bioihbjkbjnl/mcl2 huggingface dataset:
Zinc Supplements in Lowering Cadmium Levels in Smokers
Condition: Bladder Cancer; Cervical Cancer; Esophageal Cancer; Gastric Cancer; Head and Neck Cancer; Kidney Cancer; Leukemia; Liver Cancer; Lung Cancer; Pancreatic Cancer; Tobacco Use Disorder
MeSH terms: Lung Neoplasms; Pancreatic Neoplasms; Stomach Neoplasms; Uterine Cervical Neoplasms; Urinary Bladder Neoplasms; Esophageal Neoplasms; Liver Neoplasms; Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Zinc supplements may lower cadmium levels in smokers and may help prevent DNA
      damage.

      PURPOSE: This clinical trial is studying how well zinc supplements work in lowering cadmium
      levels in smokers.
    

Detailed description: 
      OBJECTIVES:

        -  Determine whether zinc supplements reduce cadmium levels in smokers.

        -  Measure serum levels of cotinine (a biomarker of smoking), zinc (a marker of
           compliance), and cadmium (the dependent variable) at 3 pre-supplementation visits and at
           6 supplementation visits.

        -  Determine whether serum cadmium levels (adjusted for serum levels of cotinine) decrease
           during supplementation with VisiVite Smoker's Formula.

        -  Determine if increased cadmium levels in the blood of cigarette smokers can be
           correlated with decreased mismatch repair.

        -  Determine if administration of zinc-containing supplements reverses cadmium-induced
           inhibition of mismatch repair.

      OUTLINE: This is an open-label, nonrandomized study.

      Patients receive oral zinc supplements once daily for 12 weeks in the absence of unacceptable
      toxicity.

      Blood, serum, and urine are collected once weekly for 3 weeks before beginning treatment and
      in weeks 5, 6, 9, 12, 15, and 17 for biomarker/laboratory analysis. Samples are examined for
      cadmium, zinc, and cotinine levels by atomic absorption spectrophotometry, expression of
      mismatch repair proteins (MSH2, MSH6, MSH3, MLH1, and PMS2), levels of messenger RNA by
      reverse transcriptase-polymerase chain reaction, and microsatellite instability by gel
      electrophoresis.

      After completion of study therapy, patients are followed for 5 weeks.
    

Intervention name(s): zinc oxide
Intervention type(s): Dietary Supplement
Intervention description(s): Oral daily dietary supplement containing 80 mg Zinc oxide
Intervention MeSH terms: Zinc Oxide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: renal cell carcinoma; bladder cancer; cervical cancer; esophageal cancer; gastric cancer; adult acute myeloid leukemia; pancreatic cancer; hypopharyngeal cancer; lip and oral cavity cancer; laryngeal cancer; nasopharyngeal cancer; oropharyngeal cancer; paranasal sinus and nasal cavity cancer; non-small cell lung cancer; small cell lung cancer; adult primary liver cancer; tongue cancer; tobacco use disorder
Clinical Efficacy of the Pinhole Soft Contact Lenses for Correcting Presbyopia
Condition: Presbyopia
MeSH terms: Presbyopia
Study type: Interventional

Summary: 
      For correct of presbyopia, in this study, the investigators have recruited subjects who aged
      45~65 years with presbyopia and do not have any other ocular disease(ex, ocular surface
      disease, corneal dystrophy, retinal disorders, etc.). All participants will underwent
      ophthalmic examination including manifest refraction, uncorrected distance visual acuity
      (UDVA), uncorrected near visual acuity (UNVA), corrected distance visual acuity (CDVA),
      corrected near visual acuity(CNVA), Goldmann visual field test, depth of focus Contrast
      sensitivity test, slit-lamp examination, topography with scheimp flug device(OCULUS pentacam
      ®) OSDI(ocular surface disease index) and Questionnaire about visual function and ocular
      symptoms. Apply pinhole soft contact lens (eyelike NoanPinhole ® , seoul, south Korea, Koryo
      Eyetech) on non-dominant eye of participants and/or soft contact lens for distance vision on
      dominant eye of participants. The investigators recommend use of pinhole contact lens at
      least 3 hours in a day for 1 week. And, participant will underwent the all ophthalmic
      examination same above 2 weeks after first apply of pinhole contact lens. The investigators
      will compare ophthalmic parameters mentioned above before and after wearing pinhole contact
      lens and evaluate the efficacy and safety of pinhole soft contact lens for correcting
      presbyopia.
    


