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D010300: Parkin

Developed by Shray Alag, The Harker School
Sections: Correlations, Clinical Trials, and HPO

Correlations computed by analyzing all clinical trials.

Navigate: Clinical Trials and HPO


Correlated Drug Terms (19)


Name (Synonyms) Correlation
drug2331 Levodopa/Carbidopa (LD/CD) Wiki 0.30
drug4928 eM2M Wiki 0.30
drug528 BMS-986337 Placebo Wiki 0.30
Name (Synonyms) Correlation
drug1575 Experimental 2 Wiki 0.30
drug3249 Placebo for Levodopa/Carbidopa (LD/CD) Wiki 0.30
drug3498 Questionnaire and interview Wiki 0.30
drug4653 Video Dance classes Wiki 0.30
drug3246 Placebo for ABBV-951 Wiki 0.30
drug4579 Unsupervised physical activities Wiki 0.30
drug2862 Non-invasive brainstem stimulation Wiki 0.30
drug2822 No Intervention - Observational Study Wiki 0.30
drug4946 exposure Wiki 0.30
drug2080 Immediate vs. delayed provision of antibody test results Wiki 0.30
drug527 BMS-986337 Wiki 0.30
drug86 ABBV-951 Wiki 0.30
drug909 Cannabis, Medical Wiki 0.30
drug1574 Experimental 1 Wiki 0.30
drug986 Cholecalciferol Wiki 0.13
drug1640 Famotidine Wiki 0.13

Correlated MeSH Terms (33)


Name (Synonyms) Correlation
D016135 Spinal Dysraphism NIH 0.30
D000070627 Chronic Traumatic Encephalopathy NIH 0.30
D009069 Movement Disorders NIH 0.30
Name (Synonyms) Correlation
D003291 Conversion Disorder NIH 0.30
D005879 Tourette Syndrome NIH 0.30
D001714 Bipolar Disorder NIH 0.21
D000070642 Brain Injuries, Traumatic NIH 0.20
D006816 Huntington Disease NIH 0.17
D012640 Seizures NIH 0.17
D002547 Cerebral Palsy NIH 0.17
D006526 Hepatitis C NIH 0.17
D001930 Brain Injuries, NIH 0.17
D000690 Amyotrophic Lateral Sclerosis NIH 0.15
D000755 Anemia, Sickle Cell NIH 0.15
D016472 Motor Neuron Disease NIH 0.15
D009103 Multiple Sclerosis NIH 0.14
D005356 Fibromyalgia NIH 0.13
D001927 Brain Diseases NIH 0.12
D013119 Spinal Cord Injuries NIH 0.11
D015212 Inflammatory Bowel Diseases NIH 0.10
D014947 Wounds and Injuries NIH 0.10
D004194 Disease NIH 0.09
D059350 Chronic Pain NIH 0.08
D003424 Crohn Disease NIH 0.08
D020521 Stroke NIH 0.07
D012598 Scoliosi NIH 0.07
D040921 Stress Disorders, Traumatic NIH 0.05
D013313 Stress Disorders, Post-Traumatic NIH 0.05
D013577 Syndrome NIH 0.03
D003141 Communicable Diseases NIH 0.02
D007239 Infection NIH 0.01
D045169 Severe Acute Respiratory Syndrome NIH 0.01
D018352 Coronavirus Infections NIH 0.01

Correlated HPO Terms (12)


Name (Synonyms) Correlation
HP:0002414 Spina bifida HPO 0.30
HP:0100022 Abnormality of movement HPO 0.30
HP:0100754 Mania HPO 0.21
Name (Synonyms) Correlation
HP:0001264 Spastic diplegia HPO 0.17
HP:0006802 Abnormal anterior horn cell morphology HPO 0.15
HP:0007354 Amyotrophic lateral sclerosis HPO 0.15
HP:0001250 Seizure HPO 0.13
HP:0001298 Encephalopathy HPO 0.12
HP:0002037 Inflammation of the large intestine HPO 0.10
HP:0012532 Chronic pain HPO 0.08
HP:0100280 Crohn's disease HPO 0.08
HP:0001297 Stroke HPO 0.07

Clinical Trials

Navigate: Correlations   HPO

There are 11 clinical trials


1 Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19

This will be a multistate, multicenter clinical study to determine the efficacy and safety of medical cannabis for a wide variety of chronic medical conditions.

NCT03944447
Conditions
  1. Chronic Pain
  2. Chronic Pain Syndrome
  3. Chronic Pain Due to Injury
  4. Chronic Pain Due to Trauma
  5. Fibromyalgia
  6. Seizures
  7. Hepatitis C
  8. Cancer
  9. Crohn Disease
  10. HIV/AIDS
  11. Multiple Sclerosis
  12. Traumatic Brain Injury
  13. Sickle Cell Disease
  14. Post Traumatic Stress Disorder
  15. Tourette Syndrome
  16. Ulcerative Colitis
  17. Glaucoma
  18. Epilepsy
  19. Inflammatory Bowel Diseases
  20. Parkinson Disease
  21. Amyotrophic Lateral Sclerosis
  22. Chronic Traumatic Encephalopathy
  23. Anxiety
  24. Depression
  25. Insomnia
  26. Autism
  27. Opioid-use Disorder
  28. Bipolar Disorder
  29. Covid19
  30. SARS-CoV Infection
  31. COVID-19
  32. Corona Virus Infection
  33. Coronavirus
Interventions
  1. Drug: Cannabis, Medical
MeSH:Infection Communicable Diseases Hepatitis C Coronavirus Infections Severe Acute Respiratory Syndrome Fibromyalgia Crohn Disease Inflammatory Bowel Diseases Parkin Parkinson Disease Multiple Sclerosis Brain Injuries Brain Injuries, Traumatic Seizures Motor Neuron Disease Amyotrophic Lateral Sclerosis Brain Diseases Tourette Syndrome Chronic Traumatic Encephalopathy Anemia, Sickle Cell Disease Syndrome Sclerosis Chronic Pain Wounds and Injuries Stress Disorders, Traumatic Bipolar Disorder Stress Disorders, Post-Traumatic
HPO:Abnormal anterior horn cell morphology Amyotrophic lateral sclerosis Bilateral tonic-clonic seizure Bipolar affective disorder Chronic pain Crohn's disease Encephalopathy Focal-onset seizure Generalized-onset seizure Inflammation of the large intestine Mania Seizure

Primary Outcomes

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 years

Description: 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 years

Description: 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 years

Secondary Outcomes

Description: 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 years

Description: 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 years

Description: 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 years
2 Measuring Cortisol Levels in Persons With Parkinson's (PD)

The objective of this study is to evaluate the cortisol awakening response with persons with Parkinsons Disease (PD), Huntingtons Disease (HD), and controls. These data are desired so experience can be gained with measuring stress levels subjectively and objectively in persons with PD, HD, and controls.

NCT02727270
Conditions
  1. Parkinson Disease
  2. Huntington Disease
Interventions
  1. Other: No Intervention - Observational Study
MeSH:Parkinson Disease Huntington Disease

Primary Outcomes

Description: Salivary Cortisol level (ug/dL) Response is the change in cortisol between awakening and 30 minutes after awakening.

Measure: Awakening Salivary Cortisol level (ug/dL) Response

Time: Collected upon awakening and 30 minutes after awakening
3 The M2M LEADERS Project: Lakeshore Examination of Activity, Disability, and Exercise Response Study (LEADERS)

The purpose of this study is to test the effects of an innovative exercise program referred to as movement-2-music (M2M) on health and fitness outcomes in adults with physical/mobility disabilities. One hundred and eight participants with physical/mobility disabilities will be recruited and randomly enrolled into one of two groups: a) M2M or b) waitlist control. The primary aim of this study is to determine the effects of a 12-week M2M program on health and fitness in participants with physical/mobility disabilities who are in one of three functional mobility groups: 1) Group I - only able to exercise while sitting, 2) Group II - able to exercise sitting and standing with/without support, and 3) Group III - able to exercise one side of the body more than the other side. The second aim is to compare the observed effects of the program in this study to a previous M2M study that groups participants based on disability type. The third aim of this study is to test whether adherence (defined as attendance to the 12-week program) affects the effects of M2M in participants with physical/mobility disabilities. The potential influences of different functional mobility and disabilities of participants on how the program affects participants' health and fitness outcomes will also be tested. **In response to COVID-19, the 12-week M2M intervention and all assessments have been modified from being delivered in-person at Lakeshore Foundation to being delivered remotely in real-time through videoconferencing technology.**

NCT03797378
Conditions
  1. Spinal Cord Injuries
  2. Traumatic Brain Injury
  3. Spina Bifida
  4. Cerebral Palsy
  5. Stroke
  6. Parkinson Disease
  7. Multiple Sclerosis
Interventions
  1. Other: eM2M
MeSH:Parkinson Disease Multiple Sclerosis Brain Injuries Spinal Cord Injuries Brain Injuries, Traumatic Cerebral Palsy Spinal Dysraphism Wounds and Injuries
HPO:Athetoid cerebral palsy Cerebral palsy Spastic diplegia Spina bifida

Primary Outcomes

Description: The cardiorespiratory fitness is measured using a heart rate recovery test

Measure: Change from baseline cardiorespiratory fitness at 3 months

Time: Baseline and post 12-week intervention

Description: Muscle strength is measured with grip strength using a hand-held dynamometer.

Measure: Change from baseline muscle strength at 3 months

Time: Baseline and post 12-week intervention

Secondary Outcomes

Description: Lower extremity function is assessed using the Short Physical Performance Battery (SPPB)

Measure: Change from baseline lower extremity function at 3 months

Time: Baseline and post 12-week intervention

Description: Lower extremity function will be assessed using the Timed Up and Go (TUG) test.

Measure: Change from baseline lower extremity function at 3 months

Time: Baseline and post 12-week intervention

Description: Health-related quality of life is measured using the National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS) Global-10 Health Items. The instrument is a 10-item measure with the response scores ranging from 1 (very severe) to 5 (none). Two summary scores, a global physical health score and a global mental health score, can be calculated from this scale, with each score ranging from 4 to 20. Higher scores indicate better health. The total raw score is translated into a T-score for each participant for analysis.

Measure: Change from baseline health-related quality of life at 3 months

Time: Baseline and post 12-week intervention

Description: Social participation is measured using the National Institutes of Health Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities. The instrument is a 8-item measure with the response scores ranging from 1 (always) to 5 (never). The lowest possible total raw score is 8 and the highest possible score is 40. Higher scores indicate better ability to participate in social roles and activities. The total raw score is translated into a T-score for each participant for analysis.

Measure: Change from baseline social participation at 3 months

Time: Baseline and post 12-week intervention

Description: Physical activity is measured using the Godin Leisure Time Exercise Questionnaire. The questionnaire contains two questions. The first question asks participants to report weekly frequencies of activities they perform at different intensities. A total weekly leisure activity is a sum of activity scores calculated by multiplying the weekly frequencies of strenuous, moderate, and light activities by 9, 5, and 3, respectively. The second question asks participants the frequency of weekly leisure-time activities performed that are long enough to work up a sweat.

Measure: Change from baseline physical activity at 3 months

Time: Baseline and post 12-week intervention

Other Outcomes

Description: Barriers in physical activity will be assessed using the Barriers in Physical Activity Questionnaire. The instrument contains 43 items. Each item is responded with either no (1) or yes (2). If response is yes, a follow-up response that ranges from 1 (very small) to 5 (very large) is selected. There are 8 domains, which include personal health, attitudes/beliefs towards physical activity, friends, family, fitness center built environment, policy/programs/staff, community built environment, and safety. Each domain score is calculated by summing the item responses with its respective item weight. Higher domain scores indicate greater perceived barriers to physical activity.

Measure: Change from baseline barriers in physical activity at 3 months

Time: Baseline and post 12-week intervention

Description: Exercise self-efficacy will be assessed using the Exercise Self-Efficacy Scale. The scale contains 8 items, with response options of each item ranging from 0% (not at all confident) to 100% (highly confident). All items are summed and a mean score is calculated. Higher scores indicate higher levels of self-efficacy.

Measure: Change from baseline exercise self-efficacy at 3 months

Time: Baseline and post 12-week intervention

Description: Exercise goal-setting will be measured using the Exercise Goal-Setting Scale. The instrument contains 10 items with response options ranging from 1 (does not describe) to 5 (describes completely). A mean score is calculated. A higher mean score indicate better goal-setting and self-monitoring for exercise.

Measure: Change from baseline exercise goal-setting at 3 months

Time: Baseline and post 12-week intervention

Description: Outcome expectations for exercise will be assessed using the Multidimensional Outcome Expectations for Exercise Scale. The instrument contains 15 items, with the response options ranging from 1 (strongly disagree) to 5 (strongly agree). Three domains of outcome expectations for exercise are assessed, which include physical outcome expectations (6 items), social outcome expectations (4 items), and self-evaluative outcome expectations (5 items). Each dimension is scored by summing the item responses. Higher scores indicate higher levels of outcome expectations for exercise.

Measure: Change from baseline outcome expectations for exercise at 3 months

Time: Baseline and post 12-week intervention

Description: Social support will be assessed using the Social Provision Scale. The instrument contains 24 items, with the response options ranging from 1 (strongly disagree) to 4 (strongly agree). A total score is calculated by summing scores from all items. A higher score indicates a greater degree of perceived support.

Measure: Change from baseline social support at 3 months

Time: Baseline and post 12-week intervention
4 Outcomes Mandate National Integration With Cannabis as Medicine for Prevention and Treatment of COVID-19

This will be a multistate, multicenter clinical study to determine the efficacy and safety of medical cannabis for a wide variety of chronic medical conditions.

NCT03944447
Conditions
  1. Chronic Pain
  2. Chronic Pain Syndrome
  3. Chronic Pain Due to Injury
  4. Chronic Pain Due to Trauma
  5. Fibromyalgia
  6. Seizures
  7. Hepatitis C
  8. Cancer
  9. Crohn Disease
  10. HIV/AIDS
  11. Multiple Sclerosis
  12. Traumatic Brain Injury
  13. Sickle Cell Disease
  14. Post Traumatic Stress Disorder
  15. Tourette Syndrome
  16. Ulcerative Colitis
  17. Glaucoma
  18. Epilepsy
  19. Inflammatory Bowel Diseases
  20. Parkinson Disease
  21. Amyotrophic Lateral Sclerosis
  22. Chronic Traumatic Encephalopathy
  23. Anxiety
  24. Depression
  25. Insomnia
  26. Autism
  27. Opioid-use Disorder
  28. Bipolar Disorder
  29. Covid19
  30. SARS-CoV Infection
  31. COVID-19
  32. Corona Virus Infection
  33. Coronavirus
Interventions
  1. Drug: Cannabis, Medical
MeSH:Infection Communicable Diseases Hepatitis C Coronavirus Infections Severe Acute Respiratory Syndrome Fibromyalgia Crohn Disease Inflammatory Bowel Diseases Parkin Parkinson Disease Multiple Sclerosis Brain Injuries Brain Injuries, Traumatic Seizures Motor Neuron Disease Amyotrophic Lateral Sclerosis Brain Diseases Tourette Syndrome Chronic Traumatic Encephalopathy Anemia, Sickle Cell Disease Syndrome Sclerosis Chronic Pain Wounds and Injuries Stress Disorders, Traumatic Bipolar Disorder Stress Disorders, Post-Traumatic
HPO:Abnormal anterior horn cell morphology Amyotrophic lateral sclerosis Bilateral tonic-clonic seizure Bipolar affective disorder Chronic pain Crohn's disease Encephalopathy Focal-onset seizure Generalized-onset seizure Inflammation of the large intestine Mania Seizure

Primary Outcomes

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 years

Description: 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 years

Description: 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 years

Secondary Outcomes

Description: 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 years

Description: 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 years

Description: 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 years
5 A Randomized, Double-Blind, Double-Dummy, Active-Controlled Study Comparing the Efficacy, Safety and Tolerability of ABBV-951 to Oral Carbidopa/Levodopa in Advanced Parkinson's Disease Patients

Parkinson's disease (PD) is a neurological condition, which affects the brain. PD gets worse over time, but how quickly it progresses varies a lot from person to person. Some symptoms of PD are tremors, stiffness, and slowness of movement. This study measures the efficacy, safety, and tolerability of ABBV-951 versus oral Levodopa (LD)/Carbidopa (CD) [LD/CD] in advanced PD participants to achieve reduction in motor fluctuations. ABBV-951 is an investigational (unapproved) drug containing Levodopa Phosphate/Carbidopa Phosphate (LDP/CDP) given subcutaneously (under the skin) for the treatment of Parkinson's Disease. The study has two treatment arms . In one arm, participants will be given ABBV-951 plus oral placebo (does not contain treatment drug). In the second arm, participants will be given placebo solution and LD/CD tablets. Adult participants with advanced PD will be enrolled. Approximately 130 participants will be enrolled in the study in approximately 80 sites across the world. In one arm, participants will receive ABBV-951 solution as a continuous infusion under the skin plus oral placebo capsules for LD/CD. In the second arm, participants will receive placebo solution for ABBV-951 as a continuous infusion under the skin plus oral capsules containing LD/CD tablets. The treatment duration is 12 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.

NCT04380142
Conditions
  1. Parkinson's Disease (PD)
Interventions
  1. Drug: ABBV-951
  2. Drug: Placebo for Levodopa/Carbidopa (LD/CD)
  3. Drug: Levodopa/Carbidopa (LD/CD)
  4. Drug: Placebo for ABBV-951
MeSH:Parkinson Disease

Primary Outcomes

Description: "On" time without dyskinesia plus "On" time with non-troublesome dyskinesia are based on the Parkinson's Disease (PD) Diary (normalized to a 16-hour waking day averaged over 3 consecutive days). Baseline value is defined as the average of normalized "On" time without troublesome dyskinesia collected over the 3 PD Diary days before randomization.

Measure: Change in "On" Time (Hours) Without Troublesome Dyskinesia

Time: Baseline (Week 0) Up to Week 12

Secondary Outcomes

Description: "Off" time is assessed by the PD Diary.

Measure: Change in "Off" Time (Hours)

Time: Baseline (Week 0) Up to Week 12

Description: Motor Experiences of Daily Living is assessed by Part II of Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS). The Part II MDS-UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD) with scores ranging from 0 to 52.

Measure: Change in Motor Experiences of Daily Living

Time: Baseline (Week 0) Up to Week 12

Description: Sleep symptoms are assessed by the Parkinson's Disease Sleep Scale-2 (PDSS-2). The PDSS-2 consists of 15 questions that evaluate motor and non-motor symptoms at night and upon wakening, as well as disturbed sleep.

Measure: Change in Sleep Symptoms

Time: Baseline (Week 0) Up to Week 12

Description: PDQ-39 is a disease-specific instrument designed to measure aspects of health that are relevant to subjects with PD, and which may not be included in general health status questionnaires.

Measure: Change in Quality of Life Assessed by PD Questionnaire-39 item (PDQ-39)

Time: Baseline (Week 0) Up to Week 12

Description: Early morning "Off" status is assessed by the PD Diary as percentage of participants with early morning "Off" upon waking up.

Measure: Early Morning "Off" Status

Time: At Week 12

Description: EQ-5D-5L is a standardized instrument developed by the EuroQol Group as a measure of health related quality of life that can be used in a wide range of health conditions and treatments.

Measure: Change in Quality of Life Assessed by the EuroQol 5-Dimension Questionnaire (EQ-5D-5L)

Time: Baseline (Week 0) Up to Week 12

Description: The MDS-UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD) with scores ranging from 0 to 236 with 236 representing the worst disability, and 0 representing no disability.

Measure: Change in PD Symptoms as Assessed by the MDS-UPDRS Tool Part I

Time: Baseline (Week 0) Up to Week 12

Description: The MDS-UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD) with scores ranging from 0 to 236 with 236 representing the worst disability, and 0 representing no disability.

Measure: Change in PD Symptoms as Assessed by the MDS-UPDRS Tool Part III

Time: Baseline (Week 0) Up to Week 12

Description: The MDS-UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD) with scores ranging from 0 to 236 with 236 representing the worst disability, and 0 representing no disability.

Measure: Change in PD Symptoms as Assessed by the MDS-UPDRS Tool Part IV

Time: Baseline (Week 0) Up to Week 12

Description: The MDS-UPDRS is an investigator-used rating tool to follow the longitudinal course of Parkinson's Disease (PD) with scores ranging from 0 to 236 with 236 representing the worst disability, and 0 representing no disability.

Measure: Change in PD Symptoms as Assessed by the MDS-UPDRS Tool Total Score of Parts I - III

Time: Baseline (Week 0) Up to Week 12

Description: PKG wearable device is an innovative mobile health technology that provides continuous, objective, ambulatory assessment of the symptoms of PD including tremor, bradykinesia, dyskinesia, and daytime somnolence.

Measure: Change in PD Symptoms as Assessed by the Parkinson's KinetiGraph/Personal KinetiGraph (PKG) Wearable Device

Time: Baseline (Week 0) Up to Week 12
6 The Impact of Video Dance Class and Unsupervised Physical Activity on Parkinson's People During the Covid-19 Pandemic: Interventional

The aim of this study is to analyze the impact of video dance class and unsupervised physical activity on clinical-functional parameters, self-isolation and non-motors symptoms in people with Parkinson's disease during the Covid-19 pandemic.

NCT04422353
Conditions
  1. Parkinson Disease
  2. Parkinson Disease 10
Interventions
  1. Other: Video Dance classes
  2. Other: Unsupervised physical activities
MeSH:Parkinson Disease

Primary Outcomes

Description: The quality of life (QoL) will be measured by the Parkinson's Disease Quality of life (PDQ-8). PDQ-8 is a reduced version of a specific health status questionnaire comprising 39 items, with 8 items. Respondents are requested to affirm one of five ordered response categories according to how often, due to their PD, they have experienced the problem defined by each item. Each item is grouped into eight scales that are scored by expressing summed item scores as a percentage score ranging between 0 and 100 (100¼more health problems).

Measure: Quality of life (QoL)

Time: Change from baseline at 12 weeks.

Description: This outcome will be measure for the Geriatric Depression Scale - 15 item. The scale consists of 15 dichotomous questions in which participants are asked to answer yes or no about how they felt over the past week (for instance, "Do the patient feel that their life is empty?," Do the patient feel that their situation is hopeless?). Scores range from 0 to 15 with higher scores indicating more depressive symptoms.

Measure: Depressive symptoms - Geriatric Depression Scale - 15 item

Time: Change from baseline at 12 weeks.

Description: This outcome will be measure for the International Physical Activity Questionnaires (IPAQ). The IPAQ comprises a set of 4 questionnaires. Long (5 activity domains asked independently) and short (4 generic items) versions for use by either telephone or self-administered methods are available. The purpose of the questionnaires is to provide common instruments that can be used to obtain internationally comparable data on health-related physical activity.

Measure: Physical Activity - International Physical Activity Questionnaires (IPAQ)

Time: Change from baseline at 12 weeks.

Secondary Outcomes

Description: Montreal Cognitive Assessment (MoCA) is a brief screening tool for mild cognitive impairment. This evaluation accesses different cognitive domains and investigates the individual's abilities in the following areas: attention and concentration, executive functions, memory, language, visuoconstructive skills, conceptualization, calculation, and orientation. The total score of the MoCA is 30 points, with a score of 26, or more, considered normal and less than 26 is considered a cognitive impairment.

Measure: Cognitive function - Montreal Cognitive Assessment by telephone

Time: Change from baseline at 12 weeks.

Description: This outcome will be measure for the Falls - Falls Efficacy Scale - International (FES-I). FES-I can be administered as self-completion questionnaires, or administered verbally as part of a research interview or clinical assessment. To calculate the FES-I score when all items are completed, simply add the scores for each item together to give a total that ranges as follows: minimum 16 (no concern about falling) to maximum 64 (severe concern about falling).

Measure: Falls - Falls Efficacy Scale - International

Time: Change from baseline at 12 weeks.

Description: The Five Times Sit to Stand Test measures one aspect of transfer skill. This test quantifies functional lower extremity strength and identifies movement strategies a people use to complete the transitional movement.

Measure: Functional lower extremity strength -Five Times Sit to Stand Test

Time: Change from baseline at 12 weeks.
7 Evaluation of the Containment Impact Linked to the Covid-19 Pandemic in a Population of Parkinson Patients

The consequences of COVID-19 in these already fragile patients should be evaluated. It will be important to appreciate the confinement consequences imposed on the patient on the course and impact of the disease. These consequences can be assessed by the end of confinement and 6 months after the latter is lifted.

NCT04466839
Conditions
  1. Parkinson Disease
  2. COVID
Interventions
  1. Other: Questionnaire and interview
MeSH:Parkinson Disease

Primary Outcomes

Description: To compare quality of life using Parkinson Disease Questionnaire-8 Items (PDQ-8 ), during the period of confinement linked to the Covid-19 pandemic and 6 months after the end of the pandemic in patients with idiopathic Parkinson's disease. The minimum value is "never" and maximum value is "always"

Measure: Impact of containment related to the Covid-19 pandemic.

Time: 6 months after the end of the pandemic

Secondary Outcomes

Description: Describe in a cohort of Parkinson's patients the conditions of confinement during the confinement period linked to the Covid-19 pandemic such as lifestyle (patient living alone, patient living with a caregiver, patient living in nursing home) and continuing paramedical care (physiotherapist, speech therapist), thanks to a psychosocial assessment

Measure: Conditions of containment during the Covid-19 pandemic.

Time: Day 1

Description: Infected patients will be defined as having had a positive polymerase chain reaction (PCR) or compatible chest scanner. Patients potentially infected: patients who presented symptoms during the period which could suggest an infection by the Covid-19 virus: cough, fever and dyspnea

Measure: The number of patients infected or possibly infected with Covid-19

Time: 6 months after the end of the pandemic

Description: Patients will be asked to list the 3 main symptoms that have changed during the confinement period

Measure: Symptoms modifications

Time: 6 months after the end of the pandemic
8 Using Time Varying Non-Invasive Neuromodulation to Improve Neurovascular Status in Parkinson's Disease

This study is a single-site, double-blinded, placebo-controlled, randomized clinical trial designed to elucidate mechanism(s) of action for symptomatic benefits observed in Parkinson's disease (PD) patients treating twice daily time-varying caloric vestibular stimulation treatment using a solid-state device. Study participants will self-administer treatments in the home setting over a period of 12 weeks. Changes in cerebral blood flow perfusion, cerebrovascular reactivity and functional connectivity between the pre-treatment baseline and the end of the treatment period will be monitored and will be compared to changes in validated standardized clinical measures of motor and non-motor symptoms in PD. The durability of effects will be evaluated at a post-treatment assessment conducted five weeks after treatment cessation.

NCT04493697
Conditions
  1. Parkinson Disease
Interventions
  1. Device: Experimental 1
  2. Device: Experimental 2
MeSH:Parkinson Disease

Primary Outcomes

Description: Brain data will be acquired with Siemens MAGNETOM Skyra 3T MRI - range measured by statistically significant change in cerebral blood flow (CBF) measured in units of mL/100g/min

Measure: Neuroimaging

Time: Baseline

Description: Brain data will be acquired with Siemens MAGNETOM Skyra 3T MRI - range measured by statistically significant change in cerebral blood flow (CBF) measured in units of mL/100g/min

Measure: Neuroimaging

Time: Week 12

Description: Brain data will be acquired with Siemens MAGNETOM Skyra 3T MRI - range measured by statistically significant change in cerebral blood flow (CBF) measured in units of mL/100g/min

Measure: Neuroimaging

Time: Week 17

Description: Non-invasive ultrasound used to examine blood circulation within the brain - range measured by statistically significant change in mean cerebral blood flow velocity (cm/s)

Measure: Transcranial Doppler Sonography

Time: Baseline

Description: Non-invasive ultrasound used to examine blood circulation within the brain - range measured by statistically significant change in mean cerebral blood flow velocity (cm/s)

Measure: Transcranial Doppler Sonography

Time: Week 12

Secondary Outcomes

Description: Used to follow the longitudinal course of symptoms of Parkinson's disease - Each parkinsonian sign or symptom is rated on a 5-point Likert-type scale (ranging from 0 to 4), with higher scores indicating more severe impairment. The maximum total UPDRS score is 199, indicating the worst possible disability from PD

Measure: MDS-Unified Parkinson's Disease Rating Scale

Time: Baseline, Week 12, Week 17

Description: To determine fall risk and measure the progress of balance, sit to stand and walking (ranging from ≤10 seconds as normal to 30 seconds as high fall risk).

Measure: Timed Up and Go Test

Time: Baseline, Week 12, Week 17

Description: Cognitive screening test - range from zero to 30, with a score of 26 and higher generally considered normal.

Measure: Montreal Cognitive Assessment

Time: Baseline, Week 12, Week 17

Description: Scale to assess a wide range of non-motor symptoms in patients with Parkinson's disease - 30-item rater-based scale to assess a wide range of non-motor symptoms in patients with Parkinson's disease (PD). The NMSS measures the severity and frequency of non-motor symptoms across nine dimensions - the total NMSQuest score significantly increased with disease severity and duration meaning that the number of individual non-motor symptoms reported by our patients increases as the disease progresses.

Measure: Non-Motor Symptom Scale

Time: Baseline, Week 12, Week 17

Description: A self-report measure of depression in older adults - Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.

Measure: Geriatric Depression Scale

Time: Baseline, Week 12, Week 17

Description: Anxiety assessment - The PAS is a 12-item observer or patient-rated scale with three subscales, for persistent, episodic anxiety and avoidance behavior - There is a maximum total score of 48. Higher scores indicate great experiences of anxiety.

Measure: Parkinson's Anxiety Scale

Time: Baseline, Week 12, Week 17

Description: A self-administered questionnaire to assess the daytime sleepiness - The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'.

Measure: Epworth Sleepiness Scale

Time: Baseline, Week 12, Week 17

Description: A tool to help manage chronic illness - The responses to the 13 items on the FACIT fatigue questionnaire are each measured on a 4-point Likert scale. Thus, the total score ranges from 0 to 52. High scores represent less fatigue

Measure: Functional Assessment of Chronic Illness Therapy - Fatigue -

Time: Baseline, Week 12, Week 17
9 Consequences of the COVID-19 Lockdown on Health and Well-being of Patients With Parkinson Disease and Post-stroke

The study aimed at describing the effects of the COVID-19 social distancing on function, health and well-being of patients with Parkinson's disease or post-stroke, and test the association between the patient activation level and these effects.An anonymous survey was distributed through social media and patient associations.Community-living patients with Parkinson's disease or post-stroke were invited to answer the survey.

NCT04535297
Conditions
  1. Parkinson Disease
  2. Stroke
Interventions
  1. Other: exposure
MeSH:Stroke Parkinson Disease
HPO:Stroke

Primary Outcomes

Description: The PAM is a self-reported validated, licensed tool to measure a patient's knowledge, skills and confidence for self-management. The overall score captures the extent to which people feel engaged and confident in taking care of their health condition. It consists of 13 statements rated on a Likert scale according to agreement. Scores are divided into 4 levels, where 1 represents patients who tend to be passive and feel overwhelmed managing their own health, and 4 represents patients who have effectively adopted self-management behaviors. We used a validated licensed Hebrew and version of the PAM supplied by Insignia Health (https://www.insigniahealth.com/products/pam-survey), which holds the copyright to the questionnaire.

Measure: Patient Activation Measure (PAM®)

Time: 1 hour

Description: participants were asked to answer 27 multiple-choice questions regarding status and change in status of mobility, mood (depression, anxiety), tiredness, social support, body weight, physical activity, rehabilitative treatments and disease symptoms

Measure: Answers to multiple-choice questions

Time: 1 hour
10 Clinical Correlates of COVID-19 Pandemic in Patients With Functional Movement Disorder (FMD) and Parkinson's Disease (PD)

The purpose of this study is to investigate the clinical correlates of the effects of the COVID-19 pandemic on patients with Functional movement disorder (FMD) and Parkinson s Disease (PD). Primary objectives: To evaluate the change in neurological symptoms domain of the survey between pre and post-COVID 19 in FMD and PD patients. Secondary objectives: - To evaluate the change in total score of the survey between pre and post COVID 19 in FMD and PD patients - To evaluate the change in other symptom domains of the survey between pre and post COVID 19 in FMD and PD patients. Domains include: Mood/Energy, sleep, symptoms of abnormal movements related or unrelated to primary disease, physical health and exercise related change Exploratory objectives: - To evaluate whether there is a modifying effect of disease group in the changes in total score or symptom domains - To evaluate whether there is a relationship between disease severity and changes in total score or symptom domains - To evaluate whether there is a correlation between changes across symptom domains - To evaluate whether there is a correlation in raw score across symptom domains within each period Research Methods: Data will be solely collected through the use of online instruments via CiSTAR as a designed questionnaire. Questionnaire items A questionnaire aimed at determining the effects of the COVID 19 pandemic and subsequent isolation on functional state of patients with FMD and PD. The questionnaire items include: Items investigating Mood/Energy before and after COVID 19 out break Items investigating Sleep habits before and after COVID 19 out break Items investigating Neurological symptoms before and after COVID 19 out break Items investigating daily functioning before and after COVID 19 out break Items investigating Exercise habits before and after COVID 19 out break No questionnaire items will be actionable , which are items that would identify an imminent risk for participant safety requiring urgent and immediate medical or psychiatric

NCT04565080
Conditions
  1. Parkinson's Disease
  2. Functional Movement Disorders
  3. COVID-19
MeSH:Parkinson Disease Movement Disorders Disease Conversion Disorder
HPO:Abnormality of movement

Primary Outcomes

Description: Change in neurological symptoms domain of the survey between pre and post COVID 19 in FMD and PD patients.

Measure: Change in neurological symptoms domain of the survey between pre and post COVID 19 in FMD and PD patients.

Time: December 2021
11 Using Time Varying Non-Invasive Neuromodulation to Improve Neurovascular Status in Parkinson's Disease

This study is a single-site, double-blinded, randomized clinical trial designed to elucidate mechanism(s) of action for symptomatic benefits observed in Parkinson's disease (PD)

NCT04598828
Conditions
  1. Parkinson Disease
Interventions
  1. Device: Non-invasive brainstem stimulation
MeSH:Parkinson Disease

Primary Outcomes

Description: Arterial arrival time (AAT) measured using pseudo Continuous Arterial Spin Labeling (pCASL) magnetic resonance imaging (MRI) will be used to monitor changes in global perfusion.

Measure: Change in cerebral blood flow (CBF) perfusion

Time: baseline

Description: Arterial arrival time (AAT) measured using pseudo Continuous Arterial Spin Labeling (pCASL) magnetic resonance imaging (MRI) will be used to monitor changes in global perfusion.

Measure: Change in cerebral blood flow (CBF) perfusion

Time: end of treatment (week 12)

Description: AAT measured using pCASL MRI after a hypercapnic challenge will be used to monitor changes in cerebrovascular reactivity

Measure: Change in cerebrovascular Reactivity

Time: baseline

Description: AAT measured using pCASL MRI after a hypercapnic challenge will be used to monitor changes in cerebrovascular reactivity

Measure: Change in cerebrovascular Reactivity

Time: end of treatment (week 12)

Secondary Outcomes

Description: Resting-state magnetic resonance imaging (rs-MRI) will be used to monitor changes in functional connectivity

Measure: Change in functional connectivity

Time: baseline and end of treatment (week 12)

Other Outcomes

Description: Transcranial Doppler sonography (TCD), a non-invasive ultrasound, will be used to monitor changes in cerebral blood flow velocity (cm/s) in response to a hypercapnic challenge.

Measure: Change in cerebral haemodynamics

Time: baseline and end of treatment (week 12)

Description: Arterial arrival time (AAT) measured using pseudo Continuous Arterial Spin Labeling (pCASL) magnetic resonance imaging (MRI) will be used to monitor changes in global perfusion.

Measure: Durability of change of cerebral blood flow (CBF) perfusion

Time: baseline and the post-treatment follow-up (week 17)

Description: AAT measured using pCASL MRI after a hypercapnic challenge will be used to monitor changes in cerebrovascular reactivity

Measure: Durability of change of cerebrovascular Reactivity

Time: baseline and the post-treatment follow-up (week 17)

Description: Resting-state magnetic resonance imaging (rs-MRI) will be used to monitor changes in functional connectivity

Measure: Durability of change of functional connectivity

Time: baseline and the post-treatment follow-up (week 17)

Description: Used to follow the longitudinal course of symptoms of Parkinson's disease - Each parkinsonian sign or symptom is rated on a 5-point Likert-type scale (ranging from 0 to 4), with higher scores indicating more severe impairment. The maximum total UPDRS score is 199, indicating the worst possible disability from PD

Measure: Change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

Time: baseline, end of treatment (week 12), and the post-treatment follow-up (week 17)

Description: To determine fall risk and measure the progress of balance, sit to stand and walking (ranging from ≤10 seconds as normal to 30 seconds as high fall risk).

Measure: Change in the Timed Up and Go Test

Time: baseline, end of treatment (week 12) and the post-treatment follow-up (week 17)

Description: Cognitive screening test - range from zero to 30, with a score of 26 and higher generally considered normal.

Measure: Change in the Montreal Cognitive Assessment

Time: baseline, end of treatment (week 12) and the post-treatment follow-up (week 17)

Description: Scale to assess a wide range of non-motor symptoms in patients with Parkinson's disease - 30-item rater-based scale to assess a wide range of non-motor symptoms in patients with Parkinson's disease (PD). The Non-Motor Symptom Scale measures the severity and frequency of non-motor symptoms across nine dimensions - the total score significantly increased with disease severity and duration meaning that the number of individual non-motor symptoms reported by our patients increases as the disease progresses. Score range 0 - 360.

Measure: Change in the Non-Motor Symptom Scale

Time: Change between the baseline and end of treatment (week 12) measure.

Description: Scale to assess a wide range of non-motor symptoms in patients with Parkinson's disease - 30-item rater-based scale to assess a wide range of non-motor symptoms in patients with Parkinson's disease (PD). The Non-Motor Symptom Scale measures the severity and frequency of non-motor symptoms across nine dimensions - the total score significantly increased with disease severity and duration meaning that the number of individual non-motor symptoms reported by our patients increases as the disease progresses. Score range 0 - 360.

Measure: Change in the Non-Motor Symptom Scale

Time: Change between the baseline and the post-treatment follow-up (week 17) measure.

Description: A self-report measure of depression in older adults - Scores of 0-4 are considered normal, depending on age, education, and complaints; 5-8 indicate mild depression; 9-11 indicate moderate depression; and 12-15 indicate severe depression.

Measure: Change in the Geriatric Depression Scale

Time: baseline, end of treatment (week 12) and the post-treatment follow-up (week 17)

Description: Anxiety assessment - The PAS is a 12-item observer or patient-rated scale with three subscales, for persistent, episodic anxiety and avoidance behavior - There is a maximum total score of 48. Higher scores indicate great experiences of anxiety.

Measure: Change in the Parkinson's Anxiety Scale

Time: baseline, end of treatment (week 12) and the post-treatment follow-up (week 17)

Description: A self-administered questionnaire to assess the daytime sleepiness - The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'.

Measure: Change in the Epworth Sleepiness Scale

Time: baseline, end of treatment (week 12) and the post-treatment follow-up (week 17)

Description: A tool to help manage chronic illness - The responses to the 13 items on the FACIT fatigue questionnaire are each measured on a 4-point Likert scale. Thus, the total score ranges from 0 to 52. High scores represent less fatigue

Measure: Change in the Functional Assessment of Chronic Illness Therapy - Fatigue

Time: baseline, end of treatment (week 12) and the post-treatment follow-up (week 17)

HPO Nodes


HPO

Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


HPO Nodes


Reports

Data processed on December 13, 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  

Interventions

4,818 reports on interventions/drugs

MeSH

706 reports on MeSH terms

HPO

306 reports on HPO terms

All Terms

Alphabetical index of all Terms

Google Colab

Python example via Google Colab Notebook