bioihbjkbjnl/mcl2 huggingface dataset:
Long-Term Safety of Febuxostat in Subjects With Gout.
Condition: Gout
MeSH terms: Gout
Intervention: Febuxostat; Febuxostat; Febuxostat
Intervention description: Febuxostat 40 mg, tablets, orally, once daily, based on serum urate level.; Febuxostat 80 mg, tablets, orally, once daily, based on serum urate level.; Febuxostat 120 mg, tablets, orally, once daily, based on serum urate level.
Intervention MeSH terms: Febuxostat
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 116.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Uric acid; xanthine oxidase; tophi; Drug Therapy

Summary:

      The purpose of this study is to evaluate the long-term safety of febuxostat, once daily (QD),
      in maintaining serum urate levels within clinically acceptable levels in subjects with gout.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Hyperuricemia (serum uric acid ≥8.0 mg/dL upon entering parent study TMX-00-004).

          -  Must meet American College of Rheumatology criteria for gout.

          -  Must have adequate renal function (serum creatinine <1.5 mg/dL).

          -  Must have completed four weeks of double-blind dosing in Study TMX-00-004.

          -  Must not have experienced any serious study drug-related Adverse Events in Study TMX
             00-004.

          -  Females of childbearing potential who are sexually active must agree to use adequate
             contraception, and can neither be pregnant nor lactating from Screening throughout the
             duration of the study.

        Exclusion Criteria:

          -  History of xanthinuria

          -  Alcohol consumption >14/week

          -  Has a History of significant concomitant illness

          -  Has active liver disease.

          -  Has a body mass index greater than 50 kg/m2

          -  Any other significant medical condition that would interfere with the treatment,
             safety or compliance with the protocol, as defined by the investigator.
Efficacy and Safety of Twice Daily 60mg AZD9668 in COPD for 12 Weeks in Patients on Background Budesonide/Formoterol
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: AZD9668; Placebo
Intervention description: 2 x 30 mg oral tablets bd for 12 weeks; 2 x matched placebo to oral tablet bd for 12 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: 615.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Chronic; obstructive; pulmonary; lung; respiratory disease; efficacy; placebo-controlled; COPD; FEV1; St Georges Respiratory Questionnaire

Summary:

      The primary objective is to evaluate the efficacy of AZD9668 compared with placebo in
      symptomatic COPD patients by assessing the effects on lung function and symptoms of COPD
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of COPD with symptoms over 1 year

          -  FEV1/FVC < 70% and FEV1 >= 30 and < 80 % of predicted post-bronchodilator

          -  Symptomatic COPD for a total of 7 days in the two weeks prior to randomisation

          -  At least 1 COPD exacerbation from 4 weeks to 12 months before the screening visit

        Exclusion Criteria:

          -  Past history or current evidence of clinically significant heart disease

          -  Current diagnosis of asthma

          -  Patients who require long term oxygen therapy

          -  Worsening of COPD requiring treatment with antibiotics, an increase in inhaled steroid
             dose and/or oral steroids within 4 weeks of study visit 1b
Safety and Efficacy of a Metallic Cannula Versus A Standard Needle for Soft Tissue Augmentation of the Nasolabial Folds
Condition: Wrinkles
Intervention: hyaluronic acid with metallic cannula or standard needle.; Hyaluronic acid injected with the new tool.
Intervention description: The sides of injection were randomized and both the subject and the evaluator were blind to it. The injections were performed according through two different devices:
In one of the sides, the hyaluronic acid (Restylane®) was injected in its conventional pharmaceutical presentation, with a standard needle which is part of the product's kit;
In the other side, the hyaluronic acid (Restylane®) was injected through a metallic cannula, which replaced the needle of the product's kit.
Local analgesia was provided for both applications: topical analgesics 4% Lidocaine, for the application with the standard needle, and nerve block (Lidocaine 2%), where the application was performed with the metallic cannula.; hyaluronic acid with metallic cannula.
Intervention MeSH terms: Hyaluronic Acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 25.0
Sex: Female
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: metallic cannula; Hyaluronic acid

Summary:

      The purpose of this study was to assess the safety and efficacy of a new metallic cannula to
      inject hyaluronic acid for dermal augmentation in the nasolabial folds compared to standard
      needle.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects agreeing to take part of the study, after being fully informed of the purpose
             and the nature of the investigation and after having signed the informed consent form

          -  Female subjects aged from 18 to 60

          -  Fitzpatrick phototype I to VI

          -  Presence of bilateral folds graded from 2 to 3 according to the Modified

          -  Fitzpatrick Wrinkle Scale

          -  Subjects that have never performed any treatment of nasolabial folds

          -  Female subjects of childbearing age that present a negative urine pregnancy test and
             are using an effective contraceptive method

          -  Subjects who will be available throughout the duration of the study

          -  Subjects with sufficient schooling and awareness to enable them to cooperate to the
             degree required by this protocol.

        Exclusion Criteria:

          -  Use of systemic corticosteroids

          -  History of herpes in lip

          -  Inflammation or active infection in the area to be injected

          -  Any surgical treatment or cosmetic procedure in the area to be injected that interfere
             in study's outcomes

          -  Coagulation disorders or use of anticoagulants

          -  Previous hypersensitivity responses to Hyaluronic acid.

          -  Pregnant or women in breastfeeding, or women planning to become pregnant
Study of ITCA 650 (Exenatide in DUROS) in Subjects With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: ITCA 650; Exenatide Injection; Ex Inj/ITCA 650
Intervention description: ITCA 650 (continuous delivery of exenatide in DUROS); twice daily (BID) injections of exenatide commercially available Byetta: 5 mcg/dose first 12 weeks then 10 mcg/dose for 8 weeks; twice-daily (BID) exenatide injection: 5 mcg/dose for 4 weeks then 10 mcg/dose for 8 weeks, followed by ITCA 650
Intervention MeSH terms: Exenatide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 155.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine safety, efficacy and tolerability of various doses
      of ITCA 650 in subjects with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females age 18-70 years

          -  Type 2 diabetes mellitus for ≥ 6 months prior to Screening Visit 1

          -  On a stable (> 3 months prior to Screening Visit 1) treatment regimen of metformin
             monotherapy;

          -  Fasting plasma glucose < 240 mg/dL at Screening Visit 1

          -  HbA1c ≥ 7% and ≤ 10% at Screening Visit 1

        Exclusion Criteria:

          -  Prior treatment with exenatide

          -  Treatment with any of the following antidiabetic agents within 3 months prior to
             Screening Visit 1: TZDs, sulfonylureas, DPP IV inhibitors, acarbose, or insulin
             (injected or inhaled)

          -  History of type 1 diabetes and/or history of diabetic ketoacidosis

          -  Body mass index ≥ 40 kg/m2;

          -  History of organ transplantation
Efficacy, Safety and Pharmacokinetics of Topical Timolol in Infants With Infantile Hemangioma (IH)
Condition: Infantile Hemangioma
MeSH terms: Hemangioma; Hemangioma, Capillary; Port-Wine Stain
Intervention: 0.25% Timolol Maleate Gel Forming Solution; 0.5% Timolol Maleate Gel Forming Solution
Intervention description: 50:50 Randomized 0.25% Timolol Maleate Gel Forming Solution; 50:50 Randomized 0.5% Timolol Maleate Gel Forming Solution
Intervention MeSH terms: Timolol; Pharmaceutical Solutions; Maleic acid
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 105.0
Sex: All
Maximum age: 84 Days
Healthy volunteers: No
Keywords: Hemangioma; Infantile Hemangioma; Pharmacokinetics

Summary:

      The purpose of this study is to assess the safety and efficacy of Timolol 0.25% and 0.5%
      doses.
    

Eligibility criteria:

        Inclusion Criteria

          1. Documented informed consent from legal guardian

          2. 0-84 days postnatal age at time of first study dose or when enrolled into the
             non-intervention cohort.

          3. Clinical diagnosis of superficial cutaneous or mucosal infantile hemangioma (must
             include all of the following):

               1. Superficial lesion in the dermis

               2. Thin <2 mm in thickness

               3. Small >=5 cm at its longest dimension and <=10cm2

               4. Involves skin or keratinized mucosa

        Exclusion Criteria

          1. History of previous treatment with any pharmacologic or laser therapy for IH

          2. Ongoing therapy with an oral beta blocker or oral corticosteroid (e.g., cardiac
             arrhythmia, adrenal insufficiency, upper airway obstruction, tetralogy of fallot
             (TOF), hypertension, reactive airways disease)

          3. IH that requires systemic therapy (defined by dynamic complication scale >3)

          4. IH of the non-keratinized mucosa

          5. Infants with more than one hemangioma that requires therapy

          6. Hemodynamically significant cardiovascular disease, as determined by the investigator

          7. Known allergy to beta blockers or vehicle

          8. Heart rate <100 beats per minute at screening visit

          9. Known prenatal or postnatal diagnosis of 2nd/3rd degree atrioventricular block

         10. History of Reactive Airways Disease (RAD)

         11. Any condition which would make the participant, in the opinion of the investigator
             unsuitable for the study.
Stereotactic Radiosurgery in Treating Patients With Brain Metastases
Condition: Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Brain Neoplasms
Intervention: therapeutic conventional surgery; stereotactic radiosurgery
Intervention description: Surgery of a single brain metastasis.; Pre-operative single fraction SRS
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: tumors metastatic to brain; unspecified adult solid tumor, protocol specific

Summary:

      RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and
      cause less damage to normal tissue. Giving stereotactic radiosurgery before surgery may make
      the tumor smaller and reduce the amount of normal tissue that needs to be removed.

      PURPOSE: This phase II trial is studying how well stereotactic radiosurgery works in treating
      patients with brain metastases.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Diagnosis of brain metastases from an extracranial primary site

               -  Tumor ≤ 4 cm in maximal extent in any plane on contrast MRI

          -  Scheduled to undergo gross total resection of a single brain metastasis confirmed by
             histology

               -  Up to 4 metastases allowed provided the largest mass is amenable to surgical
                  resection and all non-resected masses are amenable to stereotactic radiosurgery
                  (SRS)

          -  RTOG Recursive Partitioning Analysis (RPA) class 1 or 2, as defined by the following:

               -  RPA class 1: Karnofsky performance status (KPS) 70-100%; age < 65 years;
                  controlled primary disease; and no extracranial metastatic disease

               -  RPA class 2: KPS 70-100%; uncontrolled primary disease; and/or extracranial
                  metastatic disease

          -  No lesion located in anatomic regions that are not amenable to SRS, including the
             brain stem, optic apparatus, or eloquent cortex

          -  No primary lesion with radiosensitive histology (e.g., small cell carcinoma, germ cell
             tumors, lymphoma, leukemia, or multiple myeloma)

          -  No radiographic or cytologic evidence of leptomeningeal disease

        PATIENT CHARACTERISTICS:

          -  See Disease Characteristics

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  No concurrent uncontrolled illness including, but not limited to, any of the
             following:

               -  Symptomatic congestive heart failure

               -  Unstable angina pectoris

               -  Psychiatric illness

          -  No contraindication to SRS, whole-brain radiotherapy, or MRI

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  No prior brain surgery other than resection of metastasis

          -  No prior brain radiotherapy
Gabapentin for Bipolar & Cannabis Use Disorders
Condition: Bipolar I Disorder; Bipolar II Disorder; Cannabis Use Disorder; Substance Use Disorders
MeSH terms: Substance-Related Disorders; Marijuana Abuse
Intervention: Gabapentin; Placebo Oral Capsule
Intervention description: 5 day trial of gabapentin with titration to 1,200mg; 5 day trial of matched placebo
Intervention MeSH terms: Gabapentin
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The proposed 2-week, double-blind, crossover, proof of concept study aims to measure and
      manipulate core neurochemical (i.e., dysregulated brain GABA/glutamate homeostasis) and
      neurobehavioral (i.e., elevated impulsivity) dysfunctions characteristic of individuals with
      cannabis use disorder (CUD) and Bipolar Disorder (BD), using a medication that has been shown
      to increase cortical GABA (i.e., gabapentin) levels in past research, and to evaluate
      medication-related changes in response inhibition (go no-go) and cannabis cue reactivity
      functional Magnetic Resonance Imaging tasks, as well as cannabis use, mood symptoms
      (including anxiety and sleep), and impulsivity in individuals with CUD+BD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets DSM-V criteria for Bipolar Disorder

          -  Meets DSM-V criteria for Cannabis Use Disorder

          -  Using at least one mood stabilizing medication

        Exclusion Criteria:

          -  Serious medical or non-inclusionary psychiatric disease

          -  Concomitant use of benzodiazepine medications or any medications hazardous if taken
             with gabapentin

          -  History of clinically significant brain injury

          -  Presence of non-MRI safe material, or clinically significant claustrophobia.
A Study to Assess the Effect of a Single Infusion of VAY736 on Disease Activity in Patients With Relapsing-remitting Multiple Sclerosis
Condition: Relapse Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: VAY736; Placebo
Intervention description: Single intravenous infusion of VAY736 (10 mg/kg); Placebo to VAY736
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No
Keywords: Multiple Sclerosis; Relapsing-Remitting Multiple Sclerosis; Magnetic Resonance Imaging; VAY736; Lanalumab; monoclonal antibody; gadolinium [Gd]-enhancing lesions; B-Cell

Summary:

      This was a randomized, partially blinded, placebo-controlled, non-confirmatory study to
      assess the effects of a single infusion of VAY736 on disease activity as measured by brain
      MRI scans in patients with relapsing-remitting multiple sclerosis (RRMS).
    

Eligibility criteria:

        Key inclusion criteria:

          -  Male and female patients aged 18 to 55 years.

          -  Diagnosis of MS as defined by the 2010 revised McDonald criteria (Polman et al 2011).

          -  A relapsing-remitting course of disease with:

               -  at least 1 documented relapse during the previous 12 months (but not within 30
                  days prior to randomization ), or

               -  a positive Gd-enhancing lesion on brain MRI scan at screening.

          -  An Expanded Disability Status Scale (EDSS) score of 0-5.0 inclusive at screening.

          -  No evidence of a relapse within 30 days prior to randomization.

        Key exclusion criteria:

          -  A manifestation of another type of MS other than RRMS.

          -  Findings on screening or baseline brain MRI inconsistent with the diagnosis of MS.

          -  History of chronic disease of the immune system other than MS, or a known
             immunodeficiency syndrome.

          -  Score "yes" on item 4 or item 5 of the Suicidal Ideation section of the C-SSRS, if
             this ideation occurred in the past 6 months, or "yes" on any item of the Suicidal
             Behavior section, except for the "Non-Suicidal Self-Injurious Behavior" (item also
             included in the Suicidal Behavior section), if this behavior occurred in the past 2
             years.

          -  Women of child-bearing potential and Pregnant or nursing (lactating) women.

          -  Screening CBC (complete blood count) laboratory values as follows:

          -  Hemoglobin levels below 10.0 g/dL

          -  Total leukocyte count less than 3,000 cells/µL

          -  Neutropenia, defined as absolute neutrophil counts less than 1500 cells/mm3

          -  Platelets less than 100,000/µL
A Trial Comparing Ferumoxytol to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects With Chronic Kidney Disease
Condition: Iron Deficiency; Anemia; Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies
Intervention: Ferumoxytol; Iron Sucrose
Intervention description: IV Ferumoxytol; IV Iron Sucrose
Intervention MeSH terms: Ferrosoferric Oxide; Ferric Oxide, Saccharated
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 162.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Iron deficiency anemia; Chronic kidney disease; Feraheme; Ferumoxytol; Iron sucrose; IDA; CKD; Venofer

Summary:

      The purpose of the study is to evaluate the safety and efficacy of intravenous (IV)
      ferumoxytol compared to IV iron sucrose for the treatment of iron deficiency anemia (IDA) in
      participants with chronic kidney disease (CKD).
    

Eligibility criteria:

        Inclusion Criteria:

        Key Inclusion Criteria include:

          1. Males and females ≥18 years of age

          2. An estimated glomerular filtration rate <60 mL/minute or a diagnosis of CKD (such as
             nephropathy, nephritis)

          3. Hemoglobin <11.0 g/deciliter (dL)

          4. Transferrin saturation <30%

          5. Hemodialysis participants on maintenance dialysis for at least 3 months prior to
             screening and currently receiving dialysis 3 times per week

          6. Female participants of childbearing potential who are sexually active must be on an
             effective method of birth control for at least 1 month prior to screening and agree to
             remain on birth control until completion of the study

        Exclusion Criteria:

        Key Exclusion Criteria include:

          1. History of allergy to IV iron

          2. Allergy to 2 or more classes of drugs

          3. Female participants who are pregnant or intend to become pregnant, breastfeeding,
             within 3 months postpartum, or have a positive serum or urine pregnancy test

          4. Hemoglobin ≤7.0 g/dL

          5. Received another investigational agent within 4 weeks prior to screening, or planned
             receipt of an unspecified investigational agent during the study period

          6. Known causes of anemia other than iron deficiency (such as hemolysis and vitamin B12
             or folate deficiency)