bioihbjkbjnl/mcl2 huggingface dataset:
Mass Balance Study of [14C]ZSP1273 in Healthy Adult Male Subjects in China
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a single-center, open-label, and single-dose clinical study to evaluate the
      mass balance, biotransformation and pharmacokinetics of [14C]ZSP1273 in healthy Chinese male
      participates, revealing the overall pharmacokinetic characteristics of ZSP1273.
    


Intervention name(s): [14C] ZSP1273
Intervention type(s): Drug
Intervention description(s): 600 mg suspension containing 50μCi of [14C]ZSP1273
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
An Open-Label Evaluation of the Independent Effects of Coadministration of a High-Fat Meal and Naltrexone Blockade on the Pharmacokinetic Profile of Dilaudid OROS (Hydromorphone HCI) 16mg
Condition: Analgesia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to compare the pharmacokinetic (the way a drug enters and
      leaves the blood and tissues over time) profile of Dilaudid OROS 16mg (Dilaudid Slow Release;
      hydromorphone HCL) administered under fasting conditions, following a high-fat breakfast
      meal. The study also examined the effect of naltrexone blockade on the pharmacokinetic
      profile of Dilaudid SR.
    

Detailed description: 
      This was a randomized (patients are assigned different treatments based on chance),
      open-label, three-way crossover study, performed in normal, healthy adults. Each patient
      received orally administered treatments (a different treatment during each dosing phase):
      Treatment A: single dose of Dilaudid SR 16 mg administered under fasting conditions without
      the naltrexone block;Treatment B: single dose of Dilaudid SR 16 mg administered under fed
      conditions without the naltrexone block, Treatment C: single dose of Dilaudid SR 16 mg
      administered under fasting conditions with naltrexone HCL 50mg block (3 oral doses of 50mg
      each administered 12 hours prior to , at the time of, and 12 hours after Dilaudid SR 16mg
      administration). There was a 7-day washout period between dosing phases.

      Venous blood sampling times were 0 (prior to dosing),2,4,6,8,10,12,16,20,24,30,36,42,and 48
      hours after each Dilaudid SR administration. LC/MS/MS (Liquid Chromatography/Mass
      Spectroscopy/Mass Spectroscopy)techniques were employed for the analysis of plasma for
      hydromorphone concentration. Each patient randomly received orally-administered treatments of
      single dose of Dilaudid SR 16mg; under fasting conditions without the naltrexone block; under
      fed conditions without naltrexone block; under fasting conditions with naltrexone 50mg block
      (3 oral doses of 50mg naltrexone HCL each administered 12 hours prior to, at the time of, and
      12 hours after hydromorphone administration); 7-day washout period between dosing phases.
    

Intervention name(s): Hydromorphone HCL 16mg; Dilaudid SR 16mg; Naltrexone (opioid antagonist) 50mg.
Intervention type(s): Drug
Intervention MeSH terms: Naltrexone; Hydromorphone; Narcotic Antagonists
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Analgesia
Study of Nutrition and Activity in Kids
Condition: Obesity, Adolescent; Adolescent Behavior
MeSH terms: Pediatric Obesity
Study type: Observational

Summary: 
      While a substantial body of research suggests that RRV is related to obesity, there is very
      little research on factors that contribute to the RRV of food, particularly how patterns of
      eating can increase or decrease the motivation to eat specific foods. Previous work has
      demonstrated that a subset of individuals with obesity show increases in RRV of food after
      repeated consumption of large portions of high energy density (HED) snack foods, which has
      been conceptualized as sensitization. Preliminary data suggest that sensitization of the RRV
      of HED food is a predictor of weight gain over time. However, more work needs to be done to
      address this relationship using a planned, prospective study design, using adolescent
      research subjects, and examining potential moderators of this relationship.

      The purpose of this study is to identify risk and protective factors to excess zBMI change in
      adolescents over time. Aim 1 was to measure the relative reinforcing value (RRV) of a
      preferred HED and low energy density (LED) snack food before and after 2-weeks of daily
      exposure. Aim 2 was to assess the RRV of exercise and sedentary activity. Hypotheses include
      1) sensitization to HED food will be associated with greater zBMI at the time of testing as
      well as greater zBMI change over time 2) sensitization to LED food will be associated with
      lower zBMI at the time of testing in adolescents and less zBMI change over time. 3) Greater
      RRV of exercise will be protective against zBMI increases over time.
    


Intervention name(s): Reinforcing value of HED and LED foods in response to snack food monotony
Intervention type(s): Other
Intervention description(s): Each child will be asked to eat two different snack foods over the course of two weeks each. The RRV of that food (vs alternative reinforcer) will be tested and baseline and post exposure. Increases in RRv for food after monotony will be considered sensitization to that food. All children will be followed to observe weight change over time for 2 years each.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adolescents living in the Western New York area, aged 12-14 years at the time of
        enrollment. Flyers were posted in the community within a 30 min drive of UB South Campus.
        Additionally, flyers were sent to list serves, posted on facebook, and distributed to both
        private and public schools within a 40 min drive of the university campus.
      
Keywords: adolescent; obesity; relative reinforcing value; physical activity; weight change
Efficacy of Cardioviva™ Probiotic Supplement Capsule Formulation
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      Background: It is becoming increasingly clear that individuals from all corners of the globe
      use probiotic dietary approaches to enhance health. More recently, probiotics have shown
      promise in treating a variety of disease states, due to improved strain selection, stability
      and delivery technologies.

      Objective: The purpose of this study is to determine the lipid lowering efficacy of a
      probiotic supplement capsule containing Lactobacillus reuteri Cardioviva™, taken twice per
      day over 9 weeks, in subjects with hypercholesterolemia.

      Design: The study design is a double-blinded, placebo-controlled, randomized, parallel-arm,
      multi-centre study. The study will last a total of 13 weeks, including a 2-week wash-out
      period, a 2-week run-in period and a 9 week treatment period.
    


Intervention name(s): Cardioviva™ supplement capsule; Placebo capsule
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Twice per day (BID), 9 weeks; Twice per day (BID), 9 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect on Acetaminophen Metabolism by Liquid Formulations
Condition: Acetaminophen Metabolism; Acetaminophen Poisoning; Drug Metabolism by Excipients
MeSH terms: Poisoning
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether excipients in the liquid formulation of
      acetaminophen prevent the formation of the toxic metabolites of acetaminophen.
    

Detailed description: 
      Acetaminophen (APAP) poisoning is the most frequent cause of acute hepatic failure in the
      United States. Toxicity requires cytochrome P-450 bioactivation of APAP. Children are less
      susceptible to APAP toxicity; the current theory is that they have different metabolism than
      adults. However, children's liquid preparations of APAP contain excipients which have been
      shown to inhibit APAP bioactivation in vitro and in rodents. Children tend to ingest liquid
      preparations, which could potentially explain their decreased susceptibility instead of an
      intrinsically different metabolism. Further, our review of Poison Center epidemiologic data
      shows that liquid preparations are less toxic in adults. Our hypothesis is that excipients in
      liquid preparations inhibit the bioactivation of APAP. The design is a pharmacokinetic
      cross-over study in humans. Healthy adult subjects will be recruited for administration of
      therapeutic doses of APAP in capsule and liquid formulations. Plasma via a heplock will be
      collected at serial time points up to 8 hours and assayed for APAP and its metabolites. After
      a washout period, subjects will receive the same dose of APAP in the alternate preparation.
      The pattern of metabolites, indicating the activity of the bioactivating enzymes, will be
      compared. A significant difference in P-450 metabolites will support the hypothesis and
      provide preliminary data for studies in patients who have ingested potentially toxic doses of
      APAP. Ultimately, this work could support development of novel antidotal therapy for APAP
      overdose.
    

Intervention name(s): Acetaminophen liquid formulation; Acetaminophen solid formulation
Intervention type(s): Drug; Drug
Intervention description(s): Subjects in this arm will receive a 15mg/kg dose of a solid acetaminophen formulation.; Subjects in this arm will receive a 15mg/kg dose of a solid acetaminophen formulation.
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: acetaminophen; excipients
Oral Health in Children With Inflammatory Bowel Disease
Condition: Oral Health in Children With Inflammatory Bowel Disease
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Observational

Summary: 
      In adults with inflammatory bowel disease (IBD), a higher prevalence of dental caries and
      periodontal disease has been reported compared with healthy control subjects, but similar
      data on children are missing in the literature.We aimed to evaluate the prevalence of dental
      erosion, dental caries and periodontal disease in children with IBD.
    

Detailed description: 
      In this age- and gender-matched prospective case-control study, detailed questionnaires
      including nutritional habits and oral examinations were completed for 32 IBD patients aged 11
      to 18 (15,53±2,00 yr) and 32 healthy controls based on the established criteria of the World
      Health Organization by the same pediatric dentist.
    

Intervention name(s): No intervention was given to the patients
Intervention type(s): Other
Intervention description(s): This study was an observational epidemiological study.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Study population with inflammatory bowel disease in the remission period.
      
Keywords: inflammatory bowel disease, children, permanent dentition, nutritional habits
The Clinical Investigation of Toothpaste as Compared to Toothpaste and Mouthwash in Reducing Plaque and Gingivitis: A Six-week Clinical Study in the US
Condition: Dental Plaque; Gingivitis
MeSH terms: Gingivitis; Dental Plaque
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this clinical research study is to evaluate clinical efficacy of Colgate
      Total Toothpaste as compared to Crest Pro-Health Toothpaste and Crest Pro-Health Mouthwash,
      and Crest Cavity Protection Toothpaste and Crest Fluoride Mouthwash in reducing gingivitis
      and dental plaque in adults in a six-week clinical study.
    


Intervention name(s): Triclosan/fluoride toothpaste; stannous fluoride toothpaste; fluoride toothpaste; Fluoride Mouthwash; cetylpyridinium chloride Mouthwash
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration).; Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration).; Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration).; Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time.; Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time.
Other intervention name(s): Total toothpaste; Crest Pro-Health toothpaste; Crest Cavity Protection toothpaste; Crest Pro-Health For Me Breezy Mint mouthwash; Crest Pro-Health Multi-Protection mouthwash
Intervention MeSH terms: Triclosan; Cetylpyridinium; Fluorides; Tin Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluate the Effect of VI-0521 on the Pharmacokinetics of Oral Contraceptive in Healthy Female Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is desgigned to look at the effect of multiple dosing administration of VI-0521 on
      Oral Contraceptive medication.
    

Detailed description: 
      This study is designed to determine if multiple oral doses of VI-0521 would alter the
      pharmacokinetics of an oral contraceptive in healthy female subjects.
    

Intervention name(s): ethinyl estradiol, norethindrone, VI-0521
Intervention type(s): Drug
Intervention description(s): Oral contraceptive
Other intervention name(s): VI-0521, Ortho-Novum 1/35-28
Intervention MeSH terms: Ethinyl Estradiol; Norethindrone; Norethindrone Acetate; Norinyl; Estradiol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple dose administration; Oral Contraceptives
Radical Gastrectomy and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) in Locally Advanced Gastric Cancer
Condition: Malignant Neoplasm of Stomach
MeSH terms: Stomach Neoplasms; Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The efficacy of HIPEC in prevention of local recurrence, distant metastasis or peritoneal
      metastasis in locally advanced gastric cancer is not definite. The hypothesis of the trial is
      that radical gastrectomy plus HIPEC is superior to only radical gastrectomy in terms of
      overall survival.
    

Detailed description: 
      To determine the efficacy of HIPEC in the treatment of locally advanced gastric cancer,
      patients are randomized into HIPEC group and control group. In HIPEC group, the patients
      undergo radical gastrectomy with D2 lymphadenectomy and HIPEC with paclitaxel and 5-Fu.
      Patients in the control group just undergo radical gastrectomy with D2 lymphadenectomy.
      Patients in both groups receive 6 cycles of postoperative chemotherapy (SOX or XELOX) and are
      followed up for 5 years or until death.

      The trial is designed as a prospective, randomized, open, multicenter and parallel group
      study.
    

Intervention name(s): Hyperthermic intraperitoneal chemotherapy (HIPEC); D2 radical gastrectomy; SOX postoperative chemotherapy; XELOX postoperative chemotherapy
Intervention type(s): Procedure; Procedure; Other; Other
Intervention description(s): Normal saline 3000ml-4000ml, Paclitaxel 75mg/m2, 5-Fu 15mg/m2, 43°C, 60min.; radical gastrectomy with D2 lymphadenectomy; Oxaliplatin 130mg/m2 d1, Tegafur,Gimeracil and Oteracil Porassium Capsules 60mg, d1-14.; Oxaliplatin 130mg/m2 d1, Capecitabine 1000mg/m2 d1-14.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Treating Oxidative Stress in Children With Autism
Condition: Autistic Disorder
MeSH terms: Autistic Disorder
Study type: Interventional

Summary: 
      An open label trial was undertaken in 40 autistic children to determine whether treatment
      with metabolic precursors methylcobalamin and folinic acid would improve plasma biomarkers of
      oxidative stress and measures of core behavior using the Vineland Adaptive Behavior Scales
      (VABS). Metabolites involved in methionine and glutathione synthesis and VABS behavior scores
      were measured before and after a three month intervention period.

      The results indicated that pre-treatment metabolites in autistic children were significantly
      different from values in age-matched control children. The three month intervention resulted
      in significant increases in cysteine, cysteinylglycine, and glutathione (GSH, p < 0.001). The
      oxidized disulfide form of glutathione (GSSG) was decreased (p < 0.008) and the glutathione
      redox ratio (GSH/GSSG) was increased after treatment (p < 0.001). Although significantly
      improved, these metabolites remained below control levels after intervention (p > 0.01).
      Similarly, increases in VABS composite score and sub-scores for Socialization, Communication,
      and Daily Living Skills increased after treatment (p < 0.007) but also remained below
      standard scores.
    


Intervention name(s): Methylcobalamin (methylB12)
Intervention type(s): Drug
Intervention description(s): 75 ug/Kg methylB12 every 3 days by subcutaneous injection
Other intervention name(s): Vitamin B12
Intervention MeSH terms: Vitamin B 12
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: glutathione; methionine; folinic acid; redox; oxidative stress; behavior
Influence of the Time of Day in the Effect of Caffeine on Maximal Fat Oxidation During Exercise in Women
Condition: Dietary Supplement
Study type: Interventional

Summary: 
      Caffeine is a natural stimulant with well-recognized metabolic benefits, however, there is a
      lack of studies investigating the time-of-day caffeine influence to enhance fat oxidation in
      women. The aim of this study was to evaluate the influence of the time of the day on the
      effect of caffeine on maximal rate of fat oxidation during aerobic exercise in women.
    

Detailed description: 
      Caffeine is a natural stimulant with well-recognized sports performance benefits. Aside its
      performance-enhancing effect, caffeine has the potential of increasing fat utilization during
      aerobic exercise at submaximal intensities, lowering-down the contribution of carbohydrate as
      a fuel. This property of caffeine may provoke a glycogen-sparing effect in the skeletal
      muscle and liver for exercise situations where carbohydrate availability may be a challenge.
      Additionally, the capacity of caffeine to enhance fat utilization during exercise could be of
      interest for improving health outcomes as it may increase the rate of change in body
      composition in exercise programs. Maximal fat oxidation rate (MFO) during exercise is a
      remarkable physiological indicator associated with metabolic flexibility/body weight loss and
      endurance performance To date, it is unknown if caffeine increases MFO in the same proportion
      during morning and evening exercise trials in women. For this reason, the aim of the present
      study was to evaluate the influence of the time of the day on the effect of caffeine on MFO
      in women. We hypothesised that caffeine would increase MFO during morning and evening
      exercise and this effect would be of similar magnitude at both times of day.
    

Intervention name(s): Acute caffeine supplementation
Intervention type(s): Dietary Supplement
Intervention description(s): To evaluate the influence of the time of the day (i.e., morning vs evening) on the effect of caffeine on maximal fat oxidation in women.
Intervention MeSH terms: Caffeine
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Dietary Supplement: caffeine acute supplementation
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Parametric Testing of Direct Physiological Effects of Transcutaneous Vagus Nerve Stimulation (tVNS) in Healthy Controls
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the feasibility and safety of Transcutaneous Vagus
      Nerve Stimulation (tVNS) in healthy controls. Tested in healthy subjects (HS) the
      physiological effects of tVNS at different stimulation parameters. The electrical stimulation
      variables will be pulse width, frequency, and current. This will be tested in a laboratory
      setting and will measure tVNS effects on heart rate, respiration rate, blood pressure, and
      perceived pain. This is a feasibility and small safety study.

      Hypothesis: tVNS is feasible and safe
    


Intervention name(s): Digitmer High Voltage Stimulator model DS7A TENS unit
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Investigate Oral Bacteria in Adult Population
Condition: Oral Bacteria
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the antimicrobial efficacy of three dentifrices on oral bacteria
    


Intervention name(s): Fluoride; Fluoride, Triclosan; Stannous Fluoride
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Brush twice a day for 14 days; Brush twice daily for 14 days; Brush twice daily for 14 days
Other intervention name(s): Crest Anti-Cavity toothpaste; Total toothpaste
Intervention MeSH terms: Triclosan; Fluorides; Tin Fluorides
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Flavanols and Skin Photo Protection: a Clinical Trial
Condition: Solar Skin Damage
Study type: Interventional
Phase: Phase 2

Summary: 
      As flavanols have antioxidants, anti-inflammatory and anti-DNA damaging effects and may
      increase microcirculation in skin, the purpose of the study is to investigate the chronic
      effect of flavanol-rich chocolate as an effective strategy to protect against the harmful
      effect of ultraviolet (UV) radiation.
    

Detailed description: 
      Recent data suggested that chronic ingestion of high flavanols cocoa might be a promising
      agent for dietary photo protection against UV light. Moreover, flavanols-rich cocoa intake
      has been shown to increase microcirculation in human skin.
    

Intervention name(s): Flavanol-rich chocolate; Flavanol-free chocolate
Intervention type(s): Other; Other
Intervention description(s): High-flavanol chocolate, 12 weeks.; Flavanol-free chocolate, 12 weeks
Other intervention name(s): Experimental dark chocolate; Placebo flavanol-free chocolate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: UV radiation; photoprotection; flavanols rich chocolate