Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

All Conditions

Heart and Blood Diseases

Nervous System Diseases

Skin and Connective Tissue Diseases

Immune System Diseases

Diabetes Mellitus

Thrombosis

Embolism

Epilepsy

Migraine Disorders

Lupus Erythematosus, Systemic

Embolism and Thrombosis

Vascular Diseases

Connective Tissue Diseases

Autoimmune Diseases

Cohort includes women of reproductive age with diverse medical conditions (listed in inclusion criteria) who are referred to Family Planning felowship-trained physicians, seeking contraception counseling and administration.

Jody Steinauer, MD

Radhika Rible, MD MS

Tabetha Harken, MD MPH

Catherine Cansino, MD MPH

Sheila Mody, MD MPH

The investigators will conduct a prospective observational cohort study to investigate factors that influence contraceptive method utilization among women with medical conditions. The investigators will also investigate how women with medical conditions access to contraception and family planning fellowship trained specialist. After the baseline questionnaire, there be a 3 month and 6 month follow up questionnaire to investigate continuation and satisfaction with the contraceptive method. This study is unique because it will allow us to explore doing collaborative family planning research at the multiple UC medical campuses.

Many women with complex medical conditions who do not desire pregnancy do not receive contraception counseling from their primary or subspecialty care clinicians, and often they are not using contraception. This is an important deficiency as many have conditions that could worsen with pregnancy or for whom pregnancy can be complicated by the medical condition. Thus it is important for women with chronic disease to only become pregnant if they intend to do so. The United States Medical Eligibility Criteria for Contraceptive Use (USMEC), released in 2010, has greatly enhanced the ability of clinicians to counsel patient with complex medical conditions about their contraceptive options. It summarizes the safety of specific contraceptives when used on women with medical conditions. However, little is known about the contraceptive care of these women. We do not know if the availability of the USMEC has translated into evidence-based contraceptive counseling for these women. Further, little is known about their understanding of the interaction between their disease and pregnancy, their past experience and knowledge about contraception, and their contraceptive decision-making, satisfaction and continuation.

The purpose of the Complex Contraception Registry to is to recruit a cohort of women with complex medical conditions who are seen in contraception referral practices run by family planning fellowship trained physicians. We will assess their past experiences and baseline knowledge, their post-counseling experiences and choice of contraception, and their long-term satisfaction with and continuation of contraception. A multi-center registry is necessary because individual institutions see relatively few women with rare diseases such as a history of transplant surgery. The UC Family Planning Collaborative will facilitate recruitment of participants from the 5 UC medical campuses and will oversee their follow-up for one year.

Specific Aim include (1.) To investigate what factors influence contraceptive method utilization among women with complex medical conditions and their perceived risk of unintended pregnancy (2) To investigate how women with complex medical conditions access family planning fellowship trained specialist for contraception counseling and (3.) To assess satisfaction and continuation of contraceptive methods among women with complex medical conditions.

A Complex Contraception Registry

A Complex Contraception Registry - UC Family Planning Collaborative Study

Questionnaire is used to report continued use and satisfaction with multiple choice answer: very satisfied, somewhat satisfied, dissatisfied. Questionnaires will be administered at 3 months and 6 months after recruitment.

Measured with questionnaire at baseline, 3 months, and 6 months

Measured with questionnaire at 3 months and 6 months

University of California, Los Angeles

University of California, San Francisco

University of California, Irvine

University of California, Davis

University of California, San Diego

Assistant Professor

Neoplasms

Behaviors and Mental Disorders

Symptoms and General Pathology

Brain Neoplasms

Stroke

Cognition Disorders

Sclerosis

Multiple Sclerosis

Brain Diseases

Central Nervous System Diseases

Demyelinating Autoimmune Diseases, CNS

Autoimmune Diseases of the Nervous System

Demyelinating Diseases

Central Nervous System Neoplasms

Nervous System Neoplasms

Experimental group. Receives T-ScEmo Treatment during the study between T0 and T1

Waiting list group: Will be on waiting list for instead of the treatment for the duration of the treatment between T0 and T1.

T-ScEmo is a multifaceted treatment protocol that has the overall aim to improve social cognition, regulation of social behaviour and social participation in everyday life (Westerhof et al., 2017; 2019). The treatment includes, in addition to practicing social cognitive skills throughout the treatment, close involvement of a significant other, and homework assignments. The treatment consists of three modules that address 1) perception of social information including facial expressions of emotions, 2) perspective taking and understanding of social information and 3) regulation of social behaviour. The treatment contains 15-one hour live treatment sessions with a neuropsychologist and 5 online practice sessions, once or twice a week. In the online sessions, the patient can practice the information at home as a neuropsychologist is available for questions. When patients find it too difficult to practice individually at home, there is a opportunity to offer these sessions as live sessions

Treatment social cognition and emotion regulation (T-ScEmo)

A Heegers, MSc.

M.J.J. Gerritssen, dr.

Amber Heegers, MSc.

J.M. Spikman, Prof. Dr.

Impairments in aspects of social cognition are disorder-transcending: these have been demonstrated in various neurological disorders, such as traumatic brain injury (TBI), stroke, brain tumours (both low grade glioma's and meningioma's) and multiple sclerosis (MS). Social cognition involves processing of social information, in particular the abilities to perceive social signals, understand others and respond appropriately (Adolphs 2001). Crucial aspects of social cognition are the recognition of facial expressions of emotions, perspective taking (also referred to as mentalizing or Theory of Mind), and empathy. Impairments in social cognition can have a large negative impact on self-care, communication, social and professional functioning, and thus on quality of life of patients.

Recently, a first multi-faceted treatment for social cognitive impairments in TBI was developed and evaluated; T-ScEmo (Training Social Cognition and Emotion). T-ScEmo turned out to be effective in reducing social cognitive symptoms and improving daily life social functioning in this particular group, with effects lasting over time (Westerhof-Evers et al, 2017, 2019).

Unfortunately, up till now there are no evidence based, transdiagnostic treatment possibilities available for these impeding social cognition impairments in neurological patient groups, other than TBI. Therefore the aim of the present study is to investigate whether T-ScEmo is effective for social cognition disorders in patients with different neurological impairments, such as stroke (including subarachnoidal haemorrhage (SAH)), brain tumours, MS, infection (meningitis, encephalitis) and other. The secondary objective is to determine which patient related factors are of influence on treatment effectiveness. In short, hopefully this study can contribute to a treatment possibility for social cognition disorders for all patients with various neurological disorders.

It is expected that T-ScEmo will be effective for various neurological disorders, based on previous research of Westerhof-Evers et al. (2017, 2019). Since social cognition disorders within patients with traumatic brain injury do all have the same ethiology it is expected that the treatment will show the same effects for patients with various neurological disorders. Therefore it is expected that patients will improve on social cognition, social participation and quality of life and social behaviour, that these results will last over time.

Experimental condition T0, baseline measurement at point of inclusion (at least \> 6 months post-acute injuries) T1, post measurement within 2 weeks after treatment T2, follow-up measurement within 3 - 5 months after treatment

Waiting list condition T0, baseline measurement at point of inclusion (at least \> 6 months post-acute injuries) T1, post measurement within 3 months after T0 T2, follow-up measurement within 3 - 5 months after T1

TBI group T1, post measurement within 2 weeks after treatment T2, follow-up measurement within 3 - 5 months after treatment

The participating patients are randomly allocated into two groups: an experimental condition and a waiting list condition.

In addition, a group of patients with Traumatic Brain Injury will receive T-ScEmo following regular care.

The neuropsychologist who leads T1 and T2 measurements will be masked for the fact of which patient will be draw in which clinical condition (experimental group or control group), however this cannot be guaranteed since patients may talk about their experience.

Improving Social Cognition and Social Behaviour in Various Brain Disorders

Improving Social Cognition and Social Behaviour in Various Brain Disorders.

Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects.

Executive functioning will be measured with the Controlled Oral Word Association Test (COWAT).

Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects.

Executive functioning will be measured with the Key Search Test of the Behavioural Assessment of the Dysexecutive Syndrome.

Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects.

Verbal memory will be measured with Dutch version of the Rey Auditory Verbal Learning Test (15 Words Test).

Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects.

Working memory will be measured with the Digit Span Test of the Wechsler Adult Intelligence Scale IV.

Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects.

Language will be measured with the semantic fluency test.

Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects.

