bioihbjkbjnl/mcl2 huggingface dataset:
Immunogenicity and Safety of Inactivated H1N1 Swine-origin Influenza Monovalent Vaccine in Immunocompromised Children and Young Adults
Condition: H1N1 Pandemic Flu
Study type: Observational

Summary: 
      This study will evaluate the immunogenicity and safety of inactivated H1N1 swine-origin
      monovalent influenza vaccine in immunocompromised children and young adults.
    

Detailed description: 
      This is a prospective observational study. This study will not dictate vaccine
      administration, nor the vaccine product to be used. It will collect data in St Jude patients
      who will receive the vaccine as part of their clinical care per institutional guidelines.
      Research participants will receive two doses of inactivated H1N1 swine-origin monovalent
      influenza vaccine administered 28 days apart as part of clinical care. Each dose contains 15
      mcg of hemagglutinin antigen (HA).Follow-up visits will be scheduled 28 days after each dose
      and at day 208+/- 14 days for blood work. The day of administration of the first vaccine dose
      is counted as day 0. At each of these visits, blood will be collected to assess for
      immunogenicity. Research participants will be given a diary card to record symptoms for 28
      days . They will be asked to bring this diary back at the next visit. Other vaccine-related
      adverse events will also be collected by retrospective chart review.

      Children and young adults between the ages of 6 months and 21 years and 13 kg or greater in
      body weight who have an underlying diagnosis of cancer, HIV, sickle cell disease or receipt
      of a stem cell transplant more than a year prior to study entry and who will receive
      inactivated H1N1 swine-origin monovalent influenza vaccine in the winter/fall of 2009-2010 as
      part of their routine clinical care.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children and young adults between the ages of 6 months and 21 years and 13 kg or greater in
        body weight who have an underlying diagnosis of cancer, HIV, sickle cell disease or receipt
        of a stem cell transplant more than a year prior to study entry and who will receive
        inactivated H1N1 swine-origin monovalent influenza vaccine in the winter/fall of 2009-2010
        as part of their routine clinical care. Stem cell transplant recipients in the first year
        following their transplant are excluded.
      
Biospecimen description: 
      Blood sample collection will be done according to the description provided in the
      institutional policy manual. When possible, blood draws will be made through existing
      implanted catheters. If the research participant does not have a catheter, a peripheral
      venipuncture will be performed. Serum and whole blood for immune assays will be frozen at
      -20ºC or in liquid nitrogen until processed in batched assays.
    
Keywords: H1N1 pandemic flu
Evaluation of the Beneficial Effects of a Probiotic Product in Healthy Adult Subjects.
Condition: Disbiosis; Abdominal Pain; Constipation; Diarrhea; Stress
MeSH terms: Constipation; Diarrhea; Abdominal Pain; Dysbiosis
Study type: Interventional

Summary: 
      A randomized, double-blind, placebo-controlled, cross-over trial performed at one centre in
      Italy to explore the ability of a multistrain probiotic mixture, to modulate markers of
      inflammation and intestinal barrier function and gastrointestinal symptoms in healthy
      volunteers with self-reported anxiety.
    


Intervention name(s): Lactoflorene plus; Placebo Lactoflorene plus
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 2 vials with dosing cap (10 mL) a day per os; 2 vials with dosing cap (10 mL) a day per os
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: randomized, double-blind, placebo-controlled, cross-over trial performed at one centre
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lactoflorene plus; Bifidobacterium animalis subsp. lactis, BB-12®; Lactobacillus acidophilus, LA-5®; Lactobacillus paracasei subsp. paracasei, L. CASEI 431®; Inflammation; gut permeability; disbiosis; probiotic; IgA; IL10
Nucleoplasty for Contained Herniated Lumbar Discs
Condition: Herniated Disc
MeSH terms: Intervertebral Disc Displacement
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a prospective randomised double blind comparison trial. Fifty patients will be
      included, 25 in the nucleoplasty treatment group, 25 in the control group. The nucleoplasty
      group will undergo the nucleoplasty treatment. Control group will undergo a sham treatment.
      Both groups will undergo a standardised post-operative care program. The study hypothesis is
      that nucleoplasty will lead to earlier pain reduction as compared with the sham treatment.
    

Detailed description: 
      This study will include patients with a contained lumbar hernia of at least 6 weeks existence
      in whom leg pain is the predominant complaint. Standard treatment for these patients is
      conservative, as an operation is not without risks and is not always effective. Furthermore,
      complaints will usually resolve in due time. However, the pain limits the patients in their
      daily activities, often for a prolonged period.

      In this study, nucleoplasty will be compared with a sham treatment and not with conservative
      treatment, as the discography is thought to have some therapeutic effect.

      The primary outcome will be the proportion of patients with at least a 2.5 points decrease on
      a ten-point Jensen VAS score 3 months after treatment.
    