Intervention name(s): Pinhole Soft Contact Lens apply for presbyopia
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Targeting of Immune Response After Pneumococcal Vaccination
Condition: Pneumococcal Pneumonia
MeSH terms: Pneumonia; Pneumonia, Pneumococcal
Study type: Interventional
Phase: Phase 4

Summary: 
      Pneumococcal polysaccharide vaccine does not confer protection against noninvasive pneumonia.
      The study aims to compare lymphocyte homing in pneumonia and in those receiving Pnc
      polysaccharide vaccine (PPV) or Pnc conjugate vaccine (PCV)
    

Detailed description: 
      Pneumococcal polysaccharide vaccine does not confer protection against noninvasive pneumonia.
      The study compares the homing profiles of Pnc-specific plasmablasts in 15 patients with
      pneumonia and in 15 volunteers receiving Pnc polysaccharide vaccine (PPV) and 12 volunteers
      receiving Pnc conjugate vaccine (PCV)
    

Intervention name(s): Pneumococcal polysaccharide vaccine; pneumococcal conjugate vaccine
Intervention type(s): Biological; Biological
Intervention description(s): Pneumococcal polysaccharide vaccine 0.5 ml i.m.; pneumococcal conjugate vaccine 0.5 ml i.m.
Other intervention name(s): Pneumovax; Prevenar
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: pneumonia; pneumococcal polysaccharide vaccine; pneumococcal conjugate vaccine
A Study in Dentinal Hypersensitivity (DH) Participants to Assess the Efficacy of an Occluding Dentifrice.
Condition: Dentin Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional

Summary: 
      This study will investigate the longitudinal efficacy of two experimental oral rinses, one
      containing 1.5% weight/weight (w/w) dipotassium oxalate monohydride (KOX) /0 Parts per
      Million (ppm fluoride) and the other 2.0% w/w KOX /45ppm fluoride, for the relief of dentinal
      hypersensitivity (DH), compared to a placebo oral rinse, when used as an adjunct to twice
      daily brushing with a standard fluoride toothpaste.
    


Intervention name(s): Experimental Oral Rinse 1; Experimental Oral Rinse 2; Placebo Oral Rinse; Fluoride toothpaste
Intervention type(s): Device; Device; Other; Drug
Intervention description(s): Oral rinse containing 1.5% w/w KOX, 0ppm F, pH 4.5; Oral rinse containing 2.0% w/w KOX, 45ppm F, pH 4.5; Oral rinse containing 0% w/w KOX 0ppm F, pH 4.5; Oral rinse containing 1000ppm fluoride as sodium monofluorophosphate
Intervention MeSH terms: Fluorides
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Safety and Efficacy Study of Polydioxanone (PDS) Plates in Rhinoplasty
Condition: Rhinoplasty
Study type: Interventional

Summary: 
      The purpose of this study is to determine efficacy, safety, and ease of cartilaginous
      grafting using polydioxanone (PDS) plates in comparison to non-plated cartilaginous grafts as
      performed through an endonasal rhinoplasty approach in patients requiring a caudal septal
      extension (CSE) graft.
    


Intervention name(s): Polydioxanone (PDS) plates; Caudal septal extension graft performed through endonasal rhinoplasty; Caudal septal extension graft performed through endonasal rhinoplasty
Intervention type(s): Device; Procedure; Procedure
Intervention description(s): 0.5 mm PDS Flexible Plate made of poly-p-dioxanone, an aliphatic polyester which is manufactured by polymerization of the monomer p-dioxanone. Polydioxanone is a resorbable material degraded by hydrolysis and has been successfully used for bone discontinuities and septal reconstruction.; The caudal septal extension (CSE) graft is a common method used to alter tip projection, alar-columellar relationship, and nasolabial angle.5 However, it can be difficult to stabilize and straighten the CSE graft, especially when performed through an endonasal approach. Use of a polydioxanone plate would provide a scaffolding for the CSE graft and could allow for a technically easier and more predictable surgical procedure.; The caudal septal extension (CSE) graft is a common method used to alter tip projection, alar-columellar relationship, and nasolabial angle.5 However, it can be difficult to stabilize and straighten the CSE graft, especially when performed through an endonasal approach. Use of a polydioxanone plate would provide a scaffolding for the CSE graft and could allow for a technically easier and more predictable surgical procedure.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Caudal septal extension graft; Primary rhinoplasty; Secondary rhinoplasty
A Feasibility Study to Evaluate Safety and Initial Effectiveness of ExAblate Transcranial MR Guided Focused Ultrasound for Bilateral Anterior Capsulotomy in the Treatment of Medication-Refractory MDD
Condition: Major Depressive Diorder
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the safety and initial effectiveness of MRI-guided
      focused ultrasound thermal ablation of a designated area in the brain of patients suffering
      from medication-refractory MDD, using the ExAblate transcranial system.

      The ExAblate system is a medical device that involves a focused ultrasound system and an MRI
      scanner. ExAblate delivers a pulse of focused ultrasound energy, or sonication, to the
      targeted tissue. For MDD Patients: one or more thermal lesion will be created on Bilateral
      Anterior Limb of internal Capsule.

      The treatment begins with a series of standard diagnostic MR images to identify the location
      and shape of target to be treated. The ExAblate computer uses the physician's designation of
      the target volume to plan the best way to cover the target volume with small spots called
      "sonications". These treatment spots are cylinder shaped. Their size depends on sonication
      power and duration. During the treatment, a specific MR scan, which can be processed to
      identify changes in tissue temperature, provides a thermal map of the treatment volume to
      confirm the therapeutic effect. The thermal map is used to monitor the treatment in progress,
      and confirm that the ablation is proceeding according to plan, thus closing the therapy loop.

      The ExAblate transcranial operates a helmet-shaped transducer (currently utilizing
      1000-element phased array transducer) positioned above the subject head. The ExAblate
      transcranial system also includes means to immobilize the subject head, cool the interface
      water, and software for CT analysis and phase correction computation.

      After informed consent and screening, eligible subjects will proceed to the treatment. All
      subjects will be followed at Day 1, 7 days, 1 month , and 6 months . At follow up visits,
      patients will be evaluated for general health, neurological changes (including MMSE exam),and
      efficacy measurements as well as for device/procedure related adverse events that may have
      occurred during the follow-up period. Six (6) month follow up visit will also include Full
      Battery Cognitive/Neurological Testing
    


Intervention name(s): ExAblate
Intervention type(s): Device
Other intervention name(s): Treatment with the ExAblate Transcranial MRgFUS System
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Medication-refractory
The Effect of Uterine Size and Posture on Intrauterine Contraception in Nulliparous Women
Condition: Intrauterine Contraception
Study type: Observational

Summary: 
      As intrauterine contraception is an increasingly popular form of contraception the objective
      of our study is to examine if uterine size or posture affects the insertion or use of
      intrauterine devices. Nulliparous women requesting either the levonorgestrel-releasing device
      (LNG-IUS) or a copper-IUD (NovaT) are recruited and followed for one year.
    

Detailed description: 
      Prospective observational study among nulliparous women requesting intrauterine
      contraception.
    

Intervention name(s): Evaluation of uterine size and posture with ultrasound, IUD insertion, one year follow-up.
Intervention type(s): Other
Intervention description(s): Evaluation of uterine size and posture with ultrasound, IUD insertion, one year follow-up.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study population consists of nulliparous women attending the centralized Family
        planning center of the City of Helsinki requesting intrauterine contraception, either the
        LNG-IUS or a Cu-IUD.
      
Keywords: nulliparous; IUD; IUS; insertion; expulsion
A Study of MabThera/Rituxan (Rituximab) in Patients With Non-Bulky Follicular Non-Hodgkin's Lymphoma
Condition: Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, Follicular
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy and safety of MabThera/Rituxan (rituximab) in
      treatment-naive patients with non-bulky follicular non-Hodgkin's lymphoma. The anticipated
      time on study treatment is 3 months.
    


Intervention name(s): rituximab [MabThera/Rituxan]
Intervention type(s): Drug
Intervention description(s): 375 mg/m2 intravenously once a week for 4 weeks
Intervention MeSH terms: Rituximab
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Varenicline (Chantix™) for the Treatment of Alcohol Dependence
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the efficacy of varenicline (Chantix™) for the
      treatment of alcohol dependence.
    

Detailed description: 
      By both providing a low level of reinforcement and down-grading any "high" associated with
      concurrent administration of the abused drug, combined agonist/antagonist therapies promote
      both initial and sustained abstinence. Based on varenicline's specific affinity for the
      nicotinic acetylcholine receptors that are implicated in alcohol reward circuitry, it appears
      to be a good candidate for treatment of alcohol dependence. Alcohol can exert its reinforcing
      and dopamine-enhancing effects through activation of nicotinic receptors. In addition to its
      partial agonist activity at heteromeric α4β2 nicotinic acetylcholine receptors, varenicline
      has also been shown to be a full agonist at homomeric α7 nicotinic acetylcholine receptors.
      That full agonism at α7 may be key in reducing alcohol withdrawal and craving during early
      alcohol abstinence, and thus reducing relapse, as α7 receptors are implicated in the neural
      reward circuitry activated by alcohol use.
    

Intervention name(s): varenicline; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1.0 mg BID for 12 weeks; BID 12 weeks
Other intervention name(s): Chantix
Intervention MeSH terms: Varenicline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: alcohol; treatment; nicotinic acetylcholine receptors; pharmacotherapy; outpatient
Biopsychosocial Exploration of Pain Profiles in Inflammatory and Chronic Non-specific Axial Low Back Pain
Condition: Back Pain; Spondylitis, Ankylosing; Low Back Pain
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing; Back Pain; Low Back Pain
Study type: Observational

Summary: 
      The biopsychosocial model is well established in chronic low back pain (CLBP) research.
      Nevertheless, researchers to date have overlooked the biopsychosocial aspects of Inflammatory
      Low Back pain (ILBP). Most health care providers are biologically oriented in their treatment
      of ILBP, neglecting its possible multidimensional nature. It is true that people with ILBP
      may present with more complex pain and physical limitations than those with chronic
      non-specific low back pain (CNSLBP), but it remains unexplored whether or not these
      limitations are affected by the same pain factors that affect CNSLBP patients. This study
      aims to explore and compare the biopsychosocial back pain profiles of adults with ILBP and
      CNSLBP.
    

Detailed description: 
      This is a multicentre case-control study that will compare back pain in patients with
      ankylosing spondylitis and CNSLBP. A multidimensional pain assessment will be conducted for
      patients in both groups. Each patient will be assessed on one occasion by the same
      experienced physiotherapist.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        A convenience sample of adults with Ankylosing Spondylitis (AS) will be consecutively
        recruited from a pool of patients referred to AS clinic in the Rheumatology and
        Physiotherapy Departments of St. James's and Tallaght Hospitals in Dublin.

