bioihbjkbjnl/mcl2 huggingface dataset:
Postprandial Glucodynamic Response to Insulin Glargine/Lixisenatide Fixed Ratio Combination in Japanese Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To assess the postprandial glucodynamic response to 2 doses of insulin glargine/lixisenatide
      fixed-ratio combination compared to placebo in Japanese patients with type 2 diabetes
      mellitus (T2DM).

      Secondary Objectives:

        -  To assess the pharmacokinetics (PK) of lixisenatide following administration of 2
           different doses of insulin glargine/lixisenatide fixed-ratio combination in Japanese
           patients with T2DM.

        -  To assess the postprandial glucodynamic response to insulin glargine/lixisenatide
           fixed-ratio combination compared to insulin glargine alone in Japanese patients with
           T2DM.

        -  To assess the safety and tolerability of insulin glargine/lixisenatide fixed-ratio
           combination in Japanese patients with T2DM.
    

Detailed description: 
      The total study duration per patient will be approximately 6 to 13 weeks that will consist of
      a 2-28 days of screening period, a 3-day treatment period, a 7-14 days of washout period, and
      1-day end of study visit.
    

Intervention name(s): Insulin glargine/ lixisenatide fixed-ratio combination HOE901/AVE0010; Insulin glargine HOE901; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Pharmaceutical form: solution
Route of administration: subcutaneous; Pharmaceutical form: solution
Route of administration: subcutaneous; Pharmaceutical form: solution
Route of administration: subcutaneous
Other intervention name(s): Lantus
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Lixisenatide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of Two Different Doses of Asacol in the Treatment of Moderately Active Ulcerative Colitis
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a prospective clinical study to evaluate the safety and efficacy of two
      different doses of Asacol for the treatment of moderately active ulcerative colitis. In
      addition, a new tablet formulation will be evaluated at one of the two doses.
    


Intervention name(s): Asacol 800 mg (mesalamine); Asacol 400 mg (mesalamine)
Intervention type(s): Drug; Drug
Intervention description(s): tablets, 4.8 g/day for 6 weeks, 2 - 800 mg Asacol tablets and 2 placebo tablets 3 times daily; tablets, 2.4 g/day for 6 weeks, 2 - 400 mg Asacol tablets and 2 placebo tablets 3 times daily
Intervention MeSH terms: Mesalamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Adrenomedullin Upregulation in Apical Periodontitis
Condition: Periapical Periodontitis
MeSH terms: Periodontitis; Periapical Periodontitis
Study type: Interventional

Summary: 
      The aim of the present study was to investigate the relationship between Apical periodontitis
      (AP) severity and inflammatory markers (IL-12, TNF-alpha), and Mid-Regional Pro
      Adrenomedullin (MR-proADM) in patients with AP. A total of 174 subjects were divided into
      three categories: AP group (n=82), Chronic periodontitis (CP) group (n=42), healthy control
      group (n=50). Blood samples were collected from all of the patients. Enzyme-linked
      immunosorbent assay was used to evaluate the samples.
    

Detailed description: 
      Bone destruction in apical periodontitis (AP) depends on the microorganisms' efficiency to
      breach the host-epithelial barrier and various antimicrobial peptides. Mid-regional pro
      adrenomedullin (MR-proADM) is one such potent antimicrobial peptide, which plays a regulatory
      and stabilizing role among proinflammatory and anti-inflammatory cytokines. A broad range of
      cells and tissues produce MR-proADM such as adrenal medulla, kidney, lungs, and endothelial
      cells. MR-proADM was found to be present in circulation and in various biological fluids. It
      is reported to function both as a generalized hormone and locally affecting autocrine or
      paracrine mediator. Its plasma level is usually elevated in certain conditions such as heart
      failure, hypertensive situations, cerebro-vascular events, chronic kidney failure, diabetes
      mellitus, sepsis and periodontitis. Besides these, MR-proADM has drawn attention as it
      stimulates the proinflammatory cytokine IL-6 and suppresses cytokines, like TNF- α, for
      regulating inflammation, being a potent of inhibitor of apoptosis and stimulating
      angiogenesis in tumor cells. However, there is still a large information gap on MR-proADM.
      Despite all these effects, there is not enough information in the literature about the effect
      of MR-proADM on oral and dental health and its effectiveness in apical periodontitis. Whether
      AP can cause any alterations in the MR-proADM value is also unknown.

