bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Two Universal Composites in Posterior Teeth
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The aim of this randomized, prospective clinical study was to compare the clinical
      performance of a universal light-curing, ultra-fine particle hybrid composite with a new
      version of this product produced by the same manufacturer in Class 1 and Class 2 lesions.
    

Detailed description: 
      A total of 80 (13 Class 1 and 67 Class 2) lesions in 40 patients (21 females, 19 males) with
      ages ranging between 18-38 years (23.15±5.15) were either restored with Charisma or Charisma
      Classic (Heraeus Kulzer) in combination with an etch and rinse adhesive system (Gluma 2 Bond)
      under rubber dam isolation by two experienced operators according to the manufacturer's
      instructions. Two independent examiners, who were blinded to the composites used evaluated
      the restorations according to the FDI (World Dental Federation) criteria. Bite-wing
      radiographs and intraoral digital photographs were taken before and after treatment and at 6
      months. The statistical analyses were carried out with McNemar, Pearson Chi-square and
      Cochran Q tests (p<0.05).
    

Intervention name(s): Charisma; Charisma Classic
Intervention type(s): Other; Other
Intervention description(s): The surfaces were etched using 35% phosphoric acid for 30 s. The etched surfaces were rinsed and dried. Charisma was used in combination Gluma2 Bond etch&rinse adhesive. The composite resin restorations were light-cured (600 milliwatt/cm²). Occlusion was checked with thin articulating papers.
Restoration surfaces were finished and polished with fine finishing diamond burs, stones and rubber cups.; The surfaces were etched using 35% phosphoric acid for 30 s. The etched surfaces were rinsed and dried. Charisma classic was used in combination Gluma2 Bond etch&rinse adhesive. The composite resin restorations were light-cured (600 milliwatt/cm²). Occlusion was checked with thin articulating papers.
Restoration surfaces were finished and polished with fine finishing diamond burs, stones and rubber cups.
Other intervention name(s): universal composite; universal composite
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: composite resin; Clinical trial; FDI (World Dental Federation) criteria
Prevalence of Bacterial Contamination on Smart Cell Phone vs. Non-smart Phone
Condition: Health Care Workers, Including Physicians, Nurses, and Nursing Aids
Study type: Observational

Summary: 
      Using smartphone is increasing in hospital with various purpose and it has more extended
      surface than non-smart phone. Therefore investigators can consider the bacterial
      contamination rate of smartphone will be higher than that of non-smartphone.
    

Detailed description: 
      Hospital-acquired infections(HAI) are causing grave concern in almost all the hospitals of
      the world and causing increased morbidity and mortalities.

      The transmission of HAI occurs through hospital staff and inanimate hospital environment,
      equipment, and devices that the hospital staff use.Recently, cellphones (CP) were blamed to
      cause nosocomial infections.

      The mobile phones are used routinely all day long but not cleaned properly, as health care
      workers' may do not wash their hands as often as they should. The aim of the present study
      was to evaluate the prevalence of bacterial contamination of mobile phones in ICU health care
      providers. and especially compare the contamination rate between smartphone and
      non-smartphone.

      Using smartphone is increasing in hospital with various purpose and it has more extended
      surface than non-smart phone. therefore we can consider the bacterial contamination rate of
      smartphone will be higher than that of non-smartphone.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        healthcare providers of MICU in Seoul national university hospital and Seoul national
        university Bundang hospital who have cellular phones
Evaluating a Remotely Delivered Plant-Based Behavioral Weight Loss Treatment
Condition: Obesity; Overweight
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      Many individuals do not achieve clinically significant weight loss following traditional
      lifestyle modification interventions, potentially because weight loss is dependent upon
      calorie tracking compliance (to achieve calorie prescriptions), which decreases over time for
      most. By contrast, non-energy-restricted whole food plant-based diets (WFPBD) have been
      demonstrated to promote clinically significant weight loss even without calorie
      prescriptions. The present pilot trial represents the first, to the knowledge of our study
      team, to empirically test a remotely delivered WFPBD behavioral weight loss intervention for
      adults with overweight or obesity. Over 12-weeks, participants (N = 21) will follow a
      non-energy-restricted WFPBD and received nutritional counseling and behavioral weight loss
      intervention. Participation will occur in two phases (Phase 1: n = 7; Phase 2: n = 14),
      between which iterative changes to the intervention will be made. Assessments will occur at
      baseline, mid-treatment, post-treatment, and 3-month follow-up. Data will be analyzed using
      an intent-to-treat approach. The primary aims of the study will be to assess retention
      feasibility and acceptability. The secondary aims will be to evaluate the preliminary
      effectiveness of the intervention on: (1) percent weight loss; (2) dietary intake (i.e.,
      increased intake of low-fat plant-based whole foods and decreased in intake of processed
      foods and animal products); and (3) waist circumference. The exploratory aims will be to
      evaluate the preliminary effectiveness of the intervention on physical- and mental
      health-related quality of life, and to examine potential moderators of treatment success
      (plant-based diet history, internal disinhibition, social support vs. social sabotage,
      self-compassion, and psychological flexibility).
    


Intervention name(s): Whole Food Plant-Based Behavioral Weight Loss Treatment
Intervention type(s): Behavioral
Intervention description(s): Over the course of 12-weeks, participants will be prescribed a non-energy-restricted whole food plant-based diet and will learn behavioral weight loss strategies through an e-learning platform. Each week, participants will also complete a 15-minute coaching call to provide positive reinforcement and problem-solving support.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Weight loss; Behavioral weight loss; Overweight and obesity; Plant-based; Lifestyle modification
Phase 1 Study of ALXN1840 on the Metabolism of a CYP2C9 Substrate in Healthy Participants.
Condition: Wilson Disease
MeSH terms: Hepatolenticular Degeneration
Study type: Interventional
Phase: Phase 1

Summary: 
      This was a Phase 1, randomized, 2-period, 2-sequence, cross-over study designed to determine
      the effect of ALXN1840 on the metabolism of celecoxib, a sensitive cytochrome P450 2C9
      (CYP2C9) substrate, in healthy male and female participants. The safety and tolerability of
      ALXN1840 were determined along with ALXN1840 pharmacokinetics (PK) in plasma as measured via
      total molybdenum with the coadministration of celecoxib.
    

Detailed description: 
      The study was conducted as a randomized, 2-period, 2-sequence, cross-over study to determine
      the effect of a single dose of ALXN1840 (perpetrator) on the single-dose celecoxib (victim)
      kinetics in healthy male and female participants.

      The study had a Screening period (Day -28 to Day -2), two 11-day study periods (Day 1 to Day
      11) with a minimum of 14 days between doses of celecoxib, and an End of Study Visit (Day 15 ±
      2 days) after Period 2 dosing. Participants only reported to the clinical research unit (CRU)
      on the day prior to the first dose because they were kept in the CRU during the wash-out
      period due to coronavirus disease 2019.

      All participants received a single dose of celecoxib alone (Treatment A) and celecoxib
      coadministered with ALXN1840 (Treatment B) during the study, 1 in each treatment period.
      Based on randomization, participants were administered either Treatments A-B or Treatments
      B-A in each study period.

      The PK profile of ALXN1840 and celecoxib was determined by blood sampling following
      single-dose administration. In addition to PK sampling, safety and tolerability were assessed
      by monitoring adverse events, vital signs, 12-lead electrocardiograms, physical examinations,
      and laboratory parameters.
    

Intervention name(s): ALXN1840; Celecoxib
Intervention type(s): Drug; Drug
Intervention description(s): ALXN1840 was administered orally as a single dose as 4 x 15 milligram (mg) enteric-coated tablets with 240 milliliters (mL) of water (fasting), for a total dose of 60 mg.; Celecoxib was administered orally as a single dose as one 200-mg tablet with 240 mL of water (fasting).
Other intervention name(s): WTX101; Bis-choline tetrathiomolybdate; Tiomolibdate choline
Intervention MeSH terms: Celecoxib; Tetrathiomolybdate; Choline
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants were randomized to 1 of 2 treatment sequences: A-B or B-A.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cytochrome P450; Healthy; ALXN1840; Celecoxib; CYP2C9
Leg Exercise During ECMO
Condition: Refractory Respiratory Failure
MeSH terms: Respiratory Insufficiency
Study type: Interventional

Summary: 
      Patients undergoing extracorporeal membrane oxygenation (ECMO) are at high risk for
      deconditioning and functional decline. The primary aim of this study is to assess the
      functional impact of leg exercise during the pre-ambulation phase in patients undergoing
      ECMO.
    

Detailed description: 
      The investigators are conducting this study to explore the impact of closed-chain leg
      exercise in individuals undergoing ECMO.

      Aim 1: To determine if closed-chain leg exercise decreases the time to initial ambulation.
      The investgators hypothesize that adding leg exercise will decrease time to ambulation.

      Aim 2: To determine the impact of closed chain leg exercise on functional ability. The
      investigators hypothesize that adding leg exercise will improve functional outcomes when
      added to an existing early mobilization program.

      Aim 3: To determine the effect of closed chain leg exercise on hospital outcomes. The
      investigators hypothesize that hospital related outcomes will improve when leg exercise is
      added to an existing early mobilization program.
    

Intervention name(s): Open-Chain Leg Exercise; Closed-Chain Leg Exercise
Intervention type(s): Other; Device
Intervention description(s): Individuals in the open-chain group will progress through standard mobility progression.; Individuals in the closed-chain group will progress through standard mobility exercises with the addition of closed-chain leg exercises using the MOVEO platform.
Other intervention name(s): Moveo Platform
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 24 total subjects will be recruited; 12 per group. Approximately 3-5 patients are admitted to UMMC each month who are undergoing ECMO and could be considered for study inclusion.
Masking: None (Open Label)
Primary purpose: Treatment
Fenofibrate Versus Curcumin in Type 2 Diabetic Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to evaluate the effect of fenofibrate versus curcumin on glycemic
      status, lipids profile, hs-CRP, sirtuin-1 and fetuin-A in type 2 diabetic patients who are
      taking glimepiride.
    

Detailed description: 
      Method & Proposal Steps

      1- Approval will be obtained from Research Ethics Committee of Faculty of Pharmacy, Damanhour
      University. 2- All participants agreed to take part in this clinical study and provide
      informed consent. 3- (60) Patients with DM type 2 who's taking Glimepiride will be enrolled
      from Internal Medicine Department, Tanta University Hospital. 4- Serum samples will be
      collected for measuring the biomarkers. 5- All enrolled patients will be mentioned as two
      groups; Group I are patients who will be prescribed glimepiride plus fenofibrate. Group II
      are patients who will be prescribed glimepiride plus curcumin. 6- All patients will be
      followed up during 3 months' period. 7- At the end of 3 months on the new regimen, steps 4
      will be repeated. 8- Statistical tests appropriate to the study design will be conducted to
      evaluate the significance of the results. 9- Measuring outcome: The primary outcome is the
      change of serum levels of the measured markers after 3 months and lipid profile. 10- Results,
      conclusion, discussion and recommendations will be given.

      Methodology Serum levels of fetuin-A, and Sirtuin1 (SIRT1) will be measured ELISA. Lipid
      profile. Fasting Blood glucose and 2 hrs postprandial Blood Glucose. Hb A1C will be measured.
      BMI of the patients will be measured before and after the study. High sensitivity C-reactive
      protein (hs-CRP) will be measured.
    

Intervention name(s): Glimepiride Tablets; glimepiride plus fenofibrate; glimepiride plus curcumin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Glimepiride (4 mg) per Day; Glimepiride (4 mg) plus Fenofibrate (160 mg) per Day; Glimepiride (4 mg) plus Curcumin (1100 mg) With 5mg Black Pepper per Day
Other intervention name(s): Amaryl 4 mg; Amaryl 4 mg Plus Lipanthyl Supra (160 mg); Amaryl 4 mg Plus Curcumin (1100 mg) With 5mg Black Pepper
Intervention MeSH terms: Glimepiride; Curcumin; Fenofibrate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety, Tolerability and Pharmacokinetics of Danoprevir/r in Healthy Volunteers China
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the Pharmacokinetics of Danoprevir in single dose
      (100mg QD on day 1, day 4 and day 14) and Ritonavir-boosted Danoprevir (100mg QD on day 4 and
      day 14) in single and multiple doses (100mg BID on day 5 -day 13) in healthy volunteers.
    


Intervention name(s): Danoprevir; Ritonavir; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Danoprevir(DNV)administered orally 100mg QD on day 1, day 4 and day 14; 100mg BID on day 5 -day 13; Ritonavir administered orally 100mg QD on day 4 and day 14; 100mg BID on day 5 -day 13; ASC 08 Placebo administered orally 100mg QD on day 1, day 4 and day 14; 100mg BID on day 5 -day 13
Other intervention name(s): ASC08; RTV
Intervention MeSH terms: Ritonavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: pharmacokinetics,Danoprevir
A Non-inferiority, Multicenter and Randomized, Single-Dose Study About a Treatment to Hypolactasia (LAILAI)
Condition: Hypolactasia
MeSH terms: Lactose Intolerance
Study type: Interventional
Phase: Phase 3

Summary: 
      The study primary objective is to compare the clinical efficacy of two formulations in the
      supportive treatment of lactose intolerance.
    


Intervention name(s): Lactase
Intervention type(s): Drug
Intervention description(s): 1 chewable tablet of the test drug or comparative drug 30 minutes before the standard lactose dose (25 g).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Caldolor Versus Caldolor Plus OFIRMEV in Total Knee or Hip Arthroplasty Surgeries
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this study is to compare the effectiveness and of perioperative use of
      Caldolor alone and in combination with OFIRMEV in total knee or hip arthroplasty procedures.
    

Detailed description: 
      Patients undergoing total knee or hip arthroplasty procedures at University Pain Institute at
      Hahnemann will be included in this study.

      Following Institutional Review Board's approval, eligible patients will be selected from the
      Pre Admission Testing for total knee or hip arthroplasty surgeries planned at Hahnemann
      University Hospital.

      The cases will be randomized in a 1:1 ratio into either Group 1 or Group 2. Group 1 will
      receive 800 mg Caldolor at the induction of anesthesia, followed by 800 mg Caldolor every 6
      hours until discharge or for a total up to 120 hours (5 days) Group 2 will receive 800 mg
      Caldolor at the induction of anesthesia and 1000 mg Ofirmev at the time of surgical wound
      closure, followed by 800 mg Caldolor plus 1000 mg Ofirmev every 6 hours until discharge or
      for a total up to 120 hours (5 days)

      After the surgery, at the request of the patient they could receive morphine administered by
      patient-controlled analgesia pump, or by hospital staff.

      The analgesics and procedures involved in this study are all standard of care drugs
      prescribed and administered by the attending anesthesiologist for control of total knee or
      hip arthroplasty surgery related pain. Data collected for every patient will exist in the
      patient's medical chart as part of their standard medical care. No additional patient
      procedures or activities are mandated by this study.

      The data collection and analysis will be completed in duration of 1 year
    

Intervention name(s): Ofirmev; Caldolor
Intervention type(s): Drug; Drug
Intervention description(s): Subject receives the interventional drug, intravenous ibuprofen (800 mg Caldolor) at the induction of anesthesia and intravenous Acetaminophen (1000 mg Ofirmev) at the time of surgical wound closure, followed by 800 mg Caldolor plus 1000 mg Ofirmev every 6 hours until discharge for a total of up to 120 hours (5 days); Subject receives the interventional drug, intravenous ibuprofen (800 mg Caldolor) at the induction of anesthesia, followed by 800 mg Caldolor every 6 hours until discharge or for a total of up to 120 hours (5 days)
Other intervention name(s): Intravenous Acetaminophen; Intravenous Ibuprofen
Intervention MeSH terms: Acetaminophen; Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Anesthetics, Intravenous
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CB1 Antagonist ANEB-001 in a THC Challenge Test
Condition: Acute Cannabinoid Intoxication
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of this study is to investigate whether ANEB-001 effectively penetrates the brain and
      inhibits the psychotropic effects of Δ9-Tetrahydrocannabinol (THC), the main psychoactive
      constituent of cannabis. This randomized, placebo-controlled, double-blind study is designed
      as a proof-of-pharmacology and dose finding study for the antagonistic effect of ANEB-001
      during a THC challenge. Results of this study will inform the future potential use of
      ANEB-001 as an emergency treatment for acute cannabinoid intoxication.
    

Detailed description: 
      This study will evaluate whether ANEB-001 effectively inhibits the psychotropic effects of
      Δ9-Tetrahydrocannabinol (THC). All cohorts in part A and B of the study will be randomized,
      double-blind and placebo-controlled. Randomization is deemed appropriate to avoid selection
      bias for active compound or placebo treatment. A double-blind and placebo-controlled design
      is deemed appropriate because of the safety, tolerability and pharmacodynamic assessments
      that will be performed in this study. By double-blinding the study, bias arising from study
      subject's or investigator's knowledge about treatment assignment is avoided. Part C does not
      include a placebo group and will therefore not be blinded.
    

Intervention name(s): ANEB-001; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Experimental Treatment; Placebo comparator
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Trial Investigating the Possible Difference in Development of Type 2 Diabetes Between Caucasian and Japanese Subjects
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe and Japan. The aim of this clinical trial is to investigate
      the possible difference in the development of type 2 diabetes in a Japanese and a Caucasian
      population. Healthy subjects, subjects with impaired glucose tolerance, as well as subjects
      with type 2 diabetes will be included in the trial. The development of type 2 diabetes across
      the cohort will be investigated with regard to insulin sensitivity and B-cell capacity.
    


Intervention name(s): Oral Glucose Tolerance Test (OGTT); Euglycaemic hyperinsulinaemic clamp
Intervention type(s): Other; Other
Intervention description(s): A 5-hour oral glucose tolerance test (OGTT) is performed at visit 2; A 4-hour euglycaemic, hyperinsulinaemic clamp is performed at visit 3
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Renal Denervation in Patients With Resistant Hypertension and Obstructive Sleep Apnea
Condition: Hypertension; Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypertension
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the clinical utility of renal denervation for the
      treatment of resistant hypertension coexisting with obstructive sleep apnea.
    


Intervention name(s): Renal denervation with a catheter-based procedure (Symplicity® Catheter System)
Intervention type(s): Device
Intervention description(s): Disruption of the renal nerves with a catheter-based procedure.
Other intervention name(s): Renal Denervation (Symplicity® Catheter System)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: hypertension, resistant; obstructive sleep apnea; renal denervation; continuous positive airway pressure therapy