bioihbjkbjnl/mcl2 huggingface dataset:
Quality of Life Study Using Gabapentin Versus Venlafaxine in Treating Hot Flashes in Patients With Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms; Hot Flashes
Intervention: Gabapentin; Venlafaxine
Intervention description: Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days.; Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.
Intervention MeSH terms: Gabapentin; Venlafaxine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 5.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: hot flashes; prostate cancer

Summary:

      The purpose of this study is to assess the change in quality of life over a 6 month period
      between gabapentin and venlafaxine in men with prostate cancer treated for hot flashes
      related to androgen deprivation therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men 18 years or older with histologically proven adenocarcinoma of the prostate

          -  Prior or current androgen deprivation for at least 6 months prior to study entry with
             either bilateral orchiectomy or being maintained on a stable dose of LHRH (luteinizing
             hormone-releasing hormone) agonist or antagonist

               -  Hot flash frequency of an average of 2 or more per day (average of 14 hot flash
                  episodes per week)

        Exclusion Criteria:

          -  cannot currently be taking serotonin reuptake inhibitors (SSRIs),
             serotonin-norepinephrine reuptake inhibitors (SNRIs) or monoamine oxidase inhibitors
             (MAOIs)

               -  cannot have uncontrolled hypertension

               -  cannot have history of past or current of epilepsy, epilepsy syndrome or other
                  seizure disorder

               -  cannot have psychiatric history of mania, hypomania, bipolar disorder or anorexia
                  nervosa

               -  cannot be receiving concurrent treatment with amy medications or herbal products
                  being used with the express purpose of treating hot flashes.
Prevention of Disease Progression in Early Stage Indolent B Cell Malignancies. (SMM)
Condition: Monoclonal Gammopathy of Undetermined Significance; Smoldering Multiple Myeloma; Chronic Lymphocytic Leukemia
MeSH terms: Multiple Myeloma; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Smoldering Multiple Myeloma; Paraproteinemias; Monoclonal Gammopathy of Undetermined Significance; Disease Progression
Intervention: Omega 3 Fatty Acid
Intervention description: Omega 3 supplementation will be initiated at three 1250 mg capsules daily for the first month. If dose is well tolerated, it will be increased to six 1250 mg capsules daily for 30 days, and finally to nine 1250 mg capsules daily. Treatment period is 12 months.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: ES-CLL; MGUS; SMM; Early Stage - Chronic Lymphocytic Leukemia

Summary:

      Escalating doses of Omega 3 Fatty Acids are being used in patients who have early stage
      Chronic Lymphocytic Leukemia (ES-CLL), Monoclonal Gammopathy of Undetermined Significance
      (MGUS), or Smoldering Multiple Myeloma (SMM), whose disease does not currently require
      treatment. The primary aim of the study is to determine if the Omega 3 supplementation will
      help prevent or delay progression of the disease to a stage that requires treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must be over 18 years of age.

          -  Must be free of other medical conditions that would decrease life expectancy to less
             that 12 months.

          -  Must be free of Omega 3 supplements or other fish oil containing nutritional
             supplements for a minimum of two months prior to enrollment.

          -  Must have a ECOG performance status of 0,1 or 2.

        Exclusion Criteria:

          -  Any life-threatening condition such as (but not limited to) advanced heart disease,
             kidney or liver failure with an expected survival of less than 12 months.

          -  Any other active malignancy.

          -  Women who are pregnant or lactating.

          -  Individuals unable to give informed consent.

          -  Individuals with known allergy or intolerance to fish oil supplements.

          -  Any patient with an active bleeding diatheses or disorder.

          -  ECOG performance status of 3 or 4.
Enhancing Attention in Adults With Compulsive Hoarding
Condition: Hoarding Disorder
MeSH terms: Hoarding Disorder
Intervention: Methylphenidate ER
Intervention description: Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
Intervention MeSH terms: Methylphenidate
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 4.0
Sex: All
Minimum age: 18 Years
Maximum age: 50 Years
Healthy volunteers: No
Keywords: Hoarding

Summary:

      Available data suggest that compulsive hoarders have cognitive deficits, particularly with
      sustaining attention that might contribute their hoarding symptoms.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinically significant compulsive hoarding (Proposed DSM-V criteria) that is principal
             (i.e. currently most severe and needing of treatment) and has been present for at
             least one year.

          -  At least moderate attentional difficulties.

          -  Able to provide consent.

          -  Patients can be on or off of serotonin reuptake inhibitors (SRIs) or serotonin and
             norepinephrine reuptake inhibitors (SNRIs) but dose must be stable for 12 weeks prior
             to study.

        Exclusion Criteria:

          -  Currently taking any psychotropic medications other than SRIs or SNRIs.

          -  Presence of psychotic symptoms or lifetime history of schizophrenia, bipolar disorder
             or other psychotic disorder.

          -  Current major depression is permitted if clearly secondary in importance to the
             hoarding.

          -  Judged clinically to be at risk of suicide (suicidal ideation, severe depression or
             other factors)

          -  Any cardiovascular abnormality that increases the risk of participation, including
             significant history of cardiovascular disease or family history of sudden death.

          -  Any medical or neurological disorder that increases the risk of participation or that
             is a medical contraindication for taking methylphenidate (e.g. glaucoma or Tourette's
             syndrome).

          -  Current use of any drug that is contraindicated with methylphenidate (e.g. monoamine
             oxidase inhibitors).

          -  Female patients who are pregnant or nursing.

          -  Current or previous treatment with methylphenidate or CBT for hoarding.

          -  Current ETOH/drug abuse or dependence disorder of dependency in the past 6 months.

          -  Individuals with mild cognitive impairments, dementia, or significant intellectual
             deficits.
Oral Nitrite in Adults With Metabolic Syndrome and Hypertension
Condition: Metabolic Syndrome; Hypertension
MeSH terms: Hypertension; Metabolic Syndrome; Syndrome
Intervention: 14Nitrogen Sodium Nitrite
Intervention description: oral formulation of sodium nitrite 40 mg three times a day for 12 weeks
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 20.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      This research study is being conducted to examine the effects of daily inorganic nitrite
      treatment on the cardiometabolic and hormonal disturbances observed in overweight/obese
      adults with the metabolic syndrome and high blood pressure. Ultimately, oral nitrite therapy
      may have a major impact on the prevention and treatment of both diabetes and cardiovascular
      disease.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Age 18-60 years

          -  Body mass index (BMI) greater than or equal to 30 kg/m^2

          -  Hypertension: defined as systolic blood pressure (SBP) greater than or equal to 130
             and/or diastolic blood pressure (DBP) greater than or equal to 85 mm Hg

          -  Waist circumference: greater than 102 cm in men, greater than 88 cm in women

        Exclusion Criteria:

          -  Positive urine pregnancy test or breastfeeding

          -  Concurrent use of medications affecting glucose metabolism (oral hypoglycemics,
             insulin, atypical antipsychotics)

          -  Recent addition or change in dosing of hormonal contraceptive medications [oral
             contraceptive pill (OCP), intrauterine device (IUD), DepoProvera]

          -  Current use of greater than or equal to 3 anti-hypertensive agents regardless of blood
             pressure control or normotensive on a single or double agent

          -  Current use of phosphodiesterase-5 inhibitors or organic nitrates

          -  Not stable on treatments for the prior three months or not planning to remain on
             current dose of medications for blood pressure, contraception, etc.

          -  Known chronic psychiatric or medical conditions including diabetes, liver or kidney
             disease or obesity syndromes

          -  Thyroid-stimulating hormone (TSH) greater than 8 milli-International unit/mL

          -  Smoker

          -  Anemia (central lab hemoglobin less than 11g/dL)
Ibuprofen Versus Acetaminophen vs Their Combination in the Relief of Musculoskeletal Pain in the Emergency Setting
Condition: Pain
MeSH terms: Musculoskeletal Pain; Emergencies
Intervention: Ibuprofen; Acetaminophen; Ibuprofen-acetaminophen combination
Intervention description: single dose; single dose; single dose
Intervention MeSH terms: Acetaminophen; Ibuprofen
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 90.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: musculoskeletal pain; acetaminophen; ibuprofen

Summary:

      The purpose of this study is to determine whether the combination of ibuprofen and
      acetaminophen, is more effective than either single agent alone in treating pain from acute
      musculoskeletal injuries in the emergency department.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Adult patients who presented to the emergency department with pain (a verbal numeric
             pain score greater than 0 on a scale of 0 to 10 from none to greatest) secondary to an
             acute musculoskeletal injury of less than 24 hours of duration when one of the study
             investigators was present were eligible for enrollment

        Exclusion Criteria:

          -  Patients who had taken an opioid containing analgesic as well as those with a prior
             history of allergy or contraindications to ibuprofen or acetaminophen.
BI 2536 Second Line Monotherapy in SCLC
Condition: Carcinoma, Small Cell
MeSH terms: Carcinoma, Small Cell
Intervention: BI 2536
Intervention description: Intravenous Infusion
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      Open label, uncontrolled Phase II trial to assess the efficacy and safety of BI 2536 in
      second line treatment in sensitive-relapse SCLC patients.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients with histologically or cytologically confirmed, -sensitive-relapse- SCLC
             defined by a relapse 60 days or more after cessation of prior first-line chemotherapy.

          -  Patients with at least one measurable lesion, with longest diameter to be recorded as
             20 mm or greater.

          -  Life expectancy of at least three months and ECOG performance score of 2 or less and
             written informed consent that must be consistent with ICH-GCP Guidelines.

        Exclusion Criteria:

          -  More than one prior regimen of chemotherapy, mixed small cell/large cell or combined
             small cell histology.

          -  Symptomatic brain metastases or leptomeningeal disease

          -  Patients with ascites, patients who have any other life-threatening illness or organ
             system dysfunction, or other malignancies diagnosed within the past five (5) years
             (other than non melanomatous skin cancer)

          -  Absolute neutrophil count (ANC) <1,500/µl, platelet count <100,000/µl, or hemoglobin
             <9 mg/dl

          -  Total bilirubin >1.5 x ULN, aspartame amino transferase (AST) and/or alanine amino
             transferase (ALT) >2.5 x ULN, or aspartate amino transferase (AST) and/or alanine
             amino transferase (ALT) >5 x ULN in case of known liver metastases, serum creatinine
             >2.0 mg/dl (>176 µmol/L, SI Unit equivalent)

          -  Chemo-, hormone- (other than Megace®) or immunotherapy within the past 4 weeks or
             within less than 4 half-life times of the previous drug prior to treatment with the
             trial drug

          -  Radiation therapy within the past 2 weeks prior to or during treatment with the trial
             drug

          -  Patients with any serious active infection (i.e., requiring an IV antibiotic,
             antifungal, or antiviral agents), patients with known HIV, hepatitis-B or -C infection

          -  Known or suspected active drug or alcohol abuse

          -  Treatment with any other investigational drug within the past 4 weeks or within less
             than 4 half-life times of the investigational drug

          -  Patients with a known pre-existing coagulopathy or requiring therapeutic
             anticoagulation with warfarin (Coumadin ®)

          -  Patients with neuropathy (sensory or motor) CTCAE 3
Efficacy and Safety of Lenalidomide for Treatment of Autistic Spectrum Disorders
Condition: Autism
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Intervention: lenalidomide
Intervention description: 2.5 mgs per day orally for 12 weeks
Intervention MeSH terms: Lenalidomide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 6.0
Sex: Male
Minimum age: 6 Years
Maximum age: 16 Years
Healthy volunteers: No
Keywords: autistic spectrum disorder; lenalidomide

Summary:

      The purpose of this study is to determine if lenalidomide (Revlimid®)reduces proinflammatory
      cytokines including TNF-alpha and may actually alter the clinical course of autism for some
      children.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of autistic spectrum disorder as defined by DSM-IV criteria.

          -  Inflammatory CSF and serum markers with elevated level of TNF-Alfa (> 50pg/ml) or
             other Cytokine markers such as IL-1, IL-6 or MECP-1, or serum levels of such cytokines
             greater than 2X normal levels even in absence of CSF markers.

        or

          -  Patients with interictal epiliptiform EEG changes in the absences of clinical
             seizures, if CSF inflammatory markers are identified.

          -  Patients will maintain any other baseline medications for autistic problems or EEG
             treatment as long as on these for prior 6-8 weeks with no dosage changes. Mentally
             impaired minors require a parent or legal guardian to sign the informed consent.

        Exclusion Criteria:

          -  -Diagnosis of PPD-NOS and other autism spectrum disorders.

          -  Any serious medical condition, laboratory abnormality, genetic, brain, structural, or
             psychiatric illness that would prevent the subject from participating.

          -  History of neutropenia, thrombocytopenia or other types of myelosuppression or risk
             factors for myelosuppression.

          -  History or risk factors for thromboembolic events.

          -  Any condition, including the presence of laboratory abnormalities, which places the
             subject at unacceptable risk if he/she were to participate in the study or confounds
             the ability to interpret data from the study.

          -  Use of any other experimental drug or therapy within 28 days of baseline.

          -  Current use of steroids (e.g. dexamethasone, prednisone), anthracyclines (Doxil,
             Adriamycin).

          -  Known hypersensitivity to thalidomide.

          -  The development of erythema nodosum if characterized by a desquamating rash while
             taking thalidomide or similar drugs.

          -  Any prior use of lenalidomide.

          -  Known positive for HIV or infectious hepatitis, type A, B or C or tuberculosis.
Second Line ColoRectal Cancer Therapy in Combination With Combination of FOL- Folinic Acid(Leucovorin), F - Fluorouracil and OX - Oxaliplatin (FOLFOX)
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Intervention: AZD2171; 5-fluorouracil; Leucovorin; Oxaliplatin; Bevacizumab
Intervention description: oral tablet; intravenous infusion; intravenous infusion; intravenous infusion; intravenous infusion
Intervention MeSH terms: Leucovorin; Bevacizumab; Fluorouracil; Oxaliplatin; Cediranib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 215.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Colorectal Cancer; phase II; metastatic colorectal cancer; AZD2171; RECENTIN

Summary:

      The primary purpose of this study is to compare the efficacy of AZD2171 in combination with
      FOLFOX to the efficacy of bevacizumab in combination with FOLFOX, in the second-line
      treatment of patients with metastatic colorectal cancer
    

Eligibility criteria:

        Inclusion Criteria:

          -  Clinical diagnosis of colon or rectal cancer,

          -  Received prior systemic therapy for cancer,

          -  Cancer must have progressed during or after first treatment

        Exclusion Criteria:

          -  Prior treatment with a VEGF inhibitor,

          -  Poorly controlled hypertension
Integrated Biomarker And Imaging Study - 2
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Intervention: SB-480848; SB-480848 matching placebo
Intervention description: SB-480848 is available as enteric-coated, free-base micronized tablet; Placebo is available as enteric-coated, free-base micronized tablet
Intervention MeSH terms: Darapladib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 336.0
Sex: All
Minimum age: 18 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Coronary artery disease; Lipoprotein-associated Phospholipase A2; palpography; hs-CRP; endothelial function; intravascular ultrasound

Summary:

      IBIS-2 is a study using SB-480848 versus placebo in subjects with angiographically documented
      coronary heart disease. Endpoints include coronary imaging, endothelial function, biomarkers,
      safety and tolerability.
    

Eligibility criteria:

        Inclusion criteria:

          -  Successful PCI (Percutaneous Coronary Intervention) or uncomplicated diagnostic
             catheterization

          -  Suitable non-intervened coronary artery with IVUS

          -  Antiplatelet therapy

        Exclusion criteria:

          -  Clinical instability

          -  Previous CABG (Coronary Artery By-pass Graft) surgery

          -  Planned major surgery

          -  Recent stroke

          -  Abnormal QTc

          -  Renal or hepatic impairment

          -  Uncontrolled hypertension

          -  Use of corticosteroids

          -  Class III or IV heart failure

          -  Asthma
A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group, Clinical Study in the Treatment of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Intervention: IDP-126 Gel; IDP-126 Component A; IDP-126 Component B; IDP-126 Component C; IDP-126 Vehicle Gel
Intervention description: Gel; Component A; Component B; Component C; Vehicle Gel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 741.0
Sex: All
Minimum age: 9 Years
Maximum age: 99 Years
Healthy volunteers: No

Summary:

      A Phase 2, Multicenter, Randomized, Double-Blind, Vehicle Controlled, Parallel-Group,
      Clinical Study in the Treatment of Acne Vulgaris
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female at least 9 years of age and older.

          2. Written and verbal informed consent must be obtained. Subjects less than age of
             consent must sign an assent for the study and a parent or a legal guardian must sign
             the informed consent (if subject reaches age of consent during the study they should
             be re-consented at the next study visit).

          3. Subject must have an EGSS of 3 (moderate) or 4 (severe) at the baseline visit.

          4. Subjects with a facial acne inflammatory lesion (papules, pustules, and nodules) count
             no less than 20, but no more than 100.

          5. Subjects with a facial acne non-inflammatory lesion (open and closed comedones) count
             no less than 30, but no more than 150.

          6. Subjects with 2 or fewer facial nodules

        Exclusion Criteria:

          1. Use of an investigational drug or device within 30 days of enrollment or participation
             in a research study concurrent with this study.

          2. Any dermatological conditions on the face that could interfere with clinical
             evaluations such as acne conglobata, acne fulminans, secondary acne, perioral
             dermatitis, clinically significant rosacea, gram negative folliculitis, dermatitis,
             eczema.

          3. Any underlying disease(s) or some other dermatological condition of the face that
             requires the use of interfering topical or systemic therapy or makes evaluations and
             lesion count inconclusive.

          4. Subjects with a facial beard or mustache that could interfere with the study
             assessments.

          5. Subjects with more than 2 facial nodules.

          6. Evidence or history of cosmetic-related acne.