bioihbjkbjnl/mcl2 huggingface dataset:
Impact of Vitamin A Supplementation on Immune System in Multiple Sclerosis Patients
Condition: Relapsing Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Vitamin A; Placebo
Intervention description: 25000 IU/day (one capsule per day) Vitamin A for 6 months; 1 capsule per day for six months
Intervention MeSH terms: Vitamin A; Retinol palmitate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 36.0
Sex: All
Minimum age: 20 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Multiple Sclerosis; Vitamin A; CD4-Positive T-Lymphocytes; Th1 Cells; Th2 Cells

Summary:

      The aim of this study is to study the comparison between the effects of supplementation with
      25000 IU preformed vitamin A (retinyl palmitate) or placebo for 6 months on immune system and
      Th1/Th2 balance in patients with Multiple Sclerosis.
    

Eligibility criteria:

        Inclusion Criteria:

        Patients who have used interferon beta in last 3 months. Patients with 1-5 EDSS

        Exclusion Criteria:

          -  Patients who have diseases which affect on Th1/Th2 balance such as asthma, active
             viral infections, and autoimmune diseases, OR

          -  Patients who have allergy to vitamin A compounds, OR

          -  Patients who have used vitamin supplements in last 3 months.
An Interventional Study for Patient With Cancer Pain to Evaluate the Efficacy and Safety of OxyNorm® Compared to Morphine Sulfate Through the IV Continuous Infusion.
Condition: Cancer Pain
MeSH terms: Cancer Pain
Intervention: Oxycodone Hydrochloride; Morphine Sulphate
Intervention description: Oxycodone injection; Morphine sulphate injection
Intervention MeSH terms: Morphine; Oxycodone
Phase: Phase 4
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No
Keywords: Intravenous injection in cancer pain

Summary:

      The purpose of this study is to compare of difference in NRS scores from baseline to the
      completion of treatment (5 days) in patients with administration of morphine sulfate versus
      oxycodone hydrochloride.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adult men and women aged 19 years or more

          2. Patients with cancerous pain who are hospitalized or scheduled for hospitalization at
             Screening and not planned to be discharged during the study

          3. Patients with mean moderate to severe pain over the past 7 days at Screening as
             verbally confirmed (NRS 4 or higher)

          4. Subjects who voluntarily signed the Informed Consent Form for the study

          5. Subjects who are capable of understanding details of the study and verbal
             communication on pain intensity

        Exclusion Criteria:

          1. Patients who reached the narcotic analgesic dose corresponding to the followings for
             cancerous pain treatment immediately prior to Screening (oral morphine dose 195mg/day,
             oral oxycodone dose 130mg/day, patch fentanyl dose 75μg/hour)

          2. Patients with a medical history of hypersensitivity to an ingredient of oxycodone
             hydrochloride or morphine sulfate or other narcotic analgesics

          3. Patients who have contraindications and cautions when study drugs administered.
Magnetic Resonance Imaging of the Effect of Music Listening on Brain Activity Under Anesthesia
Condition: Healthy
Intervention: Functional Magnetic Resonance Imaging (fMRI)
Intervention description: Propofol will be administered by intravenous infusion. All anesthesia equipment, supplies, and drugs will be provided by anesthesiologists from the University of Michigan Health System. The researchers will manually control the infusion of propofol to achieve target effect-site concentrations which will be maintained for 4 minutes each.
Four types of music, including Jazz, Rock, Pop and Country, will be presented in a pseudo-randomized order. During the behavioral test period, participants will be asked to squeeze an Magnetic Resonance Imaging (MRI) compatible grip dynamometer (a rubber ball) for every 10-second periods (96 cycles in total). The beginning of each cycle will be cued with the spoken word "squeeze".
Intervention MeSH terms: Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Basic Science
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 47.0
Sex: All
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Music; Propofol

Summary:

      This study is to better understand the systems-level neuronal mechanisms by which general
      anesthetics produce loss of consciousness.The researchers believe that anesthetics suppress
      consciousness by disrupting the functioning of large-scale brain networks that support
      information integration in the brain.
    

