bioihbjkbjnl/mcl2 huggingface dataset:
Neonatal Erythropoietin And Therapeutic Hypothermia Outcomes in Newborn Brain Injury (NEATO)
Condition: Hypoxic-ischemic Encephalopathy; Neonatal Encephalopathy; Birth Asphyxia
MeSH terms: Brain Diseases; Brain Ischemia; Hypoxia-Ischemia, Brain; Asphyxia Neonatorum; Hypothermia; Asphyxia
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Hypoxic-ischemic encephalopathy (HIE), a condition of reduced blood and oxygen flow to a
      baby's brain near the time of birth, may cause death or neurologic disability. Cooling
      therapy (hypothermia) provides some protection, but about half of affected infants still have
      a poor outcome. This clinical trial will determine if the drug erythropoietin, given with
      hypothermia, is safe to use as a treatment that may further reduce the risk of neurologic
      deficits after HIE.
    

Detailed description: 
      This phase I/II clinical trial is designed to demonstrate:

        1. The feasibility of recruiting, enrolling and following 50 patients with moderate to
           severe HIE at 5 sites, while meeting specified recruitment and follow-up target goals.

        2. The safety of high-dose Epo therapy in neonates with HIE with respect to systemic organ
           function and general growth parameters.

        3. The value of brain MRI/MRS performed at 4-7 days of age as a biomarker of motor function
           at 12 months of age.
    

Intervention name(s): Erythropoietin; Normal saline
Intervention type(s): Drug; Drug
Intervention description(s): 1000 U/kg/dose IV x 5 doses; placebo: NS IV x 5 doses
Other intervention name(s): Procrit
Intervention MeSH terms: Epoetin Alfa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: erythropoietin; therapeutic hypothermia
Safety & Activity of P501-AS15 Vaccine as a First-line Treatment for Patients With Hormone-sensitive Prostate Cancer Who Show Rising PSA
Condition: Neoplasms, Prostate
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Patients with hormone-sensitive prostate cancer and rising PSA, after primary tumor
      treatment, will be treated with the P501-AS15 vaccine as out-patients. The maximum dose will
      be 16 vaccinations, given over a period of approximately one year. Thereafter, the patients'
      long-term safety and PSA status will be followed over a period of approximately 11 months.
    

Detailed description: 
      This Phase I/II study will be conducted according to a multicenter, open-label, single-group
      design at approximately ten centers in Europe. At least 21 HSPC patients with rising PSA
      after primary tumor treatment will be enrolled in this study. All patients will be treated as
      out-patients and will receive the same treatment. The maximum dose will be 16 vaccinations.
      Follow-up: The patients' long-term safety and PSA status will be followed over a period of 48
      weeks. The Protocol Posting has been updated in order to comply with the FDA Amendment Act,
      Sep 2007.
    

Intervention name(s): P501-AS15 vaccine
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Comparison Between Melatonin and Diazepam for Prevention of Recurrent Simple Febrile Seizures
Condition: Febrile Seizures
MeSH terms: Seizures; Seizures, Febrile; Hyperthermia; Fever
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the efficacy of oral melatonin compared to oral diazepam for prevention of
      recurrent simple febrile seizures.
    

Detailed description: 
      To evaluate the efficacy of oral melatonin compared to oral diazepam for prevention of
      recurrence of simple febrile seizures in children aged 6 months to 5 years.
    

Intervention name(s): oral melatonin; oral diazepam
Intervention type(s): Drug; Drug
Intervention description(s): Both melatonin and diazepam were given only during the febrile illness.; Both melatonin and diazepam were given only during the febrile illness.
Intervention MeSH terms: Diazepam; Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Melatonin; Diazepam; recurrence; prophylaxis; Febrile convulsions
Alternative and Integrative Therapy for Lumbar Disk Herniation
Condition: Sciatica; Intervertebral Disc Disorder
MeSH terms: Intervertebral Disc Displacement; Sciatica
Study type: Observational [Patient Registry]

Summary: 
      The investigators report management of lumbar disc herniation with severe sciatic pain using
      an integrative complementary and alternative medicine approach with a 5 year follow-up.
    


Intervention name(s): herbal medicine, acupuncture, bee-venom acupuncture, and Chuna manipulation
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        integrative hospital that offers both Western and traditional Korean medical services
Evaluation of the Efficacy and Safety of Indigo Naturalis Oil Extract on Psoriatic Nails
Condition: Nail Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to evaluate efficacy and safety of indigo naturalis oil extract
      in treating nail psoriasis.
    

Detailed description: 
      Nail psoriasis treatment is notoriously difficult. While indigo naturalis has been
      demonstrated safe and effective in treating skin psoriasis, its effect on nail psoriasis
      remains unverified.
    

Intervention name(s): Indigo Naturalis Extract in Oil; Olive Oil
Intervention type(s): Drug; Other
Intervention description(s): Indigo naturalis extract in oil (INEO) was applied to the fingernails of one bilateral hand (experimental group) twice daily for the first 12 weeks. INEO was applied to all affected nails on both hands twice daily for another 12 weeks; Olive oil was applied to the fingernails of the contra-lateral hand (control group) twice daily for the first 12 weeks. INEO was applied to all affected nails on both hands twice daily for another 12 weeks.
Other intervention name(s): INEO
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Nail psoriasis; Indigo naturalis
Study of Safety and Efficacy of HLX01+MTX in Patients With Rheumatoid Arthritis
Condition: Moderately to Severely Active Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the efficacy between the HLX01 group and the placebo group through the proportion
      of subjects meeting the ACR20 improvement criteria for remission
    


Intervention name(s): HLX01; Methotrexate（MTX）
Intervention type(s): Drug; Drug
Intervention description(s): HLX01,Recombinant Human-mouse Chimeric Anti-CD20 Monoclonal Antibody Injection is recombinant human-mouse chimeric anti-cd20 CD20 monoclonal antibody.; Methotrexate is a slow-acting antirheumatic drug.
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Drug Interaction Study Of Filibuvir With Methadone Among Subjects On Chronic Methadone Maintenance
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      Filibuvir, a CYP3A4 inhibitor is being developed for the treatment of chronic Hepatitis C
      infection. Given the likelihood of co administration of filibuvir and methadone, this study
      will evaluate the effect of filibuvir on the pharmacokinetics of R/S Methadone.
    


Intervention name(s): filibuvir
Intervention type(s): Drug
Intervention description(s): Filibuvir, 600mg bid administered along with methadone on days 2-11
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug interaction with methadone.
Reducing the Risk of Metabolic Decompensation in Diabetic Adolescents by Supervised School Administration of Insulin
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is a pilot study to examine and compare the efficacy of supervised injections of long
      acting insulins degludec and glargine to protect youth with poorly controlled type 1 diabetes
      (T1D) from development of ketones.
    

Detailed description: 
      This study will compare the proportion of days with fasting β-hydroxybutyrate levels ≥0.6
      mmol/L at the start of the school week following weekend/holiday breaks in subjects who have
      been randomized to receive daily injections of I-deg or I-glar. Hypothesis: β-hydroxybutyrate
      levels will be lower in the morning of the first day of the school week in subjects receiving
      I-deg than in subjects receiving I-glar, since the long half-life of I-deg will compensate
      for missed insulin doses over the weekend/holidays. To remove variability due to potential
      non-compliance during the school week, this study will utilize our routine clinical practice
      of supervised insulin administration and monitoring of blood glucose and ketones during the
      school day.
    

Intervention name(s): Insulin Degludec; Insulin Glargine
Intervention type(s): Drug; Drug
Intervention description(s): Single daily dose of insulin degludec based on their fasting blood glucose levels and current long acting insulin dose; Single daily dose of insulin glargine based on their fasting blood glucose levels and current long acting insulin dose
Other intervention name(s): I-degludec; I-glar
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The High Cup/Disc Ratio in Children
Condition: Glaucoma
MeSH terms: Glaucoma
Study type: Observational

Summary: 
      To investigate of high cup/disc ratio in children.
    

Detailed description: 
      ophthalmologic examination

        1. cycloplegic refraction

        2. axial length and anterior chamber depth

        3. intraocular pressure

      B. optic nerve head and retinal nerve fiber layer

        1. disc photography

        2. Heidelberg Retina Tomograph
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        high cup disc ratio in children
      
Keywords: high cup disc ratio; glaucoma suspect
Impact of the Source and Food Matrices on the Bioavailability of Peptan® (Collagen Peptides) in Healthy Subjects
Condition: Bioavailability
Study type: Interventional

Summary: 
      The aim of this study is the comparison of the oral bioavailability of hydroxyproline, a key
      marker for collagen peptide intake, after ingestion of collagen peptides from different
      sources, sizes and together with different food matrices, either containing high or low
      levels of polyphenols.
    

Detailed description: 
      The absorption (blood) of collagen peptides from bovine, fish and porcine source in different
      sizes and administered together with foods of different polyphenol content will be assessed.
      Pharmacokinetic parameters (AUC0-6h, Cmax and Tmax) after oral single dose administration
      will be determined to estimate the impact of different sources, different peptide sized any
      food matrix.

      The following objectives will be evaluated exploratory by comparison of pharmacokinetic
      parameters from the concentration time curve of hydroxyproline, a key marker of collagen type
      I, between:

        -  different sources of collagen peptides (bovine, fish, porcine)

        -  different sizes of collagen peptides from cattle

        -  food matrices impact on uptake of bovine collagen peptides (dissolved in water vs. food
           matrix 1 vs. food matrix 2).

      Additionally, concentration time curves of further amino acids will be assessed
      descriptively.
    

Intervention name(s): collagen peptides
Intervention type(s): Dietary Supplement
Intervention description(s): Collagen peptides will be orally administered and pharmacokinetic parameters will be assessed up to 6 hours after study product intake.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The clinical study will be performed in a double-blind, randomized, monocentric cross-over design.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: bioavailability; collagen peptides; polyphenols
Comparison of Endotracheal Intubation Success Rates Using Video Laryngoscopes in Entrapped Patients - a Manikin Study
Condition: Endotracheal Intubation
Study type: Observational

Summary: 
      The investigators will compare the success rates of endotracheal intubation in a simulated
      entrapped car accident victim (manikin) using different video laryngoscopes by experienced
      emergency physicians.

      The investigators hypothesized that video laryngoscopes may improve success rates.
    


Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        experienced emergency physicians
A Long-term Safety and Efficacy of EnXtra (E-AG-01) in Healthy Adults
Condition: Caffeine Dependence
Study type: Interventional

Summary: 
      The present study has been proposed to investigate the long-term safety and efficacy of
      EnXtra in healthy adults habituated to caffeine.
    


Intervention name(s): Alpinia Galanga; Alpinia Galanga; Microcellulose crystalline
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 2 capsules; 2 capsules; 2 capsules
Other intervention name(s): Caffeine
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Comparison of Two Phacoemulsification-methods: EasyTip 2.2mm vs. Infusion Assisted EasyTip 2.2mm
Condition: Cataracts
MeSH terms: Cataract
Study type: Interventional

Summary: 
      The aim of this study was to compare the intraoperative efficiency, safety and postoperative
      outcomes of cataract surgery with two different "high-fluidic" settings.
    


Intervention name(s): cataract surgery
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: efficiency and safety
A Study to Evaluate the Effect of Food on Levofloxacin Pharmacokinetics From an Oral Solution Formulation
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of the study was to evaluate the effect of food on the single-dose
      pharmacokinetics of an oral solution of levofloxacin.
    

Detailed description: 
      In this single-dose study conducted at a single center, the effect of food on the
      pharmacokinetics of levofloxacin was studied in 24 healthy men and women aged 18 to 55 years
      old. Subjects were assigned different treatments based on chance; both the researcher and the
      study participant knew the treatment being administered. The study consisted of 3 phases: a
      screening phase, an open-label treatment phase consisting of 2 treatment periods, and a
      post-treatment phase. Subjects who met the prestudy eligibility criteria were randomly
      assigned to 1 of 2 treatment sequence groups. In each treatment period, subjects were
      admitted to the study facility the evening before study drug administration and housed
      through 48 hours after dosing with study drug. Subjects received levofloxacin as a single
      oral dose of 500 mg under both fed (within 10 minutes after completion of a high-fat,
      high-caloric breakfast) and fasted (10-hour overnight fast) conditions according to their
      randomized treatment sequence. Each dosing day was separated by a washout period of at least
      4 days. In each treatment period, pharmacokinetic blood samples were collected immediately
      prior to dosing and at 0.25, 0.5, 0.75, 1, 1.5, 2, 4, 6, 10, 14, 24, 30, 36, and 48 hours
      after dosing for determination of plasma concentrations of levofloxacin. Safety evaluations,
      including adverse event monitoring, standard clinical laboratory evaluations (hematology,
      serum chemistry, and urinalysis), vital sign monitoring, and physical examinations were
      performed on Days 1 and 3 of each treatment period. The post-treatment phase consisted of
      safety evaluations performed after collection of the final pharmacokinetic blood sampling in
      the second treatment period. Adverse events were monitored from the time of the first
      study-related procedure through completion of post-treatment study procedures, or until the
      time of early withdrawal from the study. Levofloxacin solution administered as 2 single oral
      doses of 500 mg each, 1 in each treatment period, administered at least 4 days apart.
    

Intervention name(s): levofloxacin oral solution
Intervention type(s): Drug
Intervention MeSH terms: Levofloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: open-label; randomized; crossover; food effect
Significance of Synbiotics on Inflammation and Proliferation of Colonic Mucosa
Condition: Inflammation
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      There is a constant exchange between the gut epithelium and lumen, including microbial
      interplay. The aim of this study was to investigate dietary test products on inflammatory
      proliferation markers in the gut, and thereby if the products had positive effects in the gut
      as well as in other parts of the body.

      The hypothesis was that the test products would reduce the inflammatory and proliferation
      activity of the gut epithelium by fermentation of normal food products and by converting
      dietary phenolic compounds into anti-inflammatory substances.
    


Intervention name(s): Lactobacillus; Bifidobacterium
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Intervention (2 weeks) with a strain of Lactobacillus; Intervention (2 weeks) with a strain of Bifidobacterium
Other intervention name(s): Lactobacillus plantarum; Bifidobacterium infantis
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Performance of a New Glucose Meter System in Children and Young Adults
Condition: Diabetes
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the performance of a new blood glucose meter in the
      hands of children, teens, young adults.
    


Intervention name(s): DIDGET (Investigational Blood Glucose Monitoring System)
Intervention type(s): Device
Intervention description(s): Subjects with diabetes (with parent/guardian assistance, if applicable)and health care professionals (HCPs) each performed duplicate Blood Glucose (BG) tests from the subject's capillary blood on the DIDGET. To test the full range of glucose concentrations, a venipuncture was performed on some subjects to obtain enough blood for modifying (spiking or glycolyzing) to the extreme glucose concentrations. Results were compared to a laboratory glucose method - the Yellow Springs Instrument (YSI) Analyzer.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
A Study to Evaluate the Safety and Effectiveness of Asoprisnil and Estrogen Administration to Postmenopausal Women
Condition: Amenorrhea; Postmenopause
MeSH terms: Amenorrhea
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this study is to determine the safety and effectiveness of 3 asoprisnil
      doses when administered to postmenopausal women with Premarin® 0.625 mg.
    

Detailed description: 
      The objective of this study is to determine the safety and effectiveness of asoprisnil 5, 10,
      and 25 mg, compared to placebo, when administered to postmenopausal women, with Premarin®
      0.625 mg, for 12 weeks. Pharmacodynamic effects to be assessed include bleeding pattern,
      endometrial biopsy results, and endometrial thickness. Safety assessments will include
      clinical laboratory results, physical examination with vital signs, pelvic and breast
      examinations, ultrasound results, and adverse events
    

Intervention name(s): Asoprisnil/Premarin; Asoprisnil/Premarin; Asoprisnil/Premarin; Placebo and Premarin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Asoprisnil 5mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks; Asoprisnil 10mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks; Asoprisnil 25mg and Premarin 0.625 mg Tablets, oral Daily for 12 weeks; Placebo and Premarin 0.625 mg Tablets, oral Daily for 12 weeks
Intervention MeSH terms: Estrogens, Conjugated (USP)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postmenopausal; Amenorrhea; Hormone replacement therapy; HRT; asoprisnil
Clinical Evaluation of Approved Contact Lenses
Condition: Visual Acuity
Study type: Interventional

Summary: 
      This is a 4-week, randomized, double-masked study where subjects will wear bilaterally test
      and control lenses in random succession. The objective is to evaluate materials from
      different suppliers.
    


Intervention name(s): Test Contact Lens; Control Contact Lens
Intervention type(s): Device; Device
Other intervention name(s): senofilcon A made with material from a new supplier; senofilcon A made with material from the current supplier
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science