Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Prospective Study on Long-term Outcome and Potential Usefulness fo an Intervention Aimed at Reducing Adverse Effects in Patients With Refractory Epilepsy
Brief Summary: Over 1 million people in the European Union (EU) suffer from chronic refractory epilepsy. Their quality of life (QoL) is severely affected by seizures and by the adverse effect of antiepileptic drug (AED) treatment. Several new AEDs have been introduced in recent years, but their impact on the long-term outcome in these patients has been inadequately explored. Preliminary data from the U.S. suggests that using a standardize toll to quantitate adverse AED effects can improve outcome, but the general applicability of these findings is unclear.

Objectives: 1) To assess prospectively AED utilization patterns in patients with refractory epilepsy ; 2) to assess how such treatments and other variables correlated with seizure control, adverse effects, and QoL in these patients; 3) to establish the impact of a standardized evaluation of adverse effects on clinical outcome.

Methods: The project included a core observational study and a randomized intervention in a subcohort.

In the core (observational) study, 1,000 consecutive refractory epilepsy patients were enrolled and followed-up prospectively at 10 centres in Italy. The following parameters were recorded at 0 (entry), 6, 12 and 18 months: (i) drug therapy; (ii) seizure frequency; (iii) adverse events based on medical examination and non-structured interview; (iii) treatment costs and, (iv) for patients above age 16, standardized questionnaires for adverse effects (AEP), depressive symptoms (Becks Depression Scale, BDS), QoL (QOLIE-31) and clinical global impression (CGI). The primary outcome (changes in QOLIE-31 scores) will be related to the other variables measured.

In the randomized intervention, the subcohort meeting specific eligibility criteria (age \>16 years, no progressive disorder, AEP score\>=45 ) was randomized to two groups. In the intervention group, AEP score results were made available to the physician at each visit, while in the other group AEP scores were only made available at the end of follow-up. Primary outcome were changes in AEP score.


Options:
A: Inclusion Criteria:

* Age \>18 years
* Diagnosis of gynecologic (ovarian; cervical; uterine; primary peritoneal), lung (non-small cell; small cell), gastrointestinal (colorectal, rectal, gastric, esophageal, GI neuroendocrine, small intestine malignancy, pancreatic, hepatocellular), breast, bladder cancer or prostate malignancy
* Receiving primary medical oncology care at MSKCC medical oncology outpatient clinics
* Receiving cytotoxic chemotherapy not on a clinical trial (or a new hormonal therapy in the case of prostate cancer patients only), with treatment expected to continue for at least four weeks from the time of enrollment
* Signed informed consent and Research Authorization

Exclusion Criteria:

* ECOG performance status greater than 2
* Unable to read and comprehend English language text
B: Core study:

Inclusion Criteria:

* an established diagnosis of epilepsy;
* drug refractoriness, defined as persistence of seizures after adequately applied treatment(s) with one or more appropriate AEDs at maximally tolerated doses, excluding treatments whereby idiosyncratic reactions prevented titration to usually effective dosages;
* at least one seizure during the previous 6 months while at steady state on the currently used AED regimen;
* written informed consent.

Exclusion Criteria:

- not seizures during the previous 6 months

Inclusion Criteria for a subgroup of patients, who took part in a randomized assessment:

* age \>16 years;
* no progressive disorder;
* ability to complete the Adverse Profile AEP questionnaire;
* an AEP score \>=45

Exclusion criteria:

* age \<16 years;
* progressive disorder;
* inability to complete the Adverse Profile AEP questionnaire;
* an AEP score \<45
C: Inclusion Criteria:

* General hospital inpatients with risky drinking (AUDIT-C \>= 4/5 (women/men) and AUDIT \< 20)

Exclusion Criteria:

* Patients already recruited during an earlier hospital stay
* Patients physically and mentally not capable of participating in the study
* Patients with a hospital stay of less than 24 hours
* Patients with insufficient language/ reading skills
* Patients employed at one of the departments participating in the study or conducting the study
* Patients with more severe alcohol problems (AUDIT \>= 20)
D: Inclusion Criteria:

Veterans with heart failure (HF) treated at the VA Louis Stokes (Cleveland) facilities will be eligible if they have New York Heart Association (NYHA) Class II-III diastolic or systolic HF noted by inpatient or outpatient ICD-9 codes.

Exclusion Criteria:

Veterans treated at the VA Louis Stokes (Cleveland) facilities will be ineligible if they:

* have a serious mental illness or cognitive dysfunction, e.g., psychosis, dementia, or active substance abuse (alcohol and/or other drugs);
* do not speak English fluently;
* are receiving palliative care due to advanced HF or other health problems;
* receive the majority of their HF care from providers outside of the VA;
* are unable to use a telephone to respond to weekly automated self-management support calls; or
* are unable to nominate an eligible informal caregiver.

Answer: B