for local privacy regulations.

          -  Subjects who are candidates for cataract surgery.

          -  Subjects who are not of childbearing potential or female subjects who have a negative
             urine pregnancy test result at screening.

          -  Subjects must be able and willing to comply with all treatment and follow- up
             procedures.

        Exclusion Criteria:

          -  Subjects who have known hypersensitivity or contraindication to the study drug(s) or
             their components.

          -  Subjects who have a history or presence of chronic generalized systemic disease that
             the Investigator feels might increase the risk to the subject or confound the result
             of the study.

          -  Subjects who have a severe/serious ocular condition, or any other unstable medical
             condition that, in the Investigator's opinion, may preclude study treatment or
             follow-up.
Assessment of INS1007 in Participants With Non-Cystic Fibrosis Bronchiectasis
Condition: Non-Cystic Fibrosis Bronchiectasis
MeSH terms: Bronchiectasis; Fibrosis
Intervention: Brensocatib 10 mg; Brensocatib 25 mg; Placebo
Intervention description: Administered once per day for 24 weeks; Administered once per day for 24 weeks; Administered once per day for 24 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 256.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: P aeruginosa; bronchiectasis; active neutrophil elastase

Summary:

      The purpose of the study is to evaluate if INS1007 can reduce pulmonary exacerbations over a
      24-week treatment period in participants with non-cystic fibrosis bronchiectasis.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Clinical history consistent with NCFBE (cough, chronic sputum production and/or
             recurrent respiratory infections)

          2. Are current sputum producers with a history of chronic expectoration and able to
             provide a sputum sample during Screening

          3. Have at least 2 documented pulmonary exacerbations in the past 12 months before
             Screening

        Exclusion Criteria:

          1. Have a primary diagnosis of chronic obstructive pulmonary disease (COPD) or asthma

          2. Have bronchiectasis due to cystic fibrosis (CF), hypogammaglobulinemia, common
             variable immunodeficiency, or alpha1-antitrypsin deficiency

          3. Are current smokers

          4. Are currently being treated for a nontuberculous mycobacterial lung infection,
             allergic bronchopulmonary aspergillosis, or tuberculosis

          5. Have any acute infections, (including respiratory infections)
A Study to Evaluate the Efficacy and Safety of CNTO328 Plus Best Supportive Care in Multicentric Castleman's Disease
Condition: Multicentric Castleman's Disease
MeSH terms: Castleman Disease
Intervention: Siltuximab; Placebo; Best Supportive Care (BSC)
Intervention description: Siltuximab 11 mg/kg will be administered by 1-hour intravenous infusion every 3 weeks; Placebo will be administered by 1-hour intravenous infusion every 3 weeks; BSC included treatment for effusions, antipyretics, antipuretics, antihistamines, pain medication, treatment for infections, transfusions, management of infusion-related reactions, and corticosteroids.
Intervention MeSH terms: Siltuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 79.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Multicentric Castleman's Disease; MCD; CNTO 328; Best Supportive Care; Tumor; Symptomatic response; Pharmacokinetics; Interleukin-6; IL6

Summary:

      The purpose of this study is to demonstrate that CNTO 328 when administered in combination
      with best supportive care (BSC) is superior to BSC in terms of durable tumor and symptomatic
      response (complete response or partial response) among patients with Multicentric Castleman's
      Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Measurable and symptomatic Multicentric Castleman's Disease

          -  Adequate organ function as assessed by laboratory values evaluated by the investigator
             to determine eligibility prior to treatment

          -  Eastern Cooperative Oncology Group performance status of 0, 1, or 2

          -  Corticosteroids dose that does not exceed 1 mg/kg/day of prednisone, and has remained
             stable or decreased over the 4 weeks before treatment

        Exclusion Criteria:

          -  Human Immunodeficiency Virus or Human Herpes Virus-8 positive

          -  Skin lesions as sole measurable manifestation of Multicentric Castleman's Disease

          -  Previous history of lymphoma

          -  Malignancies, except for adequately treated basal cell or squamous cell carcinoma of
             the skin, carcinoma in situ of the cervix, or cancer other than lymphoma, from which
             the patient has been disease-free for 3 or more years

          -  Concurrent medical condition or disease that may interfere with study participation

          -  Prior exposure to Interleukin-6 or Interleukin-6 receptor targeted therapies