bioihbjkbjnl/mcl2 huggingface dataset:
N-acetyl Cysteine: the Effectiveness and Safety in a Cohort of Pediatric Patients With Chronic Kidney Disease
Condition: Chronic Kidney Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      Anemia is a common comorbidity of CKD and is associated with a decreased quality of life and
      increased healthcare resource utilization. Anemia increases the risk of CKD progression,
      cardiovascular complications, and overall mortality. The current standard of care includes
      oral or intravenous iron supplementation, erythropoiesis-stimulating agents, and red blood
      cell transfusion. Treatment with high doses of erythropoiesis-stimulating agents increases
      rates of hospitalization, cardiovascular events, and mortality. Resistance to
      erythropoiesis-stimulating agents is a therapeutic challenge in many patients .

      NAC reduces the risk of progression of CKD of any etiology to end stage renal disease (ESRD)
      but the mechanism by which it reduces the progression of CKD to ESRD is unclear. It may be
      because of its antioxidant and vasodilatory nature. Prolonged duration of administration and
      higher dosage of NAC can protect kidneys.
    

Detailed description: 
      All patients with chronic kidney disease on regular hemodialysis will be enrolled.

      - Study location: The patients will be recruited from pediatric nephrology department, Cairo
      University Children's Hospital and Beni Suef University.

      History taking including the age, sex, primary cause of CKD, onset of hemodialysis,
      medications including erythropoietin dose, frequency, and duration, oral or intravenous iron
      therapy, and frequency of blood transfusion.

      Clinical examination focusing on pallor, blood pressure, and anthropometric measurements and
      their percentile.

      Investigations including hemoglobin level at the start of the study and every month during
      the study period, serum ferritin, alanine aminotransferase, total oxidative stress (TOS),
      total antioxidant capacity (TAC), and oxidative stress index (OSI) at the start and after 3
      months of the onset of the study.

      Patients will receive N-acetyl cysteine (10 mg/kg/day, orally). The duration of the study
      will 3 months.
    

Intervention name(s): N-acetyl cysteine
Intervention type(s): Drug
Intervention description(s): mucolytic and anti-oxidant. Dose 10mg/Kg/ 12 hours orally
Other intervention name(s): NAC
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Intervention model: Single Group Assignment
Intervention model description: 50 children with chronic kidney disease will be assessed for iron profile, oxidative stress status and left ventricular functions before and after treatment with N-acetyl cysteine for 3 months
Masking: None (Open Label)
Primary purpose: Treatment
Early Feasibility Study to Evaluate the Efficacy and Safety of the RenewalNail™ Plasma Treatment System in Patients With Mild to Moderate Onychomycosis (Fungal Nail)
Condition: Onychomycosis Due to Trichophyton Rubrum; Onychomycosis Due to Trichophyton Mentagrophytes
MeSH terms: Onychomycosis
Study type: Interventional

Summary: 
      Early feasibility study to determine if a three-treatment protocol with the RenewalNail™
      plasma treatment system over a week will result in mycological cure and/or clear nail growth
      on the treated hallux toe.
    

Detailed description: 
      The Sponsor has developed the RenewalNail™ plasma treatment system to topically treat fungal
      infected toenails. The goal of the RenewalNail™ therapy is to overcome the shortcomings of
      both topical and oral therapies by combining the safety of a topical treatment with the
      efficacy of an oral treatment.

      The primary objective of this early feasibility study is to evaluate the efficacy and safety
      of the RenewalNail™ plasma treatment system and Protocol in achieving mycological cure for
      the patient. The Protocol calls for three 45-minute treatments performed over a week to
      achieve mycological cure. Mycological cure will be assessed with two consecutive mycological
      culture tests done over a week. Two consecutive negative results will confirm the elimination
      of fungus causing onychomycosis infection, as recommended by recent FDA guidance. There will
      be no placebo arm in the study.

      Secondary objectives include assessing if the treatment protocol results in clear nail growth
      for the patient over a 5-month interval.
    

Intervention name(s): RenewalNail™ Plasma Treatment System
Intervention type(s): Device
Intervention description(s): application of cold atmospheric plasma to a fungal infected toenail
Other intervention name(s): cold atmospheric plasma treatment
Intervention model: Single Group Assignment
Intervention model description: multi-center open-label study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: fungal nail; toenail fungus
Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of TAK-137 in Healthy Participants
Condition: Dose Finding Study
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the safety and tolerability profile of TAK-137
      when administered as a single dose of tablets at escalating dose levels in healthy
      participants.
    

Detailed description: 
      The drug being tested in this study is called TAK-137. TAK-137 is being tested to find a safe
      and well-tolerated dose. This study looked at safety (lab results and side effects) and
      pharmacokinetic properties (drug absorption, distribution, metabolism, and excretion) in
      people who took TAK-137. This study was designed as a single ascending 6 Cohort dose study
      with planned doses of 2, 5, 15, 50, and 100 mg and Cohort 6 dose to be determined if the
      maximum tolerated dose (MTD) was not reached. Anticipated enrollment was 48.

      This study enrolled 47 participants and consisted of 6 Cohorts. Participants in Cohorts 1, 2,
      3, 5 and 6 were randomized to receive a single dose of TAK-137 or placebo after a 10-hour
      fast. Participants in Cohort 4 were randomized to receive a single dose of TAK-137 or placebo
      under fasted conditions, followed by a single dose of TAK-137 or placebo under fed conditions
      14 days later. Participants in cohort 4 will receive the same dose in both fasted and fed
      conditions. The starting dose was 2 mg followed by administrations of 5, 10, 0.5 and 20 mg.

      This single-center trial was conducted in the United States. For Cohorts 1, 2, 3, 5, and 6
      the overall time to participate in this study was up to 42 days. Participants made 4 visits
      to the clinic including one 5-day period of confinement to the clinic, and were contacted by
      telephone 14 days after last dose of study drug for a follow-up assessment.

      For Cohort 4 the overall time to participate in this study was up to 56 days. Participants
      made 7 visits to the clinic including two 5-day periods of confinement to the clinic, and
      were contacted by telephone 14 days after last dose of study drug for a follow-up assessment.
    

Intervention name(s): TAK-137; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): TAK-137 tablets; TAK-137 placebo-matching tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Drug therapy
Assessing Tolerability of Avonex Intramuscular Injections
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate patients' views when injecting Avonex
      intramuscularly.
    


Intervention name(s): Avonex
Intervention type(s): Drug
Intervention description(s): Intramuscular injection administered using 25 gauge or 30 gauge needle
Other intervention name(s): Interferon beta-1a
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Intramuscular Injections; Relapsing Remitting
Immunogenicity and Safety of a Trivalent Inactivated Influenza Vaccine, Formulation 2010-2011, in Healthy Subjects Aged Over 6 Months Old to 18 Years Old
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      This is an open study of the use of AdimFlu-S (2010-2011 season) vaccine in young subjects
      aged between 6 months old to 18 years old. All participants will be divided into three age
      cohorts. First, participants aged 6 through < 36 months will receive 2 doses of 0.25 mL
      vaccine separated by 4 weeks. Second, participants aged 3 through < 9 years will receive 2
      doses of 0.5 mL vaccine separated by 4 weeks. Third, participants aged 9 through < 18 years
      will receive one dose of 0.5 mL vaccine. Safety outcomes included immediate reactions at the
      time of vaccination, solicited local and systemic reactions within 7 days after each
      vaccination, unsolicited adverse events, and serious adverse events. Sera prepared from blood
      samples will be collected from each subject immediately prior to, and 4 weeks after each
      vaccination. Anti-hemaglutinin (HA) antibody titers will be determined using the WHO
      haemaglutination inhibition reference technique. The analysis will be observer-blinded. All
      participants will be followed, either by clinical visit or by telephone contact, for 6 months
      after the first vaccination for safety reasons.
    


Intervention name(s): AdimFlu-S 2010-2011, inactivated
Intervention type(s): Biological
Intervention description(s): The vaccine contains not less than 90 μg haemagglutinin (HA) per mL. Per mL contains the following three strains: A/California/7/2009 (H1N1)30 μg/mL;A/Perth/16/2009 (H3N2)30 μg/mL;B/Brisbane/60/2008 30 μg/mL
6 months~<3 years;0.25 mL per injection2 injections at 4 weeks apart
3~<9 years;0.5 mL per injection2 injections at 4 weeks apart
9~<18 years;0.5 mL per injection1 injections
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza; Vaccine; Immunogenicity
Fitness and Exercise for People With Arthritis
Condition: Arthritis
MeSH terms: Arthritis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to develop and evaluate a progressive, land-based exercise
      program, that includes muscular and aerobic conditioning, resistance and stabilization
      exercises and balance training, for persons with arthritis.
    

Detailed description: 
      There is evidence that people with arthritis who participate in appropriate types of physical
      activity can improve physical function and pain management. Most existing programs focus on
      improving flexibility and balance. Less attention has been paid to conditioning and overall
      functional fitness. To address some of these concerns, this study will develop, evaluate, and
      implement a non-aquatic physical activity program to increase health-related functional
      fitness in community-dwelling adults with arthritis. Specific goals are:

        1. To develop a systematic and progressive program (FEPA: Functional Exercise for Persons
           with Arthritis) that integrates muscular and aerobic conditioning, balance and
           trunk/pelvic stabilization exercises emphasizing joint-protective, multi-plane movement
           patterns that mimic those used in everyday activities.

        2. Implement the FEPA program in an ethnically diverse, low SES community sample of older
           adults with arthritis.

        3. Conduct process, outcomes and impact evaluations to assess the effectiveness of the FEPA
           program for increasing short- and immediate-term health and functional fitness outcomes.

        4. Evaluate the sustainability of the FEPA program through a program logic model process
           and identify inputs, activities and outputs that contribute to successful program
           implementation and the building of community capacity to support long-term program
           maintenance.
    

Intervention name(s): Functional Exercise for People with Arthritis (FEPA)
Intervention type(s): Behavioral
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: arthritis; exercise; function; pain
Bioavailability Of Flucloxacillin Capsules (250 mg and 500 mg)
Condition: Infections, Bacterial
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objective:To study the absolute bioavailability, distribution and elimination
      parameters of flucloxacillin from two oral formulations of flucloxacillin in healthy male
      and/or female subjects.
    

Detailed description: 
      A mono-center, open, randomized, three-way, twelve-sequence, cross-over study to determine
      the extent of absorption (absolute bioavailability), rate of absorption and to further
      characterize distribution and elimination characteristics of a commercial 250 mg and a 500 mg
      capsule of flucloxacillin each given as a single oral dose vs. one 250 or 500 mg intravenous
      dose to 24 healthy male and/or female subjects in the fasting state
    

Intervention name(s): flucloxacillin 250 mg; flucloxacillin 500 mg
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be randomized to receive single oral dose of 250 mg flucloxacillin capsule and 250 mg Intravenous dose; Subjects will be randomized to receive single oral dose of 500 mg flucloxacillin capsule and 500 mg Intravenous dose
Other intervention name(s): flucloxacillin
Intervention MeSH terms: Floxacillin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bioavailability flucloxacillin
Study of Corneas Undergoing Balanced Salt Solution(BSS ®) Versus Glucose-bicarbonate-Ringer Lactate in Cataract Surgery
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional

Summary: 
      This is a study aimed at evaluating the effectiveness and impact of two intraocular
      irrigating solution (BSS ® versus glucose-bicarbonate-Ringer Lactate - GBRL) on the health of
      the cornea after cataract surgery by phacoemulsification.
    


