bioihbjkbjnl/mcl2 huggingface dataset:
A Phase I Study to Assess PK of AZD7986 Alone & With Verapamil, Itraconazole or Diltiazem in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1, non-randomized, fixed sequence, 3-period, drug-drug interaction study to
      assess the pharmacokinetics (PK) of AZD7986 in healthy subjects when administered alone and
      in combination with multiple doses of verapamil and itraconazole or diltiazem
    

Detailed description: 
      This study will be an open-label, non-randomised, fixed sequence, 3-period study conducted at
      a single study centre to assess the PK of AZD7986 in healthy subjects when administered alone
      and in combination with multiple doses of verapamil and itraconazole or diltiazem. An
      adaptive design with an interim analysis of the PK data from Periods 1 and 2 will be used to
      determine which of itraconazole or diltiazem will be administered in combination with AZD7986
      in Period 3.

      Treatments to be administered in a fixed order separated by a washout period:

      period 1 - single AZD7986 (25 mg) on Day 1 (1 hour before food), washout 7 days period 2 -
      verapamil (240 mg extended release formulation) daily 1 hour before food (Day 1 to 10) and a
      single dose of AZD7986 (25 mg) 1 hour before food (Day 5), washout period 14 days period 3 -
      subject to interim pharmacokinetic analysis of AZD7986 alone compared with AZD7986 and
      verapamil combined, either itraconazole (200 mg, oral solution formulation 10mg/mL)
      administered twice on Day 1 and daily on days 2 to 11 (1 hour before food) plus AZD7986
      (25mg) single dose on Day 6 (1 hour before food); or diltiazem (360 mg, extended release
      formulation) on Days 1 to 13 (1 hour before food) plus AZD7986 (25 mg) 1 hour before food on
      Day 8.
    

Intervention name(s): AZD7986; Verapamil; Itraconazole; Diltiazem
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral solution, single dose, dilution from concentrate; Extended release tablet for oral use; Oral solution; Extended release capsule
Intervention MeSH terms: Itraconazole; Verapamil; Diltiazem
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Non-randomized; Verapamil; Itraconazole; Diltiazem; Safety; Tolerability; Pharmacokinetics
Anxiolytic Effects of Lavender and Orange Oil
Condition: Anxiety State; Pediatric ALL; Dental Anxiety; Oil; Inhalation; Anesthesia
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The aim of this study is to determine the possible anxiety reducing effects of lavender oil
      and orange oil on parents with children receiving dental care under sedation during
      perioperative wait.
    

Detailed description: 
      Anxiety is a common problem for parents with children under sedation. It has long been known
      that operations, unconsciousness, the risks of the anesthesia and airway problems can cause a
      considerable amount of anxiety. Anxiety is associated with an uncertain psychological
      distress , and may vary to minor disturbances to extreme stress. The study aims to help
      parents improve their satisfaction by reducing their anxiety levels and ensure they have a
      better experience. In addition, anxiety can also prevent active participation of the parents
      during postoperative recovery. The physical and psychological effects of essential oils and
      traditional medicine practices as aromatherapy has been used for a long time and has potency
      to reduce using sedatives. Lavender oil is a fragrance that many of us have experienced in
      growing up at home and is also popular today. The lavender plant belongs to the Labitae
      family and has been used for centuries in dried or essential oil form. Lavender is obtained
      from flower heads and leaves with vapor distillation. This oil has also been specifically
      investigated and is an essential oil scientifically shown to reduce patient anxiety before
      various interventions. Orange oil is an essential oil produced by cells within the rind of an
      orange fruit (Citrus sinensis fruit). In contrast to most essential oils, it is extracted as
      a by-product of orange juice production by centrifugation, producing a cold-pressed oil. It
      is composed of mostly d-limonene. This oil has been investigated and shown to reduce anxiety
      and improve mood before various interventions.The anxiolytic effects of these essential oils
      has not been investigated for parents with children undergoing pediatric dental procedures
      under sedation.

      The aim of this study is to investigate the effects of lavender oil and orange oil diffused
      in the perioperative waiting room of parents with children under sedation.
    

