bioihbjkbjnl/mcl2 huggingface dataset:
A Pilot Study to Determine the Most Effective Dose of Arformoterol for Treating Acute Asthmatic Patients
Condition: Acute Asthma
MeSH terms: Asthma
Intervention: arformoterol (RR formoterol); placebo; levalbuterol
Intervention description: Group 1 will receive nebulized arformoterol 15 ug every 20 minutes for 3 doses.
Group 2 will receive nebulized arformoterol 15 ug first dose and then placebo every 20 minutes for 2 doses.; Group 2 will receive nebulized arformoterol 15 ug first dose and then placebo every 20 minutes for 2 doses.; Group 3 will receive nebulized levalbuterol 1.25 mg every 20 minutes for 3 doses.
Intervention MeSH terms: Albuterol; Formoterol Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 2.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Acute asthma; Arformoterol; Long acting beta agonists

Summary:

      The purpose of this study is to determine the best dose of nebulized arformoterol, a quick
      onset but long acting beta agonist, for use in treating acute bronchospasm in asthmatics
      presenting to the the Emergency Department. Also this study will evaluate the side effect and
      safety profile of arformoterol when used in this situation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent

          -  FEV1 between 20 and 60% predicted after having received 5 mg of albuterol and 0.5 mg
             of atrovent as nebulized standard of care therapy

          -  Male or female between the ages of 18 and 45

          -  Asthma diagnosed by a physician and present for at least 6 months

          -  oxygen saturation greater or equal to 90% on room air

          -  Non smoker or < 10 pack-year history

          -  No other cause for wheezing/sob as determined by the treating physician

        Exclusion Criteria:

          -  Clinical evidence or history of hepatic, renal, cardiovascular, GI, endocrine,
             metabolic or CNS disease which might interfere with the conduct of the study

          -  Acute respiratory failure or other significant pathology of the pulmonary system

          -  Female subjects who are pregnant or lactating

          -  Currently receiving therapy for a psychiatric disorder

          -  Subjects with a known sensitivity to formoterol (racemic or RR) or albuterol (racemic
             or lev)

          -  History of hospitalization for asthma within 2 months or treatment for acute asthma in
             an ED within 2 weeks of study entry

          -  Past or current use of disallowed medications

          -  Participation in an investigational study within 30 days
Lidocaine Injection and Ischemic Compression on Chronic Pelvic Pain Treatment
Condition: Pelvic Pain
MeSH terms: Myofascial Pain Syndromes; Pelvic Pain
Intervention: lidocaine; Ischemic compression
Intervention description: Women randomized for this treatment was submitted to 2mL of lidocaine 0,5% without vasoconstrictor, directly and perpendicularly on trigger point. Patients received lidocaine injections once a week for 4 weeks; Women randomized for treatment with ischemic compression will be first subjected to transcutaneal electrostimulation(TENS) for 30 minutes on trigger point to inhibit the painful stimulation. For this will be used 100 Hertz of frequency and pulse of 250ms. The intensity will be varying according the painful threshold of each patient. After, the ischemic compression will be applied. For this we will use an algometer to get maximum of homogeneity on therapy. The pressure intensity will be placed by the average between the values gotten during three previously measurements of threshold pain in each patient. The therapy will be applied in trigger point three times (60 seconds each) with 30 seconds of rest between the applications.
Intervention MeSH terms: Lidocaine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Enrollment: 30.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: lidocaine; ischemic compression; chronic pelvic pain; myofascial pain syndrome

Summary:

      Our hypothesis is that with comparison of effectiveness of two most common techniques of
      treatment for myofascial pain syndrome (injection of local anesthesia and ischemic
      compression) we could choice the most adequate to treat this disease. This way we could
      decrease the expenses with medicines, examinations, consultations and the time that women
      remains without a diagnosis and treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Women with chronic diagnosis of pelvic pain;

          2. Women in menacme;

          3. Presence of the diagnostic criteria for abdominal myofascial syndrome;

          4. Agreement with the Term of Free and Clarified Assent.

        Exclusion Criteria:

          1. Endometriosis, interstitial cystitis, syndrome of the irritable intestine or another
             illness that it justifies or it contributes for chronic pelvic pain;