Intervention name(s): Phacoemulsification cataract surgery; Glucose-bicarbonate-Ringer Lactate (GBRL); Balanced Salt Solution (BSS®)
Intervention type(s): Procedure; Drug; Drug
Intervention description(s): A group received BSS ® (ALCON LABORATORIES, INC.) and another group received glucose-bicarbonate-Ringer Lactate (GBRL) [500 cc. Ringer Lactate (GLICOLABOR, Pharmaceutical LTD.) enriched with 1.5 ml of glucose in water (25%) and 08 ml of sodium bicarbonate (8.4%)] as a solution for irrigation during surgery.
All surgeries were performed by single surgeon (HON), using the standard surgical technique quick-chop. Immediately before surgery, solutions for irrigation [BSS ® (ALCON LABORATORIES, INC..) and glucose-bicarbonate-Ringer Lactate (GBRL)] were brought to the operating table in a temperature of 22 degrees Celsius. The microcoaxial Phacoemulsification was performed under a phaco Legacy Series 20000 (ALCON LABORATORIES, INC..).; A group received BSS ® (ALCON LABORATORIES, INC.) and another group received glucose-bicarbonate-Ringer Lactate (GBRL) [500 cc. Ringer Lactate (GLICOLABOR, Pharmaceutical LTD.) enriched with 1.5 ml of glucose in water (25%) and 08 ml of sodium bicarbonate (8.4%)] as a solution for irrigation during surgery.
All surgeries were performed by single surgeon (HON), using the standard surgical technique quick-chop. Immediately before surgery, solutions for irrigation [BSS ® (ALCON LABORATORIES, INC..) and glucose-bicarbonate-Ringer Lactate (GBRL)] were brought to the operating table in a temperature of 22 degrees Celsius. The microcoaxial Phacoemulsification was performed under a phaco Legacy Series 20000 (ALCON LABORATORIES, INC..).; A group received BSS ® (ALCON LABORATORIES, INC.) and another group received glucose-bicarbonate-Ringer Lactate (GBRL) [500 cc. Ringer Lactate (GLICOLABOR, Pharmaceutical LTD.) enriched with 1.5 ml of glucose in water (25%) and 08 ml of sodium bicarbonate (8.4%)] as a solution for irrigation during surgery.
All surgeries were performed by single surgeon (HON), using the standard surgical technique quick-chop. Immediately before surgery, solutions for irrigation [BSS ® (ALCON LABORATORIES, INC..) and glucose-bicarbonate-Ringer Lactate (GBRL)] were brought to the operating table in a temperature of 22 degrees Celsius. The microcoaxial Phacoemulsification was performed under a phaco Legacy Series 20000 (ALCON LABORATORIES, INC..).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Corneal endothelium; Cataract surgery; Irrigation solutions intraocular; Phacoemulsification
Clinical Study of Visibility Tinted Clariti Contact Lens
Condition: Hyperopia; Myopia
MeSH terms: Hyperopia
Study type: Interventional

Summary: 
      The purpose of this study was to investigate the safety and efficacy of the Sauflon Clariti
      Monthly silicone hydrogel contact lenses with handling tint (Sauflon Pharmaceuticals Limited)
      by comparison with Air Optix Aqua silicone hydrogel lenses (Alcon Inc.)

      Subjects used OptiFree Replenish solution (Alcon Lboratories Inc.) for daily lens
      maintenance, care and storage.
    

Detailed description: 
      I. Study characteristics:

      The clinical study evaluates the clinical performance of a silicone hydrogel contact lens for
      daily wear, Clariti (including handling tint) (Sauflon Pharmaceuticals Ltd.) versus a
      predicate device, Air Optix Aqua (Alcon Inc.), in terms of lens performance, physiological
      response and subjective acceptance.

      Subjects used OptiFRee Replenish solution (Alcon Laboratories Inc.) for daily lens
      maintenance, care and storage.

      The key features were as follows:

        1. One month duration.

        2. Three investigator sites.

        3. Daily wear soft (hydrophilic) silicone hydrogel contact lenses, replaced on a monthly
           basis: Clariti Monthly (with handling tint)and Air Optix Aqua. Replenish was used as a
           care system by all subjects.

        4. A total of 38 subjects were enrolled, and 38 subjects accounted for 76 eyes were
           dispensed lenses. This group was randomized into 25 test subjects (50 eyes) and 13
           control subjects (26 eyes).

        5. Of the 25 test subjects, 25 (100%) completed one month of use. Of the 13 control
           subjects, 12 (92.3%)completed one month of use.

        6. There were no adverse reactions.

      II. Study period:

      The study was conducted over one month of wear. Subjects were examined initially, and at two
      follow-up visits after two weeks and four weeks respectively. Study visits commenced on June
      26, 2013 and completed on September 14, 2013.
    

Intervention name(s): Air Optix Aqua; Clariti with Handling Tint
Intervention type(s): Device; Device
Intervention description(s): Lenses will be worn on a daily wear basis (i.e. removed at night and stored in solution) and worn in the normal way. Lenses will be worn for one month. Lenses should be worn for a minimum of six hours a day, four days a week. The lenses are also to be worn for a minimum of two hours before attending all follow-up visits.; Lenses will be worn on a daily wear basis (i.e. removed at night and stored in solution) and worn in the normal way. Lenses will be worn for one month. Lenses should be worn for a minimum of six hours a day, four days a week. The lenses are also to be worn for a minimum of two hours before attending all follow-up visits.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: visibility tinted silicone hydrogel contact lenses for daily wear
Efficacy/Safety Study of Glimepiride to Type 2 Diabetes Patients Based on Metformin And Basal Insulin Treatment
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      All the guidelines suggest that metformin as the basis of type 2 diabetes medication, and
      evidence is sufficient.At the same time the basal insulin injection once a day are more and
      more widely used in diabetes patients in China.

      This study aims to evaluate the efficacy and safety of adding glimepiride to type 2 diabetes
      patients with inadequate glycemic control with combined therapy of metformin and basal
      insulin.
    


Intervention name(s): glimepiride; glargine and metformin
Intervention type(s): Drug; Drug
Intervention description(s): on the basis of metformin and glargine, glimepiride is added; with the maximun dose of glimepiride, if the targeted FPG is not reached, glargine dose will be increased.
Other intervention name(s): lantus
Intervention MeSH terms: Metformin; Glimepiride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: glimepiride; metformin; basal insulin; Hemoglobin A, Glycosylated; glucose fluctuation; hypoglycemia
Efficacy and Safety Assessment of T2345 in Ocular Hypertensive or Glaucomatous Patients
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the efficacy and safety of T2345 versus active
      comparator.
    


Intervention name(s): T2345; Prostaglandin
Intervention type(s): Drug; Drug
Intervention description(s): One drop of T2345; One drop
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Effect of Two Different Dosages of Ethinyl-estradiol in Association With Drospirenone in Women With Polycystic Ovary Syndrome.
Condition: Polycystic Ovary Syndrome; Estro-progestin Drugs
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      The estrogenic component of estro-progestin (EP) is responsible for a negative impact on the
      metabolic and lipid assessment in women with polycystic ovary syndrome (PCOS).

      The objective of this study is to compare the effects of a long term administration of two EP
      combinations, containing the same progestin (3 mg drospirenone) and a different dose of
      ethinyl-estradiol (EE) (20 vs 30 μg ) on the clinical and endocrine-metabolic parameters in
      normal weight PCOS women. The investigators enrolled 30 patients, randomly allocated to group
      A (20 µg EE - 3 mg DRSP) and 15 to group B (30 µg EE - 3 mg DRSP). Hirsutism score
      evaluation, hormonal assays, oral glucose tolerance test, euglycaemic hyperinsulinaemic clamp
      and lipid profile were performed at baseline and after 6 and 12 months of therapy.
    


Intervention name(s): 3 mg drospirenone and 20 µg ethinyl-estradiol; 3 mg drospirenone and 30 µg ethinyl-estradiol
Intervention type(s): Drug; Drug
Intervention MeSH terms: Drospirenone; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PCOS; drospirenone ethinylestradiol; androgens; metabolism