bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate Efficacy in Subjects With Esophageal Cancer Treated With Nivolumab and Ipilimumab or Nivolumab Combined With Fluorouracil Plus Cisplatin Versus Fluorouracil Plus Cisplatin
Condition: Various Advanced Cancer
Intervention: Nivolumab; Ipilimumab; Cisplatin; Fluorouracil
Intervention description: Specified dose on specified days; Specified dose on specified days; Specified dose on specified days; Specified dose on specified days
Intervention MeSH terms: Fluorouracil; Nivolumab; Ipilimumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 970.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to compare how long subjects with esophageal cancer live
      overall or live without disease progression after receiving nivolumab and ipilimumab or
      nivolumab combined with fluorouracil plus cisplatin versus fluorouracil plus cisplatin
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have histologically confirmed squamous cell carcinoma or adenosquamous cell
             carcinoma of esophagus

          -  Male or Female at least 18 years of age

          -  Must have esophageal cancer that cannot be operated on, or treated with definitive
             chemoradiation with curative intent, that is advanced, reoccurring or has spread out

          -  Must have full activity or, if limited, must be able to walk and carry out light
             activities such as light house work or office work

          -  Must agree to provide tumor tissue sample, either from a previous surgery or biopsy
             within 6 months or fresh, prior to the start of treatment in this study

        Exclusion Criteria

          -  Presence of tumor cells in the brain or spinal cord which are symptomatic or require
             treatment

          -  Active known or suspected autoimmune disease

          -  Any serious or uncontrolled medical disorder or active infection

          -  Known history of positive test for human immunodeficiency virus (HIV) or known
             acquired immunodeficiency syndrome (AIDS)

          -  Any positive test result for hepatitis B or C indicating acute or chronic infection
             and/or detectable virus

        Other protocol defined inclusion/exclusion criteria apply
RCT Comparing Methadone and Buprenorphine in Pregnant Women
Condition: Opioid Related Disorders; Pregnancy; Opioid Dependence
MeSH terms: Opioid-Related Disorders
Intervention: Methadone; Buprenorphine
Intervention description: daily oral dosing 20-140 mg; sl daily 2-32 mg
Intervention MeSH terms: Buprenorphine; Methadone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 175.0
Sex: Female
Minimum age: 18 Years
Maximum age: 41 Years
Healthy volunteers: No
Keywords: opiate addiction; opiate dependence; substance abuse; addiction; substance addiction; pregnancy; buprenorphine; methadone; fetal; neonatal; post-partum

Summary:

      Children born to women who abuse drugs have a high risk of being born with birth defects and
      developmental problems. Methadone is a drug that is commonly used for treating opioid
      dependence. However, its use by a pregnant woman can cause severe withdrawal symptoms in a
      newborn because of the prenatal exposure. The purpose of this study is to evaluate the
      effectiveness of buprenorphine, another drug, versus methadone in reducing withdrawal
      symptoms in children born to opioid-dependent women.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Current opioid dependence

          -  Current opioid use, as determined by a urine drug test

          -  Pregnant with a single child with a gestational age of 6 to 30 weeks, as determined by
             a sonogram

        Exclusion Criteria:

          -  Current medical condition that would make study participation dangerous, as determined
             by study physician

          -  Diagnosed with an acute, severe psychiatric illness

          -  Current SCID I-E module diagnosis of benzodiazepine or alcohol abuse

          -  Use of alcohol or benzodiazepines in the 30 days prior to study entry, as determined
             by the Addiction Severity Index

          -  Pending legal action that may prohibit or interfere with study participation
AZD0585 Phase III Long-term Study in Japan
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Intervention: AZD0585; AZD0585 placebo
Intervention description: 1g soft capsule; 1g soft capsule
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 383.0
Sex: All
Minimum age: 20 Years
Maximum age: 130 Years
Healthy volunteers: No

Summary:

      This study is a randomised, double-blind phase III long-term study to evaluate efficacy and
      safety of 12 weeks and 52 weeks of AZD0585 administration compared to placebo in patients
      with hyperlipidemia accompanied by hypertriglyceridemia .
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Japanese men or women, ≥20 years of age.

          -  Subjects must meet all of the following criteria;

               1. Fasting triglyceride level: average of Visit 2 and Visit 3 must be in the range
                  150 - 499 mg/dL

               2. %TG change between Visit 2 and Visit 3 must be within 30%

               3. %LDL-C change between Visit 2 and Visit 3 must be within 25%

        Key Exclusion Criteria:

          -  Allergy or intolerance to omega-3 fatty acids and omega-3-acid ethyl esters.

          -  Known lipoprotein lipase impairment or deficiency, or Apolipoprotein C-II deficiency
             or familial dysbetalipoproteinemia.

          -  Current or history of pancreatitis.

          -  Type I diabetes mellitus, use of insulin, or haemoglobin A1c >10% at Visit 1.
Prescription Opioid Addiction Treatment Study (POATS)
Condition: Opiate Dependence; Substance-related Disorders; Opioid-related Disorders
MeSH terms: Substance-Related Disorders; Opioid-Related Disorders
Intervention: Standard Medical Management (SMM) of Prescription Opiate Abuse; Enhanced Medical Management (EMM) of Prescription Opiate Abuse
Intervention description: Standard Medical Management in Phase 1 will consist of one hour-long initial visit; one individual 15-20 minute visit later in Week 1; one individual 15-20 minute visit per week through the end of Week 4; one 15-20 minute SMM visit at Week 6 and at Week 8. And in Phase 2, one 30-60 minute initial visit; one 15-20 minute follow-up visit later in Week 1; one individual session (15-20 minutes) per week through Week 12. In addition, participants in Phase 1 will receive BUP/NX at between 8 to 32mg/day; tapering to zero between weeks three and four. Those referred to Phase 2 will receive up to 32 mg/day for three months tapering to zero during month four.; Enhanced Medical Management in Phase 1 will consist of SMM plus two individual sessions with a counselor per week (45 minutes each) through Weeks 1-4, and one 45-minute counseling visit at Week 6 and at Week 8. And in Phase 2, EMM will consist of the SMM plus two individual sessions with a counselor per week (45 minutes each) during Weeks 1-6 and one individual session with a counselor per week (45 minutes each) during Weeks 7-12. In addition, participants in Phase 1 will receive BUP/NX at between 8 to 32mg/day; tapering to zero between weeks three and four. Those referred to Phase 2 will receive up to 32 mg/day for three months tapering to zero during month four.
Intervention MeSH terms: Opiate Alkaloids
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 653.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Opiate Analgesic Dependence

Summary:

      The purpose of this study is to determine whether treatment outcome for subjects dependent on
      prescription opioid analgesics can be improved by adding individual drug counseling to the
      prescription of buprenorphine/naloxone with standard medical management. This will be
      examined during: a) an initial four-week treatment with taper; b) a 12-week stabilization
      treatment for those who do not respond successfully to the initial treatment; and c) a
      long-term follow-up assessment at 1.5 years, 2.5 years, and 3.5 years after treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years old or older

          -  Physically dependent on opioids

          -  Meet DSM-IV criteria for opioid dependence

        Exclusion Criteria:

          -  Known allergy or sensitivity to buprenorphine or naloxone

          -  Unstable psychiatric disorder

          -  Pregnant or lactating females

          -  Liver function test results greater than 5 times the upper limit of normal range
Understanding the Response to Fesoterodine Through Genetic Evaluation in the Elderly (URGE)
Condition: Urge Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Urge
Intervention: Fesoterodine Fumarate
Intervention description: FDA approved anticholinergic medication used for treatment of urge urinary incontinence
Intervention MeSH terms: Fesoterodine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 61.0
Sex: Female
Minimum age: 50 Years
Healthy volunteers: No
Keywords: overactive bladder; urge urinary incontinence; pharmacogenetics

Summary:

      Urge urinary incontinence, characterized by unpredictable and embarrassing large volume urine
      leakage, is a major health issue for elderly women, as it is incredibly common and
      significantly impairs quality of life. Although anticholinergic medications are the most
      common therapy, the investigators are unable to predict an individual's response to a
      particular drug in terms of both effectiveness and side effects. Through genetic evaluation,
      the investigators have the potential to personalize and optimize drug therapy for millions of
      elderly women suffering from urge incontinence.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Women ≥ 50 years

          -  ≥ 3 UUI episodes on a 3-day voiding diary

          -  Urge-predominant incontinence, >50% of total incontinence episodes

          -  No history of failure to fesoterodine

          -  2-week washout period if currently on an anticholinergic for UUI

          -  Willingness to avoid off-protocol UUI therapy during the study period

          -  Post Void Residual (PVR) <150 mL

        Exclusion Criteria:

