bioihbjkbjnl/mcl2 huggingface dataset:
Effects of White Rice, Brown Rice, and Black Rice on Postprandial Glucose and Lipid Profiles in Healthy Korean Adults
Condition: Healthy
Study type: Interventional

Summary: 
      This study was an open, 5-treatment, 5-sequence, 5-day cross-over randomized design clinical
      trial. The present study was carried out to compare the effects of white rice, brown rice,
      and black rice on postprandial glucose and lipid profiles in healthy human subjects, using a
      white bread as a positive control.
    

Detailed description: 
      After a 12-hour fast, oral glucose and meal tolerance was measured with blood samples drawn
      at times 0, 15, 30, 45, 60, 90, 120, 150 and 180 minutes and TG was at time 0, 1, 2, 3, 4, 5
      and 6 hours.

        1. Serum levels of glucose, insulin, and TG were analyzed by biochemical autoanalyzer. The
           area under the curve (AUC) changes in blood glucose, TG were computed by the trapezoidal
           method.

        2. Glycemic index(GI): the area under the glucose response curve after consumption of a
           test food divided by the area under the curve after consumption of a control food
           containing the same amount of carbohydrate and calculated using 50 g glucose as the
           reference.
    

Intervention name(s): White rice diet; Brown rice diet; Black rice diet; Bread; Glucose solution
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement; Other
Intervention description(s): All test foods contained 50 g available carbohydrate from the test food products. A glass of 250 ml water was served together with the clinical trial food, and the participants were instructed to ingest the breakfast with 15 min; All test foods contained 50 g available carbohydrate from the test food products. A glass of 250 ml water was served together with the clinical trial food, and the participants were instructed to ingest the breakfast with 15 min; All test foods contained 50 g available carbohydrate from the test food products. A glass of 250 ml water was served together with the clinical trial food, and the participants were instructed to ingest the breakfast with 15 min; All test foods contained 50 g available carbohydrate from the test food products. A glass of 250 ml water was served together with the clinical trial food, and the participants were instructed to ingest the breakfast with 15 min; All test foods contained 50 g available carbohydrate from the test food products.and the participants were instructed to ingest the breakfast with 10 min.
Other intervention name(s): control diet; Reference diet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: male; Glucose; Triglyceride; Glycemic index; White rice; Brown rice; Black rice; Bread
Voice Quality Changes With IANB Anesthesia
Condition: Anesthesia, Local; Voice Change
MeSH terms: Dysphonia
Study type: Observational

Summary: 
      Background: Inferior alveolar nerve block anesthesia is commonly used in dental procedures,
      but its effect on the voice quality is not well understood. The aim of this study is to
      investigate the effect of mandibular anesthesia on the acoustic voice quality index.

      Objective: The primary objective of this study is to determine the effect of mandibular
      anesthesia on the acoustic voice quality index.

      Design: This is a within-subject study design. Participants will be recruited from a local
      dental clinic and will be adults aged 18 years or older. The participants will have the
      acoustic voice quality index measured before and after the administration of mandibular
      anesthesia. The parameters that will be measured include acoustic voice quality index and
      self ........ The data will be analyzed using appropriate statistical techniques.

      Expected Outcome: The study is expected to provide insights into the effect of mandibular
      anesthesia on the acoustic voice quality index. The results of this study may help in
      understanding the impact of mandibular anesthesia on voice quality and may have implications
      for dental practitioners and patients who receive mandibular anesthesia.
    


Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The study population will consist of adults aged 18 years or older who are scheduled to
        receive inferior alveolar nerve block anesthesia as part of their dental procedure.
      
Keywords: Voice Quality; Anesthesia, Dental; Mandibular Nerve; Lingual Nerve; Speech Acoustics
Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-021)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this clinical study is to determine the safety and efficacy of an
      investigational drug in patients with type 2 diabetes mellitus.
    


Intervention name(s): Sitagliptin (MK0431); Sitagliptin; Placebo; Placebo; Metformin - Rescue
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Phase A: Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks.; Phase A: Sitagliptin 200 mg once a day for 24 weeks. Phase B: Sitagliptin 200 mg once a day for 80 weeks.; Phase A: Placebo matching Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks.; Phase A: Placebo matching Sitagliptin 200 mg once a day for 24 weeks. Phase B: Sitagliptin 200 mg once a day for 80 weeks.; Phase A: Patients not meeting specific glycemic goals will receive open-label metformin as 500 mg, 850 mg, and 1000 mg oral tablets titrated at the discretion of the investigator. Phase B: These patients will not initiate Phase B double-blind medication.
Other intervention name(s): MK0431; Januvia; MK0431; Januvia; Metformin; Glucophage; Glucophage XR; Glumetza; Fortamet; Riomet
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of the Modification of the Pharmacokinetic Profile of Levodopa by the Fiber Plantago Ovata Husk
Condition: Parkinson's Disease, Idiopathic
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this trial is to study the effect of the association levodopa/carbidopa with
      plantago ovata husk in Parkinson´s disease patients of recent diagnostic, that are being
      treated with levodopa/carbidopa.
    

Detailed description: 
      Although the treatment with l-dopa is the election treatment for Parkinson´s disease, a high
      number of patients develop motor complications, including, fluctuations and dyscinesia after
      some years of treatment.

      The origin of the fluctuations is not well established, but it could be attributed, al least
      partially, a pharmacokinetics factors. So that, it could improve the answer and reduce the
      adverse reaction if we reach more stable levels of L-dopa in the circulation. The first
      experimental studies in animals showed that Plantago ovata husk has an influence in the
      pharmacokinetics parameters of L-dopa, obtaining more stable levels.
    

Intervention name(s): Plantago ovata husk; hemicellulose crystalline
Intervention type(s): Drug; Other
Intervention description(s): 5 g of effervescent powder (3.5 g pf plantago ovata husk) t.i.d. during 14 days; 5g effervescent powder t.id. during 14 days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Parkinson's Disease, Idiopathic; l-dopa levels; plantago ovata husk
Phase 3 Study of OTO-104 in Subjects With Unilateral Meniere's Disease
Condition: Meniere Disease
MeSH terms: Meniere Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of
      Meniere's disease.
    


Intervention name(s): OTO-104; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single intratympanic injection of 12 mg dexamethasone; Single intratympanic injection of placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized, Double-blind, Placebo-controlled, Multicenter
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Meniere's Disease; Vertigo; Endolymphatic Hydrops; Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases
The Effects of Oxytocin on Complex Social Cognition in Autism Spectrum Disorders
Condition: Autism; ASD
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      This study examines the effects of a single dose of intranasal oxytocin (vs. placebo) on
      complex social cognition in adults with autism spectrum disorders.
    

Detailed description: 
      Participants receive a one-time administration of 24-IU intranasal oxytocin (or placebo) and
      perform an empathic accuracy task, a novel and ecologically valid measure of complex social
      cognition, in conjunction with functional magnetic resonance imaging (fMRI). The
      investigators will investigate the effects of oxytocin (versus placebo) on the behavioral and
      neural correlates of empathic accuracy.
    

Intervention name(s): Syntocinon; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): One dose of 24 IU (3 sprays/nostril); Intranasal Placebo
Other intervention name(s): Intranasal oxytocin
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants are randomized to receive 24IU intranasal oxytocin or placebo on days separated by a minimum of 3 weeks. Randomization order to drug condition is counter-balanced.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Infant Feeding Practice and Gut Comfort Study
Condition: Healthy Infants
Study type: Observational [Patient Registry]

Summary: 
      Multi-country, cross-sectional, observational study in diverse geographic locations all over
      the world.
    

Detailed description: 
      This is a cross-sectional single time point study. Infants and caregivers who come to a
      clinic for a routine health visit who wish to participate in the study by signing the consent
      form and meet all inclusion criteria/exclusion criteria will be enrolled.

      At the visit, a research staff member will assist the parents to complete (i) Feeding
      Practice and Gut Comfort Questionnaire and (ii) Infant Gastrointestinal Symptom (IGSQ)-13
      items. Additionally, infant's anthropometrics (weight, length, head circumference) will be
      recorded. These anthropometrics will be measured by the researcher as part of the routine
      visit.
    

Intervention name(s): There is no intervention in this observational study.
Intervention type(s): Other
Intervention description(s): There is no intervention in this observational study.
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy normal developing male and female full-term infants
Effects of Essential and Non-Essential Amino Acids on Post-Exercise Muscle Collagen Synthesis in Young Men
Condition: Skeletal Muscle; Extracellular Matrix; Amino Acids Metabolism; Exercise; Dietary Supplements
Study type: Interventional

Summary: 
      The purpose of this study is to assess which amino acids are affecting acute muscle collagen
      synthesis in response to supplementation and exercise.
    

Detailed description: 
      This is a double-blinded, randomized controlled, parallel design study, with 3 treatment
      groups (placebo, collagen peptide, and essential amino acid). The study will involve 3
      visits: a baseline testing/familiarization session, and 2 exercise trials which will include
      muscle biopsies, blood draws, and the infusion of a tracer isotope in order to measure muscle
      protein synthesis.
    

Intervention name(s): Essential Amino Acid; Collagen Peptide; Maltodextrin Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Immediately following the exercise intervention participants will consume their assigned essential amino acid supplement; Immediately following the exercise intervention participants will consume their assigned collagen peptide supplement; Immediately following the exercise intervention participants will consume their assigned maltodextrin supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: - Double-blinded, randomized controlled, parallel design study, with 3 treatment groups (placebo, collagen peptide, and essential amino acid)
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Muscle Collagen Turnover; Myofibrillar Protein Synthesis; Extracellular Matrix; Anabolism Signaling; Resistance Exercise; Skeletal Muscle; Bone Turnover
Impact of Nutrition Intervention on HIV/AIDS Infected Patients
Condition: Human Immunodeficiency Virus (HIV); Acquired Immune Deficiency Syndrome (AIDS)
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections; Immunologic Deficiency Syndromes
Study type: Interventional
Phase: Phase 3

Summary: 
      Intervention to investigate the efficacy of a nutritional supplement among ARV-naïve,
      asymptomatic HIV positive patients with a CD4 count in the range 300-550 cells/ul.
    

Detailed description: 
      To investigate the efficacy of a nutritional supplement among ARV-naïve, asymptomatic HIV
      positive patients with a CD4 count in the range 300-550 cells/ul.

      A total of 120 participants will be stratified by age and gender and randomly assigned to two
      treatment arms. Sixty (60) participants will be assigned to receive dietary counselling and a
      multivitamin/mineral supplement, with sixty (60) additionally receiving an oral Medical
      Nutritional Supplement (MNS).

      Participants will be followed for six months post-randomization: at baseline, 3 months and 6
      months. The principal outcome measure is Body Mass Index, used as a proxy for 'nutritional
      status'. Secondary outcome measures include immune status and antioxidant status.
    

Intervention name(s): Theragran-M; Ensure Plus; Theragran-M
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Theragran-M: One tablet daily for 6-months. Ensure Plus: One 8 fl.oz. bottle daily for 6-months. Nutritional counselling: at baseline, and at monthly follow-up visits.; Theragran-M: One tablet daily for 6-months. Nutritional counselling: at baseline and at monthly follow-up visits.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HIV/AIDS; Nutrition Therapy; Dietary Supplement; Antioxidant; Immunity; CD4 count; Anthropometry; Body Mass Index
Study to Evaluate the Interaction Potential of Clarithromycin XL on Diltiazem Hydrochloride Cream 2% in Healthy Subjects
Condition: CLARITHROMYCIN/DILTIAZEM [VA Drug Interaction]
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the drug-drug interaction potential of
      clarithromycin XL on Diltiazem hydrochloride (DTZ) 2% cream.
    

Detailed description: 
      This study was designed to investigate the potential effect of clarithromycin XL at steady
      state (administered orally, once daily on Days 4 through 9 as 2 x 500 mg tablets, 1000 mg per
      day, for a total of 6000 mg) on the PK of a single topical dose of diltiazem hydrochloride 2%
      cream applied to the perianal area (~2.5 cm [1 inch]; ~8.5 mg). This was a Phase 1 study with
      a single treatment arm. Efficacy was not assessed; therefore the study was of open-label
      design.
    

Intervention name(s): Clarithromycin XL; 2% Diltiazem
Intervention type(s): Drug; Drug
Intervention description(s): Clarithromycin XL administered once daily on Days 4 through 9 as 2 x 500 mg tablets, 1000 mg per day, for a total of 6000 mg; 2% Diltiazem Hydrochloride Cream applied on Day 1 & Day 8 to the perianal area (~2.5 cm [1 inch]; ~8.5 mg)
Intervention MeSH terms: Clarithromycin; Diltiazem
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Cognitive Functions and BDNF in T2DM and Prediabetes Patients
Condition: Diabetes Type 2; PreDiabetes; Cognitive Impairment
MeSH terms: Prediabetic State; Glucose Intolerance; Diabetes Mellitus, Type 2; Cognitive Dysfunction
Study type: Observational

Summary: 
      Clinical and epidemiological studies suggest links between cognitive impairments and Type 2
      diabetes (T2DM). The underlying mechanisms and causality in diabetes-related cognitive
      impairment are largely unknown. The aim of this study is to investigate cognitive impairment
      and the role of BDNF in prediabetes and diabetes patients.
    

Detailed description: 
      Cognitive dysfunction is increasingly recognized as a common complication and comorbidity in
      both type 1 and type 2 diabetes (T2DM). Due to the increasing incidence of diabetes and the
      life expectancy of individuals with T2DM, it is important to determine the cognitive problems
      and related factors in these patients. Cognitive impairment can be observed in all age groups
      in individuals with diabetes, and its severity can range from mild cognitive impairment to
      dementia. Although there are few studies in the literature investigating cognitive impairment
      in prediabetes, it is not clear whether it is a risk factor.

      The number of studies investigating biomarkers of potential importance for understanding
      changes in the brain of T2DM patients is increasing rapidly. The relationship of biomarkers
      associated with the main pathologies of dementia, including Alzheimer's disease (AD) and
      vascular disease, as well as various biomarkers associated with brain parenchymal damage,
      blood flow and metabolism, with the cognitive status of diabetic patients are investigated.
      It has been determined in animal experiments that Brain Induced Neurotrophic Factor (BDNF)
      may be among the molecular factors linking T2DM with dementia neuropathology. It has also
      been stated that high glucose levels are associated with cognitive impairment and total
      hippocampal volume reductions, and hippocampal changes can be used as an early marker of
      diabetes-related brain damage. Considering that the expression of BDNF in the brain is high
      in hippocampus neurons, it may be an early marker of cognitive impairment in diabetes.

      This research is a cross-sectional observational study. The aim of this study is to
      investigate cognitive impairment and the role of BDNF in prediabetes and diabetes patients.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Diabetes, prediabetes and control patients who applied to the internal medicine outpatient
        clinic of Bezmialem Vakıf University and met the inclusion/exclusion conditions of the
        study
      
Keywords: diabetes; BDNF; T2DM; prediabetes; cognition
Evaluating the User Performance and Experience of Nucleus Pen vs. Commercially Available Pen Needle
Condition: Diabetes
Study type: Interventional

Summary: 
      This is a multi-site, prospective, open-label, randomized, 2 period cross over study
      comparing the subjects' current 32G pen needle (four groups of pen needles) to the BD Nucleus
      pen needle. The study will consist of two 15 day periods ( in which the subject will use each
      pen needle [BD Nucleus pen needle or subject's current pen needle, order randomized] for
      injection. At the end of the last study period, each subject will be asked to evaluate his or
      her perceptions using a 150mm relative VAS scale.
    


Intervention name(s): BD Nano™ vs Nucleus; NovoFine® vs Nucleus; NovoTwist®/NovoFine® Plus vs Nucleus; Other Commercially Available Pen Needles (Unifine® Pentips®/Mylife Clickfine®) vs Nucleus
Intervention type(s): Device; Device; Device; Device
Intervention description(s): Subjects will be randomized to
Nucleus pen needle for the first 15-day period, or current pen needle (BD Nano™) for the second 15-day period or
subject's current pen needle (BD Nano™) for the first 15-day period, Nucleus pen needle for the second 15-day period; Subjects will be randomized to
Nucleus pen needle for the first 15-day period, or current pen needle (NovoFine®) for the second 15-day period or
subject's current pen needle (NovoFine®) for the first 15-day period, Nucleus pen needle for the second 15-day period; Subjects will be randomized to
Nucleus pen needle for the first 15-day period, or current pen needle (NovoTwist®/NovoFine Plus®) for the second 15-day period or
subject's current pen needle (NovoTwis®t/NovoFine® Plus) for the first 15-day period, Nucleus pen needle for the second 15-day period; Subjects will be randomized to
Nucleus pen needle for the first 15-day period, or current pen needle (Other Commercially Available Pen Needles) for the second 15-day period or
subject's current pen needle (Other Commercially Available Pen Needles) for the first 15-day period, Nucleus pen needle for the second 15-day period
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other