Addiction

Prevalence of New Psychoactive Substances Use

Prevalence of New Psychoactive Substances Use Among Outpatient of Addiction Management Clinic in Assiut University Hospital

All participant will subjected to the following:
Special sheet designed for the study in department of neurology and psychiatry at Assiut University hospital asking about spychoactive substance use regarding to type, amount, duration,cause of use, and cause for stoppage.
Addiction severity index Urinary drug screen

AAEsraa

Princible investigator

Assiut University

A group of patients who aged 12 years or above and have a diagnosis of epilepsy with simple partial seizure and/or complex partial seizures

Focal Epilepsy

Generalized Epilepsy

Partial Seizures, Simple

This study collects clinical information during the first 16 weeks after the first dose of AMPA/NMDA receptor antagonist. Subjects or caregivers shall provide seizure diary which documents seizure type and seizure frequency as per usual medical care. The final visit will be based on the week-16 visit.

Perampanel

Prince of Wales Hospital

Post-market Study of AMAP Receptor Antagonists for Epilepsy Patients in Hong Kong

The primary efficacy end-points evaluates seizure frequency (per month) in week 0 (baseline) and week 16 (maintenance phase). The investigators will used those seizure frequencies (per month) to calculate the percentage change from baseline to maintenance phase for each subject and categories: no change, between 0 to 50% decrease, 50% to 75% decrease, 75% to 100% decrease.

The proportion of subjects achieving seizure freedom during the maintenance period will be documented. The percentage of seizure free days in the maintenance phase will also be collected. The investigators will report the seizure freedom rate for the present study population and the average days of achieving seizure freedom.

The investigators would use the Neuropsychiatric Inventory Questionnaire (NPI) with 12 domains to evaluate the neuropsychiatric events in week 0 (baseline) and week 16 (maintenance phase). The investigators will record each symptom severity (rated 1 occasional to 4 very frequent) and frequency (rated 1 mild to 3 severe).

This is a cohort study for perampanel in Hong Kong. There is no plan to make individual participant data to share. The results would be shared in publications. Electronic data will be saved in secured computer of the individual sites with restricted access. The anonymous data will be managed installed for developing future studies.

Dr. Howan Leung

Associate consultant

Chinese University of Hong Kong

Children born to mothers, who have accepted to participate, will be randomised to either intervention group or to the control group at birth. Block-randomisation stratified by hospital, gender and gestational age (≥37 weeks of gestation vs. < 37 weeks of gestation) will be performed electronically just before vaccination by the overall study electronic case report system (e-crf).
Children randomised to the BCG vaccination group will receive an intradermal BCG vaccine (Statens Serum Institute "CG vaccine" in the standard dose 0.05 ml in the upper, lateral part of the arm of the child by a specially trained midwife or a study physician.

Control children will be treated as usual, since no suitable placebo exists.

BCG-vaccine

Control Children

Total

Gender of the child. In multiple births: gender of the first born child.

Sex: Female, Male

All three study sites are situated in Denmark.

Region of Enrollment

Premature birth

To test that infants who get the BCG vaccine at birth experience 20% fewer hospitalisations in early childhood than non-BCG-immunised infants.

Control Children (no Intervention)

All-cause Hospitalisations

To test that infants who get the BCG vaccine at birth are prescribed less antibiotics during early childhood than non-BCG-immunised infants. Use of antibiotics was defined as one or more precriptions of systemic antibiotics (ATC groups J01, J02, J05, all subgroups inclusive).

Antibiotics

To test if BCG vaccination within 7 days after birth influence the risk of atopic dermatitis defined by clinical examination at 13 months of age using "scoring atopic dermatitis (SCORAD)" or by parental report of physician diagnosed atopic dermatitis in the telephone interview at 13 months of age.

Atopic Dermatitis

Number of participants with specific IgE (Phadiatop Infant) above the clinical cut-of level of 0.35.

Specific IgE

To test that infants who get the BCG vaccine at birth respond in weight.The Z-score indicates the number of standard deviations away from the mean weight-for-age of the WHO anthropometric reference population (http://www.who.int/childgrowth/standards/en/). A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.

Standardized Weight at 13 Months

To test that premature infants with gestational age less than 37 weeks who get the BCG vaccine at birth have unaffected psychomotor development measures: ASQ: Ages and stages questionnaire - a parent reported questionnaire that measures child psychomotor development. Total range of ASQ score: 0 to 300 points. Higher scores indicate higher level of psychomotor development.

Psychomotor Development in Premature Infants

To test that infants who get the BCG vaccine at birth has unaffected coverage with the subsequent 3rd diphtheria, tetanus, acellular pertussis, polio, Haemophilus influenzae type b (DTaP-IPV-Hib) vaccination scheduled to 12 months of age according to the Danish child vaccination programme. Since we did not expect all children to get their immunizations exactly at 12 months of age, the children were followed up until 13-months of age.

DTaP-IPV-Hib Vaccination Coverage at 12 Months of Age

The Z-score indicates the number of standard deviations away from the mean weight-for-age of the WHO anthropometric reference population (http://www.who.int/childgrowth/standards/en/). A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.

Standardized Weight, Length and Head Circumference of Premature Children at 13 Months

Number of participants diagnosed with episodic viral wheeze by a physician and treated with anti-asthmatic medicine according to the telephone interview.

Episodic Viral Wheeze

Number of participants with food allergy diagnosed by a physician and mentioned in the telephone interview at 13 months of age

Food Allergy

To test if infants who get the BCG vaccine at birth respond in length. The Z-score indicates the number of standard deviations away from the mean weight-for-age of the WHO anthropometric reference population (http://www.who.int/childgrowth/standards/en/). A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.

