bioihbjkbjnl/mcl2 huggingface dataset:
Assessing the Impacts of a UESAD on Laryngeal Symptoms and Salivary Pepsin
Condition: Laryngopharyngeal Reflux
MeSH terms: Laryngopharyngeal Reflux
Study type: Interventional

Summary: 
      It is postulated that the incompetence of the upper esophageal sphincter (UES) to restrict
      passage of esophageal refluxate is fundamental to the development of LPR. The UES Assist
      Device (UESAD) is a novel device that applies relatively modest external cricoid pressure,
      which results in a 20 to 30 mmHg intraluminal UES pressure increase. Pepsin, a proteolytic
      enzyme produced in the stomach, has been detected in the laryngeal epithelium of patients
      with reflux associated laryngeal symptoms and implicated in the pathogenesis of
      laryngopharyngeal reflux. This study will assess the effectiveness of a UESAD worn for 2
      weeks on LPR symptoms and salivary pepsin levels.
    

Detailed description: 
      A cost-effective and care appropriate algorithm to streamline the diagnosis and management of
      patients with laryngopharyngeal reflux (LPR) has not been described. It is postulated that
      the incompetence of the upper esophageal sphincter (UES) to restrict passage of esophageal
      refluxate is fundamental to the development of LPR. The UES Assist Device (UESAD) is a novel
      device that applies relatively modest external cricoid pressure, which results in a 20 to 30
      mmHg intraluminal UES pressure increase. Pepsin, a proteolytic enzyme produced in the
      stomach, has been detected in the laryngeal epithelium of patients with reflux associated
      laryngeal symptoms and implicated in the pathogenesis of laryngopharyngeal reflux. A study
      examining salivary pepsin levels for patients pre- and post-fundoplication for LPR found that
      all patients with positive preoperative pepsin levels and postoperative elimination had
      symptom improvement, suggesting that changes in pepsin level may be reflective of surgical
      responsiveness. This study seeks to explore the therapeutic role of the UESAD in patients
      with LPR symptoms, and measure its effectiveness by objective criteria (salivary pepsin) and
      symptomatic improvement. In this study, 25 patients seen in GI clinic with laryngeal
      complaints will complete validated symptom questionnaires - the RSI, GerdQ and N-GSSIQ
      scores. Those with an RSI > 13 and GerdQ > 8 will be included. They will submit 3 baseline
      sputum samples for pepsin analysis, taken upon awaking. They will then be advised to use the
      UESAD nightly for 2 weeks. 3 follow-up sputum samples for pepsin analysis will be taken and
      symptom scores reevaluated after the 2 week period.
    

Intervention name(s): UESAD
Intervention type(s): Device
Intervention description(s): Device designed to provide modest cricoid pressure to reduce reflux
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Immunogenicity and Safety of a Fractional Booster Dose of IPV Intradermally Versus Full Dose Intramuscularly
Condition: Poliomyelitis
MeSH terms: Poliomyelitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate the use of a fourth fractional booster dose of
      sanofi pasteur's IMOVAX Polio injected intradermally (using the Mantoux technique) as booster
      dose between 15 to 18 months of age, in terms of immunogenicity and safety.

      Objectives:

        -  To describe in each group the immunogenicity of IMOVAX Polio administered intradermally
           or intramuscularly, one month after the booster dose given at 15-18 months of age in
           toddlers previously primed with three doses of IMOVAX Polio vaccine during the IPV25
           study.

        -  To describe in each group the safety of the booster dose of IMOVAX Polio vaccine
           administered intradermally or intramuscularly.
    


Intervention name(s): Inactivated types 1, 2, and 3 poliovirus, D antigens; Inactivated types 1, 2, and 3 poliovirus, D antigens
Intervention type(s): Biological; Biological
Intervention description(s): 0.1 mL, intradermal; 0.5 mL, Intramuscular
Other intervention name(s): Imovax Polio; Imovax Polio
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Poliomyelitis; intradermal
Smart-phone Application to Promote Medication Adherence in Adolescents and Young Adults (AYA) With Cancer
Condition: Neoplasms
MeSH terms: Neoplasms
Study type: Observational

Summary: 
      To explore use of a smart-phone medication reminder application to promote adherence to oral
      medications by AYA with cancer.
    

Detailed description: 
      Non-adherence to oral medications is a prevalent problem in adolescents and young adults
      (AYA) with cancer that may impact both survival and quality of life while on treatment. The
      purpose of this study is to explore use of a smart-phone medication reminder application to
      promote adherence to oral medications by AYA with cancer. The study's primary aim is to
      explore the feasibility and acceptability of using a smart-phone medication reminder
      application to promote adherence to oral medications by AYA with cancer as well as to
      characterize application use. Secondary aims include: 1) to obtain initial estimates of
      intervention effect- measured by pre-intervention to post-intervention differences in
      perceived behavioral control for adherence, intention to adhere, and adherence behavior - to
      inform design of a future trial powered to detect a clinically significant effect of
      smart-phone medication reminder application use on adherence to oral medications; and 2) to
      examine the relationships among perceived behavioral control for adherence, intention to
      adhere, and adherence behavior. A pre-post single group design will be used. Data will be
      collected weekly for 4 weeks before introduction of the intervention and for 8 weeks
      following introduction of the intervention. Analytic approaches will include descriptive
      statistics and generalized estimating equation (GEE) modeling.
    

Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary care clinics for patients be treated for cancer.
      
Keywords: neoplasms; adolescent; young adult; medication adherence
A Study to Describe the Immunogenicity, Safety, and Tolerability of Neisseria Meningitidis Serogroup B Bivalent Recombinant Lipoprotein 2086 Vaccine (Bivalent rLP2086) in Healthy Subjects Aged ≥24 Months to <10 Years
Condition: MENINGOCOCCAL INFECTION
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is looking at a new vaccine that might prevent meningococcal disease, and will
      study the immune response elicited by this vaccine when given to healthy young children. The
      study will also look at the safety of the new vaccine as well as how it is tolerated.
    


Intervention name(s): Bivalent rLP2086 Vaccine; Licensed pediatric hepatits A vaccine; Normal Saline
Intervention type(s): Biological; Biological; Other
Intervention description(s): 1 dose of 120 μg of bivalent rLP2086 by intramuscular injection at Months 0, 2, and 6 into the upper deltoid muscle of the arm.; 1 0.5 mL dose by intramuscular injection at Months 0 and 6 into the upper deltoid muscle of the arm.; Sterile saline solution for injection (0.85% sodium chloride) in a 0.5 mL dose at Month 2.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Cross-sectional Dietary Intake Survey on Ivorian School-Aged Children and Women of Reproductive Age
Condition: Diet; Deficiency
MeSH terms: Malnutrition
Study type: Observational

Summary: 
      A cross-sectional dietary intake study was conducted with 423 Ivorian school aged children
      (SAC, 6-12 years) and 423 women of reproductive age (WRA, 15-49 years) from four cities,
      recruited by two-stage random sampling.
    

Detailed description: 
      A cross-sectional dietary intake study was conducted with 423 Ivorian school aged children
      (SAC, 6-12 years) and 423 women of reproductive age (WRA, 15-49 years) from four cities,
      recruited by two-stage random sampling. Dietary intake data were collected by multiple pass
      24-hour recall. For a sub-sample (10% subjects) two-day non-consecutive multiple pass 24-hour
      recall was collected.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        healthy children and women living in the cities of Ivory Coast
      
Keywords: Nutrient Inadequacy; Dietary Patterns; Food Intake
Adipose Tissue Function and Response to Exercise Training in Women With and Without Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      The primary aim of this trial is to investigate adipose tissue function in women with and
      without polycystic ovary syndrome (PCOS). PCOS is a common endocrine disorder in young women.
      The pathogenesis behind PCOS is complex and only partly understood, and deeper mechanistic
      insight is needed. Insulin resistance is a central feature of PCOS, and recent studies have
      suggested that this is linked to aberrant adipose tissue function. Exercise training has been
      found to improve the symptoms in PCOS, but we need more knowledge about why. While processes
      involved in skeletal muscle oxidative remodeling are well described, it is to a large extent
      unknown whether the oxidative capacity of human adipose tissue is modified by endurance
      training. The women included in this study will be matched (for body mass index, body weight,
      and age) to participants in another study. This will enable the investigators to do a
      comparison between cases (women with PCOS) and controls (women without PCOS) at baseline, and
      to assess the responses to exercise training in adipose tissue.
    


Intervention name(s): 4x4 minutes high intensity interval training; 10x1 minute high intensity interval training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Treadmill running/walking with 10 minutes warm-up at 60-70% of maximum heart rate, 4x4 minute intervals at 90-95% of maximum heart rate separated by 3-minutes active pauses at 60-70% of maximum heart rate, and 3 minutes cool-down.; Treadmill running/walking with 10 minutes warm-up at 60-70% of maximum heart rate, ten 1-minute intervals at maximal intensity (that can be performed for one minute), separated by 1-minutes active pauses at 60-70% of maximum heart rate, and 3 minutes cool-down.
Other intervention name(s): High-intensity exercise; Aerobic exercise; High-intensity exercise; Aerobic exercise
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Exercise therapy; Adipose tissue; Mitochondria; Oxidative Phosphorylation
Combination Chemotherapy in Treating Patients With Advanced Non-Small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of carboplatin, gemcitabine, and exisulind
      in treating patients who have advanced non-small cell lung cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the 18-month survival rate in patients with advanced non-small cell lung
           cancer treated with carboplatin, gemcitabine, and exisulind.

        -  Determine the feasibility and toxicity of this regimen in these patients.

        -  Determine the response rate, progression-free survival, and overall median survival of
           patients treated with this regimen.

      OUTLINE: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and carboplatin IV
      over 30 minutes on day 1. Chemotherapy repeats every 21 days for up to 6 courses. Patients
      also receive oral exisulind twice daily beginning on day 1 of course 1 and continuing until
      disease progression or unacceptable toxicity occurs.

      Patients are followed every 3 months for 2 years and then every 6 months for 2 years.

      PROJECTED ACCRUAL: A total of 55 patients will be accrued for this study within 6 months.
    

Intervention name(s): carboplatin; exisulind; gemcitabine hydrochloride
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Sulindac sulfone; Carboplatin; Gemcitabine
Primary purpose: Treatment
Keywords: recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer
Flow Controlled Ventilation in Cardiac Surgery
Condition: Respiration; Artificial; Positive-Pressure Respiration
Study type: Interventional

Summary: 
      This trial investigates effects of individualized (by compliance guided pressure settings)
      flow-controlled ventilation compared to best clinical practice pressure controlled
      ventilation in cardiac surgery requiring cardiopulmonary bypass.
    

Detailed description: 
      The aim of the study is to investigate flow-controlled ventilation (FCV) during cardiac
      surgery requiring cardiopulmonary bypass. Previous preclinical trials have already shown
      improved oxygenation and CO2 removal within a significantly reduced respiratory minute volume
      as an expression of more efficient gas exchange with FCV compared to volume controlled
      ventilation (VCV). Preliminary data of our own animal study comparing individualized FCV by
      compliance guided pressure settings with state-of-the-art low tidal volume pressure
      controlled ventilation (PCV) confirmed previous findings with a significantly improved
      oxygenation by 20% while reducing respiratory minute volume. We therefore assume that FCV may
      be a more lung protective ventilation method.

      Open heart surgery requires bridging of the heart and lung function with a cardiopulmonary
      bypass (CPB) performed by a heart-lung machine. During this time the lung is most frequently
      not ventilated at all and lies collapsed in the chest for several hours. After weaning from
      CPB, the lungs must be recruited and ensure sufficient gas exchange of the blood. Not
      surprisingly, the incidence of postoperative pulmonary complications (PPC) at 20-30% is
      comparatively high after cardiac surgery and is the leading cause of perioperative mortality.
      Based on previous trials we expect improved oxygenation and thus arterial partial pressure of
      oxygen (pO2) is the main primary outcome parameter of this study. Furthermore, we expect
      improved recruitment of lung tissue due to controlled expiratory flow in FCV without the need
      of recruitment maneuvers, which may cause deleterious effects on lung tissue. Thus, lung
      tissue aeration assessed by Hounsfield units analyses of a postoperative computed tomography
      will be a secondary outcome parameter.
    

Intervention name(s): Evone; Primus
Intervention type(s): Device; Device
Intervention description(s): Airway ventilation device; Airway ventilation device
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: controlled, prospective
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: flow controlled ventilation; pressure controlled ventilation; cardiac surgery
Behavioral Economic Incentives to Improve Glycemic Control Among Adolescents and Young Adults
Condition: Diabetes; Type 1 Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 3

Summary: 
      In this study the investigators will compare a novel approach using daily financial
      incentives and a tiered sponsor network to motivate adolescents and young adults with type 1
      diabetes to improve glycemic control.
    

Detailed description: 
      Participants will be given daily glucose monitoring goals of ≥4 glucose checks per day with
      ≥1 readings within goal range (70-180 mg/dL) and provided with iHealth wireless glucometers.
      Half of the study participants will be randomized to the 3-month intervention arm on Way to
      Health. The intervention includes daily financial incentives ($60 in an account at beginning
      of each month with $2 daily loss if non-adherent) and a 2-level tiered sponsor network (youth
      select 2 people who will be notified of non-adherence after 2 and 5 consecutive days). The
      primary outcome will be HbA1c at 3 months compared to baseline. Secondary outcomes will
      include HbA1c at 6 months and the proportion of participants adherent to daily glucose
      monitoring goals. Exit interviews will elicit intervention feasibility and feedback from a
      youth perspective.
    

Intervention name(s): Daily feedback; Financial incentive
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Daily feedback on glucose levels from wireless glucometers; Participant receive a $2 daily financial incentive framed as a loss with money allocated upfront and taken away each day of non-adherence to goal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: diabetes; adolescent; young adult; behavioral economics; financial incentives; social incentives
No Drop Post-Op Cataract Surgery
Condition: Cataract
MeSH terms: Cataract
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the effect of Intraocular Phenylephrine/Ketorolac Infusion on Retinal
      Thickness and Macular Edema in Cataract Surgery. Participants will receive infusions of
      Phenylephrine/Ketorolac during surgery instead of receiving topical NSAID drops pre and post
      operatively.
    

Detailed description: 
      Topical NSAIDs have been known to reduce post-operative macular edema, inflammation and pain
      in patients undergoing cataract surgery. Routine cataract surgery without the protection of
      topical NSAIDs results in an increase of the number of patients with macular edema and
      macular thickening.

      Omidria (phenylephrine and ketorolac injection 1%/0.3%) infusion is used in patients during
      cataract surgery to decrease post-operative pain and inflammation. It is also indicated to
      maintain pupil dilation during cataract surgery.

      This study will evaluate whether treating patients with Omidria during cataract surgery will
      control post-operative pain and inflammation as well as reduce or eliminate macular edema
      without the use of adjunctive topical NSAIDs.
    

Intervention name(s): Omidria
Intervention type(s): Drug
Intervention description(s): Phenylephrine and Ketorolac infusion of 1%/0.3% during cataract surgery.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of Valsartan 320mg Tablets Under Fasting Conditions
Condition: Healthy
Study type: Interventional

Summary: 
      The study was an open label, balanced, randomized, two-treatment, four-period, two sequence,
      single oral dose, crossover, fully replicate bioequivalence study of two formulations of
      Valsartan 320 mg under fasting conditions.
    

Detailed description: 
      Tablet in healthy, adult human subjects under fasting condition, with a screening period of
      28 days prior to dose administration in Period-I. In each study period, twenty-four (24)
      blood samples, including two (02) predose blood samples, each of 02 mL were collected from
      each subject except for the discontinued / withdrawn subjects to analyze the pharmacokinetic
      profile of the test as well as the reference product.

      The pharmacokinetic parameters were calculated from the drug concentration vs. time profile
      by non-compartmental model using WinNonlin Professional Software-Version 5.3 (Pharsight
      Corporation, USA) for Valsartan. Statistical comparison of the pharmacokinetic parameters of
      the two formulations was carried out using PROC MIXED of SAS® Version 9.3 (SAS Institute
      Inc., USA) to assess the bioequivalence of both the formulations.
    

Intervention name(s): Valsartan
Intervention type(s): Drug
Other intervention name(s): 320mg tablets
Intervention MeSH terms: Valsartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Nutritional Prevention of Diabetes Mellitus Type 2
Condition: Type 2 Diabetes Mellitus; Nutritional and Metabolic Diseases; Liver Fat; Insulin Sensitivity
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Insulin Resistance; Metabolic Diseases
Study type: Interventional

Summary: 
      This study investigates the influence of red meat and fibers on glucose metabolism and body
      fat composition in subjects at increased risk for type 2 diabetes.
    

Detailed description: 
      The epidemiologic evidence for increased red meat intake and decreased fiber intake as risk
      factors for T2D is solid. However, few intervention studies have been performed in order to
      investigate the role of whole-grain intake or the consumption of red meat in glycemic control
      and prevention of diabetes, yielding contradicting results. Thus, in order to prove
      causality, further identify potential underlying mechanisms and be able to improve lifestyle
      modification programs, we performed a randomized, controlled intervention study over six
      months. The participants are individuals at increased risk for tyoe 2 diabetes. They were
      randomised to 3 interventions groups: 1) caloric restriction of 400 kcal/day (control group),
      2) caloric restriction plus no red meat consumption 3) caloric restriction and increase in
      fiber intake. Subjects where thoroughly phenotyped by anthropometric parameters, oral glucose
      tolerance tests, and MRI measurements of body fat composition and iron content in the liver.
      In this study, we want to compare the effectiveness of reduced caloric intake only versus
      reduced caloric intake with an additional modification of diet composition in terms of red
      meat and fiber consumption.
    

Intervention name(s): Caloric restriction; no red meat; Increased fiber intake
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): After the baseline measurements individuals underwent dietary counseling and had 6 sessions with a dietician (after, 1,4,8,12 16 and 20 weeks).; After the baseline measurements individuals underwent dietary counseling and had 6 sessions with a dietician (after, 1,4,8,12 16 and 20 weeks).; After the baseline measurements individuals underwent dietary counseling and had 6 sessions with a dietician (after, 1,4,8,12 16 and 20 weeks).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention