bioihbjkbjnl/mcl2 huggingface dataset:
IV Dexketoprofen vs Placebo in Migranie Attack
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Dexketoprofen; Normal Saline
Intervention description: 50 mg intravenous arveles in 50 ml saline in 5 minutes; 50 ml normal saline
Intervention MeSH terms: Dexketoprofen trometamol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 224.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: migraine, emergency department, dexketoprofen, placebo

Summary:

      H0 hypothesis: IV dexketoprofen is equivalent to placebo in ceasing migraine attack in
      emergency department.

      H1 hypothesis: IV dexketoprofen is not equivalent (superior) to placebo in ceasing migraine
      attack in emergency department.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients presented with headache who diagnosed as migraine attack according to the
             international headache society

        Exclusion Criteria:

          -  denied to give inform concent, illiterate patients, chronic renal failure, taking
             NSAIDs during the last six hours, pregnancy
A Study of Herceptin (Trastuzumab) in Combination With Standard Chemotherapy in Patients With HER Positive Metastatic Gastric Cancer
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Intervention: trastuzumab [Herceptin]
Intervention description: Loading dose of 8 mg/kg on day 1, followed by 6 mg/kg intravenous infusion every 3 weeks until disease progression in combination with standard chemotherapy
Intervention MeSH terms: Trastuzumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, multi-center study will evaluate the efficacy and safety of Herceptin
      (trastuzumab) in combination with standard chemotherapy as first-line treatment in patients
      with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction.
      Patients will receive standard chemotherapy for a maximum of 6 cycles, and 8 mg/kg Herceptin
      as loading dose on day 1, followed by 6 mg/kg intravenous infusion every 3 weeks until
      disease progression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >/=18 years of age

          -  Histologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction
             with advanced or metastatic disease, not amenable to curative therapy

          -  Measurable disease, according to the Response Evaluation Criteria in Solid Tumors
             (RECIST)

          -  HER2 positive tumor (primary tumor or metastasis

          -  ECOG Performance status 0, 1 or 2

          -  Life expectancy of at least 3 months

        Exclusion Criteria:

          -  Previous chemotherapy for advanced or metastatic disease less than 6 month before
             study start

          -  Lack of physical integrity of the upper gastrointestinal tract or malabsorption
             syndrome (patients with partial or total gastrectomy are allowed to participate in the
             study)

          -  Patients with active (significant or uncontrolled) gastrointestinal bleeding

          -  Residual relevant toxicity resulting from previous chemotherapy

          -  Other malignancy within the last 5 years (except carcinoma in situ of the cervix, or
             basal cell carcinoma)
ASCERTAIN: Assessment of Everolimus in Addition to Calcineurin Inhibitor Reduction in the Maintenance of Renal Transplant Recipients
Condition: Renal Transplantation
Intervention: Everolimus (RAD001); Calcineurin Inhibitors (CNI); Mycophenolate acid (MPA)/Azathioprine (AZA); Steroids
Intervention MeSH terms: Everolimus; Azathioprine; Calcineurin Inhibitors
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 394.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Renal transplantation, everolimus, calcineurin inhibitors, GFR

Summary:

      The study is designed to evaluate whether the initiation of everolimus together with the
      reduction or discontinuation of calcineurin inhibitors (CNIs) will improve graft function in
      the maintenance of renal transplant recipients with renal impairment by reducing the
      progression of chronic allograft nephropathy. The development of atherosclerosis in the
      native arteries of the patients will also be explored.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patient at least 18 years of age.

          -  Patient who has undergone a primary or secondary renal transplant 12-96 months ago
             from a living related or unrelated donor or a cadaveric donor.

          -  Patient receiving cyclosporine microemulsion with a C2-h level ≥ 400 ng/mL or
             tacrolimus with a C0-h level ≥ 4 ng/mL with or without mycophenolic acid or
             azathioprine plus or minus steroids.

          -  The immunosuppressive regimen must remain unchanged within the last 3 months.

          -  Patient with renal impairment defined as GFR between 30 and 70 mL/min/1.73 m^2 by
             Cockcroft-Gault formula.

        Exclusion Criteria:

          -  Patient who is recipient of multiple organ transplants.

          -  Patient with protein/creatinine ratio ≥ 150 (mg/mmol).

          -  Patient with a treated acute rejection episode within the last 3 months.

          -  Patient with any past or present BK-polyomavirus nephropathy.

          -  Patient with de novo or recurrent glomerular nephritis.

        Other protocol defined inclusion/exclusion criteria may apply.
Botox Cosmetic and the Young Patient With Glabellar Furrows
Condition: Glabellar Furrows
Intervention: Botox
Intervention description: Botox Cosmetic will be delivered in standard doses of 4 units per injection site over a total of 5 sites, thus treating the procerus and corrugator superciliaris muscle groups
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: Female
Minimum age: 30 Years
Maximum age: 50 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Glabellar lines of moderate severity at maximum frown

Summary:

      The purpose of this study is to see if consistent treatment with Botox will lead to longer
      lasting effects. Botox is an injectable liquid that is approved by the U.S. Food and Drug
      Administration to reduce wrinkles on the forehead in the area between the eyebrows. In this
      study a different dosing schedule of Botox injections will be used to see if the effects of
      the Botox treatment last longer than the effects of the standard injection regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female

          -  Fitzpatrick Skin Types I-III

          -  Between 30 and 50 years of age

          -  At least moderate severity at maximum frown

        Exclusion Criteria:

          -  Prior botulinum toxin treatment

          -  Any disorder (such as myasthenia gravis, Eaton-Lambert syndrome) or agent (such as
             aminoglycoside antibiotics) that might interfere with neuromuscular function

          -  Any other condition or situation that might put the subject at significant risk,
             confound the study results (such as significant pre-existing brow or eyelid ptosis)

          -  Allergy or sensitivity to any study component

          -  Participation in another clinical study within 30 days of the study start date

          -  Are planning other facial cosmetic procedures during the study period, or are
             pregnant, breastfeeding, or planning a pregnancy during the study.
Efficacy of Formoterol vs Ipatropioum Bromide Plus Fenoterol in Children (5-<12 Years) With Acute Bronchial Obstruction
Condition: Acute Bronchial Obstruction, Asthma
MeSH terms: Asthma
Intervention: Formoterol fumerate; fenoterol/ipratropium bromide
Intervention description: 12 micrograms stat (twice if necessary). Inhaled via aerolizer; 0.5 micrograms/0.25 milligrams (20 drops) inhaled via nebulization diluted in 3cc of 0.9% saline.
Intervention MeSH terms: Bromides; Fenoterol; Formoterol Fumarate; Ipratropium
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 5 Years
Maximum age: 12 Years
Healthy volunteers: No
Keywords: Asthma, Formoterol, Bronchial Obstruction, Children

Summary:

      To determine efficacy and tolerability of inhaled Formoterol vs nebulized Ipatropioum Bromide
      plus Fenoterol in cumulative sequential doses in asthmatic children (5-<12 years) with acute
      bronchial obstruction attending emergency services
    

Eligibility criteria:

        Inclusion Criteria:

          -  Asthmatic children 5-<12 years old, requiring emergency services for acute bronchial
             obstruction mild to moderate determined by functional and clinical evidence

        Exclusion Criteria:

          -  Patients with severe acute bronchial obstruction determined by functional and clinical
             evidence

          -  Patients unable to use the inhaling device at time of treatment

          -  Patients who received a bronchodilator drug within the last 12 hours

          -  Patients who received inhaled steroids within the last 72 hours

          -  Patients who received systemic steroids within the last 7 days

          -  Patients with near fatal asthma history

          -  Patients with fever (>38.5°C axillar temp)

          -  Patients with any clinical significance condition

        Other protocol-defined inclusion/exclusion criteria may apply
VAccination to Improve Clinical outComes in Heart Failure Trial: a Feasibility Study (VACC-HeFT)
Condition: Chronic Heart Failure
MeSH terms: Heart Failure
Intervention: Influenza vaccine
Intervention description: Influenza vaccine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 48.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      A multi-center, prospective, randomized, open-label blinded-endpoint trial in patients with
      heart failure will be conducted; 20 will be assigned to the standard dose vaccine dose and 20
      patients to high dose influenza vaccine. Post-vaccine antibody measurements will be assessed,
      as well as tolerability differences between groups.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adults > 18 years old

          2. Able to give informed consent

          3. Systolic or diastolic dysfunction

          4. Previously or currently symptomatic heart failure

          5. Stable on current heart failure drug therapy regimen for > 30 days and no change in
             heart failure drug therapy regimen on day of enrollment

          6. Hospitalization (for any reason) in last 12 months

          7. Received influenza vaccination the prior season

        Exclusion Criteria:

          1. History of allergic reaction or adverse event to influenza vaccine

          2. Documented severe allergy to egg products

          3. Unwilling or unable to give consent

          4. Moderate to severe acute febrile illness at baseline

          5. Immunologic conditions that may affect immune responses per clinical judgment of the
             investigators

          6. Use of immunosuppressants or immunomodulating therapies within 3 months of the study,
             including prednisone, cyclosporine, tacrolimus, methotrexate, azathioprine,
             mycophenolate mofetil, cyclophosphamide, and injectable interferons

          7. Participation in a clinical trial within 30 days

          8. Absence for more than 7 consecutive days during the surveillance period
Sleep Efficiency Assessed by Polysomnography (PSG Sleep Lab Testing) in Advanced Parkinson's Disease
Condition: Advanced Idiopathic Parkinson's Disease
MeSH terms: Parkinson Disease
Intervention: Placebo; Rotigotine
Intervention description: Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.
Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day.; Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.
Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day.
Intervention MeSH terms: Rotigotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rotigotine; Neupro; Polysomnography; Sleep efficiency; Advanced Idiopathic Parkinson's Disease; Sleep Disorder

Summary:

      This is a phase 4 study to evaluate with Polysomnography (PSG) and subjective measures the
      effect of Rotigotine on sleep efficiency, maintenance, insomnia, nocturnal akinesia and
      night-time movement in bed, in patients with advanced Parkinson's disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Advanced Parkinson's disease (ie, takes Levodopa (L-DOPA))

          -  Hoehn and Yahr stage score of 2 to 4

          -  Subject has sleep-maintenance insomnia

        Exclusion Criteria:

          -  Significant skin disease that would make transdermal drug use inappropriate

          -  Subject received therapy with controlled-release Levodopa (L-DOPA), entacapone or
             Stalevo® within 28 days prior to the Baseline Visit or has received therapy with
             Tolcapone

          -  Atypical Parkinsonian syndromes

          -  Previous diagnosis of Narcolepsy, Sleep Apnoea Syndrome, significant Rapid Eye
             Movement (REM) Sleep Behavior Disorder (RBD), moderate to severe Restless Legs
             Syndrome (RLS) or Periodic Limb Movement Disorder
Nicotine as an Adjuvant Analgesic for Third Molar Surgery
Condition: Dental Crowding
Intervention: Nicotine; Placebo
Intervention description: Nicotine nasal spray 3mg x 1 before surgery; Placebo nasal spray 0mg x 1 before surgery
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Third Molar; Pain

Summary:

      Third molar surgery is complicated by pain and swelling for several days after surgery.
      Non-steroidal antiinflammatory drugs have been useful in combination with opioids for
      treatment. Nicotine has antiinflammatory and pain relieving properties. We will use nicotine
      or placebo as a nasal spray before surgery to determine whether nicotine affects pain or
      inflammation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  over 18

          -  4 molars to be removed

        Exclusion Criteria:

          -  pregnant

          -  lactating

          -  chronic pain

          -  narcotic use

          -  asthma

          -  ex-smokers
NAS Treatment - Opiate Versus Non-Opiate
Condition: Neonatal Abstinence Syndrome
MeSH terms: Neonatal Abstinence Syndrome; Syndrome
Intervention: Morphine; Clonidine
Intervention description: Start at 0.4mg/kg/day (divided every 3-4 hours, given with feeds. Dose may be increased 25% of initial dose until symptoms are stable, up to 1 mg/kg/day.
Once stable for 72 hrs, weaning may begin (decrease 10% of max dose, every other day). When total dose is <0.1mg/kg/day, may discontinue.; Initial dose is 5 mcg/kg/day (divided every 3-4 hrs, given with feeds). Will increase 25% of initial dose every 12-24 hrs until stable, up to 12 mcg/kg/day. Dose is unchanged for 72 hours once stable, then may decrease by 10% every other day. If re-escalation is required, the previous dose may be used with 72 hours for stabilizing.
Intervention MeSH terms: Clonidine; Morphine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 31.0
Sex: All
Minimum age: 1 Day
Maximum age: 7 Days
Healthy volunteers: No
Keywords: Prenatal opiate exposure; neonatal withdrawal; Pharmacologic treatment

Summary:

      The purpose of this study is to compare two different medicines to treat babies with opiate
      withdrawal. The treatment medicines are morphine, which is an opiate, and clonidine, a
      non-opiate. Morphine is a narcotic medicine, with is included in most pain killers. Clonidine
      is another drug, but is different from morphine. It is also used for babies, and even adults
      for withdrawal symptoms. Both drugs are effective, but the purpose of this study is to see if
      one may be better than the other.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Admitted to Neonatal Intensive Care Unit (NICU)- Gestational age (GA) >or= 35 wks

          -  Known prenatal opiate exposure (maternal history, positive opiate screen, positive
             neonatal urine or meconium screen)

          -  Symptomatic with Finnegan Neonatal Abstinence Scores meeting NICU protocol for
             treatment

        Exclusion Criteria:

          -  Seizures

          -  Major congenital malformations

          -  Unlikely to survive

          -  Parents not able to understand English
ACCELERATE Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C (CHC) Infection.
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Copegus; Copegus; peginterferon alfa-2a [Pegasys]; peginterferon alfa-2a [Pegasys]
Intervention description: 400mg po bid for 16 weeks; 400mg po bid for 24 weeks; 180 micrograms sc weekly for 16 weeks; 180 micrograms sc weekly for 24 weeks
Intervention MeSH terms: Peginterferon alfa-2a; Interferon-alpha; Ribavirin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1469.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy and safety of different durations of treatment with
      PEGASYS combined with ribavirin in patients with CHC genotype 2 or 3 infection who have never
      previously received interferon (IFN) therapy. The anticipated time on study treatment is 3-12
      months and the target sample size is 500+ individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  patients >=18 years of age;

          -  CHC infection (genotype 2 or 3);

          -  liver biopsy (in <24 calendar months of first dose), with results consistent with CHC
             infection;

          -  use of 2 forms of contraception during study and 6 months after the study in both men
             and women.

        Exclusion Criteria:

          -  women who are pregnant or breastfeeding;

          -  male partners of women who are pregnant;

          -  conditions associated with decompensated liver disease;

          -  other forms of liver disease, including liver cancer;

          -  human immunodeficiency virus infection;

          -  previous treatment with an IFN, pegylated IFN, ribavirin, viramidine, levovirin, or
             amantadine.
Pilot - Peri-operative Beta Blockade
Condition: Adrenergic Beta-Receptor Blockader; Troponin Levels; Cardiomyopathy, Post-surgical
MeSH terms: Cardiomyopathies
Intervention: metoprolol
Intervention MeSH terms: Metoprolol
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 70.0
Sex: All
Minimum age: 51 Years
Healthy volunteers: No

Summary:

      Perioperative cardiac adverse events [heart injuries caused by general anesthesia and
      surgical procedures] are a significant public health issue, with more than 60,000 deaths per
      annum in patients having surgery for non-heart related issues. There are virtually no
      evidence-based medical strategies for effective prevention of these events. Preoperative drug
      treatment with beta blockade drugs used for high blood pressure, perioperative therapy with
      lipid lowering drugs such as statins, alpha-receptor agonists such as clonidine used for high
      blood pressure, and aspirin have all been investigated as potential mitigating treatments,
      but without positive clinical outcomes and, in some cases, creating more hemodynamic
      instabilities that result in heart injury. In light of this, investigators propose to
      evaluate the safety and efficacy of using increasing doses of beta blockade drugs immediately
      after surgery and to assess the value of high-sensitivity cardiac troponin level testing of
      the blood in predicting those patients who would benefit most from perioperative beta blocker
      therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age >50 years

          -  American Society of Anesthesiologists (ASA) risk status III-IV

          -  Revised Cardiac Risk Index ≥2

          -  β-blocker naïve (not having received β-blocker within 30 days prior to surgery)

          -  Previously diagnosed coronary artery disease (CAD) or at high risk for CAD:

          -  History of peripheral vascular disease, or

          -  Diabetes and currently on oral anti-diabetic drug or insulin therapy, or

          -  Chronic renal failure (eGFR <30 m/min)

          -  Major non-cardiac surgery under general anesthesia

        Exclusion Criteria:

          -  History of stroke

          -  Heart rate <55bpm

          -  Heart failure

          -  Second or third degree AV block without pacemaker

          -  Active asthma or COPD

          -  Anemia [Hb<9g/dL]

          -  Allergy to beta-blockade drugs

          -  Hemodynamic instability

          -  Uncontrolled hemorrhage

          -  Unwilling or unable to give consent for participation