bioihbjkbjnl/mcl2 huggingface dataset:
Gemcitabine/Cisplatin for Resected Pancreas Cancer: Establishing the Role of ERCC1 in Treatment Decision
Condition: Pancreatic Neoplasms; Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Gemcitabine; Cisplatin
Intervention description: Standard of care chemotherapy and dosage
Dose - 1000 mg/m²
Schedule - Days 1 and 15; Q 28 days; Dose - 50 mg/m²
Schedule - Days 1 and 15; Q 28 days
Intervention MeSH terms: Gemcitabine
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: Pancreatic Neoplasms; Pancreatic cancer

Summary:

      The purpose of this study is to investigate if the investigators can use a specific marker in
      the pancreatic tumor itself to determine which patients will benefit from receiving
      combination chemotherapy of gemcitabine and cisplatin after undergoing resection of a
      pancreatic cancer.

      The investigators will also investigate if there is any benefit to receiving both
      chemotherapy drugs as opposed to only gemcitabine after undergoing complete resection of the
      tumor.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Adults (≥ 18 years) at the time of signing informed consent form

          2. Understand and voluntarily sign informed consent form

          3. Able to adhere to study visit schedule and other protocol requirements

          4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

          5. Absolute neutrophil count ≥ 1500 / mm³

          6. Platelet count ≥ 100,000 / mm³

          7. Resectable pancreatic adenocarcinoma

          8. Pathologic diagnosis of pancreatic adenocarcinoma

        Exclusion Criteria:

          1. Any serious medical condition, laboratory abnormality, or psychiatric illness that
             would prevent the subject from signing informed consent form

          2. A history of renal dysfunction (serum creatinine > 1.8 mg/dL)

          3. Presence of active infection

          4. Untreated second malignancy

          5. Pregnant or breast feeding females (A urine pregnancy test will be obtained in all
             women of child-bearing age at initial screening prior to study enrollment and
             administration of chemotherapy.)
Study of Pharmacodynamics of LIK066 in Overweight and Obese Women With Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome
MeSH terms: Polycystic Ovary Syndrome; Overweight; Syndrome
Intervention: LIK066; Placebo
Intervention description: LIK066 tablets for oral administration; Placebo tablets matching LIK066 tablets, for oral administration
Intervention MeSH terms: Licogliflozin
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 29.0
Sex: Female
Minimum age: 18 Years
Maximum age: 40 Years
Healthy volunteers: No
Keywords: Polycystic ovary syndrome; PCOS; hyperandrogenism; insulin resistance; overweight; obesity

Summary:

      The purpose of the study was to evaluate whether LIK066 can be developed for the treatment of
      polycystic ovary syndrome (PCOS) in overweight and obese women.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  PCOS (diagnosed as clinical or biochemical hyperandrogenism, amenorrhea or
             oligomenorrhea and exclusion of other causes of hyperandrogenism.

          -  Overweight/obese female subjects with BMI of 28 - 45 kg/m^2, inclusive, and stable
             weight +/- 3 kg over previous 3 months

          -  Subjects must use non-hormonal methods of contraception during the study.

        Key Exclusion Criteria:

          -  Subjects with exogenous causes of hirsutism

          -  Menstruation in the 30 days prior to screening or treatment

          -  Pregnant or nursing (lactating) women

          -  Use of prohibited medications

          -  Preexisting medical condition which may significantly alter the absorption,
             metabolism, or excretion of the study drug, or which may jeopardize the subject in
             case of participation in the study
Assess the Efficacy and Safety of Exenatide SR for the Prevention of Diabetes After Kidney Transplantation
Condition: Pre Diabetes
MeSH terms: Diabetes Mellitus; Prediabetic State
Intervention: Exenatide SR
Intervention description: Exenatide SR 2 mg subcutaneous (SQ) weekly
Intervention MeSH terms: Exenatide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Kidney Transplant

Summary:

      Researchers are trying to determine if an anti-diabetes medication, called Exenatide SR, is
      well tolerated in kidney transplant patients with elevated blood glucose levels, and if it's
      effective in preventing diabetes.
    

Eligibility criteria:

        Inclusion criteria:

          -  Recipients of solitary kidney transplants (i.e. not combined liver-kidney,
             pancreas-kidney etc.)

          -  At 4 months after transplantation: Prediabetes (fasting blood glucose 100-125 mg/dl;
             or 2 hr glucose 140-199 or HgbA1c 5.7-6.4%)

        Exclusion criteria:

          -  Diabetes pre-transplantation

          -  Diabetes at 4 months

          -  <18 years of age

          -  eGFR <30 ml/min (estimated by MDRD equation from serum creatinine)

          -  Active acute cellular rejection including borderline (If treated and resolved, these
             patients can be included)

          -  BK nephropathy active

          -  History of pancreatitis, pre-existing moderate-to-severe gastroparesis, liver
             cirrhosis or family /personal history of multiple endocrine neoplasia 2 or medullary
             thyroid cancer

          -  Pregnant or breastfeeding women. Female Subject must be either:

               -  Of non-child bearing potential: Post-menopausal (defined as at least 1 year
                  without any menses) prior to screening , or documented surgically sterile or
                  status post-hysterectomy

               -  Or if childbearing potential, agree not to try and become pregnant during the
                  study for at least 90 days after the final study drug administration. And have a
                  negative serum or urine pregnancy test. And if heterosexually active, agree to
                  consistently use two forms of highly effective birth control.

          -  Hypersensitivity to Exenatide
Study Evaluating SKI-606 (Bosutinib) In Philadelphia Chromosome Positive Leukemias
Condition: Chronic Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Philadelphia Chromosome
Intervention: Bosutinib
Intervention description: Part 1, starting dose 400 mg oral, daily dosing in the dose-escalation component.
Part 2, 500 mg oral, continuous, daily dosing.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 571.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Leukemia; tyrosine kinase inhibitor; philadelphia chromosome; Myeloid; Philadelphia Positive

Summary:

      This is an open-label, continuous daily dosing, two-part safety and efficacy study of SKI-606
      (bosutinib) in Philadelphia chromosome positive leukemias (Ph+). Part 1 is a dose-escalation
      study in chronic phase Chronic Myelogenous Leukemia (CML) subjects to establish the maximum
      tolerated dose (MTD) in this subject population. Part 2 has begun after the completion of
      Part 1 and after a dose has been established for the compound in chronic phase subjects. Part
      2 is a study of the the efficacy of 500mg daily oral SKI-606 (bosutinib) in patients with all
      phases of Ph+ CML and Ph+ Acute Lymphocytic Leukemia (ALL). The protocol will test the
      hypotheses that oral daily dosing of bosutinib at 500 mg will attain (1) Major Cytogenetic
      Response (MCyR) in chronic phase CML patients and (2) Overall Hematological Response (OHR) in
      advanced leukemia patients. Each phase of the disease will be evaluated as a separate cohort.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Ph+ CML or Ph+ ALL who are primarily refractory to full-dose imatinib (600 mg), have
             disease progression/relapse while on full-dose imatinib, or are intolerant of any dose
             of imatinib.

          -  At least 3 months post stem cell transplantation

          -  Able to take daily oral capsules/tablets reliably

        Exclusion Criteria:

          -  Subjects with Philadelphia chromosome, and bcr-abl negative CML

          -  Overt leptomeningeal leukemia

          -  Subjects without evidence of leukemia in bone marrow (extramedullary disease only)
The Effect of Bevacizumab (Avastin) on Pterygium
Condition: Pterygium
MeSH terms: Pterygium
Intervention: local injection of bevacizumab
Intervention description: Upon enrollment into the study: - initial injection of bevacizumab, a 1 week post-injection visit,and monthly visits thereafter for a total of 6 months. At the 1-month and 3-month visit post-injection visit, an additional bevacizumab injection will be offered if pterygium regression has not occurred. All injections of bevacizumab will consist of injecting 0.1mL of a 2.5mg/0.1mL concentration of bevacizumab into the head of the pterygium.
Intervention MeSH terms: Bevacizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: All
Minimum age: 19 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether local injection of bevacizumab might halt
      and or cause regression of pterygium growth. This may enable earlier treatment and prevention
      of pterygium growth into the patient's line of sight thereby limiting the need for surgery
      and improving quality of life for patients with pterygia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  19 years of age and older

          -  Diagnosis of pterygia

          -  healthy enough to make scheduled follow-up visits

        Exclusion Criteria:

          -  Women of childbearing potential and males who plan to father a child during their
             participation in the study will be excluded from the study.
Phase IIb Safety and Efficacy Study of Different Oral Doses of BAY94-8862 in Subjects With Worsening Chronic Heart Failure and Left Ventricular Systolic Dysfunction and Either Type 2 Diabetes Mellitus With or Without Chronic Kidney Disease or Chronic Kidney Disease Alone
Condition: Heart Failure
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Heart Failure; Ventricular Dysfunction, Left; Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Finerenone (BAY94-8862); Placebo; Inspra (eplerenone)
Intervention MeSH terms: Eplerenone
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1066.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Heart Decompensation

Summary:

      To assess a new drug, BAY94-8862, given orally at different doses, to evaluate whether it was
      safe and can help the well-being of patients with worsening chronic heart failure and either
      type II diabetes with or without chronic kidney disease or kidney disease alone. These
      treatment doses were compared to eplerenone, another marketed drug approved to treat heart
      failure.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and women aged 18 years and older. The lower age limit may be higher if legally
             required in the participating country

          -  Women of childbearing potential can only be included in the study if a pregnancy test
             is negative and if they agree to use adequate contraception when sexually active

          -  Subjects with worsening chronic heart failure requiring emergency presentation to
             hospital and treatment with intravenous diuretics at hospital

          -  Subjects with clinical diagnosis of chronic heart failure (CHF) either ischemic or non
             ischemic, New York Heart Association (NYHA) functional class II-IV

          -  Subjects with type 2 diabetes mellitus and / or

          -  Subjects with 30 mL/min/1.73m^2 </= eGFR </= 60 mL/min/1.73m^2 (MDRD, Modification of
             Diet in Renal Disease Study Group) at screening

          -  Left ventricular ejection fraction (LVEF) </= 40%

          -  Blood potassium </= 5.0 mmol/L at screening

          -  Systolic blood pressure >/= 90 mmHg without signs and symptoms of hypotension at the
             screening visit

        Exclusion Criteria:

          -  Acute de-novo heart failure or acute inflammatory heart disease, e.g. acute
             myocarditis

          -  Acute coronary syndrome (ACS) in last 30 days prior to screening

          -  Cardiogenic shock

          -  Valvular heart disease requiring surgical intervention during the course of the study

          -  Stroke or transient ischemic cerebral attack in the last 3 months prior to the
             screening visit

          -  Concomitant treatment with any mineralocorticoid receptor antagonist (MRA), renin
             inhibitor, or potassium-sparing diuretic
Treatment of Myelodysplastic Syndrome (MDS) With Cytokine-Immunotherapy for Low-Risk MDS
Condition: Myelodysplastic Syndrome
MeSH terms: Preleukemia; Myelodysplastic Syndromes; Syndrome
Intervention: Erythropoietin; Cyclosporin A; G-CSF; Prednisone
Intervention description: 40,000 units injected under the skin (SQ) weekly; 300 mg (tablets) by mouth daily for 6 months; 300 mcg injected under the skin (SQ) two times per week; 60 mg per day for 7 days, taper over 1 month
Intervention MeSH terms: Cyclosporine; Prednisone; Epoetin Alfa; Darbepoetin alfa; Cyclosporins
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 15.0
Sex: All
Healthy volunteers: No
Keywords: Myelodysplastic Syndrome; MDS; Erythropoietin; Darbepoetin alfa; Aranesp; Erythropoiesis stimulating protein; G-CSF; Filgrastim; Neupogen; Prednisone; Cyclosporin A; Sandimmune; CYA; Cyclosporine

Summary:

      Objectives:

      Primary: To evaluate the response rate of total cytokine-immunotherapy for low-risk
      myelodysplastic syndromes (MDS).

      Secondary: To evaluate response duration, survival and side effects of the treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients with MDS and </= 10% blasts or International Prognostic Scoring System (IPSS)
             low or intermediate 1. No prior intensive chemotherapy or high-dose ara-C (>/= 1g/m2).
             Prior cytokines, biologic therapies, targeted therapies, or single agent chemotherapy
             allowed. Procrit, G-CSF are allowed before therapy. Patients with blasts < 5% must
             have an indication for therapy, such as transfusion needs, symptomatic anemia or Hb <
             11g/dl, platelets < 100 x 10 9/L, or granulocytes < 10 9/L.

          2. Performance 0-2 (Eastern Cooperative Oncology Group (ECOG)). Adequate liver function
             (bilirubin of < 2mg/dl) and renal function (creatinine < 2mg/dl). Adequate cardiac
             functions (New York Heart Association (NYHA) cardiac III-IV excluded)

          3. Signed informed consent

        Exclusion Criteria:

          1. Nursing and pregnant females are excluded. Women of childbearing potential should
             practice effective methods of contraception. Should a woman become pregnant or suspect
             she is pregnant while participating in this study, she should inform her treating
             physician immediately.

          2. Patients with active and uncontrolled infections.
Study of Silodosin to Facilitate Passage of Urinary Stones
Condition: Ureteral Calculi; Kidney Stones; Urolithiasis
MeSH terms: Kidney Calculi; Nephrolithiasis; Urolithiasis; Urinary Calculi; Ureteral Calculi; Ureterolithiasis; Calculi
Intervention: silodosin; placebo
Intervention description: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks; one placebo capsule orally, once daily, with food for up to 4 weeks
Intervention MeSH terms: Silodosin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 239.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ureteral calculi; renal colic; ureteral stones; kidney stones; medical expulsive therapy

Summary:

      The purpose of this study is to assess if patients treated with silodosin will have a higher
      spontaneous passage rate of their ureteral stone than those treated with placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  At least 18 years of age or older

          -  Male or a non-pregnant, non-lactating female using adequate means of birth control, if
             not menopausal

          -  Have radiopaque unilateral ureteral calculus ≥4mm and ≤10mm in any location of the
             ureter

        Exclusion Criteria:

          -  Multiple ureteral calculi, or a solitary kidney, or refractory renal colic, or a
             non-opaque calculus, or active urinary tract infection, or severe hydronephrosis

          -  History of previous ureteral surgery or ureteral stricture on affected side

          -  History of any of the following conditions: myasthenia gravis, myopathy, spina bifida,
             spinal cord injury, autonomic nervous system disorder, fibromyalgia, breast cancer

          -  Moderate to severe renal impairment or severe liver insufficiency

          -  History of significant postural hypotension

          -  Is receiving medication(s) which preclude safe participation in the study or that may
             produce a confounding effect on the variables under study

          -  History of allergy to alpha-blockers or oxycodone
Preventing Alcohol Withdrawal With Oral Baclofen
Condition: Alcoholism; Alcohol Withdrawal
MeSH terms: Alcoholism
Intervention: Baclofen; Placebo
Intervention description: Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.; Identical appearing placebo every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
Intervention MeSH terms: Baclofen
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 17.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      The purpose of this study is determine if the medication baclofen can prevent the symptoms of
      Alcohol Withdrawal Syndrome (AWS) in hospitalized patients who may be at risk for AWS. This
      medication is most often used for patients who have spasticity of their muscles due to a
      neuromuscular disease. In several European studies, and in an earlier study at Essentia
      Health (NCT00597701), baclofen has been found to have a significant effect on the severity of
      symptoms of AWS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adults (>21) admitted to inpatients units of 1 of 3 Essentia Health hospitals

          -  Patient placed on AWS watch protocol by admitting physicians.

        Exclusion Criteria:

          -  Unable to provide informed consent

          -  Unable to take swallow oral medications (tube-fed patients are to be excluded)

          -  Admitted for AWS or with Clinical Institute Withdrawal Assessment of Alcohol Scale,
             Revised (CIWA-Ar) score >8 at baseline

          -  No alcohol intake for ≥ 48 hours or AUDIT score <12 at baseline

          -  Baclofen use at baseline

          -  Baclofen sensitivity

          -  Hospital discharge anticipated in within 48 hours

          -  Pregnant or breast feeding (urine pregnancy test required of women of child-bearing
             potential)

          -  Other active drug dependence (except tobacco)
Study Assessing Effects of JZP-110 on Driving Performance in the Treatment of Excessive Sleepiness in Narcolepsy
Condition: Narcolepsy; Excessive Sleepiness
MeSH terms: Narcolepsy; Disorders of Excessive Somnolence; Sleepiness
Intervention: JZP-110; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 24.0
Sex: All
Minimum age: 21 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Driving

Summary:

      This trial is a randomized, double-blind, placebo-controlled, crossover study to evaluate the
      effect of JZP-110 on driving performance in subjects with excessive sleepiness due to
      narcolepsy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female, age 21 to 65 years inclusive

          2. Diagnosis of narcolepsy per International Classification of Sleep Disorders (ICSD-3)
             or Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5)

          3. BMI 18 to <40 kg/m2

          4. Willing and able to provide written informed consent

        Exclusion Criteria:

          1. Female subjects who are pregnant, nursing, or lactating

          2. Moderate or severe sleep apnea

          3. Any other clinically relevant medical, behavioral, or psychiatric disorder other than
             narcolepsy that is associated with excessive sleepiness

          4. History or presence of bipolar disorder, bipolar related disorders, schizophrenia,
             schizophrenia spectrum disorders, or other psychotic disorders according to DSM-5
             criteria

          5. History or presence of any unstable medical condition, behavioral or psychiatric
             disorder (including active suicidal ideation), or surgical history that could affect
             the safety of the subject or interfere with study efficacy and/or safety assessments
             per the judgment of the investigator

          6. History of bariatric surgery within the past year or a history of any gastric bypass
             procedure

          7. Presence or history of significant cardiovascular disease

          8. Unable to washout or refrain from taking any over-the-counter (OTC) or prescription
             medications that could affect sleep-wake function