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
High-Flow Oxygen for Dyspnea in Hospitalized Cancer Patients
Condition: Cancer
MeSH terms: Dyspnea
Intervention: High-flow Oxygen; Low-flow Oxygen; High-flow Air; Low-flow Air
Intervention description: Optiflow Respiratory Humidifier used to deliver HFOx. Oxygen flow will be maximized (set between 20 and 60 L/min), if tolerated, to minimize dyspnea. FiO2 will be set at 100%.; Low-flow Oxygen will be delivered by Optiflow in an identical manner to high flow, except provided at 2 L/min using a nasal cannula identical to that used for high-flow devices.; Two level air flow (high and low) will be delivered by Optiflow in an identical manner to oxygen air flows, except that researchers will use pressurized air instead of oxygen. LFOx and LFAir will be provided at 2 L/min using a nasal cannula identical to that used for high-flow devices.; Two level air flow (high and low) will be delivered by Optiflow in an identical manner to oxygen air flows, except that researchers will use pressurized air instead of oxygen. LFOx and LFAir will be provided at 2 L/min using a nasal cannula identical to that used for high-flow devices.
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 26.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: shortness of breath; oxygen; breathing therapies

Summary:

      The goal of this clinical research study is to compare high-flow oxygen, low-flow oxygen,
      high-flow air, and low-flow air in helping to decrease shortness of breath in cancer
      patients. Researchers also want to learn if these therapies can help to improve lung function
      and quality of life.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Diagnosis of cancer

          2. Patients seen by palliative care, thoracic oncology, pulmonary medicine, or emergency
             care at MD Anderson Cancer Center

          3. Dyspnea Numeric Rating Scale at rest >/=3 of 10 (average over last 24 hour)

          4. Non-hypoxemic (i.e. oxygen saturation >90% on ambient air)

          5. Able to communicate in English or Spanish

          6. Age >/= 18 years

          7. Able to tolerate high-flow oxygen/air

        Exclusion Criteria:

          1. Memorial Delirium Rating Scale >13

          2. Hemodynamic instability

          3. Respiratory failure requiring mechanical ventilation or non-invasive ventilation

          4. Frequent use of rescue opioids >8x/day or rescue bronchodilators >8x/day over last 24
             hours

          5. Currently requiring high flow oxygen for oxygenation
18F-DOPA-PET in Finding Tumors in Patients With Newly Diagnosed Gliomas Undergoing Radiation Therapy
Condition: Malignant Glioma
MeSH terms: Glioma
Intervention: Diffusion Weighted Imaging; Fluorine F 18 Fluorodopa; Intensity-Modulated Radiation Therapy; Perfusion Magnetic Resonance Imaging; Positron Emission Tomography; Quality-of-Life Assessment; Temozolomide
Intervention description: Undergo DTI; Undergo 18F-DOPA-PET; Undergo IMRT; Undergo pMRI; Undergo 18F-DOPA-PET; Ancillary studies; Receive temozolomide
Intervention MeSH terms: Temozolomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 91.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well fluorine F 18 fluorodopa (18F-DOPA)-positron emission
      tomography (PET) works in finding tumors in patients with newly diagnosed gliomas undergoing
      radiation therapy. Comparing results of diagnostic procedures done before and during
      radiation therapy may help doctors predict a patient's response to treatment and help plan
      the best treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed newly diagnosed grade IV malignant glioma; Note: grade III
             patients are no longer being enrolled

          -  Computed tomography (CT) simulation, immobilization, MRI and PET imaging, treatment
             planning, and all follow-up MRI and PET scans to be performed at Mayo Clinic
             Rochester; Note: the actual radiation therapy treatments and follow-up other than
             imaging can be performed at Mayo Clinic Rochester, Northfield, LaCrosse, Mankato, Eau
             Claire, or Albert Lea

          -  Provide written informed consent

          -  Ability to complete questionnaire(s) by themselves or with assistance

        Exclusion Criteria:

          -  Patients diagnosed with anaplastic oligodendroglioma

          -  Unable to undergo MRI scans with contrast (e.g. cardiac pacemaker, defibrillator,
             kidney failure)

          -  Unable to undergo an 18F-DOPA PET scan (e.g. Parkinson's disease, taking
             anti-dopaminergic, or dopamine agonist medication or less than 6 half-lives from
             discontinuance of dopamine agonists); NOTE: other potentially interfering drugs
             consist of: amoxapine, amphetamine, benztropine, bupropion, buspirone, cocaine,
             mazindol, methamphetamine, methylphenidate, norephedrine, phentermine,
             phenylpropanolamine, selegiline, paroxetine, citalopram, and sertraline; if a patient
             is on any of these drugs, list which ones on the on-study form

          -  Any of the following:

               -  Pregnant women

               -  Nursing women

               -  Men or women of childbearing potential who are unwilling to employ adequate
                  contraception
A Study Exploring the Safety, Tolerability and Efficacy of a 4 Week Course of INCB018424 in Subjects With Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Intervention: INCB018424; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Rheumatoid arthritis

Summary:

      The purpose of this study is to understand the safety and tolerability of INCB018424 in
      patients with rheumatoid arthritis
    

Eligibility criteria:

        Inclusion Criteria:

          1. Established diagnosis of rheumatoid arthritis

          2. Patients receiving methotrexate must be treated with for at least 6 months and
             receiving a stable weekly dose between 10 and 25 mg for at least 8 consecutive weeks
             prior to study entry.

        Exclusion Criteria:

          1. Patients who have taken the following drugs within the timeframe below:

               -  Leflunomide, infliximab, etanercept, adalimumab, abatacept, or other biological
                  therapies (except rituximab) - Within 12 weeks prior to the first dose of study
                  medication;

               -  Rituximab - Within 12 months prior to the first dose of study medication;

               -  Disease-modifying anti-rheumatic drugs (DMARDs) or other anti-rheumatic therapies
                  not specified above including but not limited to: gold, penicillamine, dapsone,
                  azathioprine, 6-mercaptopurine, chlorambucil, cyclophosphamide, cyclosporin,
                  mycophenolate mofetil - Within 12 weeks prior to the first dose of study
                  medication;

          2. Treatment with any investigational medication within 12 weeks prior to the first dose
             of study medication.
A Randomized Phase II/Genomic Trial of Two Chemotherapy Regimens in Patients With Resected Pancreatic Adenocarcinoma
Condition: Pancreatic Adenocarcinoma
MeSH terms: Adenocarcinoma
Intervention: Gemcitabine; Abraxane; FOLFIRINOX; Chemoradiation
Intervention description: 1000mg/m2 IV over 30 to 100 minutes, day 1, 8, 15; 125 mg/m2 IV over 30 minutes, day 1, 8, 15; Irinotecan 180 mg/m2 Day 1 Oxaliplatin 85 mg/m2 Day 1 5-FU 400 mg/m2 bolus with Leucovorin 200 mg/m2 over 2h, Day 1, then 5-FU 2400 mg/m2 over 46h. Four cycles, if tolerated
Intervention MeSH terms: Paclitaxel; Gemcitabine; Albumin-Bound Paclitaxel; Folfirinox
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 32.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Patients; with; resected

Summary:

      Determine the relapse-free survival of resected pancreatic cancer patients following two
      novel regimens with activity in advanced disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically or cytologically confirmed evidence of pancreatic
             carcinoma.

          -  Patients must have had all gross disease resected (R0 or R1 resection, patients who
             underwent an R2 resection are not eligible).

          -  Patients must have had no prior chemotherapy or radiation therapy for pancreatic
             cancer.

          -  Age > 18 years.

          -  Patient must have Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

          -  Patients must have normal organ and marrow function measured within 2 weeks, prior to
             registration as follows:

        Absolute Neutrophil Count (ANC) > 1,500/µL Platelets > 100,000/µL Total bilirubin less than
        2-fold upper limit of normal (ULN) Aspartate Aminotransferase (AST)/alanine
        aminotransferase (ALT)<2.5X institutional upper limit of normal Creatinine clearance >
        60mL/min for patients with creatinine levels above institutional normal.

          -  Patients must be > 4 weeks and < 12 weeks post-surgery at time of study registration.

          -  Women of childbearing potential and sexually active males are strongly advised to use
             appropriate contraceptive measures.

          -  Women must not be pregnant or breast-feeding.

        Exclusion Criteria:

          -  Patients receiving any other investigational agents.

          -  Patients with known metastases.

          -  Patients with wounds that have not fully healed.
Treatment Substitution With PRO 140 Monotherapy in Adult Subjects With HIV-1 Infection
Condition: HIV; Human Immunodeficiency Virus
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Intervention: PRO 140; Historical data
Intervention description: CCR5 Antagonist; Historical data (i.e., time to HIV-1 RNA viral load > 500 copies/mL of 29 days).
Intervention MeSH terms: Leronlimab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: HIV-1; HIV; Treatment Substitution; PRO 140; PRO140; CytoDyn; Amarex

Summary:

      This study is a Phase 2b study designed to evaluate the efficacy, safety, and tolerability of
      PRO 140 monotherapy for the maintenance of viral suppression in subjects who are stable on
      combination antiretroviral therapy.

      Consenting subjects will be shifted from their combination antiretroviral regimen to PRO 140
      monotherapy for 12 weeks. Total treatment duration with PRO 140 will be 14 weeks with the one
      week overlap of existing retroviral regimen and PRO 140 at the beginning of the study
      treatment, and one week overlap at the end of the treatment in subjects who do not experience
      virologic failure.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Males and females, age ≥18 years

          2. Exclusive CCR5-tropic virus at Screening Visit as determined by Trofile™ DNA Assay

          3. On stable antiretroviral therapy for last 12 months

          4. Subject has two or more potential alternative antiretroviral regimen options to
             consider.

          5. No documented detectable viral loads (HIV-1 RNA <50 copies/ml) within the last 12
             months prior to Screening Visit

          6. Nadir CD4 cell count of >200 cells/mm3

        Exclusion Criteria:

          1. CXCR4-tropic virus or dual/mixed tropic (R5X4) virus determined by the Trofile™ DNA
             Assay at the Screening Visit

          2. Hepatitis B infection as manifest by the presence of Hepatitis B surface antigen
             (HBsAg)

          3. Any acquired immune deficiency syndrome (AIDS)-defining illness according to the 1993
             Centers for Disease Control and Prevention (CDC) AIDS surveillance definition

          4. Prior use of any entry, attachment, CCR5 co-receptor, or fusion inhibitor, including
             PRO 140.

          5. Any other clinical condition that, in the Investigator's judgment, would potentially
             compromise study compliance or the ability to evaluate safety/efficacy
A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia Gravis
Condition: Generalized Myasthenia Gravis
MeSH terms: Myasthenia Gravis; Muscle Weakness
Intervention: M281; Placebo
Intervention description: M281 administered as IV infusion; Placebo administered as intravenous (IV) infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 68.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: M281; Generalized Myasthenia Gravis

Summary:

      The purpose of this study is to evaluate the safety, tolerability, and efficacy of M281
      administered to participants with generalized myasthenia gravis (gMG) who have an
      insufficient clinical response to ongoing standard of care therapy.
    

Eligibility criteria:

        Participants must be ≥18 years of age with a documented history of Generalized Myasthenia
        Gravis (gMG) and clinical signs/symptoms of gMG, not pregnant or breastfeeding, and no
        history of any neurologic disorder other than MG that might interfere with the accuracy of
        study assessments.

        Additional, more specific criteria are defined in the protocol.
Randomized, Placebo Controlled Study Of The Efficacy And Safety Of PF-02545920 In Subjects With Huntington's Disease
Condition: Huntington's Disease
MeSH terms: Huntington Disease
Intervention: PF-02545920; PF-02545920; Placebo
Intervention description: 20 mg twice a day (BID) for 26 weeks. Each 20 mg dose will be taken as 4 tablets of 5 mg. The 20mg dose will be titrated as follow: 5mg BID for 7 days, 10mg BID for 7 days, 15 mg BID for 7 days and 20 mg BID to week 26. Study drug will be provided in weekly blister cards.; 5 mg twice a day (BID) for 26 weeks. Each 5 mg dose will be taken as 4 tablets: one tablet of 5 mg and 3 tablets of matching placebo. The 5mg dose will not be titrated. Study drug will be provided in weekly blister cards.; Matching Placebo twice a day (BID) for 26 weeks. Each placebo dose will be taken as 4 tablets of matching Placebo. The placebo dose will not be titrated. Matching placebo will be provided in weekly blister cards.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 272.0
Sex: All
Minimum age: 30 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Huntington; chorea; total motor score; CAG repeat: total functional capacity; motor cognitive and behavioral symptoms

Summary:

      This study is a 26 week, randomized, parallel group, double blind comparison of PF-02545920 5
      mg, PF-02545920 20 mg, and placebo dosed BID in the treatment of motor impairment of subjects
      with Huntington's Disease. A total of approximately 260 subjects are planned to be randomized
      in the study. Primary endpoint is the change from baseline in the Total Motor Score (TMS)
      assessment of the Unified Huntington Disease Rating Scale (UHDRS) after 26 weeks of
      treatment. secondary endpoints will include change from baseline in the Total Maximum Chorea
      (TMC) score of the UHDRS after 13 and 26 weeks of treatment and Clinical Global
      Impression-Improvement score after 13 and 26 weeks of treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  CAG repeat equal or greater than 36;

          -  Total motor score equal or greater than 10;

          -  Total functional capacity equal or greater than 7.

        Exclusion Criteria:

          -  Clinically significant neurologic disorder other than Huntington's disease;

          -  Other severe acute psychiatric conditions, mania and/or psychosis;

          -  History of neutropenia, and myeloproliferative disorders;
A Study of Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)
Condition: Relapsing-Remitting Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: LY2127399; Placebo
Intervention description: Administered via Injection; Administered via Injection
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 245.0
Sex: All
Minimum age: 18 Years
Maximum age: 64 Years
Healthy volunteers: No
Keywords: Relapsing; Remitting; Multiple Sclerosis; Multiple; Sclerosis; MS; LY2127399

Summary:

      To look at the ability of LY2127399 to reduce magnetic resonance imaging (MRI) lesions at 12,
      16, 20, and 24 weeks compared to placebo.
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 through 64 years of age diagnosed with RRMS, who can walk without aid or rest for
             at least 200 meters (approximately 1/10 of a mile).

          -  Women who can become pregnant must use birth control.

        Exclusion Criteria:

          -  Have had a live vaccination within 12 weeks before randomization, or intend to have a
             live vaccination during the course of the study.

          -  Have had had recent surgery or are scheduled to have surgery during the study.

          -  Are immunocompromised or have evidence of active infection [such as hepatitis,
             tuberculosis or, human immunodeficiency virus (HIV)].

          -  Have been on certain drugs that are being studied for RRMS or have recently received
             prescription drugs to treat RRMS.

          -  Have had a recent serious infection.

          -  Have serious or uncontrolled illnesses other than RRMS.

          -  Have clinically significant blood test values.

          -  Have multiple or severe drug allergies.

          -  Have contraindications for MRI "scanning" or claustrophobia (fear of an enclosed
             space) that cannot be managed.