bioihbjkbjnl/mcl2 huggingface dataset:
Study of the Optimal Protocol for Methotrexate and Adalimumab Combination Therapy in Early Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: adalimumab; methotrexate; placebo
Intervention description: Adalimumab 40 mg/0.8 mL prefilled syringe injected subcutaneously (SC) every other week (eow); Methotrexate 2.5 mg tablets administered orally once a week starting at 7.5 mg/week with dose escalation (weekly or every other week) by 2.5 mg intervals to 20 mg/week.; Placebo for adalimumab 0.8 mL prefilled syringe injected subcutaneously (SC) every other week (eow)
Intervention MeSH terms: Adalimumab; Methotrexate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1032.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Early Rheumatoid Arthritis; Tumor Necrosis Factor Optimization

Summary:

      This study compared the safety and efficacy of combination therapy with adalimumab plus
      methotrexate (MTX) to that of MTX monotherapy (i.e., placebo plus MTX) in subjects with early
      rheumatoid arthritis (RA).
    

Eligibility criteria:

        Inclusion Criteria

          -  Subject must be 18 or older and in good health

          -  Subject must meet the definition of early rheumatoid arthritis (RA) defined by the
             1987-revised American College of Rheumatology (ACR) classification criteria and had
             disease duration of less than 1 year from diagnosis

          -  Subject must have a Disease Activity Score (DAS28, based on C-reactive protein)
             greater than 3.2, at least 6 swollen joints out of the 66 assessed, and at least 8
             tender joints out of the 68 assessed

          -  Subject must fulfill at least one of the following three criteria:

               -  Rheumatoid factor positive

               -  Greater than 1 joint erosion

               -  Anti-cyclic citrullinated peptide (CCP) antibody positive.

        Exclusion Criteria

          -  Subject has previously received systemic anti-tumor necrosis factor (TNF) therapy

          -  Subject has received any biologic or investigational therapy within 6 weeks prior to
             Baseline

          -  Subject has been previously treated with more than 2 disease-modifying antirheumatic
             drugs (DMARDs) or MTX, had been treated with intra-articular or parenteral
             administration of corticosteroids in preceding 4 weeks, or had undergone joint surgery
             within the preceding 2 months at joints to be assessed during the study.
Stereotaxis Study To Obliterate Persistent Ventricular Tachycardia
Condition: Ventricular Tachycardia
MeSH terms: Tachycardia; Tachycardia, Ventricular
Intervention: Magnetic irrigated ablation catheter
Intervention description: Magnetic irrigated catheter to be used with the magnetic navigation system
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 53.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: arrhythmia; ventricular tachycardia; ablation; mapping; electrophysiology

Summary:

      This is a prospective, non-randomized, multi-center clinical case series evaluating the
      outcomes of the magnetic navigation system in ventricular tachycardia (VT) cases. Subjects
      will be evaluated acutely and will be followed clinically at 1, 6 and 12 months
      post-treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must be between the ages of 18 - 80 years

          -  Willing to provide prior written informed consent per local ethics committee
             guidelines

          -  Subjects must present with ventricular tachycardia, characterized by: history of
             myocardial scar and spontaneous ventricular tachycardia

          -  Able to be safely exposed to static magnetic fields

          -  No in-situ devices are present or any in-situ devices have been verified to be
             compatible to magnetic fields

        Exclusion Criteria:

          -  Presence of a mobile ventricular thrombus

          -  Inability to access the left ventricle

          -  Subjects must not have any contraindications to short-term anticoagulation

          -  Subjects must not have a life expectancy of <1 year due to a medical illness
Treatment of Cystoid Macular Edema in Patients With Retinal Degeneration
Condition: Retinal Degenerations
MeSH terms: Macular Edema; Retinal Degeneration
Intervention: 2% dorzolamide
Intervention description: Carbonic anhydrase inhibitor, Trusopt (2% dorzolamide)
Intervention MeSH terms: Dorzolamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 44.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A small percentage of patients with retinal degeneration accumulate fluid in the center of
      their retina.

      Previous studies using an oral form of treatment has been successful in decreasing this fluid
      which improves vision.

      This study will test the use of a topically applied form of this treatment to the eye to
      reduce the amount of fluid and improve or preserve vision.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Presence of cystic macular fluid on OCT testing

        Exclusion Criteria:

          -  Allergic reaction to sulpha containing compounds

          -  Intolerance to dorzolamide (Trusopt)
Comparative Study of Superficial Cervical Plexus Block and Nerve of Arnold Block and Incidence of PONV for Inner Ear Surgery
Condition: Anesthesia, Pediatrics, Surgery
MeSH terms: Postoperative Nausea and Vomiting
Intervention: regional nerve block; Antiemetic
Intervention description: regional nerve block; Antiemetic
Intervention MeSH terms: Dexamethasone; Ondansetron; Antiemetics; Bupivacaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 37.0
Sex: All
Minimum age: 1 Year
Maximum age: 18 Years
Healthy volunteers: No
Keywords: post operative nausea vomiting; Inner ear surgery

Summary:

      The investigators would like to compare the therapeutic and cost effectiveness of established
      therapies for postoperative nausea and vomiting to regional nerve blocks of the head and neck
      area an intervention known for analgesia but for which the antiemetic effects hasn't been
      entirely explored.

      The rational is based on the knowledge of the anatomical innervation of the inner ear and the
      role of the parasympathetic nervous system in the emetic act. A lot of focus has been given
      on its counterpart the sympathetic nervous system and its role in painful conditions. The
      investigators believe that the nerve blockade of the parasympathetic innervation can have
      some beneficial effect in the post-surgical patient.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient Age 1-18 yo

          -  Scheduled to have cochlear implantation, Tympanomastoidectomy, inner ear surgery

          -  Past history of PONV susceptibility

        Exclusion Criteria:

          -  Patient/ Parents refusal

          -  Infection at the site of local anesthetic injection

          -  Known coagulopathy

          -  Existing VP shunt

          -  Severe mental disability

          -  Any known allergic to dexamethasone (Decadron) and/or ondansetron ( Zofran)
Esophageal Food Impaction
Condition: Esophageal Food Bolus Obstruction
Intervention: Nitrostat 0.4Mg Sublingual Tablet
Intervention description: Up to 3 administrations of 0.4mg sublingual nitroglycerin tablets, dissolved in 10mL tap water, given orally in a single swallow. Each administration is separated by at least 5 minutes, and only if systolic blood pressure > 100 mmHg.
Intervention MeSH terms: Nitroglycerin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is designed to obtain data on the safety and efficacy of oral nitroglycerin
      solution for the treatment of esophageal food impaction in patients presenting to the
      Emergency Department with presumed esophageal food impaction. The main hypothesis is to
      determine the success rate of oral nitroglycerin solution in relieving the food impaction by
      assessing the resolution of symptoms and the ability of the patient to swallow.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Over the age of 18 years

          -  Presentation consistent with esophageal food impaction

          -  Ability to swallow a small volume of liquid.

        Exclusion Criteria:

          -  Intractable vomiting

          -  Hemodynamic instability or SBP <100 mmHg

          -  Concern for or evidence of significant airway compromise

          -  Concern for or evidence of esophageal perforation,

          -  Concern for or evidence of coronary ischemia

          -  Presentation > 12 hours since onset.
Risperidone Treatment in Schizophrenia Patients Who Are Currently Taking Clozapine
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Placebo; Risperdal
Intervention description: Placebo capsule daily for 16 weeks; Risperdal 4 mg per day for 16 weeks
Intervention MeSH terms: Risperidone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will determine whether adding the drug risperidone (Risperdal®) is more effective
      than placebo in treating schizophrenic patients who are taking the drug clozapine.
    

Eligibility criteria:

        Inclusion Criteria:

          -  DSM-IV criteria for schizophrenia or schizoaffective disorder

          -  Current clozapine treatment

          -  Moderate illness severity and inadequate positive symptom response to clozapine
             treatment

          -  6 month period of clozapine treatment with documented clozapine blood level greater
             than or equal to 350 ng/ml or clozapine and norclozapine blood level greater than or
             equal to 450 ng/ml

        Exclusion Criteria:

          -  Organic brain disorder

          -  Mental retardation

          -  Medical condition whose pathology or treatment could alter the presentation or
             treatment of schizophrenia or significantly increase the risk associated with the
             proposed treatment protocol

