bioihbjkbjnl/mcl2 huggingface dataset:
Surveying Nutrient Assessment With Photographs of Meals (SNAPMe) Study
Condition: Food Characteristics
Study type: Observational

Summary: 
      The SnapMe Study is a single-group, prospective study that requires healthy adults to
      maintain food diaries in order to develop benchmark data for the prediction of food
      characteristics.
    

Detailed description: 
      The purpose of this study is to develop a method that uses photography to accurately
      calculate the types and amounts of nutrients in meals that are consumed by healthy
      participants, thereby replacing the use of electronic food records. Researchers expect about
      100 healthy individuals at UC Davis and around the U.S. will join to participate in this
      research. Participation in this study will involve taking pictures of every meal and snack
      the individual consumes using a smartphone for 3 days (2 weekdays, 1 weekend day) and
      uploading the images to a mobile phone application called Bitesnap. In addition, the
      participant will be asked to complete online food records on the same days using the
      Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24-2020). Each participant
      will have 4 weeks to complete the study. The study website can be viewed here:
      https://snapme.ucdavis.edu/
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy adults living anywhere in the United States of America between the ages of 18 and
        65.
      
Keywords: Artificial intelligence; Dietary records; Food systems; Computer science; Sustainability; Nutrition
The Acute Effect of Two Berry Extracts on Cognition and Mood in Adults Aged 40 to 60
Condition: Ageing
Study type: Interventional

Summary: 
      The first study of my PhD showed that acute supplementation of berry extracts can modulate
      cognitive behaviour in healthy adults. There is a growing body of evidence supporting an
      improvement in memory and learning performance in animal models following the ingestion of
      flavonoid rich fruits (Shukitt-Hale et al 2008;Spencer 2008; Spencer et al., 2008). However,
      study 2, showed no effect on any aspects of memory in healthy young adults after
      supplementation of the berry extracts. It is hypothesised that the lack of behavioural
      effects on memory of the berry juice in study 2 was because of the cohort used. These healthy
      adult participants were already performing near to their peak (Salthouse et al., 2009), and
      unlike study one, participants were not mentally fatigued enough to reveal subtle cognitive
      benefits.

      The aims of the study are to examine if acute supplementation of two berry extracts in an
      older population can augment memory, attention and executive function. Secondly, the time
      course of these behavioural effects will be measured by multiple cognitive assessments
      throughout the day after consumption of the extracts.
    


Intervention name(s): Berry drink; Control; Powdered berry drink
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Cold pressed berry drink standardised to contain 500mg of berry polyphenols; Sugar matched control containing berry flavouring and no phytochemicals; Berry drink made from a powder concentrate standardised to contain 500mg of polyphenols
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Clinical Trial for Malaria Vaccines to Test for Safety, Immune Response and Protection Against Malaria
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to test the safety and effectiveness of a new malaria vaccine,
      the DNA-Ad vaccine. The study is specifically looking at a vaccine regimen against Plasmodium
      falciparum, the most deadly form of malaria.
    

Detailed description: 
      The goal of this study is to evaluate if the DNA-Ad vaccine that targets both the liver and
      blood stages of the malaria life cycle is safe and protective, in hopes to develop a vaccine
      to prevent infection and/or lessen the severity of disease caused by the P. falciparum
      malaria parasite. More specifically, this DNA-Ad vaccine contains a liver stage antigen
      (circumsporozoite protein) and an antigen (apical membrane antigen 1) that is present in both
      the liver and blood stages designed to prevent infection by killing the majority of
      developing parasites in the liver and to prevent severe disease and death should
      break-through blood stage infections occur.

      This study is an open-label, Phase 1/2a study designed to assess the safety, immunogenicity,
      and efficacy of a DNA-Ad vaccine in healthy adults who are Ad5 seropositive or seronegative.
      The vaccinated study group will consist of up to 20 healthy, malaria-naïve adults aged 18 to
      50 years, who have been previously screened to meet inclusion and exclusion criteria and will
      receive three priming doses of the DNA vaccine and a single dose of the boosting component,
      an adenovirus-vectored vaccine to be given 4 months after the last dose of DNA. Follow up
      visits will occur after each immunization. The control group will consist of six
      non-immunized subjects that will participate in a challenge to assure that vaccinated
      subjects were indeed exposed to P. falciparum. Subjects in both the immunized and control
      cohorts will receive malaria challenge. Subjects will be assessed for development of
      parasitemia by daily blood smears and will be closely observed in hotel after the challenge.
      Subjects will then be followed periodically and have the final in-person visit twelve weeks
      after the challenge, followed by annual contact by phone, email, or mailings up to five years
      after the first dose of immunization per FDA recommendation.
    

Intervention name(s): DNA vaccine prime; adenovirus type 5 vaccine boost
Intervention type(s): Biological; Biological
Intervention description(s): 2 mg total dose (1 mg per construct in a volume of 1 mL); 2 x 1010 particle units (pu) (1 x 1010 pu per each of 2 constructs including CSP and AMA1 respectively)
Intervention MeSH terms: Vaccines
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Malaria; Vaccine
Safety and Efficacy of Vyvanse in Adults With Attention-Deficit/Hyperactivity Disorder
Condition: Attention-Deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of this study is to evaluate the maintenance of efficacy, as measured
      by Adult ADHD Rating Scale with Prompts (Adult ADHD-RS with prompts) and Clinical Global
      Impression - Severity (CGI-S) scores, through a randomized withdrawal design when subjects
      with ADHD have been on stable treatment with commercial SPD489 for a minimum of 6 months and
      are maintained on their screening dose of commercial SPD489.
    


Intervention name(s): SPD489 (Lisdexamfetamine dimesylate); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 capsule (either 30, 50, or 70mg strength) per day for 6 weeks.; 1 capsule (identical to drug capsules) per day for 4 weeks during the double blind period.
Other intervention name(s): Vyvanse
Intervention MeSH terms: Lisdexamfetamine Dimesylate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD
Central Nervous System Amplification in Lumbar Failed Back Surgery Syndrome
Condition: Chronic Pain
MeSH terms: Chronic Pain; Failed Back Surgery Syndrome
Study type: Observational

Summary: 
      The purpose of this study is to learn whether or not certain risk factors and patient
      characteristics are linked with and possibly can predict the development of chronic pain
      after lumbar spine surgery.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants will be recruited directly by the Candidate and by referral from specialist
        physicians at the KUMC Marc A. Asher, MD, Comprehensive Spine and Pain Management Center.
      
Keywords: lumbar spine surgery; lumbar failed back surgery syndrome
Effectiveness of High Dose Vitamin D Supplementation in Stage III Colorectal Cancer
Condition: Colon Cancer; Rectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      This is a pilot study to test whether there is an association between baseline Vitamin D
      levels, Vitamin D supplementation and survival in patients with stage III colon and stage
      II/III rectal cancer receiving chemotherapy. 70 patients with colon stage III or rectal stage
      II or III cancer that require chemotherapy will be screened and 60 patients will be enrolled.
      Patients will be randomized to standard dose (2000 IU daily) or high-dose (50,000 IU weekly)
      Vitamin D supplementation for 1 year after initiation of chemotherapy. Patients' Vitamin D
      levels will be checked throughout supplementation then followed for 5 years with occasional
      Vitamin D testing and surveying in order to collect information on recurrence and survival
      outcomes.
    


Intervention name(s): cholecalciferol
Intervention type(s): Dietary Supplement
Intervention description(s): 2,000 IU of Vitamin D3 daily and 50,000 IU Vitamin D3 daily
Other intervention name(s): Vitamin D3
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vitamin D
Collaborative-care Rehabilitation After Dysvascular Amputation
Condition: Diabetes Complications; Peripheral Arterial Disease
MeSH terms: Peripheral Arterial Disease; Peripheral Vascular Diseases; Diabetes Complications
Study type: Interventional

Summary: 
      The objective of this study is to examine the feasibility of using a collaborative-care,
      home-based rehabilitation program to improve functional outcomes for people recovering from
      lower limb amputation caused by vascular problems and/or diabetes complications. The primary
      hypothesis is that the rehabilitation program will result in greater improvements in
      performance-based and participant-reported measures of physical function, compared to
      standard of care after outpatient rehabilitation.
    


Intervention name(s): Exercise; Walking Program; Health Self-Management Support
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.; A walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks.; Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Amputation; Rehabilitation; Exercise; Movement
A Trial to Assess the Lot Consistency, Safety, Tolerability and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Subjects Aged ≥10 to <19 Years
Condition: Meningococcal Vaccine
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is looking at a new vaccine that might prevent meningococcal disease, and will
      study whether healthy adolescent subjects receiving different lots of vaccine respond in a
      similar way. The study will also look at the safety of the new vaccine as well as how it is
      tolerated.
    


Intervention name(s): rLP2086; rLP2086; rLP2086; Havrix (HAV); Saline
Intervention type(s): Biological; Biological; Biological; Biological; Biological
Intervention description(s): 0.5 mL dose, given at 0, 2 and 6 months (lot 1); 0.5 mL dose, given at 0, 2 and 6 months (lot 2); 0.5 mL dose, given at 0, 2 and 6 months (lot 3); 0.5 mL dose or 1.0 mL dose dependent on age given at month 0 and 6.; 0.5 mL dose of sterile normal saline for injection.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Delta Shock Index in Predicting Massive Transfusion
Condition: Trauma Patients Received Blood Transfusion ≥ 10 U; Trauma Patients Had Not Received Blood Transfusion ≥ 10 U
MeSH terms: Wounds and Injuries
Study type: Observational

Summary: 
      Background: To determine the performance of delta shock index (ΔSI), a change in shock index
      (SI) upon arrival at the emergency room (ER) from that in the field in predicting the need
      for massive transfusion (MT) among adult trauma patients with stable blood pressure.

      Methods: This study included data from all trauma patients aged 20 years and above who were
      hospitalized from January 1, 2009 to December 31, 2016 and was obtained from the registered
      trauma database of the hospital. Only patients who were transferred by emergency medical
      service from the accident site with a systolic blood pressure ≥ 90 mm Hg at the ER were
      included in this study. The 7,957 enrolled trauma patients were divided into 2 groups, those
      who had received blood transfusion ≥ 10 U (MT, n = 82) and those who had not (non-MT, n =
      7,875). The odds ratios with 95% confidence intervals for associated patient conditions and
      the odds of need for MT by a given ΔSI were measured. The plot of specific receiver operating
      characteristic (ROC) curves was used to evaluate the best cutoff point that could predict the
      patient's probability of receiving MT.
    


Intervention name(s): Massive transfusion; Non-Massive Transfusion
Intervention type(s): Other; Other
Intervention description(s): Trauma patients who had received blood transfusion≥10 U; Trauma patients who had received blood transfusion<10 U
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        All hospitalized trauma patients aged 20 years and above from January 1, 2009 to December
        31, 2016 from the registered trauma database of the hospital.
Duloxetine as an Analgesic Agent in Patients Undergoing Elective Spine Surgery
Condition: Intervertebral Disc Degeneration
MeSH terms: Intervertebral Disc Degeneration
Study type: Interventional
Phase: Phase 4

Summary: 
      Duloxetine as an analgesic agent in patients undergoing elective spine surgery: evaluation
      with fentanyl demand controlled by the patient. The primary objective is to evaluate the
      efficacy of duloxetine in fentanyl consumption during the postoperative period of patients
      undergoing elective spine surgery by intervertebral disc degeneration . Secondary endpoints
      were pain scores and the presence or absence of adverse effects such as headache, nausea,
      vomiting, itching, dizziness and drowsiness.
    

Detailed description: 
      Multimodal analgesia is widely advocated for the control of perioperative pain in an attempt
      to reduce the use of opioids and their side effects. Duloxetine is a selective inhibitor of
      serotonin and norepinephrine reuptake with demonstrated efficacy in chronic pain such as
      painful diabetic neuropathy and postherpetic neuralgia. The primary objective is to evaluate
      the efficacy of duloxetine in fentanyl consumption during the postoperative period of
      patients undergoing elective spine surgery by intervertebral disc degeneration . Duloxetine
      as an analgesic agent in patients undergoing elective spine surgery: evaluation with fentanyl
      demand controlled by the patient. The primary objective is to evaluate the efficacy of
      duloxetine in fentanyl consumption during the postoperative period of patients undergoing
      elective spine surgery by degenerative disc disease. Secondary endpoints were pain scores and
      the presence or absence of adverse effects such as headache, nausea, vomiting, itching,
      dizziness and drowsiness.
    

Intervention name(s): Duloxetine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): duloxetine 60 mg; placebo
Other intervention name(s): Cymbalta; inactive substance
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
A Clinical Trial to Evaluate the Effectiveness and Safety of Chinese Medicine in the Treatment of Mild Type of Hand, Foot, and Mouth Disease
Condition: Hand, Foot and Mouth Disease
MeSH terms: Foot-and-Mouth Disease; Hand, Foot and Mouth Disease; Mouth Diseases
Study type: Interventional

Summary: 
      The study is aimed to evaluate the effectiveness and safety of traditional Chinese medicine
      (TCM) for treatment of hand, foot, and mouth disease (HFMD).
    

Detailed description: 
      By adopting a multi-center, randomized and controlled clinical trial, this study is aimed to
      evaluate the effectiveness, safety and economic evaluation of traditional Chinese medicine
      for treatment of HFMD, and to provide scientific evidence for the construction of TCM methods
      in treating HFMD.
    

Intervention name(s): Western therapy; TCM Syndrome Differentiation and Treatment; Western therapy plus TCM treatment
Intervention type(s): Other; Drug; Other
Intervention description(s): Symptomatic treatment: vitamin B, vitamin C, mouth care and skin care.
Adopting physical cooling therapy, including physical cooling paste or warm bathing, when patient's body temperature is lower than 38.5 degree Celsius;
Using Ibuprofen suspension when patient's temperature higher than 38.5 degree Celsius;; Lung-Spleen Damp-Heat Syndrome Symptoms: Fever, maculopapule and herpes on hand, foot and buttock; herpes on oral mucous membrane; redness in throat, salivation, tiredness, faint red tongue or reddish tongue, greasy fur, speedy pulse, red and purple fingerprint.
Formula: Forsythia suspensa (Thunb.) vahl.(Lian Qiao), Lonicera japonica Thunb (Jin Yin Hua), Scutellaria baicalensis Georgi (Huang Qin), etc.
Dosage: Adjusting by age and weight of patients. Decoction.
Dampness-Heat Retention Syndrome Symptoms: High fever, dirty color of tetter, tiredness, oral ulcer, reddish tongue or deep red tongue, little saliva, yellow and greasy fur, fine and rapid pulse, deep purple fingerprint.
Formula: Forsythia suspensa (Thunb.) vahl.(Lian Qiao), Gardenia jasminoides Ellis (rough Zhi Zi), Scutellaria baicalensis Georgi (Huang Qin), etc.
Dosage: Adjusting by age and weight of patients. Decoction.; Symptomatic treatment using the same treatment methods in western therapy group;
Syndrome differentiation and treatment adopting the same methods in TCM treatment group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mild type of hand, foot and mouth disease; Traditional Chinese Medicine; Effectiveness; Safety
Study to Investigate Safety and Response to 1 or 2 g Rectal Suppositories Containing 5 or 10 mg NRL001.
Condition: Fecal Incontinence
MeSH terms: Fecal Incontinence
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a healthy volunteer three-way crossover study. A total of 12 subjects will receive
      three single administrations of 1 g rectal suppositories (containing either 5 mg NRL001, 10
      mg NRL001 or matching placebo), with a washout period of at least 7 days between dosings. A
      further 12 subjects will receive three single administrations of 2 g rectal suppositories
      (containing either 5 mg NRL001, 10 mg NRL001 or matching placebo), again with a 7 day washout
      period between dosings. The pharmacodynamic response, pharmacokinetics and safety profile
      will be determined.
    


Intervention name(s): NRL001; NRL001
Intervention type(s): Drug; Drug
Intervention description(s): Subjects receive single doses of 5 mg NRL001, 10 mg NRL001 and placebo in a 1 g rectal suppository, with a 7-day washout period between dosing.; Subjects receive single doses of 5 mg NRL001, 10 mg NRL001 and placebo in a 2 g rectal suppository, with a 7-day washout period between dosing.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Intravenous Fentanyl or Local Anesthetic Infiltration for Pain Reducing During Spinal Needle Insertion
Condition: Anesthesia; Spinal Puncture
Study type: Interventional

Summary: 
      Background and Objectives: Spinal puncture is painful procedure which may cause patient
      refusal of spinal anesthesia in future surgery. It could be minimized with topical and
      infiltration local anesthetic or intravenous opioid application before procedure. Objective
      was efficacy of intravenous fentanyl in alleviating pain during spinal needle insertion.

      Methods: Prospective, randomized study included 88 adults (33-55 ages, ASA I/II), scheduled
      for lower leg surgery. Patients were divided in four equal study groups: spinal needle
      (Quincke, 26G) with introducer (20G) was inserted alone, three minutes after local anesthetic
      infiltration (2 ml of 2% lidocaine, 25Gx11/4" needle) or intravenous fentanyl application
      (0.001 mg kg-1) and without local anesthetic, fentanyl and introducer. Pain was assessed
      immediately after procedure by VAS score. MAP, HR and SaO2 were recorded. Sedation was
      assessed by Ramsay score. Statistical analysis was performed by SPSS 11.0.
    


Intervention name(s): Comparison of intravenous fentanyl and local anesthetic infiltration in pain reducing during spinal needle puncture
Intervention type(s): Procedure
Intervention MeSH terms: Fentanyl; Anesthetics; Anesthetics, Local
Primary purpose: Treatment
Keywords: Anesthetic techniques; regional, spinal; Pain; lumbar puncture; Analgesia, local; Analgesia, intravenous
Is There a Difference in Flicker Induced Vasodilatation Between Smokers and Non-Smokers?
Condition: Ocular Physiology; Retina; Blood Flow Velocity
Study type: Interventional

Summary: 
      Habitual smoking is associated with an increased risk of coronary artery disease, cerebral
      and peripheral vascular disease, including ocular diseases like age-related macular
      degeneration or diabetic retinopathy. Data of a recent study performed in the investigators
      lab revealed abnormal choroidal blood flow regulation in chronic smokers as compared to
      age-matched non-smoking subjects during isometric exercise. However, no information is yet
      available about the regulation of retinal vascular tone in habitual smokers.

      Thus, in the current study, the investigators set out to investigate whether the regulation
      of retinal vessels diameters is affected in habitual smokers. It has been shown in several
      reports that stimulation with diffuse luminance flicker, increases retinal arterial and
      venous diameters, indicating for the ability of the retina to adapt to changing metabolic
      demands. In the current study we use this effect as a tool to investigate whether the flicker
      induced vasodilatation is affected in habitual smokers. This would indicate for an impaired
      vascular regulation process in smokers.
    


Intervention name(s): flicker light stimulation
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)