bioihbjkbjnl/mcl2 huggingface dataset:
An Open-Label Safety Study Of DIC075V (Intravenous Diclofenac Sodium) In Patients With Acute Post-Operative Pain
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: DIC075V (intravenous diclofenac sodium)
Intervention description: multiple doses up to 5 days
Intervention MeSH terms: Diclofenac
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1050.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: safety; diclofenac; pain, postoperative

Summary:

      This is an open-label, multiple-dose, safety study of DIC075V in patients with acute
      post-operative pain following abdominal or orthopedic surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  abdominal ( non-laparoscopic abdominal surgeries) or orthopedic ( hip or knee joint
             replacement) surgery or other surgeries requiring multiple doses of parenterally
             administered NSAIDs over multiple days

          -  Expected stay > 48 hrs

        Exclusion Criteria:

          -  bilirubin > 2.5 mg/dl

          -  prothrombin time is > 20% above the upper limit of normal

          -  serum creatinine is > 1.9 mg/dl at screening.

          -  known allergy or hypersensitivity to diclofenac, other NSAIDs,
Initial Combination With Pioglitazone Study (0431-064)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: sitagliptin 100 mg q.d./pioglitazone 30 mg q.d; Comparator: placebo to match sitagliptin 100 mg q.d./pioglitazone 30 mg q.d.
Intervention description: Patients will receive initial combination therapy with blinded sitagliptin 100 mg q.d. and open- label pioglitazone 30 mg q.d. for up to 24 Weeks. Sitagliptin 100 mg q.d. and pioglitazone 30 mg q.d. will be administered as oral tablets.; Patients will receive placebo to match sitagliptin 100 mg q.d. (blinded) and open label pioglitazone 30 mg q.d. for up to 24 Weeks. Placebo to match sitagliptin 100 mg q.d.(blinded) and open-label pioglitazone 30 mg q.d. will be administered as oral tablets.
Intervention MeSH terms: Pioglitazone; Sitagliptin Phosphate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 520.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A clinical study to evaluate the safety and efficacy of the initial combination therapy with
      sitagliptin and pioglitazone in patients with type 2 diabetes mellitus not on treatment with
      insulin or oral antihyperglycemic therapy.
    

Eligibility criteria:

        General Inclusion Criteria:

          -  Patients ≥18 years old with Type 2 Diabetes Mellitus (a specific type of diabetes)

        General Exclusion Criteria:

          -  Patient has a history of type 1 diabetes mellitus or history of ketoacidosis

          -  Patient was on antihyperglycemic agent therapy (oral or insulin) within the prior 4
             months

          -  Patient was on >4 weeks (cumulatively) of antihyperglycemic therapy (oral or insulin)
             over the prior 2 years
Efficacy Study Measuring the Impact of Pregabalin on Peripheral Neuropathic Pain.
Condition: Neuropathic Pain
MeSH terms: Neuralgia
Intervention: Pregabalin (Lyrica); Pregabalin (Lyrica); Pregabalin (Lyrica); Placebo
Intervention description: pregabalin 150mg/day (75mg BID); pregabalin 300 mg/day (150mg BID); pregabalin 600/day (300mg BID); Placebo
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 158.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will measure the impact of treatment with pregabalin in adult men and women who
      have a diagnosis of peripheral neuropathic pain (pain caused by a primary lesion of the
      peripheral nervous system such as Diabetic peripheral Neuropathy and Postherpetic Neuralgia).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects presenting a diagnosis of peripheral neuropathic pain, defined as pain caused
             by a lesion of the peripheral nervous system manifesting with sensory symptoms and
             signs, for at least 6 months at screening.

          -  At baseline, subjects must have completed at least 4 daily pain diaries and must have
             a mean weekly pain score equal or greater than 4.

        Exclusion Criteria:

          -  Presence of any of the following diagnoses: Cervical or lumbo-sacral radiculopathy;
             Operated or non-operated chronic low back pain Carpal tunnel syndrome or any other
             entrapment-related neuropathic pain (defined as pain associated with focal nerve
             lesion produced by constriction or mechanical distortion of the nerve, within a
             fibrous or fibro-osseous tunnel, or by a fibrous band) ; Complex regional pain
             syndrome (type 1 and 2); Fibromyalgia.
The Effect of Liraglutide on Endothelial Function in Subjects With Type 2 Diabetes Mellitus
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: liraglutide; placebo; glimepiride
Intervention description: Stepwise dose increase, s.c. (under the skin) injection, once daily; Liraglutide placebo, stepwise dose increase, s.c. (under the skin) injection, once daily; Tablets, 1 - 4 mg daily
Intervention MeSH terms: Liraglutide; Glimepiride
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 49.0
Sex: All
Minimum age: 40 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      This trial is conducted in the United States of America (USA). The purpose of the trial is to
      assess the effect of liraglutide on forearm blood flow in subjects with type 2 diabetes who
      are on diet and lifestyle changes or treated with metformin alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes

          -  Diet and lifestyle changes or metformin monotherapy for at least three months

          -  HbA1c (glycosylated haemoglobin) 6.5-9.0% (both inclusive)

          -  Body Mass Index (BMI) less than or equal to 40 kg/m^2

        Exclusion Criteria:

          -  Previous treatment with insulin (except for short term treatment with insulin in
             connection with intercurrent illness, at the discretion of the Investigator)

          -  Previous treatment with glucagon-like peptide-1 (GLP-1) analogues/mimetics, including
             treatment in a clinical trial

          -  Treatment with any oral hypoglycaemic agents other than metformin in a period of 3
             months prior to screening

          -  Current smoker or history of smoking within 6 months prior to screening

          -  Evidence of overt cardiovascular disease (documented coronary heart disease, class
             II-IV congestive heart failure, cerebrovascular disease, or peripheral vascular
             disease)

          -  Abnormal, clinically significant exercise stress electrocardiogram (ECG) test, as
             judged by the Investigator

          -  Known retinopathy or maculopathy requiring acute treatment, as judged by the
             Investigator

          -  Known autonomic neuropathy, as judged by the Investigator

          -  Initiation or change (dose or treatment regimen) in concomitant blood
             pressure-lowering or lipid-lowering medication within 4 weeks prior to screening

          -  Systolic blood pressure more than or equal to 140 mmHg and/or diastolic blood pressure
             more than or equal to 90 mmHg
Efficacy Study of DiaPep277 in Newly Diagnosed Type 1 Diabetes Patients
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: DiaPep277; Placebo
Intervention description: 1.0mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months; Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 457.0
Sex: All
Minimum age: 16 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine if DiaPep277 can effectively protect the internal
      production of insulin in patients newly diagnosed with type 1 diabetes, by stopping the
      immune destruction of insulin-producing beta-cells in the pancreas. DiaPep277 acts on the
      immune system and is expected to prevent further destruction of the beta-cells by stimulating
      regulatory responses, without causing immunological suppression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A diagnosis of type 1 diabetes for up to 3 months at screening

          -  Insulin dependency

          -  Fasting C-peptide levels >= 0.22 nmol/L

          -  Presence of at least 1 of the diabetes-related autoantibodies (IA-2A, GAD or IA)

        Exclusion Criteria:

          -  Pregnancy or intent to conceive in the next 2 years

          -  Significant diseases that could affect response to treatment, such as tumors,
             psychiatric disorders, substance abuse, severe allergies or diabetes-related
             complications.

          -  Patient has immune deficiency or receives immuno-suppressive or cytotoxic drugs.
Efficacy and Safety Study of Desmoteplase to Treat Acute Ischemic Stroke (DIAS-4)
Condition: Stroke
MeSH terms: Stroke; Ischemic Stroke
Intervention: Desmoteplase; Placebo
Intervention description: 90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes on 1st day; IV, single bolus over 1 to 2 minutes on 1st day
Intervention MeSH terms: Salivary plasminogen activator alpha 1, Desmodus rotundus
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 270.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Acute ischemic stroke; Angiography; Desmoteplase; Thrombolytic

Summary:

      The purpose of the study is to determine whether desmoteplase is effective and safe in the
      treatment of patients with acute ischaemic stroke when given within 3 to 9 hours from onset
      of stroke symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of acute ischemic stroke

          -  Informed consent

          -  Age between 18 and 85 years

          -  Treatment can be initiated within 3 to 9 hours after the onset of stroke symptoms

          -  NIHSS Score of 4 to 24

          -  Vessel occlusion or high-grade stenosis on MRI or CTA in proximal cerebral arteries

        Exclusion Criteria:

          -  Pre-stroke mRS >1

          -  Previous exposure to desmoteplase

          -  Extensive early infarction on MRI or CT in any affected area

          -  Imaging evidence of ICH or SAH; AV malformation; cerebral aneurysm; or cerebral
             neoplasm

          -  Internal carotid artery occlusion on the side of the stroke lesion

          -  Treatment with heparin in the past 48 hours and a prolonged partial thromboplastin
             time

          -  Treatment with oral anticoagulants and a prolonged prothrombin time

          -  Treatment with glycoprotein IIb - IIIa inhibitors within the past 72 hours. Use of
             single agent oral platelet inhibitors is permitted

          -  Treatment with a thrombolytic agent within the past 72 hours
A Study of 2 Doses of MAP0010 in Asthmatic Children
Condition: Asthma
MeSH terms: Asthma
Intervention: 0.135mg MAP0010; 0.25mg MAP0010
Intervention description: 0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks; 0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 40 weeks
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 192.0
Sex: All
Minimum age: 12 Months
Maximum age: 8 Years
Healthy volunteers: No
Keywords: asthmatic children

Summary:

      The purpose of this study is to examine the safety of two doses of MAP0010 in asthmatic
      children, 12 months to 8 years of age, over a 40-week period.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Completed 12 weeks of treatment in the MAP0010-CL-P301 study.

          -  Patient, parent, and guardian (as appropriate) are willing for child to undergo all
             study procedures and willing to sign the informed consent and assent, as appropriate.

        Exclusion Criteria:

          -  Less than 80% compliance with either study treatment and/or other study procedures
             (e.g., completion of symptom e-diary) in the MAP0010-CL-P301 Study.
An Open-Label Extension Trial to Assess the Safety of Long-Term Treatment of Rotigotine in Advance-Stage Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Rotigotine
Intervention description: Rotigotine transdermal patches:
10 cm2 (2 mg/24 hours); 20 cm2 (4 mg/24 hours); 30 cm2 (6 mg/24 hours); 40 cm2 (8 mg/24 hours)
Optimal dosing:
During the first year: The maximum Rotigotine dose allowed is 6 mg/24 hours.
After the first year: Allowed dose increase of Rotigotine up to a maximum of 16 mg/24 hours.
Intervention MeSH terms: Rotigotine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 258.0
Sex: All
Minimum age: 31 Years
Healthy volunteers: No
Keywords: Rotigotine; Neupro

Summary:

      The objective of this open-label extension is to assess the safety and tolerability of
      long-term treatment of the Rotigotine patch in subjects with advanced-stage idiopathic
      Parkinson's Disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who have completed six months of maintenance treatment in the SP650
             double-blind trial

        Exclusion Criteria:

          -  Subjects who had an ongoing serious adverse event from the SP650 double-blind trial
             that was assessed as related to study medication
MARLINA - T2D : Efficacy, Safety & Modification of Albuminuria in Type 2 Diabetes Subjects With Renal Disease With LINAgliptin
Condition: Diabetes Mellitus, Type 2
MeSH terms: Albuminuria; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo; Linagliptin 5mg
Intervention MeSH terms: Linagliptin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 360.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      Evaluate linagliptin in terms of glycemic control as defined by HbA1c after 24 weeks of
      treatment and in terms of renal efficacy as defined by changes in albuminuria (UACR) after 24
      weeks of treatment.
    

Eligibility criteria:

        Inclusion criteria:

          -  Diagnosis of type 2 diabetes mellitus

          -  Glycosylated Hemoglobin (HbA1c) between 6.5 and 10% (inclusive)

          -  Current therapy with ACEi or ARB at stable dose for 10 weeks

          -  Urinary albumin-to-creatinine ratio (UACR): 30-3000 mg/g creatinine documented in the
             previous 12 months or detected at Screening.

          -  Estimated Glomerular Filtration Rate (eGFR) greater than 30 ml/min.

          -  Age between 18 and 80 years.

        Exclusion criteria:

          -  Dual or triple blockade of the Renin Angiotensin System (RAS)

          -  Uncontrolled hyperglycaemia

          -  Mean arterial blood pressure > 110 mmHg

          -  Known hypersensitivity or allergy to the investigational product, or their excipients
             (including matching placebos).

          -  Treatment with a glitazone within 6 months prior to informed consent.

          -  Treatment with a DiPeptidyl-Peptidase 4 (DPP-4) inhibitor, a Glucagon Like Peptide-1
             (GLP-1) agonist, a Sodium/Glucose coTransporter 2 (SGLT2) inhibitor, a
             dopamine-agonist, a bile-acid sequestrant a short acting (prandial) insulin or
             premixed insulin within 10 weeks prior to informed consent.

