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  • Metformin for the Treatment of MCRC Patients Undergoing FOLFIRI Plus Target Therapy

    Objectives: 1. Main purpose • To investigate progression-free survival (PFS) in patients with metastatic colorectal cancer treated with chemotherapy FOLFIRI monotherapy or chemotherapy FOLFIRI combined with Metformin 2. Secondary purpose (1) To investigate the survival (OS) of patients with metastatic colorectal cancer treated with chemotherapy FOLFIRI monotherapy or chemotherapy FOLFIRI combined with Metformin (2) To investigate the disease control rate (DCR) of patients with metastatic colorectal cancer treated with chemotherapy FOLFIRI monotherapy or chemotherapy FOLFIRI combined with Metformin

    Phase

    2

    Span

    166 weeks

    Sponsor

    Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung

    Recruiting

  • Perioperative NALIRIFOX (liposomal Irinotecan in Combination with Fluorouracil, Leucovorin, and Oxaliplatin) in Resectable Pancreatic Adenocarcinoma: Randomized Phase II Trial

    Adjuvant chemotherapy after surgery significantly improved the survival of pancreatic cancer patients, but there is a problem that only about 50% of patients start adjuvant chemotherapy after pancreatectomy. Neoadjuvant chemotherapy might control potential metastatic lesion which are not being detected in early disease status and improve the R0 resection rate. Additionally, it prevents unnecessary surgeries by selecting patients with rapid disease progression. Furthermore, compared with chemotherapy administered after surgery, more patients can complete the planned chemotherapy schedule in neoadjuvant setting. NALIRIFOX was approved its efficacy and safety in metastatic pancreatic cancer, but its role in perioperative setting is unknown. In this study, we want to o explore the safety and activity of NALIRIFOX in the perioperative and adjuvant treatment in resectable pancreatic adeneocarcinoma.

    Phase

    2

    Span

    153 weeks

    Sponsor

    Taichung Veterans General Hospital

    Kaohsiung

    Recruiting

  • Comparison of Remimazolam and Propofol in Endoscopic Examinations and Treatments

    Objective This study aims to evaluate the efficacy and safety of Remimazolam, either used alone or in combination with Propofol, for moderate sedation anesthesia during endoscopic therapies or examinations. Additionally, it seeks to explore whether their combination can further enhance the quality of patient anesthesia and recovery outcomes. Methods The investigators will conduct a prospective, randomized, single-center study. Eligible patients will be randomly allocated into three groups: the first group receiving Propofol alone for moderate sedation anesthesia (control group), the second group receiving Remimazolam alone for anesthesia, and the third group receiving a combination of Propofol and Remimazolam for anesthesia. The investigators will record anesthesia depth (DSA values of BIS), heart rate, blood pressure, oxygen saturation, and other indicators during the procedure, as well as postoperative recovery time, time to consciousness recovery, oxygen desaturation, instances of inadequate anesthesia depth, intraoperative patient movement or recall, surgeon satisfaction, patient satisfaction, readmission rate within 14 days, complications, and length of hospital stay.

    Phase

    4

    Span

    99 weeks

    Sponsor

    Kaohsiung Veterans General Hospital.

    Kaohsiung

    Recruiting

  • Geriatric Trauma Care Program for Living Alone Older Adults With Injuries

    Traumatic injuries among older adults represent a significant public health concern due to their potential to severely affect individuals' long-term physical, emotional, and social well-being. Older adults who experience traumatic injuries often face substantial challenges during recovery, particularly those living alone who may lack sufficient support systems, exacerbating their vulnerability to chronic health issues. Pain, functional disability, depression, loneliness, and diminished health-related quality of life are prevalent adverse outcomes following traumatic injuries, underscoring the critical need for effective, targeted care strategies to address these multidimensional impacts. The Geriatric Trauma Care Program (GTCP) is a nurse practitioner-led, digitalized trauma care program designed to provide comprehensive and accessible intervention aimed at improving immediate trauma care outcomes and facilitating sustainable recovery among older adults. While short-term benefits of digitally supported, geriatric-focused trauma interventions have been documented, the long-term effectiveness of such programs, especially for older individuals who live alone, remains less understood. Consequently, examining the enduring impact of the GTCP is essential to determine its effectiveness in fostering sustained recovery and improving quality of life for this vulnerable population. This study aims to address this gap by evaluating the long-term effects of the GTCP on pain, functional disability, depression, loneliness, and health-related quality of life among older adults with traumatic injuries who live alone. Findings from this research will provide valuable insights for healthcare providers and policymakers to enhance care delivery models, optimize resource allocation, and ultimately improve long-term outcomes for older adults recovering from traumatic injuries.

