bioihbjkbjnl/mcl2 huggingface dataset:
Do Treatments for Smoking Cessation Affect Alcohol Drinking?
Condition: Alcohol Drinking
MeSH terms: Alcohol Drinking
Intervention: varenicline; placebo
Intervention description: 2mg/day or 1mg/day with 1-week medication lead-in period.; placebo
Intervention MeSH terms: Varenicline
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 60.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: alcohol; smoking cessation; varenicline; bupropion; smoking cessation medications

Summary:

      The purpose of this study is to examine the effect of smoking cessation medications on
      alcohol drinking. Effect of 2mg/day, 1mg/day, placebo varenicline was evaluated.

      Following 7 days of medication pre-treatment to achieve steady state levels, participants
      complete a laboratory session assessing alcohol self-administration behavior.

      Study enrolls heavy drinking smokers (not tested under nicotine deprivation), non-daily
      smokers, and nonsmokers. Volunteers are administered either varenicline (Chantix) or placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  21 years old or older

          -  Able to read and write in English

          -  Smokers, non-daily smokers, and non-smokers

          -  Heavy Drinkers and/or meet criteria for alcohol use disorders

        Exclusion Criteria:

          -  Any significant current medical or psychiatric conditions that would contraindicate
             the consumption of alcohol

          -  Significant hepatocellular injury

          -  Positive test result at intake appointments on urine drug screens conducted for
             opiates, cocaine, or benzodiazepines

          -  Women who are pregnant or nursing

          -  Suicidal, homicidal, or evidence of severe mental illness

          -  Prescription of any psychotropic drug in the 30 days prior to study enrollment

          -  Blood donation within the past 8 weeks

          -  Individuals who are seeking treatment for drinking or smoking or who have attempted to
             quit drinking or smoking within the past 3 months

          -  Specific exclusions for administration of bupropion not specified above including:
             having taken monoamine inhibitors in the past six weeks; history of anorexia or
             bulimia; previous hypersensitivity to bupropion; history of alcohol or drug dependence
             in the past year; history of seizure disorder of any etiology

          -  Known allergy to varenicline or taking H2blockers

          -  Participation within the past 8 weeks in other studies that involve additive blood
             sampling and/or interventional measures that would be considered excessive in
             combination with the current study

          -  Subjects likely to exhibit clinically significant alcohol withdrawal during the study
A Phase 2 Trial to Evaluate the Efficacy and Safety of OCV-501 in Elderly Patients With Acute Myeloid Leukemia
Condition: Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Intervention: OCV-501; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 134.0
Sex: All
Minimum age: 60 Years
Healthy volunteers: No
Keywords: OCV-501; Acute Myeloid Leukemia; Antigen specific cancer immunotherapeutic

Summary:

      To compare disease-free survival in patients 60 years or older with acute myeloid leukemia
      (AML) who are randomly assigned to receive either OCV-501 monotherapy or placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with AML who achieved first complete remission within one or two courses of
             standard induction therapy, and completed standard consolidation therapy (more than
             one course).

          -  Patients who are 60 years or older.

          -  Patients who have provided written informed consent within 90 days from the last dose
             of consolidation therapy on an informed consent form that has been approved by an
             institutional review board or independent ethics committee.

        Exclusion Criteria:

          -  Patients who have acute promyelocytic leukemia (APL) with t(15;17) (q22;q12),
             (PML/RARA) karyotype abnormalities, and other variant types.

          -  Patients who are scheduled for hematopoietic stem cell transplantation.

          -  Patients who have received drugs potentially affecting the immune system within 4
             weeks before starting IMP administration or who may receive such drugs after start of
             the trial.

          -  Patients who have a severe concurrent disease or psychiatric illness likely to
             interfere with participation in this trial.

          -  Patients who are HIV antibody positive, HBV-DNA positive or have unrecovered chronic
             hepatitis C with positive HCV antibody.

          -  Patients who have cirrhosis.