Eligibility criteria:

        Inclusion Criteria:

          -  American Society of Anesthesiologist physical status of 1 (ASA-1), Healthy,
             non-smoking, no or minimal alcohol use

          -  Right-handed

          -  Body mass index (BMI) of less than 30

          -  English speakers

        Exclusion Criteria:

          -  Medical contraindication to Magnetic Resonance Imaging (MRI) scanning

          -  Unable to undergo MRI scanning because of possible pregnancy

          -  BMI over 30

          -  Tattoos in the head or neck region

          -  Unwilling to abstain from alcohol for 24 hours prior to dosing
Local Phase 4 Pan-European SMART Study
Condition: Asthma
MeSH terms: Asthma
Intervention: Budesonide/formoterol
Intervention MeSH terms: Budesonide; Formoterol Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 8424.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Asthma

Summary:

      The purpose of this study is to evaluate the effect of two different maintenance doses of
      Symbicort Maintenance And Reliever Therapy (SMART) in adult asthmatic patients. A 6 month
      treatment period
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients at out-patient clinics

          -  >18 years with a minimum of 6 months documented history of persistent asthma who have
             used inhaled glucocorticosteroids for at least one month and have a history of use in
             rapid-acting B2 agonists for symptom relief

        Exclusion Criteria:

          -  Asthma exacerbation within the last 14 days prior to study start

          -  subject aged >40 years with a smoking history of >10pack-years

          -  subjects with chronic obstructive lung disease or other significant respiratory
             disease
Personalized Medicine Interface Tool (PerMIT): Warfarin: A Trial Comparing Usual Care Warfarin Initiation to PerMIT Pharmacogenetic Guided Warfarin Therapy
Condition: Blood Clotting
MeSH terms: Thrombosis
Intervention: warfarin pharmacogenetic dosing; Warfarin
Intervention description: Warfarin pharmacogenetic dosing incorporated into a validated clinical algorithm displayed in a computer (PERMIT) management interface; Usual care warfarin dosing
Intervention MeSH terms: Warfarin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Warfarin; Pharmacogenetic

Summary:

      Warfarin is the most commonly used oral anticoagulant medicine (blood thinner). Although this
      medicine works well, it is difficult to know how much medicine a patient needs. Many things
      affect how much medicine a patient needs and doses can be very different from patient to
      patient. It is important for patients to get the right dose to prevent clotting or bleeding
      problems that can happen with this medicine if the dose is too low or too high. These
      problems can be life-threatening. To help find the right dose, patients on warfarin must have
      frequent blood tests to measure how well the medicine is working. The investigators know
      differences in people's genes can affect how much warfarin medicine someone needs, but they
      don't yet know with certainty how to use this information in making patient care decisions.
      The hypothesis of this study is that using a patients warfarin related genetic information
      incorporated into a computer algorithm to be used by a warfarin provider will lead to better
      warfarin management compared to usual care.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Prescribed warfarin for any indication, so long as they are naïve to the drug at
             enrollment and are expected to receive therapy for at least 12 weeks

        Exclusion Criteria:

          -  Recent cardiothoracic surgery as indication for warfarin.
Pharmacokinetic Study of Hydrocodone/APAP in Chronic Pain Patients
Condition: Chronic Pain
MeSH terms: Chronic Pain
Intervention: Hydrocodone
Intervention description: Dose: Standard prescribed dose Frequency: Once Duration: Once
Intervention MeSH terms: Hydrocodone
Phase: Phase 4
Study type: Interventional
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Pharmacokinetics; Hydromorphone; Hydrocodone; APAP

Summary:

      Objective is to evaluate the pharmacokinetics profile of hydrocodone's metabolite
      hydromorphone in patients who are taking hydrocodone on a routine basis for more than 3
      months for chronic pain and correlate hydromorphone levels to their hydrocodone usage.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Man or woman aged 18-75

          -  Documented clinical diagnosis of chronic pain.

          -  Have been taking hydrocodone/APAP for their chronic non-cancer pain.

          -  Subjects currently on hydrocodone/APAP must be taking minimal daily dose of 15mg of
             Hydrocodone for at least 30 days.

          -  Subjects must have signed an informed consent document indicating that they understand
             the purpose of and procedures required for the study and are willing to participate in
             the study.

        Exclusion Criteria:

          -  Subjects who are taking concomitant medications or Nutraceuticals that interfere with
             Hydrocodone metabolism as listed in Appendix 11 and/or as deemed clinically
             significant by a pharmacovigilance team that is contracted to monitor and advise.

          -  Health concerns that the study physician feels may confound study results.

          -  Individuals who are cognitively impaired or who are not able to give informed consent.

          -  Previous participation in a clinical research trial within 30 days prior to
             randomization.

          -  The subject has an ongoing abuse of illicit substances, alcohol, or actively smoking
             marijuana.
Trial of Alvimopan in Major Spine Surgery
Condition: Constipation
MeSH terms: Constipation
Intervention: Alvimopan; Placebo
Intervention description: Alviimopan 12 mg twice daily up to 15 doses; Placebo twice daily up to 15 doses
Intervention MeSH terms: Alvimopan
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No

Summary:

      The Investigator has chosen to study the reconstructive spinal surgery patient population
      because it is believed that the use of alvimopan in these patients at the University of
      Virginia will give the scientific community significant insight into the broader
      applicability of this drug into other surgical populations, the impact of this drug on the
      perception of pain (as opposed to simply the consumption of opioids), and its impact on total
      hospital charges, resource utilization, and functional outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Major spine surgery scheduled as part of clinical care

          -  18-80 years

        Exclusion Criteria:

          -  More than three doses of any opioid within one week of surgery

          -  Pregnancy

          -  Prisoners

          -  Unable to provide consent

          -  Emergency surgery

          -  Chronic kidney disease stage 5 (GFR < 15 ml/min)

          -  Severe hepatic impairment

          -  Recent myocardial infarction (within the last 3 months)
A Prospective Randomized Double-Blind Trial Comparing 3 Doses of Intravenous Ketorolac for Pain Management
Condition: Pain
Intervention: 10 mg of Ketorolac; 15 mg of Ketorolac; 30 mg of Ketorolac
Intervention description: Patients will receive 10 mg of Ketorolac for pain control.; Patients will receive 15mg of Ketorolac for pain control.; Patients will receive 30mg of Ketorolac for pain control.
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 240.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Hypothesis: Intravenous administration of Ketorolac in a dose of 10 mg is as effective in
      treating severe acute pain in patients presenting to the ED as 15 mg and 30 mg.
    

Eligibility criteria:

        Inclusion Criteria:

        Severe flank and abdominal pain, severe musculoskeletal pain (traumatic and non-traumatic
        in origin), headache, dental pain.

        Exclusion Criteria:

        Age >65, Active Peptic Ulcer disease, Acute Gastrointestinal Hemorrhage, Known Hx of Renal
        or Hepatic insufficiency, Hx of allergies to NSAIDS.
Study of Efficacy and Safety of Vigadexa in Treating Inflammation and Infection Post-cataract Surgery
Condition: Cataract
MeSH terms: Cataract; Inflammation
Intervention: Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops
Intervention description: 1 drop every 6 hours into the study eye
Intervention MeSH terms: Moxifloxacin; Dexamethasone; Ophthalmic Solutions
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Cataract

Summary:

      To demonstrate that the combination formulation of Moxifloxacin/Dexamethasone Eye Drop is
      effective and safe for the prevention of postoperative inflammation as a consequence of
      cataract extraction surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ≧18 years of age

          -  able to sign an informed consent and complete all required visits

          -  intends to have a cataract extraction surgery followed by implantation of a posterior
             chamber Intraocular lens (IOL)

          -  Intraocular Pressure (IOP) ≦ 20 millimeters mercury (mmHg)

        Exclusion Criteria:

          -  Uncontrolled glaucoma or IOP

          -  use of ocular anti-infectious during the study and within 30 days prior to the
             enrollment, secondary implantation or replacement of IOL in the study eye

          -  use of steroid during the study or within 14 days prior to enrollment
Changing the Default for Tobacco Treatment
Condition: Tobacco Use Cessation
Intervention: Opt Out Treatment Program; Nicotine Replacement Therapy; Opt In Treatment Program; Nicotine Replacement Therapy
Intervention description: Tobacco Treatment (UKanQuit) staff will complete a treatment plan for all participants.; Unless they Opt Out all participants will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria.; Tobacco Treatment (UKanQuit) staff will complete a treatment plan for participant's who are ready to quit smoking. For patient's not ready to quit, motivational counseling will be provided to participants based on principles of Motivational Interviewing.; Participants ready to quit will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria.
Intervention MeSH terms: Nicotine
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1000.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: tobacco treatment

Summary:

      The purpose of this study is to determine the impact and efficacy of a new approach to
      smoking cessation treatment versus the traditional approach.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Speak English or Spanish

          -  Have access to a telephone or mobile phone

          -  Not be currently pregnant or breast feeding

          -  Have no significant co-morbidity that precludes participation

          -  Current daily smoker

          -  Not in treatment for tobacco dependence

          -  Reside in Kansas or Missouri

        Exclusion Criteria:

          -  Admission greater than 3 days
A Study of Fuzeon (Enfuvirtide) With an Integrase Inhibitor Plus Optimized Background in Treatment-Experienced HIV-1 Infected Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Intervention: enfuvirtide [Fuzeon]; Optimized background ARV; Integrase inhibitor; enfuvirtide [Fuzeon]
Intervention description: 90 mg SC twice daily; As prescribed; As prescribed; 180 mg SC once daily
Intervention MeSH terms: Enfuvirtide; HIV Integrase Inhibitors; Integrase Inhibitors
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Treatment Experienced

Summary:

      This 2-arm study evaluated the efficacy and safety of Fuzeon with an integrase inhibitor in
      an expanded access program plus an optimized background antiviral regimen (AVR) in HIV-1
      infected patients naive to Fuzeon and an integrase inhibitor. In the first cohort phase of
      the study (Phase I), eligible patients received Fuzeon 90 mg subcutaneously (SC) twice daily
      until confirmation of response (min/max = 8/16 weeks). In Phase II, the randomised comparator
      phase of the study, responders were randomized to receive Fuzeon either 90 mg SC twice a day
      or 180 mg SC once a day for a further 16 weeks. Non-responders and virological failures were
      terminated from the study. The anticipated time on study treatment was 3-9 months, and the
      target sample size was 210 individuals.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >=18 years of age

          -  HIV-1 infection

          -  Triple class treatment-experienced, Fuzeon- and integrase-inhibitor naive

          -  GSS >= 3 ; nucleosides excluded

        Exclusion Criteria:

          -  Adverse clinical or laboratory experience >ACTG Grade 4

          -  Untreated infection, intercurrent illness, drug toxicity or other condition
             contraindicating an antiretroviral regimen

          -  Malignancy requiring chemotherapy or radiotherapy
Colchicine in Percutaneous Coronary Intervention
Condition: Coronary Artery Disease; Acute Coronary Syndrome
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Acute Coronary Syndrome
Intervention: Colchicine vs Placebo
Intervention description: Colchicine vs Placebo 1.8 mg PO over 1 hour
Intervention MeSH terms: Colchicine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 714.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: inflammation; percutaneous coronary intervention; coronary artery disease; colchicine

Summary:

      Inflammation in the arteries of the heart may increase the risk of cardiac death. The
      proposed research seeks to identify the potential beneficial role of a safe anti-inflammatory
      medication, colchicine, on reducing damage caused by opening up a blockage in the arteries of
      the heart. With its quick onset of action and excellent safety profile, colchicine may have
      the potential to reduce risk of major adverse events related to the heart. This research also
      seeks to better understand the role of neutrophils, the most common type of inflammatory
      white blood cell in the body, when there is damage to the heart.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Referred for possible PCI

        Exclusion Criteria:

          -  Colchicine use within 1 month

          -  History of colchicine intolerance

          -  Glomerular filtration rate <30mL/minute or on dialysis (due to the need to adjust
             colchicine dose in this setting)

          -  Active malignancy or infection (major confounder with increased inflammatory markers)

          -  History of myelodysplasia (due to suggested cautionary use of colchicine in this
             setting)

          -  High-dose statin load <24 hours prior to procedure (major confounder that is known to
             reduce inflammatory levels in 12 to 24 hours)

          -  Use of anti-inflammatory agents (except aspirin) within 5 halflives of the individual
             drug

          -  Use of strong Cytochrome P450, Family 3, Subfamily A, Polypeptide 4 (CYP3A4) and/or
             P-glycoprotein inhibitors (e.g. ritonavir, ketoconazole, clarithromycin, cyclosporine,
             diltiazem and verapamil, again due to drug interactions)

          -  Unable to consent

          -  Participating in a competing study

          -  Any significant condition or situation that may put the subject at higher risk,
             confound the study results or interfere with adherence to study procedures