bioihbjkbjnl/mcl2 huggingface dataset:
Inactivated Influenza Via Jet Injection
Condition: Influenza, Human
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if the administration of flu vaccine using
      Needle-Free is equivalent to Needle and Syringe administration as measured by laboratory
      tests of immune response.
    

Detailed description: 
      Primary:

      To evaluate the non-inferiority of flu vaccine administered by needle-free intramuscular (IM)
      injection versus needle and syringe IM injection as determined with serum hemagglutination
      inhibition (HAI) reciprocal titers in healthy adults between 18-64 years.

      Secondary:

      To compare tolerability and safety of the vaccine in the same population based on
      specifically solicited local and systemic reactions occurring through 7 days
      post-immunization and adverse events spontaneously reported through approximately 28 days
      post immunization.
    

Intervention name(s): Influenza Vaccine
Intervention type(s): Biological
Intervention description(s): Influenza Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Needle Free, Influenza
Comparative Oral Bioavailability Study of MT-1303
Condition: Relapsing-remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the comparative oral bioavailability of a Formulation
      B versus the Formulation A of MT-1303.
    


Intervention name(s): MT-1303-FormA; MT-1303-FormB
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,6 Month Schedule
Condition: Hepatitis B; Hepatitis A
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to evaluate the long-term persistence of hepatitis A and B
      antibodies at Years 6, 7, 8, 9 and 10 after subjects received their first two doses primary
      vaccination schedule of combined hepatitis A/hepatitis B vaccine.

      This protocol posting deals with objectives & outcome measures of the extension phase at year
      6 through to 10.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    

Detailed description: 
      To evaluate the long-term antibody persistence, volunteers will be bled at Years 6, 7, 8, 9
      and 10 after the first vaccine dose of the primary vaccination course to determine their
      anti-HAV and anti-HBs antibody concentrations.

      If a subject has become seronegative for anti-HAV antibodies or lost anti-HBs seroprotection
      concentrations at the long-term blood sampling time point (i.e. Years 6, 7, 8, 9 or 10), he/
      she will be offered an additional vaccine dose.
    

Intervention name(s): TWINRIX™ ADULT; Engerix TM
Intervention type(s): Biological; Biological
Intervention description(s): 2 doses IM injection in primary study; If a subject has become seronegative for anti-HAV antibodies or lost anti-HBs seroprotection concentrations at the long-term blood sampling time point (i.e. Years 6, 7, 8, 9 or 10), he/ she will be offered an additional vaccine dose.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Hepatitis A; Hepatitis B; TWINRIX™ ADULT
Magnetic Resonance Imaging (MRI) and Decline of Aging Aviator Performance
Condition: Age-related Cognitive Decline
MeSH terms: Cognitive Dysfunction
Study type: Observational

Summary: 
      The primary purpose of this study is to apply state-of-the-art Magnetic Resonance Imaging
      (MRI) and Magnetic Resonance Spectroscopic Imaging (MRSI) techniques to measure changes over
      time in the brain.
    

Detailed description: 
      We expect that MRI and MRSI techniques will be a useful adjunct in research efforts to
      understand individual differences in performance of a complex attention-demanding task, such
      as flying a plane or driving a car. Other predictors of change in performance of a complex
      task may include simple tests of processing speed and working memory, past training and
      recent practice of the task, and genetic risk factors for degenerative brain disease. In this
      project, we will examine whether baseline MR measures are as useful as longitudinal MR
      measures in predicting amount of change over time in task performance.

      This research is part of a long-term effort to achieve earlier identification of individuals
      at risk of decline and ultimately minimize loss of function.
    

Intervention name(s): MRI
Intervention type(s): Device
Intervention description(s): MRI - routine imaging sequences, designed for anatomical quantification
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        active healthy pilots
      
Biospecimen description: 
      frozen genomic DNA
    
Keywords: Cognitive Aging; Apolipoproteins E; Magnetic Resonance Imaging
Nutritional Supplementation in Adults With Chronic Respiratory Disease
Condition: Malnutrition; Pulmonary Disease, Chronic Obstructive; Other Pulmonary Disease, Chronic Obstructive
MeSH terms: Lung Diseases; Pulmonary Disease, Chronic Obstructive; Respiratory Tract Diseases; Respiration Disorders; Malnutrition; Chronic Disease
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether nutritional support with a complete formula
      is effective to improve malnutrition and respiratory function in patients with chronic
      pulmonary disease compared to the standard hospital dietary advise.
    

Detailed description: 
      This is a unicenter, controlled, randomized, prospective, parallel-group, open-label study to
      evaluate the effect of a nutritional formula on nutritional status, pulmonary function and
      quality of life. Adult patients will be randomized to receive the nutritional formula or to
      follow the standard hospital' dietetic recommendations during 12 weeks.
    

Intervention name(s): Complete enteral formula; Dietary Advise
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Product: Complete nutritional formula in powder enriched with key nutrients to be administered orally (200 ml of water per 57 g product).
Time of intervention: 3 months.; Patients will receive the usual dietary advise in these patients according hospital clinical practice .
Other intervention name(s): Vitafos; Vitafos Adultos; Vitafos Vainilla
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Malnutrition; Dietary supplement; Nutritional supplement; Complete enteral formula; COPD
A Study to Evaluate the Safety and Tolerability of Using the SHR-1210 in Patients With Advanced Melanoma
Condition: Advanced Melanoma
MeSH terms: Melanoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single center, non-randomized, dose escalation phase I trial to
      evaluate safety and tolerability of SHR-1210 (camrelizumab) in patients with advanced
      melanoma with disease progression after standard treatment, unresectable lesions, or
      metastases. Between Apr 13, 2016, and Jan 8, 2020, 36 patients were enrolled from Beijing
      Cancer Hospital.
    


Intervention name(s): SHR-1210
Intervention type(s): Biological
Intervention description(s): A fully human monoclonal immunoglobulin (IgG4 subtype)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PD-1/PD-L1 Advanced Melanoma Immunotherapy
Epidemiology of Human Papillomavirus Infection Among Women Living on the Maroni and the Oyapock Rivers
Condition: Human Papillomavirus Viruses
Study type: Observational

Summary: 
      Cervical cancer is the second most frequent cancer of women in French Guiana. Studies have
      shown that populations living in remote villages in the interior of the territory have early
      sexual relations and that multiple sexual partnerships are frequent. Hence, the main
      objective of the study was to determine the prevalence of HPV in these areas, and the
      predictive factors and epidemiology of this viral infection.

      Methods - This multicentric cross sectional study aimed the population of women aged 20 to 65
      years, living in the remote villages along the Maroni and Oyapock rivers. Women wishing to
      participate will be included after being informed of the study team schedule through radio
      address and key opinion leaders. The search for HPV and cytologic examinations will be
      performed for each woman. 2 samples will be taken from each woman: one sample will be sent to
      Fort De France hospital for cytology, and HPV testing; cytologic analyses will be performed
      using the 2001 Bethesda classification. Another sample will be sent to Pasteur Institute in
      Cayenne for sequencing and detection of E6 and E7 RNA which are associated with
      carcinogenesis. HPV infection will be defined by the detection of viral DNA using the
      GREINER-BIO-ONE kit. Statistical analysis of the results will use STATA software and mapping
      will use Mapinfo.
    


Intervention name(s): Cervico-Vaginal Smears analysis
Intervention type(s): Other
Intervention description(s): Cervico-Vaginal Smears analysis
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        women from 20 to 65 years living on the Maroni and the Oyapock rivers having already had
        sexual intercourse
      
Biospecimen description: 
      Cervico-Vaginal Smears
Flumazenil Reversal of Oral Triazolam
Condition: Dental Anxiety
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      An increase in the utilization of anesthesia and sedation medications by
      non-anesthesiologists, including dentists, has grown dramatically. This has been prompted, in
      part, by the need for pharmacological tools to address high levels of fear and anxiety about
      dental care among the US population and the evidence of oral health disparities among those
      who are fearful . Given the prevalence of dental fear in the general population and in the
      various populations with the greatest burden of oral diseases, effective sedation techniques
      are needed that are safe and effective in the hands of general dentists that make up the
      "front line" in the efforts to reduce oral health disparities. This study is to determine
      whether, when compared to a saline placebo, a single intraoral submucosal administration of
      the benzodiazepine antagonist flumazenil (0.2 mg) is capable of attenuating in 10 minutes or
      less the central nervous system (CNS) depression produced by a paradigm of stacked sublingual
      dosing of triazolam (3 doses of 0.25 mg over 90 minutes).
    


Intervention name(s): Flumazenil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2 mL, 0.2 mg SM; 2 mL sterile saline SM
Intervention MeSH terms: Flumazenil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: conscious sedation; dental anxiety/drug therapy; behavior/drug effects
Remediation of Emotional Processing Deficits in MS
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      This study will test the effectiveness of an emotional processing intervention in individuals
      with MS in a double blind placebo controlled randomized clinical trial. We will utilize an
      intervention which has been successfully used in other populations, including Schizophrenia
      and Traumatic Brain Injury. Our pilot data shows that this intervention is effective in
      individuals with MS as well
    

Detailed description: 
      This study will test the effectiveness of an emotional processing intervention in individuals
      with MS in a double blind placebo controlled randomized clinical trial RCT). We will utilize
      an intervention which has been successfully used in other populations, including
      Schizophrenia and Traumatic Brain Injury. Our pilot data shows that this intervention is
      effective in individuals with MS, as well.

      All participants will undergo a baseline evaluation assessing emotional processing abilities,
      cognitive functioning, and psychological functioning. Participants will then be randomized
      into two groups. During the treatment phase, the experimental group will receive the proposed
      intervention while the control group will receive a "placebo" treatment. Neuropsychological
      assessment will be repeated at the end of the intervention.
    

Intervention name(s): Emotional Processing Training; Placebo control exercises
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants in the experimental group will receive computerized exercises administered on a laptop computer. They will undergo 12 sessions of 45-60 minutes each (twice a week for 6 weeks).; Participants in the control group will receive computerized control exercises administered on a laptop computer. They will undergo 12 sessions of 45-60 minutes each (twice a week for 6 weeks).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: emotional processing; multiple sclerosis; cognition
Efficacy in Reducing Fractures and Safety of Zoledronic Acid in Men With Osteoporosis
Condition: Male Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will investigate if the drug zoledronic acid given once yearly is safe and has
      beneficial effects in treating osteoporosis by reducing bone loss and fractures in men with
      osteoporosis.
    


Intervention name(s): Zoledronic acid 5 mg iv; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Zoledronic acid 5 mg iv given once a year.; Placebo intravenous (i.v.) once a year
Other intervention name(s): Aclasta,; Reclast
Intervention MeSH terms: Zoledronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Osteoporosis; males; vertebral fractures; clinical fractures; bone mineral density; bone biomarkers; zoledronic acid
Reduction of Pro-Inflammatory Synovial Fluid Biomarkers in Osteoarthritis of the Knee With Alpha-2 Macroglobulin
Condition: Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the current study is to assess the ability of alpha-2-macroglobulin treatment
      to reduce the level of pro-inflammatory synovial fluid biomarkers in patients with
      osteoarthritis of the knee.

      This is a double-blinded rationalized control trial with prospective data collection. The
      study will collect and analyze the synovial fluid, serum, and urine of patients presenting
      with knee osteoarthritis in Kellegren-Lawrence grade 2 or 3. It will compare synovial fluid
      biomarker levels between patients receiving an intra-articular alpha-macroglobulin,
      intra-articular PR injection and intra-articular corticosteroid serving as a control.
      Pre-injection pain and function will be assessed. Post-injection pain, function and outcomes
      will be assessed after six weeks and three months.
    


Intervention name(s): synovial fluid biomarker concentrations
Intervention type(s): Biological
Intervention description(s): Synovial fluid samples will be obtained pre-injection, Post Injection 3 Weeks, Post Injection 6 Weeks, Post Injection 9 Weeks, Post Injection 3 Months, Post Injection 6 Months, Post Injection phone call at 1 Year
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Paleo Diet 8wk Feasibility in Overweight Adults
Condition: Overweight and Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Overweight, physically inactive but otherwise healthy adults habitually eating a traditional
      Western diet will follow an ad libitum self-administered Paleo diet for 8-weeks. Blood and
      body composition will be measured before and after the intervention period.
    

Detailed description: 
      The Paleo diet is a dietary method that is gaining popularity among the general population
      due to potential weight loss and disease prevention benefits. The feasibility of the Paleo
      diet and the effectiveness of self-administration in improving cardiometabolic disease risk
      factors remains uncertain. Examination od cardiometabolic disease risk factors in overweight,
      physically inactive adults before and after 8-weeks of an ad libitum self-administered Paleo
      dietary intervention. Methods: Overweight, physically inactive but otherwise healthy adults
      habitually eating a traditional Western diet follow an ad libitum self-administered Paleo
      diet for 8-weeks. Blood samples were analyzed for fasting cardiometabolic disease biomarkers.
      Participants complete three-day dietary recalls prior to, and during weeks 4 and 8 of the
      intervention to confirm Western diet consumption at pre-, track compliance, and to assess
      dietary changes.
    

Intervention name(s): Diet
Intervention type(s): Other
Intervention description(s): Participants provided with a brochure providing a thorough description of the diet, ~8 example recipes for each meal (i.e. breakfast, lunch, dinner, and snacks) included as a sample menu, and guidance to assist in shopping and self-preparation of food for the prescribed diet and to improve adherence. Diet consisted of following the popular "paleolithic" diet
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Effects of Food on Oxycodone Pharmacokinetics in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To estimate the effect of food on the pharmacokinetics and relative bioavailability of
      oxycodone following oral administration of single 40 mg doses of PF 00345439 Formulation K
      taken whole or after chewing in healthy volunteers. We have described below the two cohorts
      each with two arms in this crossover study by listing them as four Arms/Groups in order to
      capture the differences between the cohorts prior to the crossover and after the crossover.
      14 participants are planned for the first cohort and 18 participants are planned for the
      second cohort.
    


Intervention name(s): Oxycodone; Oxycodone; Oxycodone; Oxycodone
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): One capsule of 40 mg PF-00345439 Formulation K, taken whole, single dose, under fasting conditions; One capsule of 40 mg PF-00345439 Formulation K, taken whole, single dose, under fed conditions; One capsule of 40 mg PF-00345439 Formulation K, Chewed, single dose, under fasting conditions; One capsule of 40 mg PF-00345439 Formulation K, Chewed, single dose, under fed conditions
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: pharmacokinetics; relative bioavailability; food effects; oxycodone
A Relative Bioavailability Study of Two Formulations of BCX7353
Condition: Hereditary Angioedema
MeSH terms: Angioedema; Angioedemas, Hereditary
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, randomized study to investigate the relative bioavailability of two
      formulations of BCX7353 and to determine if there is a food effect
    

Detailed description: 
      In this study, 24 healthy subjects will be randomized to receive a single dose of two
      formulations of BCX7353 and one of the formulations administered with a high-fat meal. A
      14-day washout period will separate each dose.
    

Intervention name(s): BCX7353
Intervention type(s): Drug
Intervention description(s): BCX7353
Intervention MeSH terms: Berotralstat
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Three way crossover to evaluate two formulations of BCX7353 and to determine if there is a food effect
Masking: None (Open Label)
Primary purpose: Treatment
Lurtotecan Liposome in Treating Patients With Advanced Solid Tumors
Condition: Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase I trial to study the effectiveness of lurtotecan liposome in treating patients
      who have advanced solid tumors.
    

Detailed description: 
      OBJECTIVES: I. Determine the maximum tolerated dose (MTD) and the future dose of lurtotecan
      liposome in patients with advanced solid tumors. II. Assess the toxicity and pharmacokinetics
      of this treatment regimen in this patient population. III. Assess the response to this
      regimen by patients with measurable disease.

      OUTLINE: This is a dose escalation, multicenter study. Patients receive lurtotecan liposome
      (NX211) IV over 30 minutes on days 1, 2, and 3. Courses are repeated every 3 weeks. Treatment
      continues for up to 6 courses in the absence of unacceptable toxicity or disease progression.
      The dose of NX211 is escalated in cohorts of 3-6 patients until the maximum tolerated dose
      (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients
      experience dose limiting toxicity. Patients are followed at 4 weeks and every 3 months for 1
      year.

      PROJECTED ACCRUAL: A total of 20-25 patients will be accrued for this study within 12-15
      months.
    

Intervention name(s): lurtotecan liposome
Intervention type(s): Drug
Intervention MeSH terms: Lurtotecan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: unspecified adult solid tumor, protocol specific