    Phase

    N/A

    Span

    71 weeks

    Sponsor

    Kaohsiung Medical University

    Kaohsiung

    Recruiting

  • A Phase Ⅲ Study of Rilvegostomig in Combination With Fluoropyrimidine and Trastuzumab Deruxtecan as the First-line Treatment for HER2-positive Gastric Cancer

    The purpose of this study is to assess the efficacy and safety of rilvegostomig in combination with fluoropyrimidine and T-DXd (Arm A) compared to trastuzumab, chemotherapy, and pembrolizumab (Arm B) in HER2-positive locally advanced or metastatic gastric or GEJ adenocarcinoma participants whose tumors express PD L1 CPS ≥ 1. Rilvegostomig in combination with trastuzumab and chemotherapy will be evaluated in a separate arm (Arm C) to assess the contribution of each component in the experimental arm. This study will be conducted at up to 200-250 sites globally in approximately 25 countries.

    Phase

    3

    Span

    298 weeks

    Sponsor

    AstraZeneca

    Kaohsiung

    Recruiting

  • Short Course Regimen in Low Risk Active Tuberculosis- a Multicenter, Randomized, Active-controlled, Trial

    This prospective, multicenter, randomized, open-labeled 3-year study, will recruit 270 adult patients with newly diagnosed tuberculosis with low risk of recurrence, and randomized 1:1 to a 4 months 2HREZ/2HRE (n=135) versus standard, 6 months regimen 2HREZ/4HRE (n=135). Expected enrollment will be 90 patients in year 1, 90 in year 2 and 90 in year 3. This study aims to evaluate the efficacy, safety and long-term recurrence rate of a short-course, 4-months regimen including 2HREZ/2HRE compared with the standard 6-months regimen, 2HREZ/4HRE, and the impact of short regimen on reducing the costs and loading to the public health and medical system

    Phase

    3

    Span

    261 weeks

    Sponsor

    Kaohsiung Veterans General Hospital.

    Kaohsiung

    Recruiting

  • Study of Novel Treatment Combination Therapies in Participants With Head and Neck Squamous Cell Carcinoma.

    This platform study will begin with a substudy targeting first-line (1L) recurrent or metastatic (r/m) HNSCC regardless of programmed cell death ligand 1 (PD-L1) expression status (Substudy-01), and new substudies may be added in the future targeting different study populations of HNSCC. All substudies evaluating additional drugs will be added in a staggered manner when relevant nonclinical and/or clinical data become available. Additional drugs may also be added to Substudy-01 in the future. (GS-US-699-7184-01) Substudy-01 will evaluate the efficacy and safety of novel combination of treatment regimens, domvanalimab (DOM) and zimberelimab (ZIM) combined with chemotherapy vs ZIM combined with chemotherapy. The primary objective is to assess the efficacy of DOM and ZIM in combination with chemotherapy versus ZIM in combination with chemotherapy. Substudy-01 planned enrollment is approximately 100.

    Phase

    2

    Span

    80 weeks

    Sponsor

    Gilead Sciences

    Kaohsiung

    Recruiting

  • A Study of Belantamab Mafodotin Administered in Combination With Lenalidomide and Dexamethasone (BRd) Versus Daratumumab, Lenalidomide, and Dexamethasone (DRd) in Participants With Newly Diagnosed Multiple Myeloma (NDMM) Who Are Ineligible for Autologous Stem Cell Transplantation (TI-NDMM)

    Phase

    3

    Span

    380 weeks

    Sponsor

    GlaxoSmithKline

    Kaohsiung

    Recruiting

  • A Study of Amorphous Calcium Carbonate in Postmenopausal Women

    This is an open-label study to evaluate the effect of DensityTM, amorphous calcium carbonate (ACC), in postmenopausal women, compared to FREEDOM substudy. Subjects with a BMD T-score between -4.0 to -2.5 will be invited to enroll into this study. After signed ICF, eligible subject who meet NHI reimbursement criteria for use of denosumab will be assigned to A arm, and subject who does not meet NHI reimbursement criteria for use of denosumab, or who is no willing to receive denosumab treatment during study period, even meet NHI reimbursement criteria will be assigned to B arm. A total of 205 subjects will be enrolled into this study, in which 142 subjects in A arm and 63 subjects in B arm. In A arm, subject will receive 5 DensityTM tablets (equal to 1000 mg calcium element) daily with injections of 60 mg of ProliaTM (denosumab) every 6 months at study site, while in B arm, eligible subject will receive 5 DensityTM tablets (equal to 1000 mg calcium element) daily only. DensityTM tablets will be administered as follows: 5 tablets will be taken after meal. In addition, all subjects with a baseline 25-hydroxyvitamin D level of 12 to 20 ng/ml will be given 800 IU of vitamin D3 daily, while those with a baseline level above 20 ng/ml received 400 IU of vitamin D3, both administered after meal. The study will consist of 7 clinical visits. Subjects will come to the clinics at Visit 1 (screening visit, Month -1), Visit 2 (regimen start, Day 0 in Month 0), and Visit 3 to 7 (follow-up visits, Month 1, 6, 12, 18, 24). BMD assessment and blood drawing will be performed before study medication administration and at Month 1, 6, 12, and 24.

    Phase

    N/A

    Span

    104 weeks

    Sponsor

    Universal Integrated Corp.

    Kaohsiung

    Recruiting

  • Amniotic Suspension Allograft Injection for Knee Osteoarthritis

    According to statistics from the Ministry of Health and Welfare, the prevalence of knee osteoarthritis in Taiwan is approximately 15%. The main causes of the disease include overuse of joint cartilage and abnormal synovial fluid secretion, which impair joint mobility and cause symptoms like pain, swelling, and warmth. In severe cases, bone spurs and joint deformities can develop, further limiting mobility. Non-surgical treatment options for knee osteoarthritis currently include the use of braces, weight loss, lifestyle changes, oral pain relievers, and intra-articular injections, with only a small number of patients requiring surgery due to severe joint cartilage wear. In terms of injection treatments, given the limited efficacy of traditional corticosteroid and HA injections for knee osteoarthritis, an increasing number of physicians are using platelet-rich plasma (PRP) injections. Numerous clinical trials have supported this treatment option1-3. However, the effectiveness of PRP treatment is partly dependent on the quality of the patient's blood. If the patient has poor blood quality (e.g., due to old age, multiple chronic diseases, autoimmune disorders, or use of anticoagulants), the efficacy of PRP injections will be significantly reduced. Recently, a highly promising treatment option-placental-derived tissues-has begun to be used for knee osteoarthritis. Historically, placental-derived tissues have been applied to burns, ulcers, and other difficult-to-heal wounds such as corneal ulcers4. More recently, these tissues have been applied in the orthopedic field5-7. These products come in several formulations, some containing pulverized tissues (amniotic membrane, chorion, or both), cells from amniotic fluid, amniotic fluid itself, or a combination of these components8. Placental tissues have been shown to contain a variety of anti-inflammatory cytokines, growth factors, and inhibitors, which are believed to reduce the inflammatory response associated with arthritis9,10. Reducing this inflammation can not only alleviate the pain of knee osteoarthritis but also improve the quality of life for patients.

    Phase

    3

    Span

    102 weeks

    Sponsor

    Chang Gung Memorial Hospital

    Kaohsiung

    Recruiting

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