bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis
Condition: Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a two-part trial consisting of Part A (see NCT01628393) and Part B, presented
      within this record.

      The primary objective of Part B is to assess whether the clinical efficacy of ozanimod
      (RPC1063) is superior to interferon beta-1a (IFN β-1a; Avonex®) in reducing the rate of
      clinical relapses at the end of Month 24 in patients with relapsing multiple sclerosis (RMS).
    

Detailed description: 
      This clinical trial (RPC01-201; RADIANCE) consisted of 2 parts, each reported separately on
      ClinicalTrials.gov: Part A (NCT01628393) and Part B (this record).

      Part A was a phase 2 study in which two doses of ozanimod were administered daily for 24
      weeks with an efficacy and safety comparison to a placebo control and is reported separately
      as ClinicalTrials.gov record NCT01628393.

      Part B, reported herein, was a phase 3 study in which two doses of ozanimod were administered
      daily for a 24 month period compared to an active control, interferon β-1a. Participants were
      allowed to enroll in the open-label extension study RPC01-3001 (NCT02576717) or complete the
      study with a safety follow-up visit 28 days after their last dose of study treatment.
    

Intervention name(s): Ozanimod; Ozanimod placebo; Interferon beta-1a; Interferon beta-1a placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral capsule, daily for 24 months; Oral capsule, daily for 24 months; Intramuscular injection, 30 µg, weekly for 24 months; Intramuscular injection, weekly for 24 months
Other intervention name(s): RPC1063; Zeposia®; Avonex
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a; Ozanimod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Sonendo GentleWave™ System for Treatment in Molar Teeth Requiring Root Canal Therapy
Condition: Root Canal Therapy
Study type: Interventional

Summary: 
      A prospective, literature controlled, clinical study evaluating healing rates for the Sonendo
      GentleWave System in the treatment of 1st and 2nd molars indicated for root canal therapy.
    

Detailed description: 
      A prospective, non-significant risk device, literature controlled, study evaluating healing
      rates for the Sonendo GentleWave System in the treatment of 1st and 2nd molars indicated for
      root canal therapy.

      All patients will receive root canal therapy with the Sonendo GentleWave System. All patients
      will be followed for 24 months post procedure.
    

Intervention name(s): Sonendo GentleWave™ System
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Combined Use of Respiratory Devices After Thoracic Surgery
Condition: Dyspnea; Well Being
MeSH terms: Dyspnea
Study type: Interventional

Summary: 
      In a rehabilitation setting, respiratory muscle training with re-expansion techniques in
      patients following cardio-thoracic surgery represents a consolidated intervention. New
      devices called RESPILIFT® and RESPIVOl® improve deep inspiration and pulmonary volume with an
      effect on respiratory muscle performance and perceived dispnoea. The aim of the investigators
      study is to test the clinical efficacy of RESPILIFT® and RESPIVOl® in patients with a recent
      history of cardio-thoracic surgery.
    


Intervention name(s): Combined use of RESPIVOL® and RESPILIFT®; Combined use of RESPIVOL® and RESPILIFT®
Intervention type(s): Device; Device
Intervention description(s): Active devices (combined) for 14 consecutive session, bid, for 15 minutes.; Sham devices (combined) (without resistive load)for 14 consecutive session, bid, for 15 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: cardio-thoracic surgery; patients; pulmonary volume; respiratory muscle performance
A Phase I Study to Compare 3 Different Strengths of an Extended Release Formulation of ASP015K to an Immediate Release Formulation of ASP015K
Condition: Pharmacokinetics of ASP015K; Food Effect; Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the pharmacokinetics (PK) profiles of three different
      strengths of ASP015K extended release formulation and an immediate release formulation and to
      evaluate food effect on extended release strengths in healthy volunteers.
    

Detailed description: 
      Study involves 3 parallel groups. Subjects in each group will receive 3 single-dose
      treatments with a washout period of at least 7 days separating the dosing between two
      consecutive treatments. Dosing conditions include both fed and fasted conditions.
    

Intervention name(s): ASP015K ER; ASP015K IR
Intervention type(s): Drug; Drug
Intervention description(s): oral extended release (ER) at three dosing levels; oral immediate release (IR)
Intervention MeSH terms: Niacinamide; Peficitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: ASP015K Extended Release; ASP015K Immediate Release; Food Effect; Healthy Volunteers
A Trial of Yoga in Pediatric Inflammatory Bowel Disease
Condition: Inflammatory Bowel Disease; Crohn's Disease; Ulcerative Colitis
MeSH terms: Crohn Disease; Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      IBD adds additional stressors as a chronic disease that has unpredictable and sometimes
      embarrassing symptoms to the normal challenges that teenagers face. Stress and how stressful
      events are perceived, may contribute to worsening of disease. Complementary and alternative
      medicine (CAM), are used often by pediatric IBD patients and maybe beneficial in decreasing
      stress and improving quality of life. Yoga could be a well suited paring with standard
      medical therapy to decrease and provide a better sense of control and improve quality of
      life.
    

Detailed description: 
      Approximately 25% of Inflammatory bowel disease (IBD) is diagnosed in the pediatric age
      group, with the peak age of onset in the adolescent years. IBD adds additional stressors of a
      chronic disease with unpredictable and potentially embarrassing symptoms to the expected
      challenges of psychological and social adjustment that teenagers face. Various techniques,
      such as psychotherapy programs and IBD overnight camp experiences, have been studied to
      decrease psychological distress and improve quality of life. Stress, and particularly how
      stressful events are perceived, may play a role in triggering IBD flares. Complementary and
      alternative medicine (CAM), especially mind-body techniques are used often by pediatric IBD
      patients and may be beneficial in decreasing stress and improving quality of life (QOL). Yoga
      may be well suited as an adjunct to conventional IBD therapy to decrease stress, provide a
      greater sense of bodily control and improve QOL.

      The primary goal of this project is to determine if a structured Yoga program, in addition to
      standard medical therapy, improves HRQOL in pediatric patients diagnosed with inflammatory
      bowel disease (IBD). Investigators will also examine if the yoga program improves self
      efficacy, which is a person's belief about their ability to influence events that affect
      their lives. Disease response and remission rates will be followed as well, in order to
      stratify HRQOL outcomes in the yoga group.

      Patients will each serve as their own control and complete questionnaires at enrollment and
      at the start and end of the 12 week group yoga class sessions. They will also complete the
      questionnaires three months after finishing the class sessions. .The program will consist of
      a live group class session over 12 weeks. Baseline and follow-up questionnaires will be used
      to determine there are changes in QOL, self-efficacy, and disease response.
    

Intervention name(s): Yoga
Intervention type(s): Behavioral
Intervention description(s): 1 Hour yoga class
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Healthier Hearts and Brains in Treating Smoking: The HABITS Study
Condition: Smoking
Study type: Interventional

Summary: 
      80 nicotine dependent adults ages 18-65 who desire to quit smoking will be screened and, if
      eligible, enrolled and randomized to one of two four-week treatments for smoking cessation.
      The treatments are standard behavioral therapy and Mindfulness Based Addiction Therapy
      (MBAT), which is standard therapy plus mindfulness. Standard therapy and MBAT incorporate
      elements of widely-used tools for smoking cessation including managing craving and strong
      emotions, problem solving, tips on healthy eating and keeping active, and exercises based on
      cognitive and behavioral therapy. MBAT uniquely incorporates mindfulness practice (a
      relaxation therapy) into standard therapy. Participants complete questionnaires and undergo
      an fMRI scan at baseline and at the end of therapy (after they complete the 4 weeks of
      standard therapy or MBAT). During each scan, participants will complete a validated
      smoking-related cue paradigm and a validated affect labeling paradigm.
    


Intervention name(s): Standard Behavioral Therapy; Mindfulness Based Addiction Therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Standard therapy to help participants with smoking cessation.; A novel mind body therapy that extends basic behavioral therapy principles to include the practice of mindfulness, which fosters a dispassionate approach to the experience of craving.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Smoking cessation; Tobacco dependence; Mindfulness; fMRI; Craving
Trial to Assess Immunogenicity and Safety of GlaxoSmithKline (GSK) Biologicals' Meningococcal ABCWY Vaccine as Compared to Meningococcal B Vaccine in Adolescents
Condition: Infections, Meningococcal
MeSH terms: Meningococcal Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purposes for conducting the study are firstly to assess immunological
      non-inferiority of the MenABCWY vaccine, administered according to 0, 2 month schedule to
      healthy adolescents 10 to 18 years of age, to those of the licensed rMenB+OMV vaccine
      (Bexsero™) in terms of hSBA GMTs at one month after the second vaccination, secondly to give
      the flexibility for the national vaccination program by showing the safety and immunogenicity
      of MenABCWY administrated according to four different vaccination schedules and additionally
      to evaluate a potential benefit of the 3-dose vaccination series.
    


Intervention name(s): Bexsero; Saline Placebo; Havrix; MenABCWY
Intervention type(s): Biological; Other; Biological; Biological
Intervention description(s): Two doses administered intramuscularly into the deltoid area at Months 0 and 2 in rMenB_0_2 Group.; One dose administered intramusculary in the deltoid muscle at Month 1 in ABCWY_ 0_2 Group and rMenB_0_2 Group, Month 2 in ABCWY_0_6 Group and ABCWY_0_11 Group and Month 6 in ABCWY_0_1 Group.; Two doses administered in the deltoid muscle at Month 2 and 12 in ABCWY_0_1 Group, Month 1 and 12 in Group ABCWY_0_6 Group and ABCWY_0_2_6 Group , Month 0 and 6 in ABCWY_0_11 Group and Month 6 and 12 in ABCWY_ 0_2 Group and rMenB_0_2 Group.; Two to three doses administered in the deltoid muscle at Month 0 and 1 in ABCWY_0_1 Group, Month 0 and 6 in ABCWY_0_6 Group, Month 1 and 12 in ABCWY_0_11 Group, Month 0, 2 and 6 in ABCWY_0_2_6 Group, Month 0 and 2 in ABCWY_ 0_2 Group and rMenB_0_2 Group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Performance of the Tasman Continuous Positive Airway Pressure (CPAP) System
Condition: Obstructive Sleep Apnea
MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Study type: Interventional

Summary: 
      Assessment of the performance of the Tasman CPAP system in treating obstructive sleep apnea.
      The purpose of this study is to (1) evaluate the performance of this system in the efficacy
      of the treatment in comparison to S8 Escape, and (2) to evaluate the performance of the
      Tasman device via subjective assessment of comfort and ease of breathing compared to the
      participant's current CPAP device.
    

Detailed description: 
      Obstructive Sleep Apnoea (OSA) is a condition characterised by partial or complete collapse
      of the upper airway during sleep. The treatment of choice for OSA is Continuous Positive
      Airway Pressure (CPAP). CPAP acts as a positive airway splint, delivering a fixed positive
      airway pressure to the upper airway via a tube and mask. The mask is attached to the
      participant's nose via head straps. The type of mask used is dependent upon participant
      choice and comfort and the mask that provides the best fit.

      Some participants stop using CPAP therapy finding it difficult to tolerate due to leak issues
      or discomfort from their nasal mask. Another frequent concern is mask dislodgment while
      sleeping causing leaks and consequently waking the patient up.

      The purpose of this study is to evaluate the performance of the Tasman CPAP system via
      objective and subjective assessment of comfort and ease of breathing compared to the
      participant's current CPAP device.

      Aim

        -  To determine if the efficacy of the treatment is clinically equivalent to or better than
           the predicate device (S8 Escape)

        -  To evaluate the performance of the Tasman CPAP system in terms of comfort of breathing
           and general ease of use
    

Intervention name(s): Tasman CPAP system
Intervention type(s): Device
Intervention description(s): Participants will trial the Tasman CPAP system for a duration of 1 week in place of their current CPAP system.
Other intervention name(s): ResMed Tasman
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Water-based Zinc Efficacy Trial in Beninese Shool Children
Condition: Zinc Deficiency
Study type: Interventional

Summary: 
      The general objective of this study is to determine the effect of the daily consumption of
      zinc-fortified water provided by the LSF-filter on zinc status and diarrhea rates in school
      age children from rural areas characterized by a high risk of zinc deficiency and by elevated
      stunting prevalence.
    

Detailed description: 
      A double-blind efficacy study will be carried out over 4 months in school age children
      enrolled in a primary school equipped with a water pump, in the rural area of the commune of
      Natitingou, Benin. Participating children will be randomly assigned to one of two groups of
      intervention or control. On a daily basis, all children will consume a defined quantity of
      pump-water outside of meals. The water offered to children in the first group of intervention
      will be previously filtered and zinc-fortified by the LSF-filter; the children in the second
      group will receive water that has been filtered only. A nutrition survey will provide an
      indication of dietary zinc intake. The effect of enriched water consumption on children's
      zinc status will be evaluated by analyzing the concentration of zinc in serum at baseline,
      midpoint and endpoint of the intervention. Diarrhea rates will be monitored by recording
      episodes of diarrhea.
    

Intervention name(s): LSF-filtering device
Intervention type(s): Device
Intervention description(s): LifeStraw Family is a water purification device that by means of hollow fibres removes solid particles (<0.5 NTU turbidity reduction), bacteria (>Log 6 reduction), viruses (>Log 4 reduction) and cysts (>Log 3 reduction). Zinc fortification is provided by a chamber housing a zinc releasing glass-plate that is placed annexed to the hollow fibre column. It is estimated that the LSF can provide about 5 mg of zinc/l of filtered water. By consuming daily a portion of 0.6 litres of enriched water, >100% of the age-specific estimated physiologic requirement would be covered, assuming a fractional absorption of 40%.
Other intervention name(s): LifeStraw Family by Vestergaard Frandsen SA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
The Effects of Western Diet Patterns on Plasma Inflammatory and Cardio Metabolic Health Signatures in Middle-aged Adults
Condition: Healthy Diet
Study type: Interventional

Summary: 
      The Western diet pattern or standard American diet is a modern dietary pattern that is
      characterized by high intakes of meat, pre-packaged foods, fried foods, high-fat dairy
      products, eggs, refined grains etc. When considering the role of saturated fat, it may be
      prudent to advise limiting all foods that contain saturated fats, including
      unprocessed/minimally processed meat, eggs, whole dairy in addition to processed,
      pre-packaged foods; however, this reductionist approach fails to take into account the food
      matrix and overall diet in which these nutrients are consumed.

      Epidemiological evidence suggests that increased modern, pre-packaged food consumption is a
      major risk factor for metabolic disease by promoting inflammation. Based on these data, the
      investigators hypothesize that the pro-atherogenic effect of the Western diet is caused by
      the pro-inflammatory effects of consuming large amounts of modern ultra-processed foods, and
      that consumption of a similar amount of fat from minimally processed beef, poultry, dairy,
      eggs, as part of an unprocessed diet will positively impact inflammatory markers and
      lipoprotein profiles of study participants when compared to a diet rich in modern
      ultra-processed foods.
    


Intervention name(s): Traditional Diet; Modern Diet
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Consuming an traditional whole foods based diet for 4 weeks.; Consuming an processed formulation of the traditional diet for 4 weeks.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Basic Science
The Glycemic Response Elicited by Beta-glucans of Different Physical Properties and Form
Condition: Type 2 Diabetes
Study type: Interventional

Summary: 
      The ability of oat β-glucan to lower postprandial glycemic responses has been attributed to
      the viscosity of the solution in which the fibre is solubilized. To our knowledge, no studies
      have investigated the effect of β-glucan solutions on glycemic response when concentration,
      and thus viscosity, is varied by changing the solution volume but not the β-glucan dose.
      Therefore, the investigators will test the effects of altering β-glucan solution viscosity by
      altering solution volume at a fixed amount of β-glucan fibre.
    

Detailed description: 
      The ability of β-glucan to lower postprandial glycemic responses has been attributed to the
      viscosity of the solution in which the fibre is solubilized. It has been demonstrated that
      the viscosity of a β-glucan solution increases with the molecular weight (MW) of β-glucan
      polymers, as well as the dose or concentration (C) of those polymers in solution. Numerous
      studies have shown that glycemic response-lowering is strengthened when the C of a β-glucan
      solution of fixed liquid volume is increased by increasing β-glucan dose. However, the C of a
      β-glucan solution depends on not only the amount of fibre present but also on the solution
      volume. To our knowledge, no studies have investigated the effect of β-glucan solutions on
      glycemic response when C, and thus viscosity, is varied by changing the solution volume but
      not the β-glucan dose. Therefore, the investigators will test the effects of altering
      β-glucan solution viscosity by altering solution volume at a fixed amount of β-glucan fibre.
      Knowing how to incorporate β-glucan into solution so that its physiological benefits are
      preserved will assist in the development of β-glucan-containing functional foods.
    

Intervention name(s): oat beta-glucan; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 4g dose for each arm of trial. Form (volume and viscosity) varies between arms. 2h acute trial beginning between 8 and 10 am. Minimum 1 day wash out between arms.; Control without beta-glucan. Form (volume) varies between arms. 2h acute trial beginning between 8 and 10 am. Minimum 1 day wash out between arms.
Other intervention name(s): oat soluble fibre
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: postprandial blood glucose; dietary fiber; beta-glucan
Novel Method of Surveillance in Barrett's Esophagus
Condition: Barrett Esophagus
MeSH terms: Barrett Esophagus
Study type: Observational

Summary: 
      This study is being done to see how biomarkers (abnormalities in molecules of cells ) present
      in their Barrett's esophagus agree with results from surveillance biopsies; and to compare
      three different brush devices used to collect cells to see which of these 3 brush devices
      obtains a higher number of cells.
    

Detailed description: 
      During an endoscopy done for clinical surveillance of your Barrett's Esophagus participants
      are randomized to one of three brush devices by random chance like a flip of a coin. This is
      being done to see if one collects more cells than the others. A soft brush will be used to
      collect cells from the lining of the esophagus, this is known as brush cytology. With the
      endoscope positioned in your esophagus, samples (biopsies) of lining of the esophagus will
      then be taken to determine the nature of the Barrett's mucosa in the same manner as for any
      patient undergoing routine surveillance endoscopy for Barrett's esophagus. A part of the
      specimen will be used to store tissue samples that can later be used.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with barretts esophagus
      
Biospecimen description: 
      cytology specimens
    
Keywords: Barrett's; Esophagus; Reflux; dysplasia; adenocarcinoma