- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06134219
Course for Brain Fatigue After Graves' Disease Controlled Study (MF-Course)
A Mental Fatigue Course to Graves' Disease Patients With Mental Fatigue -a Randomized Controlled Study
BACKGROUND. Mental fatigue (MF) is common in the most common form of hyperthyroidism, Graves' disease (GD). Clinically, MF is the primary mental symptom in patients with GD and is characterized by difficulties maintaining attention, exhaustion during cognitively demanding tasks, memory difficulties, irritability, and emotional lability. It may be the main contributing factor to the continued low quality of life in many patients with GD. MF can be measured with an MF score (MFS). The pathophysiology is unknown. There is no medical treatment, which requires patients to adapt to the situation.
AIM. In this project, the investigators want to test the hypothesis that mental fatigue improves - with secondary benefits on mental capacity, quality of life (QoL), and function - in patients with persistent mental fatigue in GD, through an MF course as an addition to standard care, compared to patients who receive only standard care. The investigators also test the hypothesis that the MF course is a cost-effective intervention.
METHOD. In a randomized controlled study, the investigators evaluate the effect of the MF course compared to standard care only in 96 patients with persistent MF in GD. Markers of mental health, QoL, and activity capacity are evaluated at baseline, 3, 6, and 12 months after intervention/inclusion. The primary outcome measure is MFS at 3 months.
CLINICAL SIGNIFICANCE. Patients report feeling neglected by healthcare for decades, and healthcare professionals are frustrated by the lack of guidance. Patient organizations highlight the need for research; they want mental symptoms to be characterized as a consequence of thyroid disease, they demand biomarkers, specific treatments, and personalized care. Our research group is working to address the cause of MF in GD and also to alleviate the symptoms. The MF course may prove to be an important tool that can be quickly implemented in clinical practice, especially in primary care. Our involvement in regional/national working groups will facilitate implementation in other units.
In this project, the investigators want to test the hypothesis that mental fatigue improves - with secondary benefits on mental capacity, quality of life (QoL), and function - in patients with persistent mental fatigue at GD, through an MF course as an addition to regular healthcare, compared to patients receiving only regular healthcare.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Agneta Lindo
- Phone Number: +4676-6185481
- Email: agneta.lindo@vgregion.se
Study Locations
-
-
-
Göteborg, Sweden, 413 45
- Recruiting
- Agneta Lindo
-
Contact:
- Agneta Lindo
- Phone Number: +4676-6185481
- Email: agneta.lindo@vgregion.se
-
Principal Investigator:
- Helena Filipsson Nyström
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 18-72 years old
- 15-72 months since first Graves' diagnosis
- high free thyroxin and thyroid antibodies (TRAb) at diagnosis
- euthyroid the last 6 months normal thyroid hormone levels at inclusion
- symptoms on MF in connection to Graves diagnosis
- MF-scale ≥10.5 points
Exclusion criteria:
- other diseases or situations that may be associated with mental fatigue (such as other active inflammatory disease, neurological disease)
- pregnancy
- lactation
- assessment that the patient cannot follow the study protocol.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Mental Fatigue course + Usual care in clinical care
|
A course consisting of six 2-hour-meetings every two-weeks with 10-15 participants (12 weeks in total).
The meetings have different themes related to MF, such as understanding, practices for a deeper understanding of emotions, balance in everyday life with rest and activity, meditation practice to give time for brain rest, and mindfulness).
The usual health care consists of one or few follow-up visits with blood tests at Sahlgrenska university hospital in Gothenburg or follow-up at the primary care after the end of treatment for Graves' treatment.
|
Active Comparator: Control Group
Usual care in clinical care
|
The usual health care consists of one or few follow-up visits with blood tests at Sahlgrenska university hospital in Gothenburg or follow-up at the primary care after the end of treatment for Graves' treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mental fatigue score
Time Frame: Change from baseline examined at 3 months follow-up.
|
Scores at the Mental Fatigue Scale are compared between the intervention and the control group.
Scores is between 0-42 and higher scores mean more brain fatigue.
|
Change from baseline examined at 3 months follow-up.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Days of sick-leave and cost related to health care and medication
Time Frame: Change from baseline examined at 3 months follow-up.
|
Evaluated sick leave days between the intervention and the control group.
|
Change from baseline examined at 3 months follow-up.
|
Days of sick-leave and cost related to health care and medication
Time Frame: Change from baseline examined at 6 months follow-up.
|
Evaluated sick leave days between the intervention and the control group.
|
Change from baseline examined at 6 months follow-up.
|
Days of sick-leave and cost related to health care and medication
Time Frame: Change from baseline examined at 12 months follow-up.
|
Evaluated sick leave days between the intervention and the control group.
|
Change from baseline examined at 12 months follow-up.
|
Levels of thyroid autoantibodies
Time Frame: Change from baseline examined at 3 months follow-up.
|
Levels of thyroid autoantibodies, analysed with the standard method of the laboratory at Sahlgrenska University Hospital, compared between the intervention and the control group.
|
Change from baseline examined at 3 months follow-up.
|
Levels of thyroid autoantibodies
Time Frame: Change from baseline examined at 6 months follow-up.
|
Levels of thyroid autoantibodies, analysed with the standard method of the laboratory at Sahlgrenska University Hospital, compared between the intervention and the control group.
|
Change from baseline examined at 6 months follow-up.
|
Levels of thyroid autoantibodies
Time Frame: Change from baseline examined at 12 months follow-up.
|
Levels of thyroid autoantibodies, analysed with the standard method of the laboratory at Sahlgrenska University Hospital, compared between the intervention and the control group.
|
Change from baseline examined at 12 months follow-up.
|
Levels of thyroid hormones
Time Frame: Change from baseline examined at 3 months follow-up.
|
Levels of thyroid hormones, analysed with the standard method of the laboratory at Sahlgrenska University Hospital, compared between the intervention and the control group.
|
Change from baseline examined at 3 months follow-up.
|
Levels of thyroid hormones
Time Frame: Change from baseline examined at 6 months follow-up.
|
Levels of thyroid hormones, analysed with the standard method of the laboratory at Sahlgrenska University Hospital, compared between the intervention and the control group.
|
Change from baseline examined at 6 months follow-up.
|
Levels of thyroid hormones
Time Frame: Change from baseline examined at 12 months follow-up.
|
Levels of thyroid hormones, analysed with the standard method of the laboratory at Sahlgrenska University Hospital, compared between the intervention and the control group.
|
Change from baseline examined at 12 months follow-up.
|
Comprehensive psychopathological rating questionnaire (CPRS)
Time Frame: Change from baseline examined at 3 months follow-up.
|
Evaluated by the validated questionnaire the Comprehensive Psychopathological Rating Scale (CPRS).
Scores are compared between the intervention and the control group.
Higher scores at the Comprehensive Psychopathological Rating Scale mean more symptoms of anxiety and depression.
The Scores for anxiety is between 0-27 and for depression is between 0-27.
|
Change from baseline examined at 3 months follow-up.
|
Comprehensive psychopathological rating questionnaire (CPRS)
Time Frame: Change from baseline examined at 6 months follow-up.
|
Evaluated by the validated questionnaire the Comprehensive Psychopathological Rating Scale (CPRS).
Scores are compared between the intervention and the control group.
Higher scores at the Comprehensive Psychopathological Rating Scale mean more symptoms of anxiety and depression.
The Scores for anxiety is between 0-27 and for depression is between 0-27.
|
Change from baseline examined at 6 months follow-up.
|
Comprehensive psychopathological rating questionnaire (CPRS)
Time Frame: Change from baseline examined at 12 months follow-up.
|
Evaluated by the validated questionnaire the Comprehensive Psychopathological Rating Scale (CPRS).
Scores are compared between the intervention and the control group.
Higher scores at the Comprehensive Psychopathological Rating Scale mean more symptoms of anxiety and depression.
The Scores for anxiety is between 0-27 and for depression is between 0-27.
|
Change from baseline examined at 12 months follow-up.
|
Coping Orientations to Problems Experienced (Brief cope)
Time Frame: Change from baseline examined at 3 months follow-up.
|
Evaluated by the validated questionnaire Brief cope.
The Brief COPE is a shorter version of the COPE Inventory composed of 28-items rated on a 4-point ordinal scale that measure 14 subscales of coping style (2-items each).
The overall mean is calculated with more than three being worse outcome.
Coping strategies are compared between the intervention and the control group.
|
Change from baseline examined at 3 months follow-up.
|
Coping Orientations to Problems Experienced (Brief cope)
Time Frame: Change from baseline examined at 6 months follow-up.
|
Evaluated by the validated questionnaire Brief cope.
The Brief COPE is a shorter version of the COPE Inventory composed of 28-items rated on a 4-point ordinal scale that measure 14 subscales of coping style (2-items each).The overall mean is calculated with more than three being worse outcome.
Coping strategies are compared between the intervention and the control group.
|
Change from baseline examined at 6 months follow-up.
|
Coping Orientations to Problems Experienced (Brief cope)
Time Frame: Change from baseline examined at 12 months follow-up.
|
Evaluated by the validated questionnaire Brief cope.
The Brief COPE is a shorter version of the COPE Inventory composed of 28-items rated on a 4-point ordinal scale that measure 14 subscales of coping style (2-items each).The overall mean is calculated with more than three being worse outcome.
Coping strategies are compared between the intervention and the control group.
|
Change from baseline examined at 12 months follow-up.
|
General Self-Efficacy Scale (GSE)
Time Frame: Change from baseline examined at 3 months follow-up.
|
Evaluated by the validated questionnaire General Self-Efficacy.
Scores are compared between the intervention and the control group.
The total score ranges between 10 and 40, with a higher score indicating more self-efficacy.
|
Change from baseline examined at 3 months follow-up.
|
General Self-Efficacy Scale (GSE)
Time Frame: Change from baseline examined at 6 months follow-up.
|
Evaluated by the validated questionnaire General Self-Efficacy.
Scores are compared between the intervention and the control group.
The total score ranges between 10 and 40, with a higher score indicating more self-efficacy.
|
Change from baseline examined at 6 months follow-up.
|
General Self-Efficacy Scale (GSE)
Time Frame: Change from baseline examined at 12 months follow-up.
|
Evaluated by the validated questionnaire General Self-Efficacy.
Scores are compared between the intervention and the control group.
The total score ranges between 10 and 40, with a higher score indicating more self-efficacy.
|
Change from baseline examined at 12 months follow-up.
|
Perceived Stress Scale (PSS-14)
Time Frame: Change from baseline examined at 3 months follow-up.
|
Evaluated by the validated questionnaire Perceived Stress Scale (PSS-14).
Scores are compared between the intervention and the control group.
The total score ranges between 0 and 56, with a higher score indicate more symptoms of stress.
|
Change from baseline examined at 3 months follow-up.
|
Perceived Stress Scale (PSS-14)
Time Frame: Change from baseline examined at 6 months follow-up.
|
Evaluated by the validated questionnaire Perceived Stress Scale (PSS-14).
Scores are compared between the intervention and the control group.
The total score ranges between 0 and 56, with a higher score indicate more symptoms of stress.
|
Change from baseline examined at 6 months follow-up.
|
Perceived Stress Scale (PSS-14)
Time Frame: Change from baseline examined at 12 months follow-up.
|
Evaluated by the validated questionnaire Perceived Stress Scale (PSS-14).
Scores are compared between the intervention and the control group.
The total score ranges between 0 and 56, with a higher score indicate more symptoms of stress.
|
Change from baseline examined at 12 months follow-up.
|
Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39)
Time Frame: Change from baseline examined at 3 months follow-up.
|
Evaluated by the validated questionnaire Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39).
Scores are compared between the intervention and the control group.
ThyPRO scales is scored as a summary score and linearly transformed to range 0- 100.
Higher scores at the Thyroid-specific Patient-Reported Outcome short-form means worse quality of life.
|
Change from baseline examined at 3 months follow-up.
|
Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39)
Time Frame: Change from baseline examined at 6 months follow-up.
|
Evaluated by the validated questionnaire Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39).
Scores are compared between the intervention and the control group.
hyPRO scales is scored as a summary score and linearly transformed to range 0- 100.
Higher scores at the Thyroid-specific Patient-Reported Outcome short-form means worse quality of life.
|
Change from baseline examined at 6 months follow-up.
|
Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39)
Time Frame: Change from baseline examined at 12 months follow-up.
|
Evaluated by the validated questionnaire Thyroid-specific Patient-Reported Outcome short-form (ThyPro 39).
Scores are compared between the intervention and the control group.
hyPRO scales is scored as a summary score and linearly transformed to range 0- 100.
Higher scores at the Thyroid-specific Patient-Reported Outcome short-form means worse quality of life.
|
Change from baseline examined at 12 months follow-up.
|
Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL).
Time Frame: Change from baseline examined at 3 months follow-up.
|
Evaluated by the validated questionnaire the Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL).
Scores are compared between the intervention and the control group.
The range of each score is from 0 to 100, higher scores indicating better health.
|
Change from baseline examined at 3 months follow-up.
|
Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL).
Time Frame: Change from baseline examined at 6 months follow-up.
|
Evaluated by the validated questionnaire the Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL).
Scores are compared between the intervention and the control group.
The range of each score is from 0 to 100, higher scores indicating better health.
|
Change from baseline examined at 6 months follow-up.
|
Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL).
Time Frame: Change from baseline examined at 12 months follow-up.
|
Evaluated by the validated questionnaire the Graves' Ophthalmopathy Quality of Life Questionnaire (GO QoL).
Scores are compared between the intervention and the control group.
The range of each score is from 0 to 100, higher scores indicating better health.
|
Change from baseline examined at 12 months follow-up.
|
EuroQol- health questionnaire (EQ-5D)
Time Frame: Change from baseline examined at 3 months follow-up.
|
Evaluated by the validated questionnaire EuroQol- health (EQ-5D).
Scores are compared between the intervention and the control group.
Each question may have 1 of 3-level answers, and a visual analog scale (VAS) on which patients can mark their current health state.
The EQ-5D-3L index is calculated by subtracting the values of the descriptive EQ-5D system from the numerical value 1.
This corresponds to the best possible health status, while an index value of <0 represents the worst possible health status.
|
Change from baseline examined at 3 months follow-up.
|
EuroQol- health questionnaire (EQ-5D)
Time Frame: Change from baseline examined at 6 months follow-up.
|
Evaluated by the validated questionnaire EuroQol- health (EQ-5D).
Scores are compared between the intervention and the control group.
Each question may have 1 of 3-level answers, and a visual analog scale (VAS) on which patients can mark their current health state.
The EQ-5D-3L index is calculated by subtracting the values of the descriptive EQ-5D system from the numerical value 1.
This corresponds to the best possible health status, while an index value of <0 represents the worst possible health status.
|
Change from baseline examined at 6 months follow-up.
|
EuroQol- health questionnaire (EQ-5D)
Time Frame: Change from baseline examined at 12 months follow-up.
|
Evaluated by the validated questionnaire EuroQol- health (EQ-5D).
Scores are compared between the intervention and the control group.
Each question may have 1 of 3-level answers, and a visual analog scale (VAS) on which patients can mark their current health state.
The EQ-5D-3L index is calculated by subtracting the values of the descriptive EQ-5D system from the numerical value 1.
This corresponds to the best possible health status, while an index value of <0 represents the worst possible health status.
|
Change from baseline examined at 12 months follow-up.
|
Frenchay Activities Index (FAI)
Time Frame: Change from baseline examined at 3 months follow-up.
|
Evaluated by the validated Frenchay Activities Index (FAI).
Compare function and work ability between the intervention and the control group.
Questionnaire consisting of 15 items on frequency of social everyday activities and the score is based on the frequency with which an activity has been performed during the previous 3 or 6 months.
The total score ranges from 0 (inactive) to 45 (very active).
|
Change from baseline examined at 3 months follow-up.
|
Frenchay Activities Index (FAI)
Time Frame: Change from baseline examined at 6 months follow-up.
|
Evaluated by the validated Frenchay Activities Index (FAI).
Compare function and work ability between the intervention and the control group.
Questionnaire consisting of 15 items on frequency of social everyday activities and the score is based on the frequency with which an activity has been performed during the previous 3 or 6 months.
The total score ranges from 0 (inactive) to 45 (very active).
|
Change from baseline examined at 6 months follow-up.
|
Frenchay Activities Index (FAI)
Time Frame: Change from baseline examined at 12 months follow-up.
|
Evaluated by the validated Frenchay Activities Index (FAI).
Compare function and work ability between the intervention and the control group.
Questionnaire consisting of 15 items on frequency of social everyday activities and the score is based on the frequency with which an activity has been performed during the previous 3 or 6 months.
The total score ranges from 0 (inactive) to 45 (very active).
|
Change from baseline examined at 12 months follow-up.
|
Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI)
Time Frame: Change from baseline examined at 3 months follow-up.
|
Evaluated by the validated Work Productivity and Activity Impairment questionnaire (WPAI). Compare Work Productivity and Activity between the intervention and the control group. Four main outcomes can be generated from the WPAI-GH and expressed in percentages by multiplying the following scores by 100: 1) percent work time missed due to health = Q2/(Q2 + Q4) for those who were currently employed; 2) percent impairment while working due to health = Q5/10 for those who were currently employed and actually worked in the past seven days; 3) percent overall work impairment due to health Q2/(Q2 + Q4) + ((1 - Q2/(Q2 + Q4)) × (Q5/10)) for those who were currently employed; 4) percent activity impairment due to health Q6/10 for all respondents. |
Change from baseline examined at 3 months follow-up.
|
Evaluated by the validated Work Productivity and Activity Impairment questionnaire (WPAI).
Time Frame: Change from baseline examined at 6 months follow-up.
|
Evaluated by the validated Work Productivity and Activity Impairment questionnaire (WPAI). Compare Work Productivity and Activity between the intervention and the control group. Four main outcomes can be generated from the WPAI-GH and expressed in percentages by multiplying the following scores by 100: 1) percent work time missed due to health = Q2/(Q2 + Q4) for those who were currently employed; 2) percent impairment while working due to health = Q5/10 for those who were currently employed and actually worked in the past seven days; 3) percent overall work impairment due to health Q2/(Q2 + Q4) + ((1 - Q2/(Q2 + Q4)) × (Q5/10)) for those who were currently employed; 4) percent activity impairment due to health Q6/10 for all respondents. |
Change from baseline examined at 6 months follow-up.
|
Work Productivity and Activity Impairment questionnaire (WPAI). Productivity and Activity Impairment questionnaire (WPAI)
Time Frame: Change from baseline examined at 12 months follow-up.
|
Evaluated by the validated Work Productivity and Activity Impairment questionnaire (WPAI). Compare Work Productivity and Activity between the intervention and the control group. Four main outcomes can be generated from the WPAI-GH and expressed in percentages by multiplying the following scores by 100: 1) percent work time missed due to health = Q2/(Q2 + Q4) for those who were currently employed; 2) percent impairment while working due to health = Q5/10 for those who were currently employed and actually worked in the past seven days; 3) percent overall work impairment due to health Q2/(Q2 + Q4) + ((1 - Q2/(Q2 + Q4)) × (Q5/10)) for those who were currently employed; 4) percent activity impairment due to health Q6/10 for all respondents. |
Change from baseline examined at 12 months follow-up.
|
Clinical Activity Score (CAS)
Time Frame: Change from baseline examined at 3 months follow-up.
|
Comparison of Clinical Activity Score (a composite measure of ophthalmological signs and symptoms) between the intervention and the control group.
Scores can be between 0-10 and higher scores mean more eye symptoms.
|
Change from baseline examined at 3 months follow-up.
|
Clinical Activity Score (CAS)
Time Frame: Change from baseline examined at 6 months follow-up.
|
Comparison of Clinical Activity Score (a composite measure of ophthalmological signs and symptoms) between the intervention and the control group.
Scores can be between 0-10 and higher scores mean more eye symptoms.
|
Change from baseline examined at 6 months follow-up.
|
Clinical Activity Score (CAS)
Time Frame: Change from baseline examined at 12 months follow-up.
|
Comparison of Clinical Activity Score (a composite measure of ophthalmological signs and symptoms) between the intervention and the control group.
Scores can be between 0-10 and higher scores mean more eye symptoms.
|
Change from baseline examined at 12 months follow-up.
|
Severity score
Time Frame: Change from baseline examined at 3 months follow-up.
|
Comparison of Severity score (a composite measure of ophthalmological signs and symptoms) between the intervention and the control group.
Scores can be between 0-29 and higher scores mean more eye symptoms.
|
Change from baseline examined at 3 months follow-up.
|
Severity score
Time Frame: Change from baseline examined at 6 months follow-up.
|
Comparison of Severity score (a composite measure of ophthalmological signs and symptoms) between the intervention and the control group.
Scores can be between 0-29 and higher scores mean more eye symptoms.
|
Change from baseline examined at 6 months follow-up.
|
Severity score
Time Frame: Change from baseline examined at 12 months follow-up.
|
Comparison of Severity score (a composite measure of ophthalmological signs and symptoms) between the intervention and the control group.
Scores can be between 0-29 and higher scores mean more eye symptoms.
|
Change from baseline examined at 12 months follow-up.
|
Mental fatigue score
Time Frame: Change from baseline examined at 6 months follow-up.
|
Scores at the Mental Fatigue Scale are compared between the intervention and the control group.
Scores can be between 0-42 and higher scores mean more brain fatigue.
|
Change from baseline examined at 6 months follow-up.
|
Mental fatigue score
Time Frame: Change from baseline examined at 12 months follow-up.
|
Scores at the Mental Fatigue Scale are compared between the intervention and the control group.
Scores can be between 0-42 and higher scores mean more brain fatigue.
|
Change from baseline examined at 12 months follow-up.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Helena Filipsson Nyström, Sahlgrenska Universitet sjukhus
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- MF-Course
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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