bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Hall Technique and Atraumatic Restorative Treatment for Management of Caries in the Primary Dentition
Condition: Primary Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The aim of the present study is to evaluate both Hall technique and atraumatic restorative
      technique in comparison to the conventional restorative technique in the management of
      carious lesions in primary molars.
    

Detailed description: 
      This study is a three arm randomized controlled clinical trial. Eligible children will be
      selected from the outpatient clinic of Pediatric Dentistry and Public Health Department,
      Faculty of Dentistry, Alexandria University after securing necessary consents. One hundred
      and fifty five teeth will be randomly allocated into 3 groups fifty two each. Group I will be
      assigned to Hall technique Group II will be assigned to atraumatic restorative treatment
      using Glass ionomer cement, and Group III will be assigned to a conventional restoration and
      will serve as a control.
    

Intervention name(s): Hall technique; Atraumatic restorative treatment; Conventional restorative treatment
Intervention type(s): Other; Other; Other
Intervention description(s): Orthodontic separators will be used to create space for fitting the stainless crown, then removed after 3-5 days
Occlusion will be measured assessing the patient's occlusal-vertical dimensions (OVD) using a modified version of van der Zee and van Amerongen method with a millimeter probe measuring the distance from the lowest point of the gingiva, around the lower canine on the vestibular side up to the point where the tip of the upper canine ends in order to assess the degree of overbite after mounting of the crown.
The correct crown size will be selected. The crown should cover all the cusps and approaches the contact points, with a slight feeling of "spring back." till reaching the gingival margin. Cementation will be done using glass ionomer cement; Caries removal using excavators, then restoration using glass ionomer (GIC); Complete caries removal using high-speed hand piece, and an excavator to clear carious dentin from the pulpal wall. Then, stainless steel crown preparation, selection of the proper size with the smallest crown size that completely covers the preparation chosen. The correct occlusogingival crown length will be established. Cementation will be done using glass ionomer cement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
The Physiological Response to Routine Head and Neck Cancer Surgery
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Observational

Summary: 
      The main objective of this pilot study is to observe and document the range of changes in the
      blood concentrations of certain hormones, inflammatory chemicals and immune chemicals in
      response to the stimulus of Head and Neck cancer
    

Detailed description: 
      This project is in keeping with the strategy of the anaesthetic and intensive care
      departments to push towards greater understanding of the immune, metabolic and inflammatory
      changes associated with surgery and how these may be modified through use of different
      anaesthetic and intensive care techniques. Through increased understanding of the stress,
      inflammatory and immune responses to surgery we may be able to modulate peri-operative care
      to reduce cytotoxic(Natural Killer and Cytotoxic T cell) immunosuppression and hence
      micrometastatic spread at the time of surgery in future studies.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with a diagnosis of cancer involving the head and neck region of the body.
Bioequivalence Study of Sitagliptin Hydrochloride / Metformin Hydrochloride Extended-release Film Coated Tablets 50 mg /500 mg (FDC) in Healthy Adult Male and Female Subjects Under Fed Conditions.
Condition: Bioequivalence; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to evaluate and compare the bioavailability and therefore to
      assess the bioequivalence of two different formulations of sitagliptin/metformin extended
      release tablets after a single oral dose administration under fed conditions.
    


Intervention name(s): Sitagliptin/Metformin HCl 50/500 mg extended release film-coated tablet
Intervention type(s): Drug
Intervention description(s): The subjects randomly received single oral dose of Sitagliptin/Metformin HCl 50/500 mg extended release film-coated tablet (Test or reference)
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Study to Determine the Utility of FES-PET in the Prediction of Response to Fulvestrant in Women With Estrogen Positive Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Effects of fulvestrant on the ERs may be evaluable by molecular imaging using positron
      emission tomography with the ER-specific FES tracer. In this study we will determine the
      utility of FES-PET in the prediction of response to fulvestrant 500 mg in women with estrogen
      positive metastatic breast cancer
    

Detailed description: 
      More than 70% of patients with metastatic breast cancer present with hormone receptor
      positive disease and for whom hormonal therapy is the preferred treatment approach.
      First-line treatment recommendations for women with hormone receptor positive locally
      advanced or metastatic disease includes a generation aromatase inhibitors or tamoxifen.
      Fulvestrant, a 17β-estradiol analog, is an antiestrogen that suppresses estrogen signaling by
      binding to ER and inducing oestrogen receptor degradation and has estrogen antagonistic
      activity but no estrogen agonistic effect. Fulvestrant has been shown to have superiority
      over other endocrine therapy in a series of randomized controlled trials.

