Preliminary Case Series Study Research Articles

Transosseous Suturing for the Correction of Juvenile Hallux Valgus: A Preliminary Case Series Study.

Background and Objectives: Many treatment modalities are available for juvenile hallux valgus. However, all of them have some disadvantages. Therefore, we developed a transosseous suturing procedure. Materials and Methods: Six patients (seven feet) with juvenile hallux valgus received transosseous suturing procedure. Clinical and radiological examinations were performed preoperatively and postoperatively. All patients underwent the soft tissue release procedure, followed by transosseous suturing with Fiberwire (in which sutures are anchored with mini plates). Results: The mean IMA and HVA decreased from 15.6° ± 2.6° to 7.3° ± 1.1° and 39.2° ± 3.3° to 12.5° ± 3.1°, respectively. Corrections achieved in the IMA and HVA of all patients were maintained through the last follow-up. The mean American Orthopedic Foot & Ankle Society score improved from 53.3 ± 3.5 to 86.9 ± 4.7 points. Conclusions: Based on these preliminary data, the transosseous suturing technique demonstrated satisfactory results and apparent improvements in the IMA and HVA without early complications.

Short-course radiotherapy and chemotherapy for conversion surgery in patients with unresectable metastatic rectal cancer: a preliminary case series study.

Curative treatment is challenging in patients with locally advanced rectal cancer and unresectable metastases. The aim of this study was to evaluate the clinical outcomes of short-course radiotherapy (RT) followed by systemic chemotherapy for patients with rectal cancer with mesorectal fascia (MRF) involvement and unresectable distant metastases. The study included consecutive patients diagnosed as having metastatic mid-to-low rectal cancer treated with short-course RT followed by systemic chemotherapy for conversion radical or palliative surgery between 2014 and 2019 at Gil Medical Center. The patients had primary rectal tumors involving the MRF and unresectable distant metastases. The treatment strategies were determined in a multidisciplinary team discussion. Seven patients (five men and two women) underwent short-course RT (5×5 Gy) and preoperative systemic chemotherapy. The median age was 68 years (range, 46-84 years), and the median distance from the anal verge to the primary tumor was 6.0 cm (range, 2.0-9.0 cm). During the median follow-up period of 29.4 months, three patients underwent conversion radical surgery with R0 resection, two underwent palliative surgery, and two could not undergo surgery. No postoperative major morbidity or mortality occurred. The patients who underwent conversion complete radical surgery showed good long-term survival outcomes, with an overall survival time of 29.4-48.8 months and progression-free survival time of 14.7-41.1 months. Short-course RT followed by systemic chemotherapy could provide patients with unresectable stage IV rectal cancer a chance to undergo to conversion radical surgery with good long-term survival outcomes.

Initial Experience of Clinical Use of [99mTc]Tc-PSMA-T4 in Patients with Prostate Cancer. A Pilot Study.

Numerous different molecules of prostate-specific membrane antigen (PSMA) ligands are used to detect prostate cancer (PCa); most approaches utilize gallium PET and a few reports describe the role of SPECT/CT. [99mTc]Tc-PSMA-T4 is a new radiopharmaceutical designed for the diagnosis of patients with PCa. We conducted a single site, prospective, preliminary case series study that included 31 patients with PCa; all had undergone clinical, biochemical or imaging examination and exhibited clear or suspicious active disease or clinical/biochemical recurrence of PCa. Whole-body (WB) SPECT/CT after i.v. administration of [99mTc]Tc-PSMA-T4 was utilized; acquisition images were obtained at three time points. The clinical value of the images was assessed in regard to the evaluation of tumor extent in patients with confirmed PC that qualified for initial therapy and the evaluation of tumor recurrence; both provided encouraging results. The late acquisition of WB-SPECT resulted in better lesions delineation. The results of the analysis of the sensitivity/specificity were: 92%/100% in cases of primary cancer, 83%/100% in terms of pelvic lymph nodes disease, 100%/95% in other lymph nodes and soft tissue involvement, respectively, and bone mets were both 100%. An oncotropic SPECT [99mTc]Tc-PSMA-T4 can help in selecting a rational therapeutic strategy for a patient with an initial diagnosis of PCa by assessing the extent of cancer and also after complex radical or palliative therapy in case of biochemical recurrence for re-staging.

