bioihbjkbjnl/mcl2 huggingface dataset:
Chiron Corp HCV E1/E2 Vaccine
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are to evaluate the safety, tolerability, and effectiveness of a
      vaccine (the HCV E1/E2/MF59 vaccine) against hepatitis C (HCV). The vaccine will be given to
      60 healthy adult volunteers (aged 18-45 years) and the study will compare the immune system
      (the body's protective response) response to the HCV E1/E2 vaccine given at different dosage
      levels: 4 micrograms, 20 micrograms, or 100 micrograms in MF59 adjuvant (substance that can
      improve vaccine effectiveness). The volunteers will be assigned randomly (by chance) to 1 of
      4 different groups. Volunteers in each group will receive a shot of the vaccine or a placebo
      (shot with no medication). Participants will be involved in study related procedures for up
      to 71 weeks, which includes blood samples, recording symptoms on a diary card, and 4 vaccine
      or placebo injections.
    

Detailed description: 
      Hepatitis C virus (HCV) has emerged as a significant public health concern throughout the
      world. Its estimated prevalence in the US is 1.5 percent, or 2.7 million people with chronic
      infection. As many as 170 million people may have chronic HCV infection worldwide. The
      Centers for Disease control currently estimates that 40,000 HCV infections occur yearly in
      the US, with most current infection acquired through illegal injection drug use. It is
      estimated that 70 percent of those infected will develop chronic liver disease. The purpose
      of this study is to conduct a Phase I vaccine trial with a novel vaccine, HCV E1E2/MF59. The
      study objectives are to evaluate the safety, tolerability, and immunogenicity of HCV
      E1E2/MF59 vaccine administered to healthy adult subjects and to compare the immune response
      to HCV E1E2 vaccine given at 4, 20, or 100 mcg in MF59 adjuvant. Sixty healthy adults, aged
      18-45, will be randomized to receive one of 3 different doses of vaccine or placebo. Each
      subject will receive vaccine at 0, 4, 24, and 48 weeks. Study procedures will include blood
      sample collections and questions regarding risk factors for acquiring HCV.
    

Intervention name(s): HCV E1E2/MF59; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): The investigational vaccine contains envelope glycoproteins gpE1 and gpE2 and the adjuvant, MF59. MF59 is a sterile oil-in-water emulsion in a citrate buffer, which comprises 50 percent of the vaccine. The antigen and adjuvant are combined prior to the injection. The volume to be administered is 0.5 mL for all vaccine dose levels. The vaccine has a milky white opacity. Vaccine dosages: 4 mcg, 20 mcg and 100 mcg.; Four doses sterile saline (0.5 mL total volume) at 0, 4, 24, and 28 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: hepatitis C, HCV, vaccine, recombinant vaccine, adjuvant
The Effect of the Timing of Colloid and Crystalloid Infusions on Postspinal Hypotension After Spinal Anesthesia for Caesarian Section
Condition: Complications; Anesthesia, Spinal and Epidural, in Pregnancy
MeSH terms: Hypotension
Study type: Interventional

Summary: 
      Prevention of postspinal hypotension after spinal anesthesia for caesarian section by use of
      preoperative or intraoperative volume replacement. The comparison of crystalloid and colloid
      infusions and their timing via perfusion index and plethysmographic variability index.
    

Detailed description: 
      To Prevent hypotension fluid replacement is usually used in pregnant patients scheduled for
      C/S. Different types of fluids can be used in order to achieve this. Also the timing of fluid
      replacement is important. In the present study patients were separated into 4 groups. Each
      receiving a one of two fluids in different times. ( Colloid pre-load, colloid co-load,
      crystalloid co-load and crystalloid pre-load.) The effect of overall hemodynamics and the
      incidence of hypotension are evaluated. Also peripheric monitors like perfusion index and
      plethysmographic variability index are evaluated for correlation.
    

Intervention name(s): Colloid Preload; colloid co-load; Crystalloid preload; Crystalloid Co-load
Intervention type(s): Other; Other; Other; Other
Intervention description(s): preload infusion; co-load infusion; preload infusion; co-load infusion
Other intervention name(s): Gelofusin; gelofusin; Ringers lactate solution; Ringers lactate solution
Intervention MeSH terms: Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 4 group of patients were sheduled to receive either kristalloid or kolloid two gropus before and two groups during anesthesia induction
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
EFESO - EFficacy Enterogermina Small Intestinal Bacterial Overgrowth
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary objective: to assess the efficacy of Bacillus clausii versus metronidazole in the
      eradication of the small intestinal bacterial overgrowth, 30 days after the end of treatment.

      Secondary objective: to assess the efficacy of Bacillus clausii versus metronidazole in
      avoiding recurrence of the small intestinal bacterial overgrowth, 90 days after the end of
      the treatment; to assess the efficacy of Bacillus clausiiversus metronidazole in improving
      irritable bowel syndrome -related symptoms; to assess the efficacy of Bacillus clausii versus
      metronidazole in the satisfactory relief of overall irritable bowel syndrome symptoms and of
      abdominal discomfort or pain; to assess the efficacy of Bacillus clausii versus metronidazole
      in improving irritable bowel syndrome quality of life.
    


Intervention name(s): Bacillus clausii; Metronidazole
Intervention type(s): Drug; Drug
Intervention description(s): 3 bacillus clausii vials/day for one month; 3 Metronidazole tablets/day for one week
Intervention MeSH terms: Metronidazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Atazanavir Twice Daily
Condition: HIV Infections; Protease Inhibitor
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this clinical research study is to assess the pharmacokinetics of atazanavir
      administered twice-daily relative to historical data from atazanavir/ritonavir 300/100 mg,
      given once daily.
    


Intervention name(s): Atazanavir Sulphate; Atazanavir Sulphate; Atazanavir Sulphate
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Capsules, Oral, 200 mg, twice daily, 7 days.; Capsules, Oral, 300 mg, twice daily, 8 days.; Capsules, Oral, 400 mg, twice daily, 9 days.
Other intervention name(s): Reyataz; Reyataz; Reyataz
Intervention MeSH terms: Atazanavir Sulfate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enhanced Critical Care Air Transport Team Training for Mitigation of Task Saturation
Condition: Task Saturation
Study type: Observational

Summary: 
      This study involves two tasks. The first involves observation of patient care during
      simulated aeroevacuation missions in order to gauge task saturation. The second involves
      review of records from actual evacuation flights in order to determine the effects of task
      saturation on patient care.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The population for the first task will consist of 4 CCATT teams (of 3 members each)
      
Keywords: Task saturation
Parental Touch Trial (Petal)
Condition: Infant Development; Pain, Procedural; Parents
MeSH terms: Pain, Procedural
Study type: Interventional

Summary: 
      This is a two centre two-arm randomised controlled interventional trial. We aim to determine
      whether parental touch prior to a painful clinical procedure provides effective analgesia in
      neonates.
    

Detailed description: 
      This is a multicentre randomised-controlled interventional trial, with two research sites
      (John Radcliffe Hospital, Oxford, and Royal Devon and Royal Devon and Exeter Hospital,
      Devon). In this study we aim to determine whether parental touch prior to a painful clinical
      procedure provides effective analgesia.

      The primary objective is to determine whether parental touch reduces noxious-evoked brain
      activity following a heel lance. In addition, our secondary and exploratory objectives
      include investigating the effect of touch on behavioural and electrophysiological measures
      evoked by a heel lance. Neonates will be randomised to receive parental touch either prior to
      or post a clinically required heel lance. We will also investigate how parental touch impacts
      post-procedural clinical stability and explore whether this intervention affects parental
      anxiety.

      Neonates will be recruited during a 9-month period. Participants will be studied on a single
      test occasion while they are in hospital, when they require a clinical heel lance. No extra
      blood tests or noxious procedures will be performed for the purpose of the study.
      Participants will be included in the study for approximately an hour period. This will be
      approximately 30 min before and after the time when the heel lance is performed. Individual
      babies will only be included in the trial once. If a neonate requires additional heel lances
      to acquire sufficient blood for clinical assessment at the time of the test occasion, we will
      also record the responses to this.
    

Intervention name(s): Parental touch
Intervention type(s): Behavioral
Intervention description(s): Parental touch in the form of stroking at 3cm/s for 10 seconds on the posterior lower limb where the heel lance will be/has been administered
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Parental touch; Brain activity; Stroking; Anxiety; Clinical pain score; Heart rate; Respiratory rate
Prospective Observational Analysis Of CR With Sunitinib Treatment In mRCC Patients
Condition: Complete Remission in Renal Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Renal Cell
Study type: Observational

Summary: 
      This prospective study will investigate the characteristics of mRCC patients at time of CR in
      comparison with mRCC patients non on CR treated with Sunitinib, in order to provide some
      answers/ refection leads to the following questions :

      Can we identify blood specificity at time of CR vs non on CR? Shall we distinguish CR with
      sunitinib alone from combined CR (sunitinib with local treatment), while in clinical report
      these 2 cohorts present similar time to recurrence (ALBIGES, ASCO 2010)? Can we identify
      potential predictive serum biomarkers of recurrence? (With the aim of isolating blood
      biomarker that can help on treatment discontinuation decision?)
    

Detailed description: 
      The main objective of the study is to describe the characteristics of mRCC patients on CR
      with Sunitinib (Cases) and compare them to the characteristics of mRCC patients non on CR
      (controls) in order to identify factors associated with the occurrence of complete remission.

      The results obtained on the sample must be representative of the population targeted by the
      study. The most appropriate method to obtain a representative sample is probability sampling.

      A sample size of N = 40 (cases) and N = 80 (Controls) will provide a power of 80% in the
      detection of a frequency difference between cases and controls corresponding to an OR of 0.24
      for a parameter frequency 10% in control arm and an OR of 0.30 for a parameter frequency of
      around 30% in control arm. The significance level was set at bilateral 5%.

      The data will be analyzed using SAS software (version 9.1 - SAS Institute, North Carolina,
      United States).
    

Intervention name(s): sunitinib; sunitinib
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg 4/2 ,oral, once a day 4 weeks on and 2 weeks off for 6 months; 50 mg 4/2 ,oral, once a day 4 weeks on and 2 weeks off for 6 months
Other intervention name(s): Cases; Controls
Intervention MeSH terms: Sunitinib
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        complete remission in mRCC patients treated with sunitinib versus non complete remission in
        mRCC patients treated with sunitinib
      
Biospecimen description: 
      whole blood and serum
    
Keywords: complete remission
Phase I Open-label Study to Evaluate Pharmacokinetics of TAK-272 in Participants With Renal or Hepatic Impairment
Condition: Renal Impairment; Hepatic Impairment
MeSH terms: Liver Diseases; Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine the effects of renal and hepatic impairment on
      TAK-272 pharmacokinetics with a single oral administration of TAK-272 in participants with
      renal or hepatic impairment.
    

Detailed description: 
      This study is a phase I, open-label, parallel-group, comparative study to evaluate the
      effects of renal or hepatic impairment on pharmacokinetics of TAK-272 with a single oral
      administration of TAK-272 in participants with renal or hepatic impairment as compared with
      participants with normal renal and hepatic function.
    

Intervention name(s): TAK-272
Intervention type(s): Drug
Intervention description(s): TAK-272 tablet
Intervention MeSH terms: Imarikiren hydrochloride
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug therapy
A Trial Comparing Efficacy and Safety of Voriconazole Administered With Therapeutic Drug Monitoring vs. Standard Dosing
Condition: Fungal Infection
MeSH terms: Mycoses
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a prospective, multicenter, randomized trial to study therapeutic drug monitoring
      (TDM) of voriconazole among patients with an invasive mould infection (IMI). The primary
      objective of this study will be to assess the effect of prospective voriconazole TDM on the
      composite of adverse events (AE) and clinical response.
    

Detailed description: 
      This is a prospective study of patients who receive voriconazole as treatment for an IMI
      (proven, probable, and possible by the EORTC/MSG definitions), other than zygomycosis.
      Patients will be randomized to receive either standard dosing or dosing based on TDM,
      stratified by whether initial voriconazole therapy is PO or IV. Assessment of outcomes will
      be made 42 days after start of voriconazole. An additional follow up for safety reporting
      will be performed 4weeks after completion of voriconazole

      The patients will be randomized to:

        -  Prospective TDM: voriconazole dose will be adjusted based on per protocol obtained TDM
           levels, and

        -  Standard dosing: standard doses of voriconazole will be used.

      In the prospective TDM arm, voriconazole TDM will be performed in real time at each site and
      results will be reported to treating physicians for dose adjustment. All efforts will be
      taken to obtain results within 24 hours of blood sample collection. In the standard dosing
      arm, blood samples will be collected, stored, and batched for voriconazole levels to be
      tested retrospectively. Voriconazole plasma levels will be measured by validated high
      performance liquid chromatography (HPLC) assays as detailed. Voriconazole trough levels will
      be performed on Day Baseline/Screening, 5, 14, 28, and 42.

      Voriconazole peak level will be measured on Day 5. Trough voriconazole levels will be
      obtained in case of an event, defined as suspected drug-associated toxicity and/or clinical
      failure.

      Assessment of AEs for all patients will be monitored during the study and response to
      treatment will be assessed. The composite of overall AE/clinical failure will be assessed on
      day 42.
    

Intervention name(s): Prospective TDM Arm
Intervention type(s): Drug
Intervention description(s): Voriconazole dose will be adjusted based on per protocol obtained TDM levels
Other intervention name(s): VFEND
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Voriconazole; Therapeutic drug monitoring; Hematopoietic stem cell transplant; Hematologic malignancy; Invasive mould infection
The Tailgate Study: A Pilot Study Measuring the Impact of Acute Alcohol Intake on Intrahepatic Lipid
Condition: Obesity
MeSH terms: Alcohol Drinking
Study type: Observational

Summary: 
      College drinking associated with sporting events is characterized by excess alcohol, along
      with food intake, over the duration of hours has the potential to cause a build up of fat in
      the liver. Fatty liver can increase blood glucose concentrations leading to a prediabetes
      like state.

      The present study will determine how overweight men respond to the over-consumption of
      alcohol/food to identify which characteristics might protect some men from fatty liver, while
      others might be more susceptible to this condition.

      The goal of this work is to determine the direct impact of alcohol/food intake to cause acute
      fatty liver through the stimulation of de novo lipogenesis in 20 overweight, healthy men.
      Understanding individual susceptibility to alcohol-induced fatty liver will aid in the
      development of strategies designed to help people mitigate these risks.

      Hypothesis is that 5h excess consumption of alcohol and food will increase liver
      triglycerides by 4% or more, in comparison to fasting state.
    

Detailed description: 
      Subjects will participate in a single screening visit and a 24 hours in-patient stay at the
      clinical research center for treatment and tests.

      No drugs will be used in this study, however, amounts of alcohol will be consumed to achieve,
      and maintain a breath alcohol at the legal limit (0.10).

      The goals are to quantitate the increase in lipogenesis due to acute alcohol/food intake and
      to determine the effects of acute alcohol/food intake on liver-triglycerides.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy and overweight sedentary men.
      
Keywords: Obesity
Lifetime Impact Study for Achondroplasia
Condition: Achondroplasia
MeSH terms: Achondroplasia
Study type: Observational

Summary: 
      Observational study looking at the burden of illness in achondroplasia subjects aged 3 and
      above. The study will include a 3 year review of historical clinical data as well as a single
      point collection of questionnaire data to look at the impact on the following in individuals
      with achondroplasia versus a normative population:

        -  Quality of life

        -  Clinical burden

        -  Healthcare resource use

        -  Socio-economic burden

        -  Psychosocial burden

      Up to 175 subjects will be enrolled in sites in Argentina, Colombia and Brazil.
    

Detailed description: 
      This is a multinational, epidemiological, observational, retrospective, cross-sectional study
      of individuals with achondroplasia (subjects). This study will be conducted at up to
      approximately 4 sites in Latin American Countries - Brazil, Argentina and Colombia.

      Subjects will be identified for participation in the study via three routes:

        1. During routine hospital visits

        2. From clinic lists of those previously treated but no longer followed at the study site.

        3. Through collaboration of the Investigator with Achondroplasia patient organizations,
           other Achondroplasia-related organizations, other healthcare professionals in their
           country and Achondroplasia-related social media sites. A recruitment flyer will be
           provided to these organizations, healthcare professionals and distributed to potential
           subjects.

      Data will be collected over a minimum of the three years prior to the date of enrolment.
      Clinical and healthcare resource use data will be collected from medical records. For each
      subject enrolled, data from medical records will be collected and entered onto an electronic
      case report form (eCRF) at each site. Data collection from medical records will be
      supplemented by records provided by the subject and, if necessary, confirmed by the family
      Doctor.

      Data about QoL, mobility, psychosocial burden, socio-economic burden and healthcare resource
      use will be collected via a booklet of validated and structured questionnaires.

      Characteristics of subjects with achondroplasia (QoL scores, healthcare resource use,
      educational level, family status, employment status) will be compared with those of the
      general population, where available.

      As this is an observational study, participation will not affect the subject/Investigator
      relationship, nor influence Investigator's treatment, therapeutic or other management of the
      subject.

      Subject participation onto the study will be voluntary, without financial support to the
      subject.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Individuals with a diagnosis of Achondroplasia aged 3 years or older in Argentina, Brazil
        and Colombia
A Comparison Between Two Formulations of NN5401 in Healthy Subjects
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in the United States of America (USA). The aim of the trial is to
      compare the exposure of two formulations of insulin degludec/insulin aspart (NN5401) in
      healthy subjects.
    


Intervention name(s): insulin degludec/insulin aspart
Intervention type(s): Drug
Intervention description(s): Each subject will be allocated to two single injections of trial product on two separate dosing visits with each of the two insulin degludec/insulin aspart formulations. The trial products will be administered as a subcutaneous injection (under the skin).
Intervention MeSH terms: Insulin; Insulin Aspart
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment