bioihbjkbjnl/mcl2 huggingface dataset:
A Collaborative Trial in Injectors of Individualized Treatment for Genotype 2/3
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Pegylated interferon alfa 2b; Ribavirin
Intervention description: Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed.; Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses.
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2b
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 93.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hepatitis C; treatment; injection drug users or receiving opiate substitution therapy

Summary:

      This sudy will determine whether shortening treatment for hepatitis C is feasible, safe and
      effective for patients who are current injection drug users or receiving opiate substitution
      therapy and who are responding well to treatment early on.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age

          -  chronic HCV infection

          -  HCV genotype 2/3 infection

          -  active injection drug use (within 24 weeks prior to consent) or currently receiving
             opiate substitution therapy

          -  compensated liver disease

          -  negative pregnancy test (within 24 hours of first dose of study medication)

          -  effective contraception for the duration of the study

          -  written informed consent

        Exclusion Criteria:

          -  previous interferon or ribavirin therapy

          -  investigation drug use in the 6 weeks prior to first dose of study medication

          -  infection with HCV genotypes other than 2/3

          -  HIV infection

          -  HBV infection

          -  ongoing severe psychiatric disease

          -  frequent drug use that is judged by the treating physician to compromise treatment
             safety

          -  standard clinical and medical exclusions for treatment with pegylated interferon alfa
             2b and ribavirin
Xenetix® 350: Comparative Assessment of Image Quality for Coronary CT Angiography
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Intervention: iobitridol; iopromide; iomeprol
Intervention description: single IV injection; Single IV injection; Single IV injection
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 468.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: iodinated contrast media, coronary artery disease

Summary:

      The purpose of this study is to demonstrate the (statistical) non-inferiority of iobitridol
      (Xenetix® 350) when compared to contrast agents with higher iodine concentrations, iopromide
      (Ultravist® 370) and iomeprol (Iomeron® 400) in terms of coronary CT scan evaluability
      (quality and interpretability of images).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female adult patient (having reached legal majority age)

          -  Symptomatic patient suspected for coronary artery disease scheduled for a coronary CT
             angiography

        Exclusion Criteria:

          -  Patient with a heart rate > 65 beats per minute (bpm) and contraindication or
             intolerance to b-blocker administration

          -  Patient with arrhythmia or non-sinus rhythm

          -  Patient with decompensated heart failure

          -  Patient with evidence of ongoing or active clinical instability (suspected or known
             acute myocardial infarction, cardiac shock, acute pulmonary oedema)

          -  Patient who has previously undergone coronary artery bypass graft

          -  Patient who has previously undergone percutaneous transluminal coronary stent
             placement

          -  Patient with artificial heart valve

          -  Patient with known moderate to severe aortic stenosis
1 Week Versus 6 Weeks of Levetiracetam in Surgical Brain Tumor Patients
Condition: Brain Neoplasms; Brain Cancer; Brain Tumors; Cancer of the Brain; Cancer of Brain; Seizure
MeSH terms: Brain Neoplasms; Seizures
Intervention: Levetiracetam
Intervention MeSH terms: Levetiracetam
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 81.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to see if there are any differences in patient reported
      neurotoxicity between patients who receive Levetiracetam tablets for one week after surgery
      to remove a brain tumor versus those who receive Levetiracetam tablets for six weeks after
      surgery. Specifically, we will see if one group has less side effects than the other, and
      whether or not one group has more seizures than the other.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult (>18 years of age and older) patients who have or will have undergone surgical
             resection or biopsy of a supratentorial brain tumor and are able to consent for
             themselves.

          -  Able to be randomized prior to or up to 48 hours after surgery.

        Exclusion Criteria:

          -  No known history of seizure activity.

          -  Pregnant or breastfeeding.

          -  Renal dysfunction (CrCl < 30ml/min).

          -  Beck's Depression Inventory (BDI) ≥14

          -  Allergy to levetiracetam.
Ketamine vs Hydromorphone
Condition: Laparoscopic Gastric Bypass; Obesity; Pain, Postoperative
MeSH terms: Pain, Postoperative
Intervention: Ketamine; Narcotics; pain scale
Intervention description: Anesthesia of only Ketamine; The narcotic group will receive no ketamine but rather a more standard anesthetic; 0-10 pain scale. 0 = no pain and 10 = worst pain
Intervention MeSH terms: Ketamine; Narcotics
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This study will help to determine if investigators can minimize narcotic use in laparoscopic
      gastric bypass patients while maintaining adequate pain control. This will allow
      investigators to minimize the negative side effects of narcotics which is a goal in this
      population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Obese patient presenting for laparoscopic gastric bypass between 18 and 65 years of
             age

        Exclusion Criteria:

          -  Hypersensitivity, allergy, or contraindications to fentanyl, propofol, or ketamine.
Retinol on Human Skin Aging in East Asian Descent
Condition: Intrinsic Aging of Skin
Intervention: Retinol; Placebo
Intervention description: Retinol in the form of vitamin A lotion; Placebo of Retinol
Intervention MeSH terms: Vitamin A
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 110.0
Sex: Female
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      There has been increasing evidence for different rates of natural aging in humans and one of
      the best organs to study human aging is skin. Studies have demonstrated anti-aging effects of
      topical agents (such as creams, gels, lotions, or ointments) and one of them, retinol or
      vitamin A, was shown to decrease fine wrinkling in skin of older individuals. Additionally,
      studies of retinol in humans have largely occurred in white populations and so this study
      aims to focus on skin aging in individuals of East Asian descent as they represent a majority
      of the world population. This study aims to better characterize the molecular basis of
      rejuvenation effects and to potentially discover new topical agents with similar and/or more
      effective preservation of skin youthfulness.
    

Eligibility criteria:

        Inclusion Criteria:

          -  able to provide written informed consent

          -  older group: age between 50 and 75 years

          -  young group: age 18 to 25 years

          -  all four grandparents of Han Chinese, Japanese, Korean descent

          -  body mass index within normal or overweight range

          -  no history of weight loss of >20 lbs within past 5 years

        Exclusion Criteria:

          -  skin condition in the areas of skin biopsy that would obscure results of analysis

          -  topical creams or treatment to arms 2 weeks prior to study baseline visit

          -  individuals with known hypersensitivity to retinoid class of agents (older group only)

          -  prior anti-aging treatments to arms including retinol, microdermabrasion within 2
             weeks of baseline visit

          -  prior laser therapy or surgical procedure to arms

          -  prior radiation or other trauma (extensive burns or abrasions) to arm skin

          -  hormone-based therapy within 4 weeks of enrollment
The Use of Inhaled Aztreonam in Children With a Tracheostomy Tube and Pseudomonas
Condition: Tracheostomy Infection
MeSH terms: Pseudomonas Infections
Intervention: Inhaled Aztreonam
Intervention description: Inhaled antibiotic with anti-pseudomonal properties
Intervention MeSH terms: Aztreonam
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Intervention model description: two-center, prospective, case control clinical trial
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 7 Years
Maximum age: 21 Years
Healthy volunteers: No
Keywords: tracheostomy tube; Pseudomonas aeruginosa

Summary:

      This is a prospective, case-control clinical trial using inhaled Aztreonam (AZLI) in
      pediatric patients with a tracheostomy tube colonized with Pseudomonas aeruginosa. The aim of
      the study is to see if AZLI being taken in a one month on / one month off cycle over the
      course of a year can decrease the need for systemic antibiotics and/or hospitalizations.
    

Eligibility criteria:

        Inclusion Criteria:

          -  o Age: 7 - 21 years old

               -  Currently has a tracheostomy tube

               -  One of previous 3 tracheostomy tube aspirate cultures positive for Pseudomonas
                  aeruginosa

               -  Non-smoker

               -  Ability of parent to provide informed consent, as evidenced by signing a copy of
                  the consent form approved by the Institutional Review Board of the subject's
                  respective study institution.

               -  Written assent for children 7-17 years of age.

               -  Informed consent for children ages 18-21, as evidence by signing a copy of the
                  consent form approved by the Institutional Review Board of the subject's
                  respective study institution.

        Exclusion Criteria:

          -  o History of immunodeficiency

               -  History of cystic fibrosis. Primary ciliary dyskinesia, or bronchiectasis

               -  History of tuberculosis

               -  History of positive culture for Burkholderia cepacia

               -  Use of inhaled antibiotics in the last 6 months
Study of the Golimumab Exposure-Response Relationship Using Serum Trough Levels
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative
Intervention: Golimumab
Intervention description: A biologic agent which acts by antagonising the effects of tumour necrosis factor (TNF) alpha
Intervention MeSH terms: Golimumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 112.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to gain insight into the exposure-response relationship of
      golimumab in moderate-to-severe Ulcerative Colitis (UC).

      Patients commencing induction therapy with golimumab will be enrolled into a prospective
      study and evaluated at three time-points (weeks 6, 10 and 14) for clinical and biochemical UC
      disease activity as well as serum golimumab concentrations and the presence of anti-golimumab
      antibodies. Patients already established on stable golimumab maintenance therapy will be
      enrolled into a cross-sectional study with the same evaluations taken at a single time point.
    

Eligibility criteria:

        Inclusion Criteria for cohort 1:

          -  Aged 18 years or over

          -  Moderate-to-severe UC, defined as:

        SCCAI > 5 and, i. A raised fecal calprotectin (> 59 μg/g) or, ii. A raised CRP (> 5 mg/L)
        or, iii. Endoscopic disease activity Mayo 2 or above, Evaluated within 4 weeks of study
        enrollment

          -  Commencing golimumab treatment

          -  Written informed consent to participate

          -  Sufficient English language skills to understand the patient information sheet and
             consent form

        Inclusion Criteria for cohort 2:

          -  Aged 18 years or over

          -  Receiving golimumab treatment for UC for over 18 weeks (6 injections)

          -  Written informed consent to participate

          -  Sufficient English language skills to understand the patient information sheet and
             consent form

        Exclusion Criteria (cohort 1 only):

          -  Contra-indication to golimumab: tuberculosis or severe infections

          -  Imminent need for colectomy (i.e. colectomy is being planned)

          -  Previous primary non-response to anti-TNF therapy in the opinion of the investigator

          -  Previous treatment with more than one anti-TNF therapy (excluding golimumab)
Additional Insulin for Fat and Protein in Children With Diabetes Study
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Intervention: Insulin, Asp(B28)-
Intervention description: This insulin dose is sometimes given for fat and protein content of food in children using insulin pumps, in prolonged boluses. The investigators are replicating this in children using multiple insulin injections at various times related to the meal
Intervention MeSH terms: Insulin; Insulin Aspart
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 38.0
Sex: All
Minimum age: 6 Years
Maximum age: 18 Years
Healthy volunteers: No

Summary:

      The aims of the study are to see if additional insulin doses for the fat and protein in a
      meal, given at different times, improve blood glucose levels and are safe and acceptable to
      children with Type 1 diabetes using multiple daily insulin injections.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of Type 1 diabetes (for at least a year)

          -  On multiple daily insulin injections, including basal long-acting insulin and
             rapid-acting insulin before each meal.

          -  HbA1c < 75 mmol/mol (9.0%)

          -  Participant and/or parent/legal guardian willing and able to give informed consent for
             participation in the study.

          -  Family have a freezer in which to safely store the test meals.

          -  In the Investigator's opinion, is able and willing to comply with all trial
             requirements.

        Exclusion Criteria:

          -  HbA1c greater than 75 mmol/mol (9.0%)

          -  Child unwilling to agree to second insulin injection at a meal-time

          -  Untreated coeliac disease or other concomitant condition likely to affect BG control

          -  Food allergies (other than controlled Coeliac Disease)

          -  Vegetarians, vegans or patients with religious dietary restrictions (as the standard
             meal contains meat)

          -  Participant taking any glucose-containing medication concurrently
Evaluation of Biocleanse Allografts For ACL Reconstruction
Condition: Anterior Cruciate Ligament Tear
MeSH terms: Anterior Cruciate Ligament Injuries
Intervention: ACL reconstruction control; ACL Biocleanse, surgical
Intervention description: The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.; The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 67.0
Sex: All
Minimum age: 18 Years
Maximum age: 55 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the efficacy of patellar tendon allografts that
      have undergone the BioCleanse™ process.
    

Eligibility criteria:

        Inclusion Criteria:

          -  ACL reconstruction

        Exclusion Criteria:

          -  none
A Clinical Trial of CSL's 2010/2011 Formulation of Enzira® in a Healthy Adult Population
Condition: Influenza
Intervention: CSL's 2010/2011 Formulation of Enzira® Vaccine
Intervention description: 45 mcg of HA antigen in 0.5 mL administered by intramuscular injection into the deltoid region of the arm on Day 0
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 120.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to determine whether the 2010/2011 Formulation Enzira vaccine is
      safe and elicits an immune response to seasonal influenza in healthy adults.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female aged 18 years and older at the time of the first study vaccination.

        Exclusion Criteria:

          -  Known hypersensitivity to a previous dose of influenza virus vaccine or allergy to
             eggs, chicken protein, neomycin, polymyxin, or any components of the Study Vaccine.

          -  Clinical signs of an active infection

          -  Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months
             preceding study entry

          -  Females who are pregnant or lactating
Mechanisms of Immune Reconstitution & Reduced Immune Activation Following Darunavir-based ART
Condition: Human Immunodeficiency Virus Infection
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Intervention: darunavir with ritonavir and fixed-dose viread+emtricitabine daily
Intervention MeSH terms: Ritonavir; Darunavir; Emtricitabine
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 37.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HIV; cardiovascular risk; systemic immune activation

Summary:

      Potent HIV suppression with Darunavir-based antiretroviral therapy (ART) will lead to
      repopulation of gastrointestinal-associated lymphoid tissue (GALT) cluster of differentiation
      (CD)4+ T-cell populations, normalization of systemic immune activation, and improved
      HIV-associated cardiovascular disease (CVD) risk.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing to sign consent form

          -  Naïve to ART (remote ART use >5 years will be considered on a case by case basis)

          -  No known GI or cardiovascular disease

          -  Between the ages of 18 and 60

          -  No active opportunistic infections or therapy for acute OI within 30 days of entry.
             Subjects can be on secondary prophylaxis with a history of AIDS defining illness.

          -  All women of childbearing potential (WCBP) must have a negative urine pregnancy test
             before any of the invasive or radiation exposure study procedures.

          -  Normal population should be free of chronic metabolic conditions such as diabetes,
             hypercholesterolemia, or coronary artery disease

          -  There are no CD4+ T-cell count or HIV plasma viral load restrictions.

        Exclusion Criteria:

          -  Abnormal coagulation parameters (PT>1.2 upper limit of normal (ULN))

          -  Thrombocytopenia (platelet count <50.000 within 6 weeks)

          -  Contra-indications to upper endoscopy or conscious sedation

          -  Anemia (>grade 1 [appendix 1])

          -  Aspirin, ibuprofen, warfarin or other agents that interfere with the coagulation
             cascade are prohibited within 1 week of endoscopy.

          -  Renal insufficiency (serum Creatinine >1.2 ULN)

          -  History of chronic proteinuria that could impact viread use.

          -  Allergy to contrast used for CT angiography

          -  Requirement to take medications that are contraindicated with study ART regimen.