bioihbjkbjnl/mcl2 huggingface dataset:
Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2020-2021 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively
Condition: Influenza Immunization; Healthy Volunteers
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective:

      To provide serum samples (collected from participants before vaccination [Blood Sample 1] and
      after final vaccination [Blood Sample 2]) to Center for Biologics Evaluation and Research
      (CBER) for further analysis by the World Health Organization (WHO), Centers for Disease
      Control and Prevention (CDC), and Food and Drug Administration (FDA) to support formulation
      recommendations for subsequent influenza vaccines. In addition, serum samples from adult
      participants may be further analyzed by the Sponsor to assess breadth of immune response
      induced by the study vaccines.
    

Detailed description: 
      Study duration per participant was approximately 28 days for participants 6 months to less
      than (<) 9 years of age, and 21 days for participants greater than or equal to (>=) 65 years
      of age, including 1 to 3 visits (1 or 2 vaccination visits) and 1 or 2 telephone calls,
      depending on study Group.

      The aim of study GRC00101 was to obtain serum samples for submission to CBER to aid in the
      influenza vaccine strain selection process. There were no outcome measures defined in the
      protocol; however, the number of collected samples was listed as an outcome for disclosure
      purposes since outcomes were mandatory for study registration.
    

Intervention name(s): Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2020-2021 formulation; Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2020-2021 formulation
Intervention type(s): Biological; Biological
Intervention description(s): Pharmaceutical form: Suspension for injection in a pre-filled syringe,
Route of administration: Intramuscular (IM); Pharmaceutical form: Suspension for injection in a pre-filled syringe,
Route of administration: IM
Other intervention name(s): Fluzone® Quadrivalent; Fluzone High-Dose Quadrivalent
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Computerized Vestibular Rehabilitation
Condition: Vestibular Diseases
MeSH terms: Vestibular Diseases
Study type: Observational

Summary: 
      Disorders of vestibular function and balance are an important component of many conditions
      that commonly affect veterans, such as inner ear diseases, diabetes, and traumatic brain
      injury. Veterans with vestibular impairment have reduced quality of life, limitations on work
      and physical activities, and an increased risk of falls. The goal of this research is to
      develop a more engaging and effective interactive tool for vestibular rehabilitation to
      improve the lives of affected veterans. The first steps in this process will be to test the
      ability of the application to facilitate vestibular learning and to test its feasibility in
      vestibular patients. The hypothesis is that computer-game-based adaptation will induce robust
      VOR motor learning and will provide an engaging platform for vestibular rehabilitation.
      Ultimately, our application has the potential to provide more flexible vestibular exercises
      that will allow therapy to be customized for each patient. It will also have the ability to
      track a patient's progress over time and to advance exercises as function improves.
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Normal volunteers and patients with vestibular hypofunction
      
Biospecimen description: 
      No biological specimens will be retained.
    
Keywords: neurologic rehabilitation; computer games
Vital Signs and Pain During Insertion of IUD
Condition: Contraception; Acute Pain
MeSH terms: Acute Pain
Study type: Observational

Summary: 
      Cross-sectional cohort study to evaluating pain and vital signs variations (blood pressure
      and radial pulse) during the placement of the intrauterine device.
    

Detailed description: 
      The intrauterine device (IUD), which is one of the most effective and safe contraceptives is
      still little used by women. It is considered a long action reversible contraception (LARC).
      Among the many reasons for this resistance stands the fear of pain, the complications that
      can occur during the insertion.

      Objective: To evaluate the intensity of pain on outpatient insertion of IUD. In addition to
      evaluating changes in vital signs and detect which are the factors associated with pain on
      outpatient insertion of IUD. Methods: Cross Sectional Retrospective study of 285 procedures
      of outpatient insertion of IUD.

      Inclusion criteria were age older than 18 years, cervical cytology without abnormalities,
      classification for Category 1 or 2 of the WHO eligibility criteria for IUD. The criteria for
      non inclusion were patients with cardiac arrhythmias and gynecological disorders. The
      insertions of IUD were conducted on an outpatient basis without the use of painkillers.

      Evaluation of vital signs ( blood pressure and radial pulse) was performed pre and five
      minutes after the procedure. The pain assessment was performed using the scale visual analog
      (VAS), five minutes after the procedure.Correlations of the pain's score with clinical
      factors as age, parity, BMI, hysterometry, previous vaginal delivery were also performed.
    

Intervention name(s): Application of the Visual Analog Scale of pain; Evaluation of blood pressure; Evaluation of radial pulse
Intervention type(s): Behavioral; Procedure; Procedure
Intervention description(s): Evaluation of pain previous and 5 minutes after outpatient insertion of IUD / IUS using the Visual Analog Scale of Pain; Evaluation of Blood pressure ( mmHg), previous and 5 minutes after outpatient insertion of IUD / IUS by sphygmomanometer.; Evaluation of radial pulse (beats per minute) previous and 5 minutes after outpatient insertion of IUD / IUS by pulse oximetry
Other intervention name(s): VAS; BP evaluation; Pulse evaluation
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Women that attended to clinical visit to insertion of IUD
      
Keywords: Contraception; Contraception Behavior; Intra uterine device; Intra uterine System; IUD; IUS; Acute Pain
Transversus Abdominis Plane Block For Renal Transplant Recipients
Condition: Disorder Related to Renal Transplantation; Pain
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the efficacy of a local anaesthetic injection in the
      plane between the abdominal muscles in reducing the amount of pain relief required after
      surgery.
    

Detailed description: 
      The aim of this study is to evaluate the efficacy of transversus abdominis plane block in
      reducing the morphine requirements after renal transplantation.
    

Intervention name(s): TAP block; TAP block with placebo
Intervention type(s): Procedure; Procedure
Intervention description(s): TAP block using 20 ml of a local anaesthetic agent will be used in the treatment group; TAP block using a placebo after induction of anaesthesia
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: transversus abdominis plane block; relief
Efficacy and Safety Study of ELND005 as a Treatment for Agitation and Aggression in Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease; Psychomotor Agitation; Aggression
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary purpose of this study is to determine whether ELND005 is effective in treating
      symptoms of agitation and aggression in patients with Alzheimer's disease
    


Intervention name(s): ELND005; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Scyllo-inositol
Intervention MeSH terms: Inositol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Agitation; Aggression; patients
Effectiveness of a 12 Week Theory Driven Intervention Promoting Adherence to the MIND Diet
Condition: Cognitive Change
Study type: Interventional

Summary: 
      This study aims to test the feasibility and acceptability of a 12 week online dietary
      promoting MIND diet behaviour. This study also tests the effectiveness of the MIND diet on
      cognitive function, mood, quality of life and participants capability, opportunity and
      motivation towards adoption of the MIND diet.
    

Detailed description: 
      This study is a randomized controlled prospective follow up study, condition (control Vs
      intervention) x time(baseline Vs follow up) ANOVA with repeated measures design. Outcome
      measures for COM-B, cognitive function, mood and quality of life were recorded for both the
      intervention and control groups. With power set at .80, and alpha = .05, G*Power indicated
      that a sample size of 36 would be required. Forty-one participants took part in the study.
      Participants were healthy male, and female aged between 40-55 years old living in Northern
      Ireland.

      There are 2 intervention arms and one control group. The intervention was designed using the
      Behaviour Change Wheel, with prior qualitative research informing the intervention.

      All statistical analyses were performed using the Statistical Package for the Social Sciences
      (SPSS) with significance set at P < 0.05 throughout
    

Intervention name(s): MIND diet; MIND diet with no support
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 12 week MIND diet study: Participants access a website that is theory driven using the Behaviour Change Wheel to help motivate and promote MIND diet adherence. Participants are to consume MIND diet foods daily and meet MIND diet weekly recommendations; Participants are to consume MIND diet food recommendations over a 12 week period with no support except for a self-monitoring resource and MIND diet guidelines
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: This study includes 2 intervention arms and one control group
Masking: None (Open Label)
Primary purpose: Prevention
Actigraphy Sleep Parameters in Obstructive Sleep Apnea Patient's
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Those patient's that come to the sleep unit and that accept to participate in the study will
      undergo a polysomnography with the extra of an actigraphy placed in their no dominant arm
      wrist. The outcomes that will be analyzed are:

      Time in bed, assumed sleep time, wake time, sleep efficiency, sleep latency, light's
      on/light's off
    


Intervention name(s): Polysomnography; Actigraphy
Intervention type(s): Device; Device
Intervention description(s): Patient's undergo a polysomnography; Patient's wear an actigraphy while doing the polysomnography
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Actigraphy; Polysomnography; Obstructive Sleep Apnea
Prevention With Oleanolic Acid of Insulin Resistance
Condition: Insulin Resistance; Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Insulin Resistance; Syndrome
Study type: Interventional

Summary: 
      Oleanolic acid (OA), a triterpene that is highly present in olive leaves, has been proposed
      as component of functional foods in the prevention of metabolic syndrome due to its
      anti-inflammatory activity. In this research project we will study the presence of OA in
      postprandial TRL in healthy adolescents and in normal weight. Moreover, THP-1 macrophages
      will be incubated with LPS for 48h after pretreatment with OA at different concentrations.
      Also, TRL will be isolated from healthy adolescents before and 2 and 5h postprandially after
      the intake of a meal containing the functional olive oil or common olive oil and incubated
      with THP-1 macrophages.
    


Intervention name(s): Functional olive oil; Olive oil
Intervention type(s): Other; Other
Intervention description(s): Eleven adolescents will consume OA-enriched functional olive oil. After eating the olive oil, aliquots of cubital blood will be drawn at 2 and 5 hours of the postprandial period. During that time, free access to water intake will be allowed.; Eleven adolescents will consume olive oil. After eating the olive oil, aliquots of cubital blood will be drawn at 2 and 5 hours of the postprandial period. During that time, free access to water intake will be allowed.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
rTMS in the Treatment of PTSD
Condition: Post-traumatic Stress Disorder (PTSD)
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The purpose of this study is to assess the effects of repetitive transcranial magnetic
      stimulation (rTMS) in civilian patients with a confirmed diagnosis of post-traumatic stress
      disorder (PTSD). This research study will determine whether low-frequency (1 Hertz [Hz]) or
      high-frequency (10 Hz) rTMS over the right dorsolateral prefrontal cortex (DLPFC) has an
      effect on symptoms of PTSD compared to sham rTMS treatment.
    


Intervention name(s): rTMS
Intervention type(s): Device
Intervention description(s): Magstim Super Rapid-2
Other intervention name(s): repetitive transcranial magnetic stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Post-traumatic stress disorder; Repetitive transcranial magnetic stimulation; Civilians; Neurostimulation; Dorsolateral prefrontal cortex
Effect of Cherry Powder Supplementation on Vascular Function
Condition: Healthy
Study type: Interventional

Summary: 
      Examining the effect of four weeks of cherry powder supplementation on flow mediated
      dilatation
    


Intervention name(s): Cherry powder; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
The Safety and Efficacy of Sublingual/Oral Immunotherapy for the Treatment of Milk Protein Allergy
Condition: Milk Allergy
MeSH terms: Hypersensitivity; Milk Hypersensitivity
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to determine if small oral and sublingual doses of milk protein
      are safe and effective in decreasing sensitivity to cow's milk in allergic children.
    


Intervention name(s): Milk Protein Extract Immunotherapy goal of 4mg/day; Milk Protein Extract Immunotherapy goal of 7mg/day; Milk Powder Immunotherapy goal dose 2000 mg/day; Milk Powder Immunotherapy goal dose 1000mg/day
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Sublingual extract given daily in escalating doses with goal of 4 mg/day for approximately 20 weeks.; Sublingual extract daily in escalating doses to goal of 7mg/day for approximately 1 1/2 years.; Milk powder given orally in escalating doses with a goal dose of 2000mg/day given for approximately 1 1/2 years.; Milk powder given orally in escalating doses with a goal of 1000mg/day for approximately 1 1/2 years.
Intervention MeSH terms: Immunomodulating Agents; Immunologic Factors; Caseins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Food Allergy; Oral Immunotherapy; Immunoglobulin E
Rituximab and Combination Chemotherapy in Treating Patients With Relapsed or Refractory Large Cell Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill
      them or deliver cancer-killing substances to them without harming normal cells. Drugs used in
      chemotherapy use different ways to stop cancer cells from dividing so they stop growing or
      die. Combining combination chemotherapy with monoclonal antibody therapy may kill more cancer
      cells.

      PURPOSE: Phase II trial to study the effectiveness of rituximab and combination chemotherapy
      in treating patients who have relapsed or refractory large cell lymphoma.
    

Detailed description: 
      OBJECTIVES: I. Determine the complete response rate in patients with relapsed or refractory
      CD20-positive diffuse large cell, immunoblastic, or anaplastic large cell lymphoma treated
      with cytoreduction and mobilization with rituximab, ifosfamide, carboplatin, and etoposide
      (RICE). II. Assess the ability of this regimen to deplete the stem cell harvest of B-cells
      and tumor cells in these patients. III. Assess the efficacy of this regimen to mobilize
      peripheral blood progenitor cells in these patients. IV. Assess the safety and toxicity of
      this regimen in these patients.

      OUTLINE: Cytoreduction and mobilization: Patients receive ifosfamide IV over 24 hours and
      carboplatin IV on day 4 and etoposide IV over 1 hour on days 3-5. Chemotherapy repeats every
      2 weeks for 3 courses. Patients receive rituximab IV on day -2 before initiation of
      chemotherapy and on day 1 of each course of chemotherapy. Patients receive filgrastim (G-CSF)
      subcutaneously (SC) daily on days 7-14 of each course of chemotherapy. Patients with complete
      or partial response after completion of course 3 continue to receive G-CSF SC daily until
      peripheral blood stem cells (PBSC) are harvested. When blood counts recover, PBSC are
      harvested and selected for CD34+ cells. If sufficient numbers of CD34+ cells are not
      obtained, patients undergo bone marrow harvest.

      PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study within 2 years.
    

Intervention name(s): filgrastim; rituximab; carboplatin; etoposide; ifosfamide
Intervention type(s): Biological; Biological; Drug; Drug; Drug
Intervention MeSH terms: Rituximab; Carboplatin; Etoposide; Ifosfamide
Primary purpose: Treatment
Keywords: recurrent adult diffuse large cell lymphoma; recurrent adult immunoblastic large cell lymphoma; anaplastic large cell lymphoma
Comparison of Two KADIAN 10 mg Capsules to a KADIAN 20 mg Capsule Under Fasted Conditions
Condition: Healthy
MeSH terms: Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this single-dose, open-label, randomized, two-treatment, two-period
      crossover study was to compare the relative bioavailability of a test formulation of KADIAN
      (2 x 10 mg) capsules manufactured by Alpharma Inc. to an equivalent oral dose of the
      commercially available reference product, KADIAN (1 x 20 mg)capsules manufactured by Alpharma
      Branded Products Inc. following an overnight fast of at least 10 hours.
    


Intervention name(s): morphine sulfate extended-release capsules; KADIAN (morphine sulfate extended-release) capsules
Intervention type(s): Drug; Drug
Intervention description(s): 2 x 10 mg, single-dose capsule; 1 x 20 mg, single-dose capsule
Other intervention name(s): Treatment A; Test product; Treatment B; Reference product
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: bioequivalence; 10 mg; KADIAN capsules; 20 mg; under fasted conditions
Reliability and Validity of Online Cognitive Assessments
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the concurrent validity (correlation coefficient of
      scores at 1 time point) between the Brain Performance Test (BPT, Lumos Labs, Inc.) and a
      validated third party computerized assessment.
    

Detailed description: 
      Each subject will complete two sessions, each approximately 1 hour in total duration,
      approximately 2 weeks apart for a total duration of participation of 2 hours over 2 weeks
    

Intervention name(s): Brain Performance Test (BPT, Lumos Labs, Inc); Computerized Assessment
Intervention type(s): Other; Other
Intervention description(s): A brief, repeatable, online battery of cognitive assessments used to measure functioning in five cognitive domains across time.; a validated, computerized cognitive assessment tool
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: cognitive assessment; Brain Performance Test; Lumosity; concurrent validity; computerized assessment