bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Pharmacokinetics Study in VLBW Neonates With BSYX-A110
Condition: Neonatal Staphylococcal Sepsis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      "Phase I/II, Randomized, Double Blind, Placebo Controlled, Dose Escalating, Safety and
      Pharmacokinetics Study in Very Low Birth Weight Neonates of Four Doses of BSYX-A110 for the
      Prevention of S. epidermidis Infection." The purpose of this study is to evaluate the safety
      and pharmacokinetics of escalating doses of BSYX-A110 administered on Study Days 0 and 14.
    

Detailed description: 
      "Phase I/II, Randomized, Double Blind, Placebo Controlled, Dose Escalating, Safety and
      Pharmacokinetics Study in Very Low Birth Weight Neonates of Four Doses of BSYX-A110, a Human
      Chimeric Anti-Staphylococcal Monoclonal Antibody for the Prevention of S. epidermidis
      Infection" will be the first study of BSYX-A110 in the target population of hospitalized,
      very low birth weight infants. The purpose of this study is to evaluate the safety and
      pharmacokinetics of escalating doses of BSYX-A110 administered on Study Days 0 and 14.

      This will be a randomized, double blind, placebo controlled, dose escalating study of
      BSYX-A110 in 48 very low birth weight neonates. The dose levels to be evaluated are 10, 30,
      60 and 90 mg/kg. Each dose level will enroll 12 infants who will receive two doses of
      BSYX-A110 or placebo intravenously at a ratio of 2:1 while hospitalized following birth.
      Infants will be followed for 8 weeks following the first dose of BSYX-A110 or placebo. The
      primary objective of this study is to evaluate safety and tolerability. The secondary
      objective is to analyze the pharmacokinetics of BSYX-A110. Positive cultures obtained during
      the study period will be recorded and analyzed.
    

Intervention name(s): Pagibaximab (formerly BSYX-A110)
Intervention type(s): Drug
Intervention description(s): Pagibaximab at 10, 30, 60, 90 mg/kg intravenously at Days 0 and 14.
Other intervention name(s): BSYX-A110; HU96-110; Pagibaximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Staphylococcal; Monoclonal antibodies; Very Low Birth Weight Infants; Prophylaxis
Dental Office Prevention Strategies for Children
Condition: Dental Plaque
MeSH terms: Dental Plaque
Study type: Interventional

Summary: 
      The overall goal of this study is to improve the standard of care in treating young children
      who often suffer from chronic caries (dental decay). Current standard of care for children
      under 12 years old includes a dental cleaning and fluoride treatment. Often this dental
      cleaning includes a 'dental prophylaxis' with a pumice based paste delivered by a small
      rubber-like cup that rotates on a slow-speed dental handpiece. The procedure of this dental
      prophylaxis removes the gross levels of plaque around the supragingival tooth surfaces. After
      this prophylaxis, a fluoride treatment is delivered. The National Maternal and Child Oral
      Health Resource Center at Georgetown University has published (Bertness J, Holt K) an
      extensive publication proving that 5% sodium fluoride varnish has become the 'standard of
      care' for fluoride treatment in children. This study includes this fluoride standard of care.

      Prior to the administration of this standard of care fluoride treatment, a separate step of
      cleansing the tooth after the dental prophylaxis is added. This study uses a cleansing
      procedure of 10% povidone iodine (PI) cleansing prior to fluoride varnish (FV) application.

      The primary aims of this study are:

        1. to measure the changes in overall plaque levels after using a 10% povidone iodine (PI)
           cleansing prior to fluoride varnish (FV) application.

        2. to measure the short term changes in the oral microbial ecology of dental plaque after
           10% povidone iodine (PI) cleansing prior to fluoride varnish (FV) application.
    


Intervention name(s): Single cleansing procedure of 10% Povidone Iodine
Intervention type(s): Procedure
Intervention description(s): Single cleansing procedure of 10% Povidone Iodine prior to an in-office 5% Sodium Fluoride varnish application
Intervention MeSH terms: Povidone-Iodine; Povidone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Children, Plaque
A Phase Ⅲ Clinical Study Trial of Felbinac Trometamol Injection in China
Condition: Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      A multi-center, randomized, double-blind, placebo parallel controlled phase Ⅲ clinical trial
      on the efficacy and safety of felbinac trometamol Injection in the treatment of moderate and
      severe postoperative pain.main purpose is to evaluate the efficacy of Felbinac Trometamol
      Injection in the treatment of moderate and severe pain after surgery.Secondary purpose is to
      evaluation the safety of Felbinac Trometamol Injection in the treatment of moderate and
      severe pain after surgery.
    


Intervention name(s): Felbinac Trometamol Injection; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Felbinac Trometamol Injection diluted to 100 ml with 0.9% sodium chloride injection.Use a micro-injection pump to inject intravenously at a constant speed for 30 min (± 2 min)..
One dose at 8h、16h 、24h、32h and 40h after the start of the first dose,the first intravenous infusion was started at the end of the operation (Skin suture completes the last stitch).The drug was given 6 times,3 times/day,once every 8 hours.; Placebo diluted to 100 ml with 0.9% sodium chloride injection.Use a micro-injection pump to inject intravenously at a constant speed for 30 min (± 2 min).
One dose at 8h、16h 、24h、32h and 40h after the start of the first dose,the first intravenous infusion was started at the end of the operation (Skin suture completes the last stitch).The drug was given 6 times,3 times/day,once every 8 hours.
Other intervention name(s): 4-Biphenylacetic Acid Trishydroxymettiylaminometnane; Normal saline
Intervention MeSH terms: Biphenylylacetic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Laser Biostimulation With Mandibular Ridge Splitting and Peek Overdenture
Condition: Ridge Splitting
Study type: Interventional

Summary: 
      This study was conducted to determine the effectiveness of two-implant retained
      polyetheretherketone (PEEK) overdentures on reducing the transmitted forces on implants
      placed with ridge splitting either treated with laser biostimulation or not.
    

Detailed description: 
      This randomised controlled trial was executed on 18 completely edentulous patients from the
      Outpatient Clinic of the Faculty of Dentistry at Mansoura University in Egypt.
    

Intervention name(s): ridge splitting with implant placement
Intervention type(s): Procedure
Intervention description(s): ridge splitting of mandibular denture followed by two implant placement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: peek , laser
Comparison of Different Feeding Appliances for Cleft Palate Babies
Condition: Cleft Palate
MeSH terms: Cleft Palate
Study type: Interventional

Summary: 
      This study will compare flexible , rigid feeding plates and a special feeding bottle for
      children with cleft palate.
    

Detailed description: 
      This study will compare flexible , rigid feeding plates and a special feeding bottle for
      children with cleft palate.

      The purpose of the present study will be explained to the patient's parents and informed
      consent will be obtained according to the guidelines on human research adopted by the
      Research Ethics Committee, Faculty of Dentistry, Tanta University.
    

Intervention name(s): flexible feeding plate
Intervention type(s): Device
Intervention description(s): One mm thick clear thermoplastic sheet was adapted over the cast using a vacuum-forming machine.
Other intervention name(s): special feeding appliance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: feeding appliance ,flexible, rigid
Antineoplaston Therapy in Treating Children With Brain Tumors
Condition: Childhood Brain Tumors
MeSH terms: Brain Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Current therapies for childhood brain tumors provide limited benefit to the
      patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove
      beneficial in the treatment of childhood brain tumors.

      PURPOSE: This study is being performed to determine the effects (good and bad) that
      Antineoplaston therapy has on children (> 6 months of age) with brain tumors.
    

Detailed description: 
      OVERVIEW: This is a single arm, open-label study in which children with brain tumors receive
      gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal)
      until the maximum tolerated dose is reached. Treatment continues for at least 12 months in
      the absence of disease progression or unacceptable toxicity.

      OBJECTIVES:

        -  To determine the efficacy of Antineoplaston therapy in children with a brain tumor, as
           measured by an objective response to therapy (complete response, partial response or
           stable disease).

        -  To determine the safety and tolerance of Antineoplaston therapy in children with a brain
           tumor.

        -  To determine objective response, tumor size is measured utilizing MRI scans, which are
           performed every 8 weeks for the first two years, every 3 months for the third and fourth
           years, every 6 months for the 5th and sixth years, and annually thereafter.

      PROJECTED ACCRUAL: A total of 20-40 patients will be accrued to this study.
    

Intervention name(s): Antineoplaston therapy (Atengenal + Astugenal)
Intervention type(s): Drug
Intervention description(s): Children with a brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal).
Other intervention name(s): A10 (Atengenal); AS2-1 (Astugenal)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Anaplastic astrocytoma; Anaplastic glioma; Anaplastic oligodendroglioma; Astrocytoma; Astrocytoma pilocytic; Brain stem glioma; Craniopharyngioma; Ganglioglioma; Glioblastoma multiforme; Gliosarcoma; Medulloepithelioma; Neurocytoma; Oligodendroglioma; Oligodendroglioma-brainstem; Primitive neuroectodermal tumor
PENS or TENS for Pain in Pancreatic Cancer
Condition: Pain; Cancer Pain; Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms; Cancer Pain
Study type: Interventional

Summary: 
      This study evaluates the effect of percutaneous electrical nerve stimulation (PENS) and
      transcutaneous nerve stimulation (TENS) for pain relieving in patients with pancreatic
      cancer. Patients will randomly allocated into PENS group, Tens group and control group.
    

Detailed description: 
      PENS and TENS have been reported with analgesic effect in patients with pain, including
      cancer pain, lower back pain, neck pain, stomachache and so on.

      Effect and mechanism of PENS on pain relieving has been widely researched. With additional
      electrical stimulation in certain frequency and intensity to conventional acupuncture, pain
      controlling effect has been largely enhanced. However, invasive operation limits its
      application and acceptability, especially on pancreatic cancer.

      TENS is an advanced technique generated from PENS, which is much more welcome for its
      noninvasive character. Further more, its analgesic effect on cancer pain has been proved by
      several multi-central, randomized, clinical trials.
    

Intervention name(s): PENS; TENS
Intervention type(s): Device; Device
Intervention description(s): percutaneous electrical nerve stimulation; transcutaneous electrical nerve stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: patients with pancreatic cancer pain
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: percutaneous electrical nerve stimulation; transcutaneous electrical nerve stimulation; pain; pancreatic cancer
Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With Hepatitis C Infection
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      Egypt has the highest prevalence of hepatitis C virus (HCV) in the world, estimated
      nationally at 14.7%. Genotype 4 (and subtype 4a in particular) dominates the HCV epidemic in
      Egypt. For decades the antiviral therapy of chronic HCV infection was based on the
      administration of Interferon(IFN), initially alone and then in combination with Ribavirin
      (RBV), but this regimen was effective in only 50% of patients with genotype 1, with
      significant side effects.
    

Detailed description: 
      Egypt has the highest prevalence of hepatitis C virus (HCV) in the world, estimated
      nationally at 14.7%. Genotype 4 (and subtype 4a in particular) dominates the HCV epidemic in
      Egypt. For decades the antiviral therapy of chronic HCV infection was based on the
      administration ofInterferon(IFN), initially alone and then in combination with Ribavirin
      (RBV), but this regimen was effective in only 50% of patients with genotype 1, with
      significant side effects. The introduction of direct acting antiviral agents, in particular
      sofosbuvir (SOF), has revolutionized the treatment for chronic hepatitis C virus.
    

Intervention name(s): Sofosbuvir; Ribavirin; Pegylated-interferon alfa-2a; Simeprevir; Daclatasvir; Ritaprevir, paritaprevir, ombetasvir; Sofosbuvir and Ledipasvir; Salvage therapy
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Sofosbuvir 400 mg daily.; Ribavirin 1000-1200 mg daily; Pegylated interferon alfa-2a once weekly for 3 months; Olysio once daily.; Dakla once daily for three months.; Querevo for three months; Once daily for three months; three months in repeated treatment failure
Other intervention name(s): sovaldi , mpiviropack; Rebetol, Riba; peginteron, pegasys; Olysio; Daklatasvir, Dakla; querevo; Harvony; Sofosbuvir,simeprevir, daclatasvir, ribavirin or sofosbuvir and querevo
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a; Sofosbuvir; Ledipasvir; Simeprevir; Ledipasvir, sofosbuvir drug combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetics of LCP-Tacro in Stable Kidney Transplant Patients
Condition: Renal Failure
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 2

Summary: 
      A three sequence, open-label, multi-center, prospective, study in stable kidney transplant
      patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of
      LCP-Tacro (tacrolimus) tablets versus Prograf (tacrolimus) capsules.
    

Detailed description: 
      A three sequence, open-label, multi-center, prospective, study in stable kidney transplant
      patients to assess and compare the pharmacokinetics (Cmax, C24, and AUC), and safety of
      LCP-Tacro (tacrolimus) tablets versus Prograf (tacrolimus) capsules.

      Stable kidney transplant patients who fulfill all I/E criteria will be enrolled and kept on
      Prograf for 7 days. Following a 24-hour PK study on Day 7 to determine pharmacokinetics for
      Prograf, all patients will be converted to once daily LCP-Tacro for 7 days with no dose
      changes allowed. On Day 14 and Day 21 a 24-hour LCP-Tacro PK study will be performed. On Day
      22 patients will be converted back to their original twice daily dose of Prograf for a safety
      follow-up period of 30 days ending with a safety assessment on day 53.
    

Intervention name(s): LCP Tacro (tacrolimus); Prograf
Intervention type(s): Drug; Drug
Intervention description(s): Prograf will be administrated twice a day, per product labeling, with an interval of 12 ± 1 hours between the morning and evening doses. Patients will continue on the same dose on Day0 through Day 7 to maintain target trough levels of 7-12 ng/mL. On the morning of Day 8, following the final blood draw for the PK assessment, patient will be converted to LCP-Tacro using the conversion Ratio 0.66-0.8. LCP-Tacro tablets will be administered orally once daily in the morning, with an interval of 24 ± 1 hours between doses.
Other Names:
Tacrolimus modified-release LCP-Tacro tablets were provided in 3 strengths: 1 mg, 2 mg, and 5 mg oral tablets.; Prograf will be administrated twice a day, per product labeling, with an interval of 12 ± 1 hours between the morning and evening doses. Patients will continue on the same dose on Day0 through Day 7 to maintain target trough levels of 7-12 ng/mL. On the morning of Day 8, following the final blood draw for the PK assessment, patient will be converted to LCP-Tacro using the conversion Ratio 0.66-0.8. LCP-Tacro tablets will be administered orally once daily in the morning, with an interval of 24 ± 1 hours between doses.
Other Names:
Tacrolimus modified-release LCP-Tacro tablets were provided in 3 strengths: 1 mg, 2 mg, and 5 mg oral tablets.
Other intervention name(s): tacrolimus; Tacrolimus
Intervention MeSH terms: Tacrolimus
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tacrolimus; Pharmacokinetics; Kidney Transplantation
Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Comparison of the Remission Rates of Once Daily Treatment With Esomeprazole 20mg and Lansoprazole 15mg for 6 Months in Patients Whose EE Has Been Healed
Condition: Erosive Esophagitis
MeSH terms: Esophagitis
Study type: Interventional
Phase: Phase 4

Summary: 
      A study to look at the rates of remission (non re-appearance of erosive esomeprazole) when
      treated with esomeprazole or lansoprazole; in patients in with erosive esomeprazole (EE) that
      is in remission (i.e. previously healed EE).
    


Intervention name(s): Esomeprazole; Lansoprazole
Intervention type(s): Drug; Drug
Other intervention name(s): Nexium; Prevacid
Intervention MeSH terms: Esomeprazole; Lansoprazole; Dexlansoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Erosive Esophagitis; Nexium; Esomeprazole; Lansoprazole; Heartburn
Efficacy and Safety of FG-4592 for Treatment of Anemia in Participants With Lower Risk Myelodysplastic Syndrome (MDS)
Condition: Anemia; Myelodysplastic Syndrome
MeSH terms: Preleukemia; Anemia; Myelodysplastic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The objective of this study to evaluate the efficacy FG-4592 for the treatment of anemia in
      Chinese participants with lower risk MDS.
    

Detailed description: 
      This is a Phase 2/3 trial with sequential Phase 2 and Phase 3 components. In each part, there
      is an up to 4 weeks screening period followed by a treatment period of 26 weeks and a 4 week
      follow-up period.
    

Intervention name(s): FG-4592; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral; Oral
Other intervention name(s): Roxadustat; AZD9941
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Myelodysplastic Syndromes; Anemia; Hemoglobin (Hb); Low Risk Myelodysplastic Syndrome
Low Carbohydrate Diet - Effect on Plasma Lipids and Metabolic Markers
Condition: Overweight and Obesity; Type IIb Hyperlipidaemia; Hypercholesterolemia Aggravated
MeSH terms: Hyperlipidemia, Familial Combined; Overweight; Hypercholesterolemia; Hyperlipidemias
Study type: Interventional

Summary: 
      Low carbohydrate diet may influence the plasma lipid levels.
    

Detailed description: 
      Fasting plasma lipids will be measured in healthy volunteer randomized to low carbohydrate
      diet or usual diet for a period
    

Intervention name(s): Low carbohydrate dietary advice; Continue usual diet
Intervention type(s): Other; Other
Intervention description(s): Dietary advice; Dietary advice
Other intervention name(s): Dietary advice; Lifestyle counseling to continue usual diet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Cardio vascular risk factors
A Chronic-Dose Safety and Efficacy Study of Albuterol Multi-Dose Dry Powder Inhaler in Pediatric Asthmatics
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is to evaluate the chronic-dose efficacy and the safety of Albuterol MDPI compared
      to placebo in pediatric participants with asthma.
    


Intervention name(s): Albuterol MDPI; Placebo; ProAir HFA inhaler
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 90 mcg/actuation of the multidose dry powder inhaler (MDPI).; Matching Placebo delivered via a multidose dry powder inhaler (MDPI).; Rescue medication, ProAir hydrofluoroalkane (HFA) inhaler, was dispensed at the run-in visit for the relief of asthma symptoms to be administered as needed.
Other intervention name(s): Spiromax®; albuterol
Intervention MeSH terms: Albuterol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Study of Trazodone & Cognitive Behavioral Therapy to Treat Insomnia
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effect of a 3 month medication trial of
      Trazodone versus 3 months of Cognitive Behavioral Therapy (CBT) in patients with chronic
      insomnia.
    

Detailed description: 
      Participants with chronic insomnia associated with objective short sleep duration will be
      recruited to participate in a 3 month clinical trial on the efficacy of trazodone versus CBT,
      with a 6 month follow up. The primary outcome measure will be objective sleep duration as
      measured by both actigraphy and polysomnography. The secondary outcome measure will be
      subjective severity of sleep disturbance.
    

Intervention name(s): Trazodone; Cognitive Behavioral Therapy
Intervention type(s): Drug; Behavioral
Intervention description(s): 50 mg once a day, for 3 months; The CBT Protocol is implemented over a period of 12 weeks, with 4 consultations held on a weekly basis and 4 held on a biweekly basis.
Intervention MeSH terms: Trazodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Insomnia; Short Sleep Duration; Trazodone; Cognitive Behavioral Therapy; Efficacy