bioihbjkbjnl/mcl2 huggingface dataset:
Triple-Therapy in Patients With HCV Genotype 3 Who Previously Failed Treatment
Condition: Hepatitis C
MeSH terms: Hepatitis C; Hepatitis
Intervention: Boceprevir
Intervention description: All patients will receive a 4-week lead-in with Peginterferon and Ribavirin therapy, followed by 24 weeks of Pegetron 1.5microg/kg + weight-based ribavirin + boceprevir 800mg tid. HCV RNA (Cobas TaqMan) will be measured at baseline and at treatment weeks 4, 6,8,12,16,20,24 and 28, and post-treatment weeks 12 and 24 (to obtain SVR-12 and SVR-24 results).
Intervention MeSH terms: Protease Inhibitors
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Boceprevir; Hepatitis C Genotype 3

Summary:

      The purpose of this study is to test the potential antiviral efficacy of triple-combination
      therapy with Peginterferon α-2b + ribavirin + boceprevir (PRB) in patients with HCV genotype
      3 who previously failed Peginterferon α + ribavirin (non-responders or relapsers).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects will be eligible for the study if they meet the following inclusion criteria:

               1. 18 years of age or older

               2. Infected with HCV genotype 3 (mixed genotypes are NOT permitted)

               3. Have received at least 12 weeks of previous treatment with peginterferon-α +
                  ribavirin

               4. Detectable serum HCV-RNA

               5. No significant co-morbid conditions

               6. Liver biopsy is not necessary

               7. Cirrhotic patients will be eligible to participate if Child-Pugh class A (maximum
                  15% of subjects)

        Exclusion Criteria:

          -  Subjects will be excluded from participation in this study if the following conditions
             are present:

               1. Significant comorbidities: uncontrolled psychiatric conditions including severe
                  depression, cardiovascular, respiratory, renal or metabolic conditions, active
                  carcinoma.

               2. Active substance abuse within the past 12 months

               3. Co-infection with hepatitis B or HIV

               4. Decompensated cirrhosis (Child-Pugh class B or C)

               5. Significant cytopenia - any of the following: platelets <80 x 109/L, neutropenia
                  <1.2 x 103/L, Hb <120 g/l for men or 110 g/l for women

               6. Lack of informed consent

               7. Previous null-responders (<2 log10 decrease at week 12 with previous PR therapy)
Study Evaluating Bazedoxifene/Conjugated Estrogens Combinations In Postmenopausal Women
Condition: Endometrial Hyperplasia; Osteoporosis
MeSH terms: Osteoporosis; Endometrial Hyperplasia; Hyperplasia
Intervention: Bazedoxifene/Conjugated Estrogen; Bazedoxifene/Conjugated Estrogen; CE 0.45 mg/MPA 1.5mg; Placebo
Intervention description: Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.; Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.; Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.; Subjects will take 1 capsule orally, once daily, at approximately the same time each day continuously for the duration of the study.
Intervention MeSH terms: Bazedoxifene; Estrogens; Estrogens, Conjugated (USP)
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 1083.0
Sex: Female
Minimum age: 40 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Endometrium; Uterus; Menopause

Summary:

      The purpose of this study is to determine whether bazedoxifene/conjugated estrogens
      combinations are effective for the prevention of endometrial hyperplasia and for the
      prevention of osteoporosis in postmenopausal women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Generally healthy, postmenopausal women, aged 40 to less than 65 years

          -  Intact uterus

          -  At least 12 months of spontaneous amenorrhea, OR 6 months spontaneous amenorrhea with
             follicle-stimulating hormone (FSH) levels > 40 mIU/mL.

        Exclusion Criteria:

          -  Use of oral estrogen-, progestin-, androgen-, or SERM-containing drug products within
             8 weeks before screening (12 weeks for the osteoporosis substudy)

          -  A history or active presence of clinically important medical disease

          -  Malabsorption disorders
Tanezumab In Osteoarthritis Of The Hip Or Knee
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: tanezumab 10 mg; tanezumab 5 mg; oxycodone; placebo
Intervention description: tanezumab 10 mg one dose at weeks 0 and 8; tanezumab 5 mg one dose at weeks 0 and 8; oxycodone CR, 10-40 mg q12h; placebo
Intervention MeSH terms: Oxycodone; Tanezumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 614.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: monoclonal antibody; RN624; PF-04383119; nerve growth factor; OA; pain; arthritis

Summary:

      The purpose of the study is to test the efficacy and safety of 2 doses of tanezumab compared
      to oxycodone CR and placebo in patients with osteoarthritis
    

Eligibility criteria:

        Inclusion Criteria:

          -  osteoarthritis of the knee or hip according to Kellgren-Lawrence x-ray grade of 2

        Exclusion Criteria:

          -  pregnancy or intent to become pregnant

          -  BMI greater than 39

          -  other severe pain, significant cardiac, neurological or psychiatric disease
Laparoscopic-Assisted Resection or Open Resection in Treating Patients With Rectal Cancer
Condition: Colorectal Cancer
MeSH terms: Rectal Neoplasms
Intervention: Open laparotomy and rectal resection; Laparoscopic-assisted rectal resection
Intervention description: Patients undergo open laparotomy and rectal resection.; Patients undergo laparoscopic-assisted rectal resection.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 486.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: rectal cancer; adenocarcinoma of the rectum

Summary:

      This study is being done to compare two types of surgery currently used for rectal cancer.
      The two types of surgery are laparoscopic-assisted rectal resection and open laparotomy
      rectal resection. Although laparoscopic-assisted rectal resection is being used for rectal
      cancer in some medical centers, the effectiveness of this type of surgery compared to open
      surgery is unknown. The study will compare the safety and effectiveness of the surgeries,
      recovery from surgery in the hospital, overall recovery from surgery and cancer outcome.
    

Eligibility criteria:

        Eligibility Criteria:

          1. Histologic diagnosis of adenocarcinoma of the rectum (≤ 12 cm from the anal verge)

          2. T3, N0, M0, T1-3, N1-2, M0 disease as determined by pre-neoadjuvant therapy CT scans
             and pelvic MRI or transrectal ultrasound. Patients with T4 disease are not eligible.

          3. Completion of pre-operative 5FU based chemotherapy and/or radiation therapy.
             Capecitabine may be substituted for 5FU.

          4. Age ≥ 18 years

          5. ECOG (Zubrod) Performance Status ≤ 2

          6. Body Mass Index (BMI) ≤ 34

          7. No evidence of conditions that would preclude use of a laparoscopic approach (eg,
             multiple previous major laparotomies, severe adhesions)

          8. No systemic disease (cardiovascular, renal, hepatic) that would preclude surgery. No
             other severe incapacitating disease:

               -  ASA IV: A patient with severe systemic disease that is a constant threat to life.
                  OR

               -  ASA V: A moribund patient who is not expected to survive without the operation.

          9. No concurrent or previous invasive pelvic malignancy (cervical, uterine and rectal)
             within five years prior to registration

         10. No history of psychiatric or addictive disorders or other conditions that, in the
             opinion of the investigator, would preclude the patient from meeting the study
             requirements.

        NOTE: Incompetent patients are not eligible for this trial.
A 17-Week Trial To Assess Pregabalin For The Treatment Of Nerve Pain Due To Spinal Cord Injury
Condition: Neuralgia; Spinal Cord Injuries
MeSH terms: Spinal Cord Injuries; Neuralgia; Wounds and Injuries
Intervention: placebo; pregabalin
Intervention description: Placebo; Pregabalin capsules taken twice daily up to 17 weeks (150-600 mg/day)
Intervention MeSH terms: Pregabalin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 220.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Pain; central neuropathic pain

Summary:

      The purpose of this study is to evaluate if pregabalin relieves nerve pain associated with
      spinal cord injury compared to placebo (pill that contains no active medicine). This study
      will also evaluate the safety of pregabalin in this patient population.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects with nerve pain after Spinal cord injury (traumatic, diving, ischemic and
             after removal of benign tumors (except meningioma and fibromas)

          -  Pain has to be chronic(continuous for at least 3 months or intermittent for at least 6
             months

          -  Pain score at least 4 in 4 of 7 days prior to receive treatment.

        Exclusion Criteria:

          -  Pregabalin use in the last 60 days, prior intolerance to pregabalin

          -  Creatinine clearance <60 mL/min.

          -  White blood cell count <2500/mm3; neutrophil count <1500/mm3; platelet count <100 x
             103/ mm3.

          -  Abuse of drugs or alcohol

          -  Unstable medial conditions

          -  Clinically significant abnormal electrocardiogram (ECG).

          -  Presence of severe pain associated with conditions other than spinal cord injury that
             could confound the assessment or self-evaluation of pain due to spinal cord injury.
Safety and Efficacy of Dose Conversion From Vicodin® to Buprenorphine Transdermal System (Butrans™) in Subjects With OA Pain
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Intervention: Buprenorphine transdermal patch
Intervention description: Buprenorphine transdermal patch applied for 7-day wear.
Intervention MeSH terms: Buprenorphine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 204.0
Sex: All
Minimum age: 40 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Osteoarthritis, opioid, transdermal

Summary:

      The objective of this study is to evaluate the safety and efficacy of dose conversion from
      hydrocodone/ acetaminophen (Vicodin®) to the buprenorphine transdermal system (Butrans™) in
      subjects with osteoarthritis pain of the hip or knee. The double-blind treatment intervention
      duration is 2 weeks during which time supplemental analgesic medication will be allowed.
    

Eligibility criteria:

        Inclusion Criteria:

        - osteoarthritis of the hip or knee taking a regularly scheduled regimen of hydrocodone/
        acetaminophen for their osteoarthritis OA pain.

        Exclusion Criteria:

          -  currently have condition requiring a stable regimen of acetaminophen (APAP).

          -  a history of chronic conditions, other than OA of the hip or knee joints, requiring
             frequent, intermittent analgesic therapy.

        Other protocol-specific exclusion/inclusion criteria may apply.
The CANTATA-D Trial (CANagliflozin Treatment and Trial Analysis - DPP-4 Inhibitor Comparator Trial)
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Placebo; Canagliflozin; Sitagliptin; Metformin immediate release
Intervention description: One matching placebo capsule orally (by mouth) once daily for 26 weeks with protocol-specified doses of metformin immediate release.; One 100 mg or 300 mg over-encapsulated tablet orally once daily for 52 weeks with protocol-specified doses of metformin immediate release.; One 100 mg over-encapsulated tablet orally once daily for 52 weeks (sitagliptin 100 mg arm) or once daily beginning at Week 26 until Week 52 (placebo/sitagliptin arm). Sitagliptin will be given with protocol-specified doses of metformin immediate release.; The patient's stable dose of metformin immediate release background therapy should be continued throughout the study.
Intervention MeSH terms: Metformin; Sitagliptin Phosphate; Canagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 1284.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Type 2 diabetes mellitus; Canagliflozin; Placebo; Sitagliptin; Januvia; Metformin Immediate Release (IR); Hemoglobin A1c

Summary:

      The purpose of this study is to evaluate the efficacy and safety of canagliflozin compared
      with sitagliptin and placebo in patients with type 2 diabetes mellitus who are receiving
      treatment with metformin monotherapy (i.e., treatment with a single drug) and have inadequate
      glycemic (blood sugar) control.
    

Eligibility criteria:

        Inclusion Criteria:

          -  All patients must have a diagnosis of T2DM and be currently treated with metformin IR

          -  Patients in the study must have a HbA1c between >=7 and <=10.5%

          -  Patients must have a fasting plasma glucose (FPG) <270 mg/dL (15 mmol/L)

        Exclusion Criteria:

          -  History of diabetic ketoacidosis, type 1 diabetes mellitus (T1DM), pancreas or beta
             cell transplantation, diabetes secondary to pancreatitis or pancreatectomy, or a
             severe hypoglycemic episode within 6 months before screening
An Extension to Study AZA PH GL 2003 CL 001 Allowing for Continuation of Azacitidine Treatment in Patients With Myelodysplastic Syndromes (MDS)
Condition: Myelodysplastic Syndromes
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Intervention: Azacitidine
Intervention description: Azacitidine was injected subcutaneously (SC) for 7 days. The 7-day dosing was repeated every 28 days with dose adjustments allowed. The initial dose during the primary study was 75mg/m^2/day.
Intervention MeSH terms: Azacitidine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Myelodysplastic Syndromes; MDS

Summary:

      At the conclusion of study AZA PH GL 2003 CL 001 (NCT00071799), eligible participants could
      be enrolled in an optional extension phase in order to continue treatment with azacitidine
      until it became commercially available; the continued treatment was for ethical and safety
      reasons only and not to provide additional efficacy data.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants were considered eligible if they had been randomized to azacitidine
             treatment in the primary study and were receiving azacitidine at the time of study
             closure, had completed 12 months of treatment and observation in the primary study,
             and had signed the informed consent document for the extension phase of the study.

          -  See study: AZA PH GL 2003 CL 001 for a list of inclusion criteria for the primary
             study.

        Exclusion Criteria:

          -  None specific to the extension phase of the study

          -  See study: AZA PH GL 2003 CL 001 for a list of exclusion criteria for the primary
             study.
Study of Idalopirdine in Patients With Mild - Moderate Alzheimer's Disease Treated With Donepezil
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Placebo; Idalopirdine
Intervention description: Once daily, matching placebo capsules, orally; Once daily, encapsulated tablets, orally
Intervention MeSH terms: (2-(6-fluoro-1H-indol-3-yl)-ethyl)-(3-(2,2,3,3-tetrafluoropropoxy)benzyl)amine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 933.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No

Summary:

      To establish efficacy of idalopirdine as adjunctive therapy to donepezil for symptomatic
      treatment of patients with mild-to-moderate Alzheimer's disease (AD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient has a knowledgeable and reliable caregiver.

          -  The patient is an outpatient.

          -  The patient has probable AD.

          -  The patient has mild to moderate AD.

          -  Stable treatment with donepezil.

          -  The patient, if a woman, must have had her last natural menstruation ≥24 months prior
             to baseline, OR be surgically sterile.

          -  The patient, if a man, agrees to protocol-defined use of effective contraception if
             his female partner is of childbearing potential, OR must have been surgically
             sterilised prior to the screening visit.

        Exclusion Criteria:

          -  The patient has evidence of any clinically significant neurodegenerative disease, or
             other serious neurological disorders other than AD.

          -  The patient has a Diagnostic and Statistical Manual of Mental Disorders, 4th edition,
             Text Revision (DSM-IV-TR) Axis I disorder other than AD.

          -  The patient has evidence of clinically significant disease.

          -  The patient's donepezil therapy is likely to be interrupted or discontinued during the
             study.

          -  The patient is currently receiving memantine or has taken memantine within 2 months
             prior to screening.

        Other inclusion and exclusion criteria may apply.
A Study of Avastin (Bevacizumab) and Xeloda (Capecitabine) as Maintenance Treatment in Patients With Metastatic Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: Bevacizumab; Capecitabine; Oxaliplatin
Intervention description: Bevacizumab was supplied as a solution in single-use vials.; Capecitabine was supplied as film-coated tablets.; Oxaliplatin was supplied as a lyophilized powder in vials.
Intervention MeSH terms: Bevacizumab; Capecitabine; Oxaliplatin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 123.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This 2 arm study assessed the efficacy and safety of maintenance treatment with Avastin
      (bevacizumab) + Xeloda (capecitabine), after initial treatment with Xeloda + oxaliplatin +
      Avastin, in patients with metastatic colorectal cancer. Patients were randomized into one of
      2 groups to receive 1) Xeloda + oxaliplatin + Avastin until disease progression or 2) Xeloda
      + oxaliplatin + Avastin for 6 3-week cycles, followed by Xeloda + Avastin until disease
      progression. Xeloda was administered at a dose of 1000 mg/m^2 orally twice a day on days 1-14
      of each cycle, oxaliplatin at a dose of 130 mg/m^2 intravenously (iv) on day 1 of each cycle,
      and Avastin at a dose of 7.5 mg/kg iv on day 1 of each cycle.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients, ≥ 18 years of age.

          -  Histologically confirmed colon or rectal cancer, with unresectable metastatic disease.

          -  At least 1 measurable lesion.

          -  Outpatient, with Eastern Cooperative Oncology Group (ECOG) Performance Status = 0-1.

        Exclusion Criteria:

          -  Previous treatment with Avastin.

          -  Previous systemic treatment for advanced or metastatic disease.

          -  clinically significant cardiovascular disease.

          -  Daily chronic treatment with high doses of aspirin (> 325 mg/day) or non-steroidal
             anti-inflammatory drugs.