bioihbjkbjnl/mcl2 huggingface dataset:
Nutrition, Arsenic and Cognitive Function in Children
Condition: Arsenic Exposure
Study type: Interventional

Summary: 
      The main goals of this study are to evaluate whether supplementation with folate and vitamin
      B12 to 8 to 10 year old children, in conjunction with reduction in arsenic exposure, can
      increase arsenic methylation and lower blood arsenic and blood monomethyl arsenic (as
      previously observed in adults). The investigators will also explore whether folate and B12
      can mitigate arsenic-related decrements in cognitive abilities.
    

Detailed description: 
      While reducing arsenic (As) exposure in Bangladesh and the U.S. must continue to be a top
      priority, this has proven difficult. After decades of efforts to reduce exposure, 42 million
      people in Bangladesh remain exposed to As above 10 µg/L, the WHO guideline for As in drinking
      water. Risk for arsenic-related health outcomes lingers for decades after exposure has been
      reduced. Innovative strategies to lower arsenic exposure and and reduce its potential adverse
      health effects of As are needed.
    

Intervention name(s): Vitamin B12; Placebo; Folic Acid
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 5 μg/d vitamin B12 to be given orally. This is a standard nutritional supplement commonly used in the US.; Placebo pills, with same appearance as intervention pills.; 400 μg/d folic acid to be given orally. This is a standard nutritional supplement commonly used in the US.
Intervention MeSH terms: Folic Acid; Vitamin B 12; Hydroxocobalamin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: Arsenic exposure
Detection of Colonic Polyps Via a Large Scale Artificial Intelligence (AI) System
Condition: Colonic Polyp
MeSH terms: Polyps; Colonic Polyps
Study type: Interventional

Summary: 
      Colonoscopy is the gold standard for detection and removal of precancerous lesions, and has
      been amply shown to reduce mortality. However, the miss rate for polyps during colonoscopies
      is 22-28%, while 20-24% of the missed lesions are histologically confirmed precancerous
      adenomas. To address this shortcoming, the investigators propose a new polyp detection system
      based on deep learning, which can alert the operator in real-time to the presence and
      location of polyps during a colonoscopy. The investigators dub the system DEEP: (DEEP)
      DEtection of Elusive Polyps. The DEEP system was trained on 3,611 hours of colonoscopy videos
      derived from two sources, and was validated on a set comprising 1,393 hours of video, coming
      from a third, unrelated source. For the validation set, the ground truth labelling was
      provided by offline gastroenterologist annotators, who were able to watch the video in
      slow-motion and pause/rewind as required; two or three specialist annotators examined each
      video.

      This is a prospective, non-blinded, non-randomized pilot study of patients undergoing
      elective screening and surveillance colonoscopies using DEEP.

      The aim of the study is to:

      Assess the:

        1. Number of additional polyps detected by the DEEP system in real time colonoscopy.

        2. Safety by prospective assessment of the rate of adverse events during the study period
           attributed or not to the use of the DEEP system.

        3. Stability of the DEEP system by measuring the rate of false positives (False Alarms) per
           colonoscopies 4 And to examine its feasibility and usefulness of in clinical practice by
           assessing the colonoscopist user experience while using the DEEP system in a 5 point
           scale.
    


Intervention name(s): AI polyp detection system based on deep learning
Intervention type(s): Device
Intervention description(s): A Polyp detection system based on deep learning and artificial intelligence, which can alert the operator in real-time to the presence and location of polyps during a colonoscopy.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Colonoscopy Performance
MR Spectroscopy as a Diagnostic and Outcome Measure in Pain and SCI
Condition: Spinal Cord Injury; Hyperalgesia, Secondary; Hyperalgesic Sensations
MeSH terms: Spinal Cord Injuries; Hyperalgesia
Study type: Observational

Summary: 
      The goal of this study is to compare the changes that occur in sensation and chemical
      properties of the brain following SCI between individuals that experience chronic pain and
      those that do not, and between those with SCI and the able-bodied.
    

Detailed description: 
      This study investigates the differences in certain neurochemicals present in areas of the
      brain linked to pain processing in people with SCI and neuropathic pain, in people with SCI
      but no pain, and in able-bodied persons. We will also investigate the relationship between
      these concentrations of neurochemicals and different aspects of chronic neuropathic pain,
      including the intensity of pain, quality of life issues, sensitivity changes in areas of the
      body that are both painful and non-painful, and neurological status.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Both spinal cord injured (85) and able-bodied (25) subjects will be studied. Of those with
        spinal cord injury, 60 will be those who experience central neuropathic pain and 25 will
        not. An additional 25 people who screen positive for mild to moderate TBI symptoms and pain
        attributable to TBI will be studied.
      
Keywords: Spinal Cord Injury Pain; Chronic Neuropathic Pain; SCI Pain; Pain, Chronic Neuropathic; Spectroscopy, Magnetic Resonance; MRS; Traumatic Brain Injury Pain
Evaluation of the Beneficial Effects of a Nasal Spray of Resveratrol in Children With Seasonal Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to evaluate whether treatment with a nasal spray based on
      resveratrol has some benefit in patients with seasonal allergic rhinitis, mild, moderate, or
      severe.
    

Detailed description: 
      The aim of this study is to evaluate whether treatment with a nasal spray based on
      resveratrol has some benefit in patients with seasonal allergic rhinitis, mild, moderate, or
      severe. The primary objective is to assess whether the treatment with nasal spray based
      resveratrol is able to improve the allergic rhinitis symptoms during the two months of
      treatment. The secondary aim is to evaluate if the resveratrol nasal spray is able to reduce
      respiratory infections and wheezing episodes.
    

Intervention name(s): Resveratrol nasal spray
Intervention type(s): Drug
Intervention MeSH terms: Resveratrol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: nasal obstruction; sneezing; itching; rhinorrhea; respiratory infections; wheezing
LEAN Project: Weight Loss and Appetite Suppression
Condition: Weight Loss
MeSH terms: Body Weight; Weight Loss
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary aim is to examine whether the intake of PhosphoLEAN is effective in aiding a
      cohort of women in losing weight. Participants taking the supplement will have significantly
      greater improvement in study outcomes than those taking the placebo.
    

Detailed description: 
      Participants will be randomized to either a control or treatment group taking the dietary
      supplement containing a soy lecithin-derived N-oleoyl-phosphatidyl-ethanolamine (NOPE) and
      caffeine free Green Tea-derived epigallocathchin gallate (EGCG) whose trade name is
      PhosphoLean. The outcome is to determine the effects on indices of weight loss and appetite
      suppression. Participants will return at 6, 12, and 16 weeks for clinical measures.
    

Intervention name(s): PhosphoLean
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: green tea; weight; women
Reinforcing Effects of Cocaine During Phendimetrazine Maintenance
Condition: Cocaine Use Disorder
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will determine the initial efficacy of phendimetrazine as a pharmacotherapy for
      cocaine dependence. A rigorous, inpatient human laboratory study will be conducted in which
      the subjective, physiological and reinforcing effects of cocaine are evaluated during
      maintenance on placebo and phendimetrazine.
    


Intervention name(s): Phendimetrazine; Cocaine; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Phendimetrazine will be administered in divided doses twice daily.; Intranasal cocaine will be administered during experimental sessions.; Placebo capsules will contain only cornstarch.
Other intervention name(s): Bontril
Intervention MeSH terms: Cocaine; Phendimetrazine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Basic Science
Effect of Somatropin on Left Ventricular Mass in Growth Hormone Deficient Adult Patients
Condition: Growth Hormone Disorder; Adult Growth Hormone Deficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      This trial is conducted in Europe. The aim of this trial is to assess the effect of
      somatropin (Norditropin®) replacement therapy on the left ventricular mass of adult patients
      with a growth hormone deficiency.
    


Intervention name(s): somatropin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): Initial dosage 0.5 IU/day, injected subcutaneously (s.c., under the skin) once daily. Dosage will be adjusted monthly depending on clinical safety up to a maximum dose of 3 IU/day. Subjects are treated for six months (randomised trial period) followed by an 12-month open-label trial period with somatropin.; Initial dosage 0.5 IU/day, injected subcutaneously (s.c., under the skin) once daily. Dosage will be adjusted monthly depending on clinical safety up to a maximum dose of 3 IU/day. Subjects are treated for six months. After treatment in the randomised trial period, placebo will be discontinued.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Lower Extremity Outcome Measures in SCI
Condition: Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries
Study type: Observational

Summary: 
      Lower extremity (LE) function of patients with a spinal cord injury (SCI) will be assessed in
      an observational project with a cross-sectional and a longitudinal study design. The main
      goal is to identify kinematic and kinetic parameters to precisely characterize LE function
      and in parallel the impairment and limitation in SCI patients throughout rehabilitation in
      acute patients and in chronic patients to define LE function and LE recovery.
    


Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with an acute or chronic spinal cord injury
Comparison of I-gel LMA, Classical LMA With a New Supraglottic Airway the Baska Mask® in Urological Surgery
Condition: Airway Management
Study type: Interventional

Summary: 
      The most used airway management strategies are different types of supraglottic airway devices
      (SAD) for transurethral resection of bladder and ureteroscopy in urological surgery .
      Classical laryngeal mask airway (LMA-C) and I-Gel SADs are being used already. The aim of
      this study was to evaluate and compare the performance of a new type of SAD the Baska Mask®
      with I-gel and LMA-C regarding their insertion times, durations, perioperative complications
      and effects on hemodynamic parameters, peak airway pressures (Paw) and airway plato pressures
      in urological surgery as well.
    

Detailed description: 
      The most used airway management strategies are different types of supraglottic airway devices
      (SAD) for transurethral resection of bladder and ureteroscopy in urological surgery .
      Classical laryngeal mask airway (LMA-C) and I-Gel SADs are being used already. The aim of
      this study was to evaluate and compare the performance of a new type of SAD the Baska Mask®
      with I-gel and LMA-C regarding their insertion times, durations, perioperative complications
      and effects on hemodynamic parameters, peak airway pressures (Paw) and airway plato pressures
      in urological surgery as well.

      The main suggestion about the Baska Mask® is that it's the most appropriate airway device
      with high Paws. In high Paws, higher air leaks may occur from the sides of cuff and this
      causes hypoventilation. So the main aim of this study is to evaltuate three devices in terms
      of insertion and ventilation times, the "first attempt" success rates, the additional
      maneuvering requirements and complications developed after intervention.

      The secondary objective of the study was to evaluate all three SADs in terms of airway
      pressures producing sufficient tidal volume and hemodynamical parameters.
    

Intervention name(s): LMA-C; Baska Mask; I-gel
Intervention type(s): Device; Device; Device
Intervention description(s): LMA-C will be placed into the patients airway following anesthesia induction. The placement will be done as suggested in supine position with a standard gel pillow under patients head.; Baska Mask will be placed into the patients airway following anesthesia induction. The placement will be done as suggested in supine position with a standard gel pillow under patients head.; I-gel LMA placement will be done as suggested in supine position with a standard gel pillow under patients head.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Laryngeal Mask Airway; Urologic Surgical Procedure
Inflammatory Processes in the Airway of Asthmatics With Persistent Bronchial Hyperreactivity
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional

Summary: 
      The purpose of this study is to examine inflammatory processes in the airway of moderate to
      severe persistent asthmatics who have persistent bronchial hyperreactivity despite chronic
      administration of inhaled glucocorticoids.
    

Detailed description: 
      BACKGROUND:

      The Inhaled Glucocorticoid Withdrawal Protocol will investigate abnormalities in the
      asthmatic airway that occur in the setting of a "natural" endogenous exacerbation. It is
      known that chronic treatment with inhaled glucocorticoids causes a nearly complete
      disappearance of inflammatory cells from the airway and improvement in bronchial
      hyperreactivity, yet such patients have persistent bronchial hyperreactivity. Withdrawal of
      inhaled glucocorticoids causes a worsening of bronchial hyperreactivity. These observations
      suggest that a chronic derangement in the asthmatic airway might exist, which is unmasked by
      withdrawal of inhaled glucocorticoids and which reinitiates the inflammatory process. These
      "persistent" abnormalities in the asthmatic airway may be seen during quiescent stages of
      chronic asthma even when airway inflammatory changes are not evident. The abnormalities may
      be seen during the period of treatment with inhaled glucocorticoids or they may appear as one
      of the first signs after the withdrawal of inhaled glucocorticoids, thereby initiating the
      recurrence of asthma and promoting inflammation.

      DESIGN NARRATIVE:

      The purpose of this study is to examine inflammatory processes in the airway of moderate to
      severe persistent asthmatics who have persistent bronchial hyperreactivity despite chronic
      administration of inhaled glucocorticoids. Each participant will undergo bronchoscopic
      procedures and have assessment of bronchial hyperreactivity at the following two time points:
      1) during treatment with inhaled fluticasone; and 2) after acute withdrawal of inhaled
      fluticasone.

      The primary outcome of this study is the change in CD3 positive T cells in the airway
      submucosa.

      The key secondary outcomes are as follows: 1) other inflammatory cell markers in the airway
      (e.g., CD4, CD8, CD68, CD45, EG2/MBP, tryptase, and neutrophil elastase); 2) RANTES
      (regulated on activation, normal T expressed and secreted) expression in airway; 3) FEV1 peak
      expiratory flows; 4) methacholine PC20; and 5) asthma symptom score.
    

Intervention name(s): Bronchoscopic
Intervention type(s): Procedure
Intervention description(s): Bronchoscopic procedure
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: asthma, corticosteroids
Evaluating How the Treatments in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Study Affect Diabetic Retinopathy (The ACCORD Eye Study)
Condition: Diabetic Retinopathy
MeSH terms: Retinal Diseases; Diabetic Retinopathy
Study type: Interventional
Phase: Phase 3

Summary: 
      Diabetic retinopathy (DR) is an eye disease that can occur in people with diabetes and can
      cause poor vision or blindness. The Action to Control Cardiovascular Risk in Diabetes
      (ACCORD) study is examining the effect of various treatments on cardiovascular disease in
      people with diabetes. This current study will examine the effects of the ACCORD treatments on
      the progression of DR in people participating in the ACCORD study.
    

Detailed description: 
      DR is the most common diabetic eye disease and is the leading cause of blindness in adults in
      the United States. It is caused by damage to the blood vessels of the retina, which is the
      light-sensitive outer layer of the eye. Retinal blood vessels are often affected by the high
      blood sugar levels associated with diabetes. Older people have an increased risk of
      developing DR; however, DR is likely to occur earlier and be more severe in anyone who has
      poorly controlled diabetes. Almost everyone who has had diabetes for more than 30 years will
      eventually show signs of DR. Symptoms of DR include poor night vision, seeing spots in front
      of the eyes, blurred vision, and blindness. The ACCORD study is a study that is examining the
      effects of different treatments on cardiovascular disease in people with diabetes.
      Participants in the ACCORD study will receive one of eight different combinations of
      treatment, including blood sugar control, blood pressure control, and cholesterol-controlling
      medication. This study will enroll participants in the ACCORD study and will examine the
      effects of the study treatments on DR. The results from this study may be used to develop new
      treatments to help prevent diabetes-related blindness.

      Study visits will occur at baseline and Year 4. At each study visit, participants will have
      an eye exam and specialized fundus photographs taken of the back of the eye and retina.
    

Intervention name(s): Hypoglycemic Agents; Standard glycemia control; Intensive BP treatment; Standard BP control; Fenofibrate; Simvastatin; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Multiple drugs including insulins and oral hypoglycemia agents for HbA1c less than 6%; A strategy of glycemia drugs for HbA1c 7% - 7.9%; A strategy of multiple BP agents to reduce SBP less than 120 mm Hg; A strategy of BP drugs for SBP less than 140 mm Hg; Blinded fenofibrate; Simvastatin 20-40 mg/d; Placebo
Intervention MeSH terms: Hypoglycemic Agents; Simvastatin; Fenofibrate
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Type 2 Diabetes Mellitus; Cardiovascular Diseases
Risk-Group Classification of Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Condition: Untreated Adult Acute Lymphoblastic Leukemia; Untreated Childhood Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Observational

Summary: 
      This clinical trial is studying risk-group classification of patients with newly diagnosed
      acute lymphoblastic leukemia. Developing a risk-group classification guide may help doctors
      assign patients with newly diagnosed acute lymphoblastic leukemia to treatment clinical
      trials.
    

Detailed description: 
      OBJECTIVES:

      I. Provide a classification guide that will organize the clinical and laboratory data
      necessary for assigning each patient with newly diagnosed acute lymphoblastic leukemia (ALL)
      to a specific treatment clinical trial.

      II. Provide an administrative base to capture classification data for correlative studies
      accompanying current Children's Oncology Group (COG) ALL treatment clinical trials.

      III. Provide a central reference guide for all required and research only ALL studies that
      will be conducted at local and reference laboratories.

      IV. Provide a mechanism for optional banking of leukemia and germline specimens for current
      and future research.

      OUTLINE:

      Patients undergo blood collection and bone marrow biopsies at baseline and at the end of
      induction therapy for immunophenotyping for marker identification; molecular testing for
      translocations; trisomy analysis by fluorescence in situ hybridization (FISH); and DNA
      ploidy. Immunophenotype results obtained on this study are used to determine the patient's
      assignment to specific treatment clinical trials (consistent with acute lymphoblastic
      leukemia).

      After completion of induction therapy, patients are followed once or twice annually.
    

Intervention name(s): laboratory biomarker analysis
Intervention type(s): Other
Intervention description(s): Correlative studies
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Any patient with newly diagnosed acute lymphoblastic leukemia meeting other criteria.
      
Biospecimen description: 
      marrow and blood samples
Safety and Efficacy Study of Dexmethylphenidate in Children With ADHD
Condition: ADHD
MeSH terms: Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the safety and efficacy of two doses of
      dexmethylphenidate to two doses of an approved, long-acting, marketed medication for ADHD
      (MPH) and placebo in children ages 6-12 diagnosed with ADHD.
    


Intervention name(s): Focalin XR
Intervention type(s): Drug
Intervention MeSH terms: Dexmethylphenidate Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: ADHD, children