bioihbjkbjnl/mcl2 huggingface dataset:
Measurement of Viral Load Reduction in the Oral Cavity After a Regimental Use of OC Toothpaste Products
Condition: Covid19
Study type: Interventional
Phase: Phase 3

Summary: 
      SARS COVID 2 has caused a pandemic of proportions unparalleled in the past 100 years. The
      virus has an uncanny ability for transmission and as such has been difficult to control. The
      spread of the virus has affected everything from education, business, politics and survival.
      While the investigators have learned a great deal in the last 9 months they still face an
      uncertain day to day existence. Health care workers are particularly vulnerable to
      transmission of this virus because of their close contact with patients. Moreover, dentists
      are particularly vulnerable because the virus is spread via aerosols which are generated
      quite easily in the dental office putting dentists and their associates at risk. The oral
      cavity appears to be a likely domain for viral carriage particularly since both taste and
      smell are hallmark effects of the virus. With these issues at hand it will be of great
      advantage to have a simple routine oral hygiene method in the effort to reduce the oral viral
      load. There is some reason to expect that oral hygiene procedures with known anti-microbial
      effects could have some use in our efforts to reduce or control the oral viral load. With
      this issue in mind investigators feel that stannous fluoride could modify the virus in such a
      manner as to effectively reduce the oral viral load.
    

Detailed description: 
      Study will measure reduction of SARS-CoV-2 levels in the oral cavity after brushing for up to
      an hour. Subject sampling will occur at baseline, 15 min, 30 min, and 60 min
    

Intervention name(s): Colgate Total Clean Mint; Tom's Botanically Bright Peppermint
Intervention type(s): Drug; Drug
Intervention description(s): 2 minutes of whole mouth toothbrushing; 2 minutes of whole mouth toothbrushing
Other intervention name(s): Toothpaste; Toothpaste
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Feasibility and Acceptability of the Online JOBS Program
Condition: Unemployment
Study type: Interventional

Summary: 
      The aim of this study is to test the feasibility and acceptability of a web-based adaptation
      of the Jobs program (developed by Curran et al., 1999).
    

Detailed description: 
      The current study is an open trial that will test the feasibility and acceptability of a
      web-based adaptation of the Jobs program (further be referred to as iJobs). We will use a
      repeated measures design: one group and three measurements (baseline, post-intervention, 3
      months follow-up). iJobs consists of five sessions spread over a two-week period. The
      participants will learn and exercise successful job search strategies (e.g. finding job
      openings, creating an attractive resume, demonstrating effective interviews).
    

Intervention name(s): iJobs
Intervention type(s): Behavioral
Intervention description(s): During the program, the participants will learn and exercise successful job search strategies. The web-based adaptation of the Jobs program will allow self-administration. After each session, they will receive written feedback from trainers on the platform.
Intervention model: Single Group Assignment
Intervention model description: Open-label pilot study
Masking: None (Open Label)
Primary purpose: Other
Preliminary Study of Piclozotan in Patients With Motor Complications Associated With Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to obtain preliminary information on the effect of piclozotan on
      motor complications associated with Parkinson's Disease.
    


Intervention name(s): piclozotan; 0.9% sodium chloride (normal saline)
Intervention type(s): Drug; Drug
Intervention description(s): piclozotan, intravenous (IV) infusion; 0.9% sodium chloride (normal saline) intravenous (IV) infusion
Other intervention name(s): SUN N4057
Intervention MeSH terms: Piclozotan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Parkinson's Disease; motor complications; dyskinesia; Motor complications associated with Parkinson's
Three-Arm Study of the Safety and Efficacy of Pirfenidone in Patients With Idiopathic Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The objectives of this study are to assess the safety and efficacy of treatment with
      pirfenidone 2403 milligrams per day (mg/d) compared with placebo in patients with idiopathic
      pulmonary fibrosis (IPF), to assess the safety and efficacy of treatment with pirfenidone
      1197 mg/d in patients with idiopathic pulmonary fibrosis and to characterize the
      pharmacokinetic disposition of pirfenidone in patients with idiopathic pulmonary fibrosis.
    

Detailed description: 
      This is a Phase 3, randomized, double blind, placebo-controlled, three-arm, safety and
      efficacy study of pirfenidone in patients with idiopathic pulmonary fibrosis. Approximately
      400 patients at approximately 70 centers will be randomly assigned (2:2:1) to receive either
      2403 milligrams (mg) of pirfenidone, placebo equivalent, or 1197 mg of pirfenidone
      administered in divided doses three times per day (TID) with food. Patients will be
      randomized by geographic region.

