Developed by Shray Alag, The Harker School
Sections: Correlations,
Clinical Trials, and HPO
Navigate: Clinical Trials and HPO
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug1715 | Fremanezumab Wiki | 0.65 |
| drug1716 | Fremanezumab-Vfrm Wiki | 0.38 |
| drug516 | BLAfit® Wiki | 0.38 |
Navigate: Correlations HPO
There are 7 clinical trials
The objective of this study is to provide remote mindfulness session(s) to help during the COVID-19 pandemic.
Description: Total scale 1-5. Higher scores denotes better outcomes.
Measure: Helpfulness of the session Time: Post-Intervention (upon completion of session up to 15 minutes)Description: Total scale 1-5. Higher scores denotes better outcomes.
Measure: Platform effectiveness Time: Post-Intervention (upon completion of session up to 15 minutes)Description: Total scale 1-5. Higher scores denotes worse outcomes.
Measure: Change in Anxiety Level Time: Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes)Description: Total scale 1-5. Higher scores denotes worse outcomes.
Measure: Change in Stress Level Time: Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes)Description: Total scale 1-5. Higher scores denotes better outcomes.
Measure: Value of the session Time: Post-Intervention (upon completion of session up to 15 minutes)Description: Total scale 1-5. Higher scores denotes better outcomes.
Measure: Satisfaction with the session Time: Post-Intervention (upon completion of session up to 15 minutes)Description: Percentage of participants that would prefer to participate in daily, weekly or monthly similar sessions again if offered
Measure: Percentage of participants by session frequency preference Time: Post-Intervention (upon completion of session up to 15 minutes)Description: Total scale 1-5. Higher scores denotes worse outcomes.
Measure: Concern level about the COVID 19 pandemic Time: Pre- Intervention, Post-Intervention (upon completion of session up to 15 minutes)Chronic Migraine is a disabling condition that affects the 2% of migraine population. It is often associated with medication overuse that makes this condition very difficult to treat. The literature of the last decades confirm the efficacy of withdrawal for patients with medication overuse but it is also confirmed that patients have to be carefully followed in the last period after withdrawal to avoid relapses and to improve the clinical benefit of the therapeutic approach. It has been also reported how the clinical results can be improved when traditional therapies are combined with behavioral approaches in particular mindfulness, that help patient to become more conscious about their symptoms and able to manage pain without medication. Generally patients after withdrawal follow a specific prophylaxis for migraine, but also come weekly to the hospital for practicing mindfulness for 6 sessionsAs the emergency situation due to the Corona-virus pandemic phenomenon in Italy, patients will miss the possibility to come for the regular practice to the hospital: for this reason the investigator propose a small pilot study to enforce the use of technology for our patients so that they can continue to be followed in their therapeutic process. This preliminary study will be conducted on 25 patients that have been submitted to a withdrawal according to the standard procedure at our hospital and they will practice mindfulness daily by a standard session of 12 minutes on their smartphone recorded by the expert who generally manage their sessions at the hospital and also a weekly video-call to evaluate the clinical condition and to encourage to use strategies for pain management. This modality will allow the patients to continue their therapeutic process and to be followed regularly during the one year after withdrawal
Description: Changes in migraine /days per month and medication intake/month (decrease of at least 50% in at least 50% of CM-MO patients)
Measure: Efficacy of Mindfullness by Smartphone Time: at 6 months and 12 months follow-up compared with baseline (Headache Daily Diary)Description: Changes in disability, impact Migraine Disability Assessment Score (MIDAS questionnaire) minimum score 0-maximum score 270 HIGHER SCORES worse outcome (they indicate more disability)
Measure: Change of Disability Score Time: 6months - 12monthsDescription: Changes in Headache Impact Test (HIT-6) minimum score 36- maximum score 78 HIGHER SCORES worse outcome (they indicate more impact)
Measure: Change in Quality of life Time: 6months - 12 monthsMedication Overuse Headache (MOH) is a disabling condition that affects the 2% of migraine population. Medication overuse (MO) makes this condition very difficult to treat. The literature of the last decades confirm the efficacy of withdrawal for patients with medication overuse, but it is also confirmed that patients have to be carefully followed after withdrawal to avoid relapses and to improve the clinical benefit of the therapeutic approach. Clinical results can be improved when traditional therapies are combined with behavioral approaches in particular mindfulness, that help patient to become more conscious about their symptoms and able to manage pain without medication. As the emergency situation due to the Corona-virus pandemic phenomenon in Italy, the regular clinical practice adopted for patients with CM-MO has changed in the last weeks: patients cannot come to the hospital for the withdrawal iv therapy and for regular follow up as the reduced mobility due to the emergency in particular in the Lombardia region, but all over Italy. So the investigators propose a pilot study to enforce the application of a Home-program for the withdrawal procedure for patients and the use of technology like smartphone and video calls so that patients can continue to be followed in their therapeutic process by using behavioral support and mindfulness practice. Patients will perform the withdrawal program at home, by oral administration of therapies, with specific instructions and education. Also the information for behavioral approach and mindfulness practice will be given, to use every day at home. Daily standardized mindfulness sessions of 12 minutes on their smartphone will be combined with weekly video-call to evaluate the clinical condition and to encourage the use strategies for pain management. Face-to-face visits at the follow up every three months will be scheduled. This modality will allow the patients to continue their therapeutic process and to be regularly followed during the one year after withdrawal.
Description: Drop-out rates after withdrawal treatment
Measure: Drop out rates Time: at 12 monthsDescription: Percentages of patients with absence of Medication Overuse Headache
Measure: Absence of Medication Overuse Headache (MOH) Time: at 12 months from withdrawal program (assessed by Daily Diary Card)The primary objective of the study is to evaluate the effectiveness of fremanezumab as compared to placebo for the preventive treatment of episodic migraine (EM). Secondary objectives are to further demonstrate the efficacy of Fremanezumab as compared to placebo for the preventive treatment of EM, to evaluate the safety and tolerability of Fremanezumab in the preventive treatment of EM and to evaluate the immunogenicity of Fremanezumab and the impact of antidrug antibodies (ADAs) on clinical outcomes in participants exposed to Fremanezumab. The total duration of the study is planned to be up to 36 months.
Description: The Pediatric Migraine Disability Assessment (PedMIDAS) is used to assess migraine disability across multiple domains of functioning including school, home, social, and recreational. The measure consists of 6 items measuring the number of days in which activities were missed as a result of headache/migraine. The measure yields a total score by summing items. Total scores correspond to one of four "disability grades:" 0-10 = little to no disability, 11-30 = mild disability, 31-50 = moderate disability, and >50 = severe disability.
Measure: Mean change in the PedMIDAS questionnaire after administration of the first dose of study drug Time: Baseline and Month 3Description: Pediatric Quality of Life Inventory (PedsQL) A health-related quality-of-life instrument that consists of a well-validated generic core measure and some condition and disease-specific modules. The instructions ask how much of a problem each item has been during the past 1 month. A 5-point response scale is utilized across child self-report and parent proxy report as follows: 0=never a problem; almost never a problem; sometimes a problem; often a problem; almost always a problem.
Measure: Mean change PedsQL after administration of the first dose of study drug Time: Baseline - Month 3Description: including local injection site reaction/pain
Measure: Number of adverse events Time: Baseline - Month 3Description: (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate), height, and weight measurements
Measure: Incidence of abnormal vital signs Time: Baseline - Month 3Description: Columbia-Suicide Severity Rating Scale (C-SSRS) The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. Scale range: Yes or No response to 10 questions, with minimum to maximum range of 0 to 10. Lower score represents better outcomes.
Measure: Yes/No suicidality ideation Time: Screening - Month 3Description: The impact of ADAs on safety and efficacy will be analyzed if the number of ADA-positive participants allows.
Measure: Number of participants developing antidrug antibodies (ADAs) throughout the study Time: Baseline - Month 3The primary objective of the study is to evaluate the effectiveness of fremanezumab as compared to placebo for the preventive treatment of chronic migraine (CM). Secondary objectives are to further demonstrate the efficacy of Fremanezumab as compared to placebo for the preventive treatment of CM, to evaluate the safety and tolerability of Fremanezumab in the preventive treatment of CM and to evaluate the immunogenicity of Fremanezumab and the impact of antidrug antibodies (ADAs) on clinical outcomes in participants exposed to Fremanezumab The total duration of the study is planned to be 48 months.
Description: The Pediatric Migraine Disability Assessment (PedMIDAS) is used to assess migraine disability across multiple domains of functioning including school, home, social, and recreational. The measure consists of 6 items measuring the number of days in which activities were missed as a result of headache/migraine. The measure yields a total score by summing items. Total scores correspond to one of four "disability grades:" 0-10 = little to no disability, 11-30 = mild disability, 31-50 = moderate disability, and >50 = severe disability.
Measure: Mean change in the PedMIDAS questionnaire after administration of the first dose of study drug Time: Baseline and Month 3Description: Pediatric Quality of Life Inventory (PedsQL) A health-related quality-of-life instrument that consists of a well-validated generic core measure and some condition and disease-specific modules. The instructions ask how much of a problem each item has been during the past 1 month. A 5-point response scale is utilized across child self-report and parent proxy report as follows: 0=never a problem; almost never a problem; sometimes a problem; often a problem; almost always a problem.
Measure: Mean change PedsQL after administration of the first dose of study drug Time: Baseline - Month 3Description: including local injection site reaction/pain
Measure: Number of adverse events Time: Baseline - Month 3Description: (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate), height, and weight measurements
Measure: Incidence of abnormal vital signs Time: Baseline - Month 3Description: Columbia-Suicide Severity Rating Scale (C-SSRS) The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. Scale range: Yes or No response to 10 questions, with minimum to maximum range of 0 to 10. Lower score represents better outcomes.
Measure: Yes/No suicidality ideation Time: Screening - Month 3Description: The impact of ADAs on safety and efficacy will be analyzed if the number of ADA-positive participants allows.
Measure: Number of participants developing antidrug antibodies (ADAs) throughout the study Time: Baseline - Month 3The primary objective of the study is to evaluate the long-term safety and tolerability of subcutaneous fremanezumab in the preventive treatment of migraine in pediatric participants 6 to 17 years of age (inclusive at enrollment in the pivotal study). Secondary objectives are to evaluate the efficacy of subcutaneous fremanezumab in pediatric participants with migraine and to evaluate the immunogenicity of fremanezumab and the impact of ADAs on clinical outcomes in pediatric participants exposed to fremanezumab. The total duration of the study is planned to be up to 60 months.
Description: including local injection site reaction/pain
Measure: Incidence of adverse events Time: Day 1 - Day 393Description: (systolic and diastolic blood pressure, pulse, temperature, and respiratory rate), height, and weight measurements
Measure: Incidence of abnormal vital signs Time: Day 1 - Day 253Description: Columbia-Suicide Severity Rating Scale (C-SSRS) The C-SSRS is an assessment tool that evaluates suicidal ideation and behavior. Scale range: Yes or No response to 10 questions, with minimum to maximum range of 0 to 10. Lower score represents better outcomes.
Measure: Yes/No suicidality ideation Time: Day 1 - Day 393Description: The Pediatric Migraine Disability Assessment (PedMIDAS) is used to assess migraine disability across multiple domains of functioning including school, home, social, and recreational. The measure consists of 6 items measuring the number of days in which activities were missed as a result of headache/migraine. The measure yields a total score by summing items. Total scores correspond to one of four "disability grades:" 0-10 = little to no disability, 11-30 = mild disability, 31-50 = moderate disability, and >50 = severe disability.
Measure: Mean change in the PedMIDAS questionnaire score Time: Day 1 - Day 393Description: The impact of ADAs on safety and efficacy will be analyzed if the number of ADA-positive participants allows.
Measure: Proportion of participants developing antidrug antibodies (ADAs) throughout the study Time: Day 1 - Day 393To understand the impacts of using a fixed orthotic facial exercise appliance (BLAfit®) for migraine reduction, as compared to medication (fremanezumab-vfrm) and control.
Description: The frequency and pain level of subjects' migraines will be assessed upon the conclusion of the study through surveying and comparing to previous survey data.
Measure: Frequency and Pain Level of Migraines Post-Treatment Time: 4 months after startAlphabetical listing of all HPO terms. Navigate: Correlations Clinical Trials
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