bioihbjkbjnl/mcl2 huggingface dataset:
Morning Light Treatment to Improve Glucose Metabolism
Condition: PreDiabetes; Circadian Dysregulation
MeSH terms: Chronobiology Disorders
Study type: Interventional

Summary: 
      The primary purpose of this pilot study is to test a novel head worn light device (Re-Timer®)
      as an intervention to improve glucose metabolism in people with prediabetes. The hypothesis
      is that morning light treatment will improve glucose metabolism. This is a pilot study and
      the data from this project will be used to develop a larger clinical trial.
    

Detailed description: 
      This is a pilot study to determine whether light treatment can improve glucose metabolism in
      people with prediabetes. Individuals will be asked to complete a baseline session with
      one-week of at-home sleep monitoring followed by a 24-hour stay in the clinical research
      unit. During this stay, we will sample saliva in the evening to measure melatonin to estimate
      the timing of the internal biological clock ("circadian phase") and then we will perform a
      3-hour oral glucose tolerance test in the morning to estimate markers of glucose metabolism,
      including insulin sensitivity. The participants will then be given a light device and
      instructed on its use. They will use the device for four weeks and visit our laboratory every
      week for a check-in. At the end of the four weeks, they will repeat the 24-hour stay in the
      clinical research unit.
    

Intervention name(s): Bright Light; Dim Light
Intervention type(s): Other; Other
Intervention description(s): 1 hour daily morning light treatment provided through a head-worn device for 4 weeks with the following settings: irradiance is 230 μW/m2 and lux is 500 lux.; 1 hour daily morning light treatment provided through a head-worn device for 4 weeks with the following settings: irradiance in this dimmed is reduced from 230 μW/m2 to 3 μW/m2, and lux reduced from 500 lux to 7 lux
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: half will receive active light treatment device, the other half will receive a placebo device
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: diabetes; sleep; circadian rhythm; light treatment
Performance Evaluation of a Novel Non-invasive Glucometer, Calibrated Against Validated Interstitial Glucose References
Condition: Diabetes Mellitus
Study type: Interventional

Summary: 
      This clinical study has been launched to collect spectral Raman data on the Investigational
      Medical Device (IMD) compared with reference methods in terms of interstitial fluid samples
      and capillary and venous references.
    

Detailed description: 
      Subjects will visit the clinic for a baseline visit and two in-clinic visits. On in-clinic
      days, subjects will attend the clinic in a fasting state. They will have inserted a Dexcom
      and Freestyle Libre and a microdialysis catheter. At time = 0, subjects will be administered
      a glucose rich drink and every 6. minut measurements will be performed. These include a
      measurement on the IMD, microdialysate, FreeStyle Libre and Dexcom readings. Every 18. minut
      a venous blood sample will be included and every 36. minut a capillary blood sample will be
      collected. This continues until time = 180 minutes.
    

Intervention name(s): Working Model 3.4NR
Intervention type(s): Device
Intervention description(s): Investigational Medical Device collecting spectral Raman data from tissue
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Non-invasive glucose monitoring; Raman spectroscopy
Ascending Dose Tolerability Trial and PK Assessment in Healthy Volunteers After Single & Multiple Oral Intake of DF2755A
Condition: no Condition
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary objective:

      •To evaluate the tolerability and safety of ascending single doses of DF2755A in healthy
      adultmale and female volunteers.

      Secondary Objectives:

        -  To determine the pharmacokinetics parameters of DF2755A

        -  To establish a dose concentration-response relationship over a wide range of doses in
           order toselect a narrower range of dose and dosing regimen to be subsequently studied in
           patients aftersingle administration

        -  To evaluate the effect of ascending single doses on the pharmacodynamics parameters

        -  To compare metabolites pathway in Human with the one observed in animals
    

Detailed description: 
      The study is a phase I, single center, double-blind, placebo controlled, randomized,
      ascending single doses study in healthy male and female volunteers.

      The design consists of a double blind comparison of the test compound versus placebo in which
      the dose is increased in successive treatment periods.

      Dose was escalated in order to achieve enough safety information on an interval of doses
      possibly encompassing both the effective dose and the maximum tolerated dose (defined as the
      highest dose devoid of any clinical signs/symptoms).

      The study has been terminated after Part A (single ascending doses) so the methodology was
      revised accordingly.
    

Intervention name(s): DF2755A
Intervention type(s): Drug
Intervention description(s): DF2755A was planned to be administered in two different parts:
Part A: Single oral dose administration on D1 according to the randomization (50, 150, 300 and 300 mg oad).
Part B: was planned (100 mg bid, 200 mg bid or 300 mg bid) not performed (repeated oral administration from Day 1 to Day 14).
Hence, only part A of the study was accomplished.
Other intervention name(s): allosteric inhibitor of CXCR1/2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Healthy volunteers
A Safety, Tolerability and Efficacy Study of V158866 in Central Neuropathic Pain Following Spinal Cord Injury
Condition: Neuropathic Pain Due to Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Neuralgia; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate whether V158866 is safe and effective for the
      treatment of neuropathic pain due to spinal cord injury.
    


Intervention name(s): V158866; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Neuropathic pain; Spinal cord injury
Fermented Soy and Heartburn Symptom Relief
Condition: Heartburn; Acid Regurgitation
MeSH terms: Heartburn
Study type: Interventional

Summary: 
      Heartburn is as common gastrointestinal symptom experienced by otherwise healthy adults and
      typically manifests as a painful burning sensation in the upper abdomen or in the chest.
      Typically, heartburn symptoms are treated with over-the-counter (OTC) medications which may
      come with side effects.

      There is suggestive evidence of the efficacy of fermented soy (Gastro-AD®) for the heartburn
      symptom relief. The aim of the study is to evaluate the effect of a fermented soy on
      heartburn symptom relief and time to onset.
    

Detailed description: 
      Heartburn is as common gastrointestinal symptom experienced by otherwise healthy adults and
      typically manifests as a painful burning sensation in the upper abdomen or in the chest.
      Usually it is caused by the regurgitation of gastric acid into the esophagus. The prevalence
      of heartburn is 10-20% worldwide and is increasing. Typically, heartburn symptoms are treated
      with over-the-counter (OTC) medications which may come with side effects.

      Gastro-AD® is a commercially available food supplement produced by fermentation of soy by a
      specific strain of Lactobacillus. There is suggestive evidence, in vivo as well as in vitro
      studies, of the efficacy of fermented soy (Gastro-AD®) for the heartburn symptom relief. The
      aim of the study is to evaluate the effect of a fermented soy on heartburn symptom relief and
      time to onset. It is hypothesized that the consumption of 1-3 g of fermented soy will relieve
      the heartburn symptom severity.
    

Intervention name(s): Gastro-AD®; Placebo
Intervention type(s): Other; Other
Intervention description(s): The product under study is Gastro-AD® fermented soy powder in the form of orodispersible flavored powder packed in non-transparent sachets.
Content: 1 g of Gastro-AD® powder per sachet + flavoring agents.; The placebo product will have very similar appearance, color, texture and taste as the Gastro-AD® flavored sachet. The placebo sachets contain the respective amount of maltodextrin (1 g) and exactly the same flavoring and coloring agents as Gastro-AD® powder flavored sachets.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
TMC435350-TiDP16-C109: A Safety Study for TMC435350 in an Oral Solution Containing Either 100, 200 or 400 mg Equivalent of TMC435350 or Placebo in Healthy Japanese Male Volunteers
Condition: HCV
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of three different doses
      of TMC435350 compared to placebo in healthy Japanese males.
    

Detailed description: 
      This is a Phase I, double-blind (neither the physician or the volunteer knows the dose of the
      study medication), randomized (study medication assigned by chance), placebo-controlled (dose
      without the study medication present) trial to determine the safety, tolerability and plasma
      pharmacokinetics (amount of medication in the blood) of TMC435350 after single and multiple
      oral doses in healthy male Japanese volunteers. 100 mg, 200 mg and 400 mg doses will be given
      as an oral solution. Six (6) doses will be given with a 3 day follow-up between the first and
      second dose. Additional follow-up will be done for 3 days after the last dose and at
      approximately 2 and 4 weeks after the last dose.
    

Intervention name(s): TMC435350
Intervention type(s): Drug
Intervention MeSH terms: Simeprevir
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: TMC435350; HCV; Hepatitis C; TMC435350-TiDP16-C109; TMC435350-C109
Safety and Efficacy of a Retinoid for the Treatment of Severe Chronic Hand Dermatitis
Condition: Hand Dermatoses
MeSH terms: Dermatitis; Skin Diseases; Hand Dermatoses
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients with severe chronic hand dermatitis, that has not responded to topical treatment,
      including topical steroids and the avoidance of aggravating factors, will be treated with the
      oral medication alitretinoin. The study aims to investigate the safety and efficacy of the
      medication when given over a period of 6 months.
    

Detailed description: 
      For severe, chronic hand dermatitis, refractory to topical treatment and the avoidance of
      aggravating factors such as allergens and irritants, no registered systemic treatment is
      available. Current systemic treatment options consist in the off-label use of systemic immune
      suppressants, such as cyclosporine, methotrexate.

      Severe chronic hand dermatitis is a debilitating disease, with massive impact on social life
      and working ability. A huge proportion of the population suffers for more than a decade, and
      job losses are a frequent consequence.

      This open-label trial investigates the safety and efficacy of oral alitretinoin 30mg as a
      single daily dose for up to 6 months. The trial is complementary to the pivotal efficacy
      study BAP00089.
    

Intervention name(s): alitretinoin
Intervention type(s): Drug
Intervention MeSH terms: Alitretinoin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hand Dermatoses,; hand dermatitis; hand eczema; chronic hand dermatitis; retinoid
Evaluation of Free Aminoacids in Saliva as A Diagnostic Biomarker of Periodontal Disease
Condition: Periodontitis; Diagnoses Disease
MeSH terms: Periodontitis; Periodontal Diseases
Study type: Interventional

Summary: 
      Amino acids (AAs) are organic molecules that are associated with inflammation and innate
      immunity diseases with critical roles in the cell repair and protection process. Our aim was
      to identify the free amino acids in saliva of a group of periodontitis patients and healthy
      individuals and additionally to assess their levels in different periodontal disease types
      and compare it to the healthy individuals.
    

Detailed description: 
      The study consisted of three groups: healthy individuals (control(C); n=20), Stage III Grade
      B generalized periodontitis (GP-B; n=20), and Stage III Grade C generalized periodontitis
      (GP-C; n=20). Clinical periodontal parameters (plaque index (PI), gingival index (GI),
      probing depth (PPD), gingival recession (GR), clinical attachment level (CAL) and bleeding on
      probing (BOP)) were measured. The amino acid analysis in saliva was accomplished by liquid
      chromatography-mass spectrometry (LC MS/MS) as mean concentration.
    

Intervention name(s): Saliva collection of patients and salivary free amino acids analysis
Intervention type(s): Other
Other intervention name(s): Salivary free amino acids in patients with periodontitis
Intervention model: Single Group Assignment
Intervention model description: Saliva of periodontitis patients collected for analyzing free amino acids.
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Saliva; Amino acids; Periodontitis
The Study of Oral Fluorescite to Confirm the Authenticity of Point of Care Urine Samples
Condition: Urine Sample Authenticity
Study type: Interventional
Phase: Phase 1

Summary: 
      During this study, participants will ingest 100 mg of fluorescein disodium or a placebo (no
      drug) mixed in GatoradeTM. Participants will then provide a urine sample after 10, 15, 20 or
      30 minutes to see if the investigator can detect fluorescein fluorescence (light) in the
      urine.
    

Detailed description: 
      Every year, millions of dollars are spent on urine drug testing. Urine samples are generally
      provided in an unwitnessed fashion. Only a small percentage of samples involve direct
      observation of urination. The authenticity of the provided sample greatly affects its
      clinical utility and/or the validity of the test results. Direct observation of urination can
      be unpleasant and humiliating for people. For the institution, there are increased costs (for
      example, staff, insurance) and risks regarding impropriety when direct observation is
      utilized.

      Participants are being asked to take part in a research study of an approved drug called
      FluoresciteTM. FluoresciteTM is an intravenous drug (administered into a vein) that has been
      approved by Health Canada. The active ingredient in FluoresciteTM is fluorescein disodium
      (10% fluorescein disodium in sterile water).

      Fluorescein disodium has been used medically for over fifty years. It is a fluorophore (emits
      light, similar to a yellow glowstick) that is most commonly used in ophthalmology (the study
      and treatment of disorders and diseases of the eye). It is currently used in angiography (to
      view blood vessels), or topically for staining the eye's cornea. FluoresciteTM or fluorescein
      disodium has not been approved by Health Canada for oral administration.

      During this study, participants will ingest 100 mg of fluorescein disodium or a placebo (no
      drug) mixed in GatoradeTM. The Investigator will then ask the participant to provide a urine
      sample after 10, 15, 20 or 30 minutes to see if he can detect fluorescence (light) in the
      urine.

      The purpose of this study is to:

        -  Develop a new standardized protocol for urine sampling that will increase sample
           authenticity and make the situation between the patient/physician more pleasant.

