bioihbjkbjnl/mcl2 huggingface dataset:
A Trial to Compare American Heart Association (AHA) and Simple (SIM)Method to Give Adenosine to Treat Supra-ventricular Tachycardia (SVT)
Condition: Supra-ventricular Tachycardia
MeSH terms: Tachycardia; Tachycardia, Ventricular; Tachycardia, Supraventricular
Intervention: Adenosine
Intervention description: A vial of adenosine with 6mg
Intervention MeSH terms: Adenosine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomizes Control trial
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Study to compare non inferiority of giving adenosine with the simplified method vs the AHA
      method
    

Eligibility criteria:

        Inclusion Criteria:

          -  Svt

          -  normal blood pressure

          -  normal mentation

          -  Give consent

        Exclusion Criteria:

          -  recent coffee

          -  Allergy to adenosine

          -  Asthma

          -  cardiac operations
Gabapentin Compared to Standard of Care in Preventing Mucositis in Patients With Stage III-IV Head and Neck Cancer Undergoing Primary or Adjuvant Chemoradiation Therapy
Condition: Malignant Head and Neck Neoplasm; Mucositis; Radiation-Induced Disorder
MeSH terms: Head and Neck Neoplasms; Mucositis
Intervention: Educational Intervention; Gabapentin; Pain Therapy; Quality-of-Life Assessment; Questionnaire Administration; Oxycodone/Acetaminophen; Hydrocodone/Acetaminophen; Fentanyl; Ibuprofen; Magic Mouthwash
Intervention description: Undergo oral care and pain management education session; Given PO; Receive usual oral health care; Ancillary studies; Ancillary studies; Analgesia; Analgesia; Transdermal Analgesia; NSAID Analgesia; Oral Solution to treat mucositis
Intervention MeSH terms: Acetaminophen; Ibuprofen; Acetaminophen, hydrocodone drug combination; Fentanyl; Oxycodone; Hydrocodone; Gabapentin
Phase: Phase 3
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 79.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      This randomized phase III trial studies how well gabapentin plus standard of care work
      compares to standard of care without Gabapentin in preventing inflammation of the mucous
      membranes (mucositis) in patients with stage III-IV head and neck cancer that are undergoing
      primary or subsequent (adjuvant) chemoradiation therapy. Radiation therapy to the head and
      neck may cause a burn involving the inside of the mouth, throat, and nasal passages,
      resulting in pain. Gabapentin may help prevent (or minimize) pain associated with
      radiation-induced mucositis in patients with head and neck cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically proven cancer of the head and neck cancer

          -  Stage 3 or 4

          -  Planned primary or adjuvant chemoradiation therapy

          -  Willing and able to provide informed consent

          -  English speaking

        Exclusion Criteria:

          -  Currently on gabapentin

          -  Prior non-tolerance of gabapentin

          -  History of seizure disorder
A Study of LY2951742 (Galcanezumab) in Participants With Cluster Headache
Condition: Episodic Cluster Headache; Chronic Cluster Headache
MeSH terms: Cluster Headache; Headache
Intervention: Galcanezumab
Intervention description: Administered SC
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 165.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: cluster headache; headache; brain diseases; central nervous system diseases; headache disorders; headache disorders, primary; nervous system diseases; neurologic manifestations; pain; trigeminal autonomic cephalalgias

Summary:

      The main purpose of this study is to assess the long-term safety and tolerability of
      galcanezumab administered up to once monthly in participants with episodic or chronic cluster
      headache who have completed study I5Q-MC-CGAL (NCT02397473) or study I5Q-MC-CGAM
      (NCT02438826).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants who participated in and completed either study CGAL or study CGAM.

          -  Investigator judges the participant as reliable to follow all study procedures, keep
             all study visits, and be compliant with study requirements.

        Exclusion Criteria:

          -  Current enrollment in or discontinuation within the last 30 days from, a clinical
             trial involving any investigational drug or device (with the exception of Study CGAL
             or Study CGAM).

          -  Current use or any prior exposure to any calcitonin-gene-related peptide (CGRP)
             antibody, any antibody to the CGRP receptor, or antibody to nerve growth factor (NGF)
             (with the exception of Study CGAL or Study CGAM).

