bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Compare the Efficacy of Fluticasone Furoate/Vilanterol Inhalation Powder With Usual Inhaled Corticosteroids (ICS)/Long Acting Beta Agonists (LABA) in Persistent Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The combination of FF, an ICS and VI, an orally inhaled LABA has been developed as a
      once-daily combination therapy for the long-term maintenance treatment of asthma in adults
      and children >=12 years of age. Pivotal phase III studies have demonstrated the safety and
      efficacy of FF/VI in asthma. However, it is increasingly acknowledged that randomised
      clinical trials tend to be highly controlled and enrol a more highly selected subject
      population than is expected to be prescribed the medication post-approval. There is a need
      for data in a more representative population in close to a 'real life' conditions, where
      physicians have the ability to choose the best treatment in their view for any individual
      subject and adapt treatments to subjects' characteristics and response. This multi-center,
      open-label, randomized, parallel group study will evaluate the efficacy and safety of FF/VI
      compared with two usual ICS/LABA fixed combination (fluticasone propionate/salmeterol [FP/S]
      or budesonide/formoterol [BUD/F]) in subjects with persistent asthma, in a "close to real
      life" settings. FF/VI will be administered once-daily (QD) via ELLIPTA dry powder inhaler
      (DPI) and FP/S or BUD/F will be administered twice daily (BID) via DISKUS™ and TURBUHALER™
      DPI respectively. ELLIPTA is a new powder inhaler designed to be easy to use. The total
      duration of subject participation will be approximately 6 months (24 weeks). ELLIPTA and
      DISKUS are registered trademarks of the GSK group of companies. TURBUHALER is a registered
      trademark of AstraZeneca.
    


Intervention name(s): Fluticasone Furoate; Vilanterol; Fluticasone propionate; Salmeterol; Budesonide; Formoterol Fumarate
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): FF 92 mcg or 184 mcg blended with lactose administered once daily via ELLIPTA DPI; Vilanterol 22 mcg blended with lactose and magnesium stearate administered once daily via ELLIPTA DPI; FP 250 mcg or 500 mcg blended with lactose administered twice daily via DISKUS DPI; Salmeterol 50 mcg blended with lactose administered twice daily via DISKUS DPI; Budesonide 200 mcg or 400 mcg blended with lactose administered twice daily via TURBUHALER DPI; Formoterol Furoate 6 mcg or 12 mcg blended with lactose administered twice daily via TURBUHALER DPI
Intervention MeSH terms: Fluticasone; Xhance; Budesonide; Formoterol Fumarate; Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dry powder inahler; vilanerol; efficacy; safety; fluticasone furoate; quality of life
Study of PF-04965842 Effect on Dabigatran Pharmacokinetics in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, 2 way crossover, single dose, open label study of the effect
      of PF 04965842 on dabigatran PK in healthy participants. Participants will be randomized to 1
      of 2 treatment sequences as described below. A total of 20 healthy male and/or female
      participants will be enrolled in the study so that 10 participants will be enrolled in each
      treatment sequence. Each treatment sequence will consist of 2 periods that are each 3 days in
      duration. The total duration of participation from the Screening Visit to Day 7 will be a
      maximum of 35 days and from the Screening Visit to Follow-up Contact/Visit will be a maximum
      of 70 days.
    


Intervention name(s): PF-04965842; Dabigatran
Intervention type(s): Drug; Drug
Intervention description(s): Single oral 200 mg dose of PF-04965842; Single 75 mg dose of dabigatran
Intervention MeSH terms: Dabigatran; Abrocitinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Curcumin Biomarker Trial in Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Early Phase 1

Summary: 
      There is considerable evidence that turmeric consumption may have a protective effect against
      cancer progression. The purpose of this study is to examine the short-term effects of
      supplementation with a turmeric extract, Curcumin C3 Complex®, on biomarkers of head and neck
      squamous cell carcinoma (HNSCC).
    

Detailed description: 
      This is an open label, exploratory biomarker trial of the food substances Curcumin C3
      Complex® in subjects with newly diagnosed HNSCC. Curcumin, a novel safe nutritional
      interventional agent has exciting potential usage as a preventive/adjuvant agent, and
      prevents tumor formation by inhibiting an important molecular pathway that is shown to cause
      cancer progression, which we will test as a tumor marker in this clinical trial.

      The primary objective is to evaluate biomarker response of HNSCC patients to the food
      substances Curcumin C3 Complex®. This will be done by comparing post-intervention values to
      baseline values. In addition, we will determine the levels of curcumin and its metabolites in
      tumor and adjacent tissue.
    

Intervention name(s): Microgranular Curcumin C3 Complex®
Intervention type(s): Drug
Intervention description(s): 4 grams twice daily for 21-28 days
Intervention MeSH terms: Curcumin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: cancer
Wavefront Analisys and Contrast Sensitivity of Spherical and Aspherical Intraocular Lenses
Condition: Cataract; Pseudophakia
MeSH terms: Cataract; Pseudophakia
Study type: Interventional
Phase: Phase 4

Summary: 
      Purpose:To compare visual performance, total and high order wavefront aberrations (coma,
      spherical aberration and other terms) and contrast sensitivity in eyes implanted with one
      monofocal aspheric intraocular lens (IOL) and two spherical IOLs (SofPort AO,
      Soflex,AcrySof®IQ (40 eyes), AcrySof®Natural and AMO®Sensar)
    


Intervention name(s): phacoemulsification (cataract surgery)
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Cesarean Niche Examination by Transvaginal us
Condition: Cesarean Section; Dehiscence
Study type: Observational

Summary: 
      The developed uterine scar developing due to cesarean section is usually clinically evaluated
      and visualized by transvaginal sonography (TVS) and saline infusion sonography (SIS) or Gel
      installation sonography (GIS)
    

Detailed description: 
      In 2015, WHO displayed and reveled a systematic review of the research studies in the
      scientific literature to evaluate and asses the linkage and connection between cesarean
      section rates and maternal
    

Intervention name(s): transvaginal us with 2D and 3D SHG
Intervention type(s): Diagnostic Test
Intervention description(s): transvaginal us is made to all women with SHG
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        In 2015, WHO displayed and reveled a systematic review of the research studies in the
        scientific literature to evaluate and asses the linkage and connection between cesarean
        section rates and maternal,
A Randomized, Phase I, Cross-Over Study to Assess the Relative Bioavailability of Single-Dose Cobimetinib (GDC-0973) in Tablet vs. Capsule Formulation
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be a Phase 1, open-label, randomized, 2-period, 2-treatment sequence
      crossover study to determine the relative bioavailability of cobimetinib administered as a
      single dose of the tablet formulation relative to a single dose of the capsule formulation to
      healthy male and female participants. A minimum of 24 participants (12 participants per
      sequence) will complete the study. Participants will be randomly assigned to 2 possible
      sequences (i.e., I: A/B, II: B/A) where the treatments are as follows: Treatment A: One
      cobimetinib tablet administered as a single oral dose after at least an 8-hour fast;
      Treatment B: Four cobimetinib capsules administered as a single oral dose after at least an
      8-hour fast. The study is expected to last approximately 7 weeks.
    


Intervention name(s): cobimetinib; cobimetinib
Intervention type(s): Drug; Drug
Intervention description(s): Single, oral dose given as a tablet on Day 1 after a minimum 8 h fast; Single, oral dose given as 4 capsules on Day 1 after a minimum 8 h fast
Other intervention name(s): GDC-0973, XL-518; GDC-0973, XL-518
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
S1 Transforaminal Injection and Vascular Incidence
Condition: Inadvertent Arterial Puncture
Study type: Interventional

Summary: 
      Intravascular incidence during S1 transforaminal injection is known to be higher than lumbar
      injection. Its incidence is reported to be 15~25%.

      This study was aimed to see if there is any benefit of reducing the intravasuclar injection
      rate when S1 transforaminal injection was performed by different fluorosopic approach.
    

Detailed description: 
      Fluorosocpically guided transforaminal epidural steroid injection is a popular interventional
      procedure that is effective in radicular pain conditions such as herniated interverebral
      disc, spinal stenosis and failed back surgery syndrome.

      The incidence of inadvertent intravascular needle injection during lumbar transforaminal
      injection is reported as from 9.9% to 30.8%. In particular, S1 intravascular injection rate
      is more frequent than at the lumbar level.

      Previous study reported that guiding the needle toward the S1 foramen using the S1 scotty dog
      image as a bony landmark, not in the classic way, but in an oblique fluoroscopic view, during
      L5 and S1 transforaminal epidural steroid injection, can save procedure time and reduce the
      risk of radiation exposure.

      In this stidy, the investigators aimed to compare the incidence of intravascular injection
      rate by anteroposterior and oblique view approaches for S1 transforaminal epidural steroid
      injection. In addition, the investigators also compared the procedure time and radiation
      exposure between two approach method.
    

Intervention name(s): tranforaminal epidural injection
Intervention type(s): Procedure
Intervention description(s): tranforaminal epidural injection which is performed by fluoroscopic guidance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: intravascular injection transforaminal injection
The Effects of Long-acting Methylphenidate on Academic Activity and Related Constructs in Children With ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims at investigating the direct effects of methylphenidate on school performance
      of primary school children. Although behavioral effects of this frequently prescribed drug
      are thoroughly studied (and confirmed), the effects of methylphenidate on school performance
      are less clear. Recent overviews indicate that effects are mainly quantitative and
      subject-specific. To gain more insight in this issue, the current double blind placebo
      controlled crossover study investigates not only the effects of methylphenidate on school
      performance but also it's effect on related variables such as short term memory, motivation
      and behavior. 60 children with ADHD are included and tested twice (with medication and with
      placebo) at their primary school.
    

Detailed description: 
      Rationale: ADHD (attention deficit hyperactivity disorder) is a common childhood
      developmental disorder. Besides the behavioural symptoms of ADHD, many children with ADHD
      experience problems with academic activities. More specifically, these children show problems
      with math, spelling and reading. The most common treatment for ADHD is medical treatment with
      methylphenidate (MPH). This treatment is effective in the reduction of ADHD symptoms.
      However, it is unclear whether treatment with MPH can also improve academic activity. If MPH
      improves academic activity, it is of great interest to understand which variables influence
      or mediate this effect. The results from this study can give more insight in the working
      mechanisms and effectiveness of MPH in reducing the academic problems commonly observed in
      children with ADHD.

      Objectives: The main objective of this study is to assess the impact of MPH on academic
      activity and to estimate the role of three putative mediators in this relation.

      Study design and population: This study is a randomised, double-blind, placebo-controlled
      cross-over design with a patient group and a control group. Main study parameters/endpoints:
      The main study parameters are changes in academic activity (ability, effort and engagement).
      In addition, changes in putative mediators are assessed.
    

Intervention name(s): Methylphenidate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Drug: Methylphenidate; Drug: Placebo
Other intervention name(s): Equasym; empty capsule
Intervention MeSH terms: Methylphenidate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; Methylphenidate; Academic; Motivation
Effects of Trunk Exercise on Trunk Control and Balance in Persons With Stroke
Condition: Cerebrovascular Accident; Balance Impairment
MeSH terms: Stroke
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study examined the effects of trunk exercise on unstable surfaces on trunk control and
      balance for persons in the sub-acute stage of stroke. The hypothesis was that, compared to
      upper limb exercises in well supported sitting position, this exercise would lead to better
      trunk control and sitting and standing balance. The results supported the hypothesis.
    

Detailed description: 
      Inpatients in the sub-acute stage of stroke were randomly assigned to receive upper limb
      range of motion exercises in well supported sitting position or trunk exercises on unstable
      surfaces in supine and sitting, 30 min per session, 2 sessions per week for 6 weeks, in
      addition to their daily conventional stroke rehabilitation. Sensorimotor functions, including
      hand grip strength, plantar sensitivity, stroke rehabilitation assessment of movement and
      Fugl-Meyer lower extremity motor scale, and clinical outcome assessments, including Trunk
      Impairment Scale and 6-meter walk test, were conducted by a blinded assessor. Biomechanical
      outcome measures included center of pressure area while maintaining static posture and peak
      displacement while leaning forward, and the average speed of the unaffected arm raising (to
      represent the ability to provide a stable foundation for focal movement). These measures were
      taken in sitting without foot support, sitting with foot support and standing to reflect
      trunk control, sitting balance and standing balance, respectively.
    

Intervention name(s): trunk exercise on unstable exercise; Upper limb range of motion exercise
Intervention type(s): Other; Other
Intervention description(s): Participants would receive exercises on unstable surface. Started from supine position, participants had abdominal drawer-in maneuver with soft foam under the pelvic. Lower trunk rotation, bridging and abdominal muscles isometric contraction exercises were also used in this exercise during supine position, with different unstable surfaces used. Including soft foam under the feet, then progressed to BOSU ball under the feet, then progressed to the a BOSU ball under the feet combined with pelvic on soft foam. During sitting, BOSU ball and Swiss ball were used as unstable surface. Pelvic anterior-posterior tilt, lateral tilting, rotation, lifting, and stepping with arm swing were used in this position.; Upper limb range of motion exercise with trunk fully supported
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: stroke; balance; Trunk exercise; Trunk control; standing
Dasotraline Binge Eating Disorder Extension Study
Condition: Binge Eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      Binge Eating Disorder Extension Study.
    

Detailed description: 
      This is a Phase 3, 12 month, multicenter, open-label, flexibly-dosed, safety study in adults
      with Binge Eating Disorder.
    