        -  To evaluate the safety and tolerability of orally ingested fluorescein disodium.
    

Intervention name(s): fluorescein sodium; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Fluorescein sodium in 500mL Gatorade; 500mL Gatorade
Other intervention name(s): Fluorescite
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Screening
A Pilot Observational Study to Assess Changes in Biochemical Parameters of Ovarian Reserve With Chemotherapy
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      Premenopausal women who are diagnosed with breast cancer are frequently treated with
      chemotherapy. Chemotherapy can affect the ovaries, and the effects can range from temporary
      loss of menstrual periods to permanent menopause. It is difficult to predict how an
      individual's ovarian function will be affected by chemotherapy. There are a number of
      hormones which can be measured in the blood which are related to fertility and ovarian
      function. The levels of these hormones may change with chemotherapy, and may relate to the
      effect of chemotherapy on the ovaries.

      In this study, we plan to enroll 28 women ranging in age from 25 to 50 who are diagnosed with
      breast cancer and will be treated with chemotherapy. We will check blood levels of the
      hormones before, immediately after, and 1 year after treatment with chemotherapy. We will
      only be checking these blood tests for this study; the type of chemotherapy given will be up
      to the patient and her oncologist. We will also ask some questions about factors that can
      influence the levels of these hormones, such as number of children, age of menopause of other
      family members, and smoking history. The results from this study will be used to help us
      develop future studies looking at changes in ovarian function with chemotherapy, and the
      effects of other breast cancer therapies, such as endocrine therapy, on the ovaries.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        premenopausal women with invasive adenocarcinoma of the breast between the ages of 25 and
        50.
      
Biospecimen description: 
      Serum
    
Keywords: premenopausal women with breast cancer
Effects of Dronabinol (Oral THC) on Cannabis Use
Condition: Marijuana Smoking
MeSH terms: Marijuana Abuse; Marijuana Use
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Study participants received dronabinol (0, 120mg/day and 240mg/day) for 12 consecutive days
      in a randomized order. During each dronabinol maintenance period they were able to
      self-administer active or placebo cannabis using either a progressive ratio schedule or
      choice between cannabis and monetary alternative.
    


Intervention name(s): Dronabinol 120mg/day; Placebo; Dronabinol 240mg/day
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants receive 40mg dronabinol 3 times daily; Participants receive placebo; Participants receive 80mg dronabinol 3 times daily
Other intervention name(s): Marinol; THC; Marinol; THC
Intervention MeSH terms: Dronabinol
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: marijuana; dronabinol; pharmacotherapy
Pirfenidone and Its Role in Burn Wound Healing
Condition: Second-degree Burn
MeSH terms: Burns
Study type: Interventional
Phase: Phase 2

Summary: 
      Burn patients which skin has been lost a rapid growth of the skin is a foremost in their
      treatment. Due to the injury, burn patients undergo a systemic inflammation that helps the
      skin heal faster. However, several studies have shown that this inflammation increases the
      levels of several inflammatory molecules that impairs skin growing, which further delays the
      recovery of burn patients. As such, by inhibiting these inflammatory molecules with the
      administration of a medication called pirfenidone burn patients might present faster rates of
      skin growth and recovery. Thus, patients suffering from a burn injury will be recruited at
      the emergency department of the Hospital University in Monterrey Mexico. Afterward, patients
      will be randomized to either receive pirfenidone 600 mg orally once per day or usual care
      consisting of covering the wound with hydrocolloid dressings. To assess the amount of newly
      growth skin investigators will take a small piece of the skin to further evaluate it through
      a microscope.
    


Intervention name(s): Pirfenidone Oral Product
Intervention type(s): Drug
Intervention description(s): A pill containing 600 mg of pirfenidone
Other intervention name(s): Kitoscell
Intervention MeSH terms: Pirfenidone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Burn patients will be divided to receive either 600 mg of pirfenidone or usual care
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Burns; Partial-thickness burn wounds; Re-epithelization; Second-Degree Wound; Pirfenidone; Wound Healing
Study To Evaluate Safety And Efficacy Of PF-06700841 In Subjects With Moderate To Severe Plaque Psoriasis
Condition: Chronic Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether PF-06700841 is safe and effective in the
      treatment of chronic plaque psoriasis.
    


Intervention name(s): PF-06700841; Placebo
Intervention type(s): Drug; Other
Intervention MeSH terms: PF-06700841
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: plaque psoriasis