bioihbjkbjnl/mcl2 huggingface dataset:
Zomig - Treatment of Acute Migraine Headache in Adolescents
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Headache
Intervention: Placebo; Zolmitriptan; Zolmitriptan; Zolmitriptan
Intervention description: Placebo nasal spray; 0.5 mg nasal spray; 2.5 mg nasal spray; 5.0 mg nasal spray
Intervention MeSH terms: Oxazolidinones; Zolmitriptan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1653.0
Sex: All
Minimum age: 12 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Migraine; Headache; Pain; Efficacy; Adolescents

Summary:

      The purpose of this study is to investigate if Zomig® Nasal Spray will help children (age
      12-17 years) with migraine headaches feel better. This will be done by comparing 3 different
      doses of Zomig Nasal Spray with placebo nasal spray (inactive treatment).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Provision of written informed consent by parent or legal guardian, and written assent
             provided by patient prior to any study specific procedures.

          -  Established diagnosis of migraine.

          -  History of a minimum of 2 migraine attacks (moderately or severely disabling)per
             month.

        Exclusion Criteria:

          -  Any medical condition that may put the patient at increased risk with exposure to
             zolmitriptan or that may interfere with the safety or efficacy assessments.

          -  A history of basilar, ophthalmoplegic, or hemiplegic migraine headache or any
             potentially serious neurological condition that is associated with headache.

          -  Have had an unacceptable adverse experience following previous use of any 5HT1B/1D
             agonist drug.
Evaluating the Efficacy and Compatibility of Efinaconazole 10% Solution (Jublia) for the Treatment of Toenail Onychomycosis in Patients Wearing Toenail Polish Compared to Those Without Polish
Condition: Onychomycosis of Toenail
MeSH terms: Onychomycosis
Intervention: Efinaconazole 10% Topical Application Solution [JUBLIA]; Application of Nail Polish
Intervention description: Topical efinaconazole 10% solution (Jublia); Application of Nail Polish
Intervention MeSH terms: Efinaconazole
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: Female
Minimum age: 19 Years
Maximum age: 70 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study will test how well efinaconazole solution (Jublia) works to treat toenail fungal
      infections in patients who wear polish compared to those who do not.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female age 19-70, as 19 is the legal age in Alabama

          -  DLSO affecting at least 1 great toenail diagnosed with positive potassium hydroxide
             microscopy and culture of a dermatophyte

          -  Suitable for application of topical antifungal therapy, in the opinion of the
             investigator

          -  Target toenail thickness of 3 mm or less as measured by digital caliper, as thickness
             greater than 3 mm may allow inclusion of patient with severe onychomycosis, and this
             was the criteria used in the pivotal trial using topical efinaconazole for
             onychomycosis

          -  Women of childbearing potential will be required to use birth control and a negative
             urine pregnancy test must be documented prior to initiating treatment

        Exclusion Criteria:

          -  History of immunosuppression or concurrent use of immunosuppressant drugs

          -  History of uncontrolled diabetes mellitus

          -  History of psoriasis or any other condition that might interfere with the toenail
             evaluation

          -  Three or more dermatophytomas (streaks) on the target nail

          -  Severe DLSO of the target nail

          -  Patients who cannot refrain from wearing gel or plastic based polishes that are used
             in salons and that require curing
Candesartan Effect in Second Stage Arterial Hypertension
Condition: Stage II Hypertension
MeSH terms: Hypertension
Intervention: Candesartan Cilexetil; Hydrochlorothiazide; Candesartan Cilexetil
Intervention description: Candesartan Cilexetil 16 mg oral; Hydrochlorothiazide 12.5 mg; Candesartan Cilexetil 32 mg oral
Intervention MeSH terms: Hydrochlorothiazide; Candesartan; Candesartan cilexetil
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 214.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Candesartan Cilexetil; hydrochlorothiazide; severe hypertension

Summary:

      To compare the changes in mean sitting DBP from baseline after 4 weeks of therapy with either
      candesartan cilexetil/HCT combination therapy or candesartan cilexetil monotherapy regimen
    

Eligibility criteria:

        Inclusion Criteria:

          -  Stage II essential hypertension (SBP≥ 160 or DBP≥100 mmHg), untreated, or treated with
             a maximum of 2 class of antihypertensive drugs

        Exclusion Criteria:

          -  Current serum-creatinine >3 mg/dL, Current serum-potassium >5.5 mmol/L, 16.

          -  Pregnant or lactating women or women of childbearing potential who were not protected
             from pregnancy
Visual Function With Contralateral AcrySof® ReSTOR® Aspheric SN6AD1 and SN6AD3
Condition: Cataract
MeSH terms: Cataract
Intervention: AcrySof ReSTOR Aspheric IOL models SN6AD1 and SN6AD3
Intervention description: Contralateral implantation of AcrySof ReSTOR +3 Intraocular Lens (IOL) in one eye, AcrySof ReSTOR +4 IOL in the other eye following cataract removal.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Cataract IOL ReSTOR Aspheric; Bilateral cataract

Summary:

      The objective of this study is to prospectively evaluate the visual parameters in a series of
      patients after phacoemulsification cataract surgery in a series of patients bilaterally
      implanted with the AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL) Models SN6AD1 And SN6AD3.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Prospective subjects should be 21 years of age and older, be of any race and gender
             and meet study entry criteria. Subject must require extraction of cataracts followed
             by implantation of a posterior chamber intraocular lens (IOL). Subjects must be
             candidates for bilateral removal of the natural crystalline lens followed by
             implantation of a multifocal IOL and be willing and able to complete all follow-up
             visits.

        Exclusion Criteria:

          -  Subjects with pre-existing conditions that could skew the results or are
             contraindications for the AcrySof® ReSTOR® IOL should be excluded from the study.
             Please consult the AcrySof® ReSTOR® Aspheric product inserts under "Precautions" for
             subject groups that should be excluded from this study.

          -  All subjects must have ≤ 0.75 diopters of astigmatism preoperatively as measured by
             Keratometry (K) readings. If the surgeon determines that a correction of cylinder is
             necessary postoperatively, this may be performed after the three month evaluations are
             completed.
Pain With Trigger Finger Injection: A Comparison of Steroid Alone Versus Steroid/Lidocaine Mixture
Condition: Trigger Finger Disorder
MeSH terms: Trigger Finger Disorder
Intervention: Dexamethasone Sodium Phosphate; Xylocaine; Sodium Chloride
Intervention description: adreno-cortical steroid anti-inflammatory drug; a local anesthetic agent; Sodium chloride is a sterile, nonpryogenic solution for fluid and electrolyte replenishment
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Lidocaine; Dexamethasone 21-phosphate; BB 1101
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Maximum age: 90 Years
Healthy volunteers: No
Keywords: flexor tendon entrapment; snapping finger; trigger digits; trigger thumb

Summary:

      This research is being done to compare pain relief and efficacy of trigger finger injection
      using a combination of lidocaine/corticosteroid versus corticosteroid injection alone versus
      corticosteroid/saline combination.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-90

          -  Male or female (non-pregnant)

          -  Clinically diagnosed trigger digit

          -  Subject is able to provide voluntary, written informed consent

          -  Subject, in the opinion of the clinical investigator, is able to understand the
             clinical investigation and is willing to perform all study procedures and follow-up
             visits.

        Exclusion Criteria:

          -  Age <18 or >90

          -  Pregnant or lactating women

          -  Non-English speaking individuals

          -  Medication contradictions to lidocaine, corticosteroids and/or saline

          -  Prior injection or surgery on the affected finger

          -  Diagnosis of reflex symptomatic dystrophy (RSD) or complex regional pain syndrome
             (CRPS)

          -  Open wound
Safety/Efficacy of Tigan® to Control Nausea/Vomiting Experienced During Apokyn® Initiation and Treatment
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease; Nausea; Vomiting
Intervention: Tigan®; Placebo
Intervention description: Oral capsule, 300mg three times daily; Oral capsule, three times daily
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 117.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Parkinson's disease; Anti-emetic; Nausea; Vomiting

Summary:

      The purposes of the study are to determine:

      i. To assess the efficacy of Tigan® (trimethobenzamide) in preventing nausea and vomiting
      when initiating therapy with Apokyn® (apomorphine)

      ii. To determine the optimal duration for continuation of Tigan® following initiation of
      Apokyn® therapy

      iii. To assess the safety of Tigan® in combination with Apokyn®

      iv. To characterize the pharmacokinetic (PK) profile of apomorphine in subjects treated
      concomitantly with and without Tigan®
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects aged 18 years or over

          -  Subjects with advanced Parkinson's disease with disabling hypomobility ("off"
             episodes) who are to be initiated with Apokyn® by intermittent subcutaneous injection

          -  Able to swallow Tigan®/placebo capsules

          -  Subjects willing and able to comply with scheduled visits, treatment plan, laboratory
             tests and other study procedures

          -  Women of child bearing potential must have a negative serum pregnancy test (beta hCG)
             prior to receiving study drug and must be using an appropriate form of contraception

          -  Willing and able to provide informed consent

        Exclusion Criteria:

          -  Hypersensitive to apomorphine hydrochloride or any of the ingredients of Apokyn®
             (notably sodium metabisulfite)

          -  Hypersensitive to trimethobenzamide or any of the ingredients of Tigan®

          -  Previous treatment with Apokyn®

          -  Participation in any other clinical trial within 14 days of the present trial

          -  Contraindications to Apokyn® or Tigan®

          -  Currently taking, or likely to need to take at any time during the course of the
             study, any 5HT3 antagonist (ondansetron, alosetron, granisetron, palonosetron or
             dolasetron)

          -  Malignant melanoma or a history of previously treated malignant melanoma

          -  Pregnancy or breast feeding

          -  Receipt of any investigational (i.e. unapproved) medication within 30 days of starting
             the present trial

          -  Any significant medical disorder, condition, concomitant medication or psychiatric
             disorder according to DSM-IV criteria which would, in the opinion of the investigator,
             represent a hazard to the subject or prevent the subject from completing the trial
Study to Measure Drug Satisfaction of Patients With Schizophrenia After Switching From Risperidone to Paliperidone
Condition: Schizophrenia
MeSH terms: Schizophrenia
Intervention: Oral Risperidone; Paliperidone ER
Intervention description: 4 or 6 mg MG once daily for 0-2 weeks; 6, 9 or 12 MG once daily for 4-6 weeks
Intervention MeSH terms: Risperidone; Paliperidone Palmitate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 201.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: schizophrenia; medication satisfaction, Invega

Summary:

      The purpose of this study is to evaluate medication satisfaction after at least 4 weeks of
      paliperidone ER (extended-release), an antipsychotic, treatment in patients with
      schizophrenia who were previously taking either 4 or 6 mg of risperidone daily by mouth, but
      who are not satisfied with their treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be able to understand, in the opinion of the investigator, the informed consent
             form.

          -  be diagnosed with schizophrenia

          -  report dissatisfaction with current medication

          -  have an aspect of schizophrenia management which could potentially benefit from a
             change in antipsychotic medication

          -  receive risperidone 4 mg or 6 mg for at least 4 weeks before the start of the study.

        Exclusion Criteria:

          -  Unable to swallow study drug whole with the aid of water

          -  cannot have received an investigational drug, used an investigational medical device,
             or participated in a clinical study that altered their medication within 6 months
             before the first administration of study drug, or have participated in more than 2
             investigational drug studies within the past 12 months

          -  no other major mental health diagnosis except for tobacco dependance

          -  no use of cocaine or heroin within 3 months before the first administration

          -  no history of treatment with any antipsychotic in addition to treatment with
             risperidone, or treatment with paliperidone, within 30 days before the baseline visit.
Influence of Mild Hypothermia on Reversal of Rocuronium With Sugammadex
Condition: Underdosing of Other General Anesthetics
MeSH terms: Hypothermia
Intervention: sugammadex
Intervention description: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state
Reversal effect of sugammadex in temperature state
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: 20 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The primary efficacy endpoint is the time from the start of administration of sugammadex to
      recovery of the TOF ratio to 0.9 in deep neuromuscular block (1-2 twitches post-tetanic
      count) induced by rocuronium during mild hypothermia with core temperatures between 34.5°C
      and 35°C, and compared with the normal thermal condition.

      Secondary endpoints include time from the start of administration of sugammadex to recovery
      of the TOF ratio to 0.7 or 0.8 in both groups, vital signs [heart rate and blood pressure] at
      pre-reversal, post-reversal, recovery and post-anesthetic visit, the incidence of residual
      neuromuscular blockade, post-operative nausea and vomiting (PONV) and adverse events during
      mild hypothermia and the normal thermal condition.

      We hypothesize that mild hypothermia with core temperatures between 34.5°C and 35°C diminish
      the efficacy of sugammadex.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient for elective abdominal surgery from 20 years (yrs) to 65 yrs Patient in
             American Society of Anesthesiologists criteria 1 or 2 Patient in the supine position
             with arm available for neuromuscular monitoring during operation

        Exclusion Criteria:

          -  Patients expected to have a difficult airway, known neuromuscular disease, significant
             hepatic or renal dysfunction, family history of malignant hyperthermia, known allergy
             to one of the drugs used in this protocol, intake of any medication that might
             interact with muscle relaxants, pregnant, or breast feeding
Methylphenidate for the Treatment of Gait Impairment in Parkinson's Disease
Condition: Parkinson's Disease; Gait Impairment
MeSH terms: Parkinson Disease
Intervention: Methylphenidate (MPD); Placebo
Intervention description: Participants will be given 1 mg/kg of MPD divided in three doses (at 8 am, 12 noon, and 4 pm). A four-week titration period will be used, using 0.25-mg/kg increments per week until achieving the weight-adjusted target dosage, which may range from five to eight 10-mg tablets per day. The maximum daily dose will be 80 mg/day.; Participants will be given placebo instead of active MPD.
Intervention MeSH terms: Methylphenidate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 23.0
Sex: All
Minimum age: 35 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: freezing; gait; festination; shuffling; balance

Summary:

      The purpose of this research study is to examine whether Methylphenidate (MPD) can result in
      improvement of gait (walking) in a population of Parkinson's Disease (PD) patients whose main
      disability is freezing of gait. MPD (Ritalin®) is a drug which can excite or stimulate
      certain systems of the body that control motor function. This drug is FDA approved for the
      treatment of attention hyperactivity disorder, a condition unrelated to PD.

      The researchers hypothesize that daily treatment with a tolerable daily oral dose of MPD will
      improve gait velocity, stride length, cadence, and decrease freezing of gait, 3 months from
      treatment initiation in patients with moderately advanced PD, whose gait impairment is an
      important source of disability despite optimized antiparkinsonian treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with a definite diagnosis of Parkinson's disease for at least 5 years.

          -  Patients with mild to severe gait disturbance.

          -  Patients on a stable dose of anti-parkinsonian medications that will not be expected
             to require medication adjustments.

          -  Mini-Mental State Examination (MMSE) score of 25 or greater.

        Exclusion Criteria:

          -  Patients with musculoskeletal disorders such as severe arthritis, post knee surgery,
             hip surgery, or any other condition that the investigators determine may impair
             assessment of gait.

          -  Previous treatment with DBS (deep brain stimulation).

          -  Those with history of stroke.

          -  Those with cerebellar, vestibular, or sensory ataxia.

          -  Concurrent use of, or within two weeks from discontinuing, MAO inhibitor drugs
             (selegiline, rasagiline).

          -  Women of childbearing potential.
Ezetimibe Plus (+) Simvastatin Versus Atorvastatin Comparative Study (0653A-092)(COMPLETED)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: ezetimibe (+) simvastatin; atorvastatin
Intervention description: simvastatin/ezetimibe 10/20 mg; atorvastatin 10 mg
Intervention MeSH terms: Atorvastatin; Simvastatin; Ezetimibe
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 203.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is an efficacy and safety study of Vytorin (ezetimibe (+) simvastatin) compared to
      atorvastatin (ezetimibe/simvastatin) at week 6 in primary hypercholesterolemia patients in
      Korea. The primary hypothesis being tested is that daily administration of Vytorin will
      result in a greater reduction of low density lipoprotein cholesterol (LDL-C) concentration
      from baseline after 6 weeks treatment compared to atorvastatin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of hypercholesterolemia

          -  LDL-C >/= 130 mg/dL but </=250 mg/dL and triglyceride (TG) </= 350 mg/dL

          -  National Cholesterol Education Program (NCEP) Adult Treatment Panel (ATP) III
             guideline

        Exclusion Criteria:

          -  Hypersensitivity to 3-hydroxy-3-methyl-glutaryl-CoA reductase (HMG-CoA reductase)
             inhibitors or Ezetimibe