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Safety, pharmacokinetics, and pharmacodynamics of LBP-EC01, a CRISPR-Cas3-enhanced bacteriophage cocktail, in uncomplicated urinary tract infections due to Escherichia coli (ELIMINATE): the randomised, open-label, first part of a two-part phase 2 trial.

BACKGROUND: The rate of antibiotic resistance continues to grow, outpacing small-molecule-drug development efforts. Novel therapies are need … p C, all of whom received 1 × 1011 LBP-EC01 intravenously, had non-serious tachycardia and afebrile chills after the second intravenous dose. A rapid reduction of E coli in urine was observed by 4 h after the first treatment and maintained at day 10 in all 16 evaluable patients; these individuals had complete resolution of UTI symptoms by day 10. INTERP …

Immunogenicity and reactogenicity of modified vaccinia Ankara pre-exposure vaccination against mpox according to previous smallpox vaccine exposure and HIV infection: prospective cohort study.

BACKGROUND: Pre-exposure vaccination with MVA-BN has been widely used against mpox to contain the 2022 outbreak. Many countries have defined … lected after the first MVA-BN dose (T1). Systemic (S-AEFIs: fatigue, myalgia, headache, GI effects, chills) and local (L-AEFIs: redness, swelling, pain) AEFIs were graded as absent (grade 0), mild (1), moderate (2), or severe (3). The maximum level of severity for S-AEFIs and L-AEFIs ever experienced over the 30 days post-dose by vaccination exposure gro …

Acute Chest Syndrome.

AUDIENCE: Emergency medicine residents and medical students on emergency medicine rotations. INTRODUCTION: Acute chest syndrome is a life-t … terial), rib infarction, and fat emboli.1,2,4 Patients commonly present with fever, dyspnea, cough, chills, chest pain, or hemoptysis. Diagnosis is made through physical exam, blood work, and chest imaging.1,2 Chest radiograph is considered the gold standard for imaging modality.3 Management of acute chest syndrome includes hydration with IV crystalloid …

A randomised, partially observer blind, multicentre, head-to-head comparison of a two-dose regimen of Baxter and GlaxoSmithKline H1N1 pandemic vaccines, administered 21 days apart.

OBJECTIVES: To evaluate the immunogenicity of a two-dose schedule of Baxter cell-cultured, non-adjuvanted, whole-virion H1N1 vaccine, and Gl … ies, the severity of solicited local (pain, bruising, erythema and swelling) and systemic symptoms (chills, malaise, muscle aches, nausea and headache), oral temperature and use of analgesic medications. MAIN OUTCOME MEASURES: Vaccine immunogenicity using the CHMP and the FDA licensing criteria. Antibody titres were measured using haemagglutination inhi …

[Granulomatous diseases and pathogenic microorganism].

Granuloma formation is a chronic inflammatory reaction where macrophage system and other inflammatory cells are involved. After some antigen exposure and processing, T cells, macrophages, epithelioid cells, and giant cell are activated, and granulomas are formed. Granuloma is considered as a defense mechanism against antigens, which stay in the organs without inactivation. Granulomas including fibroblasts extra-cellular matrix surround and isolate the antigens. Granulomas are classified to noninfectious granulomas and infectious granulomas. However recent studies revealed pathogenic microorgan

Virtualized clinical studies to assess the natural history and impact of gut microbiome modulation in non-hospitalized patients with mild to moderate COVID-19 a randomized, open-label, prospective study with a parallel group study evaluating the physiologic effects of KB109 on gut microbiota structure and function: a structured summary of a study protocol for a randomized controlled study.

OBJECTIVES: These 2 parallel studies (K031 and K032) aim to evaluate the safety of KB109 in addition to supportive self-care (SSC) compared … aseline that have not been present for more than 5 days ▪ Cardinal COVID-19 symptoms include fever, chills/repeated shaking with chills, cough, shortness of breath, headache, muscle pain, anosmia/ageusia, and sore throat. The 5 additional symptoms include gastrointestinal (GI) disturbance/symptoms (other than diarrhea), diarrhea, fatigue, nasal congestio …

Drawing conclusions: blood culture yield across clinical scenarios in hematologic malignancy.

Patients with hematologic malignancies are excluded from most blood culture stewardship algorithms. We evaluated blood culture collection patterns and bloodstream infection incidence across clinical scenarios in this population. Blood culture yield varied substantially by indication, identifying high-yield scenarios and opportunities to refine diagnostic stewardship while preserving patient safety.

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… The highest yield occurred in cultures obtained for chills or rigors (23.8%), followed by suspected skin and soft tissue or bone infection (13.5%) and intra-abdominal infection (10.7%). … Although neutropenic fever accounted for nearly half of all BCx collection cases, the highest yield was observed among cultures obtained to evaluate patients with chills or rigors or to rule out dissemination of focal infections. …

Реальная медикаментозность атумумаба при множественном склерозе: всеобъемлющий анализ данных FAERS.

Офатумумаб, полностью человеческий моноколональный антитело, направленный на CD20, утвержден для лечения повторного множественных склерозов. Всеобъемлющие данные о безопасности в реальном мире имеют решающее значение для информирования о клинической практике. МЕТОДЫ: База данных Системы отчетности об отрицательных событиях УЛХ использовалась для проведения непропорционального анализа, охватывающего отчеты за период с 3 2020 года по 2 2024 год, в которых атумумаб был определен в качестве основного предполагаемого наркотика. Применявшиеся статистические подходы включали в себя соотношение "

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… The age subgroup analysis indicated that the distribution of AEs was relatively consistent across all age groups, with fatigue, headache, chills, pyrexia, and dizziness being common positive signals in all cohorts. … The results indicated that adverse reactions such as fatigue, headache, chills, pyrexia, dizziness, muscle spasms, tremor, insomnia, migraine, somnolence, and urinary tract infection remained persistent positive signals. …

Results of an early access treatment protocol of daratumumab in United States patients with relapsed or refractory multiple myeloma.

BackgroundDaratumumab is a human CD38-directed monoclonal antibody indicated for the treatment of relapsed and refractory multiple myeloma (MM).MethodsA multicenter, open-label treatment protocol provided early access to daratumumab for patients who had progressive MM after they received ≥3 prior lines of therapy that included a proteasome inhibitor and an immunomodulatory agent or if they were refractory to both a proteasome inhibitor and an immunomodulatory agent. Patients received daratumumab 16 mg/kg weekly for 8 weeks, every other week for 16 weeks, and monthly until they developed diseas

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… The most frequently reported IRs were chills (15%), cough (14%), dyspnea (9%), IR NOS (8%), nausea (7%), throat irritation (6%), and nasal congestion (5%). … Gastrointestinal symptoms were observed in 4% and 11% of patients who did or did not receive montelukast, respectively, whereas chills were observed in 14% of patients in both groups. …

Patients' Perceptions of Physician-Patient Discussions and Adverse Events with Cancer Therapy.

OBJECTIVES: Patients with cancer who are treated with chemotherapy report adverse events during their treatment, which can affect their quality of life and increase the likelihood that their treatment will not be completed. In this study, patients' perceptions of the physician-patient relationship and communication about cancer-related issues, particularly adverse events were examined. METHODS: We surveyed 508 patients with cancer concerning the occurrence of adverse events and their relationship and communication with their physicians regarding cancer, treatment, and adverse events. RESULTS:

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… Specifically, serious adverse events such as fever and chills (69%) and low white blood cell counts (79%) were discussed less frequently than events such as nausea (93%) and tiredness and weakness (91%). … The frequencies of such events ranged from 95% for tiredness, weakness, or exhaustion to 46% for fever (temperature, chills). …

Clinical Features and Outcomes of Pediatric and Adult Patients Hospitalized for Coronavirus Disease 2019: A Comparison Across Age Strata.

BackgroundCoronavirus disease 2019 (COVID-19) continues to cause hospitalizations and severe disease in children and adults.MethodsThis study compared the risk factors, symptoms, and outcomes of children and adults hospitalized for COVID-19 from March 2020 to May 2023 across age strata at 5 US sites participating in the Predicting Viral-Associated Inflammatory Disease Severity in Children with Laboratory Diagnostics and Artificial Intelligence consortium. Eligible patients had an upper respiratory swab that tested positive for severe acute respiratory syndrome coronavirus 2 by nucleic acid amp

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… Regarding symptoms, children more commonly had fever, nasal congestion/rhinorrhea, conjunctivitis, and nausea/vomiting but less commonly had chills, headache, fatigue, cough, shortness of breath, and anosmia/dysgeusia ( P < .05 for all comparisons). … In our study, we also observed that infants had the highest frequency of nasal congestion/rhinorrhea and conjunctivitis, whereas older children had a higher proportion of chills, headache, shortness of breath/dyspnea, and myalgias. …

Interventions for preventing oral mucositis in patients with cancer receiving treatment: oral cryotherapy.

BackgroundOral mucositis is a side effect of chemotherapy, head and neck radiotherapy, and targeted therapy, affecting over 75% of high risk … cryotherapy was shown to be safe, with very low rates of minor adverse effects, such as headaches, chills, numbness/taste disturbance, and tooth pain. This appears to contribute to the high rates of compliance seen in the included studies.There was limited or no evidence on the secondary outcomes of this review, or on patients undergoing other chemother …

P1505: TOLERABILITY AND SAFETY OF INTRAVENOUS IMMUNOGLOBULINS (5% AND 10%) FOR THE TREATMENT OF PATIENTS WITH SECONDARY IMMUNODEFICIENCIES – FINAL SUBGROUP RESULTS OF A NON-INTERVENTIONAL SAFETY STUDY

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… The most frequent ADRs in patients treated with IVIG 5% were chills, back pain and pruritus and with IVIG 10% chills, nausea, pyrexia and rash. …

Hypercalcemia-Associated Hodgkin's Lymphoma Presenting as Normal Pressure Hydrocephalus: A Case Report.

Hodgkin's lymphoma is a malignancy of the lymphatic system that can rarely present with advanced-stage features such as spinal cord involvement and hypercalcemia. We present the case of a 63-year-old Caucasian male with advanced Hodgkin's lymphoma, presenting with hypercalcemia and symptoms resembling normal pressure hydrocephalus. The patient exhibited gait impairment, altered mental status, and urinary incontinence, forming the classic triad seen in normal pressure hydrocephalus. Laboratory findings revealed leukocytosis, anemia, hypercalcemia, and acute kidney injury. Imaging showed extensi

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… The family denied any symptoms of cough, congestion, fever, chills, changes in bowel habits, abdominal pain, or syncopal episodes. … In contrast, our patient experienced chronic back pain, unexplained weight loss, and weakness but did not present with the typical B-symptoms of chills, fever, or night sweats. …

Effects of therapeutic plasma exchange (TPE) on efficacy and adverse events in patients with autoimmune neurological diseases: a systematic review and meta-analysis based on real-world studies and single-arm clinical trials.

BackgroundTherapeutic plasma exchange (TPE) is a core intervention for autoimmune neurological diseases (ANDs). To date, clinical efficacy and safety of TPE across disease subtypes, age strata and regions have not been systematically synthesized. This meta-analysis aimed to evaluate the clinical response, mortality and adverse event (AE) rates of TPE in patients with ANDs.MethodsRelevant real-world observational studies and single-arm trials were retrieved from PubMed, Embase and Cochrane Library. We conducted single-arm meta-analysis to pool effect sizes with 95% confidence intervals (CIs). S

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… The main adverse events encompassed fever and chills, dyspnea, allergic reactions, hypocalcemia, arrhythmia, nausea and vomiting, hypertension, hypotension, catheter-related infections, deep vein thrombosis, and coagulation disorders. … Incidence rates of adverse events based on TPE sessions: Fever and chills were reported in 5 studies with 1,067 exposures, with a pooled incidence rate of 4% (95% CI: 2–10%, I 2 = 86.4%). …

Active body surface warming systems for preventing complications caused by inadvertent perioperative hypothermia in adults.

BACKGROUND: Inadvertent perioperative hypothermia is a phenomenon that can occur as a result of the suppression of the central mechanisms of … s of ABSW is scant, although there is some evidence of a beneficial effect in the same direction on chills/shivering with electric or resistive-based heating systems. Some evidence suggests that extending systemic warming to the preoperative period could be more beneficial than limiting it only to during surgery. Nothing suggests that ABSW systems pose a …

Folliculotropic Cutaneous Metastases and Lymphangitis Carcinomatosa: When Cutaneous Metastases of Breast Carcinoma Are Mistaken for Cutaneous Infections.

Dear Editor, Cutaneous metastases (CM) are detected in about 0.6-10.4% of patients with an internal malignancy (1-3). Excluding melanoma, br … in differential diagnoses are erysipelas and cellulitis. However, CLC is not associated with fever, chills, and leukocytosis. Furthermore, CLC shows no response to antibiotic therapies. Several clinicopathological types of cutaneous metastasis have been reported in the literature, including telangiectatic metastatic breast carcinoma (TMBC) and carcinoma …

Rhabdomyolysis secondary to COVID-19 infection and vaccination: a review of literature.

Rhabdomyolysis (RML), characterized by the breakdown of skeletal muscle fibers and the release of muscle contents into the bloodstream, has emerged as a notable complication associated with Coronavirus disease 2019 (COVID-19) infection and vaccination. Studies have reported an increased incidence of RML in individuals with severe COVID-19 infection. However, the exact mechanisms remain unclear and are believed to involve the host's immune response to the virus. Furthermore, RML has been documented as a rare adverse event following COVID-19 vaccination, particularly with mRNA vaccines. Proposed

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… The patient had an unknown outcome. | ( 54 ) Chedid et al. (2020) | A 51-year-old male with HTN, T2DM, obstructive sleep apnea, and CKD stage-2 presented with diffuse myalgia, dry cough, and mild chills. … The patient survived. | ( 9 ) Mukherjee et al. (2020) | A 49-year-old male with T2DM and HTN presented with fever, chills, dyspnea, myalgia, cough, hyponatremia, and hypokalemia. …

Efficacy of Invariant Natural Killer T Cell Infusion Plus Transarterial Embolization vs Transarterial Embolization Alone for Hepatocellular Carcinoma Patients: A Phase 2 Randomized Clinical Trial.

PurposeInvariant NKT cells (iNKT) are CD1d-restricted T cells with the capacity of antitumor immunity. The safety of autologous iNKT cell treatment in hepatocellular carcinoma (HCC) has been verified. This study aimed to investigate its efficacy in advanced HCC after transarterial chemoembolization (TACE) failure.Patients and methodsThis open-label, randomized, controlled, trial enrolled 60 patients with unresectable HCC after TACE failure at three centers. Transarterial embolization (TAE) was used instead of TACE to protect iNKT cell function. Patients were randomly assigned (1:1) to receive

Allergy in Cancer Care: Antineoplastic Therapy-Induced Hypersensitivity Reactions.

As the backbone of oncological treatments, systemic chemotherapy is still one of the main pawns in cancer care, alone or in combination with newer targeted agents. All chemotherapy agents can be associated with a type of adverse event called an infusion reaction, which can be characterized as unpredictable, non-dose related, and unexplained by the cytotoxic profile of the drug. For some of these events, a certain immunological mechanism can be identified by blood or skin testing. In this case, we can speak of true hypersensitivity reactions that occur as a response to an antigen/allergen. The

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… Abdominal pain, chill, fever, diaphoresis, and other unspecific symptoms can also be present. Delayed reactions are rare, with few cases presented in the literature [ 41 ]. … The clinical characteristics of a doxorubicin-related infusion reaction may include rash, dyspnea, headache, back pain, chills, and sometimes hypotension [ 91 ]. …