How to Trip Rapid Review

Step 1: Select articles relevant to your search (remember the system is only optimised for single intervention studies)

Step 2: press

Step 3: review the result, and maybe amend the or if you know better! If we're unsure of the overall sentiment of the trial we will display the conclusion under the article title. We then require you to tell us what the correct sentiment is.

3,430 results for

Periodic Limb Movement

by
...
Latest & greatest
Alerts

Export results

Use check boxes to select individual results below

SmartSearch available

Trip's SmartSearch engine has discovered connected searches & results. Click to show

3001. Treatment of Shoulder Subluxation in Chronic Stroke Patients

stimulation because of excessive adipose tissue; Presence of other unrelated shoulder problems; Severe hemineglect ( patient is unable to acknowledge or answer questions about the involved limb) Cancer or other serious illness, including a disease other then stroke resulting in dysfunction of movement. Subject is currently enrolled in another clinical trial or research study that involves therapy or intervention to the upper limb. Contacts and Locations Go to Information from the National Library (...) , functional activity, spasticity/tone, subject satisfaction and pain) which may reveal secondary benefits of treatment with BIONs. The investigation is expected to last up to 21 weeks for each study participant. The study will be completed over a 5-year period. Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 30 participants Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose

2008 Clinical Trials

3002. Sleep in Osteoarthritis Project

, with no major medical or psychiatric illness known to disturb sleep or cause pain Exclusion Criteria: Sleep disorders other than insomnia (e.g., obstructive sleep apnea, periodic limb movement disorder, etc.) Apnea/Hypopnea Index (AHI) of greater than 15 Significant rheumatologic or painful disorders other than knee OA (including fibromyalgia, rheumatoid arthritis, neuralgia, etc.) Any major medical diseases known to impact sleep or cause pain (including chronic obstructive pulmonary disease, diabetes (...) than or equal to 1 Experiences knee pain more than 5 days per week for more than 6 months Reports at least typical arthritic pain (a score of at least 2 out of 10, with 0 being no pain and 10 being the most extreme pain imaginable) Patients taking non-steroidal anti-inflammatory drugs (NSAIDs) or acetaminophen must be on a stable dose for at least 1 month prior to study entry Not scheduled for arthroplasty or surgery during projected period of study participation For participants with insomnia

2007 Clinical Trials

3003. [Trial of device that is not approved or cleared by the U.S. FDA]

Probable diagnosis of a current sleep disorder including but not limited to insomnia, sleep apnea, restless legs syndrome, or periodic limb movement disorder History of current or recent (e.g. within past 5 years) alcohol, narcotic or any other drug abuse as defined by the Diagnostic and Statistical Manual of Mental Disorders of the American Psychiatric Association, 4th Edition (DSM-IV) Currently works night shift or rotating shift Travel or planned travel across more than 1 time zone within one week (...) and females Able and willing to provide written informed consent Self reported habitual bedtime between 2100 and 0100 hours, which does not vary by more than 1 hour at least 5 nights per week Self reported 7.5-9 hrs. habitual sleep time Able to commit to 9 hrs of sleep opportunity throughout the study, but especially for the 3 nights prior to their PSG Pass Berlin questionnaire, i.e. low likelihood of sleep disordered breathing No history or evidence of RLS(restless leg syndrome) /PLMS (periodic limb

2007 Clinical Trials

3004. Efficacy of Ramelteon on Speeding Up Sleep in Subjects With Delayed Sleep Phase Syndrome

), hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematological, or metabolic disease, as determined by the investigator. Has a probable current diagnosis of another circadian rhythm disorder or a sleep disorder other than Delayed Sleep Phase Syndrome that is the primary cause of insomnia. Had an apnea hypopnea index greater than 10 on the first night of Polysomnography Screening. Has periodic limb movements during sleep with arousal index greater than 10 as seen on the first (...) non-wake epochs divided by 2). Total Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 6-7) [ Time Frame: Nights 6-7 ] The sum of all of the minutes of Stages 1, 2, 3, 4, and rapid eye movement (REM) sleep. Total Sleep Time Over a 2-night Average Measured by Polysomnography (Nights 13-14) [ Time Frame: Nights 13-14 ] The sum of all of the minutes of Stages 1, 2, 3, 4, and REM sleep. Sleep Efficiency Over a 2-night Average Measured by Polysomnography (0-3 Hours) (Nights 6-7

2008 Clinical Trials

3005. Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hibâ„¢

: Day 0 up to Day 7 post-vaccination ] Solicited injection site reactions: Tenderness, Erythema, and Swelling; Systemic reactions: Fever (Temperature), Vomiting, Crying, Somnolence, Anorexia, and Irritability. Grade 3 reactions are defined as: Tenderness - cries when injected limb is moved or the movement of the injected limb is reduced; Erythema and Swelling - ≥ 5cm; Fever - temperature ≥ 39.5ºC; Vomiting - ≥6 episodes per 24 hours; Crying - inconsolable crying for >3 hours; Somnolence - sleeping (...) if appropriate (independent witness mandatory if parent is illiterate) Able to attend all scheduled visits and to comply with all trial procedures Exclusion Criteria: Participation in another clinical trial in the 4 weeks preceding the trial vaccination Planned participation in another clinical trial during the present trial period Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term (for more than 2 weeks) systemic corticosteroid therapy within the preceding 3 months Known

2007 Clinical Trials

3006. A Study of Purified Human Antibodies Administered Subcutaneously to Patients With Multifocal Motor Neuropathy (MMN)

and right side) muscle groups, each rated between 0 (no movement) to 5 (normal movement/power). A higher MRC sum score indicates greater muscle contraction/limb movement. Positive values for change in MRC sum score indicate improvement, with a more positive value indicating greater muscle contraction/ limb movement compared with the value at baseline. Mean Overall MRC Score at Baseline and Week 24 [ Time Frame: Baseline and week 24 ] The 200-point MRC sum score is the sum of scores for 20 bilateral (...) (left and right side) muscle groups, each rated between 0 (no movement) to 5 (normal movement/power). A higher MRC sum score indicates greater muscle contraction/limb movement. Secondary Outcome Measures : Change From Baseline to Week 24 in Disability [ Time Frame: Baseline to week 24 ] The change in disability score was determined at week 24 compared to baseline using descriptive statistics and nonparametric two-sided 95% confidence intervals based on the Hodges-Lehmann method. Data for one

2008 Clinical Trials

3007. Tai Chi Effects on Chronic Insomnia in Breast Cancer Survivors: Immune Mechanisms

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 (apnea-hypopnea index >15) or periodic limb movements during sleep (myoclonic index with arousal >15) as assessed by PSG; Presence of another sleep disorder (e.g., Advanced or Delay Sleep Phase Syndrome) Current or History of another major psychiatric disorder Cognitive impairment as suggested (...) at pre-treatment, during midtreatment, post-treatment, 3-month follow-up and 12-month follow-up. At all 5 assessment periods, indices of sleep quality as measured by sleep diaries and clinical ratings will be obtained along with measures of mood, health functioning, proinflammatory cytokine activity and heart rate variability (HRV). The pre-treatment and post-treatment assessment periods will also include all-night polysomnography along with nocturnal sampling of proinflammatory cytokine activity

2008 Clinical Trials

3008. Safety of Ramelteon in Subjects With Mild to Moderate Obstructive Sleep Apnea

or has substantially altered their exercise routine within 30 days prior to Day 1 of study medications. History of seizures, sleep apnea, restless leg syndrome, period limb movement disorder, other known sleep disorders, schizophrenia, bipolar disease, mental retardation, or cognitive disorder. History of psychiatric disorder within the past 12 months. History of drug addiction or drug abuse within the past 12 months. History of alcohol abuse within the past 12 months and/or regularly consumes 4 (...) Saturation Means for Non-Rapid Eye Movement Sleep Stage. [ Time Frame: Periods 1 and 2. ] Oxygen Saturation Means for Rapid Eye Movement Sleep Stage. [ Time Frame: Periods 1 and 2. ] Percentage of oxygen saturation is less than 80%. [ Time Frame: Periods 1 and 2. ] Latency to Persistent Sleep. [ Time Frame: Periods 1 and 2. ] Total Sleep Time. [ Time Frame: Periods 1 and 2. ] Sleep Efficiency. [ Time Frame: Periods 1 and 2. ] Awake Time after Persistent Sleep. [ Time Frame: Periods 1 and 2. ] Number

2008 Clinical Trials

3009. Safety of Ramelteon in Subjects With Mild to Moderate Chronic Obstructive Pulmonary Disease

within three months prior to Day 1 of study medication, or has flown across greater than three time zones within seven days prior to screening. Participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to Day 1 of study medications. History of seizures, sleep apnea, restless leg syndrome, period limb movement disorder, other known sleep disorders, schizophrenia, bipolar disease, mental retardation, or cognitive disorder. History of psychiatric (...) Measures Go to Primary Outcome Measures : Mean Oxygen Saturation during sleep for the entire night. [ Time Frame: Periods 1 and 2. ] Secondary Outcome Measures : Mean Oxygen Saturation for each hour of the night. [ Time Frame: Periods 1 and 2. ] Mean Oxygen Saturation for awake Time Sleep Stage. [ Time Frame: Periods 1 and 2. ] Mean Oxygen Saturation for Nonrapid Eye Movement Sleep Stage. [ Time Frame: Periods 1 and 2. ] Mean Oxygen Saturation for Rapid Eye Movement Sleep Stage. [ Time Frame: Periods 1

2008 Clinical Trials

3010. Safety and Efficacy of Ramelteon in Healthy Subjects

is longer. Sleep schedule changes required by employment (eg, shift worker) within three months prior to the administration of single-blind study medication. Flown across greater than three time zones within 21 days prior to or during screening. Participated in a weight loss program or has substantially altered their exercise routine within 30 days prior to the administration of single-blind study medication. Ever had a history of seizures, sleep apnea, restless leg syndrome, periodic limb movement (...) Revised, or regularly consumes more than 14 alcoholic drinks per week, or consumes any alcoholic drinks 2 hours prior to bedtime. History of drug abuse within the past 12 months. Current neurological, hepatic, renal, endocrine, cardiovascular, gastrointestinal, pulmonary, hematologic, or metabolic disease. Apnea hypopnea index (per hour of sleep) greater than 10. Periodic leg movement syndrome with arousal index (per hour of sleep) greater than 10 as seen on the polysomnography screening night

2008 Clinical Trials

3011. A Phase III Study of Eszopiclone in Patients With Insomnia (Study SEP 190-150)

-alcohol) dependence and abuse Anorexia nervosa Bulimia nervosa Anti-social personality disorder Participants with pharmacologically induced insomnia (drug-induced insomnia). Participants with comorbid primary sleep disorders (circadian rhythm disorder, restless legs movement syndrome, periodic limb movement disorder, sleep apnea syndrome, etc.) other than primary insomnia. Participants with symptoms that significantly disturb sleep such as pain, fever, diarrhea, frequent micturation, and cough (...) tablet and 1 tablet of placebo 2 mg daily by mouth at bedtime for 24 weeks. Dose escalation occurred after 4 weeks of treatment. Participants received 1 mg placebo tablet additionally to maintain blind until the end of study treatment. Other Name: SEP-190 Outcome Measures Go to Primary Outcome Measures : Incidence of Adverse Events [ Time Frame: Up to 25 weeks (24 weeks treatment period & 1 week follow-up) ] Incidence of adverse events was defined as: (number of participants with adverse events

2008 Clinical Trials

3012. A Phase II/III Study of SEP-190 (Eszopiclone) in Patients With Primary Insomnia (Study 190-126)

consecutive PSG days, or objective wake time during sleep of more than or equal to 20 minutes for 2 consecutive PSG days Exclusion Criteria: Participants with comorbid primary sleep disorders (e.g., circadian rhythm disorder, restless limb syndrome, periodic limb movement disorder, sleep apnea syndrome), other than primary insomnia. Participants with insomnia caused by pharmacological actions (drug-induced insomnia). Participants with comorbid sleep disorder associated with other disease(s (...) Phase 3 Detailed Description: This is a multicenter, randomized, double-blind, placebo-controlled, 5-way cross-over study to investigate and evaluate the efficacy of eszopiclone in Japanese participants with primary insomnia. The treatment period consists of two consecutive days (two nights) as one term. Patients will receive oral eszopiclone (1, 2, 3 mg), zolpidem tartrate (10 mg), or placebo once daily at bedtime for each use. Participants were randomly assigned to one of 10 prespecified treatment

2008 Clinical Trials

3013. Bracing and Strengthening for Posterior Tibial Tendon Dysfunction

. Participants increased resistance by using thera-bands with higher levels of resistance over the 12 week period. The amount of resistance was progressed according to patient tolerance at each visit. Strengthening exercises were preceded by the control stretching exercises which constituted a "warm up." Other: Stretching exercises Subjects were provided with written descriptions and pictures demonstrating 2 range-of-motion exercises which included a wall calf stretch, and a supine ankle active range (...) ] A 3 dimensional foot kinematic model including the tibia, calcaneus (hindfoot), 1st metatarsal, 2-4th metatarsals and hallux was used to measure foot movement. Six infrared cameras (Optotrak Motion Analysis System, Northern Digital Inc, CAN), synchronized with force plate data (Model 9286, Kistler, Switzerland), were used to collect kinematics (60 Hz) and force (1000 Hz) data with the Motion Monitor software Version 7.24 (Motion Monitor, Innsport Training Inc, USA). Anatomically based coordinate

2008 Clinical Trials

3014. CPAP Therapy in Patients With Heart Failure and Obstructive Sleep Apnea.

inhibitors(SSRI), neuroleptic, narcotic or other medications which may alter sleep or sleep-disordered breathing central sleep apnea other primary sleep disorder (i.e. periodic limb movement with arousal >5 events/hr, narcolepsy, rapid eye movement (REM) behaviour disorder) requiring supplemental oxygen therapy at night debilitating daytime somnolence (indicating clear-cut indication for CPAP therapy) a previous cardiac transplant a large transmural scar defined on previous perfusion imaging(severe

2008 Clinical Trials

3015. Safety and Feasibility of Sodium Oxybate in Mild Alzheimer's Disease Patients

of a sleep disorder (such as sleep apnea, periodic limb movements, primary insomnia, or narcolepsy) On screening polysomnogram (PSG) an apnea/hypopnea index (AHI) > 15/hr using CMS criteria, oxygen desaturation < 80%, or periodic limb movement arousal index > 10/hr. Current unstable major medical or psychiatric disorder (unrelated to dementia) A history of succinic semialdehyde dehydrogenase (SSADH) deficiency History of seizure disorder or major affective disorder History of substance abuse Poor gait (...) and coordination Currently taking CNS depressants, stimulants, or other medications in the opinion of the investigator that may affect sleep architecture (other than approved AI therapy). Consistent with study drug labeling, patients taking sedative/hypnotics and unable to washout of those medications at least 7 half-lives prior to completion of initial screening will be excluded. Typically consume > 600 mg caffeine in a 24 hour period and/or unwilling to refrain from caffeine consumption within 4 hours

2008 Clinical Trials

3016. Cortical GABA Concentrations in Insomnia

disorders previously identified as related to other conditions including sleep disordered breathing, restless leg syndrome, periodic limb movement disorder, chronic pain, gastro-esophageal reflux disease, sleep paralysis, nocturnal seizures, nocturia, enuresis; also narcolepsy and REM behavior disorders (assessed by clinical interview and Harvard Center and Cognition Habitual Sleep Survey). Inclusion Criteria for Depressed Subjects: Males or females between the ages of 25 and 55 years Clinical diagnosis (...) including sleep disordered breathing, restless leg syndrome, periodic limb movement disorder, chronic pain, gastro-esophageal reflux disease, sleep paralysis, nocturnal seizures, nocturia, enuresis; also narcolepsy and REM behavior disorders. Inclusion Criteria for Healthy Control Subjects: Males or females between the ages of 25 and 55 years No lifetime history of psychopathology or insomnia (current SOL < 30mins, ISI < 4, TST > 6.5 hrs) At low risk for depression (e.g., no first degree relative

2008 Clinical Trials

3017. The Effect of Sodium Oxybate on Sleep Architecture

alcohol withdrawal AST/ALT >2 times ULN, INR >2 or T bilirubin > 1.5 Current or prior use of sodium oxybate in the -past 30 days. Hypernatremia with a serum sodium >150 Current use of the following hypnotics: barbiturates, melatonin, zolpidem, eszopiclone, or zaleplon Use of neuromuscular blocking agents Allergy to sodium oxybate Known succinic semialdehyde dehydrogenase deficiency History of periodic limb movement disorder. A prognosis considered to be hopeless (as per MICU team) Inability to obtain

2008 Clinical Trials

3018. Study Evaluating the Impact of the 13-valent Pneumococcal Conjugate Vaccine (13vPnC) in Alaskan Native Children.

proportion of participants. Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 1 [ Time Frame: Day 1 through Day 7 after vaccination 1 for Group 4 and after the single vaccination in Group 5. ] Local reactions were reported by the parent/legal guardian using a diary card. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any (redness or swelling present); Mild (0.5 centimeters [cm (...) ] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (> 7.0 cm). Participants may have been represented in more than 1 category. Percentage of Participants Reporting Pre-Specified Local Reactions: Catch-up Dose 2 [ Time Frame: Day 1 through Day 7 after vaccination 2 for Group 4 ] Local reactions were reported by the parent/legal guardian using a diary card. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Redness and swelling were scaled as Any

2008 Clinical Trials

3019. Ultrasound Guidance for Interscalene Brachial Plexus Block

: This study has been designed to assess the possible advantages of using ultrasound imaging to block the brachial plexus (i.e., nerves of the upper limb) in patients undergoing shoulder surgery. The ultrasound technique will be compared with the current gold standard, electrical nerve stimulation. The aim of this study is to define which technique is better in terms of time to onset of anesthesia. Condition or disease Intervention/treatment Phase Shoulder Orthopedic Surgery Nerve Block Procedure (...) g iv q8h Other Names: Acetaminophen Perfalgan Analgesic Drug: Morphine 5 mg im prn q1h (in the postoperative period) Other Names: Opioid Narcotic Analgesic Drug: Fentanyl 50 µg iv prn (in the intraoperative period) Other Names: Opioid Narcotic Analgesic Procedure: General anesthesia Will be given in case of block failure and/or patient discomfort intractable with fentanyl during the procedure. The technique will be left at the discretion of the attending anesthesiologist. Monitored anesthesia

2008 Clinical Trials

3020. Evaluate the Maintenance of Effect After Long-term Treatment With Sativex® in Subjects With Symptoms of Spasticity Due to Multiple Sclerosis

. In the arm the three movements are; pinch grip, elbow flexion and shoulder abduction and the three leg movements are, ankle dorsiflexion, knee extension and hip flexion. The total arm/leg score is then the addition of the score for the three arm/leg movements. One point is then added to each limb score so that the maximum score is 100 points. The higher the score the better the limb movement. Timed 10-metre Walk. [ Time Frame: Week 2 and Week 5 ] The time taken to travel 10 metres. Daily Sleep Disruption (...) receiving long-term benefit from treatment with Sativex®. Condition or disease Intervention/treatment Phase Spasticity Multiple Sclerosis Drug: Sativex Drug: Placebo Phase 3 Detailed Description: This five week (one week baseline and four weeks randomised treatment period), multi-centre, placebo controlled, parallel group, randomized withdrawal study will evaluate the maintenance of effect after long-term treatment with Sativex® in subjects with symptoms of spasticity due to MS who have been receiving

2008 Clinical Trials

To help you find the content you need quickly, you can filter your results via the categories on the right-hand side >>>>