Intervention name(s): Lavender/Orange
Intervention type(s): Behavioral
Intervention description(s): A diffuser containing 120 ml water and 0.3 ml lavender oil / 0.3 ml orange oil will be set into the parents' perioperative waiting rooms to mist at least 1 hour before the parent arrive.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Perioperative Anxiety; Lavender Oil; Orange Oil; Pediatric Dentistry; Deep Sedation
Study of the Hummingbird TTS™ Tympanostomy Tube System
Condition: Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Observational

Summary: 
      The objective of this study was continued commercial evaluation of the intraoperative safety
      and performance of the H-TTS for the placement of ventilation tubes in pediatric patients
      undergoing a tympanostomy procedure under moderate sedation and local anesthetic.
    

Detailed description: 
      The study was a multi-site, prospective and retrospective, treatment-only post-market study
      of the H-TTS. The study was performed in a commercial environment. Patients were already have
      a scheduled tympanostomy procedure with the H-TTS under moderate sedation and local
      anesthetic.
    

Intervention name(s): Hummingbird Tympanostomy Tube System
Intervention type(s): Device
Intervention description(s): Insertion of a ventilation tube under sedation and local anesthetic
Observational model: Case-Only
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        Children 6 months through 5 years of age, who are candidates for placement of VT.
      
Keywords: tympanostomy; myringotomy; otitis media; ear tubes; ear infection
AD816 Crossover Study
Condition: OSA; Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The VicTor Study is a randomized, double blind, placebo-controlled, 3-period, multiple-dose
      crossover study in participants with OSA.
    


Intervention name(s): Period A; Period B; Period C
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Week 1: Viloxazine low dose + placebo; Week 2: Viloxazine high dose + placebo; Week 1: AD816 low dose; Week 2: AD816 high dose; Week 1: Placebo + Placebo; Week 2: Placebo + Placebo
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Assessment of the Bioavailability of Iron in Iron Fortified Bouillon Cubes in Healthy Nigerian Women
Condition: Iron Deficiency Anemia
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      The prevalence of iron deficiency anemia is a wide spread problem in Africa and iron
      fortification can be an effective strategy to decrease this.

      In the current study adding different levels of a stabilizer to iron fortified cubes and it's
      effect on iron bioavailability from these cubes will be studied in the context of a Nigerian
      meal in women.

      24 Female subjects with low serum ferritin levels will be included in the study. The study
      will last 64 days and subjects will be asked to consume a breakfast and lunch prepared with a
      bouillon cube with isotope labeled iron during 3 periods of 5 consecutive days. The
      absorption of iron will be evaluated after every period and compared between the cubes.
    


Intervention name(s): Meals prepared with iron fortified cube with Low stabilizer level; Meals prepared with iron fortified cube with Medium stabilizer level; Meals prepared with iron fortified cube with High stabilizer level
Intervention type(s): Other; Other; Other
Intervention description(s): Meals prepared with iron fortified cube with Low stabilizer level; Meals prepared with iron fortified cube with Medium stabilizer level; Meals prepared with iron fortified cube with High stabilizer level
Intervention MeSH terms: Iron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Iron fortification; Bioavailability; Nigeria; Women; Bouillon cubes
Observational Study to Investigate the Effects of Training on the Administration of Cardioplexol™
Condition: Coronary Artery Bypass Surgery; Valve Surgery
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-center, open label, single group, observational study designed to evaluate
      the effects of a Cardioplexol™ preparation and administration training program proposed to
      cardiac surgeons and cardiotechnicians inexperienced in the use of Cardioplexol™.

      The training program aims at increasing the efficacy of Cardioplexol administration while
      reducing the risk of false manipulations. During the training possible risks and consequences
      of incorrect applications as well as the measures to take in case of administration error,
      are discussed. The training program includes one standardized theoretical part and one
      practical part consisting of a direct intra-operative coaching of surgeons practicing their
      first 2 operations.

      The effect of the training will then be assessed by evaluating each trained surgeon's 4 next
      consecutive patients operated with Cardioplexol and without the coach.
    


