bioihbjkbjnl/mcl2 huggingface dataset:
Bioavailability and Metabolism of Anthocyanins Following Acute Cranberry Consumption
Condition: Bioavailability; Cardiovascular Disease
MeSH terms: Cardiovascular Diseases
Study type: Observational

Summary: 
      This study hypothesis is that anthocyanins from cranberry juice are bioavailable and can be
      measured in blood and urine after a single acute consumption of cranberry juice.
    

Detailed description: 
      Little is known about the acute or chronic pharmacokinetics and metabolism of anthocyanins
      consumed in amounts relevant to usual dietary intakes. Thus, we hypothesize that anthocyanins
      from a single oral dose of cranberry juice will be absorbed quickly and can be measured in
      the circulation and urine within 2-4 h. Further, these anthocyanins will undergo a degree of
      metabolism but will circulate as well as be removed from blood as both parent compounds and
      metabolic products.

      This research proposal is submitted as an independent sub-study of an existing project,
      "Effects of Cranberry Juice on Endothelial Function in Patients with Coronary Artery
      Disease", conducted by Joseph A. Vita, MD at the Boston University School of Medicine and
      sponsored by Ocean Spray Cranberries, Inc.

      This study includes 15 subjects aged 21-80 y and with demonstrated endothelial dysfunction
      and angiographically proven coronary artery disease who will receive a single dose of 480 mL
      cranberry juice.

      To test the hypotheses of the study to be conducted at HNRCA Tufts, we will utilize blood and
      urine samples that are already collected and stored. We will separate and analyze
      anthocyanins in these samples by HPLC and determine the pharmacokinetics of relevant
      anthocyanins.
    

Intervention name(s): Experimental
Intervention type(s): Dietary Supplement
Intervention description(s): Administration of of 480 mL cranberry juice
Other intervention name(s): Cranberry Juice
Observational model: Cohort
Sampling method: Probability Sample
Study population: 
        Subjects aged 21-80 y and with demonstrated endothelial dysfunction and angiographically
        proven coronary artery disease
Effects of Steady State Tipranavir/Ritonavir or Darunavir/Ritonavir or Ritonavir on Platelet Function, Coagulation and Fibrinolysis Biomarkers in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Study to determine the effect of steady-state plasma concentration of Tipranavir/ritonavir
      (TPV/r) on platelet aggregation in healthy subjects and investigate the effect of TPV/r at
      steady state plasma concentrations on other platelet functions and biomarkers of coagulation
      and fibrinolysis.
    


Intervention name(s): Tipranavir; Ritonavir; Darunavir; Aspirin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): single dose on day 2
Other intervention name(s): APTIVUS®; Norvir®; PREZISTA®; Acetylsalicylic acid
Intervention MeSH terms: Aspirin; Ritonavir; Darunavir; Tipranavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of a Reusable Silicone Hydrogel Multifocal Contact Lens
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional

Summary: 
      This study is a randomized, single-masked, crossover clinical trial. There are two study
      lenses. Each lens will be dispensed for 3 ± 1 days and then an optimization visit will occur.
      The final lens pair will be dispensed for 12 ± 2 days and the follow-up on the final lens
      pair will occur. The second study lenses will then be fit and the above sequence repeated.
    


Intervention name(s): JJV Investigational Multifocal Contact Lens; 1-Day Acuvue® Moist Brand Multifocal Contact Lens
Intervention type(s): Device; Device
Intervention description(s): TEST; CONTROL
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Safety and Immunogenicity Study of a Booster Vaccination With a Non-Adjuvanted H5N1 Influenza Vaccine (Follow Up to Study 810501)
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this Phase II follow-up study (to study 810501) is to assess the
      immunogenicity and safety of a booster vaccination with a non-adjuvanted H5N1 influenza
      vaccine administered 12 to 17 months after a two-dose regimen of different doses of an
      adjuvanted or non-adjuvanted H5N1 influenza vaccine in a healthy young adult population. A
      data safety monitoring board will review the safety data after the booster vaccination. The
      H5N1 influenza antibody persistence 180 days after the booster vaccination will also be
      assessed.
    


Intervention name(s): H5N1 influenza vaccine (whole virion, Vero cell-derived), 7.5 µg HA antigen, non-adjuvanted
Intervention type(s): Biological
Intervention description(s): All subjects who have completed the Day 42 visit at the Austrian study site in Study 810501 will be invited to receive a booster vaccination, 12 to 17 months after the first vaccination with the A/Vietnam/1203/2004 influenza vaccine administered in Study 810501, with a heterologous whole virion, Vero cell-derived influenza vaccine containing 7.5 mg A/H5N1/Indonesia/05/2005 hemagglutinin (HA) antigen in a non-adjuvanted formulation.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pandemic influenza
Safety, Tolerability, and Efficacy of Monotherapy and Combination Regimens in Participants With Nonalcoholic Steatohepatitis (NASH)
Condition: Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of study
      drug(s) in participants with nonalcoholic steatohepatitis (NASH).
    


Intervention name(s): Semaglutide; Firsocostat; Cilofexor
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Solution administered subcutaneously with pre-filled PDS290 pen-injector once weekly; Tablets administered orally once daily; Tablets administered orally once daily
Other intervention name(s): GS-0976; GS-9674
Intervention MeSH terms: Firsocostat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Assessing the Impact of Weighted Blankets on Anxiety Among Inpatients With Anorexia Nervosa: a Study Protocol
Condition: Anorexia Nervosa; Avoidant/Restrictive Food Intake Disorder; Anxiety
MeSH terms: Anorexia; Body Weight; Anxiety Disorders; Anorexia Nervosa; Avoidant Restrictive Food Intake Disorder
Study type: Interventional

Summary: 
      The aim of this study is to conduct a randomized control trial (RCT) to assess the efficacy
      of weighted blankets (WB), on anxiety for patients with severe anorexia nervosa (AN) and
      avoidant restrictive food intake disorder (ARFID) in an inpatient medical setting. We
      hypothesize that using weighted blankets will reduce anxiety in these patient populations.
    

Detailed description: 
      Anorexia nervosa (AN) has one of the highest mortality rates of any psychiatric disorder with
      anxiety being a common comorbidity. The standard of care for inpatient medical stabilization
      for patients diagnosed with AN is a multidisciplinary approach with emphasis on nutrition,
      psychotherapy, and medical management of complaints. Weighted blankets, an example of deep
      pressure stimulation, have been shown to reduce anxiety. However, not much is known about the
      effect of weighted blankets in the eating disorder population. Therefore, this randomized
      control trial (RCT) protocol outlines a study design for assessing the effect of weighted
      blankets on patients with AN.

      A two-arm RCT design will be implemented for this study. A convenience sample of 24 patients
      will be enrolled with 12 patients in the control and intervention groups based on inclusion
      criteria. The control group will receive Denver Health's standard of care for patients
      admitted to its well-known medical stabilization unit for patients with extreme form of
      eating disorders, while the intervention group will receive both the standard of care and a
      weighted blanket. A mixed-design ANOVA will be performed to explore differences in the Beck's
      Anxiety Inventory and Subjective Units of Distress Scale between the intervention and control
      groups.
    

Intervention name(s): Weighted blanket
Intervention type(s): Other
Intervention description(s): Patients that were randomly assigned to the intervention group received a weighted blanket to use at their will to reduce anxiety
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: anorexia nervosa; weighted blankets; occupational therapy; anxiety; deep pressure stimulation; randomized control trial
Melatonin Agonist Effects of Tasimelteon Versus Placebo in Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of an 8-week double-masked
      treatment of tasimelteon or placebo in male and female subjects with Major Depressive
      Disorder.
    

Detailed description: 
      This is a randomized, parallel, double-masked, placebo-controlled, multicenter outpatient
      study comparing tasimelteon with placebo in the treatment of subjects with Major Depressive
      Disorder (MDD).

      The study has three phases: the pre-randomization phase, the randomization phase, and an
      open-label extension phase. The pre-randomization phase comprises a screening visit where
      subject's initial eligibility will be evaluated. The randomization phase is comprised of an
      8-week double-masked segment. Subjects meeting all entry criteria for the study will enter
      the randomization phase. During this phase, subjects will be asked to take either 20 mg
      tasimelteon or placebo for 8 weeks in a double-masked fashion. At the end of the 8-week
      double-masked phase, those subjects who completed the 8-week treatment phase will be offered
      to enroll into a 52-week open-label extension where each subject will receive daily doses of
      20 mg tasimelteon.
    

Intervention name(s): tasimelteon; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 20 mg once daily; once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tasimelteon; Major Depressive Disorder; MDD; depression
Gradual Vs. Rapid Buprenorphine Detoxification - 2
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine an optimal detoxification dose reduction schedule
      with buprenorphine.
    


Intervention name(s): Buprenorphine
Intervention type(s): Drug
Intervention MeSH terms: Buprenorphine
Masking: Double
Primary purpose: Treatment
AD109 Dose Finding in Mild to Moderate OSA
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, 3-period, placebo-controlled, crossover, phase 2 clinical study to
      examine the efficacy and safety of 2 doses of AD109 vs placebo in patients with mild
      obstructive sleep apnea.
    

Detailed description: 
      Participants underwent initial pre-screening to determine potential study eligibility.
      Participants selected for further screening had either a previous history of OSA of a
      severity consistent with enrollment criteria or were at high risk (e.g. as assessed by
      STOP-Bang Questionnaire score). Only participants who met all non polysomnography (PSG)
      enrollment criteria at Visit 1 were eligible for a screening PSG.
    

Intervention name(s): AD109 dose1- A; AD109 dose2- B; Placebo- C
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Oral administration at bedtime; Oral administration at bedtime; Oral administration at bedtime
Other intervention name(s): AD109 75; AD109 37.5
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effect of Platelet-rich Fibrin on Soft Tissue, Periodontal Pocket Healing and Alveolar Bone Height After Third Molar Surgery
Condition: Platelet-rich Fibrin
MeSH terms: Periodontal Pocket
Study type: Interventional

Summary: 
      A Randomized, controlled clinical trial and split-mouth design was performed to assess and
      compare the effect of platelet-rich fibrin (PRF) on soft tissue healing, periodontal pocket
      depth and alveolar bone height distal to second molar of the study and control groups after
      third molar surgical removal.

      Sample include of participants who had indication of impacted lower third molars extraction
      on both sides with symmetrically orientation and same difficult index. All participants had
      same extraction protocol on both side at Department of Oral surgery, Faculty of
      Odonto-stomatology, University of Medicine and Pharmacy, Ho Chi Minh City.

      Soft tissue healing, periodontal pocket depth and distal bone height were evaluation by an
      independent investigator.
    


Intervention name(s): PRF; standard third molar surgical removal
Intervention type(s): Other; Other
Intervention description(s): centrifuge patient's blood to collect 1 block of yellowish condensed fibrin, which is platelet-rich fibrin; standard third molar surgery following surgical protocol of Department of Oral Surgery, University of Medicine and Pharmacy
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: split-mouth study, 1 side would be the study side and other side would be control side
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel™ or DAPTACEL®
Condition: Diphtheria; Tetanus; Pertussis
MeSH terms: Whooping Cough; Tetanus; Diphtheria
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objectives:

        1. To present the safety profile after a 5th dose of DAPTACEL® in children 4 to 6 years of
           age who have previously received 4 doses of DAPTACEL® or Pentacel™.

        2. To present the pre-Dose 5 and post-Dose 5 antibody responses to the antigens in
           DAPTACEL® in children 4 to 6 years of age who have previously received 4 doses of
           DAPTACEL® or Pentacel™.

      Observational Objectives:

        1. To compare under equivalence criteria the pre-Dose 5 and post-Dose 5 antibody responses
           to the antigens in DAPTACEL® in children 4 to 6 years of age who have previously
           received 4 doses of DAPTACEL® or Pentacel™.

        2. To present the pre-vaccination anti-poliovirus GMTs and seroprotection rates.

        3. To present the post-vaccination anti-poliovirus GMTs and seroprotection rates among
           subjects receiving a 4th dose of IPV concurrently with the 5th dose of DAPTACEL and a
           2nd dose of MMR.
    


Intervention name(s): DAPTACEL®: DTaP; DAPTACEL®: DTaP
Intervention type(s): Biological; Biological
Intervention description(s): 0.5 mL, Intramuscular; 0.5 mL, Intramuscular
Other intervention name(s): DAPTACEL®; DAPTACEL®
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: DAPTACEL®; Pentacel™; Diphtheria; Tetanus; Pertussis; Whooping cough; Acellular Pertussis Vaccine Adsorbed
Breakfast Meal Replacement
Condition: Body Composition, Beneficial; Basal Metabolic Rate; Satiety; Overweight; Obese
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Purpose: To evaluate the effects of replacing breakfast with a high protein, high fat, high
      fiber meal replacement in overweight individuals, on body composition.

      Participants: Healthy, overweight and obese individuals (ages 18-45 yrs) with no history of
      disease. Procedures (methods): In a randomized control intervention, subjects will complete 5
      different testing sessions (pre-screening, 2 baseline testing sessions, and 2 post testing
      sessions) as well as an 8 week intervention period. Pre-screening will include written
      informed consent, health history questionnaire, nutrition analysis, and baseline
      anthropometric measures. Baseline testing will be split into two sessions and include
      measurements of resting metabolic rate (RMR), body composition, blood and saliva hormones,
      mood, satiety, and health related quality of life questionnaires, and a cardiorespiratory
      fitness assessment.

      Subjects will be randomly assigned to treatment (8 week supplementation with meal replacement
      to be taken at breakfast) and control groups (continue normal eating habits) with 4
      electronic correspondences throughout the supplementation period. All measures will be
      repeated in two post-testing sessions.
    


Intervention name(s): Meal replacement
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Study to Assess the Efficacy of Larazotide Acetate for the Treatment of Celiac Disease
Condition: Celiac Disease
MeSH terms: Celiac Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was conducted to evaluate the efficacy of multiple doses of larazotide acetate in
      preventing intestinal permeability changes induced by a 6- week gluten challenge in subjects
      with celiac disease.
    

Detailed description: 
      This was a Phase IIb, randomized, double-blind, placebo-controlled, dose ranging, multicenter
      Study to determine the safety, tolerance, and efficacy of larazotide acetate in subjects with
      celiac disease during a gluten challenge. Subjects remained on their gluten-free diet
      throughout the duration of the trial. Study drug or drug placebo capsules were administered
      TID 15 minutes before each meal. Gluten or gluten placebo capsules will be taken TID with
      each meal.
    

Intervention name(s): larazotide acetate; placebo; 900 mg gluten
Intervention type(s): Drug; Drug; Dietary Supplement
Intervention description(s): gelatin capsules; gelatin capsules; gelatin capsules
Other intervention name(s): AT-1001; INN-202
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, double-blind, placebo Controlled, dose ranging, multicenter Study
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: larazotide acetate
Mass Balance Study of NV-5138 in Healthy Male Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study is to assess the mass balance and routes of excretion of total
      radioactivity after a single oral dose of 1600 mg [14C]-NV-5138.
    


Intervention name(s): [14C]-NV-5138
Intervention type(s): Drug
Intervention description(s): Single dose, given as oral solution, 1600 mg
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Tolerability of Baclofen for Alcohol Dependence
Condition: Alcohol Dependence
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a study of the efficacy and safety of baclofen for alcohol dependence. 80 outpatient
      subjects with DSM-IV alcohol dependence will be randomized to 10 mg three times a day (tid)
      baclofen or tid placebo. An effort will be made to recruit 40 men and 40 women. Subjects will
      receive BRENDA counseling over the 12 weeks of the trial. The Timeline Followback (TLFB)
      method will be used to assess drinking patterns. The primary outcome is % heavy drinking
      during the trial.
    

Detailed description: 
      The study will explore the efficacy and tolerability of a 12-week regimen of 10 mg t.i.d.
      baclofen vs. placebo in conjunction with behavioral therapy for reducing heavy drinking in 80
      alcohol dependent individuals. Prior studies (Addolorato et al. 2000, 2002; Flannery et al.,
      2004) have found that baclofen reduces self-reported anxiety and craving; therefore, the
      proposed study also will assess baclofen's ability to reduce symptoms of these affective
      states. Furthermore, in our pilot study (Flannery et al, 2004), women appeared to respond
      more consistently than men, and therefore the study will also be balanced by gender.
    

Intervention name(s): baclofen; placebo; BRENDA counseling
Intervention type(s): Drug; Drug; Behavioral
Intervention description(s): 10 mg Baclofen administered tid for 11 weeks; Placebo administered tid for 11 weeks
Other intervention name(s): Lioresal
Intervention MeSH terms: Baclofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: alcohol dependence; baclofen; pharmacotherapy; women
Plasma Pharmacokinetics of Alkylresorcinol Metabolites; New Candidate Biomarkers for Whole Grain Rye and Wheat Intake
Condition: Kinetics of Alkylresorcinol Metabolites
Study type: Observational

Summary: 
      The purpose of this study is to investigate the kinetics of two known alkylresorcinol
      metabolites in human subjects after intake of high-fiber rye bread. Whole grain rye is the
      most abundant source of alkylresorcinols.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        healthy, free-living females and males
      
Keywords: kinetics; alkylresorcinol metabolites; rye fiber