Radiological and Clinical Efficacy of Intra-Arterial 90Y-DOTATATE in Patients with Unresectable, Progressive, Liver Dominant Neuroendocrine Neoplasms

This study was performed to determine if intra-arterial (i.a.) administration of 90Y DOTATATE can provide an effective and safe alternative to the accepted standard for i.v. of peptide receptor radionuclide therapy (PRRT) in liver-dominant metastases of gastrointestinal pancreatic neuroendocrine neoplasm (GEP-NEN). A single site, prospective, preliminary case series study included 39 patients with histologically proven liver-dominant NEN. PRRT in the form of 1.15GBq 90Y DOTATATE was given selectively into the liver via radiological catheterization of the hepatic artery, up to four times. The endpoint was radiological response (RECIST). Secondary endpoints assessed clinical well-being post-treatment, progression-free survival (PFS), overall survival (OS), and toxicity. Partial response (PR) was noted in 13% of subjects six weeks post-therapy, increasing to 24% at six months and dropping to 13% at 36 months. Disease progression (DP) was not seen at six weeks, was 5% at six months, and 47% at 36 months. Clinical response based on PS seen in 74% of patients at six weeks, 69% at six months, and 39% at 36 months had PFS and OS, respectively, of 22.7 months and 38.2 months. There was no difference in OS/PFS between those with RECIST PR and SD. One patient had significant toxicity (3%). Use of i.a. PRRT appears to be safe and effective in treating patients with liver-dominant NEN. In addition, the best OS (51 vs. 22 months) was seen when i.a. was used as an upfront treatment of bulky GEP-NEN liver metastases and not after i.v. 90Y DOTATATE. The use of i.a. 90Y DOTATATE PRRT appears to be safe and effective in treating patients with liver-dominant NEN.

COVID-19 situation in Baden-Württemberg, Germany: Preliminary case series study during the first wave

The present case series study presents the preliminary data of 347 of severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) positively tested patients in the Mittelbaden hospital, Baden-Baden Bühl, Germany, during the period from March to June 2020. Among the 347 patients, 55% were males. The mean age-wise was 52.5±20.2 years in the overall cohort and 78.9±11.1 years in fatal outcome cases. A total of 120/347 patients (34.6%) required hospitalization, but only 36/347 (10.37%) cases required intensive care. The overall fatality rate was 6.6% (23/347), of which 12 patients were from the intensive care unit. The most frequent clinical symptoms observed were cough (62.5%), hyperthermia (47.8%), rhinorrhea (25.1%), sore throat (23.1%), dyspnea (22.8%), and headache (19.3%). Laboratory data analysis showed no specific findings, but severe laboratory disturbances could predict critical illness. A higher risk of severe illness or lethal outcome in elderly patients with several comorbidities was the most frequent. The fight against COVID-19 infection in Germany seems to be more successful during the first wave than in other countries. The improvement of the healthcare system against infectious outbreaks depends directly on the analysis of regional factors.

Effects of language stimulation on cognition of institutionalized aged people: a preliminary case series study.

ABSTRACT.Cognitive stimulation programs for institutionalized elderly people show positive results, however few studies have investigated the effectiveness of language stimulation programs for the health of this population.Objectives:To characterize the cognitive-linguistic profile of institutionalized elderly and to compare their performance before and after a language stimulation program (LSP).Methods:An exploratory case series study was conducted with nine residents of a Home for the Aged. Elderly people aged 60 or over, of both sexes, without neurological or neuropsychiatric diseases, communication disorders, intellectual impairment or severe visual or hearing impairment were included. The participants were submitted to an initial assessment through the Montreal Cognitive Assessment (MoCA) and Montreal Toulouse Battery Language Assessment – Brazil to characterize the cognitive-linguistic profile of the studied group. Five elderly were selected to participate in the LSP, of wich only two participated effectively in the program, but all were reassessed after the program was completed.Results:on the initial assessment, of the nine participants, only one had adequate cognitive performance and all presented changes in macro and/or microlinguistics aspects of oral discourse, with oral comprehension preserved. On the reassessment carried out with five participants, only two participants who adhered effectively to the program obtained improvements in MoCa scores. In regarding language, three participants performed better in the oral emission measures. The performance of the participants in oral comprehension remained or declined.Conclusion:The speech-language therapy intervention through a LSP contributes to improving the cognitive-linguistic performance of institutionalized elderly.

経皮的腰椎椎体間固定術（PELIF）の成績

経皮的腰椎椎体間固定術（PELIF）の成績

Endoscopic Doppler probe ultrasonography for detecting blood flow at post-endoscopic submucosal dissection ulcers of the stomach.

Background and study aims The rate of early rebleeding after endoscopic submucosal dissection (ESD) for early gastric cancer ranges from 5 % to 38 %, despite application of preventive methods. Post-ESD rebleeding may be caused by “invisible” vessels that may not be detectable using ultrasonographic techniques. Recently, Doppler probe ultrasonography (DOP) has been used in endoscopy. Because little is known about the usefulness of DOP for decreasing the post-ESD rebleeding rate, we performed a preliminary case series study. Patients and methods Twelve patients underwent DOP for post-ESD ulcer evaluation after visible vessel coagulation. In this study, the novel DOP system used in the vascular surgery department was used. DOP-positive invisible vessels were shown as a pulse wave on the monitor. Results No (0 %) cases of post-ESD rebleeding occurred. Twenty invisible vessels were detected, and 13 were subjected to additional coagulation up to a depth of 3 mm. Mean DOP procedure time was 11.6 minutes (range: 8–18 minutes). In these latter cases, disappearance of the Doppler pulse wave was confirmed. No early rebleeding or other adverse events were experienced. Conclusion DOP is a safe and feasible method for detecting invisible vessels in post-ESD ulcers. Further investigation of the clinical relevance is warranted.

Effect of Sensory Loss on Improvements of Upper-Limb Paralysis Through Robot-Assisted Training: A Preliminary Case Series Study

Sensory disorder is a factor preventing recovery from motor paralysis after stroke. Although several robot-assisted exercises for the hemiplegic upper limb of stroke patients have been proposed, few studies have examined improvement in function in stroke patients with sensory disorder using robot-assisted training. In this study, the efficacies of robot training for the hemiplegic upper limb of three stroke patients with complete sensory loss were compared with those of 19 patients without complete sensory loss. Robot training to assist reach motion was performed in 10 sessions over a 2-week period for 5 days per week at 1 h per day. Before and after the training, the total Fugl–Meyer Assessment score excluding coordination and tendon reflex (FMA-total) and the FMA shoulder and elbow score excluding tendon reflex (FMA-S/E) were evaluated. Reach and path errors (RE and PE) during the reach motion were also evaluated by the arm-training robot. In most cases, both the FMA-total and the FMA-S/E scores improved. Cases with complete sensory loss showed worse RE and PE scores. Our results suggest that motor paralysis is improved by robot training. However, improvement may be varied according to the presence or absence of somatic sensory feedback.

Gait Rehabilitation Using Functional Electrical Stimulation Induces Changes in Ankle Muscle Coordination in Stroke Survivors: A Preliminary Study.

Background: Previous studies have demonstrated that post-stroke gait rehabilitation combining functional electrical stimulation (FES) applied to the ankle muscles during fast treadmill walking (FastFES) improves gait biomechanics and clinical walking function. However, there is considerable inter-individual variability in response to FastFES. Although FastFES aims to sculpt ankle muscle coordination, whether changes in ankle muscle activity underlie observed gait improvements is unknown. The aim of this study was to investigate three cases illustrating how FastFES modulates ankle muscle recruitment during walking.Methods: We conducted a preliminary case series study on three individuals (53–70 y; 2 M; 35–60 months post-stroke; 19–22 lower extremity Fugl-Meyer) who participated in 18 sessions of FastFES (3 sessions/week; ClinicalTrials.gov: NCT01668602). Clinical walking function (speed, 6-min walk test, and Timed-Up-and-Go test), gait biomechanics (paretic propulsion and ankle angle at initial-contact), and plantarflexor (soleus)/dorsiflexor (tibialis anterior) muscle recruitment were assessed pre- and post-FastFES while walking without stimulation.Results:Two participants (R1, R2) were categorized as responders based on improvements in clinical walking function. Consistent with heterogeneity of clinical and biomechanical changes commonly observed following gait rehabilitation, how muscle activity was altered with FastFES differed between responders. R1 exhibited improved plantarflexor recruitment during stance accompanied by increased paretic propulsion. R2 exhibited improved dorsiflexor recruitment during swing accompanied by improved paretic ankle angle at initial-contact. In contrast, the third participant (NR1), classified as a non-responder, demonstrated increased ankle muscle activity during inappropriate phases of the gait cycle. Across all participants, there was a positive relationship between increased walking speeds after FastFES and reduced SOL/TA muscle coactivation.Conclusion:Our preliminary case series study is the first to demonstrate that improvements in ankle plantarflexor and dorsiflexor muscle recruitment (muscles targeted by FastFES) accompanied improvements in gait biomechanics and walking function following FastFES in individuals post-stroke. Our results also suggest that inducing more appropriate (i.e., reduced) ankle plantar/dorsi-flexor muscle coactivation may be an important neuromuscular mechanism underlying improvements in gait function after FastFES training, suggesting that pre-treatment ankle muscle status could be used for inclusion into FastFES. The findings of this case-series study, albeit preliminary, provide the rationale and foundations for larger-sample studies using similar methodology.

Effects of neurofeedback training with an electroencephalogram-based Brain–Computer Interface for hand paralysis in patients with chronic stroke: A preliminary case series study

To explore the effectiveness of neurorehabilitative training using an electroencephalogram-based brain- computer interface for hand paralysis following stroke. A case series study. Eight outpatients with chronic stroke demonstrating moderate to severe hemiparesis. Based on analysis of volitionally decreased amplitudes of sensory motor rhythm during motor imagery involving extending the affected fingers, real-time visual feedback was provided. After successful motor imagery, a mechanical orthosis partially extended the fingers. Brain-computer interface interventions were carried out once or twice a week for a period of 4-7 months, and clinical and neurophysiological examinations pre- and post-intervention were compared. New voluntary electromyographic activity was measured in the affected finger extensors in 4 cases who had little or no muscle activity before the training, and the other participants exhibited improvement in finger function. Significantly greater suppression of the sensory motor rhythm over both hemispheres was observed during motor imagery. Transcranial magnetic stimulation showed increased cortical excitability in the damaged hemisphere. Success rates of brain-computer interface training tended to increase as the session progressed in 4 cases. Brain-computer interface training appears to have yielded some improvement in motor function and brain plasticity. Further controlled research is needed to clarify the role of the brain-computer interface system.

Immunogenetic differences between Caucasian women with and those without silicone implants in whom myositis develops

To determine whether patients in whom myositis develops after they receive silicone breast implants have distinct clinical, serologic, and/or immunogenetic features compared with patients with myositis who do not have silicone implants. A preliminary case series study was followed by a larger, independent, matched case-control study to evaluate women in whom myositis developed after they received silicone implants (MASI patients) compared with healthy women with silicone implants and women with myositis but without silicone implants (idiopathic inflammatory myopathy; IIM patients). In a preliminary study, 11 MASI patients differed from 76 IIM patients in having an increased frequency of HLA-DQA1*0102 (odds ratio [OR] 9.8, 95% confidence interval [95% CI] 1.77-96.79) and decreased frequencies of the myositis-associated risk factor DRB1*0301 (OR 0.1 [95% CI 0.002-0.63]) and its linked allele DQA1*0501 (OR 0.2 [95% CI 0.02-0.87]). A subsequent independent, matched case-control study revealed that although clinical features and autoantibodies did not differ significantly between the MASI and IIM groups, MASI patients again had decreased frequencies of DRB1*0301 (OR 0.2 [95% CI 0.07-0.72]) and DQA1*0501 (OR 0.2 [95% CI 0.08-0.84]) compared with IIM patients. Additional comparisons between MASI patients from both studies combined (n = 37) and a larger population of IIM patients (n = 453) suggested that HLA-DQA1*0102 may be uniquely associated with MASI (OR 2.6 [95% CI 1.25-5.46]). Women in whom inflammatory myopathy develops after they receive silicone implants constitute an immunogenetically distinct group of patients with myositis. These and other data suggest that autoimmune diseases as now defined may consist of multiple distinct entities, each of which is characterized by different genes and environmental exposures.

Sulpiride adjunction to clozapine in treatment-resistant schizophrenic patients: a preliminary case series study

Six chronic neuroleptic-resistant schizophrenic patients, partial responders to clozapine, were co-administered 600 mg/day of sulpiride (a selective D(2) dopaminergic antagonist) as an augmentation to clozapine (a relatively weak D(2) blocker), for 10 weeks, open-labeled. A remarkable reduction in positive and negative symptoms was observed in four of the six patients.