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Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug494 | BNT162b3 Wiki | 0.23 |
| drug480 | BLZ945 Wiki | 0.23 |
| drug2980 | Placebo oral capsule; From August 2020 'no additional treatment' Wiki | 0.23 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1330 | Early Aggressive Therapy or Traditional Therapy Wiki | 0.23 |
| drug64 | 40mg of MitoQ Wiki | 0.23 |
| drug2705 | Online support Group Wiki | 0.23 |
| drug3068 | Prednisolone 5 mg Wiki | 0.23 |
| drug844 | Cannabis, Medical Wiki | 0.23 |
| drug3642 | Skin biopsy Wiki | 0.23 |
| drug3920 | TeleCAM Wiki | 0.23 |
| drug43 | 20 mg MitoQ Wiki | 0.23 |
| drug3338 | Repository Corticotropin Injection Wiki | 0.23 |
| drug3682 | Spasticity Take Control Wiki | 0.23 |
| drug3961 | Testing of SARS-CoV-2 antibodies Wiki | 0.23 |
| drug1322 | ESPRIMO Wiki | 0.23 |
| drug3790 | Stretching for People with MS: An Illustrated Manual Wiki | 0.23 |
| drug3493 | SPIN-CHAT Program Wiki | 0.23 |
| drug4692 | rDirectCAM Wiki | 0.23 |
| drug1240 | DirectCAM Wiki | 0.23 |
| drug3383 | Rituximab Wiki | 0.16 |
| drug493 | BNT162b2 Wiki | 0.13 |
| drug492 | BNT162b1 Wiki | 0.13 |
| drug3364 | Rifampin Wiki | 0.11 |
| drug614 | Blood sampling Wiki | 0.09 |
| drug3204 | Questionnaires Wiki | 0.07 |
| drug2916 | Placebo Wiki | 0.04 |
| drug421 | Azithromycin Wiki | 0.04 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D009103 | Multiple Sclerosis NIH | 0.81 |
| D000690 | Amyotrophic Lateral Sclerosis NIH | 0.40 |
| D020529 | Multiple Sclerosis, Relapsing-Remitting NIH | 0.40 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| D016472 | Motor Neuron Disease NIH | 0.40 |
| D012595 | Scleroderma, Systemic NIH | 0.32 |
| D012594 | Scleroderma, Localized NIH | 0.23 |
| D000070627 | Chronic Traumatic Encephalopathy NIH | 0.23 |
| D005879 | Tourette Syndrome NIH | 0.23 |
| D005221 | Fatigue NIH | 0.19 |
| D001049 | Apnea NIH | 0.16 |
| D009128 | Muscle Spasticity NIH | 0.16 |
| D001714 | Bipolar Disorder NIH | 0.16 |
| D012640 | Seizures NIH | 0.13 |
| D000755 | Anemia, Sickle Cell NIH | 0.11 |
| D005356 | Fibromyalgia NIH | 0.10 |
| D020181 | Sleep Apnea, Obstructive NIH | 0.10 |
| D001927 | Brain Diseases NIH | 0.10 |
| D012891 | Sleep Apnea, NIH | 0.10 |
| D000070642 | Brain Injuries, Traumatic NIH | 0.08 |
| D010300 | Parkinsonian NIH | 0.08 |
| D015212 | Inflammatory Bowel Diseases NIH | 0.08 |
| D003424 | Crohn Disease NIH | 0.07 |
| D001930 | Brain Injuries, NIH | 0.06 |
| D059350 | Chronic Pain NIH | 0.06 |
| D040921 | Stress Disorders, Traumatic NIH | 0.04 |
| D014947 | Wounds and Injuries NIH | 0.04 |
| D013313 | Stress Disorders, Post-Traumatic NIH | 0.04 |
| D004194 | Disease NIH | 0.04 |
| D013577 | Syndrome NIH | 0.02 |
| D003141 | Communicable Diseases NIH | 0.02 |
| D011014 | Pneumonia NIH | 0.01 |
| D007239 | Infection NIH | 0.01 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.01 |
| D018352 | Coronavirus Infections NIH | 0.01 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0006802 | Abnormal anterior horn cell morphology HPO | 0.40 |
| HP:0007354 | Amyotrophic lateral sclerosis HPO | 0.40 |
| HP:0012344 | Morphea HPO | 0.23 |
| Name (Synonyms) | Correlation | |
|---|---|---|
| HP:0012378 | Fatigue HPO | 0.19 |
| HP:0002104 | Apnea HPO | 0.16 |
| HP:0001257 | Spasticity HPO | 0.16 |
| HP:0100754 | Mania HPO | 0.16 |
| HP:0001250 | Seizure HPO | 0.11 |
| HP:0002870 | Obstructive sleep apnea HPO | 0.10 |
| HP:0010535 | Sleep apnea HPO | 0.10 |
| HP:0001298 | Encephalopathy HPO | 0.10 |
| HP:0002037 | Inflammation of the large intestine HPO | 0.08 |
| HP:0100280 | Crohn's disease HPO | 0.07 |
| HP:0012532 | Chronic pain HPO | 0.06 |
| HP:0002090 | Pneumonia HPO | 0.01 |
Navigate: Correlations HPO
There are 19 clinical trials
Multiple sclerosis (MS) is an inflammatory, demyelinating disease which affects the central nervous system (CNS). The etiology of MS is unknown, although the immune system appears to play a role. Many different infectious agents have been proposed as potential causes for MS, including Epstein-Barr virus, human herpesvirus 6, and coronaviruses. Recently Dr. Sriram at Vanderbilt University has found evidence for active Chlamydia pneumonia infection in the CNS of MS patients. These findings have been replicated in part by other laboratories. The purpose of the current study is to test whether antibiotic treatment aimed at eradicating Chlamydia infection will reduce the disease activity in MS. The primary outcome measure will be reduction in new enhancing MS lesions on brain MRI. Forty patients will be entered into the trial. To be eligible, patients must have evidence of chlamydia infection in their spinal fluid and enhancing lesions on their pre-randomization MRI scans. Patients who meet these criteria will be randomized to either placebo or antibiotic therapy, and followed for 6 months on treatment.
The purpose of this study is to compare the effects of two delivery models of an evidence-based complementary alternative medicine (CAM) program that combines neurorehabilitative (functional) exercise, yoga, and Pilates for adults age 18-70 with multiple sclerosis (MS). CAM will be delivered as a 12-week program through two different delivery forms: On-site at a clinic (DirectCAM) and telerehabilitation (TeleCAM). Participants will be randomly assigned to one of these two groups. **On March 16th, 2020, the University of Alabama at Birmingham halted all onsite non-essential research in response to the Covid-19 pandemic. Since then, the study has begun to conduct all testing remotely through videoconferencing technology. In addition, another study group, remote DirectCAM (rDirectCAM), has been incorporated into the study to continue the 12-week program delivery for newly recruited participants via videoconferencing technology.**
Description: Measured by 36-Item Short Form Survey (SF-36).
Measure: Pain Time: 48 weeksDescription: Measured by Modified Fatigue Impact Scale (MFIS).
Measure: Fatigue Time: 48 weeksDescription: Measured by 36-Item Short Form Survey (SF-36).
Measure: Quality of life Time: 48 weeksDescription: Measured by the Godin Leisure Time Exercise Questionnaire (GLTEQ).
Measure: Physical activity Time: 48 weeksDescription: Measured using the Berg Balance Scale (BBS).
Measure: Balance Time: 48 weeksDescription: Measured using the 6-minute Walk Test (6MWT).
Measure: Endurance Time: 48 weeksDescription: Measured using the Timed 25-Foot Walk (T25-FW).
Measure: Gait Time: 48 weeksDescription: Measured using a hand-held dynamometer.
Measure: Strength Time: 48 weeksDescription: Measured by the Multidimensional Outcome Expectations for Exercise Scale (MOEES).
Measure: Outcome expectations for exercise Time: 48 weeksDescription: Measured by the Exercise Self-efficacy Scale.
Measure: Exercise self-efficacy Time: 48 weeksDescription: Measured by the Social Provisions Scale.
Measure: Social support for exercise Time: 48 weeksDescription: Measured by the Exercise Goal-setting Scale.
Measure: Exercise self-regulation Time: 48 weeksThis is a multicenter, multiple dose study to estimate the response rate, and examine the safety of H.P. Acthar® Gel (Acthar) in subjects with RRMS who have not responded to high dose steroids. Approximately 66 subjects will be randomized.
Description: The EDSS is a 10 step assessment of neurological impairment/disability in MS ranging from 0 (normal neurological examination) to 10 (death due to MS) that is completed by a blinded rater. The blinded rater will not be involved in any aspects of participant care and management other than performing the EDSS/FSS evaluations in participant in the study.
Measure: Response rate on Expanded Disability Status Scale (EDSS) at Day 42 Time: Day 42Description: Data for AE and SAE will be presented.
Measure: Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) Time: Up to Day 42Description: Data will be summarized for each visit.
Measure: Change from Baseline in diastolic/systolic blood pressures Time: Baseline and Up to Day 42Description: The MSIS-29 measures the physical (20 items) and psychological (9 items) impact of MS from the participant's perspective. This validated questionnaire will result in a total score between 29 and 145 and can provide separate scores for physical and psychological impact. The MSIS-29 will be completed by the participant at all required times points during the study except on Study Day 14 when the MSIS-29 will be administered via telephone by a call center trained in the administration of the MSIS-29 or captured via a web portal.
Measure: The response rates on Multiple Sclerosis Impact Scale Version 1 (MSIS-29) and 90% confidence intervals (CIs) Time: Days 7, 14, 21 and 42Description: The EDSS is a 10 step assessment of neurological impairment/disability in MS ranging from 0 (normal neurological examination) to 10 (death due to MS) that is completed by a blinded rater. The blinded rater will not be involved in any aspects of participant care and management other than performing the EDSS/FSS evaluations in participant in the study.
Measure: The response rates on EDSS and 90% CIs on Day 7 and Day 21 Time: Days 7 and 21Description: The CGI-I was developed for use in clinical research to provide a brief overview of the change in a participant's global function compared to baseline and regardless of study drug treatment. It requires a rating from 1 (very much improved) to 7 (very much worse).
Measure: Clinical Global Impression of Improvement Scale (CGI-I) mean scores and 90% CIs Time: Days 7, 21 and 42This study will examine the impacts of two different methods of managing MS-related spasticity of the lower limbs. Both interventions will be presented via video teleconference in group classes consisting of exercises to reduce spasticity.
Description: Impact of spasticity will be measured using the Multiple Sclerosis Spasticity Scale-88 at one month post intervention.
Measure: Impact of spasticity, measured by the Multiple Sclerosis Spasticity Scale-88 Time: One month post-interventionDescription: Severity of spasticity will be measured using the Numeric Rating Scale for Spasticity at one month post intervention.
Measure: Severity of spasticity, measured by the Numeric Rating Scale for Spasticity Time: One month post-interventionDescription: Fatigue will be measured using the Modified Fatigue Impact Scale at one month post intervention.
Measure: Fatigue, measured by the Modified Fatigue Impact Scale Time: One month post-interventionDescription: Sleep quality and quantity will be measured using Pittsburgh Sleep Quality Index at one month post intervention.
Measure: Sleep quality and quantity, measured by the Pittsburge Sleep Quality Index Time: One month post-interventionDescription: Impact on day-to-day life, measured by the Multiple Sclerosis Impact Scale-29 at one month post intervention.
Measure: Impact on day-to-day life, measured by the Multiple Sclerosis Impact Scale-29 Time: One month post-interventionDescription: Emotional Distress - Depression will be measured using PROMIS Item Bank v1.0 - Emotional Distress - Depression-Short Form 8a at one month post intervention.
Measure: PROMIS Item Bank v1.0 - Emotional Distress - Depression-Short Form 8a Time: One month post-interventionDescription: Impact on multiple sclerosis on walking, measured by the Multiple Sclerosis Walking Scale-12 at one month post intervention.
Measure: Impact on multiple sclerosis on walking, measured by the Multiple Sclerosis Walking Scale-12 Time: One month post-interventionDescription: Walking will be measured using the Timed 25 Foot Walk at one month post intervention, only if visit is in person.
Measure: Walking measured by the Timed 25 Foot Walk Time: One month post-interventionDescription: Walking and turning measured by the Timed Up and Go will be measured at one month post intervention, only if visit is in person.
Measure: Walking and turning measured by the Timed Up and Go Time: One month post-interventionDescription: Pain severity and interference measured by a modified version of the Brief Pain Inventory at one month post intervention.
Measure: Pain severity and interference Time: One month post interventionThe overarching goal of this study is to determine whether rituximab (RTX) offers effectiveness and safety advantages over other commonly used approved Disease-Modifying Drugs (DMT) in the largest real-world population-based structured prospective follow-up cohort of Relapsing-Remitting Multiple Sclerosis (RRMS) patients. The study will include both treatment naïve patients starting their first DMT and patients switching from a previous first line DMT (escalation/second-line).
Description: - Proportion of patients with baseline EDSS ≤2.5 progressing to 12 months confirmed EDSS ≥3 among those over 3 years of follow up
Measure: Confirmed disease progression in patients with Expanded Disability Status Scale (EDSS) ≤2.5 at baseline Time: 3 yearsDescription: - Proportion of patients with baseline EDSS ≥2.5 experiencing 6 months confirmed EDSS increase of 1 point among those over 3 years of follow up
Measure: Confirmed disease progression in patients with EDSS ≥2.5 at baseline Time: 3 yearsDescription: - Change in MSIS-29 over 3 years of follow up (change from baseline; mean value ±SD)
Measure: Disease-related impact on daily life Time: 3 yearsDescription: - Rate of malignancy, cardiovascular disease, serious infections and all-cause mortality in populations on therapy and ever treated, respectively
Measure: Risk and side effect assessments Time: 3-9 yearsDescription: - The occurrence of serious adverse events (SAE) of all types that are possibly or likely related to DMT treatment
Measure: Occurence of Serious Adverse Reactions Time: 3-9 yearsDescription: - Comparison of mean number of relapses per year between the different treatments
Measure: Annual relapse rate Time: 3-9 yearsDescription: - Comparison of mean number of CEL on yearly MRI between the different treatments
Measure: Number of Contrast-enhancing lesions (CEL) Time: 3-9 yearsDescription: - Comparison of yearly increase in mean and median EDSS between the different treatments
Measure: Increase in EDSS Time: 3-9 yearsDescription: - Comparison of yearly proportion of patients with at least 1 step increase in EDSS between the different treatments
Measure: Proportion of patients with at least 1 step increase in EDSS Time: 3-9 yearsDescription: - Comparison of early proportion of patients with No Evidence of Disease Activity (NEDA) -2 (free of exacerbations, new/enlarged T2-lesions and occurrence of CEL) between the treatments
Measure: Proportion of patients with No Evidence of Disease Activity (NEDA) -2 Time: 3-9 yearsDescription: - Comparison of early proportion of patients with NEDA-3 (NEDA-2 plus no worsening of EDSS from baseline) between the treatments
Measure: Proportion of patients with NEDA-3 Time: 3-9 yearsDescription: - Comparison of mean levels of Neurofilament-Light chain (NFL) in serum between the different treatments
Measure: Levels of Neurofilament-Light chain (NFL) in serum Time: 3-9 yearsDescription: - Comparison of yearly brain atrophy rate measured as per cent brain parenchymal fraction (BPF) loss in relation to baseline values between the different treatments
Measure: Brain atrophy rate Time: 3-9 yearsDescription: - Comparison of time to drug discontinuation between the different treatments. Separate analyses will be performed depending on reason to drug discontinuation, mainly side effects and lack of efficacy
Measure: Time on drug Time: 3-9 yearsDescription: Comparison of patient satisfaction with their treatment using the Treatment Satisfaction Questionnaire (TSQ) between the treatments
Measure: Treatment satisfaction Time: 3-9 yearsDescription: - Comparison of health related QoL measured by EQ-5D between the treatments
Measure: Quality of life assessments Time: 3-9 yearsDescription: Comparison of fatigue measured by the Fatigue Scale for Motor and Cognitive Functions (FSMC) between the treatments
Measure: Fatigue Time: 3-9 yearsDescription: - Estimation of total societal costs per year after initiating treatment
Measure: Health economy Time: 3-9 yearsDescription: - Proportion of patients treated with RTX developing high-titer anti-RTX ADA
Measure: Occurrence of Anti-drug antibodies (ADA) Time: 3-9 yearsDescription: - Comparison of mean number of working hours per week between the treatments.
Measure: Employment rate Time: 3-9 yearsDescription: Number of hospital and ICU admittance in people with MS compared to population
Measure: Severity assessments of COVID-19 in MS Time: 1-2 years after COVID-19 epidemicDescription: Number of hospital and ICU admittance in people with MS in relation to DMD
Measure: Severity assessments of COVID-19 in MS in relation to DMD Time: 1-2 years after COVID-19 epidemicFDA-approved multiple sclerosis (MS) disease-modifying therapies (DMTs) target the relapsing phase of MS but have minimal impact once the progressive phase has begun. It is unclear if, in the relapsing phase, there is an advantage of early aggressive therapy with respect to preventing long-term disability. The infectious risks and other complications associated with higher-efficacy treatments highlight the need to quantify their effectiveness in preventing disability. The TRaditional versus Early Aggressive Therapy for MS (TREAT-MS) trial is a pragmatic, randomized controlled trial that has two primary aims: 1) to evaluate, jointly and independently among patients deemed at higher risk vs. lower risk for disability accumulation, whether an "early aggressive" therapy approach, versus starting with a traditional, first-line therapy, influences the intermediate-term risk of disability, and 2) to evaluate if, among patients deemed at lower risk for disability who start on first-line MS therapies but experience breakthrough disease, those who switch to a higher-efficacy versus a new first-line therapy have different intermediate-term risk of disability.
Description: Time to sustained disability progression is measured by the Expanded Disability Status Scale plus (EDSS+): a composite endpoint that includes EDSS change (change at any 6 month time point of > 1.0 point if baseline EDSS is < 5.5 or of > 0.5 if baseline EDSS is > 6.0, that is sustained 6 months later) OR 20% worsening on either of two specific components of the Multiple Sclerosis Functional Composite (MSFC), the timed 25-foot walk test (T25FWT) and the nine hole peg test (9HPT) that is sustained 6 months later.
Measure: Time to sustained disability progression Time: From date of randomization until the date of first documented sustained disability progression, up to 63 monthsDescription: The change in overall burden of MS will be defined for the COVID-19 related substudy as the occurrence of breakthrough disease (relapses or new MRI activity) or the development of new (or worsening baseline) MS symptoms, which are (for TREAT-MS) and will continue to be (during the substudy) documented at clinical visits, whether in-person or on tele-visits.
Measure: Change in Overall Burden of MS Time: up to 48 weeks from enrollment into COVID-19 related substudyDescription: PDDS is a self-assessment scale of disability due to MS on a scale from 0 to 8 and will be administered as an electronic patient-reported outcome (PRO).
Measure: Patient-Determined Disease Steps (PDDS) Time: up to 63 monthsDescription: The MSFC consists of the timed 25 foot walk test, the 9-hole peg test, and the Paced Auditory Serial Addition Test (PASAT) and a composite MSFC z-score will be evaluated.
Measure: Multiple Sclerosis Functional Composite (MSFC) Composite Score Time: up to 63 monthsDescription: Time taken to complete the timed 25 foot walk test, measured twice in units of seconds, will be averaged and evaluated.
Measure: Timed 25 Foot Walk Test Time: up to 63 monthsDescription: Time taken to complete the nine-hole peg test, measured twice for each hand (dominant and non-dominant) in units of seconds, will be averaged for each hand and evaluated.
Measure: Nine-hole Peg Test Time: up to 63 monthsDescription: The paced auditory serial addition test that measures processing speed will be administered once; number and percent correct will be evaluated.
Measure: Paced Auditory Serial Addition Test (PASAT) Time: up to 63 monthsDescription: Low-contrast letter acuity (binocular, 2.5% contrast Sloan charts)
Measure: Low contrast visual acuity Time: up to 63 monthsDescription: Among participants identified to have a relapse, relapse recovery will be defined as complete or incomplete based on patient self-report.
Measure: Patient-reported incomplete relapse recovery Time: up to 63 monthsDescription: Among participants identified to have a relapse, relapse recovery will be defined as complete or incomplete based on neurologic examination (those who have increased Functional System scores, corresponding to the relapse symptoms, of 1.0 point or greater for at least 6 months after the relapse onset, without subsequent accrual of worsening in that same Functional System (e.g. more indicative of progression), will be considered to have incomplete relapse recovery).
Measure: Neurologic exam-based incomplete relapse recovery Time: up to 63 monthsDescription: The SDMT is commonly used in MS to assess processing speed and will be administered orally and used to evaluate changes in cognition throughout the study.
Measure: Cognition using Symbol Digit Modality Test (SDMT) Time: up to 63 monthsDescription: The MSIS-29 will be used to evaluate the impact of MS on the participants and will be administered as an electronic PRO.Multiple Sclerosis Impact Scale (MSIS-29) is an instrument used for measuring the physical (20 items) and psychological (nine items) impact of multiple sclerosis.
Measure: Multiple Sclerosis Impact Scale (MSIS-29) Time: up to 63 monthsDescription: The Anxiety Subscale of Neuro-QoL will be administered as an electronic PRO.
Measure: Quality of Life in Neurological Disorders (Neuro-QoL): Anxiety Subscale Time: up to 63 monthsDescription: The Depression Subscale of Neuro-QoL will be administered as an electronic PRO.
Measure: Quality of Life in Neurological Disorders (Neuro-QoL): Depression Subscale Time: up to 63 monthsDescription: The Fatigue Subscale of Neuro-QoL will be administered as an electronic PRO.
Measure: Quality of Life in Neurological Disorders (Neuro-QoL): Fatigue Subscale Time: up to 63 monthsDescription: The Upper Extremity Function Subscale of Neuro-QoL will be administered as an electronic PRO.
Measure: Quality of Life in Neurological Disorders (Neuro-QoL): Upper Extremity Function Time: up to 63 monthsDescription: The Lower Extremity Function Subscale of Neuro-QoL will be administered as an electronic PRO.
Measure: Quality of Life in Neurological Disorders (Neuro-QoL): Lower Extremity Function Time: up to 63 monthsDescription: The Cognitive Function Subscale of Neuro-QoL will be administered as an electronic PRO.
Measure: Quality of Life in Neurological Disorders (Neuro-QoL): Cognitive Function Time: up to 63 monthsDescription: The Positive Affect/Well-being Subscale of Neuro-QoL will be administered as an electronic PRO.
Measure: Quality of Life in Neurological Disorders (Neuro-QoL): Positive Affect/Well-being Time: up to 63 monthsDescription: The Sleep Disturbance Subscale of Neuro-QoL will be administered as an electronic PRO.
Measure: Quality of Life in Neurological Disorders (Neuro-QoL): Sleep Disturbance Time: up to 63 monthsDescription: The Ability to Participate in Social Roles and Activities Subscale of Neuro-QoL will be administered as an electronic PRO.
Measure: Quality of Life in Neurological Disorders (Neuro-QoL): Ability to Participate in Social Roles and Activities Time: up to 63 monthsDescription: The Satisfaction with Social Roles and Activities Subscale of Neuro-QoL will be administered as an electronic PRO.
Measure: Quality of Life in Neurological Disorders (Neuro-QoL): Satisfaction with Social Roles and Activities Time: up to 63 monthsDescription: The Stigma Subscale of Neuro-QoL will be administered as an electronic PRO.
Measure: Quality of Life in Neurological Disorders (Neuro-QoL): Stigma Time: up to 63 monthsDescription: The incidence of change in employment to "disabled" or "looking for work, unemployed," will be evaluated for all participants through an electronic PRO.
Measure: Employment status Time: up to 63 monthsDescription: Incident divorce or separation, among those who previously were married or in a domestic partnership, will be evaluated for all participants through an electronic PRO.
Measure: Marital status Time: up to 63 monthsDescription: SAEs (clinically significant infections, malignancies, or the development of other serious comorbidities, as well as unplanned hospitalizations [for non-elective issues, excluding MS relapse] and death)
Measure: Serious Adverse Events (SAEs) Time: up to 63 monthsDescription: Adverse events meaningful enough to lead to medication discontinuation
Measure: Adverse event resulting in a decision to change disease-modifying therapy Time: up to 63 monthsDescription: Severe COVID-19 infection will be defined as an outcome of "hospitalization or death" due to confirmed or suspected COVID-19 infection
Measure: Severe COVID-19 Infection Time: up to 48 weeks from enrollment into COVID-19 related substudyDescription: Changes in brain MRI measures of neurodegeneration, including whole brain and normalized gray matter volumes, cortical thickness, subcortical gray matter compartment volumes, and measures of T2 lesion burden.
Measure: Brain Magnetic Resonance Imaging (MRI) evidence of neurodegeneration Time: From 6 months after starting 1st therapy up to 63 months after randomizationDescription: The number of relapses (new or worsening neurologic symptoms lasting for 24 hours or more in the absence of fever).
Measure: Number of relapses Time: up to 63 monthsDescription: The number of new/enlarging T2-weighted hyperintense lesions and T1-weighted hypointense lesions will be quantified on each MRI scan
Measure: Number of new brain lesions on MRI Time: up to 63 monthsDescription: Retinal nerve fiber layer and ganglion cell/inner plexiform thickness will be evaluated among patients at centers and offices with access to OCT as standard of care
Measure: Retinal layer thickness by Optical Coherence Tomography (OCT) Time: up to 63 monthsDescription: As an exploratory outcome, the number of newly-prescribed or dose-escalated medications used for treating MS symptoms (including pain, weakness, numbness/tingling, trouble walking, cognitive problems, fatigue, depression, anxiety, visual dysfunction, spasticity, vertigo, or bladder/bowel/sexual dysfunction) during the trial will be evaluated using the electronic health record. In addition, non-pharmacologic interventions (and referrals to other healthcare providers) for symptom management will also be captured.
Measure: Number of new medications, escalated dosage of medications, and non-pharmacologic interventions for MS-related symptoms Time: up to 63 monthsThis is a randomised placebo-controlled study of moderate dose prednisolone for 6 months in patients with early diffuse cutaneous systemic sclerosis (dcSSc). Seventy-two patients within 3 years of the onset of skin thickening will be recruited from 14 UK centres over 3 years. Co-primary end-points will be the Health Assessment Questionnaire Disability Index (HAQ-DI) and the modified Rodnan skin score (mRSS). Patients will be assessed 5 times: screening, baseline, 6 weeks, 3 and 6 months, with a code-break on exit from the study at 6 months. Please note: From August 2020, the trial was re-started following halt due to Covid-19 as open-label. The placebo arm is the 'no treatment' arm and there is no longer a code-break at study exit.
Description: The mean difference in HAQ-DI at 3 months
Measure: Health Assessment Questionnaire Disability Index (HAQ-DI) Time: Baseline to 3 monthsDescription: The difference in mRSS at 3 months
Measure: modified Rodnan Skin Score (mRSS) Time: Baseline to 3 monthsDescription: HAQ-DI
Measure: Quality of life and functional ability - Assessed by Questionnaire Time: Baseline to 6 weeks and 6 monthsDescription: Skin involvement as measured by the mRSS
Measure: Pain and disability Time: Baseline to 6 weeks and 6 monthsDescription: 11-point Scleroderma Functional Index
Measure: Functional ability - Assessed by Questionnaire Time: Baseline to 6 weeks, 3 months and 6 monthsDescription: Assessment of Pruritus
Measure: Pain associated with itch - Assessed by Questionnaire Time: Baseline to 6 weeks, 3 months and 6 monthsDescription: Cochin Hand Function
Measure: Hand function - Assessed by Questionnaire Time: Baseline to 6 weeks, 3 months and 6 monthsDescription: Functional Assessment of Chronic Illness Therapy (FACIT)
Measure: Fatigue - Assessed by Questionnaire Time: Baseline to 6 weeks, 3 months and 6 monthsDescription: Hospital Anxiety and Depression Scale (HADS) . This questionnaire has 14 questions, each with 4 options designed to assess aspects of mental health
Measure: Anxiety and depression - Assessed by questionnaire Time: Baseline to 6 weeks, 3 months and 6 monthsDescription: Helplessness Questionnaire
Measure: Health related quality of life - Assessed by Questionnaire Time: Baseline to 6 weeks, 3 months and 6 monthsDescription: Short Form (36) Health Survey
Measure: Health related quality of life - Assessed by Questionnaire Time: Baseline to 6 weeks, 3 months and 6 monthsDescription: EuroQol 5 Dimensions
Measure: Health related quality of Life - Assessed by Questionnaire Time: Baseline to 6 weeks, 3 months and 6 monthsDescription: Patient Global Assessment
Measure: Pain and disability Time: Baseline to 6 weeks, 3 months and 6 monthsDescription: Physician Global Assessment
Measure: Pain and disability Time: Baseline to 6 weeks, 3 months and 6 monthsDescription: Digital Ulcer Count: The site and total number of ulcers on the hand are recorded by the patients clinician on a diagram of a hand
Measure: Assessment of pain - Clinician assessment Time: Baseline to 6 weeks, 3 months and 6 monthsDescription: Tender Friction Rubs - the total number of tendon friction rubs on 12 possible anatomical sites are recorded
Measure: Assessment of pain - Clinician assessment Time: Baseline to 6 weeks, 3 months and 6 monthsDescription: Joint Count: The number of tender or swollen joints are assessed from 14 anatomical sites (both left and right side) and recorded out of a total of 28 (14 sites, left and right side) tender joints and 28 swollen joints
Measure: Assessment of pain - Clinician assessment Time: Baseline to 6 weeks, 3 months and 6 monthsDescription: Assessment of Arthritis Index
Measure: Pain and disability - Assessed by Questionnaire Time: Baseline to 6 weeks, 3 months and 6 monthsDescription: Assessment in percentage change of mRSS
Measure: Pain and disability Time: Baseline to 6 weeks, 3 months and 6 monthsThis will be a multistate, multicenter clinical study to determine the efficacy and safety of medical cannabis for a wide variety of chronic medical conditions.
Description: Covid-19 infection rates in cannabis users will be compared to rates in the general population. Our online questionnaire responses will compare infection rates of cannabis users in this study against the Johns Hopkins University Coronavirus Research Center data (https://coronavirus.jhu.edu).
Measure: Prevention of COVID-19 Time: Five yearsDescription: Severity of persistent symptoms in cannabis users testing positive for active infection and/or antibodies will also be compared to the general population. Patients will answer the widely used FLU-PRO questionnaire, which asks about flu symptoms and severity, to capture diagnoses, symptoms, and medical interventions related to COVID-19. The data from cannabis user patients will be compared with national and international data surveys, such as the Covid Symptom Study (https://covid.joinzoe.com/us-2).
Measure: Treatment of COVID-19 Time: Five yearsDescription: The primary objective is to assess the efficacy and safety of medical cannabis as medicine for treatment of chronic pain and other chronic debilitating diseases. Pain will be measured by Brief Pain Inventory (BPI) numeric scale. Change from baseline in BPI will be assessed at 3-month intervals. For prospective associations between cannabis use and outcomes, use of a lagged mixed-effects models will examine temporal associations between cannabis use and pain severity, opioid sparing, and patient satisfaction. Data will be analyzed from baseline and the annual follow-up waves.
Measure: Treatment of Symptoms Time: Five yearsDescription: Secondary objectives include evaluating increases or decreases in quality of life, and increases or decreases in concomitant opioid use. Satisfaction with treatment will be measured by a Visual Analog Score (VAS). Change From baseline in Satisfaction with treatment measured by (VAS) be assessed at 3-month intervals.
Measure: Cannabis Impact on Quality of Life Time: Five yearsDescription: Tertiary objectives will examine preferences for routes of administration, and preferences for THC / CBD ratios. Categorical factors will be summarized using frequencies and percentages, while continuous measure distributions will be described using means, standard deviations, and quartiles of interest.
Measure: Cannabis Route and Dosing Time: Five yearsDescription: Incidence of Treatment-Related Adverse Events will be measured by Physician Global Assessment (PGA) numeric scale. Number of participants with Treatment-Related Adverse Events will be assessed by CTCAE v4.0.
Measure: Monitoring Adverse Events Time: Five yearsIt is an open label study to evaluate safety, tolerability and brain microglia response in participants with ALS following multiple doses of BLZ945.
Description: Volume of distribution (Vt) in different brain regions for each [11C]-PBR28 PET scan, and change after BLZ945 treatment, compared to baseline. Evaluate brain microglial reduction, as measured by reduction in TSPO binding following oral doses of BLZ945 in ALS participants by using PET imaging with [11C]-PBR28.
Measure: Change from baseline in volume of distribution (Vt) in different brain regions for [11C]-PBR28 PET scan Time: Day -42, up to Day 22Description: Measured by Cmax - The maximum plasma concentration of BLZ945
Measure: Plasma Pharmacokinetics (PK) of BLZ945 - Cmax Time: Day 1; up to Day 17Description: Measured by Tmax - Time to Reach the Maximum Concentration After Drug Administration of BLZ945
Measure: Plasma Pharmacokinetics (PK) of BLZ945 - Tmax Time: Day 1; up to Day 17Description: Measured by AUC - Area under the curve of BLZ945
Measure: Plasma Pharmacokinetics (PK) of BLZ945 - AUC Time: Day 1; up to Day 17Description: Measured by T1/2 - The elimination half-life of BLZ945
Measure: Plasma Pharmacokinetics (PK) of BLZ945 - T1/2 Time: Day 1; up to Day 17Description: Urine renal clearance (CLR) of BLZ945
Measure: Renal Clearance (CLR) of BLZ945 Time: Day 1; up to Day 7Description: To assess the CYP2C8 pharmacogenomic-pharmacokinetic relationship; CYP2C8 genotyping and BLZ945 plasma PK parameters
Measure: CYP2C8 genotyping and BLZ945 plasma PK parameters Time: Day 1; up to Day 17The purpose of this study is to determine whether MS patients who receive Oral mitoquinone (MitoQ) have less fatigue than those receiving a placebo. A comparison between patient's fatigue scored at baseline and fatigue scored 12 weeks after drug initiation will assess if MitoQ has a significant change in fatigue.
Description: MFIS is a self -reported fatigue survey. Scale 0 - 84
Measure: Modified Fatigue Inventory Scale (MFIS) Time: 12 weeksDescription: SDMT measures cognitive function. Scale 0-110
Measure: Symbol Digit Modalities Test (SDMT) Time: 12 weeksDescription: EDSS measures neurological function. Scale 0-10
Measure: Expanded Disability Status Scale (EDSS) Time: 12 weeksDescription: BDI is a self-reported questionnaire measuring depression. Scale 0-21
Measure: Beck's Depression Inventory (BDI) Time: 12 weeksContagious disease outbreaks, such as the coronavirus disease 2019 (COVID-19) outbreak, and associated restrictions to prevent spread can lead to negative psychological outcomes, including loneliness, depression, and anxiety, particularly in vulnerable populations at risk due to existing medical conditions. To date, no randomized controlled trials have tested interventions to reduce mental health consequences of contagious disease outbreaks. Systemic sclerosis (SSc; scleroderma) is a rare, chronic, autoimmune disease characterized by vasculopathy and excessive collagen production. Systemic Sclerosis can affect multiple organ systems, including the skin, lungs, gastrointestinal tract, and heart. Many people with scleroderma are at risk of serious complications from COVID-19 if infected due to lung involvement (> 40% have interstitial lung disease) and common use of immunosuppressant drugs. The objective of The Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together (SPIN-CHAT) Trial is to evaluate a videoconference-based intervention designed to improve symptoms of anxiety and other mental health outcomes among individuals with systemic sclerosis at risk of poor mental health during the COVID-19 pandemic. The trial is a pragmatic randomized controlled trial that will be conducted using an existing cohort of systemic sclerosis patients. We will use a partially nested design to reflect dependence between individuals in training groups but not in the waitlist control. The SPIN-CHAT Program includes activity engagement, education on strategies to support mental health, and mutual participant support.
Description: The PROMIS Anxiety 4a v1.0 is a 4 item scale that asks participants, in the past 7 days, how often: (1) "I felt fearful"; (2) "I found it hard to focus on anything other than my anxiety"; (3) "My worries overwhelmed me"; and (4) "I felt uneasy". Items are scored on a 5-point scale (range 1-5), and response options include "never", "rarely", "sometimes", "often", and "always". Higher scores represent more anxiety. PROMIS Anxiety 4a v1.0 has been validated in SSc.
Measure: Anxiety: Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety 4a v1.0 Time: 4-weeks post-randomizationDescription: The PROMIS Anxiety 4a v1.0 is a 4 item scale that asks participants, in the past 7 days, how often: (1) "I felt fearful"; (2) "I found it hard to focus on anything other than my anxiety"; (3) "My worries overwhelmed me"; and (4) "I felt uneasy". Items are scored on a 5-point scale (range 1-5), and response options include "never", "rarely", "sometimes", "often", and "always". Higher scores represent more anxiety. PROMIS Anxiety 4a v1.0 has been validated in SSc.
Measure: Anxiety: Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety 4a v1.0 Time: 10-weeks post-randomizationDescription: PHQ-8 items measure depressive symptoms over the last 2 weeks on a 4-point scale, ranging from 0 (not at all) to 3 (nearly every day) with higher scores (range 0 to 24) indicating more depressive symptoms. The PHQ-8 performs equivalently to the PHQ-9, which has been shown to be a valid measure of depressive symptoms in patients with scleroderma.
Measure: Depression symptoms: Patient Health Questionnaire (PHQ-8) Time: 4-weeks post-randomization, 10-weeks post-randomizationDescription: The 6-item ULS-6 is a short version of the 20-item ULS, which is designed to assess subjective feelings of loneliness and social isolation. Respondents indicate the degree to which feelings described in each item apply to them. Items are scored on a 4-point scale from 0 (never) to 3 (often); total scores range from 0 to 18.
Measure: Loneliness: University of California, Los Angeles (UCLA) Loneliness Scale (ULS-6) Time: 4-weeks post-randomization, 10-weeks post-randomizationDescription: The full MSBS is a 29-item measure of state boredom with items on five factors that load onto a single higher-order factor. The 8-item MSBS is a short version with scores that correlate very closely to scores from the full MSBS (r = 0.96) Item responses are on a 7-point Likert-type scale from 1 (strongly disagree) to 7 (strongly agree) and assess the degree to which each item reflects the respondant's experience currently. Total scores range from 8 to 56 with higher scores reflecting greater boredom.
Measure: Boredom: Multidimensional State Boredom Scale (MSBS-8) Time: 4-weeks post-randomization, 10-weeks post-randomizationDescription: The 4-item IPAQ-E is a short-form version of the full IPAQ designed to assess physical activity over the last week, including time spent sitting, walking, and in moderate and vigorous physical activity. Compared to other short-form versions of the IPAQ, the IPAQ-E has examples of exercise specific to older adults.
Measure: Physical activity: International Physical Activity Questionnaire - modified for the elderly (IPAQ-E) Time: 4-weeks post-randomization, 10-weeks post-randomizationDescription: Adverse Effects will be assessed by ongoing monitoring during the trial and by asking participants post-intervention to describe any adverse experiences or outcomes that may have occurred.
Measure: Adverse Effects Time: 4-weeks post-randomization, 10-weeks post-randomizationDescription: The COVID-19 Fears Questionnaire for Chronic Medical Conditions is a 10-item scale that ask participants to rate, on a typical day in the last week, how much they were afraid from "not at all" to "extremely" about aspects of COVID-19. Items are scored on a 5-point scale (range 1-5). Higher scores represent greater fear. The scale has been validated among people with scleroderma.
Measure: Fear: COVID-19 Fears Questionnaire for Chronic Medical Conditions Time: 4-weeks post-randomization, 10-weeks post-randomizationThe aim of the study is to understand the impact of COVID-19 on People with Multiple Sclerosis in the United Kingdom.
Description: Targeted questionnaire dependent on COVID Status
Measure: Incidence of COVID-19 Infections within an MS Cohort in the UK Time: Through study completion, an average of 1 yearDescription: Monitor admission rates in linked population
Measure: Hospitalisations in MS Patients with COVID-19 Time: 1 Year (regular outputs)Description: Death data from routinely reported government level data (HES/PEDW)
Measure: Mortality Time: 1 Year from study commencementDescription: Patient Reported Outcome for MS disability
Measure: Patient Reported Expanded Disability Status Score Time: 1 year (at least 6 monthly)Description: Patient Reported Outcome for anxiety and depression
Measure: Hospital Anxiety and Depression Scale Time: 1 year (at least 6 monthly)Description: Patient Reported Outcome for Multiple sclerosis impact on physical and psychological status
Measure: Multiple Sclerosis Impact Scale 29 V2 Time: 1 year (at least 6 monthly)Description: Patient Reported Outcome for walking status
Measure: Multiple Sclerosis Walking Scale 12 V2 Time: 1 year (at least 6 monthly)Description: Patient Reported Outcome for impact of fatigue
Measure: Fatigue Severity Scale Time: 1 year (at least 6 monthly)Description: Patient Reported Outcome for general quality of life
Measure: EuroQol 5D (3l) Time: 1 year (at least 6 monthly)Stress and anxiety can have an adverse impact on health, and the experience of many around the 2020 outbreak of COVID-19 is affecting health and well-being. Individuals with chronic disease such as multiple sclerosis may be particularly vulnerable in some ways, but also particularly resilient in others. This study evaluates the effects of belonging to online support groups that meet weekly for 12 weeks to address the stress and anxiety felt by individuals with Multiple Sclerosis (MS). This study will also measure and explore the effects of online support groups.
Description: Acceptable rate is defined as at least 66% of participants who complete follow-up surveys.
Measure: Rate of completion Time: Up to 12 weeksDescription: Acceptable rate is defined as at least 66% of sessions being attended.
Measure: Rate of adherence Time: Up to 12 weeksDescription: The STAI is a commonly used measure of trait and state anxiety that is scored from 20 (minimum score) to 80 (maximum score), with a higher scores indicating higher anxiety (worse outcome).
Measure: Score on the State Trait Anxiety Inventory (STAI) Time: Up to 12 weeksDescription: Mood as measured by change in depression or depressive symptoms will be measured with the 8-item PHQ-8 which is scored from 0 (minimum score) to 24 (maximum score), in which higher scores indicate higher depression or depressive symptoms (worse outcome).
Measure: Score on the Personal Health Questionnaire Depression Scale (PHQ-8) Time: Up to 12 weeksThis study aims to develop - in collaboration with patients with multiple sclerosis (MS)- a psychosocial and physical activity intervention (i.e., ESPRIMO intervention) for young adults with MS targeted at improving patients' health-related quality of life (HRQoL). Further, the study seeks to preliminarily test the effect, feasibility, and acceptability of the ESPRIMO intervention using a pilot sample of young adults with MS. Given that the ESPRIMO study will be conducted immediately after the COVID-19 emergency, it does not seem reasonable to start the co-creation of the intervention without taking into account the potential impact of this pandemic on the quality of life and well-being of patients with MS and on their management of care. Thus, the investigators seek to better understand the needs of the target population under these particular circumstances.
Description: Health-related Quality of Life at 1 day post-intervention will be Health-related quality of life will be measured by the Italian version of the "Coop/Wonca charts" [van Weel et al., 1993] at baseline and 1 day post-intervention assessing the changes between the two time points. The Coop/Wonca questionnaire is a self-reported single-item scale to explore HRQoL, including physical (fitness and daily activities), mental (emotions), social domains (social contacts) and above that general health and change in health status [Weel et al., 1995]. Each chart consists of a single question referring to the preceding two weeks and are scored on a 5-level ordinal scale ranging from 1 (no impact) to 5 (high impact), illustrated by a simple picture.
Measure: Change from Baseline Health-related Quality of Life up to 1 week post-intervention Time: T0: baseline, T1: up to 1 week post-interventionDescription: An ad hoc questionnaire (one of the two specific outcome measures evaluating the feasibility of the intervention) using closed (rated by Likert scales ranging from 1 (not at all) to 10 (very much, with higher scores reflecting higher levels of acceptance and satisfaction) and open questions will be administered to evaluate the acceptance and satisfaction of participants. Information on participants' experience will inform the intervention and its administration and will reduce barriers to participation for future patients.
Measure: Acceptance and Satisfaction with the Intervention assessed by an ad hoc questionnaire Time: T1: up to 1 week post-interventionDescription: Resilience will be measured using the Italian version of the "Connor-Davidson Resilience Scale" [CD-RISC; Connor & Davidson, 2003] at baseline and 1 day post-intervention assessing the changes between the two time points. The CD-RISC is designed to assess resilience features in adolescents and adults and composed of 25 items and evaluated on a 5-point Likert scale (ranging from 0 "not true at all" to 4 "true nearly all of the time"), with higher scores reflecting higher levels of resilience.
Measure: Change from Baseline Resilience Features up to 1 week post-intervention Time: T0: baseline, T1: up to 1 week post-interventionDescription: Well-being will be measured using the Italian version of the "Short Form 12 general health questionnaire" [SF12, Apolone et al., 2001] at baseline and 1 day post-intervention assessing the changes between the two time points. The SF12 is a validated 12-item questionnaire with Physical and Mental Component Summary (PCS and MCS, respectively) scores. The SF12 uses different types of scales (e.g., Yes/No questions, scales ranging from 1(always) to 6 (never)).
Measure: Change from Baseline Well-being up to 1 week post-intervention Time: T0: baseline, T1: up to 1 week post-interventionDescription: Mindfulness traits will be assessed using the Italian version of the "Five Facet Mindfulness Questionnaire" [FFMQ; Baer et al., 2006; Giovannini et al., 2014] at baseline and 1 day post-intervention assessing the changes between the two time points. The FFMQ-SF is a 24-item self-report questionnaire measuring one general mindfulness factor and five secondary facets (i.e., Observe, Describe, Act with Awareness, Nonjudge, and Nonreact) on a 5-point Likert scale, ranging from 1 ("never or very rarely true") to 5 ("very often or always true"), with higher total scores reflecting a greater degree of mindfulness.
Measure: Change from Baseline Mindfulness Traits up to 1 week post-intervention Time: T0: baseline, T1: up to 1 week post-interventionDescription: Self-efficacy will be measured using the "Self-Efficacy in Multiple Sclerosis Scale" [SEMS; Bonino et al., 2016] at baseline and 1 day post-intervention assessing the changes between the two time points. It is a 15-item self-completion instrument using a 5-point Likert scale (from 0 = not at all confident to 4 = very confident). Items are conceptually allocated to two areas: "Goal setting" (9 items) and "Symptom management" (6 items).
Measure: Change from Baseline Self-efficacy in MS up to 1 week post-intervention assessed by the "Self-Efficacy in Multiple Sclerosis Scale" (SEMS) Time: T0: baseline, T1: up to 1 week post-interventionDescription: Perceived social support will be measured using the "Multidimensional Scale of Perceived Social Support" [MSPSS; Prezza & Principato, 2002; Zimet et al., 1988] at baseline and 1 day post-intervention assessing the changes between the two time points. It is a 12-item self-report measure, assessing on a 7-point Likert scale (from 1 "strongly disagree" to 7 "strongly agree") the level of perceived social support of various sources: family, friends, and significant others.
Measure: Change from Baseline Perceived Social Support up to 1 week post-intervention Time: T0: baseline, T1: up to 1 week post-interventionDescription: Levels of anxiety and depression will be measured using the "Hospital Anxiety and Depression Scale" [HADS; Zigmond & Snaith, 1983; Costantini et al., 1999] at baseline and 1 day post-intervention assessing the changes between the two time points. The HADS is a brief self-report questionnaire composed of 14 items describing on a 4-point scale from 0 to 3 the levels of anxiety a person is experiencing. HADS anxiety (HADS-A, 7 items) and depression (HADS-D, 7 items) subscale scores will be calculated, possibly ranging from 0 (no symptoms) to 21 (most severe symptoms). A HADS-A and HADS-D score of ≥8 indicates a high risk of anxiety and depressive disorder.
Measure: Change from Baseline Levels of Anxiety and Depression up to 1 week post-intervention Time: T0: baseline, T1: up to 1 week post-interventionDescription: Illness perception will be measured using the "Brief Illness Perception Questionnaire" [Brief IPQ-R; Broadbent et al., 2006; Pain et al., 2006] at baseline and 1 day post-intervention assessing the changes between the two time points. It is a 9-item self-completion instrument using a 5-point Likert scale (from "strongly disagree" to "strongly agree") providing a quantitative measurement of the components of illness representations [Leventhal et al., 1984; Leventhal et al., 1997].
Measure: Change from Baseline Illness Representations up to 1 week post-intervention Time: T0: baseline, T1: up to 1 week post-interventionDescription: The construct of committed action is measured applying the Italian version of the "The Committed Action Questionnaire-8" (CAQ-8) [McCracken et al., 2015] at baseline and 1 day post-intervention assessing the changes between the two time points. The CAQ-8, a short version of The Committed Action Questionnaire [McCracken, 2013], is an 8-item questionnaire using a 7-point Likert scale (from 0 = never true to 6 = always true).
Measure: Change from Baseline Committed Action up to 1 week post-intervention Time: T0: baseline, T1: up to 1 week post-interventionDescription: Fatigue will be measured applying the "Fatigue Scale for Motor and Cognitive Functions" [FSMC; Penner et al., 2009; Elbers et al., 2012] at baseline and 1 day post-intervention assessing the changes between the two time points. It is a self-report fatigue questionnaires validated in patients with multiple sclerosis (MS) and useful to evaluate both motor and cognitive fatigue. It is composed by 20 items evaluated on a Likert scale, ranging from 1 (it never happens) to 5 (it always happens), with higher scores reflecting higher levels of motor and cognitive fatigue.
Measure: Change from Baseline Levels of (Motor and Cognitive) Fatigue up to 1 week post-intervention Time: T0: baseline, T1: up to 1 week post-interventionDescription: Perceived autonomy support (as part of a set of variables reflecting attitudes towards physical activity and motivation to be physically active) will be measured with the "Perceived Autonomy Support Scale for Exercise Setting" (PASSES; Hagger et al., 2007) at baseline and 1 day post-intervention assessing the changes between the two time points. The 12 items are rated on a 7-point Likert scale ranging from 1(totally disagree) to 7 (totally agree), with higher scores reflecting greater perceptions of autonomy support.
Measure: Change from Baseline Perceived Autonomy Support up to 1 week post-intervention Time: T0: baseline, T1: up to 1 week post-interventionDescription: Autonomous motivation (as part of a set of variables reflecting attitudes towards physical activity and motivation to be physically active) will be measured with the "Behavioral Regulation in Exercise Questionnaire" [BREQ-3; Markland et al., 2014] at baseline and 1 day post-intervention assessing the changes between the two time points. The 24 items are rated on a 5-point Likert scale ranging from 1 (totally disagree) to 5 (totally agree).
Measure: Change from Baseline Autonomous Motivation up to 1 week post-intervention Time: T0: baseline, T1: up to 1 week post-interventionDescription: Attitudes (as part of a set of variables reflecting attitudes towards physical activity and motivation to be physically active) will be measured by a scale developed by Galli et al. [2018], following the recommendations of Ajzen [1991] at baseline and 1 day post-intervention assessing the changes between the two time points. The scale comprises 6 items with responses provided on seven-points scales (with contrasting adjectives (e.g.,"bad - good", "harmful-beneficial").
Measure: Change from Baseline Attitudes up to 1 week post-intervention Time: T0: baseline, T1: up to 1 week post-interventionDescription: Subjective norms (as part of a set of variables reflecting attitudes towards physical activity and motivation to be physically active) will be measured by a scale developed by Galli et al. [2018], following the recommendations of Ajzen [1991] at baseline and 1 day post-intervention assessing the changes between the two time points. The 3 items of the scale are rated on a 7-point Likert scale, ranging from 1 (strongly disagree) to 7 (strongly agree), with a greater single score (aggregated item scores) indicating greater normative social pressure toward the behavior.
Measure: Change from Baseline Subjective Norms up to 1 week post-intervention Time: T0: baseline, T1: up to 1 week post-interventionDescription: Perceived Behavioral Control (as part of a set of variables reflecting attitudes towards physical activity and motivation to be physically active) will be measured by a scale developed by Galli et al. [2018], following the recommendations of Ajzen [1991] at baseline and 1 day post-intervention assessing the changes between the two time points. The 3 items of the scale are rated on a 7-point Likert scale, with a greater single score (aggregated item scores) indicating greater perceived confidence toward the behavior.
Measure: Change from Baseline Perceived Behavioral Control up to 1 week post-intervention Time: T0: baseline, T1: up to 1 week post-interventionDescription: A smartwatch will be used by each patient for 5 days at baseline (T0) and 5 days after the intervention (T1) in order to compare the number of steps/day.
Measure: Change from baseline number of steps/day to 5 days post-intervention Time: T0: baseline, T1: 5 days post-interventionDescription: A smartwatch will be used by each patient for 5 days at baseline (T0) and 5 days after the intervention (T1) in order to compare the number of km traveled/day.
Measure: Change from baseline km traveled/day to 5 days post-intervention Time: T0: baseline, T1: 5 days post-interventionDescription: A smartwatch will be used by each patient for 5 days at baseline (T0) and 5 days after the intervention (T1) in order to compare the number of active hours/day.
Measure: Change from baseline number of active hours/day to 5 days post-intervention Time: T0: baseline, T1: 5 days post-interventionDescription: A smartwatch will be used by each patient for 5 days at baseline (T0) and 5 days after the intervention (T1) in order to compare the number of inactive hours/day.
Measure: Change from baseline number of inactive hours/day to 5 days post-intervention Time: T0: baseline, T1: 5 days post-interventionDescription: A smartwatch will be used by each patient for 5 days at baseline (T0) and 5 days after the intervention (T1) in order to compare the number of hours of sleep/day.
Measure: Change from Baseline number of hours of sleep/day to 5 days post-intervention Time: T0: baseline, T1: 5 days post-interventionDescription: A smartwatch will be used by each patient for 5 days at baseline (T0) and 5 days after the intervention (T1) in order to compare the heart rate (HR).
Measure: Change from baseline heart rate to 5 days post-intervention Time: T0: baseline, T1: 5 days post-interventionDescription: A smartwatch will be used by each patient for 5 days at baseline (T0) and 5 days after the intervention (T1) in order to compare the heart rate variability (HRV).
Measure: Change from baseline heart rate variability to 5 days post-intervention Time: T0: baseline, T1: 5 days post-interventionDescription: A smartwatch will be used by each patient for 5 days at baseline (T0) and 5 days after the intervention (T1) in order to compare the estimated kilocalories consumed/day.
Measure: Change from estimated kilocalories consumed/day at baseline to 5 days post-intervention Time: T0: baseline, T1: 5 days post-interventionDescription: The number of drop outs is the second specific outcome measure evaluating the feasibility of the intervention.
Measure: Number of Drop Outs Time: T1: up to 1 week post-interventionDescription: The exact time point of dropping out will also be assessed.
Measure: Exact Time of Dropping Out Time: T1: up to 1 week post-interventionDescription: Patients who drop out during the interventions will be contacted to assess the underlying reasons using an ad hoc questionnaire with open questions.
Measure: Underlying Reasons for Dropping Out assessed by an ad hoc questionnaire with open questions Time: T1: up to 1 week post-interventionHundreds of thousands of confirmed cases have been reported worldwide, just 3 months after the first patients were identified in Wuhan, China. Just like other members of the community, MS patients are uncomfortable with the emotional distress and health anxiety caused by the COVID-19 outbreak. Most MS patients receive immunosuppressive or immunomodulatory therapies. Patients taking immunosuppressive agents are theoretically at increased risk of being affected by viral pandemics, and a higher health concern is expected in this group of patients. Moreover, MS patients lose social support. Patients with increased duration of stay can no longer access physical and cognitive rehabilitation therapies. We also know that increased anxiety and sleep disorders can cause MS patients to have an attack. When literature is examined, it is known that MS patients' physical activity levels decrease, fatigue, sleep quality and anxiety levels increase, so their quality of life and participation in daily life activities decrease. MS patients lose social support during the COVID-19 outbreak. For all these reasons, we think that the fatigue, physical activity level, anxiety level and sleep disturbances affected before the COVID-19 outbreak will be further affected for these reasons.
Description: Fatigue was assessed by the Fatigue Severity Scale (FSS). This is a 9-item questionnaire that assesses the effect of fatigue on daily living. Each item is a statement on fatigue that the subject rates from 1 "completely disagree" to 7 "completely agree". A score of 4 or higher generally indicates severe fatigue
Measure: Fatigue Time: 4 weekDescription: Physical activity levels were assessed by the International Physical Activity Questionnaire (IPAQ): short form. The online self-reporting questionnaire consisted of questions investigating the respondents' PA practice in terms of frequencies and durations of sitting, walking, moderate-intensity physical activities and vigorous-intensity physical activities. The MET-minutes per week (MET-min/week) were calculated using the following formula: intensity (MET) x duration x frequency. Physical activity levels were classified as physically inactive (<600 MET-min/week), with low levels of physical activity (600-3000 MET- min/week) and physical activity level that is sufficient (> 3000 MET-min/week)
Measure: Physical activity Time: 4 weekDescription: The Pittsburgh Sleep Quality Index (PSQI) questionnaire was used to measure sleep quality using an 18-item scale containing seven items that included sleep quality, sleep duration, sleep latency, habitual sleep efficiency, sleep disturbance, use of sleeping medications, and daytime dysfunction. Each dimension scored between 0-3, with a total score ranging from 0-21, and a higher score indicating lower sleep quality.
Measure: Sleep quality Time: 4 weekDescription: The Hospital Anxiety and Depression Scale (HADS) was composed by two subscales (i.e., anxiety and depression), with 7-items each. The anxiety part of HADS was used to evaluate the anxiety levels of the patients. Each dimension scored between 0-3, with a total score ranging from 0-21, and a higher score indicating higher anxiety level.
Measure: Anxiety Time: 4 weekThe primary goal of this research is to study the prevalence of the wearing-off effect and possible risk factors for wearing-off symptoms in patients with multiple sclerosis using ocrelizumab with the use of questionnaires. Furthermore, the goal is to study whether patients receiving extended dosing of ocrelizumab experience more wearing-off symptoms or adverse events in general. Finally, we would like to extend knowledge on wearing-off symptoms in general.
Description: Prevalence of wearing-off symptoms prior to ocrelizumab infusion (yes/no assessed on questionnaires)
Measure: Wearing-off symptoms Time: BaselineRationale: Patients with MS are possibly more vulnerable to infection with SARS-CoV-2. Furthermore the use of immunomodulatory treatment could have an effect on the course of COVID-19 disease. This has resulted in an alteration of current immunomodulatory treatment strategies and delaying the start of certain medications, which could induce MS disease activity. However, certain immunomodulatory treatments are also hypothesized to have a positive effect on COVID-19 disease. Besides lack of information regarding the effects of MS treatments on COVID-19, there is significant uncertainty in how we should advise MS patients in terms of self-isolation, resulting in many patients staying at home reluctant to perform their work or other daily activities. Nationally and locally, we are collecting information regarding COVID-19 in MS patients but numbers are low and only those who are severely affected are tested. Furthermore, there is no information regarding SARS-CoV-2 immunity in MS patients, which could be affected by certain MS treatments. Consequently, there is an urgent need for reliable information about infection rates/immunity and course of COVID-19 in relation to MS characteristics and treatments. Objectives: The objectives of this study are 1. to study the course of COVID-19 in MS patients in relation to immunomodulatory treatment and other patient and MS characteristics and 2. to study the proportion of MS patients with SARS-CoV-2 antibodies and 3. to establish the antibody profile in positive tested patients and 4. to study the longitudinal course of these antibody profiles in positive tested patients. Study design: This is a mono-center cohort study in patients of the MS Center Amsterdam. Study population: All patients with a diagnosis of MS currently under follow-up in the Amsterdam MS Center. Intervention (if applicable): Single venous puncture for drawing blood and questionnaire. For a minority of patients (max 25%) who test positive for antibodies we will draw blood a again with questionnaires after six and twelve months. Main study parameters/endpoints: Course of COVID-19 in MS patients in relation to MS immunomodulatory treatment.
Description: Correlationg of disease course of COVID-19 in patients with positive SARS-CoV-2 antibodies defined by questionnaires (asymptomatic, mild symptoms, severe symptoms, hospitalization) with MS immunomodulatory treatment (asked by questionnaires)
Measure: The correlation of COVID-19 disease course with MS immunomodulatory treatment Time: at baseline questionnaires and lab resultsAmyotrophic lateral sclerosis (ALS) is a relentlessly progressive and fatal neurodegenerative disease characterized by progressive weakness involving limb, bulbar, and respiratory muscles.There is currently no information suggesting how COVID-19 affects patients diagnosed with amyotrophic lateral sclerosis (ALS). This is especially important as respiratory compromise is common in ALS patients and can complicate the clinical course as COVID-19 could lead to respiratory failure and need for intubation. We intend that this registry will guide our understanding of how COVID-19 affects patients with ALS.
Description: Assessed through outcomes reporting ranging from recovered infections to patient death reported in a patient facing registry.
Measure: COVID-19 incidence and prevalence in the ALS population Time: Data will be collected through study completion, an average of 3 yearsThis study will evaluate the influence of sleep apnea on clinical and radiological features of MS. Sleep apnea is associated with hypoxemia during sleep, which we believe is detrimental to MS. We will examine clinical data (MRI, lab results, medical history, labs, and sleep studies) of Dr. Sloane's MS patients. This will allow us to study correlations between MRI, clinical data, lab studies and sleep studies. We are specifically interested in the type of sleep apnea associated with MS, and whether MRI or clinical metrics of MS severity correlate with presence or absence of sleep apnea.
Description: Home Sleep Study Data
Measure: Home Sleep Study Data Time: 1 yearDescription: sleep quality, quality of life, depression and anxiety scales
Measure: Questionnaire data Time: 1 yearAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
Data processed on September 26, 2020.
An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.
Drug Reports MeSH Reports HPO Reports