bioihbjkbjnl/mcl2 huggingface dataset:
Hypoallergenicity Evaluation of a New Extensively Hydrolyzed Formula
Condition: Cow Milk Allergy
MeSH terms: Milk Hypersensitivity
Study type: Interventional

Summary: 
      Infants/children with cow's milk allergy will take part in 2 double-blinded
      placebo-controlled food challenges (DBPCFC) of 2 extensively hydrolyzed formulas in random
      order. If both food challenges are passed, subjects will be asked to consume the Test formula
      in an at-home open challenge for 7 days.
    


Intervention name(s): Test extensively hydrolyzed formula; Control extensively hydrolyzed formula
Intervention type(s): Other; Other
Intervention description(s): extensively hydrolyzed formula with HMOs; extensively hydrolyzed formula without HMOs
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluation of a School-based Influenza Vaccination Program
Condition: Influenza; Influenza Vaccines
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether inactivated influenza vaccines are
      effective to protect school children and their households from getting influenza infection
      and further prevent student's absenteeism.
    

Detailed description: 
      School children were found to be the possible spreaders of the influenza. The successful
      prevention measure on school children was crucial for controlling the epidemic. In Taiwan,
      the national influenza immunization program on the grade 1-2 students started in winter,
      2007. In this intervention study, the two study townships with 27 schools were included as
      our study population. The three time questionnaires were issued for collecting the health
      status of the children during the influenza season. The information on the vaccines' safety
      was also collected after the vaccination. The community collaborative clinics were
      responsible for taking the specimens.
    

Intervention name(s): Trivalent inactivated influenza vaccine
Intervention type(s): Biological
Intervention description(s): one dose
Other intervention name(s): Brand Name: VAXIGRIP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: school children; influenza vaccination; vaccine effectiveness; influenza attack rate; absenteeism; Influenza vaccine
Safety and Protective Efficacy of FF-3 Dry Powder in Healthy Subjects Infected With Influenza Challenge Strain
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study are to determine the effect FF-3 in comparison to placebo in
      subjects who are experimentally inoculated with a live, challenge strain of influenza A
      virus.
    


Intervention name(s): FF-3 dry powder; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): FF-3 dry powder administered by nasal inhalation; Placebo dry powder administered by nasal inhalation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: antiviral; influenza; challenge
Cross-Over Study to Assess the Cardiovascular Effects of GSK2336805
Condition: Hepatitis C
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, randomized, two part, double-blind, crossover study in healthy adult
      subjects to assess the effect of a single dose of GSK2336805 150mg on cardiac function
      comparing with placebo using echocardiography as a primary assessment modality
    


Intervention name(s): GSK2336805 150mg; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Single Dose; Single Dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy of Cold-FX (CVT-E002) in the Prevention of Upper Respiratory Tract Infections in Healthy Adults
Condition: Upper Respiratory Infection
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the Study is to determine the prophylactic effects of CVT-E002 treatment for
      upper respiratory tract infections in healthy adult employees working with residents in
      continuing care facilities. It is hypothesized that the use of CVT-E002 will effectively
      reduce the incidence, severity and duration of upper respiratory infections among the
      participants when compared to placebo.
    

Detailed description: 
      Eligible continuing care employees will be randomly assigned to either the treatment or
      placebo group with equal numbers in each group. The treatment will consist of taking two
      capsules of CVT-E002 (400mg)or placebo every morning, after breakfast, for a period of 12
      weeks. The subjects will be given an assessment form to log specific symptoms on a daily
      basis if they get a cold.

      Symptoms include sore throat, runny nose, nasal congestion, hoarseness, cough, earaches, and
      fever. Subjects will be required to maintain the same dosing even during an upper respiratory
      infection and will be requested not to take any additional medication for their upper
      respiratory infection unless prescribed by their family physicians.
    

Intervention name(s): CVT-E002 (Cold-FX); a natural health product
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: cold; influenza
Effect of Ciprofloxacin Versus Levofloxacin on QTc-interval and Dysglycemia
Condition: QTc Prolongation, Hyperglycemia, Hypoglycemia
MeSH terms: Hypoglycemia; Hyperglycemia
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare intravenous levofloxacin and ciprofloxacin regarding their risk on the corrected
      QT interval (QTc) prolongation and dysglycemia in diabetic and non-diabetic patients.
    

Detailed description: 
      Fluoroquinolones represent an important class of antibacterial drug and they are used
      worldwide.Fluoroquinolones are classified into generations according to the spectrum of
      antimicrobial activities that targeted them.Fluoroquinolones may cause several side effects
      as tendon rupture, central nervous toxicity, cardiovascular toxicity, gastrointestinal
      toxicity, phototoxicity, disrupted glucose metabolism, skin disorders and hypersensitivity.
      Ciprofloxacin, a second generation fluoroquinolone, is one of the most successful and widely
      used compounds of fluoroquinolone. On the other hand, levofloxacin is a third generation
      fluoroquinolone.

      Diabetes mellitus (DM) is chronic disease and a serious of metabolic disorder associated with
      the presence of hyperglycemia due to partial or complete insulin deficiency. Diabetes
      mellitus is a major risk factor for cardiovascular diseases.

      Fluoroquinolone class is associated with cardiac side effects as QTc prolongation. Some
      agents of fluoroquinolones were withdrawn from market. However, cardiac adverse effects has
      been developed with fluoroquinolones still in market. Members of fluoroquinolones class have
      different effects on QT interval. The US FDA suggested that the risk and benefits ratio of
      fluoroquinolones should be taken into consideration.

      In addition to hyperglycemia events are more common with fluoroquinolones than with other
      classes of antibiotics. The food and drug administration (FDA) confirmed the current warning
      that fluoroquinolones may cause decrease in blood sugar especially in diabetic patients.
      However, other study proved that fluoroquinolones may cause dysglycemic events in diabetic
      and non-diabetic patients.
    

Intervention name(s): Ciprofloxacin 400 MG/200 ML Intravenous Solution; Levofloxacin 750 MG
Intervention type(s): Drug; Drug
Intervention description(s): antibiotic; antibiotic
Intervention MeSH terms: Ciprofloxacin; Levofloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: fifty diabetic patients received intravenous levofloxacin 750 mg/24 hours. fifty diabetic patients received intravenous ciprofloxacin 400mg/12 hours. fifty non-diabetic patients received intravenous levofloxacin 750 mg/24 hours. fifty non-diabetic patients received intravenous ciprofloxacin 400mg/12 hours.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Levofloxacin, ciprofloxacin, QTc prolongation, dysglycemia.
Safety and Efficacy Study of Sublingual Immunotherapy (SLIT) to Treat House Dust Mite Allergic Rhinitis
Condition: Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to assess the efficacy of two doses of sublingual immunotherapy
      (SLIT) administered as allergen-based tablets once daily over a period of 12 months compared
      to placebo, for reduction of allergic rhinitis symptoms and rescue medication usage
    

Detailed description: 
      Allergic rhinitis is a high-prevalence disease in many developed countries, affecting about
      10 to 20% of the general population. House dust mite allergens are known to cause perennial
      allergic rhinitis.

      In designing the present study, the guidelines proposed by the World Allergy Organization
      (WAO) task force for methodology of immunotherapy studies have been taken into consideration.

      After a 2-month screening period, patients will be administered the dose of 300 IR- or 500
      IR-house dust mite allergen-based tablets or placebo for a period of 12 months. The
      carry-over effect will be evaluated after a treatment-free follow up period of 12 months.
    

Intervention name(s): 300 IR house dust mites allergen extract tablet; 500 IR house dust mites allergen extract tablet; Placebo tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One sublingual tablet daily for one year; One sublingual tablet daily for one year; One sublingual tablet daily for one year
Other intervention name(s): Sublingual immunotherapy tablet; Sublingual immunotherapy tablet; Sublingual placebo tablet
Intervention MeSH terms: Immunomodulating Agents; Immunologic Factors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: House dust mites allergy
Efficacy Study of Dysport® in the Treatment of Anal Fissure.
Condition: Anal Fissure
MeSH terms: Fissure in Ano
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the effect on healing rates of two different prognostic factors in patients
      treated with Dysport® for anal fissure: duration of fissure and dose of study drug
    


