bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of Intravenous Ferric Carboxymaltose in Pediatric Patients With Iron Deficiency Anemia and Unsatisfactory Response Oral Iron Under Study Protocol 1VIT17044
Condition: Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Intervention: Ferric carboxymaltose
Intervention description: IV iron
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: This is a single arm, open-label, multi-center, multi-national, non-randomized study that will evaluate the efficacy and safety of a one course treatment with FCM in participants who had an unsatisfactory response to oral iron in study 1VIT17044.
Masking: None (Open Label)
Enrollment: 7.0
Sex: All
Minimum age: 1 Year
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      Evaluating the Efficacy and Safety of Intravenous Ferric Carboxymaltose in Pediatric Patients
      with Iron Deficiency Anemia and an Unsatisfactory Response to Oral Iron under Study Protocol
      1VIT17044
    

Eligibility criteria:

        Inclusion Criteria:

          1. Unsatisfactory response to oral iron or those that required a concomitant
             intervention, (defined as, blood transfusion, use of IV or oral iron outside of
             protocol, increase in erythropoietin for any reason [Day 0 thru Day 35 of study
             protocol 1VIT17044], change in IBD treatment).

          2. Hgb <11 g/dL

          3. Ferritin ≤300 ng/mL and TSAT <30%

        Exclusion Criteria:

          1. Known history of hypersensitivity reaction to any component of FCM.

          2. History of acquired iron overload, hemochromatosis, or other iron accumulation
             disorders.

          3. History of significant diseases of the liver, hematopoietic system, cardiovascular
             system, psychiatric disorder, or other conditions which, in the opinion of the
             investigator, may place a subject at added risk for participation in the study.

          4. Any existing non-viral infection.

          5. Known history of positive HBsAg or HCV with evidence of active hepatitis.

          6. Known history of positive HIV-1/HIV-2 antibodies (anti-HIV).

          7. Anemia due to reasons other than iron deficiency (e.g., hemoglobinopathy and vitamin
             B12 or folic acid deficiency) that has not been corrected.

          8. Administration and / or use of an investigational product (drug or device) within 30
             days of screening.

          9. Alcohol or drug abuse within the past six months.

         10. Female participant who is pregnant or lactating, or sexually active females who are of
             childbearing potential not willing to use an acceptable form of contraceptive
             precautions during the study.

         11. Unable to comply with study procedures and assessments.
Impact of Community Scabies Treatment on Head Lice Prevalence in the Solomon Islands
Condition: Scabies; Head Lice
MeSH terms: Lice Infestations; Scabies
Intervention: Ivermectin; Permethrin 5%; Malathion Shampoo 0.5%
Intervention description: A single weight based dose of ivermectin; Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated; Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated
Intervention MeSH terms: Ivermectin; Permethrin; Malathion
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 118.0
Sex: All
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This is a pilot study evaluating if treatment for scabies also treats headlice in the same
      community
    

Eligibility criteria:

        Inclusion Criteria:

          -  All participants living in the community will be offered treatment

        Exclusion Criteria:

          -  Patients with a contradindication to study medication

          -  Patients unable to provide consent
Long-term Safety and Efficacy Study of Teduglutide in Pediatric Participants With Short Bowel Syndrome (SBS)
Condition: Short Bowel Syndrome
MeSH terms: Short Bowel Syndrome; Syndrome
Intervention: TED; SOC; Syringe; Needle
Intervention description: 0.05 mg/kg SC injection once daily.; Standard safety assessments and adjustments in nutritional support.; Teduglutide will be administered using syringe.; Teduglutide will be administered using needle.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: All
Healthy volunteers: No

Summary:

      This study will follow participants who completed the TED-C14-006 study. The purpose of this
      study is to evaluate the long-term safety and efficacy of teduglutide in pediatric
      participants with Short Bowel Syndrome (SBS). This study will also offer teduglutide
      treatment to eligible participants, regardless of treatment received in TED-C14-006 or
      SHP633-301.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Participant provides written informed consent (participant, parent or legal guardian
             and, as appropriate, informed assent) to participate in the study before completing
             any study-related procedures.