      Therefore, the aim of this study is to investigate the relationship between AP severity and
      inflammatory markers (IL-12, TNF-alpha), and MR-proADM in patients with AP. In addition, the
      results will be compared with the results of healthy controls and patients with chronic
      periodontitis.
    

Intervention name(s): Apical periodontitis; Chronic periodontitis
Intervention type(s): Diagnostic Test; Diagnostic Test
Intervention description(s): Radiography of the patients were taken. Blood samples were collected from those patients.; Radiography of the patients were taken. Blood samples were collected from those patient
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: Apical periodontitis, Chronic periodontitis, Mid regional proadrenomedullin, IL-12, TNF-α
Internet-based Treatment for Chronic Insomnia
Condition: Insomnia; Insomnia Disorder
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Study Objectives. Despite effective cognitive behavioral treatments for chronic insomnia,
      such treatments are underutilized. This study evaluates the impact of a 6-week, online
      treatment for insomnia.

      Design This is a randomized controlled trial with online treatment and waiting list control
      conditions.

      Participants

      Participants are adults in Manitoba Canada with chronic insomnia.

      Setting

      Participants receive online treatment from their homes. Intervention. Online treatment
      consists of psychoeducation, sleep hygiene and stimulus control instruction, sleep
      restriction treatment, mindfulness training, relaxation training, cognitive therapy, and help
      with medication tapering. Measurement and Results. The impact of online treatment on primary
      end points of sleep quality, insomnia severity, and daytime fatigue will be assessed.
    


Intervention name(s): Cognitive Behavioral Therapy
Intervention type(s): Behavioral
Intervention description(s): 6 weeks of relaxation training, cognitive therapy, sleep restriction, stimulus control, sleep hygiene, psychoeducation, hypnotic tapering and mindfulness training
Other intervention name(s): CBT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: insomnia; online systems
A Study to Assess the Analgesic Efficacy and Safety of ASP8062 in Subjects With Fibromyalgia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to assess analgesic efficacy of ASP8062 relative to placebo as
      well as the safety and tolerability. This study also assessed the treatment differences in
      physical function as well the improvements in overall subject status (e.g., fibromyalgia
      symptoms, global functioning) of ASP8062 relative to placebo.
    


Intervention name(s): ASP8062; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ASP8062 30 mg was administered orally as a single daily dose, taken preferably in the morning with or without food.; Placebo was administered orally as a single daily dose, taken preferably in the morning with or without food.
Intervention MeSH terms: ASP8062
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ASP8062; Fibromyalgia
Heart Failure IDentification in a High Risk Cardiovascular OutpatiEnt Population (HIDE)
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      This is a pilot, multicenter, real-world, single-visit, low risk, phase IV interventional
      study to efficiently identify new cases of heart failure (HF) Stage C in subjects who are at
      risk of cardiovascular (CV) disease in high-volume ambulatory primary care settings in 3
      countries in Central America.
    

Detailed description: 
      Subjects with 2 or more CV risk factors will be identified and will undergo an NYHA score
      assessment. If the NYHA score is ≥ II, the serum NT-proBNP concentration will be determined
      on-site on the same day. If the serum NT proBNP concentration is ≥ 125 pg/mL, the subject
      will be referred to a country specific central echocardiography laboratory for a
      transthoracic echocardiogram to measure the left ventricular ejection fraction (LVEF) and
      relevant structural heart disease.
    

Intervention name(s): NYHA assessment; Serum NT-proBNP concentration; Transthoracic Ecocardiogram
Intervention type(s): Diagnostic Test; Procedure; Diagnostic Test
Intervention description(s): The New York Heart Association (NYHA) functional classification of HF; Subjects with NYHA score ≥ II will undergo a rapid, on site serum NT-proBNP test on the same day of the visit. Roche CARDIAC proBNP+ test, using the Cobas h 232 device, is a quantitative immunological test for the determination of NT-proBNP in heparinized venous blood.; Subjects with a serum NT-proBNP result of ≥ 125 pg/mL at Visit 1 will be referred to a study cardiologist for a transthoracic echocardiogram to assess LVEF and relevant structural heart disease
Intervention model: Single Group Assignment
Intervention model description: A recent Cochrane analysis reported a high burden of HF in Latin America (Ciapponi et al 2016), reporting an incidence of HF of 199 cases per 100 000 person-years. A cross-sectional study of 633 individuals aged ≥ 45 years, randomly selected and registered in a primary care program in Brazil (Jorge et al 2016) reported 36.6% of patients with Stage A HF, 42.7% with Stage B, and and 9.3% with symptomatic HF (Stage C). In real world settings primary care physician may attend to up to 40 patients per day, which rose to as many as 70 patients per day during high season demand, meaning in some circunstances physicians may only have up to 12 minutes per patient so patients with HF may go unnoticed. The aim of this study is to assess the practicality of an algorithm to identify new cases of HF Stage C in subjects who are at risk of CV disease in real world high-volume ambulatory primary care settings in Central America.
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Heart failure; Cardiovascular risk factors; NT-proBNP; NYHA assessment
A Study of V110 a Pneumococcal Vaccine in Healthy Adults (V110-013)
Condition: Healthy; Pneumococcal Infections
MeSH terms: Pneumococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this trial is to evaluate the safety, tolerability, and immunogenicity of an
      investigational pneumococcal vaccine in healthy adults.
    


Intervention name(s): V110, pneumococcal vaccine polyvalent
Intervention type(s): Biological
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Diagnosis and Prediction of Pre-Eclampsia by Using Congo Red Dot Test in Bangladesh and Mexico
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia
Study type: Observational

Summary: 
      A cross sectional study design will evaluate the diagnostic value of the CRD test to the
      pregnant women attending the Dhaka Medical College Hospital and Hospital Materno-Infantil
      Inguarán, tertiary level facilities in Bangladesh and Mexico City.
    

Detailed description: 
      A cross sectional study design will evaluate the diagnostic value of the Congo Red Dot test
      to the pregnant women attending the Dhaka Medical College Hospital and Hospital
      Materno-Infantil Inguarán, tertiary level facilities in Bangladesh and Mexico City. Women
      attending the hospital with clinically confirmed cases of preeclampsia and clinically healthy
      women who deliver at term will be eligible for the study. Investigators will enroll about 200
      women at each facility. Investigators will target the following women for enrollment: women
      with clinical diagnosis of preeclampsia (severe, mild or superimposed) (n=100); and
      clinically healthy women who deliver at term (n=100). The purpose of the research is to
      determine the clinical utility of congophilia (affinity for the dye Congo Red) in the
      diagnosis and prediction of preeclampsia. Investigators will determine the diagnostic value
      of this test by testing the urine sample provided to determine the presence or absence of
      proteinuria or congophilia.
    

Intervention name(s): Congo Red Dot Test
Intervention type(s): Device
Intervention description(s): The Congo Red Dot test is a simple test has been developed to detect unfolded or misfolded proteins in urine.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women attending Dhaka Medical College Hospital and Hospital Materno-Infantil Inguarán with
        clinically confirmed cases of preeclampsia and clinically healthy women who deliver at term
        will be eligible for the study.
      
Biospecimen description: 
      urine samples collected
    
Keywords: Congo Red Dot Test
An Iodine Balance Experiment
Condition: Iodine Deficiency; Nutritional Requirements
Study type: Interventional

Summary: 
      A 4-week study was conducted in 25 Chinese euthyroid women. Unified diets with different
      iodine contents (cooked with non-iodized salt or iodized salt) were provided in two different
      periods. The total iodine intake from diet, water and air as well as the total iodine
      excretion by urine, faces and respiration were monitored and determined, and a total of 300
      samples were collected. The sweat iodine loss was also considered. Moreover, the regression
      curve model between the 24-h iodine intake and 24-h iodine excretion was also established.
    

Detailed description: 
      The experiment was conducted between November and December with a total duration of 1 month.
      Referring to the experience from Harrison and Dworkin, however, considering the negative
      iodine balance reported, during the first 3 weeks, the diet was provided with non-iodized
      salt, while the diet with iodized salt was only offered in the last week. The total daily
      iodine intake consisted of dietary iodine intake, water iodine intake and iodine from
      breathing, while iodine could be excreted out of human body by urine, faces, sweat and
      breathing. The 24-h iodine intake and 24-h iodine excretion were determined in each
      individual participant, and the iodine balance was calculated accordingly.
    

Intervention name(s): iodized table salt, non-iodized table salt
Intervention type(s): Dietary Supplement
Intervention description(s): During the first 3 weeks, the diet was provided with non-iodized salt, while the diet with iodized salt was only offered in the last week.
Intervention model: Single Group Assignment
Intervention model description: Participants received a diet with iodized table salt or non-iodized table salt
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Iodine; Balance experiment; EAR; Chinese women; Euthyroid
Clinical Study of TA-650 in Patients With Behcet's Disease (BD) With Special Lesions
Condition: Behcet's Disease; Behcet Syndrome; Neuro-Behcet's Disease
MeSH terms: Behcet Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics of TA-650
      in patients with Behcet's disease ( BD ) with special lesions after the administration of
      TA-650 at a dosage of 5 mg/kg in weeks 0, 2, and 6, then every 8 weeks after week 14 up to
      week 46.
    


Intervention name(s): TA-650
Intervention type(s): Drug
Intervention description(s): TA-650 will be intravenously infused at a dosage of 5 mg/kg slowly over a period of more than 2 hours at the first administration (weeks 0), 2, and 6, and then every 8 weeks up to week 46. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Behcet's disease; intestinal Behcet's disease; neuro-Behcet's disease; vascular Behcet's disease
A Study Evaluating the Relative Bioavailability and Food Effect of a Tablet Formulation of VX-147
Condition: Focal Segmental Glomerulosclerosis (FSGS)
MeSH terms: Glomerulosclerosis, Focal Segmental
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the relative bioavailability (BA) and the effect of
      food on the pharmacokinetics (PK), and the safety and tolerability of VX-147 test tablet
      formulation.
    

Detailed description: 
      This clinical trial information was submitted voluntarily under the applicable law and,
      therefore, certain submission deadlines may not apply. (That is, clinical trial information
      for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public
      Health Service Act and 42 CFR 11.60 and is not subject to the deadlines established by
      sections 402(j)(2) and (3) of the Public Health Service Act or 42 CFR 11.24 and 11.44.).
    

Intervention name(s): VX-147
Intervention type(s): Drug
Intervention description(s): Tablets for oral administration.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Preventing American Indian Children From Becoming Overweight
Condition: Cardiovascular Diseases; Heart Diseases; Obesity
MeSH terms: Cardiovascular Diseases; Heart Diseases; Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to establish an intervention to keep American Indian/Alaskan
      Native (AI/AN) children from becoming overweight.
    

Detailed description: 
      BACKGROUND:

      AI/AN children have overweight rates that are 18 to 30 percent higher than the general
      American population of children. Adult obesity has early antecedents, and data show that
      eating and physical activity behaviors are formed and set as early as 3 years of age, through
      primary socialization within families. Yet there are few, if any, obesity prevention programs
      that target children younger than 3 years of age.

      DESIGN NARRATIVE:

      This is a community-partnered randomized study to prevent early childhood overweight in AI/AN
      children. A birth cohort of about 780 children from six Indian communities born over a period
      18 months will be randomized by community to either a control (3 communities) or intervention
      condition (3 communities). The intervention comprises a community-wide intervention coupled
      with individualized family counseling to improve nutrition and physical activity in infants
      and toddlers. Nutrition goals are to increase breastfeeding initiation and sustainability,
      limit sugared beverages for infants and toddlers, and make healthful choices during weaning
      and solid food introduction. Physical activity goals include promoting motor development,
      limiting video/TV viewing, and creating play opportunities for infants and toddlers.
      Intervention approaches and methods used in the pilot study on which this project is based
      will be combined with new formative data collected at the beginning of the project to enhance
      the intervention's feeding and physical activity components. Each component in the
      community-wide interventions will be collaboratively designed with the tribes, and tailored
      to each community's needs. Trained peer counselors will deliver the family interventions,
      during a series of 12 cluster visits, each covering a different developmental stage of the
      infant/toddler.
    

Intervention name(s): Diet; Exercise
Intervention type(s): Behavioral; Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Postoperative Pain of Rotary Versus Reciprocating Motions of Two Single Files
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      An equivalent parallel randomized clinical trial was approved by the local University
      Committee of Ethics. 260 children with necrotic primary molars were allocated into 2 equal
      groups (82 children per group). The participants were allocated into two groups; group "1"
      teeth were instrumented with OneShape rotary system (Micro Mega, Besancon, France), and group
      "2" teeth were instrumented with WaveOne Gold reciprocating system (Dentsply Maillefer,
      Ballaigues, Switzerland). Postoperative pain was assessed using a four-point pain intensity
      rating scale adopted from Wong-Baker FACES (WBF) pain scale . The face scale consists of four
      faces with a brief title describing each face representing a scale from the first face (score
      1), second face (score 2), third face (score 3), and forth face (score 4) 3. Postoperative
      pain was assessed at 6 six time intervals (at 6, 12, 24, 48, 72 hours and one-week).
    


Intervention name(s): OneSahpe single file; WaveOne Gold single file
Intervention type(s): Device; Device
Intervention description(s): The rotary motion of OneShape single file; reciprocation motions of WaveOne Gold single file
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment