bioihbjkbjnl/mcl2 huggingface dataset:
Postprandial Responses to Hydroxytyrosol-enriched Bread
Condition: Postprandial Responses
Study type: Interventional

Summary: 
      The amelioration of postprandial glucose and insulin responses to bread is of great
      importance since it may have significant beneficial effects on health. A number of studies
      have shown that hydroxytyrosol may have positive metabolic effects. However, this compound
      presents high hydrophilicity which constitutes the major barrier to its potential application
      in foods. Microencapsulation arises as a technological strategy to protect it and increase
      its stability. Alpha-cyclodextrin besides being a great carrier molecule, seems to also be
      beneficial to postprandial glucose levels. Enrichment of bread with encapsulated
      hydroxytyrosol could examine potential postprandial benefits.

      Ten healthy normoglycemic subjects will participate in the study and will be provided with
      either a solution of glucose (reference food) or white wheat bread or wheat bread enriched
      with a-cyclodextrin or wheat bread enriched with hydroxytyrosol encapsulated in
      a-cyclodextrin, with 1-week intervals in amounts that yielded 50 g of available
      carbohydrates. Venous blood samples will be collected before consumption and at 30, 45, 60,
      90, 120 and 180 min postprandially. Postprandial glucose, insulin and appetite-related
      hormone responses as well as glycemic index (GI) and subjective appetite ratings will be
      evaluated.
    


Intervention name(s): Enriched wheat bread
Intervention type(s): Other
Intervention description(s): Either 50g of glucose dissolved in 250mL water or white wheat bread or wheat bread enriched with 5mg a-cyclodextrin or wheat bread enriched with a 5mg mixture of a-cyclodextrin and encapsulated hydroxytyrosol (per 50g of available carbohydrates).
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: hydroxytyrosol; a-cyclodextrin; bread; glycaemic index; appetite
Clinical Outcomes of Buffered 1% Lidocaine vs. Non-buffered 2% Lidocaine
Condition: Anesthesia
Study type: Interventional

Summary: 
      Anecdotal data suggest that the buffered form of the local anesthetic is more potent at equal
      dosages, and a lower dosage of the drug might be used with an effect equal to higher dosage
      not buffered. Clinical data are needed to confirm these anecdotal data. No data exist
      comparing buffered local anesthetics at lower drug concentrations to current dosages commonly
      used in dental and oral surgical procedures
    

Detailed description: 
      Specific Aims:

      Compare clinical depths of pulpal anesthesia (cold, Electronic Pulp Test) for mandibular
      molar, and canine teeth at 30 minute intervals post injection for mandibular block anesthesia
      with buffered 1% lidocaine with 1/100,000 epinephrine as compared to non-buffered 2%
      lidocaine with 1/100,000 epinephrine.

      Hypotheses:

      No differences exist in anesthetic depth for pulpal anesthesia after intraoral injection for
      mandibular block anesthesia between buffered 1% lidocaine with 1/100,000 epinephrine as
      compared to non-buffered 2% lidocaine with 1/100,000 epinephrine.

      Study Time Frame: 6 months Month One: Recruit 24 volunteers as subjects. Prepare case-books.
      Months Two-Three: Clinical Study, Months Four-Five: Analyze data Month Six: Prepare
      Abstracts, Papers Methods: Blinded, Randomized Clinical Design Recruit subjects with
      Institutional Review Board approved consent at UNC Subjects will serve as their own controls
      in a cross-over AB/BA study design which is uniform within sequences, uniform within periods,
      and balanced Randomized subjects to be injected orally for mandibular block (inferior
      alveolar, lingual, buccal nerves) alternatively with 4cc of buffered 1% lidocaine with
      1/100,000 epinephrine and 4cc non-buffered of 2% lidocaine with 1/100,000 epinephrine.

      Assessment: pre, and post-anesthetic administration for pulpal anesthesia with cold,
      Electronic Pulp Test: Mandibular molar, canine at 30 minute intervals Inclusion Criteria: Age
      18-30 years, American Society Anesthesiologists (ASA) I Exclusion Criteria Allergy to
      lidocaine class of anesthetic drugs, Local anesthetic drug past week Current symptoms teeth
      or oral mucosa. SAS will be used for database management and statistical analysis.
    

Intervention name(s): Lidocaine
Intervention type(s): Drug
Intervention description(s): Lidocaine
Other intervention name(s): xylocaine
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: lidocaine, jaw
Evaluation of OSSIX-Plus Resorbable Collagen Membranes for Alveolar Ridge Preservation Following Exodontia
Condition: Alveolar Bone Loss; Loss of Teeth Due to Extraction; Edentulous Alveolar Ridge
MeSH terms: Alveolar Bone Loss
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate clinically, histologically and radiographically the
      healing of extraction sockets covered with a resorbable collagen membrane (OSSIX-Plus) 12
      weeks following exodontia.
    

Detailed description: 
      Reduction in alveolar ridge height and width may prohibit optimal implant placement, and
      often compromises the esthetic and functional result. Alveolar ridge preservation has been
      evaluated in many studies. A variety of bone grafting materials and barrier membranes have
      been studied for their ability to enhance bone formation in damaged alveolar ridges, and to
      evaluate their bone healing and bone-forming capacity in extraction sockets. However, the
      newly developed resorbable collagen membrane OSSIX-Plus has not been evaluated for this
      purpose. This study is designed to test the ability of OSSIX-Plus (OraPharma Inc.,
      Warminster, Pennsylvania) in promoting optimal bone healing following exodontia. We
      hypothesize that use of OSSIX-Plus will result in preservation of the height, width and
      density of the residual alveolar ridge following tooth extraction.
    

Intervention name(s): OSSIX-Plus
Intervention type(s): Device
Intervention description(s): resorbable collagen membrane
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: extraction; implant; alveolar ridge preservation
De-implementation of Outdated Colonoscopy Surveillance Interval Recommendations Among Patients With Low-risk Adenomas
Condition: Polyp of Colon
MeSH terms: Adenoma; Colonic Polyps
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effectiveness of three standard of care outreach
      approaches (i.e., mailed letter, secure message, and telephone call) on patient adoption of
      the new 10-year colonoscopy surveillance interval recommendation for a random sample of
      health plan members who have a now-outdated 5-year surveillance interval due to a finding of
      1-2 small adenomas at their prior colonoscopy. The primary study endpoint is the proportion
      of patients in each outreach arm who adopt the new 10-year colonoscopy surveillance interval.
    


Intervention name(s): Outreach
Intervention type(s): Behavioral
Intervention description(s): Mailed letter, secure message or telephone outreach will be used depending on arm enrolled
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Long-Term Efficacy of Ramelteon on Endocrine Function in Adult Subjects With Chronic Insomnia
Condition: Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the long-term effects of Ramelteon, once daily
      (QD), on endocrine function values.
    

Detailed description: 
      Insomnia is characterized by a complaint of either difficulties initiating and maintaining
      sleep or of nonrestorative and non-refreshing sleep. Transient insomnia affects approximately
      one-third to one-half of the US population, based on the results of 2 surveys of
      representative samples of the adult US population conducted by the Gallup Organization in
      which respondents were asked if they had "ever had difficulty sleeping." Based on reports of
      "regular" or "frequent" sleep difficulty, results from the same studies suggest that
      approximately one-tenth of the US population experiences chronic insomnia. The ideal
      treatment for insomnia would reduce the latency to onset of sleep and increase total sleep
      time, without a negative impact on sleep architecture and without safety concerns or next-day
      effects.

      Ramelteon is a melatonin-1 receptor agonist under global development by Takeda Chemical
      Industries, Ltd., Osaka, Japan, for the treatment of transient and chronic insomnia and for
      the treatment of Circadian Rhythm Sleep Disorders.

      This study has been designed to determine the long-term (6 month) effects of Ramelteon on
      endocrine function values. Study participation is anticipated to be about 7 months.
    

Intervention name(s): Ramelteon; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ramelteon 16 mg, tablets, orally, once nightly for up to 6 months.; Ramelteon placebo-matching tablets, orally, once nightly for up to 6 months
Other intervention name(s): Rozerem; TAK-375
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sleep Disorder; Insomnia
Provision of Breakfast Food in Behavioral Weight Loss
Condition: Obesity
MeSH terms: Weight Loss
Study type: Interventional

Summary: 
      A contributing factor to the rising prevalence of obesity may be increased portion sizes.
      However, the effect of portion size has not been studied independent of the effect of
      quantity of food in the context of a behavioral weight loss program. Providing pre-portioned
      single servings of food may make it easier to reduce caloric and dietary fat intake improving
      weight loss. In addition, breakfast skipping is associated with obesity and breakfast
      consumption is associated with weight loss success. Therefore, the objective of the proposed
      study is to investigate the effect of portion size on consumption of provided breakfast foods
      in the context of a behavioral weight loss program. Participants will be randomized to 1 of 2
      standard 12-week behavioral obesity interventions. The first intervention, serving as a
      control, will provide participants with breakfast foods in non-portioned containers
      (Standard). A second intervention will provide participants with the same type and quantity
      of breakfast foods but they will be provided in pre-portioned single servings (Portion).
      Dependent variables include the number of calories consumed from the provided foods as well
      as overall caloric and fat consumption. If the provision of food in pre-portioned servings is
      effective at decreasing intake, future directions include conducting longer interventions to
      improve long-term weight loss outcomes in standard behavioral interventions.
    


Intervention name(s): Eating breakfast with portion and unportioned foods
Intervention type(s): Behavioral
Intervention description(s): Behavioral: eating breakfast with portion and unportioned foods
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
ST-Segment Resolution as a Marker for Myocardial Scar in ST-Segment Elevation Myocardial Infarction
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Observational [Patient Registry]

Summary: 
      Clinical studies found that poor ST-segment resolution (STR) in electrocardiogram (ECG)
      occurred in major adverse cardiovascular events (MACE), arrhythmia and heart failure was
      significantly higher . In clinical work, in patients have poor ST-segment decline, the
      investigators found by CMR-LGE the corresponding myocardium become thinner and other signs of
      myocardial scar.

      The investigators aimed to establish whether poor ST-segment resolution in ECG, as well as
      CMR-LGE, could detect the presence of myocardial scar in early STEMI patients. In order to
      provide convenient, cheap and widely used test method for patients who cannot tolerate
      CMR-LGE.

      42 STEMI patients with single-branch coronary artery stenosis or occlusion were enrolled.
      ST-segment elevations were measured on the baseline and 24 hours after PCI. The study
      population was divided into two groups by late gadolinium enhanced cardiac magnetic resonance
      (LGE- CMR), with transmural myocardial scar (>75%) or non-transmural myocardial scar (<75%).
    


Intervention name(s): ST-segment resolution <40.15%
Intervention type(s): Diagnostic Test
Intervention description(s): Forty-two STEMI patients with single-branch coronary artery stenosis or occlusion were enrolled. ST-segment elevations were measured at emergency admission and at 24 h after PCI. Late gadolinium-enhanced cardiac magnetic resonance imaging (CMR-LGE) was performed 7 days after PCI to evaluate myocardial scars.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        42 patients.
Dry Needling and High Intensity Laser Therapy in Treatment of Myofascial Pain Syndrome
Condition: Myofascial Pain Syndrome
MeSH terms: Myofascial Pain Syndromes; Fibromyalgia; Syndrome; Somatoform Disorders
Study type: Interventional

Summary: 
      108 myofascial pain syndrome (MPS) diagnosed patients will be randomly divided into 3 groups.
      To groups; exercise, exercise+high-intensity laser therapy (HILT) and exercise+dry needling
      will be applied. Visual anolog scale (VAS) scores and neck range of motion (ROM) of the
      patients before-after treatment will be recorded and will be evaluated statistically.
    

Detailed description: 
      Myofascial pain syndrome (MPS) is a very common disease in the population that seriously
      affects the quality of life. Although many modalities are used in its treatment, there is
      still no common protocol. In this study, the investigators aim to compare the effectiveness
      of high-intensity laser therapy (HILT), which has been popular in recent years, with exercise
      and dry needling options that have been used for years.

      In our study 108 myofascial pain syndrome (MPS) diagnosed patients will be randomly divided
      into 3 groups. To groups; exercise, exercise+high-intensity laser therapy (HILT) and
      exercise+dry needling will be applied. Visual anolog scale (VAS) scores and neck range of
      motion (ROM) of the patients before-after treatment will be recorded and will be evaluated
      statistically.
    

Intervention name(s): dry needle; high intensity laser therapy
Intervention type(s): Other; Device
Intervention description(s): dry needling (on 3 trigger points on the bilateral trapezius muscle) will applied to the other 36 randomly selected patients with an acupuncture needle with a size of 0.25x0.25 by the PMR specialist for a total of 6 sessions twice a week for 3 weeks.; High intensity laser therapy (HILT), one of the physical therapy methods, was approved by the FDA in 2002. Its beneficial and versatile effect has been proven in the treatment of many musculoskeletal diseases. In addition to the exercise program, randomly selected 36 case patients + HILT (BTL brand 6000 series, United Kingdom), to the cervical area, for the a period of 3 week-weekdays, 15-minute period and 15 sessions (1.02 minutes for each 25 cm² painful area, analgesic phase, with an anergy 8.0 W, a dose 5 J / cm², a frequency of 25 Hz and total 125 joules) will be applied.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Myofascial pain syndrome; high-intensity laser therapy; dry needling; exercise
Quantitative Measurement of ARI
Condition: Orthodontic Appliance Complication
Study type: Interventional

Summary: 
      A crucial step at end of debonding is to evaluate the site of bond failure. An accurate
      assessment of the site of bond failure will allow the clinician to select an optimum method
      for adhesive remnant removal from the enamel surface.

      The aim of this study is to do a randomized clinical trial to measure adhesive remanent index
      quantitively after debonding with wing and base method of debonding
    

Detailed description: 
      After informed consent data would be collected from patients who are undergoing debonding of
      orthodontic brackets after comprehensive orthodontic treatment of at least 2 years. Only the
      cases which have no loose anterior upper and lower brackets for the last 6 months would be
      randomly allocated to one of the two sides in each arch for debonding with a specific
      technique. A protocol of block randomization would be followed for this study. Debonding of
      brackets would be done either by wing or base method in a split fashion after removal of
      orthodontic wires. The patient would be explained that both methods are conventional used and
      are safe for debonding. After debonding each bracket the patient would be asked for the level
      of pain he felt during the debonding of that specific bracket. The patient will explain the
      pain level on a scale of 0-10 with 0 referring to no pain while 10 referring to maximum pain.
      After debonding a digital microscope (Supereyes) would be used along with plastic tubing for
      taking the adhesive remanent pictures intraorally from the labial surface of teeth. The
      plastic tubing would have a calibrated scale attached to it. For each new patient, a new
      tubing or disinfected tubing would be used. The available data would be measured extra orally
      on a computer-based software (ImageJ). Variable like age, gender, oral hygiene, ARI, side of
      adhesive flush, and pain would be analyzed.
    

Intervention name(s): Debonding
Intervention type(s): Device
Intervention description(s): Debonding of orthodontic brackets with wing or base method with a conventional debonding plier
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Split mouth design
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bracket Debonding , Wing method, Base method , ARI
Sustained Virological Response (SVR) to Antiviral Treatment of Liver Transplant Recipients With Recurrent Hepatitis C
Condition: Hepatitis C; Liver Transplantation
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will assess the rates of Sustained Virological Response following anti-viral
      therapy with Peg-Interferon plus Ribavirin in patients that have been liver transplanted with
      recurrent Hepatitis C and treated with Neoral or tacrolimus.
    


Intervention name(s): cyclosporin (Neoral); tacrolimus (Prograf)
Intervention type(s): Drug; Drug
Intervention description(s): Neoral capsules bid, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges; Tacrolimus capsules bid, doses were adjusted as necessary to achieve and maintain recommended C0 target ranges.
Intervention MeSH terms: Cyclosporine; Tacrolimus; Cyclosporins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C; liver transplantation; anti-viral therapy
Probiotics: Clinical Intervention Trial in Patients With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      This study evaluates the benefits of probiotics in patients with fibromyalgia syndrome.
    

Detailed description: 
      Probiotics has demonstrated to be effective in the management of anxiety and depression.
      Although these results are promising, more research is needed to explore the role of
      probiotics to improve physical, emotional and cognitive processes in different clinical
      populations that are associated with altered microbiome. Thus, the main aim of the present
      project is to explore whether the oral intake of probiotics might provide benefits to a group
      of patients with fibromyalgia.

      The investigators expect to found significant differences between some physical, emotional
      and cognitive measures assessed pre- and post-treatment demonstrating the effects of
      microbiota on the Central Nervous System as well as its potential as a therapeutic tool for
      the treatment of Fibromyalgia.
    

Intervention name(s): Lactobacillus acidophilus; Lactobacillus Rhamnosus GG ®; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement; Other
Intervention description(s): Probiotic 5000, a commercial probiotic product provided by the company "Complementos Fitonutricionales, S.L."; Ergyphilus confort, a commercial probiotic product provided by the nutritional supplements lab "Laboratorios Nutergia"; Innocuous substance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Probiotics
Randomized Comparison of Sharp Versus Blunt Techniques at Cesarean
Condition: Disruption of Uterine Incision After Cesarean Section
MeSH terms: Surgical Wound
Study type: Observational

Summary: 
      The purpose of this study is to determine whether a specific surgical technique, blunt
      compared with sharp expansion of the transverse lower uterine incision, is associated with
      risk of unintended extension of uterine incision
    


Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        elective cesarean delivery cases
      
Keywords: unintended extension; blunt; sharp; maternal blood loss