bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Efficacy of Sustained Erythropoietin Therapy
Condition: Anemia
MeSH terms: Anemia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purposes of this study are to assess safety, efficacy, and subject satisfaction of
      EPODURE Biopump (an autologous dermal biopump capable of sustained secretion of therapeutic
      EPO in the body, using a small tissue explant from the patient's own skin) treatment in
      Chronic Kidney Disease (CKD) patients over a period of up to six (6) months.
    

Detailed description: 
      Anemia, is a common complication of chronic kidney disease (CKD) resulting from insufficient
      production of the hormone erythropoietin by the damaged kidney leading to a decrease in red
      blood cells production by the bone marrow.

      Replacement therapy with recombinant human erythropoietin can effectively correct anemia in
      patients. However, despite the availability of recombinant human erythropoietin for more than
      a decade for use in CKD patients, two thirds of patients initiating dialysis have a
      hematocrit less than 30%, and three fourths have a hemoglobin (Hb) less than 11 g/dL the
      level recommended by the National Kidney Foundation Kidney Disease Outcome Quality
      Initiative. Treatment with recombinant human erythropoietin typically involves subcutaneous
      (SC) administration at regular intervals followed by frequent laboratory tests to monitor
      hemoglobin concentration. There is a need to provide an significantly improved care in this
      area using a sustained therapy approach.

      EPODURE, is an autologous dermal biopump capable of sustained secretion of therapeutic EPO in
      the body, using a small tissue explant from the patient's own skin. The EPODURE biopump is
      harvested directly from the patient's dermis under local anesthetic. EPODURE Biopumps,
      produced by ex vivo transduction of MOs with Helper Dependent Adenoviral EPO vectors
      (HDAd-EPO), expresses and secretes EPO. The EPODURE Biopump is subsequently implanted
      subcutaneously back to the patient in order to provide continuous delivery of a known amount
      of EPO.
    

Intervention name(s): EPODURE (dermal Biopump for erythropoietin)
Intervention type(s): Biological
Intervention description(s): Subjects will undergo similar study procedures and evaluations; however each dosage group will receive a different targeted dose of EPO delivered via EPODURE Biopump
Intervention MeSH terms: Epoetin Alfa
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Prophylactic Anecortave Acetate in Patients With a Retisert Implant
Condition: Uveitis, Posterior; Glaucoma
MeSH terms: Glaucoma; Uveitis; Uveitis, Posterior
Study type: Interventional
Phase: Phase 1

Summary: 
      Retisert implant is an effective therapy for controlling inflammation in patients with
      non-infectious posterior uveitis. One of the major complications of this device is the
      development of elevated intraocular pressure (IOP) following implantation in 60% of patients.
      Glaucoma filtering is required in over 30% of patients at 2 years. Anecortave acetate (AA)
      has been shown to reduce steroid induced elevated IOP. The purpose of this study was to
      evaluate the ability of prophylactic anterior juxtascleral depot administration of AA to
      prevent this Retisert induced elevated IOP.
    

Detailed description: 
      Test Article: Anecortave Acetate: 6% and 10% Sterile Suspension

      Drug Study Dosage: Patients will receive an injection (0.5 mL, 0.4 mL, or 0.2 mL of the 6%
      Anecortave Acetate suspension or 0.5 mL of the 10% suspension) of study medication every 4
      months.

      Active Ingredients: Anecortave Acetate (AL-3789)

      Route of Administration: Sub-Tenon injection

      Objective(s): To evaluate the safety and efficacy of four dosages (50 mg, 30 mg, 24 mg, or 12
      mg) of Anecortave Acetate (AA) for the prevention of steroid-induced intraocular pressure
      (IOP) elevations caused by Retisert.

      Study Population: Approximately 24 patients

      Structure: Parallel Group Duration of Treatment: 3 years

      Description: Observer-masked study of the safety and efficacy of Anecortave Acetate 6% or 10
      % administered by a sub-Tenon injection. Up to 24 patients with recent implantation of a
      Retisert implant will be given a sub-Tenon injection of either 0.5 mL, 0.4 mL, or 0.2 mL of
      6% Anecortave Acetate Sterile suspension or 0.5 mL of the 10% suspension. Patients will
      receive periodic evaluations and re-treatment every 4 months for as long as 3 years. The end
      point will be an IOP which requires surgical intervention. An initial assessment of efficacy
      will be made at 18 months. If any patient treated with a lower dose develops an IOP of
      greater than 30mHg, then they are eligible to receive the 50 mg dose.

      Multicenter: Yes Number of Centers: 1 Masking: Observer masked (IOP-reader)

      Method of Patient Assignment:

      Randomization: Yes
    

Intervention name(s): anecortave acetate
Intervention type(s): Drug
Intervention description(s): Patients will receive the specified dose of anecortave acetate every 4 months in an anterior juxtascleral depot injection
Intervention MeSH terms: Anecortave
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Retisert; Uveitis; glaucoma
Genetic Variation in Platelet Aggregation
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      The aim of the study is to test whether genetic variation in the alpha 2A adrenergic receptor
      affects diurnal variation in platelet aggregation.
    

Detailed description: 
      There is a marked diurnal fluctuation in the occurrence of acute myocardial infarction and
      sudden death, with peak incidences occurring in the early morning. Platelet aggregation has
      also been shown to increase in the early morning. The investigators will test the hypothesis
      that alpha 2a-adrenergic receptor (ADRA2A) genetic variation, specifically haplotype 4,
      affects platelet aggregation. The investigators will compare diurnal platelet aggregation in
      haplotype 4 subjects with subjects in the other haplotype families. In addition, the
      investigators will compare platelet aggregation after the cold pressor test in haplotype 4
      with the other haplotype families. If there are no differences among haplotypes, then the
      haplotypes will be combined to analyze.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy subjects will be recruited by advertisement and word-of-mouth.
      
Biospecimen description: 
      Blood samples for DNA and plasma/serum for subsequent biomarker analysis if required.
    
Keywords: Myocardial infarction; Platelet aggregation; cold pressor test; Genetics
Clinical Evaluation and Assesment of Ginigivitis Patients Treated by Yarrow Natural Extract in Compare to a Contro Group
Condition: Gingivitis
MeSH terms: Gingivitis
Study type: Interventional
Phase: Phase 1

Summary: 
      A double-blind, prospective, randomized, intra-individual comparative, single-center clinical
      study was conducted. Participants were placed in parallel groups, and the study was performed
      in the Department of Operative Dentistry and Periodontology, Dental School and Hospital,
      Minia university to compare the antibacterial activity of yarrow Moringa herbal combinations
      nanoparticles in compared to Chlorhexidine as a potential treatment for gingivitis.
    


Intervention name(s): Yarrow and moringa mixture
Intervention type(s): Drug
Intervention description(s): yarrow and moringa mixture nano particles loaded on buccal film
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Loves Company: Combatting Emotional Disturbance in the Digital Age
Condition: Adolescent - Emotional Problem
MeSH terms: Affective Symptoms
Study type: Interventional

Summary: 
      The goal of this study is to determine whether a community-based website that is intended to
      provide support for adolescents experiencing psychological distress can improve members'
      mental health outcomes. The investigators want to understand if a digital platform can help
      young people who are suffering and may be unlikely to access more traditional forms of mental
      health services.
    


Intervention name(s): anonymous social support; psychoeducation; online resources
Intervention type(s): Other; Other; Other
Intervention description(s): Participants randomized to the intervention condition will be able to communicate with one another and offer social media-based forms of support (e.g., post music, photos, etc).; educational materials related to mental health; links to online mental health resources
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: adolescent; mental health; social media
A Pilot Study of a New PEG3350 Dose Formulation For Use in Constipated Children
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the patient acceptance of a new PEG3350 dose formulation in children currently
      treated with PEG3350 powder for treatment of constipation.
    


Intervention name(s): PEG3350
Intervention type(s): Drug
Intervention description(s): PEG3350
Intervention MeSH terms: Polyethylene glycol 3350
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Comparative Study of Inhaled Ciclesonide Versus Placebo in Children (6-11 Years) With Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the efficacy of inhaled ciclesonide at three
      different dose levels compared with placebo with respect to pulmonary function, asthma
      symptoms, and use of rescue medication in children aged 6-11 years with asthma. Treatment
      medication will be administered as follows: ciclesonide or placebo will be inhaled once daily
      in the evening. The study consists of a baseline period (2 to 4 weeks) and a treatment period
      (12 weeks). The study provides further data on safety and tolerability of ciclesonide.
    

Detailed description: 
      The drug being tested is called ciclesonide. This study looked at the safety and efficacy of
      inhaled ciclesonide in children with asthma. The study enrolled 1080 patients.

      Participants were randomly assigned to 1 of 4 treatment groups which were undisclosed to the
      patient and study doctor during the study:• Ciclesonide 40 µg, 80 µg or 160 µg • Placebo-
      this is similar to study drug but has no active ingredient. Ciclesonide was inhaled via a
      metered-dose inhaler (MDI with HFA-134a propellant), with or without spacer, once daily in
      the evening throughout the study. All participants were asked to document daily AM and PM
      peak expiratory flow (PEF), daytime and nighttime asthma symptom scores and number of puffs
      of rescue medicine in an electronic diary. This multi-centre trial was conducted worldwide.
      The overall time to participate in this study was 20 weeks. Participants made multiple visits
      to the clinic plus a final visit 30 days after the last dose of study drug for a follow-up
      assessment.
    

Intervention name(s): Ciclesonide; Placebo; Salbutamol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): inhaled Ciclesonide; Ciclesonide placebo-matching inhaler; Salbutamol inhalation powder
Intervention MeSH terms: Ciclesonide; Albuterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Asthma; Ciclesonide; children
Effect of Oxygen Supplementation During Exercise in Chronic Obstructive Pulmonary Disease Patients
Condition: Chronic Obstructive Pulmonary Disease; Hypoxia
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Hypoxia
Study type: Interventional

Summary: 
      The project will test the hypothesis that lung ventilation during exercise is unaffected by
      oxygen supplementation. In addition, the acute effect of oxygen supplementation on dyspnoea,
      heart rate and blood pressure will be studied.
    


Intervention name(s): Oxygen
Intervention type(s): Drug
Intervention description(s): supplementary oxygen during exercise
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pallidal Stimulation in Patients With Post-anoxic and Idiopathic Dystonia
Condition: Dystonia
MeSH terms: Dystonia; Dystonic Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Bilateral pallidal stimulation is effective in the treatment of patients with generalised
      idiopathic dystonia. The aim of this study is to evaluate the efficacy of bilateral pallidal
      stimulation in patients with post-anoxic generalised dystonia or non-generalised primary
      dystonia.
    

Detailed description: 
      Evaluate the effect of bilateral pallidal stimulation on the motor disability of patients
      with post-anoxic generalised dystonia or primary dystonia.
    

Intervention name(s): Deep brain stimulation
Intervention type(s): Procedure
Intervention description(s): internal pallidal deep brain stimulation
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Dystonia; deep brain stimulation; globus pallidus; Post-anoxic dystonia
Effects of Iron and/or Zinc Supplementation in Mexican School Children Exposed to Lead
Condition: Lead Poisoning
MeSH terms: Poisoning; Lead Poisoning
Study type: Interventional

Summary: 
      Lead is negatively linked to nutritional status, behavior and cognition in children. Despite
      extensive knowledge of its toxicity and efforts to reduce exposure, lead continues to be a
      problem in developed and developing countries. When lead exposure is unavoidable due to its
      pervasive nature, effective means of protecting or disrupting that exposure need to be
      developed. Nutritional interventions are one such option. We conducted a 2x2 factorial,
      placebo-controlled trial of 6-month iron and zinc supplementation among lead-exposed children
      in Torreón, Mexico (altitude 1060 m). Nine schools were selected based on proximity to a lead
      smelter and first-graders were individually randomized to daily treatment with 30 mg iron, 30
      mg zinc, both, or placebo. In addition to biochemical indicators, cognitive functions and
      behavior were evaluated at baseline, after the 6-month supplementation period, and again
      after another 6 months (without supplementation).

      At baseline, 602 children ages 6.2-8.5 years were enrolled.
    

Detailed description: 
      We conducted a 2x2 factorial, placebo-controlled trial of 6-month iron and zinc
      supplementation among lead-exposed children in Torreón, Mexico (altitude 1060 m) to test the
      hypothesis that supplementation with iron, zinc or both will reduce blood lead concentrations
      of the children and improve their cognition and behavior. Nine schools were selected based on
      proximity to a lead smelter and first-graders were individually randomized to daily treatment
      with 30 mg iron, 30 mg zinc, both, or placebo. In addition to biochemical indicators (blood
      lead, serum ferritin, CRP, serum zinc, urinary arsenic concentrations), cognitive functions
      and behavior were measured. Assessments were conducted at three time points: at baseline,
      after the 6 month treatment, and again after another 6 months without treatment. At baseline,
      602 children ages 6.2-8.5 years were enrolled.
    

Intervention name(s): Ferrous fumarate; Zinc oxide; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Tablet formulated from 30 mg ferrous fumarate.; Tablet formulated from 30 mg zinc oxide
Intervention MeSH terms: Ferrous fumarate; Zinc Oxide
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: blood lead, iron, zinc, child, cognition, behavior, Mexico
Does Treatment With Montelukast Improve Symptoms of Atopic Dermatitis in Children?
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      An open-label (outcome assessor blinded) prospective crossover cohort study of children 6-16
      years assessing effects of Montelukast on moderate to severe atopic dermatitis.
    

Detailed description: 
      An open-label, prospective cohort study with two arms over 16 weeks comprising 8 weeks of
      treatment with montelukast and 8 weeks without treatment of montelukast. All patients will be
      followed from recruitment to the study end date.

      Study Population 62 patients aged 6-16 years old with moderate to severe atopic dermatitis
      recruited from the Royal Children's Hospital and Box Hill Hospital dermatology clinics having
      already previously received eczema education (SCORAD >25) Study Product Oral tablet
      montelukast Dose Regimen For patients 6-8 years old - 4mg montelukast once daily For patients
      9-13 years old - 5mg montelukast once daily For patients 14-16 years old - 10mg montelukast
      once daily Evaluation Criteria Primary objective measurement: mean change in SCORAD index at
      8 weeks Patients will be randomized into 2 arms: Arm 1 treated with montelukast therapy over
      8 weeks followed by no montelukast therapy for 8 weeks. Arm 2 followed for 8 weeks without
      montelukast therapy followed by 8 weeks with montelukast therapy.

      Assessment Schedule Clinical assessment will be conducted at baseline (week 0), and reviewed
      every 4 weeks over 16 weeks with a safety follow-up visit 2 weeks after the treatment ends
      (week 18). At the first clinic visit, demographic data, medical history and baseline SCORAD
      and cDLQI will be recorded. cDLQI will be completed by the participants. Participants with
      SCORAD <25 are considered to have mild disease and will not be included in the study.
      Suitable participants will be prescribed oral montelukast as an adjunct to their standard
      topical therapy (corticosteroids, emollients) or immunosuppressive therapy. Adverse effects,
      SCORAD (assessed by a blinded assessor) and cDLQI will be assessed at each review.

      Data will be analyzed based on intention-to-treat. Paired data on SCORAD and cDLQI will be
      analyzed. A p value <0.05 will be considered statistically significant. A 30% improvement in
      SCORAD and cDLQI scores will be considered clinically significant.
    

Intervention name(s): Montelukast
Intervention type(s): Drug
Intervention description(s): daily dose according to age for 8 weeks out of 16 weeks of assessment
Other intervention name(s): Apo-Montelukast, Singulair
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Pharmacokinetics and Safety of Cefazolin 2g in DUPLEX
Condition: Infection
MeSH terms: Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to demonstrate the safety and pharmacokinetics of Cefazolin 2g
      for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System to Cefazolin
      1.5g for Injection USP and Dextrose Injection USP in daily doses of 6g in healthy adult
      subjects for 11 days of administration.
    

Detailed description: 
      B. Braun Medical Inc. intends to conduct human PK studies and obtain marketing approval for
      Cefazolin 2g in the United States with identical indications of those already approved for
      the 1g strength. A pharmacokinetic study will be conducted with the Cefazolin 2g product
      manufactured by B. Braun Medical Inc. Cefazolin 1.5g dose will be prepared using 10g
      Cefazolin pharmacy bulk with 5% Dextrose. The clinical study proposed in this protocol is
      designed to evaluate the pharmacokinetic characteristics of 2g and 1.5g Cefazolin in Dextrose
      in healthy subjects at the maximum recommended infusion dose of 6g per day per FDA's
      recommendation.

      The study is designed to simulate clinical practice and overall experience with cephalosporin
      administration. Cefazolin may be reconstituted with dextrose (or a number of other diluents
      as recommended in the innovator's package insert) in order to achieve an osmolality
      appropriate for intravenous infusion.

      According to B. Braun's approved package insert for Cefazolin 1g, the maximum dose of 1.5g
      Cefazolin for Injection USP and Dextrose Injection USP is 1.5 grams every 6 hours for severe,
      life-threatening infections. In rare instances, doses of up to 12 grams of Cefazolin per day
      have been used. Lower doses are stated in the B. Braun package insert.
    

Intervention name(s): Cefazolin 2g for Injection USP and Dextrose Injection USP; Cefazolin 1.5g
Intervention type(s): Drug; Drug
Intervention description(s): Cefazolin 2g for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur three times per day (t.i.d.) over an eleven (11) day period, with nine (9) days of repeated dosing.; Cefazolin 1.5g for Injection USP and Dextrose Injection USP in a pharmacy-prepared container. Administration will occur four times per day (q.i.d.) over an eleven (11) day period, with nine (9) days of repeated dosing.
Other intervention name(s): Cefazolin 2g in DUPLEX (50ml); Cefazolin 1.5g (50ml)
Intervention MeSH terms: Cefazolin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cefazolin; Caphalosporin; antibiotic; gram positive; Infection control
Study of SECOX Versus Sorafenib as First-Line Treatment in Patients With Advanced Hepatocellular Carcinoma (HCC)
Condition: Carcinoma, Hepatocellular; Secondary
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if sorafenib, capecitabine and oxaliplatin (SECOX)
      regimen is more effective than sorafenib alone in the treatment of advanced liver cancer.
    


Intervention name(s): Sorafenib; Capecitabine; Oxaliplatin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): PO; PO; IV
Other intervention name(s): Nexavar; Xeloda
Intervention MeSH terms: Capecitabine; Oxaliplatin; Sorafenib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sorafenib; Drug Therapy