Intervention name(s): Nucleoplasty
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: hernia; nucleoplasty; radicular pain; Contained lumbar herniated disc
Functional Limitations Due To The Foot Involvement In Spondyloarthritis
Condition: Ankylosing Spondylitis; Psoriatic Arthritis
MeSH terms: Spondylitis; Arthritis; Arthritis, Psoriatic; Spondylarthritis; Spondylitis, Ankylosing
Study type: Observational

Summary: 
      Seronegative spondyloarthritis (SpA) is a group of rheumatic diseases Foot involvement of the
      SpA is common and enthesitis, erosive changes or ankylosis are the frequent lesions. The
      functional status of the SpA patients are usually evaluated globally.The aim of this study is
      to assess specifically the foot -related functional limitations of the SpA patients.
    

Detailed description: 
      SpA patients who had foot pain at least for 4 weeks and those having bilateral
      anteroposterior and lateral feet x-rays will be included into the study. Foot x-rays will be
      evaluated by a radiologist by using the spondyloarthropathy tarsal radiographic index
      (SpA-TRI). The foot related functional status of the patients will be determined by the
      Turkish version of the Foot and Ankle Outcome Score (FAOS).
    

Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        patients with SpA and foot pain
      
Keywords: ankylosing spondylitis; Psoriatic arthritis; Foot; FAOS; SpA-TRI
[18F]-F13640 as a New Brain Radiopharmaceutical
Condition: Neurological Pathology; Healthy Subjects
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This clinical assay is designed to validate that [18F]F13640 as a radiotracer of 5-HT1A
      functional receptors. A first group of healthy subjects underwent a PET scan with arterial
      blood sampling to determine the kinetic model of the tracer. A second group of healthy
      subjects underwent a classical test-retest study (i.e two distant PET scans) to determine the
      reproducibility of measures.
    


Intervention name(s): [18F]F13640; [18F]F13640
Intervention type(s): Drug; Drug
Intervention description(s): Radiotracer injection and PET scan acquisition of 90 min:
*150 Mbq + 1 MBq/Kg of [18F]F13640 at t=0 min
Arterial Blood Sampling during the 90min acquisition; 2 Radiotracer injections and PET scan acquisition of 90 min distant from 1 to 3 weeks: For each exam: 150 MBq + 1 MBq/kg of [18F]F13640 at t=0 min
Intervention MeSH terms: Befiradol
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PET imaging- Serotonin-Radiotracer
Therapeutic Touch on Labour Pain, Anxiety and Childbirth Attitude
Condition: First Pregnancy; Vaginal Delivery
MeSH terms: Labor Pain
Study type: Interventional

Summary: 
      Introduction: Touching ensures physical, emotional and spiritual relaxation, confidence,
      peace, calmness and well-being, and increases self-esteem. The aim of this study is to
      determine the effect of therapeutic touch on labour pain, anxiety and childbirth attitude.

      Methods: The sample of this randomized controlled experimental research consisted of 80
      (intervention group: 40; control group: 40) women. Data were collected using a Personal
      Information Form, Visual Analogue Scale, State Anxiety Inventory and Childbirth Attitudes
      Questionnaire.
    


Intervention name(s): Therapeutic touch
Intervention type(s): Other
Intervention description(s): Therapeutic touch was applied twice to the women in the intervention group in addition to routine practices. The first application was performed in the active phase of the first stage of labour, and the second was done in the second stage of labour.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: therapeutic touch; labour pain; anxiety; childbirth attitude
Lidocaine Infusion for Pain Relief in Children Scheduled for Tonsillectomy and Adenoidectomy
Condition: Children, Only; Tonsillar Hypertrophy; Adenoid Hypertrophy
MeSH terms: Hypertrophy
Study type: Interventional
Phase: Phase 4

Summary: 
      Lidocaine is widely available and is a very commonly used local anesthetic. When administered
      intravenously, lidocaine infusions have anti-inflammatory effects and have significantly
      decreased the reliance on opioid use for adequate pain management in adult abdominal and
      spine surgeries. A major advantage of lidocaine infusion is that it is not associated with a
      significant side effect profile.The role of lidocaine in pediatric acute perioperative pain
      remains limited.
    

Detailed description: 
      The aim of the study is to determine if using lidocaine continuously during anesthesia care
      will decrease post-operative pain for children having their tonsils and adenoids removed.
    

Intervention name(s): Lidocaine Iv; Saline Solution
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous infusion; Intravenous infusion
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Enrolled patients will be randomly assigned into one of two intervention groups:
Group 1: systemic lidocaine infusion Group 2: normal saline infusion
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lidocaine; Tonsillectomy and Adenoidectomy; Pain
Study of SHR-1210 in Combination With Chemotherapy in Advanced Esophageal Cancer
Condition: Advanced Esophageal Cancer
MeSH terms: Esophageal Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomised, double-blinded, placebo-controlled, multi-center phase III trial,
      comparing the efficacy and safety of SHR-1210 + paclitaxel + cisplatin vs placebo+paclitaxel
      +cisplatin as 1L therapy for advanced esophageal cancer patients in China. SHR-1210 is a
      humanized anti-PD1 IgG4 monoclonal antibody.
    

Detailed description: 
      In this study, eligible subjects will be randomized into study arm or control arm. Treatment
      cycles of chemotherapy will be at most 6 cycles which would be decided by the investigators.
      Progression-free survival (PFS) assessed by the Independent Review Committee (IRC) and
      overall survival (OS) will be the primary outcomes.
    

Intervention name(s): SHR-1210; Placebo; paclitaxel; cisplatin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): SHR-1210 200mg; Placebo; paclitaxel 175mg/m2; cisplatin 75mg/m2
Other intervention name(s): camrelizumab
Intervention MeSH terms: Paclitaxel; Cisplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PD-1Antibody; advanced esophageal cancer; paclitaxel; cisplatin
Azithromycin for Uncomplicated Severe Acute Malnutrition in Burkina Faso (Pilot)
Condition: Uncomplicated Severe Acute Malnutrition
MeSH terms: Malnutrition; Severe Acute Malnutrition
Study type: Interventional
Phase: Phase 3

Summary: 
      This pilot study is a randomized controlled trial designed to test the effect of the
      administration of adjunctive azithromycin in conjunction with standard outpatient treatment
      for uncomplicated severe acute malnutrition (SAM) in children aged 6-59 months. Children
      presenting to nutritional programs in Burkina Faso who meet eligibility criteria will be
      randomized to a single dose of oral azithromycin or a 7-day course of amoxicillin (standard
      of care) upon admission into the program. All enrolled children will receive ready-to-use
      therapeutic foods (RUTF). Enrolled children will be followed at each weekly clinic follow-up
      visit up to 8 weeks following admission. Data on anthropometric indicators, vital status, and
      adverse events will be collected during follow-up. Nutritional recovery over the 8-week study
      period will be compared by arm.
    


Intervention name(s): Azithromycin; Amoxicillin
Intervention type(s): Drug; Drug
Intervention description(s): Children enrolled in the trial and randomized to azithromycin will receive a single directly observed dose of oral azithromycin at 20 mg/kg up to the maximum adult dose of 1 g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.; Children enrolled in the trial and randomized to azithromycin will receive a 7-day course of oral amoxcillin given in twice-daily doses of 50-100 mg/kg, per the Burkina Faso guidelines for the management of severe acute malnutrition. The first dose will be administered at the time of enrollment and the remaining dose will be administered by the caregiver at home. Enrolled children will also receive RUTF.
Other intervention name(s): Zithromax
Intervention MeSH terms: Amoxicillin; Azithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Manipulating Tobacco Constituents in Male Menthol Smokers
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      This study examines the potential effect of reducing nicotine content or menthol or both in
      men. It will also examine whether there are gender differences in manipulating tobacco
      flavors and nicotine concentrations in cigarettes on smoking behavior.
    

Detailed description: 
      The FDA has the regulatory authority to reduce, but not eliminate, nicotine from cigarettes.
      The Tobacco Products Scientific Advisory Committee has noted, among other things, that
      removal of menthol cigarettes from the marketplace would benefit the public health. A parent
      study (NCT02048852) examines the potential impact of these two regulatory actions alone and
      in combination in female menthol smokers. This supplemental study will recruit an additional
      group of male menthol smokers, which will examine whether there are gender differences in
      manipulating flavors and nicotine concentrations in cigarettes on smoking behavior. The
      approach to add the opposite sex allows findings of sex/gender to be incorporated in the
      design and development of new technologies (i.e., modified cigarettes). Emerging research
      shows that women may be more responsive to the non-nicotine sensory aspects of smoking such
      as menthol flavor, whereas men may smoke primarily for nicotine intake. Consequently, this
      study expects to observe gender differences in response to manipulating flavors and nicotine
      content in cigarettes.
    

Intervention name(s): Reduced Nicotine Non-Menthol (RNC); Reduced Nicotine Menthol (RNC-Men); Conventional Nicotine Non-Menthol (CN)
Intervention type(s): Other; Other; Other
Intervention description(s): Switch from own brand of cigarette to an investigational tobacco product with a reduced nicotine content of 0.07mg nicotine yield without menthol.; Switch from own brand of cigarette to an investigational tobacco product with a reduced nicotine content of 0.07mg nicotine yield with menthol.; Switch from own brand of cigarette to an investigational tobacco product which contains conventional nicotine yield.
Other intervention name(s): SPECTRUM Research Cigarette - NRC 200; SPECTRUM Research Cigarette - NRC 201; SPECTRUM Research Cigarette - NRC 600
Intervention MeSH terms: Menthol; Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: menthol; nicotine; reduced nicotine; smoking; cigarette; cigarettes; men smoking; smoking research; nicotine dependence
A 12-Week Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 4

Summary: 
      A 12-Week, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study.
    


Intervention name(s): Pitavastatin; Pravastatin
Intervention type(s): Drug; Drug
Intervention description(s): Pitavastatin 4 mg QD; Pravastatin 40 mg QD
Other intervention name(s): Livalo
Intervention MeSH terms: Pravastatin; Pitavastatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Risedronate for the Treatment of Osteoporosis for People With Spinal Cord Injury
Condition: Osteoporosis
MeSH terms: Osteoporosis; Spinal Cord Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to find out if risedronate works for the treatment of
      osteoporosis for people with spinal cord injury.
    


Intervention name(s): Risedronate
Intervention type(s): Drug
Intervention MeSH terms: Risedronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Spinal cord injury
Integrated Diabetes Management Protocol Using Smartphone
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The investigators aim to assess whether using integrated diabetes management protocol using
      smartphone would increase glucose control among diabetes patients.
    

Detailed description: 
      Smartphones and digital healthcare is expected to provide better diabetes care. The
      investigators aim to assess whether using integrated diabetes management protocol using
      smartphone would increase glucose control among diabetes patients.

      Smartphone apps for food diary, activity monitor, blood glucose will be used for three
      months.

      Blood glucose control and patient satisfaction will be assessed.
    

Intervention name(s): Integrated Diabetes Management Protocol; Standard Diabetes Management Protocol
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioavailability Of Lersivirine Single 750 Mg Tablet Versus 3 X 250 Mg Tablets
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized study to assess whether the pharmacokinetics of a new single 750 mg
      tablet is similar to 3 x 250 mg tablets (750 mg total).
    


Intervention name(s): Lersivirine; Lersivirine
Intervention type(s): Drug; Drug
Intervention description(s): Oral Lersivirine 750 mg (1 x 750 mg) single dose; Oral Lersivirine 750 mg (3 x 250 mg) single dose
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioavailability; Bioequivalence; Lersivirine; UK-453; 061; Pharmacokinetics
Development of Alternatives for the Estimation of the Resting Metabolic Rate From Anthropometry in Paralympic Athletes
Condition: Resting Metabolic Rate; Disability Physical; Athletic Injuries
MeSH terms: Athletic Injuries
Study type: Observational

Summary: 
      To our knowledge no study has evaluated neither feasible methods for the assessment of
      anthropometric profile nor indirect methods to estimate energy expenditure (EE) for adapted
      athletes. The primary aim is to develop and validate new RMR prediction models, for the
      estimation of the resting metabolic rate from anthropometric variables in young Mexican
      Paralympic athletes; our second objective is to evaluate the agreement between RMR and the
      prediction models of Cunningham, Harris-Benedict, Henry, Valencia, Chun, Nightingale &
      Gorgey, FAO/WHO, Mifflin, Müller, Owen, and our own models. A comparative cross-sectional
      quantitative study was designed. Participants report to the testing laboratory only once for
      data collection. The Strengthening the Reporting of Observational Studies in Epidemiology
      criteria guidelines for cross-sectional research (STROBE) is followed in the design/reporting
      of this study.
    


Intervention name(s): Indirect Calorimetry
Intervention type(s): Other
Intervention description(s): RMR was calculated by breath oxygen consumption (O2 in mL·min-1), minute by minute, using a portable device (Breezing®, Arizona, USA), and the Weir equation (1949), while participants remained in a sitting position for ≈15 to 20 minutes.
The anthropometric measurements were performed by certified level 3 anthropometrists following the guidelines of the International Society for the Advancement of Kinanthropometry, ISAK
Other intervention name(s): Anthropometry
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Mexican Paralympic swimmers from the national and the state adapted swimming team.
      
Keywords: Anthropometry; Indirect Calorimetry; Bioenergetics; Metabolic rate; Paralympic Athletes
A Study to Assess the Pharmacokinetics of Certolizumab Pegol in Adults With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the pharmacokinetics and safety of certolizumab pegol
      in adults with active rheumatoid arthritis.
    


Intervention name(s): Certolizumab pegol
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form: Solution for injection
Route of administration: Subcutaneous Subjects will receive certolizumab pegol in a pre-specified sequence during the study.
Intervention MeSH terms: Certolizumab Pegol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Rheumatoid arthritis; Phase 1; Cimzia; Certolizumab pegol; Electrochemiluminescent immune-assay