bioihbjkbjnl/mcl2 huggingface dataset:
CAS Versus Traditional Freehand Technique for Mandibular Reconstruction With Free Vascularized Fibular Flap
Condition: Operation Time; Complication of Surgical Procedure
Study type: Observational

Summary: 
      A total of 153 patients who underwent mandibular reconstruction by VFF were included from Jan
      1999 to Dec 2019. The mandibular resection and reconstruction were performed by four
      experienced oral and maxillofacial surgeons. Reasons for reconstruction were oncologic,
      osteoradionecrosis, trauma, and osteoporosis. All the patients were followed up
      postoperatively for at least one year. Eighteen pairs were formed with the matched cohort
      consisting of a total of 36 patients who underwent primary mandibular reconstruction without
      additional combined flaps. The surgery-related and patient-related continuous and categorical
      parameters were assessed in both groups.
    


Intervention name(s): Computer-assisted surgery
Intervention type(s): Procedure
Intervention description(s): Preoperative head and neck computed tomography (CT) and lower extremity CT angiography were acquired for all patients. In the CAS group, CT images (slice thickness<1 mm) were imported into a 3D surgical planning software (Proplan, Version 2.0/3.0 Materialise, Leuven, Belgium). Virtual surgical planning was performed to determine the mandibular and fibular resection and cut margins with localization of the optimal angles for performing osteotomies. After that, surgical guides were designed utilizing a 3D designing software (3-Matic, Version 9.0-13.0, Materialise, Leuven, Belgium). The generated virtual templates were exported in Standard Tessellation Language (STL) format and printed with a professional 3D printer (Connex 350, Stratasys, Eden Prairie, MN, USA). The reconstructive plates were pre-bent on a 3D printed planned mandibular model.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        A total of 153 patients who underwent mandibular reconstruction by VFF were included from
        Jan 1999 to Dec 2019.
      
Keywords: Computer-Assisted Surgeries; Mandibular Reconstruction; Matched-Pair Analysis
Safety of Nasal Influenza Immunisation in Egg Allergic Children - The SNIFFLE 2 Study
Condition: Egg Hypersensitivity
MeSH terms: Hypersensitivity; Egg Hypersensitivity
Study type: Interventional
Phase: Phase 4

Summary: 
      Egg allergy is common in early childhood, affecting at least one in 50 preschool children.
      Influenza ("'flu") vaccines contain egg protein, as the vaccine is cultured in hen's eggs.
      There is robust data to support the safety of influenza vaccines (containing low or
      negligible amounts of egg protein) in patients with egg allergy.

      A new influenza vaccine, known as LAIV (Live Attenuated Intranasal Vaccine) has recently been
      approved by a number of licensing boards and is given by a spray into the nose. This new
      vaccine has been available in the United States for several years and is highly effective and
      against influenza infection, with an excellent safety profile in children without egg
      allergy. However, LAIV is also grown in hen's eggs and contains egg protein, and there are NO
      published data on the safety of LAIV in egg-allergic children. In SNIFFLE 1 Study, 433 doses
      were given to 282 egg-allergic children; data is currently being analysed.

      The objective of this multicentre study is to further assess the safety of intranasal LAIV in
      egg-allergic children, in order to demonstrate that these children can safely be given the
      new LAIV within a primary care health environment.
    


Intervention name(s): Administration of Live attenuated influenza vaccine (LAIV)
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Evaluate the Effect of Lorcaserin Hydrochloride on Smoking Cessation
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 2

Summary: 
      In smokers who are motivated to stop smoking, treatment with lorcaserin compared with placebo
      will provide greater abstinence as measured by the last 4 weeks of treatment (Weeks 9-12).
      The target quit date was Day 15.
    


Intervention name(s): APD356-lorcaserin hydrochloride; Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Belviq
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Coenzyme Q10 in Relation to the Antioxidative Vitamins, Oxidative Stress and Inflammation in Coronary Artery Disease Patients During Statin Therapy
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Cardiovascular disease (CVD) is the leading cause of Taiwan. American Heart Association (AHA)
      indicated that CVD patients with Statin therapy would decrease the recurrence of CVD. The
      goal for lipid lowering in CVD patients was set at the level of low-density lipoprotein
      cholesterol (LDL-C) below 100 mg/dL. Coenzyme Q10 is recognized as a lipid soluble
      antioxidant, Statin treatment might affect the level of coenzyme Q10. Therefore, the purposes
      of this study are going to investigate the relation of coenzyme Q10 with other antioxidant
      vitamins (Vitamin A and E), the markers of lipid peroxidation, antioxidant enzymes
      activities, and the inflammatory markers in coronary artery disease (CAD) patients during
      Statin therapy. The study is going to design a placebo-controlled study. The investigators
      will recruit coronary artery disease (CAD) patients who are identified by cardiac
      catheterization as having at least 50% stenosis of one major coronary artery, and healthy
      subjects. CAD subjects are randomly assign to placebo and coenzyme Q10 supplements (150
      mg/bid = 300 mg/d) groups. Intervention is going to administration for three months. Fasting
      blood will be obtained in each month and determine the concentration of antioxidant vitamins,
      lipid peroxidation markers, antioxidant enzymes activities after intervention. Meanwhile, the
      investigators will measure the level of inflammatory markers in all subjects of this study.
      Hopefully, the results of this study could provide information of coenzyme Q10
      supplementation for clinical dietitian in advising CAD patients who are under Statin therapy.
    


Intervention name(s): Coenzyme Q10; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Coenzyme Q10 300 mg/d (150 mg/bid); Placebo :starch
Other intervention name(s): Ubquionine
Intervention MeSH terms: Ubiquinone; Coenzyme Q10
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Evaluating the Safety, Pharmacokinetics, and Anti-Viral Activity of VRC01 and VRC01LS in the Serum and Mucosa of Healthy, HIV-Uninfected Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety, pharmacokinetics, and antiviral activity of
      VRC-HIVMAB060-00-AB (VRC01) and VRC-HIVMAB080-00-AB (VRC01LS) in the serum and mucosa of
      healthy, HIV-uninfected adults.
    

Detailed description: 
      This study will evaluate two experimental human monoclonal antibodies (mAbs):
      VRC-HIVMAB060-00-AB (VRC01) and VRC-HIVMAB080-00-AB (VRC01LS). VRC01LS is designed to have a
      longer half-life than VRC01. The purpose of this study is to evaluate the safety,
      pharmacokinetics, and antiviral activity of VRC01 and VRC01LS in the serum and mucosa of
      healthy, HIV-uninfected adults.

      This study will enroll healthy, HIV-uninfected adults into five groups. At various time
      points during the study, participants in Groups 1, 2, and 4 will receive intravenous (IV)
      infusions of VRC01, and participants in Groups 3 and 5 will receive IV infusions of VRC01LS.
      Participants in Groups 1, 2, and 3 will attend 13 to 14 study visits over about 1 to 1 ½
      years; participants in Groups 4 and 5 will attend 7 to 9 study visits over about 6 months to
      1 year. At certain time points, study visits will include physical examinations, blood
      collection, urine collection, and interviews and questionnaires. At other time points,
      depending on group assignment and gender, visits will also include collection of
      cervicovaginal secretions, rectal secretions, and semen; and cervical, vaginal, and rectal
      biopsies.
    

Intervention name(s): VRC01; VRC01LS
Intervention type(s): Biological; Biological
Intervention description(s): Administered by intravenous (IV) infusion; Administered by intravenous (IV) infusion
Other intervention name(s): VRC-HIVMAB060-00-AB; VRC-HIVMAB080-00-AB
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
An Arts-Based Initiative for the Prevention of Violence Against Women and Girls
Condition: Violence
Study type: Interventional
Phase: Phase 1

Summary: 
      this project will evaluate a community and school based program to promote healthy
      relationships and prevent violence (physical, emotional and sexual dating violence) among
      predominately African American middle school adolescents in an urban setting (Baltimore, MD).
    

Detailed description: 
      This initiative includes 4 major components: 1) A variety of arts based student activities
      related to violence prevention (during and after school theatre projects, during and/or after
      school visual arts project, and the web page design project. (All students will either
      directly participate in these activities or at least see them), 2) Curricular components for
      all 7th graders, 3) Violence prevention and early intervention student support/discussion
      groups, and 4) Faculty and staff training on the subject. The evaluation is a
      quasi-experimental pre/post test comparison group design (2 schools in each group), where our
      comparison schools convert to intervention schools one year after serving as comparison
      schools. We are using both group (student and teacher surveys) and school wide (climate of
      the school) measures pre and post intervention.
    

Intervention name(s): Arts Based Program; Curriculum
Intervention type(s): Behavioral; Behavioral
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: dating violence; violence against women
Consumer in Stream and Container Collected Study
Condition: Determination of Pregnancy Status
Study type: Interventional

Summary: 
      Female volunteers, requiring to conduct a personal pregnancy test will use Clearblue Advanced
      Pregnancy test, following the instructions for use. The test will be conducted following both
      the instructions for the in stream method of sampling and the method of testing when a sample
      is collected into a container. The results will be compared to those achieved by the study
      technician.
    

Detailed description: 
      The study will compare the performance of the Clearblue Advanced Pregnancy Test, when used by
      consumers according to the instructions for use leaflet (IFUL), and by trained coordinators.
      Consumer testing will include both sampling in the urine stream and the testing method for
      urine collected into a container.

      In addition, the performance of the Clearblue Advanced Pregnancy Test will be compared to
      that of the currently marketed Clearblue Digital Pregnancy Test for the detection of
      pregnancy. In this comparison, both tests will be performed by a trained coordinator using
      the testing method for urine collected into a container on each volunteer's urine sample.

      The study will involve the recruitment of a cross-section of the target pregnancy test users
      in the United Kingdom, that is, women aged 18-45 who are seeking a pregnancy test. The study
      will aim to recruit at least 100 volunteers, a minimum of 30 (30%) of whom will be pregnant.

      Volunteers will use the Clearblue Advanced Pregnancy Test device using the urine stream
      method of sampling according to the product instructions. In addition volunteers will be
      asked to collect a urine sample from the same void and conduct a second Clearblue Advanced
      Pregnancy Test, using the testing method for urine collected in a container. The volunteer
      will then complete a study questionnaire on ease of use and leaflet comprehension. The
      questionnaire, urine sample and used devices will be retained by SPD for evaluation Agreement
      between the volunteer Pregnancy Test result and study coordinator Pregnancy Test result will
      be reported.
    

Intervention name(s): Clearblue Advanced
Intervention type(s): Other
Intervention description(s): Pregnancy test
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Pregnancy
Comparison of 0.375% Ropivacaine and 0.25% Levobupivacaine for Infraclavicular Brachial Plexus Block
Condition: Regional Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      Infraclavicular brachial plexus block has been used more frequently with the development of
      high-resolution ultrasound. Compared with peripheral nerve block using landmark technique or
      nerve stimulator technique, ultrasound-guided peripheral nerve block decreases the required
      dose of local anesthetics. As the dose of the drug used decreases, the systemic toxic effects
      of local anesthetics are reduced. However, the decreased dose of the drugs might have
      influence on the onset time of local anesthetics. Thus, the investigator aimed to evaluated
      the onset time of the two equipotent local anesthetics, 0.375% ropivacaine and 0.25%
      levobupivacaine.
    


Intervention name(s): Ropivacaine solution; Levobupivacaine solution
Intervention type(s): Drug; Drug
Intervention description(s): ultrasound-guided infraclavicular brachial plexus block with 0.375% ropivacaine solution; ultrasound-guided infraclavicular brachial plexus block with 0.25% levobupivacaine solution
Other intervention name(s): rop; levo
Intervention MeSH terms: Ropivacaine; Levobupivacaine; Pharmaceutical Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
CrossFit Exercise to Improve Glucose Control for Overweight and Obese Adults
Condition: Hyperglycemia
MeSH terms: Overweight; Hyperglycemia
Study type: Interventional

Summary: 
      The purpose of this study was to examine the differences in glucose control, fitness, and
      body composition between a standard aerobic and resistance exercise training program and a
      shorter-duration, high-intensity CrossFit training program in overweight and obese physically
      inactive adults.

      Hypotheses:

        1. Both groups would improve glucose control, with the CrossFit group improving
           significantly more than the aerobic and resistance training group.

        2. Both groups would improve fitness, with the CrossFit group improving significantly more
           than the aerobic and resistance training group.

        3. Both groups would demonstrate decreases in body fat percentage and fat mass and
           increases in lean body mass, with the CrossFit group improving significantly more than
           the aerobic and resistance training group.
    

Detailed description: 
      Overweight or obese participants will take part in an 8-week exercise intervention after
      clearance from a doctor, that is expected to improve glucose control, fitness (Eurofit and
      peak aerobic capacity), and body composition (body fat percentage, fat mass, and lean body
      mass). After stratification by age and body mass index, participants will be randomized to
      either a standard aerobic and resistance training exercise program or a relatively higher
      intensity, shorter duration CrossFit exercise program.
    

Intervention name(s): High-Intensity Functional Training; Aerobic and Resistance Training
Intervention type(s): Other; Other
Intervention description(s): Participants were instructed to work as hard as they could while maintaining safe technique and proper form to achieve as many reps or rounds as possible in the prescribed time frame. As HIFT participants became accustomed to specific movements, less time was dedicated to practicing movements and technique.; The protocol was based upon current guidelines of 150 minutes moderate-intensity aerobic activity and 2 days of muscle strengthening per week.
Other intervention name(s): CrossFit
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exercise; Physical Fitness; Body Composition, Beneficial
A Pilot Study to Assess the Glucose Lowering Effect of Metformin and Sitagliptin in Adolescents With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to see if the use of metformin and sitagliptin used in
      conjunction with insulin can improve the blood sugars of teenagers with Type 1 diabetes.
    

Detailed description: 
      -  The study will include a total of 4 visits. The time period between the very first visit
           and the very last visit will be between 10 and 15 weeks. Each participant will be
           randomized to one of the 3 groups in the study. The groups are as follows:

        -  Group 1: Insulin and sitagliptin

        -  Group 2: Insulin and metformin

        -  Group 3: Insulin and combination of sitagliptin and metformin

        -  The study is a randomized open label design. All subjects will undergo a screening
           visit; if inclusion and exclusion criteria are fulfilled they will be enrolled in the
           study. At the time of enrollment the subject will continue their home insulin regimen
           and will be randomized to an add an oral hypoglycemic agent(s) : metformin, sitagliptin
           or combination therapy (metformin and sitagliptin). The total duration on study
           medication will be 6 weeks. All subjects will undergo a baseline mixed meal tolerance
           test (MMTT) in their standard or usual insulin Each subject will undergo a total of two
           studies. Blood draws will be necessary.
    

Intervention name(s): Sitagliptin; Metformin; Sitagliptin + Metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): up to 50 mg twice a day; up to 1000 mg twice a day; up to 50/1000 mg twice a day
Other intervention name(s): Januvia; Glucophage; Sitagliptin + Metformin = Janumet
Intervention MeSH terms: Metformin; Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adolescents
Metabolic Syndrome in PCOS: Precursors and Interventions
Condition: Polycystic Ovary Syndrome; Metabolic Syndrome
MeSH terms: Polycystic Ovary Syndrome; Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the metabolic effects of anti-androgens and oral
      contraceptive pills (OCPs), compared with placebo, in the treatment of women with PCOS. We
      hypothesized that controlling elevated androgen levels with either anti-androgens or OCPs
      would produce improvement in metabolic markers in PCOS women and would reduce their long term
      metabolic risk.
    

Detailed description: 
      Polycystic ovary syndrome (PCOS) is one of the most common conditions of young women, and it
      is frequently associated with insulin resistance or metabolic syndrome (MBS). In addition,
      affected women have significantly elevated mean low-density lipoprotein (LDL) levels and an
      increased prevalence of at risk LDL levels, independent of obesity. We are directly testing
      the role of androgens in the metabolic abnormalities in PCOS by examining the impact of
      direct androgen receptor blockade by anti-androgen medications and indirect suppression of
      androgen production through suppression of leutinizing hormone (LH) with oral contraceptive
      pills (OCPs), compared with placebo, on visceral adiposity, circulating LDL levels, insulin
      secretion and sensitivity as measured by frequently-sampled IV glucose tolerance tests
      (FSIGT) and oral glucose tolerance tests (OGTT), resting energy expenditure, and maximal
      aerobic capacity measurement.

      Note: Originally there were 2 additional study arm, Metformin only and Metformin + Flutamide.
      These study arms were ultimately eliminated and were not included in analysis of baseline
      characteristics or endpoints.
    

Intervention name(s): flutamide; ethinyl estradiol 35 mcg and drospirenone 3 mg; placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): 250 mg twice daily; one active pill per day for three weeks and then 1 sugar pill per day for one week
Other intervention name(s): Eulexin; Yasmin; sugar pill
Intervention MeSH terms: Flutamide; Drospirenone; Ethinyl Estradiol; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Polycystic Ovary Syndrome; Metabolic Syndrome; PCOS; overweight; infertility; Insulin Resistance; menstrual cycle
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of SUVN-G3031 in Healthy Subjects
Condition: Cognitive Disorders
MeSH terms: Cognitive Dysfunction; Cognition Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of
      SUVN-G3031 in healthy male subjects following single or multiple ascending doses.
    

Detailed description: 
      This is a single and multiple ascending dose study to assess the safety, tolerability and
      pharmacokinetics of SUVN-G3031 administered orally once a day to healthy male subjects. The
      study will be conducted under double-blind conditions.

      The primary objective is to evaluate the safety and tolerability of SUVN-G3031 following oral
      administration of single or multiple ascending doses and estimate the maximum tolerated dose
      of SUVN-G3031, if possible.

      The secondary objectives are to evaluate the single and repeat dose plasma pharmacokinetics
      following oral administration of single and multiple ascending doses of SUVN-G3031 in healthy
      male subjects.
    

Intervention name(s): SUVN-G3031; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: SUVN-G3031; histamine 3 (H3) receptor inverse agonist; first in human; safety; pharmacokinetics; tolerability; single dose; repeat dose