          2. Endometrioma or hernia evidenced to the ultrasound of the abdominal wall.
Lopinavir/Ritonavir (Kaletra) PK in Children
Condition: HIV/AIDS Treatment; HIV Infections
MeSH terms: HIV Infections; Acquired Immunodeficiency Syndrome
Intervention: lopinavir/ritonavir (Kaletra®) tablets
Intervention description: The subject will bring their own prescription of lopinavir/ritonavir. The patient will take a witnessed dose of lopinavir/ritonavir with an 6 ounce glass of cool water (if taken whole) or mixed in 4 ounces of Jell-O brand pudding (if crushed).
Intervention MeSH terms: Ritonavir; Lopinavir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 12.0
Sex: Female
Minimum age: 6 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: HIV/AIDS; pediatrics; resource-limited settings; lopinavir; ritonavir; Kaletra®; antiretroviral treatment; crushed tablets; treatment experienced

Summary:

      The objective of this study is to compare the pharmacokinetics of lopinavir tablets
      administered to pediatric patients as either whole or crushed tablets. The study is a
      randomized,open-label, crossover study of pediatric subjects already taking
      lopinavir/ritonavir tablets as part of their clinical care. THe investigators hypothesize
      that lopinavir exposure in pediatric patients will be lower after taking a dose of the tablet
      formulation, crushed and mixed with pudding or yogurt, as compared to the exposure after
      taking a dose with tablets swallowed whole.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented HIV infection

          -  Taking lopinavir/ritonavir (Kaletra) tablets at standard pediatric doses for greater
             than two weeks

          -  Concomitant medications and/or natural products, including potentially interacting
             products, have been stable for greater than two weeks and are not expected to change
             over the course of the study

          -  Ability to understand study procedures and assent to participate

          -  Parental or guardian consent

          -  Aged 6 - 17 years

        Exclusion Criteria:

          -  Acute serious medical illness or infection (in the judgment of the
             investigator)requiring treatment and/or hospitalization within 14 days prior to study
             entry

          -  Pregnancy

          -  Concomitant medications/natural products that have been started within past two weeks
             and/or that will be changed over the course of the study.
Effect of SIMBRINZA® Suspension as an Added Therapy to a Prostaglandin Analogue
Condition: Ocular Hypertension; Open Angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension
Intervention: Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension; Vehicle; Prostaglandin analogue
Intervention description: Inactive ingredients used as a placebo comparator
Intervention MeSH terms: Brimonidine Tartrate; Travoprost; Brinzolamide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 282.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: glaucoma; prostaglandin analogue; brinzolamide; brimonidine

Summary:

      The purpose of this study is to demonstrate the additive effect of brinzolamide
      1%/brimonidine 0.2% (SIMBRINZA® suspension) in subjects with either open angle glaucoma or
      ocular hypertension who are currently on a prostaglandin analogue (PGA) monotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of open angle glaucoma (including open-angle glaucoma with pseudoexfoliation
             or pigment dispersion) or ocular hypertension;

          -  Mean intraocular pressure (IOP) measurements in at least 1 eye (study eye) of ≥ 21
             mmHg and <32 mmHg at 2 consecutive visits (Eligibility 1 and Eligibility 2);

          -  Previously prescribed TRAVATAN Z® 0.004%, XALATAN® 0.005%, or LUMIGAN® 0.01%
             monotherapy for at least 28 days prior to the Screening Visit;

          -  Able to understand and sign Informed Consent Document;

          -  Other protocol-defined inclusion criteria may apply.

        Exclusion Criteria:

          -  Women of childbearing potential who are pregnant, breastfeeding, or do not agree to
             use an adequate birth control method throughout the study;

          -  Any form of glaucoma other than open angle glaucoma or ocular hypertension;

          -  Severe central visual field loss;

          -  Chronic, recurrent, or severe inflammatory eye disease;

          -  Ocular trauma within the past 6 months;

          -  Ocular infection or ocular inflammation within the past 3 months;

          -  Best-corrected visual acuity score worse than approximately 20/80 Snellen;

          -  Eye surgery within the past 6 months;

          -  Any condition, including severe illness, which would make the subject unsuitable for
             the study in the opinion of the Investigator;

          -  Use of any additional topical or systemic ocular hypertensive medication during the
             study;

          -  Patients who, in the opinion of the Investigator, cannot discontinue all IOP-lowering
             ocular medication(s) per the appropriate washout schedule prior to Eligibility 1
             Visit;

          -  Other protocol-defined exclusion criteria may apply.
A Study of Herceptin (Trastuzumab) in Combination With a Taxane in Participants With HER2-Positive Breast Cancer Who Relapsed After (Neo)Adjuvant Herceptin Treatment
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Docetaxel; Paclitaxel; Trastuzumab
Intervention description: 100 mg/m2 iv every 3 weeks, 6 cycles (18 weeks); 90 mg/kg iv (+/-10%) every 3 weeks for 6 3-week cycles (18 weeks); 4 mg/kg iv loading dose on Day 1, 2 mg/kg iv on Day 8 and weekly thereafter
Intervention MeSH terms: Paclitaxel; Docetaxel; Trastuzumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This single arm, open-label study will evaluate the efficacy and safety of Herceptin
      (trastuzumab) in combination with a taxane as first line therapy in participants with
      HER2-positive breast cancer who relapsed after neoadjuvant or adjuvant Herceptin treatment.
      Participants will receive Herceptin (loading dose of 4 mg/kg intravenously [iv], 2 mg/kg iv
      weekly thereafter) with 6 3-week cycles of either docetaxel (100 mg/m2 iv every 3 weeks) or
      paclitaxel (90 mg/m2 every week). Herceptin treatment will be continued until disease
      progression or unacceptable toxicity occurs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female participants , >/= 18 years of age

          -  Locally recurrent/metastatic breast cancer (relapse in supra- or infraclavicular lymph
             nodes is regarded as metastatic disease)

          -  HER2-positive primary disease

          -  Participants must have received Herceptin in the adjuvant and/or neoadjuvant setting

          -  Relapsed breast cancer >/= 6 months after discontinuing last drugs of Herceptin and/or
             chemotherapy in the adjuvant and/or neoadjuvant setting for HER2-positive breast
             cancer

          -  Measurable disease according to RECIST 1.0

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Maximum cumulative dose of doxorubicin </= 360 mg/m2 or of epirubicin </= 720 mg/m2 or
             no prior anthracyclines

          -  At least 3 weeks after prior surgery or radiotherapy

        Exclusion Criteria:

          -  Pregnant or breastfeeding women

          -  Previous chemotherapy for metastatic breast cancer (prior endocrine therapy till
             progressive disease is allowed)

          -  Pleural effusions, ascites or bone lesions as only manifestation of disease

          -  Brain metastases

          -  Invasive malignancy other than metastatic breast cancer

          -  Inadequate bone marrow, hepatic or renal function

          -  Prior treatment with anti-HER therapies other than (neo)adjuvant Herceptin
Dose Response Effects of Quillivant XR in Children With ADHD and Autism: A Pilot Study
Condition: ADHD; Autism
MeSH terms: Autistic Disorder
Intervention: Very Low Dose Quillivant XR; Low Dose Quillivant XR; Moderate Dose Quillivant XR
Intervention description: Oral suspension dose once a day increasing to a 10mg dose; Oral suspension dose once a day increasing to a 20mg dose; Oral suspension dose once a day increasing to a 40mg dose
Intervention MeSH terms: Methylphenidate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 36.0
Sex: All
Minimum age: 5 Years
Maximum age: 16 Years
Healthy volunteers: No
Keywords: Quillivant

Summary:

      The purpose of this study is to determine whether Quillivant XR is effective in the treatment
      of ADHD in children with Autism Spectrum Disorder (ASD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  A clinical diagnosis of Autistic disorder or Asperger's disorder by DSM-IV or Autism
             Spectrum Disorder by DSM-V.

          -  A DSM-V diagnosis of ADHD based upon the K-SADS-P.

          -  Clinical Global Impressions - Severity for ADHD (CGI-S-ADHD) rating > 4.

          -  Findings on physical exam, labs and ECG are judged to be normal for age with pulse and
             blood pressure within 95% of age and gender mean.

          -  Informed consent by a parent or legal guardian, and assent for children with
             developmental age 7 years or older.

          -  At least one parent fluent in English

        Exclusion Criteria:

          -  History of Seizure disorder (Febrile seizures are non-exclusionary).

          -  History of Intellectual Disability (IQ< 70)

          -  Treatment with MAO Inhibitor (or within 14 days following discontinuation of MAO
             Inhibitor).

          -  Other psychotropic medication other than stable dose of Selective Serotonin Reuptake
             Inhibitors, which is permitted)

          -  Known to be hypersensitive to methylphenidate, or other components of Quillivant XR

          -  Cardiac or other medical contraindications for stimulant trial (e.g., family history
             of heart attack at age younger than 40 years, personal history of heart disease,
             history of fainting while exercising, structural cardiac abnormalities,
             cardiomyopathy, serious cardiac arrhythmias, coronary artery disease, or other serious
             cardiac problems. If any doubt, children will be referred to a cardiologist for a
             cardiac clearance.

