Clinical Trial Design and Concepts Specific for Biologic Agents in the Treatment of Rheumatic Diseases
Thomas F. Kresina in Monoclonal Antibodies, Cytokines, and Arthritis, 2020
Mild to moderate constitutional symptoms, typical following the administration of biologic proteins, were observed during the treatment days. Fever with and without rigor, associated with nausea, fatigue, and malaise were seen. Symptoms decreased when premedication with acetaminophen, diphenhydramine, and metaclopromide was administered. In some patients, myalgias and muscle weakness were noted after later infusions, although muscle tenderness and creatine phosphokinase (CPK) elevations were rarely seen. These symptoms defined the MTD of 0.33 mg/kg/day for the five-day treatment regimen. Increased extravascular volume, manifested by pedal and/or periorbital edema, occurred after treatment, not associated with abnormalities of renal or hepatic function. All treatment-related symptoms resolved without sequelae.
Interventional Ultrasound in Diagnosis and Treatment of Female Infertility
Asim Kurjak in Ultrasound and Infertility, 2020
Premedication of the patient is the same. Each patient should have a full bladder and is placed in the lithotomy position. There is no need for either abdominal wall or probe sterilization. The vagina is cleaned with an antiseptic solution (Betadine®). The operator holds the probe with one hand and the needle with the other. Local anesthesia of the vaginal wall may be used, but seems not to be necessary. The needle is introduced into the vagina through the speculum. The probe is placed on the lower abdomen and a longitudinal or slightly oblique scan is then employed to visualize the ovary and the needle in the vagina. The lowest-lying follicle should be selected as the initial target. Penetration of the needle through the posterior vaginal fornix into the follicle is continuously monitored. Therefore, transabdominally monitored transvaginal puncture also represents a kind of “free hand” technique, and a steering device is not used (Figure 4C).
Mammography and Interventional Breast Procedures
Raymond Taillefer, Iraj Khalkhali, Alan D. Waxman, Hans J. Biersack in Radionuclide Imaging of the Breast, 2021
Before the needle localization (Fig. 30), the radiologist must have an accurate idea of the three-dimensional location of a lesion and be confident of ability to place the tip of the needle at the lesion. An additional straight lateral projection should be obtained before needle placement to provide true perpendicular coordinates to the craniocaudal view. If the location is uncertain, methods have been described to assist in confirmation and triangulation [120,121]. Procedure should be explained to the patient in details. Premedication is not recommended because it reduces the patient's ability to be fully cooperative for the localization procedure. Local anesthesia can be used, but it is not needed for most women and may be more painful than the localization itself. The development of dedicated mammography equipment has led to the ability to accurately position needles into or alongside the smallest mammographically detected abnormalities. This is most accurately and safely accomplished by introducing the needle while the breast is held in the mammographic compression system and the needle usually introduced parallel to the chest wall. This approach uses compression plates with a series of holes permitting access to the breast and the lesion while the breast is held compressed. To reduce the amount of tissue that must be traversed by the surgeon, the shortest distance to the lesion from the skin should be chosen for the introduction of the needle. Using the appropriate technique, the needle shaft should be placed >5 mm from the lesion [116].
A Comparative Efficacy Evaluation of Recombinant Topical Thrombin (RECOTHROM®) With A Gelatin Sponge Carrier Versus Topical Oxidized Regenerated Cellulose (TABOTAMP®/SURGICEL®) In A Porcine Liver Bleeding Model
Published in Journal of Investigative Surgery, 2021
Paul Slezak, Claudia Keibl, Dirk Labahn, Anna Schmidbauer, Yuri Genyk, Heinz Gulle
Two treatment arms were investigated. The rT (active treatment) used was RECOTHROM®; Baxter Healthcare Corporation, Deerfield, IL, USA, with a gelatin sponge carrier (SPONGOSTAN™; Ethicon, Norderstedt, Germany). The ORC (passive treatment) used was TABOTAMP® Original/SURGICEL® Original; Ethicon, Norderstedt, Germany. Treatments were tested in 8 male pigs weighing approximately 35 kg, with a target of 15 applications per animal. Premedication and anesthesia were performed as previously described.21 Briefly, animals were premedicated with a combination of tiletamine and zolazepam intramuscularly, followed by inhalation anesthesia with isoflurane. Upon completion of the experiment, animals were humanely euthanized under deep anesthesia with a lethal intravenous dose of thiopental sodium and embutramide/mebezonium iodine/tetracaine hydrochloride.
Healthcare resource utilization in a phase 3 study of CPX-351 in patients with newly diagnosed high-risk/secondary acute myeloid leukemia
Published in Journal of Medical Economics, 2020
Kathleen F. Villa, Robert J. Ryan, Michael Chiarella, Arthur C. Louie
Induction treatment response (CR and CRi) was assessed according to the Revised International Working Group Criteria for AML18. Patients with CR or CRi (and who had adequate cardiac function and ECOG PS 0–2) could receive up to two cycles of consolidation: CPX-351 65 units/m2 (equivalent to cytarabine 65 mg/m2 + daunorubicin 29 mg/m2), given as a 90-min infusion on Days 1 and 3, or 5 + 2 regimen of cytarabine 100 mg/m2/day continuous infusion for five days plus daunorubicin 60 mg/m2 on Days 1 and 2. Patients received premedication according to participating centers’ guidelines. Patients could also receive a hematopoietic cell transplantation at the investigator’s discretion according to institutional guidelines. The follow-up period continued until a patient’s death or five years after randomization.
Challenge of using Intranasal dexmedetomidine as a premedication modality in pediatric patients: A meta-analysis of randomized controlled trials
Published in Egyptian Journal of Anaesthesia, 2023
Mohamed Said Mostafa Elmeligy, Ahmed Mostafa Abdelhamid, Enas Wageh Mahdy
With the aid of predetermined selection criteria, two reviewers independently identified all the studies. Disagreements that arose during the selection of the primary study were arbitrated by a third reviewer. The following criteria should be met by studies to be included in this meta-analysis: Subject: pediatric patients who will receive premedication before going to surgery.Interventions: studies which Analyze the impact of the dexmedetomidine premedication.Comparisons: Control group received other premedication regimesOutcomes: emergence agitation, sedation score, blood pressure, heart rate, and incidence of postoperative complications. The included study must have reported at least one of the results.Type of literature: Clinically randomized controlled trials (RCTs) all published journals.
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