          -  Treatment with anti-obesity drugs 10 weeks prior to informed consent.

          -  Alcohol or drug abuse within 3 months prior to informed consent that would interfere
             with trial participation or any ongoing condition leading to a decreased compliance to
             study procedures or study drug intake in the opinion of the investigator.

          -  Current treatment with systemic steroids (glucocorticoids) at time of informed consent
             or change in dosage of thyroid hormones within 6 weeks prior to informed consent.

          -  Participation in another trial with an investigational drug within 2 months prior to
             informed consent.
A Study to Assess the Efficacy and Safety of BIVV009 (Sutimlimab) in Participants With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion (Cardinal Study)
Condition: Agglutinin Disease, Cold
MeSH terms: Anemia, Hemolytic, Autoimmune
Intervention: BIVV009
Intervention description: Sutimlimab was administered as intravenous (IV) infusion.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of Part A was to determine whether sutimlimab administration resulted in a
      greater than or equal to (>=) 2 grams per deciliter (g/dL) increase in hemoglobin (Hgb)
      levels or increased Hgb to >= 12 g/dL and obviated the need for blood transfusion during
      treatment in participants with primary cold agglutinin disease (CAD) who had a recent history
      of blood transfusion. The purpose of Part B was to evaluate the long-term safety and
      tolerability of sutimlimab in participants with CAD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body weight of >= 39 kg at screening.

          -  Confirmed diagnosis of primary CAD based on the following criteria: a) Chronic
             hemolysis; b) Polyspecific direct antiglobulin test (DAT) positive; c) Monospecific
             DAT strongly positive for C3d; d) Cold agglutinin titer >= 64 at 4 degree celsius; e)
             Immunoglobulin G (IgG) DAT less than or equal to (<=) 1+, and f) No overt malignant
             disease.

          -  History of at least one documented blood transfusion within 6 months of enrollment.

          -  Hemoglobin level <= 10.0 g/dL.

          -  Bilirubin level above the normal reference range, including participants with
             Gilbert's Syndrome.

        Exclusion Criteria:

          -  Cold agglutinin syndrome secondary to infection, rheumatologic disease, or active
             hematologic malignancy.

          -  Clinically relevant infection of any kind within the month preceding enrollment (e.g.,
             active hepatitis C, pneumonia).

          -  Clinical diagnosis of systemic lupus erythematosus; or other autoimmune disorders with
             anti-nuclear antibodies at Screening. Anti-nuclear antibodies of long-standing
             duration without associated clinical symptoms adjudicated on a case-by-case basis
             during the Confirmatory Review of Patient Eligibility.

          -  Positive hepatitis panel (including hepatitis B surface antigen and/or hepatitis C
             virus antibody) prior to or at Screening.

          -  Positive human immunodeficiency virus (HIV) antibody at screening.

          -  Treatment with rituximab monotherapy within 3 months or rituximab combination
             therapies (e.g., with bendamustine, fludarabine, ibrutinib, or cytotoxic drugs) within
             6 months prior to enrollment.
One-Piece Hydrophobic Acrylic Intraocular Lens in Subjects Undergoing Cataract Extraction
Condition: Aphakia; Cataract
MeSH terms: Cataract; Aphakia
Intervention: enVista
Intervention description: One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ocular surgery; phacoemulsification

Summary:

      The objective of this study is to evaluate the safety and effectiveness of the enVista®
      One-Piece Hydrophobic Acrylic intraocular lens (IOL), following primary implantation for the
      visual correction of aphakia in adults 18 years of age or older in whom the cataractous lens
      has been removed by an extracapsular cataract extraction method (eg, small incision
      phacoemulsification).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have a clinically documented diagnosis of age-related cataract that is
             considered amenable to treatment with standard phacoemulsification/extracapsular
             cataract extraction.

          -  Subjects must have a best corrected visual acuity (BCVA) equal to or worse than 20/40
             in the study eye, with or without a glare source.

          -  Subjects must have a BCVA projected to be better than 20/30 after IOL implantation in
             the study eye.

        Exclusion Criteria:

          -  Subjects with any anterior segment pathology for which extracapsular
             phacoemulsification cataract surgery would be contraindicated.

          -  Subjects with any other serious ocular pathology, or underlying serious medical
             conditions, which based on the Investigator's medical judgment, could confound the
             results of the study.