bioihbjkbjnl/mcl2 huggingface dataset:
Treatment of Strongyloides Infection
Condition: Strongyloides Stercoralis Infection; Strongyloidiasis
MeSH terms: Infections; Communicable Diseases; Strongyloidiasis
Intervention: Ivermectin
Intervention description: Ivermectin is an anti-parasitic
Intervention MeSH terms: Ivermectin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Ivermectin; S. stercoralis; parasite; helminth; Filariform; larvae; Baermann technique

Summary:

      The aim of this study is to evaluate the serologic response in patients with S. stercoralis
      infection after treatment with a regimen of two single doses of 200 µg/kg of ivermectin given
      2 weeks apart versus a regimen of two single doses of 200 µg/kg of ivermectin given in two
      consecutive days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age

          -  Positive for Strongyloides serology infection (as determined by ELISA)

        Exclusion Criteria:

          -  Severe intestinal Strongyloides infection

          -  Disseminated Strongyloidiasis infection

          -  Pregnant and breastfeeding women

          -  HTLV-1 co-infection

          -  Patients with indeterminate results on Strongyloides serology

          -  Patients who are immunosuppressed

          -  Unable to read and understand consent form
Use of the Combination of Olmesartan and Hydrochlorothiazide in Essential Hypertension
Condition: Essential Hypertension
MeSH terms: Hypertension; Essential Hypertension
Intervention: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets and placebo; olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets; olmesartan medoxomil/hydrochlorothiazide tablets; olmesartan medoxomil/hydrochlorothiazide tablets
Intervention description: olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) Tablet 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 week; olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks; olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks; olmesartan medoxomil (OM)/hydrochlorothiazide (HCTZ) tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
Intervention MeSH terms: Hydrochlorothiazide; Olmesartan; Olmesartan Medoxomil
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 972.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Moderate-to-Severe Hypertension; Essential Hypertension; Combination Therapy; Fixed-Combination Dose

Summary:

      The study will evaluate the blood pressure lowering effects of two different dosages of the
      combination of olmesartan and hydrochlorothiazide in patients with moderate or severe high
      blood pressure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female Europeans aged 18 years or older with moderate to severe hypertension
             (HTN)

        Exclusion Criteria:

          -  Female patients of childbearing potential pregnant, lactating or planning to become
             pregnant during the trial period.

          -  Patients with serious disorders which may limit the ability to evaluate the efficacy
             or safety of the study medication, including cerebrovascular, cardiovascular, renal,
             respiratory, hepatic, gastrointestinal, endocrine or metabolic, haematological or
             oncological, neurological and psychiatric diseases.

          -  Patients having a history of the following within the last six months:

               -  myocardial infarction,

               -  unstable angina pectoris,

               -  percutaneous coronary intervention,

               -  severe heart failure,

               -  hypertensive encephalopathy,

               -  cerebrovascular accident (stroke) or

               -  transient ischaemic attack.

          -  Patients with clinically significant abnormal laboratory values at screening.

          -  Patients with secondary HTN.
Beta Glucan Assay in Patients Receiving Voriconazole Prophylaxis
Condition: Leukemia; Fungal Infection
MeSH terms: Mycoses
Intervention: Voriconazole; Voriconazole
Intervention description: Starting dose of 400 mg by mouth twice a day for first day, followed by 200 mg by mouth twice a day thereafter.; 6 mg/kg by vein for first dose, followed by 200 mg by mouth twice a day thereafter.
Intervention MeSH terms: Voriconazole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Leukemia; Cancer of the blood; Cancer of the bone marrow; Hematologic malignancy; Invasive fungal infection; Voriconazole; Vfend; antifungal prophylaxis

Summary:

      Objectives:

      To investigate the relationship between the administration of intravenous (IV) and oral
      voriconazole (vori) and the occurrence of false positive (1,3) beta-d- glucan (BG) relative
      to the standard assessment criteria used to diagnose invasive fungal infection in patients
      with hematologic malignancies.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of hematologic malignancy with indication to receive antifungal prophylaxis.

          2. Age >/= 18 years.

          3. Patients must sign an informed consent.

        Exclusion Criteria:

          1. Patients with history of anaphylaxis attributed to azole compounds: voriconazole,
             itraconazole, fluconazole, posaconazole

          2. Patients with clinical or other evidence that indicates that they have proven or
             probable invasive fungal infection prior to enrollment (European Organisation for
             Research and Treatment of Cancer (EORTC) criteria).

          3. Patients with total bilirubin levels > 3 times the upper normal limits (i.e. > 3.0
             mg/dl); or aspartate aminotransferase (AST or SGOT) or alanine aminotransferase (ALT
             or SGPT)> 5 times upper limit normal.

          4. Patients receiving any medication that is contraindicated with the use of
             voriconazole. Voriconazole is contraindicated with the co-administration of the
             following drugs:sirolimus, terfenadine, astemizole, cisapride, pimozide, quinidine,
             ergot alkaloids, rifabutin, rifampin, high-dose ritonavir (400 mg Q12h),
             carbamazepine, long-acting barbiturates, efavirenz (with standard dose vfend and
             efavirenz), St. John's Wort.

          5. Patients currently receiving voriconazole for antifungal prophylaxis.
Sitagliptin Metformin/PPARg Agonist Combination Therapy Add-on (0431-052)
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: sitagliptin; Comparator: Placebo; rosiglitazone; metformin; glipizide
Intervention description: Sitagliptin 100mg tablet each day for 54 weeks. All subjects will be given placebo to sitagliptin for a 2 week period.; Placebo to sitagliptin 100mg tablet each day for 54 weeks.; Subjects taking 4mg or greater rosiglitazone at screening will enter a 6 week stable dose period followed by a 54 week treatment period. Subjects who are taking less than 4mg/day or no rosiglitazone at screening will be titrated to a stable dose of at least 4mg over a a maximum of 8 weeks followed by a dose stable period of up to 12 weeks then a 54 week treatment period. Total treatment will be up to 77 weeks.; Subjects taking 1500mg or greater metformin at screening will enter a 6 week stable dose period followed by a 54 week treatment period. Subjects who are taking less than 1500mg/day or no metformin at screening will be titrated to a stable dose of at least 1500mg over a a maximum of 8 weeks followed by a dose stable period of up to 12 weeks then a 54 week treatment period. Total treatment will be up to 77 weeks.; Subjects not meeting specific glycemic controls during the 54-week treatment period will use glipizide as rescue therapy. Glipizide will be titrated in 5mg doses up to a maximum 40mg each day. (In Canada, the rescue therapy will be a sulfonylurea agent marketed in that country.)
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Rosiglitazone; Glipizide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 262.0
Sex: All
Minimum age: 18 Years
Maximum age: 78 Years
Healthy volunteers: No
Keywords: Type 2 Diabetes Mellitus

Summary:

      A clinical study to determine the safety and efficacy of sitagliptin in patients with Type 2
      Diabetes Mellitus who have inadequate glycemic control on metformin/peroxisome
      proliferator-activated receptor gamma (PPARg) agonist combination therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient has type 2 diabetes mellitus

          -  Patient is inadequately controlled while taking two oral antidiabetic medications

        Exclusion Criteria:

          -  Patient has a history of type 1 diabetes mellitus or history of ketoacidosis

          -  Patient required insulin therapy within the prior 3 months

          -  Patient has been taking Byetta (R) (exenatide) within the prior 3 months
Multicenter Extension Study of Velaglucerase Alfa in Japanese Patients With Gaucher Disease
Condition: Gaucher Disease
MeSH terms: Gaucher Disease
Intervention: velaglucerase alfa
Intervention description: 15-60 U/kg, EOW
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 2 Years
Healthy volunteers: No

Summary:

      Gaucher disease is an inherited deficiency of the lysosomal enzyme glucocerebrosidase (GCB)
      that leads to progressive accumulation of glucocerebroside within macrophages and subsequent
      tissue and organ damage; typically of the liver, spleen, bone marrow, and brain. Type 1
      Gaucher disease affects an estimated 30,000 persons worldwide and is the most common. Type 1
      Gaucher disease does not involve the central nervous system. Patients with Type 2 Gaucher
      disease present with acute neurological deterioration, which leads to early death. Those with
      Type 3 disease typically display a more sub-acute neurological course, with later onset and
      slower progression.

      The primary objective of this study is to evaluate the long-term safety of every other week
      (EOW) dosing of velaglucerase alfa in Japanese patients with Gaucher disease who completed
      study HGT-GCB-087 and elected to continue treatment with velaglucerase alfa.

      Velaglucerase alfa has been developed and approved as an enzyme replacement therapy for Type
      1 Gaucher disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient has completed treatment with EOW velaglucerase alfa through Week 51 of
             study HGT-GCB-087.

          -  Female patients of child bearing potential must agree to use a medically acceptable
             method of contraception at all times during the study.

          -  The patient, the patient's parent(s)or legal guardian(s) has provided written informed
             consent that has been approved by the Institutional Review Board/Independent Ethics
             Committee(IRB/IEC)

          -  The patient must be sufficiently cooperative to participate in this clinical study as
             judged by the Investigator.

        Exclusion Criteria:

          -  The patient has received treatment with any investigational drug, other than
             velaglucerase alfa, or investigational device within 30 days prior to study entry;
             such use during the study is not permitted.

          -  The patient, patient's parent(s), or patient's legal guardian(s) is/are unable to
             understand the nature, scope, and possible consequences of the study.

          -  The patient has a significant comorbidity, as determined by the Investigator that
             might affect study data or confound the study results.

          -  The patient is unable to comply with the protocol as determined by the Investigator.
A Study of MCI-196 in Chronic Kidney Disease Stage V Subjects on Dialysis With Hyperphosphatemia
Condition: Chronic Kidney Disease; Dialysis; Hyperphosphatemia
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperphosphatemia
Intervention: MCI-196; Another Phosphate binder (Sevelamer)
Intervention description: 3g to 15g/day (3 times a day), Tablet, 40 weeks of flexible dose; Current approved dosing recommendations for 12 weeks
Intervention MeSH terms: Sevelamer
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 632.0
Sex: All
Healthy volunteers: No
Keywords: Chronic Kidney Disease; Dialysis; Hyperphosphatemia

Summary:

      This is a PIII multi-center, open-label, flexible dose, long-term safety study, that in
      conjunction with the E07(NCT00416520), E08(NCT00542386) and E09(NCT00451295) studies will
      allow exposure to MCI-196 for up to 52 weeks
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinically stable haemodialysis or peritoneal dialysis treatment.

          -  Stable phosphate control

          -  Stabilised phosphorus diet.

          -  female subjects of child-bearing potential must have a negative serum pregnancy test.

          -  Male subjects must agree to use appropriate contraception.

          -  Completed one of the MCI-196 PIII studies

        Exclusion Criteria:

          -  Current clinically significant medical comorbidities, which may substantially
             compromise subject safety, or expose them to undue risk, or interfere significantly
             with study procedures and which, in the opinion of the Investigator, makes the subject
             unsuitable for inclusion in the study.

          -  Body Mass Index (BMI) <= 16.0 kg/m2 or =>40.0 kg/m2.

          -  Current or a history of significant gastrointestinal motility problems

          -  Positive test for HIV 1 and 2 antibodies.

          -  History of substance or alcohol abuse within the last year.

          -  Seizure disorders.

          -  History of drug or other allergy.

          -  Temporary catheter with active signs of inflammation or infection.

          -  The subject has participated in a clinical study with any experimental medication
             (with the exception of MCI-196 PIII studies) in the last 30days or experimental
             biological product within the 90 days prior to signing of informed consent form.
Efficacy and Safety of MP-424, Peginterferon Alfa-2b and Ribavirin in Non-responder Genotype 2 Hepatitis C Infected Patients
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: MP-424 (generic name:Telaprevir); Ribavirin; Peginterferon alfa-2b
Intervention description: 750mg q8h for 12 weeks; 400 - 1000 mg/day based on body weight for 24 weeks; 1.5mcg/kg/week for 24 weeks
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 10.0
Sex: All
Minimum age: 20 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Genotype 2

Summary:

      This study will evaluate the efficacy and safety of MP-424 with Peginterferon Alfa-2b and
      Ribavirin (RBV) in patients with genotype 2 hepatitis C, who did not respond to previous
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Genotype 2, chronic hepatitis C

          -  Non-responders (patient who did not respond to previous treatment)

          -  Able and willing to follow contraception requirements

        Exclusion Criteria:

          -  Cirrhosis of the liver or hepatic failure

          -  Hepatitis B surface antigen-positive or HIV antibodies-positive

          -  History of, or concurrent hepatocellular carcinoma

          -  History of, or concurrent depression, schizophrenia,; or suicide attempt in the past

          -  Pregnant, lactating, or suspected pregnant patients, or male patients whose female
             partner is pregnant
The Everolimus-Transplant Exit Strategy Trial (E-TEST)
Condition: Kidney Failure, Chronic
MeSH terms: Renal Insufficiency; Kidney Failure, Chronic
Intervention: Everolimus
Intervention description: Everolimus will initially be dosed at 0.75 mg tablet taken orally twice a day. The dose will be adjusted to maintain serum trough concentrations of 5-8 ng/ml.
Intervention MeSH terms: Everolimus
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Chronic allograft failure; Kidney Transplantation

Summary:

      The purpose of this study is to test the safety and effectiveness of everolimus (Zortress®)
      in preventing antibody formation in patients with chronic failing kidney transplants.
      Everolimus (Zortress®) is approved by the U.S. Food and Drug Administration for the
      prevention of rejection in kidney transplant.

      The primary objective for the study is to determine whether conversion of patients with
      chronic renal graft failure approaching dialysis to an everolimus-based regimen will prevent
      allosensitization. The secondary objective will be to determine whether conversion of
      patients with chronic renal graft failure to everolimus (elimination of calcineurin
      inhibitor) will delay the onset of dialysis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  recipient of deceased or living donor kidney transplant

          -  Age 18-75 years (inclusive)

          -  Male or female

          -  renal allograft dysfunction/deterioration evidenced by glomerular filtration rate
             (GFR) less than or equal to 35

          -  Grade 2 or 3 Interstitial fibrosis/tubular atrophy (IF/TA) on renal allograft biopsy
             within 5 years of enrollment

          -  Willing and able to provide informed consent for study participation

        Exclusion Criteria:

          -  Prior solid organ transplant (other than kidney)

          -  History of donor-specific antibody

          -  History of biopsy-proven acute rejection within 1 year prior to enrollment

          -  Proteinuria greater than or equal to 1.5 gm on spot urine protein/creatinine ratio

          -  Evidence of Hepatitis C virus infection (antibody positive or polymerase chain
             reaction(PCR) positive)

          -  Epstein Barr Virus (EBV) or cytomegalovirus (CMV) viremia at the time of enrollment

          -  Subjects receiving belatacept (Nulojix)

          -  Pregnant or nursing (lactating) women

          -  Women of child-bearing potential (WOCBP) who are unwilling or unable to use two
             birth-control methods throughout participation in the study
A Study of Different Titration Schedules of ALKS 5461 in Adults With Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: ALKS 5461
Intervention description: Sublingual tablet taken once daily
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: depression; major depressive disorder; Alkermes; ALKS 5461; samidorphan; buprenorphine

Summary:

      This is a Phase 3 study designed to evaluate the safety and tolerability of two titration
      schedules for ALKS 5461.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Body mass index of 18-40 kg/m2

          -  Have a diagnosis of MDD

          -  Have a current major depressive episode (MDE) lasting 8 weeks to 24 months

          -  Have been treated with an adequate dose of an approved antidepressant during the
             current MDE for at least 8 weeks

          -  Have an inadequate response to current antidepressant treatment

          -  Agree to use an approved method of birth control for the duration of the study

          -  Additional criteria may apply

        Exclusion Criteria:

          -  Currently pregnant or breastfeeding

          -  History of or current infection with Hepatitis B Virus, Hepatitis C Virus or Human
             Immunodeficiency Virus (HIV)

          -  Have experienced hallucinations, delusions, or any psychotic symptoms in the current
             MDE

          -  Have used opioid agonists (eg, codeine, oxycodone, tramadol, or morphine) or opioid
             antagonists (eg, naloxone, naltrexone) within 14 days

          -  Have received electroconvulsive therapy treatment within the last 5 years

          -  Have attempted suicide within the past 2 years

          -  Have a history of intolerance, allergy, or hypersensitivity to buprenorphine or opioid
             antagonists (eg, naltrexone, naloxone)

          -  Have had a significant blood loss or blood donation with 60 days of screening

          -  Additional criteria may apply