bioihbjkbjnl/mcl2 huggingface dataset:
Thiamine as an Adjunctive Therapy in Cardiac Surgery
Condition: Coronary Artery Bypass; Cardiac Surgical Procedures
Intervention: Thiamine; Normal saline solution
Intervention description: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit); 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)
Intervention MeSH terms: Thiamine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 64.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Thiamine; Vitamin B1; Coronary artery bypass grafting; Cardiac surgery; Lactate; Pyruvate dehydrogenase

Summary:

      The main purpose of this pilot study is to test the effects of thiamine (vitamin B1)
      administration before and after major cardiac surgery. Half of patients will receive thiamine
      and the other half will receive placebo.

      The investigators' main hypothesis is that thiamine will improve cellular oxygen consumption
      and lead to decreased levels of post-operative lactate levels and ultimately improved patient
      outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult (≥ 21 years)

          -  Coronary artery bypass grafting (CABG) with or without concomitant valve procedures

          -  EuroSCORE II > 1.5%

        Exclusion Criteria:

          -  Current thiamine supplementation

          -  Known allergy to thiamine

          -  Competing indication for thiamine administration as judged by the clinical team (e.g.,
             alcoholic)

          -  Research-protected populations (pregnant women, prisoners, the intellectually
             disabled)

          -  Emergent or salvage CABG (as defined by the Society of Thoracic Surgeons)

          -  Off-pump surgery (i.e. surgery without cardiopulmonary bypass)
Study to Investigate the Analgesic Efficacy of a Single Dose of AZD1386
Condition: Pain
Intervention: AZD1386; Naproxen; Placebo
Intervention description: 95mg, oral solution, single dose; 500mg, capsule, single dose; AZD1386 Placebo oral solution
Intervention MeSH terms: Naproxen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 103.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Analgesic effect

Summary:

      The primary aim of this study is to investigate if AZD1386 can relieve the pain induced by
      the surgical removal of one lower wisdom-tooth. This will be done by comparing the effect of
      AZD1386 to placebo ("inactive substance") on pain. A number of patients will instead receive
      the common painkiller naproxen for comparison purposes. Rescue medication, acetaminophen,
      will be allowed if a need for additional painkillers would arise. A number of patients will
      receive naproxen as control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients scheduled for surgical removal of one partial or complete impacted mandibular
             third molar.

          -  Provision of signed informed consent.

        Exclusion Criteria:

          -  History of somatic disease/condition, which may interfere with the objectives for the
             study, as judged by the investigator.

          -  Clinically significant illness or clinically relevant trauma within the 2 weeks prior
             to the administration of the investigational product, as judged by the investigator.

          -  A family history of short QT syndrome (SQTS) or sudden cardiac death (SCD) amongst
             first degree relatives

          -  Patients with a body temperature >37.5°C at Visit 2, before start of surgical
             procedures
A Study To Investigate The Safety And Efficacy Of CP- 690,550 In Patients With Moderate And Severe Ulcerative Colitis.
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Intervention: CP- 690 550; CP- 690 550; CP- 690 550; CP- 690 550; placebo
Intervention description: Administration via oral route twice daily for the duration of treatment; Administration via oral route twice daily for the duration of treatment; Administration via oral route twice daily for the duration of treatment; Administration via oral route twice daily for the duration of treatment; Administration via oral route twice daily for the duration of treatment
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 195.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: treatment of ulcerative colitis; CP 690 550

Summary:

      The hypothesis of the study is that at least one dose of CP 690 550 is superior to placebo
      (inactive drug) in inducing remission in patients with moderate to severe ulcerative colitis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be at least 18 years of age at screening

          -  Males and female patients with clinical diagnosis of ulcerative colitis ≥3 months
             prior to entry into the study.

          -  Male and female patients with active currently moderate to severe ulcerative colitis
             defined by Mayo score of ≥6

          -  Patients with endoscopic sub-score of ≥2 on the Mayo score determined within 7 days of
             baseline.

        Exclusion Criteria:

          -  Diagnosis of Crohn's disease or diagnosis of indeterminate colitis

          -  Treatment naive subjects who have not had previous exposure to treatment for
             ulcerative colitis

          -  Patients that are currently receiving immunosuppressants, anti-TNFα therapy or
             interferon
Safety of LEO 43204 for Actinic Keratosis Applied on Face/Chest, Scalp and Trunk/Extremities, Respectively
Condition: Actinic Keratosis
MeSH terms: Keratosis, Actinic; Keratosis
Intervention: LEO 43204
Intervention description: Treatment of actinic keratosis
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 189.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The objective of the trial is to investigate the Safety of LEO 43204 0.018%, 0.037% and 0.1%
      for actinic keratosis applied once daily for three consecutive days on face/chest, scalp and
      trunk/extremities, respectively.
    

Eligibility criteria:

        Inclusion Criteria:

        Subjects with 5 to 20 clinically typical, visible and, discrete, nonhyperkeratotic and
        non-hypertrophic AKs within a selected treatment area of sun-damaged skin on either:

          -  The full face

          -  The full balding scalp

          -  A contiguous area of approximately 250 cm2 on trunk or extremities

        Exclusion Criteria:

        Location of the treatment area (full face, full balding scalp or chest) within 5 cm of an
        incompletely healed wound or within 5 cm of a suspected basal cell carcinoma (BCC) or SCC.

        Previously assigned treatment in this clinical trial or previously participated in a
        clinical trial in the LEO 43204 programme.

        Treatment with ingenol mebutate gel in the selected treatment area within the last 12
        months

        Lesions in the treatment area that have: atypical clinical appearance (e.g. cutaneous
        horns) and/or, recalcitrant disease (e.g., did not respond to cryotherapy on two previous
        occasions).
Vitamin D Levels in Stage IV Colorectal Cancer Patients
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units)
Intervention description: Patients will be given vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units) three times per week until the target vitamin D level of 40 ng/ml is achieved, and vitamin D3 maintenance initiated at 2,000 International Units daily thereafter.
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 45.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Vitamin D; Vitamin D3; colon cancer; rectum cancer; Cholecalciferol; 09-143

Summary:

      The purpose of this study is to find out what effects, good and/or bad, vitamin D blood
      levels has on stage IV colorectal cancer. Tbe doctors want to see if it is possible to
      increase low vitamin D levels into normal range using vitamin D supplements taken by mouth.
      Low vitamin D levels have been associated with worse outcomes in persons who have cancer. Low
      vitamin D may also cause people to have symptoms such as pain and fatigue. We want to see if
      increasing low vitamin D levels will help improve cancer outcomes. Vitamin D is routinely
      repleted in all subjects known to be vitamin D deficient. Therefore, the treatment given
      would be considered standard of care.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with Stage IV (metastatic) colorectal cancer

          -  Baseline 25-hydroxy vitamin D level < 30 ng/ml

          -  Age ≥18 years of age

        Exclusion Criteria:

          -  Current or previous malignancy except adequately treated non-melanoma skin cancer,
             curatively treated in-situ cancer of the cervix, or other solid tumors curatively
             treated with no evidence of disease for > 3 years

          -  Albumin < 3.2

          -  Patients on concurrent chronic steroids, other than those allowed for routine
             antiemetics, or inhaled steroids

          -  Patients receiving phenobarbital, phenytoin, orlistat and cholestyramine

          -  Hypercalcemia (Calcium >10.5 mg/dl)

          -  Calcium x Phosphorus > 70 mg2/dL2
A Safety and Efficacy Study of CNTO1275 in Patients With Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Intervention: CNTO 1275
Intervention MeSH terms: Ustekinumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 249.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Multiple Sclerosis

Summary:

      The purpose of the study is to evaluate the effectiveness and safety of CNTO 1275 in patients
      with Multiple Sclerosis
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have a definite diagnosis of Relapsing remitting Multiple Sclerosis

          -  Have a history of at least 1 of the following:a. A minimum of 2 relapses of MS within
             the previous 2 years but not within the 1-month period prior to screening. b. A
             relapse of MS within the previous 6 months but not within the 1-monthperiod prior to
             screening

        Exclusion Criteria:

          -  Have a CNS disease (eg, CNS lymphoma, systemic lupus erythematous)

          -  Have significant bulbar involvement of MS or other neurologic deficits

          -  Have a decubitus ulcer

          -  Have received immunomodulatory therapies within 3 months of screening
Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias
Intervention: Evolocumab; Ezetimibe; Placebo to Evolocumab
Intervention description: Administered by subcutaneous injection; Administered orally once a day; Administered by subcutaneous injection
Intervention MeSH terms: Ezetimibe; Evolocumab; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 160.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Proprotein convertase subtilisin/kexin type 9 (PCSK9); Cholesterol; High Cholesterol; Raised Cholesterol; Elevated Cholesterol; Statin intolerant; Hypercholesterolemia

Summary:

      The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG
      145), compared with ezetimibe, on percent change from baseline in low-density lipoprotein
      cholesterol (LDL-C) in patients with hypercholesterolemia unable to tolerate an effective
      dose of a statin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female ≥ 18 to ≤ 75 years of age

          -  On a statin or a low dose statin with stable dose for at least 4 weeks

          -  Lipid lowering therapy has been stable prior to enrollment

          -  Fasting triglycerides must be < 400 mg/dL.

          -  Subject not at LDL-C goal

        Exclusion Criteria:

          -  New York Heart Association (NYHA) III or IV heart failure or known left ventricular
             ejection fraction < 30%

          -  Uncontrolled cardiac arrhythmia

          -  Myocardial infarction, unstable angina, percutaneous coronary intervention (PCI),
             coronary artery bypass graft (CABG) or stroke within 3 months prior to randomization

          -  Type 1 diabetes or newly diagnosed type 2 diabetes (HbA1c > 8.5%)

          -  Uncontrolled hypertension
Dose-ranging Efficacy and Pharmacokinetics Study of Intravenous Atorvastatin in Hypercholesterolemic Patients
Condition: Hypercholesterolemia; Dyslipidemias
MeSH terms: Hypercholesterolemia; Dyslipidemias
Intervention: Atorvastatin injection
Intervention description: statin (i.e., 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor) for injection
Intervention MeSH terms: Atorvastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Open-label study will titrate doses of intravenous atorvastatin and monitor respective LDL-C
      levels in hypercholesterolemic patients previously controlled on oral atorvastatin.
    

Eligibility criteria:

        Inclusion Criteria:

          -  On stable dose of daily oral atorvastatin for >= 5 weeks (oral atorvastatin may be
             provided during a lead-in period for subjects not previously taking atorvastatin)

          -  Stable LDL-C confirmed in the previous 7 to 10 days prior to enrollment into the
             treatment phase.

        Exclusion Criteria:

          -  History of myopathy or rhabdomyolysis

          -  Liver disease including current biliary disorders

          -  Positive for HIV, Hepatitis B or Hepatitis C Virus

          -  Abuse of alcohol or non-prescribed drugs

          -  Unstable angina or arrhythmias or a cardiac event in the previous three months

          -  hypothyroidism, diabetes, or hypertension that is not under control

          -  pregnant or plans to be pregnant
Recombinant Human Prolactin for Lactation Induction
Condition: Lactation
Intervention: Recombinant Human Prolactin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Female
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Lactation; Breastfeeding; Prolactin; Primary lactation insufficiency

Summary:

      The purpose of the study is to assess the safety and determine the effects of the hormone
      prolactin on lactation (breast milk production).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy women, aged 18-45 years

          -  Prolactin deficiency due to congenital deficiency, surgery or radiation, or Sheehan's
             syndrome during the current or previous pregnancies, for women who desire to
             breastfeed their infants.

          -  Postpartum at the time of study participation

          -  Milk must fail to come in by 2-4 days after delivery.

          -  Prolactin levels will be less than the lower limit of normal for the assay performed.
             If a subject is postpartum, prolactin levels will be less than the normal range for
             postpartum women (<= 138.0 ± 11.9 ng/mL).

          -  Free T4 index must be normal either on or off thyroid hormone replacement.

          -  Fasting am cortisol or 1 hour Cortrosyn 0.25 mg stimulated cortisol must be normal
             (>18 mg/dL). If it is not normal, subjects must be on glucocorticoid replacement and
             have no symptoms of adrenal insufficiency.

          -  History of normal spontaneous puberty or Tanner stage V breast development after
             previous estrogen replacement therapy.

        Exclusion Criteria:

          -  Current use of medications known to increase or decrease prolactin

          -  Anatomical breast abnormalities

          -  Previous mammoplasty

          -  Breast augmentation

          -  Current use of hormonal contraception

          -  Allergies to mannitol

          -  Medications contraindicated for breastfeeding mothers
Velcade (Bortezomib, PS-341) and Rituximab in Relapsed/Refractory Mantle Cell and Follicular Non-Hodgkin's Lymphoma
Condition: Non-Hodgkin's Lymphoma; Mantle Cell Lymphoma
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin; Lymphoma, Mantle-Cell; Lymphoma, Follicular
Intervention: Velcade; Rituximab
Intervention description: Induction: 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13 & 14.
Maintenance: 1.3 mg/m2 IV day 1 weekly x 2 weeks beginning week 20 and continuing every 6 months until month 23.; Induction: 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13 and 14 prior to Velcade administration.
Maintenance: 375 mg/m2 day 1 weekly x 4 weeks.
Intervention MeSH terms: Rituximab; Bortezomib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Relapsed/Refractory; NHL; Follicular; Mantle Cell; non-Hodgkin's lymphoma

Summary:

      This study will determine the overall response rate and toxicity of rituximab and Velcade in
      combination in patients with relapsed or refractory mantle cell non-Hodgkin's lymphoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed mantle cell or follicular lymphoma

          -  Relapsed or refractory disease

          -  ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, 2 or 3

        Exclusion Criteria:

          -  Pre-existing sensory or motor peripheral neuropathy

          -  No active or untreated CNS (Central Nervous System) lymphoma

          -  History of severe, life-threatening hypersensitivity or infusion reactions prior
             rituximab treatment.
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Canakinumab; Placebo; Metformin
Intervention description: Canakinumab given as single dose IV injection of 0.03 mg/kg, or single dose IV infusion at doses of 0.1 mg/kg 0.3 mg/kg, 1.5 mg/kg or 10 mg/kg.; Placebo to Canakinumab given as single dose IV injection of 0.03 mg/kg, or single dose IV infusion at doses of 0.1 mg/kg 0.3 mg/kg, 1.5 mg/kg or 10 mg/kg.; Participants continued on their stable daily dose of metformin throughout the study
Intervention MeSH terms: Metformin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 231.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes Mellitus; Canakinumab; ACZ885; IL-1B antagonist; metformin; glycemic control; insulin sensitivity

Summary:

      The purpose of this study was to evaluate, in patients with Type 2 Diabetes Mellitus, whether
      Canakinumab can lower Glycosylated hemoglobin / hemoglobin A1c (HbA1c) and/or peak glucose
      levels in response to an oral glucose tolerance test (OGTT).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients aged 18 to 70 years, with type 2 diabetes mellitus
             (non-insulin dependent diabetes) for at least 6 months prior to study start

          -  HbA1c between 7.0 and 9.5%

          -  On stable dose metformin monotherapy

          -  Stable body weight

        Exclusion Criteria:

          -  Poorly controlled type 2 diabetes (very low or very high blood sugar levels, or other
             indicators of poor control)

          -  Acute infections prior to dosing

          -  Patients with type 1 diabetes (insulin-dependent diabetes)

          -  Taking diabetes medication (other than metformin)

        Other protocol-defined inclusion/exclusion criteria may apply
Analgesic Efficacy of Perineural Dexamethasone During Supraclavicular Block for Hand Surgery
Condition: Surgery, Hand
Intervention: Ropivacaine; Dexamethasone; Placebo
Intervention MeSH terms: Dexamethasone; Ropivacaine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether the addition of dexamethasone prolongs
      analgesia when added to long-acting local anesthetic during single-injection supraclavicular
      block for outpatient hand surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients 18 years of age and older

          -  Patients scheduled for elective outpatient hand surgery with same day discharge at the
             Duke Ambulatory Surgery Center

        Exclusion Criteria:

          -  Patients who refuse regional anesthesia

          -  Patients in whom peripheral nerve block is contraindicated

          -  Patients unable to sign/understand consent

          -  Patients with significant language barriers who cannot comply with data collection
             process

          -  Patients with known allergies to local anesthetics

          -  Pregnancy

          -  Chronic pain patients or patients requiring chronic opioid treatment

          -  Patients with a history of diabetes

          -  Patients with contraindication to steroid administration (allergy, chronic steroid
             use)