          -  Raynaud's disease

          -  Pregnancy or Breast-feeding.
Visual Outcome in Patients With Symptomatic Macular Polypoidal Choroidal Vasculopathy (PCV) Treated With Either Ranibizumab as Monotherapy or Combined With Verteporfin Photodynamic Therapy (vPDT)
Condition: Age-related Macular Degeneration; Polypoidal Choroidal Vasculopathy
MeSH terms: Macular Degeneration; Polypoidal Choroidal Vasculopathy; Vascular Diseases
Intervention: Ranibizumab; Verteporfin PDT; Sham PDT
Intervention description: Intravitreal injection of 0.5 mg ranibizumab; Infusion of 30 ml verteporfin in 5% dextrose solution followed by 83 sec of laser light (50J/cm2; 600mW/cm2; 689 nm); Infusion of 30 ml 5% dextrose solution followed by 83 sec of laser light (50J/cm2; 600mW/cm2; 689 nm)
Intervention MeSH terms: Ranibizumab; Verteporfin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 321.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Polypoidal choroidal vasculopathy; Visual acuity; Ranibizumab; Verteporfin PDT

Summary:

      This study compared the effect of ranibizumab administered as monotherapy versus ranibizumab
      administered in combination with verteporfin photodynamic therapy (PDT) on visual acuity in
      patients with symptomatic macular polypoidal choroidal vasculopathy (PCV). The results of
      this study provided long-term safety and efficacy data used to generate further guidance on
      the management of patients with PCV.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of symptomatic macular PCV in the study eye

          -  A qualifying vision score at study entry

          -  A qualifying lesion size in the study eye at study entry

        Exclusion Criteria:

          -  Active inflammation or infection in the study eye

          -  Uncontrolled intraocular pressure in the stuy eye

          -  Ocular condition in the study eye which may impact vision and confound study outcomes

          -  Prior treatment of the study eye with anti-VEGF therapy, verteporfin PDT, other laser
             and surgical interventions, intraocular corticosteroids
Use of Protamine for Heparin Reversal After Catheter Ablation of Atrial Fibrillation
Condition: Atrial Fibrillation; Catheter Ablation
MeSH terms: Atrial Fibrillation
Intervention: Protamine Sulfate
Intervention description: Protamine sulfate is a highly basic protein that forms stable compounds with acidic heparin to rapidly neutralize the anticoagulation effects.
Intervention MeSH terms: Protamines
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 153.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: atrial fibrillation; catheter ablation; protamine sulfate; anticoagulation reversal

Summary:

      The objective of this study is to evaluate the safety, efficacy and efficiency of rapid
      anticoagulation reversal with protamine sulfate versus routine activated clotting time (ACT)
      monitoring in patients undergoing catheter based ablation of atrial fibrillation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient's referred for radiofrequency ablation (RFA) or cryoablation for atrial
             fibrillation or atrial flutter (left atrial).

          -  Age ≥ 18 year

          -  Patients who are mentally and linguistically able to understand the aim of the trial,
             comply with the trial protocol, verbally acknowledge the risks, benefits, and
             alternatives in this trial.

        Exclusion Criteria:

          -  Previous intolerance or allergy to heparin products.

          -  Current or prior administration of protamine products

          -  History of femoral access site complications including hematoma, AV fistula,
             pseudoaneurysm, aneurysm.

          -  Known lower extremity venous thrombosis.

          -  Coagulopathy or blood dyscrasias.

          -  Active malignancy.

          -  Thrombocytosis (platelet count >600k/ul) or thrombocytopenia (platelet count <100k/ul)

          -  Planned use of vascular closure device
Study Of Celecoxib In Healthy Subjects
Condition: Healthy Volunteers
Intervention: Celecoxib; Loxoprofen; Placebo
Intervention description: Celecoxib 100mg tablet twice a day with meal for 2 weeks; Loxoprofen 60mg tablet three times a day with meal for 2 weeks; Placebo tablet three times a day with meal for 2 weeks
Intervention MeSH terms: Celecoxib; Loxoprofen
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 190.0
Sex: All
Minimum age: 40 Years
Maximum age: 74 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Endoscopy

Summary:

      A study to confirm the superiority of celecoxib 100 mg BID to loxoprofen 60 mg TID in the
      incidence of gastroduodenal endoscopic ulcers after 2 weeks treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy Volunteers

        Exclusion Criteria:

          -  Endoscopic evidence of ulceration, erosion or active bleeding etc. in the esophagus,
             stomach, pylorus and/or duodenum prior to treatment endoscopy

          -  A history of gastrointestinal ulcer

          -  Any use of celecoxib, nonsteroidal anti-inflammatory drugs (including aspirin),
             anti-ulcer medication, antacids, systemic steroids or antibiotics within four weeks
             prior to the first dose of study medication