bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Shedding and Safety of Trivalent Influenza Virus Vaccine Live, Intranasal in Infants and Young Children
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      Open label, single arm, multicenter study of the shedding and safety of a single dose of
      trivalent, influenza virus vaccine live, intranasal in children 6 to < 60 months of age, with
      28-day shedding follow-up and 180-day safety follow-up.
    

Detailed description: 
      This was a Phase 2, open-label, single-arm, multicenter study designed to evaluate vaccine
      virus shedding and safety of trivalent influenza virus vaccine live, intranasal in children 6
      to < 60 months of age. Enrollment of approximately 200 participants was stratified by age,
      with 100 participants 6 to < 24 months of age (who reached their sixth month but not their
      second year birthday) and 100 participants 24 to < 60 months of age (who reached their second
      year but not their fifth year birthday). Baseline medical history data collection included
      the participants prior receipt of influenza vaccine or history of laboratory-confirmed
      influenza illness in the previous influenza season.
    

Intervention name(s): Trivalent influenza virus vaccine live, intranasal
Intervention type(s): Biological
Intervention description(s): A single, intranasal dose of 0.2 mL (approximately 0.1 mL in each nostril) FluMist trivalent influenza virus vaccine live on Day 0 of the study. Each dose of FluMist vaccine contained 10^7 FFU of three influenza virus strains.
Other intervention name(s): FluMist; Cold-adapted influenza virus vaccine, trivalent (CAIV-T); Live attenuated influenza virus (LAIV)
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: children, FluMist, shedding,
A Tolerance and Pharmacokinetic Study of Trodusquemine in Healthy Volunteers
Condition: Obesity
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerance of single intravenous
      (through a vein) doses of trodusquemine. Different amounts of trodusquemine will be given to
      each volunteer group throughout the study. Another purpose is to evaluate the
      pharmacokinetics (PK - the study of the way the drug enters and leaves the blood and tissues
      over time) of trodusquemine. Finally, this study will also determine whether trodusquemine
      has any effect on appetite, mood or behavior, and selective biomarkers (substances in your
      blood that may change in response to the study drug).
    


Intervention name(s): trodusquemine
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Variability of Whole Blood Clotting Time Measurements in Ex Vivo Human Blood Samples Spiked With Anticoagulants
Condition: Healthy
MeSH terms: Thrombosis
Study type: Observational

Summary: 
      The study will assess the distribution and variability of whole blood clotting time (WBCT)
      measurement in human blood collected from healthy volunteers that is untreated and spiked
      with predetermined concentrations of edoxaban or enoxaparin.
    

Detailed description: 
      Twelve healthy volunteers aged 18 to 65 years (6 subjects per spiking anticoagulant) will be
      enrolled. A total of 8 blood samples (12 mL/sample) will be collected by direct venipuncture.
      The samples from will be spiked with predetermined concentrations of edoxaban or enoxaparin
      (baseline, saline control and 6 specified concentrations of anticoagulant).

      Each blood sample will be tested for whole blood clotting time (WBCT), Point of Care
      activated partial thromboplastin time (aPTT) and prothrombin time (PT).
    

Intervention name(s): Blood drawn by direct venipuncture; edoxaban; Enoxaparin; Saline sham
Intervention type(s): Other; Drug; Drug; Drug
Intervention description(s): Subjects will have blood sampled (12 mL/sample) a total of 8 times by direct venipuncture. Samples will be spiked with predetermined concentrations of anticoagulants, or saline sham.
Intervention MeSH terms: Enoxaparin; Edoxaban
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        healthy volunteers
      
Keywords: Whole blood clotting time
A Study of TMC207 in Patients With Moderately Impaired Hepatic Function
Condition: Moderate Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetics (what the body does to the
      medication), safety and tolerability of TMC207 and its N-monodesmethyl metabolite (M2) in
      healthy participants and in patients with moderate hepatic impairment after administration of
      a single 400 mg dose of TMC207.
    

Detailed description: 
      This is a Phase I, open label (all people know the identity of the intervention) study of
      TMC207. The study consists of a screening period and a 4-weeks treatment period. Sixteen
      participants will be enrolled in two panels. Panel A will include 8 patients of moderate
      hepatic impairment and Panel B will include 8 healthy participants. Safety evaluations
      including adverse events, clinical laboratory tests, electrocardiogram, vital signs, and
      physical examination will be monitored throughout the study. The entire study duration for
      each participant will be approximately 7 weeks.
    

Intervention name(s): TMC207
Intervention type(s): Drug
Intervention description(s): 400 mg (4 tablets of 100 mg) of TMC207 will be administered as a single dose on Day 1 of the treatment period to participants of both the Panels (Panel A and Panel B)
Other intervention name(s): R207910
Intervention MeSH terms: Bedaquiline
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Moderate Hepatic Impairment; Tuberculosis; TMC207; Mycobacterial adenosine triphosphate (ATP)-synthase
Local Anesthesia and Pain Perception During an Amniocentesis
Condition: Pregnancy
Study type: Interventional

Summary: 
      This study is been designed to answer the question of whether local anesthesia (1% lidocaine)
      decreases the perception of pain associated with amniocentesis in a randomized double blind
      placebo controlled manner. Our objective is to determine the effect of local anesthesia on
      the maternal pain perception from an amniocentesis.
    

Detailed description: 
      Women meeting criteria for project and agreeing to treatment will be randomized into either
      the 1% Lidocaine or placebo(normal saline) group. The initial injection of either 1%
      lidocaine or placebo (normal saline) will be administered 2 minutes prior to the
      amniocentesis procedure. 2cc of 1% lidocaine or placebo (normal saline) will be initially
      administered as an intradermal "wheal", followed by a deeper infiltration of the 1% lidocaine
      or placebo (normal saline) to the depth of the peritoneum. All procedures will be performed
      by either the Maternal-Fetal medicine (MFM) or the reproductive geneticist utilizing
      continuous ultrasound guidance under sterile conditions. Each woman will be asked to rate
      their pain perception immediately after the procedure on two pain scales.
    

Intervention name(s): Local Anesthesia; Placebo Group
Intervention type(s): Drug; Drug
Intervention description(s): Local anesthesia: 2 cc of 1% Lidocaine; Placebo Group: 2cc Normal Saline
Other intervention name(s): Amniocentesis; Amniocentesis
Intervention MeSH terms: Anesthetics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Diagnostic
Keywords: Amniocentesis; Genetic amniocentesis; Fetal lung maturity; Pain control; Pregnancy; High risk pregnancy
A Phase I Study of Bavituximab, Capecitabine, and Radiation for the Treatment of Rectal Adenocarcinoma
Condition: Rectal Adenocarcinoma
MeSH terms: Adenocarcinoma; Rectal Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I study incorporating bavituximab into the care of patients with rectal
      adenocarcinoma simultaneously treated with capecitabine and radiation therapy. There is no
      reference therapy as we are trying to identify the MTD of bavituximab in this combination.
    

Detailed description: 
      The investigational drug in this protocol is bavituximab, which will be delivered
      concurrently with the radiation therapy for 6 weeks (one time each week), followed by 2 weeks
      of bavituximab administration by itself. If the other therapies are terminated after week 4
      the bavituximab treatment may be continued per protocol. A chemotherapy agent, capecitabine,
      will be delivered twice daily p.o. on the days of radiation treatment, at a dose of 825
      mg/m2. Radiation therapy will be administered daily, Monday-Friday, for a total of 28
      treatments, delivered at 1.8 Gy/fraction. Surgery will follow the last bavituximab
      administration by 4-8 weeks (6-10 weeks following completion of radiation therapy.
    

Intervention name(s): Radiation; Bavituximab; Capecitabine
Intervention type(s): Radiation; Drug; Drug
Intervention description(s): Radiation therapy will be administered daily, Monday-Friday, for a total of 28 treatments, delivered at 1.8 Gy/fraction.; Bavituximab will be delivered concurrently with the radiation therapy for 6 weeks (one time each week), followed by 2 weeks of bavituximab administration by itself.; capecitabine, will be delivered twice daily p.o. on the days of radiation treatment, at a dose of 825 mg/m2.
Other intervention name(s): Phosphatidylserine-Targeting Antibody; Xeloda
Intervention MeSH terms: Capecitabine; Bavituximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rectal cancer; Bavituximab; Capecitabine; Radiation Therapy
Effects of Probiotics in Immune System of Healthy Adults
Condition: Conditions Influencing Health Status
Study type: Interventional

Summary: 
      The present report describes the design of a clinical trial performed on healthy adult
      individuals to check whether the daily intake of the new Hero strains contribute to
      intestinal colonization, under safe and tolerable conditions, with a positive contribution to
      health and wellbeing of healthy individuals.

      Daily intake of one or several probiotic strains, (CNCM I-4034, CNCM I-4035, CNCM I-4036),
      increases intestinal microbiota in healthy adults, being safe and well tolerated. The regular
      intake has positive effects on the gastrointestinal and immune system.
    

Detailed description: 
      The project will be based on a double-blind, randomized, and placebo-controlled clinical
      trial. It will be multi-Centre, with four groups plus a control group.

      The colonization performed by the strains and the modification of the intestinal microbiota
      will be evaluated by means of strain identification with RT-PCR equipped with specific
      primers, and bacterial population counting with in situ immunofluorescence techniques.

      The safety of strain intake will be evaluated with physical examination, blood parameters,
      and test son faeces to check for resistance to ampicillin and tetracycline by lactic flora.

      Tolerance will be evaluated by means of the record of gastrointestinal symptoms and the
      record of aspect and frequency of faeces.

      The effect on the systemic and adaptive immune system will be measured by means of lymphocyte
      populations and plasma cytokine present on blood, IgAs on serum, saliva and faeces. Also AGCC
      on faeces.
    

Intervention name(s): Probiotic CNCM I-4034; Probiotic CNCM I-4035; Probiotic CNCM I-4036; Probiotics CNCM I-4035 and CNCM I-4036; Placebo
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Probiotic CNCM I-4034 in a concentration of 9x10E9 cfu (colony forming unit) per day during 28 days.; 9x10E9 cfu (colony forming unit) per day during 28 days.; 9x10E9 cfu (colony forming unit) per day during 28 days.; 9x10E9 cfu (colony forming unit) per day during 28 days.; Placebo capsule for 28 days.
Other intervention name(s): CNCM I-4034; CNCM I-4035; CNCM I-4036; CNCM I-4035+CNCM I-4036; Placebo, group E
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: Probiotic; Immunity; Gastrointestinal symptoms
Evaluating the Influence of the Strategy Intraoperative Anesthetic (Desflurane Versus Propofol) on Cognitive and Psychomotor Functions in Output Post Interventional Room Monitoring - COGNIDES
Condition: Orthopedic Surgery; Total Hip Prosthesis; Total Knee Replacement
Study type: Interventional
Phase: Phase 2

Summary: 
      The recovery of cognitive and psychomotor functions is best performed under anesthesia after
      desflurane when propofol in that obtaining a Aldrete score> 8/10 output of the allowing SSPI.

      The principal objective is to compare the cognitive and psychomotor status of patients
      recovered an Aldrete score> 8/10 according to the anesthetic agent (propofol or desflurane)
      using three tests (Stroop test, Digit Symbol Substitution task and a test of verbal memory
      (visual verbal learning test) made SSPI.
    

Detailed description: 
      The day before surgery, patients sign the consent and will be randomized. Then 3 tests
      (Stroop test, Digit Symbol Substitution Task and visual verbal learning test) will be
      performed. No anxiolysis will be given to the patient. The anesthetic induction will be with
      IV propofol (2-3 mg / kg). The maintenance will anesthetic, desflurane by for a minimum
      alveolar concentration of between 2% and 6% or propofol for intravenous anesthesia user
      target controlled. In SSPI, the Aldrete score will be evaluated every 5min. Upon obtaining a
      Aldrete score> 8/10, the day before the tests will be carried out again
    

Intervention name(s): Intraoperative anesthetic strategy by Propofol; Intraoperative anesthetic strategy by Desflurane
Intervention type(s): Drug; Drug
Intervention description(s): 1- Arm Propofol: Propofol TCI induction target between 2 and 6 mg / mL
Sufentanil (0.15 mg / kg intravenously (IV))
Atracurium (0.5 mg / kg IV) Maintenance mode by Propofol TCI target between 2 and 4 micrograms / mL tune to 40 <BIS <60 Sufentanil bolus according to intraoperative analgesia Atracurium bolus according to the level of neuromuscular blockade; 2- Arm Desflurane Desflurane induction (2-3 mg / kg)
Sufentanil (0.15 mg / kg IV)
Atracurium (0.5 mg / kg IV)) Desflurane closed by maintenance target with minimal alveolar concentration (MAC) to adapt the circuit to obtain a figure 40 <BIS <60 Sufentanil bolus according to intraoperative analgesia Atracurium bolus according to the level of neuromuscular blockade
Intervention MeSH terms: Propofol; Anesthetics; Desflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Orthopedic Surgery; Total hip prosthesis; Total knee replacement; Intraoperative anesthetic strategy; Propofol; Desflurane
Effects of Two Multimodal-programs of Exercises in Male Soccer Players.
Condition: Sports Physical Therapy
Study type: Interventional

Summary: 
      The prevention of injuries has a close relation with the proprioception. In this sense, the
      proprioception is defined as the information about the corporal and segmental movement, as
      well as the position of the body and the corporal segments of oneself in the space. Some
      authors divide the proprioception into kinesthesia and the Joint Position Sense (JPS).

      The hypothesis of the study is the implantation of a progressive multimodal exercise protocol
      with transferences to sport in the trainings of amateur male soccer players in the age range
      from 18 to 30 years, can decrease the adverse effects of the fatigue during the high
      intensity activities and its relation with the JPS. Due to the close relation between fatigue
      and incidence of injuries, the obtaining of positive results could be an important finding
      for the design of prevention and rehabilitation protocols in soccer.
    


Intervention name(s): IAI Exercises Protocol; FIFA 11+
Intervention type(s): Other; Other
Intervention description(s): Progressive exercises to improve the strength and propioception of the male soccer players.; Progressive exercises protocol to prevent injuries in male soccer players which has been created by "FIFA". It is based in different body wieght exercises to improve the neuromuscular control and stabilization.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Soccer; Prevention injury
Feasibility and Safety Study Comparing REG1 Anticoagulation System With Unfractionated Heparin in Elective PCI
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if it is feasible and safe to use the REG1
      Anticoagulation System instead of unfractionated heparin during percutaneous coronary
      intervention (PCI) in subjects with coronary artery disease (CAD).
    

Detailed description: 
      The study drug, REG1, is the first specific, direct-acting, antidote-controlled anticoagulant
      ever described. Regado is developing REG1 for use in patients suffering from acute coronary
      syndrome who undergo coronary revascularization procedures. These procedures, which include
      coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI), put
      patients at high risk for therapy-related bleeding complications. REG1 is being developed
      initially to increase therapeutic flexibility and improve patient outcomes in coronary
      revascularization procedures.

      REG1 is a two-component system, consisting of an aptamer-based anticoagulant and its matched
      antidote. The REG1 anticoagulant component (RB006) is a single-stranded, nucleic acid
      aptamer. RB006 selectively and potently binds to and inhibits Factor IXa, a protein critical
      to blood coagulation. The antidote component, RB007, is a complementary nucleic acid that
      binds to and neutralizes RB006. The binding of RB007 to RB006 causes the predictable and
      rapid reversal of the RB006 effect and allows the patient's blood to return to normal.
    

Intervention name(s): REG1; REG1; Unfractionated Heparin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ii. The REG1 anticoagulation system consists of a drug (RB006) and antidote (RB007). The drug (RB006) is administered via IV bolus to achieve anticoagulation. The antidote (RB007) is administered as an IV bolus dose at approximately 10% the total reversal dose followed by the remaining dose several hours later to counteract RB006 induced anticoagulation.; ii. The REG1 anticoagulation system consists of a drug (RB006) and antidote (RB007). The drug (RB006) is administered via IV bolus to achieve anticoagulation. The antidote (RB007) is administered as an IV bolus dose at 100% of the total reversal dose to counteract RB006 induced anticoagulation.; Heparin will be administered per standard of care at sites
Other intervention name(s): UFH
Intervention MeSH terms: Heparin; Calcium heparin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CAD; PCI; ANTICOAGULANT
Comparison of Two Formulations of AZD5363 and the Effect of Food on Pharmacokinetic Exposure, Safety and Tolerability
Condition: Advanced Solid Malignancy,; Safety and Tolerability,; Pharmacokinetics, Pharmacodynamics,; Tumour Response,
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      Comparison of Two Formulations of AZD5363 and the Effect of Food on Pharmacokinetic Exposure,
      Safety and Tolerability
    

Detailed description: 
      This study is designed to investigate the safety, tolerability and pharmacokinetics of a new
      drug, AZD5363, in patients with advanced cancer . This study will investigate how the body
      handles AZD5363 (ie, how quickly the body absorbs and removes the drug), the comparison of a
      capsule and a tablet formulation and the effect of food on AZD5363 tablet formulation.
    

Intervention name(s): AZD5363; AZD5363
Intervention type(s): Drug; Drug
Intervention description(s): Oral AZD5363 twice daily, 4 days on 3 days off: tablet formulation for one week, followed by two weeks with capsule formulation.; Oral AZD5363 twice daily, 4 days on 3 days off, tablet formulation. On day 4 AZD5363 tablet without food. On day 11 AZD5363 tablet with food.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Advanced solid malignancy, AZD5363,; food effect,; formulation comparison
Growth and Tolerance of Hypoallergenic Formulas
Condition: Growth of Term Infants
Study type: Observational

Summary: 
      This clinical trial will evaluate two investigational hypoallergenic infant formulas with a
      differing protein content to determine if they provide normal growth and are well tolerated
      by term infants as compared to a marketed hypoallergenic formula.
    


Intervention name(s): Infant formula
Intervention type(s): Other
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Heatly, term infants