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Periodic Limb Movement

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3081. Antihypertensive Treatment in Acute Cerebral Hemorrhage

. At least one point is given in each category. The scale ranges from 3 to 15, with 3 indicating deep unconsciousness and 15 indicating consciousness is not impaired. The National Institutes of Health Stroke Scale (NIHSS) quantifies neurologic deficits in 11 categories. Level of consciousness, horizontal eye movements, visual fields, facial palsy, movement in each limb, sensation, language and speech, and extinction or inattention on one side of the body are tested. Scores range from 0 to 42; 0 indicates (...) intervention to prevent permanent impairment or damage. Subjects were followed closely from randomization through 90 days. The initial 72-hour period was chosen as the most meaningful time period for which to examine SAEs likely to be related to the acute safety of the study treatment. Secondary Outcome Measures : Particpants Who Tolerate Rapid Systolic Blood Pressure Reduction and Maintain Treatment Goals [ Time Frame: 3 months ] The ability to maintain the Specified Systolic Blood Pressure Range

2006 Clinical Trials

3082. Comparison of a DTaP-IPV-HB-PRP~T Combined Vaccine to Infanrix™-Hexa, When Administered With Prevnar® in Thai Infants

: Pain, Erythema, and Swelling. Solicited Systemic Reactions: Pyrexia, Vomiting, Crying, Somnolence, Anorexia, and Irritability Grade 3: Pain, cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling, ≥5 cm. Grade 3: Pyrexia, >39°C; Vomiting, ≥6 episodes per 24 hours or requiring parenteral hydration; Crying, >3 hours; Somnolence, Sleeping most of the time or difficult to wake up; Anorexia, Refuses ≥3 feeds/meals or refuses most feeds/meals (...) with all trial procedures. Exclusion Criteria : Participation in another clinical trial in the 4 weeks preceding the first trial vaccination. Planned participation in another clinical trial during the present trial period. Systemic hypersensitivity to any of the vaccine components or history of a life threatening reaction to the trial vaccine or a vaccine containing the same substances. Congenital or acquired immunodeficiency, or immunosuppressive therapy such as long-term systemic corticosteroid

2006 Clinical Trials

3083. Pressure Ulcer Formation Prevention in Paraplegics Using Computer and Sensory Substitution Via the Tongue.

applied at the seat/skin interface in order to prevent the formation of pressure ulcer? We will try to demonstrate that paraplegic subject move in an appropriate matter, in term of pressure, after a movement way advised by periodical electric stimuli on the tongue. Condition or disease Intervention/treatment Phase PARAPLEGIA Device: Tongue Display Unit Phase 2 Detailed Description: The objective of this study will be, to validate or not, the possibility to inform, in a suitable way, paraplegic subject (...) . Phase II Treatment Equivalent. Study Start Date : September 2006 Actual Primary Completion Date : January 2009 Actual Study Completion Date : March 2009 Resource links provided by the National Library of Medicine related topics: resources: Arms and Interventions Go to Arm Intervention/treatment No Intervention: 2 no medical device Experimental: 1 medical device Device: Tongue Display Unit lingual electric stimulation Outcome Measures Go to Primary Outcome Measures : Difference of adapted movement

2007 Clinical Trials

3084. A Comparison of Ropinirole Immediate Release With Ropinirole Prolonged Release in Patients With Advanced Parkinson's

the duration of "off" and "on" periods. During the treatment period 2, 24 hour diary cards were completed by the participants (except for the Baseline period when four diary cards were completed). The participants completed diary cards on the same 2 days of each relevant week. Each 30 minute period was marked as either "off", "on" or asleep. Troublesome dyskinesias were involuntary twisting, turning movements which caused discomfort were also recorded. The general definition of "off" included a lack (...) twisting, turning movements which caused discomfort were also recorded. The general definition of "off" included a lack of mobility with or without additional features such as tremor or rigidity. The total number of hours spent both "off" and "on" or asleep were summed for the two (four for the Baseline Period) 24 hour diary cards and the amount of awake time spent "off" per 24 hour period was determined. Week 0 was the baseline and change from Baseline was calculated by subtracting the baseline values

2006 Clinical Trials

3085. Treatment of Insomnia in Patients With Parkinson's Disease: A Multi-site, Placebo-controlled Study of Eszopiclone

and it is not taken as a sleep aid. Other medications with CNS activity that the patient is on at screening, e.g., dopaminergic drugs, B-blockers, etc, will be kept constant throughout the acute phase. Exclusion Criteria: Evidence on PSG and symptoms or complaints (as defined below) of, significant sleep disordered breathing (central or obstructive apnea), periodic limb movement disorder (PLMD), or REM sleep behavior disorder (RBD). Significant sleep disordered breathing will be defined as an AHI > 15 events/hr (...) depression or anxiety in the opinion of the investigator. Any current (within three months) diagnosis of alcohol or substance abuse/dependence (with the exception of nicotine dependence). Currently on psychotropic medications, other than antidepressants or benzodiazepines. If the patient is on other psychotropics, and can be safely removed from these medications at the time of initial screening, there will be a washout period prior to entering the study. Sleep medication that the patient is on during

2006 Clinical Trials

3086. Efficacy and Safety of Ramelteon in Subjects With Mild to Moderate Alzheimer's Disease

or vascular dementia. History of severe renal dysfunction or disease. History of cancer, other than basal cell carcinoma, that has not been in remission for at least 5 years prior to the first dose of study drug. (This criterion does not include those subjects with basal cell or Stage 1 squamous cell carcinoma of the skin.) Any clinically significant movement disorder including but not limited to: akinesia, periodic limb movement disorder, restless leg syndrome, epilepsy, uncontrolled Parkinson's disease (...) with no planned move during the entire investigation period. Residing in the same residence with a responsible spouse, family member, or a professional caregiver who is present during the night who would agree to assume the role of the principal caregiver for the duration of the protocol period. Able to ingest oral medication and participate in all scheduled evaluations. Clinical laboratory evaluations (including clinical chemistry, hematology, and urinalysis) within the reference range as tested

2006 Clinical Trials

3087. The Efficacy and Safety of Electronic Stimulation in Patients Who Underwent Reconstruction of the Anterior Cruciate Ligament

Underwent Reconstruction of the Anterior Cruciate Ligament (ACL) Resource links provided by the National Library of Medicine related topics: Arms and Interventions Go to Outcome Measures Go to Primary Outcome Measures : the outcome measure is muscle weakness and atrophy (after six weeks) measured by isometric device Secondary Outcome Measures : range of movement measured by protractor swelling measure by physical examination stability of the knee measure by KT1000 knee history measure by IKDC2000 (...) for Study: 18 Years to 40 Years (Adult) Sexes Eligible for Study: All Accepts Healthy Volunteers: No Criteria Inclusion Criteria: Males and females between 18-40 years old. Subjects who are planning to undergo ACL surgery. The surgery is performed within 3 weeks - 5 years since the injury. Ability to follow instructions during the study period. Signed Informed Consent. Exclusion Criteria: Bi-lateral surgery of the knee Recurrent ACL surgery (patients who already underwent ACL surgery) Complex injuries

2006 Clinical Trials

3088. A Treatment Study Comparing Two Non-Drug, Self-Help Treatment of Chronic Insomnia.

at least 3 days per week Exclusion Criteria: Body Mass Index greater than 32 Presence of anxiety disorder Secondary forms of insomnia Presence of a substance use disorder Concurrent treatment for another mental disorder History of other sleep disorders, including: apnea, restless legs, periodic limb movement disorder, or narcolepsy 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