        Adults with chronic non-specifi low back pain (CNSLBP) (control group) will be
        consecutively recruited from a pool of patients referred to the Physiotherapy Department of
        St. James's and Tallaght Hospitals in Dublin. An invitation to participate in the study and
        an information leaflet will be extended to the patients who potentially meet the
        recruitment criteria.
      
Keywords: Inflammatory back pain; Ankylosing spondylitis; Non-specific low back pain; Pain experience; Disability; Behavioural; Psychological; Biopsychosocial; Pain profiles
Transcorneal Electrical Stimulation - Multicenter Safety Study
Condition: Retinitis Pigmentosa
MeSH terms: Retinitis; Retinitis Pigmentosa
Study type: Interventional

Summary: 
      The purpose of this study is to expand the safety assessment of repeated applications of an
      electrical current from a DTL-like electrode in patients with RP.
    

Detailed description: 
      This is a single-arm open label interventional safety trial with RP patients, who receive
      weekly TES for 6 months on 1 eye followed by observation for another 6 months without
      stimulation. The primary outcome measure is safety, indicated by the frequency and severity
      of adverse events.
    

Intervention name(s): Transcorneal electrostimulation
Intervention type(s): Device
Intervention description(s): Weekly stimulation for 30 minutes with current of TES delivered of 150% of the individual phosphene threshold.
Other intervention name(s): OkuStim; TES; TcES
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: transcorneal electrostimulation
Extension Study of MT-1303
Condition: Relapsing-remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the long-term safety and tolerability of MT-1303 in subjects with relapsing
      remitting multiple sclerosis (RRMS).
    


Intervention name(s): MT-1303-Low; MT-1303-Middle; MT-1303-High
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: relapsing-remitting multiple sclerosis; RRMS
Real-Time CAD for Colonic Neoplasia: A RCT
Condition: Colorectal Cancer; Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Study type: Interventional

Summary: 
      This study assesses the sensitivity and added benefits of computer-aided detection compared
      to standard care (white-light) in detecting colon polyps in patients undergoing colonoscopy.
    

Detailed description: 
      Failure in polyp detection leads to colon cancer after colonoscopy. Artificial intelligence
      systems allow real-time computer-aided detection of polyps with high-accuracy. This study
      will compare GI-Genius, a real-time CAD system to standard colonoscopy in terms of how many
      colonoscopies detect an adenoma.
    

Intervention name(s): Real-Time Computer Aided Detection; Stanford Colonoscopy
Intervention type(s): Device; Procedure
Intervention description(s): This intervention involves using computer-aided detection using a real-time system (GI-Genius, Medtronic); This involves white-light colonoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Screening
Keywords: artificial intelligence
Multi-marker Stool Test for Detection of Colorectal Neoplasia: Marker Panel Selection and Technical Development Studies
Condition: Colorectal Neoplasms; Digestive System Diseases; Colonic Diseases; Colorectal Cancer
MeSH terms: Neoplasms; Colorectal Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases
Study type: Observational

Summary: 
      The objective of this study is to confirm the sensitivity of a stool DNA test for detection
      of colorectal cancer and pre-cancer.

      Another objective is to provide anonymous, clinically characterized specimens for a
      bio-repository for future colorectal cancer-related test development.
    

Detailed description: 
      Patients who have been recently diagnosed with colo-rectal cancer or pre-cancer will be asked
      to submit a stool sample(s)(at least 7 days AFTER colonoscopy) and will have the option of
      submitting blood and tissue samples for future colo-rectal cancer-related test development.
    

Observational model: Case-Only
Sampling method: Non-Probability Sample
Study population: 
        Patients who have had colorectal cancer or pre-malignancy confirmed by colonoscopic
        biopsy-based diagnosis.
      
Biospecimen description: 
      Residual specimens and histopathology tissue slides or blocks will be stored for up to 10
      years in the Sponsor's on-site bio-repository or similar commercial bio-repository contracted
      by the Sponsor.
    
Keywords: Cancer; Colorectal Cancer; Neoplasm; Colorectal Neoplasm; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases