bioihbjkbjnl/mcl2 huggingface dataset:
Study of of URC102 to Assess the Efficacy and Safety in Gout Patients
Condition: Gout
MeSH terms: Gout
Study type: Interventional
Phase: Phase 2

Summary: 
      To confirm the safety and efficacy (dose response and optimal dose according to the serum
      uric acid response rate) of URC102 when orally-administered to patients with gout and
      gout-related hyperuricemia in comparison with placebo.

      Therapeutic dose-finding study, Placebo-controlled, randomized, double-blind, multicenter,
      phase 2 clinical trial.
    

Detailed description: 
      Placebo-controlled, randomized, double-blind, multicenter, phase 2 clinical trial.
    

Intervention name(s): arm 0; arm 1; arm 2; arm 3; arm 4
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): placebo group; 3 mg of the URC102 group; 6 mg of the URC102 group; 9 mg of the URC102 group; Febuxostat 80 mg
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Natalizumab Temporary Discontinuation Study
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the discontinuation of natalizumab either immediately or tapered off in
      the treatment of multiple sclerosis. Half of the fifty (50) participants will discontinue
      natalizumab immediately and the other half will taper off the drug, having two additional
      infusions, one at six weeks- and one at eight weeks-post discontinuation.
    

Detailed description: 
      Natalizumab is a pharmaceutical intervention used in the management of multiple sclerosis.

      The decision to discontinue natalizumab therapy is often raised in patients defined as
      high-risk for PML despite good clinical efficacy. During the therapy cessation period
      following large phase III trials, a return to the prestudy disease activity was reached by
      four months post-discontinuation. Shorter therapy was associated with a trend for a more
      severe disease activity pointing to a possible 'rebound' effect after natalizumab
      discontinuation.

      This study focuses on two different approaches: an immediate versus a step-wise/tapered down
      natalizumab discontinuation protocol, both with reinstitution of a different disease
      modifying therapy (DMT) within 1-6 months from the last natalizumab infusion.
    

Intervention name(s): Natalizumab discontinuation
Intervention type(s): Other
Intervention description(s): Patients will be randomized to one of two groups: The Immediate Discontinuation Group (stop natalizumab immediately and continue with new DMT 1 month afterward) and the Taper-off Group (two additional infusions of natalizumab, one at 6 weeks and the next at 8 weeks following discontinuation. A new DMT will be initiated within 2 months of final natalizumab infusion).
Intervention MeSH terms: Natalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
At-risk Intervention and Mentoring Evaluation
Condition: Violence
Study type: Interventional

Summary: 
      The purpose of this study is to determine if a hospital-based violence intervention programs
      can make sustainable behavior changes in at-risk youth using two key components, brief
      intervention at the hospital bedside and case management.
    

Detailed description: 
      This study will be a randomized controlled trial. Youth presenting to the emergency
      department with an intentional injury (gunshot wound, stab wound, or assault) will be given a
      behavioral assessment. Participants will be categorized according to risk (low, moderate,
      high). Only moderate or high youth will continue in the study and be randomized. Low risk
      youths will receive the medical standard of care and be re-assessed at 18 months.

      Randomization will place participants in one of two arms. Arm 1 will receive the standard of
      care PLUS a brief intervention with AIM outreach workers. Arm 2 will receive standard medical
      care PLUS a brief intervention PLUS case management.

      Every randomized youth will be assessed for risk and protective factors and have have data
      collected at 6-month intervals (0, 6, 12, 18 months).
    

Intervention name(s): Brief Intervention; Case Management; Standard Medical Care
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Goals of the bedside intervention will be to help the patient understand their risky behaviors that resulted in the injury and to assess and deescalate any threat of retaliatory violence by the patient. The outreach worker will: (1) develop a rapport with the patient by introducing themselves and describing their (outreach worker's) background and reason for the bedside visit; (2) assess the emotional response to the current injury; (3) ensure the patient and/or family understand the nature of the injury and ED course; (4) address any immediate concerns of the patient; and (5) develop a plan for staying safe following discharge.; Case management based on needs-assessment. Resource connection and mentoring.; This will include physician discretion for medical treatment and potentially a social worker visit as the physician sees fit for the patient. This will also include a list of resources that are typically needed and used for violently injured youth.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Violence; At-risk youth; Intentional Injury; Violence Intervention; Youth; recidivism
A Pilot Study to Test the Safety and Feasibility of a Brillouin Ocular Analyzer
Condition: Measurement of the Elasticity of the Anterior Eye Segment
Study type: Interventional

Summary: 
      A Brillouin ocular analyzer uses a low-power near infrared laser light to probe the
      viscoelastic properties of the cornea and crystalline lens in the eye. The study hypothesis
      is that the instrument can measure the Brillouin light scattering spectra from the eye safely
      and effectively from human subjects.
    


Intervention name(s): Brillouin Ocular Analyser
Intervention type(s): Device
Intervention description(s): Measurement of the local viscoelastic properties (Brillouin Shift) of the Anterior Eye Segment.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Lens; Cornea; Presbyopia
Safety and Efficacy Study of Prefilled Liquid Etanercept(Yisaipu) for Active Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 3

Summary: 
      This randomized, double-blind, phase III parallel-group non-inferiority study aimed to
      investigate the efficacy and safety of prefilled liquid etanercept (Yisaipu) versus
      lyophilized etanercept powder (Yisaipu) in active ankylosing spondylitis patients.
    

Detailed description: 
      The study carried out between March 6, 2014 and July 13, 2015 across multiple medical centers
      in China enrolled adult active ankylosing spondylitis patients aged between 18 and 65 years.
      Patients were randomized in a 3:1:1 ratio to receive twice weekly 25 mg prefilled liquid
      etanercept for totally 24 injections (group I) or once weekly 50 mg prefilled liquid
      etanercept for totally 48 injections (group II), or 25 mg twice weekly lyophilized etanercept
      powder for totally 48 injections (group III). The primary efficacy outcome was the proportion
      of patients who achieved ASAS20 at week 24.
    

Intervention name(s): prefilled liquid etanercept(Yisaipu); lyophilized etanercept powder(Yisaipu)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Etanercept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: prefilled liquid etanercept; lyophilized etanercept powder; ankylosing spondylitis
Acupuncture for Post Operative Pain Following Total Knee or Hip Arthroplasty
Condition: Arthroplasty Complications
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Post operative pain (POP) is a major obstacle on the road to healing, despite the increasing
      interest in postoperative pain management and development of pain control modalities (1).
      Postoperative pain is still insufficiently treated with more than 50% of patients suffering
      from moderate to severe pain early after surgery .Pain after orthopedic surgery is considered
      especially difficult to manage. Approximately half of total knee or hip arthroplasty patients
      present with extreme pain immediately after surgery. Total knee and hip arthroplasty often
      results not only in severe perioperative pain and debilitation, but chronic pain, joint
      stiffness, and functional disability many months or even years following the procedure.
      Various modalities of treating orthopedic POP exist, but the optimal management of
      postoperative pain remains controversial with no clear consensus of the best method.We
      suggest that acupuncture can be an effective treatment for post operative pain after total
      knee or hip arthroplasty.
    


Intervention name(s): acupuncture
Intervention type(s): Other
Intervention description(s): acupuncture for post operative pain
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Feedback on Physical Activity Surveillance Using Wearable Device-Smartphone Application for Resolution of Metabolic Syndrome in Aged 60 or Older
Condition: Metabolic Syndrome; Physical Activity; Wearable Device
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The Effect of Feedback on Physical Activity Surveillance using Wearable Device-Smartphone
      Application for Resolution of Metabolic Syndrome in Aged 60 or older; a 12-Week Randomized
      Control Study
    

Detailed description: 
      Research on whether wearable device interventions can effectively prevent metabolic syndrome
      remains insufficient. This study aimed to evaluate the effect of feedback on clinical
      indicators in patients with metabolic syndrome aged 60 or older on activities measured using
      wearable devices, such as smartphone apps. Patients aged 60 or older diagnosed with metabolic
      syndrome were recruited and prescribed to survive for 12 weeks using wrist-worn devices
      (B.BAND, B Life Inc, Korea). The block randomization method was used to distribute the
      participants between an intervention group (n=20) and control group (n=20). In the
      intervention group, an experienced study coordinator provided feedback on physical activity
      to individuals through telephone counseling every other week.
    

Intervention name(s): Receving feedback; No regular feedback
Intervention type(s): Other; Other
Intervention description(s): Receving regular feedback from a health provider; No regular feedback from a health provider
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In the intervention group, the researcher provided feedback on the participants' exercise amount through telephone contact every two weeks during the 12-week study period. It includes recommendations for continuing exercise therapy based on the recommendations for physical activity. Through phone consultations, they answered questions about exercise or discussed problems, were encouraged to continue exercising, answered questions or discussed problems related to wearable devices and apps, and encouraged for continuous data transmission.
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Menstrual Migraine Treatment With TREXIMET (Formerly Known as TREXIMA)
Condition: Migraine; Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was designed to determine efficacy of TREXIMET (sumatriptan/naproxen sodium),
      formerly known as TREXIMA compared to placebo for the treatment of a menstrual migraine.
    