          -  Pregnancy

          -  DSM-IV criteria for current alcohol or substance dependence within the last 6 months
             or DSM-IV criteria for alcohol or substance abuse within the last month

          -  Previously received adjunctive risperidone (at doses greater than or equal to 8
             mg/day) with their clozapine treatment for greater than or equal to 6 weeks
Effects of a Common Cold Treatment on Cognitive Function
Condition: Common Cold
MeSH terms: Common Cold
Intervention: Paracetamol and Caffeine; Paracetamol
Intervention description: Paracetamol 1000 mg and caffeine 130 mg; Paracetamol 1000 mg
Intervention MeSH terms: Acetaminophen; Caffeine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Enrollment: 72.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Paracetomol; Caffeine; Common cold

Summary:

      A reduction in alertness and lower levels of performance are commonly associated with the
      common cold. Paracetamol has been shown to be more effective than placebo in treating
      symptoms associated with upper respiratory tract infection; caffeine has been shown to
      increase levels of alertness and improve performance of people suffering from colds. This
      study will investigate any improvement in alertness and performance based on cognitive
      function and mood assessment in subjects suffering from the common cold, when taking a novel
      paracetamol and caffeine combination verses paracetamol alone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Present with symptoms of the common cold of no more than 96 hours duration

          -  Score of "2" or more on a self-rating for malaise and at least 4 other cold symptoms

        Exclusion Criteria:

          -  Pregnancy or lactation

          -  Hypersensitivity to drugs

          -  Have taken caffeine in the last 12 hours or treated their cold
Examining Genetic Influence on Response to Beta-Blocker Medications in People With Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Atenolol
Intervention description: 12.5 mg twice daily of atenolol for 1 week; increased to 25 mg twice daily for a total of 8 weeks, if the medication is well tolerated
Intervention MeSH terms: Atenolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Diabetes; Atenolol; Genetic

Summary:

      Beta-blockers are medications used to treat cardiovascular disease (CVD) symptoms, including
      high blood pressure and chest pain. People with diabetes who receive beta-blockers may
      experience adverse health effects, but the exact cause of why this happens remains unknown.
      This study will examine the genetic factors that may influence how atenolol, a beta-blocker
      medication, affects fat breakdown, blood sugar levels, and heart function in people with type
      2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Type 2 diabetes

          -  Pre-Diabetes

        Exclusion Criteria:

          -  Insulin therapy

          -  Treatment with any beta-blocker in the 30 days before study entry

          -  Asthma

          -  Chronic obstructive pulmonary disease (COPD)

          -  Greater than first degree heart block

          -  Heart rate less than 60 bpm

          -  Systolic blood pressure less than 90 mm Hg

          -  Raynaud's phenomenon

          -  Known history of angina, heart attack, heart failure, coronary revascularization, or
             automatic implantable cardioverter defibrillators

          -  Pregnant

          -  Creatinine clearance less than 35 ml/min

          -  Hematologic dysfunction (white blood cell [WBC] count less than 3000 or hematocrit
             less than 28%)

          -  Allergy to amide anesthetics
An Exploratory Study to Assess Multiple Doses of Omalizumab in Patients With Cystic Fibrosis Complicated by Acute Bronchopulmonary Aspergillosis (ABPA)
Condition: Cystic Fibrosis; Allergic Bronchopulmonary Aspergillosis
MeSH terms: Aspergillosis; Pulmonary Aspergillosis; Aspergillosis, Allergic Bronchopulmonary; Cystic Fibrosis; Fibrosis
Intervention: Omalizumab; Placebo; Itraconazole
Intervention description: Omalizumab subcutaneous injections of 600 mg daily.; Placebo subcutaneous injections blinded to match experimental arm dosing regimen.; Itraconazole twice daily with a maximum daily dose of 400 mg.
Intervention MeSH terms: Omalizumab; Itraconazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 14.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Cystic Fibrosis; Allergic Bronchopulmonary Aspergillosis; omalizumab; oral corticosteroid use; anti-immunoglobulin E

Summary:

      This study will evaluate the safety and efficacy of omalizumab for the treatment of Allergic
      Bronchopulmonary Aspergillosis (ABPA) in patients with Cystic Fibrosis aged 12 years and
      older.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Cystic Fibrosis complicated by Allergic Bronchopulmonary Aspergillosis
             (ABPA)

          -  Oral corticosteroid use for ABPA flare

          -  Age 12 years and older (except for Italy; ≥ 18 years)

          -  Total serum IgE levels ≥ 500 IU/mL

        Exclusion Criteria:

          -  History of cancer in the last 10 years.

          -  History of severe allergic reactions

          -  Pregnant and lactating women

          -  Prior use of Xolair

        Other protocol-defined inclusion/exclusion criteria may apply.
Imaging Cardiac Amyloidosis: A Pilot Study Using F-18 Florbetapir Positron Emission Tomography
Condition: Cardiac Amyloidosis
MeSH terms: Amyloidosis
Intervention: F-18 florbetapir PET
Intervention description: Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid)
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Amyloidosis; Cardiac; Heart; Imaging; Diagnosis

Summary:

      The primary aim of this pilot study is to determine whether amyloid deposits in the heart can
      be measured non-invasively by F-18 florbetapir (Trade Name: Amyvid) positron emission
      tomography (PET) in 30 individuals with documented cardiac amyloidosis. We will also enroll
      15 individuals without cardiac amyloidosis to undergo the F-18 florbetapir imaging as a
      control group.

      The primary hypothesis of this study is that a specific amyloid binding radiotracer will bind
      to the myocardial amyloid deposits and help quantify cardiac amyloid burden.

      A secondary aim of this study is to determine reproducibility of F-18 florbetapir imaging of
      the myocardium.
    

Eligibility criteria:

        Inclusion Criteria:

        Inclusion criteria for amyloid subjects:

          -  Age > 18 years

          -  Biopsy proven amyloidosis outside the heart with typical echocardiographic appearance
             of cardiac involvement, or a positive cardiac biopsy.

          -  Diagnosis of AL amyloidosis by standard criteria (evidence of plasma cell dyscrasia
             with appropriate tissue staining for AL) OR

          -  Diagnosis of TTR amyloidosis (no evidence of plasma call dyscrasia and positive TTR
             staining of amyloid in tissue biopsy)

          -  Able and willing to provide informed consent to participate in the study procedures

        Exclusion Criteria:

          -  Pregnancy

          -  Serious non-cardiac medical illness which will preclude research study participation
AbsorbaTack Evaluation of Postoperative Pain Following Laparoscopic Hernia Repair
Condition: Hernia, Inguinal; Hernia, Ventral
MeSH terms: Pain, Postoperative; Hernia; Hernia, Inguinal; Hernia, Ventral
Intervention: AbsorbaTack; ProTack
Intervention description: Comparison of different devices for mesh fixation. This intervention arm has absorbable tacks as the method of hernia mesh fixation. Application is during hernia repair and tacks will essentially absorb within the body after 1 year.; Comparison of different devices for mesh fixation. This intervention is a permanent tack for hernia mesh fixation. Application is during hernia repair and the tacks will remain in the body.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 216.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hernia

Summary:

      The objective of this study is to assess pain that occurs following hernia repair that is
      related to mesh fixation. The study is designed to see if there is any difference in pain
      after surgery between absorbable and permanent methods of mesh fixation in inguinal and
      ventral hernia repair.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ability and willingness to provide written informed consent and comply with the
             schedule of protocol assessments

          -  Age > 18 years

          -  Subjects undergoing laparoscopic hernia repair with Parietex or Parietex Composite
             reinforcements depending on indication and fixation of reinforcements with helical
             tackers (ProTack, Covidien) or absorbable tacks (AbsorbaTack, Covidien) in accordance
             with recommendations for use

        Exclusion Criteria:

          -  Pregnancy

          -  Patients considered to have greater than reasonable surgical risk associated with
             general anesthesia and laparoscopic hernia repair

          -  Known active infection or any major episode of infection requiring hospitalization or
             treatment with IV antibiotics or oral antibiotics within 30 days prior to screening

          -  History of alcohol or drug abuse within 6 months prior to screening

          -  History of chronic pain condition requiring more than 30 days of medical management

          -  Use of an additional nonresorbable means of fixation (inguinal)

          -  Patients considered not able to comply with the protocol and follow up schedule

          -  ASA grade of 4 or above