bioihbjkbjnl/mcl2 huggingface dataset:
Robotic Laparoscopic Radical Prostatectomy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Observational

Summary: 
      This is a pilot study to evaluate the role of RALRP in the management of localized prostate
      cancer.
    

Detailed description: 
      To establish a robotic-assisted laparoscopic radical prostatectomy programme at the
      University of Western Ontario/London Health Sciences Centre and to critically evaluate the
      role of this programme in the management of localized prostate cancer in surgical candidates
      Details of surgical procedure, operative outcome, patient outcome including quality of life
      will be collected.
    

Intervention name(s): Laparoscopic
Intervention type(s): Procedure
Intervention description(s): Patients with prostate cancer who are eligible for a radical prostatectomy will have their surgery conducted with the aid of surgical robots.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Prostate cancer patients eligible for a radical prostatectomy
Safety, Tolerability, and Efficacy of XT-150 for the Treatment of Osteoarthritic Pain
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      Evaluation of Safety, Tolerability, and Efficacy of XT-150, a plasmid DNA with a variant of
      human IL-10 transgene. XT-150 will be a single injection into the knee synovial capsule for
      the Treatment of Osteoarthritic Pain.
    

Detailed description: 
      Phase 1 dose escalation study to evaluate the safety, tolerability, and efficacy of a plasmid
      DNA encoding a variant of human IL-10. This 6-month study will follow subjects with severe
      osteoarthritis of the knee. Safety labs, physical exams, and blood levels of the IL-10
      variant will be assessed for tolerability and any adverse events associated with the
      treatment.
    

Intervention name(s): XT-150
Intervention type(s): Biological
Intervention description(s): Human IL-10 variant transgene in a plasmid DNA vector
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Ascending dose-ranging study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: inflammation; Cytokines; Interleukin-10; Gene therapy
Double-Blind Lamictal (Lamotrigine) in Neurotic Excoriation
Condition: Neurotic Excoriation; Pathologic Skin Picking; Psychogenic Excoriation; Dermatillomania
MeSH terms: Dermatitis; Self-Injurious Behavior
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of the proposed study is to evaluate the comparative efficacy of Lamictal
      (lamotrigine) to placebo in neurotic excoriation. Thirty subjects with neurotic excoriation
      will receive 12 weeks of double-blind treatment with Lamictal (lamotrigine) or matching
      placebo. The hypothesis to be tested is that Lamictal (lamotrigine) will be more effective
      than placebo in patients with neurotic excoriation. The proposed study will provide needed
      data on the treatment of a disabling disorder that currently lacks a clearly effective
      treatment.
    

Detailed description: 
      The study will consist of 12 weeks of double-blind treatment with Lamictal (lamotrigine)
      compared to placebo (1:1) in 30 subjects with neurotic excoriation.
    

Intervention name(s): Lamictal (lamotrigine); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): once daily from beginning to end of study. Dosage varies.; daily
Other intervention name(s): lamotrigine
Intervention MeSH terms: Lamotrigine; Anticonvulsants
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Neurotic Excoriation; Pathologic Skin Picking; Psychogenic Excoriation
Tumor Lysate Pulsed-Dendritic Cell Vaccines After High-Dose Chemotherapy for Non-Hodgkin's Lymphoma
Condition: Lymphoma, Non-Hodgkin
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 3

Summary: 
      When patients relapse after primary chemotherapy for Non-Hodgkin's lymphoma, they may be
      eligible to receive high-dose chemotherapy with autologous stem cell support. Unfortunately
      high-dose chemotherapy is curative in less than half the patients who receive it. This study
      is being conducted to determine the safety, side effects, and the ability to respond to an
      investigational vaccine that consists of tumor-pulsed dendritic cells given with an immune
      stimulating drug called interleukin-2. The patient must have a lymphomatous node accessible
      for excision to prepare the vaccine. Dendritic cells are immune cells that are obtained from
      the blood, and are important in the body's immune response to foreign substances. This study
      will examine the response of the immune system after three vaccinations (composed of
      dendritic cells, which have been exposed to dead fragments of lymphoma cells) given beginning
      three months after transplant. Vaccination may result in sensitizing the patient's dendritic
      cells to his lymphoma cells, potentially resulting in an immune response against the
      lymphoma. Twelve patients will be treated on study.
    


Intervention name(s): tumor-pulsed dendritic cells
Intervention type(s): Biological
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dendritic cells
Comparison of Exercise Intervention Effects Following Lumbar Microdiscectomy
Condition: Injury of Nerve Root of Lumbar and Sacral Spine
Study type: Interventional

Summary: 
      Low back pain is common, costly and affecting up to 80% of the population with the lumbar
      discectomy being a frequent spinal procedure for disc herniations. Pain & mobility
      impairments persist in patients following microdiscectomy with long term issues of back pain.
      The question remains as to why some patients recover quickly and without lasting difficulties
      while other patients persist with prolonged disability following the same surgery. The
      purpose of this study is to determine how to guide the patient towards full function and
      evaluate the timing to initiate strengthening, neurodynamics and a walking exercise program.
    

Detailed description: 
      The direction of treatment for low back pain both surgically and conservatively seeks to
      improve function in both daily and sporting activities for all patients. The patients
      continuing to suffer from a significant level of pain, disability and reduced function
      following single level microdiscectomy may benefit from a multi-factorial approach. A
      reduction in neurodynamic mobility related to dural adhesions is considered to be a
      contributing factor in this persistent peripheral neuropathic pain. The clinical efficacy of
      this study will address an exercise protocol post surgery in order to provide an optimal
      approach in the prevention of scar tissue that may be contributing to persistent pain post
      microdiscectomy. Mobility and motor control impairments are considered the consequence to the
      onset of pain. Education, neurodynamics and stabilization exercises are instrumental in the
      recovery post microdiscectomy with a reduction in pain and disability and the goal towards
      full functioning. The introduction of a neurodynamic protocol as an early exercise
      intervention may serve to reduce pain inhibition resulting with improved mobility and motor
      control. The recording of step count per day following a lumbar microdiscectomy will serve to
      document daily and physical activity levels following surgery. The purpose of this study is
      to determine whether or not there is a significant difference in pain levels and lumbar
      mobility between an early exercise intervention group versus a late exercise intervention
      group post microdiscectomy.
    

Intervention name(s): Exercise Intervention
Intervention type(s): Behavioral
Intervention description(s): Early versus later stabilization and neurodynamic exercise intervention following a post-op lumbar microdiscectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: exercise; lumbar microdiscectomy
Treatment of Periodontal Intrabony Defects With A-PRF+ or EMD
Condition: Periodontal Diseases
MeSH terms: Periodontal Diseases
Study type: Interventional

Summary: 
      The aim of this randomized clinical trial was to clinically evaluate and compare the healing
      of intrabony defects after treatment with advanced platelet-rich fibrin (A-PRF+) to enamel
      matrix derivatives (EMD) in periodontitis patients.
    

Detailed description: 
      Thirty (30) intrabony defects of 18 patients (9 males, 9 females) were randomly divided in
      two treatment groups: test (n = 15) and control (n = 15). The intrabony defects were filled
      with A-PRF+ (n=15) in the test group, respectively with EMD in the control group, and fixed
      with sutures to ensure wound closure and stability.
    

Intervention name(s): A-PRF/EMD
Intervention type(s): Procedure
Intervention description(s): Comparing healing effect of an autologous and a xenogenic product
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Intrabony Defects; New-Generation Platelet-Rich Fibrin; Enamel Matrix Derivatives; Periodontal Regeneration; EMD; A-PRF+; Advanced Platelet-Rich Fibrin
Treatment of the Face and Neck With Lower Ulthera System Energy Settings
Condition: Skin Laxity
MeSH terms: Cutis Laxa
Study type: Interventional

Summary: 
      Up to 60 subjects will be enrolled. Enrolled subjects will receive one Ulthera® treatment on
      the face and neck. Follow-up visits will occur at 90 and 180 days post-treatment. Study
      images will be obtained pre-treatment, immediately post-treatment, and at each follow-up
      visit.
    

Detailed description: 
      This trial is a prospective, single-site, double-blinded, randomized, split-face design.
      Subjects will be randomized to one of three treatment groups, receiving treatment using
      different energy levels. Global Aesthetic Improvement Scale scores and patient satisfaction
      questionnaires will be obtained.
    

Intervention name(s): Ulthera System Treatment
Intervention type(s): Device
Intervention description(s): Focused ultrasound energy delivered below the surface of the skin
Other intervention name(s): Ultherapy™
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Ulthera® System; Ultherapy™ Treatment; Ulthera, Inc.; Ultrasound treatment for skin tightening
An RCT of an Online Training for Vulnerable Patients to Use an Online Patient Portal Website
Condition: Electronic Health Records; Chronic Disease; Health Literacy
MeSH terms: Chronic Disease
Study type: Interventional

Summary: 
      Online patient portals are becoming ubiquitous in the US. Previous research has documented
      substantial usability barriers, especially among patients with limited health literacy. This
      pilot randomized pilot trial had the goal of determining the effectiveness of an in-person
      training with a scalable online video-based training program to increase portal use among
      patients in a safety net healthcare setting.
    

Detailed description: 
      The intervention in this study was a patient portal training curriculum with simple
      instructions and 11 how-to videos for accessing features of an online patient portal. Using a
      deeply participatory approach, this curriculum was created in consultation with a patient
      advisory board from the San Francisco Health Network, a local Medicaid health plan. From June
      until October 2016, 93 patients with 1 or more chronic diseases were randomized to receive
      either: 1) an in-person tutorial with a trained research assistant versus 2) a link to view
      the videos on their own. The primary outcome was portal log-in (yes/no) between 3 and 6
      months post-training, assessed through a portal administrative dashboard within the EHR.
      Secondary outcome included baseline and follow-up survey measures on participants'
      perceptions of the portal use and their care, as well as views of the web-based lessons.
    

Intervention name(s): Take-home online training; In-person online training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): We randomized patients to receive a link to access the online tutorial on their own. Participants in the take-home arm were given a paper handout with a link to the training materials and an outline of the steps for accessing the training curriculum.; For participants randomized to the in-person training arm, a trained research assistant prompted participants to log into the learning platform and guided them in accessing the training materials for portal features that were of interest to them. The staff member provided further explanation or clarification if participants had questions about the training material.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Patient Portal; Healthcare disparities; Safety net healthcare system
Investigating the Effect of Onyx Sorghum on Blood Glucose in Individuals With Type 2 Diabetes
Condition: Diabetes Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      To evaluate the effect of onyx sorghum on blood glucose levels in patients with type 2
      diabetes (T2DM).
    

Detailed description: 
      The plan is to study 24 participants with T2DM, who are otherwise healthy. The study will be
      double-blinded and randomized. Participants will first attend a screening visit (Visit #1) to
      determine eligibility. Then, eligible participants will be asked to wear a FreeStyle Libre
      Pro continuous glucose monitor (CGM) for up to 14 days (Visit #2). After this 14-day CGM
      session, participants will be randomly assigned (1:1) to one of two groups that will receive:
      1) food products containing onyx sorghum (Onyx Group) or 2) food products with wheat flour
      (Control Group). The diet intervention will last a total of 28 days. Participants will have
      weekly visits to pick up food and bi-weekly blood draws (no more than 20mL at each visit).
      They will also be asked to wear the CGM throughout the diet intervention and will record
      their food intake in a daily food diary to confirm that the diet intervention is being
      followed.
    

Intervention name(s): onyx sorghum; whole wheat flour
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The diet intervention will last a total of 28 days. Per the American Heart Association (AHA) and American Diabetes Association (ADA) recommendations, the daily diet plan will consist of 50-55% carbohydrate, 15-20% protein, and 25-30% fat. In the Onyx Group, 25% of carbohydrate will come from the onyx sorghum, and at least three foods per day (including cereals, bread, muffins, pasta, and smoothie boosters) will contain this.; Per the American Heart Association (AHA) and American Diabetes Association (ADA) recommendations, the daily diet plan will consist of 50-55% carbohydrate, 15-20% protein, and 25-30% fat.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: double blinded randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Modulation of GABA-A Receptors in Parkinson Disease-Flumazenil Arm
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This arm is a positron emission tomography (PET) biomechanistic GABA-A receptor target
      engagement study that includes detailed clinical and motor assessments before and after the
      i.v. administration of 1 mg flumazenil or placebo in Parkinson disease subjects. Each subject
      will receive 1mg flumazenil or placebo at two visits.
    

Detailed description: 
      This biomechanistic GABA-A receptor target engagement study includes clinical and motor
      assessments before and at various time points up to approximately 90 minutes after the i.v.
      administration of 1 mg flumazenil and placebo in Parkinson disease subjects. Thirty Parkinson
      disease subjects with disease severity (Hoehn and Yahr) stages 2-4 will be recruited.
      Baseline [11C]FMZ and vesicular monoamine transporter type 2 (VMAT2) [11C]DTBZ brain PET
      imaging will be performed prior to drug administration to assess for GABA-A receptor
      availability and the integrity of nigrostriatal dopaminergic nerve terminals, respectively.
    

Intervention name(s): Flumazenil; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1mg in 10cc normal saline; 10 cc normal saline
Intervention MeSH terms: Flumazenil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: Gait; Balance; Flumazenil; PET Imaging; MRI; Mobility; Intravenous
Safety Study of a Long-Acting Injectable Steroid to Treat Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to understand the pharmacokinetics of EP-104IAR and to
      determine whether it is safe to use in patients with osteoarthritis (OA) of the knee. The
      study will also provide some preliminary insights into whether the experimental treatment
      reduces pain in the knee.

      Osteoarthritis is the most common joint disease, affecting over 20 million people in the US
      alone. Currently, pain treatments that are injected directly into the knee often work for
      only a short time and may also have side effects within the rest of the body. The
      experimental treatment is a steroid that is in the same family of drugs as the most common
      current injectable treatments for knee osteoarthritis. For this study, the drug is coated
      with a polymer intended to prolong the time it stays inside the knee and lessen potential
      side effects.
    


Intervention name(s): EP-104IAR; Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): Single, ultrasound-guided injection of EP-104IAR into the knee; Single, ultrasound-guided injection of vehicle placebo into the knee
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: osteoarthritis; knee
A PK/PD Study of Polyethylene Glycol Loxenatide in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      Polyethylene Glycol Loxenatide (PEX168) is a new human glucagon-like peptide 1 (GLP-1)
      analogue that created on the basis of the Exenatide and modified by polyethylene glycol
      (PEG).

      This study aims to evaluate the effective therapeutic concentration range of PEX168, also
      decided to observe safety and PK/PD correlation by long-term continuous administration.
    


Intervention name(s): PEX168 or placebo
Intervention type(s): Drug
Intervention description(s): injection has to administered subcutaneously weekly
Other intervention name(s): Polyethylene Glycol Loxenatide or Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: PEX168; Phase I/II; add on to metformin
Biomarkers Identification of Anti-tumor Necrosis Factor (TNF) α Agent's Efficacy in Ankylosing Spondylitis Patients
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 4

Summary: 
      To identify new candidate genes and proteins that are differentially expressed in responders'
      vs non-responders to anti-TNF alpha therapy at the several time points the investigators will
      use the transcriptomic and proteomic analyses. Demonstrate a link between gene expression and
      protein markers regarding prediction to anti-TNF alpha therapy efficacy.
    


Intervention name(s): Adalimumab
Intervention type(s): Drug
Intervention MeSH terms: Adalimumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Ankylosing Spondylitis; adalimumab; TNF-alpha agents; spondyloarthritis; biologic therapies; AS; biomarkers; efficacy prediction
TOL-463 Phase 2 Study for Vaginitis
Condition: Bacterial Vaginosis; Vulvovaginal Candidiasis
MeSH terms: Candidiasis; Vaginosis, Bacterial; Candidiasis, Vulvovaginal; Vaginal Diseases; Vaginitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase II study designed to assess the safety and efficacy of an investigational
      product, TOL-463, to treat vaginitis.
    

Detailed description: 
      This is a Phase II randomized single blind safety and efficacy study of TOL-463, administered
      to female adults to treat vaginitis. Participants will be randomly assigned (1:1) to dose
      TOL-463 Gel or TOL-463 Insert. Study medication will be administered vaginally, once nightly
      for seven days. The duration of the study for each participant will be approximately 21-30
      days.
    

Intervention name(s): TOL-463; TOL-463
Intervention type(s): Drug; Drug
Intervention description(s): TOL-463 vaginal gel; TOL-463 vaginal insert
Intervention MeSH terms: TOL-463
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bacterial; Candidiasis; Gel; Insert; TOL-463; Vaginal; Vaginitis; Vaginoses; Vulvovaginal