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Periodic Limb Movement

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3101. Body Weight Regulation in Patients With Narcolepsy

(for women only) Use of any experimental drug or current participation in another research protocol Chronic amphetamines in the last 2 months and any drug known to influence the autonomic nervous system including appetite suppressants Excessive daytime sleepiness (EDS) related to: Sleep apnea Periodic limb movements Substance disorder or alcohol consumption Any concurrent psychiatric, neurological, neoplastic, endocrinologic, or infectious disease that may contribute to EDS Insufficient sleep (less than (...) tests and procedures over 5 weeks before resuming medications. Blood draw for genetic studies. Collection of a cerebrospinal fluid sample. Diet to keep subjects' weight constant. Activity watch, using a device worn on the wrist to measure amount of movement, and an activity monitor worn at the waist to measure physical activity and caloric expenditure. Questionnaires about sleepiness, symptoms, food intake, exercise and mood. 24-hour urine collection and 24-hour blood draw to measure hormones

2006 Clinical Trials

3102. Cognitive-Behavioural and Hypnotic Treatment of Chronic Primary Insomnia Among the Elderly

. Exclusion Criteria: use of hypnotic medication the last 4 weeks before project start use of antidepressive or antipsychotic medications signs of dementia or other serious cognitive impairment defined by a score under 25 on the Mini-Mental State Examination presence of a major depressive disorder or other severe mental disorder as identified by a clinical assessment based on The Structured Clinical Interview for DSM-IV (SCID-I) presence of sleep apnea defined as (A/H index > 15) or periodic limb (...) movements during sleep (PLM index with arousal > 15), working nightshifts and unable or unwilling to discontinue this work pattern, willingness or inability to stop taking sleep medication before start having a serious somatic conditions preventing further participation 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

2006 Clinical Trials

3103. Residual Effects of Zolpidem Tartrate Extended Release and Eszopiclone Vs Placebo

, hematological, neurologic or psychiatric disease, any acute infectious disease or signs of acute illness, and myasthenia gravis Any disorder initiating or maintaining sleep such as Obstructive Sleep Apnea, Insomnia, Restless Leg Syndrome, Periodic Limb Movement Disorder, Circadian Rhythm Disorder and Parasomnia Frequent headaches and/or migraine, recurrent nausea and/or vomiting (more than twice a month). Symptomatic hypotension, whatever the decrease of blood pressure, or asymptomatic postural hypotension (...) ). The flurazepam arm always comes last due to the long washout period associated with it. The other 3 arms are randomized. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Enrollment : 36 participants Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Primary Purpose: Treatment Official Title: Investigation of Psycliomotor and Cognitive Residual Effects After Single Oral Doses of Zolpidem Tartrate Extended Release 12.5 mg

2006 Clinical Trials

3104. A Trial to Evaluate the Effects of Rotigotine Transdermal Patch on Early Morning Motor Impairment and Sleep Disorders Idiopathic Parkinson's Disease

diagnosis of narcolepsy, sleep apnea syndrome, rapid eye movement (REM) behavior disorder, restless legs syndrome, or periodic limb movement disorder. 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): NCT00243945 Locations Layout table for location (...) with rotigotine transdermal patches. Trial medication will be titrated to an optimal daily dose, or to the maximal dose. Following a Titration period of up to 8 weeks, subjects will be maintained on the optimal or maximal dose for 4 weeks. After the Maintenance period, subjects will have the option to enter into an open-label extension study. The first subject was enrolled in December 2004. The last subject was enrolled in April 2005 and the last subject visit was conducted in July 2005. This study is now

2005 Clinical Trials

3105. Adult Polysomnography Primary Insomnia Cross Over Study (0928-049)(TERMINATED)

, bipolar disorder or psychotic disorder Difficulty sleeping due to other medical condition History of narcolepsy, circadian rhythm sleep disorder, parasomnia, sleep apnea, periodic limb movements or restless legs syndrome History of neoplastic malignancy within the last 5 years Positive alcohol breath test during the screening visits 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

2007 Clinical Trials

3106. Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Infants

); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more than 1 category. Percentage of Participants Reporting Pre-Specified Systemic Events [ Time Frame: During the 4-day period after each dose ] Systemic events (fever ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C (...) of 13vPnC given at 3, 5 and 11 months of age. Active Comparator: 2 7-valent pneumococcal conjugate vaccine Biological: 7 valent pneumococcal conjugate vaccine Single 0.5 mL dose of 7vPnC given at 3, 5 and 11 months of age. Outcome Measures Go to Primary Outcome Measures : Percentage of Participants Reporting Pre-Specified Local Reactions [ Time Frame: During the 4-day period after each dose ] Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present

2006 Clinical Trials

3107. Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants.

of age) ] Percentage of Participants Reporting Pre-Specified Local Reactions [ Time Frame: During the 4-day period after each dose ] Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig) (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod) (2.5 to 7.0 cm); Severe (>7.0 cm). Participants may be represented in more (...) than 1 category. Percentage of Participants Reporting Pre-Specified Systemic Events [ Time Frame: During the 4-day period after each dose ] Systemic events (fever [Fv] ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased [Decr] appetite, irritability, increased [Incr] sleep, decreased sleep, hives, use of medication [Med] to treat symptoms [sx], and use of medication to prevent symptoms) were reported using an electronic diary. Participants may

2006 Clinical Trials

3108. Impact of Different Dialysis on Sleep Apnea in Patients With Renal Failure

to Primary Outcome Measures : Reduction in apnea hypopnea index after a treatment period of three months of hemodiafiltration; scored on overnight polysomnography Secondary Outcome Measures : Generic Quality of life specific quality of life related to sleep apnea specific quality of life related to Restless leg syndrome 24 hour blood pressure control Periodic limb movement indices Validity of a positive screening sleep study specific quality of life related to sleep Upper airway neuronal afferent (...) in kidney failure. It has been used successfully in Europe for over 15 years. However, the effects of hemodiafiltration on sleep apnea in dialysis patients have never been assessed. We are conducting a clinical trial to examine the effects of hemodiafiltration on sleep apnea in dialysis patients. Fifteen patients with sleep apnea, already on dialysis will be treated with hemodiafiltration 3 times a week, instead of their regular hemodialysis treatment for a period of 3 months. We will repeat sleep

2006 Clinical Trials

3109. Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. Percentage of Participants Reporting Pre-Specified Local Reactions [ Time Frame: During the 4-day period after each dose ] Local reactions were collected using an electronic diary. Tenderness (Tender)was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 (...) centimeters [cm] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (Sev) (>7.0 cm). Participants may be represented in more than 1 category. Percentage of Participants Reporting Pre-Specified Systemic Events [ Time Frame: During the 4-day period after each dose ] Systemic events (fever [fv] ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased [decr] appetite, irritability, increased [incr] sleep, decreased sleep, hives, use of medication [med] to treat symptoms

2006 Clinical Trials

3110. Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants.

and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod)(2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may be represented in more than 1 category. Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) [ Time Frame: Day 1 through 4 after each dose ] Systemic events (any fever ≥ 38 degrees Celsius [C], decreased appetite, irritability, increased sleep, decreased sleep (...) Volunteers: Yes Criteria Inclusion Criteria: Aged 2 months (56 to 112 days) at time of enrollment. Available for entire study period and whose parent(s) or legal guardian(s) could be reached by telephone. Healthy infant, as determined by medical history, physical examination, and judgment of the investigator. Parent(s) or legal guardian(s) had to be able to complete all relevant study procedures during study participation. Exclusion criteria: Previous vaccination with licensed or investigational

2006 Clinical Trials

3111. Efficacy, Safety and Tolerability of Rotigotine Nasal Spray for the Acute Treatment of RLS Symptoms

severity scale, where 0=not severe and 10=very severe. Average PLMWI (Periodic Leg Movement Index During Wakefulness) After Single Dose of Rotigotine Nasal Spray or Matching Placebo. [ Time Frame: 4 hours post-treatment period at each treatment day ] The Periodic Limb Movement (PLM) during Wakefulness Index (PLMWI) measures the number of limb movements per hour and indicates the frequency of PLMs when the subject is awake and the degree of motor symptoms of the disorder during wake time. No movements (...) Description: Each patient of the placebo and rotigotine group performed an Eligibility Assessment, as well 4 treatment days at which subjects performed a repeated 'Suggested Immobilization Test' (SIT) during a 30min pre-dose and a 4 hours post-dose period. During these periods the severity of RLS symptoms in the legs was assessed by the subject using a numeric symptom severity scale. In addition the leg movements were measured by actigraphy to assess the Periodic Leg Movement Index during Wakefulness

2006 Clinical Trials

3112. Phase IV Trial With Pramipexole to Evaluate Safety and Efficacy in Patients With RLS Associated With Mood Disturbances

in addition to the legs) The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night. (When symptoms are very severe, the worsening at night may (...) -I, IRLS and BDI-II responder rate, VAS score for pain in limbs, RLS-6 item scores, HADS-A score, RLS-QoL score, PGI responder rate, Adverse events profile, Systolic and diastolic blood pressure, Pulse rate [ Time Frame: 12 weeks ] Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you

2006 Clinical Trials

3113. Recovery of Hand Function Through Mental Practice.

before and after a four-week evaluation period. In this randomised controlled trial 45 patients daily mentally rehearse movements with their affected hand under close supervision. Their recovery is compared to 45 patients who perform closely supervised non-motor mental rehearsal, and 45 patients who are not engaged in a training program. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Estimated Enrollment : 135 participants Allocation: Randomized (...) : the sports literature; neurophysiological evidence; evidence from health psychology research; as well as preliminary findings using motor imagery techniques in stroke patients. There is evidence to suggest that mental rehearsal of movement can produce effects normally attributed to practising the actual movements. Imagining hand movements could stimulate the redistribution of brain activity, which accompanies recovery of hand function, thus resulting in a reduced motor deficit. Patients are assessed

2006 Clinical Trials

3114. Quetiapine for the Treatment of Insomnia in Alzheimer's Disease

liver function, cardiac arrhythmia, sitting blood pressure below 110/70 or above 140/100 or postural blood drop 20 mm Hg. Symptoms suggesting other sleep disorders (e.g., periodic limb movement disorder, restless legs syndrome, obstructive sleep apnea syndrome), may be present but in the opinion of the PI, do not account for the primary symptoms of insomnia. Sleep disturbance symptoms that suggest a parasomnia. Parasomnias may include behavioral manifestations of epileptiform activity or REM (...) and alcoholic beverages during the study period. A neuroimaging study at the time of initial diagnosis, or any time since that is consistent with AD and effectively rules out dementia related only to stroke, hydrocephalus or other neurological condition. Exclusion Criteria: Medical disorders that may account for sleep disturbance, especially delirium, Major Depressive Disorder (DSMIV) and severe or significant acute or chronic pain. Have acute or unstable medical conditions including renal failure, abnormal

2005 Clinical Trials

3115. Using Behavioral Programs to Treat Sleep Problems in Individuals With Alzheimer's Disease

in a residential home with a family member caregiver Able to walk without assistance Exclusion Criteria for Alzheimer's Disease Patients: Pre-existing diagnosis of a primary sleep disorder, such as sleep apnea or periodic limb movement disorder Blindness Current use of photosensitizing medication Inclusion Criteria for Family Caregiver: Currently caring for a family member with Alzheimer's disease Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you (...) disturbance education. Walking program participants will have three 1-hour visits with a therapist over an 8-week period. The therapist and the participant will set an initial daily walking goal and develop a plan for gradually increasing the participants' walking to 30 minutes/day, to be increased at a participant-selected pace. Pedometers will be given to participants to monitor daily activity. The therapist will also discuss exercise safety and will review ways to prevent muscle soreness. Light program

2005 Clinical Trials

3116. Walking Aids in the Management of Knee Osteoarthritis

Go to Primary Outcome Measures : Peak Vertical Force on Affected Limb [ Time Frame: Baseline and end of first intervention period (2 months) ] An in-shoe dynamic, pressure distribution system (Pedar-X System, Novel Electronics, Inc., St. Paul, MN) was utilized to measure the vertical ground reaction force at the baseline visit and at the end of the first intervention period (two months) gait evaluations for both the control arm and cane user arm. The control arm was not given a cane to use (...) at home during the two month intervention period. Peak vertical force on the affected limb was measured in the laboratory setting when both control group and cane user group walked with and without a cane at baseline and at the end of the first intervention period (2 months). Eligibility Criteria Go to Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study

2005 Clinical Trials

3117. CAFE Study

Pain in Previous 2 Weeks [ Time Frame: Baseline and 1 month ] The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain or back problems. Change in Activities of Daily Living (...) - Activities Reduced Due to Back Pain in Previous 2 Weeks [ Time Frame: Baseline, 1 month, 3 months, 6 months, and 12 months ] The Activities of Daily Living assessment comprised three questions about the effects of back pain or back problems over the previous 2-week period. The patient was asked if they had cut down on usual activities, the number of days in which the patient had cut down on usual activities and the number of days that the patient had spent at least half a day in bed because of back pain

2005 Clinical Trials

3118. Safety and Efficacy of Ramelteon in Adults With Chronic Insomnia

screening. Periodic leg movement with arousal index (per hour of sleep) >10 as seen on PSG, on the first night of PSG screening. Any additional condition(s) that in the investigator's opinion would (a) affect sleep/wake function, (b) prohibit the subject from completing the study, or (c) not be in the best interest of the subject. Had lower limb prosthetics. Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact (...) such as: Orthostatic hypotension. Dizziness. Vertigo, or benign paroxysmal positional vertigo. A history of seizures, sleep apnea, chronic obstructive pulmonary disease, restless leg syndrome, periodic leg movement syndrome, or fibromyalgia. A history of psychiatric disorder (including anxiety, depression, mental retardation, cognitive disorder, bipolar illness and schizophrenia) within the past 6 months. A history of drug addiction or drug abuse within the past 12 months. A history of alcohol abuse within

2005 Clinical Trials

3119. Study Evaluating Pneumococcal Vaccine in Healthy Infants

[ Time Frame: Within 15 days after each dose ] Local reaction events were collected using a paper worksheet. Tenderness was scaled as Any (tenderness present); Significant (Sig.) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters [cm] to 2.0 cm); Moderate (Mod.)(2.5 to 7.0 cm); Severe (Sev.)(> 7.0 cm). Participants may be represented in more than 1 category. Percentage of Participants Reporting Pre-Specified (...) of gestational age, Subject must be available for entire study period and whose parent/legal guardian can be reached by telephone, Parent/legal guardian must be able to understand and sign an informed consent form prior to participation and complete a parent worksheet during study participation. Exclusion Criteria: Previous vaccination with licensed or investigational pneumococcal vaccine, Previous vaccination with Hib conjugate, DTaP or IPV vaccines, Contraindication to immunization with HepB, Hib conjugate

2005 Clinical Trials

3120. Use of Cannabinoids in Patients With Multiple Sclerosis

of Roma La Sapienza Information provided by: S. Andrea Hospital Study Details Study Description Go to Brief Summary: This is a 10-week, randomised, double blind, placebo-controlled, crossover trial to investigate the effect of Cannabis Based Medicine Extract (Sativex) on patterns of brain activation associated with movement in 20 MS patients suffering from lower limb spasticity. Spasticity is a common symptom in Multiple Sclerosis (MS), occurring all over the course of the disease, particularly (...) ), and cannabinoids in general, can reduce muscle spasticity in people with MS. Aim of the study will be to evaluate the effect of Sativex on: (i) patterns of brain activation associated with movement (fMRI) in MS patients suffering from spasticity; (ii) changes in level of spasticity (H-reflex); (iii) changes in intracortical excitability and on synaptic intracortical network of the motor areas (double shock TMS). Condition or disease Intervention/treatment Phase Multiple Sclerosis Drug: Sativex Phase 2 Detailed

2005 Clinical Trials

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