A Dose Escalation Study of HBI-2438 in Patients With Solid Tumors Harboring KRAS G12C Mutation
Lung CancerNon Small Cell Lung Cancer5 moreA Phase 1 dose escalation study in patients with advanced solid tumors harboring KRAS G12C mutation to determine the maximum tolerated dose and recommended Phase II dose of HBI-2438 and characterize its pharmacokinetic profile.
This is an Open-label, Single Arm Study to Evaluate the Safety and Tolerability of Treatment With...
Relapsed and/or Refractory Multiple MyelomaThis is an open-label, single arm study to evaluate the safety and tolerability of treatment with CT0591CP in patients with relapsed and/or refractory multiple myeloma.
Alveolar Ridge Preservation With Putty Allograft vs. Putty Alloplast Graft
Alveolar Bone ResorptionThe primary aims of this study are to compare, after 4 months, the clinical and histologic results of a combination demineralized/mineralized putty allograft vs. synthetic calcium phosphosilicate (CPS) putty alloplast graft utilization in socket preservation procedures. A regenerative tissue matrix membrane will be used to cover each graft lying below the flap.
Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434
Hepatic ImpairmentCirrhosisIn this study, a single dose of VIR-2218 up to 200 mg SC or VIR-3434 at 300 mg SC monotherapy or a combination of VIR-2218 and VIR-3434 will be administered to assess the pharmacokinetic (PK) exposure, safety, and tolerability of VIR-2218 and VIR-3434 in participants with cirrhosis and Hepatic Impairment, defined using the Child-Pugh-Turcotte (CPT) categorization.
Safety and Pharmacokinetics of SAD/MAD Oral Doses of SRP-3D (DA)
PainThis is a two-part randomized, double-blind, placebo-controlled study.
A Study to Evaluate the Efficacy and Safety of ZM-H1505R in Combination With ETV Compared With ETV...
Hepatitis BChronicThis is a multicenter, randomized, double-blind, placebo-controlled phase IIa study, designed to evaluate the efficacy and safety of ZM-H1505R in combination with Baraclude versus Baraclude monotherapy in adult CHB subjects with HBV DNA <2000 IU/mL but ≥ 50 IU/mL and who have received ETV (0.5 mg, once daily [QD)] monotherapy for at least 12 months. The study is planned to enroll 90 adult CHB subjects who have received ETV monotherapy for at least 12 months and are still receiving ETV monotherapy (0.5 mg, QD) continuously. Eligible subjects will be randomized in a 1:1:1 ratio into 3 treatment groups. Both HBeAg positive and negative subjects will be included. There will be 20 HBeAg positive subjects and 10 HBeAg negative subjects in each treatment group. After 48 weeks of treatment with the corresponding regimen, subjects will continue to take Baraclude 0.5 mg QD, as a monotherapy for a 12-week follow-up period for observation of efficacy and safety of ZM-H1505R.
A Study to Explore Pamiparib Treatment in Epithelial Ovarian Cancer After Prior PARP Inhibitor Exposure...
Epithelial Ovarian CancerThe PamiAP will be a Phase II, single-arm, open label study to explore the efficacy and safety of Pamiparib treatment in patients with Epithelial Ovarian Cancer(EOC) who have had exposure to prior a PARP (poly(ADP-ribose)-polymerase) inhibitor
Iron Supplementation for Geriatric Hip Fractures
Hip FracturesFragility Fracture1 moreGeriatric hip fracture is an important disease that affects the health life of the elderly in China. Geriatric hip fracture is often complicated by a variety of comorbidities due to advanced age. And anemia is a common comorbidity. At present perioperative management of geriatric hip fracture, transfusion is only indicated for moderate and severe anemia, while no special medical intervention for mild anemia in China. More and more studies have found that iron can not only correct anemia, but also improve cardiac function, patients' quality of life and function. This study investigated the effect of perioperative iron supplementation on activity tolerance in elderly patients with hip fracture complicated with iron deficiency anemia. The study was a randomized, parallel controlled clinical study. Due to the requirements of the ethics committee, the unblinded setting was cancelled due to ethical considerations. Research will be grouped according to whether to accept iron supplementation treatment, are divided into 2 groups, respectively, iron treatment group and the traditional method. The method of randomization was stratified block randomization. The experimental group added to the intravenous iron sucrose during perioperative period according to the degree of iron deficiency. If there is still a iron deficiency or anemia at discharge, oral ferrous lactate is added after discharge. The outcomes include 6-minute walk distance, Harris score, EQ-5D score six months after surgery, perioperative blood transfusion rate, and so on in the two groups.
A Trial of ATG-101 in Patients With Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin...
Advanced Solid TumorMetastatic Solid Tumor1 moreThis is a First-in-Human Phase I trial of ATG-101 in Patients with Metastatic/Advanced Solid Tumors and Mature B-cell Non-Hodgkin Lymphomas.
Adjuvant Treatment in Elderly Patients With Periodontitis Through the Administration of a Supplement...
PeriodontitisLife expectancy has dramatically increased in the last century, although this process has not been always accompanied by an equivalent increase in healthy life expectancy. However, extending longevity without decreasing the risk of age-associated pathologies would not be desirable since non-communicable diseases can diminish seniors' quality of life, raise health-care costs, and increase pressure on family members who are responsible for their care. Maintaining a good health would help to ensure independence, security, and continued productivity in the later years helping both health systems and pensions lower costs. Thus, many scientific studies have tried to delay the age of onset of major age-related chronic diseases. In other words, research has been more focused on extending healthspan rather than lifespan. Actually, numerous experimental studies have shown that the extension of lifespan by modifying risk factors is usually accompanied by delayed or reduced morbidity, including cardiovascular disease, neurodegeneration, and tumors. In the dietary context, modifications of the diet energy and/or macronutrient balance has shown to contribute to healthy aging, increasing healthspan and probably lifespan. Likewise, some foods would be able to supply a significant amount of compounds to the human diet, including non-nutrients which are thought to exert effects in the same sense. Thus, adequate nutritional intervention would be considered geroprotective interventions that would positively influence health by slowing basic biological processes of aging, such as cellular senescence, mitochondrial dysfunction, age-related decline of stress resistance, dysregulated cellular energy sensing/growth pathways, impaired proteostasis, deteriorated stem cell function/bioavailability, as well as inflammation/oxidative stress. The use of nutraceuticals and functional foods from olive products and by-products can be useful in the treatment of pathologies associated with aging, such as periodontitis, as well as from the point of view of a proper nutrition during aging. The study is a double-blind clinical trial of parallel design whose main objective is to evaluate the usefulness of a dietary supplement rich in oleuropein from the olive tree (leaf) in the adjuvant treatment of patients with age-related periodontitis. Efforts will be made to ensure that men and women be represented homogeneously in all study groups, although it is known that gender does not influence the appearance of periodontitis. The experimental design foresees the inclusion of 130 patients with chronic periodontitis aged 60 years or older, 65 for the control group and 65 for the treatment group. Volunteers will be recruited from new patients attending the Faculty of Odontology at the University of Sevilla, Sevilla (Spain) by one study team member. The investigational product will be provided by Natac Company (Madrid, Spain), a corporate group dedicated to researching, developing, manufacturing, and marketing natural ingredients to be used in food supplements, feed, pet food, as well as in functional foods, and as natural, active pharmaceutical ingredients. The planned schedule for the participating subjects is as follows: Day 0: diagnosis of periodontitis, proposal to participate in the study, delivery of consent and information to the patient. Day 15: oral exams, collection of sociodemographic data, study of anthropometric characteristics and blood pressure, evaluation of eating habits, urine and blood sampling, collection of samples for the study of the periodontal microbiota and data collection and calculation of the index of successful ageing. Day 16 to 30 periodontal treatment. Day 16 to 136: administration of treatment (oleuropein or placebo). Day 136: oral exams, collection of sociodemographic data, study of anthropometric characteristics and blood pressure, evaluation of eating habits, urine and blood sampling, collection of samples for the study of the periodontal microbiota and data collection and calculation of the index of successful ageing. The analytical part of the of the clinical trial will be developed mostly in the Biomedical Research Center (CIBM) of the University of Granada. The field part of the clinical trial in patients with periodontitis will be carried out at the Faculty of Dentistry of the University of Seville. The design of the clinical trial provides for the participation of specialists from several disciplines, including specialists in Nutrition and Physiology, clinical specialists in Pathological Anatomy and Dentistry, technicians from the Center of Scientific Instrumentation of the University of Granada (specialists in various subjects such as microscopy, biochemical analysis, histology and veterinary) as well as technicians from the Marketing Unit of the OTRI of the University of Granada.