Mental speed and attention will be measured with the Trail Making Test (TMT).

Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects.

Mental speed will be measured with the Symbol Digit Modalities Test (SDMT).

Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects.

Premorbid intelligence will be measured with Dutch version of the Adult Reading Test (NLV).

Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects.

The level of physical and mental fatigue will be measured with the Dutch Multifactor Fatigue Scale (DMFS).

This scale has a range between 38 and 190. A higher outcome means more complaints.

Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects.

Health related physical and practical limitations will be measured with the RAND-36 Health Survey.

A higher outcome means better functioning.

Only at baseline (T0), the following additional measures will be determined, allowing to control for factors that may interfere with treatment effects.

Coping will be measured with the Utrecht Coping List (UCL)

A higher outcome means a better fitting coping style.

The main study parameter will be the difference between baseline (T0) and follow-up (T2) on Dysexecutive Questionnaire Social scales proxy version (DEX-Socproxy; Spikman et al., 2013; Westerhof-Evers, 2017). This scale is scored by the involved proxy of the patient (life partner, family member, friend) and measures the social aspects in daily life: 1) social convention, 2) behavioural-emotional selfregulation 3) metacognition. A higher outcome means more behavioural complaints.

Performance on neuropsychological test measuring emotion recognition; Eckman-60 faces test (EFT). This test has a range between 0 and 60. A higher outcome means a better performance.

Performance on neuropsychological test measuring Theory of Mind; Happé cartoons test. This test has a range between 0 and 36. A higher outcome means a better performance.

Performance on neuropsychological test measuring Theory of Mind: Faux Pas test. This test has a range between 0 and 10. A higher outcome means a better performance.

Performance on neuropsychological test measuring inhibition; Hailing Sentence Completion Test. This test has a range between 1 and 10. A higher outcome means a better performance.

Demographic information such as age, sex, educational level, will be obtained from medical records and anamnesis.

Self-reated social behaviour will be measured with a self rating on the Dysexecutive questionnaire Social Scales. Measuring the social aspects in daily life: 1) social convention, 2) behavioural-emotional selfregulation 3) metacognition. This scale has a range between 0 and 80. A higher outcome means more complaints.

Self-rated social behavior will be measured with the Interpersonal Reactivity Index (IRI). This scale has a range between 0 and 108. A higher outcome means less behavioural complaints.

Self-rated social behavior will be measured with The Dutch version of the BAFQ social scales (BAFQ-SOC). Moreover, patients answer if they have changed on that certain topic after brain damage. A higher outcome means less behavioural complaints and more change.

Proxy-rated social behavior will be measured with the Interpersonal Reactivity Index, proxy version (IRI). This scale has a range between 0 and 108. A higher outcome means less behavioural complaints.

Proxy-rated social behavior will be measured with the Socioemotional Dysfunction Scale (SDS). This scale has a range between 40 and 200. A higher outcome means more complaints.

Proxy-rated social behavior will be measured with the Dutch version of the BAFQ social scales, proxy version (BAFQ-SOC). Moreover, proxies answer if patients have changed on that certain topic after brain damage. A higher outcome means less behavioural complaints and more change.

The presence of alexithymia will be measured with a self-rating on the Toronto Alexithymia Scale (TAS-20). This scale has a range between 20 and 100. A higher outcome means more complaints.

Quality of life will be determined with a self-rating on the Life Satisfaction Questionnaire (LSQ-9). This scale has a range between 6 and 54. A higher outcome means a higher subjective quality of life.

The level of societal participation will be measured with the scores on the Utrecht Scale for Evaluation of Rehabilitation (USER-P). A higher outcome means higher participation rate.

The level of societal participation will be measured with the Impact on Participation and Autonomy (IPA). A higher outcome means lower participation rate.

The level of mood and anxiety will be obtained with the Hospital Anxiety and Depression Scale (HADS). This scale has a range between 0 and 42. A higher outcome means more complaints.

The extend to which proxies experience a burden in taking care of the patient wil be measured with the Zarit burden interview. This scale has a range between 0 and 48. A higher outcome means more burden.

The extent to which patients in the treatment condition improve on their set treatment goals will be measured with the Goal Attainment Scale (GAS). This scale has a range between 1 and 10. A higher outcome means better attainment.

University Medical Center Groningen

Rare Diseases

Glioma

Motor Disorders

Cognitive Dysfunction

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Neuroepithelioma

patients with a history of surgical removal of diffuse low grade glioma located in the supplementary motor area

patients with a history of surgical removal of diffuse low-grade glioma located in another brain area

motor and neuropsychological test battery

Test battery

Ilyess ZEMMOURA

Background : The supplementary motor area is the most common/preferential brain location of LGG. This area plays an important role in many motor and cognitive functions such as motor initiation, bimanual coordination and executive functions. Many studies describe the supplementary motor area syndrome resulting from lesions in this area. News managements for LGGs consisting in intraoperative mapping in awake patients reduce significantly neurological disorders and increase also the overall survival . However, the literature does not provide data concerning motor and cognitive functions in a long term and their consequences in the quality of life of patients.

Objective : The aim of our research project is to identify whether there are some motor or neurocognitive deficit in the short and the long term in a population of patients who have medical story of LGG resection in the supplementary motor area.

Patients and Methods : 20 patients who have medical story of LGG in the supplementary motor area and 20 patients who have medical story of LGG resection in other locations are recruited. Firstly, patients have to complete a self-assessment questionnaire about their quality of life, sent by regular mail or e-mail. Then, patients are admitted on the same day as their follow up visit and underwent motor and neurocognitive screening tests ( "Bilan des 400 points", Tests of Attentional Performances) for an hour. The investigators will analyse data and compare between the 2 groups.

Evaluation of Cognitive and Motor Neurological Disorders in the Short and Long Term After Surgery for the Removal of a Diffuse Low-grade Glioma of the Supplementary Motor Area

analysis of the scores obtained at the tests 4 tests :

* Hand mobility
* Grip strength
* Single-handed grasp and movement of objects
* Two-handed grasp and movement of objects Minimum value = 0 Maximum value = 100 100/100 means that the various tests regain good motor skills and hand grasp

analysis of the scores obtained Phase alert system

* Reaction time (RT) and standard deviation (SD) measurement with horn
* Measurement of reaction times (RT) and standard deviation(SD) without horn
* Measurement of the phase alert index

Flexibility

* Measurement of reaction times (RT) and standard deviation (SD) with hand change
* Measurement of reaction times (RT) and standard deviation (SD) without hand change
* Overall performance index
* Speed accuracy trade off index
* Number of wrong answers

Incompatibility

* Measurement of reaction times (RT) and standard deviation (SD) in compatible condition
* Measurement of reaction times (RT) and standard deviation (SD) in incompatible condition
* F (visual field)
* F (hand)
* F (incompatibility: fields \* hand)
* Number of false responses

RT min : 0 SD min : 0 No maximum value: calculation against standard values

Analysis of the location of diffuse low-grade gliomas

Analysis of the lesion volume of diffuse low-grade gliomas

analysis of the results obtained 136 questions with responses True or False Minimum value = 0 Maximum value = 136 136/136 means that the quality of life is very negatively affected

analysis of the results obtained 40 questions with responses

* It is quite true
* It is rather true
* It is neither true nor false
* It is rather false
* It is completely false

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Complex Contraception Registry	NCT02219269	Diabetes Cardiovascular ... Epilepsy Migraine Neurological Di... Cancer Bariatric Surge... Organ or Tissue... Lupus Erythemat... Other Hematolog... Other Venous Em...		18 Years - 45 Years	University of California, San Diego
A Complex Contraception Registry	NCT02219269	Diabetes Cardiovascular ... Epilepsy Migraine Neurological Di... Cancer Bariatric Surge... Organ or Tissue... Lupus Erythemat... Other Hematolog... Other Venous Em...		18 Years - 45 Years	University of California, San Diego
Improving Social Cognition and Social Behaviour in Various Brain Disorders	NCT06330298	Stroke Multiple Sclero... Brain Tumor	Treatment socia...	18 Years - 75 Years	University Medical Center Groningen
Evaluation of Cognitive and Motor Neurological Disorders in the Short and Long Term After Surgery for the Removal of a Diffuse Low-grade Glioma of the Supplementary Motor Area	NCT05373394	Cognitive Disor... Motor Disorders Low-grade Gliom...	Test battery	18 Years -	University Hospital, Tours

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