Length at 13 Months of Age

To test if infants who get the BCG vaccine at birth respond in head circumference. The Z-score indicates the number of standard deviations away from the mean weight-for-age of the WHO anthropometric reference population (http://www.who.int/childgrowth/standards/en/). A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.

Standardized Head Circumference at 13 Months of Age

To test that infants who receive the BCG at birth respond in thymic gland size defined by ultra sound examination. First, the thymus gland was identified in a horizontal scanning plane and the largest transverse diameter of the thymus was obtained. Second, in a sagittal scanning plane, the area of the largest lobe was assessed. Both measurements were obtained twice, and in case of more than 15% difference, both measurements were repeated. The mean of the two measurements were multiplied and defined as the thymic index.

Thymic Gland Size at 3 Months of Age

To test if infants who receive the BCG at birth respond in leucocyte count (white blood cell count) measured as geometric mean (GM) cell concentrations (GM*10^9 cells/L).

Leucocyte Count 4 Days After Randomisation/Vaccination

To test if infants who receive the BCG at birth respond in monocyte count measured as geometric mean (GM) cell concentrations (GM*10^9 cells/L).

Monocyte Count 4 Days After Randomisation/Vaccination

To test that infants who receive the BCG at birth respond in interferon-gamma response upon stimulation with BCG. The interferon gamma response was defined as a value above the cut-off value of 107 pg/ml.

Interferon Gamma Response

To test the tetenus antibody response in BCG-vaccinated vs. non-BCG vaccinated children following routine immunisation against tetanus at 3, 5 and 12 months of age in blood samples obtained 13 months of age.

Number of Participants With Antibody Concentration (AC) Against Tetanus of > 0.1 IU/mL

To test that Danish infants who get the BCG vaccine at birth experience less events of common cold until 13 months of age than non-BCG-immunised infants.

Number of Events of Common Cold

To test that Danish infants who get the BCG vaccine at birth get less pneumonia at 13 months of age than non-BCG-immunised infants.

Number of Events of Pneumonia

To test that Danish infants who get the BCG vaccine at birth get less febrile episodes at 13 months of age than non-BCG-immunised infants.

Number of Events of Febrile Episodes

To test that Danish infants who get the BCG vaccine at birth develop less episodes with diarrhoea and vomiting at 13 months of age than non-BCG-immunised infants.

Number of Events With Diarrhoea and Vomiting

To test that Danish infants who get the BCG vaccine at birth develop less acute otitis media at 13 months of age than non-BCG-immunised infants.

Number of Events of Acute Otitis Media

To test that Danish infants who get the BCG vaccine at birth develop less febrile convulsions at 13 months of age than non-BCG-immunised infants.

Number of Events of Febrile Convulsions

After parents having made the decision about whether to accept vaccination of their newborn through participation in The Danish Calmette Study, O'Connor's Decisional Conflict Scale was used to identify decisional conflicts. The score ranges from 0 (no decisional conflict) til 100 (maximum decisional conflict). Scores lower than 25 are associated with implementing decisions; scores exceeding 37.5 are associated with decision delay or feeling unsure about implementation; so a low score reflects a low level of doubt about the decision about participation/decline participation in the trial, and a high score reflects a high level of doubt.

Mothers who decided to let their child participate in the study

Participating Mothers

Mothers who decided not to let their child participate in the study

Declining Mothers

Decisional Conflict Scale Score

To test that the use of telephone and internet was acceptable in the study population using the Quality of Informed Consent (QuIC) questionnaire. The questionnaire was divided into six categories; five on study comprehension and one on satisfaction with the information process. The items in the first five categories could be answered with "yes", "no" or "do not know". The last category was rated on a 7-point Likert scale, with 1 being "very dissatisfied" and 7 being "very satisfied". The primary outcome was the sum of the score for comprehension items and satisfaction items. Comprehension items were scored 1 point for each correct answer and 0 points for each incorrect answer. Satisfaction items were scored as rated on the 7-point Likert scale. Total score ranged from 7 to 69 points, comprehension score from 0 to 20 points and satisfaction score from 7 to 49 points. The higher score, the better comprehension and satisfaction.

Randomized to receive information about the study by telephone

Telephone

Randomized to receive information about the study by standard face-to-face consultation.

Face-to-face

Quality of Communication and Information

Overall Study

Lone Graff Stensballe, Research leader, Pediatrician, PhD

Prospective

Single-blind

Clinical

Trial

Intervention

BCG-vaccine (SSI)

Rigshospitalet

Hvidovre Hospital

Kolding Sygehus

Bacille Calmette Guérin Immunisation at Birth and Childhood Morbidity in Danish Children.

Bacille Calmette Guérin Immunisation at Birth and Childhood Morbidity in Danish Children. A Prospective, Randomised, Clinical Trial.

Lone Graff Stensballe

MD, PhD

Hvidovre University Hospital

Danish National Research Foundation

Research Center for Vitamins and Vaccines (CVIVA)

Multiple Sclerosis

Multiple Sclerosis Center Carmel Medical Center

Observational Study for Assessment of the Effect of Fampyra on the Manual Function of Persons With Multiple Sclerosis

Scores of hand function tests before treatment with Fampyra and at several timepoints after treatment initiation will be compared.

Assessment of daily function before treatment with Fampyra and 4 months after initiation of treatment will be compared.

Improvement in patient manual function after 1 to 4 months of initiation of treatment with Fampyra will be compared to patient improvement in ambulation over the same period of time.

common cold/seizures

Prevalence of New Psychoactive Substances Use

Post-market Study of AMAP Receptor Antagonists for Epilepsy Patients in Hong Kong

Bacille Calmette Guérin Immunisation at Birth and Childhood Morbidity in Danish Children.

Observational Study for Assessment of the Effect of Fampyra on the Manual Function of Persons With Multiple Sclerosis

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