      The whole-body imaging of the availability of ER using FES-PET may prove valuable to evaluate
      the effects of fulvestrant on the ER non-invasively in individual patients. This potentially
      allows early prediction of therapy efficacy to fulvestrant in women with estrogen positive
      metastatic breast cancer.

      In this pilot-study we will evaluate 35 patients who received fulvestrant as treatment for
      metastatic breast cancer. All patients will undergo FES-PET/CT at baseline and FES-PET after
      28 days. Whenever possible, tumor biopsies will be performed to correlate to FES-PET results.
    

Intervention name(s): Fluoroestradiol (18F)
Intervention type(s): Drug
Intervention description(s): A FES-PET/(CT) will be performed twice during protocol execution. Patients will be injected with approximately 222 MBq 18F-FES each time.
Intervention model: Single Group Assignment
Intervention model description: All patients will undergo FES-PET/CT at baseline and FES-PET after 28 days of fulvestrant treatment. Whenever possible, tumor biopsies will be performed to correlate to FES-PET results.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fulvestrant 500 mg; fluorine-18 fluoroestradiol PET-CT
Targeted Management Intervention for African-American Men With TIA or Stroke
Condition: Stroke; Transient Ischemic Attack (TIA)
MeSH terms: Stroke; Ischemic Attack, Transient
Study type: Interventional

Summary: 
      Stroke is the leading cause of disability, third leading cause of death, and one of the most
      resource-intensive diseases among Americans. African-Americans (AA) have a stroke rate nearly
      double that of Euro-Americans (EA), and AA who experience a first-ever stroke are younger,
      have greater stroke disability, more post-stroke complications, and slower recovery compared
      to EA.
    


Intervention name(s): Psychoeducation
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Stroke; TIA; African American
Extracorporeal Photopheresis (ECP) With Methoxsalen for Chronic Graft Versus Host Disease (cGVHD)
Condition: Chronic Graft Versus Host Disease
MeSH terms: Bronchiolitis Obliterans Syndrome; Graft vs Host Disease
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Chronic graft-versus-host disease (cGVHD) is a long-lasting complication that can occur after
      transplants. The transplanted cells seem to fight with the patient's own cells.

      Extracorporeal photopheresis (ECP) is a fairly new procedure for cGVHD. The participant gets
      a port to hook up to a machine. The machine removes the white blood cells, mixes them with a
      light-sensitive drug, shines light on it, and puts all the blood back in.

      This study will find out if patients respond better if they get ECP with methoxsalen, in
      addition to the pills normally used to treat cGVHD.
    

Detailed description: 
      The investigation of extracorporeal photopheresis (ECP) plus standard of care (SoC) (SoC+ECP)
      in chronic graft-versus-host disease (cGVHD) within prospective, randomized clinical studies
      is limited, despite its frequent clinical use.

      This phase 1/pilot study was the first randomized, prospective study to investigate ECP use
      as first-line therapy in cGVHD, based on the 2015 National Institutes of Health (NIH)
      consensus criteria for diagnosis and response assessment.

      Adult patients with new-onset (≤3 years of hematopoietic stem cell transplantation) moderate
      or severe cGVHD were randomized 1:1 to 26 weeks of SoC+ECP vs SoC (corticosteroids and
      cyclosporine A/tacrolimus) between 2011 and 2015. The primary endpoint was overall response
      rate (ORR), defined as complete or partial response, at week 28 in the intention-to-treat
      population (ITT).
    

Intervention name(s): ECP Methoxsalen; Standard of Care
Intervention type(s): Drug; Drug
Intervention description(s): Methoxsalen delivered by ECP; Tapered prednisone with cyclosporine or tacrolimus via oral administration, consistent with local institutional practice (corticosteroids and cyclosporine A/tacrolimus)
Other intervention name(s): Uvadex; Extracorporeal photopheresis (ECP); Reference therapy
Intervention MeSH terms: Methoxsalen
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Pilot Study for the 2015 NIH Consensus Criteria to inform the design of subsequent studies
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Extracorporeal photopheresis therapy; Methoxsalen; cGVHD; hematopoietic stem cell transplantation
Study of the Effects of the Pulsed-dye Laser at 585nm and 595nm to Treat Post-operative Scars on Suture-removal Day
Condition: Cicatrix; Scars
MeSH terms: Cicatrix
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effects of the pulsed-dye laser (PDL) at two
      different wavelengths, 585nm and 595nm, in the treatment of post-surgical scars starting on
      suture-removal day.
    

Detailed description: 
      Many treatment modalities have been used for the treatment of scars such as dermabrasion,
      cryotherapy, intralesional corticosteroids, surgical scar revision, and lasers, among others.
      Previous studies have shown that treatment of scars with the pulsed dye laser (PDL) alone or
      in combination with other modalities (e.g. corticosteroids, 5-Fluoruracil, silicone sheets)
      improves the vascularity, pliability, color, and height of hypertrophic scars and keloids.
      Currently, the PDL has become the laser of choice for the treatment of scars.

      To our knowledge, there are no reports in the literature comparing the effects of different
      wavelengths of the PDL for the treatment of scars. The objective of this study was to compare
      the effects of the PDL at 585nm vs 595nm in the treatment of postsurgical linear scars
      starting the day of suture removal.
    

Intervention name(s): PDL 450 microseconds; PDL 1.5 milliseconds
Intervention type(s): Procedure; Procedure
Intervention description(s): The scar will be randomly divided into three equal fields. One third of the scar will receive PDL 585 nm using a 7 mm spot size at 4.0 J (Joules) for 450 microseconds. First treatment will be immediately after suture removal, and then monthly for 3 months.; The scar will be randomly divided into three equal fields. One third of the scar will receive PDL 585 nm using a 7 mm spot size at 4.0 J (Joules) for 1.5 milliseconds. First treatment will be immediately after suture removal, and then monthly for 3 months.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pulsed-Dye Laser
Dexmedetomidine on Pediatric Heart Operation
Condition: Acute Renal Injury
MeSH terms: Acute Kidney Injury
Study type: Interventional

Summary: 
      we hypothized dexmedetomidine could reduce the reduction of renal function after
      cardiopulmonary bypass weaning in pediatric patients
    

Detailed description: 
      dexmedetomidine, a2-adrenoreceptor agonist has been used for sedation or hemodynamic
      stability for operative procedure. It had been already reported that dexmedetomidine reduce
      the impairment of renal functon after cardiac operation in adult. we hypothized
      dexmedetomidine could reduce the reduction of renal function after cardiopulmonary bypass
      weaning in pediatric patients
    

Intervention name(s): Dexmedetomidine; no dexmedetomidine
Intervention type(s): Drug; Drug
Intervention description(s): administration of dexmedetomidine on dexemedetomidine group; no administration of dexmedetomidine on control group
Other intervention name(s): administration of dexmedetomidine; no administration of dexmedetomidine
Intervention MeSH terms: Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Effects of Ketogenic Diet in Body Builders
Condition: Diet, Healthy; Body Weight
MeSH terms: Body Weight
Study type: Interventional

Summary: 
      the study sought to investigate the influence of 8 weeks of a very low carbohydrate ketogenic
      diet on body composition, muscle strength, muscle area and blood parameters in competitive
      natural body builders.
    

Detailed description: 
      nineteen natural body builders were randomly assigned to a ketogenic diet (KD) group or to a
      normal diet group (ND) with a traditional meal pattern. The two diets were isocaloric and
      included the same amount of protein per kg of body weight; but differed in the distribution
      of fats and carbohydrates; the latter were kept below 5% daily (less than 50g/day) in the KD
      group while represented 55% of the caloric intake in the WD group During the experimental
      period, training loads were similar in the two groups. Athletes were tested before and after
      8 weeks of the intervention. Body composition , basal metabolism, muscle strength and blood
      parameters were measured.
    

Intervention name(s): Ketogenic Diet; Normal Diet
Intervention type(s): Other; Other
Intervention description(s): KD group consumed less than 50g/day of carbohydrates; ND group consumed 55% of the caloric intake from carbohydrates
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
Keywords: ketogenic diet; body builders; athletes; body composition; hormones
A Safety & Efficacy Study of Treatment With AP1189 in Rheumatoid Arthritis Patients naïve to DMARD Treatment
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is a multicenter, randomized, double-blind, placebo-controlled study to evaluate
      the safety and efficacy of 12 weeks daily treatment with 100 mg AP1189 in RA patients who are
      to start up-titration with methotrexate (MTX).
    


Intervention name(s): 100 mg AP1189; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): AP1189 tablets for oral use; Matching placebo for oral use
Other intervention name(s): AP1189 tablets for oral use
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multi-center, randomized, double-blind, placebo-controlled study with 12 weeks of treatment with AP1189 or placebo
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Reperfuse Ischemic Vessels With Endovascular Recanalization Device in JAPAN (RIVER JAPAN)
Condition: Acute Ischemic Stroke
MeSH terms: Ischemic Stroke; Ischemia
Study type: Interventional

Summary: 
      The main objective of this study is to document that the thrombectomy catheter (Rev-01) is
      effective and safe when used for revascularization in subjects with acute ischemic stroke
      within 8 hours of symptom onset who are ineligible for treatment with IV t-PA, or in whom
      treatment with IV t-PA has been ineffective.
    


Intervention name(s): Rev-01
Intervention type(s): Device
Intervention description(s): Treatment arm patients have used Rev-01 at least once
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ischemia; Stroke; Ischemic Stroke; Thrombectomy; Brain clot; Cerebrovascular disease; Recanalization; Revascularization; Clot Retriever; Neurovascular Intervention; Interventional Neuroradiology; neurovascular clinical trial
Observation of Side Effects and Effectiveness of Desloratadine (Aerius) Syrup in Filipino Children (Study P05634)
Condition: Rhinitis, Allergic, Seasonal; Rhinitis, Allergic, Perennial; Urticaria
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal; Rhinitis, Allergic, Perennial; Urticaria
Study type: Observational

Summary: 
      The purpose of this study is to observe the side effects of desloratadine syrup and how
      effective it is in relieving symptoms of allergic rhinitis or hives in Filipino children. The
      participants will take desloratadine syrup for 14 days. At the end of treatment, side effects
      will be recorded, as well as how the participants tolerate the medication. Effectiveness will
      also be rated at the end of treatment.
    

Detailed description: 
      Physicians who commonly prescribed desloratadine treatment as standard care of treatment were
      selected enroll participants.
    

Intervention name(s): Desloratadine Syrup
Intervention type(s): Drug
Intervention description(s): Desloratadine (Aerius) Syrup;
Dose selection was based upon the age of the participant, and the timing of dose for each participant was once daily (QD) as described in the Product Insert for 14 days:
Children 6 through 11 years of age, 5 mL (milliliters) of Aerius Syrup (2.5 mg [milligrams] of desloratadine)
Children 1 through 5 years of age, 2.5 mL of Aerius Syrup (1.25 mg of desloratadine)
Children 6 months to 11 months of age, 2 mL of Aerius Syrup (1 mg of desloratadine)
Other intervention name(s): Aerius, Clarinex, SCH 34117, descarboethoxyloratadine
Intervention MeSH terms: Desloratadine
Observational model: Ecologic or Community
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A total of 3000 prospective outpatient pediatric participants with either allergic rhinitis
        or chronic idiopathic urticaria will be enrolled in the study coming from about 300 sites
        in the Phillipines
An Iron-containing Food Product for the Prevention of Diminished Iron Status in Soldiers
Condition: Iron Deficiency; Iron Deficiency Anemia
MeSH terms: Anemia, Iron-Deficiency; Iron Deficiencies
Study type: Interventional

Summary: 
      Military personnel face intense physical and cognitive demands. Diminished iron status
      affects physiologic responses to these challenges. Both cross-sectional and longitudinal
      studies indicate a significant decrement in iron status in enlisted female military personnel
      immediately following basic combat training (BCT). Decrements in iron status are associated
      with diminished cognitive and physical performance, and may affect body composition. The
      primary objective of this randomized, placebo controlled study is to assess the utility of an
      iron-containing food product for maintaining iron status during BCT. This study will provide
      insight into the utility and efficacy of an iron-containing food product for the maintenance
      of iron status during military training. Furthermore, it will provide novel scientific data
      regarding the relationship between iron status and physical and cognitive performance in
      female Soldiers.
    


Intervention name(s): Iron-containing food product
Intervention type(s): Other
Keywords: Iron; Iron status; Iron deficiency; Iron deficiency anemia
Ocular Tolerance, Safety and Ocular Pharmacokinetics After 1 Drop of T1225 0.5, 1.0, 1.5% in 48 Healthy Volunteers
Condition: Eye Infections, Bacterial
MeSH terms: Bacterial Infections; Eye Infections; Eye Infections, Bacterial
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the ocular tolerance, the safety and the ocular pharmacokinetics of 3
      concentrations (0.5% - 1.0% - 1.5%) and the vehicle of T1225 after one drop instillation
    

Detailed description: 
      The aim of the present study was to compare the ocular tolerance, safety and the ocular
      pharmacokinetics after a single administration of T1225 eye drops (0.5%, 1.0%, or 1.5%) in
      healthy volunteers.
    

Intervention name(s): Azithromycin (T1225)
Intervention type(s): Drug
Intervention MeSH terms: Azithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment