ABSTRACT
BACKGROUND: Phelan-McDermid syndrome (PMS) is caused by haploinsufficiency of the SHANK3 gene and is characterized by global developmental delays and autism spectrum disorder (ASD). Based on several converging lines of preclinical and clinical evidence supporting the use of insulin-like growth factor-1 (IGF-1) in PMS, this study aims to follow-up a previous pilot study with IGF-1 to further evaluate this novel therapeutic for core symptoms of ASD in children with PMS. METHODS: Ten children aged 5-9 with PMS were enrolled. Participants were randomized to receive IGF-1 or placebo (saline) using a 12-week, double-blind, crossover design. Efficacy was assessed using the primary outcome of the Aberrant Behavior Checklist-Social Withdrawal (ABC-SW) subscale as well as secondary outcome measures reflecting core symptoms of ASD. To increase power and sample size, we jointly analyzed the effect of IGF-1 reported here together with results from our previous controlled trail of IGF-1 in children with PMS (combined N = 19). RESULTS: Results on the ABC-SW did not reach statistical significance, however significant improvements in sensory reactivity symptoms were observed. In our pooled analyses, IGF-1 treatment also led to significant improvements in repetitive behaviors and hyperactivity. There were no other statistically significant effects seen across other clinical outcome measures. IGF-1 was well tolerated and there were no serious adverse events. LIMITATIONS: The small sample size and expectancy bias due to relying on parent reported outcome measures may contribute to limitations in interpreting results. CONCLUSION: IGF-1 is efficacious in improving sensory reactivity symptoms, repetitive behaviors, and hyperactivity in children with PMS. Trial registration NCT01525901.
Subject(s)
Chromosome Disorders , Insulin-Like Growth Factor I , Child , Chromosome Deletion , Chromosome Disorders/drug therapy , Chromosome Disorders/genetics , Chromosomes, Human, Pair 22 , Humans , Insulin-Like Growth Factor I/therapeutic use , Pilot ProjectsABSTRACT
In the present study, 61 persons taken into police custody due to drunkenness were compared with 57 persons admitted to hospital due to intoxication with alcohol. The persons with alcohol problems taken into police custody numbered more younger men, fewer retired persons and the alcohol problems were more often acute intoxication than alcohol dependence. None of the persons placed in police custody were advised to seek help for their alcohol problems in contrast to 45 out of the 57 admitted to the hospital who started treatment. Detoxification in hospitals is far more suitable to motivate persons with alcohol problems to seek help. Detoxification should, for non criminal intoxicated people, be performed in hospitals.
Subject(s)
Alcoholic Intoxication , Adolescent , Adult , Alcoholic Intoxication/therapy , Denmark , Female , Humans , Inactivation, Metabolic , Male , Middle Aged , Patient Admission , Prisons , Socioeconomic Factors , Surveys and QuestionnairesSubject(s)
Carcinoma, Squamous Cell , Mouth Neoplasms , Oral Ulcer/etiology , Carcinoma, Squamous Cell/diagnosis , Carcinoma, Squamous Cell/surgery , Female , Humans , Lymphatic Metastasis , Mandible/pathology , Middle Aged , Mouth Neoplasms/diagnosis , Mouth Neoplasms/surgery , Neoplasm Invasiveness , Prognosis , Radiotherapy, Adjuvant , Surgery, Plastic , Tomography, X-Ray ComputedABSTRACT
In a double-blind clinical trial, a total of 463 volunteers were enrolled in a study designed to compare the effects of zinc gluconate lozenges (4.5 mg zinc) and a placebo for common cold. The tablets were to be taken every 1-1 1/2 waking hours at the first symptoms and for the following days until the common cold was over, but for no longer than 10 days. During the winter months of 1987 and 1988, 145 experienced a common cold and 130 completed the study. For final analysis, 61 patients in the zinc lozenge group and 69 patients in the placebo lozenge group were evaluated. Based on the patients' records the duration and severity of the common cold were compared. No statistically significant differences were found between the patient groups. Two recent studies using a five-time higher zinc dose per lozenge for common cold showed a significant, positive effect, but associated with frequent side-effects, first of all taste distortion. In the present study there was a weak tendency (not statistically significant, p = 0.12) towards more patients in the zinc lozenge group than in the placebo lozenge group reporting side-effects.
Subject(s)
Common Cold/drug therapy , Gluconates/administration & dosage , Adolescent , Adult , Aged , Antiviral Agents , Clinical Trials as Topic , Denmark , Double-Blind Method , Drug Administration Schedule , Humans , Middle Aged , Placebos , Seasons , TabletsABSTRACT
Based on the experience of 115 examinations, the authors first describes the normal radiological appearances on arthrography of the elbow joint. Subsequently, the radiological criteria are discussed which permit a diagnosis of intra- and para-articular soft tissue lesions due to closed trauma of the elbow joint. Arthrography with positive (water-soluble) contrast media enables one to diagnose rupture of the joint capsule and ligaments, and to diagnose with certainty subluxations of the various parts of the joint. Is is also possible to demonstrate haematomas between the muscles, which may lead to a reduction in joint function. Negative contrast medium (carbon dioxide, oxygen) permits the diagnosis of rupture of the insertion of the biceps.
