bioihbjkbjnl/mcl2 huggingface dataset:
Immunogenicity and Reactogenicity of a Meningococcal B Outer Membrane Vesicle Vaccine Given in a 0,6,12 Month Schedule to Health UK Adults
Condition: Neisseria Meningitidis
Study type: Interventional
Phase: Phase 2

Summary: 
      To measure the serum bactericidal antibody levels and cell mediated immune responses before
      and six weeks after each dose of meningococcal outer membrane vesicle vaccine given at 0,6
      and 12 weeks to healthy UK adults.
    


Intervention name(s): Meningococcal outer membrane vesicle vaccine "MenBVac"
Intervention type(s): Biological
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Restorative Exercise for Strength Training and Operational Resilience (RESTORE) for Chronic or Recurrent Low Back Pain
Condition: Lower Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of the study is to learn about the effect of integrative therapies on chronic or
      recurrent low back pain.

      The intervention called RESTORE (Restorative Exercises for Strength Training and Operational
      Resilience) is based on a series of gentle stretching and strengthening exercises
      incorporating breath-work and mindfulness. The study is designed to discover the impact of
      RESTORE on pain levels, physical function, and behavioral health.
    


Intervention name(s): RESTORE Intervention
Intervention type(s): Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Pharmacogenomic Evaluation of Antihypertensive Responses in Induced Pluripotent Stem (iPS) Cells Study
Condition: Hypertension
MeSH terms: Hypertension
Study type: Observational

Summary: 
      Patients enrolled in this study will have completed one of the parent studies
      "Pharmacogenomic Evaluation of Antihypertensive Responses" (PEAR-1 or PEAR-2) evaluating how
      well their blood pressure was controlled by medication. Patients in the current study will
      provide a single tube of blood which will be used to create adult stem cells that can be
      converted into other cell types, like heart or vasculature. Patients will not be asked to
      return for any follow up visits.
    

Detailed description: 
      If the patient decide to participate in this study, they will have 1 visit for the study that
      will include a blood draw. Upon arrival to the clinic, the study will be explained to the
      patient in detail. The patient will be asked at that time to sign this consent form. The
      patient will have the opportunity to ask questions and the research staff will answer those
      questions. If the patient decides to participate in this study and sign a consent form, then
      a blood sample will be collected from a vein in the arm. A total of 2 teaspoons full of blood
      will be drawn for the study.

      During this visit, in addition to collecting a blood sample, patients will be asked about
      their medical history and medications they are currently taking, and will have their vital
      signs assessed, including blood pressure, pulse, and temperature.

      Blood will be drawn by a trained nurse or a phlebotomist at a family medicine clinic in
      Gainesville, Florida. The blood sample will be further processed in laboratories at the
      University of Florida, for the establishment of iPS cells. iPS cells will retain the
      patient's genetic makeup which makes them useful for research. Several experiments will be
      conducted on these cells that will provide data that can be used to learn more about how
      genetic markers can lead to differences in blood pressure response to medicines. These cells
      will be used for up to 8 years.
    

Intervention name(s): iPSC
Intervention type(s): Genetic
Intervention description(s): Single blood draw for the production of induced pluripotent stem cells.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Study participants recruited from the Pharmacogenomic Evaluation of Antihypertensive
        Responses studies; PEAR (#201-2005) and PEAR-2 (#271-2010) funded by the National
        Institutes of Health. Participants in the study have completed either PEAR or PEAR-2
        studies
      
Biospecimen description: 
      Induced Pluripotent Stem Cells (iPS cells)
    
Keywords: Hypertension
Positron Emission Tomography Study Using 2-[18F]-F-A85380 to Determine α4β2 Neuronal Nicotinic Receptor Occupancy of AZD3480 After Oral Administration to Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is being performed in order to learn more about AZD3480 (potential as treatment for
      patients with Alzheimer's Disease) and to investigate how much of AZD3480 is bound to the
      nicotinic receptors in the brain at different concentrations of AZD3480 in blood, as well as
      to investigate the period of time for this binding.
    


Intervention name(s): AZD3480; 2-[18F]-F-A85380
Intervention type(s): Drug; Radiation
Intervention description(s): single dose, oral; Single dose, IV
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PET; AZD3480; PET examination
Effect of Korean Red Ginseng (KRG) on Dry Mouth
Condition: Xerostomia
MeSH terms: Xerostomia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the effect of KRG (Korean Red Ginseng) on Dry Mouth
      (Xerostomia).
    

Detailed description: 
      Korean Red Ginseng

        -  Worldwide use

        -  A main herb of old oriental prescriptions for dry mouth

        -  Need for correct information by RCT
    

Intervention name(s): Korean Red Ginseng Powder Capsule; Corn-starch powder with ginseng flavor
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Generic name: Korean Red Ginseng Powder Capsule Original herb name: Panax ginseng Form and contents: Capsule with powder of steamed root of 6-year Panax ginseng Dosage and frequency: 6 g per day (twice a day), Oral administration Administration duration: 56 days in the study; There is no specific name because this intervention is placebo. This placebo has the same form, color and flavor as Korean Red Ginseng Powder Capsule.
The dosage form, dosage, frequency and duration is also same as experimental intervention (Korean Red Ginseng Powder Capsule).
Main contents: corn-starch with Panax ginseng flavor
Other intervention name(s): Brand Name: Korean Red Ginseng Powder Capsule; Corn-starch powder capsule with Korean Red Ginseng flavor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Xerostomia; Panax ginseng(Korean Red Ginseng); Visual Analogue Scale; Salivary Flow Rates
Impact of COVID-19 Pandemic on Hepatopancreatobiliary Surgical Services in Singapore
Condition: COVID-19; Surgery
MeSH terms: COVID-19
Study type: Observational

Summary: 
      This paper is intended to report our observational study in evaluating the impact of the
      COVID-19 pandemic on Tan Tock Seng Hospital hepatopancreatobiliary unit's surgical workload
      from January to June across 2019 to 2022, corresponding to the pre-pandemic baseline to its
      peak and the gradual normalization of hospital services as Singapore entered the transition
      phase to COVID-19 resilience.
    

Detailed description: 
      This paper is intended to report our observational study in evaluating the impact of the
      COVID-19 pandemic on Tan Tock Seng Hospital hepatopancreatobiliary unit's surgical workload
      from January to June across 2019 to 2022, corresponding to the pre-pandemic baseline to its
      peak and the gradual normalization of hospital services as Singapore entered the transition
      phase to COVID-19 resilience.

      A comparative audit of the unit's surgical workload for the months of January-June across
      2019 to 2022, which corresponded to pre-COVID-19, the height of the pandemic, and a gradual
      normalization of surgical services. Operations performed by the unit were collected from the
      surgeons' electronic case logs. These operations were sorted based on the Singapore Ministry
      of Health's table of surgical procedures, which assigns charge codes to different procedures.
      The retrospective data across the 4 years were compared and analysed.

      No patient contact or identifiers were retrieved, stored or disseminated and thus exempt from
      ethics board review.
    

Intervention name(s): COVID-19 pandemic
Intervention type(s): Other
Intervention description(s): To retrospectively review the surgical volume across 2019-2022 to see the impact of the COVID-19 pandemic.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All patients who underwent gallbladder, hernia, liver or pancreas resection surgeries
        during the periods of January to June of 2019/2020/2021/2022.
Clinical Immunization Safety Assessment (CISA) Project: Pilot Study to Assess the Effect of Prophylactic Antipyretics on Immune Responses and Fever After IIV
Condition: Fever
MeSH terms: Fever
Study type: Interventional
Phase: Phase 4

Summary: 
      The study team aims to conduct a double-blind, placebo-controlled, pilot study to assess the
      effect of prophylactic antipyretics on the immune responses and rates of fever after
      inactivated influenza vaccine (IIV) in children 12 through 35 months of age. In this pilot,
      40 healthy children, 12 through 35 months of age, including some children at risk of febrile
      seizure, will be randomized to receive prophylactic acetaminophen or oral placebo immediately
      following and every 4 to 6 hours in the 24 hours after receipt of a dose of IIV. Data derived
      from the pilot study will be used to assess the feasibility of conducting a larger scale
      study. Feasibility will include assessments of the speed and ease of study recruitment and
      adherence to and completion of study assessments. Children will be followed for the
      occurrence of fever, fussiness, changes in appetite and sleep patterns, and use of medical
      services on the day of and day following vaccination. Antibody to influenza antigens
      contained in the 2013-2014 vaccine as measured by hemagglutination inhibition (HAI) antibody
      will be assessed at baseline and four weeks following vaccination. The proportions of
      children experiencing fever, having solicited reactions, using medical services,
      demonstrating a serologic response corresponding to seroprotection and seroconversion to each
      of the IIV antigens will be determined for groups of children receiving acetaminophen and
      placebo. Likewise geometric mean HAI titers (GMT) and corresponding 95% confidence intervals
      for each IIV antigen will be calculated for both vaccine groups.
    


Intervention name(s): Acetaminophen; Placebo
Intervention type(s): Other; Other
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: fever; antipyretics; acetaminophen; influenza vaccine; influenza, human; body temperature changes; Orthomyxoviridae Infections; RNA virus infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases
Kochujang, a Fermented Soybean-based Red Pepper Paste, Decreases Visceral Fat and Improves Blood Lipid Profiles in Overweight Adults
Condition: Overweight
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 2

Summary: 
      With the epidemic of obesity and diabetes growing around the world, Kochujang (KCJ) may be
      potentially effective in preventing and treating obesity and cardiovascular risks if proven
      in humans. However, human trial still have not been reported with KCJ supplementation. In the
      present study, we investigated the hypothesis that KCJ supplementation can be decrease the
      body fat and improve blood lipid profiles in overweight adults.
    

Detailed description: 
      The aim of this study was to evaluate the efficacy of KCJ supplementation on anthropometric
      parameters, visceral fat/subcutaneous fat, and blood lipid profiles in overweight subjects.

      Sixty overweight subjects with BMI >25 kg/m2 and waist-hip-ratio (WHR) ≥ 0.90 for men and ≥
      0.85 for women were randomly assigned to either KCJ supplement (n=30, 32 g/day) or placebo
      (n=30, 32 g/day) group for 12 weeks.
    

Intervention name(s): Kochujang; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Kochujang (32g/day) for 12weeks.; placebo(32g/day) for 12weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Kochujang,; visceral fat; population
Safety Study of Tezepelumab (AMG 157) in Healthy Adults and Adults With Atopic Dermatitis
Condition: Atopic Dermatitis; Healthy Volunteers
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a single dose escalation study of tezepelumab (AMG 157) in healthy adults (Part
      A) and adults with moderate to severe atopic dermatitis (Part B). The purpose of the study is
      to evaluate the safety, tolerability, immunogenicity and pharmacokinetics of tezepelumab.
    


Intervention name(s): Tezepelumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered by subcutaneous or intravenous injection; Matching placebo administered by subcutaneous or intravenous injection.
Other intervention name(s): AMG 157; Tezspire
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Escalating dose cohorts will be enrolled sequentially based on a blinded review of safety data up to day 15 of the previous dose cohort with consideration of predefined stopping rules.
The first 2 participants in Cohort 1 will be a sentinel pair, randomized at a 1:1 ratio to receive either tezepelumab or placebo and monitored for safety and tolerability. Once the safety in the sentinel pair is confirmed the subsequent six participants will be randomized at a 5:1 ratio for tezepelumab or placebo treatment. In cohorts 2 through 8 (escalating doses, healthy subjects), participants will be randomized to receive tezepelumab or placebo at a 6:2 ratio. In cohort 9 (700 mg IV, atopic dermatitis subjects),a sentinel pair will again be used to first establish safety, and the subsequent 10 participants will be randomized to receive tezepelumab or placebo at a ratio of 8:2, for a total of 12 evaluable participants in this cohort.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: atopic dermatitis; skin diseases; healthy volunteer
Bioequivalence Study of Gabapentin 400 mg Capsules Under Fed Conditions
Condition: Healthy
MeSH terms: Disease
Study type: Interventional

Summary: 
      To compare the single-dose oral bioavailability of metformin HCI liquid 500 mg/5 mL of
      Ranbaxy with Glucophage® 1000 mg tablets of Bristol-Myers, USA following administration of a
      1000 mg dose in healthy, adult, male and female volunteers under fasting conditions
    

Detailed description: 
      This was an open-label, randomized, single-dose, 2-way crossover, relative bioavailability
      study performed on 24 healthy adult volunteers and 2 alternates. All 26 subjects completed
      the clinical phase of the study. In each period, subjects were housed from the evening before
      dosing until after the 36-hour blood draw. Single oral 400 mg doses were separated by a
      washout period of 7 days A total of 24 healthy adult volunteers and 2 alternates (17 males
      and 9 non-pregnant females) enrolled in and completed the clinical phase of the study
    

Intervention name(s): 400 mg Gabapentin Capsules
Intervention type(s): Drug
Intervention MeSH terms: Gabapentin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence gabapentin fed conditions
The Effects of Ketamine and Guanfacine on Working Memory in Healthy Subjects
Condition: NMDA Receptor Function
Study type: Interventional

Summary: 
      The purpose of the study is

        1. To establish the feasibility of fMRI studies of the interaction of guanfacine and
           ketamine.

        2. To explore the possibility that guanfacine can ameliorate the negative effects of
           ketamine on task-related prefrontal activation.

        3. To assess the strength of any interaction between guanfacine and ketamine.
    

Detailed description: 
      Potential subjects will be interviewed over the phone and, if appropriate, will be scheduled
      for a screening session. Participants who meet study criteria will participate in two study
      sessions separated by at least two weeks. The sessions will be identical except on one day
      they will receive guanfacine and on the other, they will receive a placebo.

      This study was initially completed in 2014. Upon analysis of the collected data, it was
      decided to add additional subjects and gather additional data to verify results seen in the
      collected data. The study was reopened and new data was added beginning in September 2016.
      Information about the study beginning in 2016 is available in a separate record.
    

Intervention name(s): Guanfacine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be given 3mg of guanfacine before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) will be given during the visual fixation scan. Immediately after completion of the 1 min bolus, the participant will receive a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation will be measured during a spatial working memory task. The entire scan will last approximately two and a half hours and the ketamine infusion will be up to one hour and 15 minutes.; Subjects will be given a placebo before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) will be given during the visual fixation scan. Immediately after completion of the 1 min bolus, the participant will receive a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation will be measured during a spatial working memory task. The entire scan will last approximately two and a half hours and the ketamine infusion will be up to one hour and 15 minutes.
Intervention MeSH terms: Guanfacine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Guanfacine; Ketamine; Functional Magnetic Resonance Imaging; Prefrontal Cortex Activity; Receptors, N-Methyl-D-Aspartate; Receptors, Adrenergic, alpha-2; Memory, Short-Term; Schizophrenia
Bioequivalence Study of Two Finasteride 5 mg Tablet Formulations Under Non-Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to evaluate the relative bioavailability of the test
      formulation of finasteride 5 mg tablets (Dr. Reddy's Laboratories Limited) with the reference
      formulation PROSCAR® 5 mg Tablet (Merck & Co., Inc.)under fed conditions in healthy adult
      male subjects.
    

Detailed description: 
      This randomized, single-dose, two-treatment, two-way, crossover study was conducted to
      compare the relative bioavailability of two formulations of 5 mg finasteride tablets under
      fed conditions. The study was conducted with 26 (24 completed) healthy adults. The subjects
      received the test product in one study period and the reference product in the other period;
      the order of administration was according to the dosing randomization schedule. There was a
      7-day interval between treatments.
    

Intervention name(s): Finasteride
Intervention type(s): Drug
Intervention description(s): Finasteride Tablets 5 mg
Other intervention name(s): Proscar
Intervention MeSH terms: Finasteride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence; Finasteride; crossover
Safety, Tolerability, and Immunogenicity Study of a Cell-based Virosomal Influenza Vaccine in Healthy Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to examine the safety and tolerability after administration of
      trivalent and quadrivalent cell-based virosomal influenza vaccine in healthy adults.
    

Detailed description: 
      This is a double-blind and randomized study in healthy adults. The duration of study will be
      approximately 90 days per participant. The study will include 4 visits: Day 1 (for
      vaccination), Day 4, Day 22 and day 90 (Follow-up visits). Safety and tolerability will be
      assessed by the rate of solicited, unsolicited, and serious adverse events.
    

Intervention name(s): Trivalent virosomal influenza vaccine; Commercial vaccine 1; Quadrivalent virosomal influenza vaccine; Commercial vaccine 2
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Trivalent virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.; Trivalent commercial virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.; Quadrivalent virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.; Quadrivalent commercial influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.
Other intervention name(s): Trivalent FluCell; Inflexal V (trivalent); Quadrivalent FluCell; Fluarix Tetra (quadrivalent)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Healthy participants; Immunogenicity; Influenza; Prevention; Safety