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Filter by:The hypothesis in this study was that ticagrelor switched to 60 mg after 1 month of standard dose, with antiplatelet activity that is not inferior to the standard dose and better than 75 mg clopidogrel for patients with ACS after PCI.
1. Advantages of albumin-bound paclitaxel Paclitaxel for injection (albumin-binding type) uses human serum albumin (HAS) as a carrier, and paclitaxel and HSA are made into paclitaxel-bound albumin nanoparticles by a high-pressure homogenization technique. After injection of paclitaxel (albumin-binding) into the blood, it rapidly disintegrates and disperses into a smaller albumin-paclitaxel complex, which binds and activates the gp60 albumin receptor on vascular endothelial cells, interacts with Caveolin on the cell membrane, and then is transported to the tumor intercellular substance by transcytosis. Tumor cells can secrete a SPARC protein with a specific affinity for albumin, which actively captures the albumin-paclitaxel complex in the tumor stroma and accumulates around the tumor cells. Since tumor neovascular endothelial cells highly express gp60 receptor and the SPARC protein is also highly expressed in the tumor region, the special transport mechanism of "gp60- Caveolin / caveola -SPARC protein" makes the paclitaxel for injection (albumin binding) have unique targeting and penetrating properties toward tumor tissues, hence the drug is highly concentrated in the tumor tissue, which can better increase the therapeutic effect and reduce the damage to normal tissues. Paclitaxel for injection (albumin-binding type) has the following advantages: (1) it is unnecessary to pre-administer anti-allergic drugs, the infusion time is within 30 min, and patients have good compliance; (2) due to its higher safety, the dosage can be given as high as 260-300 mg/m2; (3) it makes full use of gp60 / cysteine acid secretory protein (SPARC protein) channel to make the drug enrich toward the tumor area, and the effect is good; (4) as the dosage is within 80 ~ 300 mg/m2, the AUC increase proportionally with the administered dose, ]the body is linearly metabolized., the half-life period does not prolong with the dose, and the clinical medication is safe and controllable. Currently, the drug has been approved for breast cancer treatment in China; approved by the US Food and Drug Administration (FDA) for breast cancer, lung cancer, and pancreatic cancer treatment; approved for gastric cancer treatment in Japan; and NCCN guidelines recommend it for the treatment of intrahepatic cholangiocarcinoma, melanoma, ovarian cancer, and cervical cancer. In summary, based on the biological advantages of albumin-binding paclitaxel such as high-distribution, high-dose, high-efficiency, and low-toxicity, the reported good clinical benefit and safety for hepatobiliary and malignant tumors, and the limited data about albumin-bound paclitaxel + oxaliplatin as the first-line treatment for advanced hepatobiliary and pancreatic malignancies, especially in Chinese patients, our center believes that is feasible and necessary to explore the effectiveness and safety of paclitaxel for injection (albumin-binding) combined with oxaliplatin as the first-line drugs for treatment of advanced oxaliplatin-based malignant tumors. 2 Purposes To evaluate the efficacy and safety of paclitaxel (albumin-bound) combined with oxaliplatin as the first-line drugs for treatment of advanced hepatobiliary and malignant tumors. Primary endpoint: progression-free survival (PFS) Secondary study endpoints: disease control rate (DCR), overall survival (OS), and incidence and severity of adverse events (AE). 3 Research plan 3.1 Research Design This study was a single-center, one-arm, phase II/III clinical trial, which plans to recruit 57 patients.
Title: A Phase I, Single Centre, Open-label, Dose-escalation Study of A-319 in Patients With Relapsed or Refractory B-cell Lymphoma
A prospective, open-label, interventional phase IV study to assess the safety of EupentaTM Inj.{fully liquid pentavalent vaccine, Adsorbed Diphtheria-Tetanus-whole-cell Pertussis-Hepatitis B (rDNA [recombinant-deoxyribonucleic acid])-Haemophilus influenzae type b conjugate vaccine}
This study wants to demonstrate the non-inferiority in terms of efficacy and safety of treatment with cidofovir (1%) in topical ointment or topical sinecatechins (10%) ointment versus electrocoagulation (control group) for the treatment of high-grade anal intraepithelial neoplasia (HGAIN). The target patients are Human Immunodeficiency Virus (HIV)-infected homosexual males. All these patients will be randomized by a proportion of 1:1:1 setting up 3 different parallel arms of the study: control group, cidofovir (1%) group and topical sinecatechins (10%) group.
Type 1 diabetes mellitus (T1DM), makes its appearance during childhood and youth, but management implications last till late adulthood. Its treatment includes the combination of multiple daily glucose measurements, insulin administration and balanced nutrition. The goals of therapy are to achieve glycemic control (HbA1c < 7.5%), and minimal glycemic excursions. Furthermore, recent studies imply that keeping HbA1c within target range is not sufficient to prevent complications, attributed mainly to blood glucose level fluctuating from high to low, associated with food intake and adolescents behavior. The current implication of glycemic control on the central nervous system (CNS) includes abnormal electrical brain activity, structural changes in brain's white and grey matter, and cognitive impairment. Still, little is known on the effect of sleep pattern, including circadian rhythm reversal ("biological clock) on asymptomatic glycemic excursions, and on CNS functions. There is no data regarding the association of the biologic clock on CNS functionality among adolescents, nonetheless among T1DM adolescents, for whom behavior and circadian rhythm alterations may have harmful effect. The investigators propose a cross-over designed study by examining adolescents with and without T1DM during 2 weeks of regular sleeping pattern (night sleep), and during 2 weeks of sleeping during the day as happens during summer vacation. The main objective of the proposed study is to offer proof of the clinical and metabolic relevance and cognitive effects of the reversal of the circadian clock in adolescents with and T1DM during summer vacations and weekends. Study is designed to demonstrate a difference among healthy and diabetics during reversed night/day circadian clocks in the time spent within target range of glucose, performance on neuro cognitive tasks, electrical brain activity, and hormonal profile.
Single arm phase II trial designed to assess the efficacy of durvalumab treatment in terms of 6-month progression-free survival. We will include 22 patients who will receive 1500 mg durvalumab (MEDI4736) via IV infusion Q4W <<for up to a maximum of 12 months (up to 13 doses/cycles) with the last administration on week 48>> or <<until confirmed disease progression>> unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met. If a patient's weight falls to 30 kg or below for 1 week or longer ( ≥ 7 days) durvalumab will be permanently discontinued.
The aim of the study is to evaluate the complications rate of high risk patients undergoing non-cardiac surgery that receive two different protocols of hemodynamic optimization. A group of patients receive a protocol based on dynamic parameters of fluid responsiveness; the other group of patients receive a protocol based of the optimization of oxygen extraction. The hypothesis is that a perioperative hemodynamic optimization protocol based on oxygen extraction is not inferior to a protocol based on dynamic parameters of fluid responsiveness considering the complication rate developed postoperatively.
The objective of the study is to evaluate Tolerability, Safety, and primary Efficacy of Gentuximab Injection at different dosage in combination with Paclitaxel in Advanced Gastric or Gastroesophageal Junction Cancer patients, to ensure adequate treatment dosage for further study. Meanwhile, the study also evaluate Pharmacokinetics of Gentuximab Injection at different dosage in combination with Paclitaxel.
All ceramic crowns are indicated in case of mild to moderate discoloration, restoration of traumatized or fractured teeth and abnormal tooth anatomy. The success of dental restorations is determined by four main factors: biocompatibility, aesthetic value, resistance to fracture and marginal adaptation. . An inadequate marginal fit may compromise the longevity of the restoration since cement film exposure to the oral environment can lead to its dissolution . . Polyetheretherketone (PEEK) is a polymer that has many potentials uses in dentistry. Polyetheretherketone (PEEK) can be used to support fixed dental prostheses. However, information about physio mechanical characterization is still scarce. Aim of the study: - The aim of this study is to evaluate the internal fit of milled BioHPP PEEK-based versus zirconia-based single crowns.