bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Immunogenicity Study of Live Attenuated Vaccine Against Varicella Without Gelatin
Condition: Chickenpox; Zoster
MeSH terms: Chickenpox; Herpes Zoster
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to observe the occurrence of adverse reaction and antibody
      positive rate, the elevated level of antibody，Geometric mean titer (GMT) between groups of
      live attenuated varicella vaccine without gelatin.
    

Detailed description: 
      Observational Objectives:

      To describe the safety of evaluated vaccine, in children aged ≥ 1th birthday and ≤ 12th
      birthday.

      To describe the immunogenicity of evaluated vaccine, in children aged ≥ 1th birthday and ≤
      12th birthday.
    

Intervention name(s): vaccine without gelatin; vaccine with gelatin
Intervention type(s): Biological; Biological
Intervention description(s): use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection; use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: varicella vaccine; gelatin
Dose Proportionality of TFV-DP After a Single Dose of GS-7340 in Women
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Purpose:

      The purpose of this study is to characterize the dose-proportionality in the distribution of
      tenofovir alafenamide (TAF) and tenofovir (TFV) in plasma and mucosal tissues, and
      TFV-diphosphate (TFV-DP) in peripheral blood mononuclear cells (PBMCs) and mucosal tissues of
      healthy female subjects following a single oral dose of GS-7430 at 5mg, 10mg, and 25mg.
    

Detailed description: 
      Participants:

      This study will consist of approximately 24 premenopausal healthy volunteer women between
      18-49 years of age with an intact cervix, uterus, and gastrointestinal tract. Women will be
      enrolled in the study within 42 days of screening depending on the timing of their menstrual
      cycle in comparison to the screening visit, and then will be on study for 14 days, with
      follow-up 1-14 days after the end of study sampling. All study visits will be conducted in
      the North Carolina Translational and Clinical Sciences (NCTraCS) Clinical Translational
      Research Center (CTRC) at the University of North Carolina at Chapel Hill.

      Procedures (methods):This is a Phase 1, single center, open-label, dose-ranging
      pharmacokinetic study of TFV and TFV-DP mucosal tissue concentrations measured after a single
      dose of GS-7340. Each arm is divided into three dosing groups: 5, 10, or 25mg. Participants
      will take a single dose of study drug within 7-14 days following the end of the subjects'
      menstrual period. Participants will be sequentially assigned to one of the three TAF doses
      and four biopsy schedules. Two women from each of the dosing groups will be assigned to one
      of four biopsy schedules for a total of 8 women per dosing group. Samples of blood plasma,
      cervicovaginal fluid (CVF), cervical tissue, vaginal tissue, and rectal tissue will be
      collected from participants at varying time points over the 14 days post-dose. Subjects will
      return to clinic within 14 days after the last sampling to complete a follow-up safety visit.
    

Intervention name(s): GS-7340
Intervention type(s): Drug
Intervention description(s): Medication is supplied in 10 or 25mg tablets, so subjects will receive either 1/2 or one tablet in a single dose.
Other intervention name(s): TAF; Tenofovir Alafenamide
Intervention MeSH terms: Tenofovir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Participants; HIV-1 negative
Simultaneous Gemcitabine and Irreversible Electroporation for Locally Advanced Pancreatic Cancer
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Study type: Interventional

Summary: 
      The aim of this study was to compare the therapeutic efficacy between simultaneous
      gemcitabine administration and IRE and IRE alone for locally advanced pancreatic cancer
      (LAPC)
    

Detailed description: 
      in the GEM- IRE group, before the IRE ablation started, patients received 1000 mg/m2
      gemcitabine hydrochloride [Qilu pharmaceutical (Hainan) Co., Ltd. Haikou, China]
      intravenously (over approximately 30 min).

      In the IRE group, the IRE ablation was performed without gemcitabine intravenous infusion
      before IRE.

      The aim of this study was to evslusted the overall survival (OS), objective response rate
      (ORR) and adverse events after simultaneous therapy.
    