Intervention name(s): Botulinum toxin type A
Intervention type(s): Biological
Other intervention name(s): AbobotulinumtoxinA (Dysport®)
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sub-dissociative Ketamine for the Management of Acute Pediatric Pain
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The proposed trial is a prospective, double blinded, randomized control trial with the
      primary aim of determining whether a single, sub-dissociative dose of ketamine will decrease
      the total narcotic requirements of pediatric patients requiring intravenous analgesia in an
      urban emergency department (ED) compared to a group of patients who receive morphine alone
      for pain management. Patients are randomized to receive either a single bolus of ketamine
      (0.3 mg/kg) or a single bolus of morphine (0.05mg/kg). All subsequent pain management will be
      accomplished using morphine. Patient, family member, and research staff pain scores will be
      recorded, until 3 hours post study medication administration. Family members are contacted
      via telephone 24 hours post-ED discharge, and again at 7 days post-hospital discharge, for
      evaluation via Post Hospitalization Behavior Questionnaire. Narcotic equivalents will be
      calculated for up to 3 hours post study medication administration and compared between the
      ketamine and morphine groups.
    


Intervention name(s): Ketamine; Morphine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Ketamine; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: pain management; ketamine; morphine; pediatrics; emergency medicine
Bioequivalence Study of Atorvastatin Calcium Tablets, 40 mg of Dr. Reddy's Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the bioequivalence between Atorvastatin calcium 40 mg
      of Dr. Reddy's Laboratories Limited, India and Lipitor® 40mg Tablets of Pfizer Ireland
      Pharmaceuticals in healthy, adult, human subjects under fed condition.
    

Detailed description: 
      Open-label, balanced, randomized, two-treatment, two-sequence,two-period, single-dose,
      crossover oral bioequivalence study of Atorvastatin calcium 40 mg Tablets of Dr. Reddy's
      Laboratories Limited, India and Lipitor® 40 mg Tablets of Pfizer Ireland Pharmaceuticals in
      healthy, adult, human subjects under fed conditions.
    

Intervention name(s): Atorvastatin Calcium Tablets, 40 mg
Intervention type(s): Drug
Intervention description(s): Atorvastatin Calcium Tablets, 40 mg of Dr. Reddy's Laboratories Limited
Other intervention name(s): Lipitor® 40 mg Tablets
Intervention MeSH terms: Atorvastatin; Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Atorvastatin calcium; crossover
Xylitol Syrup for the Prevention of Acute Otitis Media in Otitis-prone Children
Condition: Acute Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the proposed study is to determine the effectiveness and safety of
      orally administered viscous-adherent xylitol syrup given in a dose of five grams three times
      daily for 12 weeks in reducing the incidence of clinically-diagnosed acute otitis media (ear
      infection) in children with a history of recurrent acute otitis media.
    


Intervention name(s): Xylitol syrup; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 7.5 mL (5 grams) by mouth three times daily; 7.5 mL by mouth three times daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: otitis media; ear infection
A Clinical Trial Evaluating the Safety and Efficacy of IDP-110 in Patients With Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the effectiveness of IDP-110 in treating patients with
      acne vulgaris.
    


Intervention name(s): IDP-110; Clindamycin; Benzoyl peroxide; Vehicle
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Topical application for 12 weeks; Topical application for 12 weeks; Topical application for 12 weeks; Topical application for 12 weeks
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of Milnacipran in Patients With Inadequate Response to Duloxetine for the Treatment of Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to evaluate the safety, tolerability and efficacy of
      milnacipran in patients with an inadequate response to duloxetine for the treatment of
      fibromyalgia.
    

Detailed description: 
      -  Two weeks Duloxetine 60 mg Open-Label Period

        -  Randomization to Double-Blind Treatment Period: 10 weeks Milnacipran (direct switch) or
           10 weeks placebo (one week blinded 30 mg duloxetine)

        -  One week Double-Blind Down-Taper Period
    

Intervention name(s): Placebo; Milnacipran
Intervention type(s): Drug; Drug
Intervention description(s): Placebo tablets, oral administration, twice daily for 10 weeks during randomized, double-blind treatment period. Duloxetine capsules, oral administration, 30 mg/day for 1 week after randomization to effect a duloxetine down-taper.
Placebo tablets, twice daily for 1 week during double-blind down-taper treatment period.; Milnacipran tablets, 100 to 200 mg/day, oral administration, twice daily in divided doses for 10 weeks during randomized, double-blind treatment period. Placebo capsules, 1 capsule/day administered for 1 week after randomization to maintain double-blind duloxetine down-taper.
Milnacipran tablets, 100 to 0 mg/day, oral administration, twice daily in divided doses for 1 week during double-blind down-taper treatment period.
Other intervention name(s): Savella
Intervention MeSH terms: Milnacipran; Levomilnacipran
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Milnacipran; Duloxetine; Switch; Forest Research Institute
Trial of Afatinib in Pediatric Tumours
Condition: Neuroectodermal Tumors; Rhabdomyosarcoma
MeSH terms: Rhabdomyosarcoma; Neuroectodermal Tumors; Neuroectodermal Tumors, Primitive
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Open-label, dose escalation, monotherapy, basket trial with biomarker specific MTD expansion
      cohort/Phase II part.

      The trial will consist of 2 parts:

        1. Dose finding part to determine the MTD

        2. Biomarker specific MTD expansion cohort/Phase II part to assess clinical anti-tumour
           activity in included tumour types
    


Intervention name(s): afatinib
Intervention type(s): Drug
Intervention MeSH terms: Afatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Short-Term and Long-Term Effects of Ankle Joint Taping and Bandaging on Balance, Proprioception and Vertical Jump Among Volleyball Players With Chronic Ankle Instability
Condition: Chronic Ankle Instability
Study type: Interventional

Summary: 
      Objective: This study aimed to 1) investigate the long-term effect of taping and bandaging on
      proprioception, balance, and vertical jump among volleyball players with ankle instability,
      2) Compare the short-term effects of taping and bandaging on these outcome measures, 3)
      Compare the long-term effects of taping and bandaging on these outcome measures.

      Design: A single-blinded randomized controlled study Setting: Rehabilitation Laboratory at
      Istanbul Gelisim University, Turkey Subjects: One-hundred participants with a chronic ankle
      sprain (CAI) Primary outcome measures: Proprioception (ankle range of motion absolute error),
      balance(Y-balance test), and vertical jump (vertical jump tester) Interventions: Participants
      were distributed into three groups: taping group (n=33) received ankle rigid taping,
      bandaging group (n=33) received ankle bandaging, and control group (n=34) received placebo
      taping. All three previous external supports were applied for 8 weeks. The measurements were
      performed at baseline, immediately after applying for support, two weeks after support and
      eight months after support.
    


Intervention name(s): Taping and Bandaging
Intervention type(s): Other
Intervention description(s): Ankle taping: a hard preventive Zinc oxide tape was used. The taping procedures consisted of three separate steps. 1) included the application of the anchor tape. 2) application of the stirrup tape. The stirrup tape was performed two times by holding the foot in a neutral position and the tape is placed as it passed through the medial side of the ankle (under the foot), just over the heel area (posterior one-third of the foot) and up along the lateral side of the ankle. Bandaging: standard 10cm width elastic bandage used. The bandage wrapped around the ankle joint in the form of an 8-figure. Bandage started from the forefoot, moving diagonally upwards and steeply enough to go well above the heel to end around the lower calf area to form an anchor. Then, it moved diagonally down across the mid-foot. Placebo: 10cm long tape was applied on the lateral side of the leg, just above the lateral malleolus and aligned with peroneus longus tendon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Study to Assess the Safety and Pharmacokinetics of TPOXX® When Administered Orally for 28 Days
Condition: Smallpox
MeSH terms: Smallpox
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to evaluate the immunogenicity profile of JYNNEOS® when 2 doses are
      administered subcutaneously (SC) 4 weeks apart; and potential immunological interference
      while concomitantly administering TPOXX or placebo orally twice daily (BID) for 28 days.
    

Detailed description: 
      This is a Phase 2, open-label (JYNNEOS), double-blind (TPOXX and placebo), multicenter,
      randomized, placebo-controlled, drug-vaccine interaction study to examine whether
      administering TPOXX with JYNNEOS concomitantly affects JYNNEOS immunogenicity in healthy
      adult subjects. A total of 100 subjects (approximately 50 subjects per treatment group), ages
      18 to 42, inclusive, will be enrolled and randomly assigned to 1 of 2 treatment groups.
    

Intervention name(s): JYNNEOS + TPOXX; JYNNEOS + TPOXX PLACEBO
Intervention type(s): Biological; Biological
Intervention description(s): biologic + drig; biologic + drug placebo
Intervention MeSH terms: Tecovirimat; Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment