First-in-man histotripsy of hepatic tumors: the THERESA trial, a feasibility study.

Rationale Current hepatic locoregional therapies are limited in terms of effectiveness and toxicities. Given promising pre-clinical results, a first in-human trial was designed to assess the technical effectiveness and safety profile of histotripsy, a noninvasive, non-thermal, non-ionizing focused ultrasound therapy that creates precise, predictable tissue destruction, in patients with primary and secondary liver tumors.Methods A multicenter phase I trial (Theresa Study) was performed in a single country with 8 weeks of planned follow-up. Eight of fourteen recruited patients were deemed eligible and enrolled in the study. Hepatic histotripsy, was performed with a prototype system (HistoSonics, Inc., Ann Arbor, MI). Eleven tumors were targeted in the 8 patients who all had unresectable end-stage multifocal liver tumors: colorectal liver metastases (CRLM) in 5 patients (7 tumors), breast cancer metastases in 1 (1 tumor), cholangiocarcinoma metastases in 1 (2 tumors), and hepatocellular carcinoma (HCC) in 1 (1 tumor). The primary endpoint was acute technical success, defined as creating a zone of tissue destruction per planned volume assessed by MRI 1-day post-procedure. Safety (device-related adverse events) through 2 months was a secondary endpoint.Results The 8 patients had a median age of 60.4 years with an average targeted tumor diameter of 1.4 cm. The primary endpoint was achieved in all procedures. The secondary safety profile endpoint identified no device-related adverse events. Two patients experienced a continuous decline in tumor markers during the eight weeks following the procedure.Conclusions This first-in-human trial demonstrates that hepatic histotripsy effectively destroys liver tissue in a predictable manner, correlating very well with the planned histotripsy volume, and has a high safety profile without any device-related adverse events. Based on these results, the need for more definitive clinical trials is warranted. Trial Registration: Study to Evaluate VORTX Rx (Theresa). NCT03741088. https://clinicaltrials.gov/ct2/show/NCT03741088 KEY POINTSHistotripsy, a new noninvasive, non-thermal, non-ionizing focused ultrasound therapy, safely created a zone of tissue destruction in the liver that correlated very well with the pre-defined planned tissue destruction volume.In this first human trial histotripsy was well tolerated with no histotripsy device-related adverse events and its primary endpoint of acute technical success was achieved in all 8 enrolled patients with primary or secondary liver tumors.This new locoregional therapy for patients with liver tumors is safe and effective, warranting further trials.

Analysis of Homeopathic Genus Epidemicus for COVID-19 Patients in Spain.

BACKGROUND: Homeopathy has had documented success treating epidemics in the last two centuries. We aimed to obtain a clear homeopathic clinical picture of coronavirus disease 2019 (COVID-19) and postulate the genus epidemicus of the disease in order to inform and enhance future treatment and prophylaxis options. METHODS: We conducted a prospective case series study, collecting data from 19 homeopaths in Catalonia, Spain, from patients who presented with fever and/or cough and/or breathlessness and/or confirmed COVID-19 infection or close contact with a confirmed case. We included 107 patients, and data were recorded through a checklist questionnaire on the day of the case analysis and at day 10-15 after commencing treatment. Symptoms were collected and analyzed with the help of homeopathic repertories. RESULTS: A total of 103 cases were mild or moderate; four were severe. The severe cases were excluded from the analysis and the 103 mild and moderate cases were analyzed and a clear overall clinical picture with mental, general, and particular symptoms was achieved. Eighty-eight cases had a complete recorded follow-up. The most prescribed medicines were Bry, Ars, Phos and Gels, whilst those with the best rates of good response were Sulph, Puls and Bry. Time to full recovery after homeopathic treatment ranged from 3.5 to 14.4 days, depending on the medicine used. The potency 200c was associated with faster rates of full recovery and a lesser need to change remedy. CONCLUSION: We have defined the symptomatic homeopathic characteristics of mild and moderate COVID-19 in Spain and established a set of medicines that might be useful to consider as effective genus epidemicus.

Enfermedades infecciosas cutáneas importadas / No disponible

La inmigración y los viajes a países tropicales,suponen un aumento en la incidencia de enfermedadesimportadas, llamadas así por ser contraídasen otros países, especialmente los situados en unalatitud tropical.Los problemas de salud más comunes al regreso del trópicoson la diarrea (70%), seguida del síndrome febril (11-19%) y en tercer lugar los problemas cutáneos (15%).Las dermatopatías importadas pueden estar en elcontexto de una enfermedad sistémica o constituirpor si misma un problema único y localizado.Los problemas dermatológicos importados más comunesson picaduras de insecto, larva migrans cutánea,reacciones alérgicas, infecciones bacterianas (heridasinfectadas y abscesos), dermatitis por artrópodos,miasis, tungiasis, urticaria, fiebre, exantema, leishmaniasiscutáneas y quemaduras. Se considera quehasta un 3% de las personas procedentes de latitudestropicales presentarán dermatopatías y la mayoría decasos (61%) aparecen estando aún en aquel país.El tratamiento de las parasitosis será específico(mebendazol, ivermectina o albendazol), el de lasinfecciones bacterianas, los antimicrobianos deprimera elección en infecciones cutáneas (amoxicilina-clavulánico, clindamicina) administrados porvía oral o tratamiento local según la entidad de laclínica. Los procesos alérgicos e inflamatorios setratarán sintomáticamente(AU)

Inmigration and travels to tropical countrys, are thecause of incidence growing of skin imported infectiousdiseases, usually fron tropical countrys.The most common clinical problems returningfrom tropical latitudes are diarrhoea (70%), fever(11-19%), and in thirth place skin lesions.Importedskin diseases can be in the context of sistemicdiseases or to be an unic and localized problem.The imported skin lesions mor common are insectbites, cutaneous larva migrans, allergys and bacterialinfections, arthropod-reactive dermatitis,myasis, tungiasis, urticaria, fever, rush, cutaneusleishmaniasis and burns. About 3% of the peoplecomming from tropical countrys will present skinlesiond and the mayority of cases (61%) to appearbefore to come back.The parasitosis treatment will be specific (mebendazol,ivermectine, albendazol), skin infections withthe antibiotics of first choice (amoxicilin-clavulanic,clindamicin) per os o local treatment dependingof the clinical problem. Allergys and inflamatoryproblems will be symptomatic treated(AU)

Global cardiovascular risk in patients with HIV infection: concordance and differences in estimates according to three risk equations (Framingham, SCORE, and PROCAM).

To compare cardiovascular risk stratification according to Framingham, PROCAM (Prospective Cardiovascular Münster), and SCORE (Systematic Coronary Risk Evaluation) equations in patients with HIV infection, a cross-sectional study of a well-characterized cohort of 760 HIV-infected adults managed at the outpatient Infectious Disease Unit in 2003 was conducted. Cardiovascular risk score was examined and patients were classified as having low, moderate, or high risk using Framingham and PROCAM (<10%, 10%-20%, and <20%, respectively) and SCORE (<3%, 3%-4%, and >/=5%, respectively) equations. The prevalence of patients with low, moderate and high cardiovascular risk was 76.6%, 15.1%, and 8.3% by the Framingham, respectively, 90.1%, 4.9%, and 5% by the PROCAM, respectively, and 88.6%, 3%, and 8.4% by SCORE, respectively. Concordance between these three risk functions was significant, but globally moderate (Framingham and PROCAM, kappa 0.36, p < 0.0001; Framingham and SCORE, kappa 0.32, p < 0.0001; PROCAM and SCORE, kappa 0.46, p < 0.0001). The Framingham equation categorized a higher proportion of HIV-infected male patients with moderate cardiovascular risk and a lower proportion of those with low risk (p < 0.0001) compared with PROCAM and SCORE. The present study showed a high prevalence of HIV-infected patients at low cardiovascular risk regardless of the assessed coronary risk system used. However, compared with PROCAM and SCORE, Framingham risk equation in HIV-infected patients identified a higher number of male patients with moderate cardiovascular risk.