      Patients will receive blinded study treatment from the time of randomization until the last
      patient randomized has been treated for 72 weeks. A Data Monitoring Committee (DMC) will
      periodically review safety and efficacy data to ensure patient safety.

      After week 72, patients who meet the Progression of Disease (POD) definition, which is a ≥
      10% absolute decrease in percent predicted FVC or a ≥ 15% absolute decrease in percent
      predicted carbon monoxide diffusing capacity (DLco), will be eligible to receive permitted
      IPF therapies in addition to their blinded study drug. Permitted IPF therapies include
      corticosteroids, azathioprine, cyclophosphamide and N-acetyl-cysteine (with restrictions).
    

Intervention name(s): Pirfenidone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1197 or 2403 mg/day given orally, and administered in divided doses three times daily with food, for the duration of the study.; Placebo equivalent, given orally, and administered in divided doses three times daily with food, for the duration of the study.
Intervention MeSH terms: Pirfenidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Idiopathic; Pulmonary; Fibrosis; Lung; Pirfenidone; InterMune
Sudoscan in Patients With Autoimmune Disorders
Condition: Autoimmune Disease
MeSH terms: Autoimmune Diseases
Study type: Observational

Summary: 
      The purpose of this study is to assess the diagnostic utility of Sudoscan in assessing small
      fiber nerve function, specifically those of the sudomotor, in patients with autoimmune
      disorders (i.e fibromyalgia and rheumatoid arthritis).
    

Detailed description: 
      Small fiber neuropathy can manifest in different autonomic and painful symptoms, but current
      diagnostic tools are confined to nerve conduction studies and quantitative sensory testing.

      The former can only asses the large nerve fibers and fail to reflect sudomotor function, the
      latter tool can be subject to technical error. Pain and autonomic dysfunction, which reflect
      small fiber dysfunction has recently gained much interest in disorders with polyneuropathy
      but current studies have been confined mostly to diabetic polyneuropathies. There has been
      growing evidence that autoimmune disorders such as fibromyalgia can also manifest in small
      fiber dysfunction. Because of the complexity of diagnosing small fiber dysfunction, there are
      yet no standard protocols on how to assess and treat these patients. Sudoscan uses reverse
      iontophoresis to assess the function of the sweat glands. The tool is easy to use,
      non-invasive with quantitative results that are objective.

      The objective of this study is to assess the small fiber function; that is the sudomotor
      function; using Sudoscan in patients diagnosed with fibromyalgia and rheumatoid arthritis.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        patients who meet the following diagnostic criteria for either 1. Fibromyalgia or 2.
        Rheumatoid arthritis
      
Keywords: fibromyalgia,; polyneuropathy; small fiber neuropathy; rheumatoid arthritis; sudomotor
31P MRS Ischaemic Exercise Optimisation and COPD
Condition: Atrophy, Muscular
MeSH terms: Muscular Atrophy
Study type: Interventional
Phase: Phase 1

Summary: 
      An MRI study to develop a reliable methodology for 31P MRS ischaemic exercise in order to
      obtain a consistent standard of measurement of muscle metabolism while maintaining an
      acceptable level of subject comfort and use optimised method to measure and compare
      metabolism in the biceps and quadriceps of patients with COPD-related myopathy and control
      subjects
    

Detailed description: 
      31P Magnetic Resonance Spectroscopy (31P MRS) is a non-invasive method to measure muscle
      metabolism during exercise. This protocol is intended to provide information for planning
      future clinical trials applying 31P MRS as an endpoint measure for proof of pharmacology
      studies with novel therapeutic molecules. Parts A & B of this study will refine imaging and
      exercise protocols for 31P MRS during brief periods of muscle ischaemia and will assess the
      test-retest variance. In Part C we will apply 31P MRS with aerobic exercise in a pilot study
      to estimate differences in skeletal muscle oxidative metabolism between age- and sex-matched
      control subjects and patients with myopathy associated with Chronic Obstructive Pulmonary
      Disease.
    

Intervention name(s): MRI scan
Intervention type(s): Other
Intervention description(s): MRI scan only, methodology study with no other intervention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Statins and the Urinary Proteome
Condition: Statin Induced Proteinuria
MeSH terms: Proteinuria
Study type: Interventional

Summary: 
      This study aims to investigate whether statines (rosuva- and pravastatin) induce tubular
      proteinuria.
    

Detailed description: 
      The proximal tubular cells of the kidney are responsible for reabsorption of proteins from
      the tubular lumen. In a study using Opossum kidney (OK) cells, receptor-mediated protein
      endocytosis was reduced by statins, inhibitors of 3-hydroxy-3-methylglutaryl CoA (HMG-CoA)
      reductase, which are widely used for therapeutic reduction of plasma cholesterol levels (1).
      In a subsequent in vitro study protein endocytosis in human mixed proximal/distal kidney
      tubular cells was investigated in the presence and absence of statins to explore the possible
      clinical relevance of the observations in OK cells (2). The uptake of FITC-labeled albumin in
      these cultures occurred selectively into proximal tubular cells while it was absent in distal
      tubular/collecting duct cells. Three statins (simvastatin, pravastatin, and rosuvastatin)
      significantly inhibited the uptake of protein in a concentration-dependent way. This
      inhibitory effect of statins could be prevented by the co-addition of mevalonate, the product
      of HMG-CoA reductase. This effect was not the result of a statin-induced cytotoxicity since
      cell-viability was unaffected.

      These data suggest that statins have the potential to inhibit albumin uptake by the human
      proximal nephron as a result of inhibition of HMG-CoA reductase in the proximal tubule cells.
      A reduced prenylation of some proteins critically involved in endocytosis has been put
      forward as the underlying mechanism.

      Knowing these data it has been suggested that the occurrence of proteinuria in some patients
      treated with high statin doses is the result of a reduced tubular reabsorption/endocytosis of
      normally filtered proteins. To further explore the clinical relevance of such a mechanism,
      the composition of the urinary proteome under statin treatment will be investigated in normal
      healthy volunteers by two-dimensional gel electrophoresis based proteomics analysis.
    

Intervention name(s): Rosuvastatin-Crestor; Pravastatin-Pravasine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Rosuvastatin Calcium; Pravastatin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Diagnostic
Keywords: statins; proteinuria; proteomic analysis; healthy volunteers
The Role of Neural Systems for Emotion Regulation in Coping With Alcohol Craving
Condition: Alcoholism
MeSH terms: Alcoholism
Study type: Interventional

Summary: 
      Cognitive Behavioral Coping Skills Therapy (CBCST) is a commonly utilized, evidence-based
      psychosocial therapy (talk therapy) for alcohol dependence. By identifying the neural
      mechanisms through which CBCST changes drinking behavior, it may be possible to improve its
      efficacy. CBCST promotes abstinence by teaching "coping skills" for managing alcohol-related
      thoughts and emotions. In this pilot study, the investigators examine the neural systems that
      play a role in the learning of coping skills through CBCST, specifically focusing on the role
      of emotion regulation systems.
    

Detailed description: 
      The study combines 1) a 12-week clinical trial of CBCST in currently drinking alcohol
      dependent patients (target N=25) who are seeking treatment to reduce their drinking with 2)
      functional magnetic resonance imaging (fMRI) experiments that probe neural activity related
      to the utilization of copings skills taught in CBCST. The fMRI studies will be performed both
      before and after treatment with CBCST, with the goal of determining 1) the pattern of neural
      activity that is related to coping skills utilization prior to undergoing CBCST, with
      particular focus on neural systems known to play a role in emotion regulation; 2) how CBCST
      changes this pattern of neural activity; and 3) how these changes in neural activity predict
      changes in alcohol use during CBCST.
    

Intervention name(s): Cognitive Behavioral Coping Skills Therapy
Intervention type(s): Behavioral
Intervention description(s): Cognitive Behavioral Coping Skills Therapy (CBCST) is an individual psychotherapy for alcohol dependence that helps individuals to reduce drinking by addressing the ability to regulate, or "cope" with alcohol cravings and other emotions that promote alcohol use.
Other intervention name(s): Cognitive Behavioral Therapy; Relapse Prevention Therapy
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Alcohol dependence; Cognitive Behavioral Therapy; Functional neuroimaging
Optimizing Dose of Bupivacaine in Combined Spinal Epidurals To Reduce Side Effects
Condition: Pregnancy
Study type: Interventional

Summary: 
      The purpose of this study is to determine what dose of medication administered through a
      combined spinal epidural (CSE) provides the optimal pain relief with the minimal amount of
      side effects. The 3 doses studied here (1.25, 1.66 and 2.5mg) are routinely use on the labor
      floor (depending on the physician preference) but the idea is to quantify safety, efficacy
      and side effects for each of these doses.
    

Detailed description: 
      A combined spinal epidural (CSE), which is the investigators' customary method of providing
      pain relief during your labor, is the identification of the epidural space in your lower back
      with a needle, followed by passing a thinner and longer needle through the first needle. This
      second needle will enter the patient's "spinal" (intrathecal) space by passing through the
      dura (thin covering separating the epidural space from the spinal space). The spinal
      (intrathecal) space is identified by flow of spinal fluid. The dura is the envelope around
      the spinal cord and the intrathecal space which is filled with spinal fluid. Medication will
      be injected at once into the spinal space, the thinner needle removed and a fine tube
      (catheter) will be threaded through the first needle into the epidural space. This catheter
      is in the epidural space and medication can be given through this catheter later on (hence
      the term combined) if needed. This study is a comparison of three different dosages (1.25mg,
      1.66mg and 2.5 mg) of the local anesthetic (Bupivacaine) that we frequently use in the
      spinal, mixed with 20 mcg of Fentanyl (also routinely used in standard of care practice), and
      of its effects on the patient's blood pressure (risk of maternal's drop of the blood pressure
      with possible bad effects on the blood flow to the baby), on the patient's baby's heart rate
      (risk of slowing down of the baby heart rate as a consequence of decreased blood flow to the
      baby), and the patient's pain relief (higher dose of medications are usually more effective
      for maternal pain relief but have side effects that can be bad for the mother and the baby).
      The doses of Bupivacaine the investigator routinely use on the labor and delivery floor go
      from 1.25 to 2.5 mg depending on clinician preferences. These doses are considered standard
      of care in the literature.
    

Intervention name(s): Bupivacaine; Fentanyl
Intervention type(s): Drug; Drug
Intervention description(s): The dose of bupivacaine administered intrathecally during placement of the spinal anesthetic.; 20 micrograms routinely administered in combination in the spinal anesthetic
Other intervention name(s): Fentanyl
Intervention MeSH terms: Fentanyl; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Pain control; labor; epidural; pregnant
A Study of LY2940094 in Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety and tolerability of ascending single
      and multiple oral doses of LY2940094 in healthy male subjects.
    


Intervention name(s): LY2940094; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Depression
A Positron Emission Tomography Study of SLV354 in Healthy Subjects and Subjects With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label, Phase 1 study will investigate the 5-hydroxytryptamine 6 (5-HT6) receptor
      occupancy in the brain using positron emission tomography (PET) following single oral doses
      of SLV354. Up to 22 healthy male subjects and male subjects with stable schizophrenia,
      between 18-55 years of age are to complete the study.
    

Detailed description: 
      This is an exploratory, open-label PET study designed to examine the relationship between
      SLV354 plasma concentration and 5-HT6 receptor occupancy in the brain following single oral
      doses of SLV354 in healthy male subjects and male subjects with stable schizophrenia. A total
      of up to 22 subjects are to complete the study, including approximately 12 subjects with
      schizophrenia on a stable dose of an atypical antipsychotic medication. Within 60 days prior
      to the PET scan, subjects will be screened based on medical history, physical examination,
      vital signs, ECG, clinical laboratory tests, response to Columbia-Suicide-Severity Rating
      Scale (C-SSRS) and for schizophrenia subjects only, the diagnosis of schizophrenia based on
      Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision
      (DSM-IV-TR). Following Screening, eligible subjects will have a Magnetic Resonance Imaging
      (MRI) scan, unless one was performed within one year of the PET scan, to delineate the region
      of interest for the individual PET images. The radiotracer [11C]-QUICS will be used for the
      PET scans.

      All subjects will receive a single oral dose of SLV354. Healthy subjects will have one PET
      scan prior to and two PET scans after administration of SLV354. Schizophrenia subjects will
      have two PET scans prior to and one PET scan after administration of SLV354.
    

Intervention name(s): SLV354
Intervention type(s): Drug
Intervention description(s): One dose of ABT-354
Other intervention name(s): ABT-354
Intervention model: Single Group Assignment
Masking: None (Open Label)
Opioid Modulation and Neural Reward Activation in Healthy Adults
Condition: Alcohol Drinking; Opioid Use, Unspecified
MeSH terms: Alcohol Drinking
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a double blind study of the effects of opioid antagonism on the brain's reward
      response. The investigators will recruit participants to undergo two scans, one on active
      medication and one on placebo. During the scan, the investigators will assess reward.
    

Detailed description: 
      The study will employ a crossover design. The study will use the monetary incentive delay
      task during functional MRI to assess reward. This task presents participants with cues
      indicating whether they are playing to win $5, win $0, or to avoid losing $5. This task has
      been well-validated to elicit activation in a key reward response area of the brain called
      the ventral striatum.
    

Intervention name(s): Naltrexone; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Naltrexone is an opioid antagonist with primary action at the mu opioid receptor.; Placebo will be used to control for expectancy effects
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will be counterbalanced for the order they undergo placebo and medication.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science