          -  A history of migraine variants that could implicate or could be confused with
             ischemia.

          -  Known hypersensitivity to multiple drugs, monoclonal antibodies or other therapeutic
             proteins.

          -  A history or presence of other medical illness that indicates a medical problem that
             would preclude study participation.

          -  Evidence of significant active or unstable psychiatric disease, in the opinion of the
             investigator.

          -  Women who are pregnant or nursing.
A Trial of Ferumoxytol for the Treatment of Iron Deficiency Anemia in Pediatric Participants With Nondialysis-Dependent Chronic Kidney Disease
Condition: Iron Deficiency Anemia; Nondialysis-dependent Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Intervention: Ferumoxytol; Oral Iron
Intervention description: Experimental: Ferumoxytol; Active Comparator: Oral iron
Intervention MeSH terms: Ferrous fumarate; Ferrosoferric Oxide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 14.0
Sex: All
Minimum age: 6 Months
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Iron deficiency anemia; Feraheme; ferumoxytol; CKD; pediatric; nondialysis-dependent

Summary:

      Study evaluating the efficacy and safety of intravenous (IV) ferumoxytol compared with oral
      iron for the treatment of pediatric participants with chronic kidney disease (CKD).
    

Eligibility criteria:

        Key Inclusion Criteria for this study include:

          1. Males or females 6 months to <18 years of age

          2. Nondialysis dependent CKD, including kidney transplant recipients

          3. Has iron deficiency anemia defined as: a) hemoglobin level <11.0 grams (g)/deciliter
             (dL) and b) transferrin saturation level <20%

          4. 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 participation in the study

        Key Exclusion Criteria for this study include:

          1. History of allergy to either oral or IV iron

          2. Allergy to two or more classes of drugs

          3. Female participants who are pregnant, intend to become pregnant, are breastfeeding,
             within 3 months postpartum, or have a positive serum/urine pregnancy test

          4. Hemoglobin level ≤7.0 g/dL

          5. Serum ferritin level >600 nanograms/milliliter
Study of Efficacy and Safety of QAW039 When Added to Standard-of-care Asthma Therapy in Patients With Uncontrolled Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: QAW039; Placebo
Intervention description: QAW039 once daily; Placebo once daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 704.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: QAW039, uncontrolled asthma

Summary:

      A randomized, multicenter, double-blind, placebo- controlled parallel-group study to
      determine the efficacy and safety of QAW039, compared with placebo, when added to
      standard-of-care (SoC) asthma therapy in adult and adolescent (≥ 12 years) patients with
      uncontrolled asthma with respect to change from baseline in forced expiratory volume in 1
      second (FEV1) at the end of 12 weeks of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A diagnosis of asthma (according to GINA 2016) for a period of at least 6 months.

          -  Treated with medium dose inhaled corticosteroid (ICS), or high dose ICS, or low dose
             ICS plus long- acting beta agonist (LABA), or low dose ICS plus leukotriene receptor
             antagonist (LTRA), or medium dose ICS plus LABA for at least 3 months prior to Visit 1
             and the doses have been stable for at least 4 weeks prior to Visit 1.

          -  FEV1 of ≤85% for patients aged ≥18 years. FEV1 of ≤90% for patients aged 12 to <18
             years.

          -  Daytime asthma symptom score (0 to 6 scale) of ≥1 per day during 4 of the last 7 days
             of the placebo run- in period.

          -  Total daily SABA use ≥1 puff per day during 4 of the last 7 days of the placebo run-in
             period.

          -  Demonstrated reversible airway obstruction.

          -  Asthma control questionnaire (ACQ) score ≥ 1.5.

        Exclusion Criteria:

          -  Use of other investigational drugs within 5 half-lives of enrollment, or within 30
             days, whichever is longer.

          -  A resting QTcF (Fridericia) ≥450 msec (male) or

             ≥460 msec (female).

          -  Pregnant or nursing (lactating) women.

          -  Serious co-morbidities.

          -  Patients on >20 mg of simvastatin, > 40 mg of atorvastatin, >40 mg of pravastatin, or
             >2 mg of pitavastatin.

        Other protocol-defined inclusion/exclusion criteria may apply.
MT10109L in the Treatment of Glabellar Lines
Condition: Glabellar Lines
Intervention: MT10109L; Placebo
Intervention description: MT10109L will be injected into the GL.; Placebo will be injected into the GL.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 234.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      To evaluate the safety and efficacy of MT10109L in the treatment of glabellar lines (GL) in
      participants with moderate to severe GL.
    

Eligibility criteria:

        Inclusion Criteria

        • Female participants must not be pregnant or planning to get pregnant and willing to
        minimize the risk of inducing pregnancy for the duration of the clinical study and
        follow-up period.

        Exclusion Criteria

          -  Known immunization or hypersensitivity to any botulinum toxin serotype.

          -  Any medical condition that may put the participant at increased risk with exposure to
             MT10109L including diagnosed myasthenia gravis, Eaton Lambert syndrome, amyotrophic
             lateral sclerosis, or any other condition that might interfere with neuromuscular
             function.

          -  History of facial nerve palsy.

          -  Any uncontrolled systemic disease.

          -  Anticipated need for treatment with botulinum toxin of any serotype for any reason
             during the study (other than study intervention).

          -  Anticipated need for surgery or overnight hospitalization during the study.

          -  Prior exposure to botulinum toxin of any serotype for any reason.

          -  Prior periorbital surgery, facial lift (full face or mid-face), thread lift, brow
             lift, or related procedures (eg, eyelid [blepharoplasty] and/or eyebrow surgery).

          -  Prior facial treatment with permanent soft tissue fillers, synthetic implantation (eg,
             Gore-Tex®), and/or autologous fat transplantation.

          -  Current enrollment in an investigational drug or device study or participation in such
             a study within 30 days of entry into this study.

          -  Females who are pregnant, nursing, or planning a pregnancy during the study.

          -  Participants who plan for an extended absence away from the immediate area of the
             study site that would preclude them from returning for all protocol-specified study
             visits.
Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound
Condition: Bronchiectasis Adult; Mediastinal Lymphadenopathy; Pneumonia; Chest--Diseases; Infiltrates; Bronchopulmonary Disease; Cancer, Lung
MeSH terms: Lung Neoplasms; Bronchiectasis; Lymphadenopathy
Intervention: Topical lidocaine; Nebuliser solution; Nebuliser Suspension
Intervention description: 1% lidocaine topically applied in 4 mL aliquots; 2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer; 2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer
Intervention MeSH terms: Lidocaine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to assess if there is decrease in cough during flexible
      bronchoscopy and endobronchial ultrasound when different modes of lidocaine administration
      are used. The modes of administration being evaluated are topical, nebulized and atomized.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of mediastinal and/or hilar lymphadenopathy requiring endobronchial
             ultrasound evaluation and transbronchial needle aspiration.

          -  Diagnosis of pulmonary disease requiring flexible bronchoscopy

          -  Greater than 18 years of age.

        Exclusion Criteria:

          -  Any intervention beyond flexible bronchoscopy and endobronchial ultrasound

          -  Inability to tolerate bronchoscopy.

          -  Patients that receive paralytics.

          -  Patients with neuromuscular diseases.

          -  Inability to consent for procedures.

          -  Allergies to lidocaine or any other drugs used in protocol.

          -  Existing renal insufficiency or liver disease
A Study to Evaluate Efficacy of Ivacaftor in Subjects With Cystic Fibrosis Who Have a 3849 + 10KB C→T or D1152H CFTR Mutation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Ivacaftor; Placebo
Intervention description: IVA 150 mg tablet.; Placebo matched to IVA tablet.
Intervention MeSH terms: Ivacaftor
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 38.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No

Summary:

      This study will evaluate the efficacy of ivacaftor treatment in subjects with CF 6 years of
      age and older who have a 3849 + 10KB C→T or D1152H CFTR mutation.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Confirmed diagnosis of CF based on protocol-specified clinical features and at least
             one of the following: increased sweat chloride level, identification of 2 CF causing
             mutations, or demonstration of abnormal nasal epithelial ion transport.

          -  A 3849 + 10KB C→T or D1152H mutation on at least 1 CFTR allele.

          -  FEV1 ≥40% of predicted and ≤105% of predicted at screening.

        Exclusion Criteria:

          -  A G551D, G1244E, G1349D, G178R, G551S, S1251N, S1255P, S549N, S549R, or R117H
             mutation.

          -  History of any illness or any clinical condition that, in the opinion of the
             investigator, might confound the results of the study or pose an additional risk in
             administering study drug to the subject.

          -  Ongoing or prior participation in an investigational drug study within 30 days before
             the Screening Visit.

          -  Protocol-specified abnormal laboratory values at the Screening Visit

          -  For subjects <18 years of age at the Screening Visit, evidence of cataract/lens
             opacity determined to be clinically significant by the ophthalmologist or optometrist
             during the ophthalmologic examination (OE) at the Screening Visit.

          -  Use of any moderate or strong inducers or inhibitors of cytochrome P450 (CYP) 3A,
             including consumption of certain herbal medications and certain fruit and fruit
             juices, within 14 days before Day 1.

          -  Pregnant, breastfeeding, or planning to become pregnant during the study.

          -  Sexually active subjects of reproductive potential must be willing to use appropriate
             contraception.
A Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both to a Placebo Control in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: Tazarotene Cream 0.1%; Tazorac®; Placebo
Intervention description: Tazarotene Cream 0.1% applied to cover the affected areas of the face once daily for 84 +/- 4 days.; Tazorac® applied to cover the affected areas of the face once daily for 84 +/- 4 days.; Placebo (vehicle of the test product) applied to cover the affected areas of the face once daily for 84 +/- 4 days.
Intervention MeSH terms: Nicotinic Acids; Tazarotene
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1110.0
Sex: All
Minimum age: 12 Years
Maximum age: 40 Years
Healthy volunteers: No

Summary:

      A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing
      Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both Active Treatments to a
      Vehicle Control in the Treatment of Acne Vulgaris
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis
             of acne vulgaris.

          -  Must have a minimum of ≥ 25 non-inflammatory lesions and ≥ 20 inflammatory lesions and
             ≤ 2 nodulocystic lesions at baseline on the face.

          -  Must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as
             per the Investigator's Global Assessment.

        Exclusion Criteria:

          -  Female subjects who are pregnant, nursing or planning to become pregnant during study
             participation.

          -  Have a history of hypersensitivity or allergy to tazarotene, retinoids and/or any of
             the study medication ingredients.

          -  Presence of any skin condition that would interfere with the diagnosis or assessment
             of acne vulgaris.
Pharmacokinetic Effects of QTI571 on Sildenafil and Bosentan in Pulmonary Arterial Hypertension Participants
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Imatinib; Sildenafil; Bosentan
Intervention description: Film coated tablets, oral administration; Oral Administration; Oral Administration
Intervention MeSH terms: Imatinib Mesylate; Bosentan; Sildenafil Citrate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 21.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pulmonary Arterial Hypertension; Pulmonary Vascular Resistance; Imatinib; Bosentan; Sildenafil

Summary:

      The purpose of this study was to investigate the effects of QTI571 (imatinib) on
      pharmacokinetics of bosentan and sildenafil at steady state when co-administered to
      participants with pulmonary arterial hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with Pulmonary arterial hypertension (PAH) in World Health Organization
             (WHO) Diagnostic Group 1, with pulmonary vascular resistance > 800 dyne*sec*cm^-5,

          -  On stable doses of bosentan and sildenafil

        Exclusion Criteria:

          -  Other diagnosis of PAH in World Health Organization (WHO) Diagnostic Group 1 such as
             congenital large or small unrepaired systemic to pulmonary shunts, portal
             hypertension, Human Immunodeficiency Virus (HIV) infection, glycogen storage disease,
             Gaucher's disease, hereditary hemorrhagic teleangiectasia, hemoglobinopathies,
             myeloproliferative disorders, veno-occlusive pulmonary disease

          -  Significant lung diseases not related to PAH

          -  Significant cardiovascular system disorders, hematological system disorders, liver
             insufficiency

          -  Significant diseases in other organ system.

        Other protocol-defined inclusion/exclusion criteria may apply