Intervention name(s): Cardioplegia Solution
Intervention type(s): Drug
Intervention description(s): Cardioplexol™ will be adminstered in cardiac surgery as cardioplegic solution
Other intervention name(s): Cardioplexol™
Intervention MeSH terms: Cardioplegic Solutions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Cardioplegic Solutions
Modified Pre-operative Oral Doses Acetaminophen Versus Intravenous Acetaminophen
Condition: Tonsillectomy; Adenoidectomy
Study type: Interventional
Phase: Phase 4

Summary: 
      Acetaminophen is frequently used as an adjunct for pain management in pediatric surgical
      patients. The drug is available in an over the counter, inexpensive oral form as well as a
      considerably more expensive intravenous form. This study will compare opioid requirements and
      acetaminophen plasma levels post operatively for two dosing regimens to compare oral versus
      intravenous routes given pre operatively.
    

Detailed description: 
      The primary purpose of this study is to compare opioid utilization in post-operative patients
      undergoing tonsillectomy and adenoidectomy, between IV and PO acetaminophen. Secondarily, it
      will provide information regarding possible cost savings, pharmacokinetics and safety between
      these two regimens.
    

Intervention name(s): Acetaminophen
Intervention type(s): Drug
Intervention description(s): already included in arm/group descriptions
Other intervention name(s): OFIRMEV
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Targeted Dose Finding of Canakinumab (ACZ885) for Management of Acute Flare in Refractory or Contraindicated Gout Patients
Condition: Acute Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 2

Summary: 
      This 8-week study is designed to determine the target dose of canakinumab (ACZ885) for the
      management of acute flare in gout patients who are contraindicated to Non-Steroidal
      anti-inflammatory drugs and/or colchicine. The efficacy of ACZ885 will be compared to the
      corticosteroid triamcinolone acetonide.
    


Intervention name(s): Canakinumab; Canakinumab; Canakinumab; Canakinumab; Canakinumab; Triamcinolone acetonide
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.; Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1.; Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1.; Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1.; Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once, on Day 1.; Randomized patients received triamcinolone acetonide 40 mg i.m. once and placebo matching canakinumab s.c. once, on Day 1.
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Antibodies, Monoclonal; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Acute flares; Gout; Anti-interleukin-1β monoclonal antibody; Colchicine; Triamcinolone acetonide
Study of Insulin Lispro in Participants With Inadequately Controlled Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Evidence regarding optimal methods of insulin dose adjustment is lacking in the literature.
      The purpose of this study is to evaluate the efficacy and safety of two approaches to
      escalate prandial insulin therapy in participants with type 2 diabetes mellitus not achieving
      adequate glycemic control on basal insulin.
    

Detailed description: 
      Participants who enter the study and are already taking insulin glargine with a screening
      HbA1c >7.0% will be randomized to one of two treatment arms. Both arms will add prandial
      insulin to existing basal insulin therapy.
    

Intervention name(s): Insulin lispro; Glargine
Intervention type(s): Drug; Drug
Intervention description(s): Administered subcutaneously, up to three times daily for 24 weeks; Administered subcutaneously, dosage determined by investigator once daily for 24 weeks
Other intervention name(s): Humalog; LY275585
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 Diabetes; Insulin; Algorithms; Blood glucose levels
Impact of Binaural Audition on Postural Performance and Orientation
Condition: Unilateral Cochlear Implants; Bilateral Cochlear Implants
Study type: Interventional

Summary: 
      This is a prospective research study talking place at University hospital of Dijon and
      requiring the inclusion of 20 healthy subjects, 10 patients with unilateral cochlear implants
      and 10 patients with bilateral cochlear implants to carry out:

        -  an audio-vestibular examination,

        -  a videonystagmoscopic study,

        -  a posturography study and

        -  a movement study. The aim of the study is to evaluate the impact of binaural audition on
           postural performance and orientation.
    


Intervention name(s): Audio-vestibular examination; Videonystagmoscopic study; Posturographies study
Intervention type(s): Other; Other; Other
Intervention description(s): Vestibular tests (videonystagmoscopy and head video impulse test), the tonal and vocal audiogram and the localigramme to the cochlear implanted subjects. Tonal audiometry and localigramme to the healthy subjects.; Rotating sound stimulation on a rotatory armchair and a laborer of Fukuda with sound stimulation and questionary before and after examination.; (stabilometry, sensory preferences, indications of energy consumption) with stereophonic stimulation and questionnaire before and after the examination.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
DP-R208 Pharmacokinetic Study
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      An open label, randomized, 2-sequence, 2-period, single-dose cross-over study to evaluate the
      pharmacokinetics characteristics of DP-R208 (Candesartan cilexetil 8mg/Rosuvastatin 10mg), a
      fixed dose combination compared with coadministration of separate constituents in healthy
      adult volunteers
    


Intervention name(s): DP-R208; Candesartan cilexetil; Rosuvastatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Investigational product is prescribed to all of randomized subjects; Investigational product is prescribed to all of randomized subjects; Investigational product is prescribed to all of randomized subjects
Intervention MeSH terms: Candesartan; Candesartan cilexetil; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DP-R208
Effects of Lipemia and Metformin on Endothelial Function
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Eating a diet high in fat contributes to the development of atherosclerosis (hardening of the
      arteries). Acute fat consumption increases levels of fat in the blood and temporarily reduces
      the ability of blood vessel to dilate (open up to carry additional blood). A similar response
      is observed during infusion of Intra-Lipid (a fat emulsion used for intravenous nutrition).
      The present study is designed to help us understand the effects of a fat load on blood vessel
      function. We will measure arterial dilation using non-invasive techniques before and at the
      end of a 5-hour infusion of Intra-Lipid in healthy subjects. Subjects will then take the
      approved drug metformin for two weeks and return for repeat studies of endothelial function
      with Intra-Lipid infusion. We expect that metformin will help preserve the normal function of
      blood vessels during a fat load. This study will help us understand how fat affects blood
      vessels and therefore will advance our knowledge of the development of atherosclerosis and
      potentially lead to improved methods to prevent and treat heart disease.
    


Intervention name(s): Metformin
Intervention type(s): Drug
Intervention description(s): Metformin 1 gram per day
Intervention MeSH terms: Metformin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: endothelium; cardiovascular disease; dietary fat; insulin resistance
Cervical Intraepithelial Neoplasm (CIN)-Warts Efficacy Trial in Women (Gardasil)(V501-013)(COMPLETED)
Condition: Cervical Cancer; Genital Warts
MeSH terms: Warts; Condylomata Acuminata; Uterine Cervical Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary purpose of the study is to determine if GARDASIL (V501) with four components is
      able to prevent cervical cancer, cervical dysplasia, including Cervical Intraepithelial
      Neoplasia (CIN)(Any Grade) and Adenocarcinoma In Situ (AIS), and genital warts.
    


Intervention name(s): V501; Comparator: Placebo; Human Papillomavirus (HPV) 16 Monovalent
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Final Manufactured Product (FMP) quadrivalent HPV vaccine, a 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.; a 0.5 mL intramuscular placebo injection given at Day 1, Month 2 and Month 6.; HPV 16 Monovalent vaccine, a 0.5 mL intramuscular injection given at Day 1, Month 2 and Month 6.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
ROTATEQ Reexamination Study (V260-037)
Condition: Gastroenteritis Rotavirus
MeSH terms: Gastroenteritis
Study type: Observational

Summary: 
      This survey is conducted for preparing application materials for re-examination under the
      Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the
      clinical usefulness of Rotateq through collecting the safety information according to the
      Re-examination Regulation for New Drugs.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        6-32 week old Korean Infants who are vaccinated with Rotateq in usual practice
      
Keywords: Gastroenteritis rotavirus
Glucose Monitor Accuracy Investigation (Ⅰ)
Condition: Healthy
Study type: Observational

Summary: 
      According to Section 7.3 and Section 7.4, ISO 15197(2003), it adopts the whole blood of
      fingertips and vein as samples to evaluate the accuracy of portable BGM.
    

Detailed description: 
      The clinical medical technologists collected blood samples from 308 volunteers including 87
      diabetics and 221 healthy people. The range of the blood glucose concentration was from
      41.2mg/dL to 521mg/dL. The result of clinic evaluation shows that the accuracy of BGM matches
      the requirement of ISO15197(2003).
    

Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The glucose concentrations of volunteer shall be distributed as specified in ISO15197 Table
        3