bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Safety and Efficacy of AJM300 in Participants With Active Ulcerative Colitis
Condition: Colitis, Ulcerative
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      The study will investigate the efficacy and safety of an oral dose of AJM300 960 milligram
      (mg)/dose administered three times daily for 8 weeks in participants with active ulcerative
      colitis.
    


Intervention name(s): AJM300; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): AJM300 film-coated tablets.; Placebo matched to AJM300 tablets.
Other intervention name(s): Carotegrast methyl
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Ulcerative Colitis; Inflammatory Bowel Disease, Ulcerative Colitis Type; Colitis; AJM300
Effect of Sulforaphane in Broccoli Sprouts on Nrf2 Activation
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional

Summary: 
      The purpose of this study to investigate the effect of sulforaphane from macerated broccoli
      sprouts in humans and to evaluate less invasive methods of assessing potential
      anti-inflammatory drugs in CF.
    

Detailed description: 
      The hypothesis to be tested is that sulforaphane consumed from macerated broccoli sprouts
      will activate Nrf2, reduce oxidative metabolites and reduce neutrophils in the oral mucosa
      after 5 days of therapy in healthy volunteers and CF subjects.

      The study requires 6 brief outpatient visits over 8 days. Study procedures include medical
      history, height, weight, vital signs, blood and urine collection, nasal curettage, saline
      mouthwash, and ingestion of broccoli sprouts (100 gm of 3 to 5 day old raw broccoli sprouts
      once daily for 5 consecutive days).
    

Intervention name(s): Broccoli sprouts
Intervention type(s): Dietary Supplement
Intervention description(s): Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days.
Other intervention name(s): sulforaphane
Intervention MeSH terms: Sulforaphane
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: broccoli sprouts; sulforaphane; triterpenoid; Nrf2 activation; cystic fibrosis; healthy volunteers; anti-inflammatory
The Curative Effect of the Length of the Jejunum Exclusion in Grstric Bypass Surgery for Type 2 Diabetes
Condition: Type 2 Diabetes; Obesity
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the curative effect of the length of the jejunum
      exclusion in gastric surgry for T2DM and metabolic syndrome,and to draft Scientific and
      reasonable operation parameters.
    

Detailed description: 
      Currently, there is a growing evidence supports the efficacy of Roux-en-Y gastric bypass for
      the treatment of Type 2 diabetes mellitus. However,there still have a great controversy about
      the operation parameters. With randomized controlled trial, Patients of BMI>21kg/m2 with type
      2 diabetes were randomly divided into two groups: short biliarypancreatic limb:50cm;long
      biliarypancreatic limb :100cm. The investigators followed-up 3,6,12,24 months of the change
      of BMI,FBG,HbA1c,Blood pressure,Blood fat after surgery.
    

Intervention name(s): short biliarypancreatic limb; long biliarypancreatic limb
Intervention type(s): Procedure; Procedure
Intervention description(s): biliarypancreatic limb:50cm;roux limb:150cm.; biliarypancreatic limb:100cm;roux limb:100cm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: T2DM; RYGB; RCT
Biomarker for Peritoneal Ultrafiltration Failure
Condition: Continuous Ambulatory Peritoneal Dialysis
Study type: Observational

Summary: 
      This study will examine the peritoneal tissue, serum and dialysate proteins of peritoneal
      dialysis (PD) patients with different types of peritoneal solute transport by differential
      proteomics techniques.

      This study will be performed to identify the molecular difference between different types of
      peritoneal solute transport and explore biomarker for early detection as well as early
      intervention of peritoneal ultrafiltration failure.
    

Detailed description: 
      Ultrafiltration failure (UFF) is an important cause of technical failure in PD patients. It
      may develop over time and is, therefore, especially important in longterm PD. However, the
      study on UFF is very limited so far, there are still lack of biomarker for early detection
      and intervention of UFF.

      Proteomics uses a rapidly evolving group of technologies to identify, quantify, and
      characterize a global set of proteins. It is characterized by high-throughput, high
      specificity and high-sensitivity. Therefore, proteomics has become a major focus of recent
      medical research.

      This study will examine the peritoneal tissue, serum and dialysate proteins of continuous
      ambulatory peritoneal dialysis (CAPD) patients with different types of peritoneal solute
      transport by differential proteomics techniques. Correlation analysis will be used for the
      relationship between clinical data and the differential proteins, as well as verification of
      the differential proteins in the peritoneal tissue, serum and dialysate of patients with UFF.
      This study will be performed to identify the molecular difference between different types of
      peritoneal solute transport and explore biomarker for early detection as well as early
      intervention of peritoneal ultrafiltration failure.
    

Observational model: Case-Control
Sampling method: Non-Probability Sample
Study population: 
        Inpatients and outpatients in the peritoneal dialysis center of 1st Affiliated Hospital,
        Sun Yat-Sen University
      
Biospecimen description: 
      peritoneal tissue will be collected at the time of peritoneal dialysis catheter insertion or
      extubation. Serum and dialysate samples will be collected for protein analysis.
    
Keywords: Continuous Ambulatory Peritoneal Dialysis; Ultrafiltration failure; Biomarker; Proteomics
The Health Effects of Blueberry Anthocyanins in Metabolic Syndrome (the CIRCLES-study)
Condition: Insulin Resistance; Metabolic Syndrome X
MeSH terms: Metabolic Syndrome; Insulin Resistance; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to determine the dose-dependent impact of 6 month freeze-dried
      blueberry powder intake on insulin sensitivity and resistance, cardiovascular disease risk
      factors, and lung and cognitive function in overweight and obese participants with metabolic
      syndrome. We will also examine acute post-prandial effects of blueberry intake (at baseline
      and at 6-months).
    


Intervention name(s): Full dose blueberry; Half dose blueberry; Control
Intervention type(s): Other; Other; Other
Intervention description(s): Full dose: 26g of freeze dried blueberry powder to be incorporated into the habitual diet.
Dietary restrictions will be observed (i.e. avoidance of blueberry, and restricted intake of anthocyanin rich foods) for 21 days prior to the first assessment visit and throughout the study.; Half dose: 26g of freeze dried powder (containing 13g of freeze dried blueberry powder and 13g of placebo comparator material) to be incorporated into the habitual diet.
Dietary restrictions will be observed (i.e. avoidance of blueberry, and restricted intake of anthocyanin rich foods) for 21 days prior to the first assessment visit and throughout the study.; Control: 26g of placebo comparator material to be incorporated into the habitual diet.
Dietary restrictions will be observed (i.e. avoidance of blueberry, and restricted intake of anthocyanin rich foods) for 21 days prior to the first assessment visit and throughout the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Correlation Between Central Sensitization Inventory and Posturographic Data
Condition: Central Nervous System Sensitization
Study type: Observational

Summary: 
      To investigate the use of balance as a screening tool for Central Sensitization, a condition
      of the nervous system that is associated with the development and maintenance of chronic
      pain. This is done by comparing the scores of a gold standard screening tool (the Central
      Sensitization Inventory) with balance data.
    

Detailed description: 
      First, subjects will be asked to answer a brief medical questionnaire pertaining their
      general health status: since some of the subjects will be self-assessed to be "healthy" (no
      medical examination will be conducted to determine if this is indeed the case), the
      questionnaire will be used to determine if there are any possible known causes of poor
      balance performance. The questionnaire will not constitute an inclusion/exclusion criterion,
      it just has a classification purpose.

      Subjects will then be asked to fill in the Central Sensitization Inventory (CSI), scoring
      each of the 25 items on a scale from 0 (never) to 4 (always).

      Then, subjects will stand for 2 minutes on a compliant surface (a 4" tall foam cushion of
      known mechanical properties) to "learn" how to stand on it. Afterward, they will undergo
      posturography testing using the extended modified Clinical Testing of Sensory Integration in
      Balance (ext_mCTSIB) protocol: the subjects will be required to stand on a hard or compliant
      surface in a comfortable posture, feet shoulder width, with eyes open or closed, arms to the
      side and free to move, gazing forward, and breathing normally, with head straight, turned
      right or left, flexed or extended.
    

Intervention name(s): Posturography Evaluation; Central Sensitization Inventory
Intervention type(s): Diagnostic Test; Other
Intervention description(s): Posturography testing using the extended modified Clinical Testing of Sensory Integration in Balance (ext_mCTSIB) protocol: the subjects will be required to stand on a hard or compliant surface in a comfortable posture, feet shoulder width, with eyes open or closed, arms to the side and free to move, gazing forward, and breathing normally, with head straight, turned right or left, flexed or extended; Standard chronic pain questionnaire: the subjects will be required to score each of the 25 items on a scale from 0 (never) to 4 (always)
Other intervention name(s): Balance Testing; CAPS® Testing
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Adults, self assess to be in good health or diagnosed with Central Nervous System
        Sensitization
      
Keywords: balance, postural; postural equilibrium; chronic pain; Chronic nonspecific low back pain; Fibromyalgia; Cervicogenic headache; Chronic tension type headache; Irritable bowel syndrome; Whiplash associated disorder; Temporomandibular disorder
Feasibility of a Cognitive Intervention for Youth Post Concussion
Condition: Mild Traumatic Brain Injury; Concussion, Mild
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the feasibility and effects of a cognitive
      intervention for youth following concussion
    

Detailed description: 
      Concussion, a form of mild traumatic brain injury, is one of the most commonly reported
      injuries in youth. While most recover quickly, a substantial subset (30-58.5%) report
      symptoms that persist at one month with a reported 11-14% who continue to report symptoms
      beyond three months. Currently, there are no evidence-based guidelines for treatment that
      address occupational (meaningful activity) concerns for youth who are slower to recover
      post-concussion. It is postulated that a top-down rehabilitation approach with metacognitive
      strategy training as the core of the intervention might be effective.The Cognitive
      Orientation to Occupational Performance (CO-OP) Approach is a metacognitive strategy training
      approach with a growing body of literature supporting it's value in improving participation
      in meaningful activity and achieving self-selected occupation-based goals for adults with
      brain injury and youth with moderate to severe brain injury.Given the long-term occupational
      concerns in youth with persistent post-concussion symptoms, and the lack of evidence based
      interventions for these youth, it is hypothesized that the CO-OP Approach may facilitate
      return to meaningful occupation in this population.
    

Intervention name(s): Cognitive Orientation to Occupational Performance (CO-OP)
Intervention type(s): Other
Intervention description(s): In the CO-OP intervention participants are first assisted to identify 3-5 occupation based goals which then become the focus of the intervention sessions. Over the course of the 10 intervention sessions, participants are guided to learn and practice problem solving using a metacognitive strategy, "Goal-Plan-Do-Check" applied to their self-identified goals. Study therapists use 'guided discovery' an iterative technique to facilitate problem solving by the participant to develop plans to work toward their goals and to evaluate their progress. Intervention takes place in the location that is most meaningful for the participant's selected goal (e.g. home, school, playground etc.). Participants are provided with a work book to track progress.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatrics; case series; feasibility
A Pharmacokinetic Study of SID1903 (FDC of Dapagliflozin and Sitagliptin) in Healthy Adult Volunteers
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to compare and evaluate the safety and pharmacokinetic characteristics (PK)
      after administration of SID1903 and SID1903-R1/SID1903-R2 in healthy adult volunteers.
    


Intervention name(s): SID1903 (FDC); Dapagliflozin and Sitagliptin
Intervention type(s): Drug; Drug
Intervention description(s): Single oral administration of SID1903 (FDC) after an overnight fast; Single oral administration of Dapagliflozin and Sitagliptin after an overnight fast
Intervention MeSH terms: Sitagliptin Phosphate; Dapagliflozin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Role of Trimetazidine on Right Ventricle Function in Pulmonary Arterial Hypertension
Condition: Precapillary Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Pulmonary Arterial Hypertension; Hypertension
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The study will evaluate the effect of trimetazidine versus placebo in addition to standard
      pulmonary arterial hypertension regime on right ventricular function in pulmonary arterial
      hypertension patients.
    

Detailed description: 
      Right ventricular dysfunction is the worst mortality predictor in pulmonary arterial
      hypertension (PAH). Recent study has described that approximately 25% of PAH patients will
      developed into right ventricular failure despite therapeutic reduction of pulmonary vascular
      resistance. Subsequently, several studies have shown that fatty acid accumulation in right
      ventricle was inversely correlated with right ventricular function in PAH patients. Several
      PAH animal studies have revealed that metabolic glucose oxidation impairment through
      increased aerobic glycolysis, mitochondrial dysfunction, and lipotoxicity play significant
      role in right ventricular failure. Moreover, several pulmonary hypertension animal studies
      have demonstrated the benefit of partial fatty acid inhibitor such as trimetazidine on right
      ventricle function. It was hypothesize that trimetazidine improved right ventricular function
      through indirect effect of increased glucose oxidation by blocking the Randle cycle.
      Therefore, we hypothesize that trimetazidine can improve right ventricular function in
      pulmonary arterial hypertension patients.
    

Intervention name(s): Trimetazidine; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): The participant will received trimetazidine 35 mg bid for 3 months on top of their regular PAH specific therapy.; The participant will received placebo oral capsule bid for 3 months on top of their regular PAH specific therapy.
Other intervention name(s): Trizedon MR; sugar pill
Intervention MeSH terms: Trimetazidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Low-level Laser Therapy After Surgical Removal of Impacted Lower Third Molar
Condition: Facial Swelling; Pain; Trismus
MeSH terms: Trismus
Study type: Interventional

Summary: 
      Goal: The aim of this study was to evaluate the effects of low-level laser (LLL) after
      surgical removal of impacted lower third molars (ILTM).
    

Detailed description: 
      Goal: The aim of this study was to evaluate the effects of low-level laser (LLL) after
      surgical removal of impacted lower third molars (ILTM), including pain level, postoperative
      facial swelling, trismus and non-stimulated saliva secretory immunoglobulin A (sIgA).
    

Intervention name(s): GaAlAs laser
Intervention type(s): Device
Intervention description(s): GaAlAs laser (AMD Picasso, Dentsply Sirona, York, Pennsylvania, USA) with a wavelength of 810 nm was placed intraorally, at a distance of 1 cm in the position of the extracted tooth socket and circling in a 2 cm - diameter area. The power applied was 0.5 ± 20% W, continuously for 30 s. The total real energy released was 12.8 J and the real energy density applied was 4 J/cm2. Each patient was irradiated 3 times consecutively right after surgery, day 1 and day 2 after surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
UW-CTRI Triple Medication Smoking Cessation Study
Condition: Smoking
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will focus on enhancing future smoking cessation treatment effectiveness by
      piloting a potentially more powerful combination of three FDA-approved pharmacotherapies:
      varenicline plus combination of two types of nicotine replacement therapy (NRT) treatment
      (nicotine lozenge and nicotine patch). Data from this pilot study will help inform the design
      of future studies that would use this combination treatment as a cessation tool within the
      chronic care arsenal of treatments.
    

Detailed description: 
      Recent research suggests that a new combination therapy may be especially effective in
      increasing long-term abstinence from smoking. A key purpose of the proposed study is to
      examine what types of tolerability concerns, if any, emerge from the simultaneous use of
      three FDA-approved cessation medications (varenicline, nicotine patch, and nicotine lozenge)
      and the timing of those events, in order to better assess how the use of this combination of
      tobacco cessation medicines can be most effectively and safely delivered and monitored. Study
      participants will take the three medications for 12 weeks in a manner consistent with
      labeling. Adverse events will be assessed at all study visits.
    

Intervention name(s): Varenicline; Nicotine Transdermal Patch; Nicotine Mini
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Standard FDA approved 12 weeks of treatment with Varenicline; Standard FDA approved 12 weeks of treatment with Nicotine Transdermal Patch; Standard FDA approved 12 weeks of treatment with Nicotine Mini-Lozenge
Other intervention name(s): Chantix; Nicotine Mini-Lozenge
Intervention MeSH terms: Nicotine; Varenicline
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: medication tolerability
Clinical Trial to Evaluate the Effect on the Pharmacokinetic Characteristics of HCP1007 Capsule
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate pharmacokinetics and safety after oral
      administration of HCP1007 capsules and Rosuvastatin plus Omega-3.
    

Detailed description: 
      The purpose of this study is to evaluate pharmacokinetics and safety after oral
      administration of HCP1007 capsules and Rosuvastatin plus Omega-3.
    

Intervention name(s): HCP1007 / omarco and crestor
Intervention type(s): Drug
Intervention description(s): HCP1007 / Rosuvastatin plus Omega-3
Intervention MeSH terms: Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HCP1007; Rosuvastatin; Omega-3