bioihbjkbjnl/mcl2 huggingface dataset:
The CANTATA-MP Trial (CANagliflozin Treatment and Trial Analysis - Metformin and Pioglitazone)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo; Canagliflozin; Sitagliptin; Metformin; Pioglitazone
Intervention description: One matching placebo capsule orally (by mouth) once daily for 26 weeks with stable doses of metformin and pioglitazone.; One 100 mg or 300 mg over-encapsulated tablet orally once daily for 52 weeks with stable doses of metformin and pioglitazone.; One 100 mg over-encapsulated tablet orally once daily beginning at Week 26 until Week 52 with stable doses of metformin and pioglitazone.; The patient's stable dose of metformin background therapy should be continued throughout the study.; The patient's stable dose of pioglitazone background therapy should be continued throughout the study.
Intervention MeSH terms: Metformin; Pioglitazone; Sitagliptin Phosphate; Canagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 344.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Canagliflozin; Placebo; Sitagliptin (Januvia); Metformin; Pioglitazone (Actos); Hemoglobin A1c; Type 2 diabetes mellitus

Summary:

      The purpose of this study is to evaluate the efficacy and safety of 2 different doses of
      canagliflozin compared with placebo in patients with type 2 diabetes mellitus who are
      receving treatment with metformin and pioglitazone and have inadequate glycemic (blood sugar)
      control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients must have a diagnosis of T2DM and be currently treated with PPAR gamma
             agent ((pioglitazone or rosiglitazone) and another anti-diabetes agent (metformin)

          -  Patients in the study must have a HbA1c between >=7 and <=10.5% and a fasting plasma
             glucose (FPG) <270 mg/dL (15 mmol/L)

        Exclusion Criteria:

          -  History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta
             cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy

          -  or a severe hypoglycemic episode within 6 months before screening
MYL-1402O Compared With Avastin®, in Patients With Stage IV nsNSCLC
Condition: NSCLC Stage IV
Intervention: Bevacizumab as MYL-1402O; Bevacizumab as Avastin
Intervention description: Bevacizumab as MYL-1402O 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV; Bevacizumab as Avastin 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV
Intervention MeSH terms: Bevacizumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multicenter, Double-Blind, Randomized, Parallel-Group
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking description: Double blind
Enrollment: 671.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Assess the Efficacy and Safety of MYL-1402O Compared with Avastin®, in the First-line
      Treatment of Patients with Stage IV Non-Squamous Non-Small Cell Lung Cancer
    

Eligibility criteria:

        Key Inclusion Criteria:

          1. Written and signed informed consent

          2. Male or female at least 18 years of age with documented imaging diagnosis of Stage IV
             unresectable, recurrent or metastatic nsNSCLC with at least one measurable lesion as
             defined by RECIST 1.1

          3. Documented histologic or cytologic diagnosis of advanced nsNSCLC with negative or
             unknown sensitizing epidermal growth factor receptor (EGFR) mutation, and negative or
             unknown echinoderm microtubule-associated protein like 4 anaplastic lymphoma kinase
             (EML4 ALK) rearrangement.

          4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          5. Has not received any prior systemic therapy for first-line treatment of advanced lung
             cancer, except adjuvant chemotherapy, and remained disease-free for at least 12 months
             from time of surgery, and at least 6 months from last dose of chemotherapy.

          6. Treated and stable brain metastasis.

        Key Exclusion Criteria:

          1. Documented squamous NSCLC or small cell type or large cell neuroendocrine histology

          2. History of significant hemoptysis, central tumors with proximity to large vessels and
             tumor with cavitation

          3. Received prior treatment with paclitaxel, bevacizumab or anthracycline or had known
             hypersensitivity to any of these components.

          4. Recent significant cardiac condition or vascular event or inadequately controlled
             hypertension.

          5. On anticoagulant therapy not considered stable

          6. Risk of hemorrhage in the central nervous system

          7. Recent history of surgery, nonhealing wound, active ulcer, or untreated bone fracture.

          8. History of gastrointestinal fistula, perforation, or abscess.
Comparison of 4.0 mg/kg Sugammadex at 1-2 Post Tetanic Counts (PTC) in Renal or Control Patients (19.4.328)(P05769)
Condition: Anesthesia
Intervention: sugammadex
Intervention description: Each subject will receive an
intravenous (i.v.) single bolus dose of 0.6 mg.kg-1 rocuronium. After
this dose, maintenance doses of 0.1 - 0.2 mg.kg-1
rocuronium may be given. In case of maintenance dosing, the target depth of
neuromuscular blockade has to be maintained at 1-2 post-tetanic counts (PTC). After the last dose of rocuronium has been administered, the subject will receive a single bolus dose of 4.0 mg.kg-1 sugammadex at a target depth of blockade of 1-2 PTC.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 69.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The current trial was designed to investigate the effects of 4.0 mg.kg-1 of sugammadex on
      efficacy, safety and pharmacokinetics in subjects with severe renal impairment in comparison
      to subjects with normal renal function.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age

          -  ASA class 1-3

          -  Creatinine clearance (CLcr) < 30 mL/min and no anticipated clinical

        indication for high flux hemodialysis during first 24 hours after

        sugammadex administration (for renally impaired group) or CLcr >= 80

        mL/min (for control group)

        -Scheduled for a surgical procedure under general anesthesia with propofol

        requiring neuromuscular relaxation with the use of rocuronium

          -  Scheduled for a surgical procedure in supine position

          -  Written informed consent

        Exclusion Criteria:

        - Subjects known or suspected to have neuromuscular disorders impairing

        neuromuscular blockade and/or significant hepatic dysfunction

          -  Subjects scheduled for renal transplant surgery

          -  Subjects known or suspected to have a (family) history of malignant

        hyperthermia

        -Subjects known or suspected to have an allergy to narcotics, muscle

        relaxants or other medication used during general anesthesia

          -  Subjects receiving fusidic acid, toremifene and/or flucloxacillin

          -  Subjects who have already participated in a sugammadex trial

          -  Subjects who have participated in another clinical trial, not pre-approved

        by the sponsor, within 30 days of entering into 19.4.328 (P05769)

          -  Female subjects who are pregnant

          -  Female subjects who are breast-feeding
An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness
Condition: Generalized Myasthenia Gravis
MeSH terms: Myasthenia Gravis; Muscle Weakness; Paresis
Intervention: ARGX-113; Placebo
Intervention description: Intravenous administration of ARGX-113; Intravenous administration of placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 167.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A randomized, double-blind, placebo controlled, multicenter Phase 3 trial to evaluate the
      efficacy, safety, tolerability, quality of life and impact on normal daily activities of
      ARGX-113 in patients with gMG.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with the ability to understand the requirements of the trial, provide written
             informed consent, and comply with the trial protocol procedures.

          2. Male or female patients aged ≥ 18 years.

          3. Diagnosis of MG with generalized muscle weakness meeting the clinical criteria for
             diagnosis of MG as defined by the Myasthenia Gravis Foundation of America (MGFA) class
             II, III, IVa and IVb.

        Other, more specific inclusion criteria are defined in the protocol

        Exclusion Criteria:

          1. Pregnant and lactating women, and those intending to become pregnant during the trial
             or within 90 days after the last dosing.

          2. Male patients who are sexually active and do not intend to use effective methods of
             contraception during the trial or within 90 days after the last dosing or male
             patients who plan to donate sperm during the trial or within 90 days after the last
             dosing.

          3. MGFA Class I and V patients.

          4. Patients with worsening muscle weakness secondary to concurrent infections or
             medications.

          5. Patients with known seropositivity or who test positive for an active viral infection
             at Screening with:

               -  Hepatitis B Virus (HBV) (except patients who are seropositive because of HBV
                  vaccination)

               -  Hepatitis C Virus (HCV)

               -  Human Immunodeficiency Virus (HIV)

        Other, more specific exclusion criteria are further defined in the protocol.
Long-term Safety and Tolerability Study of Adalimumab in Subjects With Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Adalimumab
Intervention description: Adalimumab 40 mg by subcutaneous injection every other week or every week
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: 777.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      To evaluate the long-term maintenance of response, safety and tolerability of repeated
      administration of adalimumab in subjects with Crohn's disease who participated in and
      successfully completed Protocol M02-404 or Protocol M04-691.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must have successfully completed either the M02-404 (NCT00077779) or M04-691
             (NCT00105300) protocol to be eligible for this study

          -  Diagnosis of Crohn's disease

          -  Willing and able to give informed consent

        Exclusion Criteria:

          -  Diagnosis of ulcerative colitis

          -  Women cannot be pregnant or breastfeeding

          -  Previous history of listeria infection or untreated tuberculosis

          -  Previous history of cancer other than successfully treated skin cancer or
             carcinoma-in-situ of the cervix
Efficacy and Safety of Propranolol Versus Atenolol on the Proliferative Phase of Infantile Hemangioma
Condition: Hemangioma
MeSH terms: Hemangioma; Hemangioma, Capillary; Port-Wine Stain
Intervention: Propranolol; Atenolol
Intervention description: Initiated at a dosage of 1 mg/kg per day divided 3 times daily for 1 week, and then increased to 2 mg/kg per day divided 3 times daily from weeks 2 to 24.; Initiated at a dosage of 0.5 mg/kg per day in a single dose for 1 week, and then increased to 1 mg/kg per day in a single dose from weeks 2 to 24.
Intervention MeSH terms: Propranolol; Atenolol
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Enrollment: 377.0
Sex: All
Maximum age: 24 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Infantile hemangioma; Propranolol; Atenolol; Efficacy; Safety

Summary:

      The purpose of this study is to compare the efficacy of orally administered propranolol
      versus atenolol in the treatment of potentially disfiguring or functionally threatening IHs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients younger than 24 weeks.

          -  Presenting a hemangioma with the following characteristics:

          -  Subcutaneous and/or cutaneous

          -  Minimum diameter of 1.5 cm on face, 3 cm outside face and 1.5 cm if it is ulcerated.

          -  Consent of both parents (or the person having parental authority in families)

        Exclusion Criteria:

          -  Infant presenting contraindications for the administration of propranolol or atenolol.

          -  Hemangioma has been previous treated with corticosteroids, laser, cryotherapy, or only
             other treatments.

          -  Patients with an inability to participate or to follow the study treatment and
             assessment plan.
A Study of Nivolumab Plus Brentuximab Vedotin Versus Brentuximab Vedotin Alone in Patients With Advanced Stage Classical Hodgkin Lymphoma, Who Are Relapsed/ Refractory or Who Are Not Eligible for Autologous Stem Cell Transplant,
Condition: Hodgkin's Disease
MeSH terms: Hodgkin Disease
Intervention: Nivolumab; Brentuximab vedotin
Intervention description: Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Nivolumab; Brentuximab Vedotin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether an investigational immuno-therapy
      combination, nivolumab with Brentuximab vedotin compared to Brentuximab vedotin alone is safe
      and effective in the treatment of relapsed and refractory Classical Hodgkin Lymphoma. The
      participants of this trial will comprise of patients who have relapsed or did not respond to
      treatment and are not eligible for stem cell transplant
    

Eligibility criteria:

        Inclusion Criteria

          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.

          -  Participants must have a pathologic diagnosis of classical Hodgkin lymphoma (cHL) who
             are relapsed or refractory with one of the following:.

             i) Autologous stem cell transplant (ASCT) ineligible patients.

        ii) Patients after failure of ASCT.

        - Must have at least one lesion that is > 15 mm (1.5 cm) in the longest diameter and avid
        by Fluoro Deoxy Glucose (FDG) Positron Emission Tomography (PET) scan.

        Exclusion Criteria

          -  Known central nervous system lymphoma.

          -  Participants with nodular lymphocyte-predominant Hodgkin lymphoma (HL).

          -  Participants with known history of pancreatitis or progressive multifocal
             leukoencephalopathy (PML).

          -  Other protocol-defined Inclusion/Exclusion criteria apply.
Remission in Subjects With Crohn's Disease, Open Label Extension
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Intervention: Adalimumab 40 mg eow or ew
Intervention description: Adalimumab 40 mg by subcutaneous injection every other week or every week
Intervention MeSH terms: Adalimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 177.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: HUMIRA; adalimumab; Inflammatory Bowel Disease

Summary:

      The objectives were: (1) To demonstrate the efficacy of adalimumab in the long-term
      maintenance of clinical remission in participants with Crohn's disease; and (2) To delineate
      the long-term safety of adalimumab when administered to participants with Crohn's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participant had completed the Year 1 of Study M02-433 (NCT00055497)

          -  Diagnosis of Crohn's disease

          -  Willing and able to give informed consent

        Exclusion Criteria:

          -  Diagnosis of ulcerative colitis

          -  Pregnancy or breastfeeding

          -  Previous use of infliximab or other anti-TNF (tumor necrosing factor) antagonists

          -  Previous history of active tuberculosis or listeria infection

          -  Previous history of cancer other than successfully treated skin cancer
Safety Study of the VEGA UV-A System to Treat Keratoconus
Condition: Keratoconus
MeSH terms: Keratoconus
Intervention: The VEGA UV-A Illumination System; Riboflavin
Intervention description: This is a portable electronic device designed to deliver a dose of UV-A light to the treatment area; Riboflavin is a solution that will be delivered to the treatment area
Intervention MeSH terms: Riboflavin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 127.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to test the safety, tolerability, and effectiveness of
      corneal collagen cross-linking (CXL), when used to treat keratoconus.
    

Eligibility criteria:

        Inclusion Criteria:

          -  12 years of age or older

          -  Having a diagnosis of keratoconus

          -  Presence of central or inferior steepening

          -  Topography consistent with keratoconus

          -  Presence of one or more slit lamp or retinoscopy findings associated with keratoconus

          -  Contact lens wearers only:Removal of contact lenses for the required period of time

          -  Signed written informed consent

          -  Willingness and ability to comply with schedule for follow-up visits

        Exclusion Criteria:

          -  For keratoconus, a history of previous corneal surgery or the insertion of Intacs in
             the eye to be treated

          -  Corneal pachymetry ≤ 400 microns

          -  Previous ocular condition that may predispose the eye for future complications or
             prevent the possibility of improved vision

          -  A history of chemical injury or delayed epithelial healing in the eye(s) to be
             treated.

          -  Pregnancy (including plan to become pregnant) or lactation during the course of the
             study

          -  A known sensitivity to study medications

          -  Nystagmus or any other condition that would prevent a steady gaze during the
             cross-linking treatment or other diagnostic tests

          -  A condition that, in the investigator's opinion, would interfere with or prolong
             epithelial healing.

          -  Presence or history of any other condition or finding that, in the investigator's
             opinion, makes the patient unsuitable as a candidate for cross-linking or study
             participation or may confound the outcome of the study.
Comparison of the Effect of an Ongoing Treatment With Alendronate or a Drug Holiday on the Fracture Risk in Osteoporotic Patients With Bisphosphonate Long Term Therapy
Condition: Osteoporosis
MeSH terms: Osteoporosis
Intervention: Alendronate; Placebo
Intervention description: 70 mg per week; 1 pill per week
Intervention MeSH terms: Alendronate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 436.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: Osteoporosis; Osteoporotic fractures; Bisphosphonate; Pretreatment with bisphosphonates

Summary:

      The purpose of this study is to evaluate the efficacy and safety of bisphosphonates in long
      term treatment of osteoporosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women or men > 60 years

          -  DXA T-Score at lumbar spine, total hip or femur neck <-2,0 before the start of the
             bisphosphonate therapy or at baseline or at least one low trauma vertebral fracture
             grade 2-3 or multiple low trauma vertebral fractures independent of bone mineral
             densitiy

          -  Pretreatment with bisphosphonates for at least four years

          -  Risk for hip and vertebral fractures min. 30% according to DVO-guideline for
             osteoporosis 2009

          -  Signed informed consent

        Exclusion Criteria:

          -  Other pharmacological treatment of osteoporosis during the last 48 months

          -  Other bone diseases

          -  Malabsorption syndromes

          -  Renal insufficiency with a calculated creatinine clearance < 35 ml/min

          -  Diseases of the esophagus, delayed esophageal clearance

          -  UUnability to realise the intake instructions

          -  Hypocalcemia
A Trial of Magnesium Dependent Tinnitus
Condition: Tinnitus
MeSH terms: Tinnitus
Intervention: Magnesium; Placebo
Intervention description: Magnesium 532 mg a day; matching form/dosage
Phase: Phase 3
Study type: Interventional
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hearing; magnesium

Summary:

      The purpose of this study was to examine any potential benefit in lessening the severity of
      tinnitus (ringing or booming sensation in one or both ears) in subjects supplemented with
      magnesium (532 mg daily).
    

Eligibility criteria:

        Inclusion criteria:

          -  Normal Kidney function (last checked within 6 months). Serum creatinine levels 1.5
             mg/dL or below for females, 2.0 mg/dL for males.

          -  An audiogram within the past 6 months

          -  Mayo Clinic patients who live in Phoenix area

        Exclusion criteria:

          -  Any participant with decreased kidney function within past 6 months, over 1.5 mg/dL
             for females and over 2.0 mg/dL for males.

          -  Current treatment with Lithium

          -  Tinnitus rating with 0, 1, or 2 on the 0-10 Tinnitus scale