          2. Participant completed the TED-C14-006 or SHP633-301 studies (including participants in
             the standard of care treatment arms). Participants are considered to have completed
             SHP633-301 if they completed study assessments through week 24.

          3. Participant understands and is willing and able to fully adhere to study requirements
             as defined in this protocol.

        Exclusion Criteria:

        1. There are no exclusion criteria for this study.
Evaluation of the Effect of Ketamine on Remifentanil-induced Hyperalgesia
Condition: Pain; Hyperalgesia; Inflammatory Response
MeSH terms: Hyperalgesia
Intervention: Ketamine; Saline
Intervention description: Patients in group ketamine was administrated ketamine (5mcg/kg/min) during the surgery.; Patients in group N (placebo) was administrated saline during surgery.
Intervention MeSH terms: Ketamine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 78 Years
Healthy volunteers: No
Keywords: Remifentanil; Hyperalgesia; Ketamine; Von Frey's filament; Algometer; Interleukines; Opioid-induced hyperalgesia

Summary:

      The aim of this study was to determine if the addition of ketamine reduces
      remifentanil-induced hyperalgesia, improves its analgesic effect, inhibits IL(interleukin)-6
      and IL-8 (inflammatory cytokines), and stimulates IL-10 (an anti-inflammatory cytokine).
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≥ 18 years old

          -  both sexes

          -  ASA physical status I or II

          -  undergoing laparoscopic cholecystectomy

        Exclusion Criteria:

          -  chronic users of analgesics or had used opioids within 12 h of surgery

          -  history of drug or alcohol abuse or psychiatric disorder

          -  contraindications to self-administration of opioids (ie, unable to understand the
             patient-controlled analgesia [PCA] device)

          -  contraindication for the use of ketamine, such as a psychiatric disorder, acute
             cardiovascular disorder, or unstable hypertension
Telcagepant (MK-0974) Long-Term Safety Study in Adult Participants With Acute Migraine (MK-0974-012)
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: Telcagepant 300 mg soft gel capsules; Telcagepant 280 mg tablets; Rizatriptan 10 mg tablets; Placebo to telcagepant capsules; Placebo to telcagepant tablets; Placebo to rizatriptan tablets
Intervention description: One capsule taken orally at onset of migraine; One tablet taken orally at onset of migraine; One tablet taken orally at onset of migraine; One capsule taken orally at onset of migraine; One tablet taken orally at onset of migraine; One tablet taken orally at onset of migraine
Intervention MeSH terms: Rizatriptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1068.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to investigate the safety and tolerability of telcagepant
      (MK-0974) in the long-term treatment of acute migraine in adult participants. The primary
      hypothesis of this study is that telcagepant is well tolerated in the long-term treatment of
      acute migraine in adult participants.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 1 year history of migraine (with or without aura)

          -  Females of child bearing potential must use acceptable contraception throughout trial

          -  In general good health based on screening assessment

        Exclusion Criteria:

          -  Pregnant/breast-feeding (or is a female expecting to conceive during study period)

          -  History or evidence of stroke/transient ischemic attacks, heart disease, coronary
             artery vasospasm, other significant underlying cardiovascular diseases, uncontrolled
             hypertension (high blood pressure), uncontrolled diabetes, or human immunodeficiency
             virus (HIV) disease

          -  Major depression, other pain syndromes that might interfere with study assessments,
             psychiatric conditions, dementia, or significant neurological disorders (other than
             migraine)

          -  History of gastric, or small intestinal surgery, or has a disease that causes
             malabsorption

          -  History of cancer within the last 5 years
Trial to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine GSK2186877A in Adults 65 Year of Age and Older
Condition: Influenza
MeSH terms: Influenza, Human
Intervention: GSK Bio's influenza vaccine GSK2186877A; Fluarix TM
Intervention description: IM administration, two times one annual dose, 3 different lots will be tested; IM administration, two times one annual dose
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 43695.0
Sex: All
Minimum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Efficacy; Influenza Vaccines; Influenza; Vaccine; Elderly

Summary:

      The purpose of this study is to evaluate the efficacy of GlaxoSmithKline Biologicals'
      influenza vaccine GSK2186877A in adults 65 year of age and older. The study design is divided
      in two surveillance phases: one passive phase along the study during the influenza season and
      one active surveillance phase during the influenza peak season.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects who the investigator believes that they can and will comply with the
             requirements of the protocol.

          -  A man or woman aged 65 years or older at the time of the vaccination.

          -  Written informed consent obtained from the subject.

          -  Subjects with residence status allowing free mixing with general community.

        Exclusion Criteria:

          -  Bedridden subjects

          -  Previous vaccination against influenza since February 2008.

          -  Previous vaccination in the last three years with an investigational adjuvanted
             candidate seasonal or pandemic influenza vaccine.

          -  Use of any investigational or non-registered product (drug or vaccine) other than the
             study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned
             use during the study period.

          -  Any contra-indication to intramuscular administration of the influenza vaccines.

          -  History of hypersensitivity to a previous dose of influenza vaccine.

          -  History of allergy or reactions likely to be exacerbated by any component of the
             vaccine including egg and chicken protein.

          -  Acute disease at the time of enrolment. Acute disease is defined as the presence of a
             moderate or severe illness with or without fever. All vaccines can be administered to
             persons with a minor illness such as diarrhoea, mild upper respiratory infection with
             or without low-grade febrile illness, i.e. Oral temperature <37.5°C (99.5°F).
A Comparison of SYMBICORT® pMDI With Formoterol Turbuhaler® in Subjects With COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Budesonide/formoterol (SYMBICORT) pMDI; Formoterol Turbuhaler
Intervention MeSH terms: Budesonide; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 1200.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD

Summary:

      The purpose of this study is to determine if SYMBICORT® delivered via a pressurized
      metered-dose inhaler, referred to as a pMDI, is effective in preventing COPD exacerbations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A current clinical diagnosis of COPD with COPD symptoms for more than 2 years

          -  Current smoker or smoking history of 10 or more pack years (1 pack year = 20
             cigarettes smoked per day for one year)

          -  A history of at least 1 COPD exacerbations requiring a course of steroids and/or
             antibiotics within 1-12 months before the first visit

        Exclusion Criteria:

          -  A history of asthma at or after 18 years of age

          -  A history of allergic rhinitis at or after 18 years of age

          -  Subjects taking oral steroids

          -  Any significant disease or disorder that may jeopardize a subject's safety
A Study of Rizatriptan for the Treatment of Acute Migraine in Patients on Topiramate for Migraine Prophylaxis
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: rizatriptan benzoate; Comparator: placebo
Intervention description: rizatriptan 10 mg Orally Disintegrating Tablet (ODT) orally for a moderate or severe migraine attack; Placebo to rizatriptan 10 mg ODT orally for a moderate or severe migraine attack
Intervention MeSH terms: Rizatriptan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 108.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will provide additional efficacy data for rizatriptan when used for an acute
      migraine attack in patients already taking topiramate for migraine prophylaxis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has a history of migraine with or without aura for more than one year, with
             between 2 and 8 moderate to severe attacks per month

          -  Patient is currently taking at least 50 mg topiramate daily for migraine prophylaxis

          -  Patient can distinguish between migraine and other types of headache

          -  Patient agrees to remain abstinent or use effective birth control during the study

        Exclusion Criteria:

          -  Patient is pregnant or breast-feeding

          -  Patient has a history of mostly mild migraines or migraines that resolve within 2
             hours

          -  Patient has more than 15 headache-days per month or has taken medication for acute
             headache on more than 10 days per month in the 3 months prior to screening.

          -  Patient was > 50 years old at age of migraine onset

          -  Patient has history of heart disease

          -  Patient has uncontrolled hypertension

          -  Patient has had cancer within 5 years of screening (excepting certain skin and
             cervical cancers)

          -  Patient has started taking Selective Serotonin Reuptake Inhibitors (SSRIs) or
             Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) or has changed doses within 3
             months of screening

          -  Patient is taking more than one other migraine prophylactic medication

          -  Patient has repeatedly failed to respond to or tolerate rizatriptan
Phase III Study of Edasalonexent in Boys With Duchenne Muscular Dystrophy
Condition: Muscular Dystrophy, Duchenne
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Intervention: Edasalonexent; Placebo
Intervention description: 100 mg/kg/day; Placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 131.0
Sex: Male
Minimum age: 4 Years
Maximum age: 7 Years
Healthy volunteers: No
Keywords: Muscular Dystrophies; Musculoskeletal Diseases; Neuromuscular Diseases; Duchenne muscular dystrophy; DMD; dystrophin; dystrophy; Duchenne

Summary:

      The PolarisDMD study is a Phase 3, global study to evaluate the efficacy and safety of
      edasalonexent in pediatric patients with a genetically confirmed diagnosis of DMD. Male
      patients from 4-7 years of age (up to 8th birthday) will be enrolled.

      Edasalonexent is an orally administered small molecule that inhibits NF-kB, which is the key
      link between loss of dystrophin and disease pathology and plays a fundamental role in the
      initiation and progression of skeletal and cardiac muscle disease in DMD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Written consent/assent by patient and/or legal guardian as per regional and/or
             Institutional Review Board (IRB)/Independent Ethics Committee (IEC) requirements

          -  Diagnosis of DMD based on a clinical phenotype with increased serum creatine kinase
             (CK) and documentation of mutation(s) in the dystrophin gene known to be associated
             with a DMD phenotype

          -  Able to perform stand from supine without assistance in ≤ 10 seconds

          -  Able to perform the 10MWT and 4-stair climb

          -  Followed by a doctor or medical professional who coordinates Duchenne care on a
             regular basis and willingness to disclose patient's study participation with medical
             professionals

        Exclusion Criteria:

          -  Use of corticosteroids within 24 weeks prior to Day 1; use of inhaled, intranasal, and
             topical corticosteroids is permitted

          -  Use of another investigational drug, idebenone, or dystrophin-focused therapy within 4
             weeks. Exception: Patients who have received at least 24 weeks of a stable dose of
             eteplirsen prior to Day 1, and expected to continue treatment, will be eligible

          -  Use of the following within 4 weeks prior to Day 1: immunosuppressive therapy,
             warfarin, phenytoin, S mephenytoin, cyclosporine, dihydroergotamine, ergotamine,
             fentanyl, alfentanil, pimozide, quinidine, sirolimus, tacrolimus, or paclitaxel

          -  Use of human growth hormone within 3 months prior to Day 1

          -  Other prior or ongoing significant medical conditions
Generalized Anxiety Disorder Adjunct Study
Condition: Anxiety; Anxiety Disorders; Anxiety Neuroses; Anxiety States
MeSH terms: Anxiety Disorders
Intervention: Placebo; quetiapine fumarate XR
Intervention description: oral; oral
Intervention MeSH terms: Quetiapine Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 409.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Generalized anxiety disorders; anxiety; adjunct treatment in anxiety; anxiety disorder; partial or non-responder in anxiety

Summary:

      This study is being carried out to see if extended release quetiapine fumarate (Seroquel®XL)
      when added to standard selective serotonin reuptake inhibitor (SSRI) /
      serotonin-norepinephrine reuptake inhibitor (SNRI) therapy is effective and safe for the
      treatment of Generalized Anxiety Disorder in patients with partial or no response to
      SSRI/SNRI alone or in combination with a benzodiazepine, and if so, how it compares with
      placebo
    

Eligibility criteria:

        Inclusion Criteria:

        Provision of Informed Consent

          -  Documented diagnosis of Generalized Anxiety Disorder

          -  Female patients must not be pregnant and be willing to use a reliable method of birth
             control

          -  Be able to understand and comply with study requirements

        Exclusion Criteria:

        Other psychiatric disorders that could confound the study results, as judged by the study
        doctor

          -  Moderate to severe depression

          -  Other clinically relevant diseases, as judged by the study doctor

          -  Medication that you are taking, as judged by the study doctor