bioihbjkbjnl/mcl2 huggingface dataset:
Lot Consistency Clinical Trial of of Recombinant HPV Bivalent Vaccine in 9 to14 Years Old Healthy Female
Condition: Cervical Intraepithelial Neoplasia; Cervical Cancer; Vaginal Intraepithelial Neoplasia; Vulvar Intraepithelial Neoplasia; Persistent Infection
MeSH terms: Persistent Infection; Neoplasms; Carcinoma in Situ; Uterine Cervical Dysplasia
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is to evaluate lot-lot consistency of Recombinant Human Papillomavirus Bivalent
      (Types 16, 18) Vaccine (Escherichia coli) .
    

Detailed description: 
      This study is a mono-center, randomization, double-blind clinical trial in healthy Female
      subjects between 9 to 14. Under the premise of full informed consent, 540 subjects that meet
      the requirement of clinical trial in the age of 9-14 will be randomly divided into 3 groups
      in a ratio of 1:1:1 and injected 2 consecutive batches of Recombinant Human Papillomavirus
      Bivalent (Types 16, 18) Vaccine (Escherichia coli) Cecolin® separately. The main outcome
      measures are the immunogenicity consistency and safety surveillance after inoculation
      according to prescribed immunization procedure.The total number of subjects should be ≥540
      and ≤570.
    

Intervention name(s): Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli) / Cecolin®
Intervention type(s): Biological
Intervention description(s): The bivalent HPV 16/18 vaccine was a mixture of two aluminum hydroxide adjuvant-absorbed recombinant L1 VLPs of HPV-16 and HPV-18 expressed in E. coli. A 0.5 ml dose of the bivalent HPV test vaccine comprised 40 μg of HPV-16 and 20 μg of HPV-18 L1 VLPs absorbed with aluminum adjuvant.
Other intervention name(s): There is no other Intervention in this study
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Human Papillomavirus Infection; Bivalent HPV Vaccine; Immunogenicity
Biweekly Versus Triweekly Raltitrexed With Oxaliplatin (With or Without Bevacizumab) in First-line Metastatic Colorectal Cancer
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Raltitrexed is a potent thymidylate synthase (TS) inhibitor. Conversely to 5-fluorouracil
      (5FU), raltitrexed can be administered safely in patients with cardiovascular disease, as
      well as in patients with dihydropyrimidine dehydrogenase deficit. Since raltitrexed is
      administered in 15-minutes infusion, complications related to continuous infusion can be
      avoided, and it becomes a potential good candidate for locoregional treatments as hepatic
      intra-arterial or intra-peritoneal infusion. Despite these potential benefits over 5FU,
      clinical trials failed in their temptation to replace the 5FU in colorectal cancer patients,
      mainly due to raltitrexed toxicity at 3mg/m2 every 3 weeks. Oxaliplatin has demonstrated a
      synergic effect when combined with TS inhibitors, and its association with raltitrexed was
      evaluated at 130mg/m2 of oxaliplatin and 3mg/m2 of raltitrexed, every 3 weeks. Actually, one
      of the first-line standard regimens in metastatic colorectal cancer patients is the biweekly
      FOLFOX (85mg/m2 of oxaliplatin, and infusional 5FU) plus bevacizumab regimen, since a
      significant progression-free survival (PFS) benefit was observed over FOLFOX plus placebo.
      Biweekly administration of raltitrexed at 2mg/m2 demonstrated a favorable toxicity profile
      even in patients aged >65 years. Besides, the association of raltitrexed, oxaliplatin and
      bevacizumab seems safe.

      Then, the investigators decided to perform a randomized pharmacokinetic comparative study
      between biweekly TOMOX (raltitrexed 2 mg/m2 and oxaliplatin 85mg/m2) and triweekly TOMOX
      (raltitrexed 3 mg/m2 and oxaliplatin 130mg/m2) regimens in metastatic colorectal cancer
      patients, in a "ping-pong" crossover strategy to reduce the intra-individual variability.
      Bevacizumab was allowed at the dose of 5mg/kg or 7.5mg/kg, in biweekly and triweekly
      schedules, respectively. The secondary end-points were, objective response rate evaluated by
      RECIST 1.1 criteria, PFS, overall survival (OS), toxicity, and the comparison of toxicity
      between two arms for the first 2 cycles.
    


Intervention name(s): TOMOX; Bevacizumab
Intervention type(s): Drug; Drug
Intervention description(s): Bevacizumab was allowed and used at 7,5 mg/kg or 5 mg/kg every 2 weeks.
Other intervention name(s): Tomudex-Oxaliplatin; Raltitrexed-Oxaliplatin
Intervention MeSH terms: Bevacizumab; Oxaliplatin; Raltitrexed
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Colorectal cancer; raltitrexed; oxaliplatin; bevacizumab; biweekly; triweekly
Distinction Risk of Severe Infection in Febrile Neutropenia After Chemotherapy
Condition: Febrile Neutropenia, Rule of Clinical Decision, Chemotherapy
MeSH terms: Neutropenia; Febrile Neutropenia; Hyperthermia; Fever
Study type: Observational

Summary: 
      Evaluate the reproducibility and validate a posteriori a new rule of clinical decision on a
      multi-center population of children with a post-chemotherapy febrile neutropenia
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patient with hematology or cancer who consults for febrile neutropenia post-chemotherapy
Study Evaluating ACC-001 in Japanese Patients With Mild To Moderate Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The study is to evaluate the safety, tolerability and whether there is an immune system
      response to multiple doses of ACC-001 with or without the use of a substance that may
      increase the response to the drug.
    


Intervention name(s): ACC-001; QS-21; ACC-001; QS-21; PBS
Intervention type(s): Biological; Other; Biological; Other; Other
Intervention description(s): IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12; IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12; IM injection, dose of 3, 10, 30 micrograms, Day 1, month 3, 6, 9, 12; IM injection, dose of 50 micrograms, Day 1, month 3, 6, 9, 12; IM injection, Day 1, month 3, 6, 9, 12
Intervention MeSH terms: Saponin QA-21V1
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Phase IIa; multiple ascending dose study of ACC-001
Interaction Effect of Asthma and Aeroallergen Category on the Psychological Status in Allergic Rhinitis Patients
Condition: Hypersensitivity; Psychologic Factors in Physical Conditions Classified Elsewhere; Respiratory Tract Diseases; Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Respiratory Tract Diseases; Hypersensitivity
Study type: Observational

Summary: 
      Allergic rhinitis (AR) and asthma are considered as "one airway, one disease". Although there
      is increasing evidence for an association between allergy and depression, it remains unknown
      if the relationship between AR and asthma has extra influence on the psychological status of
      the patients. The aim of our study was to investigate the influence pattern of asthma on the
      psychological status in AR patients. The Symptom Checklist-90 (SCL-90) was employed to
      analyze the psychological status of 524 individuals with AR. Independent sample T-tests,
      one-way ANOVA and multivariate ANOVA were used for data analyses.
    


Observational model: Cohort
Sampling method: Probability Sample
Study population: 
        524 affected individuals (311 males and 213 females) with AR were prospectively recruited
        from the rhinology clinic of the Otolaryngology, Head and Neck Surgery Department of
        Beijing Tongren Hospital from February 2009 to November 2009.
      
Keywords: Allergic rhinitis; Psychological status; Asthma; Aeroallergen
Disease Modification in Toxaemia of Pregnancy
Condition: Pre-eclampsia
MeSH terms: Eclampsia; Pre-Eclampsia
Study type: Observational

Summary: 
      Short description of the primary purpose of the protocol intended for the lay public. Include
      brief statement of study hypothesis

      Pre-eclampsia (toxemia of pregnancy) is the most cause of death among pregnant women in North
      America. It also causes many complications for fetuses (unborn children) and neonates
      (newborn children). Pre-eclampsia is defined by high blood pressure (hypertension), the loss
      of protein into the urine (proteinuria), and disorders of many body systems, including the
      blood clotting (coagulation) and inflammation. What is needed is a compound that will safely
      prolong pregnancies, to give babies more time to grow inside their mothers, and will help the
      recovery in those mothers after delivery.

      We are going to investigate a compound (recombinant human activated protein C (rhAPC)) that
      has the potential to modify disease activity in pre-eclampsia by reducing coagulation and
      inflammation disorders. rhAPC is effective in patients suffering from septic shock. We will
      test rhAPC in women who develop severe pre-eclampsia in two ways. First, in women with severe
      pre-eclampsia remote from term who are carrying small babies (intent: safely prolong their
      pregnancies). Second, in women who have had severe pre-eclampsia before their baby delivered
      (including women in the first group), or whose disease develops/worsens after delivery
      (intent: switch off the disease so dangerous complications do not arise).

      This study is a preliminary one to look for possible risks and benefits for these women. Only
      40 women will be studied to provide initial evidence on which to base a larger international
      trial which is planned. We will study their pregnancy outcomes as well as markers of disease
      activity, to gain a better understanding of the mechanisms by which these women become
      unwell.
    


Intervention name(s): Recombinant human activated protein C or drotrecogin alpha
Intervention type(s): Drug
Intervention description(s): We are going to investigate a compound (recombinant human activated protein C (rhAPC)) that has the potential to modify disease activity in pre-eclampsia by reducing coagulation and inflammation disorders.
Intervention MeSH terms: Drotrecogin alfa activated; Protein C
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women with pre-eclampsia ('toxaemia of pregnancy').
Medium-Term Supplementation With Herbal Extract for Exercise Performance and Antioxidant Status
Condition: Exercise Performance
Study type: Interventional

Summary: 
      We evaluated here the effects of 6-week intervention with herbal supplement on exercise
      performance outcomes and serum biomarkers of antioxidant status. In addition, we also
      assessed the long-term effects (6-month) of the intervention in elderly adults.
    

Detailed description: 
      Experimental protocol

        -  Double-blind, randomized, placebo-controlled cross-over trial

        -  6-week intervention trial (with additiional follow-up arm after 6 months)

        -  Experimental intervention (PhytoDyNAmic) = 6 capsules per day

        -  Placebo (inulin) = 1 g per day b.i.d.

        -  Administration = 3 capsules with breakfast and 3 capsules with dinner

        -  Wash-out period = 2 weeks

        -  No changes in physical activity patterns and diet during the study

      Outcomes assessed at baseline and at each follow-up:

        -  Exercise performance during incremental running-to-exhaustion test

        -  Serum biomarkers of antioxidant status

        -  Total antioxidant capacity (TAC)

        -  Superoxide dismutase (SOD)

        -  Telomerase activity

      Early termination criteria

      - Serious subjective side effects of an intervention (e.g. nausea, vomiting, bloating)
    

Intervention name(s): PhytoDyNAmic; Inulin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): PhytoDyNAmic (6 capsules per day); Inulin (6 capsules per day)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
The Rifaximin Study in CVID
Condition: Common Variable Immunodeficiency (CVID)
MeSH terms: Immunologic Deficiency Syndromes; Common Variable Immunodeficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      Patients with Common variable immunodeficiency (CVID) have various forms of autoimmune and
      auto inflammatory disorders. The study will investigate if intervention with Rifaximin
      modifies the gut microbiota with a subsequent alteration in markers of systemic immune
      activation and inflammation in patients with CVID. The investigators hypothesize that the gut
      microbiota of CVID patients, at least partly through interaction with the innate immune
      system within the intestine, contribute to a low-grade systemic inflammation in these
      patients, and that an intervention with the non-absorbable antibiotic Rifaximin attenuates
      systemic inflammation through modulation of the gut microbiota. The study may lead to
      increased understanding of the interaction between microbiota and the immune system. The
      study could give new insight into important disease processes in relation to the interaction
      between the microbiota, the intestine and the systemic compartment, and potentially be the
      basis of new therapeutic strategies in these patients to prevent and down-regulate the
      auto-inflammatory and autoimmune complications seen in CVID. The findings could also be of
      relevance for other disorders where the interaction between microbiota and intestinal and
      systemic inflammation is involved such as various cardiovascular and metabolic disorders.

      The investigators hypothesize that the gut microbiota of CVID patients, at least partly
      through interaction with the innate immune system within the intestine, contribute to a
      low-grade systemic inflammation in these patients, and that an intervention with the
      non-absorbable antibiotic Rifaximin attenuates systemic inflammation through modulation of
      the gut microbiota.
    


Intervention name(s): Rifaximin
Intervention type(s): Drug
Other intervention name(s): Xifaxan
Intervention MeSH terms: Rifaximin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Triple Therapy With Tegoprazan in H. Pylori Positive Patients_PILOT
Condition: Helicobacter Pylori Infection
Study type: Interventional
Phase: Phase 3

Summary: 
      This study aims to compare safety and efficacy in an exploratory manner between a Tegoprazan
      triple therapy and a RAPAE01 triple therapy in H. pylori positive patients.
    

Detailed description: 
      A Randomized, Double-Blind, Active-controlled, Multicenter, Pilot Study to Investigate the
      Safety and Efficacy of a Tegoprazan triple therapy and a RAPAE01 triple therapy in H. pylori
      positive patients.
    

Intervention name(s): Tegoprazan; RAPAE01
Intervention type(s): Drug; Drug
Intervention description(s): Tegoprazan 50 mg or 100 mg/Clarithromycin/Amoxicillin BID peroral; RAPAE01/Clarithromycin/Amoxicillin BID peroral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Peri-operative Prediction of Prolonged Stay in the Cardiac Intensive Care Unit for Adult Cardiac Surgery
Condition: Heart; Dysfunction Postoperative, Cardiac Surgery; Cytokine Release Syndrome
MeSH terms: Cytokine Release Syndrome
Study type: Observational

Summary: 
      The purpose of this study is to create a model using intra-operative modified SOFA score and
      peri-operative clinical factors to predict prolonged stay in the cardiac intensive care unit
      (CICU) for adult cardiac surgery with heart-lung machine
    

Detailed description: 
      Cardiac surgery using cardiopulmonary bypass (CPB) is commonly associated with a systemic
      inflammatory response that exacerbates peri-operative life-threatening complications and
      multiple organ dysfunction syndromes. These features can prolong the stay in the CICU. Many
      peri-operative clinical risk factors contribute to those adverse outcomes resulting in
      prolonged CICU stay. If the investigators can create a model to identify the effects of these
      intra-operative clinical risk factors to prolonged CICU stay
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        adult patients who had undergone elective cardiac surgery with CPB
      
Biospecimen description: 
      whole blood taken from arterial line
    
Keywords: cardiac surgery; cytokine; clinical scoring system; risk factor
Retrospective Evaluation of Perampanel in a French Neurology and Epileptology Department (Hospices Civil de Lyon)
Condition: Refractory Epilepsy
MeSH terms: Drug Resistant Epilepsy
Study type: Observational

Summary: 
      Perampanel is a non-competitive antagonist of the AMPA (
      2-amino-3-(5-méthyl-3-hydroxy-1,2-oxazol-4-yl)) propanoïc acid receptors which was approved
      by the European Medicines Agency as adjunctive treatment for partial-onset seizures in
      patients 12 years and older, in 2012. The aim of this study is to evaluate effectiveness and
      safety of perampanel as add-on treatment in patients with refractory epilepsy.

      The investigators retrospectively collected and analyzed the data of patients with refractory
      epilepsy who had been treated with perampanel between May of 2014 and April of 2015. In
      total, one hundred and ten patients were included (mean age 41 [SD = 15.2]). The mean
      duration of epilepsy was 25 years (SD = 14.4). The mean perampanel dose was 5.7 mg/d (SD =
      2.3). The retention rate was 77% at 6 months and 61% at 12 months. After 6 months, the
      responder rate was 35.5%. Eight patients (7.3%) became seizure free. Adverse effects were
      reported in 60 patients (54.5%). Most common side effects were behaviour disturbance (22.7%),
      dizziness (15.5%), asthenia (11.8), somnolence (10%) and ataxia (9.1).
    