Intervention name(s): simultaneous gemcitabine and irreversible electroporation; irreversible electroporation
Intervention type(s): Procedure; Procedure
Intervention description(s): gemcitabine intravenous infusion prior to irreversible electroporation treatment; percutaneous irreversible electroporation was performmed for locally advaanced pancreatic cancer.
Intervention MeSH terms: Gemcitabine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Comparative Efficacy and Safety Study of Compound Carraghenates Cream With Mayinglong Musk Hemorrhoid Ointment in the Treatment of Hemorrhoids
Condition: Hemorrhoids
MeSH terms: Hemorrhoids
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare the therapeutic effect and safety of compound
      carraghenates cream with Mayinglong musk hemorrhoid (swollen veins in the lower part of the
      rectum or anus) ointment in the treatment of hemorrhoids, especially regarding the relief of
      pain.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), randomized (study
      drug assigned by chance), multi-center (when more than one hospital or medical school team
      work on a medical research study), controlled clinical trial and comparative study of safety
      and efficacy of compound carraghenates cream with Mayinglong musk hemorrhoid ointment in the
      treatment of hemorrhoids, especially regarding the relief of pain. Participants will be
      randomly assigned to either of the two treatment groups that are carraghenates cream
      (Titanoreine) group or Mayinglong musk hemorrhoid ointment group. The total duration of the
      study will be 1 Week (7 days). In carraghenates cream group, 3-4 gram (g) cream will be
      administered each time through anal canal, twice a day, once in the morning and once in the
      evening for consecutive 6 days and in the Mayinglong musk hemorrhoid ointment group, 2 g
      ointment will be administered each time through anal canal, twice a day, once in the morning
      and once in the evening for consecutive 6 days. Efficacy will be assessed by using Numeric
      Rating Scale (NRS) and participants' safety will be monitored throughout the trial.
    

Intervention name(s): Carraghenates Cream; Mayinglong Musk Hemorrhoid Ointment
Intervention type(s): Drug; Drug
Intervention description(s): Carraghenates cream will be administered 3-4 gram (g) each time (one sixth of a piece) through anal canal, twice a day (once in the morning and once in the evening); for consecutive 6 days.; Mayinglong musk hemorrhoid ointment will be administered 2 g each time through anal canal, twice a day (once in the morning and once in the evening) for consecutive 6 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hemorrhoids; Carraghenates; Mayinglong Musk; Titanoreine
Effect of Lozenges Containing Probiotic Lactobacilli on Enamel Demineralization Assed by QLF
Condition: Caries Dentalis
Study type: Interventional

Summary: 
      Clinical trials in children and adults have suggested that daily consumption of probiotic
      lactic acid bacteria can reduce caries risk and caries development in primary teeth in
      preschool and stop root caries in the elderly. However, it is not known whether probiotic
      bacteria can affect the increased porosity in young permanent teeth in children and
      adolescents with many cavities.

      It can be difficult to measure the increased porosity of the enamel by tooth decay, but this
      can be done using quantitative laser fluorescence (QLF). The method is based on visible light
      with a wavelength of 370 nm, addressing enamel. This produces an image consisting of red and
      green color tones and the dominant color of the enamel is green. Increased porosity of the
      enamel, resulting in a reduction of the auto-fluorescence and the loss (or gain) of the
      mineral can be quantified by means of a corresponding software.

      The purpose of this study is to investigate the effect of a daily supplement of probiotic
      lactic acid bacteria on the loss of mineral in enamel assessed with QLF. The null hypothesis
      is that the mineral content will not differ from baseline in either the test group or the
      placebo group.
    


Intervention name(s): L. retueri; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): two tablets a day for 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Probiotic bacteria; Caries dentalis; QLF
A Study to Test a Potential New Treatment for COPD Patients Suffering From the Common Cold or Influenza
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to assess the safety of inhaled SNG001 and the ability of inhaled
      SNG001 to 'switch on' the cells' anti-viral defences in patients with chronic obstructive
      pulmonary disease (COPD). The study consist of two parts.

      Part 1 will assess the safety of inhaled SNG001 in ten patients with stable COPD.

      Part 2 will assess efficacy and safety of inhaled SNG001 in 120 patients with COPD with a
      cold or COPD exacerbation.
    

Detailed description: 
      When people with COPD get a respiratory virus such as a cold or flu it often increases their
      COPD symptoms, leading them to require treatment with either antibiotics or oral steroids and
      severely affecting their quality of life. SNG001 is the study medication, and it contains
      interferon beta (interferon-β) which is a natural antiviral protein. In this study we will
      look to see whether inhaled SNG001 can boost anti-viral responses and minimise the worsening
      of COPD symptoms/lung function when patients have a confirmed respiratory virus.

      In Part 1 ten COPD patients without a respiratory virus will be randomised to receive three
      days of SNG001 or placebo. The aim of this part of the study is to assess safety of SNG001 in
      COPD patients.

      In Part 2 COPD patients will contact the research team when they experience cold or flu
      symptoms or a deterioration of their COPD symptoms. At this point, eligible patients will
      undergo a virus detection test and those that test positive for a virus will be randomised
      1:1 to receive SNG001 or placebo once daily for 14 days. The first dose of study medication
      will be administered within 48 hours. Other assessments will be performed during the 14 days
      of treatment to look for changes in anti-viral biomarkers, lung function and COPD symptoms.
      Patients will also be followed up 14 days post end of treatment.
    

Intervention name(s): Interferon Beta-1A; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Interferon Beta-1A via inhalation; Placebo via inhalation
Other intervention name(s): SNG001
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD
Safety, Tolerability, and Pharmacokinetics of Single, Escalating Oral Doses of RTI-336 in Healthy, Male Subjects
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This is the first study to be conducted in humans for RTI-336, a new chemical entity, with
      evaluations focusing on the safety, tolerability, and pharmacokinetics of RTI-336 following
      administration of single, oral doses. RTI-336 is a novel dopamine transporter inhibitor of
      the 3-phenyltropane class, and is currently being developed by RTI International as a
      potential pharmacotherapy to treat cocaine dependence. Data from this study will be used to
      plan and define dose ranges for subsequent studies.
    

Detailed description: 
      Cocaine abuse has been an epidemic in the United States since the mid- to late-1970s. It is
      hypothesized that a medication to treat cocaine addiction should have some, but not all, of
      the behavioral pharmacological properties of cocaine. Substantial evidence links the euphoric
      highs and addictive properties of cocaine to the inhibition of the dopamine transporter (DAT)
      in the brain. Cocaine binds quickly and potently to this transporter and blocks the
      presynaptic uptake of dopamine, resulting in subjective highs and reinforcing effects in both
      preclinical studies and humans. Compounds that mimic the DAT-binding properties of cocaine
      that are less stimulating and act with a slower receptor onset and offset may prove useful as
      treatment for cocaine dependence. The 3-phenyltropane analog, RTI-336, is a potent and
      selective DAT inhibitor that has demonstrated desirable pharmacological properties in
      preclinical species and is an appropriate compound to test for its potential as a medication
      to treat cocaine dependence.

      This is the first study to be conducted in humans for RTI-336, a new chemical entity, with
      evaluations focusing on the safety, tolerability, and pharmacokinetics of RTI-336 following
      administration of single, oral doses, with the possibility of identifying the maximum
      tolerated dose in humans. Data from this study will be used to plan for and define dose
      ranges for subsequent studies.
    

Intervention name(s): RTI-336 (CTDP 31862)
Intervention type(s): Drug
Intervention description(s): The RTI-336 drug product is formulated as hard, white, gelatin capsules. The dosage levels are 0.3, 1.0, and 3.0 mg (Cohort 1) and 6.0, 12.0, and 20.0 mg (Cohort 2). Subjects will receive a single dose of the study drug on study day 1.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Pediatric Taste Test Study of Cefdinir (Omnicef) Versus Amoxicillin Antibiotic Suspension Medications
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      To compare the taste and smell acceptability scores of cefdinir (Omnicef) versus amoxicillin
      oral antibiotic suspension medications in pediatric subjects. It was designed to determine if
      Omnicef or amoxicillin is preferred to the other with regard to taste or smell.
    

Detailed description: 
      The Primary Purpose for the study is "Other". Per ClinicalTrials.gov, more information
      regarding the primary purpose is provided here; this study is a pediatric taste test.
    

Intervention name(s): cefdinir (Omnicef); amoxicillin
Intervention type(s): Drug; Drug
Intervention description(s): 2.5 ml of strawberry cream flavored oral suspension 125 mg/5 ml; 2.5 ml of bubble-gum flavored amoxicillin oral suspension 125 mg/5 ml
Other intervention name(s): ABT-198; Omnicef; cefdinir
Intervention MeSH terms: Amoxicillin; Cefdinir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Keywords: Pediatric taste test; Antibiotic taste test; cefdinir; amoxicillin
A Study to Evaluate CNTO 1959 in the Treatment of Patients With Moderate to Severe Plaque-type Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of CNTO 1959 in the
      treatment of patients with moderate to severe plaque psoriasis.
    

Detailed description: 
      This is a multicenter, dose-ranging study of CNTO 1959 in patients with moderate to severe
      plaque psoriasis. Patients who satisfy all inclusion and exclusion criteria will be assigned
      by chance to one of 7 treatment groups: a placebo group (a placebo is a treatment identical
      in appearance to CNTO 1959 but does not contain active drug), 1 of 5 dose groups for CNTO
      1959, or adalimumab. Patients assigned to adalimumab will be dosed according to the labeled
      dosing for psoriasis. At Week 16, patients initially assigned to placebo will begin receiving
      CNTO 1959. Patients initially assigned to CNTO 1959 will continue to receive the same
      assigned dose level of study agent from Week 16 through Week 40. Patients receiving
      adalimumab will continue the labeled dosing regimen. All patients will be reassessed for
      clinical response every 4 weeks from Week 4 through Week 40. Patients will continue dosing
      through Week 40, with a subsequent efficacy and safety follow-up visit at Week 52. Patient
      safety will be monitored throughout the study.
    

Intervention name(s): CNTO 1959 (5 mg); CNTO 1959 (15 mg); CNTO 1959 (50 mg); CNTO 1959 (100 mg); CNTO 1959 (200 mg); Adalimumab; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Subcutaneous (SC) injections; SC injections; SC injections; SC injections; SC injections; SC injections; SC injections
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Moderate to Severe Plaque-Type Psoriasis; Psoriasis; Plaque-type psoriasis; CNTO 1959; adalimumab
Jet Injection for Influenza
Condition: Influenza, Human
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if the administration of a seasonal flu vaccine
      using a PharmaJet's needle-free injection device (STRATIS) is equivalent to needle and
      syringe administration, as measured by laboratory tests of immune response.
    


Intervention name(s): AFLURIA vaccine (2012-2013 formulation); Needle-Syringe; Stratis needle-free injection device
Intervention type(s): Biological; Device; Device
Intervention description(s): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.
Other intervention name(s): trivalent inactivated influenza vaccine (TIV); influenza virus vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Injections, Jet; Influenza Vaccines
Biomarker Feedback for Smoking Cessation
Condition: Cigarette Smoking
Study type: Interventional

Summary: 
      The purpose of this study is to examine the impact of providing light smokers with feedback
      about their health, including exposure to tobacco-related chemicals.
    

Detailed description: 
      The smoking pattern among adults in the US is undergoing a remarkable change. A substantial
      proportion of smokers are now light smokers (smoke ≤ 10 cigarettes per day), yet little is
      known about how to help light smokers quit. The prevalence of light smoking is high (~50%)
      among African Americans (AAs) who compared to other groups have high cotinine levels, are
      less successful quitting smoking, and experience disproportionately higher smoking-related
      cancers. Because light smokers often think that smoking fewer cigarettes a day is safe, a
      potential smoking cessation strategy is therefore to provide light smokers with feedback on
      biomarkers of tobacco exposure and increased cancer risk. The objective of this proposal is
      to develop and pilot test a biomarker risk assessment intervention to enhance smoking
      cessation for AA light smokers. The proposal builds on our previous work that shows that
      light smokers have 1) difficulty quitting smoking, 2) lower perceived health risks, but high
      levels of biomarkers (e.g. cotinine). This study will occur in 2 phases. Phase 1 will utilize
      focus groups to examine prevailing knowledge, attitudes, and beliefs about biomarkers as well
      as preferences about how participants would like to receive biomarker feedback (BF; e.g. by
      mail, phone, in-person). In Phase 2, data from the focus groups will be used to develop a
      (BF) intervention for light smokers. The new intervention will undergo further feasibility
      evaluation among 60 adult light smokers. Outcomes in Phase 2 will include process measures,
      (e.g. perceived usefulness, acceptance, and adherence) and changes in biomarker values with
      smoking reduction or cessation. By the end of the proposed pilot study, we expect to have
      developed a replicable, feasible, and acceptable BF intervention that will be ready for
      efficacy testing in a large clinical trial for smoking cessation or smoking reduction. The
      aims of the application are to: 1) Examine the prevailing knowledge, attitudes, beliefs, and
      preferences about BF for smoking cessation among AA light smokers; 2) Develop a BF
      intervention for smoking cessation among AA light smokers; and 3) Test the feasibility of a
      BF intervention for smoking cessation in AA light smokers.
    

Intervention name(s): urine analyses feedback
Intervention type(s): Other
Intervention description(s): biomarker feedback report regarding the urine sample analyzed for the tobacco chemicals, cotinine, nicotine and NNAL
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment