bioihbjkbjnl/mcl2 huggingface dataset:
Dose-optimization in Adolescents Aged 13-17 Diagnosed With Attention-deficit/Hyperactivity Disorder (ADHD) Using Extended-release Guanfacine HCl
Condition: Attention-Deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the efficacy of optimized Extended-release Guanfacine Hydrochloride compared with
      placebo in the treatment of adolescents aged 13-17 years with a diagnosis of ADHD as measured
      by the ADHD-RS-IV
    


Intervention name(s): Extended-release Guanfacine Hydrochloride; Placebo
Intervention type(s): Drug; Other
Intervention description(s): The test product will be provided as 1, 2, 3, and 4mg tablets. Subjects will be administered a once-daily dose between 1-7mg/day depending on weight.; Matching placebo will be provided as 1,2,3, and 4mg tablets. Subjects will be administered a once-daily dose of placebo between 1-7mg/day depending on weight.
Other intervention name(s): Intuniv
Intervention MeSH terms: Guanfacine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Safety and Efficacy Study of Paclitaxel-eluting Balloon to Paclitaxel-eluting Stent
Condition: Coronary Instent Restenosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of successful interventional
      therapy and unblocked blood vessel maintaining in the treatment of coronary in-stent
      restenosis by paclitaxel -eluting PTCA- balloon catheter (3μg/mm2 balloon surface area)
      versus paclitaxel-eluting stent Taxus® Liberte, and the reference diameter of coronary artery
      stenosis is 2.5mm-4.0mm and the length ≤30mm.
    


Intervention name(s): SeQuent® Please; Taxus Liberte
Intervention type(s): Device; Device
Intervention description(s): SeQuent® Please with a length of 10mm,15mm,17mm,20mm and 26mm and diameter of 2.5 mm, 2.75 mm, 3.0mm, 3.5mm and 4.0mm are to be used in the trial; Taxus Liberte with a length of 8mm,12mm,16mm,20mm and 24mm and diameter of 2.5 mm, 2.75 mm, 3.0mm, 3.5mm and 4.0mm are to be used in the trial
Other intervention name(s): Paclitaxel Drug-eluting Coronary Artery Balloon Catheter; Paclitaxel Drug-eluting Coronary Stent and Conveying System
Intervention MeSH terms: Paclitaxel; Albumin-Bound Paclitaxel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Tolerability of Fingolimod in Patients With Relapsing-remitting Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This 4 month, open-label study will evaluate the safety and tolerability of fingolimod 0.5 mg
      in patients with relapsing-remitting multiple sclerosis (RRMS) and generate additional data
      in Multiple Sclerosis (MS) patient population that closely resembles the clinical population
      seen in routine medical care.
    


Intervention name(s): Fingolimod
Intervention type(s): Drug
Intervention description(s): Fingolimod will be supplied as 0.5mg capsules in bottles of 35.
Intervention MeSH terms: Fingolimod Hydrochloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Relapsing-Remitting
Impact of Silicon-based Formulations on Wound Healing of Laser-induced Microscopic Skin Lesions
Condition: Wound Healing
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      Delayed wound healing is considered a health problem with devastating consequences for
      patients, healthcare systems, and societies. Over the past 20 years, many other groups, as
      well as ourselves, have evaluated various alternatives to improve wound healing. Despite
      this, the scientific evidence demonstrating the efficacy of recently developed treatments is
      often limited. Stratacel® and Stratamed® are two gels approved by Swissmedic and the FDA for
      use in improving wound healing. To this end, the efficacy of these formulations has been
      visually tested by a physician or by patients. Using the most advanced medical technologies
      (confocal microscopy and LCOCT), this study aims to investigate the effect of these
      formulations on the healing of human skin. For this research, a total of 20 volunteers will
      be included in this study. Volunteers will have up to 7 follow-up appointments over 21 days.
      Each appointment will last approximately 30 minutes and will be used to perform external
      measurements of skin healing. All volunteers will use the same formulations (Stratacel® and
      Stratamed®) with the only difference between volunteers being the anatomical area of
      application of the formulation. This will be determined by chance. The active participation
      of the participant is requested for the application of the formulations on the skin twice a
      day during the trial.
    


Intervention name(s): Stratacel; Stratamed
Intervention type(s): Device; Device
Intervention description(s): Silicone-based formulation registered as a European class IIa, TGA (Therapeutic Goods Administration) and FDA listed Class I medical device (wound dressing).; Silicone-based formulation registered as a European class IIa, TGA (Therapeutic Goods Administration) and FDA listed Class I medical device (wound dressing).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Safety and Immunogenicity of Different Dosages of High-Dose Quadrivalent Influenza Vaccine in Children 6 Months to 17 Years of Age
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The objectives of this study were:

        -  To describe the safety of each dosage of high-dose quadrivalent influenza vaccine
           (QIV-HD) used in the study during the 28 days following each vaccination, and serious
           adverse events (including adverse events of special interest throughout the study).

        -  To describe the antibody response induced by each dosage of QIV-HD used in the study
           compared with unadjuvanted standard-dose quadrivalent influenza vaccine (QIV-SD) by
           hemagglutination inhibition (HAI) measurement method.

        -  To describe the antibody response induced by each dosage of QIV-HD used in the study
           compared with unadjuvanted QIV-SD by virus seroneutralization (SN) measurement method.

        -  To describe the antibody response induced by the highest acceptable dosage of QIV-HD
           compared with adjuvanted trivalent influenza vaccine (TIV) by HAI and virus SN
           measurement methods.
    

Detailed description: 
      Study duration per participant was approximately 180 days for participants who received one
      dose of vaccine and 208 days for participants who received two doses of vaccine.
    

Intervention name(s): High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 30 μg (split-virion, inactivated); High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 45 μg, (split-virion, inactivated); High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 60 µg (split-virion, inactivated); Fluarix Quadrivalent Influenza vaccine (Unadjuvanted QIV-SD) (Inactivated); FLUAD Pediatric (adjuvanted TIV) (Surface Antigen, Inactivated)
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM; Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM; Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM; Pharmaceutical form: Solution for injection Route of administration: IM; Pharmaceutical form: Solution for injection Route of administration: IM
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: The study was divided into 13 groups and enrolled participants in 4 stages. The study used a stepwise age de-escalation and dose ascension design for children 6 months to less than (<) 5 years of age.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
GSK1349572 Repeat Dose Escalation and Relative Bioavailability Study
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a repeat dose escalation study of GSK1349572 followed by a relative bioavailability
      study comparing tablet and suspension formulations in healthy volunteers.
    

Detailed description: 
      ING111322: A Double-Blind, Randomized, Placebo-Controlled, Repeat Dose Escalation Study to
      Investigate the Safety, Tolerability and Pharmacokinetics of GSK1349572 Followed by A Single
      Dose, Randomized, 3-Period, Balanced, Crossover Study to Assess the Relative Bioavailability
      of Two Formulations and Food Effect on GSK1349572 in Healthy Male and Female Subjects
    

Intervention name(s): GSK1349572
Intervention type(s): Drug
Intervention MeSH terms: Dolutegravir
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: GSK1349572,; healthy volunteers,; repeat dose,; relative bioavailability; Healthy subjects
Effect of Pentoxifylline on Endothelial Dysfunction in Patients With Acute Coronary Syndrome
Condition: Acute Coronary Syndrome
MeSH terms: Acute Coronary Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study aims to investigate the effect of pentoxifylline administration on the status of
      endothelial function and oxidative stress biomarkers in patients with Acute Coronary Syndrome
      (ACS).
    

Detailed description: 
      The study will be carried out at Ain Shams University Hospitals. Patients with ACS who meet
      the eligibility criteria and consent to participate in the study will be randomly allocated
      to either the intervention group or the control group.

      All participants will receive the standard pharmacologic treatment for ACS according to the
      applied guidelines offered by the facility. In addition, patients in the intervention group
      will receive Pentoxifylline tablets 400mg orally three times daily.

      Patient follow-up will be scheduled every 2 weeks for each patient to check the tolerability,
      the development of side effects, any medication change and medication adherence. Physical
      examination at each visit will be done by physician in attendance for all patients in both
      groups.

      A blood sample will be taken at baseline and at the end of the study after 2 months. for
      measurement of basic laboratory parameters (Complete Blood Count, Liver Function Tests,
      Kidney Function Tests ,..etc), the level of Soluble Vascular Cell Adhesion Molecule-1
      (sVCAM-1) as a marker for endothelial dysfunction, the level of Malondialdehyde (MDA) as a
      marker for oxidative stress.
    

Intervention name(s): Pentoxifylline
Intervention type(s): Drug
Intervention description(s): Pentoxifylline tablets 400mg three times daily for 2 months
Intervention MeSH terms: Pentoxifylline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Acute Coronary Syndrome; Pentoxifylline; Endothelial Dysfunction; Oxidative Stress
Efficacy, Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail
Condition: Onychomycosis
MeSH terms: Onychomycosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is designed to assess the efficacy, safety and tolerability of a topical
      formulation of terbinafine solution applied daily in patients with toenail fungus. This trial
      will study patients with mild to moderate toenail fungus disease of the big toenail and their
      responses to two treatment durations, 24 or 48 weeks.
    


Intervention name(s): terbinafine; Placebo; terbinafine; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 48 weeks; vehicle (placebo) applied once daily for 48 weeks; Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 24 weeks; vehicle (placebo) applied once daily for 24 weeks
Other intervention name(s): Lamisil; Lamisil
Intervention MeSH terms: Terbinafine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Toenail fungus; Onychomycosis; Nail fungus; Toenail fungal infection; Tinea unguium; Dermatophytes; Foot dermatoses
E-health Tool for Management of Chronic Pain Patients.
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Observational

Summary: 
      Chronic pain affects approximately 20% of adults, 50% of the elderly population and over 1.5
      billion people worldwide. Societal and economic issues are also crucial, as 60% of people
      with pain are less able or unable to work and 20% say they have lost their jobs because of
      pain. The overall cost of chronic pain is estimated at around 300 billion euros in the EU.
      Unfortunately, current treatments for chronic pain have limited effectiveness. Pain clinics,
      which support the most complex and refractory cases of chronic pain, as well as general
      practitioners and patients expect improvements, both in terms of therapeutic efficacy and
      organization of care.

      In order to allow the characterization and a personalized follow-up of chronic pain patients,
      Investigator has created e-DOL, a smartphone application for patients and a web platform for
      physicians. The purpose of this study is to evaluate the feasibility and clinical interest of
      an e-Health smartphone application for the characterization and follow-up of chronic pain
      patients..
    

Detailed description: 
      This first clinical study will assess the acceptability of the tool both by caregivers at the
      13 pain clinics and by a panel of 300 patients followed for 6 months. Based on the results of
      the study (end 2019), investigator will improve the tool in a version 2.0, which will then be
      evaluated in a large impact study, measuring the intrinsic therapeutic effect of eDOL.
    

Intervention name(s): e-DOL
Intervention type(s): Device
Intervention description(s): e-health program (smartphone and web platform)
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with chronic pain
      
Keywords: Chronic pain; e-Health
Effect of 4 Weeks Fish Oil Supplementation on Cycling Performance in Healthy Male Cyclists
Condition: Exercise-induced Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      Research Plan

      Eleven trained cyclists have completed 4 cycling performance trials, before and after 4 weeks
      of fish oil supplementation and before and after 4 weeks of placebo with a 4 week washout
      between supplementation periods. During the performance trials blood, expired air and heart
      rate were collected. The blood samples have been used to investigate the production of
      inflammation resulting from the cycling performance test. Inflammation has been assessed
      using enzyme-linked immunosorbent assay for IL-6, which is an inflammatory cytokine. Work
      done from the cycling performance will be analysed to investigate whether there is a
      relationship with power and inflammation and whether this is modulated by fish oil
      supplementation.

      Specific Aims

        1. Does 4 weeks of Fish Oil supplementation attenuate the inflammatory response following
           high intensity cycling.

        2. Is a modulation of the inflammatory response connected to cycling performance.

      Hypotheses

        1. Four weeks of n3-PUFA supplementation will reduce the inflammatory response

        2. A reduction in inflammation will improve cycling performance

      Anticipated Outcomes

      A high level of cycling performance, indicated by a high average power, will be associated
      with high levels of systemic inflammation. n3-PUFA supplementation will decrease the level of
      inflammation and consequently cycling performance will be improved.
    


Intervention name(s): n-3 PUFA; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): n-3 PUFA capsules containing EPA and DHA; Olive oil capsules
Other intervention name(s): Fish Oil supplementation; Omega-3; Olive Oil
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomised, placebo-controlled, double blind, crossover design study
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Exercise; Fish Oil; Cycling; Inflammation; Oxidative stress
Influence of CPB Temperature on CABG Morbidity
Condition: Cardiovascular Diseases; Coronary Disease; Heart Diseases; Myocardial Ischemia; Neurologic Manifestations
MeSH terms: Neurologic Manifestations; Cardiovascular Diseases; Heart Diseases; Coronary Disease; Myocardial Ischemia; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare three accepted modes of myocardial preservation, warm, tepid, and cold blood
      cardioplegia, coinciding with normothermic (37 degrees centigrade), tepid (32 degrees
      centigrade) and hypothermic (8 to 10 degrees centigrade) cardiopulmonary bypass (CPB) to
      define differences in neurologic function in coronary artery bypass graft (CABG) patients.
    

Detailed description: 
      BACKGROUND:

      A pilot study of warm versus cold perfusion and preservation was completed in 32 patients
      prior to the ongoing study. The findings of the pilot study showed 53 percent of patients had
      evidence of new neurologic disturbance at postoperative day four. Only the neurologic
      dysfunction could be correlated with warm versus cold perfusion (37.5 percent warm versus 75
      percent cold, P less than 0.05). The changes in neurologic function had abated or clearly
      improved by one month of follow-up, and the distinction in neurologic dysfunction grading was
      no longer apparent between the two groups.

      DESIGN NARRATIVE:

      Patients were randomly assigned to cold, tepid, or warm blood cardioplegia, coinciding with
      normothermic, tepid, and hypothermic cardiopulmonary bypass. All patients received a standard
      anesthetic protocol combining narcotic and inhalational anesthesia. Each patient entering the
      study had extensive clinical data collected prospectively incorporating most aspects of
      measurable determinants related to myocardial preservation. Additionally, neurologic tests
      were performed by a blinded neurologist and rated by an objective scoring system, the Mathew
      scale. The studies were performed preoperatively, on the third or fourth postoperative day,
      and at one month following surgery. Hematologic data were measured for fibrinolytic
      potential.
    

Intervention name(s): cardiopulmonary bypass; heart arrest, induced
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Primary purpose: Treatment
Preliminary Performance Study of the New TIPI Device in the Prevention of Stress Urinary Incontinence
Condition: Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      Stress urinary incontinence (SUI) is most prevalent among women. SUI is characterized by loss
      of urine from increased abdominal pressures caused by coughing, laughing, sneezing, running,
      lifting or walking. SUI cause women to avoid routine physical activities, thus detracting
      significantly from their quality of life.

      The purpose of this study is to evaluate the performance of new designs of the TIPI device, a
      conservative, disposable, treatment for temporary management of SUI.
    


Intervention name(s): TIPI vaginal pessary
Intervention type(s): Device
Intervention description(s): TIPI vaginal pessary G3 model, and TIPI SMD's
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
DARWeb: an Online Psychosocial Intervention for Children With Recurrent Abdominal Pain and Their Families.
Condition: Abdominal Pain
MeSH terms: Abdominal Pain
Study type: Interventional

Summary: 
      Chronic and recurrent pain is a very important issue in the society, and its treatment is
      challenging.

      In children, one of the most common pain problems is recurrent abdominal pain. This problem
      can affect up to 12% of the children population, and can interfere on daily activities of
      both children and parents. Recurrent abdominal pain in children is also associated with other
      health problems, and can be related to problems in adulthood. Unfortunately, the current
      health system does not have an effective treatment for these children and their families.
      This is why the investigators propose an online intervention, DARWeb, for people in this
      situation.

      DARWeb provides an innovative solution using Information and Communication Technology to
      facilitate access. It is also innovative because it is directed towards secondary prevention,
      in contrast to the majority of current treatments available for pain problems that are
      focused in reducing the impact of pain when it is already severe. Thus, the objective of
      DARWeb is to provide information and teach strategies to children and their parents that help
      them to cope with pain and prevent pain interference in their daily lives (in the short,
      medium and long term).

      With this project, the investigators plan, first, to create a new version of their treatment
      program (DARWeb V2) from the results of the pilot study. Second, the investigators will test
      the effects of DARWeb V2 through a randomized clinical trial with a large sample, and they
      will assess the short, medium and long term effects. In addition, the investigators want to
      study which of the variables that are addressed in their intervention are responsible for the
      potential changes observed.

      The investigators expect that their treatment program will be effective to reduce pain in the
      short, medium and long term.
    


Intervention name(s): DARWeb
Intervention type(s): Behavioral
Intervention description(s): Psychosocial Intervention from the cognitive-behavioral model, including different but related units for parents and children with recurrent abdominal pain.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Online Intervention; Recurrent Abdominal Pain; Children