Intervention name(s): Perampanel
Intervention type(s): Drug
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with refractory focal epilepsy in which Perampanel were introduced between May
        2014 and April 2015
Safety, Tolerability, Pharmacokinetics of Intravenous RPX2014 and RPX7009 in Healthy Adult Subjects
Condition: Healthy Volunteers; Bacterial Infections
MeSH terms: Bacterial Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      RPX7009 (beta-lactamase inhibitor) is being studied in combination with a carbapenem
      (RPX2014) to treat bacterial infections, including those due to multi-drug resistant
      bacteria.
    

Detailed description: 
      The worldwide spread of resistance to antibiotics among Gram-negative bacteria, particularly
      members of the ESKAPE group of pathogens, has resulted in a crisis in the treatment of
      hospital acquired infections. In particular, the recent dissemination of a serine
      carbapenemase (e.g., KPC) in Enterobacteriaceae in US hospitals now poses a considerable
      threat to the carbapenems and other members of the beta-lactam class of antimicrobial agents.

      Rempex is developing a fixed combination antibiotic of a carbapenem (RPX2014) plus a new
      beta-lactamase inhibitor (RPX7009) which has activity against serine beta-lactamases,
      including KPC. This Phase 1 study will assess the safety, tolerability and pharmacokinetics
      of intravenous RPX2014 and RPX7009, administered alone and in combination, in healthy adult
      subjects.
    

Intervention name(s): RPX7009; RPX2014; Placebo; Combination RPX7009 and RPX2014
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Two (2) groups of 15 subjects (12 active and 3 placebo) are planned for evaluation in cohort 1. Cohorts 2-5, 14 subjects (11 active and 3 placebo) are planned for evaluation in each cohort. 14 subjects (12 active and 2 placebo) are planned for evaluation in cohort 6.; Two (2) groups of 15 subjects (12 active and 3 placebo) are planned for evaluation for cohort 1. Cohorts 2-5, 14 subjects (11 active and 3 placebo) are planned for evaluation in each cohort. 14 subjects (12 active and 2 placebo) are planned for evaluation in cohort 6.; Two (2) groups of 15 subjects (12 active and 3 placebo) are planned for evaluation for cohort 1. Cohorts 2-5, 14 subjects (11 active and 3 placebo) are planned for evaluation in each cohort. 14 subjects (12 active and 2 placebo) are planned for evaluation in cohort 6.; Two (2) groups of 15 subjects (12 active and 3 placebo) are planned for evaluation in cohort 1. Cohorts 2-5, 14 subjects (11 active and 3 placebo) are planned for evaluation in each cohort. 14 subjects (12 active and 2 placebo) are planned for evaluation in cohort 6.
Other intervention name(s): (beta-lactamase inhibitor); Normal saline
Intervention MeSH terms: beta-Lactamase Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Phase 1 LEP-F1 + GLA-SE Vaccine Trial in Healthy Adult Volunteers
Condition: Leprosy
MeSH terms: Leprosy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the safety, tolerability, and immunogenicity in
      healthy adult subjects of an investigational vaccine being developed for the prevention of
      leprosy. Two dose levels of the vaccine will be evaluated.
    

Detailed description: 
      The purpose of this study is to compare the safety, tolerability, and immunogenicity of the
      LEP-F1 + GLA-SE vaccine. The vaccine consists of the recombinant four-antigen Mycobacterium
      leprae antigen LEP-F1 in combination with the adjuvant formulation GLA-SE (Glucopyranosyl
      Lipid A - Stable Emulsion) and is being developed for the prevention of leprosy disease. This
      is a first-in-human study and will be conducted in healthy adult subjects. Two dose levels of
      the vaccine (2 μg LEP-F1 + 5 μg GLA-SE and 10 μg LEP-F1 + 5 μg GLA-SE) will be given by
      intramuscular administration on study Days 0, 28, and 56.
    

Intervention name(s): LEP-F1 + GLA-SE
Intervention type(s): Biological
Intervention description(s): Investigational vaccine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Leprosy, vaccine, adjuvant, GLA, GLA-SE