2006 Clinical Trials

3089. Ipratropium Spray for Drooling Saliva in Parkinson's Disease

. All patients are recruited from the Movement Disorders Clinic, Toronto Western Hospital and informed consent is obtained. Patients are randomised to receive ipratropium bromide, 1- 2 metered doses (sprays) of active drug (21 micorgram per metered dose) or matching placebo, up to a maximum of 4 times per day, in a double-blind, cross-over design using randomisation tables. Total treatment length is two weeks for each limb of the study with a 1-2 week wash out period. The primary outcome measure (...) be on a stable medication regimen for the preceding one-month run-in period. In addition, patients or a caregiver must be able to complete a daily record card, and patients must be able to tolerate an oral dental roll for 5-minute periods for saliva measurements. Exclusion Criteria: Patients taking acetylcholinesterase inhibitors, cholinergic agents, or anticholinergic agents, history of glaucoma, clinically significant urinary outflow obstruction or urinary retention, active psychosis or hallucinations

2006 Clinical Trials

3090. Chronic Sleep Deprivation as a Risk Factor for Metabolic Syndrome and Obesity

sleep duration [Intervention Group] or maintain sleep duration [Comparison Group]. CPAP treatment that has been in place for 3 months or more and improves sleep is acceptable). Restless leg syndrome or periodic limb movement disorder Parasomnias (including REM sleep behavior disorders, confusional arousals, sleep terrors, sleepwalking, sleep violence) Primary bruxism is allowed as long as it does not interfere with the ability to sleep an additional 90 minutes a night Narcolepsy Central apnea (...) societies attach an economic value to maximizing the waking period to the longest tolerable limit by sleeping as little as possible. Average sleep time has decreased over the last century by 2 hours. Chronically sleeping less has been associated with increased weight, endocrine and metabolic health risks including glucose intolerance, cardiovascular disease, and mortality. The possibility that the current epidemic of obesity and metabolic health risks may be partially related to insufficient sleep

2005 Clinical Trials

3091. Immunogenicity Study of Antibody Persistence and Booster Effect of PENTAXIMâ„¢ at 18 Months in Healthy Argentinean Infants

to Day 30 post-booster vaccination ] Solicited Injection Site Reactions: Pain, Erythema, Swelling. Solicited Systemic Reactions: Pyrexia (Temperature), Vomiting, Crying, Somnolence, Anorexia, Irritability. Grade 3 was defined as: Pain, cries when injected limb is moved or movement of limb is reduced; Erythema and Swelling, ≥ 5 cm; Pyrexia, ≥ 39.6ºC; Vomiting, ≥ 6 episodes/24 hour or requiring parenteral hydration; Crying, > 3 hours; Somnolence, sleeping most of the time or difficulty to wake up (...) , conjugated to tetanus protein (DTaP-IPV-HB-PRP~T) or PENTAXIM™ and ENGERIX B® PEDIATRICO at 2, 4, and 6 months of age Written informed consent form signed by at least one parent or by a legal representative and an independent witness Able to attend all scheduled visits and to comply with all trial procedures. Exclusion Criteria: Participation in another clinical trial in the four weeks preceding the trial vaccination Planned participation in another clinical trial during the present trial period

2006 Clinical Trials

3092. Behavioral Treatment of Insomnia in Aging

Criteria: Evidence that insomnia is directly related to a medical disorder (e.g., hyperthyroidism) or effects of a medication that affects sleep structure and/or immune functioning Presence of sleep apnea or periodic limb movements during sleep Presence of another sleep disorder (e.g., Advanced or Delay Sleep Phase Syndrome) Regular use of a hypnotic or psychotropic medication (sleeping pills) and/or current psychotherapy or other behavioral therapy that would confound CBT or TCC Current history (...) practice and skill application. Experimental: TCC Behavioral: Tai Chi Chih (TCC) Participants will learn and practice 20 movements in 1 hour sessions twice per week for 16 weeks Active Comparator: SS Behavioral: Sleep Seminar (SS) Each 2-hour session, held once a week for 16 weeks, consists of a 60-minute video presentation followed by a 60-minute question-and-answer discussion. Outcome Measures Go to Primary Outcome Measures : Changes in insomnia symptoms as measured by subjective report and objective

2006 Clinical Trials

3093. Effect of Atomoxetine on ADHD-Related Insomnia in Children and Adolescents

or legal guardian willing to participate in the study Exclusion Criteria: Have any other primary sleep disorder(s) (e.g. obstructive sleep apnea or periodic limb movement disorder) Have a history of significant chronic medical (e.g. diabetes, severe asthma) or psychiatric (e.g. depression) illness Have a history of chronic use of sedating (e.g. antihistamines) or alertness enhancing (e.g. caffeine) medications Have a history of failure to respond to an adequate (defined as appropriate dose and adequate (...) sleep, but it could potentially improve ADHD symptoms as well. The main purpose of this study is to examine the effects of atomoxetine on ADHD-related insomnia. Atomoxetine (Strattera®) is a non-stimulant drug used to treat ADHD symptoms in both children and adults, and there is evidence that it may also have a positive effect on sleep in children with ADHD. During the study, participants will receive either atomoxetine or placebo for a period of four weeks. We expect that the effects of atomoxetine

2005 Clinical Trials

3094. Effectiveness of Physiotherapy on Postcesarean Pain and Functional Activities

functional activities are evaluated by daily 0-10 cm visual analogue scales (VASs). Also, intensities of back pain, low back pain, headache, bloated feeling of the abdomen, and fatigue are also evaluated by daily VASs. Physiotherapy program included breathing exercises, active joint movements of the lower limbs, posture exercises, connective tissue manipulation and transcutaneous electrical nerve stimulation. Study Design Go to Layout table for study information Study Type : Interventional (Clinical (...) a physiotherapy intervention group and a control group. Physical characteristics, obstetrical and surgical histories, and systemic problems, back pain, low back pain, headache, urinary/fecal incontinence problems and bowel habit of the subjects both in pregnancy and postpartum periods are recorded. First ambulation time after cesarean, presence of syncope, related vital signs, onset time of bowel peristalsis and defecation are also recorded. Intensities of incisional pain and difficulty in performing

2006 Clinical Trials

3095. Measures of Motor Impairment in Early Parkinson's Disease

. They will be trained to perform the task and transmit data on a weekly basis. Outcome measures: We will analyze time-related changes in several domains of motor function (tremor, limb bradykinesia, fine motor bradykinesia, voice, reaction time/movement time) and correlate these changes with the UPDRS at 3 and 6 months. We hypothesize that patients will find this assessment technology easy to use, a positive force in their lives, and that they will be committed to the program throughout its duration. Further, we (...) a technician come to their homes to set up the equipment, check on it periodically, and remove it at study end. EXCLUSION CRITERIA: Patients who have comorbid neurological or psychiatric disorders (even if they don't require medications). Patients who have had Parkinson's disease for more than 5 years. Patients who have another movement disorder (Progressive supranuclear palsy, Multiple system atrophy, drug-induced parkinsonism, Lewy body dementia). Disruptive non-compliance with requirements of the study

2006 Clinical Trials

3096. Improving Sleep and Psychological Functioning in People With Depression and Insomnia

form of contraception for the duration of the study Uncontrolled symptoms of menopause, including hot flashes Uncontrolled hypertension (systolic blood pressure consistently greater than 140 mm Hg, diastolic blood pressure consistently greater than 90 mm Hg) Diagnosis of sleep apnea, periodic limb movement disorder, or restless leg syndrome Reports habitual bedtime earlier than 9 PM or later than 1 AM more than 2 times per week Reports habitual rising time later than 9 AM more than 2 times per week (...) , in addition to fluoxetine. All treatments will be given for 8 weeks. Participants will attend study visits at various points throughout the treatment phase. Follow up visits will occur periodically over the next 4 months. Assessments will include physiological measures during sleep, mood, suicidal thinking, quality of life and actigraphy, which measures the amount of movement during sleep. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment

2005 Clinical Trials

3097. A Sleep Lab Trial to Investigate the Efficacy and Safety of Transdermal Rotigotine in Subjects With Idiopathic Restless Legs Syndrome

Recruitment Status : Completed First Posted : January 11, 2006 Last Update Posted : September 25, 2014 Sponsor: UCB Pharma Information provided by: UCB Pharma Study Details Study Description Go to Brief Summary: The objective of this trial is to demonstrate that rotigotine (SPM 936) is effective in subjects with idiopathic RLS based on the PLMI (Periodic Limb Movements Index)(PLMs/total time in bed) as measured by polysomnography (PSG). The primary variable is the reduction of PLMI at the end (...) -group, Sleep Lab Trial to Investigate the Efficacy and Safety of Transdermal Rotigotine in Subjects With Idiopathic Restless Legs Syndrome Study Start Date : November 2005 Actual Primary Completion Date : July 2006 Actual Study Completion Date : July 2006 Resource links provided by the National Library of Medicine related topics: related topics: available for: Arms and Interventions Go to Outcome Measures Go to Primary Outcome Measures : Efficacy is assessed by reduction of Periodic Limb Movement

2006 Clinical Trials

3098. mCIMT and Eye Patching for Neglect Rehabilitation Post Stroke: A Longitudinal Study of Separate and Combined Effects

on motor, attentional, and activities of daily living functions in stroke patients with unilateral neglect (UN). UN represents a failure to respond or orient to stimuli presented contralateral to a brain lesion. Constraint-induced movement therapy is made up of a family of treatment that involve repeatedly practicing use of the affected limb and constraining use of the unaffected arm in the clinic and at home. mCIMT is an intervention based on modifications to conventional CIMT by distributing practice (...) by National Taiwan University Hospital. Recruitment status was: Recruiting First Posted : November 15, 2005 Last Update Posted : December 21, 2005 Sponsor: National Taiwan University Hospital Information provided by: National Taiwan University Hospital Study Details Study Description Go to Brief Summary: The purpose of the current study is to evaluate relative efficacy of (1)modified constraint-induced movement therapy (mCIMT) combined with eye patching, (2)mCIMT, and (3) traditional rehabilitation

2005 Clinical Trials

3099. A Randomized Placebo Controlled Study to Show That Rasagiline May Slow Disease Progression for Parkinson's Disease

treatment and will not require for the next 9 months. Willing and able to give informed consent. Exclusion Criteria: Subjects younger than 30 or older than 80 years. Subjects with loss of postural reflexes. Subjects with UPDRS Tremor score of 3 or greater in any limb. Subjects with Hoehn &Yahr Stage III or greater at screening. Subjects with freezing while walking. Subjects with any of the following features that tend to exclude PD as the cause of Parkinsonism: History of repeated strokes with stepwise (...) (including anticholinergics) for less than 3 weeks during the 3 month period prior to baseline. (not including a single L-Dopa dose as part of L-Dopa test) Subjects having used any other anti-PD medication (including anticholinergics) for less than 3 weeks prior to the 3 month period preceding baseline whose anti-PD medication is intentionally ceased in order for the subject to enter the study. Subjects who have a clinically significant or unstable medical or surgical condition that may preclude safe

2005 Clinical Trials

3100. Efficacy Study of LY2422347 to Treat Insomnia

) or periodic limb movement disorder (PLMD) cannot have obstructive sleep apnea (OSA), or be considered by the study doctor to have probable OSA based upon patient history and physical examination cannot be currently using antidepressants, antipsychotics, stimulants, antihistaminics, or other medications that are known to effect sleep cannot have a current or previous major psychiatric disorder (other than insomnia) such as depression, schizophrenia, bipolar disorder, social anxiety, or another psychotic

2005 Clinical Trials

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