bioihbjkbjnl/mcl2 huggingface dataset:
Study of Ruxolitinib in Pancreatic Cancer Patients
Condition: Pancreatic Cancer
MeSH terms: Pancreatic Neoplasms
Intervention: Capecitabine; Ruxolitinib; Placebo
Intervention description: Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day (BID)) (NOTE: Frequency of administration may be adjusted during the study.); Ruxolitinib starting dose - 15 mg BID (NOTE: Starting dose of randomized study drug may be 10 mg BID based on results from safety run-in study. Dose of ruxolitinib may be increased during randomized study.); Placebo matching ruxolitinib
Intervention MeSH terms: Capecitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 136.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Metastatic pancreatic cancer

Summary:

      The purpose of this study was to determine whether ruxolitinib added to capecitabine is
      effective in improving the overall survival of patients with metastatic pancreatic cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  Diagnosis of metastatic pancreatic cancer; subjects must have had measurable, or
             evaluable disease that was histologically confirmed

          -  Karnofsky performance status of ≥ 60

          -  Subjects must have failed 1st-line gemcitabine treatment for metastatic pancreatic
             cancer:

             o An alternate chemotherapeutic agent was an acceptable substitute as 1st-line therapy
             in the event that the subject was intolerant to or ineligible to receive gemcitabine

          -  ≥ 2 weeks elapsed from the completion of previous chemotherapy, and subjects must have
             recovered or been at new stable baseline from any related toxicities

        Exclusion Criteria:

          -  More than 1 prior chemotherapy regimen (not including adjuvant therapy) for metastatic
             disease

          -  Evidence of central nervous system (CNS) metastases (unless stable for > 3 months) or
             history of uncontrolled seizures

          -  Ongoing radiation therapy or prior radiation therapy administered as a second-line
             treatment

          -  Other active malignancy except basal or squamous carcinoma of the skin

          -  Inability to swallow food or any condition of the upper GI tract that precluded
             administration of oral medications

          -  Inadequate renal, hepatic and bone marrow function demonstrated by clinical
             observations and/or laboratory assessments
Chemotherapy for Patients With Osteosarcoma
Condition: Osteosarcoma
MeSH terms: Osteosarcoma
Intervention: Pemetrexed
Intervention description: 500 mg/m^2, IV every 21 days until disease progression, unacceptable toxicity, participant or physician's decision.
Intervention MeSH terms: Pemetrexed
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The primary purpose of your participation in this study is to help answer the following
      research questions, and not to provide you treatment for your condition.

        -  To assess how well treatment with pemetrexed works for patients with your type of cancer

        -  To assess for any side effects that might be associated with pemetrexed.

        -  To look at the characteristics and levels of certain of your genes and proteins to learn
           more about osteosarcoma and how pemetrexed works in your body.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histological diagnosis of high grade locally advanced or metastatic osteosarcoma

          -  Must have one prior chemotherapy regimen for advanced disease

          -  At least 1 unidimensional measurable lesion by computed tomography (CT) scan

          -  Have a good performance status

          -  Adequate organ function

        Exclusion Criteria:

          -  Have a serious concomitant systemic disorder (for example active Human
             Immunodeficiency Virus infection)

          -  Have brain metastases not adequately treated

          -  Significant weight loss (that is more than 20%) over the previous 6 weeks before study
             entry

          -  Inability or unwillingness to take folic acid or vitamin B12 supplementation and
             corticosteroids

          -  Pregnant or breast-feeding
A Study of Avastin (Bevacizumab) and Oxaliplatin Plus Xeloda (Capecitabine) in Patients With Advanced Colorectal Cancer.
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: bevacizumab [Avastin]; capecitabine [Xeloda]; oxaliplatin
Intervention description: 5 mg/kg intravenously every 14 days; 1000 mg/m2 orally b.i.d. , Days 1 - 14 of every 28-day cycle; 40 mg/m2 iv weekly
Intervention MeSH terms: Bevacizumab; Capecitabine; Oxaliplatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study will assess the efficacy and safety of treatment with the combination Avastin
      (bevacizumab) 5mg/kg iv every 2 weeks, Xeloda (capecitabine) 1000 mg po b.i.d. on Days 1-14
      of every 28-day cycle and oxaliplatin 40mg/m2 iv weekly in patients with inoperable locally
      advanced or metastatic colorectal cancer. The anticipated time on study treatment is until
      disease progression.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients >=18 years of age

          -  Locally advanced or metastatic colorectal cancer

          -  No previous treatment with chemotherapy for metastatic disease

          -  Measurable and/or evaluable lesions

        Exclusion Criteria:

          -  Radiotherapy within 4 weeks before study

          -  Untreated brain metastases or primary brain tumors

          -  Chronic, daily treatment with high-dose aspirin (>325mg/day)

          -  Co-existing malignancies, or malignancies diagnosed within the last 5 years, with the
             exception of basal and squamous cell cancer, or cervical cancer in situ
A Study of RPL554 Drug Administered by Metered Dose Inhaler to Treat Chronic Obstructive Pulmonary Disease
Condition: COPD
Intervention: Part A: RPL554; Placebos; Part B: RPL554
Intervention description: Single dose RPL554 via metered dose inhaler.; Part A: Single dose placebo via metered dose inhaler. Part B: Repeat doses of placebo via metered dose inhaler in crossover fashion. One dose administered twice daily over 7 days.; Part B: Repeat doses via metered dose inhaler in crossover fashion. One dose administered twice daily over 7 days.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking description: Double blind
Enrollment: 40.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: COPD; Adults; Phase II; RPL554; Ensifentrine

Summary:

      The purpose of this study is to investigate 5 doses of RPL554 and placebo, administered by
      pressurized metered dose inhaler (pMDI), in patients with moderate to severe chronic
      obstructive pulmonary disease (COPD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female patients with moderate to severe COPD, with a post bronchodilator FEV1
             of 40 to 80% of predicted and FEV1/FVC ratio of ≤0.70.

          -  They must have a baseline increase in FEV1 of >150 mL following four puffs of
             salbutamol.

          -  They must have at least a 10 pack-year smoking history, and may be either a current or
             former smoker.

        Exclusion Criteria:

          -  Patients must be clinically stable without recent COPD exacerbations or
             hospitalisations.

          -  They must not have uncontrolled disease or chronic heart failure.
Safety & Efficacy of Eculizumab to Prevent AMR in Living Donor Kidney Transplant Recipients Requiring Desensitization
Condition: Antibody Mediated Rejection
Intervention: Eculizumab
Intervention MeSH terms: Eculizumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 102.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Antibody Mediated Rejection; AMR; Acute Humoral Rejection; AHR; Living Donor; Kidney Transplant

Summary:

      The purpose of this trial was to determine the safety and efficacy of eculizumab in the
      prevention of antibody-mediated rejection (AMR) in sensitized recipients of a living donor
      kidney transplant requiring desensitization therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female patients ≥18 years old

          2. Patients with Stage IV or Stage V chronic kidney disease who will receive a kidney
             transplant from a living donor to whom they are sensitized and require desensitization
             prior to transplantation

        Exclusion Criteria:

          1. ABO incompatible with living donor

          2. Any medical condition that, in the opinion of the Investigator, might interfere with
             the patient's participation in the study, poses an added risk for the patient, or
             confounds the assessment of the patient
Efficacy of Aliskiren in the Treatment of Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Intervention: Aliskiren; Placebo
Intervention description: 300 mg once daily; Matching placebo once daily
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 39.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Diabetes; Macular edema; Aliskiren; Diabetic retinopathy; Diabetes mellitus type 1; Diabetes mellitus type 2

Summary:

      To assess the efficacy of oral aliskiren as a therapy for diabetic macular edema
    

Eligibility criteria:

        Inclusion criteria:

          -  Type 1 or type 2 diabetes

          -  Diabetic macular edema

        Exclusion criteria:

          -  Recent intra-ocular surgery in the study eye (e.g., cataract surgery in the last 6
             months)

          -  Recent laser photocoagulation in the study eye

          -  Recent treatment with Avastin, Lucentis, or intravitreal corticosteroids in the study
             eye

        Other protocol-defined inclusion/exclusion criteria applied
Comparison Of 5 CP-690,550 Doses Vs. Placebo, For The Treatment Of Rheumatoid Arthritis In Japan
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: Placebo; CP-690,550; CP-690,550; CP-690,550; CP-690,550; CP-690,550
Intervention description: Placebo BID, 3 blinded tablets administered BID for 12 weeks; 10mg BID, 3 blinded tablets administered BID for 12 weeks; 15mg BID, 3 blinded tablets administered BID for 12 weeks; 1mg BID, 3 blinded tablets administered BID for 12 weeks; 3mg BID, 3 blinded tablets administered BID for 12 weeks; 5mg BID, 3 blinded tablets administered BID for 12 weeks
Intervention MeSH terms: Tofacitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 318.0
Sex: All
Minimum age: 20 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Phase 2 monotherapy in Japan

Summary:

      To evaluate the dose-response relationship of 5 dose of CP-690,550, compared to placebo for
      the treatment of signs and symptoms in patients with active RA who failed an adequate trial
      of therapy with at least 1 DMARD in a 12-week therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects must have failed an adequate trial of therapy with at least 1 DMARD due to
             lack of efficacy or toxicity.

        Exclusion Criteria:

          -  Current therapy with any DMARD
Comparative Study of NXL104/Ceftazidime Versus Comparator in Adults With Complicated Urinary Tract Infections
Condition: Complicated Urinary Tract Infection
MeSH terms: Infections; Urinary Tract Infections
Intervention: NXL104/ceftazidime; Imipenem/Cilastatin
Intervention description: 125mg/500mg TID; 4 x daily
Intervention MeSH terms: Imipenem; Ceftazidime; Avibactam; Cilastatin
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Enrollment: 137.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine whether NXL104 plus ceftazidime is effective in the
      treatment of complicated urinary tract infections as compared to a comparator group.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Acute pyelonephritis or other complicated urinary tract infection due to gram negative
             pathogens

        Exclusion Criteria:

          -  ileal loops or vesicoureteral reflux

          -  complete obstruction of any portion of urinary tract, perinephric or intrarenal
             abscess.

          -  fungal urinary tract infection

          -  permanent indirect catheter or nephrostomy unless removed within 48 hours of study
             entry

          -  history hypersensitivity to study medication
Acarbose Anti-aging Effects in Geriatric Subjects (Substudy B & C)
Condition: Aging
Intervention: acarbose
Intervention description: acarbose treatment with meals
Intervention MeSH terms: Acarbose
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 8.0
Sex: All
Minimum age: 70 Years
Maximum age: 95 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study addresses a "lifespan approach to healthy development and aging" with direct
      relevance to humans by testing the anti-aging effects of acarbose in humans. It is a pilot
      study to: i) better estimate power for a larger trial, ii) establish the safety and potential
      beneficial effects of acarbose in non-diabetic elderly humans, and iii) determine whether the
      effects of acarbose on the microbiome likely play a role in its enhancement of longevity
      and/or healthy aging. These are essential initial steps for translating acarbose into an
      anti-aging human therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  age 70-95

          -  participants will be in good health with all chronic diseases (hypertension, coronary
             artery disease, etc.) clinically stable.

          -  participants must have adequate cognitive function to be able to give informed
             consent. This will be established by enrolling participants with CLOX 1 scores of ≥10.

        Exclusion Criteria:

          -  unstable ischemic heart disease

          -  clinically significant pulmonary disease

          -  history of immunodeficiency or receiving immunosuppressive therapy

          -  history of a coagulopathy or receiving a medical condition requiring anticoagulation

          -  an estimated glomerular filtration rate of <30ml/min

          -  uncontrolled hypercholesteremia >350mg/dl;

          -  uncontrolled hypertriglyceridemia >500mg/dl

          -  diabetes

          -  history of skin ulcers or poor wound healing

          -  smoking

          -  liver disease treatment with drugs known to affect cytochrome P450 3A (diltiazem,
             erythromycin)
The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With Hyperkalemia
Condition: ESRD; Hyperkalemia; End Stage Renal Disease
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Hyperkalemia
Intervention: Patiromer
Intervention description: Patiromer will be orally self-administered by participants.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Sequential Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: End Stage Renal Disease; ESRD; Hyperkalemia

Summary:

      The Effects of Patiromer on Serum Potassium Level and Gut Microbiome of ESRD Patients With
      Hyperkalemia (potassium greater than 5 milliequivalents per liter) is a non-randomized,
      crossover study. This is an open-label, pilot clinical trial with 3 sequential phases of (a)
      2 weeks of no intervention, (b) 12 weeks of Patiromer treatment, and (c) 6 weeks of no
      intervention. Treatment with Patiromer will be initiated at a dose of 8.4 grams, once daily
      and observed for a week, then uptitrated to 16.8 grams once daily. Eligible study subjects
      will collect stool samples and provide blood and urine samples.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects on stable hemodialysis for more than 90 days.

          -  Age 18-85 years.

          -  Persistent hyperkalemia, defined as elevated serum potassium > 5.0 mEq/L in more than
             2 occasions during the previous 3 months.

        Exclusion Criteria:

          -  Use of pre- or probiotics during the past 2 months

          -  Use of antibiotics within the past 2 months, if the patient received a single course
             of antibiotic.

          -  Presence of chronic wound infection and osteomyelitis

          -  Inflammatory bowel disease, chronic diarrhea, current C. difficile infection

          -  Liver cirrhosis or chronic active hepatitis

          -  Treatment with immunosuppressive medications in the past 6 months or more than a week
             of treatment with prednisone > 10 mg in the last 3 months

          -  Anticipated kidney transplant within 9 months

          -  Expected survival < 9 months

          -  Pregnancy, anticipated pregnancy, or breastfeeding

          -  Incarceration

          -  Participation in another intervention study

          -  severe anemia defined as hemoglobin < 8.0 g/dl any time during the last 2 months
Targeted Pharmacological and Behavioral Treatments for Smoking in Schizophrenia Study 1
Condition: Tobacco Dependence
MeSH terms: Tobacco Use Disorder; Schizophrenia
Intervention: Varenicline; Placebo
Intervention description: Standard dosing: 0.5 mg/day on days 1-3, 0.5 mg twice daily (morning, evening) on days 4-7, then 1 mg twice daily to the end of the medication period.; Dosing schedule matched to active comparator: on tablet on days 1-3, one tablet twice daily (morning, evening) on days 4-7, then one tablet twice daily to the end of the medication period.
Intervention MeSH terms: Varenicline
Phase: Phase 2
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 5.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      Schizophrenia is associated with high rates of cigarette smoking and associated morbidity and
      mortality. In this study, smokers with schizophrenia will complete a baseline session and
      then randomized to varenicline (VAR) or placebo (PLA). After 1 week on medication,
      participants will complete a cigarette rating task session. Participants will then undergo a
      72-hr abstinence period in which they will come to the laboratory twice per day and receive
      high-value cash reinforcement contingent upon meeting a strict breath CO abstinence
      criterion. At each visit, they will rate withdrawal symptoms, mood and craving. At the end of
      the abstinence period, they will repeat the cigarette rating task. Participants will return
      to the lab to provide a CO sample 24 hours later, and will text the lab with videos of their
      CO samples for one week. Date and time of smoking relapse will be measured from these
      samples.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men and women

          2. Ages 18-65

          3. Have schizophrenia or schizoaffective disorder

          4. Would like to quit smoking within the next 6 months

          5. Have smoked at least 10 cigarettes per day in the past year

          6. Have breath CO level > 10 ppm

          7. Able to speak, read and comprehend English well enough to complete study procedures

        Exclusion Criteria:

          1. Pregnant, breast-feeding, or unwilling to use medically-approved contraception

          2. Currently using varenicline, bupropion or nicotine replacement therapy for smoking
             cessation

          3. Medical disease that would preclude participation

          4. Unstable psychiatric conditions

          5. Body mass index (BMI) < 15 or > 38 kg/m2

          6. Past-month suicidal intention, with or without a specific plan

          7. Positive urine drug screen or breath alcohol level > 0.01% at screening
Proof of Concept in Patients With Generalized Anxiety Disorder (GAD)AZD7325
Condition: Anxiety Disorders
MeSH terms: Anxiety Disorders
Intervention: AZD7325; AZD7325; Lorazepam; Placebo
Intervention description: 4 tablets and 1 capsule taken twice a day for 28 days; 4 tablets and 1 capsule taken twice a day for 28 days; 4 tablets and 1 capsule taken twice a day for 28 days; 4 tablets and 1 capsule taken twice a day for 28 days
Intervention MeSH terms: Lorazepam
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 369.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Generalized Anxiety Disorder; GAD; Anxiety

Summary:

      The purpose of this research study is to determine whether AstraZeneca's drug AZD7325 is safe
      and effective in the treatment of generalized anxiety disorder.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Signed informed consent before any study-related procedures start.

          -  The patient is previously diagnosed with Generalized Anxiety Disorder.

          -  The patient has a HADS-A (anxiety) score ≥10 at both screening and randomization.

        Exclusion Criteria:

          -  Patient has a lifetime history of schizophrenia or other psychotic disorders

          -  Patient has a history of seizures or seizure disorder.

          -  Patient is pregnant or breast feeding.

          -  Patient has received electroconvulsive treatment (ECT) in the past.