bioihbjkbjnl/mcl2 huggingface dataset:
Lot Consistency Clinical Trial of Bivalent HPV Vaccine in 9 to 30 Years Old Healthy Females
Condition: HPV Infection
MeSH terms: Papillomavirus Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the immunogenicity and safety of three consecutive
      lots of bivalent HPV (Type 16,18) vaccine (Pichia pastoris) in healthy female subjects aged 9
      - 30 years, and demonstrate the non-inferiority of the candidate HPV vaccine manufactured at
      commercial scale compared with a pilot scale.
    


Intervention name(s): Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris)
Intervention type(s): Biological
Intervention description(s): sterile solution for intramuscular injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Efficacy of Bilateral Superficial Cervical Plexus Block vs. Local Infiltration of Lidocaine 2% in Tracheostomy Procedure
Condition: Tracheostomy
Study type: Interventional

Summary: 
      The aim of this study was to compare the efficacy between superficial cervical plexus block
      and local infiltration of lidocaine 2% in patients undergoing tracheostomy procedure.
    

Detailed description: 
      Ethical approval was obtained from Ethics Committee of Faculty of Medicine, Universitas
      Indonesia - Dr. Cipto Mangunkusumo Hospital.

      Eligible subjects for this study will be recruited with consecutive sampling method within
      certain period until minimum number of subjects required for this study is filled.

      Informed consents will be given to each subject before participating in the study. Patients
      will be randomly divided into two groups using closed envelops.

      Subjects who will receive bilateral superficial cervical plexus block is the interventional
      group whereas subjects who will receive local infiltration of lidocaine 2% is the control
      group.

      Before, during, and after the procedure, all subjects are monitored (blood pressure, heart
      rate, respiratory rate, and electrocardiography). Monitoring data, including pain, will be
      recorded. Pain is measured by using visual analog scale or verbal numeric rating scale.

      Arterial blood sample (approximately 3 cc) from each subject will be withdrawn twice and put
      into tubes containing anticoagulant for substance-P examination. Initial withdrawal is done
      before the anesthetics are given while the last one is done after the tracheostomy procedure.

      Before the procedure, location for incision and block will be marked. Interventional group
      will be given 10 mL of Bupivacaine 0.5% on each side of the neck (as marked) by using 20 mL
      spuit with 25 G 1.5 inch needle whereas control group will be given 4 mL of Lidocaine 2% on
      incisional region (as marked) by using 5 mL spuit with 25 G 1.5 inch needle. 1 mg of
      Midazolam can be given intravenously before the block if there is no contraindication.
      Tracheostomy will be performed 15 minutes after the block is administered or local
      infiltration has worked. After tracheostomy, patients will be continually monitored in
      post-anesthesia care unit while their blood samples will be delivered to laboratory for ELISA
      test.
    

Intervention name(s): Analgesic Technique
Intervention type(s): Procedure
Intervention description(s): Patients undergoing tracheostomy procedure must be administered with analgesics, such Lidocaine 20% or Bupivacaine 0.5%
Intervention MeSH terms: Analgesics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: local infiltration; bilateral superficial cervical plexus block; lidocaine; bupivacaine; substance-p
SMP-986 Phase 2 Proof of Concept in Patients With Overactive Bladder Syndrome (OABS)
Condition: Overactive Bladder Syndrome (OABS)
MeSH terms: Urinary Bladder, Overactive; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      SMP-986 is a compound being developed for the treatment of overactive bladder syndrome
      (OABS). This clinical study is designed to test the hypothesis that SMP-986 at doses of 20mg,
      40mg, 80mg or 120mg provides greater symptom relief in OABS compared to placebo. The
      hypothesis will be tested by measuring the change in mean voids/24 hrs after treatment with
      SMP-986 compared to placebo, as well comparing the change in: the severity of urgency
      episodes, mean number of urgency episodes/24 hr, mean number of incontinence episodes/24 hr
      and the mean void volume/void between SMP-986 and placebo.
    

Detailed description: 
      A multicenter study conducted in patients with OABS comprising a 2-week single blind placebo
      run-in period followed by an 8-week randomized, double-blind, placebo controlled treatment
      period with patients randomized to receive 20 mg, 40 mg, 80 mg or 120 mg SMP 986 or placebo
      in a 1:1:1:1:1 ratio in parallel groups on an outpatient basis with study center visits.
    

Intervention name(s): Placebo; Placebo; SMP-986
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo, 2 week duration.; Taken for the 8 week duration, in parallel with alternative arms (doses of 20, 40, 80 or 120mg SMP-986).; Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Insulin Detemir Given Once or Twice Daily in Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial is conducted in Europe. The aim of this research study is to compare the efficacy
      (reduction in HbA1c and in blood glucose levels) of insulin detemir once daily injection
      compared to insulin detemir twice daily injection administered as basal insulin for the
      treatment of type 1 diabetes and to verify the safety of use (number and severity of episodes
      of hypoglycemia, body weight and side effects).
    


Intervention name(s): insulin detemir; insulin aspart
Intervention type(s): Drug; Drug
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin Detemir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Kansas University DHA Outcome Study (KUDOS) Follow-Up
Condition: Pregnancy
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a continuation study to KUDOS (NCT00266825). The purpose of this study is to
      follow-up with participants on the original study to determine if the effects of increasing
      DHA intake during pregnancy increase cognitive development in 2 to 6 year-old children.
    

Detailed description: 
      Numerous trials show benefits of postnatal DHA supplementation for visual acuity. There are
      also numerous observational(not intervention)studies that link higher maternal DHA status
      during pregnancy to higher cognitive function. Intervention studies that increase DHA
      exposure during fetal life and that measure cognitive development of infants are lacking; and
      no study to date has systematically followed children whose mothers were randomly assigned to
      DHA supplementation to school age with regular 6 month assessments of age-appropriate
      assessments of cognitive development. The absence of such studies is a serious limitation
      because there is evidence that differences in cognitive function due to such interventions do
      not become robust until around age 4 years. Women in the US consume low amounts of DHA
      compared to other world populations, and this likely means less DHA transfer to the fetus
      than in many other populations. Prenatal DHA exposure may be more important than postnatal
      exposure, because animal studies show critical windows for brain DHA accumulation in relation
      to effects on neurotransmitters such as serotonin, dopamine and GABA.
    

Intervention name(s): DHA; Placebo Capsule
Intervention type(s): Drug; Drug
Intervention description(s): 600 mg DHA capsule; 600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
Other intervention name(s): docosahexaenoic acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: DHA; childhood development
Intranasal Lorazepam Versus Intramuscular Paraldehyde in Paediatric Convulsions
Condition: Status Epilepticus; Convulsions
MeSH terms: Status Epilepticus; Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate intranasal lorazepam in paediatric status
      epilepticus. This is a potentially, more effective, safer and cheaper treatment for a common
      paediatric medical emergency compared to our present first line therapy intramuscular
      paraldehyde.
    

Detailed description: 
      The ideal first line anticonvulsant agent would be one that can be safely and easily given at
      a primary health care facility. It should be quick acting, have minimal cardiorespiratory
      side effects and have a relatively prolonged effect and be cheap. No combination of drug or
      delivery system fully satisfies these criteria. There are no large published studies
      evaluating intranasal lorazepam in paediatric status epilepticus. Given its favourable
      pharmacokinetics and potential practical advantages, we wished to assess the efficacy and
      safety of intranasal delivery of lorazepam compared to intramuscular paraldehyde, our
      existing first line anticonvulsant agent in the treatment of acute seizures in children.
    

Intervention name(s): intranasal lorazepam; intramuscular paraldehyde
Intervention type(s): Drug; Drug
Intervention MeSH terms: Lorazepam; Paraldehyde
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: intranasal; lorazepam; paediatric; convulsions
The Efficacy, Safety and Tolerability of Oral LPCN 1144 in Subjects With Nonalcoholic Steatohepatitis
Condition: Nonalcoholic Steatohepatitis (NASH)
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, randomized, double-blind, placebo controlled, three arm study in adult men
      with biopsy confirmed NASH. The study is aimed at evaluating efficacy and tolerability of
      LPCN 1144 in adult men with NASH.
    

Detailed description: 
      This is a Phase 2, randomized, double-blind, placebo controlled, three arm study in adult men
      with biopsy confirmed NASH. The study is aimed at evaluating efficacy and tolerability of
      LPCN 1144 in adult men with NASH. The study will be conducted across multiple centers in the
      United States.