          -  Contraindications to fesoterodine (e.g., bladder outlet obstruction, narrow angle
             glaucoma, myasthenia gravis, severe hepatic or renal impairment)

          -  Inability to complete study-related items and visits - i.e., cognitive impairment
             based on Mini-Cog test score (exclude if score of 0 or 1-2 (Abnormal))

          -  Urinary retention requiring catheterization

          -  Symptomatic, untreated urinary tract infection not resolved prior to starting
             fesoterodine

          -  Botulinum toxin injection for UUI in the last year

          -  Current therapy with peripheral or sacral neuromodulation

          -  Neurologic conditions that may affect urinary function (stroke, multiple sclerosis,
             spinal cord injury, Parkinson's disease)

          -  Women taking potent CYP3A4 inhibitors
Safety and Efficacy Study of Albiglutide in Type 2 Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: albiglutide; albiglutide uptitration; placebo
Intervention description: albiglutide weekly injection; albiglutide uptitration at week 12; matching albiglutide placebo weekly injection
Intervention MeSH terms: rGLP-1 protein; Glucagon-Like Peptide 1
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 309.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: placebo; albiglutide; monotherapy; diabetes

Summary:

      The purpose of this study is to determine whether albiglutide is effective in the treament of
      patients with type 2 diabetes.
    

Eligibility criteria:

        Inclusion Criteria:

          -  type 2 diabetes

          -  BMI 20-45kg/m2 inclusive

        Exclusion Criteria:

          -  females who are pregnant, lactating, or <6 weeks post-partum

          -  CHF NYHA class III-IV
Efficacy and Safety of IV Diclofenac (DIV075V)for Pain After Elective Orthopedic Surgery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Intervention: IV Diclofenac; IV ketorolac; Placebo
Intervention description: IV Diclofenac q6h; IV ketorolac q6h; Placebo q6h
Intervention MeSH terms: Diclofenac; Ketorolac
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 277.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No

Summary:

      This study will compare repeated intermittent IV dosing of diclofenac in patient with
      moderate to severe post-surgical pain from elective orthopedic surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Scheduled within three weeks of the screening visit to undergo elective orthopedic
             surgery.

          -  Moderate to severe pain within 6 hours following completion of the required surgery.

        Exclusion Criteria:

          -  Chronic pain conditions.

          -  Chronic disease or recent cardiovascular events.

          -  Known allergy or hypersensitivity to the active compounds or any of the excipients
             used in the study.
ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Treatment-Naïve and Treatment-Experienced, Non-Cirrhotic Asian Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection
Condition: Hepatitis C Virus (HCV)
MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Intervention: ombitasvir/paritaprevir/ritonavir and dasabuvir; Placebo for ombitasvir/paritaprevir/ritonavir and dasabuvir
Intervention description: Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet; Placebo for ombitasvir/paritaprevir/ritonavir and dasabuvir
Intervention MeSH terms: Ritonavir
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 650.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: HCV Infection; Chronic Hepatitis C Virus; Hepatitis C Virus (HCV) Genotype 1b

Summary:

      This is a study to evaluate ABT 450/r/ABT-267 and ABT-333 in treatment-naïve and
      treatment-experienced Asian adults with subgenotype 1b chronic HCV without cirrhosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Chinese, South Korean, and Taiwanese descent with full Chinese, South Korean, and
             Taiwanese parentage

          -  Chronic hepatitis C virus (HCV) infection prior to study enrollment.

          -  Screening laboratory result indicating HCV subtype 1b (GT1b) infection.

          -  Per local standard practice, documented absence of cirrhosis.

          -  Participant has never received antiviral treatment (including interferon [IFN]-based
             therapy [alpha, beta or pegylated (peg)IFN] with or without RBV) for HCV infection
             (treatment-naïve participant) or participant must have documentation that they met the
             definition of one of the following categories (treatment experienced participant):
             Non-responder or Relapser

          -  Participant has plasma HCV RNA level > 10,000 IU/mL at Screening.

        Exclusion Criteria:

          -  HCV genotype performed during screening indicating unable to genotype or infection
             with any HCV genotype other than GT1b.

          -  Positive test result at Screening for hepatitis B surface antigen (HBsAg), or
             hepatitis B virus DNA (HBV-DNA) > Lower Limit of Quantification (LLOQ) if HBsAg
             negative, or anti-human immunodeficiency virus antibody (HIV Ab) positive.

          -  Any current or past clinical evidence of cirrhosis.

          -  Any primary cause of liver disease other than chronic HCV infection.

          -  Screening laboratory analyses showing abnormal kidney, hepatic, or hematologic
             function.

          -  Use of known strong inducers of cytochrome P450 3A (CYP3A) or strong inhibitors of
             cytochrome P450 3A (CYP2C8) within 2 weeks or within 10 half-lives, whichever is
             longer, of the respective medication/supplement prior to study drug administration.
One-Year Trial of Oral Ziprasidone in Bipolar Patients With Metabolic Syndrome
Condition: Bipolar Disorder
MeSH terms: Metabolic Syndrome; Bipolar Disorder
Intervention: Ziprasidone HCL (oral)
Intervention description: Ziprasidone Hydrochloride 20 to 80 mg administered orally twice a day (40-160 mg total daily dose) for up to 1 year.
Intervention MeSH terms: Ziprasidone
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Ziprasidone; Bipolar Disorder; Metabolic Syndrome

Summary:

      The purpose of this study is to explore the impact of Ziprasidone HCl on the distribution of
      metabolic syndrome (MS) risk factors in a population of Bipolar patients presenting with
      glucose intolerance, dyslipidemia and/or elevated waist circumference associated with their
      current antipsychotic medication.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subject must present at least 2 of the following risk factors of MS at screening:
             Elevated waist circumference: >102 cm in men and >88 cm in women; Elevated
             triglycerides (TGs): ≥1.7 mmol/L (≥150 mg/dL); Reduced HDL-Cholesterol: <1.03 mmol/L
             (<40 mg/dL) in men and <1.3 mmol/L (<50 mg/dL) in women; Elevated fasting glucose: ≥
             5.6 mmol/L.

          -  According to the clinical judgment of the investigator, the risk factors for MS have
             developed in close temporal relationship to starting an antipsychotic medication.

          -  Substitution to a less metabolically disruptive antipsychotic medication is considered

        Exclusion Criteria:

          -  Subjects with contraindication(s) to the use of Ziprasidone according to Canadian
             prescribing information.

          -  Subjects with a history of treatment resistance.

          -  Subjects with any medical condition (e.g. pre-existing diabetes, pre-existing
             dyslipidemia, thyroid pathology) or taking any concomitant medication (e.g. topiramate
             or other weight loss-promoting agents, hypoglycemic agents, hypolipemic agents), that
             may confound the evaluation of the study drug.

          -  Body mass index ≥ 40 at baseline.
Aromatase Inhibitors in the Treatment of Male Infertility
Condition: Obesity; Oligospermia
MeSH terms: Infertility; Oligospermia
Intervention: Anastrozole; Placebo
Intervention description: 1 mg qd for 4 months; Placebo Comparator
Intervention MeSH terms: Anastrozole
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 20.0
Sex: Male
Minimum age: 16 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Obesity; Low sperm count; Male infertility

Summary:

      Obesity is associated with an increase in blood levels of estrogen. Estrogen or "female
      hormone" is believed to have a negative effect on sperm production. Aromatase inhibitors such
      as anastrozole work to decrease the production of estrogen and increase testosterone in the
      body. By decreasing the level of estrogen, sperm production should improve. In this study,
      the investigators will try to determine the benefit of anastrozole in obese men and follow
      pregnancy outcomes.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male partner of a couple presenting for infertility work up after one year of
             unprotected intercourse

          2. Moderate oligozoospermia (defined as mean sperm count ≤ 20 × 106/mL and ≥ than 3 ×
             106/mL) of at least two separate occasions spanning a minimum of two weeks

          3. Obese men BMI ≥ 30

          4. FSH and LH levels < 10 mIU/mL

        Exclusion Criteria:

          1. Severe Oligozoospermia: Sperm count < than 3 × 106/mL, including azoospermia

          2. Age less than 18 or greater than 65 years

          3. Pyospermia or leukospermia: defined by white blood cells ≥ 1 million leukocytes per
             milliliter of semen

          4. Cryptorchidism

          5. Vasectomy reversal

          6. Regular use of tobacco products

          7. BMI < 30

          8. Use of anabolic steroids or testosterone replacement

          9. All patients with abnormal initial liver function tests "AST or ALT" will be excluded
             form the study