Detailed description: 
      A randomized, double-blind, single migraine attack, placebo-controlled, parallel-group,
      multicenter study to evaluate the efficacy and tolerability of TREXIMA* (sumatriptan
      succinate/naproxen sodium) tablets vs placebo when administered during the mild pain phase of
      menstrual migraine in women with dysmenorrhea (*TREXIMET)
    

Intervention name(s): sumatriptan succinate/naproxen sodium
Intervention type(s): Drug
Intervention MeSH terms: Naproxen; Sumatriptan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: menstrual migraine; headache; early intervention; dysmenorrhea
PEEK Bar Versus Titanium Bar Fabricated by CAD-CAM in Mandibular Hybrid Prostheses: A Comparative Study
Condition: Edentulous Jaw
MeSH terms: Jaw, Edentulous
Study type: Interventional

Summary: 
      CAD/CAM-fabricated PEEK bar exhibited greater dimensional deviation in comparison to its
      titanium counterpart. Nevertheless, patients with PEEK bars reported higher satisfaction
      levels and lower marginal bone loss when compared to those with titanium bars.
    

Detailed description: 
      Fourteen patients with completely edentulous mandibular arch opposing natural dentition were
      selected and divided into two groups, seven patients in each. All patients received
      implant-supported hybrid prostheses with a bar fabricated by CAD/CAM milling technique. In
      group I (control), bar was fabricated from titanium, while in group ӀӀ, the bar was
      fabricated from PEEK. The evaluation of the study was done at 6 and 12 follow-up periods
      according to the following: 1- Experimentally by Geomagic (Geomagic, Japan) to detect any
      dimensional deviation of PEEK bars compared to titanium bars. 2-Clinically by questionnaire
      to evaluate the patient satisfaction. 3- Radiographically (digital periapical) to measure
      marginal bone loss around the implants.
    

Intervention name(s): implant placement
Intervention type(s): Procedure
Intervention description(s): All patients received four implants in the lower arch
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: completely edentulous mandibular arch opposing natural dentition were selected
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Hybrid prosthesis, Polyether-ether-ketone,
Feasibility of a Yoga Intervention in Sedentary African-American Women
Condition: Sedentary Behavior
Study type: Interventional

Summary: 
      This study aims to test the feasibility, acceptability, safety of a 3-month hatha and
      restorative yoga intervention to decrease sedentary behavior, stress and blood pressure in
      sedentary African-American women.
    

Detailed description: 
      This study aims to assess feasibility of a hatha and restorative yoga intervention compared
      to a control group. Investigators will examine feasibility of participant recruitment,
      retention and adherence; fidelity of intervention delivery; and intervention materials.
      Investigators also aim to evaluate the acceptability and safety of a hatha and restorative
      yoga intervention compared to a control group. Investigators will examine the acceptability
      of intervention location and strategies, class format, enjoyment of sessions, and safety of
      the intervention. Finally, investigators aim to test feasibility and appropriateness of the
      targeted outcomes for subsequent trials. Expected outcomes will be properly measured, but no
      comparisons between intervention and control groups will be made.
    

Intervention name(s): Yoga Intervention
Intervention type(s): Behavioral
Intervention description(s): This group will have in-person, 60 minute yoga sessions three times per week for 12 weeks. These sessions will also include a sharing circle to provide group feedback as to how the practice felt and integration into ones' daily life. There will be biweekly themes established for these sessions (i.e. common yoga poses, importance of breath) and biweekly in-person workshops will be offered. These will be specialty classes for participants to experience additional exposure to meditation and breathing. They will be a longer format so participants can delve deeper into yogic philosophy and practice. There will also be a private Facebook group for participants to connect with each other and for the research staff to maintain contact and share information with the participants (eg. weekly reminder for yoga sessions and workshops).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Yoga; African-American; Feasibility Study
Nurse Initiated Acupressure for Pain Management
Condition: Pain, Postoperative; Pain, Acute
MeSH terms: Pain, Postoperative; Acute Pain
Study type: Interventional

Summary: 
      The purpose of pilot study is to test the feasibility of nurse initiated post-operative
      bilateral auricular acupressure as an adjunct to medication for post-operative pain
      management.
    

Detailed description: 
      Postoperative pain management has become an area of concern over the last decade due to the
      opioid epidemic and concerns related to their use as the primary pain management strategy.
      Joint Commission requires that hospitals have additional pain non-pharmacologic pain
      management tools at their disposal to an effort decrease the reliance on opioids. Acupuncture
      and acupressure have been used for centuries in the management of a variety of disorders
      including pain. Unlike acupuncture, acupressure can be easily applied with limited training
      and is within the scope of practice for nurses, according to the North Carolina Board of
      Nursing. Thus evidence based non-pharmacologic strategies that can be deployed by nursing are
      of benefit to hospital organizations.
    

Intervention name(s): Auricular acupressure; Standard of care pain management
Intervention type(s): Device; Other
Intervention description(s): Trained nurses in auricular acupressure will place acupressure beads on 5 acupoints on each ear (cingulate gyrus, thalamus, omega-2, point zero, and Shen Men). The nurse will do the initial activation of the acupressure site by applying pressure for 30 seconds to each point until the participant reports tingling or moderate degree of pressure. Participant will be given instructions to do this three times a day for a total of 5 days. Acupoints were selected based on recommendation of faculty acupuncturist.; The participant post-operative pain will be managed following the standard protocol by the treating physician.
Other intervention name(s): acupressure
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Arm 1 Treatment group, Arm 2 Control group, Arm 3 Nurse Interventionist group
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: auricular acupressure; anesthesia
The Role of Antimicrobial Foam Dressing in Prevention of Cesarean Section Wound Complications
Condition: Cesarean Section; Complications, Wound, Dehiscence
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      Post-cesarean section wound infections are responsible for longer hospital stays,
      readmissions, and ultimately, increased costs to the healthcare system. Silver-containing
      dressings may prevent wound infections. The purpose of the current study is to determine if
      the use of a silver-impregnated dressing decreases the occurence of wound infection following
      cesarean delivery.
    

Detailed description: 
      A single-centered, single-arm clinical trial was originally designed to investigate the
      effects of an adherent soft silicone anti-microbial occlusive foam silver-impregnated
      dressing in preventing surgical site infection (SSI) in women delivered by primary cesarean
      section (CS). We sought to determine if the incidence of SSIs, would be lower in patients who
      received a silver-impregnated dressing as compared to those who received a standard dressing,
      when used as part of the overall hospital protocol for reducing SSIs. Given the addition of
      adjunctive azithromycin antibiotic prophylaxis for those who labored or had rupture of
      membranes prior to undergoing a non-elective CS right at the time of initiation of the study
      to our institution perioperative bundle, we also elected to undertake further analyses of
      observational data on those with the same study inclusion criteria receiving standard
      dressing undergoing primary CS with subcuticular skin closure during the same time period,
      rather than limiting comparisons of our outcomes solely to our historical SSI rates. In order
      to have this comparison group, patients who declined participation in the experimental groups
      were selected as our non-randomized control group, given fiscal restraints precluded
      conducting a randomized clinical trial (RCT). Demographic, labor, delivery, intraoperative
      and postoperative characteristic data were collected in a de-identified fashion. Medical
      record review and data entry were conducted by trained research personnel. All study
      procedures were approved by the Investigational Review Board.
    

Intervention name(s): Silver-impregnated antimicrobial dressing
Intervention type(s): Device
Intervention description(s): All participants will receive an adherent soft silicone silver impregnated anti-microbial occlusive foam dressing after cesarean section. The dressing will stay on for up to seven days.
Other intervention name(s): Mepilex Border AG
Intervention MeSH terms: Anti-Infective Agents; Anti-Bacterial Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: pregnancy; delivery; cesarean section; wound healing; silver-containing dressing
Epidemiology of Helicobacter Pylori Infection Among Shanghai Children
Condition: Bacterial Infection Due to Helicobacter Pylori (H. Pylori)
MeSH terms: Infections; Communicable Diseases; Bacterial Infections
Study type: Observational

Summary: 
      Epidemiology of Helicobacter Pylori Infection Among Shanghai Children.
    

Detailed description: 
      To get an understanding of the Hp infection general situation and provide evidence for Hp
      control, we are planning to run a free physical examination and lab test for a group of
      children. We are going to proceed with Hp-IgG test, 13C urea breath test and salivary Hp urea
      antigen test together to screening and diagnosing it.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Age 3~18 children
      
Biospecimen description: 
      serum will be storage in to -80℃ fridge for further test. other biospecimen will be test at
      site and disposed.