bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of a "Flash-free" Adhesive Resin for Orthodontic Bracket Bonding
Condition: Malocclusion
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      The purpose of this study is to compare bonding time, bond survival, amount of adhesive
      remaining on the tooth surface after bracket debonding, and time required for adhesive
      remnant cleanup between a new "flash-free" and a conventional adhesive resin for orthodontic
      bracket bonding.
    

Detailed description: 
      Patients presenting for comprehensive orthodontic treatment with fixed appliances at the
      University of Minnesota, who are willing to participate, will be included in the initial
      study. Selection criteria will include full permanent dentition through the first molars,
      teeth with sound, non-carious buccal enamel and no pretreatment with chemical agents such as
      hydrogen peroxide, and no previous orthodontic treatment with fixed appliances. The patients
      will have their maxillary incisors, canines, and premolars bonded with ceramic orthodontic
      brackets pre-coated with a "flash-free" adhesive resin (Clarity Advanced Brackets APC
      flash-free, 3M Unitek, Monrovia, CA, USA) on one side and a conventional adhesive resin
      (Clarity Advanced Brackets APC II, 3M Unitek) on the other side. The side allocation and
      order of bonding will be randomized for each patient.
    

Intervention name(s): APC Flash-Free Adhesive Coated Appliance System; APC II Adhesive Coated Appliance System
Intervention type(s): Device; Device
Intervention description(s): APC Flash-Free Adhesive Coated Appliance System; APC II Adhesive Coated Appliance System
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: Split-mouth
Masking: None (Open Label)
Primary purpose: Treatment
Achievement of Improved Survival by Molecular Targeted Chemotherapy and Liver Resection for Not Optimally Resectable Colorectal Liver Metastases
Condition: Liver Only Metastasis From KRAS Exon 2 Wild Type (Under Protocol 1.0-1.2 Edition) and RAS Wild Type (Under Protocol 2.0 Edition) Colorectal Cancer
MeSH terms: Colorectal Neoplasms; Neoplasm Metastasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate efficacy and safety of mFOLFOX6+bevacizumab and
      mFOLFOX6+cetuximab for liver only metastasis from KRAS Exon 2 wild type (under protocol
      1.0-1.2 edition) and RAS wild type (under protocol 2.0 edition) colorectal cancer.
    

Detailed description: 
      Description: The purpose of this study is to evaluate efficacy and safety of
      mFOLFOX6+bevacizumab and mFOLFOX6+cetuximab for liver only metastasis from KRAS Exon 2 wild
      type (under protocol 1.0-1.2 edition) and RAS wild type (under protocol 2.0 edition)
      colorectal cancer.
    

Intervention name(s): Bevacizumab; Cetuximab; L-OHP; l-LV; 5-FU; 5-FU
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 5 mg/kg intravenously administered over 90 minutes (can be reduced to 30 minutes at the minimum) on day 1 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.; 250 mg/m2 intravenously administered over 60 minutes (400 mg/m2 over 120 minutes as the initial dose) on day 1 and day 8 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.; 85 mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.; 200 mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.; 400 mg/m2 intravenous bolus on day 1 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.; 2400 mg/m2 continuous infusion over 46 hours on day 1 and 2 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.
Other intervention name(s): Avastin; Erbitux; Oxaliplatin; Levofolinate; Fluorouracil; Fluorouracil
Intervention MeSH terms: Bevacizumab; Cetuximab; Fluorouracil; Oxaliplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bevacizumab; Cetuximab; KRAS wild type colorectal cancer; RAS wild type colorectal cancer; liver metastasis
Acid-Associated Heartburn Symptoms and Dose of Esomeprazole
Condition: Heartburn
MeSH terms: Heartburn
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multi-center, double-blind, parallel-group, randomized, proof of concept trial to
      investigate the relationship between dose of esomeprazole magnesium and acid-associated
      heartburn symptoms during 4 weeks of treatment. The safety and tolerability of esomeprazole
      magnesium in doses up to 40 mg BID will also be assessed.
    


Intervention name(s): Esomeprazole magnesium (Nexium)
Intervention type(s): Drug
Intervention MeSH terms: Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
A Study to Evaluate Raptiva in Combination With Topical Psoriasis Therapies
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is an open label, randomized, multicenter study designed to compare the efficacy
      of 12 weeks of subcutaneously administered efalizumab (monotherapy) with that of combination
      therapy (Efalizumab and a topical corticosteroid ointment) in subjects with moderate to
      severe plaque psoriasis who are candidates for systemic therapy. The study will also evaluate
      the safety and tolerability of 30 months of continuous efalizumab treatment in those subjects
      who derive benefit from the initial 12 weeks of treatment.
    


Intervention name(s): Raptiva (efalizumab)
Intervention type(s): Drug
Allocation: Randomized
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Distraction on Pain and Distress During Venepuncture in Children
Condition: Hospitalism in Children; Pain
Study type: Interventional

Summary: 
      The main purpose of this study is Investigating the effectiveness of distraction by
      evaluating the children's perception of pain during venepuncture.
    


Intervention name(s): play computer game
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: venepuncture; distraction; distress
Cannabidiol Oral Solution as an Adjunctive Treatment for Treatment-resistant Seizure Disorder
Condition: Seizures
MeSH terms: Seizures; Epilepsy
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multicenter, open-label trial to assess the long-term safety and efficacy of
      Cannabidiol Oral Solution as adjunctive therapy for pediatric participants with
      treatment-resistant seizure disorders, including Lennox-Gastaut syndrome (LGS) or Dravet
      syndrome (DS). All participants have rolled over from previous trials: INS011-14-029
      (NCT02324673) and INS011-15-054 (NCT02551731).
    


Intervention name(s): Cannabidiol Oral Solution
Intervention type(s): Drug
Intervention description(s): An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).
Intervention MeSH terms: Cannabidiol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lennox-Gastaut syndrome; Dravet syndrome; Treatment-resistant seizures
Effect of Early Morphine Administration on the Development of Acute Opioid Tolerance During Pediatric Scoliosis Surgery
Condition: Scoliosis
MeSH terms: Scoliosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to examine if morphine administered by bolus before initiating
      Remifentanil by infusion decreases the incidence of acute post-operative opioid tolerance as
      demonstrated by decreased post - operative morphine consumption in children undergoing
      scoliosis surgery.
    

Detailed description: 
      At our institution, a study has recently demonstrated that intraoperative infusion of
      remifentanil is associated with development of clinically relevant acute opioid tolerance in
      adolescents undergoing scoliosis surgery. This results in increased morphine consumption
      which in turn is associated with increased incidence of side effects such as respiratory
      depression, nausea and vomiting, pruritus, ileus and urinary retention. All of these side
      effects can result in increased consumption of rescue medications with the additional
      potential for increased duration of patient stay. Any measures that can be introduced to
      decrease the development of acute opioid tolerance in this patient population would have
      significant impact on patient morbidity, patient comfort and possibly duration of patient
      stay.
    

Intervention name(s): Morphine; Saline
Intervention type(s): Drug; Other
Intervention description(s): 150 mcg/kg diluted in normal saline to a volume of 10 ml at time of induction of anesthesia; 10 ml saline alone
Intervention MeSH terms: Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pediatrics; Scoliosis; Morphine; Surgery; Analgesia
Analgesia in Laparoscopic Cholecystectomy
Condition: Pain, Postoperative; Chronic Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The investigators hypothesis is that perioperative infusion of 0.75 ropivacaine in patients
      undergoing laparoscopic cholecystectomy may modify the intensity of postoperative pain or the
      analgesic consumption during the first 24 hours.
    

Detailed description: 
      Patients scheduled for laparoscopic cholecystectomy were randomly assigned to receive via a
      subcutaneous catheter 2 ml per hour of 0.75 ropivacaine or same volume of normal saline. The
      catheter was inserted after induction of general anesthesia and before beginning of surgery
      and continued for the first 24 postoperative hours. The solutions were administered by means
      of an elastomeric pump. Before induction of anesthesia metoclopramide 10 mg, ranitidine 50 mg
      and droperidol 0.75 mg were given intravenously. In the operating room the routine monitoring
      was applied. Anesthesia was induced with thiopental 5-6 mg/kg, fentanyl 2 μg/kg, and
      rocuronium 0.6 mg/kg, and maintained with sevoflurane 1-1.5 Minimum Alveolar Concentration
      (MAC) in a nitrous oxide/oxygen mixture. After induction of anesthesia diclofenac 75 mg I.V
      was given within 30 min. Before wound closure each hole was infiltrated with 2 ml of
      ropivacaine 0.75 or normal saline. At the end of surgery neuromuscular block was reversed
      with sugammadex 2 mg/kg., the patient was extubated and transferred to the Post-anesthesia
      Care Unit (PACU).

      Intra-operatively, the intra-abdominal pressure, the rate of carbon dioxide insufflation and
      the total amount of carbon dioxide insufflated are recorded every 5 minutes.

      Besides the ropivacaine infusion in the operative site, postoperative analgesia is assured in
      the PACU with paracetamol 1 gr and tramadol 100 mg if Visual Analogue Scale (VAS) score is
      above 40 mm.In the ward Lonarid tablets are given instead.

      VAS values and analgesic consumption are recorded in the PACU, and 2, 4, 8, 24 and 48 hours
      after surgery.

      The catheter is removed 24 hours after surgery. One and three months after surgery patients
      are interviewed by phone for the presence of pain due to surgery.
    

Intervention name(s): Ropivacaine 0.75; Normal saline
Intervention type(s): Drug; Drug
Other intervention name(s): Naropeine; 0.9% saline
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: acute postoperative pain; late pain; chronic pain; wound irrigation with local anesthetic
Melatonin Supplements for Improving Sleep in Individuals With Hypertension
Condition: Sleep Disorders; Hypertension
MeSH terms: Sleep Wake Disorders; Parasomnias; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the effectiveness of treatment with melatonin supplements in
      improving sleep in individuals with high blood pressure who are taking beta-blockers.
    

Detailed description: 
      Hypertension, or high blood pressure, is a condition in which an individual's blood pressure
      is higher than the normal level. It is estimated that one in three individuals in the United
      States has high blood pressure, though many do not know it because there are usually no
      symptoms. Uncontrolled hypertension may lead to stroke, heart attack, heart failure, or
      kidney failure. Beta-blockers are one class of drugs that have been developed to help lower
      blood pressure, and thereby decrease the risk for these serious problems. Beta-blockers also
      lower the levels of melatonin, a hormone that has a sleep-promoting effect. Many individuals
      who take beta-blockers for hypertension complain that they have trouble sleeping, which may
      be related to the beta-blockers' effect on melatonin levels. This study will evaluate the
      effectiveness of treatment with melatonin supplements in improving sleep in individuals with
      high blood pressure who are taking beta-blockers. In addition, the study will examine whether
      the melatonin supplements aid in lowering blood pressure.

      Participants in this double-blind study will be randomly assigned to receive either melatonin
      supplements or placebo for the duration of the study. Participants will take part in two
      inpatient phases. Each inpatient stay will last 4 days and will be separated by 3 to 4 weeks.
      While in the clinic, participants' sleep patterns and core temperature will be recorded and
      plasma, saliva, and urine samples will be collected. Blood pressure will be measured before
      and after each inpatient stay, as well as at points during the stay. Throughout the study,
      participants' activity will be monitored by an accelerometer worn around the wrist.
    

Intervention name(s): Melatonin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2,5 mg melatonin, by mouth, 1 per day, for 3-4 weeks; Placebo
Other intervention name(s): N-acetyl-5-methoxytryptamine
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Sleep disorders; High blood pressure
Safety and Efficacy Study of Fluzone® Vaccine Combined With Different Doses of JVRS-100 Adjuvant
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to assess safety, tolerability and immunogenicity of Fluzone® vaccine
      with four dose levels of JVRS-100 adjuvant compared to Fluzone® vaccine alone in healthy
      adults 18-49 years of age.
    

Detailed description: 
      The purpose of this trial is to evaluate the safety and tolerability of graded, ascending
      doses of JVRS-100 adjuvant when administered in combination with a vaccine antigen.
    

Intervention name(s): Fluzone vaccine with JVRS-100 adjuvant; Fluzone vaccine; Fluzone vaccine
Intervention type(s): Biological; Biological; Biological
Intervention description(s): One vaccination on Day 0 with Fluzone vaccine at 22.5µg mixed with JVRS-100 adjuvant at one of four dose levels (7.5µg, 25µg, 75µg, 225µg) given by IM injection in the upper deltoid.; One vaccination on Day 0 with Fluzone vaccine at 22.5µg given by IM injection in the upper deltoid.; One vaccination on Day 0 with Fluzone vaccine at 45µg given by IM injection in the upper deltoid.
Other intervention name(s): Fluzone vaccine; adjuvant; Flu vaccine; Flu vaccination
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Flu; Influenza vaccine; Adjuvant; Safety of an adjuvanted vaccine; Immune response to an adjuvanted vaccine
Study to Compare the Effect of a Combination of Cetirizine With Pseudoephedrine Versus Placebo on Symptoms in Patients With Allergic Rhinitis Within/Out of Season
Condition: Atopy; Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional

Summary: 
      A previous study has shown very clearly that the treatment with the combination of cetirizine
      and pseudoephedrine is superior to the treatment with the single agents regarding the
      reduction of symptoms in patients with allergic rhinitis. These data, obtained after
      controlled pollen exposure out of the pollen season, showed highly reproducible individual
      responses prior to dosing. It is not clear, however, whether the same results can be obtained
      during the pollen season, when additional natural pollen exposure may influence the
      variability of the individual reactions.
    

Detailed description: 
      The aim of this study is to evaluate prospectively, if reproducible results can be shown when
      testing a combination of cetirizine and pseudoephedrine in an Environmental Exposure Unit
      setting once inside and once outside the grass pollen season. An equivalent outcome would
      validate the ECC for testing anti-allergic substances during the pollen season in the future.
      Up to now these studies have been restricted to the pollen-free season.
    

Intervention name(s): cetericine and pseudoephedrine
Intervention type(s): Drug
Intervention MeSH terms: Pseudoephedrine; Ephedrine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Seasonal allergic rhinitis
Study to Compare Efficacy and Safety of Primapur and Gonal-f in Women for Assisted Reproductive Treatment
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to show equivalence with regard to the number of oocytes
      retrieved between follitropin alfa (pen-injectors) Primapur® and Gonal-f® in woman undergoing
      IVF/ICSI
    


Intervention name(s): Follitropin alfa (Gonal-f); Follitropin alfa (Primapur)
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation; Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
Intervention MeSH terms: Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: in vitro fertilization
Forces and Translation Distance During an Inferior Glide of the Shoulder
Condition: Asymptomatic Condition
MeSH terms: Asymptomatic Diseases
Study type: Interventional

Summary: 
      This study evaluates the force and translation distance in the GH joint during a manual
      inferior glide of the humerus.
    

Detailed description: 
      There has been limited research on how the variance of force affects MT outcomes and what the
      best practices of MT should be. No specific force threshold necessary to achieve a
      predetermined translational distance within the joint has been quantified within the
      literature. The purpose of this study was to quantify the amount of force necessary to
      perform an inferior glide to the glenohumeral joint and reach to end-range. A secondary aim
      was to determine the impact of co-variables, such as gender, height, weight, and age, on the
      amount of force required to translate the humeral head within the glenohumeral joint.
      Musculoskeletal Ultrasound imaging using the GE LogiQe was used to measure the translation of
      the humeral head. The manipulation force was measured using the Novel Pliance Glove device
      and software.
    

Intervention name(s): Inferior glide humerus in GH joint
Intervention type(s): Procedure
Intervention description(s): Supine inferior glide GH joint
Intervention model: Single Group Assignment
Intervention model description: Within subject design
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Manipulation force; Glenohumeral joint; Musculoskeletal Ultrasound Imaging
Zinc and Selenium Supplementation in Atherosclerosis
Condition: Dietary Selenium Deficiency; Dietary Zinc Deficiency
MeSH terms: Atherosclerosis
Study type: Interventional

Summary: 
      The aim of this randomized double-blind study was to evaluate the effect of oral zinc and
      selenium supplementation on oxidative stress and inflammation biomarkers as well as the
      status of zinc and selenium in patients with atherosclerosis and angina stable treated with
      rosuvastatin. The hypotheses tested in this study were: Treatment with rosuvastatin impairs
      zinc and selenium status in patients with atherosclerosis and stable angina? Zinc and
      selenium supplementation, concomitantly with rosuvastatin, influences the antioxidant and
      anti-inflammatory as well as the status of minerals?
    

Detailed description: 
      The study included 47 men and 29 women, average age around 60 years, with coronary
      atherosclerosis diagnosed by angiography. Data from patients were obtained at beginning and
      after four months of treatment with 10 mg rosuvastatin, concomitantly with zinc (30mg/d) and
      selenium (150μg/d) supplementation or placebo. The anthropometric and dietary data, zinc and
      selenium concentrations in plasma and erythrocyte, lipid profile, electronegative LDL
      (LDL(-)), anti- electronegative LDL, Ac-LDL(-) immune complexes, GPx and SOD activities, IL-6
      and hs-CRP were evaluated in all patients.
    

Intervention name(s): zinc and selenium supplementation; rosuvastatin + placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Data from patients were obtained at beginning and after four months of treatment with 10 mg rosuvastatin, concomitantly with zinc (30mg/d) and selenium (150μg/d) supplementation or placebo. The anthropometric and dietary data, zinc and selenium concentrations in plasma and erythrocyte, lipid profile, electronegative LDL (LDL(-)), anti- electronegative LDL, Ac-LDL(-) immune complexes, GPx and SOD activities, IL-6 and hs-CRP were evaluated in all patients; Data from patients were obtained at beginning and after four months of treatment with 10 mg rosuvastatin, concomitantly with zinc (30mg/d) and selenium (150μg/d) supplementation or placebo. The anthropometric and dietary data, zinc and selenium concentrations in plasma and erythrocyte, lipid profile, electronegative LDL (LDL(-)), anti- electronegative LDL, Ac-LDL(-) immune complexes, GPx and SOD activities, IL-6 and hs-CRP were evaluated in all patients
Other intervention name(s): Zinc and selenium supplementation + rosuvastatin; placebo group
Intervention MeSH terms: Zinc; Selenium; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: atherosclerosis; zinc and selenium status; rosuvastatin; oxidative stress biomarkers; inflammation biomarkers