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Six Item Cognitive Impairment Test

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1361. ELND005 in Patients With Mild to Moderate Alzheimer's Disease

of the six items range from 0 to 3; hence the total score is between 0 and 18. Higher scores suggest greater cognitive impairment. Change in Neuropsychiatric Inventory (NPI) Score From Baseline to Week 78 (Full Analysis Set; FAS) [ Time Frame: Baseline and 78 weeks ] The NPI is used to obtain information on the presence of severity of neuropsychological symptoms, and was specifically designed for use in Alzheimer's disease subjects. The scale consists of 12 items with each item having outcomes from 0 (...) weeks ] The NTB assessment is comprised of 9 instruments that measure cognition and executive function. Three of these tests measure immediate memory, next three measure delayed memory, and remaining three assess executive function. The total score is a weighted mean of the nine tests, referred to as the Z-score. Typically, scores range from -3 and 3, with lower scores suggesting greater cognitive impairment. Additional Analysis of Primary Outcome Measure: Change From Baseline to Week 78

2007 Clinical Trials

1362. Re-Evaluation of GAmma3 Intramedullary Nails in Hip Fracture (REGAIN)

osteodystrophy, or osteomalacia). Moderate or severe cognitively impaired patients (i.e., Six Item Screener with three or more errors). Patients with Parkinson's disease (or dementia) severe enough to increase the likelihood of falling or severe enough to compromise rehabilitation. Likely problems, in the judgment of the investigators, with maintaining follow-up. We will, for example, exclude patients with no fixed address, those who report a plan to move out of town in the next year, or intellectually (...) to trial protocol, confirm or refute our anticipated ability to achieve close to 100% follow- up, assess our ability to maintain 100% data quality, field test our case report forms for clarity and appropriateness, and to determine whether we can successfully manage the logistics of coordinating trial activities across multiple sites. This trial is a pilot, multi-center, concealed randomized controlled trial. Surgeons will use one of the two surgical strategies in patients who have sustained

2007 Clinical Trials

1363. Memory and Attention Problems in Lupus: New Treatment Trial With Modafinil

endorsement of ≥6 items on the Cognitive Symptoms Inventory (CSI). The CSI is a 21-item, self-report questionnaire designed to assess ability to perform everyday activities in patients with rheumatic disease.47 No physical or mental disabilities that would preclude or confound the results of the neuropsychological testing, e.g., compromised use of hands, severe visual or hearing impairment Able to read normal newsprint and hear a normal speaking voice Normotensive at time of enrollment with or without (...) quality of life. Thus, treatment of decreased cognitive performance in SLE when it occurs, no matter how mild, and regardless of its potential for permanence or progression, is of paramount importance. It is imperative to provide SLE patients with cognitive performance difficulties with the means to functionally cope with their impairments so that they can maintain, if not regain their independence. Modafinil is a safe, orally administered wakefulness-promoting agent approved for use in adults

2006 Clinical Trials

1364. Prospective Research in Memory Clinics (PRIME)

questionnaire test that is used or the assessment of dementia patients' cognitive impairment. Evaluation of points are as follows: 24 to 30 = no cognitive impairment, 18 to 23 = mild cognitive impairment, 0 to 17 = severe cognitive impairment. Lower scores indicate worsening. The Alzheimer's Disease Assessment Scale (cognitive total score) [ Time Frame: Baseline, 3, 6, 12, 24 and 36 months ] Alzheimer's Disease Assessment Scale is consists of 11 items, which assess memory, language and praxis, and can (...) be administered independently of the non-cognitive portion. The total score ranges between 0 (best) and 70 (worst), with eight of the eleven items scoring between 0 (no impairment) and 5 (most impairment), and three of the items scoring from 0 to 8 (orientation questions), 0 to 10 (word recall) and 0 to 12 (word recognition). Higher scores indicate worsening The Clock Drawing Test (total score) [ Time Frame: Baseline, 3, 6, 12, 24 and 36 months ] The Clock Drawing Test is a simple and reliable measure

2006 Clinical Trials

1365. The Effect of the Patient Activation Measure on Chronic Care

and older (Adult, Older Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: active VNS CHOICE patient on one of the 22 Intervention or Control teams at the start of the intervention period, in care for less than or equal to 730 days, a formal diagnosis of HTN (using appropriate ICD codes recorded in the patient record), and English speaking. Exclusion Criteria: moderate or severe cognitive impairment as measured by a six-item short portable mental status (...) by: Weill Medical College of Cornell University Study Details Study Description Go to Brief Summary: We will test - in a chronically ill managed long term care population - the effectiveness of an intervention that provides nurse Care Managers with an inventory of evidence-based practices tailored to patients with different levels of knowledge, skills and confidence to engage in self-care management. Specifically, we will develop a "change package" of evidence-based hypertension (HTN) management

2006 Clinical Trials

1366. An Open Label Phase I/II Study of the Safety and Dopamine Transporter Binding Properties of C-11 Altropane in Normal Human Subjects and in Subjects With ADHD

either a HR+ or Siemens Biograph 64 PET/CT camera. Secondary Outcome Measures : Neuropsychological tests [ Time Frame: Examination of cognitive-neuropsychological functioning will take approximately 2.5 hours to complete. ] Cognitive-neuropsychological functioning will be examined by selected tests that are thought to reflect basic deficits in ADHD, mainly those believed to measure components of attention and prefrontal brain systems. Genotyping [ Time Frame: A sample of blood (2 tablespoons (...) prior to PET scan. Subjects receiving psychotropic medication. Any clinically significant abnormality in the screening laboratory tests, vital signs, or 12-lead ECG, outside of normal limits. Any woman of childbearing potential who is seeking to become pregnant or suspects that she may be pregnant. Subjects with a known recent history (within the past six (6) months) of illicit drug or alcohol dependence. Contacts and Locations Go to Information from the National Library of Medicine To learn more

2006 Clinical Trials

1367. Study on the Tolerability of Duloxetine in Depressed Patients With Parkinson's Disease

Score [ Time Frame: baseline, 12 weeks ] The PDQ-39 has 39 items. Higher scores reflect lower quality of life. The PDQ-39 has eight subscales: mobility (10 items), activities of daily living (six items), emotional wellbeing (six items), stigma (four items), social support (three items), cognition (four items), communication (three items), and bodily discomfort (three items). Items in each subscale, as well in the total scale, can be summarized into an index and transformed linearly to a 0-100 scale (...) . Change From Baseline to 12 Weeks on the UKU (Udvalg for Kliniske Undersogelser: Committee for Clinical Investigations) Side Effect Rating Scale [ Time Frame: baseline, 12 weeks ] Clinician-rated scale, providing side effect ratings of psychopharmacological medications. 48 items, each item is rated on a 4-point scale (0=not present; 1=mild; 2=moderate; 3=severe). The test is divided in 6 subscales, total scores for each subscale are calculated based on a weighted secondary scoring system. Subscales

2007 Clinical Trials

1368. Preserving Function in Breast Cancer Patients

patients undergoing chemotherapy at the Norris Cotton Cancer Center in Lebanon, NH. Criteria Inclusion Criteria: Females, age > 18 years. First breast cancer diagnosis, Stages 1-3. Beginning the second chemotherapy cycle. English speaking and literate. Exclusion Criteria: Previous or concurrent malignancy, except for non-melanotic skin cancers. Lifetime diagnosis of schizophrenia or bipolar disorder. Moderate-severe cognitive impairment indicated by a score < 3 on a 6-item cognitive screener. Contacts (...) cancer patients undergoing adjuvant treatment randomly assigned to PST or to usual care. The intervention group will receive weekly phone-based PST sessions for six consecutive weeks. The specific aims of this R03 small grant application are to:1) Test the feasibility of enrolling and retaining newly diagnosed breast cancer patients in a clinical trial to assess telephone-based PST. 2) Collect preliminary data on outcome measures of function to determine effect size estimates that will inform power

2007 Clinical Trials

1369. Beyond Ageing Project: A Study for the Prevention of Depression

seven-day period. Cognitive impairment [ Time Frame: Baseline, 12-, and 48-month followups. ] The modified Telephone Interview of Cognitive Status has a max. total score= 39, and comprises 4 domains: orientation; recent memory and delayed recall; attention; and, semantic memory. It has excellent discrimination in cognitive performance in the general population. Processing speed was measured (Brief Test of Adult Cognition-Telephone) with the task to count backwards quickly from 100 by 1's for 30 (...) of Sydney Commonwealth Scientific and Industrial Research Organisation, Australia Information provided by (Responsible Party): Dr Janine Walker, Australian National University Study Details Study Description Go to Brief Summary: The purpose of this study is to determine whether folate and vitamin B12, physical activity and mental health literacy can prevent depression, and folate and vitamin B12 and physical activity can prevent cognitive impairment in older people. Also the study aims to assess

2005 Clinical Trials

1370. Topiramate in the Treatment of Posttraumatic Stress Disorder in Civilians

the Efficacy and Safety of Topiramate in the Treatment of Posttraumatic Stress Disorder in Civilians Study Start Date : October 2001 Study Completion Date : March 2004 Resource links provided by the National Library of Medicine related topics: available for: Arms and Interventions Go to Outcome Measures Go to Primary Outcome Measures : The primary efficacy variable for this study will be the change of the 17-item total severity score of the CAPS from baseline to the last visit of Double-Blind Phase (...) the study research staff using the contacts provided below. For general information, Layout table for eligibility information Ages Eligible for Study: 19 Years to 64 Years (Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: Yes Criteria Inclusion Criteria: Subjects must have a diagnosis of PTSD as defined by DSM-IV for at least six months, supported by the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID-I). Subjects must be female between 19 and 64 years of age, inclusive

2005 Clinical Trials

1371. Coaching to Improve Care of Cancer Pain

visit (audio-taping); and then two, six, and 12 weeks after the visit (phone interview). In addition to assessing effectiveness of the intervention, the study is designed to measure potential mediators and intermediate outcomes (attitudes, beliefs, self-efficacy, patient participation, quality of care, and adherence) and to examine the mechanisms underlying the intervention's beneficial effects. The study will contribute to a test of Social Cognitive Theory by examining whether the benefit (...) beneficial therapy. The proposed project is valuable in that it will confirm the benefit of patient coaching, elucidate its mechanisms, and test Social Cognitive Theory. The proposed model will enlarge existing research on pain management in that it is: a (1) pilot tested, easily implementable intervention that is (2) applicable in the outpatient setting, (3) based on strong theory that makes predictions about mechanisms of benefit, and (4) focused on patient activation as well as education. Study Design

2006 Clinical Trials

1372. Selective Estrogen Receptor Modulators

and serotonin pathways in a similar fashion to conjugated estrogen. A study (Nickleisen et al 1999) on the effect of Raloxifene on cognition in healthy, postmenopausal women found a slight increase in verbal memory performance after one month of high dose treatment, while no other differences were found after 12 months of treatment. There are no studies in women with cognitive impairment where a treatment effect would be more likely to be apparent. Similarly, there are no clinical studies to date (...) Measures Go to Primary Outcome Measures : PANSS score at trial completion (12 weeks) [ Time Frame: baseline, week 2,4,6,8,10,12 ] Secondary Outcome Measures : MADRS score at trial completion (12 weeks) [ Time Frame: baseline, week 2,4,6,8,10,12 ] Cognitive Test scores at trial completion (12weeks) [ Time Frame: baseline and week 12 ] Adverse Symptom Checklist score at trial completion (12 weeks) [ Time Frame: baseline, week 2,4,6,8,10,12 ] Hormone level change over study duration (12 weeks) [ Time

2006 Clinical Trials

1373. Non-Pharmacological Interventions on Sleep in Post-Acute Rehabilitation

Behavioral: Active control Not Applicable Detailed Description: The purpose of this study is to perform a randomized controlled trial to test whether a multicomponent, nonpharmacological intervention improves sleep/wake patterns and functional recovery among older people (N = 214) undergoing post-acute rehabilitation. The intervention will combine: 1) structured sleep assessment, 2) patient education in key elements of cognitive behavioral strategies to improve sleep, and 3) environmental interventions (...) cognitive impairment not enrolled within one week of admission to rehabilitation unit too ill to participate and planned discharge to a nursing home for total nursing care Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00333619 Locations Layout table

2006 Clinical Trials

1374. Safety And Efficacy Of Ziprasidone In Adolescents With Schizophrenia

or guardian) to assess 17 distinct symptom areas to derive an index of depression severity. Discrepancies between informants' responses resolved by using most impaired rating given by valid informant. Impaired Schoolwork (Item 1) assesses school function for the subgroup of subjects reported to be in school. Rated on a 7-point scale; range from 1 (no impairment) to 7 (indicates greater impairment). Change From Baseline in CNS Vital Signs Cognitive Test Battery (Includes Sedation Item): Subscales [ Time (...) Frame: Baseline, Week 6, ET ] A computerized subject-administered test battery with subtests for verbal and visual memory, processing speed, nonverbal reasoning, executive functioning, working memory, and sustained attention. A computerized 7-point sedation item (0 [not sleepy] to 10 [very sleepy]) was completed prior to test battery. The Neurocognitive index score was derived from subtest scores per an algorithm. The index score and subtest scores assessed the subject's changes in cognition. Scores

2005 Clinical Trials

1375. Mifepristone Used to Treat Patients With Non-psychotic Major Depressive Disorder Referred for Bilateral Electroconvulsive Therapy (ECT)

treatment may reduce cortisol levels and reduce the incidence of cognitive impairment observed after ECT. Condition or disease Intervention/treatment Phase Depression Drug: Mifepristone Drug: Placebo Oral Capsule Not Applicable Detailed Description: Patients referred to the Stanford ECT Service who provide informed consent for this study will be screened for eligibility. Day -4 to 0: Screening (visit 1) will occur three to six days prior to the first ECT treatment. Screening procedures will include (...) Mifepristone and ECT appear to normalize hyperfunctioning of the hypothalmic-pituitary-adrenal (HPA) axis, which has been found among patients with major depression referred for ECT. The combination of these two treatments in major depression may lead to a more rapid clinical response than ECT alone. Additionally, there appears to be a connection between pre-ECT higher cortisol levels due to HPA axis hyperfunctioning and post-ECT cognitive impairment. Administration of mifepristone prior to and during ECT

2006 Clinical Trials

1376. CJD (Creutzfeldt-Jakob Disease) Quinacrine Study

impairment. In about 10 minutes it samples functions including arithmetic, memory and orientation. A score greater than or equal to 25 points (out of 30) indicates a normal cognition. Lower scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-24 points) cognitive impairment. Low to very low scores correlate closely with the presence of dementia, although other mental disorders can also lead to abnormal findings on MMSE testing. Barthel Score Change After 2 Months [ Time Frame (...) of time and physical assistance required to perform each item are considered in scoring each item. For subjects unable to return for month-2 visit, Barthel Index was performed via telephone. Change in Clinical Dementia Rating Scale Sum of Boxes (CDRS-SB) After 2 Months [ Time Frame: Baseline, 2 months ] Clinical Dementia Rating Scale Sum of Boxes (CDRS-SB). The CDR is obtained through semistructured interviews of patients and informants, and cognitive functioning is rated in 6 domains of functioning

2005 Clinical Trials

1377. Coordinating Center for Enhancing ADRD Caregiving

Condition – problem solving training Procedure: REACH for TLC (Telephone Linked Computer) system Not Applicable Detailed Description: Six sites (Boston, Birmingham, Memphis, Miami, Palo Alto, and Philadelphia) developed and evaluated a variety of multi-component interventions for family caregivers of persons with Alzheimer’s Disease (AD) at the mild or moderate level of impairment. The multi-component interventions implemented across the six sites included: 1) Individual Information and Support (...) . Specifically, REACH has two goals: to test the effectiveness of multiple different interventions and to evaluate the pooled effect of REACH interventions overall. REACH grew out of a National Institute of Health (NIH) initiative that acknowledged the well-documented burdens associated with family caregiving as well as the existence of promising family caregiver interventions reported in the literature. Condition or disease Intervention/treatment Phase Dementia Alzheimer Disease Procedure: Skill Training

2005 Clinical Trials

1378. Ehlers-Danlos Syndrome

, and is usually diagnosed before the age of 2 years. Fragility, bruising and sagging are severe, but healing is not impaired. Diagnosis requires extreme skin fragility and the characteristic craniofacial features, plus either one other major criterion or three minor criteria. Confirmatory testing is needed for diagnosis. Major criteria Extreme skin fragility with congenital or postnatal skin tears. Characteristic craniofacial features. Redundant, almost lax skin, with excessive skin folds at wrists and ankles (...) subtypes and within subtypes. They are described in more detail below. There is some symptom overlap with and . The first presentation, at birth, may be premature rupture of the membranes. Investigations [ ] In the case of hEDS, diagnosis is normally made on the clinical presentation, by a specialist with expertise in the area. Molecular genetic testing is now recommended for the definitive diagnosis of the other subtypes, although not all patients with the specific condition will demonstrate

2008 Mentor

1379. Raloxifene and Rimostil for Perimenopause-Related Depression

as a 17 item Hamilton Depression score greater than or equal to 10. Subjects will be excluded if they meet any of the following criteria: major depression of greater than moderate severity, DSM-IV criteria # 9 (suicide), or anyone requiring immediate treatment after clinical assessment or functional impairment ratings of five or six for more than seven consecutive days on daily ratings; Evidence of perimenopausal reproductive status; Age 40 to 60; No prior hormonal therapy for the treatment (...) in this protocol: 1) Severe major depression with any of the following: positive (threshold) response to SCID major depression section item # 9, suicidal ideation; anyone requiring immediate treatment after clinical assessment; severity ratings greater than moderate on the SCID IV interview; functional impairment ratings of five or six for more than seven consecutive days on daily ratings. 2) Current treatment with antidepressant medications. Our main concern is to exclude subjects taking medications

2002 Clinical Trials

1380. Randomized, Double-Blind, Placebo-Controlled Trial of Nimodipine for the Neurological Manifestations of HIV-1

., rash, headache, gastrointestinal symptoms, nausea, dyspnea, muscle pain or cramp, acne) of nimodipine. SECONDARY: To assess the efficacy of nimodipine in stabilizing the progression of HIV-Associated Motor / Cognitive Complex by improvement in neuropsychological test performance, peripheral neuropathy, or other neurologic manifestations. HIV-infected patients may develop a condition known as HIV-Associated Motor / Cognitive Complex (also known as AIDS dementia complex) that causes damage (...) with clarithromycin, azithromycin, amikacin, ethambutol, clofazimine, ciprofloxacin, and rifampin for disseminated Mycobacterium avium infection. Maintenance therapy for opportunistic infections (e.g., PCP, MAI, CMV). Patients must have: Documented HIV infection. HIV-Associated Motor / Cognitive Complex. Acceptable neurological and neuropsychological impairment scores. Estimated premorbid IQ of 70 or greater, consistent with completion of the sixth grade or ability to read at the sixth grade level. Current

1999 Clinical Trials

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