bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Contrast Media on Subjects With Stable Reduced Renal Function Undergoing Contrast-Enhanced Computed Tomography
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Intervention: Ioversol 320 mgI/mL; Iodixanol 320 mgI/mL
Intervention description: 125 mL of Ioversol administered in the vein; 125 mL of Iodixanol administered in the vein
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 6.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Renal; Kidney; Contrast Induced Nephropathy

Summary:

      The purpose of this study is to evaluate the contrast-induced nephropathy (CIN) rate in
      subjects randomized to receive either Ioversol or Iodixanol for contrast-enhanced computed
      tomography.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males and females 18 years of age or older

          -  Subjects scheduled for a clinically indicated CECT requiring 40 grams of iodine (125
             mL)

          -  Subjects have an abnormal screening SCr that results in a calculated eGFR of < 60
             mL/min/1.73 m2 using the MDRD formula and acute causes for an elevation in SCr have
             been excluded

          -  Subjects have stable reduced renal function which is defined as an abnormal screening
             SCr measurement with a < 15% difference from the oldest historical SCr measurement
             obtained within the proceeding 1 week to 12 weeks

          -  Subjects must provide written consent and agree to abide by the site and study
             requirements

        Exclusion Criteria:

          -  Subjects previously entered into this study

          -  Subjects on dialysis

          -  Subjects received any investigational drug within 30 days of contrast administration
             or participated in an investigational study within 30 days prior to study enrollment

          -  Subjects have undergone a procedure using iodinated or gadolinium contrast agent
             within 7 days prior to contrast administration, or is scheduled to receive additional
             doses of contrast agents during the 48-72 hour post-study contrast administration

          -  Subjects in acute renal failure or have one or more known causes of acute renal
             failure

          -  Subjects have known or suspected unstable renal function

          -  Subjects scheduled for a surgical intervention or other procedure within 72 hours
             after the contrast administration

          -  Subjects taking NSAIDs (with the exception of ASA) and/or any type of diuretics who
             cannot discontinue these drugs post contrast administration and hold all subsequent
             doses until the 48-72 hour post contrast SCr has been drawn

          -  Subjects taking aminoglycosides

          -  Subjects known to have an organ transplantation

          -  Subjects have severe congestive heart failure (Class III-IV)
The Effects of Increased Inoculum on Oral Rotavirus Vaccine Take and Immunogenicity
Condition: Rotavirus Infection; Vaccine Response Impaired; Vaccine Virus Shedding
MeSH terms: Rotavirus Infections
Intervention: Rotarix, dose 1; Rotarix, dose 2; Placebo (for Rotarix dose 2)
Intervention description: Rotarix, dose 1; Rotarix, dose 2; Sterile water to provide volume equivalent as a second dose of Rotarix
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 220.0
Sex: All
Maximum age: 15 Weeks
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Rotavirus; Oral vaccines; Vaccine underperformance; Vaccine shedding

Summary:

      Rotavirus is the leading cause of diarrhea in children worldwide. Oral rotavirus vaccines
      work remarkably well in high-income countries, but for unclear reasons they underperform in
      low-income countries. A double-blind, randomized control trial will be performed to evaluate
      whether using a higher dose of a currently licensed vaccine (Rotarix, GlaxoSmithKline) can
      improve immune responses among infants in Dhaka, Bangladesh.

      Infants will be randomized 1:1 to receive either a standard or a double dose of Rotarix at 6
      and 10 weeks of life. Infants will be assessed for fecal vaccine shedding and serum
      rotavirus-specific IgA responses to determine vaccine immunogenicity.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Generally healthy infant (as determined by medical officers)

          2. Age 0-7 days at enrolment

          3. Mother willing and able to provide signed informed consent

          4. Mother willing to allow infant to be vaccinated according to study schedule

          5. Mother willing to allow biological specimens, including blood, stool, and saliva, to
             be collected from infant according to study protocol

          6. Mother willing and able to adhere to study schedule

        Exclusion Criteria:

          1. Obvious congenital malformation

          2. Birth weight (if known) or enrolment weight (if birth weight unknown) < 2000 gm

          3. Known immunocompromising condition in infant

          4. Enrolment in other vaccine research trials

          5. Other household member enrolled in this study
Use of Sitagliptin for Stress Hyperglycemia or Mild Diabetes Following Cardiac Surgery
Condition: Diabetes Mellitus, Type 2; Hyperglycemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Hyperglycemia
Intervention: Sitagliptin; Placebo
Intervention description: Sitagliptin prior to hospital discharge and 6 weeks following discharge.; Patients are reandomized to Sitagliptin or placebo for 6 weeks post-operatively
Intervention MeSH terms: Sitagliptin Phosphate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 8.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a randomized controlled trial to determine the safety and efficacy of Sitagliptin in
      patients with stress hyperglycemia or mild diabetes following cardiac surgery. Patients will
      receive Sitagliptin or placebo. Sitagliptin may be of particular use in this patient
      population due to the effects on hepatic glucose production (a major feature of SH), safety
      (lack of contra-indications for heart failure or renal failure and no hypoglycemia), and
      tolerability. The secondary objective of this study is to determine whether the management of
      patients with persistent insulin requirements following cardiac surgery differs among
      patients with stress hyperglycemia or mild diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Either of the following: Mild Diabetes Mellitus or Stress Hyperglycemia

          -  AND:

          -  Cardiac Surgery

          -  Insulin Requirement between 8-30 units subcutaneous on post-op day 3 or later off
             pressors, off enteral feeding, extubated OR glucose >150 mg/dL at least twice in a 24
             hour period (>4 hours apart) and otherwise not requiring basal insulin

        Exclusion Criteria:

          -  use of pressors, mechanical ventilation, or enteral or parenteral feeding within
             previous 12 hours

          -  glucocorticoids in doses exceeding the equivalent of Prednisone 10 mg/day within the
             previous 48 hours

          -  left ventricular assist device

          -  percutaneous or laparoscopic surgery

          -  end stage renal disease

          -  end stage liver disease

          -  history of pancreatitis

          -  type 1 diabetes

          -  pregnancy

          -  unable to give consent in english

          -  no phone

          -  prisoners

          -  less than 18 years of age
Comparison of Excision Versus Punch Incision in the Treatment of Epidermal Cysts
Condition: Epidermal Cyst
MeSH terms: Cysts; Epidermal Cyst
Intervention: Excisional surgery of epidermal cyst; Punch incision of epidermal cyst
Intervention description: Traditional extirpation of cyst en toto; removal of cyst first with incisional effort with a punch biopsy tool
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Epidermal cyst; Epidermoid cyst; Sebaceous cyst; Pilar cyst

Summary:

      The purpose of this trial is to compare two standard of care treatments for removing
      epidermal cysts. Surgical excision removes the entire cyst but requires a larger hole in the
      skin. A punch incision makes a smaller hole through which the cyst can be removed. The
      trial's purpose is to determine if one method is better than another in terms of recurrence,
      infection, or other side effects.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult 18 years or older

          -  Epidermal cyst 1-3 cm in diameter on the trunk

        Exclusion Criteria:

          -  Infected cyst requiring systemic antibiotics

          -  Pregnant females

          -  Unable to return to clinic for suture removal

          -  Previous excision of target cyst
A Noninferiority Study of Alglucosidase Alfa Manufactured at the 160 L and 4000 L Scales in Treatment Naïve Patients With Infantile-Onset Pompe Disease
Condition: Pompe Disease (Infantile-Onset); Glycogen Storage Disease Type II (GSD II); Glycogenosis 2; Acid Maltase Deficiency
MeSH terms: Glycogen Storage Disease Type II; Glycogen Storage Disease
Intervention: alglucosidase alfa; alglucosidase alfa
Intervention description: Intravenous (IV) infusion of alglucosidase alfa (4000 L material) 20 mg/kg every other week (QOW); IV infusion of alglucosidase alfa (160 L material) 20 mg/kg QOW.
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Maximum age: 12 Months
Healthy volunteers: No

Summary:

      A study to demonstrate comparable safety, efficacy, and pharmacokinetics (PK) of
      alglucosidase alfa manufactured at the 160 litre (L) and 4000 L scales in participants who
      had been diagnosed with infantile-onset Pompe disease. Participants were treated with
      alglucosidase alfa 160 L scale product in the United States (US) and 4000 L scale product in
      the regions outside the US.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The participant's parent/legal guardian was willing and able to provide signed
             informed consent.

          -  The participant might be less than or equal to 12 months of age.

          -  The participant might have documented GAA enzyme deficiency from blood, skin, or
             muscle tissue.

          -  The participant might be naïve to treatment with alglucosidase alfa.

        Exclusion Criteria:

          -  The participant was cross-reactive immunologic material negative.

          -  The participant required invasive ventilator support at the time of enrollment.

          -  The participant had decompensated clinical heart failure.

          -  The participant had a major congenital abnormality, excluding cardiac hypertrophy.

          -  The participant had a clinically significant organ disease (excluding the signs and
             symptoms of Pompe disease).

          -  The participant was currently receiving any investigational product.

          -  The participant was participating in another clinical study.

          -  The participant and/or the patient's parent/legal guardian was unable to adhere to the
             requirements of the study.
A Study of Tarceva (Erlotinib) in First Line in Patients With Locally Advanced or Metastatic Lung Adenocarcinoma With EGFR Mutations
Condition: Non-Squamous Non-Small Cell Lung Cancer
MeSH terms: Adenocarcinoma; Adenocarcinoma of Lung
Intervention: erlotinib [Tarceva]
Intervention description: 150 mg orally daily, until disease progression, unacceptable toxicity or withdrawal due to any reason
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, non-randomized, one-arm study will evaluate the safety and efficacy of
      Tarceva (erlotinib) as single-agent first-line treatment in patients with locally advanced or
      metastatic non-small cell lung cancer who show epidermal growth factor receptor (EGFR)
      activating mutations. Patients will receive Tarceva 150 mg orally daily until disease
      progression or unacceptable toxicity occurs.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, >/= 18 years of age

          -  Histologically or cytologically documented, inoperable, locally advanced, recurrent or
             metastatic (Stage IIIB or Stage IV) lung adenocarcinoma

          -  Non-small cell lung cancer with an EGFR activating mutation

          -  Patients must have evidence of disease, but measurable disease is not mandatory

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Adequate renal and liver function

        Exclusion Criteria:

          -  Prior chemotherapy or other systemic anti-cancer treatment. Neoadjuvant/adjuvant
             chemotherapy is allowed if completed within 6 months prior to enrolment. Prior
             radiochemotherapy is allowed if completed more than 6 months before start of study
             treatment

          -  Prior therapy with systemic anti-tumour therapy with HER1/EGFR inhibitors

          -  Any other malignancies within 5 years, except for adequately treated carcinoma in situ
             of the cervix or basal or squamous cell skin carcinoma

          -  Brain metastasis or spinal cord compression not yet definitely treated with surgery
             and/or radiation

          -  Patients unable to take oral medication or requiring intravenous alimentation, with
             prior surgical procedures affecting absorption or active peptic ulcer disease

          -  Any significant ophthalmologic abnormality, especially those likely to increase the
             risk of corneal epithelial lesions; the use of contact lenses is not recommended
             during the study

          -  Pregnant or breast-feeding women
An Efficacy, Safety and Effects on Quality of Life of Tramadol/Paracetamol as Add-on Therapy in Chronic Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Tramadol/Paracetamol (APAP); Non-Tramadol/APAP
Intervention description: Celecoxib 200 milligram (mg) once daily for 4 weeks and fixed dose combination of Tramadol 37.5 mg/Paracetamol 325 mg thrice daily for 4 weeks as add-on therapy.; Celecoxib 200 mg alone once daily for 4 weeks.
Intervention MeSH terms: Acetaminophen; Tramadol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 473.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Osteoarthritis; Celecoxib; Tramadol; Paracetamol

Summary:

      The purpose of this study is to evaluate the efficacy, safety and effects on Quality of Life
      (QOL) of tramadol/paracetamol (APAP) as an add-on therapy (medication taken in addition to
      another medication) in Filipino participants with chronic (lasting a long time)
      osteoarthritis (disorder, which is seen mostly in older persons, in which the joints become
      painful and stiff).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosed with chronic osteoarthritis of knee or hip for greater than (>) or equal to
             (=) 1 year (based on the American College of Rheumatology (ACR) diagnostic criteria
             for osteoarthritis), who are experiencing at least moderate osteoarthritis pain (>=50
             millimeter [mm] in 100 mm Visual Analog Scale [VAS])

          -  On any Cyclooxygenase - 2 (COX-2) inhibitors for at least 2 weeks preceding the study

          -  Women with childbearing potential must have negative pregnancy test

          -  Women of child bearing potential must agree to use accepted methods of contraception

          -  Participant has signed the written informed consent form

        Exclusion Criteria:

          -  Participants taking Monoamine oxydase (MAO) inhibitors, neuroleptics or drugs for
             seizures

          -  Severe hepatic impairment (the impaired ability of the liver to fulfill its role in
             metabolism)

          -  On maintenance tramadol and/or paracetamol(APAP)

          -  On sedative hypnotics, short-acting analgesics, topical medications and anesthetics,
             and/or muscle relaxants

          -  Pregnant, lactating or breastfeeding participants
Efficacy and Safety of Valsartan Versus Amlodipine in Postmenopausal Women With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Intervention: Valsartan 320 mg; Amlodipine 10 mg; Hydrochlorothiazide
Intervention description: Patients received 160 mg valsartan for 4 weeks. Patients were then up-titrated to receive either 320 mg valsartan for the following 8 weeks.; Patients received 5 mg amlodipine for four weeks. Patients were then up-titrated to receive 10 mg amlodipine for the following 8 weeks.; At Week 12, patients who did not meet target Blood Pressure for both Systolic Blood Pressure < 140 mmHg and Diastolic Blood Pressure < 90 mmHg were eligible to receive 12.5 mg open-label Hydrochlorothiazide for the following 26 weeks.
Intervention MeSH terms: Amlodipine; Valsartan; Hydrochlorothiazide
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 125.0
Sex: Female
Minimum age: 50 Years
Maximum age: 75 Years
Keywords: hypertension; postmenopausal; valsartan; amlodipine; hydrochlorothiazide

Summary:

      The purpose of this study is compare treatment with valsartan with the possible addition of a
      diuretic, hydrochlorothiazide, on high blood pressure with the drug amlodipine with the
      possible addition of a diuretic, hydrochlorothiazide. In particular, the effect of treatment
      on the stiffness of the blood vessels will be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Postmenopausal women

          -  Mild to moderate hypertension

          -  Statin therapy or LDL≤ 4.1 mmol/L

        Exclusion Criteria:

          -  Severe hypertension

          -  LDL > 4.1 mmol/L if not taking anti-hyperlipidemic medication

          -  Certain hormonal therapy

          -  History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart
             rhythm

          -  Liver, kidney, or pancreas disease

          -  Diabetes

          -  Raynaud's disease or any other significant peripheral vascular disease

          -  Allergy to certain medications used to treat high blood pressure

        Other protocol-defined inclusion/exclusion criteria may apply.
Testosterone Replacement in Men With Diabetes and Obesity
Condition: Hypogonadism
MeSH terms: Hypogonadism
Intervention: testosterone; placebo
Intervention description: intramuscular every 2 weeks; saline intramuscular every 2 weeks
Intervention MeSH terms: Testosterone
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 137.0
Sex: Male
Minimum age: 30 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: diabetes; hypogonadism; obesity; testosterone; insulin sensitivity; inflammation

Summary:

      The purpose of this study is to examine the effect of having testosterone deficiency in men
      with diabetes and with obesity. The study will also evaluate the effect of testosterone
      therapy. This will be done by comparing the changes in several body response indicators
      following treatment with testosterone in diabetic or obese-non diabetic men with low
      testosterone levels and comparing them to diabetic or obese-non diabetic men with low
      testosterone who are not treated with testosterone.
    

Eligibility criteria:

        Inclusion Criteria:

          -  T2D arm: Males with age 30-65 years

          -  Obese non-diabetic arm: Obese non-diabetic males with age 30-65 years

        Exclusion Criteria:

        1)Coronary event or procedure(myocardial infarction, unstable angina, coronary artery
        bypass, surgery or coronary angioplasty) in the previous twelve weeks; 2) PSA > 4ng/ml;
        3)Hemoglobin A1c > 8%; 4)h/o prostate carcinoma; 5)Hepatic disease (transaminase > 3 times
        normal) or cirrhosis; 6)Renal impairment (defined as GFR<30); 7)HIV or Hepatitis C positive
        status; 9)Participation in any other concurrent clinical trial; 10)Any other
        life-threatening, non-cardiac disease; 11)Use of over the counter health supplements which
        contain androgens; 12)Use of an investigational agent or therapeutic regimen within 30 days
        of study; 13)prostate nodule or severe enlargement on digital rectal examination; 14)Use of
        testosterone currently or in the past 4 months; 15)Hematocrit > 50%; 16)History of
        untreated severe obstructive sleep apnea(defined as apnea-hypopnea index ≥30); 17)symptoms
        suggestive of severe BPH; 18)Congestive heart failure, class III or IV; 20)Known to have
        anemia secondary to iron, B12 or folic acid deficiency; 21)bone marrow disorder such as
        myelodysplasia or aplastic anemia; 22) currently suffering from symptomatic depression,
        with or without treatment; 23) history of severe depression in the past which needed
        hospitalization; 24)currently suffering from foot ulcer, significant periodontal disease or
        any other chronic infectious condition; 25)planning to have children. 26) Subjects on
        testosterone or with testosterone replacement in the past 4 months will be excluded.