bioihbjkbjnl/mcl2 huggingface dataset:
Sleep Habits and AMI and Gensini Score
Condition: Sleep Disorder; Acute Myocardial Infarction
MeSH terms: Sleep Wake Disorders; Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      This study was to examine the effects of sleep habits on acute myocardial infarction (AMI)
      risk and severity of coronary artery disease (CAD) in Chinese population from two centers. A
      total of 873 patients were recruited from the inpatient cardiology department of the
      Affiliated Jiangning Hospital and the First Affiliated Hospital of Nanjing Medical
      University. Investigators used a 17-item sleep factors questionnaire (SFQ) to evaluate sleep
      habits comprehensively by face-to-face interview.
    

Detailed description: 
      Growing evidence indicates that poor sleep harms health. Early to bed and early to rise is
      considered as a healthy lifestyle in Chinese population. The current study aimed to examine
      the effects of sleep habits on acute myocardial infarction (AMI) risk and severity of
      coronary artery disease (CAD) in Chinese population from two centers. A total of 873 patients
      including 314 with AMI were recruited from the inpatient cardiology department of the
      Affiliated Jiangning Hospital and the First Affiliated Hospital of Nanjing Medical
      University. 559 controls included 395 CAD cases and 164 non-CAD cases. Investigators used a
      17-item sleep factors questionnaire (SFQ) to evaluate sleep habits comprehensively by
      face-to-face interview. The severity of CAD was assessed by Gensini score in AMI and CAD
      groups. The effects of sleep factors on AMI risk and Gensini score were examined by
      unconditional logistic regression. The timing of sleep (24:00 and after), sleep duration
      (<6h) and frequency of night-time waking (3 times) increased the risk of AMI. In subjects
      with age ≤60 years, daytime napping reduced the risk of AMI. The correlation between sleep
      quality and AMI became insignificant after subgroup analysis by age. Short sleep duration
      also increased the risk of high Gensini score.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        A case-control study was designed to investigate the effects of sleep habits on AMI and
        severity of CAD. After patients were in stable condition, trained physicians administered a
        questionnaire survey by a face-to-face interview. Information on demographic
        characteristics, hypertension, diabetes and dyslipidemia history, drug use, smoking,
        drinking, dietary habits, exercise and sleep habits were collected.
      
Keywords: sleep habits; sleep duration; daytime napping; Gensini score; late sleeping
Characterization of Pain Processing Mechanisms in Irritable Bowel Syndrome
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to provide new information and to determine which kinds of
      brief, tolerable, experimental pain are affected by the drugs being studied in patients with
      irritable bowel syndrome, a disease that causes chronic abdominal pain. The effects of
      dextromethorphan, naloxone, and fentanyl on experimental pain stimuli will be tested in these
      studies to better understand what causes irritable bowel syndrome.
    


Intervention name(s): Viceral Perception Testing
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Diagnostic
Keywords: Irritable Bowel Syndrome; Visceral Hypersensitivity; Visceral Pain
A Comparison of Mouth Rinse Containing Alcohol-free Chlorhexidine With a Cetylpyridinium Chloride in Periodontal Diseases
Condition: Periodontal Diseases
MeSH terms: Periodontal Diseases
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Aim: clinical effectiveness of 0.05% cetylpyridinium chloride mouth rinse in patients with
      gingivitis as compared to non-alcoholic chlorhexidine mouth wash.

      Methods & Material: Twenty-four subjects, without systemic diseases, with plaque-induced
      gingivitis will be selected for this study. The patients were treated with scaling and root
      planing at the baseline; Oral hygiene instructions were given that included brushing twice-
      daily, The volunteers brushed their teeth with the Bass brushing technique for at least 2
      minutes, these patients were randomly ,equally divided into two groups, Group A: perform
      daily mouthwashes twice a day with the solution containing 10 ml of 0.05 cetyl pyridinium,
      (Vi-one, Rojin, Cosmetic-Lab, Kurdistan -Iran), Group B: use daily mouthwashes twice a day
      with 10ml of the chlorhexidine(Kin Laboratories, Spain), On day 0,7,15 and day 21 of each
      phase the Plaque Index (PI), Pocket depth(PD), Stain Index(SI) and Bleeding Index (BI) of
      each volunteer were measured.
    

Detailed description: 
      In this study, 34 patients referred to periodontics Department that no serious systemic
      disease in terms of periodontitis and disease Gingivitis (ie pockets of periodontal tissue to
      a depth of less than or equal to 4 mm without CAL in the jaw down or up) the following
      explanation necessary for the procedure tastings consent, the index of oral hygiene (plaque
      index) index # Turesky, pocket depth and to control the inflammatory condition * bleeding
      index bleeding during the probe based on Carter and Barnes (if any bleeding number 1 and its
      absence 0) and attachment loss were evaluated areas. The amount of pigment (Stain) after of
      using mouthwash based on S.I (Stain Index) was evaluated .
    

Intervention name(s): cetylpyridinium chloride mouthwash; Chlorhexidine mouthwash
Intervention type(s): Drug; Drug
Intervention description(s): cetylpyridinium chloride mouthwash, 10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks.; Chlorhexidine mouthwash,10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks.
Other intervention name(s): control; Experimental Chlorhexidine mouthwash made by Perio-Kin, Livar CO. Spain
Intervention MeSH terms: Chlorhexidine; Chlorhexidine gluconate; Cetylpyridinium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Adductor Canal Block and Arthroscopic Knee Surgery, High Pain Responders
Condition: Arthroscopic Knee Surgery
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators want to explore the analgesic effect of Adductor Canal Blockade (a
      peripheral nerve block) in high pain responding patients after arthroscopic knee surgery. The
      investigators hypothesize that the nerve block will have an abrupt analgesic effect.
    


Intervention name(s): Intervention group, block no. 1 - Ropivacain; Control group: 1. block - saline
Intervention type(s): Procedure; Procedure
Intervention description(s): Intervention group: 1. block ropivacaine - 2. block saline; Control group: 1. block saline - 2. block ropivacaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Minor arthroscopic knee surgery including ACL-reconstruction (hamstrins graft); High pain responders; Adductore Canal Block; Analgesics; Ultrasound guided nerve block
Effect of Food and Calcium on Pharmacokinetics of a Single Dose of S-888711 in Healthy Adult Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objectives of this study were:

        -  To assess the effect of a high-fat diet on the pharmacokinetics (PK) of a 0.75 mg single
           dose of S-888711 orally administered as 0.25 mg tablets in healthy volunteer adults

        -  To assess the effect of a calcium supplement on the PK of a 0.75 mg single dose of
           S-888711 orally administered as 0.25 mg tablets in healthy volunteer adults
    


Intervention name(s): S-888711; Calcium Antacid
Intervention type(s): Drug; Dietary Supplement
Intervention description(s): Administered orally as three 0.25 mg tablets; Calcium carbonate 4000 mg chewable tablets
Intervention MeSH terms: Antacids; Calcium Carbonate; Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Zirconia Versus Lithium Di-silicate Overlays for Restoring Hypomineralized Molars Affected With MIH
Condition: Molar Incisor Hypomineralization
MeSH terms: Molar Hypomineralization; Dental Enamel Hypoplasia
Study type: Interventional

Summary: 
      the study evaluate the clinical outcome of zirconia versus lithium disilicate overlays
      restorations for restoring vital young permanent first molar teeth affected with moderate
      form of molar Incisor hypomineralization: randomized clinical trial.
    

Detailed description: 
      To compare the one-year clinical outcome of zirconia versus lithium disilicate overlays
      restorations. Materials and methods: Twenty patients were distributed into two groups in
      relation to the material used for the fabrication of overlays restorations; group (Z) (n=10):
      patients received zirconia restorations, group (EC): patients received IPS E.max Cad
      restorations. Clinical and radiographic evaluations of these restorations were carried out at
      base line (1 week), 3, 6 and 12 months after cementation using FDI World Dental Federation
      criteria
    

Intervention name(s): overlay
Intervention type(s): Procedure
Intervention description(s): Lithium Disilicate partial coverage of hypo-mineralized defected enamel
Other intervention name(s): Zirconia partial coverage of hypo-mineralized defected enamel
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Clinical Trial
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MIH - zironia - Lithium Disilicate - Overlays
Placebo-controlled Trial in Subjects at Ultra-high Risk for Psychosis With Omega-3 Fatty Acids in Europe
Condition: Ultra High Risk for Psychosis
MeSH terms: Psychotic Disorders; Mental Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether omega-3 fatty acids are effective in the
      prevention of psychosis in individuals at ultra-high risk for psychosis.
    

Detailed description: 
      PURPOSE is a randomized double-blind placebo-controlled study. Main objective is to assess
      the effectivity of omega-3 fatty acid treatment in the prevention of psychosis. The primary
      outcome measure is the rate of transition to psychosis as determined through CAARMS. Subjects
      in the age range of 13-20 years with a higher chance of developing psychosis, as determined
      by the CAARMS, are treated for 6 months with omega-3 fatty acids or placebo. This study in
      conducted at 14 sites in 9 countries.
    

Intervention name(s): Omega-3 fatty acids; Placebo
Intervention type(s): Drug; Other
Other intervention name(s): Fishoil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Ultra-high risk; UHR; psychosis
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD5718 After Single and Multiple Ascending Dose Administration to Healthy Japanese Men
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I study to investigate the safety, tolerability, pharmacokinetics (PK) and
      pharmacodynamics (PD) of the novel compound, AZD5718 in healthy Japanese men. The results
      from this study will form the basis for decisions on future studies.
    

Detailed description: 
      This study will be a Phase 1, randomized, single-blind, placebo-controlled, single and
      multiple ascending dose sequential group design in up to 48 healthy male Japanese subjects,
      performed at a single study center. The planned number of cohorts is 4 but up to 6 cohorts
      may be included if the Safety Review Committee (SRC) considers it necessary to repeat a dose
      level or if additional dose steps are required. Screening will be completed between Days -28
      and -1. Primarily gradual escalation of the dose will be conducted with the oral suspension.
      Eight subjects will participate in each cohort. Four ascending dose levels are planned.
      Within each cohort 6 subjects will be randomised to receive AZD5718 and 2 subjects randomised
      to receive placebo. Each subject will receive one dose of AZD5718 or placebo on the first
      dosing day (Day 1, single ascending dose, SAD) and on Days 3 to 10 (multiple ascending dose,
      MAD). On Day 2 no dose will be given to the subject. In total each subject will receive 9
      doses. Dosing for each ascending dose cohort will proceed after the SRC has evaluated the
      safety, tolerability and other relevant data of a completed cohort. The subjects will stay at
      the study site until 48 hours post-dose and will return 7 to 10 days after dosing for a
      follow-up visit. Each subject will be involved in the study for 7 weeks.
    

Intervention name(s): AZD5718 oral suspension; Placebo matching AZD5817 oral suspension
Intervention type(s): Drug; Other
Intervention description(s): In all cohorts, randomized subjects will receive orally AZD5718 oral suspension SAD (60 mg) on Day 1 and MAD (180 mg, 360 mg and 600 mg) from Days 3 to 10. On Day 2, no dose will be given. In total each subject will receive 9 doses of AZD5718.; In all cohorts, randomized subjects will receive orally placebo matching AZD5718 oral suspension on Day 1 and from Days 3 to 10. On Day 2, no dose will be given.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Coronary Artery Disease,; Cardiovascular disease (CAD),; 5-lipoxygenase activating protein (FLAP) inhibitor,; Leukotrienes.
The Long Term Clinical Course of Postinfectious Irritable Bowel Syndrome After Shigellosis; A 10 Year Follow up Study
Condition: Shigella Sonnei Infection
MeSH terms: Dysentery, Bacillary; Irritable Bowel Syndrome; Disease Progression
Study type: Observational

Summary: 
      Background: The incidence of postinfectious irritable bowel syndrome (PI-IBS) was reported to
      be in the range of 5-30%, but limited number of long-term follow-up results.

      Objective: To investigate the long term clinical course of PI-IBS after Shigellosis.

      Setting: A Shigellosis outbreak in a tertiary referral hospital with about 2,000 employees in
      Korea at 2001.

      Patients: A Shigella-exposed cohort of 124 hospital employees who had been infected by
      Shigella sonnei due to contaminated food in the employee-cafeteria in Gangnam Severance
      Hospital, Seoul, Korea, at December 2001. A control cohort of age and sex-matched,
      non-infected 105 contemporary hospital employees.

      Measurements: Questionnaire survey for bowel symptoms at 1, 3, 5, 8 and 10 years after
      outbreak.
    

Detailed description: 
      Postinfectious-IBS (PI-IBS) can be defined as the acute onset of new IBS symptoms in an
      individual, who has not previously met the criteria for IBS, immediately following an acute
      illness characterized by 2 or more of the following: fever, vomiting, diarrhea, or a positive
      bacterial stool culture.

      Our group previously have reported clinical course of PI-IBS in a homogenous cohort which was
      comprised of patients recovered from Shigellosis. And in current study, we finally report a
      collective result of 10-year long-term follow-up of our small, but well-followed, homogenous
      cohort of PI-IBS after Shigellosis.
    

Intervention name(s): Shigella sonnei infection
Intervention type(s): Other
Intervention description(s): A Shigella-exposed cohort of 124 hospital employees who had been infected by Shigella sonnei due to contaminated food in the employee-cafeteria in Gangnam Severance Hospital, Seoul, Korea, at December 2001.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        a Shigellosis outbreak took place at Gangnam Severance Hospital in Seoul, Korea, due to the
        consumption of contaminated food in the hospital cafeteria for employees. The causative
        pathogen was Shigella sonnei, and a total of 181 patients were diagnosed and treated for
        Shigellosis. After the termination of Shigellosis outbreak, we could establish a cohort of
        the Shigella-exposed group for serial surveys. The initially established Shigella-exposed
        cohort was comprised of 143 subjects, and we also could recruited the control group as age-
        and sex-matched healthy volunteers who were also hospital employees at same period and had
        not been infected, nor exposed to causal food.
Brain Imaging Study Of Rosiglitazone Efficacy And Safety In Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a placebo-controlled study evaluating the effects of rosiglitazone on functional
      brain activity and cognition in patients with mild to moderate Alzheimer's Disease (AD).
    


Intervention name(s): Rosiglitazone; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Extended Release Tablets; Placebo dummy to match
Intervention MeSH terms: Rosiglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: rosiglitazone; cognition; cerebral glucose metabolism; positron emission tomography (PET); Alzheimer's Disease
Study To Evaluate The Effects Of Gabitril™ In Patients With Social Anxiety Disorder
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional
Phase: Phase 4

Summary: 
      The main purpose of this study is to determine how safe and effective Gabitril is for
      outpatients with Social Anxiety Disorder (SAD).
    

Detailed description: 
      This study is being conducted at two sites in the United States. Approximately 50 patients,
      who are between the ages of 18 and 65 years old will be enrolled at Emory. This study
      consists of two parts. The first part consists of 12 weeks of open-label treatment with
      Gabitril. If the study doctor determines that the patients condition has improved and they
      have completed the initial 12 weeks of treatment they may be eligible for the second part of
      the study. This part is a 24-week double-blind treatment period with either Gabitril or
      placebo (inactive medication). There will also be a follow-up visit about 1 to 3 weeks after
      they have completed taking the study medication. Altogether study participation is expected
      to last approximately 37 weeks.
    

Intervention name(s): Gabitril
Intervention type(s): Drug
Intervention MeSH terms: Tiagabine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Social Anxiety Disorder; Mental Health
The Effect of MK 0633 in Patients With Atherosclerosis (0633-008)(COMPLETED)
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      A study to test the effects of study drug (MK 0633) on patients with Atherosclerotic disease
    


Intervention name(s): MK0633
Intervention type(s): Drug
Intervention description(s): Single dose MK0633 100mg po in the fed state administered during a 4-wk study.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Pharmacokinetics and Bioavailability of Pomegranate Phenolics and Urolithins in Healthy Subjects.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Pomegranate phenolics (such as the ellagitannin punicalagin and ellagic acid) are metabolized
      by the human gut microbiota to yield a number of metabolites called urolithins (mainly
      Uro-A). Both ellagic acid (EA) and urolithins can exert a number of biological activities.
      However, the bioavailability of ellagic acid has been reported to be very low and the
      existing studies are controversial so far. The investigators want to carry out a robust
      (cross-over, double-blind) pharmacokinetic assay in 20 healthy volunteers, using two types of
      pomegranate extracts (PEs). PEs with low (PE-1) and high (PE-2) punicalagin:EA ratio will be
      administered. The investigators will analyze blood and urine samples using
      UPLC-ESI-QTOF-MS/MS. The investigators will evaluate:

        -  The pharmacokinetics of EA.

        -  The effect of punicalagin:free EA ratio on the pharmacokinetics of EA and urolithins
           production.
    


Intervention name(s): Pomegranate extract; Pomegranate extract
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Crossover study: The group will consume the pomegranate extract with low punicalagin:EA ratio (PE-1). After 2 weeks of washout, the same group will also consume the other extract with high punicalagin: EA ratio (PE-2).; Crossover study: The group will consume the pomegranate extract with high punicalagin:EA ratio (PE-2) after 2 weeks of washout. The same group will also consume the other extract with low punicalagin: EA ratio (PE-1).
Other intervention name(s): PE-1; PE-2
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Basic Science
Keywords: Pomegranate; Ellagic acid; Pharmacokinetics; Urolithins; Bioavailability
Determine Range of Tissue Frataxin Concentrations and Other Potential Biomarkers
Condition: Friedreich Ataxia; Healthy Volunteers
MeSH terms: Ataxia; Friedreich Ataxia
Study type: Observational

Summary: 
      To examine range of tissue frataxin (FXN) concentrations, specific ribonucleic acids, other
      proteins and specialized lipids in the buccal cells, blood, and skin cells of normal healthy
      volunteers without Friedreich's ataxia (FRDA).
    

Detailed description: 
      Primary Objective: To examine the range of tissue frataxin (FXN) concentrations in the buccal
      cells, blood, and skin cells of normal healthy volunteers without FRDA.

      Secondary Objective: To examine the range of specific ribonucleic acids (RNAs), other
      proteins, and specialized lipids in the buccal cells, blood, and skin cells of normal healthy
      volunteers without FRDA.
    

Intervention name(s): Buccal Swabs, Blood Draws and Skin Punch Biopsy
Intervention type(s): Diagnostic Test
Intervention description(s): Buccal Swabs - FXN and specific RNA markers; Blood Draws - Lipid panel, Protein Marker Analysis and Gene RNA Analysis; Skin Punch Biopsy - Protein Markers
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be recruited from the community.
      
Biospecimen description: 
      Buccal cells and blood