      Approximately 75 subjects will be randomized in 1:1:1 ratio to receive one of the following
      treatments:

        -  Treatment A: Oral LPCN 1144 Formulation A

        -  Treatment B: Oral LPCN 1144 Formulation B

        -  Treatment C: Oral matching placebo

      Subjects will undergo a screening period to determine study eligibility. As a part of
      screening, liver biopsies will be performed for subjects who have not had a liver biopsy
      within 6 months of Day 1, and fat fraction will be measured by magnetic resonance imaging
      derived proton density fat fraction (MRI-PDFF) in all subjects. Adult male subjects with
      histologic evidence of NASH will be enrolled into the study.

      Eligible subjects will be randomized to one of the three treatment arms. The treatment phase
      will be for a duration of 36-weeks with assessments of liver biopsies, hepatic fat fraction,
      liver enzymes, lipid levels and other safety parameters. Safety and tolerability will be
      assessed throughout the study.
    

Intervention name(s): LPCN 1144 Formulation A; LPCN 1144 Formulation B; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral LPCN 1144 Formulation A capsule, total daily dose of 450 mg testosterone undecanoate administered as 225 mg testosterone undecanoate twice daily (BID).; Oral LPCN 1144 + d-alpha tocopherol total daily dose of 450 mg testosterone undecanoate + 476 mg d-alpha tocopherol administered as 225 mg testosterone undecanoate + 238 mg d-alpha tocopherol BID; Oral matching placebo capsule administered as BID
Other intervention name(s): testosterone undecanoate; testosterone undecanoate with d-alpha tocopherol; Oral placebo
Intervention MeSH terms: Tocopherols; alpha-Tocopherol; Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized in 1:1:1 ratio to receive one of the following treatments:
Treatment A: Oral LPCN 1144 Formulation A
Treatment B: Oral LPCN 1144 Formulation B
Treatment C: Oral matching placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Effect of Itraconazole on Pharmacokinetics (PK) of SHR8554 in Healthy Adult Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This drug-drug interaction (DDI) study has been designed to characterize the pharmacokinetic
      profile of SHR8554 when co administered with a strong cytochrome P450 3A4 (CYP3A4) inhibitor
      itraconazole
    


Intervention name(s): SHR8554；Itraconazole
Intervention type(s): Drug
Intervention description(s): Drug: SHR8554 Administered as specified in the treatment arm Drug: Itraconazole Administered as specified in the treatment arm
Intervention MeSH terms: Itraconazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Sunphenon Epigallocatechin-Gallate (EGCg) in Duchenne Muscular Dystrophy
Condition: Duchenne Muscular Dystrophy
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of this multicentre, prospective, double blind, placebo controlled, randomized pilot
      study is to investigate safety and tolerance of Epigallocatechin-Gallate (EGCG, the major
      polyphenol in green tea) in patients with muscular dystrophy of the Duchenne type.

      In a second step the investigators want to investigate the effect of EGCG on the course of
      the Duchenne condition.
    

Detailed description: 
      Duchenne muscular dystrophy (DMD) is the most frequent neuromuscular condition to occur in
      childhood and youth. The course of the disease is progressive, and life expectancy is
      severely curtailed by the participation of the respiratory muscles and/or by progressive
      cardiomyopathy.

      DMD derives from mutations in the DMD gene which leads to a loss of the protein dystrophin.
      Secondary inflammatory/immunological reactions contribute to the progressive course of the
      disease (1,2).

      No curative therapy yet exists. Administration of steroids is the only established medical
      treatment. Symptomatic measures are also available, such as orthopaedic operations, the
      treatment of cardiomyopathy or, in advanced stages, home mechanical ventilation.

      In studies involving experiments on cells and animals, Epigallocatechin-Gallate (EGCG, the
      major polyphenol in green tea) has shown a neuroprotective effect. The neuroprotective
      mechanism of action is probably based on several factors, including EGCG's modulation of
      several signal transduction pathways, its influence on the expression of genes regulating
      cell survival or programmed cell death, as well as its modulation of mitochondrial function.

      The mdx mouse is the best-investigated animal model of a dystrophin-negative muscular
      dystrophy. Administration of EGCG in the mdx mouse led to both a reduction in the proportion
      of fibre necroses as well as to a less pronounced proliferation of connective tissue in the
      muscle (3,4), and also to an improvement in clinical symptoms (5,6).

      Therefore, the investigators want to investigate safety and tolerance of EGCG in a dosage of
      up to 10mg/kg in patients with muscular dystrophy of the Duchenne type in this multicentre,
      prospective, double blind, placebo controlled, randomized pilot study.
    

Intervention name(s): Epigallocatechin-Gallate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): EGCG in a dosage of up to 10mg/kg body weight
Intervention MeSH terms: Epigallocatechin gallate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Duchenne Muscular Dystrophy; Epigallocatechin-Gallate; Green tea extract
Embryo Transfer With Self-spent Culture Medium
Condition: in Vitro Fertilization
Study type: Interventional

Summary: 
      Embryo Transfer With Self-spent Culture Medium or new Culture Medium in Vitro Fertilization -
      Embryo Transfer Process, to analyze which way can improve clinical pregnancy outcomes, is
      there a significant difference between the two?
    

Detailed description: 
      Although some metabolites are present in self-spent culture medium, there are some embryonic
      exocrine factors secreted by embryo.These factors may have a positive impact on embryo
      implantation and subsequent development. So it is necessary to compare the two ways of embryo
      transfer with Self-spent Culture Medium or New Culture Medium in vitro fertilization - embryo
      transfer process.

      The purpose of this study is to analyze which way can improve clinical pregnancy and birth
      outcomes, is there a significant difference between the two?
    

Intervention name(s): Self-spent Culture Medium
Intervention type(s): Procedure
Intervention description(s): Replace embryo transfer solution with Self-spent culture medium in IVF-ET.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Screening
Keywords: Embryo Transfer
A Study to Assess the Safety and Pharmacokinetics of Inhaled Doses of GSK233705 and GW642444 in Healthy Subjects
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      GW642444 and GSK233705 are in development for treatment of Chronic Obstructive Pulmonary
      Disease. Development of these two inhaled drugs as a combination therapy would have potential
      for improved patient benefit as they both work through different mechanisms and the combined
      bronchodilatory effect might be additive. This study will look at the this combination, for
      the first time, in healthy Japanese subjects.
    


Intervention name(s): GSK233705 and GW642444; GW642444; GSK233705; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Inhaled Long acting muscarinic receptor antagonist (LAMA) and a inhaled Long acting Beta 2 agonist (LABA) both in development as treatment for Chronic Obstructive Pulmonary Disease, taken in combination.; Inhaled Long acting Beta 2 agonist (LABA); Inhaled Long acting muscarinic receptor antagonist (LAMA which is in development as a treatment for Chronic Obstructive Pulmonary Disease.; Matching placebo.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Tolerability; Muscarinic Receptor Antagonist, Anticholinergic; Safety; Anticholinergic; ß2 agonist; Pharmacokinetics
Osteopathic Manipulative Medicine to Reduce Developmental Delays
Condition: Extreme Prematurity; Neurodevelopmental Abnormality
MeSH terms: Premature Birth; Congenital Abnormalities
Study type: Interventional

Summary: 
      This randomized clinical trial seeks to determine if osteopathic manipulative medicine (OMM)
      increases the likelihood of improved neurodevelopmental outcomes as estimated by the Test of
      Infant Motor Performance (TIMP).
    

Detailed description: 
      Hypothesis: High risk preterm infants born <34 weeks of gestation who receive OMM, compared
      to the standard supportive care, will have improved neuromotor development scores on the
      TIMP.

      Specific Aims and Objectives:

      Primary aim: To determine the difference in TIMP scores between infants who receive OMM and
      those who receive only standard neonatal intensive care unit (NICU) care.

      Secondary aims:

        -  To compare length of stay between infants who receive OMM and those who receive only
           standard NICU care.

        -  To compare growth parameters including weight, length, and head circumference, (both
           means and Z scores) prior to discharge between infants who receive OMM and those who
           receive only standard NICU care.

        -  To compare percentage of subjects requiring nasogastric, orogastric, or gastrostomy tube
           feeds at discharge between infants who receive OMM and those who receive only standard
           NICU care.
    

Intervention name(s): Osteopathic Manipulative Medicine
Intervention type(s): Other
Intervention description(s): Osteopathic evaluation and treatment (gentle touch according to published protocols) will take about 15 - 20 minutes, and will be performed every 7 - 10 days during the infant's NICU stay once they reach at minimum of at least 28 weeks corrected gestational age and until they reach 36 weeks corrected gestational age.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomization 1:1 to control and intervention group
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Keywords: osteopathic manipulative medicine (OMM); test of infant motor performance (TIMP); neurodevelopmental outcomes