          -  Patients judged to be ineligible by the investigator (or subinvestigator) for any
             other reasons.
A Phase II Uncontrolled Study of BAY73-4506 in Previously Untreated Patients With Metastatic or Unresectable RCC
Condition: Carcinoma, Renal Cell
MeSH terms: Carcinoma, Renal Cell
Intervention: Regorafenib (Stivarga, BAY73-4506)
Intervention description: Patients will be treated with BAY73-4506 160 mg po qd for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off). Patients will continue treatment with BAY73-4506 until disease progression, intolerable toxicity, or patient refusal to continue with the study or investigator decision to remove the patient from study.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Renal Cell Carcinoma

Summary:

      This is a uncontrolled, open-label, non-randomized Phase II study of oral BAY73-4506 to
      evaluate the response rate of BAY73-4506 in previously untreated patients with metastatic or
      unresectable renal cell cancer (RCC).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female patients >/= 18 years of age.

          -  Patients, who suffer from unresectable and/or metastatic, measurable predominantly
             clear cell RCC (renal cell carcinoma histologically) or cytologically documented.

          -  Patients must be previously untreated for advanced disease. Prior palliative radiation
             therapy is allowed if the target lesion(s) are not included within the radiation field
             and no more than 30% of the bone marrow is irradiated.

          -  Patients who have at least one uni-dimensional measurable lesion by computed
             tomography (CT-scan) or magnetic resonance imaging (MRI) according to Response
             Evaluation Criteria in Solid Tumors (RECIST).

          -  Patients with "Intermediate" or "Low" risk per the Motzer score.

          -  Patients who have an Eastern Co-operative Oncology Group (ECOG) performance status of
             0 or 1.

          -  Adequate bone marrow, renal and hepatic function as assessed by the following
             laboratory requirements to be conducted within 7 days prior to study drug treatment

        Exclusion Criteria:

          -  Patients who have received prior systemic treatment regimens for RCC.

          -  Uncontrolled/unstable cardiac disease

          -  Uncontrolled hypertension

          -  Active clinically serious infections (> Common Terminology Criteria for Adverse Events
             [CTCAE] grade 2 )

          -  History of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C.

          -  Known history or symptomatic metastatic brain or meningeal tumours

          -  Patients with seizure disorder requiring medication

          -  Patients with evidence or history of bleeding diathesis. Any hemorrhage or bleeding
             event >/= CTCAE Grade 3 within 4 weeks of first dose of study.

          -  Pregnant or breast-feeding patients
Study of PXL065 in Patients With Nonalcoholic Steatohepatitis (NASH)
Condition: NASH - Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Intervention: PXL065; Placebo oral tablet
Intervention description: PXL065 oral tablet; Placebo oral tablet
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 117.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study will assess the effect of 3 doses of PXL065 versus placebo on liver fat content in
      NASH patients after 36 weeks of treatment
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients have given written informed consent

          -  Body mass index (BMI) ≤ 50 kg/m²

          -  For patients with type 2 diabetes mellitus: either naive of glucose lowering drug or
             under stable oral glucose lowering drug

          -  Estimated glomerular filtration rate (eGFR) ≥ 45 mL/min/1.73m²

          -  Liver fat content ≥ 8% on MRI-PDFF

          -  Qualifying liver biopsy (NAS) ≥ 4 and fibrosis score F1, F2 or F3

          -  Effective contraception for women of child bearing potential

        Exclusion Criteria:

          -  Evidence of another form of liver disease

          -  Evidence of liver cirrhosis

          -  Evidence of hepatic impairment

          -  Positive serologic evidence of current infectious liver disease

          -  History of excessive alcohol intake

          -  Acute cardiovascular disease within 6 months prior to Randomization

          -  Any disease which in the Investigator's opinion which in the Investigator's opinion
             would exclude the patient from the study

          -  Use of non-permitted concomitant medication

          -  Pregnancy or lactation
A Depot Formulation of Sunitinib Malate (GB-102) Compared to Aflibercept in Subjects With Wet AMD
Condition: Neovascular Age-Related Macular Degeneration
MeSH terms: Macular Degeneration
Intervention: Drug: GB-102; Aflibercept
Intervention description: Intravitreal injection of GB-102; Intravitreal injection of aflibercept (2 mg dose)
Intervention MeSH terms: Sunitinib; Aflibercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel-arm design
Masking: Single (Outcomes Assessor)
Masking description: Visual examiner-masked
Enrollment: 56.0
Sex: All
Minimum age: 50 Years
Healthy volunteers: No
Keywords: Age-related macular degeneration (AMD); Choroidal neovascularization

Summary:

      Phase 2b, multicenter, visual examiner-masked, randomized active-controlled, parallel-arm
      design study to evaluate the safety and duration of repeated IVT injections of 3 dose levels
      of GB-102 compared with aflibercept.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Males or females ≥ 50 years of age

          -  Presence of a choroidal neovascularization (CNV) lesion secondary to AMD treated with
             at least 3 prior intravitreal (IVT) injections of an anti-vascular endothelial growth
             factor (VEGF) agent (aflibercept, bevacizumab, or ranibizumab).

          -  Demonstrated response to prior anti-VEGF treatment since diagnosis

          -  Best-corrected visual acuity (BCVA) of 35 letters or better

        Exclusion Criteria:

          -  History, within 6 months prior to screening, of any of the following: myocardial
             infarction, any cardiac event requiring hospitalization, treatment for acute
             congestive heart failure, transient ischemic attack, or stroke

          -  Uncontrolled hypertension, diabetes mellitus or intraocular pressure (IOP)

          -  Chronic renal disease

          -  Abnormal liver function

          -  Women who are pregnant or lactating
131I-MIBG Alone VS. 131I-MIBG With Vincristine and Irinotecan VS131I-MIBG With Vorinostat
Condition: Neuroblastoma
MeSH terms: Neuroblastoma
Intervention: 131I-MIBG; Vincristine; Irinotecan; Vorinostat
Intervention MeSH terms: Irinotecan; Vincristine; Vorinostat; 3-Iodobenzylguanidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 114.0
Sex: All
Minimum age: 2 Years
Maximum age: 30 Years
Healthy volunteers: No

Summary:

      This study will compare three treatment regimens containing metaiodobenzylguanidine (MIBG)
      and compare their effects on tumor response and associated side effects, to determine if one
      therapy is better than the other for people diagnosed with relapsed or persistent
      neuroblastoma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must be > 24 months and < 30 years of age when registered on study.

          -  Patients must have relapsed neuroblastoma, refractory neuroblastoma that had less than
             a partial response to standard treatment or persistent neuroblastoma that had at least
             a partial response to frontline therapy frontline therapy with > 3 residual lesions on
             end-induction MIBG scan.

          -  Patients must have evidence of MIBG uptake into tumor at ≥ one site within 4 weeks
             prior to entry on study and subsequent to any intervening therapy.

          -  Patients must have adequate heart, kidney, liver and bone marrow function. Patients
             who have bone marrow disease must still have adequate bone marrow function to enter
             the study.

          -  Patients must have a dose of unpurged peripheral blood stem cells is 2.0 x 106 viable
             CD34+ cells/kg available.

        Exclusion Criteria:

          -  They have had previous I-131 MIBG therapy

          -  They have other medical problems that could get much worse with this treatment.

          -  They are pregnant or breast feeding.

          -  They have a history of a venous or arterial thrombosis that was not associated to a
             central line.

          -  They have active infections such as hepatitis or fungal infections.

          -  They have active diarrhea.

          -  They have had an allogeneic stem cell transplant (received stem cell from someone
             else)

          -  They can't cooperate with the special precautions that are needed for this trial.
Dose-range Finding Efficacy and Safety Study for QBW251 in COPD Patients
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Intervention: QBW251; Placebo; COPD maintenance background therapy
Intervention description: QBW251 oral capsules (450, 300, 150, 75 and 25 mg) of identical appearance to ensure blinding administered twice a day (b.i.d) for 24 weeks; Placebo oral capsules administered twice a day for 24 weeks; Combination of fluticasone furoate, vilanterol and umeclidinium bromide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 974.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No
Keywords: COPD

Summary:

      This clinical study was designed to support the dose selection for future studies by
      evaluating efficacy and safety of different QBW251 doses in Chronic obstructive pulmonary
      disease (COPD) patients with chronic bronchitis and a history of exacerbations, compared to
      placebo, when added to a triple inhaled therapy of LABA, LAMA and ICS.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male and female COPD patients aged ≥40 years, who have signed an Informed Consent Form
             prior to initiation of any study-related procedure.

          -  Current or ex-smokers who have a smoking history of at least 10 pack years.

          -  Patients who have been treated with a triple combination of LABA/LAMA/ICS for the last
             3 months prior to screening.

          -  Patients featuring chronic bronchitis

        Exclusion Criteria:

          -  Patients who have had a COPD exacerbation that required treatment with antibiotics
             and/or oral corticosteroids and/or hospitalization, or a respiratory tract infection
             in the 4 weeks prior to screening, or between screening and randomization.

          -  Patients with any documented history of asthma, or with an onset of chronic
             respiratory symptoms, including a COPD diagnosis, prior to age 40 years.

          -  Patients with a body mass index (BMI) of more than 40 kg/m2.

          -  Use of other investigational drugs (approved or unapproved) within 30 days or 5
             half-lives prior to screening, or until the expected pharmacodynamic effect has
             returned to baseline (e.g., biologics), whichever is longer; or longer if required by
             local regulations.

          -  Pregnant or nursing (lactating) women, and women of childbearing potential not willing
             to use acceptable effective methods of contraception during study participation.
Crossover Trial of AD036 in Obstructive Sleep Apnea
Condition: Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive
Intervention: AD036; Atomoxetine; Placebo
Intervention description: Oral administration before bed; Oral administration before bed; Oral administration before bed
Intervention MeSH terms: Atomoxetine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 62.0
Sex: All
Minimum age: 25 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      This is a randomized, 3-Period, Placebo-Controlled, Crossover, phase 2 clinical study to
      examine the efficacy and safety of AD036 versus placebo or atomoxetine in patients with
      obstructive sleep apnea.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or Female, between 25 to 65 years of age, inclusive, at the Screening Visit.

          -  AHI 10 to <20, or AHI ≥20 if meets PSG criteria

        Exclusion Criteria:

          -  History of narcolepsy.

          -  Clinically significant craniofacial malformation.

          -  Clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery
             disease or cardiac failure) or hypertension requiring more than 2 medications for
             control. A medication for these purposes is defined by dosage form, such that a
             combination antihypertensive medication is considered 1 medication

          -  CPAP should not be used for at least 2 weeks prior to first study PSG

          -  History of using oral or nasal devices for the treatment of OSA may enroll as long as
             the devices are not used during participation in the study.
Safety and Efficacy of Fluoxetine in Pulmonary Arterial Hypertension
Condition: Pulmonary Arterial Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension
Intervention: Fluoxetine
Intervention description: Total dose How to take:
Week 1-2 20 mg daily Week 3-4 40 mg daily Week 5-6 40 mg BID Week 7-12 40mg BID
Intervention MeSH terms: Fluoxetine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: All
Minimum age: 16 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Pulmonary Arterial Hypertension; Pulmonary Hypertension

Summary:

      This study will evaluate the safety, tolerability and efficacy of open-label fluoxetine for
      three months among patients with pulmonary arterial hypertension.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Signed informed consent prior to any study-mandated procedure

          2. PAH of the following subtypes: idiopathic PAH WHO functional class II-III

          3. Catheterization within one week showing mPAP >=25, wedge or LV end diastolic pressure
             ≤15, and PVR > 4 wood units, and baseline fick cardiac output results available

          4. Age 16-75

          5. Able to complete a six minute walk distance

          6. Women of childbearing potential*: negative serum pre-treatment pregnancy test +
             consistently and correctly uses a reliable method of contraception** Oral approved PAH
             therapy for >3 months with no change in dose for > 1 month

        Exclusion Criteria:

          1. PAH with connective tissue disease, congenital heart disease, portal hypertension,
             glycogen storage disease, Gaucher's disease, hereditary hemorrhagic telangiectasia,
             hemoglobinopathy, myeloproliferative disorders.

          2. Moderate to severe obstructive or restrictive lung disease: forced expiratory volume
             in 1 second/forced vital capacity (FEV1/FVC) < 70% and FEV1 < 60% of predicted value
             after bronchodilator administration. -or- total lung capacity (TLC) < 60% of
             predicted.

          3. Systemic systolic blood pressure <100 mmHg Breastfeeding

          4. Significant liver, renal or other medical disease preventing completion of the study
             procedures or with life expectancy <12 months, or any other acute or chronic physical
             impairment (other than dyspnea), limiting the ability to comply with study
             requirements