Intervention name(s): Dasotraline
Intervention type(s): Drug
Intervention description(s): Dasotraline 4, 6, 8 mg flexibly dosed once daily
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dietary Fiber Mixture in Constipated Pediatric Patients
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose this study was to to evaluate the therapeutic effect of a fibers mixture in the
      treatment of chronic constipation and on the colonic transit time in children.
    

Detailed description: 
      In spite of an increase in the consumption of fibers being indicated for the treatment of
      constipation, few clinical trails have evaluated its efficiency. In the majority of prior
      studies only the effect of a single type of fiber was evaluated. Each type of fiber presents
      a particular characteristic, which determines its action mechanism and performance in
      different parts of the colon. Therefore, theoretically, greater effectiveness could well be
      observed when different types of fibers are associated into a single product for fiber
      supplementation.

      A randomized, parallel, double-blind, controlled was performed to evaluate the effect of a
      dietary fiber mixture in constipated pediatric patients.

      Children aged between 4 and 12 years were included in the study and the initial diagnosis of
      functional chronic constipation was made in accordance with the Rome III criteria. The
      children having attended the Pediatric Gastroenterology Ambulatory of the Federal University
      of Sao Paulo and the Santa Casa de Misericórdia hospital in Sao Paulo city. All of the
      children were undergoing constipation maintenance treatment with the use of a laxative in a
      dosage less than 1.0 ml/Kg for milk of magnesia, mineral oil or lactulose or less than 0.5
      g/Kg for polyethylene glycol 3350.
    

Intervention name(s): Dietary Fiber Mixture
Intervention type(s): Dietary Supplement
Intervention description(s): During the four weeks the patients received fiber mixtures (intervention) or maltodextrine as the placebo. The fiber mixture was composed of six different types of fibers: 10.5% fructooligosaccharides, 12.5% inulin, 24% Arabic gum, 9% resistant starch, 33% Soya polysaccharide e 12% cellulose.
The dose was defined in accordance with the child's body weight: 6.3 grams of fiber supplement, which corresponds to 4.8 g of fiber, or placebo(1 table spoon) twice per day, diluted in 200 mL of a milky chocolate drink for children weighing up to 18 kg; 12.6 grams of fiber supplement, which corresponds to 9.6 g of fiber, or placebo (2 table spoons) twice per day, diluted in 200 mL of a milky chocolate drink for children weighing more than 18 Kg.
Other intervention name(s): Stimulance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: dietary fiber; clinical trial; constipation; children
Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis (ALS)
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to confirm the efficacy of 60 mg of MCI-186 via
      intravenous drip once a day in patients with ALS based on the changes in the revised ALS
      functional rating scale (ALSFRS-R) scores after 24 weeks administration in double-blind,
      placebo-controlled manner. And in addition, this study will be performed to examine the
      safety of MCI-186 to ALS patients.
    


Intervention name(s): MCI-186; Placebo of MCI-186
Intervention type(s): Drug; Drug
Intervention description(s): Two ampoules (60 mg) of MCI-186 injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).; Two ampoules of placebo injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). Then treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).
Other intervention name(s): Edaravone; Radicut
Intervention MeSH terms: Edaravone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Amyotrophic lateral sclerosis; free radical scavenger
Levothyroxine Sodium in Thyroidectomized Patients Taking Proton Pump Inhibitors
Condition: Hypothyroidism;Postablative
MeSH terms: Hypothyroidism
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an open-label therapeutic efficacy study of Tirosint (levothyroxine sodium) capsules
      in thyroidectomized patients taking proton pump inhibitors and levothyroxine, evaluating
      changes in serum levels of Thyroid Stimulating Hormone (TSH) upon switch to Tirosint with
      respect to baseline.
    


Intervention name(s): levothyroxine sodium capsule; Proton pump inhibitor (PPI); Levothyroxine Sodium (LT4) Tablets
Intervention type(s): Drug; Drug; Drug
Intervention description(s): after the run-in period, patients will be switched to levothyroxine sodium capsule at the same dose used during run-in; for the whole study duration all subjects will keep taking their proton pump inhibitor medication, as per prescription and as before inclusion; during the run-in period, subjects will continue taking their levothyroxine sodium tablet medication as per prescription and as before inclusion
Other intervention name(s): Tirosint; omeprazole, esomeprazole, lansoprazole, dexlansoprazole, pantoprazole, rabeprazole
Intervention MeSH terms: Esomeprazole; Omeprazole; Rabeprazole; Pantoprazole; Lansoprazole; Dexlansoprazole; Proton Pump Inhibitors
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment