bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of a Experimental Denture Adhesive to Prevent Food Ingress
Condition: Denture Retention
Study type: Interventional

Summary: 
      In this clinical study, an experimental denture adhesive with a precision tip nozzle was
      tested to evaluate the relative efficacy to reduce the ingress of food under the denture
      compared to use of no adhesive or a standard marketed adhesive.
    

Detailed description: 
      The aim of this study is to explore the mass of food particle ingress when an adhesive is
      extruded through the new nozzle with directed application compared to the use of no adhesive
      and a marketed adhesive (extruded through a flat ribbon nozzle [FRN]) with standard
      application as per product label, utilizing a peanut occlusion methodology. This was a single
      center, controlled, single blind (to the examiner performing the safety assessments (oral
      soft tissue [OST] examination) and the laboratory staff weighing the peanut particles),
      randomized, three-treatment, three-period, cross-over design in participants with full upper
      and lower dentures. Each treatment period consisted of one day of testing with at least two
      days between treatment visits. This study consisted four visits: Visit 1 - Screening Visit;
      Visit 2 - Treatment 1 Visit; Visit 3 - Treatment 2 Visit and Visit 4 - Treatment 3 Visit.
    

Intervention name(s): Experimental Denture Adhesive; Reference (Marketed) Denture Adhesive
Intervention type(s): Device; Device
Intervention description(s): Participants received a single application of test denture adhesive with a Flat Ribbon Nozzle as 3 Continuous strips those were applied to upper denture and one continuous strip that was applied to the lower denture which were placed in the mouth.; Participants received a single application of marketed denture adhesive with a flat ribbon nozzle as a 3 dabs those were applied to upper denture and 2 dabs those were applied to lower denture, which were placed in the mouth.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Efficacy of Formulated Posterior Sub Tenon Triamcinolone in Macular Edema Secondary to Non-Ischemic Retinal Vein Occlusions
Condition: Retinal Vein Occlusion
MeSH terms: Macular Edema; Retinal Vein Occlusion
Study type: Interventional

Summary: 
      Retinal vein occlusion (RVO) is considered the second vascular disorder of the retina after
      diabetic retinopathy. Patients with RVO are at risk of the development of macular edema.
      Different treatment modalities for macular edema include LASER therapy, antivascular
      endothelial growth factor (VEGF), and triamcinolone.

      Aim To detect the efficacy of formulated Triamcinolone Acetonide(TA) injection in the
      posterior subtenon space to manage macular edema secondary to non-ischemic RVOs, either
      central or branch.
    


Intervention name(s): Triamcinolone Acetonide
Intervention type(s): Drug
Intervention description(s): Triamcinolone Acetonide formulated with chondroitin sulfate and sodium hyaluronate
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Episodic Food Insecurity in African American Women With Obesity
Condition: Obesity; Food Insecurity
MeSH terms: Obesity
Study type: Observational

Summary: 
      The objective of this exploratory/developmental study is to investigate the episodic nature
      of food insecurity as a stressor via responses in body weight and psychological and
      physiological parameters longitudinally. Sixty African American women with obesity will be
      enrolled. Pennington Biomedical Research Center will coordinate this longitudinal study and
      measure 1) daily body weight remotely over 22 weeks and 2) psychological and physiological
      parameters via clinic assessments at the beginning and end of 22 weeks as well as assess
      episodes of food insecurity and stress on a weekly basis.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        African American women aged 18-65 with obesity
      
Biospecimen description: 
      Blood Urine
    
Keywords: Food Insecurity; Stress; Body Weight
Muscle Weakness and Post-traumatic Knee OA
Condition: Meniscectomy
MeSH terms: Muscle Weakness; Paresis
Study type: Interventional

Summary: 
      This is a single-center, randomized, single-blind (evaluator) study. Enrolled patients had a
      traumatic meniscal tear and underwent meniscectomy. The study included 6 weeks (12 visits) of
      standard or quadriceps intensive rehabilitation. The objective of the study was to determine
      the effect of quadriceps intensive rehabilitation on knee function and articular cartilage.
    


Intervention name(s): Quadriceps intensive strengthening; Standard rehabilitation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Quadriceps intensive strengthening includes high-intensity neuromuscular electrical stimulation to the quadriceps muscle for 10 minutes and overload to the the eccentric phase of quadriceps strengthening exercises.; Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Quadriceps strength; Knee; Rehabilitation
Safety of and Immune System Response to an HIV Vaccine (EP HIV-1090) in HIV Uninfected Adults
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to test the safety of an HIV DNA vaccine (EP HIV-1090) and to
      test whether or not the vaccine can stimulate immune system responses in HIV uninfected
      people. This vaccine uses only parts of the virus's DNA and cannot cause HIV infection.
    

Detailed description: 
      Epidemiological and animal model data support the hypothesis that HIV specific cytotoxic T
      lymphocyte (CTL) responses contribute to control and clearance of the virus. Vaccines
      designed specifically to induce CTL responses are likely to be well suited for protection
      against HIV infection and disease progression. EP HIV-1090 is a DNA vaccine composed of 21
      highly specific CTL epitopes. The vaccine is designed to optimize the immune response in
      people expressing one of three HLA Class I antigen subtypes: HLA-A2, -A3, and -B7. This
      design is predicted to induce an immune response in 85% of individuals in the general
      population. There is also a helper T lymphocyte (HTL) facilitating epitope (PADRE) in the
      vaccine. The vaccine is formulated with a water soluble polymer (polyvinylpyrrolidone) that
      protects the DNA and facilitates cellular uptake. This study will assess the safety of and
      immune response to different doses of EP HIV-1090 in healthy, HIV uninfected adults.

      Participants in this study will be randomized to receive either one of three different doses
      of vaccine or placebo. Participants will receive vaccinations or placebo at study entry and
      Months 1, 3, and 6. Both vaccinations and placebo are administered by intramuscular
      injection. Participants will be followed for 18 months and will have 12 study visits. Each
      study visit will include a physical exam, medical history, and blood and urine tests. Each
      participant will have four HIV tests during the study. Women will have at least five
      pregnancy tests during the study.
    

Intervention name(s): EP HIV-1090
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: HIV Preventive Vaccine; HIV Seronegativity; HIV-1; AIDS Vaccines; Vaccines, DNA; Dose-Response Relationship, Immunologic; CD4-Positive T-Lymphocytes; CD8-Positive T-Lymphocytes; Epitopes
Zip Arthroplasty Patient Satisfaction Evaluation
Condition: Knee Arthroplasty
Study type: Observational

Summary: 
      This study is a prospective, randomized, single center, study to evaluate Zip Closure Device
      in subjects undergoing knee arthroplasty. Patients identified as candidates for knee
      arthroplasty and meet the study selection criteria will be approached and considered for the
      study. Knee Arthroplasty of 40 subjects will be enrolled where 20 subjects will receive
      ZipLine and 20 subjects will receive Staples.
    

Detailed description: 
      Sutures and metal staples are considered standard of care methods for surgical skin closure.
      The Zip® Surgical Skin Closure device from ZipLine Medical, Inc. (Campbell, CA USA) is a more
      recent method of skin closure that utilizes skin adhesive and adjustable ratcheting straps to
      achieve and maintain tension necessary for wound closure and healing. The Zip device was
      designated Class I, 510(k) Exempt by the US FDA in 2010, and the CE Mark was affixed in 2014.

      Limited patient-reported satisfaction data exists for the Zip device as compared to staples
      and sutures, so this study will attempt to address this need.

      The purpose of the study is to evaluate patient satisfaction of closure method used after
      knee joint arthroplasty. Metal staples and the Zip® Surgical Skin Closure device are approved
      methods in regular use. Selection of method is generally based on physician preference. This
      study is to determine what, if any, differences exist in patient satisfaction amongst the two
      methods
    

Intervention name(s): Knee Arthroplasty
Intervention type(s): Device
Intervention description(s): Standard Knee Arthroplasty will be performed on study subjects. The closure method will be studied at 3 weeks and 6 weeks and patients will be asked about satisfaction with the closure method assigned.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Candidates for knee arthroplasty
Acidity Level of Blood From Primary Molar's Pulp While Undergoing Pulpotomy or Pulpectomy Procedure
Condition: Healthy
Study type: Observational

Summary: 
      The aim of this study is to evaluate the level of acidity of blood samples that are been
      taken from pulp chambers of primary molars undergoing pulpotomy or pulpectomy procedures. Our
      hypothesis is that samples from teeth undergoing pulpectomy would be acidic while samples
      from teeth undergoing pulpotomy would bo neutral.
    

Detailed description: 
      The samples will be collected by 1 m"l syringe that is pre-washed with Heparin.than the
      samples will be analyzed in an Astrop machine of neonates.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        healthy children undergoing dental treatment by residents in Hadassah hospital Jerusalem.

        Ages between 3-13 years old.
      
Biospecimen description: 
      blood specimens which are undergoing Astrop test (acidity level .po2 pco2)
    
Keywords: samples; children; the age group 3-13 years
A Clinical Study to Evaluate a Stannous Fluoride Toothpaste for the Relief of Dentinal Hypersensitivity
Condition: Dentin Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional

Summary: 
      The purpose of this study is to provide evidence of clinical efficacy of an experimental
      dentifrice containing stannous fluoride (SnF2) compared to regular fluoride dentifrice in the
      reduction of dentinal hypersensitivity (DH). This study will be considered successful if
      there is a statistically significant difference in the primary efficacy variable, change from
      baseline in Schiff sensitivity score, after 8 weeks of treatment.
    

Detailed description: 
      This will be a single centre, randomized, controlled, examiner-blind, 3 treatment arm,
      parallel group design study, stratified by maximum baseline Schiff sensitivity score (of the
      two selected test teeth), with a treatment period of 8 weeks. DH will be assessed following
      an acclimatization period of 2-6 weeks at Baseline, and after 4 and 8 weeks treatment. The
      study will be conducted in healthy participants with pre-existing self-reported and
      clinically diagnosed tooth sensitivity at Screening. A standard fluoride dentifrice with no
      specific anti-sensitivity, anti-gingivitis and anti-plaque activity will be included as the
      negative control. A Chinese marketed positive control dentifrice with sensitivity benefits
      (containing stannous chloride (SnCl2)) will also be included in this study.
    

Intervention name(s): 0.454% Stannous fluoride (SnF2) and 0.072% sodium fluoride (NaF): 1450 ppm fluoride in total; 1400 ppm fluoride as sodium monofluorophosphate (SMFP); Stannous Chloride (SnCl2) and 0.15% NaF: 1450 ppm fluoride in total
Intervention type(s): Other; Other; Other
Intervention description(s): Participants will be instructed to apply experimental dentifrice (containing 454% SnF2 and 0.072% NaF, 1450 ppm fluoride in total), covering the full length of toothbrush head (full ribbon) and will brush twice daily (morning and evening) for one timed minute (in their usual manner) and expectorate.; Participants will be instructed to apply negative control dentifrice (containing 1400 ppm fluoride as SMFP), covering the full length of toothbrush head (full ribbon) and will brush twice daily (morning and evening) for one timed minute (in their usual manner) and expectorate.; Participants will be instructed to apply positive control dentifrice (containing SnCl2 and 0.15% NaF, 1450 ppm fluoride in total), covering the full length of toothbrush head (full ribbon) and will brush twice daily (morning and evening) for one timed minute (in their usual manner) and expectorate.
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride; Tin Fluorides; Fluorophosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Impact of High Fiber Snacks on Adiposity, Glucose Regulation and Appetite
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The primary objective of the proposed research is to determine the influence of 8 weeks of
      twice daily consumption of 120 kcal servings of dried apples or a commonly consumed low fat
      120kcal muffin on components of obesity (waist circumference [waist measurement], serum
      glucose [blood sugar], triglycerides [fats in the blood] and HDL-cholesterol, and blood
      pressure) as well as antioxidant status, inflammatory markers, nutrient intake in overweight
      and obese individuals. A total of 48 children aged 10-16 years will be randomly assigned to
      groups and provided with twice daily 120 kcal servings of either dried apples or muffins for
      8 weeks of feeding. Prior to initiating the feeding trial and again after 8 weeks, blood
      samples will be collected and analyzed. During each visit to the lab, subjects will be
      weighed in minimal clothing, tested for body composition using dual energy X-ray
      absorptiometry (DXA), bioelectrical impedance (BIA) and air displacement plethysmography (Bod
      Pod) and blood pressure, and measured for waist circumference. One 24-hour recall will be
      performed prior to initiation of the study; one recall will be performed throughout the
      feeding period, and one at the end of the 8 weeks. Dietary intake of energy, macronutrients,
      vitamins and minerals will be assessed to determine diet quality. All food records will be
      analyzed using the Nutritionist Pro (First DataBank) software. The potential benefits of the
      study include determining the effects of consistent snacking and particular snack foods on
      metabolism and weight management. There are no major risks to subjects in this study. There
      are minimal risks when performing venipuncture (blood draws) including bruising, perforation
      of the vein leading to hematoma under skin, light-headedness or dizziness due to fear of
      needles, and infection. This study will hopefully allow more understanding and insight into
      the diet of children and the effect of it on body makeup and blood sugar. It is hypothesized
      that the twice a day apple snack group will have decreased waist circumference, body
      adiposity, triglycerides and total cholesterol as well as, increased blood glucose uptake at
      the end of 8 weeks.
    


Intervention name(s): dried apples; muffin
Intervention type(s): Other; Other
Intervention description(s): 120 calories; 120 calories
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: apple; high fiber; body composition; children
Lap-Band Surgery on Adolescents for Safety and Efficacy
Condition: Obesity; DM
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This study is to demonstrate the safety and efficacy of the use of the LAP-BAND surgery in
      the morbidly obese adolescent population.
    

Detailed description: 
      STUDY OBJECTIVES: Is to demonstrate the safety and efficacy of the use of the LAP-BAND®
      System in the morbidly obese adolescent population in the United States, and therefore
      provide these individuals with a significantly less morbid and reversible surgical option for
      weight loss.

      STUDY VARIABLES:The primary efficacy variable is weight loss evaluated in terms of % excess
      weight loss (EWL).

      DESIGN:Prospective, open-label, and single center
    

Intervention name(s): Lap-Band
Intervention type(s): Device
Intervention description(s): Obesity and adolescents
Other intervention name(s): Lap-Band Adjustable Gastric Band (LAGB) Operation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Child Obesity
A Randomized Double-blind Trial With 6 Antipsychotic Drugs for Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The purpose of this study is to compare the efficacy and side effects of 6 commonly used
      antipsychotic drugs in the treatment of schizophrenia in a Chinese population.
    

Detailed description: 
      The relative effectiveness of second-generation (atypical) antipsychotic drugs as compared
      with that of older agents has been incompletely addressed, though newer agents are currently
      used far more commonly. The investigators compared a first-generation antipsychotic,
      perphenazine or haloperidol, with several newer drugs in a double-blind study.

      METHODS: A total of 550 patients with schizophrenia were recruited at 4 Chinese sites and
      randomly assigned to receive perphenazine (16 to 64 mg per day) or haloperidol(6 t0 20mg per
      day), olanzapine (5 to 20 mg per day), quetiapine (400 to 750 mg per day), aripiprazole (10
      to 30 mg per day) or risperidone (2 to 6.0 mg per day) for up to 8 weeks.
    

Intervention name(s): Typical antipsychotic; Risperidone; Olanzapine; Quetiapine; Aripiprazole; Ziprasidone
Intervention type(s): Drug; Drug; Drug; Drug; Device; Drug
Intervention description(s): Haloperidol (6~20mg/day) and perphenazine (16~64mg/day), twice per day, 8 weeks; 2~6mg/day, twice per day, 8 weeks; Olanzapine, 400~750mg/day, twice per day, 8 weeks; Quetiapine, 400～750mg/day, twice per day, 8 weeks; Aripiprazole, 10～30mg/day, twice per day, 8 weeks; Ziprasidone 80~160mg/day, twice per day, 8 weeks
Other intervention name(s): Haldol and Trilafon; Risperdal; Zyprexa; Seroquel; Abilify; Geodon
Intervention MeSH terms: Olanzapine; Risperidone; Aripiprazole; Quetiapine Fumarate; Ziprasidone; Antipsychotic Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
CONNECT: Smoking Cessation and Lung Cancer Screening
Condition: Smoking Cessation
Study type: Interventional

Summary: 
      This clinical trial studies the impact of CONNECT on biochemically confirmed smoking
      abstinence among diverse current smokers who are undergoing lung cancer screening.
    

Detailed description: 
      The study team will develop and test a novel smoking cessation intervention, CONNECT, which
      will start at the time an individual is receiving lung cancer screening (LCS). CONNECT will
      include an interactive Video Doctor which will provide participants with information tailored
      to their individual responses as well as proactive outreach using brief telephone calls and
      text messaging to follow up smokers with motivation enhancement to refer and engage patients
      in evidence based smoking cessation interventions (such as quitline utilization). After
      development and usability testing, we will conduct a small feasibility study followed by a
      pilot randomized controlled trial to estimate the impact of CONNECT on biochemically
      confirmed 30-day smoking abstinence among diverse current smokers seen at the San Francisco
      Veterans Affairs Medical Center and the University of California San Francisco Division of
      General Internal Medicine. Participants will be randomized to CONNECT or a control condition.
      Data will include self-report from participants obtained at baseline, 1 and 3 months, and the
      electronic health record. Outcomes will be biochemically confirmed 30-day smoking abstinence
      at 3 months post LCS and satisfaction as well as self-reported quit attempts, and use of
      evidence-based smoking cessation resources (quitline, pharmacotherapy or counseling). The
      knowledge gained will provide the pilot data necessary to apply for a larger study to test
      our novel intervention for promoting smoking cessation among a diverse population of
      high-risk smokers undergoing Lung Cancer Screening.
    

Intervention name(s): Computer-Assisted Intervention Video Doctor; Computer-Assisted Intervention no Video Doctor
Intervention type(s): Other; Other
Intervention description(s): Complete CONNECT: participants will undergo in-person assessment questions and follow-up assessment questions. They will view and participate in the interactive Video Doctor about Smoking Cessation.; Individuals who are randomized to the control group will undergo the same assessment questions and all follow up assessments like the intervention group. Instead of viewing and participating in the interactive Video Doctor about Smoking Cessation, they receive a handout containing smoking cessation resources.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: quitting; smoking; smoking cessation tool; smoking cessation; quit smoking; smoking cessation resources; smoking cessation barriers; smoking cessation intervention tool